LAFAYETTE HILL, Pa.--Integrated Project Services (IPS), a full-service engineering, design/build, validation and compliance company dedicated to assisting pharmaceutical and biotech companies improve operations, today announced is has established a Technical Advisory Board comprised of individuals who possess specialized knowledge and technical expertise. The Technical Advisory Board will augment our established senior management team and subject matter expert resources to provide technical guidance and strategic direction to IPS and its clients.
“We are very pleased to assemble such a knowledgeable group of experts as members of IPS’ Technical Advisory Board,” said Andrew A. Signore, PE, Chief Executive Officer and Co-founder of IPS. “Our ability to recruit thought leaders to our Advisory Board demonstrates our commitment to achieving our vision of being knowledge leaders of choice by delivering technology-based business solutions which help our client’s succeed.”
The members of the newly formed IPS Technical Advisory Board include:
James Agalloco – Mr. Agalloco is founder and President of Agalloco & Associates. He has extensive leadership experience working for large, global pharmaceutical companies such as Pfizer and Bristol-Myers Squibb. Mr. Agalloco possesses over thirty years of management experience in pharmaceutical manufacturing, pharmaceutical engineering, computer systems validation, technical services and research and development and is an internationally recognized expert on process and systems validation. In addition, Mr. Agalloco has extensive knowledge of pharmaceutical and Bulk Pharmaceutical Chemicals (BPC) manufacturing technology. He has assisted over 120 firms in the United States, Puerto Rico, Canada, Mexico and Western Europe.
Metin Celik, Ph.D. - Dr. Celik is founder and President of Pharmaceutical Technologies International, Inc., and a Pharmaceutical Processing Research Professor at the Department of Industrial Engineering, Rutgers University. Dr. Celik was employed by Sandoz-Switzerland and Sandoz-Turkey prior to joining Smith Kline & French Laboratories where he established the first state-of-art Compaction Simulator System in the western hemisphere. He developed a second unit at Rutgers University, the first unit in US academia, and established an internationally recognized research center. Dr. Celik has acted a consultant to the FDA and to over forty-five global pharmaceutical, nutraceutical, excipient, and equipment companies.
William T. Hensler, Ph.D. – Dr. Hensler is a Biochemical Engineer with eighteen years of international cGMP pharmaceutical manufacturing, quality assurance and engineering experience, with particular emphasis on production of bulk biopharmaceuticals including cytokines, monoclonal antibodies, vaccines and blood products. He has extensive knowledge of manufacturing compliance, validation and regulatory requirements for bulk biopharmaceutical facilities according to US FDA, EMEA and ICH regulations (API's and final dosage forms). Dr. Hensler is technically proficient on many aspects of biopharmaceutical processing, with emphasis on large scale bulk production and process validation.
James R. Laser, P.E. – Prior to his retirement from Merck, Mr. Laser had twenty-eight years of increasingly responsible positions at that company, including that of Vice President of Vaccine Operations. He possesses significant expertise in operations, materials management, engineering and technical services in the manufacture of pharmaceutical and biological products. He has also participated in the development and implementation of global manufacturing and quality policies, including Manufacturing and Human Resource strategies.
Nigel Smart, Ph.D. – Dr. Smart is Managing Partner of Smart Consulting Group, LLC (SCG). He has over twenty five years experience in the biotechnology and pharmaceutical industry including providing technical and regulatory assistant to help clients meet cGMP production objectives. SCG guides clients through technical and regulatory hurdles associated with FDA licensure, approval and commercialization. Between the two managing partners, the range of experience includes analytical quality control, regulatory/legal, process development, manufacturing, clinical trial management and validation. Dr. Smart is a Chartered Chemist, member of Institute of Biology, and a Chartered Scientist.
Russ Somma, Ph.D. – With 30 years of pharmaceutical industry experience, Dr. Somma possesses expertise in the areas of production troubleshooting, dosage form development, manufacturing scale-up, technology transfer and Quality by Design. He has provided support for 21 NDAs in the chemistry, manufacturing and control area from submission through the pre-approval inspection phase. As president of SommaTech, LLC, his focus is on pharmaceutical technology and helping clients achieve their FDA regulated product goals and assuring a cost effective product and a secure supply chain. Dr. Somma is Chairman of ISPE’s Product Quality Lifecycle Implementation (PQLI) project, Chair of the Professional Certification Commission, CPIP and past Chairman of ISPE’s SUPAC Equipment Guidance Steering Committee. Dr. Somma is a “Hammer Award” winner, presented by Vice President Al Gore’s Committee for National Performance Review.
William B. Wiederseim – Mr. Wiederseim is President and Chief Executive Officer of PharmaBioSource, Inc., PharmaBioSource Realty and PharmaBioSource Recruiters. He has been a consultant to the pharmaceutical, chemical and automotive industries for more than twenty years. He is the co-founder and First Executive Director of The Consortium for the Advancement of Manufacturing in Pharmaceuticals (CAMP), a non-profit research consortium for the Pharmaceutical Industry, MIT and Purdue University. Mr. Wiederseim is the founder and primary person responsible for the overall development of PharmaBioSource.
About IPS
Integrated Project Services (IPS), www.ipsdb.com, is a full-service, engineering firm servicing the pharmaceutical and biotechnology industries as well as medical device, diagnostics and specialty chemical. IPS services include technical consulting, engineering and design, design/build, construction management, commissioning, and compliance. Located in Lafayette Hill, Pa., IPS has full service branch offices in Pennsylvania, North Carolina, New Jersey, California, Indiana, and Puerto Rico.
