附件二培训主要讲学专家简介

1、附件二：培训主要讲学专家简介Key Members for the NIH Principles of Clinical Pharmacology ProgramJuan J. L. Lertora, M.D., Ph.D., Director, Clinical Pharmacology Program, Clinical Center, NIHDr. Lertora joined the NIH as Director, Clinical Pharmacology Program, Div. of Clinical Research Training and Medical Educati

2、on and works at the NIH Clinical Center. Before joining the NIH, he was Professor of Medicine &Pharmacology and Head of Clinical Pharmacology at Tulane Univ. School of Medicine. Dr Lertora served as Vice Chair and Chair of the Institutional Review Board at Tulane and was the Principal Investigat

3、or of the NIAID-funded Tulane-LSU Adult AIDS Clinical Trials Unit. In addition Dr. Lertora served as Core Faculty for the K30 Mentored Clinical Research Curriculum Award, funded by NIH. Currently Dr. Lertora is Adjunct Professor of Medicine at Duke Univ. School of Medicine. Dr. Lertoras research int

4、erests include phase I-II safety and efficacy clinical trials, pharmacokinetics, drug metabolism, pharmacogenetics, drug interactions, and pharmaco-dynamics of novel therapies for HIV, resistant M.TB.Dr. Lertoras highlights of his career include the Merck Sharp and Dohme Intl Fellowship in Clinical

5、Pharmacology, a fellowship in Clinical Pharmacology at the Univ. of Iowa. He was Assistant Professor of Medicine and Pharmacology at the Clinical Pharmacology Center of Northwestern Univ., Chicago and was the recipient of a Faculty Award from the Pharmaceutical Manufacturers Association Foundation.

6、Dr. Lertora was a member of thePharmacology Committee for the Adult AIDS Clinical Trials Group (NIAID). He served on the NIH AIDS Clinical Trials & Epidemiology study section, and is a member of the Editorial Board for Clinical Pharmacology and Therapeutics. Dr. Lertora is also a member of the F

7、DA Advisory Committee for Pharmaceutical Sciences & Clinical Pharmacology, the Board of Directors of the American Society for Clinical Pharmacology and Therapeutics.Arthur J. Atkinson, Jr., M.D., Professor, Feinberg School of Medicine, Northwestern UniversityDr. Atkinson received his AB degree i

8、n Chemistry from Harvard College and his MD from Cornell Univ. Medical College. Following medical internship and residency at the Massachusetts General Hospital, he was a Clinical Associate in the Lab. of Clinical Investigation of the National Institute of Allergy and Infectious Diseases, NIH. He re

9、ceived postdoctoral training in clinical pharmacology at the Univ. of Cincinnati and was a Visiting Scientist in the Dept. of Toxicology at the Karolinska Institute before moving to Northwestern Univ. Medical School to start the program in Clinical Pharmacology. While at Northwestern, Atkinson and h

10、is colleagues set up the first U.S. laboratory devoted to general therapeutic drug monitoring, designed and conducted the first clinical investigations to develop the acetylated metabolite of procainamide as a new antiarrhythmic drug, carried out the first pharmacokinetic studies with stable isotope

11、-labeled drugs, & completed basic research that elucidated the physiologic basis of some multicompartmental models of drug distribution. In 1994, Dr. Atkinson was appointed Corporate Vice President for Clinical Development and Medical Affairs at the Upjohn Company. He then joined the Center for

12、Drug Development science at Georgetown Univ. as an Adjunct Professor of Pharmacology. He returned to the NIH as a Special Expert Consultant in Clinical Pharmacology, and held the position of Senior Advisor in Clinical Pharmacology to the Director of the NIH Clinical Center. During that time, he esta

13、blished the NIH course on Principles of Clinical Pharmacology and served as lead editor for the companion textbook. Dr. Atkinson has been President of the American Board of Clinical Pharmacology, President of the American Society for Clinical Pharmacology and Therapeutics, and is a Master of the Ame

14、rican College of Physicians. He serves as an Associate Editor of Clinical Pharmacology & Therapeutics.Sanford P. Markey, Ph.D., Chief of the Lab. of Neurotoxicology, NIMH, NIHDr. Markey received his Ph.D. degree in chemistry from MIT, then joined the Departments of Pediatrics and Pharmacology at

