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Dose-finding of Small Molecule Oncology Drugs
May 18-19, 2015 Washington Court Hotel, Washington, DC Workshop Chairs
Pasi Jänne, MD, PhD, AACR Regulatory Science and Policy Subcommittee member and Director, Lowe Center for Thoracic Oncology Scientific Director, Belfer Institute for Applied Cancer Science, Senior Physician, Dana Farber Cancer Institute and Professor of Medicine, Harvard Medical School
Dr. Jänne is translational thoracic medical oncologist at the Dana Farber Cancer Institute and a Professor of Medicine at Harvard Medical School. He is the Director of the Lowe Center for Thoracic Oncology and the Scientific co-‐director of the Belfer Institute for Applied Cancer Sciences. After earning his MD and PhD from the School of Medicine at the University of Pennsylvania, Dr Jänne completed his internship and residency in Medicine at Brigham and Women’s Hospital, Boston. He subsequently completed fellowship training at Dana Farber Cancer Institute/Massachusetts General Hospital combined program in medical oncology in 2001. In 2002 he earned a Master’s Degree in clinical investigation from Harvard University. Dr Jänne’s research combines laboratory based studies, with translational research and clinical trials of novel therapeutic agents in patients with lung cancer. His main research interests center around understanding and translating the therapeutic importance of oncogenic alterations in lung cancer. He has made seminal therapeutic discoveries, including being on one of the co-‐discoverers of EGFR mutations, and findings from his work has led to the development of several clinical trials. Dr. Jänne has received several awards for his research including from Uniting Against Lung Cancer, American Lung Association and the Bonnie J. Addario Lung Cancer Foundation. In 2008 he was elected as a member to the American Society of Clinical Investigation. He is also the recipient of 2010 American Association of Cancer Research (AACR) Richard and Hinda Rosenthal Memorial Award and a member of the 2010 AACR Team Science Award and is an active member of the AACR’s Regulatory Science and Policy subcommittee.
Geoffrey Kim, MD, Director, Division of Oncology Products1 (DOP1), OHOP, OND, CDER, FDA Geoff Kim is the director of the Division of Oncology Products 1 of the Office of Oncology Drug Products in the Center for Drug Evaluation and Research of the United States Food and Drug Administration. He is involved with numerous cross-‐center working groups, developing policies pertaining to in-‐vitro companion diagnostics, combination products, and dose finding optimization strategies for oncology products. He received his bachelor’s degree at UCLA, his medical degree at the New York Medical College, and completed his residency in internal medicine at the Montefiore Medical Center in the Bronx. Geoff completed his medical oncology fellowship at the National Cancer Institute where he was active in both laboratory and clinical research in the NCI molecular signaling section and the ovarian cancer clinic.
Amy McKee, MD, Medical Team Leader, Division of Oncology Products 1(DOP1),OHOP, OND, CDER, FDA Dr. McKee is a clinical team leader in the Division of Oncology Products 1 of the Office of Oncology Drug Products in the Center for Drug Evaluation and Research of the United States Food and Drug Administration. Before obtaining her medical degree at Tulane University School of Medicine, Dr. McKee was a reporter for Elsevier’s medical industry trade journal “The Pink Sheet.” She completed her pediatric training at the Floating Hospital for Children/New England Medical Center and her pediatric hematology/oncology training at the combined Johns Hopkins University/National Cancer Institute fellowship program, where she continued basic research on neuroblastoma in the laboratory of Carol Thiele, Ph.D., prior to joining the FDA. Since joining the FDA, she has reviewed numerous new molecular entities for marketing approval in oncology, reviews which included
presenting these applications at the Oncologic Drugs Advisory Committee, as well as authored several manuscripts on new approvals and on clinical trial endpoints for regulatory applications.
Eric Rubin, MD, AACR Regulatory Science and Policy Subcommittee member and Vice President and Therapeutic Area Head, Oncology Clinical Development, Merck Research Labs
Dr. Rubin has focused on cancer drug development for over 20 years, initially as a faculty member at the Dana-‐Farber Cancer Institute, then as a senior leader of the Cancer Institute of New Jersey. In 2008 Dr. Rubin was recruited to Merck as Vice-‐President, Oncology Clinical Research. He led the development of the anti-‐PD-‐1 antibody pembrolizumab, which was the first anti-‐PD-‐1 therapy approved in the U.S., and in the identification of the significant activity of this antibody across several additional cancer types. In his current role he oversees oncology early development and translational research activities at Merck. Dr. Rubin has authored over 100 original, peer-‐reviewed publications and book chapters related to oncology translational research, clinical trials and drug development. He has served frequently as a member of National Cancer Institute and American Cancer Society study sections, as well as on program committees for the American Association of Cancer Research (AACR) and the American Society of Clinical Oncology. In addition, he is a deputy editor for AACR’s premiere journal Clinical Cancer Research and is an active member of AACR’s Regulatory Science and Policy subcommittee.
