Speaker Spotlights

.

Michalle Adkins

Emerson

Years of Experience?
29

Website
https://www.linkedin.com/in/michalleadkins/

Please tell us how your career started.
I started as an instrumentation and automation engineer in a centralized engineering group.

What are you known for professionally? What is your area of expertise?
Life Sciences broad industry knowledge, instrumentation, automation, digitalization, MES

What path brought you to your area of expertise?
Having broad experiences at a pharmaceutical company including instrumentation, automation, computer validation, manufacturing, scheduling & planning. These experiences helped me to have a good big picture which has been invaluable in our Life Sciences consulting practice.

What advice would you give to a professional starting out in the industry?
Get some experience in manufacturing - this was invaluable in my career.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Operational Excellence, Single Use, Cell & Gene Therapy, Automation, Instrumentation, Digitalization - I love working with clients so that they can in turn provide better products and services which enhance the health of people around the world.

Professional and/or recognition(s)?
Lean Six Sigma Master Black Belt


.

Jim Agalloco

Agalloco Associates

Years of Experience?
45+

Website
www.agalloco.com

What are you known for professionally? What is your area of expertise?
I'm a thought leader in Sterilization, Aseptic Processing and Process Validation

What path brought you to your area of expertise?
I had the opportunity to lead validation activities starting in 1980, which exposed me to a wide variety of processes

What advice would you give to a professional starting out in the industry?
Never stop learning, no matter how experienced you are there's always more ways to continue your professional growth

What would be impossible for you to give up?
Reading, I've been a passionate reader since childhood. Nothing better than a good book

Any volunteer activities you enjoy? Why?
PDA, USP - because I can share what I've learned with others

How would you like to be remembered?
Teacher


.

Bob Allen

Fluor

Years of Experience?
35

Website
www.fluor.com

Please tell us how your career started.
I started my career with Fluor as an Architectural Drafter 1 in 1980 and left to get my Architectural degree from Clemson a year later and have been with Fluor ever since

What are you known for professionally? What is your area of expertise?
My particular area of expertise is the front-end/ conceptual design and scope development aspects of BioPharm facility design

What path brought you to your area of expertise?
I was working in our 'Foods' group back in the late 80's when our first biotech project came across our radar and it seemed fascinating so I jumped at the chance explore opportunities in the promising new industry

What is the biggest challenge you have faced in the industry?
Keeping up to date on the ever changing technology and regulatory compliance aspects of the BioPharm business

What advice would you give to a professional starting out in the industry?
Actively seek out opportunities that show promise and don't be afraid to look at the status quo and speak up when you see a better way to approach a particular problem

What is your biggest success thus far in your career? What has contributed to this success?
Won back to back design competitions for Single-Use Technology facilities this past year  for
Bayer and Genentech. Our team's depth of experience and innovative design solutions were mentioned by our clients as key decision factors.

What are you passionate about personally? What do you enjoy?
I enjoy spending time with my family, my career and Clemson Football (GO TIGERS!)

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
When I'm not working I love to hike, golf and fish in the Blue Ridge Mountains where we live

What would be impossible for you to give up?
Hiking in the mountains with my wife Annette and our dogs... very therapeutic and really seems to re-charge my batteries!

Any volunteer activities you enjoy? Why?
My wife and I are very involved with the United Way as we see this as an excellent way to give back to society and help those less fortunate than us.

What do you consider a personal success in your life thus far?
Raising two incredible kids and seeing them succeed in their own personal lives

How do you feel the industry changed or evolved in recent years?
Obviously single-use technology has been a game changer the last 10 - 15 years along with increased titers resultant from downstream recovery technologies

Has there been any significant advancement within your area of expertise?
Yes... new 3D software such as SketchUp allows us to more accurately convey the vertical complexity of our design solutions to clientele who might not be used to interpreting old school plans, sections and elevations

Where do you see the industry going in the next 10 years? Your area of expertise?
Virtual reality is an area in which we are anticipating great strides in the near future so we are currently investing significant resources to position ourselves to benefit from this this technology

What would you consider to be a major achievement for the industry in the near future?
Still looking to that cure for Alzheimer's... some clients seem to be getting close.


.

Todd Andrews

Colder Products Company

Years of Experience?
15

Website
www.colder.com

Please tell us how your career started.
I received a Bachelor’s Degree in Plastics Engineering from the University of Massachusetts at Lowell which eventually led me to a position at Millipore. The experience at Millipore led me Colder Products Company where I have receive my experience in single-use connection technology over the past 12 years.

What are you known for professionally? What is your area of expertise?
Subject Matter Expert for Single-Use Connection Technology

What path brought you to your area of expertise?
Working at Millipore as a Design Engineer and then Colder Products where I have been closely linked to our New Product Development as well as being integrated heavily in the outside market.

What is the biggest challenge you have faced in the industry?
The industry's resistance to change, even when the technology is significantly better and relieve obstacles and greatly improve operational efficiencies.

What advice would you give to a professional starting out in the industry?
Be open and honest with a healthy level of transparency. This is a smaller industry than it appears, trust goes a long way.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Interacting with all of the individuals in our industry. I love building relationships and enjoy working with all of my customers and industry peers. There are so many good, hard working people in our industry. i like to feel that I have left a positive impact on most of the people I have interacted with.

Professional and/or recognition(s)?
Bachelor's Degree in Plastics Engineering, Masters in Business Administration, former member of the US Army

What is your biggest success thus far in your career? What has contributed to this success?
The rapid adoption of genderless sterile connectors, including standardization within multiple global end users

What are you passionate about personally? What do you enjoy?
I love anything that makes me or other laugh. Humor is a major contributor to my happiness.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
On the weekends, I enjoy performing as a professional stand-up comedian. I also love being around my family because time with them, unfortunately, can be quite limited.

What would be impossible for you to give up?
Sweets, unfortunately.

Any volunteer activities you enjoy? Why?
Coaching youth sports, volunteering at school events.

How would you like to be remembered?
A fun and professional guy who people looked forward to spending some time around.

What do you consider a personal success in your life thus far?
Being able to juggle traveling the world, being a comedian and being a father/husband all at the same time.

How do you feel the industry changed or evolved in recent years?
Single-Use is no longer an Idea or Niche, it is quickly becoming (or has become) the standard way of creating manufacturing facilities.

Has there been any significant advancement within your area of expertise?
Yes, sterile connector technology has greatly improved since the initial one was develop 15+ years ago. It is making the manufacturing process much more flexible, robust and reliable.

Where do you see the industry going in the next 10 years? Your area of expertise?
I see the industry being less scared of changes that are done for the sake of improvement. This should accelerate innovation.

What would you consider to be a major achievement for the industry in the near future?
Standardization of componentry within SIngle-use assemblies.

What is your favorite INTERPHEX memory?
Not being able to keep up with all the traffic in our booth when we released our first sterile connector (AseptiQuik S). The excitement was through the roof and it was fun to see a lot of our internal hard work paying off first hand.


.

Ben Arriola

Emerson Automation Solutions

Years of Experience?
25+

Website
https://www.emerson.com/en-us/industries/automation/life-sciences-medical

What are you known for professionally? What is your area of expertise?
I have 20+ years of identifying, establishing, nurturing, and growing businesses in high tech industries including in the Life Sciences

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I enjoy the notion that the application of the appropriate technologies can improve people's lives
The adoption of single-use technologies has transformed manufacturing strategies

Has there been any significant advancement within your area of expertise?
The ability to leverage technologies and know-how from other process intensive industries is accelerating the use of PAT in single-use bioprocessing

What would you consider to be a major achievement for the industry in the near future?
The realization of inline monitoring and real-time release of drug product


.

Sandra Bachamp

George Butler Associates

Years of Experience?
18

Website
www.gbateam.com

What are you known for professionally? What is your area of expertise?
My primary background is aseptic facility design. However, in a full service A/E firm, I'm exposed to a variety of industries and project types. The easiest path for innovation is to find tried and true methods in one industry that can be applied to another. Being a strategic thinker, observer and reader shaped my path to master planning

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Having worked as a facility design engineer for over 15 years, it is exciting to see new technology improve the way we work. From 360 scans, to 3D models and software allowing real time collaboration from multiple locations, project timelines are decreasing while at the same time the amount of content and details improves.

What would be impossible for you to give up?
I love to read! Be it a magazine on a long commute, a technical journal during lunch or the recommended read at the library, I need the escape from the next item on my to-do list. Somehow whatever I pick up turns out to be applicable in some aspect of my life.

How would you like to be remembered?
Gene and cell therapy could change how cancer and disease impact our lives. I'd love to be remembered as part of an industry that moved us from fighting for cancer awareness, to eliminating cancer as a life threatening illness.

What would you consider to be a major achievement for the industry in the near future?
Finding the right building or the funding to renovate a space should not fall to these startup companies. I'd love to see the industry help companies succeed and for us to step up as advisers to bring all these lifesaving products to market.


.

Marco Bellentani

MG2 S.r.l.

Years of Experience?
27

Website
https://www.mg2.it/

Please tell us how your career started.
I started my career as a Software engineer developing applications for Capsule filling machines with particular focus on Weight Control Systems.

What path brought you to your area of expertise?
Quality has always been part of my experience (quality of the finished products and quality in the development life cycle). This is the main reason I moved to Quality Department as Validation Manager and subsequently involved as Project Manager and Product Manager for Processing Division.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I am most passionate about Innovation and Technology as drivers for the Process Improvement in the Pharma Industry. For example developing weight control systems that are capable to check the quality of low dosages and product combinations with extreme accuracy is the most exciting objective that we can reach as a Company.

How do you feel the industry changed or evolved in recent years?
During the recent years, Industry focused more and more on Quality aspects and Process Understanding. Continuous Manufacturing applications are evolving and are the evidence of this change.

Where do you see the industry going in the next 10 years? Your area of expertise?
Automatic machines will be redesigned following User Experience paradigm to naturally satisfy the real needs of the industry and Artificial Intelligence will be the base for the control systems of the future.


.

Mark Bellino

Precis Engineering, Inc.

Years of Experience?
29

Website
http://precisengineering.com/

Please tell us how your career started.
First job was in the water / wastewater industry for a filtration equipment manufacturer.

What are you known for professionally? What is your area of expertise?
Best known for experience in the pharmaceutical industry associated with facilities engineering and site master planning.

What path brought you to your area of expertise?
Worked for several years at a major pharmaceutical company moving from region to global engineering.

What is the biggest challenge you have faced in the industry?
Technical challenges associated with meeting manufacturing capacity requirements in limited time frames.

What advice would you give to a professional starting out in the industry?
Get hands on experience as early as possible.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Assisting customers with facility planning and guiding them in the proper direction to maximize their success.


.

Ronald Berk

Hyde Engineering + Consulting

Years of Experience?
20+

Website
www.hyde-ec.com

Please tell us how your career started.
I took an overseas assignment because I was ready for an adventure

What are you known for professionally? What is your area of expertise? Sanitary and sterile design of pharma and biopharma facilities

What path brought you to your area of expertise?
Working at Hyde got me exposed to CIP systems and CIP-able process design

What is the biggest challenge you have faced in the industry?
Remediation of facilities out of compliance

What advice would you give to a professional starting out in the industry?
Follow the developments and try to get involved with the a cutting edge project

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Cost effective sanitary design and closed processing

Professional and/or recognition(s)?
ASME BPE Systems Design Subcommittee member

What is your biggest success thus far in your career? What has contributed to this success?
Provide guidance in facility remediation - my experience in the effectiveness various design and operation options

What are you passionate about personally? What do you enjoy?
My passion is outdoor activities (sking and hiking) as well as watching soccer

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
With my family in the outdoors

What would be impossible for you to give up?
Adventure

Any volunteer activities you enjoy? Why?
ASME BPE

How would you like to be remembered?
As the crazy dutchman in biotech

Where do you see the industry going in the next 10 years? Your area of expertise?
Reduction is cost of goods and continuous manufacturing

What would you consider to be a major achievement for the industry in the near future?
Complete continuous manufacturing process in the size of 1-2 trailers

What are you most interested in seeing at INTERPHEX?
Continuous manufacturing systems


.

Eric Bohn

Jacobs Wyper Architects

Years of Experience?
38

Website
https://www.jacobswyper.com/

What are you known for professionally? What is your area of expertise?
Process Architect with a deep understanding of design for cGMP facilities

What advice would you give to a professional starting out in the industry?
Look for and accept challenges

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Helping people meet their needs and be successful

What are you passionate about personally? What do you enjoy?
I am passionate about building, music and my family. Not necessarily in that order.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Hanging with my family

What are you most interested in seeing at INTERPHEX?
To meet and connect with people


.

Erich Bozenhardt

IPS

Years of Experience?
13

Website
www.ipsdb.com

Please tell us how your career started.
My father, Herman Bozenhardt, sparked my initial interest in pharmaceuticals with his tales of the industry. A stint as a research assistant during college solidified my desire for biotechnology. Coming out of school I joined the process group at an engineering firm, BE&K, where I was able to work on projects across multiple process based industries. The breadth of knowledge gained was invaluable but my interest in biotechnology drove me to find a life science based firm.

