Consortium of Experts

D&BD has assembled a consortium of pharmaceutical, medical and regulatory experts to provide assistance and solutions to the varied needs of product development.  D&BD is pleased to be associated with the following medical, regulatory and pharmaceutical experts.

Robert Bell, Ph.D.
Dr. Robert Bell is a pharmaceutical executive with over 20 years of multidisciplinary experience in strategic global business development, product registration and commercialization of new drugs, biologics, devices and generic drug products.  Bell has extensive experience with global business collaborations and product development efforts resulting in product approvals and market opportunities.  Bell provides active leadership and mentoring involvement with pharmaceutical trade associations and academic institutions.

Bell’s employment history includes Vice President, New / Strategic Drug Development at Barr Laboratories, Inc., Vice President, Research, Development and Quality at Somerset Pharmaceuticals, Inc., Vice President, Research and Development at UDL Laboratories, Inc., Director, Research and Development at AL Pharma and Senior Chemist at Carter-Wallace, Inc.  Bell’s research interests include pharmaceutical, clinical and biomedical analysis, CMC, quality, vaccines, follow-on proteins/biologics, women’s heath and oncology therapeutics.  Bell also serves as expert witness in pharmaceutical matters (e.g.GxPs, regulatory, product development, etc.).
Bell is an Affiliate Professor of Pharmacy at the College of Pharmacy at the Medical College of Virginia, Virginia Commonwealth University.  Bell is also an Adjunct Professor of Pharmaceutics, a member of the National Advisory Board and recipient of the Distinguished Alumnus Award from the College of Pharmacy, University of Florida. Bell has published and presented extensively and has been issued several patents. Bell is the Past Chair of the Analysis and Pharmaceutical Quality (APQ) section for the American Association of Pharmaceutical Scientists (AAPS) and serves in various leadership capacities for AAPS, including chair of the 2006 National Biotechnology Conference and on the Executive Council as Member-At-Large.  Bell is a member of the United States Pharmacopeia Ad Hoc Committee on Viral Clearance, Editorial Advisory Board for the Journal of Pharmaceutical and Biomedical Analysis, American Society of Clinical Oncology, American Urology Association, International Society of Andrology, American College of Clinical Pharmacology and American Chemical Society.  Bell participates in the Visiting Scientist Program to universities, colleges and high schools.

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Jeffery Barrett, Ph.D., FCP

Dr. Jeffrey S. Barrett, is a Research Associate Professor of Pediatrics, University of Pennsylvania and the Director of the Laboratory for Applied PK/PD in the Division of Clinical Pharmacology and Therapeutics at the Children's Hospital of Philadelphia.  He is also an Associate Scholar in the Center for Clinical Epidemiology and Biostatistics at The University of Pennsylvania.  Dr. Barrett serves as the Principal Investigator for The Children's Hospital of Philadelphia's Pediatric Pharmacology Research Unit (PPRU) and heads the Kinetic Modeling and Simulation (KMAS) core of the Penn/CHOP Clinical and Translation Science Award (CTSA).  He received his B.S. from Drexel University in Chemical Engineering and his Ph.D. in Pharmaceutics from the University of Michigan.  Prior to joining The Children's Hospital of Philadelphia, Dr. Barrett spent 13 years in the pharmaceutical industry involved primarily with clinical pharmacokinetic and pharmacodynamic aspects of clinical drug development.  He was most recently at Aventis Pharmaceuticals where he was Global Head of Biopharmaceutics supporting late stage drug development in the areas of clinical pharmacology, pharmacokinetics, pharmacodynamics and clinical trial simulation.   Dr. Barrett has co-authored over 65 manuscripts, 100 abstracts for presentation at scientific meetings and has given over 60 invited lectures on a variety of topics related to PK/PD, clinical pharmacology and pharmacometrics.  He is a Fellow of the both American College of Clinical Pharmacology (ACCP) and the American Association of Pharmaceutical Scientists (AAPS) and was awarded the Tanabe Young Investigator Award from ACCP in 2002.  Dr. Barrett was the Chair of the Clinical Sciences section of AAPS and a Board of Regent of the American College of Clinical Pharmacology. He is a standing member of the FDA Clinical Pharmacology Advisory Committee.  He joined the Editorial Board of the Journal of Clinical Pharmacology in 2007 and is a member of the Board of Directors of the Metrum Research Institute.  He was also recently awarded the Clinical Pharmacology Mentorship award by ACCP (2007).  Dr. Barrett’s research interest is focused on investigating sources of variation in pharmacokinetics and pharmacodynamics. He applies clinical pharmacologic investigation coupled with modeling and simulation strategies to pursue rational dosing guidance in various populations for both marketed and exploratory compounds.  Clinical trial simulation is utilized prospectively to explore design dependencies and parameter sensitivities.  Dr. Barrett also focuses on the development of pharmacometric approaches to advance PK/PD, novel biomarker development and disease progression modeling. 