Featured Speakers and Panelists
Stuart Bailey, PhD, Global Head, Early Clinical Biostatistics, Novartis Oncology
Jeffrey Barrett, PhD, Vice-President, Interdisciplinary Pharmacometrics Group, Sanofi Dr. Jeff Barrett is Vice President, Global Head of the Interdisciplinary Pharmacometrics Program (IPP) and Global Head of Pediatric Clinical Pharmacology at Sanofi Pharmaceuticals. He leads the modeling and simulation efforts across scientific core platforms at Sanofi -‐-‐ developing, testing, and exploiting quantitative relationships to facilitate critical decisions. Jeff spent the previous 10+ years at the University of Pennsylvania where he was Professor, Pediatrics and Director, Laboratory for Applied PK/PD at the Children’s Hospital of Pennsylvania (CHOP). His academic career was highlighted by sustained NIH support for pharmacometric research across numerous therapeutic areas in adult and pediatric populations. Prior to tenure at U Penn / CHOP, Jeff spent 13 years in the pharmaceutical industry, most recently as Head of Global Biopharmaceutics at Aventis. Jeff received his B.S. in Chemical Engineering from Drexel University and Ph.D. in Pharmacokinetics from University of Michigan. He is a fellow of ACCP and AAPS and the recipient of numerous honors including ACCP awards for Young Investigator (2002) and Mentorship in Clinical Pharmacology (2007) and the AAPS Award in Clinical Pharmacology and Translational Research (2011). Dr. Barrett was awarded for Exceptional Innovation and Advancing the Discipline of Pharmacometrics at the International Society for Pharmacometrics (2013). He has co-‐authored over 140 manuscripts, 160 abstracts and has given over 125 invited lectures on PK/PD, clinical pharmacology and pharmacometrics. He serves on the Editorial Boards of the Journal of Pharmacokinetics and Pharmacodynamics and the ASCPT Pharmacometrics & Systems Pharmacology Journal and is the co-‐Specialty Chief Editor of Frontiers in Obstetric and Pediatric Pharmacology.
Akintunde Bello, PhD, Executive Director, Clinical Pharmacology Oncology and Immuno Oncology at Bristol-Myers Squibb
Richard Brennan, PhD, DABT, Scientific Advisor Preclinical Safety, Sanofi
Julie Bullock, PharmD, Director of Clinical Pharmacology, d3 Medicine
Dr. Bullock is Director of Clinical Pharmacology at d3 Medicine, a strategic global drug development advisory firm focused on providing integrated perspectives to deliver meaningful Value Focused Development solutions. Prior to her role at d3 Medicine, Dr. Bullock was the Clinical Pharmacology Team Leader for the Oncology/Hematology
team (2008-‐2014) in the Division of Clinical Pharmacology 5, which collaborated with the Division of Hematology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Dr. Bullock also spent 3 years as a primary reviewer for Investigational New Drugs and New Drug Applications reviewed in the Division of Reproductive and Urologic Drug Products (2004-‐06) and the Division of Drug Oncology Products (2006-‐08). Dr. Bullock received her doctor of pharmacy from Drake University in 2002 and completed a clinical pharmacology drug development fellowship with SUNY at Buffalo and Novartis pharmaceuticals in 2004.
Donna Dambach, VMD, PhD, Diplomate, ACVP, Senior Director, Head of Toxicology, Genentech Donna Dambach is currently Senior Director, Head of Toxicology at Genentech, Inc. The Toxicology group provides portfolio and program strategic and technical expertise from discovery through post-‐marketing including safety lead optimization and development candidate identification, the design and implementation of non-‐clinical development strategies for INDs/CTAs through NDAs/MAAs, and investigative toxicology support for programs through an Investigative Toxicology Laboratory. Donna has combined 24 years of experience in both academia and industry as a comparative anatomic pathologist and as a discovery and regulatory toxicologist, and has contributed in establishing the use of new technologies and lead optimization strategies for safety evaluation; identification of safety biomarkers; and the development of numerous drugs. Current areas of active work include development of stem cell-‐based technologies to enhance predictive and mechanistic toxicology assessments, and applying biochemical toxicology concepts to toxicology assessments (in vitro-‐in vivo correlations) through greater incorporation of physicochemical and ADME parameters. Donna received her Ph.D. from the Department of Toxicology from Rutgers University/University of Medicine and Dentistry of New Jersey (2002). Her doctoral research examined the role of inflammatory mediators and NFκB in the acetaminophen-‐induced model of acute oxidative-‐stress-‐mediated hepatotoxicity. She received her veterinary degree (V.M.D.) from the University of Pennsylvania in 1990, completed a residency in comparative anatomic pathology at the University of Pennsylvania and attained board certification (American College of Veterinary Pathology) as a diplomate in the subspecialty of Comparative Anatomic Pathology (1994). She has authored or co-‐authored over 45 peer-‐reviewed publications/book chapters and two patents for safety biomarkers.
