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Margaret Hamburg, MD
Commissioner
Food and Drug Administration (FDA)

Margaret A. Hamburg became the 21st commissioner of food and drugs on May 18, 2009. The second woman to be nominated for this position, she is an experienced medical doctor, scientist, and public health executive.

As the top official of the Food and Drug Administration (FDA), Dr. Hamburg is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health. “Strengthening FDA’s programs and policies will help us protect the safety of the food supply, give the public access to safe and effective medical products, find novel ways to prevent illness and promote health, and be transparent in explaining our decision-making,” says Dr. Hamburg. “A strong FDA is an agency that the American public can count on.”

Dr. Hamburg graduated from Harvard Medical School and completed her residency in internal medicine at what is now New York–Presbyterian Hospital/Weill Cornell Medical Center. She conducted research on neuroscience at Rockefeller University, studied neuropharmacology at the National Institute of Mental Health, and later focused on AIDS research as assistant director of the National Institute of Allergy and Infectious Diseases.

From 2005 to 2009, Dr. Hamburg was the senior scientist at the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons. From 2001 to 2005, as the foundation’s vice president for biological programs, she advocated for broad reforms to confront the dangers of modern bioterrorism as well as the threats of naturally occurring infectious diseases such as pandemic flu.

In 1997, Dr. Hamburg accepted the position of assistant secretary for policy and evaluation in the U.S. Department of Health and Human Services. In 1994, she was elected to the membership in the Institute of Medicine, one of the youngest persons to be so honored.

From 1991 to 1997, Dr. Hamburg served as commissioner of the New York City Department of Health and Mental Hygiene. In this position, she improved services for women and children, promoted needle-exchange programs to reduce the spread of HIV, and initiated the nation’s first public health bioterrorism defense program. Her most celebrated achievement was curbing the spread of tuberculosis, which resurged as a major public health threat in the 1990s. As a result of Dr. Hamburg’s reforms, New York City’s TB rate fell significantly over a five-year span. Her innovative approach, which included sending health care workers to patients’ homes to make sure they completed the drug regimen, is now a model for health departments worldwide.


Gerald Dal Pan, MD
Director, Office of Surveillance & Epidemiology
Food and Drug Administration (FDA)

Gerald J. Dal Pan, MD, MHS is the Director of the Office of Surveillance and Epidemiology (formerly known as the Office of Drug Safety) in FDA’s Center for Drug Evaluation and Research, a position he has held since November 2005. From December 2003 through November 0225, he was the Director of the Division of Surveillance, Research, and Communication Support in CDER's Office of Drug Safety. He received his medical degree from Columbia University, and his Master's degree in clinical epidemiology from Johns Hopkins University. He trained in Internal Medicine at the Hospital of the University of Pennsylvania, and in Neurology at Johns Hopkins Hospital. He is board certified in Internal Medicine and Neurology. He was an instructor in the Neurology Department at Johns Hopkins. He next worked for Guilford Pharmaceuticals in Baltimore, and then for HHI Clinical Research and Statistical Services in Hunt Valley, MD. He joined the FDA in July 2000 as a medical officer in the Division of Anesthetic, Critical Care, and Addiction Drug Products.



Louis B. Jacques, MD
Director, Coverage & Analysis Group Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services

Dr Jacques joined CMS in 2003 and has been director of the Coverage and Analysis Group (CAG) since October 2009. The group reviews evidence and develops Medicare national coverage policy. From 2004 through 2009 he was Director of the Division of Items and Devices within CAG.

Prior to his arrival at CMS, Dr. Jacques was the Associate Dean for Curriculum at Georgetown University School of Medicine, where he retains a faculty appointment. He served on a number of university committees including the Executive Faculty, Committee on Admissions and the Institutional Review Board. He previously worked in the Palliative Care program at Georgetown’s Lombardi Cancer Center where he covered the gynecologic oncology service and he made home visits as a volunteer physician for a rural hospice on the Maryland Eastern Shore.



Tamara Syrek Jensen, JD
Deputy Director Coverage and Analysis Group (CAG)
CMS

Tamara Syrek Jensen is the deputy director for the Coverage and Analysis Group (CAG) at the Centers for Medicare & Medicaid Services (CMS). CAG develops, interprets, communicates, and updates evidence based national coverage policies. These policies help provide timely access to reasonable and necessary services and technologies to improve health outcomes for Medicare beneficiaries.

Before her current position at CAG, she was the Special Assistant for the CMS Chief Medical Officer and Director of Office of Clinical Standards and Quality (OCSQ). Prior to working at CMS, she worked as a legislative assistant in the U.S. House of Representatives. Tamara is an attorney, licensed in Maryland.



John K. Jenkins, MD
Director of the Office of New Drugs, Center for Drug Evaluation and Research
FDA

Dr. Jenkins is currently the Director of the Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration. Dr. Jenkins received his undergraduate degree in biology from East Tennessee State University in 1979 and his medical degree from the University of Tennessee at Memphis in 1983. Dr. Jenkins completed his postgraduate medical training in internal medicine, pulmonary disease, and critical care medicine at Virginia Commonwealth University/Medical College of Virginia from 1983 until 1988. Dr. Jenkins is Board Certified in Internal Medicine and Pulmonary Diseases by the American Board of Internal Medicine. Dr. Jenkins is also a Fellow of the American College of Chest Physicians. Following completion of his medical training, Dr. Jenkins joined the faculty of MCV as an Assistant Professor of Pulmonary and Critical Care Medicine and as a Staff Physician at the McGuire VA Medical Center in Richmond. Dr. Jenkins joined FDA as a medical officer in the Division of Oncology and Pulmonary Drug Products in 1992. He subsequently served as Pulmonary Medical Group Leader and Acting Division Director before being appointed as Director of the newly created Division of Pulmonary Drug Products in 1995. Dr. Jenkins became the Director of the Office of Drug Evaluation II in 1999 and served in that position until he was appointed to his current position in January 2002.



Richard Pops
CEO
Alkermes

Richard Pops serves as Chairman and Chief Executive Officer of Alkermes. He joined Alkermes as CEO in 1991. Under his leadership, Alkermes has grown from a privately held company with 25 employees to an international, publicly traded biopharmaceutical company with more than 1,200 employees and a portfolio of more than 20 commercial products. Mr. Pops currently serves on the Board of Directors of Neurocrine Biosciences, Acceleron Pharma, Epizyme, the Biotechnology Industry Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA) and is also a member of the Harvard Medical School Board of Fellows.



