Mick Banks previously held the position of Vice President within Worldwide Pharmaceutical Sciences (CMC) of the Research and Development Division at Pfizer Inc, Groton, Connecticut.
Mick has over 30 years experience in drug development and has led formulation, process development, technology transfer, clinical trial material manufacture and supply, business operations and project & portfolio management groups. His experience includes progressing many products to successful global filings, approvals and commercialization. Mick also held key leadership positions during several merger and acquisition transactions at Pfizer. He has worked on R&D regional strategies including Europe/Japan/Asia. Prior to Pfizer, Mick was Head of International Formulation Development at Abbott Laboratories, UK.
Mick is a Pharmacist with a B.Sc. (Hons) Pharmacy, a Ph.D. in Pharmaceutical Technology and a MBA with distinction.
Mike Yelvigi was previously Director of Supply Chain Management at Pfizer, Inc and earlier he was Senior Director of the CMC Portfolio Management function at Wyeth Division of Pfizer. He had responsibility for co-ordination of CMC activities related to drug substance synthesis, drug product formulation, analytical development and regulatory filing for several therapeutic areas. He has over 38 years extensive experience in pharmaceutical formulation, process development/scale-up, technology transfer, process validation, manufacturing and pre-approval inspections.
Prior to joining Pfizer, he was Head of Process Development and clinical supply function at Hoffman-La Roche Company, New Jersey. He has earlier worked at other companies including Parke Davis (USA), G.D. Searle and Organon Inc., USA. He holds B.Pharm. & M.Pharm. degrees in Pharmacy and a M.S. Pharmacy, from Philadelphia College of Pharmacy.
He is an adjunct Assistant Professor of Pharmaceutics at the School of Pharmacy, University of Mississippi. Mike is also an active member of AAPS, ISPE, AAiPS and FIP. He was Chairperson of the AAPS Manufacturing Science & Engineering (MSE) section. He also develops and leads CMC/Regulatory courses around the world.
Our team consists of over 20 senior scientific and technically proficient professionals. This team has collective experience and expertise in the following:
- CMC R&D activities and commercial Manufacturing operations.
- Pharmacokinetics and Biopharmaceutics.
- Many Pharmaceutical Companies (including Multi-nationals), Universities and Regulatory Agencies (FDA, MHRA).
- Drug development with many products ,including blockbusters, successfully filed and approved with Regulatory Agencies across the world.
We have a wide knowledge and experience working with Contract Research (CRO's) and Contract Manufacturing Organisations (CMO's) in the USA, Europe, China and India. This enables us to provide:
- Identification of appropriate CMC Development laboratories and GMP Manufacturing capabilities.
- Assessment of emerging CRO's and CMO's under consideration by the client.
- The level of scientific and technical expertise available at specific companies.
- Assessment of regulatory competence.
- Value and reliability.
We are able to provide the right expertise and experience for your project.
- Close interaction with each client to fully understand the project scope.
- Provide a customised solution for each project to deliver efficiently and effectively.
- Highly responsive and cost conscious to provide value and quality to meet each client’s expectations.