Dinesh De Alwis, PhD, Executive Director, Late Stage, Quantitative Pharmacology and Pharmacometrics, Merck Research Labs
Dr. Dinesh de Alwis, is currently an Executive Director of Quantitative Pharmacology and Pharmacometrics, PPDM at Merck Research Laboratories in New Jersey, where he is responsible for late stage development within his function. Since he joined Merck in 2012, he has been actively involved in the development of both small and large molecules and played a significant part in the dose finding and registration of KEYTRUDA® for IPI refractory metastatic melanoma. He previously held several leadership and scientific roles at Eli Lilly and Company (1997 – Jan 2012), in the UK. He headed a group of PK/PD scientists (since 2004) and was the lead PK/PD Scientist for several compounds (therapeutic areas of neuroscience, cardiovascular, oncology) from pre-clinical to phase III studies for over 14 years. Dr. de Alwis has over 25 publications in peer-reviewed journals and is on the editorial board of a journal. He is also on the scientific committee of the Population Approach Group in Europe (PAGE) since 2003 and has been on the expert panel for the European Economic Community steering committee on physiologically based dynamic modeling: COST B25 (2006 – 2009). Dr. de Alwis received his PhD from the University of Manchester (1997), UK in the field of Population PK/PD.
Laura Fernandes, PhD, Mathematical Statistician, Division of Biostatistics V (DBV), OB, OTS, CDER, FDA Laura Fernandes is a statistical reviewer in the office of biostatistics and supports the division of oncology product teams at the FDA. Her PhD thesis in biostatistics at the University of Michigan, Ann Arbor, focused on adaptive dose-‐finding clinical trial designs in oncology. Prior to her PhD research, she worked at GlaxoSmithKline (GSK) as a SAS programmer analyzing clinical trial data.
Dan Howard, PhD, VP, Oncology Clinical Pharmacology, Novartis Dan Howard received his Bachelors of Science and PhD in Pharmaceutical Sciences from the University of Missouri in Kansas City. He began his professional career working in the industry as a Biopharmaceutics consultant, and accepted his first industry position as a Clinical Scientist for Marion Merrell Dow in the Drug Dynamics group of the Clinical Pharmacokinetics department. There he conducted first-‐in-‐human and clinical pharmacology studies for both large and small molecules. He has worked across the full spectrum of both nonclinical and clinical drug development, for both biologic and small molecule therapeutics. In drug metabolism and pharmacokinetics, he has managed teams in Bioanalytical Sciences, Nonclinical and Clinical Pharmacokinetics and Clinical Pharmacology. In 2005, he joined Novartis as the Global Head of the Pharmacokinetics and Pharmacodynamics department, where he worked with teams in Switzerland, England, Japan, India, China, and the United States. In 2012, accepted his current role as the Global Head of Oncology Clinical Pharmacology at Novartis Pharmaceuticals in East Hanover, NJ. He is a husband, father of three, avid reader, collector of live music, guitar-‐player, and home brewer.
Jin Jin, PhD, Associate Director, Head of Modeling and Simulation, Genentech Dr. Jin Yan Jin is Associate Director, Head of Modeling and Simulation (M&S) in Clinical Pharmacology at Genentech. She completed PhD and post-‐doc with Dr. William J. Jusko at SUNY-‐Buffalo. She worked at Eli Lilly as project PKPD lead in metabolic and neuroscience. In early 2009, Dr. Jin joined Genentech as clinical M&S lead for small molecules. Currently, she is accountable for M&S works for all molecule types (small molecules, biologics, and ADCs) in all therapeutic areas (oncology, neuroscience, ophthalmology, respiratory, CV, immunology, and ID). She is responsible for the technical strategy, implementation, and review of M&S for clinical projects and disease platforms. Dr. Jin is a strong advocate for M&S application in drug development inside/outside Genentech. Her scientific areas of expertise include mechanistic PK/PD, PBPK, population analysis, trial simulation, disease modeling, and literature meta-‐analysis. Dr. Jin is a committed member of the scientific community with active presentations/publications. She serves on the Board of Directors for International Society of Pharmacometrics (ISoP) and Editorial Board of Clinical Pharmacology and Therapeutics: Pharmacometrics and System Pharmacology (CPT:PSP). She is the Conference Chair for 2015 American Conference on Pharmacometrics annual meeting (ACoP6). She served on the Membership Action Team and is currently serving the Mentor Task Force for American Society for Clinical Pharmacology and Therapeutics (ASCPT).