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Sanford Bolton, Ph.D., FAAPS
Dr. Sanford Bolton is an internationally recognized expert in the use of statistics to evaluate pharmaceutical and biopharmaceutical drug quality. Bolton received his Bachelors in pharmacy from Rutgers University, MS and Ph.D. in Physical Pharmacy from the University of Wisconsin and MS in Biostatistics from Columbia. Bolton held positions at Endo (Director, Quality Control), Lever Brothers Research (Senior Scientist) and USV (Director, Statistics and Clinical Research Coordination) and then became professor and chairman of pharmacy at St. John's University, College of Pharmacy in New York. Bolton’s has an extensive list of over 100 publications and is the author of the textbook, "Pharmaceutical Statistics", which is now in its fourth printing. Bolton is on the editorial board of The Journal of Research Practice and Drug Regulatory Affairs and is a Fellow of AAPS. Bolton was also involved in the landmark legal decision of Barr vs. FDA in the early 1990s, which was important in defining quality control procedures for the pharmaceutical industry and resulted in significant changes in the approaches to pharmaceutical testing and quality, and the use / misuse of outliers and retesting in the pharmaceutical laboratory.

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Nicholas Bruchovsky, M.D., Ph.D., FRCPC
Dr. Bruchovsky is an internationally known medical expert in oncology, specializing in hormonal and anti-hormonal mechanisms associated with endocrine sensitive cancers. Bruchovsky’s initial research elucidated the role of dihydrotestosterone in androgen action. For over 20 years, Bruchovsky was the Head of the Department of Cancer Endocrinology, British Columbia Cancer Agency and Professor of Medicine at the University of British Columbia. Bruchovsky holds appointments as Clinical Professor at the Department of Urology, University of Washington School of Medicine, and Medical Oncology Consultant at the University of British Columbia Prostate Clinic, Vancouver Hospital and was the recipient of the Queen Elizabeth II Medal of the Golden Jubilee for Medicine.  Bruchovsky received his MD and Ph.D. in Medical Biophysics from the University of Toronto.

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Jean Fourcroy, M.D., Ph.D., M.PH.
Dr. Fourcroy received her M.D. from the Medical College of Pennsylvania and her Ph.D. from the University of California at San Francisco. Her surgery and urology residency was completed at George Washington University Medical Center and she received Board Certification in Urology in 1981. In 1999 she received her Masters in Public Health from the Medical College of Wisconsin. She has served in the Navy, as a Captain, and as a full time academic urologist at Bethesda Naval Hospital, the Uniformed Services University of Health Sciences, and the University of Medicine and Dentistry in New Brunswick, New Jersey. Fourcroy was a Medical Officer with the Food and Drug Administration in the Division of Clinical Laboratory Devices (CDRH) and Urologic and Reproductive Drug Products. As a Medical Officer she has been involved with many aspects of the regulatory process and the development of drugs and devices as well as an expert witness in areas of abuse, e.g., anabolic steroids and alternatives. She has been an invited participant with the Drug Enforcement Agency in workshops both within the United States and International and currently a member of the board of the U.S. Anti-Doping Agency. She is an active member of the American Urological Association, the American Society of Andrology, Past President of the National Council on Women's Health, and the American Medical Women's Association. In 1996, Fourcroy was given a Woman of the Year Award by the Women's Medical Association of New York City and is the recipient of a 1998 American Urological Association Presidential Citation Award. In 1999 she received the Camille Mermod award from the American Medical Women's Association. She received the Outstanding Service and Presidential Award from the American Society of Andrology in April 2000 and 2004.

