James C. Barrow is an Investigator in the Drug Discovery Division of the Lieber Institute and an Associate Professor of Pharmacology at Johns Hopkins University. Dr. Barrow leads the medicinal chemistry, biology, and drug metabolism activities of the Lieber Institute Drug Discovery Division, with the goal of validating novel mechanisms and advancing treatments for disorders of brain development. He received his PhD from Harvard University, working with Professor David A. Evans and then moved to Merck Research Laboratories. Dr. Barrow worked on drug discovery projects for cardiovascular and central nervous system disorders. His team advanced several compounds into clinical development, including MK-8998, which was investigated in phase two clinical trials as a potential antipsychotic. Dr. Barrow is an author on more than 40 publications and an inventor with 19 issued patents.
Diane Bild is a Senior Program Officer in the Clinical Effectiveness Research program at PCORI. The program supports research that compares the effectiveness and safety of alternative healthcare options to enable patients and providers to make informed healthcare decisions. Dr. Bild has almost 30 years of experience supporting and conducting research in chronic disease epidemiology and prevention. She joined PCORI from the National Heart, Lung and Blood Institute at the National Institutes of Health (NIH), where she oversaw a program of research in cardiovascular epidemiology, prevention trials and health services research. Prior to that, she was a medical officer at the Centers for Disease Control in the Division of Diabetes Control, where she focused on macrovascular complications of diabetes. Her professional interests and research topics include cardiovascular disease epidemiology and prevention, subclinical cardiovascular disease, ethnicity and disease and diabetes. She has authored more than 80 publications in these areas. She received her bachelor’s degree from the University of Illinois at Champaign-Urbana, her MD from the University of Illinois in Chicago, and her MPH in epidemiology at the University of Michigan. She trained in internal medicine at the Medical College of Wisconsin in Milwaukee.
Kenneth G. Carson earned a PhD from Cornell University under the guidance of Bruce Ganem. He then joined LeukoSite, Inc. where he worked on several inflammation-related projects such as integrin antagonists and chemokine receptor antagonists and contributed to nomination of several compounds for development (most notably CCR1 antagonists). In 2004, Dr. Carson joined Lexicon Pharmaceuticals to lead immunology chemistry. During this time, the team discovered sphingosine-1-phosphate lyase inhibitor LX2931, which entered clinical studies for rheumatoid arthritis. In 2007, he rose to Vice President of Medicinal Chemistry and took over the leadership of the medicinal chemistry group at Lexicon. His group has nominated multiple programs for clinical development in a variety of therapeutic areas.
Wayne E. Childers is Associate Professor of Pharmaceutical Sciences at the Temple University School of Pharmacy and Associate Director of the Moulder Center for Drug Discovery Research. He earned his PhD in organic chemistry from the University of Georgia in 1984, followed by a post-doctoral fellowship in bio-organic chemistry in the Department of Pharmacology at Johns Hopkins School of Medicine. Over the next 23 years at Wyeth Research he worked as a medicinal chemist on several drug discovery projects including anxiety, depression, stroke, Alzheimer’s disease and neuropathic pain. He served as a team leader on four projects that advanced candidates to clinical trials. In 2010, Dr. Childers joined Temple, where he helped establish the Moulder Center, a fully enabled academic drug discovery center that combines the efficiency, teamwork-based business model and state-of-the-art technology with the innovation of academia. He and his colleagues are currently pursuing drug discovery projects with a number of academic and industrial collaborators in cancer, Alzheimer’s disease, infectious disease, metabolic disorders, hyperlipidemia and PET/SPECT imaging ligand design.
E. LaBrent Chrite is the Dean of the School of Business and a Professor of Management and International Business at Montclair State University. Prior to joining Montclair State, Dr. Chrite was the Gemelli Faculty Fellow and Associate Dean for graduate programs at the Eller College of Management at the University of Arizona. He also spent 14 years at the University of Michigan and was the director of the School’s flagship research and outreach institute, the William Davidson Institute, focusing on the transformation of transition and emerging market economies. Dr. Chrite has been actively Moderators and Panelists involved in academic leadership, research, teaching and technical assistance engagements in emerging and transition markets around the world. He has worked extensively with business leaders, policy makers and entrepreneurs in an effort to harness the energy and the dynamism of the private sector toward the alleviation of poverty and the investment in human capital. He has led research and development projects in dozens of countries in sub Saharan Africa, the Middle East, Central Asia, Central and Eastern Europe and Russia. Dr. Chrite completed his undergraduate work at Michigan State University, his MS at the University of Missouri-Columbia and his PhD at the University of Michigan.