Gillian Woollett, MA, DPhil
Senior Vice President
Avalere Health

Gillian Woollett, Senior Vice President, leads the FDA Practice within Avalere's Center on Evidence-Based Medicine. She provides the "prequel" of scientific and regulatory strategic policy expertise that supports medicinal products gaining approval at the FDA in a manner that allows them to be successful in the public and private reimbursement world. She is building a bridge for Avalere clients from the FDA space into the traditionally separate Centers for Medicare & Medicaid Services and healthcare policy/business world.

Trained as a molecular biologist/immunologist before coming to Washington, Gillian still publishes in peer-reviewed literature on biotechnology topics, and is also a frequent speaker educating on the core prospects and promises of the emerging biosciences and their ability to support better and more focused therapies.

Immediately prior to joining Avalere, Gillian was Chief Scientist at Engel & Novitt, LLP. She was Vice President, Science and Regulatory Affairs at the Biotechnology Industry Organization (BIO), where she established and led a new department to support BIO companies’ interactions with regulatory agencies in all aspects of the discovery, development, and manufacture of biotechnology-based medicines. She joined BIO after being Associate Vice President at the Pharmaceutical Research and Manufacturers of America. She has been an appointee on federal advisory committees to the Centers for Disease Control and Prevention and the Department of Commerce.

Gillian earned her B.A., M.A. in the Natural Sciences Tripos (Biochemistry) from the University of Cambridge, and her D.Phil. in Immunology from the University of Oxford in the United Kingdom.



Marc Samuels
President & CEO
ADVI

Widely regarded as “effective,” “resourceful,” “tireless,” well prepared” and “irreplaceable,” by clients and colleagues alike Marc Samuels is President & CEO of ADVI (formerly HillcoHealth), a boutique group of seasoned principals providing advisory services to leading health care delivery, financing, manufacturing, and service entities.

Samuels joined ADVI in 2001 and became a partner in 2004, working both in Austin and Washington, DC. He co-founded ADVI soon thereafter. From 1998 to 2000, Samuels served as founder of and a partner in the Health Policy Group, a Washington, D.C.-based healthcare public policy and business strategy firm, along with J. Michael Hudson, former Deputy (and Acting) Administrator of the Centers for Medicare and Medicaid Services (CMS).  Prior to that, he held various positions within state and federal government, including advising both former President George Herbert Walker Bush and then-Texas Governor George W. Bush on healthcare issues, as well as serving as Executive Assistant to the Texas Health and Human Services Commission (HHSC).

Samuels is a graduate of The University of Texas School of Law, Yale School of Medicine and the University of Michigan.  His comments and analyses have appeared in Medical Economics, Health Systems Review, Journal of Health Care Finance, Disease Management News, the Fort Worth Star-Telegram, the Dallas Morning News, and Texas Medicine.  He is a contributor to the third edition of the Managed Care Answer Book and the second edition of the HMO and Capitation Answer Book, published by Panel Publishers, New York.



Francois Nader, MD
President and Chief Executive Officer
NPS Pharmaceuticals


Francois Nader, MD, has been president and chief executive officer of NPS Pharmaceuticals since March 2008. During his tenure he transformed NPS into a leading biopharmaceutical company focused on orphan treatments for patients with rare diseases.

Dr. Nader is a 25-year veteran of the healthcare industry. Dr. Nader joined NPS in 2006 as chief medical and commercial officer. He was promoted to chief operating officer in 2007 and named a director in January 2008. Previously, he was a venture partner at Care Capital, LLC and chief medical officer of its Clinical Development Capital unit. He was also senior vice president, integrated healthcare markets and North America medical and regulatory affairs with Aventis Pharmaceuticals, serving on the North America Leadership Team (NALT), and held senior executive positions at its predecessor companies, Hoechst Marion Roussel and Marion Merrell Dow. Prior, Dr. Nader served as head of global commercial operations at the Pasteur Vaccines division of Rhone-Poulenc.

Dr. Nader served as director for Noven Pharmaceuticals and currently serves as treasurer and trustee of Bio NJ, New Jersey’s trade association for the biotechnology community and as trustee of the Healthcare Institute of New Jersey (HINJ), a trade association for the research-based pharmaceutical and medical technology industry in New Jersey.

Dr. Nader received a French State Doctorate in Medicine from St. Joseph University (Lebanon) and a Physician Executive MBA from the University of Tennessee.


Freda C. Lewis-Hall
Executive Vice President and Chief Medical Officer
Pfizer Inc.


Freda Lewis-Hall is the chief medical officer of Pfizer Inc. Trained as a psychiatrist, she has held leadership roles in academia, medical research, front-line patient care, and at global biopharmaceutical companies including Vertex, Bristol-Myers Squibb and Eli Lilly. Prior to her work in industry, she led research projects for the National Institutes of Health and was vice chairperson of the Department of Psychiatry at Howard University College of Medicine.

In 2010, Dr. Lewis-Hall was appointed by the Obama Administration to the inaugural Board of Governors for the Patient-Centered Outcomes Research Institute (PCORI), and in 2012 she was appointed chair of the Cures Acceleration Network Review Board and a member of the National Center for Advancing Translational Sciences (NCATS) Advisory Council of the National Institutes of Health. She also serves on the Executive Committee of the Clinical Trials Transformation Initiative and on numerous other boards, including those of Harvard Medical School, The Institute of Medicine's Forum on Drug Discovery, Development, and Translation, and Save the Children.

Dr. Lewis-Hall has been named as one of Savoy's Top Influential Women in Corporate America in 2012 and was selected as the Healthcare Businesswomen's Association 2011 "Woman of the Year." A passionate advocate for empowering patients through health information, Dr. Lewis-Hall speaks frequently in venues from TEDMED to the Essence Music Festival and appears regularly on the Emmy-winning daytime syndicated show, The Doctors.



Jeff Allen, PhD
Executive Director
Friends of Cancer Research



Jeff Allen, Ph.D. serves as the Executive Director of Friends of Cancer Research (Friends), a think tank and advocacy organization based in Washington, D.C. Friends is our country’s leading voice in advocating for policies and proposing and promoting real solutions that will get treatments to patients in the safest and quickest way possible. Friends develops new, groundbreaking partnerships, creates a more open dialogue among both public and private sectors and tears down the barriers that stand in the way of conquering cancer. By collaborating with federal health and regulatory agencies, premier academic research centers, professional societies, members of congress and other advocacy organizations, Friends is able to accelerate innovation.

