Thomas J. Edkins, PhD
Principal
Edkins Pharma Services, LLC
518 West Beech Tree Lane
Wayne, PA, 19087-3229
Phone:
(215) 837-1539
Fax:
(610) 995-9561
E-mail: edkinspharma@verizon.net
SPECIALTIES:
- Analytical Chemistry
- Bioanalytical Chemistry
- Technical Project Management
- CMC And Regulatory Affairs
SERVICES PROVIDED:
Edkins Pharma Services, LLC provides consulting services in the areas of analytical and bioanalytical chemistry, CMC and technical project management. The practice encompasses several small molecule and biologics programs for small and large pharma companies, including managing several long-term multi-million dollar projects across multiple sites.
SUMMARY OF EXPERIENCE:
Dr. Edkins has over 20 years of pharmaceutical experience in analytical/bioanalytical R&D, QC and CMC coordinating GLP/GMP studies for small molecules, peptides, semi-biologics and biologics, transferring methods, characterizing raw materials, API, solid dosage, parenteral and nasal spray formulations for clinical release/commercial manufacturing, and coordinating toxicity, chemistry and formulation studies simultaneously with numerous CROs. Dr. Edkins is managing several major multi-site contract testing programs for many dosage forms and/or nonclinical and clinical programs for marketed drugs. He has contributed to many regulatory filings in the U.S. and Europe in support of GMP, GLP and GCP studies. Dr. Edkins founded Edkins Pharma Services, LLC in 2005.
Dr. Edkins has held positions of increasing responsibility at Johnson & Johnson, West Pharmaceutical Services, Vicuron Pharmaceuticals and Auxilium Pharmaceuticals, as well as others. He received his BS in Chemistry from Rutgers University and his MS and Ph.D. in Analytical Chemistry from Stevens Institute of Technology. He was an Adjunct Assistant and Associate Professor of Chemistry at the University of Arkansas. He is the author of 12 papers, a book chapter and has given more than 20 presentations at regional, national and international symposia.
SELECTED CLIENTS:
Auxilium Pharmaceuticals, Malvern, PA
Senior Quality Consultant
Auxilium Pharmaceuticals develops pharmaceutical products that focus on urology and sexual health
- As bioanalytical lead coordinated and developed all ligand binding antigen/antibody and enzyme activity neutralizing antibody assays with CROs for XiaFlex® and LC/MS/MS assays for transmucosal film (TMF) small molecule program
- Wrote and coordinated many analytical/nonclinical and clinical sections for XiaFlex® BLA
- Provide expert analytical advice to Horsham XiaFlex® manufacturing facility and coordinate related issues with CROs and partners
- Conducted CMC, bioanalytical and toxicology portions of TMF program
- As Acting QC Director streamlined DI/CAPA/CC process for 34-person analytical and microbiology group; directed key scientific initiatives
Project Manager, Large Pharma R & D
- Deliverables follow up, maintain timelines and meeting minutes and e-room
Pancrelipase Manufacturer
- Oversee NDA analytical/bioanalytical validation activities for therapeutic enzyme
Tunnell/MDS Pharma, Montreal, QC
- Bioanalytical Investigator for Five Year Review, redesigned chromatographic reintegration process, study review board member
Cephalon, Frazer, PA- CMC, RA
- Coordinated CMC efforts, prepared PROVIGIL® summary dossiers, information amendments/annual updates and agency responses; expert review of departmental chemistry issues
OTC Manufacturing Facility, DE
- Resolved all 483 issues within 30 days; re-designed OOT/OOS process, evaluated analytical capabilities
PRIOR POSITIONS:
2005-2006
Pfizer/Vicuron Pharmaceuticals, Inc., King of Prussia, PA
Senior Director, Scientific Affairs
Vicuron focused on vital medicines for hospital-based infectious diseases and was sold to Pfizer in 2005
2002-2004
West Pharmaceutical Services, Lionville, PA
Director, Analytical Development (ARD and QC), Drug Delivery Division
West Pharmaceutical Services, Drug Delivery Division, develops intranasal, oral and vaccine technologies
2001-2002
ViroPharma Incorporated, Exton, PA
Team Leader, Preclinical Development
ViroPharma develops medicines for serious diseases
1989-2001
The R. W. Johnson Pharmaceutical Research Institute, Spring House, PA
Principal Scientist, Senior Scientist, Research Scientist
EDUCATION:
Ph.D., Analytical Chemistry, Stevens Institute of Technology, Hoboken, NJ 1990.
M.S., Instrumental Chemistry, Stevens Institute of Technology, Hoboken, NJ, 1987.
B.S., Chemistry, Rutgers University, New Brunswick, NJ, 1981.
AFFILIATIONS:
American Chemical Society
American Association of Pharmaceutical Scientists
Chemical Consultant's Network