Robert M. Goldberg is Vice President and Co-Founder of the Center for Medicine in the Public Interest (www.cmpi.org), a non-profit organization that advocates for consumer access to medical innovation, better health information and personalized healthcare. He is also the founder of CMPI’s Value of Medical Innovation initiative (valueofinnovation.org) that promotes MPI. Goldberg was Director of the Manhattan Institute’s Center for Medical Progress and Chairman of its 21st-Century FDA Task Force that examined the impact of the FDA’s Critical Path Initiative on drug development and personalized medicine. His academic research focuses on the value of personalized medicine and medical innovation to longevity, economic growth and Social Security. He is the author of Tabloid Medicine: How the Internet is Being Used To Hijack Medical Science for Fear and Profit (Kaplan, 2011). Dr. Goldberg received his PhD in Politics from Brandeis University in 1984, is a devoted Yankee fan, and father of two children, Sara, 28 and Zach, 24.
David Kimball is currently Associate Vice President for Interdisciplinary and Translational Science at Rutgers University’s School of Pharmacy. The mission of his team is to build value in collaborative biomedical research at Rutgers to enable highly competitive grant applications, and to use molecular imaging technologies, chemical synthesis and other enabling technologies to support the successful growth of biomedical startups in the State of New Jersey. Prior to joining Rutgers in 2011, Dr. Kimball spent 30 years in the pharmaceutical and biotech industry in various capacities in drug discovery and development. Dr. Kimball spent 19 years at Bristol-Myers Squibb in cardiovascular research and as a Research Fellow in oncology drug discovery. He holds a PhD in Organic Chemistry/Chemical Biology from the State University of New York at Stony Brook.
Leslie Levin is Vice President of Health Quality Ontario’s (HQO’s) Evidence Development and Standards division, which provides an evidentiary platform for health-related policy and funding decision-making. Dr. Levin works closely with the leadership of the health system, academia, industry and with government. He was instrumental in creating the Ontario Health Technology Advisory Committee (OHTAC), which advises HQO and the Ministry of Health and Long-Term Care on the adoption of all non-drug health technologies including health system changes and more recently in creating the Excellence in Clinical Innovation and Technology Evaluation (EXCITE) program housed at MaRS. The EXCITE program provides pre-market evidence based assessment of new health technologies as a collaboration between industry and academia, government and the broader health system. Dr. Levin is a Professor in the Department of Medicine, University of Toronto, and is a senior consultant in medical oncology at the Princess Margaret Hospital. He was the recipient of the 2012 Excellence through Evidence award by the Canadian Health Services Research Foundation.
Gilbert J. L’Italien is Executive Director, Global Health Economics and Outcomes Research at Bristol-Myers Squibb. He earned his doctorate in Epidemiology/Biostatistics from the Boston University School of Public Health. Dr. L’Italien brings over 25 years of observational research experience to his role and has published and presented extensively in the clinical, pharmacoepidemiology and health outcomes fields. Dr. L’Italien is also Adjunct Assistant Professor at Yale University Medical School and Affiliated Faculty member for the Robert Wood Johnson Clinical Scholars Program at Yale. In 2013, he was a member of the team that participated in a EUnetHTA early (payor) dialogue in support of a rheumatoid arthritis drug currently in clinical development. In 2003, he received the Bristol-Myers Squibb Ondetti and Cushman Award for the creation of a database function unique to the pharmaceutical industry. In 2006, he received the Bristol-Myers Squibb Distinction Award for design and conduct of the first BMS comparative effectiveness trial (STAR) of antipsychotic treatments in schrizophrenia patients. He has served in an advisory capacity on several committees: AHRQ/ CERT, Green Park Collaborative, Tapestry, the Viral Hepatitis Action Coalition and The Multiple Sclerosis Outcome Assessments Consortium (M.S.OAC). Most recently, in collaboration with the CDC Foundation, Dr. L’Italien co-developed an economic model that contributed to a favorable recommendation by the USPTF on universal screening for Hepatitis C. Prior to joining BMS, he was the Director of Vascular Research at Massachusetts General Hospital and held a faculty appointment at Harvard Medical School Dr. L’Italien’s current research interests focus on use of large scale databases for comparative effectiveness research, predictive modeling, and the application of prognostic and predictive biomarkers to clinical trial development and real world research. His policy goals focus on strengthening public/private partnerships to enhance patient centered research. As a volunteer researcher, he recently designed and led a public health intervention that effectively treated 3,000 indigenous adults and children in rural Mexico to ameliorate the burden of soil transmitted helminthes.
