Neil Buckholtz, PhD, National Institute on Aging (confirmed)

Neil S. Buckholtz, Ph.D., is Chief of the Dementias of Aging Branch of the Neuroscience and Neuropsychology of Aging Program at the National Institute on Aging, National Institutes of Health (NIH), Bethesda, Maryland.  This involves overall programmatic responsibility for development, coordination, and implementation of basic and clinical Alzheimer’s disease research.  Specifically Dr. Buckholtz is the program administrator for the areas of diagnosis and treatment and management of Alzheimer’s disease.  Dr. Buckholtz holds a doctorate in physiological psychology from the University of Wisconsin, Madison and was a faculty member at the Medical University of South Carolina, Department of Psychiatry, from 1970-1983, before coming to NIH. 

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Lecturer:

Resources at the National Institute of Health

Joy Cavagnaro, PhD, Access BIO (confirmed)

Joy Cavagnaro, PhD, DABT, RAC, Fellow ATS, RAPS FELLOW is the President and Founder of Access BIO a consultancy specializing in science-based regulatory strategies and development services to facilitate biomedical research, emerging technologies and product development   Dr. Cavagnaro’s career spans academia, the CRO and biotechnology industries and government (FDA/CBER). She has served in leadership positions in SOT, RAPS, and DIA and is Past Chair and Founder of BioSafe, an expert preclinical science committee within BIO. Dr. Cavagnaro serves on a number of SAB’s and consults and lectures internationally. She contributed to and edited “Preclinical Safety Evaluation of Biopharmaceuticals: A Science-based Approach to Facilitating Clinical Trials” John Wiley and Sons, NJ which was published in 2008.

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Lecturer:

Regulatory Requirements & Strategy

Laura Chico, MS, PhD, LKC Pharma Services (confirmed)

Dr. Chico is the founder and President of LKC Pharma Services, a privately held scientific consulting firm, and holds a faculty position at Northwestern University Feinberg School of Medicine.  Dr. Chico has worked successfully with teams of chemists and biologists in the improvement of efficiencies for early stage small molecule drug discovery processes, participated in bringing novel small molecule drugs into late stage drug development for CNS disorders and facilitated the discovery of new classes of small molecule drug candidates for cancer therapeutics.  Dr. Chico’s experience also includes conducting investigations of signal transduction pathways contributing to therapeutic resistance to cancer therapies and working with bioinformatics and information technology professionals to leverage public data repositories for the discovery of novel diagnostic tools.  LKC Pharma Services uses its proprietary computational algorithms and diverse experience at the interface of pharmacological and chemical sciences to facilitate client Go/NoGo decisions or project proritizations in drug discovery and early stage product development, rendering significant time and cost savings in the short term and major risk reduction at later stages.  Dr. Chico received her Ph.D. at Northwestern University in the areas of computational biology and pharmacological sciences.  While at Northwestern University, Dr. Chico was the recipient of a National Institutes of Health traineeship and the only student to complete a novel combined training program in engineering and life sciences.  Her prior accomplishments in the biotechnology and life sciences industries include successful project management experience in a production environment and advancing software deliverables from concept to deployment.

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Lecturer:

Designing Small Molecules with Increased Potential for CNS Penetration

Tim Coetzee, PhD, MS Fast Forward (confirmed)

Dr. Timothy Coetzee is the President of Fast Forward, LLC, a venture philanthropy of the National Multiple Sclerosis Society.  In this capacity, Dr. Coetzee is responsible for the Society’s strategic funding of biotechnology and pharmaceutical companies as well as partnerships with the financial and business communities.  Prior to assuming his current position, Dr. Coetzee led the Society’s translational research initiatives on nervous system repair and protection in MS as well as the Society’s programs to recruit and train physicians and scientists in MS research.  Dr. Coetzee received his PhD in molecular biology from Albany Medical College in 1993 and has since been involved in the field of multiple sclerosis research.  He was a research fellow in the laboratory of Society grantee Dr. Brian Popko at the University of North Carolina at Chapel Hill, where he received an Advanced Postdoctoral Fellowship Award from the Society.  After completing his training with Dr. Popko, Dr. Coetzee joined the faculty of the Department of Neuroscience at the University of Connecticut School of Medicine, where he conducted research that applied new technologies to understand how myelin is formed in the nervous system.  He is the author of a number of research publications on the structure and function of myelin.  Dr. Coetzee joined the National MS Society’s Home Office staff in the fall of 2000