For over 5 years as Executive Director of Friends, Jeff has been a driving force in the growth and success of the organization. Under his leadership, Friends has evolved into a nimble, forward-thinking policy, public affairs and research think tank. Jeff leads the development and implementation of Friends’ health and research policy portfolio, scientific initiatives, and oversees Board governance and organizational operations.


Jeff is regarded as a foremost thought leader on many issues that impact the biomedical research continuum, including; Food and Drug Administration regulatory strategy, comparative effectiveness research/patient-centered outcomes research and healthcare policy. He is regularly published in many prestigious medical journals, authoritative policy publications, and frequently sought out as an expert contributor by trade, scientific, institutional and national main stream press. In addition to participating in major scientific and policy symposiums around the country each year, Jeff has had the honor to be called to testify before Congress, and contribute his expertise to the legislative process on multiple occasions.

As Executive Director of Friends, Jeff has the privilege to also serve on a variety of influential committees, boards and advisory councils, including:


  • Board Member, the Alliance for a Stronger FDA;
  • Technical Expert Panel Member, Chemotherapy Infusion Quality Measures Group, Center for Medicare and Medicaid Services;
  • Strategic Team Member, U.S. Food and Drug Administration Entrepreneurs in Residence Program;
  • Director’s Consumer Liaison Group, National Cancer Institute;
  • Governance Board Member of the Multi‐Payer Claims Database initiative of Health and Human Services;
  • Co‐Chair, Regulatory Education and Action for Patients. (REAP).
Prior to joining Friends, Dr. Allen was an endocrinology fellow at the National Institutes of Health. His background in cancer research focused upon molecular changes associated with cancer formation as well as treatments to prevent cancer progression. Dr. Allen received his Ph.D. in cell and molecular biology from Georgetown University, and holds a Bachelors of Science in Biology (cum laude) from Bowling Green State University.


Richard Pazdur, MD
Director, Office of Hematology and Oncology Products
Center for Drug Evaluation & Research, FDA

Has a distinguished career in clinical and academic oncology in addition to his experience as a regulatory expert at FDA. A native of Indiana, he obtained his M.D. from Loyola Stritch School of Medicine, where he also trained in internal medicine. He was a fellow in oncology at Rush Presbyterian-St. Luke's Medical Center at the University of Chicago. Dr. Pazdur has served as a practicing oncologist, researcher, and teacher at Wayne State University, where he was director of the medical oncology fellowship program, and for many years at the M.D. Anderson Cancer Center at the University of Texas, where he was a tenured Professor of Medicine and Assistant Vice President for Academic Affairs. He joined FDA in 1999 as the Director of the Division of Oncology Drug Products and was named Director of the Office of Oncology Drug Products in April 2005. He has authored over 160 peer-reviewed papers in the field of oncology, has written chapters for over 30 oncology textbooks, and is the editor of two standard reference oncology texts.

Dr. Pazdur is well known in the oncology community as a strong scientific leader who is committed to the care and treatment of patients with cancer. He is a member of many oncology professional societies and has served on numerous local, state, national, and international committees focused on cancer treatment, drug development, patient education, and chemoprevention. Since coming to FDA, Dr. Pazdur has collaborated extensively with the leaders at the National Cancer Institute on many aspects of facilitating sound and rapid product development for cancer treatment and prevention.


Coleen Klasmeier
Partner
Sidley Austin LLP

COLEEN KLASMEIER leads the firm’s Food, Drug and Medical Device Regulatory practice within the Global Life Sciences team, managing matters on behalf of the world’s leading biopharmaceutical, medical technology, and food and consumer product companies. Since joining Sidley from the Office of the Chief Counsel at the Food and Drug Administration in 2005, Coleen has concentrated her practice on regulatory strategy and risk management, and on FDA litigation and dispute resolution. She has been deeply involved as FDA regulatory counsel in defending numerous off-label marketing investigations, as well as in a wide variety of product liability, consumer fraud, Hatch-Waxman, criminal, and appellate matters on behalf of life sciences industry clients.

Coleen serves as FDA regulatory counsel to such companies as GlaxoSmithKline, Kimberly-Clark and Roche Diagnostics. Through Coleen’s leadership, the firm’s FDA regulatory practice has grown into a full-service group that is frequently recognized in legal and industry publications for its significant regulatory experience and in-depth industry knowledge. USNews rates the FDA practice as one of the nation’s top-tier groups. Chambers USA also rates the group among the country’s best, noting in its 2012 edition that, “This highly regarded firm is applauded for its all-encompassing approach to the various industry sectors within the healthcare and FDA space.” In 2011, Chambers USA said of the group: “Sidley Austin has developed a successfully integrated healthcare and FDA practice, widely viewed as the premier service provider for some of the leading medical device and pharmaceutical companies. Clients particularly praise its expertise in regulatory compliance . . . .”

Praised by clients for her “broad experience” and attentiveness to client needs, and her “tremendous” and “encyclopedic” knowledge of FDA rules, history, and contacts (Chambers USA 2011-2012), Coleen was also named a “Life Sciences Star” in the inaugural edition of LMG Life Sciences 2012 and has been highly ranked by The Practical Law Company in The Cross-Border Life Sciences Handbook (2007-2012). Since 2012, Coleen has been recommended by Who’s Who Legal, which reports in its 2013 edition that she is “tremendously knowledgeable about all aspects of regulation” in the life sciences sector. Coleen is recognized in the 2014 edition of Best Lawyers for her FDA practice, has been included in the Legal 500 US (2011, 2013), and was named by Washingtonian magazine as one of the DC area’s Top FDA Lawyers (2009). In the 2013 edition of Chambers USA, a source notes that Coleen is “a walking dictionary of FDA case law."



Lori M. Reilly, Esq.
Executive Vice President, Policy & Research
PhRMA

Lori M. Reilly is Executive Vice President for Policy and Research at the Pharmaceutical Research and Manufacturers of America (PhRMA). Ms. Reilly leads PhRMA’s policy and research department in the development and implementation of legislative, regulatory and political strategies to successfully navigate the ever-changing federal health care landscape, working to advance policies that encourage medical progress and patient access to the fruits of pharmaceutical innovation.

