Marijke H. Adams, PharmD, PhD
MH Adams & Associates, Inc
Dr. Adams received her PhD in Pharmacy & Pharmaceutics from the Virginia Commonwealth University, Richmond VA in 1991. The same year, she was awarded her PharmD degree. She currently holds a pharmacy practice license in both Florida and North Carolina. Dr. Adams is a member of several scientific organizations including but not limited to AAPS, ACCP and ASHP, American Society of Health System Pharmacists. In addition, she is an Adjunct Assistant Professor at Nova Southeastern University, Ft. Lauderdale, FL. She is the president and principal scientist for MH Adams and Associates Inc., Davie FL. Services include providing pharmacokinetic, drug development, medical and regulatory writing, and education/training to meet client needs. Pharmacokinetic services include study- and submission-related activities (eg, protocol design, study monitoring, data analysis, report writing). Drug development services include clinical development plans. Writing services include study protocols and Phase 1 reports, Investigators Brochures, regulatory submission documents (eg, IND, NDA), and publications. Education/training services include drug development process, Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP).
Dr. Vikram earned his Ph.D. in Pharmaceutics from the University of Florida in 2003. He has several publications in peer reviewed journals and has presented at various national and international conferences. He is a Fellow of the American College of Clinical Pharmacology (ACCP) and was recently elected to serve on the Board of Regents in ACCP. He holds an Adjunct Clinical Professor (Special Title) appointment in the Department of Pharmacy Practice at Mercer University, Atlanta, GA and Adjunct Assistant Professor appointment in the Department of Pharmaceutical Sciences at the University of Tennessee. He serves as a Section Editor in the Journal of Clinical Pharmacology (JCP), as an Editorial Board Member for JCP and International Journal of Clinical Pharmacology and Therapeutics (IJCPT), and as a peer reviewer for several other clinical pharmacology journals.
Jeffrey Barrett, PhD, FCP
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.
Robert Baughman, PharmD, PhD
Dr. Baughman is currently Vice President, Experimental Pharmacology at MannKind Corporation in Danbury, CT. He received his undergraduate degree in Biology from Loyola University, Los Angeles, and his Pharm.D. in 1978 and Ph.D. (Biopharmaceutics) in 1982 from the University of California, San Francisco. Dr. Baughman held pre-clinical and clinical research positions at Lederle Laboratories, Genentech, Penederm, Cholestech, and Emisphere Technologies prior to this tenure at MannKind. His current research interests include developing and optimizing novel dosage forms and characterizing the disposition of therapeutic peptides and proteins. He has conducted clinical studies with more that 15 macromolecular drug products, including novel, non-parenteral formulations of insulin, growth hormone, parathyroid hormone, heparin, and calcitonin. His more than 130 published works are focused on the pharmacokinetics and delivery of recombinant and synthetic drug products. He is an active member of the American Diabetes Association and the American Association of Pharmaceutical Scientists (AAPS). He was elected Chairman of the AAPS Biotechnology section and to a 3-year term as the Association’s Treasurer, as well as serving as a member of the AAPS Executive Council. He sat on the Advisory Board of the American College of Clinical Pharmacology and the Editorial Board of the International Journal of Clinical Pharmacology and Therapeutics. He has held an adjunct faculty appointment in the College of Pharmacy, University of Florida since 1988. He is lives in Ridgefield, CT, with his wife Barbara and their six children.
Robert Bell, PhD
Drug and Biotechnology Development, LLC
Drug & Biotechnology Development, LLC (D&BD) is a comprehensive consortium of experienced clinicians, pharmaceutical scientists, regulatory strategists and business development experts that provide product and business development assistance and solutions for the pharmaceutical, biotech, medical product and related industries. From project conception to product launch, D&BD provides a focused approach to the pharmaceutical and clinical development of drugs, devices and biologics for regulatory submissions. D&BD has extensive experience with all phases of product development, including pre-clinical, clinical (Phase I-IV), CMC (analysis, formulations, process, production), outsourcing, CRO oversight and regulatory interactions, document preparation, review and filings.
Veronika Butterweck, PhD
University of Basel
Dr. Veronika Butterweck is Professor at the Department of Pharmatechnology at the University of Applied Sciences in Muttenz/Basel Switzerland. She received her B.S. (1993) and PhD (1997) in Pharmacy from the University of Münster, Germany. Dr. Butterweck was a Postdoctoral Fellow at the National Institutes of Mental Health, Bethesda, Maryland, in 1999 and 2001. She received the venia legendi (Habilitation) for Pharmacology in 2003 from the University of Münster, Germany. From 2003 until 2011 she joined the the College of Pharmacy, Department of Pharmaceutics at the University of Florida as a faculty member. Dr. Butterweck is Editor of Planta Medica and was a member of the Expert Committee ‘Dietary Supplements/Botanicals” of the United States Pharmacopoeia (USP) from 2005-2010. She is also a member of the Board of Directors of the Society of Medicinal plant and Natural Products Research and Chair of the Permanent Committee for Biological and Pharmacological testing of Botanicals. Her research focuses on the development of new therapeutic concepts based on herbal medicines. In particular her laboratory has emphasized herbal medicines for the treatment of anxiety, depression and diabetes. In addition, Dr. Butterweck’s research also emphasizes the pharmacokinetics of natural products as single compounds and in comparison with herbal extract.
Philip Chaikin, PharmD, MD, FCP
Chaikin Associates, LLC
Dr. Philip Chaikin is an internationally recognized expert in global drug development and regulatory strategy. He was the 2013 recipient of the American College of Clinical Pharmacology Nathaniel Kwit Distinguished Service Award.
Dr. Chaikin spent over 25 years in Pharma R&D and was most recently Executive Vice President for Drug Development at Kyowa Pharmaceuticals and the Head of International Drug Development for Kyowa Hakko Kogyo. Previous positions include: Vice President of Oncology Research and Development at Elan Pharmaceuticals; Vice President of Worldwide Clinical Development at Rhone-Poulenc Rorer/Aventis Pharmaceuticals; Vice President of Clinical Development at Hoechst-Roussel Pharmaceuticals; Director of Clinical Pharmacology at Bristol Myers Squibb; Senior Associate Medical Director and Global Project Leader for Pfizer Pharmaceuticals; and Senior Research Scientist, Drug Metabolism and Pharmacokinetics, Ortho Pharmaceutical Corporation.
During his career in industry, Dr. Chaikin played a pivotal role in the development, registration and successful commercialization of many compounds including: Lovenox, Taxotere, Campto, Azmacort HFA, Intal HFA, Nasocort AQ, Procardia XL, Glucotrol XL, Myocet, Amaryl, Altace, Synercid and Serzone. Dr. Chaikin holds a Doctor of Pharmacy Degree from the University of Maryland School of Pharmacy and completed a Fellowship in Clinical Pharmacology at the University of Maryland Schools of Medicine/Pharmacy. He also holds a M.D. degree from New Jersey Medical School, University of Medicine and Dentistry of New Jersey. He performed his internal medicine training at Robert Wood Johnson University Hospital in New Brunswick, NJ.
Jack Cook, PhD
Jack Cook, Ph.D. is Vice President, Clinical Pharmacology Specialty Care at Pfizer, Inc., Groton, CT. Additionally, Dr. Cook is an Adjunct Professor in College of Pharmacy at the University of Michigan. He received the A.A.S degree in Industrial Chemistry Technology (1978), and B.S. degrees in Applied Mathematics (1981) and Pharmacy (1981) from Ferris State College; and the Ph.D. degree in Pharmaceutics from the University of Michigan (1987). Dr. Cook started his career with Sterling Drug Inc. in Albany, NY in 1981. In 1987 he joined Parke-Davis which later became Pfizer, Inc.
Dr. Cook’s areas of technical expertise are in biopharmaceutics, pharmacokinetics, pharmacodynamics, modeling and statistics. He is a member of the American Association of Pharmaceutical Scientists and on the Board of Directors for the Drug Delivery Foundation. His current interests include improving therapy by optimizing drug delivery and the use of modeling and simulation to make rational decisions in the development of drugs. He has published 51 original research articles and 3 book chapters.
