EXPEDIENT SOLUTIONS INTERNATIONAL - Key Persons

Job Titles:

• Physician at the Department of Medicine

Dr. Levin is currently an attending physician at the Department of Medicine, Mt. Zion/University of California San Francisco Hospital and he has held this position since 1971. He had a full time medical practice in medicine in clinical immunology and allergy, and tumor immunology for over 30 years, and has been practicing law since 1995. His expertise includes autoimmune diseases and cancer, pathology and immunopathology, general law and patent law. Throughout Dr. Levin's medical career he has worked as a clinical pathologist, holding posts as the director of laboratory of immunology at University of California and Kaiser Foundation Research Institute (1971-1974), director of immunology at Western Laboratories, (1974-1977), medical director of MML/Solano Laboratories (1977-1979), and medical director at Levin Clinical Laboratories (1979-1981) He was the Chief Medical Director of Positive Action Health Care, one of the largest HIV clinics in the United States between 1990 and 1992. Dr. Levin received his M.D. degree from University of Illinois at Chicago Medical Center and served a pre-doctoral fellowship, an internship and a post doctoral fellowship in Pediatric Immunology at Harvard Medical School. He is certified by American Board of Allergy and Immunology and American Board of Pathology. In addition, Dr. Levin received his J.D. from Golden Gate University and is admitted to practice law in California, Texas, Nevada and the U.S. Patent and Trademark Office (USPTO). Dr. Levin has published extensively in various peer-reviewed journals.

Job Titles:

• Pharmacologist
• Co - Founder of Bridge Pharmaceuticals

Dr. Ada Kung founded Expedient Solutions International Consulting firm in the US in 2008 specializing in the Preclinical Drug Development. In between she held the positions of Senior Vice president and CEO with Taiwan companies in the areas of small molecule drug and stem cell therapies. Dr. Ada H. C. Kung is the co-founder of Bridge Pharmaceuticals (now Pharmaron in Beijing, China). She held the role of General Manager of the Beijing lab in early 2006. As the GM for the laboratory, she was instrumental in establishing from ground-up one of the first bilingual (English and Chinese) Western standard GLP (Good Laboratory Practices) complied and AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) accredited state-of-the-art preclinical testing facilities in Beijing, China. Dr. Kung was responsible for staff recruitment and training as well as ensuring that the organization is compliant with Western standard GLP regulations including software and hardware validations. In this endeavor not only did she recruit and train close to 100 staff and establish technical infrastructure in general toxicology/pathology, pharmacology, animal disease modeling, drug metabolism & pharmacokinetics (DMPK)/bioanalysis, and immunology. She also constructed and created the quality assurance (QA) system, IT (Information Technology) and data acquisition systems, animal testing facility and veterinary medicine in addition to the building of the operational infrastructure including finance, legal and human resources (HR). During her tenure with Bridge Laboratories (2004- 2008) she also served in the US as Chief Technical Officer (CTO) and Senior Vice President of Operations and Product Development of Bridge Laboratories, Gaithersburg, Maryland, USA. In this role she served as a consultant for clients with their regulatory, drug development and DMPK/toxicology programs. Dr. Kung is a career Pharmacologist (animal efficacy modeling and DMPK) and Toxicologist and certified by the American Board of Toxicology. In addition, she has in-depth experience in drug development with small molecules, vaccines, peptides and protein therapeutics. Dr. Kung has extensive expertise in the regulatory and quality systems and serves as a liaison between pharmaceutical and biotechnology companies with the US FDA. She has specialized in Investigational New Drug (IND) and New Drug Application (NDA) submissions to US FDA as well as China SFDA. Dr. Kung was responsible in submitting successfully two of the first IND's to US FDA using data generated from China labs. Dr. Kung has a rare combination of China and US drug development expertise. Prior to the position at Bridge Laboratories, Dr. Kung held a variety of top management positions in the pharmaceutical industry, most recently as Vice President, Product Development and Project Management at Gryphon Therapeutics and as Director, Product Development and Project Management at SRI International. Dr. Kung has authored a book entitled: Therapeutic Proteins: Pharmacokinetics and Pharmacodynamics as well as author of numerous peer-reviewed papers. She was Invited speaker at many international industry conferences. Dr. Kung received her Ph.D. from the Ohio State University.