In addition to her public policy work, Ms. Reilly is a frequent presenter on industry-related issues and is an industry spokesperson. Ms. Reilly testified before the House Energy and Commerce Subcommittee on Health to discuss the importance of the reauthorization of the pediatric exclusivity program and the Food and Drug Administration Globalization Act.

Prior to joining PhRMA, she was counsel at the U.S. House of Representatives Committee on Commerce. And before joining the House Commerce Committee, Ms. Reilly was Chief of Staff/Counsel to Rep. Jon Christensen, a member of the House Ways and Means Committee.

Ms. Reilly is currently a Board Member of the Personalized Medicine Coalition and is a member of the Editorial Advisory Board of The Food and Drug Law Institute’s Policy Forum.

Ms. Reilly received a B.A. in Political Science from the University of Nebraska-Lincoln where she graduated with Honors, and a J.D. from the University of Nebraska College of Law. She is a Member of the Virginia Bar and currently resides in Alexandria, Virginia with her husband and their four children.


Chris Garabedian
President and Chief Executive Officer
Sarepta Therapeutics

Chris Garabedian joined Sarepta Therapeutics as President and Chief Executive Officer on January 1, 2011. He has served as a director of the Company since June 2010. Previously he was Vice President of Corporate Strategy for Celgene Corporation from July 2007. From November 2005 to June 2007, Chris served as an independent consultant to early-stage biopharmaceutical companies. From 1997 to 1998 and from 1999 to November 2005, he worked at Gilead Sciences, Inc., where he served in a number of global leadership roles, including as Vice President of Corporate Development, Vice President of Marketing, and Vice President of Medical Affairs. Chris also held various commercial roles at COR Therapeutics, Inc. from 1998 to 1999 and at Abbott Laboratories from 1994 to 1997. He started his biopharmaceutical career as a consultant with Migliara/Kaplan Associates from 1991 to 1994. Chris received his Bachelor of Science in marketing from the University of Maryland.


James M. (Mit) Spears
Executive Vice-President
General Counsel
PhRMA

James M. (Mit) Spears is Executive Vice President and General Counsel of The Pharmaceutical Research and Manufacturers of America (PhRMA). Reporting to President and CEO John J. Castellani, Spears oversees the Legal Department and also serves as a member of the PhRMA Management Committee.

A former General Counsel of the Federal Trade Commission with over 30 years of experience in both private practice and government, Spears offers broad-based expertise in health care, the life sciences and technology. In his most recent position as a partner at the Washington, D.C. office of the international law firm Ropes & Gray, LLP, he provided legal advice and strategy to biopharmaceutical companies on key industry issues. In addition to his work in the life sciences sector, Mit’s practice focused on antitrust and trade regulation, advertising and consumer law and litigation.

In addition to his tenure at the Federal Trade Commission, Mit served in various capacities at the U.S. Department of Justice including Principal Deputy Assistant Attorney General in both the Land and Natural Resources and Civil Divisions of the Department and Acting Assistant Attorney General for Legal Policy. Mit’s legal career began as a Staff Assistant to Governor William P. Clements Jr. of Texas.

A native Texan, Mit received a B.B.A from Texas Tech University and a J.D. from the University of Texas at Austin. Mit is an avid sailor and cyclist and currently resides with his wife, Kyle Gibson, in Washington DC.


Sandra Rattray, PhD
VP and Head, Global Regulatory Affairs, Oncology
Johnson & Johnson

Dr. Rattray leads the Oncology Therapeutic Area (TA) group within Global Regulatory Affairs (GRA) at Janssen Research & Development, LLC. This group provides leadership, management, strategic input and support to all projects and products across all stages of development within the Oncology/Hematology TA. In addition, Dr. Rattray manages the GRA Companion Diagnostic group, who provide regulatory leadership for companion diagnostic development across The Johnson & Johnson Family of Companies.

Prior to The Johnson & Johnson Family of Companies, Dr. Rattray had a 14-year career with Merck & Co, Inc., which spanned sales and marketing, drug discovery and regulatory affairs with Merck Research Labs (MRL). Before joining MRL Regulatory Affairs, she was a member of the MRL Department of Infectious Disease, where she held positions of increasing responsibility, culminating in Group Leader, New Lead Discovery. As a member of the MRL Regulatory Affairs organization, Dr. Rattray provided global regulatory leadership for Merck’s oncology franchise, initially as a United States liaison and Global Regulatory Team (GRT) Leader. Subsequently, as a member of the Worldwide Business Strategy team for oncology, she assumed the role of GRT advisor for the oncology therapeutic area.

Prior to joining Merck, Dr. Rattray held postdoctoral and faculty appointments in the Departments of Pharmacology and Therapeutics and Obstetrics and Gynecology, at the University of Florida. Her research throughout her academic career was focused on the discovery and development of anticancer agents.

Dr. Rattray received her undergraduate degree from Auckland University in New Zealand, as well as her master’s (First Class Honors) and doctorate in Cellular and Molecular Biology.


Joseph Leveque, MD
Vice President, US Medical – Oncology
Bristol-Myers Squibb

At BMS-USMO, Dr. Leveque is responsible for leading an integrated medical team at BMS focused on the Company’s ImmunoOncology (IO) therapeutics. IO is the science of harnessing the immune system to fight cancer. BMS is developing a number of IO therapeutics including Yervoy® (ipilimumab), nivolumab (Anti–PD-1 monocloncal antibody), elotuzumab (Anti-CS-1 monoclonal antibody), BMS-986015 (Anti-KIR monoclonal antibody) and BMS-982470 (recombinant interleukin 21 - rIL-21).

Prior to joining BMS, Dr. Leveque was Vice President of Medical and Scientific Affairs (MedSA) at Onyx Pharmaceuticals in South San Francisco, CA. At Onyx, MedSA was focused on the development of Kyprolis (carfilzomib), a next-generation proteasome inhibitor for the treatment of multiple myeloma; Nexavar (sorafenib), a targeted therapy for renal cancer and liver cancer also being developed for breast cancer, lung cancer and thyroid cancer; and other pipeline assets including JAK inhibitors for the treatment of lymphomas and myeloproliferative neoplasms (MPN).

Specifically while at Onyx, Dr. Leveque led efforts to partner with the Multiple Myeloma Research Foundation (MMRF) on the C-MAP compassionate use program for Kyprolis and the CoMMpass longitudinal observational project. In 2012, MMRF recognized Dr. Leveque as one of the top 15 innovators in multiple myeloma over the past 15 years.

