Shelah Gilbert Leader, PhD - Columbia University Mailman School

Shelah Gilbert Leader, PhD
55 East 87th St. #8H
New York, N.Y. 10128
(mobile) 202-236-0896
Harvard Business School, Executive Education; Leadership and Strategy in Pharmaceuticals and
Center for Creative Leadership: Leadership Development Program
Kennedy School of Government, Harvard: Mastering Negotiation
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
Adjunct Associate Professor, New York University Wagner School
Design and teach new course Introduction to Comparative Effectiveness
Senior Lecturer, Mailman School of Public Health, Columbia University
Design and teach new courses on the role of interest groups in health policy and comparative
effectiveness research.
Consultant, Milliman, Inc.
Contributed to studies of the value and cost of medical interventions on behalf of payers and the
pharmaceutical industry.
Consultant, R Baby Foundation
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.
Proposed and managed numerous research contracts to document the value of new products for
severe respiratory disease, psoriasis and MS.
Consultant, MAP Pharma
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
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
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
Obtained insurance coverage in Europe and Japan for Synagis, resulting in 52% growth in international
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
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
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.
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.
Backstage tour guide Metropolitan Opera; Tutor bilingual elementary school children through the Union
Settlement House; Tutor adults through Literacy Partners.
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.
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.
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
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
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, 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.
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
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
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.
Mallick R, Leader S, Sunshine J, Shaffer K, Hiring by Radiology Groups in 1996, Radiology, November
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
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.
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.
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.