Job Titles:

• Senior Director of CTPS

Dr. Charlene Chen is currently the senior director of CTPS (Center of Toxicology and Preclinical Services) at QPS Taiwan, an integrated CRO for preclinical, analytical/bioanalytical and clinical services. Dr. Chen is an expert in the REACH program and responsible in conducting studies to support REACH. Dr. Chen was the General Manager of Development Center for Biotechnology (DCB) at Taiwan. DCB is the first and largest preclinical CRO in Taiwan with over 20 years of history in the preclinical testing. During her tenure as the General Manager, Dr. Chen was instrumental in obtaining the Department of Health (DOH) GLP compliance inspection approval and the certification of OECD GLP national compliance monitoring system. Dr. Chen has held this position since 2006. Prior to that, she was the head of general/reproductive toxicology at DCB. From 2000 and 2003, Dr. Chen was a distinguished postdoctoral scholar at Academia Sinica, Institute of Biomedical Sciences. Dr. Chen has served as lecturer for many of GLP and toxicology training courses and programs in Taiwan and published in peer-reviewed journals. She was the editor of the first edition of Chinese version of globally harmonized system for classification and labeling of chemicals (GHS) in 2006. Dr. Chen is well-versed in the submission of IND and studies to support clinical trial to Taiwan DOH. Dr. Chen received her Ph.D. from Tulane University, New Orleans, LA, USA.

Job Titles:

• Director of Preclinical Development at Synta Pharmaceuticals Corp

Mr. Kitayama is currently Director of Preclinical Development at Synta Pharmaceuticals Corp. in Lexington, Mass. He is the strategic and tactical leader for preclinical development programs. In this role Mr. Kitayama is responsible for the planning, budgeting, and execution of Synta drug development programs coordinating all preclinical/nonclinical activities in toxicology and ADME/PK/PD with bioanalysis and API & drug product development and manufacturing as well as formulation development to support discovery, IND, clinical development, and NDA filings. Mr. Kitayama has extensive experiences in identifying partnering CRO's and CMO's and executing projects/studies via external partners. He has been in this position since 2003.

Job Titles:

• Independent Consultant for Consulting Services

Dr. James Chu is currently an independent consultant for consulting services in formulation design, process optimization, cGMP compliance and regulatory application for drug substance or product programs in the US, Taiwan and China. Before mid 2010, Dr. Chu tenured as Vice President of Product Development in PharmTak Inc. responsible for product development and CMC management in development of generics for US ANDA regulatory applications. He orchestrated development strategies including prototype assessment, patent reviews, competitive evaluations and clinical supply planning and hands-on managed development programs in formulation design, process optimization and manufacturing of registration batches for generic products including controlled-release, delayed-release and fast-melt dosage forms. From mid 2007 to early 2009, Dr. Chu serves as Head of Formulation Development, Pharmaceutical Development Division in KV Pharmaceutical Inc., Saint Louis, MO and was responsible for overall formulation development and clinical supplies manufacture of solid, liquid and semi-solid dosage products towards US IND, ANDA and 505b(2) regulatory applications. He managed more than 50 technical personnel with multiple projects at various stages of formulation and process development to ensure corporate milestones for clinical studies and regulatory submissions were completed on time and within budget. Prior to his service in KV Pharmaceuticals, Dr. Chu served as Vice President and Asia Operations Officer of Bridge Pharmaceuticals, Menlo Park, CA since February 2005 and was responsible for establishing Bridge's business operations and drug development infrastructures in Asia Pacific regions. He involved developing a network of manufacturing facilities in China and Taiwan focused on providing lower cost, FDA compliant drug development services for US and EU based clients. He engaged numerous site visits and audits of manufacturing facilities throughout China and Taiwan to ensure maximum efficiency, operating time, and compliance to GLP and cGMP regulations. Prior to joining Bridge, Dr. Chu served as Vice President of Technology and Product Development for Yamanouchi Pharma Technologies, Inc., USA (currently known as Astellas Pharma after merging with Fujisawa) with responsibility for all scientific activities for product development including feasibility, dosage form design, analytical method development and validation, process scale-up development, clinical material manufacturing, and technology transfer. Dr. Chu has also held previous roles in scientific, quality assurance, and product development with Industrial Technology Research Institute (ITRI) and Syntex Research, California. He has over 20 years of pharmaceutical development experience in all aspects of technology-driven product development from drug discovery, preclinical, proof of concept, preformulation, bench scale formulation through scale-up development to commercialization, including pharmacokinetic BA/BE studies, animal models, cGMP pilot scale manufacturing and release testing for clinical trial materials to fulfill CMC submissions for IND/NDA/ANDA. Dr. Chu holds a Ph.D. in Pharmaceutical Sciences from the University of Utah and a MBA from San Jose State University. He was a postdoctoral research fellow in the University of Michigan and is a certified RAC Regulatory Affairs professional.