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Panelist:  

Developing Biologics

MS Case Study

Mark Creswell, PhD, IDSC Biotech Network (confirmed) 

Mark Creswell is the founder, President and CEO of IDSC.  Mark’s 20 years Big Pharma experience began at Warner-Lambert's Ann Arbor, Michigan facility. While working in many therapeutic areas including cardiovascular, antibacterials, oncology, and CNS, Mark held many positions of increasing responsibility. In 1998, Mark accepted the responsibility of building and managing Warner-Lambert's Discovery Chemistry Outsourcing Program. He and his team pioneered the art of managing a successful outsourcing program that brought tremendous value to Warner-Lambert. Following the Pfizer acquisition of Warner-Lambert, Mark was instrumental in forming a centralized global sourcing team. Following the closure of the Pfizer Ann Arbor facility, Mark founded IDSC.

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Lecturer:

How to Outsource Early Drug Discovery

Kathleen Denis, PhD, Rockefeller University (confirmed)

Kathleen A. Denis, PhD, is the Associate Vice President of Technology Transfer at The Rockefeller University, a premier biomedical research institution located in New York City.  She is a Past President of the Licensing Executives Society USA/Canada (LES), and has served on the Board of Directors of the Association of University Technology Managers (AUTM) and the Pennsylvania Biotechnology Association.  She is a Certified Licensing Professional. Specializing in the management of intellectual assets in the life sciences, she has worked with academic institutions and industry clients to manage intellectual property portfolios, evaluate new technologies, market and license technologies and start new technology-based businesses. Dr. Denis is active in numerous professional organizations and speaks frequently about early stage technology evaluation, formation of start-up companies, conflict of interest and other issues of academic technology transfer.   Dr. Denis holds a Ph.D. in immunology from the University of Pennsylvania, an M.A. in Human Genetics from University of Texas Medical Branch at Galveston and an undergraduate degree in genetics from Cornell University. 

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Chair:

 Issues in Technology Transfer: Interactions and Intellectual Property

Lecturer:

Working Effectively with Your TTO: Roles and Responsibilities

Howard Fillit, MD, Alzheimer's Drug Discovery Foundation (confirmed) 

Howard Fillit, MD, a geriatrician and neuroscientist, is the founding Executive Director of the Institute for the Study of Aging, Inc. as well as its affiliated public charity the Alzheimer’s Drug Discovery Foundation, both of which are dedicated to funding drug discovery for Alzheimer's disease. Dr. Fillit was formally the Corporate Medical Director for Medicare at NYLCare Health Plans (now a division of Aetna, Inc.), where he was responsible for over 125,000 Medicare members in 8 regional markets. He has also had a distinguished academic career at The Rockefeller University and The Mount Sinai Medical Center (NY), where he is currently a clinical professor of geriatrics and medicine and a professor of neurobiology. Dr. Fillit has received many awards and honors, including the Rita Hayworth Award for Lifetime Achievement from the Alzheimer's Association. He is a fellow of the American Geriatrics Society, the American College of Physicians, the Gerontological Society of America, and the New York Academy of Medicine. Dr. Fillit is the author or co-author of more than 250 publications, including the leading international Textbook of Geriatric Medicine and Gerontology. He served as a consultant to a variety of individuals, managed care organizations, health care systems, and pharmaceutical and biotechnology companies.

