1 Shelah Gilbert Leader, PhD 55 East 87th St. #8H New York, N.Y. 10128 (mobile) 202-236-0896 shelah.leader@gmail.com EXECUTIVE EDUCATION Harvard Business School, Executive Education; Leadership and Strategy in Pharmaceuticals and Biotechnology Center for Creative Leadership: Leadership Development Program Kennedy School of Government, Harvard: Mastering Negotiation EDUCATION Cornell University, Post Doctoral Fellow in Demography State University of New York, Buffalo Master of Science and Ph.D. in Political Science Hofstra University, Bachelor of Arts, Political Science University of Paris, Junior year abroad program Hebrew University, Jerusalem, Israel, one year Graduate Program HEALTH POLICY: INDUSTRY, ASSOCIATION AND ACADEMIC EXPERIENCE Adjunct Associate Professor, New York University Wagner School Design and teach new course Introduction to Comparative Effectiveness 2012 Senior Lecturer, Mailman School of Public Health, Columbia University 2009-2012 Design and teach new courses on the role of interest groups in health policy and comparative effectiveness research. Consultant, Milliman, Inc. 2010 Contributed to studies of the value and cost of medical interventions on behalf of payers and the pharmaceutical industry. Consultant, R Baby Foundation 2009 Researched latest facts about pediatric emergency care in the U.S. and devised a tactical plan of action for this new parent and child advocacy foundation. Provide on-going advice on pediatric policy issues. Consultant, Novartis Inc. 2009 Proposed and managed numerous research contracts to document the value of new products for severe respiratory disease, psoriasis and MS. Consultant, MAP Pharma 2009 Researched validated patient reported outcomes instruments for pediatric asthma and advised on clinical trial design. New York City Dept. of Health and Mental Hygiene Consultant to Primary Care Information Project 2008 2 Assessed the work of the Evaluation Unit in light of the full range of activities by PCIP staff and recommended additional opportunities to systematically capture and evaluate the process of converting NYC health care provider offices to electronic health records and their impact on the quality and outcomes of patient care Boehringer-Ingelheim, Ridgefield, CT Consultant, Health Economics and Outcomes Research Led strategic planning for launch of first in class product in women’s health Wrote RFPs, selected and supervised vendors Represented HEOR department in cross-functional product planning meetings Mentored junior staff GE Healthcare, Princeton, NJ Sr. Director, Health Economics and Outcomes Research 2008 2006 to 2007 Proposed economic and quality of life endpoints for clinical trials of diagnostic devices for oncology Wrote Requests for Proposals, identified qualified consultants, recommended research priorities and budgets to marketing directors Recommended economic and quality of life measures for Target Product Profiles Served as internal expert advisor to cross-functional product development teams MedImmune, Inc., Gaithersburg, MD A division of Astra Zeneca, over $1 billion in revenue Director, Pharmacoeconomics and Outcomes Research 1999 to 2006 Built and directed a new department from the ground up by hiring talented researchers, acquiring a large research database and managing an annual budget of over $1million. Conceived and executed an ambitious research agenda by managing staff and commissioning numerous studies through contract research resulting in peer-reviewed publications. Executed innovative strategies to support market acceptance of approved products by documenting through original research the clinical, social and economic benefits of their use and addressing safety concerns. Obtained insurance coverage in Europe and Japan for Synagis, resulting in 52% growth in international sales. Overcame negative perceptions of the cost effectiveness of the company’s flagship product, Synagis, through published research and persuasive presentations to key medical experts and insurance policy makers. As a result, the mature product continued to experience double-digit growth (13% in 2005). Identified successful strategies to expand coverage policies by numerous State Medicaid programs and several Blue Cross/ Blue Shield insurers as well as Kaiser Permanente. Documented the importance of respiratory syncytial virus as the leading cause of infant hospitalization, a fact now recognized by the US Centers for Disease Control. Contributed to clinical trial designs and new business development decisions through analysis of epidemiologic, cost and burden of disease data and projected market size for new products in a competitive environment. Published