Prior to joining Onyx Pharmaceuticals, Dr. Leveque was the Vice President, Oncology MedSA at Cephalon, Inc., in Frazer, PA. He led all medical and scientific related activities in the support of the launch of Treanda (bendamustine-HCI) for the treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL) and Trisenox for the treatment of acute promyelocytic leukemia (APL).

Dr. Leveque was also Medical Director/Global Development Lead for Nplate® (AMG-531) and Neulasta (pegfilgrastim) at Amgen, Inc., in Thousand Oaks, CA. He led the clinical development program of AMG-531, a novel thrombopoiesis stimulating peptibody, for its myelodysplastic syndrome (MDS) indication. He also led the clinical development program of Neulasta in adjunctive oncology, infectious diseases, and cardiovascular diseases indications.

Dr. Leveque first entered the pharmaceutical industry with Merck working in the Vaccine Division. Following that assignment he worked developing comprehensive outpatient cancer centers, followed by a stint working on Wall Street in healthcare finance and venture capital and then founded a systems biology/bioinformatics company focused in oncology.

Dr. Leveque received his medical degree from the University of Texas Medical School in Houston, TX, and his post-graduate medical training in internal medicine and critical care at UCLA. Dr. Leveque also holds an Master’s in Business Administration from The Wharton School at the University of Pennsylvania and a Bachelor of Sciences in biology and mathematics from the Santa Clara University.


Jonathan Blum
Principal Deputy Administrator
CMS

Jonathan Blum, Acting Principal Deputy Administrator and Director of the Center for Medicare at the Centers for Medicare and Medicaid Services (CMS), is responsible for overseeing the regulation and payment of Medicare fee-for service providers, privately-administered Medicare health plans, and the Medicare prescription drug program. The benefits pay for health care for approximately 45 million elderly and disabled Americans, with an annual budget in the hundreds of billions of dollars.

Over the course of his career, Jonathan has become an expert in the gamut of CMS programs. He served as an advisor to Senate Finance Committee members and its current chairman, Sen. Max Baucus, where he worked on prescription drug and Medicare Advantage policies during the development of the Medicare Modernization Act. He focused on Medicare as a program analyst at the White House Office of Management and Budget. Prior to joining CMS, Jonathan was a Vice President at Avalere Health, overseeing its Medicaid and Long-Term Care Practice.

Most recently, Jonathan served as a health policy advisor to the Obama-Biden Transition Team. He holds a Master's degree from the Kennedy School of Government and a BA from the University of Pennsylvania.



Heidi Hunter
Head Global Department Biosimilars Business
Boehringer Ingelheim Biopharmaceuticals GmbH

Heidi Hunter is Senior Vice President and Head of Boehringer Ingelheim Global Biosimilar Business. Before joining BI, Heidi was most recently Global Vice President for Commercial Partnerships at Quintiles and prior to Quintiles, the Vice President, Strategic Planning and Commercial Development for the Biologic, Immunology and Oncology division (BIO) of Centocor - a J & J company.

Heidi’s 20 years of experience and proven success in the pharmaceutical and services industry includes working for seven years with Wyeth Pharmaceuticals, both as the Vice President of Women’s Health Care Marketing for North America and as the Global Business Leader for Oncology. She also held global marketing leadership roles at Ciba-Geigy in Switzerland and Novo Nordisk in Denmark in key disease areas including CNS and Women’s Health.

Heidi currently lives with her family in Germany.


Victor Sandor MD CM
Group Vice President, Clinical Development
Incyte Corporation

Dr. Victor Sandor is currently Group Vice President for Global Clinical Development at Incyte Corporation. He has over 10 years of experience in the pharmaceutical and biotechnology industries. Dr. Sandor is a board certified medical oncologist and has extensive experience in product development ranging from early development to late stage registration programs in Oncology. Prior to joining Incyte, Dr. Sandor was Vice President and Chief Medical Officer for Oncology at Biogen Idec, and prior to Biogen Idec, he held positions of increasing responsibility in oncology product development at AstraZeneca, where he played an important role in the registration of Arimidex for adjuvant use, the development of Faslodex, and the development of several early stage programs through proof of concept. At Incyte, Dr. Sandor played an important role in the development, approval, and commercialization of Jakafi (ruxolitinib) and is currently responsible for clinical development at the company including medical, clinical operations and biostatistics. Dr. Sandor received his MD CM from McGill University in Montreal Canada, and completed his Fellowship in Medical Oncology at the National Institutes of Health in Bethesda Maryland. He is currently also an adjunct professor in the Faculty of Medicine at McGill University.



Chuck Stevens, JD, MBA
Vice President & General Manager, Commercialization Strategy
PAREXEL International

Mr. Stevens is responsible for leading the practice including managing all reimbursement, market access and commercial strategy consulting, tactical reimbursement support help lines and PAP’s (Patient Assistance Programs) designed to provide workable solutions to support commercial success and patient access to therapy. Mr. Stevens has over 17 years of bio and pharma industry experience, including responsibility for strategic reimbursement, pricing, public and private payer strategy, product distribution/channel management and pharmaco-economics for both commercialized and non-commercialized products at the senior director level.

He has specialized expertise in Hematology, Oncology, HIV/AIDS, Addiction Medicine, Gastroenterology and Urology. He has worked extensively on issues involving the Patient Protection & Affordable Care Act (PPACA), the Medicare Modernization Act (MMA) of 2003, the Single Drug Pricer (SDP) system and obtaining product specific HCPCS codes. In 2006, he was the first person to be successful in obtaining an individual product HCPCS from CMS by making application in advance of FDA product approval, resulting in the specific code being available at time of product launch.

Chuck is a frequent presenter at national conferences, has authored articles on Comparative Effectiveness Research (CER) and has been quoted in publications such as PharmaVoice, FDA Week and the Gray Sheet.


Sumant Ramachandra, MD, PhD
Senior Vice President and Chief Scientific Officer
Hospira Inc.

Dr. Sumant Ramachandra brings 20-plus years of healthcare experience and strong leadership abilities to his role as senior vice president and chief scientific officer.
Ramachandra has made career leading scientific advancements for some of the industry’s largest pharmaceutical companies, including Merck, Pharmacia, Pfizer and Schering-Plough. As an R&D business leader, he set in motion several therapy programs that would benefit patients living with cancer – such as Camptosar® (irinotecan hydrochloride injection) and Aromasin® (exemestane tablets) at Pfizer, and Temodar® (temozolomide capsules) at Schering-Plough. He was responsible for formulating innovative strategies and executing R&D plans that resulted in successful U.S. Food and Drug Administration (FDA) approvals.