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Course Director

Lecturer:

Venture Philanthropy

Marcie Glicksman, PhD, Brigham & Women's Hospital and Harvard Medical School  (confirmed)

Marcie Glicksman is Senior Director, Leads Discovery Group at LDDN. Dr. Glicksman has extensive experience in assay development, high throughput screening, chemical databases, animal pharmacology and preclinical development. Her bachelor’s degree is from Brown University and Ph.D. from Washington University.  Before joining LDDN in 2004, she had been in industry for thirteen years. Previously, she was at the start-up company, Descartes Therapeutics focused on imaging techniques. Before this, she was Director of Leads Discovery at Cubist.  Before this, she was at DuPont-Merck and at Cephalon, Inc. She led the assay development and screening program for a cell-based protease project, and numerous G-protein coupled receptors, many of which were continued when Bristol Myers Squibb bought DuPont Pharmaceuticals. At Cephalon, she was co-inventor of CEP1347, a neuroprotective agent directed at a novel kinase, currently in Phase III clinical trials.  She also consults for industry.  She is a board member of the non-profit drug discovery organization Society for Biomolecular Screening and currently serves as the Chairman.

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Chair:

In-vitro Testing: Early Phases of Drug Discovery

Lecturer:

Developing Relevant High-Throughput Assays for the Identification of Potential Drug Candidates

Taleen Hanania, PhD, PsychoGenics (confirmed)

Taleen Hanania received her Ph.D. in Pharmacology at the University of Texas Medical Branch, Galveston. She completed her post doctoral training and was a faculty member of the Department of Pharmacology at the University of Colorado Health Sciences Center in Denver. Dr. Hanania has extensive neuropharmacology and behavioral pharmacology experience in various neuropsychiatric areas and has been instrumental in establishing and validating many of PsychoGenics' behavioral tests. Currently she is Senior Director of Pharmacology at Psychogenics Inc where she leads a team specialized in behavioral phenotyping new lines of mice and rats and also drug screening novel therapeutic compounds in rodent models of psychiatric and neurodegenerative disorders.

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Lecturer:

Behavioral Testing in Neurodegenerative Disease

Frank Longo, MD, PhD, Stanford University (confirmed)

Dr. Longo received his MD in 1981 and PhD in Neurosciences in 1983 from the University of California, San Diego. Following an internship in medicine at NYU/VA, he trained as a resident in neurology and fellow in neurobiology at University of California, San Francisco. While at UCSF he created the Neurogenetics Clinic which was the first West Coast site in the U.S. to offer DNA testing for families with Huntington’s disease. He also led the creation of a national referral center for deep brain stimulation for Parkinson’s disease and contributed to the development of programs in dementia, epilepsy and other areas. At UCSF he became professor and vice chair of the Department of Neurology and in 2001 he was recruited to become chair of the Department of Neurology at the University of North Carolina, Chapel Hill. While at UNC, Dr. Longo launched or expanded programs for Alzheimer’s disease and other dementias, stroke, epilepsy, sleep disorders, multiple sclerosis and Parkinson’s disease. In January 2006, Dr. Longo became chair of the Department of Neurology and Neurological Sciences at Stanford where he is focused on building and expanding multidisciplinary programs in neurology and neuroscience. In 2006 he was named a Stanford Fellow. Dr. Longo’s research team focuses on elucidating novel mechanisms that prevent neural degeneration and promote regeneration. He and his colleagues have pioneered the development of small, drug-like, molecules that target neurotrophin receptors to delay onset of or slow progression of Alzheimer’s and other neurodegenerative disorders.

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Moderator and Presenter:

Target Validation to Lead Optimization

AD Case Study

William Matthew, PhD, National Institute on Neurological Disorders and Stroke (confirmed)

