Introduction to Regulatory Expectations for Nonclinical Pharmaceutical Development

6.0
RAC Credits
Virtual ProgramsVirtual Programs
Thursday, 08 December 2022 (10:00 AM) - Thursday, 08 December 2022 (5:00 PM) Eastern Time (US & Canada)

In an original CTA or IND for a FIH trial, companies are primarily required to provide information on the safety and quality of the drug (or biologic) to support clinical studies. These summaries are expected in regulatory submissions and are particularly useful for supporting the mechanism of action of drugs and biologics.

While estimates vary widely based on indication, therapeutic modality, and novelty, recent analysis suggests that nonclinical testing can cover nearly half of all drug development. In addition, the need for nonclinical data from in-vitro, in-silico, and animal models generally extends well past the point of IND/CTA clearance in the form of supportive data for various waivers, designations, and labeling.

Unfortunately, much of this information is not readily available outside of the clinical setting. This workshop will provide an overview of the pertinent international and regional guidance from ICH, EMA, FDA, OECD and others that shape nonclinical development programs. It will include a discussion of how these components fit together to form the basis for regulatory decision making, and importantly, how this basis can help streamline the transition of a product into the clinic and into the market.


Registration Fees & Deadlines

19 September 2022 – 08 November 2022: Early Bird $495 Member | $580 NonMember
11 November 2022 – 08 December 2022: Regular $580 Member | $680 NonMember


Learning Objectives

Upon the conclusion of the program you will be able to:

  • Identify key global and regional guidance directing the content and timeline for completion of various aspects of a nonclinical development program.
  • Understand how product and indication specific guidance, as well as basic science can influence regulatory expectations and program planning.
  • Understand how nonclinical data can be leveraged to support key clinical planning decisions.


Who Should Attend?

  1. Individuals seeking to increase their understanding of nonclinical drug development in preparation for taking the RAC-Drugs certification exam.
  2. Medical writers and other professionals involved in assembling key components of the regulatory dossier, including Modules 2.4/2.6; nonclinical summaries found in the Investigator’s Brochure, Clinical Trial Protocol, General Investigation Plan, etc.; and justifications for various waivers (pediatric plans, TQT, carcinogenicity, etc.)
  3. Professionals involved in developing a comprehensive and efficient strategy to appropriately derisk the drug development process for a drug product with at least one novel component.

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.


Speakers:

David Horton

David Horton

David Horton, PhD is a Global Regulatory Lead within Global Regulatory Strategy for AbbVie and a subject matter expert in pharmaceutical drug development and regulatory strategy with 20 years of research and development experience in academic, government (NIH), CRO, and pharmaceutical industry settings. David has strategic development regulatory experience with virtually all therapeutic modalities (small molecules, biologics, and cell and gene therapies) across multiple therapeutic areas and at all stages of drug development. David works in close collaboration with global project development teams to create and execute effective regulatory strategies and facilitate effective partnerships with regulatory authorities. In previous roles at Medpace, David was part of the Regulatory Affairs leadership team, with oversight of the Regulatory Affairs Project Management (US and EU) and Regulatory Subject Matter Expert teams. Additionally, David was a Senior Regulatory Lead, developing and executing regulatory strategies for clients within the CRO setting. Prior to joining Medpace, David was a nonclinical Study Director, Portfolio Lead, and Team Lead within the Safety Pharmacology group at Pfizer where he contributed to the design, execution, and oversight of CNS, CV, and in vitro safety pharmacology studies. Leveraging his pharmacology background, David was an active member of multiple discovery teams, responsible for advising on efficacy strategy and translational pharmacology in the development of pharmacotherapies in the neuroscience portfolio. David was also a Drug Safety Team Lead, where he had project team responsibility for all aspects nonclinical safety and development. In addition to his role at AbbVie, David is also currently an Assistant Lecturer at the University of Copenhagen, Department of Pharmacy where he leads a Masters course titled “The regulatory environment in the USA” and a member of the external advisory board for the Kentucky Network for Innovation and Commercialization (KYNETIC) program.

Tyler Vandivort

Tyler Vandivort

Tyler Vandivort, PhD, RAC-Drugs, DABT is a board-certified toxicologist and regulatory affairs professional. He currently serves as the Director of Regulatory Affairs and Operations at Amplicore, Inc., a clinical stage biopharmaceutical company in Cincinnati-OH that seeks to develop combination therapeutics to serve unmet medical needs for musculoskeletal disorders. Tyler’s PhD/postdoctoral work as an NIH Training Grant recipient at the University of Washington and Cedars-Sinai Medical Center focused on the role of extracellular matrix proteins in the acute and chronic immune response to sterile and non-sterile injury. Following a shift into the contract research organization (CRO) space, he served first as an Immunotoxicology Research Scientist at Charles River Laboratories, and then as a consultant in the Regulatory Affairs and Scientific & Strategic Development group at Medpace before moving to Amplicore. A frequent host for the Preparing to Take the RAC-Drugs workshop, Tyler has cultivated an understanding of the key procedural and strategic components of nonclinical and early phase clinical development that drive program success.


Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and the event title. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.


Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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