Pankaj Agarwal
Senior Fellow, Computational Biology, GSK
Pankaj Agarwal is a GSK Senior Fellow. Since 1996, he has been on a quest at GSK to discover drugs, targets and indications using algorithms and machine learning. He has published innovative methods for gene set enrichment, literature analysis, network analysis, target identification, connectivity map, and drug repositioning. He has done strategic work on evaluating innovation in industry pipelines and identifying disease areas for investment. He has led GSK-wide efforts on systematic drug repurposing and evaluated rare disease strategies. Pankaj obtained a B. Tech. in Computer Science & Engineering from IIT, Delhi, Ph.D. in Computer Science from the Courant Institute of Mathematical Sciences, New York University. He was one of the founding members and directors of the International Society for Computational Biology (ISCB). He serves on the Translational Medicine Advisory Committee for PhRMA.
Samuel Agus
Chief Medical Officer, Biophytis – New Therapeutics for Aging Diseases
Samuel Agus has served as our Chief Medical Officer since July 2018. From April 2017 to June 2018 he served as Vice President, Chief Medical Officer of Hansa Medical AB (Publ), a biotechnologycompany. Prior to that, he served at various leadership positions in clinical development andmedical affairs, in several pharmaceutical companies, such as Teva Pharmaceuticals industries,Solvay Pharmaceuticals, Abbott, Shire and H. Lundbeck A/S. Dr. Agus holds a doctorate inMedicine from The Hebrew University of Jerusalem. He is a board-certified neurologist (from Israel) and has had academic training in biostatistics and bioinformatics.
Daniel Anderson
Head, Commercial Partnerships Invitae
Daniel leads the Commercial Partnerships group at Invitae where he is responsible for building the network of programs with biopharma companies and patient advocacy groups. Prior to joining Invitae, he worked in J.P. Morgan’s healthcare investment banking group where he advised biotech and medtech companies on M&A, capital raising and other strategic transactions.
Daniel started his career at the management consulting firm ZS Associates where he specialized in addressing healthcare sales and marketing issues. He has also worked in South Africa and Tanzania to expand access to vaccination programs.
Daniel lives in Denver, Colorado with his wife and 1 year old daughter.
Brian Bronk, ph.D.
Head of Business Development, Rare Diseases & Rare Blood Disorders, Global Business Development & Licensing
Since joining Sanofi in 2014, Brian has contributed to partnering and business developmentactivities through a number of different roles. He started as a member of the Sunrise team, wherehis efforts focused on building and maintaining a portfolio of investments, including MyoKardia, Portal, Warp Drive Bio, DiCE and Thermalin. Brian then joined the Sanofi Business Development team in 2017 as head of External Innovation, Rare Diseases and assumed his current responsibilities in 2018. In this role, he and his teams are responsible for working with senior leadership to define an overall portfolio strategy, with accountability for identifying and securing external opportunities that fill portfolio and business needs for each of these therapeutic areas.
Prior to joining Sanofi, Brian was Vice President of Research and Development at Satori Pharmaceuticals, where he was a member of the Executive Leadership team and led chemical sciences and drug metabolism. He also advised several venture capital and life science groups; his efforts contributed to a number of successful financing rounds, as well as advancing R&D portfoliosthrough key milestones. Brian started his professional career with Pfizer (1994-2008), rising to the level of Senior Director. During this tenure, his responsibilities included shaping R&D strategy across multiple platforms andtherapeutic areas and delivering clinical candidates in psychiatry, neurology, infectious diseasesand metabolic disorders. Brian and his teams have been involved in the discovery of more than twenty development candidates, including the launched products Draxxin™, Convenia™, Cerina™and Slentrol™.
Brian earned his bachelor’s degree from Colgate University in 1989. Following a year as a FulbrightFellow in Dortmund, Germany, he initiated his doctoral work at the Massachusetts Institute of Technology, receiving his doctorate in chemistry in 1994.
Philip John (P.J.) Brooks
Program Director, Office of Rare Diseases Research, NCATS
Philip John (P.J.) Brooks is a Program Director in the Office of Rare Diseases Research in theNational Center for Advancing Translational Sciences (NCATS). Prior to taking on this role, he was in the NCATS Division of Clinical Innovation, where he was the lead program director for the Clinical and Translational Science Awards (CTSA) Program Collaborative Innovation Awards, designed to fund projects that will result in novel and creative approaches to overcoming road blocks in translational science. In addition to his work in NCATS, Brooks is the Working Group Coordinator for the NIH Common Fund Somatic Cell Genome Editing.
Dr. Brooks earned bachelor’s and master’s degrees in psychology and received his Ph.D. in neurobiology from the University of North Carolina at Chapel Hill. After completing a post doctoral fellowship at the Rockefeller University, Brooks became an investigator in the intramural program of the National Institute on Alcohol Abuse and Alcoholism. He developed an internationally recognized research program focused on two distinct areas: the molecular basis of alcohol-related cancer, and rare neurologic diseases resulting from defective DNA repair.
Megan O’Boyle
Principal Investigator, Phelan-McDermid Syndrome International
Megan is the the parent of an 18-year-old daughter with Phelan-McDermid Syndrome (PMS). This diagnosis includes autism, intellectual disabilities, epilepsy, ADHD, and other medical conditions. She is the Principal Investigator for the Phelan-McDermid Syndrome Data Network (PMS_DN, PCORnet) and the Phelan-McDermid Syndrome International Registry (PMSIR). Megan is passionate about the value of the patient’s voice in: research, drug development, clinical trial design, development of related legislation, and quality of life decisions. She advocates for data sharing, collaborating with other advocacy groups, sharing resources and streamlining IRB practices and policies.
David Cory
President and CEO - Eiger BioPharmaceuticals
David Cory is an industry veteran with over 25 years of experience in large pharmaceuticals, emerging stage biotechnology, and specialty pharmaceutical organizations with an established track record of operational performance, including five successful Orphan Designation drug programs.
