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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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.
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.
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
Leaders in the life sciences industry
Regulatory affairs professionals
Clinical affairs professionals
Medical affairs professionals
Mark Ammann, Pharm.D. , senior vice president,
regulatory affairs, Veristat
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.
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.
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