What are you known for professionally? What is your area of expertise?
I am known for design of biopharmaceutical processes and facilities. Lately I have been focusing on cell and gene therapies.

What advice would you give to a professional starting out in the industry?
I would advise someone starting out to always remember the work we do is about people. We work with people to help people. We can get so focused on the technical aspects of what we do we forget about the impact we have on people and forget that we can’t have that impact without working as a team to deliver a product.

What is your biggest success thus far in your career? What has contributed to this success?
I have been part of several fast track projects to build or renovate facilities for critical products. The ones that went well all share a common factor, a cohesive team (inclusive of Owner Company, engineer, contractors, etc.) that collaborates and trusts each other.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
When I am not working you can find me at home with my wife and daughters. Getting out for a run or bike is my ultimate way to relax in my time off.

What would be impossible for you to give up?
Tea. I drink 6 or more cups a day.

Anything else you’d like to tell people about yourself?
Many people who have worked with me notice that I am always wearing a suit jacket or blazer. It is like a utility vest for me, getting an extra set of pockets to carry: business cards, ear buds, pens, boarding passes, etc.

How do you feel the industry changed or evolved in recent years?
10 years ago single use was still novel. Today many manufacturers have incorporated single use systems in some form into their existing processes to simplify operations and/or reduce cleaning.

Where do you see the industry going in the next 10 years? Your area of expertise?
In the next 10 years the industry is going to develop and prove out (positively or negatively) various methods of delivery personalized therapies.

What are you most interested in seeing at INTERPHEX?
Throughout the year in discussions with vendors I ask can a product be tweaked to meet a particular need or apply the technology of one product to a different application. When I walk the show floor there is nothing better than one of those vendors calling out to me saying they got similar feedback from other customers and have a new or modified product that is what we discussed.


.

Loe Cameron

Pall Biotech

Years of Experience?
15+

Website
www.pall.com

Please tell us how your career started.
I first became interested in the bioprocessing industry during an internship with the US Department of Energy. My mentor there had incredible passion for the field and always highlighted the ways that different specialties came together to drive success. It set the pace for the way I work now.

What advice would you give to a professional starting out in the industry?
Ask questions, but be willing to dive in before you know all the answers. Sometimes you can't get an answer because you still need to discover it.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I'm passionate about learning and feel lucky to be in an industry where curiosity is so valued. In addition to deepening knowledge in my own field I am exposed to so many other disciplines. Learning about them gives greater context to the work and ensures I’m never bored.

What are you passionate about personally? What do you enjoy?
Cycling. It is always a challenge and yet remains fun. I can't claim the saying but it fits - it doesn't get easier, you just get faster.

Has there been any significant advancement within your area of expertise?
When I first started in automation it was widely regarded as stagnant; change was incredibly slow. However outside forces like consumer technologies and others have changed expectations and the industry is responding. We're in a period of exponential capability growth and it is really exciting.

What are you most interested in seeing at INTERPHEX?
It is always great to see familiar faces and catch up.


.

Hillel Cohen, PhD

Sandoz Inc.

Years of Experience?
34

Website
linkedin.com/in/hillelpcohen

Please tell us how your career started.
My career journey began with QC methods development for protein drugs, followed by analytical chemistry of proteins, Regulatory CMC, Regulatory Affairs liaison to FDA and then various managerial roles in Regulatory and biosimilar policy.

What are you known for professionally? What is your area of expertise?
Science policy related to biosimilars

What path brought you to your area of expertise?
I became involved in biosimilarS in 2003 as the field began to be discussed in the US.

What is the biggest challenge you have faced in the industry?
Educating healthcare professionals, patients and the public at large that biosimilars are just as safe and effective as their reference biologics.

What advice would you give to a professional starting out in the industry? Follow your interests but be ready to reinvent yourself on a periodic basis

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I am most passionate about patient access based on the strong science supporting biosimilars and other drug therapies.

Professional and/or recognition(s)?
PhD

What is your biggest success thus far in your career? What has contributed to this success?
My biggest career successes have been leading the Sandoz efforts for the very first US Advisory Committee review of a biosimilar as well as publishing several articles about biosimilars that have each been downloaded over 10,000 times. I am also proud to have helped found a US biosimilar trade association - the Biosimilars Forum.

How do you feel the industry changed or evolved in recent years?
Biosimilars have evolved from a theoretical concept about which there were many doubts to a reality in many countries that is helping lower healthcare costs and increase patient access.

What are you most interested in seeing at INTERPHEX?
I look forward to sharing my knowledge and passion about biosimilars.


.

Scott Comeau

IPS

Years of Experience?
20

Website
ipsdb.com

Please tell us how your career started.
I was told that I get to operate really big multi-million dollar equipment and if I make a mistake I would be fired.

What are you known for professionally? What is your area of expertise?
Working on the larger more complex jobs that utilize PLCs and automation such as complex process equipment, HVAC/BAS systems, serialization/packaging lines

What path brought you to your area of expertise?
My father was an engineer. He taught me the basics of how everything worked long before I got to school

What advice would you give to a professional starting out in the industry?
You can't do enough homework to prepare for what’s ahead of you. Always maintain your professional contacts it is a small industry where you eventually see everyone again.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I'm an Engineer. I like a challenge.

What is your biggest success thus far in your career? What has contributed to this success?
Having people I admire tell me that they are impressed by what I am able to accomplish. This is all due to knowing where to find the answers.

What are you passionate about personally? What do you enjoy?
Like any Engineer I like to get it done right the first time. I enjoy finding out how everything works.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
I enjoy working on my home, my cars, my computers and electronics

What would be impossible for you to give up?
Coffee

What are you most interested in seeing at INTERPHEX?
Connecting with vendors I'm currently using or have used in the past as well as meeting new vendor with products or services I need.


.

Gregory Connelly

Vertex Pharmaceuticals

Years of Experience?
17

Website
www.vrtx.com

What path brought you to your area of expertise?
My background is in math and physics, and I have a PhD in biophysics. I started off in pharma in research and slowly moved to development and now commercial manufacturing.

What is the biggest challenge you have faced in the industry?
The tendency of people both within my company and beyond to want to apply standards applicable for batch processing to continuous

What is your biggest success thus far in your career? What has contributed to this success?
Developing the first GMP-qualified CM rig in pharma and having 2 drugs approved on it

What are you passionate about personally? What do you enjoy?
I have never owned an automobile, I get around everywhere by bicycle or public transit

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
At the piano or in my wood shop

What are you most interested in seeing at INTERPHEX?
The panel discussion on implementing CM


.

Craig Correia

Festo

 
Years of Experience?
26 total in automation, last 11 specifically with Life Science industry

Website:
https://www.festo.com/cms/en-us_us/56644.htm

Please tell us how your career started.
I started as an engineer in vibration isolation for photonics and laboratory applications. This exposed me to automation and Festo

What are you known for professionally? What is your area of expertise?
Automation solutions and corporate strategy

What is the biggest challenge you have faced in the industry?
The field of personalized medicine and single use technologies has had a large impact on our product development. It is a rapid change from traditional applications that dominated the automation potential even 5 years ago.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Sailing, skiing, coaching sports with kids.

Has there been any significant advancement within your area of expertise?
Certainly industry 4.0 and the whole concept of digitalization as a way to harness and effectively use/control big data.

What are you most interested in seeing at INTERPHEX?
To see how other automation vendors and skid builders are adapting to the trend/needs for digitalization and personalized medicine.


.

Robert Davies

Meissner Filtration Products

Years of Experience?
10 years

Website
www.meissner.com

What path brought you to your area of expertise?
Prior experience in product management within the life science industry, specifically clinical laboratory diagnostics. I have always been passionate in work that bridges commercial and technical expertise.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I have always been passionate about making a difference to patients. Making contributions that may ultimately lead to a paradigm shift that can better serve the needs of the pharmaceutical industry and patient health has been a primary driver.

What is your biggest success thus far in your career? What has contributed to this success?
My biggest success came early in life when I worked as a research associate at UCLA. There, I was able to make contributions to the field of work surrounding pediatric lupus and arthritis through the publication of several studies. Intellectual curiosity and my collaborative nature contributed to being able to leverage the knowledge of experts around me to successfully provide novel thoughts to the pathogenesis of autoimmune disease.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
I’ve recently spent a lot of time in Mexico because I love the food and the culture. Its close proximity to California makes it a convenient way to “get-out” without going far when spending time off from work.

Where do you see the industry going in the next 10 years? Your area of expertise?
The most significant advancement within the industry has been the transition to single-use solutions within pharmaceutical manufacturing. Within the next 10 years, the industry will likely see greater adoption of more robust, single-use solutions, particularly within the freeze/thaw of bulk drug substance, as a means of reducing costs, increasing operational flexibility.

What would you consider to be a major achievement for the industry in the near future?
In 2018, a group of world-class manufacturers of biopharmaceuticals created an advisory board to align on user requirements for the fill, freeze, storage, transport and thaw of biopharmaceutical drug substance using single-use storage containers. A greater collaboration amongst more world-class leaders in pharmaceutical manufacturing, across all global regions, would be a major achievement in the near future.

What are you most interested in seeing at INTERPHEX?
I look forward to learning from industry leaders and experts while also discovering new advances in the manufacturing of pharmaceuticals.


.

Yvonne Duckworth, PE

CRB

Years of Experience?
28 years

Website
www.crbusa.com

Please tell us how your career started.
I graduated from Widener University with a degree in Electrical Engineering and I got my first job at a consulting engineering company called CE&IC. They designed pharmaceutical facilities. It was a great company to start my career and a great industry to be in. I did a lot of traveling for commissioning and start-up assignments, and I think that was a great way to learn for someone right out of school. I wound up working there for 10 years.

What are you known for professionally? What is your area of expertise?
I am an automation engineer at CRB consulting engineering firm and I design instrumentation systems and control systems associated with pharma and biotech manufacturing facilities. Control system architecture design associated with either PLC-based networks as well as DeltaV control systems are several areas of my expertise.

What advice would you give to a professional starting out in the industry?
Make sure you work hard to develop good strong technical skills if you are an engineer. It's very important to establish your credibility. Also, keep on top of what is going on in the industry. Networking is very important. And one of my favorite pieces of advice is that if you are going to your boss to discuss a problem, it's good to have some options that would help to fix the problem. Be creative in your problem-solving.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I love the fact that my company (CRB) designs pharmaceutical and biotech facilities that make drugs that help to save lives. Every so often, we have a client that comes in to talk to us about the impact that a particular drug has made on people's lives. That really helps us to see the big picture and take a little break from all of the engineering details.

Professional and/or recognition(s)?
Getting my PE license was a pretty important accomplishment in my career. I also enjoyed getting my MBA. Another recent accomplishment was that I was asked to write an article on Industry 4.0 in a magazine called the Medicine Maker last year.

What is your biggest success thus far in your career? What has contributed to this success?
I’ve been invited to speak at several conferences this year on Industry 4.0 and Pharma 4.0. I have attended many seminars to become well-versed in Industry 4.0, as well as utilized many Industry 4.0 concept in the design projects that I have been involved in.

What are you passionate about personally? What do you enjoy?
I love to ski, swim, play tennis and go for walks. I love the beach and the mountains, and fortunately I live in an area that I can drive to either one within a couple hours. I love to spend time with my family, especially with my three children

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Either a ski slope or on a beach

Any volunteer activities you enjoy? Why?
I enjoy talking about engineering and STEM related issues to young men and women. I also enjoy talking about being a female engineer in a male dominated industry, especially to groups like Girl Scout troops.

How would you like to be remembered?
I would like to be remembered as a knowledgeable automation engineer that helped to make a difference in the pharmaceutical industry, as well as a good person and a great mom

What do you consider a personal success in your life thus far?
I think being a successful female automation engineer and subject matter expert in a male dominated field has been very rewarding for me.

How do you feel the industry changed or evolved in recent years?
The new automation trends associated with Industry 4.0 are making their way into the pharma and biotech industries. This is very exciting to see how the relatively conservative pharma industry is adopting the new technology associated with Industry 4.0 such as the Cloud, Augmented Reality, 3D Printing, Open Communication and Smart Manufacturing, Cyber Security, the use of wearables, etc.

What would you consider to be a major achievement for the industry in the near future?
I think the increased use of the Cloud for the pharma industry would be a major accomplishment.
There are a lot of security concerns around the use of the Cloud at this point in time, but I think as technology continues to improve, this will become more and more commonplace in pharma.

What are you most interested in seeing at INTERPHEX?
I am excited to see the impact that Industry 4.0 trends are making on the vendor's demonstrations and offerings this year. There is a lot of buzz about Industry 4.0 and I love seeing how vendors work that into their marketing strategies and vendor displays.


.

Mike Elliot

CustomVault

Years of Experience?
Thirty-five

Website
www.customvault.com

Please tell us how your career started.
In 1984 met a man names Thomas P. Brennan, who was beginning a new business. That of high security modular vault solutions. We began servicing the jewelry industry, but quickly grew into Pharma, branch banking, armored car, military and credit card security solutions. We have grown each year and have become an industry leader.