Thomas Jones, PhD, Chief Scientific Officer, Toxicology& Pathology, Eli Lilly Dr. Jones received his Ph.D. in Experimental Pathology from the University of Maryland and completed a post-‐doctoral fellowship at the Karolinska Institute in Stockholm, Sweden. He joined the faculty of the University of Maryland School of Medicine, Department of Pathology and rose to the rank of Associate Professor. His laboratory received major funding support from the American Cancer Society and the National Institutes of Health. Dr. Jones joined Eli Lilly and Co. in 1991 as a Research Scientist in Toxicology. His career has included a variety of technical and administrative roles. Currently, as Chief Scientific Officer for the Toxicology and Pathology organization, Dr. Jones has administrative responsibility for all nonclinical safety support for the Lilly Research Laboratories portfolio. Dr. Jones has been an active member of the Society of Toxicology for over 25 years. He is currently past-‐Chair of the Preclinical Safety Leadership Group within the International Consortium for Innovation and Quality in Pharmaceutical Development. This group represents the collective interests of the senior preclinical safety assessment leaders of the more than 30 member companies. He also serves as the nonclinical safety representative for the Development Special Emphasis Panel supporting the NCI Experimental Therapeutics (NExT) Program. Through his accumulated experiences, Dr. Jones has developed valuable insights into the challenges and opportunities associated with the application of nonclinical safety data in man human risk management.
Vivek Kadambi, PhD, Vice President, Chemistry, Blueprint Medicines
Dr. Vivek (Vic) Kadambi, is Vice President Nonclinical Development at Blueprint Medicines. Most recently, Vic was Vice President, Global Head of the Drug Safety Research and Evaluation Group at Takeda Pharmaceutical Company. Vic joined Millennium Pharmaceuticals in 1999 and over the years has held positions of increasing responsibility, culminating as Vice President, Drug Safety Evaluation. Vic has a B.S. and a M.S. in Microbiology from the University of Bombay and a Ph.D. in Cardiovascular Pharmacology and Physiology from the University of Cincinnati. Vivek was the recipient of the American Heart Association Fellowship, Ohio Affiliate (1997-‐1998) as well as the Young Investigator Award from the Heart Failure Society of America (1998). As a project team toxicologist, he was awarded the Millennium Outstanding Contributor Award in 2001 and 2004. Vivek has served as the Program Chair for pharmacology and toxicology related symposia and was a Councilor for the New England Society of Toxicology. Vic is the Chair of the DruSafe (Preclinical Safety Leadership Group) part of the International Consortium for Innovation and Quality in Pharmaceutical Development. He currently co-‐chairs the Nonclinical to Clinical Translational Safety Working Group which focuses on the correlation of in vivo nonclinical safety information with clinical findings. In addition, Vic is also the founder of the Boston Area Pharm/Tox group. He has over 30 publications and book chapters and has presented posters and oral talks at both national and international meetings.
William Kluwe, PhD, Oncology Therapeutic Area Head, Preclinical Safety, Novartis Institutes of Biomedical Research/Novartis Pharmaceuticals Dr. Kluwe is currently Oncology Therapeutic Area head, Preclinical Safety, at the Novartis Institutes for Biomedical Research, Novartis Pharmaceuticals. A pharmacologist by training, he has over 35 years of professional experience in the toxicological assessment and safety management of therapeutic drugs and related materials. In addition to Novartis, he has worked previously for Pfizer Pharmaceuticals, Battelle Memorial Institute and the National Institutes of Health/National Toxicology Program.
Qi Liu, PhD, Clinical Pharmacology Team Leader, Division of Clinical Pharmacology V, OCP, OTS, CDER, FDA Dr. Qi Liu is currently a team leader at Division of Clinical Pharmacology V, Office of Clinical Pharmacology, CDER, FDA. Prior to joining FDA, Dr. Liu worked as a senior pharmacokineticist at Merck & Co. Inc. She obtained her Ph.D. degree in Pharmaceutics (focus on Pharmacokinetics/Pharmacodynamics Modeling and Simulation) from the University of Florida, Gainesville. During that period, Dr. Liu also earned a Master's degree in Biostatistics. Dr. Liu also earned a Master's degree in Pharmaceutics and a B.S in Pharmacy in China.
