Last updated October 10, 2008
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Dr. Vikram Arya is a Senior Clinical Pharmacology Reviewer in the Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), FDA. He earned his Ph.D. in Pharmaceutics from the University of Florida, Gainesville, FL, 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). He holds an Adjunct Clinical Professor (Special Title) appointment in the Department of Pharmacy Practice at Mercer University, Atlanta, GA. He serves as the Section Editor in the Journal of Clinical Pharmacology (JCP) and is a member of the Editorial Board of JCP and International Journal of Clinical Pharmacology and Therapeutis (IJCPT).
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Children's Hospital
of Philadelphia |
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Dr. Barrett is Associate Professor
of Pediatrics and Pharmacology at the Children's Hospital of Philadelphia (CHOP)
and University of Pennsylvania.
He is also the Director of the Laboratory for Applied PK/PD within the Clinical
Pharmacology and Therapeutics Division at CHOP. Prior to joining CHOP, Dr. Barrett
spent 13 years in the pharmaceutical industry most recently at Aventis Pharmaceuticals
where he was Global Head of Biopharmaceutics supporting late stage development.
He received his B.S in Chemical Engineering from Drexel University in 1986 and
his Ph.D. in Pharmaceutics from the University of Michigan in 1990 under Dr.
John G. Wagner. He has been a faculty member of the Pharmaceutical Education
and Research Institute (PERI) as a lecturer for the Pharmacokinetics and Nonclinical
Statistics training courses since 1992. and was a member of both the PhRMA and
FDA Expert Panels on Individual and Population Bioequivalence. Dr. Barrett has
co-authored over 50 manuscripts and has given 35 invited lectures on a variety
of topics related to clinical drug development. He founded the Mid-Atlantic
Population Approach Users Group in 1992 and is a member of the Advisory Boards
of the East Coast Population Approach Group, the American Association of Pharmaceutical
Scientists (AAPS) Bioequivalence and Population Pharmacokinetics Focus Groups,
and the Innaphase Corporation. Dr. Barrett is a member of AAPS, ASCPT, ACCP
and ASPET and was former Chair of the Delaware Valley Drug Metabolism Discussion
Group. He was elected to Fellow of the American College of Clinical Pharmacology
in 2000 and was awarded the Tanabe Young Investigator Award in 2002. Dr. Barrett
was also recently elected to the
Board of Regents of ACCP and as Vice-Chair of the Clinical Sciences Section
of AAPS.
Focus at Children's Hospital of Philadelphia:
Dr. Barrett's current efforts in
conjunction with the mission of the Clinical Pharmacology and Therapeutics Division
are focused on the
investigation of sources of variation in pediatric pharmacokinetics and pharmacodynamics.
Applied clinical pharmacologic investigation coupled with modeling and simulation
strategies are pursued with the intention of developing rational dosing guidance
in various pediatric populations for both marketed and exploratory compounds.
Clinical trial simulation is to be utilized prospectively to explore design
dependencies and parameter sensitivities. Dr. Barrett also directs the Laboratory
for Applied PK/PD which is focused on the development of pharmacometric approaches
to advance PK/PD, novel biomarker development and disease progression modeling.
Research Interests / Current Efforts
"The focus of my research is
really driven by two objectives: (1) the utilization of PK/PD modeling and simulation
techniques to establish links between drug exposure, actions, and therapeutic
outcomes and (2) pursuit of therapeutic drug monitoring (TDM) in conjunction
with modeling and simulation strategies to improve the management of pediatric
drug therapy within CHOP." The list below describes ongoing efforts and
research topics I am currently exploring. - Development of physiologically-based
PK models to explore maternal to fetal drug transfer, - Population-based PK
model development in support of ongoing/proposed study drugs (Heparin, Midazolam
and Actinomycin-D),
- Data warehousing and data mining approaches in bio- and medical informatics,
- Development of novel biomarkers for the investigation of heparin and LMWH
patient management through anticoagulant PK/PD,
- Exploration of physiologic - developmental PK/PD models which predict drug
exposure in various pediatric populations based on drug substance /physiochemical
characteristics in conjunction within adult PK/PD behavior,
- Exploration of trial design characteristics for optimal pediatric drug trials
focused on safety, PK, PK/PD and/or efficacy through clinical trial simulation.