Cory is President and CEO, Director, and business founder of Eiger BioPharmaceuticals, leading the company since its founding in 2008 and responsible for negotiating the company’s multipletechnology and product licenses from Stanford University, Merck, Nippon Kayaku, Janssen, BMSand The Progeria Research Foundation. Prior to Eiger, Cory was President and Chief Operating Officer of Prestwick Pharmaceuticals, an orphan CNS specialty pharmaceutical company, which was acquired by Biovail for $160 million in 2007. Previously, Cory was a Co-Founder at CoTherix, an orphan pulmonary arterial hypertension company, which was acquired by Actelion for $425 millionin 2006. Cory began his biotech career at InterMune, focused on developing orphan products foridiopathic pulmonary fibrosis, where he was a Senior Vice President and a key executive in the company IPO, building and managing the company’s commercial organization, in-licensing 4 products and raising over $400 million in the capital markets. InterMune was ultimately acquired by Roche for $8 billion in 2013. Cory spent over a decade in large pharma in positions of increasing responsibilities in commercial operations at Glaxo, Glaxo Wellcome, and Glaxo Smith Kline where heled teams in oncology, critical care, CNS, infectious disease and respiratory therapeutic areas, and directed 10 newly approved pharmaceutical product launches.
Cory earned a Bachelor of Science in Pharmacy from the University of Cincinnati, College ofPharmacy, was board certified in Pharmacy in the state of Ohio, and holds a Master’s Degree inBusiness Administration from the University of Maryland.
Anne B. Cropp
Chief Scientific Officer - Early Access Care LLC
Anne has over 25 years’ experience in the biopharmaceutical industry, marked by achievements in the successful development of several new drug products in adult and pediatric populations.
Prior to Early Access Care, Anne was VP in Global Product Development at Pfizer Inc and led global teams from Phase 2 through NDA/MAA submission and successful registration and commercialization. She has partnered extensively with Patient Groups across a multitude of disease areas, including rare disease, to integrate patient and caregiver voice into development and pre-launch strategy. She has focused on removing barriers to the incorporation of the patient throughout the development of a compound and has created tools used by product teams to place patients at the center of development and launch strategies. She specializes in optimizing early access programs as part of the overall development strategy of new medicines in rare disease indications.
Anne serves as the Chief Scientific Officer for Early Access Care, providing consultative, functional and operational support to biopharmaceutical companies for global early access programs.
Khrystal Davis
CEO, Founder, Zebra Leaf Publishing, Writer, Hunt for a Cure, Author
Khrystal joined the rare disease community in 2011 when her newborn son, Hunter, was diagnosed with Spinal Muscular Atrophy (SMA) Type 1, the leading genetic cause of mortality in children under the age of two. SMA Type 1, often described as ALS in babies, robs the ability to move, swallow, and ultimately breathe. Khrystal is the author of Hunt for a Cure: An Unexpected Adventure to Save a Life. Khrystal founded Zebra Leaf Publishing to provide the rare disease community a platform to promote rare disease awareness.
In May of 2016, Khrystal advocated alongside the FAST Movement (Families for the Acceleration of Spinal Muscular Atrophy Treatments) in a meeting with top FDA representatives for access to Spinraza, an SMA treatment in clinical trials at the time. Together with other FAST members, she asked the FDA to stop placebo trials, provide a means of access for the weakest SMA patients, accelerate the approval, and approve the treatment for all SMA patients regardless of age or type of SMA. In an interim look completed on August 1, 2016, the FDA found the treatment met trial objectives. An Expanded Access Program for SMA Type 1 patients commenced August 12, 2016, and the FDA approved Spinraza for children and adults with SMA on December 23, 2016.
Khrystal is committed to improving health outcomes in those with rare diseases through improved access to rare disease treatments. She advocates for the expansion of newborn screening programs and insurance policies that conform to FDA labels for orphan drugs. She is a proponent of patient-driven access to rare disease treatments.
Khrystal holds a Juris Doctorate from Stetson University College of Law and is certified in Clinical Trial Design and Interpretation by Johns Hopkins through the Coursera program. She is a proud wife and mother of five who enjoys traveling the world with her family.
Ashish Dugar
VP, Global Medical Affairs, Sarepta Therapeutics
Bio coming soon
Julie Gortze
RN, Founder /President of Rare New England (RNE)
Julie Gortze is a registered nurse and also Founder /President of Rare New England (RNE), a nonprofit advocacy organization focused on offering educational opportunities to patients, caregivers, healthcare professionals, and other stakeholders in the rare disease community. RNE also creates awareness of available resources and builds foundations for support for patients and families touched by rare and complex disorders.
Julie has worked as an RN in pediatric home care, sub-acute care, and acute care. She has volunteered her time in several patient advocacy organizations. Julie has been involved in legislative efforts for the creation of a rare disease task force initiative through CT legislation and has been championing a similar bill, “An Act to Create a Rare Disease Advisory Council” in MA that would provide a group of rare disease stakeholders to form a committee to investigate issues in the rare disease community and collaboratively find solutions.
Julie is a member of the Regional Genetics Group Steering Committee, Global Genes Alliance, and North Attleboro Commission on Disabilities. She is a Rare Disease Advisory Panel Member through Patient-Centered Outcomes Research Institute (PCORI). Julie has been on various organizations’ conference planning committees as well as been part of organization for Rare Disease Day State House events.
Julie has personal experience with a complex disease and has learned first-hand what patients and families must deal with while searching for a cause for symptoms. As a nurse, she also understands that the average medical personnel do not have the familiarity or sufficient education for recognizing, diagnosing and treating a complex medical disorder. She recognizes a need for bridging the gap for patients and families between the busy clinics and available resources to enable more beneficial continuing of care and improved quality of lives. She strongly believes in empowering patients with information relevant to their medical issues through educational opportunities, enabling potential for improved quality of lives.
Anthony Gucciardo
Senior Vice President, Strategic Partnerships, National Kidney Foundation
Anthony is responsible for forging and maintaining relations with key external stakeholders across a wide range of industries, to advance NKF’s mission and objectives, along with those of its partner organizations. Anthony oversees two national Corporate Development Teams, focused on securing revenue necessary to ensure NKF programmatic excellence and impact. He has been with the Foundation since 2002.
Prior to NKF, Anthony was a Hematopoietic Stem Cell Technologist at Memorial Sloan-Kettering Cancer Center in New York City, where he was responsible for processing autogeneic / allogeneic bone marrow and peripheral blood stem cells for transplantation. He holds a master’s degree in Biochemistry from Columbia University.
Femida Gwadry-Sridhar
CEO & Founder Pulse Infoframe Inc.
Dr. Femida Gwadry‐Sridhar is the Founder and CEO of Pulse Infoframe Inc. She has her PhD in Research Methodology, Health Economics, McMaster University. She is a pharmacist, epidemiologist and methodologist with over 25 years of experience in clinical trials, disease registries, knowledge translation, health analytics and clinical disease outcomes. She founded the first knowledge translation health informatics lab in North America in 2006, creating a collaborative ecosystem for interdisciplinary research. In 2008 this facility, I‐THINK research, developed a physical and virtual platform to support multidisciplinary research. The platform has evolved to enable the integration of clinical, imaging and histopathology data.