Professor Emeritus Dr. Geoffrey A. Cordell
Professor Emeritus Geoffrey A. Cordell obtained his Ph.D. in synthetic natural product chemistry at the University of Manchester in 1970. After two years as a NATO postdoctoral fellow at the Department of Chemistry, M.I.T. he joined the College of Pharmacy, University of Illinois at Chicago (UIC). A Professor since 1980, he served as a Department Head for 12 years and as Interim Dean of the College of Pharmacy for almost three years. From 1984-5 he was an Associate Dean in the Graduate College and in 1986 became Assistant Vice Chancellor for Research responsible campus-wide for human and animal subject research, faculty seed grant funds, research policies, and reviewing promotion recommendations. From 1984-1988 he served as Chairman of the campus Animal Care Committee. He was the Co-founder of the US – Thai Consortium for Pharmacy Education, which developed and trained faculty for six new schools of pharmacy in Thailand. He retired from the University of Illinois in 2007. Since 1983 he has served as President of Natural Products Inc., a consulting company
He is the author of about 600 research publications, book chapters, comprehensive reviews, and professional publications. He is also the author of three books, with two more in progress, the editor of 37 books, including 29 volumes in the series “The Alkaloids: Chemistry and Biology”, and is a member of the Editorial Advisory Board of twenty-seven international scientific journals. He has traveled very widely, particularly in Asia, and has been an invited plenary symposium speaker at over 160 major international meetings in the United States, Morocco, England, France, Germany, Poland, Austria, Hungary, Italy, Turkey, Jordan, Iran, Pakistan, India, Bangladesh, Malaysia, Myanmar, Thailand, Vietnam, Indonesia, Hong Kong, the Philippines, the Republic of China, the Republic of Korea, the People’s Republic of China, Japan, Fiji, Ecuador, Brazil, Peru, Chile, Trinidad and Tobago, Jamaica, and Mexico. He is a former President of the American Society of Pharmacognosy, and is also an Honorary Member. He was recently named as the Outstanding International Ethnopharmacologist for 2015 by the Society for Ethno pharmacology
In 1981, he was an Alexander von Humboldt Fellow at the University of Munich with Prof. Hildebert Wagner and Prof. Meinhart Zenk. He is an elected Fellow of the Royal Chemical Society, the Linnean Society of London, the American Society of Pharmacognosy, and the American Association of Pharmaceutical Scientists. In addition to assisting international organizations, corporations, and academic organizations in several countries around the world develop their research and academic programs, he is an Honorary Professor at Sichuan University, Chengdu, China, and at Amity University, Noida, India. He is also a Visiting Professor at universities in Japan, Malaysia, Colombia, Peru, and Brasil, and an International Collaborative Partner of the UTAR Global Research Network in Malaysia in the areas of biodiversity and cancer. In addition, he is a member of the International Advisory Board of several natural product research institutes. His research interests include the chemistry and biosynthesis of alkaloids, the sustainability and quality control of medicinal agents, the remote detection of biologically active natural products, and the use of vegetables as chemical reagents. His recently published book is called “Alkaloids: a Treasury of Poisons and Medicines”, and a comprehensive treatise on the “Biosynthesis of Alkaloids” and a volume on “Sustainable Medicines” are in progress.
Barry Dvorchick, PhD
Barry Dvorchik, PhD, is currently President and Managing Partner of Barry Dvorchik & Associates , Inc. This company, which he founded in 1999, is an independent consulting firm with core competencies in multiple disciplines across the spectrum of pharmaceutical development with emphasis on early development (nonclinical through Phase 1) and supporting Phase 2/3 and regulatory documentation. Dr. Dvorchik has over 30 years of progressive experience in early drug development with both large and small pharmaceutical companies and a clinical pharmacology CRO, covering both nonclinical and clinical aspects of drug development. As a consultant he has developed and directed clinical pharmacology departments in small/young pharmaceutical companies supporting the successful approval of 2 NDA’s. In addition he has prepared and reviewed regulatory submissions including INDs and NDAs as well as draft labels and investigator drug brochures. He has presented before the FDA, EMA and PDMA as well as participated in FDA Advisory Committee meetings. Additionally, he has 11 years of academic experience as a funded R01 NIH grantee and as a consultant to the Commonwealth of Pennsylvania Department of Health and The FDA, Division of Biopharmaceutics. He is a fellow and past president of the American College of Clinical Pharmacology. Dr. Dvorchik holds a BS in Pharmacy from the University of Connecticut and a PhD in Pharmacology from the University of Florida.
Staffan Edsbäcker, PhD
Married, 2 children; Chemical engineer, M.Sci 1979; Joined Astra 1980 (Dept of Metabolism and Pharmacokinetics); Ph D 1986 (”Studies on the metabolic fate and pharmacokinetics of budesonide”); Assoc Prof., Experimental Clinical Pharmacology, Faculty of Medicine, Univ of Lund 1997-current; Section Head from 1990 – March 1999; Scientific Adviser at Experimental Medicine, AstraZeneca R&D Lund for 6 global AstraZeneca projects March 1999-June 2001; Secondment as Sr Director, Experimental Medicine, AstraZeneca Pharmaceuticals LP, Wilmington USA 2001-2003; Currently Senior Scientific Director for respiratory projects at AstraZeneca Respiratory & Inflammation Innovative Medicines Unit in MoIndal, Sweden. Preclinical experience in metabolism (tissue homogenates, isolated perfused tissues); Human pharmacology experience in traditional pharmacokinetics (exploratory and documentative); Lung, nasal and gut deposition studies using various techniques (modelling, scintigraphy, charcoal block etc); Interaction and tolerability studies; Scientific marketing activites; Regulatory issues (Experimental Medicine responsibility for 6 NDAs). Staffan has published about 40 full length original papers, 12 book chapters and reviews, and about 50 abstracts dealing with the deposition, pharmacokinetics and systemic pharmacodynamics of topical corticosteroids in healthy subjects and patients with asthma, rhinitis and inflammatory bowel diseases. Invited lecturer at several conferences. Tutor for 2 PhD students, one of whom defended his thesis in October 1998.
Thomas Eissing, Ph.D.
Thomas Eissing is heading the Systems Pharmacology CV group at Bayer since 2014. He joined Bayer Technology Services in 2007 as a Scientist Systems Biology and became Group Head Systems Biology in 2012. During his time at Bayer, he was and is primarily engaged in pharmacokinetic, pharmacodynamics, systems biology and pharmacology modeling and simulation for various indications with an increasing share of pharmacometrics project conception and coordination on the portfolio level as well as strategically developing the scientific and computational platform basis. Thomas studied life sciences and biotechnology at the University of Stuttgart, Germany, and the University of New South Wales, Australia. He received his Ph.D. from the Institute of Systems Theory and Automatic Control at the University of Stuttgart analyzing life and death decisions during apoptosis signal transduction. During his studies, he held interim visiting positions at the Hamilton Institute, Ireland, and Millennium Pharmaceuticals, USA. His master (diploma) thesis received an award as best technical biology thesis of the year, and his Ph.D. thesis was awarded the MTZ award for medical systems biology. Thomas has co-authored more than 20 manuscripts and dozens of abstracts and posters. He serves as a reviewer for diverse journals and has given dozens of invited lectures and trainings on physiologically-based pharmacokinetics and pharmacodynamics.
Ronald Evens, PharmD
MAPS 4 Biotec Inc.
Ronald Evens is President of MAPS 4 Biotec, Inc, consulting to the biotechnology segment of the pharmaceutical industry concerning medical affairs roles of medical communications and education, product information, and clinical trials (peri-approval and post launch). Dr. Evens is clinical professor at University of Florida, College of Pharmacy, specializing in the science and business of product development in the biopharma industry. Ron serves on the Company Review Committee for the University of Florida Sid Martin Biotechnology Incubator; and the Frontiers Committee of the American College of Clinical Pharmacy Research Institute. Invited presentations exceed 150 at national and state associations or universities. Publications are over 100, including editor of 2 books, 15 book chapters, and over 40 refereed journal articles. Previously (13 years, 1989-2002) at Amgen, he created and was Senior Director and Head of Professional Services Department with a professional staff of 145. Professional Services was responsible for medical communications/education, marketing support & oversight, phase 2 & 4 studies, field based clinical liaisons, medical science liaisons, and product information for marketed and pipeline products. Also, he created and was Senior Director and Head of PeriApproval Research at Amgen. Prior to Amgen, Dr. Evens was Associate Director, Clinical Research and Medical Services at Bristol-Myers Co. (1984-89); Associate Professor and Acting Chairman of Department of Pharmacy Practice at University of Tennessee Health Sciences Center, Memphis, TN (1981-84); Associate Professor & Director of Drug Information Center at University of Texas at Austin, College of Pharmacy, and University of Texas Center for Health Sciences, College of Medicine, San Antonio (1974-81).; staff pharmacist at E.J. Meyer Memorial Hospital associated with University of Buffalo. Dr. Evens received his B.S in Pharmacy from the University of Buffalo, and post-baccalaureate Pharm.D. and clinical residency (3 years) at University of Kentucky.