Ramachandra's award-winning work is also widely recognized through publications. He has participated in a multitude of scientific studies on tumor cell biology and immunology as well as authoring book chapters about basic cell biology and oncology. He has also filed several product patents for various cancer treatments and the use of antibodies in cancer therapy. In addition, Dr. Ramachandra has appeared in the PharmaVOICE 100, which recognizes top leaders in the health sciences, as well as Diversity MBA Magazine’s “Top 100 Under 50 Diverse Executive Leaders” and Crain’s Chicago Business’ “40 Under 40.”

He earned a bachelor's degree in biochemistry from Rutgers University, graduating with high honors. Dr. Ramachandra then pursued a combined M.D./Ph.D. degree from the University of Medicine and Dentistry-New Jersey Medical School, receiving the University's Medal of Excellence and subsequently conducting his residency at the Harvard-affiliated Massachusetts General Hospital. Ramachandra also earned an MBA at Wharton Business School.


Adriane Fugh-Berman MD
Associate Professor
Dept of Pharmacology and Physiology
Georgetown University Medical Center

Adriane Fugh-Berman, MD is an Associate Professor in the Department of Pharmacology and Physiology and in the Department of Family Medicine at Georgetown University Medical Center. As director of PharmedOut, a GUMC research and education project that promotes rational prescribing and exposes the effect of pharmaceutical marketing on prescribing practices, Dr. Fugh-Berman leads a team of volunteer professionals that has had a profound impact on prescribers’ perceptions of the adverse consequences of industry marketing.

Dr. Fugh-Berman is the lead author on key articles on physician-industry relationships, including a national survey of industry interactions with family medicine residencies, an exposé of how ghostwritten articles in the medical literature were used to sell menopausal hormone therapy, an analysis of how “key opinion leaders” are used to market drugs off-label, an exposé of drug rep tactics (all in PLoS Medicine), a discussion of prescription tracking in the Journal of General Internal Medicine and an explanation of industry publication planning in Open Medicine. An article in the Journal of Continuing Education in the Health Professions documents the effect of Why Lunch Matters, a PharmedOut presentation that is the first to document a significant change in physicians’ perceptions about their own individual vulnerability to pharmaceutical marketing.

Previously, Dr. Fugh-Berman was a medical officer in the Contraception and Reproductive Health Branch of the National Institute for Child Health and Human Development, NIH. She has also worked with the nonprofit Reproductive Toxicology Center and edited an award-winning CME newsletter on women’s health. Dr. Fugh-Berman graduated from Georgetown University School of Medicine and completed a family medicine internship in the Residency Program in Social Medicine at Montefiore Hospital in the Bronx.



Gayatri Rao, MD
Director, Office of Orphan Products Development
FDA

Gayatri R. Rao, is the Director for the Office of Orphan Products Development (OOPD) at FDA. The Office’s mission is to advance the development of promising products, including drugs, biologics, devices, and medical foods, for rare diseases. As Director, she oversees a number of programs created to promote the development of such products, including the Orphan Drug Designation Program, the Humanitarian Use Device Designation Program, the Orphan Products Grants Program, and the Pediatric Device Consortia Grant Program. In addition, she coordinates cross-Agency efforts on rare disease issues, is actively engaged in a number of internal and external collaborations to promote the development of products for rare diseases, and oversees the Office’s extensive outreach efforts to patients, sponsors, and other stakeholders. Prior to joining OOPD, Dr. Rao worked in FDA’s Office of the Chief Counsel where she provided advice on a wide range of issues related to medical devices, combination products, clinical trials, and human subject protection.



Douglas Throckmorton, MD
Deputy Director
CDER & FDA

Dr. Throckmorton is the Deputy Director for Regulatory Programs in the Center for Drug Evaluation and Research (CDER) at the United States Food and Drug Administration (FDA). He is part of a senior leadership team that works to assure that safe and effective drugs are available to improve the health of people in the United States. Among his many responsibilities are coordination with other parts of FDA on combination product development and coordination of CDER's work with the White House and the Department of Health and Human Services on regulatory and educational strategies to combat the misuse and abuse of prescription drugs. He serves as the chair of the CDER Drug Safety Oversight Board.

Dr. Throckmorton began his FDA career over 15 years ago as a medical reviewer in the Division of Cardio-Renal Drug Products, where he also served as Division Director. Prior to joining the FDA, Dr. Throckmorton conducted basic science research and practiced medicine at the Medical College of Georgia and the Veteran's Administration Hospital in Augusta, Georgia.

Dr. Throckmorton trained in Internal Medicine and Nephrology at Case Western Reserve University and Yale University. He has published numerous peer-reviewed articles and given talks on a wide variety of issues related to drug development, including the assessment of drugs for abuse potential, cardiovascular drug policy and strategies to improve medical product development.



J. Russell Teagarden
Senior Vice President, Medical & Scientific Affairs
National Organization for Rare Disorders

J. Russell Teagarden is SVP of Medical & Scientific Affairs at the National Organization for Rare Disorders (NORD) where he is responsible for the medical and scientific dimensions of research, programming, strategic alliances, and policy initiatives among others. He joined NORD after 19 years at Medco Health Solutions where he was chiefly involved in drug technology assessment, coverage policy, clinical programming, research, and clinical oversight. Prior to joining Medco, he practiced as a clinical pharmacist in critical care and drug information in the Chicago teaching hospital community. Teagarden has a BS in Pharmacy, MA in research methods, and Doctorate in Medical Humanities. He completed a residency in hospital pharmacy at Northwestern University Medical Center and was visiting scholar at the National Institutes of Health Bioethics Department.



Geoff Eich
Executive Director
Regulatory Affairs, R&D Policy
Amgen

Geoff is an Executive Director at Amgen, Inc. where he leads a global, cross-functional scientific and policy team dedicated to the topic of biosimilars (biological medicines claiming similarity to a previously approved product). He is a member of Amgen’s biosimilar development team.