15、 the Univ. of Colorado. In 1974, Dr. Markey came to the Laboratory of Clinical Science in the NIMH, NIH. Since 1996, Dr. Markey has been Chief of the NIMH Lab. of Neurotoxicology. Dr. Markey has authored over 160 scientific papers and two books and has received numerous awards. He has been an Associ

16、ate Editor of Organic Mass Spectrometry and has served on the Editorial Advisory Boards of Biological Mass Spectrometry and the Journal of the American Society for Mass Spectrometry. Dr Markeys research laboratory of Neurotoxicology has been focusing on research to determine the biochemical events t

17、hat cause neuronal injury and degeneration accompanying genetic disease, inflammation, trauma, and exposure to neurotoxic substances. The Analytical Biochemistry Section emphasizes research that utilizes qualitative and quantitative molecular structure analyses to determine cellular responses to dis

18、eases and neurotoxins. Methods for the mass spectrometric analysis of protein structures are being improved, applied and tested in projects in proteomics. Software to aid in these studies is also being developed.Robert B. Innis, Chief, Molecular Imaging Branch, National Institute of Mental Health, N

19、IHDr. Innis received his B.S. degree from Yale Univ. in 1974 and an M.D. from Johns Hopkins in 1978. He obtained a Ph.D. degree in neuropharmacology from Johns Hopkins in 1981. After completing a residency in psychiatry at Yale University, he joined their faculty in the Dept. of Psychiatry and Pharm

20、acology. Dr. Innis became Chief of a new lab. at NIMH with an emphasis on brain imaging using PET. Expanded state-of-the-art facilities for both radiochemistry and PET imaging at NIH provide unique opportunities for the application of this radiotracer method to patients with neuropsychiatric disorde

21、rs. The overall goals of Dr. Innis' laboratory are to develop new radiotracers that image molecular targets in the brain, to evaluate these tracers in animals and healthy human subjects, and then to extend their use to patients with neuropsychiatric disorders. Approximately half of our PET scans

22、 are performed in humans, with several studies that are the “first-inhuman” use novel PET readioligands. See the following web site for additional information on Dr. Innis' laboratory, including recent findings, publications in pdf format, and current studies. http：/ intramural . nimh . nih .gov

23、/mood/proginfo/mib/neuro .htmCharles Grudizinskas, PhD. Co-Founder and Principal, NDA Partners, LLC.Charles Grudzinskas received his PhD from the University of Minnesota. He is cofounder and principal at NDA Partners, LLC. Dr. Grudzinskas consults on the strategy and tactics of drug development, reg

24、ulatory strategies, and project management, working across the full range of emerging and mature companies. Dr. Grudzinskas' drug development career includes Vice President,Medications Development and Project Management, G.D. Searle and Company and Director, New Product Management at Lederle Lab

25、oratories. Prior to joining Searle, Dr. Grudzinskas was the first director of the Medications Development Division of the National Institute on Drug Abuse (NIDA) at the NIH. During his tenure at NIDA, Dr. Grudzinskas established state-of-the-art anticocaine and antiopiate discovery and clinical deve

26、lopment programs. By working closely with the FDA review division and the FDA Drug Abuse Advisory Committee, Dr. Grudzinskas' NIDA division was able to achieve an 18-day approval of LAAM, an alternative to methadone. This remarkable partnership with the FDA included the piloting of a "Rolli

27、ng NDA Process" which has now been incorporated as part of the FDA Modernization Act of 1997 (FDAMA). As a member of the 1986-89 FDA/PMA Project Management Working Group, Dr. Grudzinskas recommended to the FDA that to ensure higher quality NDAs, CDER should make better use of their Refuse to Fi

28、le authority. More rigorous enforcement of Refuse to File has played a role in ensuring higher quality NDAs, resulting in shortening NDA review times. Dr. Grudzinskas played a major role in the creation of role of Project Managers within CDER prior to PDUFA. Dr. Grudzinskas has been the course direc

29、tor for the PERI Drug Development Course and is a faculty member of PERI Courses in Project Management, R&D Finance, Clinical Trials, Primer for New Physicians and Scientists, and the NDA Game. Dr. Grudzinskas is a registered US Patent Agent.Diane Mould, PhD, President, Projections Research, Inc

