Domestic & International Consulting Services by Consultant:

MATTHEW A. AUGUSTINE PH.D.
Formulation and Manufacturing
Pharmaca Consulting LLC
-Product Formulation (topical and oral)
-Manufacturing Methods
-Business Development
Dr. Augustine has more than 30 years of experience in formulation, manufacturing and business development. Prior to becoming a consultant, he was the Chief Scientific Officer of Harmony Laboratories in Kannapolis , North Carolina . He has also worked for Briston-Myers Squibb, Chemex Pharmaceuticals, Chase Pharmaceutical, Boots Pharmaceutical, Rorer Pharmaceutical, Beecham Products and Johnson & Johnson. Dr. Augustine Received his Doctorate and Bachelors degrees from the University of Connecticut in Storrs.

IRA BERRY
International Regulatory Business Consultants, L.L.C.
GMP & CMC Compliance Services
-Site quality audits for:
•  API manufacturing
•  Contract Formulators
•  Contract Manufacturers
-CMC Reviews
-GMP Inspections
-DMF Preparation
Mr. Berry is a recognized health care manufacturing industry expert, with a blend of technical and business education and experience in global manufacturing, quality assurance, regulatory affairs, marketing and new business development. He has technical expertise in pharmaceuticals, nutritional supplements, dosage forms and bulk API. Mr. Berry is President of International Regulatory Business Consultants, L.L.C. (IRB) which provides consulting services associated with the evaluation and preparation of DMF's and CMC sections of regulatory submissions plus GMP inspections for global pharmaceutical companies. Mr. Berry has more than 25 published papers on GMP compliance, validation procedures plus various patents on controlled release, chewable soft gels and antacid products. Mr. Berry has been co-editor and editor of several books related to process validation for dose forms and API plus the pharmaceutical regulatory process. Prior to the formation of IRB, Mr. Berry had senior positions in regulatory affairs, compliance, quality assurance, operations and business development at Duramed Pharmaceuticals, Wockhardt Americas Inc., Banner Pharmacaps Inc. and Carter Wallace, Inc. Mr. Berry has a B.S in Biology/Chemistry, a M.A in Biology, and M.B.A. in Management.

CHARLES BON
Biostudy Solutions L.L.C.
Biostatistics and Pharmacokinetics Services
-Statistical Design for Protocols:
•  BA/BE Studies
•  Clinical Equivalence
•  Pharmacology Dynamic/Vascoconstrictor Studies
-Bio Statistical Analysis
-GLP Audits
Mr. Bon is a Biostatistician who has experience in the design and analysis of bioavailability / bioequivalence studies, statistical consulting to pharmaceutical clients, providing statistical support for bioanalytical operations, and to the research, manufacturing and analytical operations of a pharmaceutical company. He received a B.S. in Biology in 1971 and an M.S. in Chemistry in 1976 from Indiana University of Pennsylvania. Between 1986 and 1992 he studied Biostatistics in the Graduate School of Public Health at the University of Pittsburgh. In 1973 he joined Biodecision Laboratories (currently Novum Pharmaceutical Research) in Pittsburgh, PA as a laboratory analyst. In 1975 he became Supervisor of Microbiology, overseeing the use of agar diffusion assays in bioequivalence testing of antibiotics. In 1978, he became Supervisor of Analytical Services where he was responsible for all chromatographic and microbiological testing of drugs in biological samples. In 1983, as Director of Scientific Information, he was responsible for the design and statistical analyses of bioavailability / bioequivalence studies. He joined AAIPharma in December 1996. He has served as a member of FDA's expert panel for bioequivalence of topical corticosteroids and was a member of FDA's blue ribbon panel for population and individual bioequivalence. He is co-author, with Sanford Bolton, of the text “Pharmaceutical Statistics.”

H. JOSEPH CARDENAS
Clinical Research
RRIC Consulting, Inc.
-Site Management Review
-Recruiting Specialist
-CRF/Informed Consent Translation (Spanish)
-Site Monitoring
Joseph Cardenas was the Clinical Research Project Manager in Operations at SFBC Fort Myers, Inc. for the past five years. He has worked as an Interpreter/ Translator for IRBs and Hospitals in Tampa. He has held numerous Clinical Research Coordinator positions in Fort Myers, Florida. Joseph has been a hospital wide Spanish interpreter and translator for ten years, including legal and clinical departments. He has active memberships in the American Translators Association, the American Society of Medical Technologists and the Association of Clinical Research Professionals.

