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Part I: Assessing the Risk

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Contributors

  • Chad Briscoe, Ph.D.

    Chad is currently Chief Scientific Officer at BioAgilytix labs. He received his Bachelor of Science degree in Chemistry from Alma College in Michigan and a Master’s degree in Analytical Chemistry from the University of Michigan with a focus in the use of LC-MS/MS in Protein and Peptide analysis. Chad’s Doctorate of Philosophy at the University of Nebraska was focused on studies of Protein Binding via Immunoaffinity LC-MS/MS and utilization of computer simulations. Chad is an experienced Bioanalytical executive with nearly 25 years of experience including serving in executive operations and scientific leadership roles. He is a frequently invited speaker at scientific meetings (AAPS, WRIB, etc) in the field of Laboratory Science. He is on the organizational committee and has chaired several meetings as well including the AAPS Land O Lakes Bioanalytical Meeting, Clinical & Pharmaceutical Solutions Through Analysis (CPSA) Meeting. He is also a Bioanalysis Zone Leader, Kansas Universtity BioWEB Board member and frequent contributor to the journal Bioanalysis.

  • Paul Chamberlain

    Paul Chamberlain has been directly involved in the development of biopharmaceutical products since 1983, occupying analytical, bioanalytical, product quality control, monoclonal antibody production and regulatory roles.
    His interest in immunogenicity risk assessment was triggered by experience gained at Amgen in 1998 with PEG-MGDF and then extended through his role as a Development Programs Director at MDS Pharma Services (2001-2007). Paul started submitting the Immunogenicity Risk Assessment module in Clinical Trial Applications from 2004 and then focused on creating an Integrated Summary of Immunogenicity (ISI) to provide a self-standing section of the CTD format that incorporates the multi-disciplinary information required for a balanced regulatory assessment. His first ISI was submitted in 2009 to support the approval of XIAFLEX®, a clostridial collagenase for treatment of Dupuytren’s contracture. The ISI format was subsequently refined and then adopted into EU (2017) and FDA (2019) guidance.
    Paul has worked closely with EU and FDA regulators to understand the priorities for regulatory submissions at different stages of the product life cycle, supporting companies directly at Scientific Advice, pre-CTA/IND, End-of-Phase 2, Pre-MAA/BLA submission, Oral Hearings and FDA Advisory Committee meetings.

  • Jochem Gokemeijer, Ph.D.

    Director, Discovery Biotherapeutics
    Bristol Myers Squibb
    Jochem has been at Bristol-Myers Squibb for 15 years in different roles of responsibility focused on biotherapeutic drug development. For the last 8 years he has been focused on building a group for pre clinical immunogenicity risk assessment and mitigation. He received his training at the University of Groningen and the Dana Farber Cancer Institute

  • Vibha Jawa, Ph.D.

    Dr. Vibha Jawa is an Executive Director for Biotherapeutics Bioanalysis in Nonclinical Disposition and Bioanalysis (NDB) organization at Bristol Myers Squibb. Vibha is responsible for leading biotherapeutic and cell /gene therapy bioanalytical (BA) function supporting DMPK and immunogenicity, and provide strategic and scientific oversight for BMS developmental portfolio. Vibha was at Merck for 4 years where she lead the Predictive and Clinical Immunogenicity group and at Amgen for 14 years supporting Discovery to Development for biotherapeutics. Vibha has 20+ years of experience in diverse fields of biologics , vaccine development and gene therapy with successful support of 20 + IND, BLA and MAA filings. Vibha is a recognized leader in Bioanalysis and Immunogenicity with 75+ peer-reviewed publications and serves as a Reviewer and Editor for The AAPS Journal and J. Pharm Sci. She is an active member of multiple scientific societies and consortiums ( IQ, SC space Consortium and EIP) .Within AAPS, she is Steering Committee member of the Therapeutic Product Immunogenicity Community, past chair of Immunogenicity Risk Assessment and Mitigation Community and leads the IQ Consortium for Cell/Viral/Gene therapies. Vibha enjoys volunteering as a board member for the state youth orchestra and mentoring high school students on STEM related projects in her free time.

  • Jim McNally, Ph.D.

    Jim McNally, Ph.D. is Chief Scientific Officer for BioAgilytix, a premier large molecule CRO. Dr. McNally has an extensive background in bioanalytical assay development and program leadership spanning nearly 20 years working in the pharmaceutical and biotechnology industry. Prior to joining BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics, where he led a team of scientists to develop a portfolio of assays to support development of gene-based therapeutic candidates throughout their lifecycle. He has also previously held roles at Genzyme, Pfizer, EMD Serono, and Shire which have given him broad experience in the development of large molecule, gene therapy, and cell therapy biotherapeutics. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance. Dr. McNally obtained his B.S. in Biology from Mississippi State University, his Ph.D. Viral Immunology from Louisiana State University School of Medicine in Shreveport, and his Post-Doc in Viral Immunology from University of Massachusetts Medical School.

  • Johanna Mora, Ph.D.

    Dr. Mora is currently a Director in the Non-clinical Disposition and Bioanalysis Department at Bristol-Myers Squibb (BMS). She received a Bachelor of Science degree in Chemistry from the University of Costa Rica in 1999 and a Ph.D. in Analytical Chemistry from the University of Kansas in 2004. At BMS she has oversight of the PK and immunogenicity strategy for programs in cardiovascular, immunoscience and fibrosis. She is a mentor to her team, is an author of over 18 scientific publications and has served in several cross functional teams within BMS. She is an active member of AAPS, has served in the Emerging Technology Focus group and is Past Chair of the Therapeutic Product Immunogenicity Community. Johanna has also held active roles within Applied Pharmaceutical Analysis Regulated Bioanalysis Committee.

May 24, 2022
Tue 10:00 AM EDT

Duration 3H 0M

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