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Thomas J. Edkins

Edkins Pharma Services, LLC

 

Member profile details

Photo
First name
Thomas J.
Last name
Edkins
Organization
Edkins Pharma Services, LLC
 

Contact information

City
Saint Davids
State or Province
Pennsylvania
Zip Code
19087-7047
Country
United States
Phone
(215) 837-1539
 

Specialties and Services

Fields of Expertise
  • Analytical
  • Biotechnology
  • High Performance Liquid Chromatography
  • Pharmaceutical
  • Project Management
  • Quality
  • Regulatory Affairs
  • Validation
Other Fields of Expertise
Pharmaceutical Analytical Chemistry
Quality Assurance and Compliance
Bioanalytical Chemistry
Chemistry, Manufacturing and Controls
Project Management
Summary
Edkins Pharma Services, LLC focuses on analytical and bioanalytical chemistry, compliance, CMC and project management. The practice encompasses small molecule and biologics programs for small to large pharma and biotech companies, including simultaneously managing domestic and international multi-year projects across multiple sites.
Services
As Principal, Dr. Edkins is a highly experienced pharma and biotech consultant with over 25 years of domestic and international pharma experience, including managing successful contract testing programs for many dosage forms and/or nonclinical and clinical programs for various marketed drugs. He has an exceptional ability to lead, solve and manage multi-year programs including highly-complex scientific problems by collaborating with a network of high-level scientists, consultants and contract laboratories throughout North America and Western Europe. In addition, he has developed regulatory and compliance strategies and documentation for filings in the US, Europe and Asia in support of GMP, GLP and GCP studies.
 

Additional Information

Experience
Selected Clients, 2005-2016

Prism Pharma Co., Ltd., Yokohama, Kanagawa, Japan 2013 - Present

Quality, CMC, Bioanalytical and Project Manager Consultant
- Lead, manage and/or facilitate high-level Clinical Services and CMC teams
- Coordinate Clinical Development, CQA, PK, CMC, QA and Bioanalytical Chemistry in support of oncology programs

Ceptaris/Yaupon Therapeutics/Actelion Pharmaceuticals, Inc., Malvern, PA 2011- 2014

Senior CMC/Quality Consultant
- Managed most analytical R & D and QC activities with numerous vendors to support VALCHLOR API and drug product development
- Coordinated all Frontage laboratory LC/MS drug product analytical method activities
- Provided Quality Assurance support for audits, batch record review and related compliance activities

Auxilium Pharmaceuticals, Inc. Malvern/Chesterbrook, PA 2006 – 2014

Senior Director/Senior Bioanalytical and Quality Consultant
- Coordinated and developed 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 programs
- Wrote and coordinated many analytical/nonclinical and clinical sections for XIAFLEX® BLA
- Provided expert analytical advice to Horsham XiaFlex® manufacturing facility and coordinate related issues with CROs and partners
- As Acting QC Director streamlined DI/CAPA/CC process for 34-person analytical and microbiology group; directed key scientific initiatives
- Conducted CMC, bioanalytical and toxicology portions of TMF program

- Mid-size Pharma Co. – Acted as Principal Investigator, Subject Matter Expert (SME) for remediation and verification of bioanalytical studies

-Actelion Pharmaceuticals – Managed contract labs; drafted and finalized CMC regulatory responses for EMA submission

- University of Maryland School of Pharmacy – Lectured and organized program in Bioanalytical Chemistry and Good Laboratory Practices (GLP) for on-line MS program in Regulatory Sciences

-Asahi Kasei Pharma - Coordinated bioanalytical activities for submission of XIAFLEX® in Asian markets

- Digestive Care, Inc. - Coordinated post-submission analytical/bioanalytical validation activities for PERTZYE™ (pancrelipase); NDA approval May 2012

- Johnson & Johnson - Project manager for worldwide dermatological R&D team and coordinated nasal spray testing program

- Pfizer/Vicuron Pharmaceuticals, Inc., King of Prussia, PA 2005 - 2006

- Analytical - Directed post-NDA processes for dalbavancin, anidulafungin and a POP study; coordinated international analytical issues between Aventis, multiple CROs and Pfizer
- Formulation, Chemistry- Coordinated with CROs on chemistry and formulation POP issues
- RA- Addressed and wrote CMC responses for dalbavancin and IND filing for a POP compound
More Experience
Employee Positions Held Prior to Edkins Pharma Services, LLC

West Pharmaceutical Services, Lionville, PA 2002 - 2004

West Pharmaceutical Services, Drug Delivery Division, develoed intranasal, oral and vaccine technologies
Director, Analytical Development (ARD/QC), Drug Delivery Division (Warburg-Pincus purchased 12/04)
- Directed all analytical R&D and quality control activities
- Managed analytical and stability programs for TARGIT™ solid dosage polymer formulations for oral budesonide
- Managed complex nasal spray stability/characterization and toxicology programs
- Organized project management team for Phase II studies of intranasal Leuprolide-Chisys™
- Authored 2500-page analytical portion of nasal spray ANDA within ten weeks

ViroPharma Incorporated, Exton, PA 2001 - 2002

ViroPharma develops medicines for serious diseases
Team Leader, Preclinical Development

The R. W. Johnson Pharmaceutical Research Institute, Spring House, PA 1989 - 2001
PRI, A Johnson & Johnson Company, AR&D
Principal Scientist, Senior Scientist, Research Scientist

University of Arkansas, Fayetteville, AR 1992 - 2002
Department of Chemistry & Biochemistry
Adjunct Associate, Assistant Professor of Chemistry
Honors and Awards
Outstanding Podium Presentation, Johnson & Johnson Chromatography Symposium, May 1992
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.
Publications
- More than twenty (20) presentations at professional meetings and at universities
- Fourteen papers and one book chapter authored/co-authored

- Thomas J. Edkins, et al. “Assessment of Potential Cross-Reactivity of Human Endogenous Matrix Metalloproteinases with Collagenase Clostridium histolyticum Antibodies in Human Sera Obtained from Patients with Dupuytren’s Contracture,” Clin. Vaccine Immunol. 2012, 19(4): 562 – 569

- Thomas J. Edkins, et al. “Development and validation of novel enzyme activity methods to assess inhibition of matrix metalloproteinases (MMPs) in human serum by antibodies against enzyme therapeutics,” Journal of Pharmaceutical and Biomedical Analysis, 2012, 70, 408-414

- Donald Singer and Thomas J. Edkins, “Contract Laboratory Partnerships: How to Make a Partnership Work with a Contract Pharmaceutical Testing Laboratory,” Contract Pharma, June 2011

- Invited A-page Article, T.J. Edkins and D.R. Bobbitt, “Miniaturization of Enantioselective Detectors,” Analytical Chemistry, September 2001, 488A-496A
Miscellaneous
AFFILIATIONS:

American Chemical Society
American Association of Pharmaceutical Scientists
Chemical Consultant's Network
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