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总裁、总经理：
龚晓嘉，博士，工商管理硕士，美国毒理学会认证毒理专家
龚晓嘉博士于2008创立国际捷效医药研发技术咨询公司, 专精于临床前制药发展。在这期间龚博士也担任了一家台湾小分子制药公司的副总及另一家台湾干细胞公司的执行长。
龚
晓嘉博士是博际医药研发有限公司（现称中国北京Pharmaron公司）的创始人之一，从2006年初开始担任博际公司的总经理。作为机构的最高负责人，
她在建立中国首家通过AAALAC认证、符合美国GLP规范并且双语（英语和汉语）运作的非临床实验室的过程中起到了关键的作用。
龚博士
全权负责人员的招聘和培训以及确保机构符合美国GLP规范（其中包括软件和硬件的认证）。由此可见，她不仅仅招聘、培养了100多个员工，而且建立了毒
理、病理、药理、动物疾病模型、药物代谢动力学、生物分析和免疫学等方面的技术部门。她也建立了质量保证体系，计算机信息技术和电子数据采集系统，实验动
物设施和兽医部门。同时机构运营机制、财务、法务和人力资源等系统的成立也在她的带领下完成。
从2004到2008年，她同时也是博际在美国马里兰州总公司的首席技术官，运营和药品开发资深副总裁。在职期间，她为多个客户提供了法规、药品开发及药物代谢动力学方面的咨询。
龚
博士致力于药理学（动物模型和药物代谢动力学）、毒理学研究多年，是通过美国毒理学学会认证的CFDA毒理专家。在小分子药物、疫苗、肽类物质、蛋白质药
品的研发领域，她拥有资深的经验。龚博士在法规和质量体系方面也有渊博的知识和丰富的经验，代表医药和生物技术公司与美国FDA进行联系。她还擅长美国
FDA和中国CFDA的IND与NDA申请。龚博士也是少数同时精通中美药物研发的人才之一。
加入博际之前，龚博士担任过多个制药公司的高层管理人员，最近的是Gryphon Therapeutics公司的药品研发和项目管理副总裁，SRI International公司的药品研发和项目管理总监。
龚博士是《蛋白质药品：药物代谢和药物动力学》一书的作者，也是多篇文献的作者。她多次受邀参加国际医药界会议并发表了众多演讲。
龚博士拥有美国俄亥俄州大学的博士学位。
咨询顾问团
Advisory Board
Marc Better. Ph.D.
Dr. Better is currently Executive Director, Process
Development at Amgen in Fremont, CA. Dr. Better joined Amgen
through the acquisition of Abgenix in April 2006. At Abgenix,
he served as the Vice President, Process Sciences and led a
group of approximately 70 scientists working on process
development for panitumumab (Vectibix®)
and other products in the Abgenix portfolio. Prior to
joining Abgenix in May 2005, Dr. Better served as the Vice
President, Technical Development at XOMA (US) LLC where he
was responsible for process development and clinical
manufacturing operations. During his sixteen-year tenure at
XOMA, Dr. Better made significant contributions to various
technology platforms for product development, including gene
cloning and expression in bacterial, fungal and mammalian
cell systems. He also developed protein and peptide recovery
and purification systems. From 1984 to 1989, Dr. Better held
various research positions at International Genetic
Engineering, Inc. (INGENE), in Santa Monica, CA.
Dr. Better is named as the inventor of more than 20 patents
issued in the U.S. and Europe. He published extensively in
many peer-reviewed journals and served as invited speaker in
numerous international conferences.
He earned a Ph.D. in biochemistry from Brandeis University.
David J. Brusick, Ph.D., ATS
Dr. Brusick is currently a consultant to chemical and
pharmaceutical companies as well as contract research
organizations (CRO) worldwide.
Dr. Brusick served as Vice President of Global Resource
Management for Covance Labs, one of the largest preclinical
CRO’s in the world; supervised more than 1000 professional
and technical staff members. He developed and implemented a
Resource Management system that supported the global
toxicology infrastructure across Covance toxicology that
included metric- based costing and scheduling systems. He
was also responsible for the development of Covance’s
automated system giving clients full-time secure access to
toxicology study data (Study/Tracker™).
