Pacific-Link Consulting Services is a comprehensive drug development consulting company offering services to clients in the United States, Japan and Europe. Our associates have extensive drug development experience with emphasis on regulatory strategy, quality systems, health authority submissions, regulatory risk management and business development. Pacific-Link offers additional services through our extensive consortium of experienced clinicians, pharmaceutical experts, electronic filing experts, biostatisticians, quality auditors and licensing experts. This gives Pacific-Link not only extensive Regulatory and Quality expertise, but also the ability to support client’s needs in Biostatistics, Medical Writing, Clinical Trials (Phase I/II), electronic Common Technical Dossier Submissions (preparation of Regulatory materials and electronic publishing), Pharmaceutical Development and Audits (both GCP and GMP expertise). Pacific-Link also specializes in licensing and venture capital due diligence assessments of products and companies.

Our network of affiliates has expertise in almost every area of pharmaceutical and biotechnology development. We have representations across the US, London and in Tokyo, Japan. Pacific-Link Consulting Services has offices in San Diego, California and Tokyo, Japan. Our Tokyo office is focused on working with Japanese companies seeking to develop drugs for filing in the US and EU, as well as US companies interested in doing business with Japanese based pharmaceutical/biotechnology firms.

Richard Lowenthal, MS, MSEL

Mr. Richard Lowenthal is a pharmaceutical executive with over 20 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 also 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 gene therapy and biotechnology 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 Florida State University 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.

Robert G. Bell, PhD

Robert G. Bell, Ph.D. is President / Owner of Drug and Biotechnology Development LLC, a consultancy to the international pharmaceutical industry and academia for biological, drug and device development. Dr. Bell received his B.S. in Chemistry, M.S. in Food Science and Human Nutrition and Ph.D. in Pharmaceutics from the University of Florida. His employment history includes Carter-Wallace, Inc., AL Pharma, UDL Laboratories, Inc., Somerset Pharmaceuticals, Inc. and Barr Laboratories, Inc. Bell is an Adjunct Professor of Pharmaceutics, a member of the National Advisory Board and recipient of the Distinguished Alumnus Award at the College of Pharmacy at the University of Florida and Affiliate Faculty at the College of Pharmacy at Virginia Commonwealth University. Bell has published and presented extensively, and has been issued several patents. Research interests include pharmaceutical, clinical and biomedical analysis, CMC, quality, vaccines, FOP, women’s heath and oncology therapeutics. Bell has served in various leadership capacities within the American Association of Pharmaceutical Scientists (AAPS) including Chair of the Analysis and Pharmaceutical Quality (APQ) section, Editorial Advisory Board for the Journal of Pharmaceutical and Biomedical Analysis, 2006 National Biotechnology Conference Chair and Member-At-Large. Bell is also a member of the American Society of Clinical Oncology, American Urology Association, International Society of Andrology, American Chemical Society, and American College of Pharmacology. Bell participates in the Visiting Scientist Program to universities, colleges and high schools.

Charles S. Davis, PhD

Charles S. Davis (CSD Biostatistics, San Diego, CA) is an independent statistical consultant. Chuck provides biostatistical expertise, as well as strategic and scientific leadership, in support of medical product development and medical research. Previously, he served as Vice President, Biometrics, at Elan Pharmaceuticals in San Diego, where he build and led the Biometrics department. Prior to joining Elan in the fall of 2001, he was Assistant Professor (1987-1991), Associate Professor (1991-1996), and Professor (1996-2001) of Biostatistics at the University of Iowa. He is a Fellow of the American Statistical Association, the author of Statistical Methods for the Analysis of Repeated Measurements (Springer, 2002), and co-author of Categorical Data Analysis using the SAS System (with Maura Stokes and Gary Koch, SAS Institute, 2000]). He was formerly the Chair of the ASA Biometrics Section (2000-2001) and associate editor of The American Statistician (2001-2005) and of Controlled Clinical Trials (1994-1998). He received his Ph.D. in Biostatistics from the University of Michigan in 1987.

