Date/Time: June 11 and 13, 2024 (8:30 AM – 11:30 AM EDT)
Location: On-line
Workshop Abstract:
Providing sound, reliable data to regulatory agencies is the bedrock upon which all drug approvals are based. When the integrity of a sponsor’s data is in doubt, the affected drug product approval is put in jeopardy, as are the health and well-being of patients taking the product if it has already been approved. Various regulatory agencies have, in the past few years, censured a number of companies for serious lapses in the integrity of bioequivalence study data, resulting in the invalidation of hundreds of bioequivalence studies, significant additional costs/delays, product supply disruptions, and therapeutic equivalence downgrades from AB to BX. As a result, regulatory agencies have recently become more proactive in screening bioequivalence studies for evidence of data manipulation.
The first session of our workshop will cover the important aspect of ensuring data integrity in bioequivalence studies with the use of appropriate blinding to prevent bias. The consequences of failing to properly blind bioequivalence studies can be serious, e.g., invalidation of the study. Blinding the test and reference products in a bioequivalence study can be especially challenging when drug-device combination products are involved, often resulting in a trade-off between adequately obscuring product identity while not compromising device functionality. Blinding can affect all types of bioequivalence studies, including in vitro studies, pharmacokinetic studies, pharmacodynamic studies, and clinical endpoint bioequivalence studies.
The four speakers in our first session will discuss blinding requirements and strategies for a variety of different product types, including inhalation products, topical products, and others, as well as various study types, including in vitro, pharmacokinetic, pharmacodynamic, and clinical endpoint bioequivalence studies.
The first four speakers in our second session will focus on the various types of data manipulation that have been found in bioequivalence studies, the wide-ranging consequences that ensue when such data manipulation is detected, the efforts of regulatory agencies to screen for evidence of such data manipulation, and how sponsors can protect themselves.
The fifth speaker will address the issue of inadvertent sample swaps during the processing of blood samples into plasma/serum samples during the clinical phase of a pharmacokinetic study, and how such inadvertent swaps can be confirmed unambiguously to justify correction in the dataset.
Both sessions will close with a panel discussion to field audience questions on these important topics.
Agenda details
First session (June 11th 8:30 AM – 11:30 AM, EDT): Blinding in All Types of Bioequivalence Studies: Requirements, Issues, and Best Practices
Session Moderator: Charles DiLiberti, M.Sc. (Montclair Bioequivalence Services, LLC)
Keith Gallicano, Ph.D. (President, SAAMnow)
8:30 AM – 8:40 AM: Welcome and opening remarks
Theo Kapanadze, Ph.D. (CSO and Co-founder, Diteba Laboratories)
8:40 AM – 9:10 AM: Best practices for blinding during in vitro topical product testing – IVRT, IVPT, etc.
SPEAKER TBD (Cipla - Invited)
9:10 AM – 9:40 AM: Challenges and solutions for blinding during in vitro and in vivo testing of inhalation and other complex generic products – when and how
Break:
9:40 AM – 9:50 AM
Corrine Dias (Teva)
9:50 AM – 10:20 AM: Blinding in human bioequivalence studies – focus on clinical endpoint, irritation/sensitization, and vasoconstrictor studies
Bing Li, Ph.D. (FDA) – Invited
10:20 AM – 10:50 AM: Blinding expectations and common mistakes with in vitro and in vivo bioequivalence studies
Panel discussion on blinding: All speakers from second session plus Sean Kassim, Ph.D. (FDA Invited) and Seongeun (Julia) Cho, Ph.D. (FDA Invited)
10:50 AM – 11:30 AM
11:30 AM: Session adjourns
Second session (June 13th 8:30 AM – 11:30 AM, EDT): The Pros and Cons of Data Manipulation in Bioequivalence Studies – sorry, there are no pros, but it is a con job!
Session Moderator: Keith Webber, Ph.D. (Vice President, SAAMnow)
Helmut Schütz (President and founder of BEBAC)
8:30 AM – 9:00 AM: Data manipulation in bioequivalence studies: recent history and current practices in Europe
Scott Deckebach, M.B.A. (Lachman Consulting)
9:00 AM – 9:30 AM: Bioequivalence data integrity issues affecting US sponsors
Break:
9:30 AM – 9:40 AM
Sean Kassim, Ph.D. (FDA) – Invited
9:40 AM – 9:55 AM: FDA perspective, practices, and expectations to ensure reliable, trustworthy data in bioequivalence studies – Inspection Perspective
Minglei Cui, Ph.D. (FDA) – Invited
9:55 AM – 10:25 AM: FDA perspective, practices, and expectations to ensure reliable, trustworthy data in bioequivalence studies – Review Perspective
Keith Gallicano, Ph.D. (President, SAAMnow) or Charles DiLiberti, M.Sc. (Montclair Bioequivalence Services, LLC)
10:25 AM – 10:45 AM: Correcting inadvertent sample swap errors in bioequivalence studies
Panel discussion: Helmut Schütz, Scott Deckebach, Keith Gallicano or Charles DiLiberti, Minglei Cui (FDA Invited), and Nilufer Tampal, Ph.D. (FDA Invited)
10:45 AM – 11:30 AM
11:30 AM: Session adjourns