Eric Masson, PharmD, Executive Director, Quantitative Clinical Pharmacology, AstraZeneca Dr Eric Masson is the global clinical pharmacology discipline lead and co-‐leading oncology in Quantitative Clinical Pharmacology at AstraZeneca in Waltham near Boston, MA. Previously, Eric was leading clinical pharmacology and pharmacometrics for immunology and oncology at Bristol-‐Myers Squibb where he and his team led the development, filing and approval of ipilimumab, and also the initial filing of nivolumab. Eric also worked as clinical pharmacologist with small molecules in early and late stage development at Novartis Oncology. He started his career in Canada as Scientific Director at Anapharm Inc, as phase 1 CRO, and was assistant professor in pharmacy at Faculty of Pharmacy, Universite Laval in Quebec City, QC, Canada. Eric obtained his bachelor degree in Pharmacy from Universite Laval, Quebec, Canada; his Pharm.D. from State University of New York in Buffalo, NY, USA; and a post-‐doctoral training in Pediatric Oncology from St. Jude Children’s Research Hospital in Memphis, TN, USA.
Nitin Mehrotra, PhD, Team Leader, Division of Pharmacometrics, Office of Clinical Pharmacology (OCP), OTS, CDER, FDA Dr. Nitin Mehrotra is a Team Leader in Division of Pharmacometrics, Office of Clinical Pharmacology at the US FDA. He joined the FDA in 2007. Prior to joining FDA, Dr. Mehrotra obtained his Ph.D. degree from Birla Institute of Technology and Sciences, India. Following which, he worked as a post-‐doctoral fellow at the University of TN Health Science Center focusing on application of pharmacometrics in drug development. In his current role at the
FDA, Dr. Mehrotra works in the areas of Oncology, Metabolic and Endocrinology, gastroenterology and inborn error products. His job profile includes applying pharmacometrics for regulatory decisions such as dose selection, evidence of effectiveness, trial design, etc. Dr. Mehrotra is a strong proponent of the concept of ‘rationale dose selection’ and believes it to be pivotal for success of any drug development program. He has published several articles and has been invited to conferences to present on topics pertaining to application of pharmacometrics in drug development and regulatory decisions.
Lei Nie, PhD, Statistical Team Leader, DBV, OB, OTS, CDER, FDA
Lei Nie is a lead mathematical statistician of the Division of Biometrics V in the Office of Biostatistics (OB), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). He has authored/coauthored more than 75 peer reviewed journal papers. As a regulatory reviewer, he has review experiences in dose finding. Dr. Nie received his Ph.D. in Statistics from the University of Illinois at Chicago. Prior to coming to FDA, Dr. Nie was a faculty member in the University of Maryland Baltimore country from 2002-‐2005 and Georgetown University from 2005-‐2007.
Todd Palmby, PhD, Pharmacology/Toxicology Supervisor, FDA Dr. Palmby is a Pharmacology/Toxicology Supervisor in the Division of Hematology Oncology Toxicology leading a team supporting the Division of Oncology Products 1 of the Office of Oncology Drug Products in the Center for Drug Evaluation and Research of the United States Food and Drug Administration. Prior to joining FDA as a Pharmacology/Toxicology Reviewer in 2008, Dr. Palmby completed a post-‐doctoral fellowship in the Oral and Pharyngeal Cancer Branch within the National Institute of Dental and Craniofacial Research at the National Institutes of Health. Dr. Palmby received his PhD in Pharmacology from the University of North Carolina at Chapel Hill in 2004. His research experience was focused on mechanisms of cancer biology involving GTPase and kinase networks using cell and molecular biology approaches as well as tumor, knockout and transgenic mouse models. During his time at FDA, he has presented at national meetings on the FDA perspective of nonclinical testing of oncology therapeutics.
Kourosh Parivar, M.Pharm, Head of Clinical Pharmacology, Pfizer Kourosh received his M.Pharm., in 1989 from Uppsala University, Sweden, after which he completed his post-‐graduate training in pharmacokinetics at the University of California, San Francisco (UCSF). In 1991, after returning to Sweden, he accepted a position as Clinical Research Scientist at the department of Clinical Pharmacology at Astra Arcus AB in Sodertalje, Sweden, and worked with different compounds in the CNS therapeutic area. In 1993, Kourosh joined Pharmacia AB in Stockholm, Sweden, as Clinical Research Manager and worked with the Clinical Pharmacology development of their intravenous anesthetic drug. In 1996, he accepted a position as Clinical Pharmacology Program Leader at Pharmacia & Upjohn AB and was in charge of Clinical Pharmacology development of several compounds for treatment of diabetes and erectile dysfunction. In 1999, Kourosh was appointed as the head of Clinical Pharmacology at Pharmacia & Upjohn AB in Stockholm, Sweden. In 2000, he moved to Singapore on behalf of Pharmacia to set up a Phase I Research clinic which was completed in late 2001. In October 2001, Kourosh was appointed as the head of Clinical Pharmacology at Pharmacia’s R&D facility in Chicago, USA, overseeing the Clinical Pharmacology development of anti-‐inflammatory portfolio of Pharmacia. In 2003 Kourosh joined Pfizer as head of the Clinical Pharmacology covering antiviral, oncology, diabetes and ophthalmology therapeutic areas. He is currently the head of Clinical Pharmacology of Pfizer Oncology. His areas of interest are quantitative drug development and Clinical Development in Asia.