| Robert Baughman, PharmD, PhD
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Dr. Baughman received his B.Sc. from Loyola University in 1974, and both Pharm.D. (1978) and Ph.D. (Pharmaceutical Chemistry, 1982) degrees from the University of California, San Francisco. He has held research positions at Lederle Laboratories, Genentech, Penederm, Cholestech, and Emisphere Technologies. He is currently the Managing Director, Corporate Strategy at Emisphere while also serving as a consultant to the pharmaceutical and venture capital industries.
Dr. Baughman's research interests include characterizing absorption mechanisms for macromolecules, optimizing oral drug delivery, the disposition of therapeutic peptides and proteins, and the effect of disease states on drug pharmacokinetics. His publications include more than 130 manuscripts and abstracts in these areas, and he has authored three book chapters on the kinetics of therapeutic proteins. He co-edited the book Therapeutic Proteins: Pharmacokinetics and Pharmacodynamics (W.H. Freeman, 1992), and serves on the editorial board of the International Journal of Clinical Pharmacology and Therapeutics. He has conducted pharmacokinetic studies on over 15 recombinant products, including clinical pharmacokinetic trials with rhInsulin, rtPA, rhGH, rTNFa and rIFN-g .
Dr. Baughman is a past Chairman of the Biotechnology Section of the American Association of Pharmaceutical Scientists (AAPS), and in 1994 was elected to a three year term as the association’s Treasurer. He served on the AAPS Executive Council from 1995 – 1997. He sits on the advisory board of the American College of Clinical Pharmacology and holds an adjunct faculty appointment in Pharmaceutical Biotechnology at the University of Florida, College of Pharmacy. He is a member of AAPS, ACS, CRS, Rho Chi and Rho Pi Phi.
| Robert Bell, PhD
Drug and Biotechnology Development, LLC Email:rgb@drugbiodev.com |
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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.
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Marcus Brewster, PhD Email: Mbrewste@janbe.jnj.com |
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Dr. Marcus E. Brewster is a Senior Research Fellow and Head of the Department of Drug Delivery Research at the Janssen Research Foundation, Beerse Belgium. He also serves on the faculty of the University of Florida, College of Pharmacy as an Adjunct Associate Professor. He received his BS degree from Mercer University in 1978 and his Ph.D. from the University of Florida in 1982 working with Prof. Nicholas Bodor. Dr. Brewster also spent two years as a Visiting Scientist at the Weizmann Institute of Science in Rehovot, Israel (1996-97). He has published 146 journal articles, written or contributed to over 20 book chapters and proceedings and holds 12 patents. He is an member of several editorial boards and a recipient of the Johnson and Johnson Excellence in Science Award. Dr. Brewster’s main research interests include the use of chemically modified cyclodextrin derivatives for pharmaceutical application, brain-targeted drug delivery through the use of chemical delivery systems and the application of molecular orbital and other computational approaches in addressing items of chemical and biological concern.
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Age 48, married, 2 children 15 and 18 yrs; 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 Sr Scientific Advisor for GI and respiratory projects. 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 30 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.
Ronald Evens, PharmD Email: maps4biotec@aol.com |
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Ron Evens is President of MAPS 4 Biotec, Inc, consulting to biotechnology segment of pharmaceutical industry concerning medical affairs roles of communications, information, and clinical trials (peri-approval and post launch). Dr. Evens is clinical professor at University of Florida, College of Pharmacy. Ron serves on the Board of Directors of Cheladerm, Inc (drug company), Healthcare Distribution Management Association Healthcare Foundation and American Society of Health-Systems Pharmacists Research and Education Foundation (Vice-Chairman); and three Dean's Advisory Boards for Colleges of Pharmacy at Universities of Florida, Kentucky and Midwestern. Invited presentations exceed 150 at national and state associations or universities. Publications are over 100, including 10 book chapters and 40 journal articles. Previously (12 years, 1989-200) at Amgen, he created and was Senior Director and Head of Professional Services Department. Professional Services was responsible for medical communications/education, marketing support, phase 2 & 4 studies, field based clinical liaisons, and product information for marketed and pipeline products. Also, he created and was Senior Director and Head of PeriApproval Research at Amgen (2000-2001). 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).