and presented research findings regularly at international scientific meetings. Pracon , formerly a subsidiary of Reed Elsevier publishers, Reston VA Pharmaceutical consulting and service firm Executive Director of Health Economics, Reimbursement and Policy 3 1994 to 1999 Developed and successfully implemented a business marketing plan for the Department of Health Economics to meet annual revenue targets and maintain public visibility for completed studies. Conducted original research on the outcomes and cost of care for clients in the pharmaceutical and device industry. Developed the annual strategic plan, met with and identified client needs, approved all proposals prior to their submission, and ensured compliance with contractual obligations. Directed the reimbursement hot line business unit generating over $1 million in revenue. Supervised and approved all research designs and reports and set quality standards. Supervised 25 employees. Advised Excerpta Medica on corporate acquisition decisions. Designed and published innovative research and presented findings at international scientific meetings on behalf of corporate sponsors. American College of Obstetricians and Gynecologists, Washington DC Director Health Economics Analysis 1991 to 1994 Developed and implemented a strategic plan for a new department in a professional association of 34,000 members and 200 staff. Planned and managed annual budgets of $500,000 plus educational products and services generating annual revenue of $200,000. Represented the Association before federal policy makers, other interest groups, and the press. Wrote and presented testimony and regulatory comments on health care proposals. Devised effective strategies for achieving policy goals in state and private insurance arenas. Obtained three increases in Medicare payments for core services provided by members. Hired, trained and supervised staff. Selected and supervised outside contractors. Planned and directed policy relevant research. Formulated and recommended Association policy positions on issues affecting financing, coverage, and reimbursement of health services. Directed the work of two standing committees and advised the Executive Board on policy options concerning health economics issues. AARP, Division of Legislation & Public Policy, Washington DC Senior Analyst 1986 to 1991 Wrote and presented Congressional testimony and regulatory comments on issues relating to Medicare. Designed and directed original research by contractors I selected. Formulated alternative policies adopted by the Association on Medicare financing and payment systems; ambulatory surgery; home health care; capital payments; reform of physician payment methods; and ethical issues in health care. Organized policy briefings and seminars on critical issues in health care delivery and financing systems attended by Executive staff, subject experts, and federal policy makers. PROFESSIONAL ACTIVITIES Peer reviewer for numerous medical and policy journals including Pediatrics, Value in Health, Health Care Financing Review. Scientific reviewer for the Patient=Centered Outcomes Research Institute. VOLUNTEER Backstage tour guide Metropolitan Opera; Tutor bilingual elementary school children through the Union Settlement House; Tutor adults through Literacy Partners. 4 SELECTED PUBLICATIONS BOOKS: Leader S, Moon M, Changing America's Health Care System: Proposals for Legislative Action, Scott, Foresman & Co., Glenview, IL, 1988. Tobias S, Leader S, Leader S, Goudinoff P, What Kinds of Guns are They Buying for Your Butter? New York: William Morrow, 1982. Paper back title: The People’s Guide to Defense, New York: Quill, 1984. BOOK CHAPTERS Leader S, The Treatment of Women Under Medicare, in The Economics and Ethics of Long Term Care and Disability, Marian Ein Lewin and Sean Sullivan, eds., American Enterprise Institute Books, University Press of America, 1988. Leader S, Fiscal Policy and Family Structure, in Families, Politics, and Public Policy, Irene Diamond, ed., New York: Longman, 1983. Leader S, The Policy Impact of Elected Women Officials in The Impact of the Electoral Process, Louis Maisel, ed., California: Sage, 1977. Leader S, Women Candidates for Elective Office, in The Role of Women in Politics, Newark, Delaware: University of Delaware Press, 1974. PEER REVIEWED ARTICLES MEDICAL SCIENTIFIC RESEARCH Asche CV, Leader S, Plauschinat C, Raparla S, Yan M, Ye X, Young D. Adherence to current guidelines for chronic obstructive pulmonary disease (COPD) among patients treated with combination of longacting bronchodilators or inhaled corticosteroids. International Journal of COPD, 2012; 7: 201-209.. Plauschinat