Andrew MacKnight is the Chief Strategy Officer at Coriell Institute. In this role, he is charged with supporting the Institute’s business operations while also identifying opportunities for market expansion. Mr. MacKnight has expertise in business and market development and advances the Coriell mission by implementing strategic initiatives designed to stimulate operational growth, cultivating productive new partnerships, and assessing and optimizing best practices. Mr. MacKnight has held prominent leadership positions within the biopharmaceutical industry. He served as Vice President of Marketing for the clinical services company Covance and the Vice President of Strategic Marketing for Thermo Fisher Scientific, a leading life sciences company. In addition, he spent eight years with GlaxoSmithKline, ascending to the position of executive product director of U.S. vaccines, where he was responsible for the public health and vaccines policy team. Immediately prior to joining Coriell, Mr. MacKnight led strategy and integration operations at InVentiv Health Clinical, a leading global clinical research organization. Mr. MacKnight earned his degree in philosophy from the University of Glasgow in Scotland. Cheryl Maiello is the Associate Director/U.S. Team Lead Staffing, Global Development for Novartis Pharmaceuticals Corporation. She graduated from Montclair State University in 1997 with a degree in Communications. She was a member of the MSU Field Hockey Team and an honors member of Lambda Pi Eta. Mrs. Maiello has been with Novartis since 2008 supporting Global Development in staffing. Previously, she was with ImClone Systems and NPS Pharmaceuticals as a Senior Human Resources Generalist. She was co-chair for the Working Parents Connection Employee Resource Group for three years and active participant in other diversity and inclusion initiatives. Mrs. Maiello is the mother of two boys, ages eight and six.
Avinandan Mukherjee is Professor and Chair of the Marketing Department at the Montclair State University School of Business. Dr. Mukherjee is the Founding Editor-in-Chief of the Emerald journal – The International Journal of Pharmaceutical and Healthcare Marketing. This double-blind-reviewed scholarly research journal is dedicated to advancing theoretical and empirical understanding of marketing pharmaceutical products and healthcare services. Before joining Montclair State, Dr. Mukherjee was a full-time faculty member of Marketing at Pennsylvania State University, University of Bradford (UK), Nanyang Technological University (Singapore) and the Indian Institute of Management (India). He has a doctoral degree in Marketing from the Indian Institute of Management (Ahmedabad), and was a visiting doctoral scholar at the ESSEC Business School, France. He is an Electrical Engineer by background and has worked with ABB (a Fortune 500 company) as Marketing Manager. Dr. Mukherjee’s research and teaching interests include healthcare services, patient compliance strategies, digital healthcare, and pharmaceutical marketing. He has published more than 75 research articles in journals and conference proceedings. He has also authored eight chapters in edited books, five case studies, and three popular articles. Dr. Mukherjee has worked as a consultant with several pharmaceutical and other companies across the world. Dr. Mukherjee’s research and teaching interests include healthcare services, patient compliance strategies, digital healthcare, and pharmaceutical marketing. He has published more than 75 research articles in journals and conference proceedings. He has also authored eight chapters in edited books, five case studies, and three popular articles. Dr. Mukherjee has worked as a consultant with several pharmaceutical and other companies across the world. Moderators and Panelists
John C. O’Donnell is Vice President, Global Health Economics and Outcomes Research at Bristol-Myers Squibb. He leads a diverse global team of 55 scientists dedicated to defining, developing and delivering evidence of value to ensure patients, payers and providers have the best possible information about, and optimal access to medicines. Dr. O’Donnell is co-chair of the Worldwide Market Access Council at BMS with responsibility for ensuring appropriate reimbursement and market access considerations are incorporated throughout the development process within R&D. He is a member of Academy Health’s Methods Council which seeks to develop strategies for professional development in Comparative Effectiveness and Health Services Research methods as well as identifying future needs in the areas of training, in best practices and in the development of new methods. Dr. O’Donnell is also an Institutional Council member of the International Society of Pharmacoeconomics and Outcomes Research and was lead author and editor of the Value in Health 2009 Special Issue: Health Technology Assessment in Evidence-Based Health Care Reimbursement Decisions Around the World: Lessons Learned. The supplement provided an assessment of established HTA bodies for those countries grappling with ways to manage expanding healthcare expenditures. Dr. O’Donnell received a PhD in Health Policy and Administration from the University of North Carolina at Chapel Hill. He has 20 years of experience in health services and outcomes research in industry, in academia and in U.S. State and Federal governments, with over 15 years of experience in the pharmaceutical industry. While in government and academia, he advanced health policy research in rehabilitation services, veterans’ health and the aged through his work with the U.S. Department of Veterans Affairs and Duke University’s Center for the Study of Aging and Human Development. He also analyzed optimal social service and primary care delivery models for foster care and geriatric team care. Dr. O’Donnell is Adjunct Professor at the University of North Carolina at Chapel Hill and Adjunct Senior Fellow at Duke University Medical Center for the Study of Aging and Human Development. He has published in the areas of health economic evaluation, health policy, health services research, geriatrics and rehabilitation and is a reviewer for leading journals including Medical Care, Value in Health and the Archives of Internal Medicine.