Lilli Petruzzelli, MD, PhD, Global Head Translational Clinical Oncology, Novartis Lilli received her BS in Chemistry and Biology from MIT, and her MD and PhD from Albert Einstein College of Medicine. She did her internship and residency training in Internal Medicine and her fellowship in Hematology at the Brigham and Women’s Hospital in Boston. She was appointed Assistant Professor of Medicine at the University of Michigan in 1994 where she established a laboratory-‐based research program focused on the
regulation of integrin-‐dependent adhesion in leukocytes and a clinical practice specializing in hematologic malignancies. She was promoted to Associate Professor in 2002. Lilli began her career in the pharmaceutical industry at Millennium in 2007, where she played key role in the development of their oral second generation proteasome inhibitor. Lilli joined Novartis in 2009, was appointed a Clinical Site Head in 2011, and is now the Global Head of TCO overseeing the clinical development of the early portfolio in Oncology.
José Pinheiro, PhD, Senior Director, Janssen José Pinheiro has a Ph.D. in Statistics from the University of Wisconsin – Madison, having worked at Bell Labs and Novartis Pharmaceuticals, before his current position as Head of Statistical Modeling in the Model-‐Based Drug Development department at Janssen Research & Development. He has been involved in methodological development in various areas of statistics and drug development, including dose-‐finding, adaptive designs, and mixed-‐effects models. He is a Fellow of the American Statistical Association and the current ENAR president.
Yazdi Pithalva, PhD, Senior Director, Clinical Pharmacology, Pfizer Yazdi K. Pithavala is a member of the Clinical Pharmacology group at Pfizer. He obtained his Bachelors in Pharmaceutical Sciences degree from the University of Bombay, India, in 1990. He received his PhD in Pharmacokinetics from the University of Minnesota in 1995. Following his graduate studies, he completed a Postdoctoral Fellowship in Clinical Pharmacokinetics/Dynamics and Drug Development at the University of North Carolina and Glaxo Wellcome in 1997. He started his professional career at Agouron Pharmaceuticals (San Diego), which was acquired by Pfizer in 2000. He has worked as the Clinical Pharmacology Lead for investigational drugs for oncology, virology, and ophthalmology. He has been involved with the design and conduct of clinical studies and analysis of pharmacokinetic data from all phases of clinical development. He recently led Clinical Pharmacology efforts for the global NDA submission and approval of INLYTA® (axitinib) for the treatment of second-‐line renal cell carcinoma; the drug is currently approved in more than 60 countries. He also holds a voluntary appointment as Assistant Clinical Professor at the Skaggs School of Pharmacy, University of California San Diego (UCSD).
Nam Atiqur Rahman, PhD, Director, Division of Clinical Pharmacology V, Office of Clinical Pharmacology (OCP), OTS, CDER, FDA Nam Atiqur Rahman, PhD, is the Director of the Division of Clinical Pharmacology V within the Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research, US Food and Drug Administration (USFDA). The Division consists of 26 clinical pharmacology reviewers who are involved in pharmaceutical product development, product review, and approval. The Division supports evaluation of Hematology/Oncology and Medical Imaging products. Prior to joining FDA, Dr. Rahman completed post-‐doctoral training at the St-‐Jude Children’s Research Hospital, Memphis, Tennessee in Molecular Pharmacology and Pharmacogenomics. Dr. Rahman’s current interest includes dose optimization in Oncology drug development, application of modeling and simulation in Oncology drugs and biologics development, and application of pharmacogenomics to promote personalized medicine for patients. He leads and supports the review staff that addresses various scientific challenges in drug development and approval, and interacts with pharmaceuticals to promote and facilitate oncology drug development from Clinical Pharmacology perspectives. Dr. Rahman has been involved with the biosimilar program and a member of various committees and working groups at the Center level dealing with the FDA biosimilar program. Dr. Rahman is a member of the Biologics Oversight Board within OCP. The board provides recommendation to the review teams on Biocomparability and Biosimilarity related clinical pharmacology issues. Dr. Rahman has written four book chapters; over 35 articles in peer reviewed journals, and made numerous presentations in various national and international scientific forums.