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Mario Gonzalez,
PhD Email:
mario@pkineticsintl.com
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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. 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.
| Ricardo Gonzalez-Rothi, MD Professor of Medicine and Pharmaceutics University of Florida Email: rothirj@medicine.ufl.edu |
Not Available |
Dr. Gonzalez-Rothi is Professor of Medicine and Pharmaceutics at the University of Florida. Since joining the faculty in 1982, he has also been a Staff Physician at the Gainesville VA Medical Center, and since 1991 has had a joint appointment in the Department of Pharmaceutics and was granted Graduate Research Faculty Status. He is Chief of the Pulmonary and Respiratory Therapy Section at the Gainesville VA Medical Center and Acting Chief of the Division of Pulmonary and Critical Care at the University of Florida. Dr. Gonzalez-Rothi's major faculty responsibilities have centered on clinical teaching and education, where he has been recognized in the College of Medicine as the recipient of various teaching awards over the years. Most recently, he was awarded a State of Florida University-wide Teaching Incentive Performance Award, Dr. Gonzalez-Rothi has also been involved in education extramurally, as invited Program Faculty in clinical symposia, as well as in public education via radio and television. He is the recipient of a National Institutes of Health Tuberculosis Academic Award, for the promotion of tuberculosis education at the medical center, as well as to health professionals and the public throughout the State of Florida. He has been recognized by the Florida Voluntary Health Association as Medical Volunteer of the Year for his efforts in educating the citizens of Florida. He was selected as Founding Member of the University of Florida Society of Teaching Scholars. Dr. Gonzalez-Rothi is listed in Woodward and White's "The Best Doctors in America: Southeast Region". Dr. Gonzalez-Rothi's research interests have centered on interactions between inhaled particles and lung macrophage functions, for which he has identified specific smoking-associated defects, and described functional abnormalities in macrophages of patients with alveolar proteinosis. His interest in this area shifted to exploiting the phagocytic capacity of macrophages in developing targeted drug delivery to the lungs by the use of liposomal vesicles, specifically to deliver antimyeobacterials and glucocorticoids, He has sustained continuous extramural support since joining the faculty, has served on Graduate Student doctoral committees, and as peer-reviewer for scholarly journals and grant review sections. He is alveolar/co-author of 37 peer reviewed publications, two book chapters and multiple abstracts on various clinical and research topics.
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Boehringer Ingelheim Pharma GmbH & Co. |
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Dr. Graefe-Mody is working in Clinical Pharmacokinetics/Pharmacodynamics at Boehringer Ingelheim Pharma GmbH & Co. KG, Germany. Her responsibilities include the conduct of clinical pharmacokinetic/pharmacodynamic studies in the course of drug development and approval of new drug candidates in various therapeutic areas. This also includes POP PK/PD modeling and trial simulation to support drug development. Prior to 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-Wilhem-Scheele Award of the German Pharmaceutical Society for outstanding dissertations in Pharmaceutical Sciences.
| Ray Jurgens, PhD
Regional Medical Science Liaison Ligand
Pharmaceuticals |
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Dr. Jurgens received his Bachelor of Science in Pharmacy from Drake University. After working in retail pharmacy for a year and a half, heenrolled at the University of Florida and completed his PhD in the Pharmaceutical Sciences in 1973. He initially started out in academia, but after 3 years moved into the pharmaceutical industry. Over the last 25 years, he has moved through various departments, worked in several pharmaceutical companies and has had increasing areas of responsibilities. The first half of his career he developed expertise in formulations, parenterals and project management. The last 14 years, Dr. Jurgens has done clinical research in GI, CNS, female health care and most recently oncology. He has lectured in drug development and clinical in major academic institutions throughout the country. Currently, he owns several patents and has over 40 publications. He is on several scienitific advisory boards for academic institutions and companies. He is professionally affliated with Rho Chi, Kappa Psi, ACRP, ASHP, ACCP, and DIA. He is also a registered pharmacist. Dr.Jurgens currently resides near Clearwater, Florida and is a regionally based medical science liaison in the Medical Affairs department at Ligand Pharmaceuticals - a biotech firm located in San Diego, California.