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H. Thomas Karnes, Ph.D., FAAPS
 Dr. Karnes is Professor of Pharmaceutics at the Department of Pharmaceutics at Virginia Commonwealth University and an internationally recognized expert in bio-pharmaceutical analysis. Karnes is a Fellow of AAPS and was the 1996 recipient of the Analysis and Pharmaceutical Quality Section’s AAPS Research Achievement Award” that recognized his many scientific contributions to the discipline of Pharmaceutical Analysis. Karnes is widely acknowledged as being a leader in the fields of both bioanalytical laser induced fluorescence and bioanalytical method validation. He has published over 20 articles in peer reviewed journals in the field of bioanalytical laser induced fluorescence. Karnes was the primary co-author and creative force behind the landmark publication in the journal “Pharmaceutical Research” entitled “Validation of Bioanalytical Methods” (1991) which dealt with issues related to validation and control of bioanalytical methods.
Karnes is the North American Editor for the journal, Biomedical Chromatography, has been a member of USP, NIH, and NSF grant proposal committees. Karnes is a graduate of the University of Florida with a Ph.D. in Pharmaceutics.

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Richard Lowenthal, M.S., M.S.E.L. 

Mr. Richard Lowenthal is a pharmaceutical executive with over 17 years of Regulatory Affairs and Quality Assurance experience in various roles at both small and large pharmaceutical or biotechnology companies. Mr. Lowenthal has extensive experience with strategic global development as well as product registration of new drugs and biologics in the United States, Europe and Japan. Mr. Lowenthal has extensive experience with global business collaborations and evaluation of product licensing or investment opportunities. As founder of Pacific-Link Regulatory Consulting, Mr. Lowenthal is now dedicated to the support of pharmaceutical, biotechnology and investment companies, providing leadership and mentoring on Regulatory Affairs, Quality Assurance, Licensing and Investment opportunities. 

Mr. Lowenthal has served as Vice President, Regulatory Affairs and Quality Assurance for Cadence Pharmaceuticals, Head of Worldwide Regulatory Affairs, Quality Assurance and Drug Safety for Maxim Pharmaceuticals, Inc., Vice President of Regulatory Affairs and Quality Assurance for AnGes, MG, Inc. (a Japanese based biopharmaceutical company), Global Project Leader and Global Director Regulatory Affairs for Janssen Research Foundation (a division of Johnson & Johnson), Director of Regulatory Affairs and Quality Assurance of Somerset Pharmaceuticals, Inc., and as a New Drug Review Chemist for the US Food and Drug Administration in the Division of Neuropharmacologic Drug Products and the Division of Oncology and Pulmonary Drug Products. 

Mr. Lowenthal holds an M.S. in Organic Chemistry from FloridaStateUniversity and Masters in Business Science for Executive Leadership from the University of San Diego. Mr. Lowenthal has served as past Chair of the San Diego region for AAPS (2005/2006), as Member of the USP Biotechnology Expert Committee (2005/2006), Chair of the Virology Working group (2005/2006), Member of the National Organization of Rare Disease (NORD) Corporate Council (2002-Present), and several PhARMA and ICH Working Groups.

