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Posts Tagged ‘Prescription Drug User Fee Act’

Reporter: Aviva Lev-Ari, PhD, RN

http://www.elsevierbi.com/mkt/conf/fda-cms/2012?elsca1=fda&elsca2=fdafierce112612&utm_source=fda&utm_medium=fda&utm_campaign=%20fierce112612

The FDA/CMS Summit For Biopharma Executives
2013: Year One For PDUFA V – And The Last Chance To Prepare For Health Reform

The Affordable Care Act is a go, after surviving Supreme Court review mostly intact—and especially after the re-election of Barack Obama as President. For the biopharma industry, that means preparing to reap the benefits of insurance market expansion that industry has already paid billions of dollars for in rebates, discounts and fees. The new markets start up in 2014. That means 2013 is the last chance to prepare.

But 2013 is also the first full year to adjust to the new rules for new drug reviews at FDA and adjust to important changes ushered in by the FDA Safety & Innovation Act of 2012. And it is also the year when deficit reduction will be tops on Congress’ agenda.

What will all this mean for you and your company? Come to The Pink Sheet and The RPM Report’s FDA/CMS Summit for Biopharma Executives on December 10-11 in Washington DC to hear from FDA and industry leaders about how health reform implementation will (and won’t) change the rules of the road for drug development and commercialization.

Our jam-packed two-day agenda will also tackle urgent topics like:

        • Drug reviews and PDUFA
        • The evolving biosimilars pathway in the US
        • The implementation of the FDA Safety & Innovation Act
        • The changing rules of pharmaceutical marketing
        • Creation of new generic drug and biosimilar user fee programs
        • And much, much more!

Don’t be caught unprepared. Join us at the eighth annual FDA/CMS Summit for Biopharma Executives.

Last year was standing room only and spaces are limited so please register now!

Key Benefits for Attending FDA/CMS Summit:

  • Hear about critical trends and changes so you can create successful strategies for dealing with FDA and CMS
  • Walk away with practical, real life lessons from some of the most experienced pharmaceutical and biotechnology executives on how they handle regulatory obstacles
  • Get face-to-face access to the top regulatory thought leaders and policy makers
  • Benchmark your regulatory strategy against all the major pharmaceutical and biotech companies

 

Here is what your peers have to say about FDA/CMS Summit:

“I would like to thank the whole Windhover/RPM team for putting together this conference. Conferences are made by its participants and the group assembled here today is so diverse and truly experienced.” – Mark McClellan, MD/PhD, Former FDA Commissioner and CMS Administrator

 

 

2012 FDA/CMS Summit Preliminary Agenda

December 10 & 11, 2012

Mayflower Hotel
1127 Connecticut Avenue NW
Washington, DC 20036

 

Monday, December 10, 2012
7:00-8:00am Registration and Continental Breakfast
8:00am Welcome and Opening Remarks

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

8:15-9:00am  

KEYNOTE ADDRESS: Priorities for FDA’s Drug Center in 2012

Douglas Throckmorton, MD
Deputy Director
Center for Drug Evaluation & Research
Food & Drug Administration (FDA)

9:00-10:30am  

The New Rules of New Drug Reviews: A Roundtable

FDA’s top new drug and drug safety officials join industry leaders to discuss trends in the new drug review process and the changes enacted by the Prescription Drug User Fee Act reauthorization.

John Jenkins, MD
Director
Office of New Drugs
Food & Drug Administration (FDA)

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

Richard Pops
CEO
Alkermes

Francois Nader, MD
President and CEO
NPS Pharmaceuticals

Kay Holcombe
Senior Policy Advisor
Genzyme

Moderator: 
Kate Rawson
The RPM Report
Prevision Policy

10:30-11:00am  

Networking Break

11:00-12:00pm 2012 Elections: Implications for Pharma

What to expect from the new Administration and the new Congressional line-up for 2013.

John McManus
President
The McManus Group

Tracy Spicer
Partner
Avenue Solutions

Jeff Forbes
Partner
Forbes-Tate

Presenter/Moderator:

Marc Samuels
Founding Member & President
Hillco Health

12:00-1:00 pm  

Lunch

 

1:15-2:00pm

 

 

Fireside Chat

Jonathan Blum
Principal Deputy Administrator
Centers for Medicare & Medicaid Services (CMS)

 

2:00pm-3:30 pm

 

 

Hot Topics in Health Reform

The politics of health care reform aside, biopharma companies need to prepare for changes in the US health care system that emphasis quality and affordability of care. This session will feature presentations on different aspects of the upcoming changes in payment and delivery of care and how they will affect pharma.

 

Health Reform and The Climate for Innovation

Ron Cohen, MD
President and CEO
Acorda Therapeutics, Inc.What is Essential in Essential Health Benefits?

Ian Spatz 
Senior Advisor
Manatt Health Solutions

Medication Adherence in the Context of Health Reform

William Shrank, MD, MSHS 
Director
Rapid-Cycle Evaluation Group
Centers for Medicare & Medicaid Services (CMS)

 

Commercial Implications of Health Reform

Will Suvari
Vice President
Campbell Alliance

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

 

3:30-4:00pm  

Networking Break

4:00-4:30pm  

Keynote: Implementing Reform
Joshua Sharfstein
Secretary
Maryland Department of Health
Former Deputy Commissioner
Food & Drug Administration (FDA)

4:30-5:00pm Closing Keynote: Reimbursable Labeling

Chuck Stevens
Vice President
PAREXEL

5:30-7:30pm Cocktail Reception
Tuesday, December 11, 2012
7:00-8:00am Registration and Continental Breakfast
8:00-8:30am  

 

KEYNOTE ADDRESS

Robert J. Hugin
Chairman and CEO
Celgene Corporation

8:30-9:45am  

Biosimilars Update

Mark A. McCamish, MD, PhD
Global Head of Biopharmaceutical Development
Sandoz International

Diem Nguyen
General Manager, Biosimilars
Emerging Markets/Established Products Business Unit
Pfizer Inc.

