This is an On-demand recording from May 2020.

Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a new drug or biologic product, but how do you identify the best time to submit?  Have you conducted all the IND-enabling proof-of-concept and toxicology studies required? Is the manufacture of your product sufficiently consistent, and is it achieving the necessary quality standards? Should you wait until there more data is available, or until you run your first-in-human trial outside the US?

This webcast will cover the minimum required content for an IND submission and explore the strategic considerations for developing more than the minimum necessary data before filing an IND. Regulatory experts responsible for dozens of IND submissions will offer advice pertaining to selecting a target indication, seeking pre-IND advice from FDA, deciding whether to use US or non-US sites for early clinical research, and more. It will help you determine whether you are ready to submit your IND and offer guidance for taking the next step in the development of your product. 

Learning Level

Intermediate - Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Learning Objectives

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

·         Identify IND enabling studies

·         Determine when to approach FDA with questions about your IND

·         Decide whether you are ready to submit an IND

 

Who should attend?  

·         Leaders in the life sciences industry

·         Regulatory affairs professionals

·         Clinical affairs professionals

·         Medical affairs professionals

·         R&D Heads

Speaker(s):

·         Mark Ammann, Pharm.D. , senior vice president, regulatory affairs, Veristat

Mark is a recognized leader in the regulatory affairs community with over 25 years of extensive experience with regulatory issues and the overall biopharmaceutical development process. Mark has directly submitted more than ten INDs and supervised the NDA submission and review for eight products. He has led dozens of meetings with health authorities in both the United States and Europe including pre-IND, end-of-phase II, pre-NDA and final labeling negotiations. His expertise spans many therapeutic areas including cardiovascular, psychiatry, neurology, diabetes, metabolic, inflammation, oncology, dermatology, and nephrology.  Additionally, Mark has led regulatory activities for several novel atypical antipsychotic compounds and agents to treat multi-drug resistant tumors.

His excellent analytical, communication and negotiation skills have been used to effectively prepare and lead teams through many challenging health authority interactions. Mark received his Doctor of Pharmacy degree from the University of Michigan.

·         Mara Holinger, PhD, RAC, vice president, regulatory affairs, Veristat

Mara Holinger assists pharmaceutical, biotech and medical device firms with preparing their regulatory pathway, designing their clinical program and trials, performing gap analysis for CMC and preclinical reporting and writing regulatory applications. She has written, reviewed or provided oversight for more than 20 INDs, multiple Orphan Drug Designation (ODD) applications, breakthrough designation applications, special protocol assessments, fast track applications and several New Drug Applications, including 505(b)(2).

She is an expert in regulatory agency meeting preparation, moderation and logistical support, and services as an Authorized Regulatory Representative and US Agent. Mara earned her Ph.D. in Molecular Microbiology from Tufts University School of Medicine.

·         Kevin Hennegan, M.A., senior regulatory strategist, Veristat

Kevin Hennegan has provided strategic clinical and regulatory guidance to the pharmaceutical, biotech and medical device industry for over 15 years. He has led and participated in the preparation of many successful FDA filings, including INDs, NDAs, BLAs, Breakthrough Therapy Designations, Orphan Drug Designations and Fast Track Applications. His experience covers a wide array of therapeutic indications – oncology, neurology, rheumatology, infectious disease, etc. – and product classes including therapeutic proteins, small molecule drugs, cell therapies, gene therapies and vaccines.

Kevin earned his bachelor’s degree in Microbiology from Colorado State University and a master’s degree in Molecular, Cellular and Developmental Biology from the University of Colorado at Boulder. He is an advocate for patient-focused drug development and excels in engaging the FDA and other regulatory authorities as development partners.

Questions

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