ALEX EL-BELEIDI
Controlled Substances
-DEA Compliance Review
-SOP Preparation
-Interaction with DEA
Mr. El-Beleidi has more than 30 years of experience in FDA and DEA Regulatory Compliance. Prior to becoming a consultant, he was most recently Director, Packaging and DEA Affairs at Watson Laboratories (Andrx Pharmaceuticals) in Fort Lauderdale , Florida . He has also worked for Schein Pharmaceuticals, Sigma Technical and Consulting and Penick Corporation. Mr. El-Beleidi received his Master's degree from Rutgers University in New Brunswick, NJ and his Bachelor's degree from Alexandria University in Egypt.

RON FILLER, PH.D.
Regulatory Affairs/Scientist
Drug Development Consultants, Inc.
-Pharmacology
-Toxicology
-Safety Pharmacology 
-Clinical Writing
Dr. Filler has 20 years of experience in the pharmaceutical and biopharmaceutical industries. He has expertise in non-clinical pharmacology and toxicology, safety pharmacology, clinical writing, and in drug development. He has extensive knowledge in the preparation of a wide variety of regulatory submissions to the U.S. FDA, and in the resolution of drug development issues with world-wide drug regulatory agencies. Dr. Filler is the owner of a pharmaceutical consulting firm specializing in various aspects of drug development. His firm specializes in CMC/Formulations and Pharmacokinetics. They also have experience with preparation of non-clinical and clinical sections of IND, NDA, 505(b)(2), ANDA, CTD applications, Investigator Brochures according to ICH guidelines, and Package Inserts. He has acted as a U.S. Agent to hold an IND for foreign pharmaceutical/biopharmaceutical companies. He is also experienced with scientific presentations and writing scientific papers for publication in journals.

LOREN GELBER, PH.D.
President, RRI Consulting, Inc.
-Site quality audits for:
•  Contract Formulators
•  Contract Manufacturers
•  Contract Research Organizations
-CMC Reviews
-GMP Inspections
-IND, ANDA and DMF Preparation
-Project Management
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 was 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 as a Chemistry Reviewer for the Food and Drug Administration for approximately 10 years.

GEORGE K. GESSNER
Research Resources International
Project Management Consulting
-Program Evaluation & Coordination
-Project Tracking & Oversight
-Product Development Alliances
-Technology Evaluation
-Market Research
-Product Acceptance Analysis
-CRO Selection Assistance
-Outside Project Funding
-CRO Quotation Management
-Seminar/Workshop Management
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 products. Mr. Gessner is president of Research Resources International (RRI) which provides consulting services to pharmaceutical companies that need assistance in the management of total product development projects. Mr. Gessner recently formed RRI after retiring as Vice President of Business Development for SFBC International a leading CRO in the pharmaceutical industry. Prior to SFBC, Mr. Gessner had his own product development company and associated CRO which was merged into SFBC. 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.

LYNNE S. GESSNER, R.N.
-Site Monitoring/Oversite
•  BA/BE Studies
•  Vasoconstrictor Studies
•  Clinical Efficacy Studies
•  Dermal Safety Studies
•  Site Audits

GREG MAGUIRE, PH.D.
President, RRI Development, Inc.
Project Development Consulting
-Project Tracking & Oversight
-Product Development Alliances
-Technology Evaluation
-Data Analysis
-Product Acceptance Analysis
-CRO Selection Assistance
-CRO Quotation Management
A former neuroscience professor at the University of California , Dr. Greg Maguire has over 25 years of experience in the field of biotechnology. Dr. Maguire's research and product development has focused on tissue engineering and regeneration, and therapeutic development. To date he has founded two companies and two non-profit education and research foundations: the San Diego Neuroscience Group and the La Jolla Institute for Research.  Dr. Maguire was an NIH Fogarty Fellow and has received grants from the NIH as well as the National Science Foundation (NSF) to advance his laboratory and clinical research. He has over 70 publications, including recent publications in drug development. His most recent experience is in the development of therapeutics, including the management of international clinical trials. Dr. Maguire, president of RRI Development, Inc., one of the RRI group of companies, provides project management, CRO selection, technology and data analysis and other services for the group.

JAI MEHTA
Regulatory Affairs/Scientist
Drug Development Consultants, Inc.
-Product regulatory path planning
-Review protocols
-Prepare regulatory submission
-GMP, GLP, GCP audits
Mr. Jai Mehta had been in the pharmaceutical industry for more than twenty years, has recently founded Red River Pharma LLC along with Mr. Samuel Camp and Mr. Barry LeBlanc. He has had a successful consulting business, and has held senior management positions at various pharmaceutical manufacturing firms. His responsibilities have included R&D and Regulatory functions, with oversight of Quality and Validation disciplines as well. Mr. Mehta had filed and received numerous Drug (ANDA, IND and NDA) approvals from the FDA during his career in the industry. Mr. Mehta has audited bulk drug and dosage form facilities around the world for compliance to FDA's quality standards. Mr. Mehta's expertise encompasses product development and validation for bulk drugs and dosage forms which include sterile products including freeze-dried products, suspensions, solutions, and powders; oral products like immediate release and modified release tablets, and capsules (hard and soft gelatin); and metered dose inhalers. Mr. Mehta has a Bachelor's degree in Pharmacy and a Master's degree in Medicinal Chemistry from Bombay University and a Master's degree in Biopharmaceutics from the University of Illinois. He is a registered pharmacist in the states of Arizona and Illinois.