Leah Christl, PhD
Associate Director for Biosimilars
Office of New Drugs
Center for Drug Evaluation & Research
Food & Drug Administration (FDA)

9:45-10:00am Networking Break
10:00-11:15am  

Reinventing the Approval Pathway

PDUFA V makes important changes in drug regulation, but it doesn’t fundamentally change the standard for new drug approvals. Is it time for the US to consider moving to new models like progressive approval/adaptive licensing?

 

Mary Ellen Cosenza
Executive Director Regulatory Affairs and North America Regulatory Head
Amgen, Inc.

Steven Nissen, MD, MACC
Chairman, Department of Cardiovascular Medicine
The Cleveland Clinic Foundation

 

Barry Sickels, Ph.D.
Vice President, Regulatory Affairs and Wilmington R&D Site Leader
AstraZeneca

Moderator:
Cole Werble
Editor, The RPM Report
Founding Member, Prevision Policy LLC

 

11:15-12:00pm  

A Regulator’s Perspective

Robert Temple, MD
Deputy Director for Clinical Science
Center for Drug Evaluation & Research
Food & Drug Administration (FDA)

Moderator
Ramsey Baghdadi
The RPM Report
Founding Member, Prevision Policy

12:00-1:00pm Lunch – Sponsored by
1:00-1:45pm  

CMS Coverage Priorities: CED, NCDs and Parallel Reviews

The Medicare agency is moving forward with innovative models to use coverage policy to encourage development of better evidence for new technologies. Devices are the primary focus, but drugs won’t be far behind.

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

Tamara Syrek Jensen, JD 
Deputy Director
Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services (CMS)

Moderator
Ramsey Baghdadi
The RPM Report
Founding Member, Prevision Policy

1:45-3:00pm Right-Sizing the Demands for Evidence

FDA’s pre-market and post-market regulatory demands are increasing, and so are the expectations of public and private payors for “real world” comparative effectiveness data. How can policy makers and biopharmaceutical companies work together to assure that the need for evidence doesn’t overwhelm the capacity of innovators?

Jonathan Leff
Managing Director, Healthcare
Warburg Pincus

Martin Marciniak
Vice-President, US Health Outcomes
GlaxoSmithKline

Moderator:
Gillian Woollett

Vice President
Avalere Health

3:00-3:15pm Networking Break
3:15-4:30pm The New Generic Drug Era

The Generic Drug User Fee Act will usher in a new era for the generic drug industry, one with greater emphasis on global production quality and tough-to-copy products. What will the new era bring?

Gregory Geba
Director
Office of Generic Drugs
Food & Drug Administration (FDA) 

David Gaugh
VP-Regulatory Sciences
Generic Pharmaceutical Association

Gary Buehler
Vice President-Regulatory Strategic Operations
Teva Pharmaceuticals

Lara Ramsburg
VP-Government Relations
Mylan Inc.

Moderator:
Nancy Myers
President
Catalyst Healthcare

4:30-5:00pm A Fireside chat with:

Geno Germano
President
Pfizer Specialty Care and Oncology

2012 FDA/CMS Speakers

   
  Douglas Throckmorton, MD

Deputy Director, FDA Center for Drug Evaluation & Research

Food & Drug Administration (FDA)

Douglas C. Throckmorton, MD is the Deputy Director of the Center for Drug Evaluation and Research (CDER), FDA. In this role, he shares responsibility for overseeing the regulation of research, development, manufacture and marketing of prescription, over-the-counter and generic drugs in the U.S. Previously, he served as the Director of CDER’s Division of Cardiovascular and Renal Drug Products (DCRDP). Dr. Throckmorton joined DCRDP in 1997 as a Medical Officer, was promoted to Deputy Director in 2000 and to the Director position in 2002. Prior to joining FDA, he practiced medicine and held academic appointments at the Medical College of Georgia and the VA Medical Center in Augusta, GA. Dr. Throckmorton received an undergraduate degree in English and Chemistry from Hastings College and is Board-certified in Internal Medicine and Nephrology, having received his training at the University of Nebraska Medical School, Case Western Reserve University and Yale University.

   
  Robert J. Hugin

Chairman and CEO

Celgene Corporation

Mr. Hugin serves as Chairman and Chief Executive Officer of Celgene Corporation, a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for unmet medical needs in cancer and immune-inflammatory disease. He joined Celgene in June 1999 and has been a Director of Celgene since December 2001. Mr. Hugin also serves as a Director of The Medicines Company, Atlantic Health System, Inc. and of Family Promise, a national non-profit network assisting homeless families. He serves on the Board of Trustees of Princeton University and is Chairman-Elect of The Pharmaceutical Research and Manufacturers of America. He also serves on the Board of Trustees of The Darden Foundation, University of Virginia as well as a founding Board member of Choose NJ. Prior to joining Celgene, Mr. Hugin was a Managing Director with J.P. Morgan & Co. Inc. Mr. Hugin received an AB degree from Princeton University in 1976 and an MBA from the University of Virginia in 1985 and served as a United States Marine Corps infantry officer during the intervening period. Bob and his wife Kathy have three children and live in Summit, New Jersey.