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Dr. Sriram Krishnaswami is an Associate Director in Clinical Pharmacology at Pfizer Global R&D based in
| Michael Kurowski, PhD, MD
Email: labor-kurowski@t-online.de |
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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 Pharmacolgy, Charite, Humboldt Universität, Berlin. In addition to being Co-editor of the Journal Pharmacotherapy, Dr. Kurowski has been a consultatnt to the community of practicing physicians and Ciba-Geigy, a member of the "Drugs Commision", Chairte, 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.
| Email: Richard.Lalonde@pfizer.com |
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Richard is currently the Executive Director and Head of Clinical Pharmacokinetics and Pharmacodynamics at Pfizer Global Research and Development in Ann Arbor, Michigan. Prior to joining Pfizer (formerly Parke-Davis/Warner Lambert) in 1998, he was Senior Scientific Director at Phoenix International Life Sciences (now MDS) in Montreal, Canada. From 1984 to 1991, Richard was Assistant Professor then Associate Professor and Vice Chairman for Research at the University of Tennessee, Memphis. From 1980 – 1984 he worked at the University of Ottawa Health Sciences Centre in Ottawa, Canada. His research over the past 25 years has been focused on how to integrate pharmacokinetic and pharmacodynamic information to provide improved drug therapy in patients. He is a fellow of the American College of Clinical Pharmacology and the American College of Clinical Pharmacy and a member of the Editorial Board for Clinical Pharmacology and Therapeutics. Richard is a graduate of the University of Minnesota (Pharm.D.) and the University of Toronto (B.Sc. Pharmacy).
| Lawrence J. Lesko, PhD
Email: LeskoL@cder.fda.gov |
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Lawrence J. Lesko, Ph.D. is Director of the Office of Clinical Pharmacology and Biopharmaceutics (OCPB) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (1995-present). This Office is responsible for the review and evaluation of the biopharmaceutic, pharmacokinetic and pharmacodynamic data contained in IND’s and New Drug Applications (NDA’s). Dr. Lesko is also Chair of the Clinical Pharmacology Section of the Medical Policy Coordinating Committee, and Co-Chair of the Biopharmaceutics Coordinating Committee, in CDER that is responsible for developing guidances for industry. Dr. Lesko currently represents FDA on the Common Technical Document (Efficacy) Working Group in the International Conference on Harmonization. Dr. Lesko was previously Associate Director of Research at the FDA where he was responsible for developing and managing the Product Quality Research Program in the Office of Generic Drugs (1992-95). Prior to joining FDA, Dr. Lesko was Vice President of PharmaKinetics Laboratories (1988-92) and Associate Professor of Pharmaceutics at the University of Maryland at Baltimore (1981-88). He also held an appointment in the Laboratory of Neuroscience, National Institute on Aging, National Institutes of Health, from 1985-1988 investigating the effects of age on the pharmacokinetics and pharmacodynamics of drug substances. He was a Laboratory Director in the Clinical Pharmacology Division of the University of Massachusetts Medical Center from 1979-1981 and was on the faculty of the Massachusetts College of Pharmacy from 1973-1979. Dr. Lesko received his B.S. and Ph.D. degrees in pharmaceutics from Temple University in Philadelphia, Pennsylvania and was board certified in Clinical Pharmacology by the American Board of Clinical Pharmacology in 1992. In 1998, Dr. Lesko was awarded the Outstanding Alumni Award from Temple University. He is a member and Fellow of American Association of Pharmaceutical Sciences and serves as Chair of the Drug Development and Regulatory Science Section of American Association of Clinical Pharmacology and Therapeutics. Dr. Lesko is a Fellow and a member of the Board of Regents of the American College of Clinical Pharmacology. He is also the FDA’s Federal Liaison to European Federation for Pharmaceutical Sciences. Dr. Lesko has authored or co-authored over 125 peer-reviewed articles in biopharmaceutics and clinical pharmacology and he is a frequent speaker at national and international meetings.