Job Titles:

• Member of the Executive Team

Dr. Thirucote is currently Vice President of Pharmaceutical Sciences at ROXRO Pharma, Inc., a Strategic Product Development company based in Menlo Park, CA. Since 2001 Dr. Thirucote is a member of the Executive Team and responsible for directing all of the pharmaceutical operations for ROXRO. He is responsible for the coordination of development on three continents, the synthesis and procurement of drug substance, developing and implementing strategies for alternative sourcing, and formulation and development of company products. Dr. Thirucote has established the corporate regulatory systems for regulatory compliance and responsible for the compilation of all chemistry, manufacturing and controls (CMC) reports. He in charge of drug product development, from Phase I development to NDA submission and subsequent commercial scale production. Prior to joining ROXRO Dr. Thirucote established from ground-up the drug product manufacturing facility at SRI International from 1995 to 2001. He has designed and built a GMP compliant multi-functional manufacturing facility for small molecule and protein/peptide drugs, characterization, evaluation and development of clinical trial materials. From 1992 to 1995, Dr. Thirucote was senior scientist and project leader in Pharmaceutical Development at Agouron Pharmaceuticals, Inc., in San Diego, CA. In this role, Dr. Thirucote was responsible for preformulation research, analytical method development, and the product development of oncology drugs. Prior to the post with Agouron, Dr. Thirucote held different positions in companies in the US and India. Dr. Thirucote received his Ph.D. in Industrial Pharmacy from Massachusetts College of Pharmacy in 1991.

Job Titles:

• Physician

Dr. Chin is a physician with extensive expertise in drug and biologics development. He has overseen multiple investigational new drug applications and new drug applications/biologic license applications, and has authored several textbooks on clinical trial medicine. From 2008 until 2011, Dr. Chin served as a director and CEO of OneWorld Health, a nonprofit pharmaceutical company largely funded by the Bill and Melinda Gates Foundation. OneWorld Health is engaged in developing drugs for neglected diseases in impoverished countries. From 2006 to 2008, he was the CEO and President of OXiGENE, Inc., and served on its board of directors from 2004 to 2008. From 2004 to 2006, Dr. Chin was employed by Elan Corporation, where he served, among other roles, as Senior Vice President of Global Development. Dr. Chin also held various clinical and scientific roles for Genentech, Inc. between 1999 and 2004, including Head of Clinical Research for the Biotherapeutics Unit, overseeing approximately half of the clinical programs at Genentech. Dr. Chin began his career at Procter and Gamble Pharmaceuticals, where he served as Associate Medical Director. He received a B.A. in Biology, magna cum laude, from Harvard University and the equivalent of a J.D. with honors from Oxford University in England under a Rhodes Scholarship. Dr. Chin holds a Medical Degree from Harvard Medical School and is licensed to practice medicine in California. He currently serves on the Adjunct Faculty of the University of California, San Francisco School of Medicine, and serves on the Boards of Directors of Genmedica Therapeutics S.L., Balance Therapeutics, Inc., and Galena Biopharma, Inc.

Job Titles:

• Director of Operations
• Director of Operations & Senior Consultant / Aclairo Pharmaceutical Development Group

Dr. White is the Director of Operations and a Senior Consultant at Aclairo Pharmaceutical Development Group. She has been a consultant in the pharmaceutical industry since 2012. She advises pharmaceutical and biotech companies on nonclinical safety assessment strategies throughout the entire drug development process, including creating customized nonclinical strategies, placing and monitoring studies, developing human risk assessments for toxicology issues, addressing regulatory questions, and contributing to regulatory documents. Dr. White has deep regulatory and investigative expertise in developmental and reproductive toxicity (DART), and juvenile toxicity, and assists clients with FDA Pregnancy Labeling (PLLR) and pediatric development plans for EMA (PIP) and FDA (PSP). Prior to her position at Aclairo, Dr. White spent 14 years as a DART study director at Sanofi; a safety assessment project team representative, DART study director, and DART investigative lead at GlaxoSmithKline; and Global Director of Small Animal DART at Covance, where she gained experience with many classes of therapeutics regulated by CDER and CBER. She has served as a toxicology project team member, as well as a strategic advisor on FDA interactions, for DART and general toxicity issues, mechanisms of action, and nonclinical study planning and management. Dr. White has extensive experience in all aspects of nonclinical toxicology and safety pharmacology assessments for small and large molecules, with particular emphasis on DART and juvenile toxicity. Dr. White is the sitting Past President of the US Teratology Society (Vice President: 2014-2015, President: 2015-2016), and actively participates in the ILSI/HESI DART sub-team, including co-organization of the FDA Pregnancy and Lactation Label Rule workshop, and participation in the Neonatal Pediatric Therapeutics workgroup.