   
  John Jenkins, MD

Director, Office of New Drugs

Food and Drug Administration (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.

   
  John McManus

President

The McManus Group

John McManus is President and founder of The McManus Group, a consulting firm specializing in policy and political counsel for health care clients with issues before Congress and the Administration. The McManus Group services clients from the pharmaceutical, biotechnology and medical device industries, the physician organization and employee benefits managers.

Prior to founding The McManus Group in 2004, McManus served Chairman Bill Thomas as the Staff Director of the Ways and Means Health Subcommittee, where he led the policy development, negotiations and drafting of the Medicare Prescription Drug, Improvement and Modernization Act of 2003. The MMA provided a market-based, comprehensive prescription drug benefit, reformed Medicare and established Health Savings Accounts. McManus worked for Chairman Thomas for six years, where he also played an instrumental role in the Medicare Commission, Patients’ Bill of Rights and other Medicare legislation.

Before working for Chairman Thomas on Capitol Hill, McManus worked for Eli Lilly & Company as a Senior Associate from 1994-97 and for the Maryland House of Delegates from 1993-94 as a Research Analyst, briefing the Chairman of the Economic Matters Committee and the members of the Health Subcommittee.

McManus earned his Master of Public Policy from Duke University and Bachelor of Arts from Washington and Lee University.

   
  Tracy Spicer

Partner

Avenue Solutions

Avenue Solutions’ founding partner Tracy Spicer is a 20-year veteran of political campaigns at every level.  Ms. Spicer began her involvement in politics in 1992 in former U.S. Senator Edward M. Kennedy’s Senate office before transitioning to his campaign staff in 1994 to assist in his successful re-election campaign against Mitt Romney.  Since that time, she has worked with and coordinated numerous campaigns, ranging from municipal and state candidates to the U.S. Congress as well as the White House.

Ms. Spicer served as a longtime aide to former Senator Kennedy, quickly rising to Political Director and Deputy Chief of Staff.  During her decade of experience on Capitol Hill, she coordinated successful political and legislative strategies for Senator Kennedy.  Ms. Spicer managed Senator Kennedy’s legislative priorities in the areas of healthcare, education, labor and economic development and strategically worked with Democratic Senators and their political campaign committees to position legislative priorities for political success.

Ms. Spicer is widely recognized for her political acumen and expertise in designing legislative and regulatory strategies and her established network of long-standing professional contacts among elected officials, appointed policymakers and their staffs.  She draws on her vast political and legislative experience to help clients in navigate the labyrinth of Capitol Hill and government bureaucracy and to position them strategically to head off obstacles, find common ground and achieve success.

As founding partner of Avenue Solutions, Ms. Spicer advises a broad array of clients, including Fortune 100 companies, non-profit organizations, associations and coalitions.  She is particularly noted for her expertise in healthcare policy.  On behalf of her clients, Ms. Spicer has played a leading role in the consideration, negotiation and implementation of the Affordable Care Act (healthcare reform); Medicare and Medicaid legislation; healthcare information technology initiatives; mental health parity legislation; genetic non-discrimination legislation; small business incentive proposals; and prescription drug coverage legislation.

Ms. Spicer is a graduate of Hobart and William Smith Colleges in Geneva, NY where she earned her bachelor’s degree in Political Science.  She is married to George Spicer and has three children, Dylan, Tess and Callie and a loveable, albeit irreverent dog, Linus.

   
  Jeff Forbes

Partner

Forbes-Tate

Founding partner Jeff Forbes is a twenty-year veteran of political campaigns at every level.  Mr. Forbes began his involvement in politics in 1987 on then Senator Al Gore’s 1988 Presidential bid.  Since that time, he has worked with and coordinated more than nine different campaigns, ranging from municipal candidates to the US Congress as well as the White House.

Mr. Forbes served most recently as the Democratic Staff Director for the US Senate Committee on Finance in 2003.  Before assuming this role at the Committee, he served as chief of staff to Senator Max Baucus from 1999-2002.  Beyond his knowledge of the intricacies of tax and trade, Forbes is a veteran strategist for the Democratic National Committee.  From 1993-1995 he served as Midwest Political Director.  Mr. Forbes later served the national committee as Chief of Strategy in 1999.

A stalwart of Clinton-Gore Administration, Mr. Forbes was the New Hampshire Field Director for then Gov. Clinton’s 1992 Presidential campaign.  In President Clinton’s 1996 re-election bid, Forbes was Deputy Political Director and Director of Delegate Selection.  Following the campaign, Mr. Forbes went on to serve as a Special Assistant to the President and Staff Director for Legislative Affairs in 1997.  From 1998-99, Mr. Forbes served as the Deputy Assistant to President Clinton and was the Deputy Director of Scheduling at the White House.

Mr. Forbes is married to Linda Moore Forbes.  He earned a BA in Political Science with an Economics minor from Denison University in Granville, Ohio, in 1987.

   
  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 Jacques, MD

Director, Coverage & Analysis Group Office of Clinical Standards and Quality

Centers for Medicare & Medicaid Services (CMS)

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.

   
  Steven Nissen
Chairman, Department of Cardiology
The Cleveland Clinic Foundation

Steven Nissen, MD, is the Chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine located on the main campus of Cleveland Clinic. He was appointed in 2006. Prior to this, he served nine years as Vice-Chairman of the Department of Cardiology and five years as Medical Director of the Cleveland Clinic Cardiovascular Coordinating Center (C5), an organization that directs multicenter clinical trials.

