Additional Consultants Leadership Team


Deborah Ladenheim, Ph.D.
Senior Consultant, Regulatory Strategy

 

Dr. Deborah Ladenheim is a Senior Regulatory Strategy Consultant  at Catalyst Regulatory Services, LLC. Prior to joining Catalyst, Deborah worked for Athersys Inc, a biotechnology company specializing in stem cell product development.  At Athersys she served as Vice President of Regulatory Affairs and was responsible for global regulatory strategies and submissions, as well as pharmacovigilance and compliance. Prior to Athersys, Deborah was Vice President of Regulatory Affairs and Project Management for Avidimer Therapeutics, a startup biotechnology company developing nanotherapeutic solutions to drug delivery.  She has over twenty years of experience in the Pharmaceutical Industry and has held positions with increasing levels of responsibility within Regulatory Affairs at two major pharmaceutical companies (SmithKline Beecham and Pfizer).  She has expertise across the drug development spectrum from early development programs through marketing authorization approval both in the US as well as in the European Union. Deborah has experience in numerous therapeutic areas including oncology, inflammation, cardiovascular, women’s health, wound healing, transplant, neurology (stroke) and pain. She also has substantial experience in development of cellular therapies for clinical use.

Career highlights include:

  • Led numerous meetings with health authorities in both US and Europe including pre-pre IND, pre-IND, end-of-phase I, European scientific advice
  • Two successful orphan drug designation applications in the US
  • Responsible for regulatory strategies for novel therapeutic concepts (nanotechnology, stem cell therapy)
  • Developed regulatory strategies and submissions for pediatric projects
  • Successful IND submissions in the US and CTAs in Europe
  • Submitted sNDAs and provided responses to regulatory questions

Deborah received her Bachelor’s degree in Pharmacy from the University of Wales in the  UK and her Ph.D. from the University of Brighton, UK.