William Matthew, Ph.D. is the Director of the Office of Translational Research at The National Institute of Neurological Disorders and Stroke (NINDS).  Dr. Matthew holds a Ph.D. in biochemistry from the University of California, San Francisco.  At the beginning of his career, Dr. Matthew helped pioneer the use of antibodies as tools for neuroscience research and as therapies for neurological disease.  In the early 1980s, as a professor at Harvard Medical School, he was among the first to develop antibodies that modulate the function of neural proteins in animal models of neural injury.  In 1990, Dr. Matthew moved to Duke University Medical Center to help establish the Neurobiology Department.  With further refinements in immunologic methods, his lab was the first to create agonist antibodies capable of facilitating recovery functions of both neuronal and glial cells after injury.  In 1998, Dr. Matthew became scientific director of The George and Jean Brumley Neonatal-Perinatal Research Institute within Duke’s Department of Pediatrics.  The mission of the Institute was to apply principles of cellular and molecular developmental neurobiology to improve recovery from hypoxia in neonatal intensive care medicine.   Throughout his academic career Dr. Matthew was active in graduate and undergraduate teaching; he was the director of graduate studies at both Harvard and Duke and a member of the executive committee of the M.D./Ph.D. Program at Duke.  In 2001, Dr. Matthew was recruited to Schwarz Pharma (Monheim, Germany) to lead CNS Business Development and to transition the company from a generic drug-based enterprise to a specialty pharmaceutical company.  Dr. Matthew was integral to creating and building Schwarz Biosciences, an international research and development division.  Prior to joining NINDS he was Vice President of R&D Partnering and Business Development at UCB, a biopharmaceutical company based in Brussels.

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Lecturer:

Resources at the National Institute of Health

Lisa Minor PhD, Johnson & Johnson (confirmed)

Dr. Lisa Minor joined Johnson and Johnson directly following her postdoctoral studies at Medical College of Pennsylvania.  During her 21 years at Johnson and Johnson she was involved in target identification, assay development and screening, and secondary pharmacology.  She has been responsible for developing biochemical and cell based assays for target identification, high throughput screening and lead optimization and has been instrumental in developing new technologies for cell-based assays.  Included are assays to measure the translocation of G protein coupled receptors from the membrane to the cytoplasm using cell-based image analysis as well as developing an HTS mRNA detection assay using branched DNA and has recently been involved in exploring the use of label free tools for cell based assays.  Dr. Minor is a past Board member of the Society for Biomolecular Sciences.

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Lecturer:

Role of In Vitro Models in Drug Discovery for Neurodegenerative Disease

Colleen Niswender, PhD, Vanderbilt University (confirmed)  

Colleen Niswender obtained her Ph.D. in pharmacology in the lab of Dr. Ronald Emeson at Vanderbilt, studying the regulation of RNA editing in the mammalian central nervous system and characterization of molecular determinants regulating RNA editing events within the AMPA subtype glutamate receptor, GluR2, and the G protein-coupled 5HT 2C serotonin receptor. She then pursued postdoctoral studies with Dr. G. Stanley McKnight at the University of Washington, focusing on the study of Protein Kinase A signal transduction using recombinant mouse lines and genetically engineering mutations within the PKA enzyme. She joined the Vanderbilt Program in Drug Discovery in 2004 and has focused on the development of high throughput-compatible assays to search for ligands specific for G protein-coupled receptors (GPCRs) of the muscarinic and metabotropic glutamate receptor families. Currently, she directs the Molecular Pharmacology group within the Vanderbilt Program in Drug Discovery and is particularly interested in the concepts of functional selectivity and context-dependent pharmacology of allosteric modulators. She is also the biology project team leader for a Linked Efforts to Accelerate Parkinson’s Solutions (LEAPS) program dedicated to the development of small molecule modulators of metabotropic glutamate receptor 4 for symptomatic and disease-modifying treatment of Parkinson’s disease.

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Moderator and Presenter:

Pre-Clinical to IND Enabling

PD Case Study

Gary Olson, PhD, Provid Pharmaceuaticals, Inc. (confirmed)  

Dr. Gary L. Olson is a medicinal chemist and President & CEO of Provid Pharmaceuticals. He received his A.B. in chemistry from Columbia and his Ph.D. in organic chemistry from Stanford.  He spent 26 years at Hoffmann-La Roche, becoming Research Director in the departments of Inflammation/Autoimmune Diseases and Oncology.  In 1998 joined Praecis Pharmaceuticals as Sr. Vice President of Chemistry. In 2001, he co-founded Provid (North Brunswick, NJ) and initiated the company’s efforts in autoimmune disease therapeutics that has led to the discovery of PV-267, the company’s drug candidate for multiple sclerosis.  Dr. Olson has published over 40 papers in scientific journals and holds over 50 U.S. patents and applications. He has held an Adjunct Professorship at Rutgers in the School of Pharmacy and is a member of the board of the Residential School on Medicinal Chemistry at Drew University. 