Nicola Luciani, BS |
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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.
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| Markus Müller, MD |  |
Markus Müller, M.D. is Professor and Head of the Department of Clinical Pharmacology of the Medical University Vienna / Vienna General Hospital in Austria. He has received his M.D. from the University of Vienna Medical School with highest possible honours (sub auspiciis praesidentis rei publicae). He 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 serves as a European Expert for the European Agency for the Evaluation of Medicinal Products (EMEA) in London, UK and is a a frequent speaker at international meetings and a reviewer for several biomedical and pharmaceutical journals and scientific societies. He has published over 150 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.
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Institute of Pharmaceutical Biology and Phytochemistry
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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. em.; Dr.h.c. of the Ovidius University, Constanta, Romania (2004). Honorary member of the Society of Medicinal Plant Research (GA; 2005). 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; >190 papers in these fields; >160 lectures; >120 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 (since 1987); Member of the “Board of Directors” of the Gesellschaft für Arzneipflanzenforschung (Society of Medicinal Plant Research, 1981-2005) and the “Board of Directors” of the Gesellschaft für Phytotherapie (Society of Phytoptherapy, 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.
| Emil Pop, PhD
Alchem Laboratories, Alachua FL |
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Research Chemist (1962-1965); Research Scientist
(1965- 1978); Principal Research Scientist, Group Leader (1978- 1983) Chemical
Pharmaceutical Research Institute, Cluj, Romania. Visiting Scientist, The Rugjer
Boskovic Institute, Zagreb, Croatia (1971-72). Postdoctoral Research Associate,
University of Florida, Gainesville, FL (1983-86). Senior Research Scientist
(1986- 87); Group Leader (1987- 89); Associate Director for Chemical Development
(1989-1992; Director of Chemistry (1992), Pharmatec, Inc., Alachua, FL. Director
of chemistry (1992-95); Senior Director of Chemistry (1995-1998), Pharmos Corporation,
Alachua, FL. Founder, President and CEO, Alchem Laboratories Corporation, Alachua,
FL (1996-); Awards: The "N. Teclu" award for chemistry
granted by the Romanian Academy (1980), Honors, Distinctions:
Fellow, American Association of Pharmaceutical Scientists, Fellow, American
Institute of Chemists, Who’s Who in: Frontiers of Science and Technology;
World; Science and Engineering; South and Southeast; America (Marquis). Men
of Achievement, Dictionary of International Biography, The International Who’s
Who of Intellectuals, American Men and Women of Science. Courtesy Professor,
CDD, University of Florida; Inaugural Member of the Advisory
Board, Florida Center for Heterocyclic Compounds, University of Florida.Professional
Membership: ACS, AIC, AAAS, AAPS, IUPAC, New York Academy of Sciences, International
Society of Quantum Biology and Pharmacology, Association de Pharmacie Galenique
Industrielle.
Chairman at the First World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical
Technology; International Advisory Board, International Conferences on Drug
Optimization via Retrometabolism;Inaugural Member of the Florida Center for
Heterocyclic Compounds Industrial Advisory Board; Guest Editor of a "hot
topic" issue of Current Pharmaceutical Design; Member Editorial Advisory
Board Letters in Drug Design & Delivery. Scientific Activity:
126 publications, 23 patents, 127 presentations. Expertise:
organic, pharmaceutical, medicinal and theoretical chemistry. Drug design, synthesis
and evaluation of novel drugs, prodrugs, chemical drug delivery systems; chemistry
of synthetic cannabinoids. Basic research scale-up product and process development.