Pulse Infoframe has developed healthieTM, a revolutionary evidence-based platform transforming rare disease and cancer clinical research and treatment. Pulse’s SaaS data platform is becoming the de facto standard for real work evidence, meeting an urgent regulatory requirement. Pulse builds multi-stakeholder collaborative networks of pharmaceutical companies, researchers and patients and enables stakeholder access to clinical trials, input on trial design, new treatment development, and accelerated research. Pulse captures, organizes, analyzes, curates and shares existing and unique data using its industry leading and scalable data-sharing platform powered by AI and machine learning.
Under Dr. Gwadry-Sridhar’s guidance Pulse has developed a global presence. Pulse has collaborated with international funding agencies advancing the requirements for rare disease registries. Collecting relevant and actionable data in rare disease is essential. Pulse has addressed relevant questions about data sharing, governance, ontologies and patient reported outcomes- all key to understanding and enabling the development of real-world evidence. DrGwadry-Sridhar is a life-long collaborator and has done so across different disciplines and cultures. This experience has resulted in a comprehensive understanding of the value of collaboration to fast-forward progress and improve lives everywhere.
Aileen Healy
Exec. Director & Global Head, Emerging Science & Innovation - Rare Diseases,Worldwide R& D, Pfizer, Inc.
Aileen Healy has been focused on drug development for monogenic rare diseases for the pastdecade. At Pfizer, Aileen leads the Emerging Science and Innovation efforts for the Rare Disease Research Unit, focusing on rare hematologic, endocrine, neuromuscular diseases and inborn errors of metabolism. Prior to joining Pfizer, Aileen was Vice President of Preclinical Development at Cydan, where she co founded two companies each focused on rare diseases. Aileen began work inrare diseases at Seaside Therapeutics as Vice President of Research, where she focused ondeveloping treatments to improve the course of neurodevelopmental disorders. Aileen hasextensive experience in drug development leading preclinical research in multiple therapeutic areasat Momenta and Millennium Pharmaceuticals. She began her career as an Assistant Professor atBoston University School of Medicine, conducting biomedical research. Aileen holds patents and has published in peer-reviewed journals on a wide range of topics. Aileen received her PhD from Tufts University and post doctoral training from the Massachusetts Institute of Technology.
Derek Ansel
Director of Rare and Orphan Diseases, Synteract
Derek Ansel is Director of Rare and Orphan Diseases at Synteract, a CRO dedicated to rare disease patients. His career started in the laboratory, testing the efficacy of many vaccine products. After several years in clinical laboratory research, monitoring, and project management he developed a broad therapeutic experience that includes non-malignant hematology, disorders of autoimmunity, and other genetic conditions such as Cystic Fibrosis and Prader-Willi. Mr. Ansel is a member of the ACRP where he holds the CCRA credential. He is also a writer for the Vaccine Education Center at the Children’s Hospital of Philadelphia, an active consultant for several start-ups in the eClinical software environment, and an IRB member at the Thomas Jefferson University in Philadelphia, PA.
Prior to rareLife solutions, Tony built the clinical-outreach medical journal publisher, LeJacq Ltd. and sold it to Wiley-Blackwell. He then founded TheMedicalRoundtable.com — medical publications that harness the power of collaboration among key opinion leaders for busy clinicians.
He is currently admitted to practice law in NY and CT, holds an Advanced Certification in Healthcare & Compliance Law from Seton Hall Law School and held associate positions
at both Schulte Roth and Paul Hastings after graduating from Rutgers University School of
Law–Newark, New York University, and The Lawrenceville School.
Pedro Huertas
Chief Medical Officer, Sentien Biotechnologies
Dr. Pedro Huertas is the Chief Medical Officer at Sentien Biotechnologies, a clinical stage biopharmaceutical company developing immunomodulatory applications applications of mesenchymal stem cells for inflammatory conditions.
Dr. Huertas, a native of Chile, is a graduate of Stanford University (MS, Biochemistry), Harvard University (PhD, Cell and Developmental Biology), the Program in Health Sciences and Technology between Harvard Medical School and the Massachusetts Institute of Technology (MD), and the Sloan School of Management at the Massachusetts Institute of Technology (MS, Management). He trained in Internal Medicine, Rheumatology and Palliative Care at the Massachusetts General Hospital. He is a licensed physician in Massachusetts.
Dr. Huertas has been in the pharmaceutical industry for nearly 30 years with 10 years in basic research, 10 years in development (including translational, preclinical and clinical) and 10years in medical affairs. During these 30 years, he has worked as a bench scientist, a program leader and has managed development and early through late-stage clinical programs in biotechnological star-up companies and major pharmaceutical companies. He has been a C-level executive in several biotechnology companies.
Most recently, Dr. Huertas was Chief Medical Officer at Eloxx Pharmaceuticals (NASDAQ: ELOX), a clinical stage biopharmaceutical company developing advanced small molecules as read-through agents for genetic diseases caused by nonsense mutations. Prior to Eloxx, he served as the Precision Medicine Clinical Lead and Head of Precision Medicine for Rare Diseases at Pfizer Worldwide Research & Development. Previously, he was the Medicines Development Group Team Lead for Vyndaqel (tafamidis meglumine) in the Specialty Care Business Unit at Pfizer Inc.
Leslie Leahy
VP, Medical Sciences, Ovid Therapeutics
Leslie is a neuropsychologist with over 20 years of experience in academia, pharmaceutical and biotech neuroscience research. She is the VP of Medical Science at Ovid Therapeutics. She, along with her fellow Ovidians, are dedicated to developing medicines that significantly impact the lives of patients with rare neurological disorders.
Leslie started her pharmaceutical career in clinical development. She has led Phase 1 through 4 clinical development programs across a wide range of CNS conditions including schizophrenia, bipolar disorder, traumatic brain injury and Alzheimer’s disease. While at MGH in the Department of Psychiatry, Leslie was the Program Director for the first public health study of bipolar disorder, the Systematic Treatment Enhance Program for Bipolar Disorder (STEP-BD). Leslie holds a PhD from the University of Pittsburgh, where she also completed her post doc in adult and pediatric epilepsy. Her research interests in CNS are guided by the vision and passion of bringing innovative treatments to patients.