Sherry Ralston, PhD, Director, Preclinical Safety, AbbVie Sherry Ralston studied at Allegheny College (Meadville, PA) where she obtained a BS in Organic Chemistry in 1989. Sherry received her PhD (1996) at Purdue University (West Lafayette, IN) in Cancer Research/Biochemistry studying DNA adduct formation by polycyclic aromatic hydrocarbons. As a postdoctoral student, Sherry studied
cancer chemoprevention at the Cancer Hospital at The Ohio State University (Columbus, OH) from 1996-‐1998. Sherry started her drug development experience at Pfizer, Inc. (Groton, CT) in 1999 in the Drug Safety department as a toxicologists and project team representative primarily in Oncology but also in Neuroscience development. Sherry was hired by AbbVie in July 2008 and works in the Preclinical Safety group. Sherry currently serves as the Therapeutic Area Leader for Oncology, Neuroscience, Pain and Cystic Fibrosis and is a member of the Preclinical Safety Leadership Team supporting the operations and management of the organization. Through the years, she has had many interactions with regulatory groups, involved in many submissions (i.e. IND, CTA and/or NDA/MAA), and supported the development of a number of oncology programs.
Mark Ratain, MD, Associate Director for Clinical Sciences, Comprehensive Cancer Center, University of Chicago Dr. Ratain is a graduate of Harvard College (A.B., 1976) and Yale University School of Medicine (M.D., 1980). His postgraduate training was completed at Johns Hopkins Hospital (Internal Medicine, 1980-‐3) and the University of Chicago Hospitals (Hematology/Oncology, 1983-‐6). He has been a faculty member in the Department of Medicine at The University of Chicago since 1986, and is currently the Leon O. Jacobson Professor of Medicine, the Director of the Center for Personalized Therapeutics and Chief Hospital Pharmacologist. In addition, he serves as the Associate Director for Clinical Sciences in the University’s Comprehensive Cancer Center, leads the University of Chicago’s phase I oncology trials program and is co-‐director of the Pharmacogenomics of Anticancer Agents Research Group. Dr. Ratain’s research focuses on the development of new oncology drugs and diagnostics, and he is an international leader in phase I clinical trials, pharmacogenomics, and clinical trial methodology, with over 270 original publications. He served as the first chair of the Steering Committee of the National Institutes of Health Pharmacogenetics Research Network, as well as one of the first co-‐chairs of the National Cancer Institute Investigational Drug Steering Committee. He currently serves as co-‐Editor of Pharmacogenetics and Genomics, and is a past Associate Editor of the Journal of Clinical Oncology. He is the recipient of multiple awards, including the Research Achievement Award in Clinical Pharmacology and Translational Research from the American Association of Pharmaceutical Scientists, the Rawls-‐Palmer Progress in Medicine Award from the American Society for Clinical Pharmacology and Therapeutics, the Translational Research Professorship from the American Society of Clinical Oncology, and a Honorary Fellowship from the American College of Clinical Pharmacology.
Amit Roy, PhD, Group Leader, Clinical Pharmacology & Pharmacometrics Bristol Myers Squibb Amit Roy is currently Group Director in the department of Clinical Pharmacology & Pharmacometrics Department at BMS, were he serves as the Head of Pharmacometrics for Oncology. Amit received his undergraduate degree in Chemical Engineering from the University of Michigan, in Ann Arbor, and his Ph.D. in Chemical & Biochemical Engineering from Rutgers University in 1997, following which he was Assistant Professor in the Department of Community Medicine at the University of Medicine and Dentistry of New Jersey. Prior to joining BMS in Sept 2004, Amit worked as a clinical pharmacologist at Vertex Pharmaceuticals, in Cambridge, MA, where he supported the development of several immunology compounds.
Alice Shaw, MD, PhD, Associate Professor, Department of Medicine, Harvard Medical School and Attending Physician, Thoracic Cancer Program, Massachusetts General Hospital Mass General Alice T. Shaw is an Associate Professor of Medicine at Harvard Medical School and an Attending Physician in the Thoracic Oncology Division at Massachusetts General Hospital. She received her A.B. in Biochemistry from Harvard and her M.D. and Ph.D. degrees from Harvard Medical School. She did her residency in Internal Medicine at Massachusetts General Hospital and completed a fellowship in Hematology/Oncology at Dana-‐Farber/Massachusetts General Hospital. She completed her postdoctoral work in the laboratory of Dr. Tyler Jacks at MIT. In addition to caring for patients with lung cancer, Dr. Shaw also performs clinical and translational research. Her clinical research focuses on a variety of different molecularly-‐defined subsets of non-‐small cell lung cancer (NSCLC). She was the lead investigator for the global registration studies of crizotinib and ceritinib, which led to regulatory approval of both novel agents in advanced ALK-‐rearranged NSCLC. She was also the lead investigator for crizotinib in ROS1-‐rearranged NSCLC. Her translational research focuses on elucidating
mechanisms of resistance to targeted therapies like crizotinib and ceritinib. Based on this research, she is currently leading the effort at both the national and international level to develop novel therapeutic strategies aimed at overcoming drug resistance. Dr. Shaw has been awarded a number of research grants, including grants from the Damon Runyon Cancer Research Foundation, the Burroughs Wellcome Fund, the V Foundation for Cancer Research, Uniting Against Lung Cancer, the National Foundation for Cancer Research, and the NIH/NCI.