Dr. Brusick is an internationally recognized expert in
genetic toxicology and has published extensively in
peer-reviewed journals. He has authored many book chapters
and three books on the subject. He is also active and served
as advisor and contractor to a variety of different
government agencies including US FDA, USEPA, NIEHS, NIOSH,
and DOD. Dr. Brusick served on the editorial board for
different scientific journals, including Toxicological
Sciences and Mutation Research. He has been an invited
speaker at many US and international conferences.
Dr. Brusick received his Ph. D. from Illinois State
University.
Vera S. Byers, MD, Ph.D.
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.
Charlene Chen, Ph.D.
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.
Richard Chin, M.D., J.D.
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.
James S. Chu, MBA Ph.D.
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.
Eita Kitayama, M.S.
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.
From 2001 to 2003, Mr. Kitayama was Senior Program Manager
for early drug development at Covance Laboratories, Inc. in
Madison, Wis. In this role he assisted biotechnology and
pharmaceutical companies in the preclinical drug development
of their products. He served as a liaison between Covance
and the companies and coordinated all preclinical activities
for the clients and served as an adviser for the client
companies’ drug development programs. During his tenure Mr.
Kitayama also served as the Program Manager for Japanese
programs at Covance.
Prior to coming to the U.S., Mr. Kitayama established
himself as a toxicologist and the chief of GLP office at
Nippon Shinyaku Co, Ltd. in Kyoto, Japan (1984 – 2001). Mr.
Kitayama has unique combined experiences in the preclinical
drug development across three different countries, U.S.,
Japan, and China.
Mr. Kitayama published extensively in toxicology and was an
invited speaker in the international conferences
specifically on the subject of Asian outsourcing. Mr.
Kitayama received his M.S. from Kwansei Gakuin University in
Hyogo, Japan in 1984.
Alan S. Levin, MD, JD
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.
Xavier Paliard, Ph.D., Pharm. D.
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.
William W.Y. Pang, D.V.M., M.S., Ph.D.
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.
Ramachandran (TR) Thirucote, Ph.D.
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.
Alan G.E. Wilson, Ph.D., ATS
- Alan G. E. Wilson, PhD, ATS, is currently Vice President of
Drug Metabolism, Pharmacokinetics, and Toxicology and
Pathology at Lexicon Pharmaceuticals. He is internationally
recognized in drug metabolism, pharmacokinetics and
toxicology and has over 25 years of experience working on
product discovery and development for both small molecules
and biotherapeutics. He has significant hands-on experience
with the regulatory and GLP requirements for the conduct of
ADME, PK, CMC and safety assessment studies to support
regulatory submissions and clinical studies.
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Prior to Lexicon, Dr. Wilson held senior management
positions with Pharmacia/Pfizer where he was Senior Director
and Senior Science Fellow in Preclinical Development, with
Searle Pharmaceutical Company where he was Director and
Senior Science Fellow of ADME/PK and Investigative
Toxicology. In addition, he has had significant experience
in Regulatory Affairs and Product Registration while at
Monsanto Agricultural Company. He has been involved in the
global regulatory submission, approval and registration of a
number of successful pharmaceutical and agricultural
products. Alan has extensive experience in the application
of computational modeling approaches (i.e. in silico, PK,
PK/PD) to support product discovery and development and
clinical PK studies. As a Board Certified in Toxicologist he
has extensive experience working with regulatory agencies in
the U.S., Europe, Asia and Asia Pacific on ADME, PK,
Toxicology and registration issues. He has Board of Director
and Scientific Advisory experience with several companies.
He has chaired several Scientific Committees including
AIHC’s Dosimetry and Risk Assessment, SOT’s Biological
Modeling Subcommittee; in addition he chaired SOCMA’s
Pharmacokinetics committee which worked closely with the EPA
on the establishment of the EPA Metabolism and
Pharmacokinetic Guidelines. He is on the Editorial Board of
several scientific journals and has over 120 publications
including numerous invited speaker, and session chair,
presentations at international conferences.
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Dr. Wilson received his PhD in Drug Metabolism from the
University of Surrey in England and followed this with a
Visiting Science Fellowship in the Laboratory of
Pharmacology and Pharmacokinetics at the NIEHS in North
Carolina.
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