What are you known for professionally? What is your area of expertise?
Design, engineering and fulfillment of complex U.L. Listed/DEA approved modular vault systems and cages.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Each transaction requires the four "P's". Product knowledge, personality, passion and process. There are no shortcuts to the sales cycle. Each opportunity in itself is a challenge, and our experience is second to none which becomes very rewarding in service to our clients

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
On a golf course, with family.

How would you like to be remembered?
As a great dad!

What are you most interested in seeing at INTERPHEX?
To re-engage with existing customers and meet new ones.


.

Christel Fenge, PhD

GE Healthcare Life Sciences

Years of Experience?
30 years

Website
www.gelifesciences.com/en/us/solutions/bioprocessing

Please tell us how your career started.
Started in process development of perfusion cell culture processes for the production of recombinant therapeutic proteins

What are you known for professionally? What is your area of expertise?
Many years in biopharma process development and clinical trials production, with a strong domain in upstream but developed broadly. In recent years even product management and product development for bioprocessing.

What path brought you to your area of expertise?
Studying Biochemistry and chemical engineering, got interested in bioprocessing, started working in the biopharma industry and now enjoy product development for bioprocessing.

What is the biggest challenge you have faced in the industry?
Introduction of new technology. It can take quite some time, both reach the level of robustness needed for industrial use and also accepted by senior managers, QA, regulators (especially relevant in GMP)

What advice would you give to a professional starting out in the industry?
Chose a field that you are passionate for and have a strong interest in.

What are you passionate about personally? What do you enjoy?
Combining Biology with Technology and ultimately serving patients with better treatments.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Love holidays where I can combine nature with history. Gardening is another great hobby.

Any volunteer activities you enjoy? Why?
Serving my hometown protestant congregation as a member of the church council

How do you feel the industry changed or evolved in recent years?
Bioprocess industry has much more matured and novel treatments gaining traction needing new solutions.

Where do you see the industry going in the next 10 years? Your area of expertise?
I expect that for conventional mab treatments, COG will continue to drive downwards through technology improvements. Novel treatments are emerging such as cell and gene therapy.

What are you most interested in seeing at INTERPHEX?
Learn about technology advancements


.

Michael Francis

Emerson

Years of Experience?
2

Website
www.emerson.com

What are you known for professionally? What is your area of expertise?
I am currently the global product manager for the Emerson division of liquid analysis instrumentation. This role has enabled me to become a subject matter expert in pH, conductivity and ion-selective measuring devices across many industries, with a focus on the life science industry.

What advice would you give to a professional starting out in the industry?
The life science industry demands that your drive be focused on people because we are innovating to make the lives of our families and friends better on a daily basis. Being driven by the success and well-being of others empowers a researcher, engineer, or scientist to push through the frustrations of the daily grind and deliver a life-altering solution.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
I greatly enjoy being outside in areas that are rarely touched. Whether it be in desolate, northern Minnesota or the great national parks of the USA, I seek places where I can see unobstructed nature and be at peace. It is a bonus if I can bring a guitar and cut the silence with some music.

Any volunteer activities you enjoy? Why?
I have been active with International Justice Mission, which is a large non-profit looking to end human trafficking and modern day slavery. According to Internal Justice Mission with the collaboration of several other organizations, the current unified estimate for global slavery and child labor is 40 million people. This breaks my heart as these individuals are used and reduced lower than other humans for monetary profit.

How do you feel the industry changed or evolved in recent years?
The dawn of single-use bioprocessing has brought on a new era of cost-reducing pharmaceutical manufacturing. With these new processes, the industry can leap and miniaturize into the promising field of personalized medicines, which after a few more years of research, could be the cure we have been seeking as a species. As a instrumentation supplier, the onus is on us to deliver stable, repeatable measuring devices that lead to tight control and high quality of the end products for single-use.

What are you most interested in seeing at INTERPHEX?
I am looking forward to see innovations in single-use technology and control systems for the life science industry.


.

Blair Fraser

Quartic.ai

Years of Experience?
20

Website
www.Quartic.ai

Please tell us how your career started.
On the shop floor operating and maintaining critical equipment.

What are you known for professionally? What is your area of expertise?
Use of artificial intelligence to enhance the performance and reliability of equipment.

What path brought you to your area of expertise?
By thinking outside the box and embracing emerging technologies.

What is the biggest challenge you have faced in the industry?
With pharmaceuticals being a highly regulated industry, the saying "we have always do it this way" is the most challenging mindset to overcome.

What advice would you give to a professional starting out in the industry?
Follow your passion and speak in inquires, do not be afraid to ask "why"

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
To experiment and try new ways of solving old problems. When a new solution is implemented and the business value is achieved.

Professional and/or recognition(s)?
Many certifications in asset management, reliability and maintenance including CMRP and CRL.

What is your biggest success thus far in your career? What has contributed to this success?
Thought leadership via articles, magazines, podcasts and key notes speaking on the use of artificial intelligence to add intelligence to critical assets.

What are you passionate about personally? What do you enjoy?
Human optimization, improving body, mind and soul to achieve optimal health and cognitive performance.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Any where there is sun, beach and water

What would be impossible for you to give up?
Coffee

Any volunteer activities you enjoy? Why?
Serving on boards and speaking to young professionals.

How would you like to be remembered?
By the passion I brought

Anything else you’d like to tell people about yourself?
I am human guinea pig, testing new way to bio-hack for optimal health and performance.

What do you consider a personal success in your life thus far?
Being a father of three

How do you feel the industry changed or evolved in recent years?
Pharmaceutical manufacturing was able to leverage Industry 3.0 by adding sensors to equipment to control the varying process. These sensors are data fuel to add intelligence to legacy assets through Industry 4.0

Has there been any significant advancement within your area of expertise?
Artificial Intelligence is gaining a lot of progress in drug discovery, we are seeing more and more value being generated by implementing AI on legacy equipment to enhance the performance of critical equipment.

Where do you see the industry going in the next 10 years? Your area of expertise?
Continuous manufacturing enabled by the digital twin and AI

What would you consider to be a major achievement for the industry in the near future?
When AI is considered a necessity to operate and maintain our equipment.

What are you most interested in seeing at INTERPHEX?
To collaborate with innovators to create new ways of solving old problems.


.

Jerry Golden

B&R Industrial Automation Corp.

Years of Experience?
33

Website
br-automation.com

Please tell us how your career started.
Applications Engineering

What are you known for professionally? What is your area of expertise?
Contribute to all phases of strategic business development and improving process efficiencies.
Deliver a history of dependability, integrity and a superior work ethic.

What path brought you to your area of expertise?
Out of high school straight to a 2-year technical college while working in the industry then transferring to a 4-year program

What is the biggest challenge you have faced in the industry?
Maintain a positive leadership vision under challenging economic conditions

What advice would you give to a professional starting out in the industry?
Same path. I believe parents, educators and the government put too much emphasis on going right from high school to a 4-year institution only to fail

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
The environment in which I am in different industries, team atmosphere and solving challenges for our customers

Professional and/or recognition(s)?
Various sales awards, certifications and mentor

What is your biggest success thus far in your career? What has contributed to this success?
Achieving specifications at several oem/end user accounts. Teamwork

What are you passionate about personally? What do you enjoy?
Golf, home improvement projects and the outdoors

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Beach or the Golf course

What would be impossible for you to give up?
My partner Lisa

Any volunteer activities you enjoy? Why?
Serving meals at holiday time for underprivileged/homeless

How would you like to be remembered?
A top professional in factory automation at all levels

What do you consider a personal success in your life thus far?
Raising a daughter who has blessed me with two grandchildren

How do you feel the industry changed or evolved in recent years?
Innovation

Has there been any significant advancement within your area of expertise?
Global responsibility

Where do you see the industry going in the next 10 years? Your area of expertise?
Digitalization. Sharing explaining these innovations is key

What would you consider to be a major achievement for the industry in the near future?
AI

What are you most interested in seeing at INTERPHEX?
Transport/mover systems


.

Jeremy Griffin, MBA

Berkshire Sterile Manufacturing

Years of Experience?
15

Website
www.berkshiresterile.com

Please tell us how your career started.
My career started as a temporary laboratory analyst at Eli Lilly & Company. I worked in an HPLC laboratory testing cleaning validation samples.

What are you known for professionally? What is your area of expertise?
I am known for aseptic processing. I have spent nearly all my professional career supporting the manufacture of parenteral drugs. I am especially knowledgeable in sterilization and aseptic filling processes.

What advice would you give to a professional starting out in the industry?
Embrace that you work is in a highly regulated industry and with that comes challenges not common in other industries. Also, never stop learning.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I am passionate about technical transfer and process development. I am most excited to help bring potentially lifesaving therapies to the clinic.

Where do you see the industry going in the next 10 years? Your area of expertise?
Automation of manufacturing processes will continue to grow. Robotics and automation will take the place of people in clean rooms and isolators.

What are you most interested in seeing at INTERPHEX?
I am looking forward to seeing the equipment vendor offerings.


.

Meghan Gutierrez

Lymphoma Research Foundation

Years of Experience?
20

Website
lymphoma.org

Please tell us how your career started.
Meghan Gutierrez is the Chief Executive Officer of the Lymphoma Research Foundation, the nation’s largest nonprofit organization devoted to funding lymphoma research and education, advancing both the study of new cancer therapies and improved patient care.

What are you known for professionally? What is your area of expertise?
An expert in government relations and health care policy, Gutierrez has pursued an array of public policy issues during her career, ranging from mental health parity and rare disease awareness to medical technology and the treatment of chronic disease.

What path brought you to your area of expertise?
Following her work as a Congressional staff member for one of the U.S. House of Representatives’ foremost leaders on health care policy, she served as a health policy and communications advisor for several national nonprofit and educational institutions.

What is the biggest challenge you have faced in the industry?
LRF has successfully advocated for greater support for the nation’s clinical trials enterprise and improvements to infrastructure, including efficiencies to the clinical trial development process, maximization of secure data sharing and focus on patient-centered outcomes, as well as inclusion of the patient voice in the drug development process.

What advice would you give to a professional starting out in the industry?
To expose themselves to a variety of opinions and vantage points.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
The Lymphoma Research Foundation's work to ensure patient access to high quality cancer care.

What is your biggest success thus far in your career? What has contributed to this success?
All of the Lymphoma Research Foundation's efforts to increase investment in lymphoma research, particularly through our grants to early career investigators.

What are you passionate about personally? What do you enjoy?
I enjoy cheering for my Iowa Hawkeyes!

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
See my earlier comments regarding the Iowa Hawkeyes...

What would be impossible for you to give up?
Work and personal philanthropy which is mission-driven.

Any volunteer activities you enjoy? Why?
Volunteering for local patient groups is an important reminder of why our work is vital.

What do you consider a personal success in your life thus far?
See my earlier comments regarding the Iowa Hawkeyes...

How do you feel the industry changed or evolved in recent years?
I think trends toward patient-centered drug development and care are positive developments.

Has there been any significant advancement within your area of expertise?
We have witnessed unrepresented advances in the understanding of the lymphomas and a proliferation of new therapies. All incredible reasons for hope for our community.

Where do you see the industry going in the next 10 years? Your area of expertise?
The Lymphoma Research Foundation's mission is to eradicate this disease - I hope that we will come even closer to that goal in the next decade.

What would you consider to be a major achievement for the industry in the near future?
To continue to invest heavily in innovate treatments for lymphoma and all cancer types.

What are you most interested in seeing at INTERPHEX?
To meeting new colleagues who share our vision to eradicate lymphoma.


.

Heidi Hagen

Vineti Inc.

Years of Experience?
30 years

Website
www.vineti.com

Please tell us how your career started.
I completed graduate school as a Fellow for Quinton Instrument Co. in Seattle, where I completed my graduate thesis with a Quinton research project. From there I went to Immunex as Biochemist post-graduation.

What are you known for professionally? What is your area of expertise?
Technical and Commercial Operations

What path brought you to your area of expertise?
Drug development and Project Management roles at Immunex for 10 years followed by Dendreon where I was SVP of Operations and a tenure of 10 years there also.

What is the biggest challenge you have faced in the industry?
Commercializing the first Active Cellular Therapies, Provenge. The product had an incoming shelf life of 18 hours (fresh Apheresis) and outbound fresh cellular finish product with a shelf of 18 hours. It is still the largest volume cell therapy being produced today at ~14,000 products annually in the USA.

What advice would you give to a professional starting out in the industry?
Take on the most challenge projects you can that combine science, product development, and finances.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Helping patients receive better more efficacious products that address their personal disease.

What is your biggest success thus far in your career? What has contributed to this success?
Creating great cross functional leadership teams that can take industry challenges that no one has taken on before.

What are you passionate about personally? What do you enjoy?
I enjoy working on new innovative products and creating new companies.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Skiing and running

What would be impossible for you to give up?
My family

Any volunteer activities you enjoy? Why?
I volunteer as Chairman of the Advisory Board to the University of Washington Bioengineering dept. I enjoy helping to shape today's bioE students.

What are you most interested in seeing at INTERPHEX?
Discussing the new and growing field of cell therapy


.

Kir Henrici

The Henrici Group

Years of Experience?
12

Website
www.thehenricigroup.com

Please tell us how your career started.
In the Nutraceutical Industry; global procurement.