Eli Lilly and Company
Parag Garhyan received his bachelor’s degree in chemical engineering from Panjab University, India and doctorate in chemical engineering from Auburn University in 2004. He worked in Pfizer Global R&D at Kalamazoo, Mich. before joining the Global PK/PD/Pharmacometrics department at Eli Lilly and Company in Indianapolis in 2006. Over the years, Dr. Garhyan has worked on cross-functional teams and provided PK/PD and pharmacometrics expertise to quantitatively understand the drug behavior at various stages of development. He has contributed towards various candidate selections and subsequent clinical development of small and large molecules in diabetes, metabolic syndrome, anti-psychotic and oncology therapeutic areas. Dr. Garhyan has authored several conference abstracts and peer-reviewed journal articles, two book chapters and a chemical engineering textbook.
Joga Gobburu, PhD
University of Maryland
Dr. Gobburu is Professor with School of Pharmacy and School of Medicine, University of Maryland, Baltimore, MD, USA. He held various positions at US FDA between 1999 and 2011. Under his leadership, a Division of Pharmacometrics (DPM) was formed at the FDA and several policies were established. He is a world-recognized scientific leader in the area of quantitative disease models and their application to decisions. Dr. Gobburu is best known for transforming the field of Pharmacometrics across the world into a decision-supporting science. He also established a Pharmacometrics Fellowship program at the FDA. He received numerous FDA awards such as Outstanding Achievement Award. He also received Outstanding Leadership Award from the American Conference on Pharmacometrics (2008), Tanabe’s Young Investigator Award from American College of Clinical Pharmacology (2008). Dr. Gobburu is on the Editorial Boards of several journals. He published over 60 papers and book chapters.
Dr Navin Goyal is a Manager in the Clinical Pharmacology, Modeling and Simulation department at GlaxoSmithKline since 2009. He supports various clinical drug development projects in respiratory and cardiovascular therapy areas. His work includes population pharmacokinetic and pharmacodynamic modeling from First Time in Human to Phase III studies. Apart from clinical project work, Dr Goyal has published his research about problems with missing data, clinical utility index and placebo response in clinical trials for drug treatments for disorders such as depression and schizophrenia. His publications also discuss the impact of these issues on study outcomes and appropriate analyses warranted in such situations. He has mentored summer interns in his current position at GlaxoSmithKline. Dr Goyal is also an instructor for internal and external Pharmacometrics Workshops that promote model based drug development.
Dr Goyal received his PhD in Pharmaceutics from University of Florida in 2009. His PhD research focused on demonstrating bioequivalence of inhaled corticosteroids with pharmacokinetic data using model based approaches. During his graduate studies, he interned in industry and at the US FDA. Dr Goyal has published in several peer-reviewed journals. He is a reviewer for various clinical pharmacology and pharmacometric journals and a member of ACCP, ASCPT and ISoP.
Mario Gonzalez, PhD
Dr. González is President of P’Kinetics International, Inc. specializing in biopharmaceutics and pharmacokinetics research. Dr. González was previously President of GloboMax Américas and prior to that was Director of Biopharmaceutics and Pharmacokinetics at Schering Research, Miami (formerly Key Pharmaceuticals, Inc). His research has concentrated on the pharmacokinetic and pharmacodynamic evaluation of extended-release oral and transdermal drug delivery systems as well as in vitro/in vivo correlations. Prior to joining the pharmaceutical industry, Dr. González was on the Pharmacy faculty at Purdue University with teaching and graduate research responsibilities in clinical pharmacokinetics. Currently he is an adjunct Professor in the University of Florida College of Pharmacy. Dr. González has been active in AAPS since its inception and was Chair of the Pharmacokinetics Section in 1995. He also served on the organizing committees of the first four AAPS/FDA SUPAC Workshops and was Co-Chair of the Organizing Committee for the first Pharmaceutical Congress of the Americas held in March, 2001. Dr. Gonzalez is also a member of the Controlled-Release Society, the American College of Clinical Pharmacology, and the American Society of Health-System Pharmacists. He serves on the editorial advisory boards of the European Journal of Pharmaceutics and Biopharmaceutics and the International Journal of Clinical Pharmacology and Therapeutics. Dr. Gonzalez was appointed to the USP Biopharmaceutics Expert Committee for 2005-2010, the Dosage Forms Expert Committee for 2010-2015, and was elected as a Fellow in Clinical Pharmacology by the American College of Clinical Pharmacology.
Ulrike Graefe-Mody, PhD
Boehringer Ingelheim Pharma GmbH & Co
Dr. Graefe-Mody is working in Clinical Development/Medical Affairs as Deputy Therapeutic Area Head Metabolic Diseases at Boehringer Ingelheim’s headquarters in Germany. She is heading the Early Clinical Development Team which is responsible for the global clinical development of internal projects and clinical due diligence activities for licensing opportunities. Prior to her current role, she was part of the clinical pharmacokinetics/pharmacodynamics group led by Hans Guenter Schaefer. Before joining Boehringer Ingelheim, Dr. Graefe received her Diploma in Biology in 1997 and PhD degree in Pharmaceutical Biology in 2001 from the University of Wuerzburg, Germany. Her thesis focused on the clinical pharmacokinetics and bioavailability of phenolic compounds in phytomedicines, which was carried out in cooperation with Prof. Hartmut Derendorf at the University of Florida, Gainesville, FL. In 2001, Dr. Graefe-Mody received the Carl-Wilhelm-Scheele Award of the German Pharmaceutical Society for outstanding dissertations in Pharmaceutical Sciences. Dr. Graefe-Mody has published over 30 articles, abstracts, a book chapter and presentations with focus on clinical pharmacology of cardiometabolic drugs.
Serge Guzy, PhD
Serge Guzy is currently Affiliate Professor at the University of Maryland, adjunct Professor at the University of Minnesota, visiting Professor at the Medical School of Jerusalem, adjunct associate Professor at Sunny buffalo and courtesy Professor at the college of Pharmacy, Florida. 12 years ago, Serge Guzy founded POP_PHARM an American corporation dedicated in providing consulting in the field of Pharmacometrics. In 2011, Pop_Pharm signed a strategic alliance with Certara with main goal pursuing the development of the Phoenix NLME program and providing first class training across the globe.
Serge Guzy started his academic journey with Chemical Engineering degree from the University of Brussels, followed by a master degree at the Weizmann Institute in biomathematics and Chemistry and a Ph.D. at the Technion in Biomedical Engineering (Haifa, Israel). He then got a fellowship that enabled him to pursue his academic research at UC Berkeley and then at the school of Pharmacy in San Francisco where he started to be exposed to the field of Pharmacometrics. In 2001, he started the development of the MC-PEM algorithm for Mixed Effect Modeling which utilizes the expectation maximization algorithm combined with importance sampling and Maximum a posteriori estimation. MC-PEM became recognized a few years later as a robust and unbiased algorithm and is implemented today in most of the recognized Pharmacometrics software.
Stephen Horhota, PhD
Boehringer Ingelheim Pharmaceuticals Inc.
Dr. Horhota is a Research Fellow at Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut. He received his Bachelor of Science in Chemistry from Clarkson University, Potsdam, NY in 1972 and Doctorate in Pharmaceutics from the State University of New York at Buffalo in 1978. From 1972-1974 and 1978-1980 he was employed by Ayerst Laboratories, Rouses Point, New York in Pharmacy R&D. He joined Boehringer Ingelheim in 1980 working variously in the areas of oral, liquid and inhalation dosage formulation development with particular focus beginning in 1991 on process development and scale-up of pulmonary and nasal products. This activity has spawned a heavy involvement in both the scientific and regulatory aspects of this class of products with wide exposure to US and international approval processes. He is a named inventor on several patents involving pharmaceutical delivery systems and processing methods. His publication record includes co-authorship of chapters “Pulmonary Drug Delivery – Basics, Applications and Opportunities for Small Molecules and BioPharmaceuticals” in “Pulmonary Drug Delivery” and “Developing Performance Specifications for Pulmonary Products” in “Controlled Pulmonary Drug Delivery”. He has been a member of the USP Expert Committee on Pharmaceutical Dosage Forms and chair of the Risk Management Working Group of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS). He serves as a peer reviewer for International Journal of Pharmaceutics, AAPS Journal, and AAPS PharmSciTech.
Kazuro Ikawa, Ph.D., FCP
Kazuro Ikawa is an associate professor in the department of clinical pharmacotherapy at Hiroshima University in Japan. Starting his first career as a clinical pharmacist at Oita Medical University Hospital, he worked as a reviewer for drug approval at Ministry of Health, Labor and Welfare, and Pharmaceuticals and Medical Devices Agency (Japanese FDA), and then transferred to Hiroshima University. His research focuses on clinical pharmacokinetics and pharmacodynamics at target sites, especially for antimicrobial agents, with modeling and simulation techniques. He studied at Dr. Derendorf’s laboratory (Jul-Sep 2010) more about site-specific PK-PD and their pharmacometric application. He is a Fellow of American College of Clinical Pharmacology with more than 100 articles, and his work is awarded by several societies including International Pharmaceutical Federation.
