Joel B. Braunstein, MD, MBA Co-Founder, Managing Director
Dr.
Braunstein provides strong analytic insight in the areas of clinical
trial design, medical technology assessment, outcomes research, and
health policy and financing. Dr. Braunstein is a board-certified
internist and cardiologist who also holds an Adjunct Assistant
Professor position in the Divison of Cardiology, Department of
Medicine at the Johns Hopkins Medical Institutions and is actively
engaged as a researcher within the Department of Health Policy and
Management at the Johns Hopkins Bloomberg School of Public
Health.
Dr. Braunstein was founder of MedLink Consultants,
LLC, a firm that provided strategic and scientific due-diligence to
public and private firms in life sciences and institutional
financial services. He is currently a Scientific Advisor to Animas
Corporation (NSDQ:PUMP), a medical device manufacturer, and the
Medical Technology and Practice Patterns Institute (MTPPI), a
nonprofit Washington-based think tank organization that conducts
research on the clinical, economic, and social implications of new
and emerging health care technologies. Dr. Braunstein has also
provided expert consultative services to the Coverage Policy Group
of CMS (Medicare).
Dr. Braunstein has extensive publication
and editorial experience, through authoring more than 80 manuscripts
for peer reviewed literature and popular press, and serving as an
editor and peer-reviewer for the Journal of the American College
of Cardiology, Annals of Internal Medicine, the Journal of
Clinical Epidemiology, the Journal of General Internal
Medicine, Current Atherosclerosis Reports,
BioCritique, HeartInfo.org and Diabetes Forecast, the
main consumer journal of the American Diabetes Association.
Dr. Braunstein received his MD from Northwestern University
Medical School, where he graduated a member of the honorary medical
society, Alpha Omega Alpha, and won highest distinctions for the top
achievements in medicine, surgery, obstetrics/ gynecology, and
overall clerkships. From 1996-1999, he trained in internal medicine
at the Brigham and Women’s Hospital and Harvard Medical School.
Between 1999-2003, Dr. Braunstein completed a cardiovascular
medicine fellowship and served as a Robert Wood Johnson National
Clinical Scholar at the Johns Hopkins Medical Institutions.
Additionally, he completed an MBA with health care management focus
at the same institution.
Ilana Fogelman, MD, MPH Co-Founder, Managing
Director
Dr. Fogelman specializes in corporate and
product pipeline valuation, drug development, clinical trial design
and analysis, and FDA regulations. Her primary responsibility at
LifeTech Research is to identify and evaluate investment
opportunities of private and public companies with emerging life
sciences technologies and products in the various stages of
pre-clinical and clinical development. She also evaluates
regulatory strategies and helps clients interpret FDA actions,
decisions and requirements.
For the previous three years, Dr.
Fogelman worked as a biotechnology analyst for Merrill Lynch and
Salomon Smith Barney, covering small- to mid-cap public companies.
From 1993 to 1999, Dr. Fogelman worked for the FDA's Center for
Biologics Evaluation and Research as a medical reviewer of therapies
for infectious diseases, immunologic, and autoimmune disorders. In
that position, she reviewed more than 80 INDs, 2 BLAs, and 2 BLA
supplements for a variety of technologies, including monoclonal
antibodies, cytokines, immunomodulators, cell and gene therapies,
and vaccine therapies. While at the FDA, Dr. Fogelman was also the
Principal Investigator of an HIV clinical trial, which she designed
and implemented in collaboration with the NIH to evaluate the
immunologic reconstitution of HIV-infected patients receiving highly
active antiretroviral therapies.
Dr. Fogelman obtained her
MD from the University of São Paulo and a Master in Public Health
from Harvard University. At Harvard, she also completed two
postdoctoral research fellowships in HIV clinical trials and
immunology.
Ellen Brady, MD, MPH Director, Clinical and Regulatory Research
Dr. Brady joined LifeTech Research in 2004. She is a board certified general internist with a master’s degree from the Johns Hopkins School of Hygiene and Public Health. Dr. Brady’s early career included several years within academia with a research focus on international health and policy, health care system reform, and technology assessment. Subsequently, and prior to LifeTech, Dr. Brady spent 20 years within the pharmaceutical industry, working for both major pharmaceutical (Sandoz, Ciba-Geigy, Janssen Pharmaceuticals and Serono) and specialty pharmaceutical companies (NPS Pharmaceuticals and Esperion Therapeutics). Most recently, she was Senior Director, Clinical Research at Esperion prior to its acquisition by Pfizer.
Throughout her career, she has been responsible for clinical trial design, implementation, and oversight and strategic medical management of products at all stages of development, from pre-IND through post-marketing Phase 4. These products were indicated for use in cardiology, neurology, gastroenterology, endocrinology/metabolism, HIV/AIDS and asthma.
Dina S. Stolman, MD, MSPH Senior
Consultant, Regulatory and Clinical Affairs
Dr. Stolman is a
former FDA Medical Officer, with extensive experience in drug
development, clinical trial design and analysis, and regulatory
strategy and compliance. Between 1994 and 2001, Dr. Stolman served
as a Medical Officer in FDA's Center for Biologics Evaluation and
Research, within the Division of Clinical Trial Design and Analysis.
