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  • Monday, Dec 4th
    3:45 PM – 4:45 PM ET
    C15 - [IN-PERSON/RECORDED] The Current State of the Use of Dogs in Research
    Location: Room 146 ABC
    Speaker: Ernst Heinen (he/him/his) – Elanco Animal Health
    Speaker: Rod Christmas (he/him/his) – Boehringer Ingelheim Animal Health
    Speaker: Naomi Charalambakis, PhD (she/her/hers) – Federation of American Societies for Experimental Biology (FASEB)
    Speaker: Allison Thiede, DVM, DACLAM – AbbVie
    Pharma/Biotech PerspectivesCommunication With the PublicEmerging Research Challenges and Breaking Issues
  • Tuesday, Dec 5th
    1:00 PM – 2:00 PM ET
    D11 - [IN-PERSON ONLY] Translating Ethical Principles for the Responsible Use of Emerging Science and Technology Across a Global Pharmaceutical Company
    Location: Room 149 AB
    Speaker: Missy Heidelberg, B.S., M.S. Bioethics (she/her/hers) – Takeda Pharmaceuticals
    Speaker: Lindsay McNair, MD, MPH, MSB (she/her/hers) – Equipoise Consulting, LLC
    Speaker: David H. Strauss, MD – Columbia University
    Speaker: Karla Childers, BA, MSJ, MS (she/her/hers) – Johnson & Johnson
    Pharma/Biotech PerspectivesEmerging Research Challenges and Breaking IssuesResearch Conducted in the Digital World
  • Tuesday, Dec 5th
    1:00 PM – 2:00 PM ET
    D16 - [IN-PERSON/RECORDED] FDA Modernization Act 2.0: Fact and Fiction
    Location: Room 206
    Speaker: Brandon Morton – National Association for Biomedical Research
    Speaker: Jim Newman (he/him/his) – Americans for Medical Progress
    Pharma/Biotech PerspectivesEmerging Research Challenges and Breaking Issues
  • Tuesday, Dec 5th
    1:00 PM – 2:00 PM ET
    D21 - [ON-DEMAND] Moving the Needle: The Marseilles Declaration‐‐What Is it?
    Presenter: Jennie Lofgren, DVM, MS, DACLAM (she/her/hers) – Novartis Institutes for Biomedical Research
    Presenter: Kerstin Kleinschmidt-Doerr, DVM, PhD, MBA (she/her/hers) – Merck KGaA, Darmstadt, Germany
    Pharma/Biotech Perspectives
  • Tuesday, Dec 5th
    2:30 PM – 3:45 PM ET
    [IN-PERSON/LIVESTREAMED] Plenary Session: It's About Time: Inclusion of Sexual and Gender Minorities in Clinical Research
    Location: Hall E
    Moderator: Christina N. Dragon, MSPH, CHES (she/her/hers) – National Institutes of Health (NIH)
    Panelist: Willyanne DeCormier Plosky, DrPH (she/her/hers) – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
    Panelist: Amy Ben-Arieh, JD, MPH – The Fenway Institute
    Panelist: Keith Dawson, DNP, MS (he/him/his) – Genentech
    Populations Requiring Additional ProtectionsAdvancing Equity and Justice in ResearchHRPP/IRB Administration/Management and ProcessPharma/Biotech Perspectives
  • Wednesday, Dec 6th
    10:15 AM – 11:15 AM ET
    F14 - [IN-PERSON/RECORDED] The Ethical Conduct of Cell and Gene Therapy Research: Novel Challenges for Industry and the IRB
    Location: Room 152B
    Speaker: Missy Heidelberg, B.S., M.S. Bioethics (she/her/hers) – Takeda Pharmaceuticals
    Speaker: David H. Strauss, MD – Columbia University
    Speaker: Susan Z. Kornetsky, MPH – Boston Children's Hospital
    Pharma/Biotech PerspectivesAdvancing Equity and Justice in ResearchEmerging Research Challenges and Breaking IssuesResearch Involving Data and Biospecimens
  • Wednesday, Dec 6th
    11:30 AM – 12:30 PM ET
    G01 - [IN-PERSON/RECORDED] Look Who's Doing Research Now! What Does it Mean for Walgreens, Walmart, Etc., to Be Conducting Human Subjects Research?
    Location: Room 145 AB
    Speaker: Mark A. Munger, Dr. – University of Utah
    Pharma/Biotech PerspectivesEmerging Research Challenges and Breaking Issues
  • Wednesday, Dec 6th
    11:30 AM – 12:30 PM ET
    G16 - [IN-PERSON/RECORDED] ICH E6 Good Clinical Practice (GCP) Training: Programs‐‐Approaches to Achieving Training Compliance Certification for Researchers
    Location: Room 154 AB
    Speaker: Frederick W. Luthardt, Jr., D.Be., MA (he/him/his) – Johns Hopkins University School of Medicine
    Speaker: Jessica Rowe, MA, MS, CCRP, CIP (she/her/hers) – Yale Cancer Center, Clinical Trials Office
    Education, Qualifications, and TrainingHRPP/IRB Administration/Management and ProcessShared Research Oversight ChallengesPharma/Biotech Perspectives
  • Wednesday, Dec 6th
    1:45 PM – 2:45 PM ET
    H04 - [IN-PERSON/RECORDED] Eliminating Financial Barriers to Clinical Study Participation: The Need for Industry and Academic Partnership for a Sustainable Solution
    Location: Room 144 AB
    Speaker: Matt Stafford, MPH (he/him/his) – Yale University
    Speaker: Lindsay McNair, MD, MPH, MSB (she/her/hers) – Equipoise Consulting, LLC
    Speaker: Jaime O. Hernandez, JD, M.Be. (he/him/his) – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
    Pharma/Biotech PerspectivesAdvancing Equity and Justice in Research
  • Wednesday, Dec 6th
    1:45 PM – 2:45 PM ET
    H17 - [IN-PERSON/RECORDED] Balancing the Pressure of Getting New Therapies to Clinical Trial: Ensuring Robust Study Design, Nonhuman Animal Welfare, and Human Subjects Protections
    Location: Room 154 AB
    Speaker: David Litwack (he/him/his) – Prevail Therapeutics
    Speaker: Brad Ahrens, DVM, PhD – Labcorp
    Pharma/Biotech PerspectivesFlexibility and Innovation in Research Oversight Processes