Pravin R. Jadhav, PhD
Pravin R Jadhav is Director of Modeling and Simulation at Merck Sharp and Dohme. He is responsible for planning and executing advance research to lead high quality and cost effective drug development programs from discovery through commercialization. Before joining Merck and Co., he was Team Leader and Expert Regulatory Scientist in the Division of Pharmacometrics of the Office of Clinical Pharmacology (OCP) at the US food and Drug Administration (FDA). He has worked on more than 100 New Drug Applications and 150 Investigational New Drug applications covering aspects of exposure–response to aid in important regulatory decisions such as drug–drug interactions, dose adjustment in special populations, evidence of effectiveness, benefit/risk and labeling issues. He covered various therapeutic areas such as anti-viral, anti-infective, transplant, reproductive and urology, cardiovascular and renal, dermatology, and medical counter measures (MCM) products in 9 years at FDA. Pravin represented OCP as an internal expert on clinical pharmacology issues in pediatric drug development advising all the Office of New Drugs (OND) divisions as an appointed member of the Pediatric Review Committee (PeRC), a committee mandated by the congress. He was also a member of the IRT-QT team as a reviewer, and TQT guidance and BP risk guidance working groups. He has more than 25 publications in peer reviewed journals and 40 oral presentations at international conferences. He has received several awards and honors at the FDA, including outstanding service award in 2008 and special citation for innovative analysis on telaprevir and boceprevir new drug applications in 2011.
Pravin received his BPharm and MPharm from India, and a PhD in Pharmaceutical Sciences from the Medical College of Virginia Commonwealth University in May 2006. He is a Fellow of the American College of Clinical Pharmacology and holds an adjunct faculty appointment in the College of Pharmacy at University of Florida.
Ray Jurgens, PhD
“Ray is a Director in Pfizer’s Regional Medical & Research Specialist group in Oncology. His expertise is product development, project management, development and management of clinical trials, and formulation of drug development strategies with key opinion leaders. Located in his regional office in Florida, he works with large academic cancer centers and institutes in the Southeastern US. His current focus is in the area of solid tumors. Prior to joining Pfizer, he had similar positions at Ligand Bio Pharmaceuticals in LaJolla, California, and Berlex Laboratories in their Oncology divisions. Earlier in his career, he worked in oncology developing a novel multi drug resistance (MDR) compound at CytRx, a small biotech company in Atlanta. His industry experience also includes various clinical and project management positions at Solvay Pharmaceuticals and Mallinckrodt Medical. Ray lives near Clearwater, Florida. He received his Bachelor of Science degree in Pharmacy from Drake University and his PhD in Pharmaceutical Sciences/Drug Development from the University of Florida. He has over 40 publications and 3 patents.”
Andreas Kovar, Ph.D.
Andreas Kovar, Ph.D., F.C.P., studied Pharmacy at the University of Tübingen, Germany. After receiving his Ph.D., he held there a teaching position in Medicinal Chemistry. Subsequently, he did preclinical and clinical research on PK/PD correlations with a two-year scholarship of the DFG (German Research Foundation) at the University of Florida in Gainesville. In 1997 he joined Merck KGaA where he held various positions in research and clinical drug development such as Global Head Clinical Pharmacokinetics at Merck KGaA, Darmstadt, and Global Head Clinical Pharmacology and Pharmacokinetics for Merck Serono, Geneva; in 2008 he became Vice President, Global Head of Exploratory Medicine, with leadership for Clinical Pharmacology, Pharmacokinetics, Biomarker Strategy and Implementation as well as Modeling and Simulation activities. Since October 2014 he is Assoc. Vice President in the area of Drug Disposition, Safety & Animal Research at Sanofi Aventis. Andreas is an elected member of AGAH’s Board of Regents since 2001 and a co-organizer of the annual PK/PD-Expert Meeting in Germany. In 2007 he became a Fellow of Clinical Pharmacology of the American College of Clinical Pharmacology and serves since 2011 as a member of the Lake Nona Leadership Council of the University of Florida Center for Pharmacometrics and Systems Pharmacology (Director Prof. L. Lesko) in Orlando.
Sriram Krishnaswami, PhD
Dr. Sriram Krishnaswami is an Associate Director in Clinical Pharmacology at Pfizer Global R&D based in Ann Arbor, MI. He received his B.S. in Pharmacy in 1996 from the Birla Institute of Technology and Science, Pilani, India and Ph.D. in Pharmacokinetics/Pharmacodynamics in 2000 from the University of Florida, Gainesville. Dr. Krishnaswami is responsible for representing the clinical pharmacology function in development teams and during interactions with regulatory authorities. His current research activities include designing dose-finding strategies using modeling and simulation for new chemical entities in the inflammation/dermatology therapeutic area where treatments for diseases such as rheumatoid arthritis, psoriasis and osteoarthritis and prevention of allograft rejection are pursued. Dr. Krishnaswami has published over 30 articles, abstracts, a book chapter and presentations with focus on PK/PD modeling and pediatric pharmacology. He is chair-elect of the AAPS modeling and simulation focus group and peer reviews manuscripts for the Journal of Clinical Pharmacology.
Michael Kurowski, PhD, MD
Dr. Michael Kurowski, became a Licensed Pharmacist in 1977 and then went on to study Pharmaceutical Chemistry and received his PhD from the Freie Universität Berlin in 1980. He continued his education, receiving his MD from Friedrich Alexander Universität, Erlangen-Nuremberg, Germany in 1986. In 1989 he was Privatdozent, Senior Lecturer for Pharmacology and Toxicology at the Friedrich Alexander Universität, Erlangen-Nuremberg, and then in 1992 became a Specialist for Clinical Pharmacology, Charite, Humboldt Universität, Berlin. In addition to being Co-editor of the Journal Pharmacotherapy, Dr. Kurowski has been a consultant to the community of practicing physicians and Ciba-Geigy, a member of the “Drugs Commission”, Chair, University Hospital, and is an Associate Professor of Pharmacology and Toxicology, Martin Luther Universität Halle Wittenberg. Dr. Kurowski has received numerous awards and fellowships for his work. Dr. Kurowksi has been involved in clinical studies and analytics of analgesic and novel antiretrovial compounds since 1997 at the Private Practise Laboratory Medicine and was a Founder Therapia GmbH. He supervises not only PhD candidates but also medical students who are required to write a thesis in Germany. In addition to more than 50 publications in prestigious scientific journals he published 3 books.
Gezim Lahu, Phd
Gezim is currently heading the Global Pharmacometrics unit at Takeda Pharmaceuticals. Gezim is responsible for identifying, developing and utilizing different analytical/Modelling, Systems Pharmacology technologies and personalized medicine approaches that allow assessment of Disease, drug-exposure and biomarker response relationship in different therapeutic areas within the early and late clinical development. Before joining Takeda Pharmaceuticals Gezim headed the division of PKPD and Biomarker Sciences at Nycomed and was responsible for defining the PKPD and Biomarker strategies and development plans including the definition of the fit for purpose tailored Biomarker development, Clinical Pharmacokinetics and Modelling and simulation strategies in the translational space and for proof of concepts studies. Gezim has also headed the department of Clinical Pharmacokinetics and Pharmacometrics at Altana Pharma AG and continued to do the same at Nycomed GmbH before he took additional responsibilities in incorporating the biomarker research into the Translational Development. Previously he lead a team within DMPK at Altana Pharma AG. Gezim was also responsible for setting a PKPD and Pharmacology lab at NAD AG where he was engaged in CNS research. His expertise stretches through different therapeutic areas such as CNS, Inflammation, respiratory, metabolic diseases, oncology, GI, pain etc. Gezim studied Pharmacy at University of Sarajevo, Pharmaceutical Sciences at University of Greenwich, Toxicology at University of Surrey and completed his doctoral work at University of Tubingen. Gezim has authored book chapters and several publications in peer review journals, his topic of interest are Pharmacometrics, Systems Pharmacology, Experimental Medicine and Translational Research. Gezim is a member of CPSP Lake Nona leadership Council.
Prior to joining Pfizer via the legacy Warner Lambert organization in 1998, Dr. Lalonde was Scientific Director and Head of Clinical Pharmacology and Pharmacokinetics at Phoenix International (now MDS) in Montreal from 1991 to 1998. From 1984 to 1991 he was Assistant Professor and then a tenured Associate Professor and Vice Chair for Research in the Department of Clinical Pharmacy, College of Pharmacy, University of Tennessee, Memphis. He also worked from 1980 to 1984 at the University of Ottawa Health Sciences Centre. Richard is a Fellow of the American College of Clinical Pharmacology, the American Association of Pharmaceutical Scientists and the American College of Clinical Pharmacy. He was President of the American Society for Clinical Pharmacology and Therapeutics (2011 – 2012) and a member of its Board of Directors (2010-2013). He also served from 2004 – 2009 on the Board of Regents of the American College of Clinical Pharmacology. He has been a member of the editorial board of Clinical Pharmacology and Therapeutics since 2005 (Associate Editor 2007-2010) and was a member of the editorial board of Pharmaceutical Research from 1998 – 2001. He currently is member of the National Advisory General Medical Sciences Council at the National Institutes of Health.