Luana Pesco-Koplowitz, MD, PhD

Dr. Pesco Koplowitz received her MD from Rutgers Medical School and her PhD from Rutgers College of Pharmacy and Columbia Pacific University. She completed her training in Clinical Pharmacology at the University of Miami School of Medicine. She is adjunct Professor of Medicine, Department of Internal Medicine at the Medical Center of Delaware and is also adjunct faculty at the University of Miami Medical School, Department of Internal Medicine, and Division of Clinical Pharmacology. She is a fellow of the American College of Clinical Pharmacology and the Faculty of Pharmaceutical Medicine in the United Kingdom. Previous to her position at DUCK FLATS Pharma, she was Chief Medical & Scientific Officer of Research Assist, Inc. She also held the position of Global Group Director of Clinical Pharmacology and US Nonclinical Development for the Janssen Research Foundation of Johnson & Johnson. She has worked at Knoll Pharmaceuticals, Fujisawa Pharmaceutical Company, the Squibb Institute for Medical Research (now Bristol-Myers Squibb) and Key Pharmaceuticals. Dr. Pesco Koplowitz is a member of numerous medical and clinical pharmacology organizations and committees, most recently being asked to serve on the FDA/PhRMA QT Working Group Committee. Dr. Pesco Koplowitz has been responsible for numerous successful INDs and NDAs during her 22-year career and holds several use patents in the treatment of various diseases. She has worked in multiple therapeutic areas, and has personal interests in the areas of overall drug development, PK/PD modeling and drug-drug interactions, receptor-binding modeling and special population clinical trials, especially pediatric, elderly and critical-care patients. She is author or co-author of over 30 publications.

Neil Edwards

Neil Edwards is Managing Director of Sirius Regulatory Consulting in London, UK. Mr. Edwards has over 18 years experience in Regulatory Affairs and drug development gained within the pharmaceutical and Regulatory Affairs consulting industries. Mr. Edwards provides to client companies experience and expertise in the European development and registration of pharmaceutical products. He provides expert advice on optimal European regulatory strategies and development plans to achieve commercial objectives.

Mr. Edwards has extensive expertise in the planning and implementation of consultation meetings with Regulatory authorities to obtain input on strategic regulatory and technical issues. He provides support across a range of operational tasks including EU Marketing Authorisation compilation and submission management, orphan drug applications, company merger/ integration activities and due diligence. He has extensive experience filing various Marketing Authorisation Applications, including eCTDs. Mr. Edwards is proficient in the preparation and review of Expert Reports and CTD Summaries/ Overviews. Provides advice on strategy for Medical Device development, liaison with Notified Bodies and preparation of Technical Files. Support in establishing and optimising new Regulatory departments/ teams and provision of in-house training in all aspects of EU Regulatory Affairs and drug development. Particular therapeutic areas of expertise include oncology, respiratory diseases, cardiovascular, metabolic/ gastro-intestinal diseases and anti-infective products. He also has experience with OTC drugs, including legal reclassifications (OTC switch applications), and with biological/ biotechnology products.

Mr. Edwards has previously held positions with ALTANA Pharma, PAREXEL, Bayer Pharma and Amersham International. He has a Bachelor of Science from the University of Birmingham.

Sue Griffith, MD, PhD

Sue G. Griffith, M.D., Ph.D., M.R.C.P., ClinPharma Resources (ClinPharma Services, Inc.), is a pharmaceutical physician, based in San Diego, California. She received her Ph.D. in pharmacology in 1993 from the University of London, U.K. and co-edited a 2‑volume book with Professor Geoffrey Burnstock on the innervation of blood vessels. After her doctorate, Sue obtained her medical degree from the University of London and undertook post-graduate training in internal medicine, obtaining Membership of the Royal College of Physicians, London (M.R.C.P., equivalent to board certification in internal medicine).

Sue has more than 18 years of drug development experience working in pharmaceutical and biotechnology companies and covering a wide variety of therapeutic areas, including cardiovascular, neurology, infectious diseases (including HIV), gastro-intestinal, rheumatology, respiratory, metabolic, neuromuscular blockers, and oncology. She has worked for Pfizer and Wellcome (now GSK) in the U.K., and Procter and Gamble Pharmaceuticals, DuPont Merck/DuPont Pharmaceuticals Company (now Bristol-Myers Squibb), and Elan Pharmaceuticals in the U.S. Since 2006, she has been an independent consultant, offering clinical pharmacology and clinical consulting services.