30、.Diane R Mould obtained her bachelors degree at Stevens Institute of Technology in 1984 in Chemistry and Chemical Biology. She received her PhD in Pharmaceutics and Pharma- ceutical Chemistry at The Ohio State Univ. in 1989. She has spent 18 years as a pharmacokineticist in the pharmaceutical indust

31、ry where she specialized in population pharmacokinetic and pharmacodynamic modeling and worked as an associate Research Professor at Georgetown Univ. During this time, she has conducted population PK/PD analyses of hematopoietic agents, monoclonal antibodies, anti-cancer and anti-viral agents, antip

32、sychotic and sedative/ hypnotic agents. Dr Mould has also been involved in clinical trial simulation and optimal study design in drug development. She was a member of the Scientific Advisory Group for PharSight, where she assisted in the development of their clinical trial simulation software packag

33、e. Currently, Dr Mould is the president of Projections Research Inc, a consulting company offering pharmacokinetic and pharmacometric services to the pharmaceutical industry. She has published 26 peer- reviewed articles, 8 book chapters, and has made 52 national and international presentations on ad

34、vanced modeling approaches and simulation work and presented 41 posters. She currently holds a position as an adjunct professor at the Univ. of Rhode Island at Providence and teaches a class on disease progress modeling at the NIH.Michael M. Gottesman, Deputy Director for Intramural Research, Nation

35、al Institutes of Health (NIH)Dr. Gottesman graduated from Harvard Medical School with an MD degree magna cum laude in 1970 and completed a medical internship & residency at the Peter Bent Brigham Hospital in Boston. His research training began at Harvard in the laboratories of William Beck and B

36、ert Vallee and continued in the laboratory of Martin Gellert at NIH as a Research Associate. Dr. Gottesman spent a year as an Assistant Professor at Harvard Medical School joined the permanent staff of the NCI in 1976. He became Chief of the Molecular Cell Genetics Section of the Lab. of Molecular B

37、iology in 1980; Acting Director of the National Center for Human Genome Res.(NCHGR). He became Deputy Director for Intramural Research, NIH in 1993 & Assistant Surgeon General, Public Health Service in 1997. His research interests have ranged from how DNA is replicated in bacteria to how cancer

38、cells elude chemotherapy. He was one of the first to show that drug resistance genes could move from one replicon to another in bacteria. Applying the tools of molecular and somatic cell genetics to the study of cAMP-resistance and antimicrotubule drug resistance in mammalian cells, he isolated and

39、characterized cAMP-dependent protein kinase mutants & conditional mutants. These mutants and novel techniques of DNA transfer, which he was among the first to exploit, were used as tools to demonstrate the role of cAMP-dependent kinase in growth regulation & to study the effect of microtubul

40、e defects on mitosis. The work on anti-microtubule drug resistance led to studies on multi-drug resistance in human cancer cells. During the past 12 years, he has collaboratively identified the human gene responsible for resistance of cancer cells to many of the most common anticancer drugs and has

41、shown that this gene encodes a protein that acts to pump anticancer drugs out of drug resistant human cancers. In addition to the development ofstrategies to circumvent multi-drug resistance in cancer, these studies have led to a new generation of selectable vectors for gene therapy. Dr. Gottesman&#

42、39;s professional activities include many active memberships in professional societies and editorial boards. He was received the Milken Family Foundation Cancer Research Award; the Rosenthal Foundation Award; and the ASPET Award. As Deputy Director for Intramural Research at the NIH, he has initiate

43、d an NIH-wide lecture series; reformulated tenure and review processes in the intramural program.培训主要讲学专家简介Juan J. L. Lertora，医学博士，公共卫生博士，NIH临床药理研究中心主任Lertora博士担任NIH临床药理研究中心主任，临床研究培训和医学教育部门主要负责人，并在NIH临床中心工作。在加入NIH之前，他曾是 Tulane大学医学院担任的医药学教授和临床药理学科的带头人。Lertora博士担任了Tulane大学公共机构评审委员会的主席和副主席，他还是国立变态反应与传染

44、病研究所设立的Tulane-LSU 成人AIDS临床试验部门的主要研究者。另外，Lertora博士作为NIH的 K30 Mentored 临床研究课程核心教员。当前，Lertora博士担任Duke大学医学院的客座教授。Lertora博士的研究主要包括I、II期安全性和有效性的临床试验，药动学，药物代谢作用，药物遗传学，药物相互作用，HIV病毒，抗M.TB病毒新疗法药效学的研究。Lertora博士职业生涯的重要里程碑是在临床药理研究中建立的Merck sharp 和 Dohme Intl合作团体，这是一个在爱荷华州大学临床药理研究的团体。他曾是芝加哥的Northwestern大学临床药理学研究中