Over the past 33 years, Dr. Lalonde has been an invited speaker at various national and international meetings of professional societies, universities, FDA and served on advisory committees at FDA and NIH. His work has been focused on the quantitative application of pharmacokinetic and pharmacodynamic principles to the optimal development and utilization of new drugs in patients. Dr. Lalonde has authored over 130 manuscripts, abstracts and book chapters in this discipline. He is a graduate of the University of Minnesota (Pharm.D.) and the University of Toronto (B.Sc. Pharmacy).
Marc Lavielle is a statistician specialized in computational statistics and healthcare applications. He created and directed the Monolix team at Inria. He has worked on the development of new statistical methods, applied to a broad area of applications (geophysics, signal processing, neuro-imaging, agronomy, genetics, PKPD…). Marc Lavielle is the author of the book Mixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools(Chapman & Hall/CRC Biostatistics Series, 2014). He has also co-authored several papers on various aspects of statistical estimation and on SAEM algorithm. Several of the methods that he developed are implemented in the Monolix software. He recently developed Simulx and the mlxR package for clinical trial simulations.
Marc Lavielle holds a Ph.D. in applied mathematics from Université Paris-XI, Orsay, France (1991). He was named Assistant Professor in 1991 and Professor in 1998 at Paris Descartes University, and joined Inria in 2007 as Research Director. Marc Lavielle is also a member of the French High Council of Biotechnologies, where he is promoting and studying the application of sound statistical methods to evaluate health and environmental risks related to Genetically Modified Organisms.
Nicola Luciani, BS|
Ontario College of Pharmacy
Mr. Nicola Luciani is a Registered Pharmacist with the Ontario College of Pharmacy, having received his Bachelor of Science Degree in Pharmacy from the University of Toronto in June 1994. He currently holds the position of Pharmacy Manager with Dell Pharmacy in Hamilton, Ontario, Canada and has been working for Dell since September 1994. Mr. Luciani is an accomplished Compounding Pharmacist specializing in Veterinary Medicine and Advanced Sports Medicine. Mr. Luciani also holds a Doctorate of Acupuncture from Medicina Alternativa, received in April 2000. He has additional special interests in Nutrition, Anti-Aging and Botanical Medicine. He is currently a Board Member of SportPharm Pharmaceuticals, California, USA. Mr. Luciani is a Consultant and Lead Facilitator for Medisca Network Inc. for Certificate Programs in Pharmacy specific to Pharmaceutical Compounding; accredited by and offered at the University of Florida College of Pharmacy.
Maureen A. McKenzie, PhD
DENALI BioTechnologies, Inc.
Maureen A. McKenzie, Ph.D. is the Chief Executive Officer of DENALI BioTechnologies, Inc. Dr. McKenzie has almost 20 years of experience in biotechnology as an entrepreneur, researcher and executive, and founded the first and only company in Alaska dedicated to pharmaceutical and nutraceutical discovery and development from boreal territories. DENALI BioTechnologies focuses on plants, microbes, and marine organisms that thrive in harsh habitats, with special emphasis on novel molecules from psychrophiles (“cold-lovers”). Dr. McKenzie was Affiliate Assistant Professor in the Department of Physiology and Pharmacology at the College of Veterinary Medicine of Iowa State University, Ames, in 1994, and was an Assistant Professor of Chemical Biology and Pharmacognosy and member of the Laboratory for Cancer Research in the College of Pharmacy at Rutgers, The State University of New Jersey, New Brunswick, from 1990-1993. From 1989-1990, she was a Research/Teaching Specialist in the Departments of Biochemistry and Environmental and Community Medicine of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, Piscataway, New Jersey. Dr. McKenzie was a Staff Fellow Scientist in the Diabetes Branch of the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, from 1987-1989. Prior to graduate school, she was a Microbiologist for the Mobil Oil Corporation, Princeton, New Jersey, from 1979-1981. Dr. McKenzie received a Diabetes Research and Education Foundation Fellowship in basic research from the Hoechst-Roussel Corporation (1990-1992), The New Jersey State Commission for Cancer Research -Ciba Geigy Corporation Award for Scientific Excellence in Cancer Research (1992), and the Epsilon Award for Teacher of the Year in the College of Pharmacy at Rutgers University (1993). She was selected by the American Chemical Society in 1993 as a Preceptor for Science Experience for the Economically Disadvantaged. In 1994, she was chosen by the Des Moines Register as an Iowa “Up and Comer” for extraordinary leadership in business. In 1995, she received the Linda K. Neuman Award for the Professions by the Quad-Cities Women’s Encouragement Board, and was honored as a “Woman of Spirit and Note” in the community. She served on the Board of Directors of the Quad-Cities Chapter of the American Red Cross in 1995. She has authored or co-authored numerous peer-reviewed articles, patents and is the editor-in-chief of the Encyclopedia of Medicinal Plants scheduled for publication in 2006. Dr. McKenzie holds a Ph.D. in Biochemistry from a joint program of Rutgers, the University of Medicine and Dentistry of New Jersey and Princeton University (1987), a M.S. in Food Science from Rutgers (1982) and a B.S. in Nutrition/Food Technology from Iowa State University (1978).
Raymond Miller, D.Sc.
Adjunct Clinical Professor, Center for Pharmacometrics and Systems Pharmacology, UF College of Pharmacy, Lake Nona (Orlando)
Raymond Miller, D.Sc, is an adjunct clinical professor in the Center for Pharmacometrics and Systems Pharmacology at the University of Florida in Lake Nona (Orlando). Prior to joining UF, he was global head of modeling and simulation at Daiichi Sankyo Pharma Development from March 2010 to August 2016. He has been instrumental in developing pharmacometric initiatives at a number of institutions such as Pfizer, the Food and Drug Administration as part of the formative pharmacometric group and in academia at the University of Durban-Westville, South Africa. His primary research focus is on modeling and simulation through the drug development process with greater emphasis on clinical development. He has published numerous peer-reviewed manuscripts and is considered a thought-leader in pharmacometics.
Miller is the recipient of the 2008 AAPS Outstanding Manuscript in Modeling and Simulation Award for the paper describing a longitudinal exposure-adverse event relationship. He has served on the organizing committee for the 2009 DIA/FDA/PhRMA conference on modeling and simulation and on the organizing committee for the 2008 and 2009 American Conference on Pharmacometrics. A founding member of the International Society of Pharmacometrics, Miller currently serves on the faculty of the NIH department of clinical pharmacology. He earned three degrees (B.Sc. in pharmacy, M.Sc. in pharmacology, and D.Sc.in pharmacology from the University of Potchefstroom, South Africa. In addition, he received his diploma in clinical pharmacology from the University of California, San Francisco after a two-year post-doctoral fellowship.
Diane Mould, PhD
Projections Research Inc.
Dr Mould obtained her bachelors degree at Stevens Institute of Technology in 1984 in Chemistry and Chemical Biology. She received her PhD in Pharmaceutics and Pharmaceutical Chemistry at The Ohio State University (OSU) in 1989. She spent 25 years as a pharmacokineticist in industry where she specialized in population pharmacokinetic / pharmacodynamic modeling and was an associate Research Professor at Georgetown University. She has conducted population PK/PD analyses of hematopoietic agents, monoclonal antibodies, anti-cancer and anti-viral agents, antipsychotic, cardiovascular, and sedative/hypnotic agents. Dr Mould is 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 development of clinical trial simulation software.
Currently, Dr Mould is president of Projections Research Inc., a consulting company offering pharmacokinetic and pharmacometric services. She published 54 peer-reviewed articles, 15 chapters, made 92 national and international presentations and presented 6 podium sessions on advanced modeling and simulation approaches. Dr Mould has authored 74 posters at both national and international meetings. She is an adjunct professor at the University of Rhode Island (URI), OSU, and the University of Florida, and teaches an annual class on disease progression modeling at the National Institutes of Health. Dr Mould taught 9 courses (OSU, URI and SUNY Buffalo) on specialized aspects of population pharmacokinetic and dynamic modeling. She is a member of the editorial board for Journal of Pharmacokinetics and Pharmacodynamics, Clinical Pharmacology and Therapeutics, and Clinical Pharmacology and Therapeutics Pharmacometrics and Systems Pharmacology.