What are you known for professionally? What is your area of expertise?
I would say Data Integrity and the emerging big data/data science and AI landscape.

What path brought you to your area of expertise?
It was very organic and unintentional. Data integrity expertise was driven by need; the focus popped and opportunities and challenges ensued. The convergence with a personal fixation with big data was inexorable.

What is the biggest challenge you have faced in the industry?
I am passionate about big data integrity and am concerned that it is a knowledge gap and/or overwhelming for quality and regulatory professionals, and thus lacking in attention and readiness. The gap in keeping tenor may inhibit life-saving or life enhancing innovations.

What advice would you give to a professional starting out in the industry?
Integrate some form of data science into your body of knowledge. I would venture to say a fundamental understanding of the data lifecycle and value of data in the era of IoT is constitutional to navigating the life science industry.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Facilitating the DI/quality side of big data innovation. The potential enhancement of the well-being of human and animal life keeps me awake at night. Implementing large scale data integrity/data management programs and/or remediation with measurable success factors including product releases and approvals.

What is your biggest success thus far in your career? What has contributed to this success?
The opportunity to serve this industry in, and of itself. An immeasurable number of engaged and collaborative individuals along the way.

What are you passionate about personally? What do you enjoy?
My children and our dogs and cat. They are rescues (not the kids). They are largely traumatic cases. Our littlest guy was suffering with meningoencephalitis when he arrived. The week before we adopted James, he had been beaten, lost his right eye and had a massive skull fracture. At the same time my first born rescue, 11, was in hospice with insullinoma. Loving, bonding and caring for these guys is an indescribable joy. The plan is to move west, create a sanctuary, and pile in the rescues.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Definitely on the couch twisted up in knots of blankets, dogs, kids and my cat. Definitely eating popcorn. Definitely watching Netflix.

What would be impossible for you to give up?
Retweet the above.

Any volunteer activities you enjoy? Why?
It's going to sound like a shameless plug but I am thrilled to be a part of PDA. I also volunteer for client quality initiatives; quality promoting activities that fall outside of the traditional scope of consulting.

How would you like to be remembered?
For love. And maybe solving the DI big data challenge...

How do you feel the industry changed or evolved in recent years?
Technology is a new genesis. Digital health, AI, virtual development, smart manufacturing, IoT, mirror-world; buckle up.

Has there been any significant advancement within your area of expertise?
Data integrity is a tricky topic. Trying to wrangle in an en masse comprehension of data integrity is a major challenge. We've got start-ups, companies behind the curve or under-exposed, and we've got technological industry giants. Advancing data integrity requires a constant pivot between communicating good documentation practices and speculating on the governance of unstructured data and natural language processing. I think data integrity is a bit in the pocket, queued up and hovering.

Where do you see the industry going in the next 10 years? Your area of expertise?
Technology; big data management, algorithms, data science. With a push and a shove data stewards and regulators will harness the ability to govern the tech, ensure quality, and facilitate game-changing innovation.

What would you consider to be a major achievement for the industry in the near future?
A developed regulatory and industry framework to support and actualize value from the tech revolution.

What are you most interested in seeing at INTERPHEX?
Setting eyes on all the new tech. Peppering anyone who will listed with questions on how to get there from here.


.

Jo Anne Jacobs

Catalent

Years of Experience?
28

Website
catalentbiologics.com

Please tell us how your career started.
While in pharmacy school I had the opportunity to be involved in dosage form development and manufacturing and knew that was going to be my career path.

What are you known for professionally? What is your area of expertise?
Parenteral product development, technical transfer and manufacturing.

What advice would you give to a professional starting out in the industry?
Be patient. Take every learning opportunity you can. Find a strong mentor.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Scuba diving in clear, warm water

What would be impossible for you to give up?
My dog

What are you most interested in seeing at INTERPHEX?
It's not specific to INTERPHEX, but, the first time I attended, I had dinner with colleagues at the 'Top of the World' in the World Trade Center. That is a particularly poignant since 9/11.


.

Rick Jarrell

Eurotherm by Schneider Electric

Years of Experience?
36

Website
www.eurotherm.com/industries/life-sciences

Please tell us how your career started.
I began my career in a technical sales and service role while earning a degree from Cleveland State University. I found that an industrial automation sales role was quite different to what I had previously understood to be "sales" and found the profession quite to my liking.

What is the biggest challenge you have faced in the industry?
In a business development role in is critical that I find opportunities to talk to people. However, in today's business world everyone is very busy.

What advice would you give to a professional starting out in the industry?
Two things. First, always be learning, regardless of where you are in your career. Second, when interfacing with the stakeholders associated with your career, always place yourself in their shoes. Genuine empathy for others needs can take you a long way.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I love when the things that I do within my business can bring true benefit to the industries that I am connected to. When my company's products, services or solutions can advance or benefit a pharmaceutical or biotechnology process to the benefit of the masses, I have find that to be quite special.

What is your biggest success thus far in your career? What has contributed to this success?
I am reasonably proud of my longevity within my company. My sort of tenure does not occur very often in the business world. I think that one of the key contributions to this has been to remain agile, taking on several different roles within the business.

What are you passionate about personally? What do you enjoy?
I enjoy spending quality time with family and friends.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
I enjoy a good Netflix binge, but I am also an avid cyclist and backpacker.

What would be impossible for you to give up?
My principles of integrity and ethics

Any volunteer activities you enjoy? Why?
I have enjoyed some volunteering at a food back recently. I would like to carve out more time for volunteering.

How do you feel the industry changed or evolved in recent years?
Opportunities to automate processes continue to come at a quick pace.

Has there been any significant advancement within your area of expertise?
It seems that there is a high focus in the industry on paying close attention to data integrity. Since my company has expertise in this field, this focus has given us a lot to talk about.

Where do you see the industry going in the next 10 years? Your area of expertise?
Data management, including improving analytics, is going to be key for improving processes.

What are you most interested in seeing at INTERPHEX?
This is our first year back at INTERPHEX in quite some time as an exhibitor. We need this to be a strong event for us in 2019.


.

Harald Joos

Bosch Packaging Technology

Years of Experience?
35

Website
www.boschpackaging.com

Please tell us how your career started.
With a dual "education" where University and a company do share theoretical and practical education packages.

What are you known for professionally? What is your area of expertise?
A very wide and well balanced technical as well as commercial mix of skills.

What advice would you give to a professional starting out in the industry?
Remain yourself (stay authentic), learn from the best ones, and bring in your ideas.

Where do you see the industry going in the next 10 years? Your area of expertise?
The customers are setting the direction and they expect and require solution partners instead of product suppliers. Packaging machines will become intelligent systems managing the entire process of material handling, dosing/packing, quality management and data management.

What would you consider to be a major achievement for the industry in the near future?
Reduce waste to almost zero

What are you most interested in seeing at INTERPHEX?
Meeting people, especially customers, and learn about their present and future requirements - and to mirror our latest developments (including exhibits) against market requirements and trends.


.

Maik Jornitz

G-CON Manufacturing Inc.

Years of Experience?
32

Website
www.gconbio.com

What are you known for professionally? What is your area of expertise?
SEM of sterile filtration

What path brought you to your area of expertise?
My great mentor Theodore Meltzer, he was the one who inspired me, but also challenge me to gain more knowledge.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I am a subject matter expert in sterile filtration and it is great to share such knowledge and help out where needed.

Professional and/or recognition(s)?
I received multiple awards, recently the Honorary Member Award by PDA, but also being member of the Medicine Maker Power List.

What is your biggest success thus far in your career? What has contributed to this success?
Building organizations has always been my biggest success, however I was not the sole builder, but the team one empowers is.

What are you passionate about personally? What do you enjoy?
I am passionate about my family first and foremost. What I enjoy most is a great meal sitting around the table with the family and talk and enjoy.

What would be impossible for you to give up?
My family, I love my family and would give up everything for them.

Any volunteer activities you enjoy? Why?
I am an active volunteer of PDA, which is extremely rewarding as one learns and one has the chance to give. PDA is an organization of experts helping each other, helping the industry and regulators.

How would you like to be remembered?
To be a person who has tirelessly tried to teach and mentor. I firmly believe one has to spread ones knowledge and expertise.

Where do you see the industry going in the next 10 years? Your area of expertise?
We will see a major shift towards novel, personalized medicines, which are much more effective of what we have seen in the past

What would you consider to be a major achievement for the industry in the near future?
I see the industry morphing from large volume therapies to personalized therapies and with it the entire processing and facility design is changing. All becomes more efficient and flexible.

What are you most interested in seeing at INTERPHEX?
I enjoy the networking when I am at Interphex. It is always great to catch up with friends and colleagues and meet new peers.


.

Matt Knott

RoviSys

Years of Experience?
13

Website
www.rovisys.com

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I am passionate about find and taking on new challenges. We support our customer in a wide variety of ways that are sometimes new territory for everyone involved. We thrive on these type of challenges and it is in part was has allowed us to grow as an organization and also as individuals within that organization.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Aside of spending time with my family of course, I enjoy back country backpacking. I find the task of efficiently planning a multi-day trip with the proper gear and food challenging in that you try to bring only what you need to save space and weight; it is sort of like planning a project in planning a schedule a budget. Then there is the adventure itself; you have to make do with what you've prepared with and make adjustments to adapt.

How do you feel the industry changed or evolved in recent years?
There has been a major shift in the industry moving towards data-driven decision making. This requires a complex network and the Life Sciences industry seems to be on the leading edge of the manufacturing world to be taking the right steps in the direction of protecting that infrastructure is a safe way while retaining the necessary flexibility required.

Where do you see the industry going in the next 10 years? Your area of expertise?
It's no secret that every industry is becoming more data-driven and I foresee this transformation to continue for many years to come. There have been significant developments in the connectivity of data from the manufacturing process up to the business level systems. The next step that many need to take is to turn that data into knowledge and that knowledge into decisions to improve our methods and processes.

What are you most interested in seeing at INTERPHEX?
I'm looking forward to seeing what other exhibitors are bringing to the show this year in the way of Pharma 4.0.


.

Annette Kreuger

Industrial Information Resources

Years of Experience?
22

Website
industrialinfo.com

What are you known for professionally? What is your area of expertise?
The ability to explain complex concepts and ideas in manner that virtually anybody can understand. Who, what, when and where (along with the why) in regards to capex/mro spending within the industry.

What path brought you to your area of expertise?
Journalism

What is the biggest challenge you have faced in the industry?
BIg pharma wall of silence

What advice would you give to a professional starting out in the industry?
You don't have to be an engineer (or a scientist, financial or legal wiz), but you must have a clear understanding of what aspect of the industry you are involved with. It is not enough to say someone makes drugs. Have to know what part of the drug, an API?, the final formulation, the entire thing, etc.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Uncovering and reporting accurate details that are simply not readily available.

What are you passionate about personally? What do you enjoy?
Doing what I was told could not be done. I so enjoy watching my son, who is severely autistic, blossom into a well-adjusted, essential young man. It may take years for an achievement, but when we get there, we are both so incredibly happy.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
I love to travel, to meet the locals and learn new cultures.

What would be impossible for you to give up?
Reading.

How would you like to be remembered?
She gave it her best.

Anything else you’d like to tell people about yourself?
I don't give up until I get an answer

What do you consider a personal success in your life thus far?
Yes, in that goals I set out to accomplish long ago were met. But, as the saying goes..."there's a lotta mo..."

How do you feel the industry changed or evolved in recent years?
We are closer to actual cures for things that are considered incurable. Medicine is becoming more accessible across the world, to more people than ever before.

What are you most interested in seeing at INTERPHEX?
The very first time a client brought someone to booth, telling them that I could help them, that I was the one to talk to if they wanted to know what was going on in the industry.


.

Michael Lee, Bioprocessing

King Lai Hygienic Materials Co., Ltd

Years of Experience?
30 years

Website:
www.supremebioprocess.com

Please tell us how your career started.
My Ph.D. dissertation was associated with isolating and purifying bioactive molecules from marine invertebrates. After graduation, I headed a company where marine toxins were tested for AIDS and cancer cell activities.

What are you known for professionally? What is your area of expertise?
In 1988, I was the Hawaii Chapter President of the American Chemical Society. My area of expertise is downstream processing of biopharmaceuticals.

What path brought you to your area of expertise?
My past thirty plus years of work tenure had been associated with chromatography media and PAT-based process skid in downstream processing of biopharmaceuticals.

What is the biggest challenge you have faced in the industry?
Reluctant to have process change due to labor intensive and time consuming process.

What advice would you give to a professional starting out in the industry?
Make sure you understand process economics.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Innovation and improvement in manufacturing efficiency afford better quality product and reduced product cost for the public. Talks in scientific conferences allow participants to exchange ideas.

Professional and/or recognition(s)?
1988- Hawaii Chapter President of the American Chemical Society, 2000- invited guest editor for the American Association of Pharmaceutical Scientists, 2011- recipient of Suzhou Industrial Park leadership award

What is your biggest success thus far in your career? What has contributed to this success?
I have received 10 patents, one in the States, and nine in China. My past work experience and continued research allowed me to keep on learning.