Dr. Nissen’s research during the last two decades has focused on the application of intravascular ultrasound (IVUS) imaging for the assessment of progression and regression of coronary atherosclerosis. He has served as International Principal Investigator for several large IVUS multi-center atherosclerosis trials.

Contributions to scientific literature include more than 350 journal articles and 60 book chapters including many manuscripts in NEJM andJAMA. In recent years, he has also written on the subject of drug safety and was the author of manuscripts highlighting concerns about the COX-2 inhibitors (Vioxx™), muraglitazar and rosiglitazone (Avandia™).

Other contributions include current service as editor of Current Cardiology Report, and senior consulting editor to the Journal of the American College of Cardiology.

Dr. Nissen’s national positions include:

One-year term as president of the American College of Cardiology (ACC) from March 2006 to March 2007. He served on the ACC Executive Committee 2004-2008. He served 10 years as a member of Board of Trustees of the ACC. He has served several terms on the Program Committee for ACC Annual Scientific Sessions.

Dr. Nissen served as a member of the CardioRenal Advisory Panel of Food and Drug Administration (FDA) for five years, and as chair of the final year of his membership. He continues to serve as a periodic advisor to several FDA committees as a Special Government Employee.

Dr. Nissen is a frequent lecturer before national and international meetings. He has served as visiting professor, or provided Grand Rounds, at nearly 100 institutions.

   
  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.

   
  Francois Nader, MD

President and CEO

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.

   
  Diem Nguyen
General Manager, Biosimilars

Emerging Markets/Established Products Business Unit

Pfizer Inc.

Diem Nguyen is General Manager, Biosimilars for the Emerging Markets/Established Products Business Units. As General Manager Biosimilars, Diem Nguyen is the driving a core component of the EPBU strategy through the development and commercialization of a portfolio of post-LOE biologics through close collaboration with WRD’s Biosimilars Development Unit. Prior to this position, Diem held the position of VP, Strategy for EPBU where she was responsible for developing growth strategies for the off patent market.

Before Pfizer, Diem was a consultant for Danaher, a leading industrial and life sciences company. In 2004, she was appointed Senior Director of Corporate Development and Biotechnology at Serologicals Corporation, where she worked directly with the CEO, CFO and the Board of Directors and led enterprise level strategic planning and external development efforts. Her responsibilities included strategic planning, leading corporate development efforts and investor relations. In 2003, she took on the role of Director of Strategic Marketing, Research and Biotechnology at the Upstate Group, Inc. Diem has also previously held positions at Deloitte Consulting as a life sciences consultant and the University of Virginia Health Sciences Center as a medical researcher.

Diem received a B.A. and a Ph.D. in Biochemistry and Molecular Genetics from the University of Virginia. She attended Darden Graduate School of Business Administration, where she earned her MBA.

   
  Jonathan Blum

Principal Deputy Administrator

Centers for Medicare & Medicaid Services (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.

   
  Ian Spatz
Senior Advisor

Manatt Health Solutions

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.

   
  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.

   
  Michael McCaughan
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 is a founding member of Prevision Policy and an editor with The RPM Report.

   
  Marc Samuels
CEO
HillCo HEALTH

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

Samuels joined HillCo in 2001 and became a partner in 2004, working both in Austin and Washington, DC. He co-founded HillCo HEALTH 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.

   
  Ron Cohen, MD
President and CEO
Acorda Therapeutics, Inc

Ron Cohen, M.D., President and CEO, founded Acorda Therapeutics, Inc. in 1995. Previously he was a principal in the startup and an officer of Advanced Tissue Sciences, Inc., a biotechnology company engaged in the growth of human organ tissues for transplantation. Dr. Cohen received his B.A. with honors in Psychology from Princeton University, and his M.D. from the Columbia College of Physicians & Surgeons. He completed his residency in Internal Medicine at the University of Virginia Medical Center, and is Board Certified in Internal Medicine.

Dr. Cohen is a member of the Executive Committee of the Board of the Biotechnology Industry Organization (BIO) and is Chairman of the Emerging Company Section of BIO. He previously served as Director and Chairman of the New York Biotechnology Association (NYBA). He also serves as a member the Columbia-Presbyterian Health Sciences Advisory Council and was awarded Columbia University’s Alumni Medal for Distinguished Service.

Dr. Cohen was named NeuroInvestment’s CEO of the Year and was recognized by PharmaVoice Magazine as one of the 100 Most Inspirational People in the Biopharmaceutical Industry. He is a recipient of the Ernst & Young Entrepreneur of the Year Award for the New York Metropolitan Region and is an inductee of the National Spinal Cord Injury Association’s “Spinal Cord Injury Hall of Fame.” In 2010, Dr. Cohen was recognized by the New York Biotechnology Association as the NYBA “The Cure Starts Here” Business Leader of the Year.

   
  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.

   
  Mark A. McCamish, MD, PhD
Global Head of Biopharmaceutical Development
Sandoz International

Dr. McCamish is the Global Head of Biopharmaceutical Development for Sandoz International, a Division of Novartis. He leads research and development of all biologics at Sandoz Biopharmaceuticals, which is the world leader in development and commercialization of follow-on biologics or biosimilars. His responsibilities include leadership involving selection of the target, cloning, technical development, scale-up, pre-clinical and clinical development and interfaces with regulatory authorities worldwide. He is a senior executive with extensive therapeutic and commercial experience in global pharmaceutical and biotechnology companies. Previously he was Senior VP and Chief Medical Officer at three biotechnology companies and held senior positions at Amgen and Abbott Laboratories. He has held professorships and maintained academic practices at the University of California, Davis and The Ohio State University.He has published broadly in several therapeutic areas in multiple journals including The New England Journal of Medicine, Journal of the American Medical Association, and Lancet.

