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, are you ready?
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? And is this the best point in time to submit your application? Should you wait until there are more data available, or even run your first-in-human trial outside the US?
In this webinar, you will learn 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. You will receive advice from regulatory experts responsible for dozens of IND submissions 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. The direction provided will help you determine whether you are ready to submit your IND and take the next step in the development of your product.
Title: Are you Ready to Begin Planning your IND Submission?
LIVE Webinar Date: Wednesday, May 20, 2020 at 12 PM EDT
Webinar Learning Objectives:
Upon conclusion of the webinar, 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
About the Speakers:
Mark Amman, Pharm.D.
Senior Vice President, Regulatory Affairs, Veristat
Mark is a recognized leader in the regulatory affairs community with over 25 years of extensive knowledge of regulatory issues and the overall biopharmaceutical development process. Over the course of his career at both regulatory consulting firms and large pharmaceutical companies, 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 has directly submitted more than ten INDs and supervised the NDA submission and review for eight products.
Mark received his Doctor of Pharmacy degree from the University of Michigan.
Mara Holinger, PhD, RAC
Vice President of Regulatory Affairs, Veristat
Mara Holinger provides pharmaceutical, biotech and medical device firms with strategic consulting to prepare their regulatory pathway, design their clinical program and trials, perform gap analysis for CMC and preclinical reporting and write regulatory applications. Additionally, she is an expert in regulatory agency meeting preparation, moderation and logistical support, and services as an Authorized Regulatory Representative and US Agent. Mara has written, reviewed or provided oversight for more than 20 Investigational New Drug Applications (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).
Mara earned her Ph.D. in Molecular Microbiology from Tufts University School of Medicine and began her career as a lead scientist in anti-cancer research.
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 Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Biologics License Applications (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 (therapeutic proteins, small molecule drugs, cell therapies, gene therapies, vaccines, and more). He is an advocate for patient-focused drug development and excels in engaging the FDA and other regulatory authorities as development partners.
Kevin earned a 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.