David Litwack
Director, Regulatory Strategy and Communications, Prevail Therapeutics
Dr. Litwack received a B.S. in Chemistry from the University of Chicago, and a Ph.D. in Biology from MIT. After postdoctoral studies at the Salk Institute for Biological Studies, he joined the faculty of the University of Maryland School of Medicine as an Assistant Professor in the Department of Anatomy and Neurobiology, a member of the Program in Neuroscience, and a founding member of the School’s Center for Stem Cell Biology and Regenerative Medicine. In 2010, Dr. Litwack was awarded an AAAS Science and Technology Policy Fellowship in NCI’s Office of Biorepositories and Biospecimen Research. In that role, he led several efforts to develop policy and programs to advance the use of biobanking for personalized medicine. In 2012, Dr. Litwack joined the Personalized Medicine Staff of the Office of In Vitro Diagnostics and Radiological Health at the FDA, where he developed policies to guide the review of investigational biomarker tests, companion diagnostics, and next generation technologies. He is now Director of Regulatory Strategy and Communications at Prevail Therapeutics.
Isabelle Lousada
President & CEO, Amyloidosis Research Consortium
Isabelle Lousada is the founder and CEO of the Amyloidosis Research Consortium (ARC) formed in 2015 and located in Boston. As President & CEO of ARC, she designs and leads innovative, global programs: Bringing together doctors, researchers, patients, industry, and regulators in order to build meaningful programs and break down the barriers that prevent successful drug development for the amyloidosis diseases. Ms. Lousada leads a team of dedicated employees and volunteers and oversees ARC’s progressive initiatives.
In 1996, Ms. Lousada was diagnosed with AL amyloidosis, and was one of the first patients to successfully undergo a stem cell transplant. For the past twenty years, she has been committed to empowering other patients while serving on the boards of a number of non-profits. She developed programs to encourage research, increase access, and support the critical and unmet needs of patients.
Now in its fourth year, with Isabelle Lousada at the helm of the ARC, successful collaborations across the sectors have been created to advance the science and understanding of the amyloidosis diseases.
Elena Lungu
Manager, Policy Development, Patented Medicine Prices Review Board / Government of Canada
With both public and private sector experience, Elena Lungu is an expert in the area of pharmaceutical policy, pricing and reimbursement in Canada. Currently, she is the Manager of the Policy Development with the Patented Medicine Prices Review Board (PMPRB) and in this role, she coordinates the development of strategic policy advice related to price regulation for the Board. Previously, Elena served for a decade as the Manager of the National Prescription Drug Utilization Information System (NPDUIS) of the PMPRB, building this initiative into a leader in economic analyses related to price, utilization and cost trends in support of policy decisions in Canada. Prior to her career in the public service, Elena held various management and senior economist positions in private consulting related to market access as well as public and private reimbursement markets. Elena holds a Masters of Arts in Economics from Carleton University and has 16 years of pharmaceutical market experience.
Han C. Phan
Founder and Executive Officer, Rare Disease Research
Dr. Han Phan is a board-certified sleep medicine specialist & neurologist with special qualification in child neurology. She is currently the director of clinical research at Rare Disease Research, LLC. She has been a principal investigator many trials from phase 1-4 and has over 10 years experience in clinical research both in large academic institution and at independent clinical research center lending her the skills to navigate and expeditiously galvanize any clinical trial, big or small.
She also serves as special government employee on the FDA pediatric advisory committee and guest researcher with Centers for Disease Control and Prevention (CDC) in the Birth Defects and Newborn Screening Branch.
Amit Rakhit
Chief Medical Officer and Head of Research & Development, Ovid Therapeutics
Amit Rakhit is Chief Medical Officer and Head of R&D at Ovid Therapeutics (NASDAQ: OVID), a publicly traded biotechnology company focused on developing medicines for people living with rare neurologic conditions. In this role Amit oversees research, drug development and commercialization for the Ovid portfolio. Amit has over 20 years’ experience including both clinical practice and pharmaceutical/biotechnology industry experience. Amit earned his B.A. in molecular biology from the University of California, Berkeley, his M.D. from Tufts University, his M.S. in clinical investigation from Vanderbilt University and MBA from Columbia University. He completed his fellowship in pediatric cardiology and was subsequently on staff at The Children’s Hospital, Boston affiliated with Harvard University.
Prior to Ovid, he was SVP and Head of Worldwide Medical at Biogen where he led the medical function in disease areas such as multiple sclerosis, neurodegenerative diseases, and hemophilia, and orphan diseases such as spinal muscular atrophy and amyotrophic lateral sclerosis. Prior to Biogen, Amit was part of the R&D and medical organization at Bristol-Myers Squibb.
Amit is an Advisor Trustee for the Liberty Science Center in NJ as well as an Advisory member of the Healthcare Board of the Partnership Fund for New York City.
Julie Raskin
Executive Director, Congenital Hyperinsulinism International
Julie Raskin is a founder and the executive director of Congenital Hyperinsulinism International (CHI). CHI, a 501(c)3, is a lifeline to those born with congenital hyperinsulinism (HI) and their families. CHI is the global organization dedicated to supporting children and adults born with HI. CHI supports research for better treatments and cures, HI families every step of the way, and is the foremost advocate for increased awareness and better medical protocols for HI to reduce preventable brain damage and death from prolonged hypoglycemia. Julie works with a collaborative team to fulfil CHI’s mission to improve the lives of people born with HI.
Julie is also the Rare Action Network State Ambassador for New Jersey. The Rare Action Network is the nation’s leading advocacy network working to improve the lives of the 30 million Americans living with a rare disease at the state level. The Rare Action Network is powered by NORD.
Luke Rosen
Founder, KIF1A.ORG / Vice President, Patient Engagement & Government Affairs, Ovid Therapeutics
In his role at Ovid Therapeutics, Luke works closely with patient and family organizations to foster innovative, cross-functional collaboration between the Ovid team and members of the rare disease community. He sits on the Board of Directors of Parents for Inclusive Education (PIE) and works to ensure children with disabilities have equal access to New York City Public Schools. Luke is the Founder of KIF1A.ORG, a non-profit foundation working to support research and eliminate challenges for families affected by KIF1A Associated Neurological Disorder.
Alison Schecter
MD, FACC, FCCP, Global Program Head, Rare Disease (current), Sanofi Genzyme
Alison is currently the Global Program Head for the Rare Disease Development at Sanofi Genzyme. She is responsible for defining the strategic focus of Rare Disease development in collaboration with Head of Commercial. She works closely with external innovation and BD to make review and decide on opportunities to be brought forward for consideration including Bioverativ. In addition, Alison now leads the acid sphingomyelinase deficiency (ASMD) (formerly known as Niemann-Pick) Global Team. She coordinates the regulatory, clinical operations, medical affairs, legal and CMC to allow submission for the first in class therapy for this ultra-rare diseases with high mortality and morbidity and no known treatment.