He earned his bachelor’s and master’s degrees in exercise physiology from the University of California, Santa Barbara. His PhD is in human nutrition from Penn State University and his M.D. is from the University of California, Los Angeles. Dr. McCamish is Board Certified in Internal Medicine and Nutrition and Metabolism and he is licensed as a physician and surgeon in California.

He has published broadly in several therapeutic areas in multiple journals including The New England Journal of Medicine, Journal of the American Medical Association, and Lancet. He earned his bachelor’s and master’s degrees in exercise physiology from the University of California, Santa Barbara. His PhD is in human nutrition from Penn State University and his M.D. is from the University of California, Los Angeles. Dr. McCamish is Board Certified in Internal Medicine and Nutrition and Metabolism and he is licensed as a physician and surgeon in California.

   
  William Shrank, MD, MSHS
Director of the Rapid-Cycle Evaluation Group
CMS

William Shrank, MD, MSHS, is the Director of the Rapid-Cycle Evaluation Group at the Center for Medicare and Medicaid Innovation at the Centers for Medicare and Medicaid Services. In this capacity, Dr. Shrank leads the evaluation efforts of programs supported by the Innovation Center to reduce the cost and improve the quality of care in the U.S. He also leads the intramural research enterprise at CMS.
Dr. Shrank has served as an Assistant Professor of Medicine at Harvard Medical School and an Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. His research is focused on improving the safe, appropriate and cost-effective use of prescription medications. His research interests also include evaluating quality in pharmacologic care, enhancing adherence to chronic medications, and improving prescription drug labels.

Dr. Shrank serves or has served on national advisory committees for the FDA, AHRQ, CMS, USP, and the American College of Physicians Foundation. He attended Brown University, received his M.D. from Cornell University, and trained in Internal Medicine at Georgetown University. He finished a health services research fellowship at UCLA, Rand, and the West Los Angeles VA Hospital where he earned an M.S. in Health Services.

   
  Geno Germano 
President
Pfizer Specialty Care and Oncology

Geno Germano is President and General Manager of Specialty Care and Oncology, Pfizer Inc.

The Specialty Care Business Unit (SCBU) works closely with specialty physicians and stakeholders to provide medicines to help treat a variety of serious and life-threatening conditions. Specialty Care holds leadership positions in vaccines and in key disease areas such as inflammation, infectious disease, hemophilia and ophthalmology. SCBU’s current portfolio includes more than 20 medicines in 11 disease areas, and the pipeline contains more than 25 compounds in late-stage development.

The Oncology Business Unit (OBU) is focused on improving the standard of care for cancer patients globally. With the full scale and scope of Pfizer support, the OBU has made rapid progress, with more than 20 molecules in development for various tumors including lung, breast, prostate, liver, kidney, colon and gastric diseases.

Geno joined Pfizer from Wyeth, where he was President, U.S. and Pharmaceutical Business Units for Wyeth Pharmaceuticals, responsible for its U.S. based Pharmaceuticals, Biologics and Vaccines businesses. In addition, he led Global Strategy for the Pharmaceutical and Institutional business units for major products in Neuroscience, Gastroenterology, Women’s Health, Infectious Diseases and Immunology.

In his more than 25 years in the pharmaceutical industry, Geno has held diverse positions, including Executive Vice President and General Manager for Wyeth Global Vaccines; Managing Director, Wyeth Australia and New Zealand; and Executive Vice President and General Manager of the Pharmaceutical Business Unit. He led numerous key product launches in primary and specialty care in gastroenterology, arthritis, infectious diseases, hemophilia, transplantation and oncology. Prior to joining Wyeth, Geno held leadership positions at several Johnson & Johnson companies.

Geno serves on the Advisory Board of the Healthcare Businesswomen’s Association, is a member of the Board of the Biotechnology Industry Organization and is a Trustee of the Albany College of Pharmacy, where he received his Bachelor of Science degree in Pharmacy in 1983.

   
  Joshua Sharfstein 
Secretary
Maryland Department of Health
Former Deputy Commissioner
Food & Drug Administration

Dr. Joshua M. Sharfstein was appointed by Governor Martin O’Malley as Secretary of the Maryland Department of Health and Mental Hygiene in January 2011.

In March 2009, President Obama appointed Dr. Sharfstein to serve as the Principal Deputy Commissioner of the U.S. Food and Drug Administration. He served as the Acting Commissioner from March 2009 through May 2009 and as Principal Deputy Commissioner through January 2011.

From December 2005 through March 2009, Dr. Sharfstein served as the Commissioner of Health for the City of Baltimore, Maryland. In this position, he led efforts to expand literacy efforts in pediatric primary care, facilitate the transition to Medicare Part D for disabled adults, engage college students in public health activities, increase influenza vaccination of healthcare workers, and expand access to effective treatment for opioid addiction. In 2008, Dr. Sharfstein was named Public Official of the Year by Governing Magazine.

Dr. Sharfstein is a 1991 graduate of Harvard College, a 1996 graduate of Harvard Medical School, a 1999 graduate of the combined residency program in pediatrics at Boston Children’s Hospital and Boston Medical Center, and a 2001 graduate of the fellowship in general pediatrics at the Boston University School of Medicine.

   
  Gillian Woollett 
Vice President
Avalere Health

Gillian Woollett, 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.

