Pacific-Link Consulting

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Biotechnology Project Management

Expertise

Richard Lowenthal, MS, MSEL

Mr. Richard Lowenthal is a pharmaceutical executive with over 25 years in Strategic Drug Development, Project Leadership, Regulatory Affairs and Quality Assurance 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.

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Sarina Tanimoto, MD, PhD (Tokyo, Japan Office)

Dr. Tanimoto is a pharmaceutical professional with over 15 years of experience in clinical research and development of biotechnology products. She is the Managing Director for Pacific-Link Consulting providing a range of development services to biotechnology and pharmaceutical companies. Previously she served as Director of Business Development of AnGes MG where she contributed to license a product all the way from licensing, NDA and commercialization. Prior to taking a role in Business Development, Dr. Tanimoto supported AnGes in Clinical Development and Project Management. She started her career in pharmaceutical industry at Roche, Japan, where she served as a clinical scientist and was involved global clinical development in Japan, US and the EU.

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.

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Joyce Reyes, MAS

Ms. Joyce Reyes is an executive with over 15 years of Regulatory Affairs and Quality Assurance experience in various roles at both small and large biotechnology or pharmaceutical companies. Ms. Reyes has extensive experience in cell and viral production processes and has been in both manufacturing and quality assurance roles prior to joining regulatory groups at various companies.

Ms. Reyes has served as Vice President of Regulatory Affairs and Quality at Pacific-Link Consulting (PLC) since 2011. Prior to joining PLC Ms. Reyes worked at Somaxon Pharmaceuticals supporting the approval of Silenor; Jennerex Biotherapeutics as Director of Regulatory Affairs and Quality Assurance supporting the development of a novel vaccinia based oncolytic virus; at Geron Corporation as Manager of Regulatory Affairs and Quality Assurance supporting cell based therapies and assisted in filing the first ever human embryonic stem cell therapy to the FDA; at Cell Genesys as a Regulatory Affairs Specialist supporting cell based therapy projects; InterMune as a Regulatory Affairs Associate; Xoma Corporation as a Senior Manufacturing Associate with experience from vial thaw to fill/finish activities for various programs that involved mammalian cell culture, viruses and microbial fermentation; and prior to these positions in various manufacturing roles at Invitrogen and Baxter.

Ms. Reyes received the degree of Bachelor of Arts from St. Mary's College of California, Moraga and a Masters in Health Law from The University of California, San Diego/California Western School of Law.

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Tracy Ross-Teichert, MSc, BSc, RAC

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.

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Laura Fuchs, BSc, MBA

Ms. Laura Fuchs has over 20 years of biotechnology and medical device experience. She has held both quality and manufacturing management roles and has extensive experience in the manufacture of biologics and aseptic filling processes.

Ms. Fuchs joins Pacific-Link Consulting after serving as the Senior Manager of Quality Assurance at Ajinomoto Althea where she provided quality oversight of the biologics and fill-finish contract manufacturing processes. Prior to joining Ajinomoto Althea, Ms. Fuchs was the Senior Production Manager at Suneva Medical and was responsible for the manufacture and aseptic filling of the dermal filler ArteFillR. Prior to Suneva Medical, Ms. Fuchs held various manufacturing roles at Cell Genesys supporting the production and aseptic filling of mammalian cell based gene therapy projects. She has also held manufacturing and aseptic filling roles at Molecular Medicine and Chiron Corporation.

Ms. Fuchs received her degree of Bachelor of Science in Molecular and Cellular Biology from the University of Arizonaand holds an MBA from Webster University.

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Neil Edwards (London, EU Office)

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.

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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.

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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.

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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.

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Michael Hatfield, PhD

Michael Hatfield, PhD has over 17 years of experience in Biologics and Viral Drug Development. He has broad technical expertise in Viral Manufacturing, Sterile Fill/Finish Operations, Clinical Packaging, GMP Compliance, Cell Biology, Protein Purification and Analytical QC Method Development. Dr. Hatfield supports multiple advance biologics projects ensuring quality and timely delivery of products for our clients. His project management expertise allows him to manage CMOs for our clients or participate at a high level providing consulting and technical advice.

Dr. Hatfield has works with clients in Germany, Japan, China, Sweden, Great Britain, France and The Netherlands. His past experiences have been at senior management (VP or Director) level positions at Jennerex Inc. (San Francisco), ONYX Pharmaceuticals Inc., Selective Genetics Inc (Prizm Pharmaceuticals), Insite Vision Inc., and The Oregon Health Sciences University. His expertise and experience span from Cell Culturing to Viral product, with expertise in Stem Cell manufacturing, Gene therapy and Oncolytic Virus production.

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