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Srikumaran (Sri) Melethil, Ph.D., J.D., FACCP
Dr. Melethil is Chair of the Department of Pharmaceutical Sciences and Patent Attorney at the University of Findlay's School of Pharmacy, and Emeritus Professor of Pharmaceutics and Medicine at University of Missouri Kansas City.  In addition, Melethil is a practicing attorney and established the Law and Science consulting firm.  Melethil received his B. Pharmacy and M. Pharmacy from Andhra University, Waltair, India, Ph.D. from the Department of Pharmaceutics, State University of New York at Buffalo in New York with specialization in pharmacokinetics and drug analysis, and JD from the School of Law, University of Missouri-Kansas City, Missouri.   After graduating with his Ph.D., Melethil pursued a career in academia and was a Professor of Pharmaceutics and Medicine at University of Missouri Kansas City (UMKC) during 1979-2002 where  he taught courses in pharmacokinetics to professional and graduate students, and mentored  doctoral and post-doctoral  students.  He has published extensively in the areas of pharmacokinetics, pharmacodynamics and drug analysis, with particular focus on blood-brain barrier transport of drugs and environmental chemicals.  He was voted the 1990 Rho Chi (Pharmacy Honor Society, Alpha Omega Chapter) Teacher of the Year, elected Fellow of the American College of Clinical Pharmacology (1988), admitted to the Missouri bar in April 2003 and to the USPTO in October 2005.  He is on the editorial advisory boards of Clinical Pharmaceutical Research and Regulatory Affairs and the Indian Journal of Pharmacology.  He has been active in the American Association of Scientists (AAPS) and is the Chair of the Regulatory Sciences section.   

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John Rapoza, M.S., R.Ph.
John R. Rapoza is a regulatory expert with over 30 years experience in drug development, clinical research, drug product registration and quality/regulatory compliance.  Rapoza served as a senior executive for Drug Regulatory Affairs for Duramed, in Cincinnati; Wyeth-Ayerst in Philadelphia; Ayerst Laboratories in New York; Carter Wallace in Cranbury, New Jersey, Merrell Dow Pharmaceuticals in Indianapolis, and Dow Chemical in Midland, Michigan.  Rapoza served on active duty with the U.S. Army Medical R&D Command where he was assigned Project Officer for the Army’s Investigational Drug Review Board.  Rapoza earned his BS in Pharmacy from Massachusetts College of Pharmacy and MS in Pharmaceutical Sciences from Northeastern University and is board registered in Pharmacy in Massachusetts and Michigan.

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Mark Staples, MBA, Ph.D. 

Mark Staples received his BA in 1975 and his Ph.D. in 1979, both in Biochemistry from the University of Kansas.  He was a Postdoctoral Fellow (1979-1980) and held a part-time Research Appointment at Harvard Medical School.  For more than 20 years Dr. Staples has helped transform scientifically interesting projects into commercial products serving unmet medical needs. His product development activities include pharmaceutical development of proteins and peptides and project management of the technical (CMC) portion of regulatory submissions. He has participated in five early stage companies. His titles have been at the Director and Vice President levels since 1997. 

Highlights of projects Dr. Staples has worked on include:

• MicroCHIPS, Inc., 2003-2007: led Pharmaceutical Technology research leading to highly concentrated leuprolide and PTH(1-34) formulations suitable for delivery from an implantable MEMS-based device.  

• GlycoGenesys, Inc., 2002-2003: re-engineered the manufacturing process for the polysaccharide anti-cancer agent GCS-100, enabling clinical trials to resume.

• Praecis Pharmaceuticals Inc., 1997-2002: compiled the CMC section for Plenaxis(TM), an extended release prostate cancer therapeutic (launched in 2004).

• Biogen (1988-1997): played critical roles developing and launching the MS drug, AVONEX®, and led analytical and formulation development for the ANGIOMAX® anticlotting peptide. 

Dr. Staples continues to hold volunteer leadership positions within the American Association of Pharmaceutical Scientists (AAPS), including Chair of the BIOTEC Section (2006). He has also held positions on the Board of the Parenteral Drug Association New England Chapter (1993-2006), was President of the Chapter in 2003-2004, and in March received the PDA Chapter Volunteer Award.

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Maria-Laura “Mimi” Ferraioli
Ms. Ferraioli brings over 20 years of experience as a Sales and Marketing Consultant for the pharmaceutical industry.  Ferraioli graduated from St. Joseph’s University (BS Chemistry and Business Administration) and was employed in the biotechnology sector with BioWhittaker, Inc. and Baxter Healthcare, Inc. before starting her a sales and marketing consulting business.