Ülo Palm is Senior Vice President of Drug Development and Research Operations at Forest Laboratories. Prior to this role, he was Vice President, Clinical Operations and Therapeutic Area Head of Respiratory Clinical Development. He is a member of the Operations Committee for TransCelerate BioPharma, Inc. (TCB), where he also leads the Future Initiatives workgroup looking at new project opportunities for TCB. Including Forest, Dr. Palm has 24 years of overall experience in the pharmaceutical industry with such organizations as Novartis, Schering-Plough and Bayer. He is a Senior Member of the American Society for Quality (ASQ), as well as being certified as a Manager of Quality and Organizational Excellence (ASQ-CMQ/OE). Dr. Palm is an MD and PhD, and also holds an MBA degree.
Heidi Pfefferkorn is currently U.S. Director of Process Excellence in the Novartis Pharmaceuticals Corporation, Technical Research & Development Quality Assurance Group. She is leading a team responsible for development of an application and associated processes for the monitoring of regulatory compliance of clinical trial supplies globally. Mrs. Pfefferkorn has worked at Novartis Pharmaceuticals Corporation for 20 years, holding positions with increasing responsibilities in different areas of drug development. Her experiences include positions in: Regulatory CMC: responsible for supporting large transfer projects in commercial production; Clinical Trial supplies: leading team responsible for supply design, packaging operations, warehouse and distribution operations; Global Project Management: responsible for coordinating all development activities across multiple line functions, including budget management; and Isotope Laboratory; responsible for synthesis and analysis of radiolabeled compounds used in various laboratory and human studies. Mrs. Pfefferkorn holds a BS in Chemistry from Montclair State University and an MS in Chemistry from University of Pennsylvania, with thesis advisor Nobel Laureate, Dr. Alan MacDiarmid.
David Rotella is Sokol Professor of Chemistry in the Department of Chemistry and Biochemistry at Montclair State University. He earned a PhD in medicinal chemistry from Ohio State University and carried out postdoctoral research in organic chemistry at Penn State University. Dr. Rotella joined the faculty at Montclair State University in 2011 after a successful 20-year career in the pharmaceutical industry. His current research is focused on discovering new lead compounds for use in parasitic, central nervous system and infectious diseases. Dr. Rotella has authored 30 scientific publications, holds seven patents and has presented at more than 30 invited lectures at U.S. universities since 1991 on drug discovery topics.
John Siekierka is Sokol Professor of Medicinal Chemistry and Director of the Margaret and Herman Sokol Institute for Pharmaceutical Life Sciences. Prior to joining Montclair State University in 2007, Dr. Siekierka was director of research and development at the Center for Biomaterials and Advanced Technologies (CBAT) at Johnson & Johnson where he directed research in drug device combination technologies. Dr. Siekierka also held positions as senior research fellow and Head of Immunosuppression Research at Johnson & Johnson Pharmaceutical Research and Development, L.L.C. as well as senior research positions at Merck Research Laboratories and the Roche Institute of Molecular Biology. Dr. Siekierka is a graduate of Seton Hall University (BS), City University of New York (MS) and New York University (PhD).