RAMAKANT M. MHATRE, PH.D.
Pharmacology and Toxicology Reviews & FDA Liaison
-Toxicology Reviews
-Submission Reviews & Coordination with FDA
-Pre-Clinical Development & Review
-Pharmacology Review
-Product Safety Evaluations
Dr. Mhatre has a M.Sc. degree in medical Biochemistry and a Ph.D. in Pharmacology and Toxicology. Dr. Mhatre joined FDA in 1974 as a Pharmacology Reviewer in the Division of Biopharmaceutics. During his tenure there, he reviewed and evaluated biopharmaceutics protocols and bioavailability data submitted by the Industry in their IND's, NDA's and ANDA's. He provided special expertise in biopharmaceutics, pharmacokinetics and pharmacology. He was responsible for drafting bioavailability/bioequivalence regulations. He actively participated in discussing the regulations with representatives from other government agencies, industry and academia. Dr. Mhatre joined the Division of Bioequivalence in the Office of Generic Drugs as the Branch Chief in 1984. He prepared position papers and drafted memoranda for resolution of complex bioequivalence and regulatory issues by coordinating with the Pharmaceutical Industry. He was responsible for setting up scientific criteria for bioequivalence determination of immediate and controlled release drug products as well as other unique drug formulations. He also served as the acting Deputy Director and Director in the Division of Bioequivalence from 1994 and was responsible for developing and coordinating policies that resulted in approval of several first generic drugs and controlled release formulations. He was nominated as an expert member on various projects such as SUPAC-MR Guidance Committee, Gelatin Capsule Working Group, Biopharmaceutics and Bioequivalence Coordination Group and Biopharmaceutics Classification System (BCS). Dr. Mhatre has several scientific publications to his credit.

ROBERT MILANESE
RSM Pharmaceutical Services
Strategic Business Planning and Product Licensing
-Strategic Business Planning
-Product Acquisitions & Licensing
-Trade and Government Relations
-Market Intelligence
Mr. Milanese served as Vice President, Programs and Education of the Generic Pharmaceutical Association (GPhA) from April 2001-July 2002. He also serviced as acting Executive Director from February to April 2002. Prior to that, he served as President and Chief Executive Officer of the National Association of Pharmaceutical Manufacturers (NAPM) for more than 13 years when it merged with GPhA in April, 2001. During his tenure at NAPM, Mr. Milanese was recognized as a leading industry strategist in combating anti-competitive measures by innovator (brand name) drug companies and in helping to shape legislative and regulatory changes that influence the marketplace. Prior to joining NAPM, Mr. Milanese was Managing Director of Perlite Institute Inc., and international trade association serving the perlite industry worldwide. During his 18 year tenure, that organization grew to become a leader in international standards development for insulation and building materials. In 2002, he founded RSM Pharmaceutical Services, Inc., a consulting business focused on assisting domestic and international pharmaceutical firms in business development activities including product research and development, acquisitions, in-licensing arrangements, co-promotional partnerships, market intelligence, good business practices as well as trade and government relations. Mr. Milanese holds an MBA in Management and a B.S. degree in Mechanical Engineering from New York University. 