What are you passionate about personally? What do you enjoy?
I enjoy challenges especially difficult downstream processing of biopharmaceuticals.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Jogging and exercise in a park next to a lake help me to think better. I enjoy going to different countries to witness and feel the history.

What would be impossible for you to give up?
Jogging and exercise

How would you like to be remembered?
A person never bow to failure

Anything else you’d like to tell people about yourself?
Enjoy listening to life interesting stories

What do you consider a personal success in your life thus far?
Poverty and language barrier could not stop me from earning a Doctoral Degree in Chemistry from the United States of America.

How do you feel the industry changed or evolved in recent years?
Slowly but surely towards better process understanding

Has there been any significant advancement within your area of expertise?
Yes, instead of traditional salt gradient in ion exchange, linear pH gradient affords a different purification platform.

Where do you see the industry going in the next 10 years? Your area of expertise?
I see faster, less expensive and more efficient manufacturing process in the next 10 years. Hope that my continued research in linear pH gradient technology is part of the future exercise.

What would you consider to be a major achievement for the industry in the near future?
Any forms of diseases could be stopped and curable.

What are you most interested in seeing at INTERPHEX?
New products and new ideas in biomanufacturing


.

Robert W. Lee, PhD

Lubrizol LifeSciences

Years of Experience?
30

Website:
particlesciences.com

Please tell us how your career started.
Growing up, my passion was playing guitar. My mother (with infinite wisdom and kindness) told me I was a good guitarist – but I’d be wise to have a backup plan! She knew I excelled in math and science, and suggested pharma. I studied pre-pharma at the University of Washington and after my first class, I loved it. Later, Prof. Dr. Boris Weinstein took me on as an undergrad researcher. I finished with a degree in both chemistry and biology. Now, chemistry is my lens – it’s how I see the world.

What are you known for professionally? What is your area of expertise?
Drug product development and chemistry manufacturing controls (CMC). I was a founding member at NanoSystems and would say my expertise is CMC. I am very familiar with analytical, preformulation, drug delivery (nanotechnology, microparticles, lipidic systems), and sterile manufacturing (aseptic production, lyophilization). Particle Sciences is science-driven and technology-agnostic. We have several tools, but our goal is to use the right technology to achieve our clients target product profile.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Helping our clients succeed. Making drugs better or safer is very rewarding. What we do at Particle Sciences is significant. Nearly everyone’s life is touched by cancer. The same with ophthalmics, as the population continues to age, the need for better products in these spaces, and others, will increase. What we do can positively impact almost everyone in the world. We are set up to help our Clients take their programs to the next step, with both clinical and commercial capabilities.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
My wife and I love spending time with our children, grandchild, and family at our new vacation home in Florida. My stepson Brian is 29, loves music, and has become a wonderful young man - I love taking trips with him. My son Kevin, is 17 and enjoys soccer and snow skiing. We have deep discussion on world politics – very interesting since our views are disparate! My grandson Jude is 5, and I’m teaching him to play guitar! He is very busy and often wears me out. The whole clan loves to travel.

Where do you see the industry going in the next 10 years? Your area of expertise?
Drug delivery will continue to become more and more important – creating better, more effective drugs will be the goal. I foresee a balance between advanced technology that is scalable vs the cutting-edge technology coming into play and hopefully for the consumer, offering greater value and accessibility. Particle Sciences is set up to adapt as needed and I feel that eventually the market will flatten such that similar drugs will be available to everyone in the world.

What are you most interested in seeing at INTERPHEX?
Connecting with colleagues both new and old


.

Bob Lenich

Emerson Automation Solutions

Years of Experience?
38

Website
www.linkedin.com/in/bob-lenich

Please tell us how your career started.
My junior year at Rose Hulman Institute of Technology, our Chemical Engineering department received some thermocouples and some Z80 processors (early 1980). We got to wire our distillation column and program it for temperature control. That got me hooked on automation.

What are you known for professionally? What is your area of expertise?
Bob is an expert at applying new technology and organizational trends to solving operating issues across the process industries. I work with a wide variety of functional organizations to identify operational problems, evaluate how to make improvements, and then justify and sell the approach. I have been doing this for the Life Sciences industry for >35 years.

What path brought you to your area of expertise?
Most times we do a project with a Life Sciences manufacturing customer, they would bring in patients that were going to receive the therapy and say "we are building this plant for them". I get great satisfaction out of helping address manufacturing challenges to be able to make therapies for people. As new manufacturing challenges came up, I would get the opportunity to investigate and address them.

What is the biggest challenge you have faced in the industry?
The biggest challenge I face in the Life Sciences industry is the conservative nature of the industry. They can see that something needs to be improved, but are only now starting to embrace making that happen in a timely fashion.

What advice would you give to a professional starting out in the industry?
Take the opportunity to understand the key business processes used to develop and manufacture therapies. Know how what you do applies to those business processes and then work to improve them.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I believe the industry is going through a transformation. It has recognized that it can't follow the same development and manufacturing approaches from the last 30 years. I love being engaged in understanding what needs to change and then looking for the best technology to support those changes.

Professional and/or recognition(s)?
B.S. Chemical Engineering Rose Hulman Institute of Technology, MBA University of Texas at Austin, one patent, many papers and professional presentations.

What is your biggest success thus far in your career? What has contributed to this success?
Helping our customers make their manufacturing efficient and effective. The techniques have changed over the years, but the approach to identify needs and address them has been great.

What are you passionate about personally? What do you enjoy?
I like learning new things and then applying them to solve problems. I like helping people grow.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
I like to play golf, run, and listen to music

What would be impossible for you to give up?
Ice cream

Any volunteer activities you enjoy? Why?
I am currently on the board of my country club. We are in the process of building a new clubhouse and expanding the club. It's great to apply some work skills to something my friends and family will enjoy.

How would you like to be remembered?
As a life-long learner who helped people and the industry improve

Anything else you’d like to tell people about yourself?
I love using quotes / references to add emphasis to a topic

What do you consider a personal success in your life thus far?
Being happily married for 35 years to my high school sweet-heart and having a loving family

How do you feel the industry changed or evolved in recent years?
The Life Sciences manufacturing industry is going through a generational transformation from batch to continuous manufacturing. We are changing the dynamics of how manufacturing contributes to delivering new therapies and to the bottom line (it's not just a black box between research and patient consumption).

Has there been any significant advancement within your area of expertise?
The advancements are accelerating: adding electronic batch records, embedding advanced control/analytics, managing data more effectively for decision support / best practice applications, supporting product development via PLM, improving the understanding of the chemical and biologic processes, etc.

Where do you see the industry going in the next 10 years? Your area of expertise?
I see the industry continuing to transition to smaller, more flexible facilities to product the wide variety of new therapies being developed. Doing that will required continued advances in automation, data management and use, and improving key Life Sciences business processes like a product development lifecycle.

What would you consider to be a major achievement for the industry in the near future?
Making plug and play a reality

My favorite INTERPHEX memory?
My favorite Interphex memory was 15 years ago when my son was 9. He and my wife came out to NYC for the show. The event included St. Patrick's Day and we had a chance to see the NYC St. Patrick's Day parade.


.

William Leonardi, PhD

Avid Bioservices, Inc.

Years of Experience?
8

Website:
www.linkedin.com/wleonardi

What advice would you give to a professional starting out in the industry?
My personal advice is to have a great mindset to focus and learn. Specifically, be willing to roll your sleeve to understand how other department works. That way you will have various skill set that help you grow professionally.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I am very passionate to contribute to society. The reason that I am in this industry is to see the product that we manufacture are used by patients to improve their quality of life (either by curing them from disease or provide supporting therapy on patients life)

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Golfing and Hanging out at home. The easiest way to connect is via social media.

What do you consider a personal success in your life thus far?
Married, finishing my PhD degree before 30

Where do you see the industry going in the next 10 years? Your area of expertise?
I see the industry going to be more highly regulated thus provide better quality product for patient. At the same time, the technological advancement will help to speed up the process from drug development to commercialization. I believe personalized medicine would be the future, therefore from CDMO perspective, there will be more need for CDMO to be able to cater multiple products in smaller scale.

What are you most interested in seeing at INTERPHEX?
I am looking forward to meet/network with multiple industry partners. In particular meeting with vendor, potential investor, and also other companies that provide similar service as my current companies. All above all, I am looking forward to learn new technologies and update my skill sets in Biopharma industries.


.

John Lyons

IPS-Integrated Project Services, LLC

Years of Experience?
15

Website:
www.ipsdb.com

Please tell us how your career started.
My first job out of college was working for a small engineering group that focused on sterile processing and it's been my focus ever since. I've had the opportunity to experience the process of developing and delivering sterile filling facilities from inception through into operations.

Professional and/or recognition(s)?
Faculty for PDA's Fundamentals of Aseptic Processing Course

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Often out challenging myself physically or getting into nature with my family.

Any volunteer activities you enjoy? Why?
I've gotten involved in the local youth wrestling program and have really enjoyed being part of and contributing to that community.

Has there been any significant advancement within your area of expertise?
The range of machine options for aseptic processing and sterile filling in particular has really expanded over the past 10 years or so opening a number of opportunities to rethink about how we put together an operation.

What is your favorite INTERPHEX memory?
I don't remember exactly what year I first attended the show, but I do remember the feeling I had walking onto the floor and seeing endless rows of vendors, technology and energy in one place all related to the field I had recently entered. It was exciting and humbling all at the same time. I now have a better idea of what to expect, but am humbled each year by the number of companies represented and efforts placed on display to push our industry forward.


.

David Marks, PE

O’Neal

Years of Experience?
35

Website:
www.onealinc.com

What are you known for professionally? What is your area of expertise?
I have over 30 years of experience with process systems and facilities in biotechnology, pharmaceutical, medical device, food and chemical industries. I’ve worn many hats in my career including engineering management, process design, project management, facility and equipment design. But my professional experience is concentrated in the design of bioprocess systems and FDA-licensed commercial manufacturing facilities.

What advice would you give to a professional starting out in the industry?
Choose a career path that will build a resume. Work to develop new skills and capabilities. These will make you more marketable, but more importantly, will grow you and develop you as a person.

What is your biggest success thus far in your career? What has contributed to this success?
I’m thankful that I was able to build a design firm (DME Alliance), from the ground up that came to be a recognized leader for facility design in the life sciences industry. With that success, I was able to take a rewarding path that led to the acquisition of the firm by O’Neal Inc.

What are you passionate about personally? What do you enjoy?
I'm blessed with a terrific wife of 35+ years, 6 children, and a growing collection of grandchildren. I enjoy outdoor activities, bicycling, technology, travel, movies, chess, theology, and spending time with my family.

Any volunteer activities you enjoy? Why?
I’m fairly involved in various ministries within my church, driven by a faith in my creator and Savior. I also participate in the MS150 Bike ride. My wife developed MS early in our marriage which, obviously, gave me greater appreciation work the various MS organizations do.

What are you most interested in seeing at INTERPHEX?
Hosting, and participating in our third Facility Focus as part of the INTERPHEX technology presentations.


.

Lance Marquardt

Bristol-Myers Squibb

Years of Experience?
23

Website:
www.linkedin.com/in/lance-marquardt-a0921410

What are you known for professionally? What is your area of expertise?
Production of clinical trial enabling drug substance including First In Human (FIH) studies for biologics produced in CHO cell lines.

What is the biggest challenge you have faced in the industry?
Risk Assessments. While they can be fairly straight forward in some instances, leading cross functional risk assessments has been the most challenging part of my career.

What advice would you give to a professional starting out in the industry?
Learn to value your co-workers as people and treat them accordingly. You don't always have to show that you think you are the smartest person in the room.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Fully single use manufacturing systems, having implemented the first fully single use clinical manufacturing area within the internal manufacturing network gave me a deeper appreciation of the work needed to make it work. The fact that the products we produce will help patients that may not have any other options keeps me motivated to ensure the production schedule is maintained.

Professional and/or recognition(s)?
Member of PDA.

What is your biggest success thus far in your career? What has contributed to this success?
My biggest success was being part of team that designed and implemented the first fully single use clinical manufacturing area within the internal manufacturing network. We had a great team and engineering firm that help ensure the project was executed on time and under budget. The success of this project lead use to replace the existing SS production wing and become a fully single use facility.

What are you passionate about personally? What do you enjoy?
I am an avid science fiction reader and Trekie to the warp core. My three kids keep us busy on the weekends with their activities. I also enjoy hunting in Wisconsin for the two day a year that I am able to be there with our extended family.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
At home spending time with my family. We love to travel to see family and sights both here in the US as well as Portugal.

What would be impossible for you to give up?
Caffeine.

Any volunteer activities you enjoy? Why?
Not currently involved in any volunteer activates, but have been involved with Thrivent in the past providing local teams with funding to perform projects for food pantries, home repairs for those who cannot do the work themselves.

How would you like to be remembered?
A person who cared about those that he worked with and managed enabling them to grow in their careers.

Anything else you’d like to tell people about yourself?
I designed the 347 Shawano County (WI) Barn Quilt for our family farm.

What do you consider a personal success in your life thus far?
My three great kids, just watching them as they develop has been immensely challenging as well as rewarding.

