Edkins Pharma Services, LLC focuses on analytical and bioanalytical chemistry, CMC, project management and compliance. The practice encompasses several small molecule and biologics programs for small and large pharma companies, including managing long-term international projects across multiple sites.

• Organized series of 14 lectures (with two colleagues) in Bioanalytical Chemistry and Good Laboratory Practices for online MS program in Regulatory Sciences • Presented lectures in method development/method validation, ELISA/LC/MS/MS methods and compliance• Participated in on-line question and answer forums with students

• Ensures that all products manufactured at Contract Service Providers (CSPs) are produced, tested, and released in compliance with SOPs, cGMPs and FDA regulations.• Provides Quality oversight for decisions regarding quality and compliance for all batches and products, including discrepant batches (investigations, retesting and re-inspections). • Oversees the establishment of all systems, procedures and specifications affecting product quality (e.g., batch records, SOPs, validation protocols and reports) to minimize errors and eliminate the possibility of non-compliant products being produced or released.• Provides leadership and direction and ensures achievement of all functional accountabilities. Ensures there is Quality support during Health Authority inspections of CSPs• Maintains quality management system by directing and providing oversight and input into: batchrelease and control; change control; document management system; quality procedures, standards, and policies; product complaints and recalls; quality system reporting; investigations and CAPAs.

Lead, manage and/or facilitate high-level Clinical Services and CMC teams, encompassing Clinical Operations, CQA, PK, CMC, QA and Bioanalytical Chemistry in support of client's oncology programs.

Ceptaris Therapeutics, Inc. (formerly Yaupon Therapeutics, Inc.) developed a proprietary formulation of mechlorethamine gel for Cutaneous T-Cell Lymphoma. Ceptaris was sold to Actelion Pharmaceuticals in September 2013 for $250 million USD, concurrent with the US NDA approval of VALCHLOR™ in August 2013. Oversaw and coordinated technical and compliance issues with multiple contract manufacturing, analytical and drug storage facilities: • 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• Prepared and reviewed NDA CMC documents and provided regulatory support up to approval

Auxilium Pharmaceuticals developed pharmaceutical products that focused on urology and sexual health and was sold to Endo Pharmaceuticals, Inc. in January 2015 for $2.6 billion USD. • 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 coordinated 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

Asahi Kasei Pharma is a specialty pharmaceutical firm with a global presence that focuses on the development of new world-class drugs in selected therapeutic fields.Coordinated and oversaw bioanalytical activities with contract facilities in Western Europe and the US for submission of XIAFLEX® in Asian markets. XIAFLEX® was approved for use in Japan on July 3, 2015.

Vicuron focused on vital medicines for hospital-based infectious diseases and was sold to Pfizer in March 2005 for $1.9 billion USD. • 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• As Acting QA Director reviewed API/DP batch records and consulted with Pfizer on overall QA strategies

• 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• Managed analytical and stability programs for Chisys™

• Directed all analytical activities for Hepatitis C and pleconaril pediatric suspension programs• Supervised three-person analytical team

Conceived and stimulated an industrial-academic collaboration for utilizing laser-based polarimetric and circular dichroism HPLC detection for industrial applications with Donald C. Bobbitt, PhD, President of University of Arkansas System

• Developed and validated analytical methods for chemical intermediates, DS/DP release, stability testing and GLP studies• Formulated automated HPLC methods development strategy • Initiated and expanded use of laser-based polarimetric and circular dichroism HPLC detection • Demonstrated expertise in enantioselective separations and peptide chromatography • Managed and trained three associate staff members