Job Titles:

• President of Immunology Inc

Dr. Byers is currently the president of Immunology Inc. and acts as consultant to various pharmaceutical companies since 1993. In her role as a pharmaceutical consultant, Dr. Byers is responsible for the design of clinical protocols, selection of clinical sites and principal investigators for pharmaceutical clinical trials in autoimmune diseases, allergic diseases, and oncology indications. She also authored clinical reports in the development of biologic drugs in autoimmune diseases, allergic diseases and cancer. She has been responsible for over 40 INDs often defending before the FDA, and was part of the teams responsible for the approval of Enbrel for Rheumatoid Arthritis, Cialis for erectile dysfunction, and the monoclonal antibody based immunosuppressant H-65-RTA for autoimmune diseases. Dr. Byers co-founded Allergen Corporation and held positions in the clinical development at XOMA Corp., and Abbott Laboratories. Dr. Byers is an Adjunct Assistant Professor at University of California, San Francisco. Since 1993 Dr. Byers served as a reviewer for NIH study sections in autoimmune diseases and oncology. She has published extensively in peer-reviewed journals in immunology related areas and served on the editorial board of Cancer Immunology and Immunotherapy for 20 years. She holds 7 patents in pharmaceuticals. Dr. Byers received her MD from University of California at San Francisco and is a Fellow in the American Academy of Asthma Allergy and Immunology. She is also certified by American Board of Internal Medicine. She has a Ph.D. in Immunology from the University of California at Los Angeles and a fellowship in clinical immunology from UCSF, and was a Special Lecturer at the Cancer Campaign Research Laboratories, Univ. Nottingham in the UK in Oncology for 15 years.

Job Titles:

• Director of Veterinary Services at Charles River Laboratories Preclinical Services Shanghai

Dr. Pang is currently the Director of Veterinary Services at Charles River Laboratories Preclinical Services Shanghai, China. Prior to this, Dr. Pang was the associate director of Laboratory Animal Medicine Department at Bridge Laboratories, Beijing, China. While in Bridge he played a key role in acquiring the AAALAC accreditation for the Bridge Beijing lab which was the first Western standard GLP laboratory with multi-species from rodent, dogs to Non-human primates. He is well-versed in generating the AAALAC program descriptions and is experienced in AAALAC site evaluations. During his tenure with Bridge lab he constructed most of the veterinary care related SOP's and served as the attending veterinarian as well as a member of Institutional Animal Care and Use Committee (IACUC) and the Occupational Health and Safety Committee. He had held this position since mid 2006 to June 2008. Dr. Pang was a research scientist at the Department of Animal Health and Welfare of Grange Research Centre, Teagasc in Co. Meath, Ireland while pursuing his Ph.D. degree in veterinary medicine with University College Dublin, Ireland. Prior to that Dr. Pang served as veterinary pathologist for animal disease diagnosis, prevention and control from 1997 to 2006 at a variety of different China Research Institutes. Dr. Pang received both his veterinary degree and Masters degree in veterinary pathology from College of Veterinary Medicine, China Agricultural University, Beijing, China. In addition, Dr. Pang earned his Ph.D. from the University College Dublin in Ireland.

Job Titles:

• Vice President of Translational Research at Anaphore

Dr. Paliard has over 20 years of experience in Translational Sciences in the field of biologics, small molecules and vaccines. He has led several drug R&D projects and collaborations across a variety of therapeutic areas including immune-inflammation, anti-infective, oncology, cardiovascular and metabolic diseases. With his integrative view of R&D, his expertise spans target selection, portfolio management, planning and executing on plans from late stage discovery through clinical development and defining clear differentiation for assets based on high quality science to ensure successful clinical and commercial opportunities. Dr. Paliard currently serves as Vice President of Translational Research at Anaphore. Before this, he held positions of increasing responsibility in the pharmaceutical and biotechnology industry including ARYx, Gryphon, Merck, Chiron / Novartis, ImmuLogics and DNAX Research Institute. Dr. Paliard is a named-inventor in more than 15 patents, including two as sole inventor, and has numerous publications in peer-reviewed professional journals, including Nature and Science. Dr. Paliard holds a Pharm.D. and a Ph.D. in human immunology from the Claude Bernard University in Lyon, France and received his postdoctoral training from the HHMI laboratory of Dr. Philippa Marrack and Dr. John Kappler in Denver CO.