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Moderator and Presenter:

Developing Biologics

MS Case Study

Euan Ramsey, PhD, Centre for Drug Research and Development (CDRD) (confirmed)  

Dr. Euan Ramsay holds the position of Grant Development Scientist at the Centre for Drug Research and Development (CDRD), based in Vancouver, British Columbia, Canada. CDRD guides and supports early-stage drug development from leading academic and health research institutions to increase the successful commercialization of new therapeutics. In his current position, Euan is responsible for sourcing projects with exceptional therapeutic and commercial potential, and securing funding partnerships for academic drug discovery and development.  Prior to joining CDRD, Euan was a Senior Scientific Fellow in the Department of Advanced Therapeutics, at the British Columbia Cancer Agency where his research interests focused on the lipid nanoparticle delivery of anticancer drug combinations. Euan is the inventor on two patents, one of which describes a novel anticancer agent that has been developed in an academic setting and will enter Phase 1 clinical trials in 2010. In addition, he is an author on 20 papers and has written and contributed to grants that have secured funding in excess of $30 million.  Euan has an undergraduate degree (B.Sc. Hons) in Pharmacy from Strathclyde University, Glasgow, Scotland (1992) and a Ph.D. in Non-Viral Gene Therapy from the Welsh School of Pharmacy, Cardiff University, Wales (1999).

Lecturer:

Academic Models of Drug Discovery Services

Lorenzo Refolo, PhD, National Institute on Aging, Division of Neuroscience (Dementia Branch) (confirmed)  

Dr. Lorenzo M. Refolo received a BSc. from the University of Connecticut, and was awarded a Ph.D. in Molecular Genetics from the Department of Molecular Genetics at the Rutgers University School of Medicine and Dentistry. Subsequently, Dr. Refolo trained as a post-doctoral fellow at Mt Sinai Medical Center in New York, investigating the molecular and cell biology of the Alzheimer’s Amyloid Precursor Protein. After concluding his post-doctoral training Dr. Refolo served as Transgenics Group Leader at Athena Neurosciences and later held faculty positions at the Mayo Clinic Jacksonville and New York University’s Nathan Kline Institute for Psychiatric Research In 2001, Dr. Refolo was named the Scientific Director at the Institute for the Study of Aging, a private, disease-focused foundation with a mission to fund the discovery and clinical development of drugs for the treatment of Alzheimer’s disease.  Since 2005, Dr. Refolo has been Program Director in the Neurodegeneration Cluster at NINDS where his major responsibility was the management of a portfolio of grants on ALS, Alzheimer’s and Parkinson’s diseases and Vascular Cognitive Impairment.  In 2009, Dr. Refolo joined NIA, the Division of Neuroscience, Dementia Branch.

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Chair:

Resources and Services For Advancing Drug Discovery

Susan P. Rohrer, PhD, Merck Research Laboratories (confirmed)

Susan Rohrer obtained her undergraduate degree in biology at the University of Michigan and her graduate degree in biochemistry at the University of Notre Dame.  She joined the Merck Research Laboratories in 1987 to work on the biochemical isolation of the receptor for Merck’s antiparasitic agent known as ivermectin.  She subsequently contributed to the development of small molecule analogues of somatostatin as potential agents for the treatment of diabetes and diabetic retinopathy and to the identification of selective estrogen receptor modulators for use as safer alternatives to currently available hormone replacement therapies. 

Susan joined External Scientific Affairs as liaison for Neuroscience Licensing in September 2004.  She chairs Merck's Neuroscience Review and Licensing Committee and is responsible for identifying external licensing opportunities aligned with priorities and needs of the Neuroscience Franchise.  Her recent major licensing deals include Neuromed (NMED-160 patent license and research collaboration), Gladstone Institute of Neurological Disease (patent license and research collaboration covering ApoE mechanisms involved in neurodegenerative diseases),  Addex mGluR5 (patent license covering mGluR5 PAMs for schizophrenia) and Addex mGluR4 (patent license and research collaboration covering mGluR4 PAMs for Parkinson's disease).