   
  Robert Temple, MD

Deputy Director for Clinical Science

Center for Drug Evaluation & Research

Food & Drug Administration (FDA)

Dr. Robert Temple is Deputy Center Director for Clinical Science of FDA’s Center for Drug Evaluation and Research and is also Acting Deputy Director of the Office of Drug Evaluation I (ODE-I).     Dr. Temple received his medical degree from the New York University School of Medicine in 1967.    In 1972 he joined CDER as a review Medical Officer in the Division of Metabolic and Endocrine Drug Products.  He later moved into the position of Director of the Division of Cardio-Renal Drug Products.  In his current position, Dr. Temple oversees ODE-1 which is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products.  Dr. Temple has a long-standing interest in the design and conduct of clinical trials and has written extensively on this subject, especially on choice of control group in clinical trials, evaluation of active control trials, trials to evaluate dose-response, and trials using “enrichment” designs. He also has a long-standing interest in hepatotoxicity of drugs, having participated in the first detailed FDA-NIH-outside discussion of the subject in 1978.

   
  Jonathan S. Leff

Managing Director

Warburg Pincus

Jonathan S. Leff is a managing director with Warburg Pincus, where he has been a member of the firm’s HealthCare Group since 1996. Mr. Leff is currently a Director of InterMune, ReSearch Pharmaceutical Services, Rib-X Pharmaceuticals, Sophiris Bio and Talon Therapeutics. In addition, he serves on the Executive Committee of the Board of the National Venture Capital Association (NVCA) and leads the NVCA’s life sciences industry efforts as Chairman of NVCA’s Medical Innovation and Competitiveness Coalition, and serves as a member of the Board of the Biotechnology Industry Organization. He is also a member of the Boards of Friends of Cancer Research and the Spinal Muscular Atrophy Foundation and the Board of Advisors of Columbia University Medical Center. Mr. Leff received an A.B. in Government from Harvard University and an M.B.A. from Stanford University.

   
  Lara Ramsburg

Vice President, Government Relations

Mylan

Lara Ramsburg is Vice President of Government Relations for Mylan, the largest global generics company headquartered in the United States. During the Generic Drug User Fee (GDUFA) negotiation process, she participated on behalf of Mylan as a member of the Generic Pharmaceutical Association (GPhA) negotiating team. Lara also previously served as Chief of Staff in Mylan’s Office of the President.

Prior to joining Mylan, Lara was Director of Communications and then Director of Policy for the West Virginia Governor’s Office. She also worked previously for Rowan & Blewitt, an issue and crisis management consulting firm, and media outlet CNN, among other professional experiences. Lara holds a Bachelor of Science in communication from Ohio University and a Master of Science in corporate and professional communication from Radford University.

   
  Nancy Bradish Myers

President

Catalyst Healthcare

Nancy Bradish Myers, JD, is a Washington-based attorney with expertise in health care law and regulation, policy development, government relations and political analysis for investors. She is the President of Catalyst Healthcare Consulting, Inc., a niche consulting firm that provides clients with strategic regulatory insight and advice as they position biopharmaceutical and medical device companies, trade associations, and patient advocacy organizations on regulatory and health policy matters before the FDA and other regulatory agencies.

Ms. Myers has served in FDA’s Office of the Commissioner in various positions, including as Senior Strategic Advisor. She has also served as Special Counsel for Science Policy for PhRMA, Vice Presidential-level political healthcare analyst for a Wall Street financial services firm, Reimbursement Counsel and Director of Government Affairs for BIO, a lobbyist for the Blue Cross Blue Shield Association and staff person to a Member of Congress on Capitol Hill.

She is also an expert on FDA user fees and served as co-editor of the book PDUFA and the Expansion of FDA User Fees: Lessons from Negotiators, published by the Food and Drug Law Institute in 2011.

She is a founding Board member and past-President of the Alliance for a Stronger FDA. This 200-member coalition of former regulators, patient and consumer advocates and industry leaders works with the Administration and Congress to increase FDA federally appropriated funds. She is also a Board member of the FDA Alumni Association and is actively involved in the Food and Drug Law Institute (FDLI) and the Drug Information Association (DIA).

Ms. Myers is the 2012 recipient of FDA’s Distinguished Alumni Award, for outstanding contributions in advancing FDA’s mission, creating a strong coalition to advocate for agency resources, and establishing enduring connections between FDA alumni and staff.  Ms. Myers received her law degree from Temple University School of Law and her undergraduate degree from Duke University.

   
  Leah Christl, PhD

Associate Director for Biosimilars

Office of New Drugs

Center for Drug Evaluation & Research

Food & Drug Administration (FDA)

Dr. Christl is the Associate Director for Therapeutic Biologics in the Office of New Drugs (OND) in the FDA’s Center for Drug Evaluation and Research. Dr. Christl leads the Therapeutic Biologics and Biosimilars Team (TBBT) in OND. TBBT is responsible for ensuring consistency in the regulatory approach and guidance to sponsors regarding development programs for proposed biosimilar biological products and related issues regarding development programs for therapeutic biologics, for developing the procedures and staff training necessary to implement the Biologics Price Competition and Innovation Act of 2009 in a consistent manner across all OND review divisions, and for managing the CDER Biosimilar Review Committee.

Dr. Christl joined the FDA in 2003 as a Regulatory Project Manager in the Division of Over-the-Counter Drug Products. From 2004 – 2008, she was the Chief Regulatory Project Manager in the Division of Nonprescription Clinical Evaluation. Dr. Christl served as the Associate Director for Regulatory Affairs for the Office of Nonprescription Products, now the Office of Drug Evaluation IV, from 2005 – 2010. Prior to joining the FDA, Dr. Christl received her Ph.D. in Molecular and Cellular Biology and Pathobiology – Marine Biomedicine and Environmental Science from the Medical University of South Carolina in Charleston. She also spent 2 years at the University of South Carolina as an Associate Research Professor.

