5th PQRI FDA Conference on Advancing Product Quality
Click here to return to the main Conference Page.
Day 2 – December 2, 2021
Development Track– New Horizons for Pharmaceutical Development
The future direction of pharmaceutical development for small and large molecule drug products has been profoundly influenced by recent events and technological advances. Prominent on the horizon are emerging modalities for novel therapeutics, and innovative approaches for applying knowledge and data to expedite meaningful decision-making. This track will explore opportunities and challenges represented by these areas, superimposed on a landscape of rapidly evolving industry practice and regulatory expectations.
Bios for December 2, 2021 speakers
| Topic | Speaker | Abstract |
| SESSION 1: Accelerating Development: Fast Tracking Critical Treatments, Antibody Platforms, and Quality Standards for Emerging Modalities | ||
| Moderator: Doug Kiehl, Eli Lilly and Company | ||
| Accelerated Development of Molnupiravir
Michael Lowinger, Ph.D. Director of Oral Formulation Sciences Merck & Co., Inc. |
Molnupiravir is an investigational, orally administered antiviral drug that inhibits the replication of SARS-CoV-2. In response to the urgent unmet medical need brought forth by the COVID-19, Merck partnered with Ridgeback Biotherapeutics to develop and commercialize this potentially transformational therapeutic in a fraction of the time of a typical drug candidate. This talk will review the prudent risks, assumptions, and tradeoffs the CMC development team undertook to progress molnupiravir from Phase I to a commercial process capable of supplying nearly one billion capsules per year. | |
| Platform and Prior Knowledge in the Development of Neutralizing Monoclonal Antibodies: A Regulatory Perspective
Maria-Teresa Gutierrez-Lugo, Ph.D. Review Chief Office of Biotechnology Products OPQ/CDER/FDA |
Monoclonal platform and prior knowledge were key for accelerating the development of COVID-19 neutralizing antibodies. This talk will discuss examples of the application of this knowledge and will discuss regulatory considerations and expectations. | |
| Cell and Gene Therapy Consensus Standards – A Shared Path Forward
Catherine B. Zander, Ph.D. Scientific Program Manager The Standards Coordinating Body |
Consensus standards help accelerate the development of cell and gene therapies. However, for consensus standards to be effective they must have the appropriate subject matter experts involved, and must be accepted and adopted upon publication. The Standards Coordinating Body (SCB) works to create effective consensus standards by coordinating and facilitating discussions within the regenerative medicine community. In this presentation SCB will share its current cell and gene therapy standards efforts and explain how standards fit into the regulatory process. | |
| HOT TOPIC: Emergency Use Authorizations: COVID-19 Therapeutics
Andrew A. LeBoeuf, JD, MS Associate Director for Policy (Acting) Office of New Drug Policy, OND/CDER/FDA |
Under Section 564 of the Federal Food, Drug and Cosmetic Act, the FDA may, pursuant to a declaration by the HHS Secretary based on one of four types of determinations, authorize an unapproved product or unapproved uses of an approved product for emergency use. This presentation will provide an overview of the FDA’s authorities on Emergency Use Authorizations and how these authorities have been used to make available therapies as part of the U.S. Government’s response to the COVID-19 public health emergency. | |
| SESSION 2: Modeling and Simulations to Enable Rapid Decision Making | ||
| Moderator: Robert Meyer, Ph.D., Principal Scientist, Merck & Co., Inc. | ||
| Navigating Potentials and Pitfalls in using Artificial Intelligence for Expedited Decision Making in Pharmaceutical Problems
Rob Smith, Ph.D. CEO and Founder Prime Labs, Inc. |
Artificial intelligence provides a potential mitigation of the cascading complexity in the design, testing, and manufacturing of novel compounds. While the field is not new, few can comfortably apply best practices on standard problems while avoiding potential pitfalls. In this talk, we will simply explain the strengths, weaknesses, and best practices of AI approaches. We will distinguish between straightforward and advanced applications of AI and describe the surprising aspects of what makes the latter extremely difficult. | |
| Data Visualization Approaches for Enabling Rapid, Heuristic Interpretation of Highly Complex Mixtures of Structurally and Compositionally Diverse Chemical Entities Associated with Pharmaceutically Relevant Materials
Doug Kiehl, Eli Lilly and Company |
The detection, identification and profiling of impurities, degradation products and contaminants in pharmaceutically relevant materials is essential to the establishment of safety and purity of drug products. Leachables, as an example, represent impurities that may leach from packaging and container systems, drug delivery device components, and process equipment and can potentially pose risk to the safety, efficacy, and stability of drug products. Since leachables may represent a subset of extractables, it is necessary to establish a comprehensive profile of extractables, which may involve analysis of samples representing highly complex, structurally and compositionally diverse mixtures of organic chemical entities. Techniques such as N-dimensional mapping, mass difference correlation and visualization of high resolution LC-MS datasets may suggest some heuristic approaches to simplifying interpretation of such complex mixtures. | |
| Role of eXtended Reality (XR) in Empowering Knowledge Workers of the Future
Suresh Nulu, MS Director Merck & Co., Inc. |
The digital transformation of biopharmaceutical manufacturing is progressing at a rapid pace as companies attempt to set their sights on tapping into their data rich environments to develop therapies of the future inside factories of the future. In this talk, the speaker will highlight the role of eXtended Reality (XR) platforms in empowering the knowledge workers of the future to access data and insights, ‘just in time’ and ‘within context’ using modern devices, to take rapid decisions. This talk will also provide a snapshot into how Merck is progressing its digitization efforts, specifically within the XR ecosystem through targeted innovation, value-based prioritization, and agile execution. | |
| Roundtable: Drug-Device Combination Products | ||
| Moderator: Cheryl L.M. Stults, Ph.D., Principal, C&M Technical Consulting LLC |
||
| This roundtable focused on Drug – Device Combination Products and was organized by the PQRI Drug-Device Combination Products Focus Group. Discussions with panelists considered differences in industry practice and regulators’ approaches to various topics of interest to the combination products community. You may still contribute to a survey that PQRI is conducting that will help inform potential future activities by PQRI in this area. The survey is available here.
Panelists:
|
||