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INTERPHEX AND PHARMACEUTICAL TECHNOLOGY ANNOUNCE KEYNOTE SERIES PROGRAM

03/13/2019

INTERPHEX AND PHARMACEUTICAL TECHNOLOGY ANNOUNCE KEYNOTE SERIES PROGRAM

NEW YORK, NY – March 13, 2019International Pharmaceutical Expo (INTERPHEX), the premier event dedicated to pharmaceutical and biotechnology innovation, technology and knowledge from development through commercialization, and Pharmaceutical Technology and BioPharm International, two leading information sources for the global drug development and manufacturing community, today released the Keynote Series @INTERPHEX program for 2019. The Keynote Series features industry experts delivering insight on key industry themes, challenges and solutions to cost effectively develop and manufacture quality product. INTERPHEX takes place April 2-4, 2019 at the Javits Center, New York, NY.

Keynote Series, Innovation Stage, #1281
Tuesday, April 2, 2019

"Designing Continuous Manufacturing Processes for Solid-Dosage: Development to Commercial Scale" - 10:30am – 12:00pm

Several solid-dosage drugs are now approved for manufacture using continuous processes, and early adopters and equipment manufacturers have been making progress in addressing engineering challenges. Two of the potential advantages of continuous manufacturing compared to batch manufacturing are rapid development and flexibility in scale. This panel discussion will consider what benefits are being realized and what challenges are arising as continuous processes are commercialized. Experts will discuss best practices for and challenges in tech transfer and scale-up/scale-out from development to commercial scale.
Moderator: Jennifer Markarian, Manufacturing Editor, Pharmaceutical Technology
Panelist(s): Doug Hausner, Associate Director, Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), Rutgers University; José Luis Santos, Head of Drug Product Continuous Manufacturing, Hovione; Sharon Nowak, Global Business Development Manager, Coperion KTron; Gregory Connelly, Director, Formulation Development and Drug Product Continuous Manufacturing Lead, Vertex Pharmaceuticals

"3D Printing Applications in Pharma"
Three-dimensional printing (3DP), also called additive manufacturing, is increasing in use in a range of healthcare industries, for printing customized prosthetics, for example, and for making models doctors can use to plan a surgery. 3DP also offers a new design freedom for bio/pharmaceutical manufacturing—whether for "printing" a solid-dosage drug or for creating a piece of equipment for bio/pharmaceutical laboratories or manufacturing facilities. 3DP is being used commercially in the pharmaceutical industry today, and additional uses are being investigated for the processes and equipment of tomorrow.
Moderator: Jennifer Markarian, Manufacturing Editor, Pharmaceutical Technology

"3D Printing of Solid-Dosage Drugs: Current Capabilities and Future Vision" - 1:30pm – 2:15pm
Aprecia Pharmaceutical's Spritam tablets became the first 3D-printed drug approved by FDA in August 2015. This session will discuss how three-dimensional printing of pharmaceuticals provides an opportunity to speed the drug development process, particularly during clinical trials due to its agile manufacturing process, allowing for rapid prototyping and potentially on-demand production.
Speaker: Timothy S. Tracy, PhD, CEO, Aprecia Pharmaceuticals

"Accelerating Additive Manufacturing for Bio/Pharma" - 2­:15pm – 3pm
In 2017, GE Healthcare opened a 3D printing lab at its technology center in Uppsala, Sweden to investigate how 3DP can speed the launch of innovative products. A 3D-printed chromatography column, for example, was custom-designed for a biopharmaceutical purification process. This session will discuss uses of 3DP in bio/pharma.
Speaker: Christel Fenge, PhD, Head of Research & Development for GE Healthcare, Uppsala, Sweden

Wednesday, April 3: 10:30am – 12:00pm

"Meeting Bioprocessing Manufacturing Capacity Demands"
Capacity demands for biologic-based drugs are shifting due to high-volume demands for blockbuster and biosimilar drugs, and smaller-volume demands of targeted therapies. How is the industry responding to production-related challenges?
Moderator: Rita Peters, Editorial Director, BioPharm International and Pharmaceutical Technology

"State of the Bioprocessing Industry: Global Shifts in Capacity, Innovations, and Trends in Outsourcing"- 10:30am – 11:00am
Learn about research findings and trends in capacity demands and the application of bioprocessing technologies gleaned from a comprehensive survey of industry practices and perceptions. The discussion will include the role contract manufacturing organizations in meeting the production needs of biopharma companies.
Speaker: Eric Langer, President and Managing Partner, BioPlan Associates

