When developing a drug, biologic or combination product for approval, early and successful interactions with the US Food and Drug Administration (FDA) can reduce both costs and time to approval. Developing a strong relationship with the product’s review division is crucial in ensuring that the agency is knowledgeable about the product and supports the development. Formal meetings with the FDA will strengthen this relationship and allow them to provide input on product and program development plans. In this webinar, John Balser, Barbara Balser and Mara Holinger will discuss methods for ensuring a successful FDA meeting and developing a collaborative relationship. They will touch on why it is important to ask the right questions and provide the appropriate background information for the most successful outcomes. The speakers will share their tips and tricks based on years of experience and positive outcomes from FDA meetings.
John P. Balser, PhD, President and Co-Founder, Veristat
John Balser co-founded Veristat in 1994 and has grown the company to be a scientifically impactful clinical research partner. John is actively involved with the clinical projects of emerging and established biotech clients in his role as Veristat’s President and principal statistical consultant. In this role, he assists clients with clinical study design and program development based on his many years of experience in the statistical, regulatory and strategic aspects of clinical research. He regularly assists clients as they prepare for and engage with the regulatory agencies, particularly the US Food and Drug Administration (FDA).
John received his Master of Science and PhD in Biometrics from Cornell University and has been actively engaged in clinical biostatistics for over 30 years.Message Presenter
Barbara Balser, VMD, Executive Vice President, Chief Scientific Officer, Veristat
Barbara Balser provides biopharmaceutical clients with regulatory strategy, submission and medical writing counsel in their efforts to advance compounds to regulatory approval. With more than 30 years of clinical research experience, her passion lies in providing strategic planning, consulting, medical oversight and the architecture and production of regulatory submission documents. Her experience includes oversight and production of Investigational New Drug (IND) applications, regulatory agency briefing documents, preparation for and representation at advisory panel meetings and consultation across Phase 1 to 4 trials. Barbara’s experience expands over multiple therapeutic areas with a specific focus in oncology, rare diseases and anti-infectives. Barbara has participated in the writing, oversight and submission of countless marketing applications to US, Canadian, Japanese and European Union regulatory authorities.
Barbara holds a Bachelor of Science in Chemical Engineering from the University of Pennsylvania, School of Engineering and Applied Science, and a Veterinariae Medicinae Doctoris (VMD) from the University of Pennsylvania, School of Veterinary Medicine.Message Presenter
Mara Holinger, PhD, RAC, Vice President of Regulatory Affairs, Veristat
Mara earned her PhD in Molecular Microbiology from Tufts University School of Medicine and began her career as a lead scientist in anti-cancer research. She provides pharmaceutical, biotech and medical device firms with strategic consulting to prepare their regulatory pathway; to design their clinical program and trials; to perform gap analysis for Chemistry, Manufacturing and Controls (CMC) and preclinical reporting and to write regulatory applications. Additionally, she is an expert in regulatory agency meeting preparation, moderation and logistical support, and serves 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.Message Presenter
Kevin Hennegan, Regulatory Consultant, 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.Message Presenter
Who Should Attend?
This webinar will appeal to individuals working in the following or related areas:
- Regulatory Affairs titles (Heads, VPs, Directors) at pharmaceutical and biotechnology firms
- Emerging, small, and mid-tier biotech firms — CEO, CMO, COO or any Regulatory titles
What You Will Learn
In this free webinar, attendees will:
- Understand the different types of FDA meetings, the parameters of each and which is most relevant during different stages of development
- Develop questions that will elicit beneficial answers from the review team
- How to develop a briefing package containing the information necessary for the agency to answer specific questions
- Learn how to prepare for your meeting in a way that will ensure the most efficient use of the time allotted
Veristat is a scientifically oriented and impactful full-service clinical research organization (CRO) that is committed to partnering with emerging and small to mid-sized biotechnology firms to advance their therapies throughout the entire clinical development and regulatory submission process. Veristat helps growing clients solve the unique and complex challenges that arise when trying to accelerate therapies along the development pathway to successful regulatory approval, beginning with regulatory planning, study design, protocol development, site selection and start-up through to patient recruitment, clinical monitoring, data collection, analysis and reporting. Ultimately, we guide our clients to market success so that their therapies become available to improve and save people’s lives. Our impact is proven by our regulatory track record of success — in 2018, Veristat supported 12% of all NMEs approval by the FDA.