Dr. Schecter is an internationally recognized physician scientist and board-certified cardiologist. Her academic research focused on chemokine and cytokine signaling in cardiovascular and viral diseases focusing on vascular disease, lipids and heart failure with over 50 peer reviewed papers and multiple NIH RO1 grants that supported her independent laboratory. Dr. Schecter, as tenured Associate Professor at Mount Sinai School of Medicine, was Co-Director of the over one hundred person Mount Sinai Cardiovascular Research Center and sat on multiple NIH and AHA study sections and special panels.
Alison completed her Internal Medicine residency at the Johns Hopkins Hospital and her Cardiology fellowship at Massachusetts General Hospital with a research fellowship at Mount Sinai. She also co-founded the Women’s CARE (Cardiac Assessment and Risk Evaluation) Program to educate and treat under-served women in Spanish Harlem, NY and has appeared on national, local TV and radio as a medical expert on cardiovascular and women’s health.
Matthias Schoenermark
Managing Director, SKC Beratungsgesellscha
Prof. Matthias P. Schönermark, M.D., Ph.D., is a trained head & neck surgeon with a Ph.D. in molecular oncology. In 1998, he left his job as an Associate Professor at Hannover Medical School for a position as project leader & manager at The Boston Consulting Group, where he spent several years, supporting clients in the health care industry in Europe and overseas. In 2005, after a year as Associate Partner with A.T. Kearney, he founded the SKC Beratungsgesellschaft mbH (SKC). He was appointed as Professor of Health Care Management at Hannover Medical School in 2001. He spent several years at Columbia University in New York and at Dartmouth Medical School in Hanover, New Hampshire and lectures at universities & business schools in Europe and the U.S. on strategic issues in health care.
In his function as managing partner, he is a permanent consultant to numerous leadership personalities of international health insurance and provider organizations, as well as of medtech and pharmaceutical companies on strategic management, innovation management and change management issues. He holds an unrivalled track record of solving complex and demanding market access challenges, especially in the orphan drug and oncology sector and is one of the most experienced negotiation leaders in reimbursement and pricing procedures.
Samuel Seward, Jr.
MD, FAAP, FACP, Professor and Chair, Dept of Medicine
Dr. Seward received his M.D. from the University of Texas Southwestern School of Medicine in 1990. He joined the Sinai faculty, for the first time, in 1994, as an Associate and, later, Program Director of the Combined Internal Medicine-Pediatrics Residency. In 2004, he joined the faculty of Columbia University Medical Center, ultimately rising to Associate Vice President of Columbia Health which provided a broad array of outpatient services and programs to the Columbia community. Dr. Seward returned to Mount Sinai in 2016 as the Site Chair, Department of Medicine, Mount Sinai St. Luke’s and West hospitals. Dr. Seward is internationally known for his work with the Hermansky-Pudlak Syndrome patient population; HPS is a rare autosomal recessive disorder. In addition, his clinical interests include the care of adult patients who are survivors of congenital and pediatric disorders.
Kristin Smedley
President, Curing Retinal Blindness Foundation
Kristin Smedley’s two sons were diagnosed soon after birth with a rare blindness. Although Kristin was initially paralyzed with fear of raising two blind children, she launched an extraordinary mission to change their bleak future ahead. She worked with education systems in multiple states in which she lived to get her sons the tools they needed to achieve in public schools.
Her children have become popular, accomplished athletes, high achieving students, talented musicians, and International Braille competition finalists. Her oldest son, Michael has achieved Dean’s List in his first two college semesters.
In 2011 Kristin founded the only patient organization in the world for her sons’ inherited retinal disease. CRB1.org is a global leader in changing what a rare eye disease diagnosis means, and Kristin is a sought-after speaker and collaborator in the field.
Kristin recently published her first book, Thriving Blind: Stories of Real People Succeeding Without Sight. It hit #1 New Release in Kindle and Paperback on Amazon.com.
Michael Swit
Principal, Law Offices of Michael Swit
Michael Swit has been addressing critical U.S. Food and Drug Administration (FDA) legal and regulatory issues since 1984. Before returning to private law practice in late 2017, he served for three years at Illumina, Inc., the world’s leading developer of gene sequencing technology, as its chief regulatory counsel. Prior to that, Swit was a special counsel in FDA Practice at the global law firm of Duane Morris LLP in it’s San Diego office.
Before joining Duane Morris in March 2012, Swit served for seven years as a vice president at The Weinberg Group Inc., a preeminent scientific and regulatory consulting firm in the Life Sciences. His expertise includes product development, compliance and enforcement, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for all types of life sciences companies, with an emphasis on drugs, biologics, therapeutic biotech products, medical devices, and IVDs, but also has experience with foods, cosmetics, and clinical research issues. His FDA legal experience has included tenures in the food and drug law practices McKenna & Cuneo (now Denton’s) and Heller Ehrman, and as vice president, general counsel, and secretary of Par Pharmaceutical, a top public generic and specialty drug firm, where he helped spearhead the company’s recovery from prior management’s involvement in the Generic Drug Scandal of the late 1980’s. He also was, from 1994 to 1998, CEO of FDANews.com, a premier publisher of regulatory newsletters and other specialty information products for FDA-regulated firms. He has taught and written on many topics relating to FDA regulation and associated commercial activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned his AB, magna cum laude, with high honors in history, at Bowdoin College, and his law degree at Emory University.
Haya Taitel
Senior Vice President, Chief Commercial Officer, Kadmon Pharmaceuticals, LLC
Ms. Taitel is Senior Vice President, Chief Commercial Officer at Kadmon, where she is responsible for the strategy, tactical execution and forecasting of in-line promoted products, portfolio contracting strategies and the launch readiness of pipeline assets.
Haya leads commercial operation disciplines including marketing, sales, national accounts and contracting strategies across several therapeutic areas. She also oversees the commercial operation infrastructure, including the business analytics, market segmentation and customer service units.
Prior to joining Kadmon, Haya led the U.S. commercial franchises of both the Pharma and Device sectors of Johnson & Johnson. In her 25-year tenure with J&J, she launched new chemical entities in several therapeutic areas including neurology, analgesia, peripheral diabetic neuropathy, women’s health, and urology, with focus on interstitial cystitis.