LYNN PERSHING, PH.D.
Professor of Dermatology, University of Utah
Health Sciences Center
-Design and evaluation of pre-clinical In-Vitro studies related to the development of new
•  Topical Formulations (Branded or Generic):
•  Irritation/Sensitization Studies
•  Drug penetration and Uptake Studies in Skin (Topicals and Orals)
•  Drug Disposition in Skin Studies
-Design and evaluation of In-Vivo Safety and Proof of Concept studies
•  Topicals
•  TransDermals
•  Opthalmologicals
- Design and evaluation of In-Vivo Proof of Concept studies and Surrogate Marker Bioavailability and Bioequivalence studies.
Lynn K. Pershing, Ph.D, is Professor of Dermatology at the University of Utah Health Sciences Center. Her interests are in drug products that target the skin by multiple routes of administration. She has developed a number of in vivo / in vitro pre-clinical model systems and bioinstrumentation to elucidate the interplay between pharmacokinetics, pharmacodynamics and pharmacogenetics on the resulting drug activity in human skin. Her research interests include illuminating the roles of tissue physiology and drug physicochemical parameters on drug uptake, disposition, and elimination from skin in vivo , development of bioinstrumentation to quantify skin disease, drug activity / toxicity, and validation of surrogate and genetic biomarkers to quantify therapeutic drug activity. Her current research interest in the genetic basis for variable drug response in humans has highlighted the influence of otherwise “inactive vehicle excipients” in topical products on the drug response in human skin. She has worked extensively with the FDA to develop new methods to assess bioequivalence between innovator and generic topical drug products using pharmacokinetic and pharmacodynamic surrogate markers. She is principal investigator on numerous pre-clinical pharmaceutical industrial studies, FDA contracts, as well as NIH and NIJ grants involved in the evaluation of bioequivalence, bioavailability of topical drugs, including glucocorticosteroids, antivirals, antibacterials, antifungals, retinoids and oleoresin capsicum pepper spray products. She consults with both innovator and generic pharmaceutical companies.

BARRIE PHILLIPS, PH.D.
Clinical Research
-Study Design
-Protocol Preparation
-Toxicology
Dr. Phillips had more than 30 years of experience in the field of clinical research. Prior to becoming a consultant, he was the President of SFBC Fort Myers and before than of ClinSites/Leecoast Research Center in Fort Myers , Florida . He has also worked for International Research and Development Corporation, Industrial Bio-Test Laboratories and Miles Laboratories. Dr. Phillips received his doctorate and masters degrees from Purdue University , West Lafayette Indiana . He received his bachelors degree from Ferris State University , Big Rapids, Michigan . He is the author of more than 35 scientific publications and co-author of one patent.

LEON SHARGEL, PH.D., R.PH.
Vice President
Biopharmaceutics
-CE & BE Protocol Preparation 
-Pharmacology & Toxicology Consulting 
-Regulatory Consulting
Dr. Shargel started his career in the pharmaceutical industry more than three decades ago. A well-known pharmacologist, he most recently served as the Vice President for Biopharmaceutics Sandoz Inc. in Wilson North Carolina. Today, he specializes in CE and BE protocol preparation, consulting, regulatory consulting, pharmacology and toxicology. Over the past 30 odd years, Shargel has polished his pharmacological expertise by holding several key positions. From 1997 to 2001, he acted as Vice President and Technical Director of the National Association of Pharmaceutical Manufacturers. Prior to this job, Shargel worked as a Senior Research Pharmacist for John Hopkins Bayview Medical Center in Baltimore, MD. In addition to making great contributions to the pharma industry, Shargel also shared his extensive knowledge in the classroom. He served from 1995 to 1996 as an Adjunct Visiting Associate Professor of Pharmacy at Howard University's School of Pharmacy and Pharmacal Sciences in Washington D.C. Moreover, he's co-authored several textbooks, including Applied Biopharmaceutics and Pharmacokinetics and Development of Generic Drug Products: Solid Oral Dosage Forms. Nonetheless, these accomplishments represent merely a few on a lengthy list of professional accolades. Shargel jump started his successful career in pharmacology when he graduated Cum Laude from the University of Maryland with a B.S. in Pharmacy. He went on to receive his Ph.D. from The George Washington University, Medical Center. There, he majored in Pharmacology and minored in Physiology, Biochemistry and Drug Metabolism.

ROBERT ZEID
TLI Development
Regulatory Affairs, Quality Assurance and Technical Writing Specialist
-Regulatory Path Development
-Regulatory Submission Review For:
•  IND's
•  Bio IND's
•  ANDA's
•  505(b)(2) NDA's
•  BLA's
Mr. Zeid is Principal Consultant of TLI Development and has over 26 years experience in pharmaceutical development – the last 20 years in medical/technical writing, regulatory affairs, and quality assurance. Prior to forming TLI Development in 1997, he worked in the regulatory affairs groups at aaiPharma, Univax Biologics (now NABI Biologics), and SmithKline & French Laboratories (now GlaxoSmithKline). His freelance medical/technical writing includes projects ranging from novel anti-infective agents and AIDS products to editing pharmacology textbooks. He has extensive experience in the production and filing of BLAs, ANDAs and NDAs. His experience also includes controlled substances compliance training as well as auditing CS facilities. Mr. Zeid received his BS in Microbiology from Ohio University in 1978 and continued post-baccalaureate studies in neuroanatomy, pharmacology, and law at Wright State University (Dayton, Ohio). He was a member of the USP Complex Active Project Team and the Generic Pharmaceuticals Association (GPhA) Biotechnology Technical Advisory Committee (TAC).