MaryLinda Schumann earned a BS degree in Chemistry and Biology as well as a master’s degree in Chemistry from Montclair State University. She began her career in chemistry with a summer QC position at Andrew Jergen’s the summer she graduated from high school and worked part time while matriculating towards her BS degree at a small water treatment company doing boiler water analysis. Upon graduation she began working for Oakite Products, Inc. (now Chemetall US) as an entry-level chemist formulating metalworking fluids. Mrs. Schumann has been at Chemetall for 35 years. After starting in formulations, she has been involved in many aspects of the business, including development, support (lab and phone), analytical and manufacturing from both a hands on and a management perspective. Mrs. Schumann has had the opportunity to be the recruiter for the company’s internship program for the past nine years. On the personal side, she met her husband in her Chemistry class at Montclair State. They have two daughters; one is a Montclair State University graduate in Justice Studies and a paralegal. The other has an AAS Degree in Hospitality and is currently at Montclair State and will graduate in May 2014 with a degree in General Humanities.
Maria Webb is Chief Scientific Officer, Venenum Biodesign, and has worked in the pharmaceutical industry since 1989 when she joined Bristol-Myers Squibb to work in the Cardiovascular Pharmacology Department. Dr. Webb’s lab focused on G-protein coupled receptors (GPCRs) where she and her team worked on several cardiovascular research projects that advanced to the clinic. At BMS, Dr. Webb became interested in the underlying role of inflammation in cardiovascular disease and started working on chemokine and cytokine biology and signaling. She worked for 12 years at Pharmacopeia, Inc., a pioneering company in ECLIPS and UHTS technology from 1996 to 2008. Dr. Webb and her team implemented this technology to discover hits for many disease relevant targets such as GPCRs, kinases, nuclear hormone receptors, ion channels, integrins and others. The technology platform was used in collaborations with Roche, Celgene, Schering-Plough, Organon, GlaxoSmithKline, Daiichi, Takeda, BMS, Wyeth, Pharmacia and Upjohn, Biovitrum, Otsuka, and Kowa among others. Pharmacopeia’s discovery platform was successful at seeding pipelines, and today, the two most advanced compounds, a P38 kinase inhibitor and a CXCR2 antagonist, are in Phase 2 clinical trials with BMS and Schering-Plough (now Merck). Dr. Webb volunteers as a member of the Board of Directors for the Society of Biomolecular Screening. She worked toward the successful merger of SB.S. with the Association for Lab Automation to found the Society for Lab Automation and Screening (SLAS). She is a consultant at Mount Sinai School of Medicine for the Technology Development Fund; a member of the Advisory Council for the College of Science and Mathematics at Montclair State University; and was an advisor to the Sino-American Pharmaceutical Association in 2000- 2002. She also serves as a guest editor and peer reviewer for journals, and has co-authored 90 papers.
Greg Wiederrecht is Vice President and Head of External Scientific Affairs (ESA) in the Merck Research Laboratories division of Merck & Co., Inc. where he has been employed for the past 24 years. ESA is responsible for the scientific assessment of all licensing, partnering, and acquisition opportunities for Merck. Dr. Wiederrecht’s responsibilities include the management of a group of 66 scientists and administrators, distributed worldwide and divided by various therapeutic and platform areas, who identify and assess opportunities outside of Merck’s walls. Dr. Wiederrecht holds a BS degree from the University of California, Irvine and a PhD in biochemistry from M.I.T. Before joining Merck in 1989, he was a Helen Hay Whitney Post-Doctoral Fellow and an American Cancer Society Senior Post-Doctoral Fellow at Caltech.
Anthony J. Yanni is Head of Patient Value and Strategy, Sanofi-Genzyme Global R&D Group. Following his years in clinical practice and hospital administration, Dr. Yanni entered the pharmaceutical industry and has worked in vaccine development at Sanofi Pasteur and served as Senior Director of Medical Value and Strategy with Sanofi prior to his current role. Much of his current work involves developing and applying processes that allow the patient voice to be more directly involved in the early developmental process; impacting both pre-clinical and early clinical development programs. He also currently co-leads an organizational initiative “Patient Engagement in the R&D Process” which will systematize and make more efficient the ability to engage patients throughout the developmental process. Dr. Yanni received his BS from the University of Scranton, an MD from Drexel University’s School of Medicine, and an MBA from the University of Massachusetts at Amherst. Moderators and Panelists