How do you feel the industry changed or evolved in recent years?
Single use manufacturing is fairly well established for clinical production and is starting to be used for commercial production was well. Facilities are now being designed to a standard six pack arrangement.

Has there been any significant advancement within your area of expertise?
Modular facilities have been a significant improvement - each facility is no longer a strictly custom designed facility, unless it is being retrofitted into an existing space.

Where do you see the industry going in the next 10 years? Your area of expertise?
The industry is moving to a more personal medicine approaches such as CAR-T. Mabs will have a place and continue to be developed but new modalities will be start being used that may be easy to grow but have additional challenges in the purification of the product.

What would you consider to be a major achievement for the industry in the near future?
Continuous processing will be one of the major achievements in the near future. Developing these cost effective production methods and integrating them into the lifecycle of the product and qualified successfully.

What are you most interested in seeing at INTERPHEX?
Looking to see what solution being developed in the CAR-T gene therapy space.


.

Piritta Maunu

Vaisala

Years of Experience?
19

Website:
https://www.vaisala.com/en/industries-innovation/life-science

What are you known for professionally? What is your area of expertise?
I work as a life science industry expert. This role requires recurring education of global GxP regulations and best practices, closely following industry trends, and collaborating with many different stakeholders. Typically, I help Vaisala internal people, our partners, and our customers to learn how to design, develop, test, install, qualify, or validate sensors and systems according to stringent life science regulatory expectations within Quality Management System requirements.

What is the biggest challenge you have faced in the industry?
While I was working as a GMP Manager in a Biotech company the company went through downsizing. I was lucky to stay, but I had to take on four different roles. My new job description included - GMP Manager, Cleanroom Manager, Production Maintenance Engineer, and Production Technologist. I juggled these roles for approximately one year. As a gift of this experience, I gained a broad understanding of different knowledge areas, which I later brought to my role at Vaisala.

What advice would you give to a professional starting out in the industry?
GxP regulations, technology and industry standards change, so it’s important to follow industry best practices continuously by participating in relevant organizations, such as PDA, ISPE and ECA. Collaboration is another key. Every time I meet new customer, colleague or technical expert, I learn something. Be open-minded. Collaborate with other industry experts as much as possible!

What do you consider a personal success in your life thus far?
I feel so privileged to have been able - as a woman - to combine a professional career with family life. I live in Finland where this is more common, but it’s not the case everywhere. In addition, I’m able work with Vaisala’s global organization and travel around the world working with experts in a variety of fields; all while living with my family on a farm in Finland’s countryside surrounded by fields, lakes, and forests.

Where do you see the industry going in the next 10 years? Your area of expertise?
I think that in the future firms will need to control and monitor their critical assets more carefully.
In practice, computerized systems will be replacing manual practices. E.g. data from redundant sensors can be used to compare values of controlling and monitoring sensors. Using computerized systems with high quality measurement sensors gives firms better control of their monitored environments and faster notification of failures to excel in product quality, while saving costs and resources.

What are you most interested in seeing at INTERPHEX?
I 'm looking forward to meeting new people, technical experts and potential new customers of Vaisala. It's always good to catch up with current customers as well to learn their hopes and development ideas for existing products on the market. I also look forward to seeing other presentations to learn the latest trends and technologies related to environmental measurements in critical environments.


.

Patrick McGee

PortaFab Corporation

Years of Experience?
Company 40 Personally 6

Website:
www.portafab.com

Please tell us how your career started.
Started as a regional sales manager for the southeastern US

What are you known for professionally? What is your area of expertise?
Modular wall solutions for cleanroom structural envelopes and cleanroom retrofits

What path brought you to your area of expertise?
Focus on modular cleanroom solutions

What is the biggest challenge you have faced in the industry?
Misunderstanding of modular options and solutions

What advice would you give to a professional starting out in the industry?
Always start by finding out the true needs of your customer. Cleanrooms are often over-complicated

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I am most excited to bring the correct and needed solution to a customer and succeed in fulfilling process needs.

What is your biggest success thus far in your career? What has contributed to this success?
Expanding PortaFab further into the cleanroom industry. The success stems from educating others on true needs within their cleanroom environments

What are you passionate about personally? What do you enjoy?
I have a passion for cooking, especially BBQ, running and photography

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
On my back patio focused on perfecting the perfect smoked brisket

What would be impossible for you to give up?
Early morning runs

Any volunteer activities you enjoy? Why?
Coed sports for charity.

How would you like to be remembered?
Through my future family

How do you feel the industry changed or evolved in recent years?
There is a further understanding of the need of appropriate requirements and regulation

What are you most interested in seeing at INTERPHEX?
PortaFab looks forward to further showing our benefit to the Pharmaceutical industry through varying modular wall solutions


.

Ian Miller

Optel

Years of Experience?
10

Website:
Optelgroup.com

Please tell us how your career started.
I began my career in the packaging industry within the subset of marking and coding. Shortly thereafter, I transitioned into vision, quality inspection, and serialization.

What are you known for professionally? What is your area of expertise?
Sales Manager recognized and awarded as one of the top sales performers within the manufacturing industry. My area of expertise is within vision, serialization, coding and general processing/packaging.

What path brought you to your area of expertise?
I have spent the last ten years working with clients meet their unique packaging needs, specifically compliance with DQSA regulation.

What is the biggest challenge you have faced in the industry?
Educating the pharmaceutical and medical device industry of the value to utilizing recent advancements in technology. These advancements centered on the quality, safety, and regulatory compliance.

What advice would you give to a professional starting out in the industry?
It is never too early to develop a

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
It is exciting to see a project go from concept to design, then finally seeing the end result after months or years.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Hiking, playing baseball with my son, or travelling for leisure.

What is your favorite INTERPHEX memory?
Meeting old friends from years past, catching up with them on recent events, and learning about their recent work projects.


.

Ali Mohamed, PhD

Immatics Biotechnologies  

Years of Experience?
20

Website:
www.immatics.com

Please tell us how your career started.
PhD in Molecular Pharmacology

What are you known for professionally? What is your area of expertise?
Process development and GMP manufacturing of cell therapy products

What path brought you to your area of expertise?
Cell therapy

What is the biggest challenge you have faced in the industry?
Lack of approved products

What advice would you give to a professional starting out in the industry?
Work hard and make the right choice for the career you love

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Developing non-traditional cancer therapies. Taking and idea and making a product out of it.

Professional and/or recognition(s)?
VP of CMC at Immatics Biotechnologies

What is your biggest success thus far in your career? What has contributed to this success?
Taking 4 immunotherapies from development to IND. knowledge and team work.

What are you passionate about personally? What do you enjoy?
Developing cellular immunotherapies.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Travel & family.

What would be impossible for you to give up?
Family

How would you like to be remembered?
Someone who have contributed to society

What are you most interested in seeing at INTERPHEX?
New products to improve cell therapy manufacturing.


.

Rick Morris, Ph.D

Pall Biotech, Pall Corporation

Years of Experience?
29

Website:
Pall.com

Please tell us how your career started.
I went through a Co-Op/Internship with Courtaulds in the UK - chemicals and polymers.

What are you known for professionally? What is your area of expertise?
Known for being able to successfully launch both consumables and systems related products into both the Life Sciences and Industrial Markets.

What path brought you to your area of expertise?
Ph.D in polymer science/chromatography and biotechnology.

What is the biggest challenge you have faced in the industry?
Ensuring the correct level of automation and controls for total integrated solutions.

What advice would you give to a professional starting out in the industry?
Stay current with advances in molecular and cell biology.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Providing a process that enables a treatment or drug to be provided either in an amount that is usable and cost effective way.

Professional and/or recognition(s)?
Fellow of the Royal Society of Chemistry (FRSC), Chartered Scientist, Chartered Chemist, Member of AACC.

What is your biggest success thus far in your career? What has contributed to this success?
Being part of the launch team for The Continuous Bioprocessing Platform by Pall Corporation. Doing what is needed to make things happen.

What are you passionate about personally? What do you enjoy?
My family and I enjoy to visit with them in their different locations in the USA. I enjoy good cheese and wine. I like to watch Rugby having played in my youth.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Walking in State Parks or along the beach. Walking my dogs.

What would be impossible for you to give up?
Reading about new technologies.

How would you like to be remembered?
Someone who cared about what the customer really wanted and delivered to that expectation.
Plus making sure things get completed.

What do you consider a personal success in your life thus far?
Having three very capable children who have their own careers. Being married for 28 years.

How do you feel the industry changed or evolved in recent years?
Rapid move to gene therapy and cell therapy scale up. Large drive for cost savings in the mAb and Biosimilars area.

Has there been any significant advancement within your area of expertise?
Increase in the amount of process automation and linking operations together in order to save costs and shrink footprint.

Where do you see the industry going in the next 10 years? Your area of expertise?
There will be even more linking of processes, in line measurements of key process and product analytes, further shrinking of the footprint.

What would you consider to be a major achievement for the industry in the near future?
Increased use of continuous processes.

What are you most interested in seeing at INTERPHEX?
Seeing what advances various vendors have made with their product offerings.


.

Lance Oberlin

Rovisys

Years of Experience?
23+

Website:
www.rovisys.com

Please tell us how your career started.
My career started as an Information Systems Specialist in the United States Army. From there I spent nearly 20 years in both the Enterprise and Manufacturing Information Technology space, ranging from Infrastructure Analyst to I.T. Manager (managing teams of IT and OT engineers).

What are you known for professionally? What is your area of expertise?
My area of expertise helping clients with the convergence of IT (Business areas) and OT (Manufacturing areas). Not just the physical and logical connectivity of these two (very different worlds), but doing so while understanding and maintaining the functionality, security, and business continuity requirements the business wants and needs.

What path brought you to your area of expertise?
Throughout my career, having spent significant time in various roles within both IT and OT, and having been 'the customer' and also the integrator, I have been able to amass valuable perspective , experience, and insight that allows me to think, speak, and translate to both IT and OT personnel and mindsets effectively.

What is the biggest challenge you have faced in the industry?
Lack of understanding of the key differences between the IT and OT mindsets and priorities. For example, security is treated as paramount on the business IT side, yet rarely a consideration in the manufacturing space; instead, if it is working it isn't touch for fear of disrupting production.

What advice would you give to a professional starting out in the industry?
Achieve as much perspective as possible, don't limit yourself to 'the way it has always been or is now'. Technology, and how it is used, changes very quickly; it is easy to get 'stuck' in doing things a certain way because that's what worked. Allow yourself to see, accept, and embrace the writing on the wall.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Helping clients navigate seemingly difficult projects and ambitions. The sense of ownership and accomplishment that comes with getting a complex project across the finish line.

Professional and/or recognition(s)?
Variety of technology related certifications.

What are you most interested in seeing at INTERPHEX?
Meeting likeminded people that are interested in learning about and discussing current trends in technology and what they think the near future might hold.


.

Emily Peterson

Millipore Sigma

Years of Experience?
19

Website:
www.milliporesigma.com

Please tell us how your career started.
I started out as a Process Engineer at a small cotton bleaching plant in the Western part of Massachusetts.

What are you known for professionally? What is your area of expertise?
I think most people recognize me as a TFF (tangential flow filtration) expert. I've spent most of my career developing UF membranes and working with TFF applications.

What path brought you to your area of expertise?
While an undergrad Chem E student I had an opportunity to work with NASA on a Martian sample return canister. The idea was to design a prototype which could withstand the temperature and pressure extremes associated with inter-planet travel. Our team used microporous membranes as a way of preserving the integrity of the samples (and Earth) during its journey back from Mars. It was then I developed an interest in membrane separations.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I am passionate about making a positive impact on the health of mankind. As a child I wanted to become a Physician so I could heal people. While I eventually decided to go down the Engineering path, I find great satisfaction working with the various Biotech companies who enhance the lives of people through their therapeutic biologics and other life changing advances in the industry.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
I enjoy spending time with my family and keeping up with my two middle-schoolers' busy schedules. When I have free time I enjoy golfing, skiing, travel, at-home work-outs and cooking.

What are you looking forward to at INTERPHEX?
I'm looking forward to catching up with those whom I've met in the past as well as making new connections.


.

Tom Piombino

IPS - Integrated Project Services

Years of Experience?
24

Website:
www.ipsdb.com

Please tell us how your career started.
I entered the biopharmaceutical workforce as an architectural engineer in construction estimating in California.

What are you known for professionally? What is your area of expertise?
I am best known as a BioProcess Architect as well as for the recent launch of iCON Hybrid Modular Facility Design.

What path brought you to your area of expertise?
Joining IPS in 1998 pointed me toward biopharma as a specialty.

What is the biggest challenge you have faced in the industry?
My biggest challenge has been in reinventing myself. I started as an estimator and have pivoted towards my interests/aptitudes almost a dozen times.

What advice would you give to a professional starting out in the industry?
First, if you focus on the mission this can be a very rewarding profession. Second, I've found that peripheral vision is the key to having a true understanding of this profession and to becoming being a specialist. Solutions aren't always directly in front of you so it's important to look both ways.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
The mission of helping people in need combined with creating something innovative.

Professional and/or recognition(s)?
Recently appointed Innovation Champion within IPS.