"Solutions for Efficient, Cost-Effective Biologic Drug Manufacturing" - 11:00am – 12:00pm
Following lengthy research and development phases, drug companies are incentivized to get drugs to market quickly and seek efficient, cost-effective ways to expedite drug manufacturing processes. Equipment and facility manufacturers are introducing technology advances and contract manufacturers are offering alternatives to inhouse manufacturing. A panel of bioprocessing experts will discuss and debate how technologies and innovative manufacturing strategies can be implemented to advance the efficiency and cost-effectiveness of biomanufacturing processes. Topics include expedited process development, single-use systems, flexible facilities, scale out of multiplexed single-use bioreactors, biopharma/contract manufacturing arrangements, and more.
Panelists: Eric Langer, President and Managing Partner, BioPlan Associates; Brady Cole, Vice-President, Applications, ABEC; Madhu Raghunathan, Product Strategy Leader for BioProcess Hardware, GE Healthcare; Mike Felo, Director, Downstream Process Integration, Next Generation Processing, MilliporeSigma; Steve Perry, Senior Director, Manufacturing Sciences, Catalent Biologics; Rick Morris, Senior Vice-President, Research and Development, Pall Biotech

Minimizing Contamination in Aseptic Manufacturing
Experts look at new technologies, approaches, and services that are preventing contamination, recalls, and regulatory noncompliance in a crucial area of drug manufacturing.
Moderator: Agnes Shanley, Senior Editor, Pharmaceutical Technology

"Aseptic Processing: Industry Trends and Challenges" - 1:30pm – 2:00pm
Speaker: Jim Agalloco, Principal, Agalloco Associates

"Tech Talk: Top Issues and How New Technologies and Services Address Them" - 2:00pm – 2:30pm
Learn about current industry challenges related to aseptic processing and possible solutions including new technology advances, supply chain integration and enhanced roles for CDMOs.
Moderator:JimAgalloco, Principal,AgallocoAssociates
Speaker(s): ChrisProcyshyn, CEO,VanRx; JoAnne Jacobs, Fellow, ManufacturingTechnologySpecialist, Catalent; NicholasZasada, Director of Process Development and Manufacturing, Vetter Development Services USA, Inc.; PaulLopolito, Technical Service Senior Manager, Steris Corporation, Life Science Formulated Chemistries; ArnabGanguly, Scientist and Technology Manager, IMA Life North America, Inc.

"Regulatory Issues and Innovation" - 2:30pm – 3:00pm
Experts will debate key issues related to aseptic processing and regulatory oversight including the following: Ending the Catch 22 of aseptic technology innovation: How can regulators encourage the use of innovative technologies when they haven't yet been mentioned in a new drug application or other filing? Annex I: Does it signal deeper misunderstandings of basic concepts and science on the part of regulators, and what can be done about it?
Moderator: Agnes Shanley, Senior Editor,Pharmaceutical Technology
Panelist(s):JimAgalloco, Principal,AgallocoAssociates; ChrisProcyshyn, CEO,VanRx; Jo Anne Jacobs, Fellow, Manufacturing TechnologySpecialist, Catalent; NicholasZasada, Director of Process Development and Manufacturing, Vetter Development Services USA, Inc.; PaulLopolito, Technical Service Senior Manager, Steris Corporation, Life Science Formulated Chemistries; ArnabGanguly, Scientist and Technology Manager, IMA Life North America, Inc.

For full INTERPHEX Technical Conference details, click here.

Register today for INTERPHEX 2019 and the Keynote Series @INTERPHEX and save the onsite fee. Media who would like to cover the Technical Conference should contact kscott@reedexpo.com. INTERPHEX and INNOPHEX offer the opportunity to network with leading suppliers and industry professionals, see the latest advancements in technology and equipment and face to face discussions with subject matter experts.

About INTERPHEX

For forty years, INTERPHEX has been, and continues to be, the premier pharmaceutical, biotechnology, and device development and manufacturing event where you can "Experience Science through Commercialization". Sponsored by the Parenteral Drug Association (PDA), the event is based in New York and brings over 12,000 global industry professionals and 625+ industry leading suppliers together to "Learn it, Experience it, Procure it" through a unique combination of exhibits, demonstrations, partnering opportunities, networking and no cost technical conference to leverage quality, efficiency and cost effectiveness in today's ever-changing global market. INTERPHEX offers annual domestic and international industry events and educational opportunities around the world. INTERPHEX and INNOPHEX together, offer the very latest intelligence, cutting-edge technologies and state-of-the-art innovation throughout the product development life cycle. Follow INTERPHEX on Facebook, LinkedIn, Instagram, YouTube, and Twitter. IPX Blog continues the learning beyond the show floor. For more information, visit www.INTERPHEX.com.

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