Lecturer:

What Companies Look for in a Licensing Partner

Lee Rubin, PhD, Harvard University (confirmed)  

Dr. Rubin received his Ph.D. in Neuroscience from The Rockefeller University and completed postdoctoral fellowships in Pharmacology from Harvard Medical School and in Neurobiology from Stanford University School of Medicine. He was then an Assistant and Associate Professor at Rockefeller University. Subsequently, he joined Athena Neurosciences (now Elan Pharmaceuticals) as head of their blood-brain barrier (BBB) and multiple sclerosis groups, ultimately initiating a project to discover an antibody that blocks lymphocyte trafficking across the BBB.  This work successfully identified an anti-integrin antibody, now known as Tysabri, which has been approved for treatment of multiple sclerosis and more recently, for Crohn’s disease.  After leaving Athena, he became Professor of Anatomy and Developmental Biology at University College London and Director of the Eisai London Laboratory of Neurodegenerative Disease.  This institute was sponsored by Eisai Co., a major Japanese pharmaceutical company, and focused on discovering novel therapeutic approaches for diseases of the nervous system. In 1998, he returned to Boston as Chief Scientific Officer of Ontogeny, Inc (now Curis, Inc) a biotechnology company in Cambridge, MA, founded by Dr. Douglas Melton, a well-known stem cell and developmental biologist. Dr. Rubin's work there centered on the hedgehog (Hh) pathway and its involvement in cancer and neurodegenerative disease.  Potent small molecule Hh antagonists were identified and partnered with Genentech for clinical development.  Two INDs were submitted, and one phase II study is currently underway for an orally available Hh antagonist used to treat solid tumors.  Small molecule Hh agonists were also identified and partnered with Wyeth Pharmaceuticals for development, with stroke as the initial lead indication.  In July 2006, Dr. Rubin moved to the Harvard University Stem Cell Institute as Director of Translational Medicine and is a member of the new Department of Stem Cell and Regenerative Biology.  Much of his effort there is devoted to identifying therapeutics for orphan neural disorders such as Spinal Muscular Atrophy, Amyotrophic Lateral Sclerosis, Huntington’s Disease and multiple sclerosis using new kinds of stem cell-based screens. He also directs a group that carries out a broad set of stem cell differentiation assays with numerous other members of the Harvard Stem Cell Institute.

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Plenary Speaker

Stem Cells to Accelerate Drug Discovery for Neurodegenerative Disease

Colin G. Sandercock, Perkins Coie LLP (confirmed) 

Colin G. Sandercock is a partner in the Patent litigation group of Perkins Coie LLP, co-chair of our Life Sciences Group, and practices in the area of life sciences, including licensing, patent and trademarks, and intellectual property. Colin was recently named in The Best Lawyers in America in the field of biotechnology law. Since 1984, Colin has counseled clients in life science matters including district court litigation, interferences, licensing and the management of domestic and foreign patent portfolios. His technical experience includes biotechnologies, pharmaceutical chemistry, organic and inorganic chemistry, medical devices, and chemical and biochemical engineering. Colin has served as an adjunct professor of law at George Washington University Law School, lecturing on the licensing of intellectual property rights. Colin served on the AAA Patent Advisory Committee for patent disputes, and previously chaired the Electronic Records ad hoc Subcommittee of the AIPLA Interference Committee. He also chaired the Annual Electronic Records Conferences in London in 1999, 2000, 2002 and 2004. He has served as legal counsel to CENSA (Collaborative Electronic Notebook Systems Association) and frequently lectures on the topics of electronic record keeping for use in research, litigation and interferences.

