Developed by Pharmaceutical Technology and INTERPHEX, this comprehensive 2-day Keynote Series features industry experts delivering insight on key industry themes including Serialization, Supply Chain, Continuous Manufacturing, Cleaning Validation, Qualification, Regulatory Roadblocks and Post-Approval Changes and Japanese Market.
Tuesday, March 21, 10:30am – 12:30pm
Serialization and Traceability: The Final Countdown
As the November, 2017 deadline for serialization implementation in the US approaches, most, but not all, bio/pharma companies and contract pharmaceutical manufacturers have developed strategies for compliance. In this keynote session, speakers will look at the state of implementation, as well as best practices, results of pilot tests and research, and discuss a new program designed to help accelerate progress for companies that have not yet addressed requirements.
Moving from Compliance to Value: A State of the Industry Report
What progress have pharmaceutical manufacturers and their supply chain partners made in implementing traceability initiatives? In these final months before the Drug Supply Chain Security Act implementation deadline, what technical and cultural issues remain? This session will examine results of an extensive industry survey and focus on areas where serialization and traceability projects can bring significant business value.
Speaker from TraceLink
Accelerating Compliance in the Final Stretch
Even though the deadline for serialization compliance is months away, a few companies not have developed serialization strategies and finalized technical initiatives. Speakers discuss a new program, based on open standards and basic data communication templates, that aims to get companies up and running in time to meet the deadline.
Speakers from TraceLink and Ropack Pharma Solutions
BlockChain as a Supply Chain Tool
What is blockchain and how could it help boost supply chain security? Speakers will provide an overview of the technology, and discuss results of research into the use of blockchain within the pharma industry.
Speakers: Robert Celeste, Founder, Center for Supply Chain Studies, and Darryl Glover, chief clinical officer, i-Solve.
Robert Celeste established the Center for Supply Chain Studies in Chicago. He was formerly senior director at GS1 US.
Darry Glover is chief clinical officer at i-Solve. He has previously worked as an independent consultant, and as CEO of The Lumine Group.
Tuesday, March 21, 1:30pm – 3:00pm
Implementing Continuous Manufacturing for Solid-Dosage Drugs
Continuous manufacturing for solid-dosage drugs offers the potential for greater flexibility, efficiency, and quality. Early adopters now have FDA approval for drugs made with continuous processes. Equipment and process analytical technology for continuous tablet production is available. This session will look at some of the available technologies and at the challenges that remain.
Different Approaches to Continuous Manufacturing within the Pharmaceutical Industry
The pharmaceutical industry is in the process of modernizing its manufacturing practices. Companies are replacing outdated batch unit operations with more innovative, efficient, and automated continuous processes. Different approaches are being utilized, from targeted solutions to integrated end-to-end strategies, each with its own risks and benefits. There are many drivers for this transformation, including pressure to reduce drug costs and more stringent quality requirements imposed by regulators. This presentation will examine the different tactics companies are employing and their respective advantages, with a focus on small-molecule drugs.
Speaker: Bayan Takizawa, MD, MBA, Co-Founder & Chief Business Officer, CONTINUUS Pharmaceuticals, Inc.
Automating Continuous Manufacturing
More companies are making the move towards continuous manufacturing. Smart data solutions must be provided to streamline the dataflow and get the essential information out of the big data stream. This presentation will dive into the mechanism of continuous manufacturing, leaving the isolated ‘islands of automation’ and working towards a fully integrated approach. Real, established use cases will demonstrate how a process analytical technology (PAT) approach can be established in a continuous manufacturing area.
Speaker: Pamela (Bruen) Docherty, Life Sciences Industry Manager – USA, Siemens
Advancing Continuous Solid-Dosage Manufacturing
Over the course of the past decade the foundations for today's continuous pharmaceutical manufacturing have been developed through public private partnerships like C-SOPS. This is particularly true in the case of solid dose. Today, as the interest in transitioning to this new means of manufacturing continues to grow we continue to develop new ways to better enable technological adoption. Here we will present some of the newest innovations for faster development of products using less material along with programmatic activities aimed at easing the regulatory pathway.
Speaker: Doug Hausner is Associate Director for Industrial Relations and Business Development at the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) at Rutgers University, department of Chemical and Biochemical Engineering.
Wednesday, March 22, 10:30am – 12:30pm
Best Practices in Equipment Cleaning and Cleaning Validation
Efforts are underway to bring more scientifically-based standards to cleaning validation. Speakers will discuss new developments, and various areas of focus in a dynamic subject.
A New ASTM Standard for Cleaning Validation
This presentation will introduce the “Standard Guide for Science and Risk-based Cleaning Process Development and Validation” a standard guide in the final stage of approval in the American Society for Testing and Materials (ASTM).
Speakers: Andrew Walsh, President of the Center for Pharmaceutical Cleaning Innovation, and others TBA
Training for Qualification
Successful cleaning validation is critical to patient safety. This presentation will examine PDE and ADE cleaning limits, and what is needed for qualification for visual inspection.
Speaker: Rich Forsythe, Principal Consultant, Forsyth Pharma Consulting
Wednesday, March 22, 1:30pm – 3:00pm
Post-Approval Changes: Addressing Regulatory Roadblocks
Changes to a manufacturing process during the lifecycle of a drug product are inevitable. New regulations, materials suppliers, and facility and equipment updates can contribute to improved processes. The complications and costs of implementing these changes, particularly in a global environment, may discourage companies from updating facilities and systems, contributing to a downward quality spiral. This session will examine ongoing challenges with implementing post-approval changes, efforts to educate and harmonize national and regional regulations, and will feature an approach to address post-approval changes during the initial application process.
PDA‘s Task Force on Post Approval Change Innovation for Availability of Medicines Program
PDA’s Task Forces of Drug Shortage and Aging Facilities showed that the current complexity of Post Approval Changes is a major contributor to the hesitancy to implement new technologies and/or update processes and facilities. If such process and facilities are not updated, break-down, quality excursions or obsolescence can occur, which respectively may result in shortage of product supplies. Reviews, workshops and surveys performed by PDA showed that a major contribution for failing processes and/or facilities are post approval change timelines and regulatory burdens. PDA has formed a task force to address these issues and recommend approaches how post approval changes may be address in a faster and efficient way. The presentation will discuss findings of PDA task force activities and further steps which will be take.
Speaker: Maik Jornitz, G-Con LLC, Member, PDA Innovation for Availability of Medicines (PAC iAM) Task Force
Japan Common Technical Document: Bracketing Strategies for the Manufacturing Process
Pharmaceutical companies filing drug applications for the Japanese market must submit bracketing strategies for aspects of the manufacturing process including process parameters, quality attributes, operating and storage conditions, type and concentration of materials used, and proposals for handling post-approval changes. This is typically done by enclosing critical and non-critical aspects of the manufacturing process in major and minor brackets, respectively. Any post-approval changes in these strategies require appropriate regulatory action. Each bracketing strategy offers advantages and limitations, and determines whether a manufacturing deviation is allowed or not and whether a pre-approval for implementation of a post-approval change is required or not. Important aspects related to bracketing strategies will be discussed.
Speaker: Kashappa Goud Desai, PhD, Biopharmaceutical Product Sciences, GlaxoSmithKline