Vlademir Tomov
Chairman, National Alliance of People with Rare Diseases – Bulgaria
Chairman of the National Gaucher Association 1999-2004
President of the National Organization of the Gaucher Patients 2004-2007
Chairman of the National Alliance of People with Rare Diseases 2007- until now
Chairman of the Euro-Asian Alliance for Rare Diseases 2012- until now
President of the Confederation of Health Protection – Largest Patients Assembly in Bulgaria 2010-2013 2018 – until now
Member of the Advisory Council on Rare Diseases at the Ministry of Health – 2009-2014.
Member of the Commission for Rare Diseases аt the Ministry of Health from 2015 – until now
Member of the Advisory Council on Treatment for Chealdren at the Ministry of Health -2015 – 2018
Education: MA in Design, Pedagogy and Health Management
Speaks Russian and English.
Stephan Toutain
SVP, Operations, Anavex Life Sciences
Stephan Toutain, Senior Vice President of Operations, brings more than 25 years of drug development, general management, operations, commercial development, market access, and sales and marketing leadership with particular expertise in neurology and orphan drug markets globally. Before joining Anavex, he held the role of CCO at Interleukin Genetics. He also worked with Alnylam Pharmaceuticals to build its early access program. Previously, he led Global Commercial Development for Sarepta Therapeutics and served as General Manager for Alexion Pharmaceuticals in Europe. Mr. Toutain has also held various U.S. commercial, marketing and product management positions with Alexion Pharmaceuticals, Celgene Corporation, and Johnson & Johnson. He received a Master of Business Administration from the University of North Carolina, and a Master of Engineering in Biotechnology from the University of Nancy II in France.
Sara Tylosky
CEO and President, Farmacon.co
Sara Tylosky is an experienced Global Executive in the healthcare field with over 20 years of success leading diverse teams in a variety of competitive fast paced environments within the medical industry. As the CEO of Farmacon, a novel research-consulting firm, Sara and her medical expert network have successfully helped Pharmas and Biotechs complete enrollment goals and develop strategic plans for market access, with a particular focus in Orphan Disease projects in Latin America. Farmacon has an established record as an expert problem solver with an ability to get results by mobilizing the right groups and providing the cultural feedback and intelligence so that data endpoints can be properly met. She holds an MBA from Florida Atlantic University, is fluent in Spanish and has lived in 3 continents so far, with a passion for helping others. She is also an accomplished dressage horse rider.
Robert (Bob) Ward
Chairman, Chief Executive Officer, Eloxx Pharmaceuticals
Mr. Robert (Bob) E. Ward is the Chairman of the Board and Chief Executive Officer of Eloxx Pharmaceuticals, Inc. (“Eloxx”). He previously served as the Chief Executive Officer and President at Radius Health, Inc. (NASDAQ: RDUS) successfully completing the initial public offering that became the top performing IPO; raised over $780M from private and public sources; achieved FDA approval and launch of the new drug TYMLOStm injection while gaining Fast Track development status for the Elacestrant oncology program. Prior to joining Radius, Mr. Ward held a series of progressive management and executive roles with established companies such as NPS Pharmaceuticals, Schering-Plough (Merck), Pharmacia (Pfizer), Bristol-Myers Squibb and Genentech. Mr. Ward has been a Director of Akari Therapeutics, Plc since October 14, 2016 where he chairs the Governance Committee. He served as a Director of Radius from December 2013 until July 16, 2017. Mr. Ward serves as a Director of the Massachusetts High Technology Council. Mr. Ward received a B.A. in Biology and a B.S. in Physiological Psychology, both from the University of California, Santa Barbara, an M.S. in Management from the New Jersey Institute of Technology and an M.A. in Immunology from the John Hopkins University School of Medicine.
Patricia Weltin
CEO and Founder, Beyond the Diagnosis
Patricia Weltin is the CEO and Founder of the Beyond the Diagnosis. Beyond the Diagnosis unites art and science to inspire research and innovation of treatments for people living with orphan and neglected diseases.
Beyond the Diagnosis began working on a project to increase research and raise awareness of rare diseases within the medical community through art. Professional artists paint portraits of children living with a rare disease, the portraits then become part of a traveling exhibit for medical schools, research institutes and hospitals. This exhibit has also touched the hearts and minds of the general public. Since the debut, Beyond the Diagnosis has visited the NIH, Broad Institute, Hofstra Medical, Harvard Medical, the FDA and many more.
Patricia, the mother of two children with Ehlers-Danlos Syndrome, began working in this space by creating a new business model of working by state. Her award-winning work in state-level advocacy grew to national advocacy efforts. Today, Patricia proudly works to successfully use art as a powerful tool to create awareness and increase innovation into orphan and neglected diseases.
Dan Donovan
Founder & CEO, rareLife solutions, creators of onevoice
rareLife solutions is Dan’s second software and service focused venture. Having observed the often fractured, though always passionate stakeholders in rare diseases, Dan was inspired to create onevoice, providing rare disease specific “guided communities” thoughtfully designed to address several unmet needs while improving disease understanding and accelerating research.
Dan’s immersion into rare disease began in 2011 when he was appointed to the Board of Directors and later as Chief Business Officer of Cancer Prevention Pharmaceuticals (CPP). It was through his involvement with CPP that Dan discovered how incredibly fractured rare disease communities tend
to be and he felt there had to be a better way to help these communities who needed help the most. Prior to rareLife and CPP, Dan founded Envision Pharma in 2001, serving as President through June 2011. Dan was the visionary behind the creation and development of Datavision, the market leader in medical publications technology. Envision Pharma was acquired by the United BioSource
Corporation (UBC) in April 2008. At UBC, Dan was Senior Vice President Strategy and Market Development and a member of the Leadership Team.
Dan cut his teeth in industry at Pfizer serving in a variety of positions of increasing responsibility, ranging from sales to market research and marketing in the US domestic and international market place, culminating in his position as Director and European Team Leader for the world’s largest cardiovascular portfolio, living in Belgium. During his time at Pfizer, he played a pivotal role in the commercialization of some of the pharmaceutical industry’s most successful product launches.
Dan earned a Bachelor of Science degree in Finance at Lehigh University, where he was a 4-year varsity soccer player serving as captain his senior year. Dan lectures frequently at specialty industry conferences and webinars.
David Lapidus
President, LapidusData Inc.
David Lapidus is the founder of LapidusData Inc., a consulting firm specializing in market validation services for companies developing orphan drugs. He brings a commercial perspective to epidemiology and market research to help clients analyze patient populations for therapies where underlying population dynamics are complex or poorly characterized. LapidusData’s clients include dozens of orphan drug companies and patient organizations; these projects have analyzed the epidemiology of over 50 rare diseases.
