Management

George K. Gessner, President

Mr. Gessner has spent over 40 years in the pharmaceutical industry primarily in sales, product management and new product development of both branded and generic pharmaceutical products and devices.  Mr. Gessner is president of RRI Group, Inc. which provides regulatory and project management consulting services to pharmaceutical companies that need assistance in the development of total product projects.  Mr. Gessner formed RRI in 2005 after retiring as Vice President of Business Development for SFBC/Pharmanet, a leading CRO in the pharmaceutical industry.  Prior to SFBC, Mr. Gessner had his own product development consulting company and associated CRO which was merged into SFBC in 2000.  Mr. Gessner also held senior positions with Johnson & Johnson, Merck Inc. and William H. Rorer.  Mr. Gessner was responsible for the new product development of several marketed pharmaceutical and device products while at J&J.  Mr. Gessner holds a B.S. in Chemistry from Muhlenberg College and a B.A. and M.B.A. in Marketing from Temple University.

Loren Gelber, Ph.D., Chief Scientific Officer

Dr. Gelber has twenty years of experience in the pharmaceutical industry.  She is skilled in project management, preparation of submissions to pharmaceutical regulatory bodies, interaction with pharmaceutical regulatory bodies, interaction with contract research organizations and contract manufacturing organizations.  She is also an expert in compliance with Good Manufacturing Practice regulations, Quality Assurance and Quality Control.  She is the author or more than thirty publications and presentations.  She is a member of the Product Quality Research Institute Blend Uniformity Working Group and the Generic Pharmaceutical Association Technical Committee.

Dr. Gelber has a Ph.D. in Medicinal Chemistry from Northeastern University School of Pharmacy, an MS in Chemistry from the Polytechnic Institute of New York and a BA in Biology from Brandeis University.  She most recently worked for Andrx Pharmaceuticals, Inc. as Senior Director Quality Compliance.  Prior to that she is Executive Director Clinical Research at Universal Research Inc., Vice President Regulatory Compliance at Royce Laboratories, Inc., Director of Regulatory Affairs at Danbury Pharmacal, Inc. and Director of Regulatory Affairs at Barr Laboratories, Inc.  She also worked for the Food and Drug Administration for slightly less than ten years.

Zaidoon A. al-Zubaidy, Vice President of Operations

Zaidoon Al-Zubaidy is currently the Vice President, Operations for RRI Group, Inc. providing overall direction and guidance to the operational activities of the organization with the objective of maximizing growth and profitability as well as day-to-day leadership and management to all company operations functions.

Prior to RRI Group, Inc., Zaidoon was the Senior Director, Clinical Research and development at Actavis Inc. responsible for developing and implementing a biopharmaceutics/ pharmacokinetics program to support an R&D team devoted to the R&D of new generic drug products. Prior to Actavis Inc., Zaidoon served as the Director of R&D and Clinical Development at Interpharm Inc., New York. He was responsible for advanced research towards the development of generic pharmaceutical products and for the biopharmaceutic assessment of pharmaceutical products to determine their readiness for bioequivalence studies.

Mr. Al-Zubaidy has managed the overall clinical program for Sandoz Canada,with global experience with clinical research organizations (CROs) from India, South Africa and North America.

Prior to working for generic pharmaceutical companies, Zaidoon spent 3 years as a pharmacokinetic manager at a global CRO, responsible for the interpretation of pharmacokinetic data & compilation of pharmacokinetic related reports.

Zaidoon Al-Zubaidy served as the Chair of the Bioequivalence Committee for the Canadian Generic Pharmaceutical Association, representing the Canadian generic industry’s concerns to Health Canada, to work with the government agency.

As graduate of the University of East London, UK (B.Sc. Pharmacology) Zaidoon earned a Masters degree from the University of Alberta, Canada (Physiology).