C, Leader S, Gause D. Lack of adherence to evidence-based guidelines in COPD by physician type: data from the 2006 National Ambulatory Medical Care Survey. American Journal of Respiratory Critical Care Medicine, 181:2010 (abstract). Foley K, Auerbach P, Foley D, Leader S, Shah H, Diagnosis and Treatment of Female Sexual Dysfunction/Hypoactive Sexual Desire Disorder by OB/GYNS, Obstetrics and Gynecology, 2009 (abstract). Li S, Leader S. Economic and Social Burden of Influenza in Households with Children Aged 5 To 17 Years in the United States, 1996-2002. Journal of Respiratory Medicine, Vol.101, No.6, 2007 5 Gavin N, Leader S. Predictive Accuracy of Risk Factors for RSV-Related Hospitalizations Among Infants in Low-Income Families Born at 32 to 35 Weeks of Gestation , Journal of Clinical Outcomes Management, Vol. 14, No. 6, 2007. Baker G, McLaurin K, Leader S. Treatment-associated toxicities in US Medicare non-small cell lung cancer (NSCLC) patients. Lung Cancer, July 2005 (abstract) Baker G, Leader S. Comparative Use of Health Care Services by Premature and Term 4-12 Month Old Infants in the First Year of Life. Pediatric Research, May 2005 (abstract) McLaurin K, Leader S. Growing Impact of RSV Hospitalization Among Infants in the US, 1997-2002 . Pediatric Research, May 2005 (abstract) Ciesla G, Leader S, Stoddard J. Antibiotic Prescribing Rates in the US Ambulatory Care Setting for Patients Diagnosed with Influenza, 1997-2001, Respiratory Medicine, November, Vol. 98/11, 2004. Ciesla G, Leader S.Antibiotic Prescribing During RSV-Associated Ambulatory Care Visits by Children Age <5 Years, US, 1995-2001, Pediatric Research, May 2004 (abstract). Ciesla G, Leader S. Antibiotic Prescribing in Ambulatory Care for RSV-Associated Bronchiolitis in US Infants, 1995-2001, American Journal of Respiratory and Critical Care Medicine, April 2004 (abstract). Leader S, Kohlhase K. Recent Trends in Severe Respiratory Syncytial Virus (RSV) Among US Infants, 1997-2000, Journal of Pediatrics, Vol. 143, No. 5 (supp.), November 2003. Ciesla G, Leader S, Stoddard J. Pattern and Rate of Antibiotic Prescribing During Ambulatory Care Visits for Influenza in the US, 1997-2000. Abstract, 43rd annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, September 14-17, 2003. Kohlhase K, Leader S. RSV Associated Post-Neonatal Mortality in US Infants, 1999, Pediatric Research, April 2003 (abstract). Kohlhase K, Leader S, Impact of Congenital Heart Disease (CHD) on RSV Hospital Resource Use, Pediatric Research, April 2003 (abstract). Leader S, Yang H et.al., Time and Out of Pocket Costs Associated with RSV Hospitalization of Infants, Value In Health, Vol. 6, No.2, 2003. Leader S, Kohlhase K, Respiratory Syncytial Virus-Coded Pediatric Hospitalizations, 1997 to 1999., Pediatric Infectious Disease, July 2002. Leader S, Kohlhase K, Emergency Room Visits in the U.S. for Bronchiolitis and Pneumonia by Children Age < 5 Years, 1997-1999. Pediatric Research, Part 2, April 2002 (abstract). Leader s, Kohlhase K, Psoriasis Related Medical Care in the United States, American Academy of Dermatology annual meeting, February, 2002, (abstract). Henderson R, Carlin D, Kohlhase K, Leader S, Multicenter US study of hospital resource utilization associated with cytomegalovirus-related readmission of renal and heart transplant patients, Transplant Infectious Disease, Vol. 3, (supp. 2), 2001. 6 Leader S, Kohlhase K, Respiratory Syncytial Virus Coded US Hospitalizations, 1997-1999, Journal of Perinatology, October/November, 2001. (abstract) Leader S, Kohlhase K, Recent Trends in Respiratory Syncytial Virus-Associated US Hospitalizations, 1997-1999, Journal of Perinatology, October/November, 2001. (abstract) Leader S, Jacobson P, Marcin J, Vardis R, Sorrentino M, Murray D, A Method for Identifying the Financial Burden of Hospitalized Infants on Families, Value in Health, January 2002. Henderson R, Carlin D, Kohlhase K, Leader S, Multicenter US Study of Hospital Resource Utilization Associated with Cytomegalovirus (CMV)-Related Readmission of Renal and Heart Transplant Patients, Transplant Infectious Disease, vol. 3 (suppl 2),2001. Henderson R, Carlin D, Leader S, Impact of Cytomegalovirus (CMV)-Related Readmission on Post Heart Transplant Resource Use, Value in Health, March/April 2001 (abstract). Henderson R, Carlin D, Leader S, Hospital resource utilization associated with treatment of cytomegalovirus (CMV)-related readmission post renal transplant, Am. J. of Transplantation, 2001:1 (abstract). Harley C, Leader S, Premature Birth and Resource Utilization in a Large Employment Based Independent Practice Association (IPA), Value in Health, March/April 2001 (abstract). Leader