Melanie Pecins-Thompson, PhD
Dr. Thompson received her B.S. from University of Florida in 1989, and her Ph.D. in Pharmaceutical Science from the University of Florida in 1993. She held a research position at the Oregon National Primate Research Center. While at the Oregon National Primate Research Center, Dr. Thompson received a National Research Service Award which funded her postdoctoral studies. She was also a recipient of A Women in Endocrinology travel award. Her primary research interests are the effects of steroid hormones on serotonin neural function. She has also taught Endocrinology at Portland State University. Dr. Thompson is married with three children ages 3, 5 and 10.
Marcus Mueller, MD
Medical University Vienna
Markus Müller, M.D. is Professor and Head of the Department of Clinical Pharmacology of the Medical University of Vienna / Vienna General Hospital (AKH) in Austria. He received his M.D. from the University of Vienna and was trained in Emergency Medicine, Oncology, Endocrinology, Infectious Diseases, Chemotherapy and Angiology and is board certified for Internal Medicine, Clincal Pharmacology and Emergency Medicine. He holds the position of a Professor for Internal Medicine and Clinical Pharmacology. Dr. Müller currently serves as Vice-Rector at the Medical University of Vienna / Vienna General Hospital (AKH). He is internationally renowned for the development of clinical microdialysis in drug development and his expertise in clinical vaccine development. He has published over 200 original articles in the field of clinical pharmacology and has received several awards including Tanabe Award of the American College of Clinial Pharmacology (ACCP) in acknowledgement of innovations in clinical pharmacology trials and the Billroth Award of the Austrian Board of Physicians. His current research interests comprise the development of PET tracers for drug distribution studies, pharmacogenetics and vaccine development.
Adolf Nahrstedt, PhD
Westfälische Wilhelms Universität
Education in Pharmacy (1962 – 1966) and Food Chemistry (1966-1968) at the University of Freiburg/Germany. PhD (Pharmacognosy) Freiburg, 1971; habilitation (Pharmaceutical Biology) Freiburg,1976; assoc. Professor of Pharmaceutical Biology, Techn. Univ. of Braunschweig/Germany 1977-1986; full Professor and chair of Pharm. Biology and Phytochemistry, Univ. of Münster/Germany, 1986-2004. Since Oct 2004 Prof. emeritus.; Dr.h.c. of the Ovidius University, Constanta, Romania (2004). Honorary member of the Society of Medicinal Plant and Natural Product Research (GA; 2005). V.E.Tyler Award of the American Society of Pharmacognosy (ASP; 2009); Dr.h.c. of the Maha Sarakham University in Thailand (2010). Scientific areas: Phytochemistry, physiological activity and biopharmaceutical aspects of traditionally used medicinal plants and their constituents. Biochemistry and physiology of secondary constituents of plants and insects, in particular the cyanogenic compounds; >210 papers in these fields; >180 lectures; >140 posters together with coworkers and students. Teaching experiences: Analytics of natural products and plant secondary constituents; Phytochemistry and biochemistry of nature-derived drugs; Pharmacology of crude drugs and plant derived compounds; Pharmacognosy (microscopy) of crude drug material; Morphology and anatomy of plants. Member of the Committee of Experts “Pharmaceutical Biology (Pharmacognosy)” of the German Pharmacopoeia (1987-2008); Member of the “Board of Directors” of the Society of Medicinal Plant and Natural Product Research (1981-2005) and the “Board of Directors” of the Gesellschaft für Phytotherapie (Society of Phytotherapy; 1995-2004); Deputy-member of the Commission E of the Federal Institute of Medicinal Products and Medical Advices (2002-2004). Coeditor of Planta Medica (1983 – 1992); Editor in Chief of Planta Medica – Natural Products and Medicinal Plant Research” (1993 – 2004), since then Senior Editor of Planta Medica.
Anthony Palmieri III, PhD, RPh
Associate Scholar, University of Florida College of Pharmacy
Anthony Palmieri holds a BS and MS in pharmacy from the University of Rhode Island and the Ph.D. from the University of Georgia. Prior to his present position in the Department of Pharmaceutics, he was Assistant Director of Technology Licensing at UF. Before coming to UF, he worked for 16 years at the Upjohn Company, and was a professor of pharmacy at the University of Wyoming. He is the author of numerous scientific, academic and historical papers, and served as the Laboratory Editor for the third edition of the Handbook of Pharmaceutical Excipients. Palmieri, a past president, is very active on the national level of Kappa Psi Pharmaceutical Fraternity. He was also past chairman of the Academy of Pharmaceutical Research and Science and Chair of the basic Sciences Section of APRS. He is a fellow of APhA-APRS and has authored chapters on dissolution, microencapsulation, pharmaceutical excipients and the history of pharmacy. Palmieri is a recognized expert on drug delivery, dissolution, and intellectual property. He is currently Chair of the United States Adopted Names Council. He was the editor and an author of “Dissolution Theory, Methodology and Testing.”
Shashank Rohatagi, PhD
Sankyo Pharma Development
Dr. Shashank Rohatagi is a Senior Director in Translational Medicine and Clinical Pharmacology Department at Daiichi Sankyo Pharma Development (DSPD), Edison, NJ, since August, 2004. I am currently responsible for the pharmacokinetic and pharmacodynamic analysis (population and two-stage) of new drug candidates and line extension projects and oversee all 14C labeled pharmacokinetic studies. Previous to joining DSPD, Dr. Rohatagi was a Director, Drug Metabolism and Pharmacokinetics at Aventis Pharmaceuticals in Bridgewater, N.J, since 1996. He received a PhD degree in Pharmaceutics from the University of Florida, Gainesville, FL in 1995 and an MBA degree from St. Joseph’s University in 2000. His main interest is in elucidating pharmaceutical principles especially pharmacokinetics and pharmacodynamics in the field of asthma, oncology, immunology, cardiovascular disease, diabetes and
central nervous system (CNS). He has currently published more than 50 peer-reviewed articles, given more than 60 poster or oral presentations at various national and international meetings. He is currently a member of American Association of Pharmaceutical Scientists (AAPS), American College of Clinical Pharmacology (ACCP), American Society of Clinical Pharmacology and Therapeutics (ASCPT) and American Academy of Allergy, Asthma, and Immunology (AAAAI). He is a Fellow of American College of Clinical Pharmacology. He serves on the Editorial Board of the Journal of Clinical Pharmacology and peer review manuscripts for the International Journal of Clinical Pharmacology and Therapeutics.
Sreedharan Sabarinath, PhD
US Food & Drug Administration (FDA)
Dr. Sreedharan Nair Sabarinath is a reviewer in the Office of Clinical Pharmacology at US Food and Drug Administration (FDA) since 2010. He supports the Division of Cardiovascular and Renal Products of the Office of New Drugs (OND) in using clinical pharmacology information such as exposure-response in making important regulatory decisions on evidence of effectiveness, drug-drug interactions, need for dose adjustments in special populations, benefit/risk and other labeling issues. His commendable contributions include the utilization of physiologically based pharmacokinetic (PBPK) modeling and simulations to provide dosing recommendations for concurrently administered cholesterol lowering drug simvastatin and antihypertensive drug diltiazem, in order to minimize the risk for statin related serious adverse events. He has over 20 publications in peer reviewed journals, a book chapter and has presented his research work at various national and international conferences. He is a Fellow of the American College of Clinical Pharmacology (ACCP) and serves as an Associate Editor for the journal BMC Research Notes and serves in Editorial Board of Frontiers in Pharmaceutical Medicine and Outcomes Research. He also acts as peer reviewer for several other clinical pharmacology journals.
Sabarinath has Bachelors and Masters Degrees in Pharmacy and received a PhD in Pharmaceutical Sciences from Jawaharlal Nehru University, New Delhi, India in 2005. He also worked as a scientist at Central Drug Research Institute (CDRI) in India and was involved in the development of a new drug called arteether for treating resistant malaria. He has over 4 years of combined post doctoral research experience in quantitative clinical pharmacology from University of Goteborg, Goteborg, Sweden and University of Florida, Gainesville, Florida.