What is your biggest success thus far in your career? What has contributed to this success?
The greatest success in my career will always be the next one and having a firm "Standard of
Humility" is what keeps me driving forward.

What are you passionate about personally? What do you enjoy?
Well, I'm the guy sobbing at the Disney movies. I didn't understand this for a long time and then I realized that I enjoy being inspired. We live in a complex world and inspiration is easy to find if you're open to it. Things that inspire me are effort based so I really enjoy the "thrill of victory" and "the agony of defeat" and all that comes with the human experience.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Celebrating life with my family............................ beach, slopes, trails, happy hour.

What would be impossible for you to give up?
Being creative.

How would you like to be remembered?
I'd like to be remembered as a life contributor and someone whose presence encourages others to be their best and find fulfillment.

What do you consider a personal success in your life thus far?
I'd say but I don't want to jinx it; nothing in life is permanent!

How do you feel the industry changed or evolved in recent years?
For many years, it was assumed that biopharmaceutical innovation came from certain geographical regions; it's apparent now that this is no longer the case.

Has there been any significant advancement within your area of expertise?
Gene therapy definitely represents a shift towards a new era.

Where do you see the industry going in the next 10 years? Your area of expertise?
Hmm, I think our industry is going to face unprecedented change and opportunity in the next 10 years. We have had the luxury of being inwardly focused for nearly a half century and now we will need to balance this with outward-facing pressure that will distract us from our current focus.

What would you consider to be a major achievement for the industry in the near future?
Positive repeatable patient outcomes in viral vector based gene therapies.

What are you looking forward to at INTERPHEX?
I would like to see gene and cell therapy innovators at Interphex. There is a desperate need for the private sector to discover, document and influence manufacturing policy and techniques. Operating companies need help to scale the manufacturing platform to serve the patient population and Interphex can play a role in connecting the operating companies with the new technology.


.

Kristina Pumphrey

Precis Engineering

Years of Experience?
20

Website:
http://precisengineering.com/about.php

What path brought you to your area of expertise?
I started out of high school as a consultant in design engineering and have always been focused on the Life Sciences. Being a consultant for almost 20 years has given me a broad knowledge base and experience with a large number of companies & technologies. If I had to list my expertise it would be material handling, hazard analysis, and process optimization.

What advice would you give to a professional starting out in the industry?
First, I would tell them to take the FE exam now while your studies is still fresh. My second piece of advice...................... be open to opportunities, although a new challenge is tough it is these opportunities where you learn the most.

Any volunteer activities you enjoy? Why?
I am very active with my local ISPE-DVC chapter as I am the current president. I always take any opportunity to speak to students about what I do with the hope to inspire the next engineer. I love volunteering with Future Cities and Girls Exploring Tomorrow’s Technology (GETT). Or just talking to college and high school students about my job so they have a better idea which aspect of engineering interests them.

Where do you see the industry going in the next 10 years? Your area of expertise?
I'm very excited about the advancement in Cell and Gene Therapy, and their ability to cure patients with cancer and rare diseases. With respect to manufacturing it is going to change the game with smaller manufacturing areas (benchtop) that will need to be close to the patient.

What are you looking forward to at INTERPHEX?
INTERPHEX is such a great show to learn and show clients about the different equipment and technologies available all in one place. It is also fun to network and get to hang out with my friends in the industry.


.

Madhu Raghunathan

GE Healthcare Life Sciences

Years of Experience?
15+

Website:
www.linkedin.com/in/madhu-raghunathan

Please tell us how your career started.
Started my career by developing industrial control software applications, then moved onto a role in technology commercialization, and have since worked in a number of product management and leadership roles in the Bioprocess business at GE.

What path brought you to your area of expertise?
Being curious and open to change. I have worked across three industries but each of the previous experiences leading to this one have had a big impact on the roles I have held in my roles at GE.

What is the biggest challenge you have faced in the industry?
Coming up to speed with the language and technical knowledge that's necessary to be successful in this industry.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I am passionate about finding technological solutions to complex real-life customer problems and bringing them to market while adding value to our customers and other key stakeholders.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Spending time with the family. Going for a run or cycling with my oldest daughter in Prospect Park. Playing sports.

What is your favorite INTERPHEX memory?
Visiting Interphex for the first time and being amazed by the scale of the show and how well things were put together.


.

David Richardson, D.D.

Pnuematic Scale Angelus

Years of Experience?
38

Website:
psangelus.com

Please tell us how your career started.
Undergraduate Research

What are you known for professionally? What is your area of expertise?
Upstream and downstream processing. Bioreactors/fermenters and Centrifuges

What path brought you to your area of expertise?
Experience

What is the biggest challenge you have faced in the industry?
Bringing in new technology. Stirred tanks for cell culture, disk stack for CHO, Single use centrifuges

What advice would you give to a professional starting out in the industry?
Get experience

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
New applications. Working on several applications- currently HEK and Stem cell.

What are you passionate about personally? What do you enjoy?
Family

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
With family

What would be impossible for you to give up?
My religion

Any volunteer activities you enjoy? Why?
Church scouting group

How would you like to be remembered?
Straight shooter

Anything else you’d like to tell people about yourself?
Family Man, God fearing

What do you consider a personal success in your life thus far?
Bringing new technology to market

How do you feel the industry changed or evolved in recent years?
Higher titers

Has there been any significant advancement within your area of expertise?
Moved to Single use

Where do you see the industry going in the next 10 years? Your area of expertise?
More Single use


.

Kristen Riley

The Bioprocess Institute

Years of Experience?
25

Website:
www.bioprocessinstitute.com

Please tell us how your career started.
A graduate of URI's International Engineering Program (IEP), I started as a process engineer at Hoechst AG in Frankfurt, Germany and Hoechst Celanese, then decided to move to a small environmental business after earning my MBA.

What advice would you give to a professional starting out in the industry?
Always listen to the true needs of your customer, seeking first to understand, then to be understood.

What are you passionate about personally? What do you enjoy?
Daily exercise with cardio

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Enjoying time with my family, including 2 Russell Terriers, along with paddleboarding in the summer and skiing in the winter

Any volunteer activities you enjoy? Why?
Speaking at university/school events to inspire the next engineer

What are you looking forward to at INTERPHEX?
Making new contacts who want to understand how BPI helps its clients to make better drug therapies.


.

Dennis Romak

Plus Group

Years of Experience?
27

Website:
www.plusgroups.com

Please tell us how your career started.
As a sub-contractor installing seamless flooring systems in regulated manufacturing facilities

What are you known for professionally? What is your area of expertise?
The combination of market, project, and design experience drives a better understanding of client needs

What path brought you to your area of expertise?
Sub-contracting to product manufacturing to design services

What is the biggest challenge you have faced in the industry?
Quantity and quality of new design professionals entering the industry

What advice would you give to a professional starting out in the industry?
Explore Industrial/Process Architecture; it is an overlooked profession.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Understanding how clients make decisions so we can improve our services

What is your biggest success thus far in your career? What has contributed to this success?
Going back to school for my MBA was pivotal in my career

What are you passionate about personally? What do you enjoy?
Family, Fitness, Boating

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Summer on the lake

What would be impossible for you to give up?
Family

Any volunteer activities you enjoy? Why?
Matthew 25 Ministries

How would you like to be remembered?
Good Husband and Father
Accomplish more with less

Has there been any significant advancement within your area of expertise?
Design program advancements

Where do you see the industry going in the next 10 years? Your area of expertise?
Accomplish even more with less

What would you consider to be a major achievement for the industry in the near future?
More continuous process, and less batch production

What is your favorite INTERPHEX memory?
Seeing industry trends through the type and size of vendor booths and equipment from 20 years ago.


.

Ernest Stadler, P.E.

New Horizon Biotech, Inc.

Years of Experience?
30

Website:
www.newhorizonbiotech.com

Please tell us how your career started.
I started out as a mechanical engineer in design and project management for utility fossil and nuclear fueled power plants and then migrated to senior engineering positions involved with large scale compressors and other rotating machinery in tonnage gas air separation plants. After some years in this field I discovered the broader field of bioprocess equipment and found a great affection for the fermentation and cell culture industries.

What are you known for professionally? What is your area of expertise?
Best known for knowledge of performance prediction and scale-up on microbial fermenters and cell culture bioreactors. Areas of expertise include ability to accurately predict productivity around oxygen mass transfer, mixing, and dissolved oxygen strategies to optimize processes.

What path brought you to your area of expertise?
A mid-career change away from central station power plants and tonnage gas air separation plants. A job change in engineering management at a then small fermenter / bioreactor manufacturer gave me entree into this very interesting and at the time young field. Dedication to understanding key performance parameters around vessels, mixers, and aeration gave me important insights into the inner workings of these classes of bioprocess equipment.

What is the biggest challenge you have faced in the industry?
In the late 1980's and throughout the 1990's there was a shortage of installed fermenter / bioreactor capacity as the biotechnology industry rapidly expanded. This led to a need for designing larger scale equipment that would perform successfully in producing therapeutic proteins exactly the same as those produced in R&D at bench scale. Equipment at this time and even into the 21st century were predominately stainless steel SIP and CIP systems.

What advice would you give to a professional starting out in the industry?
Understand the science behind what is needed to keep microbes and mamallian cells alive during cultivation as they are expanded up to volumes needed to produce Kg quantities of today’s demand for biopharm biologic products. Keep in mind the necessary drivers for cell growth and all other operational factors around the control strategy for successful batch, perfusion, continuous and other cultures being used.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
The move from stainless steel to single use equipment has been dramatic in its impact on the industry and always looking for better ways to serve our industry through process improvement and novel equipment concepts is exciting. Helping users to find faster and lower cost ways to market is particularly satisfying.

Professional and/or recognition(s)?
Serving our industry through helping to educate through lectures and publications has resulted in personal recognition as an author and teacher.

What is your biggest success thus far in your career? What has contributed to this success?
Currently the biggest success is the opportunity to develop an entrepreneurial endeavor leading to the formation of a new company with a patented technology in the area of single use fermenters and bioreactors. Working through the patent process and receiving patent approval was most satisfying. Success comes from being willing to always try something new and following your passion.

What are you passionate about personally? What do you enjoy?
My life long avocation has always been the performance of music be it sacred or secular, rock or jazz, classical or pop. Throughout my life I have been fortunate to have numerous performance opportunities on piano, saxophone, flute and even vocals. I am most passionate about performing great jazz with my quintet whenever opportunities arise.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
I love to hang out with my loving wife and visit grandchildren as often as possible. At home I am either relaxing with a book, doing repairs or projects around the house or sitting at the piano working out new and interesting chord voicings' on many favorite tunes.

What would be impossible for you to give up?
Over the years I have had to give up some great hobbies such as performing late evenings in clubs, private piloting, skiing, and tennis. Giving up activities as a result of aging gracefully has not been impossible but merely practical. The one thing that would be impossible for me to give up would be not making music in some way shape or form. It began at 5 years of age with an accordion and has been a lifelong endeavor. I see this activity keeping strong well into retirement.

Any volunteer activities you enjoy? Why?
I have volunteered performing with my combo on occasion at senior homes on occasion and enjoy this as an outlet to share music with the older generation.

How would you like to be remembered?
As a father of two successful sons and as the husband of a loving wife that has supported and shared with me in all my lifelong activities. Also as a right and left bring person that contributed to the arts and engineering in many different capacities. Also as an inventor that achieved a successful patent hopefully leading to a successful SU product to serve the bioprocess community.

Anything else you’d like to tell people about yourself?
I am fortunate in that wife shares my love of science fiction. We are both Trekkies. Star Trek, Star Wars - doesn't matter so long as there are interesting alien species!

What do you consider a personal success in your life thus far?
Keeping true to my career in engineering for the betterment of man and woman kind! The cliché better products through engineering will always be true and emerging technologies keep this field alive, interesting, and challenging.

How do you feel the industry changed or evolved in recent years?
The evolution of block buster new biologics has driven the industry to find faster ways to market and lower production costs. The largest evolution in the past 10 years has been the push to migrate as much as possible away from SIP and CIP stainless steel equipment to single use equipment for almost every unit operation upstream, downstream, and even in final formulation. Legacy stainless steel equipment will continue to be replaced by SU processes.

Has there been any significant advancement within your area of expertise?
There are always improvements in defined media and production methods. Process development will continue to improve titers and yields of mammalian cells to ever higher and higher levels.

Where do you see the industry going in the next 10 years? Your area of expertise?
Small scale bioreactors for personalized medicine will continue to be an area of interest. For large scale production, perfusion and continuous culture will eventually dominate cell culture as yields improve and operating costs decline.

What would you consider to be a major achievement for the industry in the near future?
Successfully replacing batch operations with continuous culture where large scale Kg quantities of therapeutic proteins are in demand.

What is your favorite INTERPHEX memory?
Seeing and saying hello to the many colleagues that I have worked with over the years. INTERPHEX provides an important function through networking to keep business and personal relationships alive.


.

Marsha Steed

bluebird bio, Inc.