Her main responsibilities included review, analysis and oversight of
clinical trials with investigational biologic therapeutics. She also
served as primary scientific reviewer for numerous marketing
applications of novel agents within the fields of cardiovascular,
peripheral vascular, neurologic and metabolic disease. She is
principal author of the textbook chapter, Design Issues in
Clinical Trials of Thrombolytic and Antithrombotic Agents, in
New Therapeutic Agents in Thrombosis and Thrombolysis,
Sasahara, A. and Loscalzo, J.; Marcel Dekker, eds 1997 and 2002, and
is the recipient of numerous honors and awards for commendable
service while at FDA.
After leaving
FDA in 2001, she worked as an Associate Director for Medical Affairs
for Globomax, LLC (a full service CRO, now part of ICON plc), and
subsequently as Principal Consultant for RxDevelopment, LLC. In both
capacities, Dr. Stolman provided expert advice to pharmaceutical
manufacturers, emerging biotechnology firms and academic groups in
the design and development of clinical research studies, regulatory
compliance, and evaluation of preclinical and clinical data. She has
also served as an expert witness in pharmaceutical development
litigation. Dr. Stolman is also the immediate past Chair of two
institutional review boards (IRBs) for LifeBridge Health, a regional
medical center in Maryland, where she oversaw more than 200 active
clinical research projects.
Dr. Stolman
obtained her MD from the George Washington University School of
Medicine and MSPH from the UCLA Graduate School of Public Health
with a focus on Health Planning and Policy Analysis. Prior to her
tenure at FDA, she spent 10 years as a Board-certified internist in
the practice of general medicine. She maintains membership in the
Society for Clinical Trials (SCT) and the Applied Research Ethics
National Association (ARENA).
Lars Ellison, MD, MA Senior Consultant,
Technology Assessment and Health Policy
Dr. Ellison has
extensive experience in medical technology assessment, clinical
trials, and advanced computer simulation and decision model design.
In addition to his role at LifeTech Research, Dr. Ellison is an
Assistant Professor of Urology and Director of the Minimally
Invasive Urologic Surgery Program at the University of California,
Davis. Dr. Ellison serves both as an expert advisor for technology
assessment and coverage policy decisions with the Center for
Medicare and Medicaid Services (CMS), sits on the grant review
committee for the American Foundation for Urological Diseases, and
has served on the Prostate Patient Outcomes Research Team (PORT), a
federally funded health services research consortium based at
Harvard University and Dartmouth College.
In addition to
numerous publications in the peer-reviewed literature and
presentations at multiple medical specialty meetings, Dr. Ellison
serves on the peer review panel for JAMA, the Journal of
Clinical Epidemiology, the Journal of General Internal
Medicine, Urology and Pharmaco-Economics.
Dr. Ellison
received an MA in Political Economy from the University of Sheffield
(England) in 1990 and his MD from the Boston University School of
Medicine in 1995. He completed a Urology residency at the
Dartmouth-Hitchcock Medical Center in 2001; for part of that time,
he was also the Health Policy Scholar for the American Foundation
for Urological Diseases. Most recently, Dr. Ellison was a Robert
Wood Johnson National Clinical Scholar at the Johns Hopkins Medical
Institutions, where he also completed an advanced clinical
fellowship in genitourinary laparoscopic surgery and a Business of
Medicine Certificate.
Nirav R. Shah, MD, MPH Senior
Consultant, Clinical Trial Design and Analysis
Dr. Shah's
expertise includes meta-analysis, medical informatics, and
understanding bias in randomized trials and observational studies.
His professional experience includes designing and managing projects
within the pharmaceutical and biotechnology sectors in a consulting
capacity as well as four years with Harvard's Technology Assessment
Group. He has served on three national advisory committees for the
American College of Physicians and is an adjunct lecturer to
students at two medical schools in New York. He is widelypublished
in journals including JAMA, the New England Journal of
Medicine, and the Annals of InternalMedicine, and is the Principal Investigator of two NIH
grants.
Dr. Shah is an honors graduate of Harvard College and
the Yale School of Medicine. He received his MPH with distinction
from Yale, concentrating in the Epidemiology of Chronic Diseases.
Subsequently, he completed residency training in Internal Medicine
at Yale-New Haven Hospital and a fellowship in Health Services and
Outcomes Research at UCLA in the Robert Wood Johnson Clinical
Scholars Program. Dr. Shah is Board Certified and currently
part-time practicing in Internal Medicine with medical licenses in
New York and California. In addition to his role at LifeTech, he is
completing a PhD in Epidemiology from UCLA on the topic
"Methodologic quality predictors of observational studies" in
consultation with experts at RAND (Santa Monica).
Senai Asefaw, MD, MBA
Consultant,
Medical Technology Adoption
Dr. Asefaw is a
board-certified internist who has great expertise in economic and
financial modeling, and drug pipeline valuation. In addition to his
role at LifeTech Research, he is an Assistant Clinical Professor of
Internal Medicine at Yale-New Haven Hospital, the major teaching
hospital of the Yale School of Medicine.
Dr. Asefaw's
professional experience includes work as a healthcare analyst at
General Electric and a technology assessment consultant for the
Yale-New Haven Health System. Dr. Asefaw graduated with honors in
Economics from Harvard University and received his MD from the Yale
School of Medicine in 1999. He also received an MBA with focus on
finance and strategy from the Yale School of Management where he was
a Dean's Scholar. He completed his post-graduate residency training
in internal medicine at Yale-New Haven Hospital.