David’s analyses have been used to support successful M&A activity in the orphan drug field. In addition, established orphan drug companies with marketed products use LapidusData market forecasting systems for sales, marketing, and budgetary planning.
Before founding LapidusData in 2008, David began his pharma career at Decision Resources, a pharmaceutical consulting firm. After contributing several innovations to this company’s forecasting process, he moved to Genzyme, where he built a market forecasting system for the enzyme replacement therapy business unit. He holds a BA in Social Studies from Harvard University.
Dr. Neena Nizar
Founder and Executive Director, Jansen's Foundation
Dr. Nizar serves as Founder and Executive Director of the Jansen’s Foundation. She is a rare disease advocate and Change Leader in the rare disease community, specifically in the field of ultra-rare skeletal dysplasias. Dr. Nizar has a Doctoral degree in Educational Leadership from Creighton University, Nebraska, is a TEDx speaker, a blogger and passionate voice for the special needs community. She is a Trailblazer for the Rare Advocacy Movement (RAM) and Nebraska’s Mother of The Year, 2018. Dr. Nizar is also a rare disease patient and a mother to two boys with Jansen’s Metaphyseal Chondrodysplasia – a disease that affects less than 30 people worldwide.
Mike Page
Executive Director, Global Regulatory Affairs Portfolio Products, Alexion Pharmaceuticals
Maria Picone
Co-Founder/CEO Trend Community
Luke Rosen
Founder, KIF1A.ORG / Vice President, Pateint Engagement & Government Affairs, Ovid Therapeutics
Luke Rosen and Sally Jackson founded KIF1A.ORG in 2016.His mission is to accelerate biotech innovation and forge efficient collaborations within the scientific and patient communities, resulting in discovery of treatment for children living with KIF1A Associated Neurological Disorder, a rare neurological disease affecting his daughter.
With a focus on developing meaningful outcome measures, Luke works to educate and empower families affected by rare genetic diseases. By making sure rare disease families play an active role in discovery, from pre-clinical research through clinical trial readiness, Luke helps drive our mission to find therapeutic options for children living with KIF1A Associated Neurological Disorder.
In addition to his role with KIF1A.ORG, Luke serves as the Vice President of Patient Engagement & Government Affairs at Ovid Therapeutics, a biotech developing treatment for people living with rare neurological disorders.
Subha B . Basu
PHD/MBA, Managing Director, Converge Advisory Group
Subha focuses on R&D and Commercial strategies in pharma/biotech, particularly analyzing the breadth and depth of scientific, clinical and commercial information to inform drug development, business development and launch strategies. As of 2017, he started his own firm, the Converge Advisory Group (CAG), with the sole mission to bring the best assets to market faster. Subha has also held roles at Becton Dickinson, IQVIA and Frost & Sullivan, with exposure to bioprocessing, medical devices, clinical / companion diagnostics and life sciences. He has also taken two cell culture media products from concept to launch, as a marketing member on product development teams.
Over the last year, CAG has developed one of the most comprehensive data sets for rare disease and strategic analysis. Combining three large curated files, for Diseases and Epidemiology, Clinical Development / Pipeline, and Commercial / Market Access, this datamart allows just about any stakeholder, from pharma to patient advocacy groups, to better understand diseases at the indication, asset and company levels. One of the driving forces have been the lack of defensible proofs for rare disease facts and figures. So we developed our own.
Additionally, Subha is also a neuroscientist by training, having spent 10 years in academic research on rare diseases such as ALS, Batten Disease and Down Syndrome. Subha holds a bachelor’s degree in biochemistry from the University of California at Berkeley, a PhD in neuroscience from the State University of New York in Brooklyn, a post-doctoral fellowship in neuroscience from Stanford University and an MBA from Carnegie Mellon University.
Jason Cameron
Vice President, Operations, Amicus Therapeutics
Jason is currently Vice President of Global Supply Chain at Amicus Therapeutics responsible for planning, process & PMO, CMO management and distribution, he has spent over 20 years in the pharmaceutical industry firstly and Genzyme and then Synageva always within the Rare disease area, holding various role locally, regionally and globally within manufacturing and commercials always with a tie to supply chain.
Lisa Deck
Founder and Director of Sisters@Heart
Lisa Deck is a Founder & Director of Sisters@Heart, a non-profit organization that improves the lives of those affected by heart disease and stroke. Lisa is a former Go Red for Women National Spokeswomen for the American Heart Association and currently serves as an Advocacy Board Member for the American Heart Association in Boston and Southern New England.
Suffering her first three strokes twenty years ago, Lisa has been a patient activist and international speaker for the past two decades. Lisa lobbies at the local, state and Federal level for health and awareness policy development. She is a widely known advocate voice that inspires others and raises awareness of heart disease, stroke and Moyamoya disease.
In 2015, Lisa was diagnosed with Moyamoya Disease, a rare cerebrovascular disease, after an 18-year diagnostic odyssey. She underwent two brain bypass surgeries to restore blood flow to her brain. Since then, Lisa has become actively involved in rare disease advocacy, serving as a Committee member of Rare New England. Rare New England brings together New England patients, families and providers touched by rare and complex disorders. On behalf of Rare New England, Lisa produces and hosts a local cable show, The World of Rare Disease. Lisa is also active with the newly formed Moyamoya Foundation. Lisa lives in North Attleboro, MA with her husband and two children.
Robert Donnell
Head of Business Development at Durbin PLC
Robert Donnell has 20 years’ experience in the pharmaceutical sector, working for large blue-chip companies such as Procter & Gamble and AstraZeneca.Robert joined Durbin, one of the world’s leading specialist Comparator and Clinical Trials Supply companies in 2009. He is responsible for global business development across the Durbin Group, including developing relationships and devising strategic partnerships with multinational pharmaceutical and biotechnology companies.Robert has advised several UK Members of Parliament on Healthcare policy and lectures extensively on Global supply issues.
Todd Galles
Business Development Principal, Durbin
Todd Galles, Business Development Principal at Durbin in the USA, is developing and growing Durbin’s client portfolio in the US and Americas. Mr. Galles has an extensive background in the life science industry more than 30 years of experience in business development, sales, marketing, and executive management in the pharmaceutical and biotech fields. Previous companies include Syntex Laboratories, Dey LP, Santen, Mylan, and Dow Pharmaceutical Sciences. Todd has also served on numerous industry and company advisory boards. Todd focused in the clinical trial supply sector for 10 years working with leading CROs. He has been working with Durbin for 5+ years and specializes in both clinical trial supplies and managed access programs. Durbin is one of the world’s leading specialist medical suppliers and distributors of pharmaceuticals. Durbin has full service offices in the UK and USA.