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Lecturer:

Intellectual Property 101: A Primer For Investigators

Todd Sherer, PhD, Michael J. Fox Foundation for Parkinson's Research  (confirmed)  

Dr. Todd Sherer joined the Foundation as Associate Director, Research Programs, in April 2004, and was promoted to Vice President, Research Programs, in June 2006.   Dr. Sherer earned his undergraduate degree in psychology from Duke University and his PhD in Neuroscience from the University of Virginia. His thesis work focused on neurotrophins and cell death pathways in neurodegenerative disease. Dr. Sherer then became a postdoctoral fellow at the Emory University laboratory of Timothy J. Greenamyre.  During this fellowship, Dr. Sherer concentrated on understanding the role of environmental factors in Parkinson’s disease, as well as on the development of PD model systems. As a result of this work, Dr. Sherer was awarded a Postdoctoral Fellowship from The Michael J. Fox Foundation for Parkinson’s Research. Dr. Sherer is the author of over 20 research articles in the field of neurodegeneration with a focus on Parkinson’s disease.

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Chair:

Case Studies

Edward Spack, PhD, MS Fast Forward (confirmed)

Edward Spack, PhD received his doctoral degree from The Johns Hopkins University and his postdoctoral fellowship in cellular immunology at Stanford University.  He worked in Bay area biotech companies for 14 years developing therapies for autoimmunity, cancer, and infectious disease spanning discovery and preclinical development through Phase III trial support.  At SRI International, Dr. Spack directed the PharmaSTART program, a consortium of SRI, Stanford, UC Berkeley, UC San Diego, and UC San Francisco chartered to support translational development.  His responsibilities included designing preclinical development plans for academic researchers, foundations, NIH programs, and start-up companies.  He consulted with the NIH translational core services committee and several individual NIH institutes on preclinical development and served as an advisor on the NIH Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Produce Development Working Group. As Sr. Director of Business Development for SRI’s Bioscience Division, Dr. Spack was responsible for alliance management, in-licensing, and out-licensing of drug candidates.  He has served on scientific advisory boards, grant review boards, or national board of directors for several foundations, and is currently a managing director at Fast Forward LLC, supporting a translational development program advancing therapeutics for the prevention/reversal of neurodegeneration in multiple sclerosis in partnership with EMD Serono.   

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Chair:

Pre-Clinical Proof-of-Concept & Development

Lecturer:

The Basics of Pre-Clinical Development

Karen L. Steinmetz, PhD, DABT, SRI International (confirmed)

Dr. Karen Steinmetz, PhD, DABT, has over 25 years experience in the fields of early drug discovery, safety and preclinical development in a wide variety of pharmaceutical products. She has served as Study Director on numerous GLP studies in support of regulatory applications worldwide, as Principal Investigator on NIH preclinical testing contracts including those with the National Institute on Aging and National Institute of Diabetes & Digestive & Kidney Diseases, and as the preclinical representative on industrial project teams.  Dr. Steinmetz holds a doctorate in toxicology from Indiana University. Her industrial background includes overseeing preclinical development activities and IND preparation for several San Francisco Bay Area biotechnology pharmaceutical companies.  Dr. Steinmetz’ is currently the Director of the Mammalian Toxicology Program at SRI International in Menlo Park, CA.

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Lecturer:

In Vitro Toxicity Testing: What, Why & How

John S. Swartley, PhD, University of Pennsylvania (confirmed)

John S. Swartley, MBA, PhD, is Senior Director of New Ventures at the Center for Technology Transfer at the University of Pennsylvania, where he leads a team that fosters the formation of new ventures based on Penn technologies and faculty expertise.  Prior to joining Penn in 2007, Dr. Swartley served as Senior Vice President and Partner of BCM Technologies (BCMT), the venture capital investment subsidiary of Baylor College of Medicine.  Dr. Swartley joined BCMT in 2003 from the Yale University Office of Cooperative Research where he served as Associate Director of the Medical Campus. Dr. Swartley has participated in the formation and oversight of more than two dozen university spin-out companies that have collectively raised nearly one billion dollars of investment capital. He holds a B.S. in Biology from Bates College, an MBA from the Goizueta School of Business at Emory University, and a Ph.D. in Microbial & Molecular Genetics from Emory University.