   
  Will Suvari
Vice President
Campbell Alliance

Will Suvari is a Vice President in Campbell Alliance’s Pricing & Market Access practice.  He focuses on commercialization strategy and organizational structure design within the context of the reform-driven evolution of provider and payer markets.   Will brings 20 years of research, industry and consulting experience from his work with life sciences firms, leading provider networks/institutions, as well as national payers.

Prior to joining Campbell Alliance, will was an Associate Partner at Oliver Wyman.  Before Oliver Wyman, Will worked in Deloitte Consulting’s Life Sciences practice.  He worked in various functions at Amgen prior to his career in consulting.

Will holds degrees from Northwestern University in Biochemistry and English Literature.  He has an MBA from The Kellogg Graduate School of Management.

   
  Barry Sickels, Ph.D.

Vice President, Regulatory Affairs and Wilmington R&D Site Leader

AstraZeneca

Barry Sickels is Vice President, Regulatory Affairs at AstraZeneca and the R&D Site Leader for the Wilmington, Delaware campus.  He has more than 25 years experience in the pharmaceutical industry and has worked in discovery research, clinical research and development and, for the past 18 years, Regulatory Affairs. Barry has worked in many therapy areas including oncology, infectious disease, central nervous system, respiratory disease, GI and diabetes. Prior to his current role, Barry served as Vice President and Global Regulatory Therapy Area Leader for Oncology and Infection projects at AstraZeneca.  Barry also previously served as Vice President, Regulatory Affairs, Global Therapy Areas and North America at Pfizer/Wyeth.   Barry earned his BS in biology from Rider University and holds an MS in toxicology/environmental science from Rutgers University. He also holds a Master of Jurisprudence and a Doctorate in Health Law from the Widener University School of Law’s Health Law Institute.

   
  Kay Holcombe

Senior Policy Advisor

Genzyme

Kay Holcombe is Senior Policy Advisor at Genzyme, a Sanofi Company.  From Genzyme’s Washington, DC, government relations office, Kay participates in developing and implementing corporate policies and responses to government regulatory and policy initiatives.  She works with members of Congress and their staffs and with officials of government agencies.

Before joining Genzyme, Kay was Executive Vice President of Policy Directions Inc., a government relations firm specializing in strategic planning and legislative and regulatory advocacy regarding health care and related issues.  She represented a variety of clients in academia and in the pharmaceutical and biotechnology, food, and consumer products industries.

Earlier, she served as professional health legislative staff and senior health policy advisor,  House of Representatives Committee on Energy and Commerce, and professional health staff, Senate Committee on Labor and Human Resources; Deputy Associate Commissioner for Legislative Affairs, Food and Drug Administration; Executive Vice President, Foundation for Biomedical Research; Associate Director for Public Health Legislation, Office of the Assistant Secretary for Legislation,  Department of Health and Human Services; Deputy Associate Administrator for Planning, Evaluation, and Legislation, Health Resources and Services Administration, U.S. Public Health Service; Special Assistant to the Director, Division of Legislative Affairs, National Institutes of Health; Executive Secretary, National Heart, Lung, and Blood Institute National Advisory Council; and researcher, National Institutes of Health.

Kay received her B.S. in chemistry education from the University of Illinois and her M.S. in chemistry from the University of Virginia.  She was elected to Phi Beta Kappa, Phi Kappa Phi, and Iota Sigma Pi.

   
  Martin Marciniak

Vice-President, US Health Outcomes

GlaxoSmithKline

Dr. Marciniak has 13 years of strategic and health outcomes research experience in the pharmaceutical industry, most recently with GlaxoSmithKline.  His experience and leadership has been both Global and US oriented, internally and externally facing, and has included specific therapeutic research focus in the areas of oncology, neurosciences, and cardiovascular disease.  Martin’s research has been published in scholarly journals, and has been presented at both national and international congresses.  In addition to his research activities, he also serves as an ad hoc peer reviewer for scientific journals and research foundations.  Currently, Martin is one of the nonvoting industry representatives to Medicare Evidence Development & Coverage Advisory Committee for the Centers for Medicare and Medicaid Services.

Dr Marciniak has a broad academic career which includes scientific and public policy research, as well as the tactical implementation and strategic management of observational research programs.  He received his Ph.D. in Health Services and Policy Analysis with a concentration in Health Economics from the University of California at Berkeley, and a Masters in Public Policy from the John F. Kennedy School of Government at Harvard University.  His B.S is in Pharmacy from Purdue University.  Additionally, Martin also holds an executive education certificate from the Sloan School of Management at the Massachusetts Institute of Technology focusing on innovation and management.

   
  Charles A. (Chuck) Stevens, JD, MBA

Vice President & General Manager, Commercialization Strategy

PAREXEL Consulting

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 Grey Sheet.

   
  Gregory Geba

Director

Office of Generic Drugs

Food & Drug Administration (FDA)

After nearly a decade at Yale where he was a faculty member in Pulmonary and Critical Care in the School of Medicine, Dr. Geba served in senior-level clinical/managerial positions in the pharmaceutical industry for the past 15 years.  In his most recent position, he served as Deputy Chief Medical Officer for Sanofi US, where he provided medical and scientific leadership and managerial direction to multidisciplinary scientific and regulatory professionals engaged in drug development activities across all therapeutic areas, as well as to the company’s field medical group.