45、心的医药学客座教授，并获得药品制造商协会授予的Faculty Award。 Lertora博士曾是NIAID药理学会成人AIDS临床试验组成员。他负责NIH的AIDS临床试验和流行病学研究部分，是临床药理学和治疗学编辑委员会的成员。 Lertora博士还是药学和临床药理学FDA顾问委员会成员，美国社会科学临床药理学和治疗学委员会负责人。Arthur J. Atkinson,医学博士，Feinberg医学院、Northwestern大学教授Atkinson博士获得哈佛大学化学专业AB学位、康奈尔大学医学院医学博士学位。然后在马萨诸塞州总医院实习，在NIH过敏与传染性疾病国家临床研究实验室做研究助

46、理。进入Northwestern大学医学院开始临床药理研究之前，他在Cincinnati大学做过临床药理学博士后，并且在Karolinska研究所毒理室做访问学者。在Northwestern大学期间。Atkinson和他的同事们建立了美国第一家实验室进行一般治疗药物监测，首次设计指导了普鲁卡因乙酰化代谢产物作为一个新的抗心律失常药物的临床研究，首次进行了稳定同位素药物的药物代谢动力学研究，完成了一些基础研究，阐明了药物分布多室模型的生理学基础。1994年，Atkinson博士作为Upjohn公司的总裁进行临床开发和医疗事务，然后在乔治敦大学药物开发科研中心做客座教授。回到NIH任临床药理学的特

47、别专家顾问,从临床药理学的高级顾问做到美国卫生研究院临床中心主任，在这期间，他制定了NIH临床药理学原理课程并担任教科书主编。Atkinson博士现任美国临床药理学委员会会长，美国临床药理学与治疗学会会长，并做美国内科医师学会的会长，是临床药理学与治疗学的副主编。Sanford P. Markey,博士，NIH,NIMH,神经毒理学实验室负责人Markey博士在美国麻省理工学院获得了他的化学博士学位，之后，他来到了科罗拉多大学的儿科和药理系。1974年他又来到了NIH，NIMH的临床科学实验室。从1996年以来他一直担任NIMH神经毒理学实验室的负责人。他曾发表过超过160多篇的科研论文并且撰

48、写过两部书籍，获得过许多的奖励。他是Organic Mass Spectrometry的副主编。他也曾担任过生物质谱测定和美国质谱学会杂志的编委会顾问。Markey博士的神经毒理学研究实验室致力于研究能够引起神经损害和退化同时伴随遗传性疾病，炎症，外伤等的发生的生化反应。分析生物化学部门还着重于利用定性和定量的分子结构分析方法测定疾病的细胞反应和神经毒物。在蛋白组学的项目中，蛋白结构的质谱分析方法都被改进后并经过测试并应用了。在这些研究中相关的软件也正在被开发。Robert B. Innis，NIH国立精神卫生研究所分子成像部主任Innis博士1974年在耶鲁大学获得了理学学士学位，1978年

49、获得了约翰霍普金斯大学的医学博士学位，1981年又获得了约翰霍普金斯大学的神经药理学博士。在耶鲁大学完成了精神病学领域的研究之后，他进入了他们的精神病学部和药理学部。Innis博士成为一个刚建立的实验室的负责人，这个实验室设在国立精神卫生研究所，重点研究利用PET进行大脑显像。为扩大放射化学和PET成像设备工艺水平，国立卫生研究院提供机会让这种放射性示踪化合物方法应用于神经精神紊乱的病人。Innis博士实验室的主要目标就是发展新的在大脑里面的分子目标影像放射性示踪技术，用来评价这些动物和健康人群受试者的体内示踪物，然后扩大应用于神经精神紊乱的病人。有近一半的PET扫描是在人体上完成的，几项研究是第一次用于人体的新型的PET扫描。 看下面这个网站可以了解更多关于Innis博士实验室的信息，包括近期的发现，以及帕金森病基金会开本出版物和他们当前的研究。网站是http：/ /mood/proginfo/mib/neuro.htmCharles Grudizinskas，博士，LLC，NDA 合作体的联合创始