附件二培訓主要講學專家簡介

1、附件二：培訓主要講學專家簡介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.培訓主要講學專家簡介Juan J. L. Lertora，醫(yī)學博士，公共衛(wèi)生博士，NIH臨床藥理研究中心主任Lertora博士擔任NIH臨床藥理研究中心主任，臨床研究培訓和醫(yī)學教育部門主要負責人，并在NIH臨床中心工作。在加入NIH之前，他曾是 Tulane大學醫(yī)學院擔任的醫(yī)藥學教授和臨床藥理學科的帶頭人。Lertora博士擔任了Tulane大學公共機構評審委員會的主席和副主席，他還是國立變態(tài)反應與傳染

44、病研究所設立的Tulane-LSU 成人AIDS臨床試驗部門的主要研究者。另外，Lertora博士作為NIH的 K30 Mentored 臨床研究課程核心教員。當前，Lertora博士擔任Duke大學醫(yī)學院的客座教授。Lertora博士的研究主要包括I、II期安全性和有效性的臨床試驗，藥動學，藥物代謝作用，藥物遺傳學，藥物相互作用，HIV病毒，抗M.TB病毒新療法藥效學的研究。Lertora博士職業(yè)生涯的重要里程碑是在臨床藥理研究中建立的Merck sharp 和 Dohme Intl合作團體，這是一個在愛荷華州大學臨床藥理研究的團體。他曾是芝加哥的Northwestern大學臨床藥理學研究中

45、心的醫(yī)藥學客座教授，并獲得藥品制造商協(xié)會授予的Faculty Award。 Lertora博士曾是NIAID藥理學會成人AIDS臨床試驗組成員。他負責NIH的AIDS臨床試驗和流行病學研究部分，是臨床藥理學和治療學編輯委員會的成員。 Lertora博士還是藥學和臨床藥理學FDA顧問委員會成員，美國社會科學臨床藥理學和治療學委員會負責人。Arthur J. Atkinson,醫(yī)學博士，F(xiàn)einberg醫(yī)學院、Northwestern大學教授Atkinson博士獲得哈佛大學化學專業(yè)AB學位、康奈爾大學醫(yī)學院醫(yī)學博士學位。然后在馬薩諸塞州總醫(yī)院實習，在NIH過敏與傳染性疾病國家臨床研究實驗室做研究助

46、理。進入Northwestern大學醫(yī)學院開始臨床藥理研究之前，他在Cincinnati大學做過臨床藥理學博士后，并且在Karolinska研究所毒理室做訪問學者。在Northwestern大學期間。Atkinson和他的同事們建立了美國第一家實驗室進行一般治療藥物監(jiān)測，首次設計指導了普魯卡因乙?；x產物作為一個新的抗心律失常藥物的臨床研究，首次進行了穩(wěn)定同位素藥物的藥物代謝動力學研究，完成了一些基礎研究，闡明了藥物分布多室模型的生理學基礎。1994年，Atkinson博士作為Upjohn公司的總裁進行臨床開發(fā)和醫(yī)療事務，然后在喬治敦大學藥物開發(fā)科研中心做客座教授?；氐絅IH任臨床藥理學的特

47、別專家顧問,從臨床藥理學的高級顧問做到美國衛(wèi)生研究院臨床中心主任，在這期間，他制定了NIH臨床藥理學原理課程并擔任教科書主編。Atkinson博士現(xiàn)任美國臨床藥理學委員會會長，美國臨床藥理學與治療學會會長，并做美國內科醫(yī)師學會的會長，是臨床藥理學與治療學的副主編。Sanford P. Markey,博士，NIH,NIMH,神經毒理學實驗室負責人Markey博士在美國麻省理工學院獲得了他的化學博士學位，之后，他來到了科羅拉多大學的兒科和藥理系。1974年他又來到了NIH，NIMH的臨床科學實驗室。從1996年以來他一直擔任NIMH神經毒理學實驗室的負責人。他曾發(fā)表過超過160多篇的科研論文并且撰

48、寫過兩部書籍，獲得過許多的獎勵。他是Organic Mass Spectrometry的副主編。他也曾擔任過生物質譜測定和美國質譜學會雜志的編委會顧問。Markey博士的神經毒理學研究實驗室致力于研究能夠引起神經損害和退化同時伴隨遺傳性疾病，炎癥，外傷等的發(fā)生的生化反應。分析生物化學部門還著重于利用定性和定量的分子結構分析方法測定疾病的細胞反應和神經毒物。在蛋白組學的項目中，蛋白結構的質譜分析方法都被改進后并經過測試并應用了。在這些研究中相關的軟件也正在被開發(fā)。Robert B. Innis，NIH國立精神衛(wèi)生研究所分子成像部主任Innis博士1974年在耶魯大學獲得了理學學士學位，1978年

49、獲得了約翰霍普金斯大學的醫(yī)學博士學位，1981年又獲得了約翰霍普金斯大學的神經藥理學博士。在耶魯大學完成了精神病學領域的研究之后，他進入了他們的精神病學部和藥理學部。Innis博士成為一個剛建立的實驗室的負責人，這個實驗室設在國立精神衛(wèi)生研究所，重點研究利用PET進行大腦顯像。為擴大放射化學和PET成像設備工藝水平，國立衛(wèi)生研究院提供機會讓這種放射性示蹤化合物方法應用于神經精神紊亂的病人。Innis博士實驗室的主要目標就是發(fā)展新的在大腦里面的分子目標影像放射性示蹤技術，用來評價這些動物和健康人群受試者的體內示蹤物，然后擴大應用于神經精神紊亂的病人。有近一半的PET掃描是在人體上完成的，幾項研究是第一次用于人體的新型的PET掃描。 看下面這個網站可以了解更多關于Innis博士實驗室的信息，包括近期的發(fā)現(xiàn)，以及帕金森病基金會開本出版物和他們當前的研究。網站是http：/ /mood/proginfo/mib/neuro.htmCharles Grudizinskas，博士，LLC，NDA 合作體的聯(lián)合創(chuàng)始