Srikumar Sahasranaman, PhD
Dr. Srikumar Sahasranaman is a Development Scientist in Clinical Pharmacology and a Pharmacology Sub-Team Leader at Genentech, San Francisco. He received his B.S. in Pharmacy from the Birla Institute of Technology and Science, Pilani, India; M.Sc. from National University of Singapore and Ph.D. in Pharmaceutical Sciences from the University of Florida, Gainesville. Dr. Sahasranaman has over eight years of clinical pharmacology experience in the development of small molecules and biologics in multiple therapeutic areas including neuroscience, respiratory and oncology. His current research focuses on translational, clinical and pharmacometric approaches to understand the PK and PD of targeted small molecule agents and antibody drug conjugates in oncology. He has several publications in peer reviewed journals and is a member of ACCP, ASCPT and AAPS
Daniel Salazar, PhD, FCP
Chief Scientific Officer, EMS, Brazil
Dr Salazar is an accomplished pharmaceutical research and development executive with significant accomplishments across all phases of development and different therapeutic areas. His core areas of expertise are in translational science, clinical development, clinical pharmacology, pharmacokinetics, biopharmaceutics, pharmacometrics molecular pharmacology, pharmacogenomics, outsourcing, regulatory strategy, biomarkers, companion diagnostics and digital health. He has more than 25 years of experience in drug discovery, development, regulatory submissions and organizational leadership. He has made significant contributions to over 40 IND filings and 9 NDAs including Abilify®, Benicar HCT®, Azor®, Tribenzor®, Welchol®, Effient® and Lixiana®. He is currently, Principal, Drug Development Consulting, LLC. He was most recently Senior Vice President, Translational Medicine and Think Team at Otsuka Pharmaceutical Development & Commercialization and prior to that Vice President Translational Medicine and Clinical Pharmacology at Daiichi Sankyo. Dr Salazar completed his undergraduate education at Princeton University where he majored in Biology and his Doctor of Pharmaceutical Science from the State University of New York at Buffalo. He has directed over 100 clinical studies investigating dosage form bioequivalence, drug absorption, first administration to man, proof of concept, pharmacokinetics, pharmacodynamics, disease state interactions and drug-drug interactions. Dr Salazar is the co-author of 4 book chapters and 80 articles in peer reviewed journals.
Dennis Sandell, MS, PhLic
Dr. Sandell holds a MS & Ph. Lic. in Mathematical Statistics (1984 & 1990, U. of Lund, Sweden). After two years at the Swedish University for Agricultural Sciences he joined the pharmaceutical industry as a biostatistician in 1991 and has worked for AstraZeneca, Amgen and Siegfried Pharma Development GmbH in both specialist and management roles. Dr. Sandell is a leading expert in the area of CMC statistics, especially related to development, registration and commercial manufacture of inhalation products. He has deep experiences from of several innovator and generic DPIs, MDIs, nasal sprays and nebulization products, as well as different add-on devices. Dr. Sandell has worked with designing experiments and associated evaluations for common applications such as formulation development, device and drug product optimization, method and process validation, equivalence testing, justification of specifications, drug product characterizations, evaluation of stability data and justification of shelf life, QbD and multivariate analysis of large and complex data. He has a particular interest device development and in investigating IVIVC for inhalation products, and is a strong advocate for the saying that “a picture tells more than 1,000 words”. Dr. Sandell has more than 50 publications and frequently presents at international conferences. He has actively participated in different industry collaborations and working groups such as IPAC-RS (DDU and MB WGs), EPAG, PQRI and PhRMA and is further a member of USP Statistics Expert Committee for 2010-15. In May 2010 he started the consulting firm S5 Consulting, providing CMC statistical support, general inhalation development advice, and regulatory writing.
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.
Steven R. Smith, MD
Dr. Steven R. Smith earned his medical degree from the University of Texas Health Science Center in San Antonio, Texas, in 1988. He completed a residency in internal medicine at Baylor University Medical Center in Dallas, Texas in 1991. He subsequently completed at two-year fellowship in clinical endocrinology and metabolism at the Ochsner Clinic and Hospital in New Orleans, LA. Before coming to Florida Hospital, he was a faculty member at Pennington Biomedical Research Center for 15 years. Dr. Smith’s work bridges the gap between cell/molecular biology and clinical care. This approach is known as translational medicine, and involves translating discoveries in the basic sciences into the clinic and using clinical knowledge to direct the basic scientist. His research is focused on obesity, diabetes and the metabolic origins of cardiovascular disease. He is specifically focused on how individuals differ in their ability to adapt to diets high in fat and understanding how obesity leads to type 2 diabetes. Using the translational medicine approach, Dr. Smith discovered that many obese people have an inability to burn fat and require a new system to increase metabolism. Most importantly, the discovery that the inability to burn fat is programmed into muscle cells provides a novel way to identify and test new treatments for obesity and diabetes.In the clinic, Dr. Smith has a special interest in the identification and development of drugs for the treatment of obesity and diabetes. His translational work demonstrated that each person is unique at the molecular level, suggesting new ways to match therapies to the individual; this is the goal of the new field of “personalized” medicine. In his research career, Dr. Smith has published more that 100 peer-reviewed scientific manuscripts, reviews and chapters and is active in physician education.
Sean Sullivan, PhD
Dr. Sullivan has been in the field of drug delivery for the past 13 years with emphasis being placed on increasing the effectiveness of drugs and decreasing side effects. Areas of therapeutic applications have included infectious disease (HIV, HSV and Hepatitis), arthritis and cancer. The drug delivery vehicles have included both liposomes and polymers for small molecular weight, such as doxorubicin and large molecular weight drugs, such as oligonucleotides and plasmids. For the past 6 years, his research efforts have applied this technology toward the development of non-viral gene delivery systems. Non-viral gene delivery systems consist of plasmid DNA encoding a therapeutic gene isolated from bacteria and formulated with either cationic lipids or polymers yielding transfection complexes. The cationic lipid based transfection complexes were developed for transfection of tumor endothelial cells for the purpose of inhibiting tumor angiogenesis. A combination of peptide targeting to receptors on tumor endothelial cells and control of therapeutic gene expression by proliferating endothelial cell promoters are being developed to yield selective delivery and therapeutic gene expression to the tumor vasculature. In addition, polymer based formulations are being developed for intramuscular administration. The purpose is to convert the transfected muscle cells into bioreactors for expression and secretion of therapeutic proteins into the blood stream. His present research program is focused on applying these technologies to the treatment of cancer, with emphasis being placed upon brain cancer.
Hans Schreier, PhD
Dr. Hans Schreier received his dipl. pharm. ETH degree in 1976 and his Dr. sc. nat. degree in 1981 from the Swiss Federal Institute of Technology (ETH) Zurich, Switzerland, followed by postdoctoral training at UCSF and a Senior Scientist position at Liposome Technology, Inc., Menlo Park, CA. In 1986 he joined the faculty at the University of Florida College of Pharmacy, followed by an appointment at the Center for Lung Research at Vanderbilt University School of Medicine, Nashville, TN. In 1990 he founded the biennial international “Liposome Research Days” conference at the University of Florida. The conference continues to date, held at UBC, Vancouver 2010. He was a founder and Principal Scientist of Advanced Therapies, Inc., Novato, CA, a co-founder of ARYx Therapeutics, Inc., Fremont, CA, and of MCS Micro Carrier Systems GmbH, Neuss, Germany. He has published over 70 articles, reviews and book chapters and holds several patents. He continues to serve institutions and the pharmaceutical industry as consultant.
Yusuke Tanigawara, PhD
Prof. Yusuke Tanigawara is Professor of Clinical Pharmacokinetics and Pharmacodynamics, School of Medicine, Keio University, Tokyo, Japan. He received his Ph. D. in pharmaceutical sciences from KyotoUniversityin 1983. His research interests include pharmacokinetics, pharmacodynamics and dosing algorithms for personalized medicine. He has been studying clinical pharmacokinetics and pharmacodynamics for mainly oncology drugs and antimicrobial agents. His modeling and simulation studies on population pharmacokinetics and pharmacodynamics were applied to new drug development as well as rational use for patient care. Recently, he also investigates pharmacogenomics as a factor causing individual variation in drug response, and new biomarker development by means of proteomics and metabolomics techniques. He is distinguished as one of the “ISI Highly Cited Researchers.”
Jacques Turgeon, B.Pharm., Ph.D., FCAHS
Chief Scientific Officer, Tabula Rasa Healthcare
Dr. Jacques Turgeon is the chief scientific officer at Tabula Rasa Healthcare since September 2015. Dr. Turgeon served as the chief executive officer and executive director of the Centre hospitalier de l’Université de Montreal (CHUM), the major francophone university hospital in the province of Quebec, from June 2014 to September 2015. He was previously the Director of the Research Center of the Centre hospitalier de l’Université de Montréal (CRCHUM) from 2007-2014. Dr. Turgeon was Dean of the Faculty of Pharmacy at the Université de Montréal where he has taught drug metabolism, pharmacokinetics and pharmacogenomics. Dr. Turgeon received his Bachelor of Science in Pharmacy from l’Université Laval in Quebec City followed by a Master of Science in pharmacokinetics and a Ph.D. in drug metabolism from the same institution. He completed postdoctoral studies in the department of Clinical Pharmacology at Vanderbilt University. He is a Fellow of the Canadian Academy of Health Sciences, a Fellow of the National Academy of Medicine, in France, Professor Emeritus at the Université de Montréal and Adjunct professor, Department of Systems Pharmacology and Traditional Therapeutics, at University of Pennsylvania.