S, Mallick R, Roht L, Using medication history to measure confounding by indication in assessing calcium channel blockers and other antihypertensive therapy, Journal of Human Hypertension, March 2001. Smith B, Lee M, Leader S, Wertlake P, The Economic Impact of Automated Primary Screening for Cervical Cancer, Journal of Reproductive Medicine, June 1999. Leader S, Bendich A, Muhuri P, Potential Health Economic Benefits of Supplemental Calcium for Prevention of Osteoporotic Hip Fracture, Clinical Therapeutics, June 1999. Leader S, Brady C, Sadik K, Mahmoud R, Utility of a Medicaid Claims Database for Identifying Cases of Neuroleptically Induced Amenorrhea, Schizophrenia Research, (abstract) Spring, 1999. Leader S, Roht L, Evidence of Confounding by Indication: Prescribing of Calcium Antagonists, American Journal of Hypertension, (abstract)12 (4) II, 1999. Leader S, Mallick R, Antihypertensive Prescribing and Risk of Adverse Events in a Female Medicaid Population, Primary Care Update for Ob/Gyns, November 1998. Leader S, Mallick R, Tapping the Savings from Vitamin - Based Prevention, Managed Care Interface, October 1998. Leader S, Mallick R, Roht L, Selection of Anti-hypertensive Drug Classes and Pre Existence of Comorbid Conditions, Pharmacoepidemiology and Drug Safety (abstract) August 1998 . Leader S, Mallick R, Roht L, Confounding by Indication in Calcium Channel Blocker Treatment of Hypertension or Angina, Value in Health, (abstract), May/June 1998. Leader S, Mallick R, Potential Biases in Assessing the Risks of Pharmacotherapy Due to Mismeasurement of Drug Exposure, Clinical Therapeutics, January/February 1998. 7 Mallick R, Leader S, Sunshine J, Shaffer K, Hiring by Radiology Groups in 1996, Radiology, November 1997. Leader S, Mortenson L, Mallick R, Wade J, The Impact of Managed Care on Oncology Practice, Oncology Issues, September/October 1997. Bendich A, Mallick R, Leader S, Potential Health Economic Benefits of Vitamin Supplementation, Western Journal of Medicine, May 1997. Leader S, Mllick R, Evidentiary Basis of Drug Exposure in Calcium Antagonist Controversy, American Journal of Hypertension, May 1997. Leader S, Mallick R, Designing Outcomes Studies with Medicaid Data to Compensate for Missing Clinical Measures, The American Journal of Managed Care, March 1997. Leader S, Mallick R, Briggs N, Myocardial Infarction in Newly Diagnosed Hypertensive Medicaid Patients Free of Coronary Heart Disease and Treated with Calcium Channel Blockers, American Journal of Medicine, February 1997. Leader S, Mallick R, Monitoring Compliance in the Study by Pahor, et al, American Journal of Hypertension, October 1996. Leader S, Mallick R, Risk of Acute Myocardial Infarction Associated with Mono- or Dual-Drug Therapy for Hypertension in a Medicaid Population, Cardiovascular Reviews and Reports, September 1996 Leader S, Perales P, The Provision of Primary-Preventive Health Care Services by ObstetricianGynecologists, Obstetrics and Gynecology, March 1995. Leader S, Utilization Review: What's the Impact on Ob-Gyn Practice?, Contemporary Ob/Gyn, June 1992. Leader S, Ambulatory Care of Elderly Surgical Patients, Journal of Ambulatory Care Management, Vol. 13, No. 1, 1990. Leader S, Home Intravenous Drug Therapy Under Medicare, PRIDE Institute Journal, Summer 1989. Leader S, Moon M, Medicare Trends in Ambulatory Surgery, Health Affairs, Spring 1989. POLICY BRIEFING PAPERS Leader S, The Economics of Ob/Gyn Practice in the United States, 1990-91, Economic Impact, American College of Obstetricians and Gynecologists, Washington, DC, May 1992. Leader S, Impact of Medicare's New Reimbursement Method on Ob-Gyns, Economic Impact, American College of Obstetricians and Gynecologists, Washington, DC, March 1992. Leader S, Office Visits to U.S. Obstetrician-Gynecologists: 1975 and 1989, Economic Impact, American College of Obstetricians and Gynecologists, Washington, DC, July 1991. Leader S, The Outpatient Surgical Experiences of Aged Medicare Enrollees, The Public Policy Institute, American Association of Retired Persons, Washington, DC, 1990. 8 Leader S, Guildroy J, Kennan S, Lehrmann E, Skinner E, The Canadian Health Care System: A Special Report on Quebec and Ontario, The Public Policy Institute, AARP, Washington, DC, July 1988. Leader S, Medicare's Participating Physician Program, The Public Policy Institute, American Association of Retired Persons, Washington, D.C., 1987 Leader S, Hi-Tech Home Care, The Public Policy Institute, American Association of Retired Person, Washington, DC, 1987. Leader S, Home Health Benefits Under Medicare, The Public Policy Institute, American Association of Retired Persons, Washington, DC, 1987. 9