Mr. Richard Lowenthal is an executive with over 28 years of Medicinal Product Development, Project Management, Regulatory Affairs and Quality Assurance experience in various roles at both small and large biotechnology or pharmaceutical companies.  Mr. Lowenthal has extensive experience with strategic global development as well as product registration of biologics, new drugs and drug or biologic and device combinations in the United States, Europe and Japan.  He also has extensive experience with global business collaborations and evaluation of product licensing or investment opportunities.

Mr. Lowenthal, as a past FDA review in both the Division of Neuropharmacology Drug Products and Division of Oncology at the US FDA, has direct experience working within the Agency that facilitates interactions and an understanding of the FDA perspective.   The majority of his work is in advance biologic and novel drugs compounds with ongoing development efforts in the EU, Japan and US.   Mr. Lowenthal supports the development of numerous products that are both advanced biotechnology agents as well as small molecules.  His roles range from overall project management for the development program to specific strategic and regulatory development strategy advice.  Mr. Lowenthal also supports several development programs for intrathecal products intended to expand the availability of FDA regulated ethical pharmaceuticals for patients with severe chronic pain or spasticity.  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 company), Global Project Leader for Risperdal / Consta 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 Reviewer 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.

Dr. Tanimoto is a medical professional and Medical Monitor with over 25 years of experience in clinical practice, biotechnology and pharmaceutical development.  Multi-lingual (Japanese, English, French and German) with experience working and studying in the US, Canada, France and Japan, she has completed multiple graduate degrees in medicine and business administration.   Experienced as a practicing physician in Internal and Emergency Medicine in Japan. Experienced in pharmaceutical development and drug safety as a Medical Monitor at Roche Pharmaceuticals (Japan and US) conducting clinical trials for new chemical entities in the US and Japan, and at AnGes MG participating in the development of a novel gene therapy for Peripheral Arterial Disease and Ischemic Heart Disease in the US and Japan.   Overall responsibility for drug safety and clinical development at AnGes.  Significant expertise in gaining approval of Orphan medicinal products in Japan and the US. Opened an office in the US to accelerate the Business Development activities for AnGes MG and licensed two orphan products and took the lead in gaining approval and commercialization of one of these products in Japan.  Dr. Tanimoto is the Chief Medical Officer of PLC in the US and Managing Director of PLC KK in Japan.  She possesses a knowledge of clinical and business development in Japan and US with a broad network of professionals in the industry.

Dr. Tanimoto received her MD from Toyama Medical & Pharmaceutical University, Japan, MBA from McGill University, MPH from National Institute of Public Health and PhD from Nippon Medical School. Fellow of the Japanese Society of Internal Medicine.

Tracy Ross-Teichert, Sr. Director Regulatory Affairs and Pharmacovigilance, has 20 years experience in Regulatory Affairs, pharmacovigilance, and nonclinical research gained within research and pharmaceutical companies. Mrs. Ross-Teichert provides to client companies experience and expertise in the development and registration of pharmaceutical products. She provides expert advice on optimal US and Canadian regulatory strategies and development plans to achieve commercial objectives. Mrs. Ross-Teichert has extensive expertise in the planning and implementation of consultation meetings with US and Canadian regulatory authorities to obtain input on strategic regulatory and technical issues, as well as product labeling negotiations. She provides support across a range of operational tasks including US and Canadian marketing and investigational applications including strategic planning, compilation, and submission management. She has extensive experience writing and filing various INDs, as well as NDAs and NDSs in eCTD format. She is also experienced in establishing and managing pharmacovigilance departments and promotional material review committees, company merger/integration activities, and due diligence.

Mrs. Ross-Teichert has previously held positions with Intercept Pharmaceuticals, Cadence Pharmaceuticals, Pfizer, PAREXEL, Alliance Pharmaceuticals, Desmos Inc., and Houghten Pharmaceuticals.

She has a Master of Science in Regulatory Affairs and a Bachelor of Science in Molecular Cell Biology degree, as well as a current RAC certification.

Robert Hasson, Director of Clinical Operations, has over 20 years of experience in Clinical Trial Management gained through experience with pharmaceutical and biotechnology companies. Mr. Hasson provides to clients expertise in managing clinical trials from start-up through ongoing maintenance to close-out for delivery to the client. Mr. Hasson provides experience in vendor and site selection, management of study budgets and timelines, development of study concept documents, including protocols and clinical study reports, performing Site Qualification, Initiation, Monitoring, and Close-Out Visits, and serving as the main contact point for clients, sites, vendors, and clinical research associates. Mr. Hasson offers extensive experience in vendor management, including budget negotiations and implementation, and ongoing management of SOWs.

Mr. Hasson has previously held positions with Amgen, PRA International, Cadence Pharmaceuticals, Biogen, Neurocrine Biosciences, and PAREXEL International.

Mr. Hasson has a Bachelor of Arts in Business Administration with a minor in Health Care Administration.

Patricia Vidal, Sr. Manager Regulatory Operations, has 40 years of experience in Regulatory Submissions working with large pharmaceutical companies. Mrs. Vidal provides to clients an extensive knowledge of IND, NDA, and other routine and non-routine eCTD submissions. Mrs. Vidal has overseen the transition of regulatory submissions from paper to electronic and has extensive hands-on knowledge with this process. Mrs. Vidal is proficient in publishing all types of regulatory documents in preparation for submission. She provides operation oversight for the planning, preparation, publishing, validation, and timely submissions of eCTD and other submissions.

Mrs. Vidal has previously held positions with Alexion Pharmaceuticals, Bristol-Myers Squibb, and Bayer Corporation.

Mrs. Vidal has a Bachelor of Science in Business Administration.

Neil Edwards is Managing Director of Sirius Regulatory Consulting in London, UK, a partner company of Pacific-Link Consulting. 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.

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.

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.

Dr. 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 (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 built 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.

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.