Markus Veit, PhD
International Drug Regulatory Services
Dr. Veit received his PhD from JuliusMaximiliansUniversity, Würzburg Germanyin 1990. In 1998 he received the Egon-Stahl-Price award from the International Society of Medicinal Plant Research. His academic research interests included bioanalytical methods for active ingredients in herbal medicinal products, quality of herbal medicinal products, pharmacokinetics and bioavailability of plant phenolics, pharmacodynamics of plant phenolics, and the efficacy of herbal medicinal products. Dr. Veit published more than 50 peer reviewed publications. In 1999 Dr. Veit left his full position at University of Würzburg, Germanyand started a career outside academia, but he still teaches at the Schoolof Pharmacy, Universityof Frankfurt, at the Humboldt University, Berlin. Today Dr. Veit is CEO of two Companies offering regulatory and analytical services for the Pharmaceutical Industry (HWI ANALYTIK and i.DRAS). 2011 he additionally founded ALPHATOPICS, a company offering training and consultancy services. He is a member of the German Pharmacopeia Expert committee Pharmaceutical Chemistry. Since 1997 Dr. Veit organized, chaired and contributed at more than 150 symposia and seminars covering his main interests and expertise: Drug regulatory affairs, quality of pharmaceuticals and medical devices, pharmaceutical development, bioanalytical method development and validation.
Yaning Wang, PhD
Dr. Yaning Wang is currently the Associate Director for Science in the Division of Pharmacometrics in the Office of Clinical Pharmacology at FDA. Before joining FDA, Dr. Wang received his Ph.D. in Pharmaceutics and master’s degree in Statistics from theUniversityofFloridafrom 1999 to 2003. He also obtained a master’s degree in Biochemistry (1999) and a bachelor’s degree in Pharmacy (1996) fromPekingUniversityinChina. Dr. Wang joined FDA as a clinical pharmacology and pharmacometrics reviewer in 2003, conducting reviews in the therapeutic areas of anti-infectives, special pathogen, transplant, antivirals, cardiovascular and renal products, oncology, neurology, psychiatrics, metabolism and endocrinology, pulmonary and allergy. In 2005, he became a senior reviewer. In 2007, he became the pharmacometrics team leader responsible for the therapeutic areas of cardiovascular and renal products, oncology, medical imaging, hematology, gastroenterology, metabolism and endocrinology, pulmonary and allergy, special pathogen, and transplant. In 2009, his therapeutic responsibility changed to neurology, psychiatrics, pulmonary and allergy, analgesics, anesthetics, and rheumatology due to team realignment. In 2010, in addition to his team leader responsibility, Dr. Wang was appointed as the Associated Director for Science to oversee the scientific aspects of reviews, research projects, and policy development within the Division of Pharmacometrics to ensure high quality science. In 2012, he took on the team leader’s responsibility for antivirals, anti-infectives and ophthalmology, special pathogens and transplant, cardiovascular and renal products, dermatology and dental, and reproductive and urologic products. Dr. Wang received numerous awards at FDA, including Award of Merit, the most prestigious honor awarded at FDA. Dr. Wang is an Adjunct Professor in the Department of Pharmaceutics at theUniversityofFloridaand an invited lecturer in the College of Engineering and College of Pharmacy at the University o fMichigan. Dr. Wang also serves as a committee member for two Ph.D. candidates from the University of Florida and the University of Minnesota. He has published 30 papers and given more than 60 presentations at various national and international meetings. Dr. Wang serves as the FDA representative on the Scientific Advisory Board for Drug Disease Model Resources (DDMoRe) consortium and on the Editorial Advisory Board for the Journal of Pharmacokinetics and Pharmacodynamics.
Benjamin Weber, PhD
Benjamin Weber is a Pharmacometrician in the Department of Translational Medicine and Clinical Pharmacology at Boehringer-Ingelheim in Biberach, Germany. He received a professional degree in Pharmacy from University of Tuebingen (Germany, 2008), a Master of Statistics (2012), and a Ph.D. in Pharmaceutical Sciences (2013) from the University of Florida in 2013. In his dissertation research, Benjamin developed a statistical method for equivalence testing of aerodynamic particle size distribution in close collaboration with the FDA. Before joining Boehringer-Ingelheim, Benjamin gained regulatory experience as an ORISE fellow at the Office of Generic Drugs, FDA and worked as a consultant for equivalence testing of aerodynamic particle size distribution for several pharmaceutical companies. He currently supports all phases of clinical drug development as a pharmacometrician for respiratory projects. Benjamin has gained experience is population pharmacokinetic/pharmacodynamics modeling, disease progress modeling, and time-to-event analysis. Moreover, Benjamin serves as mentor for a pharmacometrics PhD student at Boehringer-Ingelheim. He has had several publications in international peer-reviewed journals and poster presentations and invited talks at international conferences. Benjamin has been recognized by the College of Pharmacy and the International Center at the University of Florida for his teaching and scientific achievements.
Russell S. Weiner, PhD
Merck Research Laboratoreis
Russ is currently Executive Director and Head of Molecular Biomarkers and Diagnostics at Merck. In this role he is responsible for delivering on global biomarker and companion diagnostic strategies for all of Merck’s therapeutic areas. After receiving his Ph.D. in Biochemistry from Albany Medical College, Russ then spent the next 18 years at BMS where he was responsible for discovery and regulated bioanalysis (GLP and clinical) in support of PK, immunogencity and biomarker assay development, validation and sample analysis. Russ has extensive experience in clinical project leadership, clinical trial conduct, development of pharmaceutical and biologics therapeutics and is well versed in using biomarkers for early decision making. Russ is an active member of the American Association of Pharmaceutical Scientists (AAPS) where he currently serves as a member of the AAPS Executive Board. Russ is well known for his passion for student mentorship and travels to graduate schools as part of the AAPS Visiting Scientist effort where he provides training on soft skills and career development.
Virginia Wotring, PhD
Baylor College of Medicine
Virginia E. Wotring, Ph.D., is an assistant professor at the Center for Space Medicine and the Department of Pharmacology at Baylor College of Medicine where she conducts research on the use and actions of medication in the unusual environment of spaceflight. She is also the Science and Integration Manager for the National Space Biomedical Research Institute, a nonprofit associated with NASA’s Johnson Space Center. Her currently funded projects include the design and implementation of a new iOS-based app for iPad collection of medication use data directly from crewmembers during future missions and an examination of potential alterations in pharmacokinetics associated with the spaceflight environment. This PK study includes Dr. Hartmut Derendorf at the University of Florida and Dr. Laura Barger of Brigham & Women’s Hospital as collaborators in the respective areas of pharmacokinetics and pharmacodynamics of sleep medications, respectively. She received her doctorate in Pharmacological and Physiological Science from Saint Louis University after earning a B.S. in Chemistry at Florida State University. She has published multiple studies on ligand gated ion channels in the brain and spinal cord. Her research experience includes drug mechanisms of action, drug receptor structure/function relationships and gene & protein expression. She became a spaceflight researcher in 2009, and in 2012, her book reviewing pharmacology in spaceflight was published by Springer: Space Pharmacology, Space Development Series.
Gerald J. Yakatan, PhD
Gerald J. Yakatan, Ph.D. is a serial entrepreneur who has been a founder of multiple companies in the pharmaceutical R&D arena and currently serves as Chairman & CEO of IriSys, Inc., a CDMO specializing in formulation development and GMP manufacturing of clinical trials materials and commercial products. He is also Chairman & CEO of MeiHua Biopharma. He served as President & CEO of Avanir Pharmaceuticals where he led development efforts resulting in the NDA submission for Nuedexta® and was responsible for the regulatory approval and commercialization of Abreva®. Dr. Yakatan has also served as Pharmaceutics Chair at University of Texas at Austin; VP for Product Development Worldwide at Warner Lambert/Parke Davis; and Founder and CEO at Tanabe Research Labs, USA. He has served on the Boards of numerous not-for-profit organizations and received distinguished alumnus awards from Temple University and from the University of Florida. His MeiHua Biopharma company in China is focused on accelerating discovery and development of novel anti-inflammatory therapeutics.
Ping Zhao, PhD
Ping Zhao is currently the Scientific Lead of PBPK (physiologically-based pharmacokinetic modeling) Program and Expert Clinical Pharmacologist in the Division of Pharmacometrics, Office of Clinical Pharmacology at US FDA in Silver Spring, MD, USA. He is responsible for assessing PBPK analyses in IND and NDA submissions. Ping’s research focuses on understanding the effect of intrinsic and/or extrinsic patient factors on drug exposure-response using PBPK models. Prior to 2008, he worked as a clinical pharmacologist at Amgen in Seattle, WA (2008), a pharmacokineticist at Sonus Pharmaceuticals in Seattle, WA (2005-2007), and a DMPK scientist at Pfizer in La Jolla, CA (2002-2005). Ping Zhao obtained his BS in Pharmacy from Beijing Medical University in China in 1994, and his PhD in Pharmaceutics from University of Washington in Seattle, WA, USA in 2002.