Years of Experience?
26

Website:
bluebirdbio.com

Please tell us how your career started.
An internship in Microbiology at a Contract Testing Lab in MA

What are you known for professionally? What is your area of expertise?
Environmental Monitoring, Contamination Control, Quality Risk Management, Cell and Gene Therapy, Aseptic MFGing

What path brought you to your area of expertise?
Years and years in the pharma/biotech industry and being active in PDA

What is the biggest challenge you have faced in the industry?
We move so slow to change the way we do things

What advice would you give to a professional starting out in the industry?
Get active in industry organizations

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Helping patients and changing lives

Professional and/or recognition(s)?
PDA Distinguished Service Award 2019

What is your biggest success thus far in your career? What has contributed to this success?
Helping get the first cell therapy product FDA approval and helping to get the first gene therapy product FDA approval

What are you passionate about personally? What do you enjoy?
Family, Beach, Vacations and living life to its fullest

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Well I just moved across the country from CA to Boston so decorating the new home

What would be impossible for you to give up?
Family time

Any volunteer activities you enjoy? Why?
PDA everything

How would you like to be remembered?
Someone who made a difference in the pharma micro world by influencing others

How do you feel the industry changed or evolved in recent years?
It's slow to change but Cell and Gene Therapy are the way of the future

Has there been any significant advancement within your area of expertise?
Cell and Gene Therapy

Where do you see the industry going in the next 10 years? Your area of expertise?
Closed processing, personalized medicines

What would you consider to be a major achievement for the industry in the near future?
Lower costs to bring these therapies to patients

What are you looking forward to at INTERPHEX?
I am looking forward to seeing all the new equipment options and networking with industry friends and peers


.

Angelo Stracquatanio

apprentice.io

Years of Experience?
10+

Website:
www.apprentice.io

What are you known for professionally? What is your area of expertise?
I am known for being the CEO & Co-founder of the first conversational augmented reality (AR) and artificial intelligence (AI) platform that 21 CFR Part 11 compliant for pharma, biotech and complex manufacturing industries. We are experts in providing AR and AI solutions to empower workforces operating in complex, compliance-driven environments.

What path brought you to your area of expertise?
I had close relationships with professionals in the pharma and biotech space who would talk about million dollar losses, massive delays, and lost batches all caused by human error. Hearing these stories changed the way I thought about how humans operate in complex, compliance-driven environments. I knew that with the right technology, these errors could be completely avoidable. So, I began to develop a solution to empower the scientists and engineers in labs and manufacturing suites.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
I believe in a humanistic approach to AR and AI for enterprise in which empowerment is achieved through sophisticated technology. The innovations we are building today have the power to improve what humans are capable of in the workplace. AR and AI is the vehicle through which we will gain insight into our human processes and unleash our workforces’ fullest potential so that scientists, SMEs, engineers and manufacturers of the world can develop the lifesaving products we need.

How do you feel the industry changed or evolved in recent years?
AR has evolved into the most promising digital technologies. It is transforming all major enterprise industries and changing the way companies compete for space. The truth is that when applied smartly, AR can unleash a workforce’s fullest potential. Industry leaders are realizing this and are accepting this tech as the way of the future. Today’s AR also focuses heavily on the improving the user experience and discovering new ways to help humans achieve goals and learn from that interaction.

Has there been any significant advancement within your area of expertise?
Enterprise AR has evolved far beyond that of Google Glass. There is endless potential for a workforce, including cost-efficient training, global collaboration, hands-free access to procedures, intelligent data capture and more. This tech significantly improves complex processes and provide solutions for batch records, tech transfer, R&D workflows plus training procedures, troubleshooting, support and more. It’s changing the way workforces across all industries solve problems and collaborate.

What are you looking forward to at INTERPHEX?
Interphex never disappoints. Each year we meet great people from all over with valuable industry insight and foresight. With the pharma industry growing so quickly, I am really excited to see the newest industry advancements and innovations. We support the pharma industry’s dedication to safer, more reliable laboratory research and drug manufacturing.


.

Mark Szczypka

Pall Biotech

Years of Experience?
20+

Website:
https://biotech.pall.com/

Please tell us how your career started.
First position as a scientist was at Dow Chemical Company in Midland Michigan. I began working in a lab as a student technologist researching polymers for biological applications.

What are you known for professionally? What is your area of expertise?
Cell and Gene Therapy.

What path brought you to your area of expertise?
Research and Development in various fields, including molecular biology, systems biology, polymer chemistry, genetic, biologics production and stem cell.

What is the biggest challenge you have faced in the industry?
Adoption of novel technologies for product manufacturing.

What advice would you give to a professional starting out in the industry?
Start by becoming technically sound in your area of expertise. Begin to expand your horizons. Establish meaningful connections with individuals in the field and maintain communication with those individuals throughout your career.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Working with individuals and groups that are developing ground breaking technologies and development of strong organizations (people, processes and technologies).

What is your biggest success thus far in your career? What has contributed to this success?
Cloning and characterization of novel genes. Using gene therapy to rescue a fatal phenotype in an animal model. Working with an excellent team that develops processes for novel therapies.

What would you consider to be a major achievement for the industry in the near future?
Full realization of affordable and efficient manufacturing platforms to enable production of therapeutic treatments to patients.

What are you looking forward to at INTERPHEX?
Would like to connect with potential collaborators that are developing breakthrough therapies for human and animal diseases.


.

Mike Ultee, PhD

Ulteemit BioConsulting

Years of Experience?
35

Website:
www.ulteemitbio.com

Please tell us how your career started.
I come from a family of chemists. My parents were both chemists, and my grandfather as well. In fact, there is even an "Ultee Reaction" named for my grandfather. With such a lineage and family resources, I soon became passionate about all types of chemistry, from inorganic to organic, nuclear to biochemistry. I loved the both the organized structure as well as creative aspects of chemistry. In biochemistry I found the challenge of the large molecules of life irresistible.

What are you known for professionally? What is your area of expertise?
Helping discovery-focused biopharma companies transform their research products into biopharmaceuticals through process development and cGMP manufacturing.

What are you passionate about personally? What do you enjoy?
I have three passions beyond biochemistry. First is home beer brewing, which I began in 1987 and from which since have been enjoying both the production and the products. Second is ringing hand bells as an active member of a bell choir. Third is oil painting of landscape scenes, which is a great way to relax.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
I enjoy traveling and exploring new places, especially in Europe.

Where do you see the industry going in the next 10 years? Your area of expertise?
I see more emphasis and progress on efficiency of biopharmaceutical production to reduce costs. In particular, I see even higher titers for recombinant protein production, faster and more efficient downstream processing moving toward continuous processing, and a rapid expansion and maturation new cell and gene therapies.

What are you looking forward to at INTERPHEX?
Interphex is a great conference both to see the latest equipment and instrumentation as well as to connect with friends in the industry.


.

James Vogel, P.E.

The BioProcess Institute

Years of Experience?
36

Website:
www.bioprocessinstitute.com

Please tell us how your career started.
I have been a BioProcess Engineer since I learned that cells can make products for mankind.

What are you known for professionally? What is your area of expertise?
BioProcess Engineering, he BioProcess Institute (BPI) provides superior consulting, testing and training services to help the biopharmaceutical industry make better drugs. We know how to find the balance between science, regulations, and operations within the complex world of bioprocessing.

What path brought you to your area of expertise?
College, then keeping focused to fulfill my goals.

What is the biggest challenge you have faced in the industry?
Leading the design of the Amgen facility in Rhode Island.

What advice would you give to a professional starting out in the industry?
Utilize your training to add value!

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Helping clients make better drugs and products!

Professional and/or recognition(s)?
BioProcess International Annual Award!

What are you passionate about personally? What do you enjoy?
Family, Cycling, Boating

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
On my boat in the Narrow River, at the beach, riding my bike

What would be impossible for you to give up?
The BioProcess Institute

Any volunteer activities you enjoy? Why?
Alphabet Soup (BPSA, ISPE, PDA, ASTM, ASME-BPE), The Narrow River Preservation Association, South Kingstown Bicycle and Pedestrian Advisory Committee

How would you like to be remembered?
Having Fun

What do you consider a personal success in your life thus far?
Raising two children who are successful Engineers

How do you feel the industry changed or evolved in recent years?
There are less overall understanding of the industry. Too much check the box and not seek to understand.

Has there been any significant advancement within your area of expertise?
Every day. Single-Use!

Where do you see the industry going in the next 10 years? Your area of expertise?
Personalized Therapies, Continuous

What are you looking forward to at INTERPHEX?
Roiling out the BioProcess Performance Report on Diaphragm Testing to the public


.

Aaron Weinstein

IPS-Integrated Project Services, LLC

Years of Experience?
20

Website:
www.ipsdb.com

Please tell us how your career started.
I was hired by Fluor Daniel as a Validation Specialist.

What are you known for professionally? What is your area of expertise?
I have a strong background in planning and executing the CQV phases of large scale projects.

What path brought you to your area of expertise?
Early in my career I was assigned to a pilot scale biotech project. As that site grew, I was able to learn more and more about the facilities, utilities, process equipment and software associated with these projects. More importantly, I was able to see how the different groups (engineering, construction, operations, maintenance, QC, QA) worked together to successfully complete a project and get the facility up and operating.

What advice would you give to a professional starting out in the industry?
Take time to listen and then ask questions. The information you gain through listening and asking the right questions will serve you immediately and also help your future growth.

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Joining a team at the right time and immediately adding value to a project. It is always exciting to learn new things and take advantage of the opportunity to share your knowledge with others.

What are you passionate about personally? What do you enjoy?
I enjoy planning and cooking meals. It is a great way to have a feeling of accomplishment while creating food that people enjoy.

Where can we find you when you’re not working? What’s your favorite way to spend some well-deserved time off?
Sitting on the beach with my family and a good book.
How do you feel the industry changed or evolved in recent years?

Much like the rest of the world, computer systems are constantly evolving in the industry. Regulators and companies have to work faster and smarter to successfully assess these new applications of technology and implement the business solutions that make sense.

What is your favorite INTERPHEX memory?
Participating in my first INTERPHEX Live to talk about Computer System Validation. It was a great opportunity to talk about a subject that I enjoy, in an easy and conversational manner!


.

Michael E. Williams, M.D.

University of Virginia Health System

Years of Experience?
33

Website:
UVA Cancer Center

What are you known for professionally? What is your area of expertise?
Lymphoma research and patient care

What path brought you to your area of expertise?
Residency and fellowship training in hematology and medical oncology

What are you most passionate about professionally? What most excites you about your work and the contribution(s) you make?
Seeing patients with otherwise treatment-resistant lymphoma achieve clinical remissions with effective and well tolerated oral therapeutics

What is your biggest success thus far in your career? What has contributed to this success?
Contributing to the understanding and treatment of lymphoma, especially mantle cell lymphoma.

Any volunteer activities you enjoy? Why?
Lymphoma Research Foundation Scientific Advisory Board member. The Foundation does outstanding work in supporting research and patient education

Has there been any significant advancement within your area of expertise?
Dramatic progress in recent years to integrate novel targeted therapeutics, many oral rather than intravenous, for lymphoma and other blood cancers.

What are you looking forward to at INTERPHEX?
Taking part in the discussion of oral anticancer therapies


.

Kathryn C. Worrilow, PhD

LifeAire Systems

Years of Experience?
31

Website:
https://lifeaire.com

Please tell us how your career started.
My absolute fascination with molecular signaling, the role of epigenetic influences and environment necessary to support the successful in vitro culture of the human embryo – all towards helping patients fulfill their dream of having a baby.

What are you known for professionally? What is your area of expertise?
I am known as a past provider of In Vitro Fertilization to patients and now as providing a solution in the support of the optimal environment for the in vitro culture of the human embryo, living cells, and ultimately towards the protection of the infant in the NICU, surgical patient in the OR, and the elderly in assisted living from airborne illness and infection-improved patient care and healthcare economics while reducing overall costs.

What is the biggest challenge you have faced in the industry?
The LifeAire System is a transformational air purification technology that offers a paradigm shift in the life sciences and healthcare industries. The technology provides airborne metrics exceeding GMP guidelines and proven necessary for the successful culture of living cells. Offering a technology that challenges existing dogma can be challenging.

Professional and/or recognition(s)?
Authored over 60 scientific papers and chapters, served as an invited editor and reviewer for leading textbooks and journals, and invited to serve as a TedTalk speaker and speak both nationally and internationally. Recipient of the e Star Award from the American Society for Reproductive Medicine in 2011-2016, and top healthcare and innovation Awards.

What do you consider a personal success in your life thus far?
I am so proud of our sons and the young men they have become-they each work hard in their chosen fields and most importantly, are med of honor, integrity and kindness towards others.

What is your favorite INTERPHEX memory?
Please respond to the chosen question from above here:
As a relatively new exhibitor for INTERPHEX, we did not expect to win the Editor’s Award, especially considering our entry among so many strong companies. When my colleague informed me of the award, I rushed through the downtown streets of NYC to the steps of the Javits Center seconds before the commencement of the ceremony. It’s a recognition that we absolutely did not expect but honored to have received and one that compels us towards a more confident and definitive path in Life Sciences.

We use cookies to operate this website and to improve its usability. Full details of what cookies are, why we use them and how you can manage them can be found by reading our Privacy & Cookies page. Please note that by using this site you are consenting to the use of cookies.