Upcoming events

    • Tuesday, June 11, 2024
    • Thursday, June 13, 2024
    • Online
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    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 three 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 fourth 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.

    Mayuri Mangale (Cipla)

    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)

    10:20 AM – 10:50 AM: Sample Blinding in Complex Generic Drug Bioequivalence Studies

    Panel discussion on blinding: All speakers from first session plus Sean Kassim, Ph.D. (FDA) and Seongeun (Julia) Cho, Ph.D. (FDA)

    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

    Minglei Cui, Ph.D. (FDA)

    9:40 AM – 10:10 AM: FDA perspective, practices, and expectations to ensure reliable, trustworthy data in bioequivalence studies – Review Perspective

    Charles DiLiberti, M.Sc. (Montclair Bioequivalence Services, LLC)

    10:10 AM – 10:40 AM: Correcting inadvertent sample swap errors in bioequivalence studies

    Panel discussion: All speakers from second session and Nilufer Tampal, Ph.D. (FDA)

    10:40 AM – 11:30 AM

    11:30 AM: Session adjourns

Past events

Wednesday, June 07, 2023 Meeting the Challenges of Biosimilar Product Approval
Wednesday, May 03, 2023 Webinar Session 3: Secrets to Successful Pre-IND Meetings for 505(b)(2) NDA Drug Development
Tuesday, May 02, 2023 Webinar Session 2: 505(b)(2) Bridges, Clinical Development Pathways, and Case Studies
Wednesday, April 26, 2023 Webinar Session 1: Strategies, Considerations, Initial Due Diligence and Early Conceptualization for Successful 505(b)(2) NDA Drug Development
Tuesday, April 26, 2022 (VIRTUAL WORKSHOP) Challenges and Strategies for Relative Bioavailability Studies on Drug Products Involving Endogenous Substances
Wednesday, February 23, 2022 Webinar Session 6: Challenges and Issues in Meeting Regulatory Requirements for In Vitro Dissolution Testing
Friday, March 26, 2021 Secrets to Successful Pre-IND Meetings for 505(b)(2) NDA Drug Development
Wednesday, November 18, 2020 In Silico Modeling Methods for Generic Drug Products: Applications and Expectations
Wednesday, June 17, 2020 505(b)(2) Webinar Series Session 3: Commercialization Strategies and Considerations for Successful 505(b)(2) NDA Drug Development
Wednesday, May 13, 2020 505(b)(2) Webinar Series Session 1 & 2
Thursday, April 16, 2020 Cutting Edge Approaches for Demonstrating Bioequivalence
Wednesday, October 16, 2019 Demystifying 505(b)(2) Development: Navigating the Scientific, Regulatory, Legal, and Business Complexities
Thursday, April 04, 2019 Challenging Statistical Issues with In Vitro and In Vivo Bioequivalence Studies: Extreme Variability, Special Study Designs and Novel Approaches
Thursday, October 18, 2018 Inaugural SAAMnow Annual Scientific Workshop