Geoff is accountable for Amgen’s worldwide policy advocacy, aspects of strategic planning related to biosimilars and integration of scientific, policy, regulatory, communications and business activities. He comes to this position with a deep experience in biosimilars as his previous role was the founding Director of Amgen’s Regulatory Biosimilar Team with significant focus on establishment and participation in the U.S. Biosimilar pathway as authorized by Congress in 2010 in the Biologics Price Competition and Innovation Act (BPCIA). Geoff’s team has been able to synthesize the scientific and technical aspects of regulatory policies and guidelines for biologics with experiences from Europe, Asia, Latin America and the multifaceted aspects of the U.S. heath care environment.

Geoff holds a Bachelors of Science degree from the U.S. Naval Academy at Annapolis and a Masters of Business Administration from the University of Maryland. He is a Paul Harris Fellow and is married with two children.



Carolyn Finkle
VP Global Regulatory Affairs
Catalent Pharma Solutions

Carolyn Finkle has over 27 years scientific and industry experience including 17 years in management of drug and biologic development, quality and regulatory affairs for companies in the U.S. and Canada, including VP, Global Regulatory Affairs, VP Regulatory Consulting for North America, Catalent Pharma Solutions, Senior Director, International Regulatory Affairs, MedImmune, Vice President, Global Product Development Strategy and VP North America Consulting, PAREXEL International, VP Regulatory Affairs at Celsion Corporation, VP PreClinical Development at TherImmune Research Corporation (acquired by Gene Logic), VP Drug Development at GeminX Biotechnologies, Director of PreClinical Development at ConjuChem and Manager of PreClinical Development at BioChem Pharma (acquired by Shire).

Carolyn Finkle holds a M.Sc. Chemistry from the University of Toronto, Canada and has a B.Sc. Chemistry from the University of Ottawa, Canada. She has worked in academic research at Stanford University, the Toronto General Hospital and spent a year as a Foreign Researcher in Chiba University, Japan, prior to her industry managerial appointments.

Carolyn Finkle currently serves as an adjunct faculty member and course co-director of the Georgetown University Master’s Program in Clinical and Translational Research and course director of the Pharmaceutical Education and Research Institute (PERI), as well as, contributor to the UCSF American Course of Drug Development and Regulatory Sciences (ACDRS). Carolyn has co-authored 1 book chapter on First-in-Man global regulatory requirements, over 18 abstracts and 12 papers for industry associations and scientific publications and chaired DIA sessions (global regulatory) at the annual meetings. She has received numerous awards and scholarships throughout her career. Ms. Finkle has given multiple presentations including but not limited to: The History of Drug Regulations: US, EU and Japan; Key Current FDA Regulations; Recent FDA Performance; US Product Label, NDA Game: CMC in Drug Development; Drug Safety Regulations; Overview of Drug Development; Basic Drug Development: Why are Drugs and Biologics Regulated?; Drug Product Manufacturing: Synthetic and Biologic Drugs; Global Regulatory Considerations in Drug Development; Recent Regulations for Biologics, Biosimilars and FOB; Overview of Regulations in ROW and Key Emerging Markets; Overview of Asian Regulations: Japan, and Drug Safety Reporting; Biosimilars: Development Considerations and Current Regulatory Environment; Global Regulatory Considerations with a Focus on China, Brazil and Japan.


Lawrence Leisure
Partner
Kleiner Perkins Caufield & Byers

Larry Leisure joined Kleiner Perkins Caufield & Byers in 2010 bringing KPCB over 30 years of experience in the health and managed care industry. He sits on the boards of several Silicon Valley health information and bioscience companies including Crescendo Bioscience, Jiff, Seriosity and Tethys Bioscience as well as Navigenics and Redbrick Health where his is a board observer.

Before coming to KPCB, he had a distinguished career in healthcare serving in a number of senior consulting and industry roles. His consulting leadership positions have included Ingenix Consulting where he led their Payer & Employer Market Group, Accenture where he was the Global Managing Partner for the Health Vertical, and Towers Perrin where he led the Managed Care practice. In these various roles he also served as client partner to many of the largest US health plans and pharmacy benefit management organizations as well as a number of the largest global employers. In 2010 he co-founded Healthspottr, a new media company focused on the acceleration of innovation in health care. From 2003 to 2007 he joined one his clients, Kaiser Permanente, where he oversaw the key market facing sales & account management functions.

He received his AB in Economics from Stanford University and his MBA in Finance from the University of California, Los Angeles.



Lindy Hinman
Chief Operating Officer
Connect for Health Colorado

Lindy Hinman joined Connect for Health Colorado as Chief Operating Officer in August 2012, directing policy implementation and business operations. Lindy previously served at Horizon Blue Cross Blue Shield of New Jersey, where she coordinated the company’s preparations for and responses to national health care legislation. Prior to that, Lindy served as Vice President of Policy at America’s Health Insurance Plans and led strategic engagements on behalf of Avalere Health. She has also held positions with the White House Office of Management and Budget and Centers for Medicare and Medicaid Services in Washington DC. She holds a Bachelor of Arts in history/biology from Washington University in St. Louis and a Masters of Health Services Administration from the School of Public Health at the University of Michigan.




Richard Moscicki, MD
Deputy Director for Science Operations
Center for Drug Evaluation & Research
FDA

Richard A. Moscicki, MD, serves as CDER’s Deputy Center Director for Science Operations. He shares in the executive direction of Center operations and provides leadership in overseeing the development, implementation, and direction of our programs.

Before joining CDER, Dr. Moscicki served as senior vice president (SVP), Head of Clinical Development at Genzyme Corporation. He joined Genzyme in 1992 as medical director and became the chief medical officer and SVP of biomedical and regulatory affairs in 1996 -- holding that post until 2011. Over the past two decades, Dr. Moscicki has been responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company.

Dr. Moscicki received his medical degree from Northwestern University Medical School. He is board certified in internal medicine, diagnostic and laboratory immunology, and allergy and immunology. He completed his residency with a focus on immunology, followed by a four-year fellowship at Massachusetts General Hospital (MGH) in immunology and immunopathology. He remains on staff at MGH and on the faculty of Harvard Medical School.



Ian Spatz
Senior Advisor, Manatt Health Solutions
Founder, Rock Creek Policy Group

Mr. Spatz is a Senior Advisor in the national healthcare practice of Manatt, Phelps & Phillips, LLP and Manatt Health Solutions. Mr. Spatz provides highly experienced insights into ongoing health reform efforts, helps develop public and private strategies and guidance on a broad array of issues affecting healthcare providers and insurers, pharmaceutical companies, the consuming public and U.S. healthcare initiatives generally, as well as the development and implementation of communication and advocacy efforts at the federal and state levels. Among his areas of expertise are national healthcare policies and programs; pharmaceutical pricing, including Medicare and Medicaid; intellectual property protection; and policies related to the U.S. Food and Drug Administration's regulation of the research, approval, manufacturing and marketing of medicines.