He has contributed to the registration of more than 20 currently marketed drugs or devices across multiple therapeutic areas. In so doing, he successfully employed his working knowledge and demonstrated practical application of drug manufacturing processes, current quality and risk management processes, and standards relevant to FDA’s laws and regulations. He brings extensive clinical research experience, including leading or serving as the key point in filing new drug applications, biologic license applications, and promotional studies comparing efficacy and effectiveness of novel biopharmaceuticals versus standard of care (including regimens containing branded or generic drugs), and has provided or supervised key safety updates and presentations to FDA Advisory Committees. Dr. Geba’s experience also includes leading medical affairs activities while serving in a variety of senior-level positions. His scope of responsibility in those activities included contribution to the design of experimental protocols and assessment of data from pre-clinical, animal, and first-in-human studies; design, implementation, analysis, and interpretation of phase 2a proof-of-concept and 2b dose ranging studies; and production of important comparative effectiveness and safety data when assessing benefit-risk relationships during phase 3, phase 3b, and phase 4 studies.

Dr. Geba received his medical degree from the University of Navarre and his M.P.H. from the Johns Hopkins Bloomberg School of Public Health. He joins OGD to lead the expanding generic program into a reorganization of both structure and process to improve coordination, communication, and efficiency, and to enhance the Office’s ability to ensure that all generic drugs-which make up nearly 80 percent of prescriptions filled in the United States-are safe, effective, of high quality, and interchangeable with the brand name drug product/reference listed drug.

   
  Mary Ellen Cosenza

Executive Director Regulatory Affairs and North America Regulatory Head

Amgen, Inc.

Mary Ellen Cosenza has almost 30 years experience in the Bio-Pharmaceutical Industry, with the last 17 years being at Amgen Inc. Mary Ellen is currently Executive Director of U.S. Regulatory Affairs with Amgen. Her role is to provide management and leadership by overseeing the execution and by providing advice on the development of regulatory strategy and plans for the FDA.  In addition, she supervises the Regulatory Promotion and Material Compliance Group, as well as supervising Amgen Regulatory policy activities and priorities in the U.S.

Prior to taking on the U.S. Regulatory team she managed the International Emerging Markets Regulatory team. She has also served at the Regulatory Therapeutic Area Head for Inflammation and Early Development and overseen the Global Regulatory Writing department.  Prior to joining Regulatory Affairs, Dr. Cosenza was Senior Director of Toxicology where she managed a department of scientists that are involved in the safety assessment of both traditional small molecules and biotechnology products.  She set policy concerning study type, study design, approval of contract laboratories and interacted with FDA and other Boards of Health.

Prior to joining Amgen (1995), Dr. Cosenza worked for the Medical Research Division of American Cyanamid Company (now Pfizer) in Toxicology Research as a Principal Scientist.  At Cyanamid, Dr. Cosenza held several positions including Group Leader of Regulatory Toxicology, Manager of the Quality Assurance Unit for GLPs and GMPs and later managed the Toxicology Operations group.

Mary Ellen received her PhD from St. John’s University, New York.  She recently received her MS in Regulatory Affairs from University Southern California, Los Angeles.  Mary Ellen also teaches a course on Food and Drug Toxicology at USC.

Dr. Cosenza is a Diplomat of the American Board of Toxicology, has her Regulatory Affairs Certification (US and EU) and is a member of the Society of Toxicology (SOT), the American College of Toxicology (ACT), Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS).  Mary Ellen was the representative for BIO on the ICH M3 Expert working group for the most recent revision.

   
  David Gaugh

VP-Regulatory Sciences

Generic Pharmaceutical Association

David Gaugh has over 25 years of leadership experience in the Healthcare and Pharmaceutical business and has been an outstanding contributor to the industry over the years. He has been employed by GPhA since February 2012 as the Senior Vice President for Sciences and Regulatory, where he is responsible for the science, regulatory and professional liaison functions between member companies, agencies of the US Government and Legislative bodies. Prior to joining GPhA, David was the Vice President and General Manager of Bedford Laboratories, a Division of Ben Venue Laboratories (a wholly owned subsidiary of Boehringer Ingelheim). David was responsible for Strategic Planning, Financial Management, Business Development, Marketing and Sales for a $500 million multi-source injectable business.

Prior to joining Ben Venue, David was Senior Director, Pharmacy Contracting and Marketing at VHA/Novation; the largest Group Purchasing Organization in the US. Prior to Novation, he was System Director of Pharmacy for St. Luke’s Health-System, a tertiary-care hospital in Kansas City, MO.

David is a registered Pharmacist and is engaged in several pharmacy-related activities such as the ASHP Education and Research Foundation Board of Directors and various Pharmacy Internship and Residency Programs.

   
  Gary Buehler
Vice President-Regulatory Strategic Operations
Teva Pharmaceuticals

Mr.  Buehler is the VP for Regulatory Strategic Operations for Teva Pharmaceuticals.  Prior to joining Teva, he worked for 24 years at the US Food and Drug Administration, starting as a Project  Manager in OND’s Cardio Renal Division.  In 1999, he joined the Office of Generic Drugs as the Deputy Director.  In 2001, after serving for over a year as Acting Director, he became the Director of OGD and served in that position until 2010. Mr. Buehler retired from the U.S. Public Health Service in April of 2000 after serving in a variety of duty stations including Indian Health Service positions in Nevada and Montana.  He graduated from Temple University School of Pharmacy.

 

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