Edward is the founder and current Principal and Head of RA at Design Space InPharmatics (DSI), a successful CMC consultancy group based in the Philadelphia tri-state area. Ed also currently serves as the Co-Chair for the RAPS Philadelphia Chapter.
Prior to DSI, Ed commenced his career in API process development and manufacturing before serving various project leadership and CMC management capacities at several biopharmaceutical companies, specializing in process and regulatory improvement. In 2001 he served as a lead for Wyeth in the area of “International Compliance Verification” and has authored and submitted more than 100 regulatory submissions. Ed has developed submission content templates and process SOPs on a variety of technical and regulatory topics for the FDA-regulated industry and more recently has trained staff from numerous FDA-regulated companies on how to improve their regulatory processes.
Ed consults widely for pharmaceutical and biotech companies on a variety of topics:
Drug Development
- Over 15 years of experience in understanding the relationship between CMC and exploratory clinical design.
CTD Content Authoring
- Extensive hands-on experience with the authoring, preparation, submission and maintenance of the CMC sections for INDs, NDAs and BLAs both in paper copy and electronic format
Product LifeCycle Management
- Active experience in all routes of drug delivery and with significant “hands on” experience to risk manage a product strategy
Due Diligence
- Years of experience at the interface of science and commerce provides for a wide perspective on bioscience opportunities.
Commercial and Strategic Management
- A proven serial entrepreneur with a unique combination of technical and commercial acumen to assist companies in developing and implementing their business strategy.