Kei Kishimoto
Chief Scientific Office, Selecta Biosciences
Dr. Kishimoto is the Chief Scientific Officer of Selecta Biosciences, a biotechnology company developing synthetic vaccines based on a novel self-assembling nanoparticle technology. Prior to joining Selecta, Dr. Kishimoto was Vice President of Research at Momenta Pharmaceuticals where he led multidisciplinary teams in inflammation, oncology, and cardiovascular disease. Previously he was Senior Director of Inflammation Research at Millennium Pharmaceuticals, where he provided the scientific leadership for four programs in clinical development, and an Associate Director of Immunology at Boehringer Ingelheim. Dr. Kishimoto received his doctoral degree in Immunology from Harvard University and his post-doctoral training at Stanford University.
M. (Ken) Kengatharan
PhD, MBA, CEO, Auxesia Orion, Executive Chairman, Helios Orion and Managing Partner, Atheneos Ventures
Dr Kengatharan is a co-founder of several San Francisco bay area-based biopharmaceutical companies where he held responsibilities in R&D and corporate development. He is currently President & CEO of Auxesia Orion, Executive Chairman of Helios Orion and a member of the board of Renexxion. He is also managing partner at Atheneos Ventures, a San Francisco bay area based evergreen healthcare incubator fund focusing on opportunities in orphan drugs and rare diseases. Previously he was President & CEO of Armetheon (renamed Espero Biopharma following a merger) and prior to that President & CSO of Altheos. He is the former Vice President, Pre-Clinical R&D of Athenagen (re-named CoMentis following a merger).
During the last 20 years, Dr. Kengatharan has been critical to the development of multiple drug candidates from concept to clinical development. Since setting-up his first company in the late 1990s, with a great team and highly supportive investors in each case, he has been critical to setting-up 9 companies and raising >$160MM in private equity and for closing partnership transactions in excess of $1bn in deal value. He has served on the boards of EPi3 (UK), Athenagen, Altheos, Armetheon, he has been an advisor/advisory board member at Spire-BioVentures, Cardinal Free Clinics (Stanford University School of Medicine), a mentor at University of California, San Francisco (UCSF)’s entrepreneurship program and a panel judge for the Stanford Business School’s Ignite Program. He trained as a cardiovascular pharmacologist in London and at Stanford after obtaining his PhD in pharmacology from the University of London under the supervision of eminent British pharmacologist and Nobel laureate, Prof. Sir John Vane FRS and Professor Christoph Thiemermann. Dr Kengatharan obtained his MBA (with Distinction) from Durham University in England, where he focused on Biotech Finance and Entrepreneurship. His current interests, based on previous experience, include capital efficient R&D, application of distributed ledger technology, AI, and novel paths to raising private equity, in healthcare. Since 2016, Dr. Kengatharan has been an advisor to PGE’s Orphan Drugs & Rare Diseases Global Congress held in Europe and in the United States.
Qing Liu
Founder & Principal Consultant, QRMedSci, former Statistical Science & Program Strategy Lead, Amicus Therapeutics
Qing Liu, Ph.D. and ASA Fellow, is the Founder of Quantitative & Regulatory Medical Science, LLC. Currently, Qing is leading Statistical Science and Program Strategy at Amicus Therapeutics, which develops precision medicines for patients suffering from rare diseases.
Qing’s mission is to bring innovative methods and technologies to clinical trials by leveraging his rich clinical trial experience, extensive research and publications in innovative design and statistical methods, and IT expertise in cloud based parallel- and super-computing.
Qing is a statistical expert who gained rich experience in broad disease areas in oncology, neurology, psychiatry, pain, cardiovascular, anti-infective, anti-virus, immunology and metabolic diseases from employment in academic institution, regulatory agency (FDA) and the bio-pharmaceutical industry. Qing’s clinical research experience includes more than 30 due-diligence projects in new drug licensing & acquisitions, numerous successful dispute resolutions with the FDA, successful implementation of various regulatory acceptable innovative trial designs and strategic clinical development planning. Qing has substantially contributed to clinical trial design, protocol review, monitoring, analysis, study report and regulatory submission.
Qing provided expert consulting for small and startup companies in efficient clinical development of innovative therapies with emphasis on medical devices, immuno-oncology, breakthrough designation drugs, rare disease therapies, and individualized medicine. To address the unique challenges in these areas, Qing specializes in blinded data monitoring (BDM) using an efficacy response signature (ERS) approach to adjust sample size and optimize statistical power for ongoing trials and in developing information enriched composite endpoints for use in efficient adaptive designs.
James P. Shaffer
MBA, Chief Business Officer, Eiger BioPharmaceuticals
James Shaffer brings extensive commercial leadership and business experience with over 20 years of experience with large pharmaceuticals, emerging biotechnology and specialty pharmaceutical companies in Infectious Disease, Neurology, Oncology, GI and Pulmonary Care.
Prior to joining Eiger, Mr. Shaffer served as Vice President and Chief Commercial Officer for Halozyme Therapeutics from 2011 to 2014 where he was responsible for Sales, Marketing and Business Development overseeing the re-launch of Hylenex® and product development in Diabetes and Oncology. From 2007-2011, Mr. Shaffer was Executive Vice President and Chief Commercial Officer responsible for Sales, Marketing, Business Development and Manufacturing with Clinical Data, Inc., who developed Viibryd®, a novel antidepressant, which was acquired by Forest Laboratories for $1.2 billion. Mr. Shaffer was Vice President of Commercial Operations for New River Pharmaceuticals which developed Vyvanse® for the treatment of ADHD and was acquired by Shire for $2.6 billion in 2007. From 2004-2007, he was Senior Director of Commercial Operations for Prestwick Pharmaceuticals overseeing the collaboration with Cambridge Labs for Xenazine®, an Orphan CNS specialty product, and responsible for the development of the companies commercial capabilities in the US and Canada. From 2001-2004, Mr. Shaffer was the National Sales Director for InterMune. Mr. Shaffer spent the first 10 years of his career in numerous sales and marketing positions of increasing responsibility with Merck and GlaxoSmithKline.
James Shaffer is a graduate of the Ohio State University where he earned a B.S. Degree in Economics and an M.B.A..
