Barbara A. Binzak Blumenfeld, Ph.D.

Barbara A. Binzak Blumenfeld, Ph.D. is Co-Head of the FDA & Biotechnology Section.  Barbara helps clients make and execute on strategic decisions about FDA-regulated products. She leverages her unique background, integrating science and biomedical ethics into her legal practice to create true value for her clients. Each client has unique goals, and Barbara formulates a regulatory strategy that is individualized to each one.

Barbara assists clients with FDA regulatory matters arising before, during, and after product approval and marketing. She has worked with clients on virtually all categories of FDA-regulated products, including drugs, biologics and biosimilars, medical devices, foods, and combination products.  She also works closely with Buchanan’s IP attorneys to create a holistic IP/FDA strategy that takes into account the company’s patent portfolio, any FDA patent listings, and FDA-granted regulatory exclusivity.

Key examples of Barbara’s experience include: 

Drugs

• Creating FDA regulatory analyses and strategies that incorporate IP assessments for investors and for companies looking to acquire or divest products.
• Working with companies to determine the appropriate data package to support 505(b)(2) new drug application (NDA) approval with 3-year exclusivity.
• Assisting a generic drug sponsor with an FDA refuse-to-file decision impacting a first filer application containing a Paragraph IV certification.
• Working with companies on complex clinical trial issues, including informed consent, data ownership, and foreign trial sites.
• Assists clients in safeguarding clinical trial data in the era of AI, ensuring compliance with regulations and securing sensitive information.

Biologics and Biosimilars

• Working with a university researcher to prepare for a pre-IND meeting and IND submission for a cell therapy product.
• Assisting a gene-modified cell therapy product sponsor with a clinical hold investigation and response.
• Completing due diligence for an investor in a cell therapy company.
• Assisting a company with FDA regulatory matters for a biosimilar product in development.

Medical Devices

• Converting a European company’s medical device CE-mark dossier into a cleared 510(k) notification.
• Assisting with 510(k) predicate device identification and Q-Submission meetings.
• Advising on Emergency Use Authorization (EUA) requirements for antibody tests.

Foods

• Counseling on legal requirements for medical foods.
• Assisting with conventional food recalls.
• Working with a medicated animal feed company on a Notice of Opportunity for Hearing (NOOH) involving an antibiotic.

Combination Products

• Arguing chemical vs. mechanical mode of action for product jurisdiction determinations.
• Arguing primary mode of action issues for lead FDA Center determinations.
• Advising on and preparing pre-request for designation (pre-RFD) and RFD submissions.

Barbara has also published and presented on numerous FDA-related topics, including 505(b)(2) NDAs; investigational new drug applications (INDs); human cells, tissues, and cellular and tissue-based products (HCT/Ps); the Drug Supply Chain Security Act (DSCSA); and risk evaluation and mitigation strategies (REMS).

My multidisciplinary training in law, science, and biomedical ethics allows me to truly understand my client’s technologies. A better understanding leads to better client communication because I can 'speak the language.' Clients look to me to be able to translate their scientific discoveries into an actionable FDA regulatory strategy.

During her 20 years of practice, Barbara has also served on various professional boards and groups. She was a working group member for a grant awarded to the University of Maryland by the National Institutes of Health’s (NIH’s) Human Microbiome Project for the study of the federal regulation of probiotics. She has held numerous positions within the Food and Drug Law Institute (FDLI), including serving as a member of the FDLI Board of Directors. Barbara also served from 2016-2023 on her alma mater Cardinal Stritch University’s College of Arts and Sciences Advisory Committee.

In 2022, Barbara was recognized by Corporate Counsel in its Women, Influence and Power in Law Awards. She was among the honorees in the Law Firm – Collaborative Leadership category. 

Prior to law school, Barbara earned her Ph.D. in molecular biology, focusing her research on the study of genes encoding proteins involved in amino acid and lipid metabolism. She then pivoted her focus from the lab to the law, using her scientific experience to further a career in food and drug law. Today, Barbara and her husband enjoy time with family and friends, listening to live jazz music, and cruising to far-off destinations.