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Lecturer:

Should You Start a Biotechnology Company?

Leticia M. Toledo-Sherman, PhD, CHDI Foundation (confirmed) 

Leticia Toledo-Sherman directs drug discovery projects at CHDI combining her expertise in the areas of medicinal and computational chemistry. Before joining CHDI in 2005, she was Executive Director of Chemistry at LymphoSign Inc., where she managed medicinal and computational chemistry as well as associated research relationships. Prior to LymphoSign Inc, Toledo-Sherman directed drug design and discovery activities at Protana Inc. (formerly MDS Proteomics). There, she led several successful discovery and lead optimization projects and managed the company's Chemical Proteomics program. The latter involved a multidisciplinary team working at multiple sites. Before Protana, Toledo-Sherman worked at Kinetix Pharmaceuticals Inc. (acquired by Amgen in December 2000), one of the earliest successful biotech companies to focus exclusively on targeted kinase inhibition. While at Kinetix, she designed and implemented a Computer-Aided Design and Virtual Screening platform that led to the discovery of several novel potent small molecule inhibitors of protein kinases. Toledo-Sherman holds a PhD in Organic Chemistry from SUNY Stony Brook. She did postdoctoral research at MIT and the Skaggs Institute of Chemical Biology at The Scripps Research Institute.

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Lecturer:

Funding and Other Challenges for Rare Diseases

D. Martin Watterson, PhD, Northwestern University  (confirmed)

Dr. Watterson is Co-Director of the University Center for Drug Discovery and Chemical Biology and holds the John G. Searle Endowed Chair in Molecular Biology and Biochemistry at Northwestern University.  He also is a Professor of Molecular Pharmacology and Biological Chemistry in the Northwestern University Feinberg School of Medicine in Chicago. Dr. Watterson has published articles in peer-reviewed journals in the areas of drug discovery, signal transduction, structural biology, pharmacology and medicinal chemistry. His Ph.D. training was in the areas of Biophysical Chemistry and Biochemical Pharmacology at Emory University, followed by postdoctoral training at Duke University Medical Center supported by a National Research Service Award in Neurosciences from the National Institutes of Health 1975 to 1977.  Dr. Watterson held the positions of Assistant Professor and Associate Professor at The Rockefeller University from 1978-1982 where he was an Andrew Mellon Fellow.  He later was a Howard Hughes Investigator and Professor of Pharmacology at Vanderbilt Medical Center before moving to Northwestern University in 1994.  In his role as Co-Director of the Center for Drug Discovery and Chemical Biology, Dr. Watterson has facilitated the development of novel compounds emanating from Center investigators and their movement towards the clinic. Center investigators experiences span the range of the entire drug discovery and development spectrum, including novel compound discovery, candidate compound optimization, preclinical IND-enabling studies, clinical trials, and FDA approval.

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Chair:

Basics of Medicinal Chemistry

Nancy Wehner, PhD, Elan Pharmaceuticals (confirmed)  

Dr. Wehner received her PhD degree in Immunology from the University of Minnesota (Minneapolis, MN) in 1987.  Her post-doctoral fellowship was at the same institution in the Department of Chemistry.  Dr. Wehner began her career in medical diagnostics research with Sanofi Diagnostics Pasteur where she specialized in assay development for autoimmune disease diagnosis.  Following a move to California, she joined Anergen where she was head of Bioanalytical Assays (clinical and nonclinical support services), Quality Control, and Pharmacology & Toxicology.  While there, she was responsible for the development of monoclonal antibodies, complex biologics and vaccines for the treatment of autoimmune diseases.  Dr. Wehner moved to Elan Pharmaceuticals, South San Francisco, CA where she held the position of Vice President of Nonclinical Safety Evaluation and was responsible for pharmacology and toxicology programs in support of the development of biologic and small molecule drug products in the areas of autoimmunity and neurology. Dr. Wehner is currently working as an independent consultant doing business as Nancy Wehner Nonclinical Consulting Services.

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Lecturer:

Requirements for a Lead Compound to Become a Clinical Candidate