NASA Johnson Space Center |
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Shashank Rohatagi, PhD,MBA,FCP Sankyo Pharma Development |
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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.
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Dr. Hans Schreier is a founder and CEO of MCS Micro Carrier Systems GmbH, a formulation development company based in Neuss, Germany. He 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 from 1981-1983 at the University of California – San Francisco (UCSF) and a Senior Scientist position at Liposome Technology, Inc., in Menlo Park, California from 1983-1986. During his academic career, he held appointments as Assistant Professor and Associate Professor of Pharmaceutics at the University of Florida College of Pharmacy (1986-1993) and Associate Professor of Medicine at Vanderbilt University School of Medicine (1993-1995). He has been a founder, Director and the Principal Scientist of Advanced Therapies, Inc., a nonviral gene delivery company (1995-1998) and is a co-founder of ARYx Therapeutics, Los Altos Hills, CA, a virtual drug discovery and pharmaceutical development company. He is the Executive Director of Liposome Research Days, Inc., a non-profit organization (since 1994) and co-organizer of the biennial international "Liposome Research Days" conference. He has published over 70 articles, reviews and book chapters and holds several patents. He is the editor of a recent book on 'Drug Targeting Technology: Physical, Chemical and Biological Methods' (Marcel Dekker, 2001). He is an Editorial Board member of the Journal of Liposome Research, and a member and elected Governor (1996-1999) of the Controlled Release Society (CRS). He maintains extensive professional links with individuals, companies, agencies and scientific organizations in the US, Europe, Japan, and Australia.
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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.
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Email: mpecinsthompson@ufl.edu |
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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.
| Markus Veit, PhD
Managing Director |
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In addition to his duties as Managing Director, Dr. Veit teaches at the University of Frankfurt School of Pharmacy, at the Humboldt University, Berlin and at the College of Pharmacy, University of Florida, where he conducts a two week course on the quality and efficacy of herbal medicinal products. Dr. Veit received his PhD from Julius Maximilians University, Würzburg Germany in 1990. In 1998 he received the Egon-Stahl-Price award from the International Society of Medicinal Plant Research. His current research interests include 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 has more than 50 peer reviewed publications. He is a member of the Member, German Pharmacopeia: Expert committee Pharmaceutical Chemistry, Chair, Scientific Expert Committee, German Pharmaceutical Manufacturers Research Association, Member, German Pharmaceutical Manufacturers Association, Expert committee on analytics and hygiene, Member, German Pharmaceutical Manufacturers Association, Expert committee on validation, Member, German Pharmaceutical Manufacturers Association, Expert committee on herbal medicinal products, a Member of the Society of medicinal plant research, in addition to being on the Expert committee on clinical studies.
FDA |
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Dr. Wang is currently the team leader for pharmacometrics team in the Office of Clinical Pharmacology at FDA. Before joining FDA, Dr. Wang received his dual degrees, PhD in pharmaceutics and master in statistics, from University of Florida in 2003. He also obtained a master degree in Biochemistry (1999) and a bachelor degree in Pharmacy (1996) from Peking University in China. Dr. Wang’s research interest involves application of quantitative methodology in clinical pharmacology to facilitate decision making in drug development and review. Dr. Wang is also a Courtesy Assistant Professor in the Department of Pharmaceutics at University of Florida and an invited lecturer in the College of Engineering and College of Pharmacy at University of Michigan.
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Dr. Way received her BS in Chemistry and Biology from Georgetown College, Georgetown, KY in 1983. She later received her Ph.D. in Pharmaceutical Sciences from the University of Kentucky in 1992. She has worked in the pharmaceutical industry since 1992 and is experienced in both solid and non-solid dosage form development. She is currently a Senior Principal Scientist in the Pharmaceutics Department at Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT. where her responsibilities include preclinical and clincial dosage form development and preformulation. This includes discovery interfacing to assist in the selection of compounds entering development. Her research interests include solubilization of poorly water soluble compounds, promotion of oral absorption, as well as in vitro/in situ models for assessing drug transport.
Director, Bristol Myers Squibb Email: russell.weiner@bms.com |
