Combination Product Regulatory Requirement Complexities and the Impact of the 21st Century Cures Act

Understanding Combination Product regulatory requirements as determined by the FDA is critical in establishing a successful development path for the ultimate approval and/or clearance of a combination product. In addition, for novel combination products or novel indications of historically approved combination products, it can become daunting to formulate the argument for the primary mode of action (PMOA) and to navigate the Office of Combination Products’ jurisdictional process of Request for Designation (RFD).

In this webinar, Diane Beatty, PhD, and Jean Dehdashti, MSc, RAC, will discuss their experience with the regulatory and product development processes for combination products to show you how to navigate regulatory complexities.

Topics will include:

• How to design efficient combination product development programs
• FDA’s classification of combination products and regulatory requirements for corresponding drug and device constituents
• The importance of ensuring your development program adequately supports FDA approval and clearance
• The impact of the 21st Century Cures Act on FDA jurisdiction decisions for combination products

Speakers

Diane Beatty, PhD, Managing Director, Regulatory Affairs and Product Development, Cardinal Health Regulatory Sciences

Diane Beatty, PhD, provides managerial and technical oversight of the regulatory affairs and product development team, which provides nonclinical, clinical and regulatory affairs consulting services. Dr. Beatty has more than 25 years of experience in scientific and regulatory strategies and development of pharmaceutical drugs, biologics, medical devices and combination products.

Dr. Beatty has been with Cardinal Health for more than 18 years. Her therapeutic experience includes analgesia, anti-infection, cardiovascular, CNS, dermatology, endocrinology, infectious diseases, oncology, over-the-counter, rheumatology, skeletal, and special pathogens. She provides regulatory and product development lectures, and is an industry expert on orphan drugs and expedited programs.

Previously, Dr. Beatty was an independent scientific and product development consultant. She also held a product manager role at Molecular Probes, Inc., where she led new product introductions from concept to packaged product. Additionally, she managed laboratory personnel and research activities at the University of Missouri-Kansas City (UMKC). Dr. Beatty received a doctorate in chemistry/biochemistry, bachelor’s degree in biology and a minor in chemistry from UMKC.

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Jean Dehdashti, MSc, RAC, Scientist III, Regulatory Affairs & Product Development, Cardinal Health Regulatory Sciences

Jean Dehdashti is a US RAC certified regulatory consultant, with 17 years of experience in scientific research and product development for pharmaceutical drug, combination product and medical device programs.

J. Dehdashti joined Cardinal Health in 2015 and has been involved in various drug, combination product and device development programs, and regularly provides lectures on medical device development. Previously, J. Dehdashti served as a lead scientific reviewer at the FDA’s CDRH, OIR, DIHD, where she was responsible for the review of hematology related device submissions.

Prior to the FDA, J. Dehdashti was a scientific project analyst and senior scientific lead at NIH, NCATS, TRND, where she was involved in several FDA and European orphan drug programs. As a research associate at Purdue University, J. Dehdashti gained scientific knowledge and experience in basic research, high-throughput drug-assay development and product lead-optimization. J. Dehdashti received a bachelor’s degree in biochemistry from the University of Kansas and an MSc in cell and molecular biology from the University of Missouri Kansas City.

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