Mr. Spatz is also the founder and principal of the policy consulting firm Rock Creek Policy Group, LLP. Beforefounding Rock Creek Policy Group, Mr. Spatz served for 15 years in increasingly responsible positions with Merck & Co., Inc., one of the world's leading research-based pharmaceutical and vaccine companies. As Merck's Vice President for Global Health Policy, he directed U.S. public policy and related public affairs activities and represented the company before Congress, the Administration, and to the media. He also directed grassroots, employee communications and political action programs.

While at Merck, Mr. Spatz led the successful five-year campaign that helped to develop and gain enactment of the Medicare prescription drug benefit, providing millions of American elderly and persons with disabilities with drug insurance for the first time. He promoted legislation to create the highly successful program of market exclusivity incentives for research on the pediatric uses of medicines and guided company efforts that resulted in resolution of international trade dispute on the licensing of medicines in the developing world.

Before joining Merck, Mr. Spatz served as Legislative Director for U.S. Senator Frank Lautenberg (D-NJ). In that role, he directed the Senator's legislative staff including developing and supervising the implementation of legislative strategies, proposal drafting and floor action. During his tenure, he coordinated the successful development and passage of two transportation appropriations bills. He began his career in the nonprofit sector where he led the public policy and government affairs activities of the National Trust for Historic Preservation, the nation's leading heritage conservation organization. While with the National Trust, he conceived the highly successful Eleven Most Endangered Historic Places list that has served as a model public relations tool for many conservation organizations. He advocated successfully for the creation of the transportation enhancements funding in the Intermodal Surface Transportation Act (ISTEA) that has resulted in more than $8 billion in spending on conservation projects.



Brian A. Cohen
Oversight & Investigations Subcommittee Staff Director and Senior Policy Adviser
Democratic Staff, Committee on Energy and Commerce

Brian Cohen is the Democratic Oversight and Investigations Subcommittee Staff Director and Senior Policy Adviser with the House Energy and Commerce Committee. He has worked as congressional staff, first with the Committee on Oversight and Government Reform and now with the Energy and Committee, for over 15 years, with extensive oversight and legislative responsibilities in numerous health-related areas including Medicare Part D, Medicaid drug payment policy, the 340B drug program, and the Affordable Care Act.



Mary Christian
Director-Global Regulatory Strategy
Bristol-Myers Squibb
Member TranCelerate Regulatory Council

Mary serves as the head of the cross company Regulatory Council supporting the TransCelerate BioPharma Inc organization. The TransCelerate Regulatory Council advises TransCelerate leadership and membership on strategies for interactions with regulators, supports work streams in planning and execution of topical meetings on behalf of TransCelerate and provides guidance for member companies to have asset level interactions

In her role at Bristol-Myers Squibb, Mary is Executive Director in Global Regulatory with responsibility to lead the GRS Mature Product and Geographic Optimization teams. Mary is responsible for the regulatory activities related to the Mature Product portfolio and has created global therapeutic area teams to provide strategic direction for the BMS MP portfolio of products and a regional structure for regulatory MP support. The Geographic Optimization efforts, in support of regulatory activities associated with Divestitures, Distributor Markets, Product deletions and country exits are also under Mary’s scope.

Mary was recently the Global Regulatory Team Leader and US Liaison for the Nulojix/belatacept program, served as co-chair of the Bristol-Myers Squibb (BMS) Pediatric Drug Development Committee, and Regional lead for GRS Middle East and Africa. She has worked with the PhRMA and NIH advocating the reauthorization of pediatric drug development legislation (through the FDAAA).

Prior to joining BMS, Mary worked in Regulatory Affairs at Johnson & Johnson Pharmaceutical Research & Development where she led regulatory teams across a number of therapeutic areas, including neuroscience, women’s health and internal medicine. She is Vice Chairman of the Board of The Center For Great Expectations, a 501(c)3 charitable organization serving homeless and pregnant women and adolescents and has led many community-based service initiatives.

Mary received her undergraduate degree at the Rutgers University College of Pharmacy and a doctorate in Clinical Pharmacy from the University of Florida. She also holds a Masters in Business Administration in Pharmaceutical Business from the University of the Sciences in Philadelphia.



Michael McCaughan
Editor, The RPM Report
Founding Member, Prevision Policy LLC

Michael McCaughan is a founding member of Prevision Policy LLC and an editor with The RPM Report. He was formerly editor-in-chief of EBI’s biopharma editorial group. McCaughan has 20 years of experience providing analysis and insight for EBI’s products, including The Pink Sheet, The Pink Sheet DAILY and The RPM Report. He speaks frequently on regulatory and policy developments affecting the industry.



Ramsey Baghdadi
Founding Member
Prevision Policy LLC

Ramsey Baghdadi covered regulation, reimbursement, and legislative policy for over a decade, most recently as Editor-in-Chief of The RPM Report and a contributing editor to The Pink Sheet. He previously served as managing editor for the OTC drug and dietary supplement industry publication, The Tan Sheet.Prior to his work in the drug sector, he covered the medical device industry as financial editor of The Gray Sheet.



Kate Rawson
The RPM Report
Prevision Policy LLC

Kate Rawson is a Senior Editor at The RPM Report. She was formerly an editor at “The Pink Sheet” where she covered drug regulation and reimbursement issues. During her ten-year tenure at FDC Reports and Elsevier Business Intelligence, she helped launch “The Pink Sheet DAILY,” and served as Managing Editor of “The Rose Sheet,” which covers regulatory and business news of the cosmetics industry.



Cole Werble
Founding Member
Prevision Policy LLC

Cole Werble has more than 35 years of experience analyzing business critical developments affecting the biopharma sector and developing world class information products for the sector. He is a founding member of Prevision Policy and was previously Senior Editorial Director for Elsevier Business Intelligence’s biopharma group. He is the former owner and editorial director of FDC Reports, Inc., the publisher of “The Pink Sheet,” “The Gray Sheet,” and other leading news publications for the health care industry, which were purchased by Elsevier in 1994 and formed the foundation for Elsevier Business Intelligence. Werble was president of FDC for eight years for Elsevier.