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  • HOME
  • SERVICES
    • FOR COMPANIES
    • FOR INVESTORS
  • ABOUT
  • OUR TEAM
CONTACT US

OUR TEAM

FDA Partners is composed of expert regulatory and clinical leaders who have dedicated their careers to guiding complex technologies through FDA pathways and decision points. We partner closely with your team, providing direct access to industry-leading advisors to assist you directly.

Detailed team member bios will be available shortly.

ABOUT FDA PARTNERS

Jonathan Helfgott, MS

Christopher Breder, MD PhD

Jonathan Helfgott, MS

At FDA Partners, our story began with a passion for helping businesses succeed. Our founders saw a need for personalized, results-driven consulting services, and set out to create a company that would meet that need. Today, we continue to uphold that same passion and commitment to excellence.

David Schodin, PhD JD

Christopher Breder, MD PhD

Jonathan Helfgott, MS

At FDA Partners, we believe that collaboration is key to success. We work closely with our clients to understand their challenges and goals, and develop solutions that are tailored to their unique needs. Our approach is transparent, results-driven, and designed to help businesses thrive.

Christopher Breder, MD PhD

Christopher Breder, MD PhD

Christopher Breder, MD PhD

We offer a variety of consulting services at FDA Partners, including marketing, strategy, operations, and more. Our team is made up of experts in each of these areas, and we work together to provide our clients with comprehensive solutions that meet their unique needs.

Adam Kaplin, MD PhD

Dr. Anupama Kumar, MBBS PhD

Christopher Breder, MD PhD

At FDA Partners, we believe that collaboration is key to success. We work closely with our clients to understand their challenges and goals, and develop solutions that are tailored to their unique needs. Our approach is transparent, results-driven, and designed to help businesses thrive.

Dr. Anupama Kumar, MBBS PhD

Dr. Anupama Kumar, MBBS PhD

Dr. Anupama Kumar, MBBS PhD

Dr. Anupama Kumar is a seasoned clinical researcher with specialized expertise in designing and managing clinical trials in neuroimmunology and psychiatry. With over a decade of hands-on research experience, Dr. Kumar excels at translating scientific innovation into effective therapeutic applications.


At Johns Hopkins School of Medicine, D

Dr. Anupama Kumar is a seasoned clinical researcher with specialized expertise in designing and managing clinical trials in neuroimmunology and psychiatry. With over a decade of hands-on research experience, Dr. Kumar excels at translating scientific innovation into effective therapeutic applications.


At Johns Hopkins School of Medicine, Dr. Kumar managed multiple concurrent clinical trials investigating psychiatric and neurological disorders. Her meticulous approach to documentation and protocol implementation resulted in perfect audit performance and a reduction in protocol deviation rates. As Co-Director of the Esketamine Clinic, she developed comprehensive treatment protocols that have been adopted by clinics nationwide.


Dr. Kumar's clinical research prowess led to her appointment as Vice President of Research at Miralogx, LLC, where she spearheaded drug development initiatives and established efficient research systems while navigating complex regulatory requirements. Her work has resulted in 14 peer-reviewed publications in prestigious journals including the New England Journal of Medicine.


With dual post-doctoral fellowships from Johns Hopkins University in Psychiatry and Neuroimmunology complementing her medical training, Dr. Kumar brings exceptional scientific rigor and organizational leadership to clinical research environments.

Tom Colonna, PhD JD

Dr. Anupama Kumar, MBBS PhD

Dr. Anupama Kumar, MBBS PhD

At FDA Partners, we believe that collaboration is key to success. We work closely with our clients to understand their challenges and goals, and develop solutions that are tailored to their unique needs. Our approach is transparent, results-driven, and designed to help businesses thrive.

Anita Ju

Penny Rassmusen, MS

Anis Rahman, MS

With over 15 years of experience leading  enterprise-wide digital initiatives across pharma, payers, and community  health clinics, I specialize in aligning innovation with impact. I lead  multidisciplinary teams of product managers, UX designers, and  innovation strategists to build and execute global digital  transformation strategies —

With over 15 years of experience leading  enterprise-wide digital initiatives across pharma, payers, and community  health clinics, I specialize in aligning innovation with impact. I lead  multidisciplinary teams of product managers, UX designers, and  innovation strategists to build and execute global digital  transformation strategies — driving measurable change in AI adoption,  omni-channel optimization, digital experience, and digital product  strategy.I bring hands-on expertise in:- Agile product management- CX  journey orchestration- Omni-channel strategy and implementation- Design  thinking & Lean Six Sigma- AI strategy, digital health, and  automation- Low-code AI agents & MVP prototyping Currently, I’m  deepening my leadership in AI and health informatics through Johns  Hopkins' part-time DrPH program designed for healthcare leaders. 

Anis Rahman, MS

Penny Rassmusen, MS

Anis Rahman, MS

At FDA Partners, we believe that collaboration is key to success. We work closely with our clients to understand their challenges and goals, and develop solutions that are tailored to their unique needs. Our approach is transparent, results-driven, and designed to help businesses thrive.

Penny Rassmusen, MS

Penny Rassmusen, MS

Penny Rassmusen, MS

At FDA Partners, we believe that collaboration is key to success. We work closely with our clients to understand their challenges and goals, and develop solutions that are tailored to their unique needs. Our approach is transparent, results-driven, and designed to help businesses thrive.

Zoe

Alexander Phillips

Penny Rassmusen, MS

At FDA Partners, we believe that collaboration is key to success. We work closely with our clients to understand their challenges and goals, and develop solutions that are tailored to their unique needs. Our approach is transparent, results-driven, and designed to help businesses thrive.

Alexander Phillips

Alexander Phillips

Alexander Phillips

At FDA Partners, we believe that collaboration is key to success. We work closely with our clients to understand their challenges and goals, and develop solutions that are tailored to their unique needs. Our approach is transparent, results-driven, and designed to help businesses thrive.

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