Natalie Simpson, PhD, Pharmacology/Toxicology Reviewer, Division of Hematology Oncology Toxicology (DHOT), OHOP, OND, CDER, FDA Dr. Simpson is a pharmacology/toxicology reviewer in the Division of Hematology Oncology Toxicology serving the Division of Hematology Products in the Office of Hematology and Oncology Drug Products (OHOP) in the Center for Drug Evaluation and Research of the United States Food and Drug Administration (FDA). Dr. Simpson obtained her Ph.D. in Pharmacology (focus on gene regulation and cancer) from New York University. Prior to coming to OHOP, Dr. Simpson was an FDA Commissioner’s Fellow at the National Center for Toxicological Research. Dr. Simpson is involved in many working groups, compiling nonclinical information used in the evaluation of antibody-‐drug conjugates and nanoparticles, and exploring the use of secondary pharmacology in regulatory decision-‐making.
Vikram Sinha, PhD, Director, Division of Pharmacometrics (DPM), OCP, OTS, CDER, FDA Vikram Sinha, Ph.D., is the Director, Division of Pharmacometric at the USFDA. In his current role, Vikram leads the Pharmacometrics Division. The Division plays a critical role in understanding the impact of variability in response to drugs and relates it to assessing benefit and risk. He leads a multidisciplinary team of quantitative clinical pharmacologists, statisticians, engineers, and data management experts. Within CDER, pharmacometric work is conducted with the intent to aid the decision to approve and label the drug product. There is particular attention on providing a consulting function on drug dosing for patients and advice on trial design decisions by sponsors. Previously, Vikram was at Eli Lilly, where he was scientific lead for global pharmacokinetics/pharmacodynamics and pharmacometrics. At Lilly, he was accountable for developing quantitative translational strategies, clinical plans, and regulatory strategies in the area of clinical pharmacology. He has 16 years of experience in the pharmaceutical industry. He has made notable contributions to the general scientific community through teaching, publications, and engagement with industry/government consortia dedicated to advancing innovation in the area of drug discovery and development. Vikram earned a bachelor’s degree in pharmacy and a doctorate degree in pharmaceutical sciences from the University of Arizona. He completed post-‐doctoral training at the University of Nebraska Medical Center.
Rajeshwari Sridhara, PhD, Director, DBV, OB, OTS, CDER, FDA Rajeshwari Sridhara, Ph.D. is the Division Director of Division of Biometrics V, Office of Biostatistics which supports Office of Hematology Oncology Products, and Office of Drug Evaluation IV (Medical Imaging Products) at the Center for Drug Evaluation and Research (CDER). She joined the Food and Drug Administration (FDA) in 1999. Dr. Sridhara routinely presents the regulatory policies and scientific philosophy of the Office at national and international professional meetings. Dr. Sridhara has contributed in the understanding and addressing the statistical issues that are unique to the oncology disease area such as evaluation and analysis of time to disease progression. Her research interests also include evaluation of surrogate markers and design of clinical trials. She has organized, chaired and given invited presentations at several workshops. She has worked on many regulatory guidance documents across multiple disciplines. She has reviewed many high profile drug applications and has made several presentations at the oncology drug advisory committee meetings. She has extensively published in refereed journals and presented at national and international conferences. Prior to joining FDA, Dr. Sridhara was a project statistician for the AIDS vaccine evaluation group at EMMES Corporation for 2 years, and she was an assistant professor at the University of Maryland Cancer Center for 6 years. She is a member of American Statistical Association and American Society of Clinical Oncology.
James Yates, PhD, Principal Scientist, AstraZeneca James Yates studied pure mathematics at the University of Warwick, UK, graduating in 2000 with a Master of Mathematics degree. He then joined the Electrical Engineering division of the School of Engineering at the University of Warwick where he obtained his Ph.D. After a short postdoctoral project at Warwick he joined AstraZeneca for a 2 year post-‐doctoral project investigating PKPD modelling. After that he became a permanent member of staff. He is now a principal scientist in the Innovative Medicines Oncology biotech unit based in Cambridge, UK providing pre-‐clinical PKPD modelling support of drug discovery and development projects. He is an active researcher in model building methodology, study design and translational PKPD modelling for oncology and safety.
