Guest Speakers

Susan Alpert

Former Chief Regulatory Officer

Medtronic

Bio

Susan Alpert, Ph.D., M.D. was most recently the Senior Vice President, Chief Regulatory Officer of Medtronic and was responsible for all Medtronic global regulatory efforts. Prior to joining Medtronic, Dr. Alpert served as Vice President of Regulatory Sciences for C.R. Bard, Inc. She also previously worked at FDA where she held a variety of positions in the centers dealing with drugs, devices and radiological health and foods, including six years as the Director of the Office of Device Evaluation. Dr. Alpert is a microbiologist and a pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials.

Dr. Alpert served on the board of advisors for the Medical Technology Leadership Forum and the board of the Women Business Leaders, or organization of women leaders in the health care sector. She also served on the Executive Committee of the Clinical Trials Transformation Initiative, one of the public/private partnerships working with FDA to streamline the development of medical products.

Dr. Alpert completed her undergraduate degree at Barnard College, Columbia University and holds a masters degree and Ph.D. in Biomedical Sciences from New York University. She received her Medical Degree from the University of Miami (Florida) and completed her clinical training at Montefiore Medical Center in the Bronx, New York and at Children’s National Medical Center in Washington, D.C.

John Avellanet

Managing Director & Principal

Cerulean Associates LLC

Bio

John Avellanet is an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging, friendly style.

Mr. Avellanet was the lead author of several certification courses on Good Manufacturing Practices (GMP) and Quality System Regulation (QSR) supplier management for the US Regulatory Affairs Professional Society (RAPS). Today, he serves as a lead expert in the ISPE’s Data Integrity special interest group and was the industry expert reviewer for the 2014 international standard, Evidential Weight and Legal Admissibility of Information Stored Electronically – Code of Practice for the Implementation of BS 10008.

He also recently co-authored the book, Pharmaceutical Regulatory Inspections (2014) along with several current and former regulatory agency officers, and his industry classic book, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine, was originally featured at BIO 2011.

In 2011, he was asked by the US Office of Inspector General, Health & Human Services to oversee the multi-million dollar Dr. Comfort Corporate Integrity Agreement (CIA) through 2016.

And in both 2009 and 2011, Mr. Avellanet won the “Best of Business” award from the US Small Business Commerce Association. His blog, ComplianceZen.com, has been repeatedly named one of the “Top 50 Blogs” worldwide on FDA compliance issues.

Over the past 10 years, he has been interviewed on public radio programs, in numerous industry magazines and multiple international news outlets. He has written more than 100 different articles on cost-effective FDA compliance, many of which have been translated and syndicated around the world. He speaks frequently for industry conferences and private corporate workshops.

Prior to founding his lean compliance consulting firm, Cerulean Associates LLC, Mr. Avellanet was a former Fortune 50 combination device C-level executive who created, developed, and ran his company’s compliance programs to achieve ISO, DEA, BIS and FDA compliance. During his career, he has had to defend decisions to investigators, auditors, and litigators alike. He now brings his hard-won, real-world expertise and practical advice to his corporate clients worldwide.

A former FDA and US Department of Justice prosecutor has said of Mr. Avellanet, “He is the best in the business. Period.”

Anthony Barrueta

Senior Vice President, Government Relations

Kaiser Foundation Health Plan, Inc.

Bio

Anthony (Tony) Barrueta is Senior Vice President of Government Relations for Kaiser Foundation Health Plan, Inc. and Kaiser Foundation Hospitals. He is responsible for guiding the development of Kaiser Permanente's positions on public policy matters of importance to the organization and its members. As part of this role, he leads Kaiser Permanente's advocates and public policy professionals in Oakland, Sacramento and Washington, D.C. in representing Kaiser Permanente before the state and federal executive and legislative branches of government. He is a member of Kaiser’s National Executive Team and chairs the organization’s national Health Policy Committee.

From 2003 to 2010, Mr. Barrueta served as Vice President in Kaiser Permanente’s Government Relations Department, working on a wide variety of policy areas, including Medicare, health insurance regulation, and health care reform. From 1994 to 2003, he served first as Counsel and then Senior Counsel for Kaiser Permanente, where, in addition to providing state and federal legislative counsel, he provided legal and policy guidance to Kaiser Permanente's pharmacy benefit management and drug purchasing leadership.

Prior to joining Kaiser Permanente, Mr. Barrueta was in private law practice in Washington, D.C., representing HMOs, pharmacy benefit management companies and trade associations before Congress and executive agencies. Mr. Barrueta serves on the Board of Directors of the Alliance of Community Health Plans, Enroll America and the Public Health Institute. He is also a Trustee for the Committee for Economic Development and a member of its Policy and Impact Committee. Previously, Mr. Barrueta served for five years as general counsel to the Hispanic College Fund.

A native of Washington, D.C., Mr. Barrueta received an A.B. in History from Boston College in 1987 and his law degree from the University of Texas at Austin.

Marlene Bobka

President

FOI Services, Inc.

Bio

Marlene Bobka serves as the President at FOI Services, Inc. In this role, she is responsible for functions that facilitate access to FDA records acquired using the Freedom of Information Act, and producing teleconferences that interpret FDA regulations, actions and expectations.

Ms. Bobka is a widely published author and speaks frequently on topics that give insight into finding and using fugitive drug, device and biologic regulatory information. She has addressed audiences worldwide for organizations including the Drug Information Association, the Regulatory Affairs Professional Association, the Special Libraries Association, the American Chemical Society, the Association of Food and Drug Officials and many others.

Before joining FOI, Ms. Bobka taught online searching strategy; conducted extensive medical, chemical, and government literature research; and designed and documented databases at Bibliographic Retrieval Services and the National Cancer Institute. She holds a B.S. in biology and chemistry and an M.L.S. with a concentration in biomedical information structure. As an undergraduate student, Ms. Bobka was awarded an AAAS research grant, and as a graduate student, she was inducted into the information science honor society, Beta Phi Mu.

Bobka has held elected office in multiple professional societies, has been named a “Thought Leader” by Pharmaceutical Executive, and was included in a listing of 100 Influential Device Executives in the publication, Medical Device & Diagnostic Industry. She has served as a guest lecturer, adjunct faculty member and Advisory Board member for graduate programs in Library and Information Sciences and FDA Regulatory Affairs.

Elizabeth Blackwood

Chief Quality Officer and Vice President, Pharmaceuticals Quality

Johnson & Johnson

Bio

Elizabeth Blackwood is the Chief Quality Officer and Vice President, Pharmaceuticals Quality at Johnson & Johnson. She has responsibility for Quality and Compliance for the Global Pharmaceuticals Segment in Pre-Market R&D, Supply Chain and Post Market Commercial. She is a member of the Johnson & Johnson Quality and Compliance Leadership Team (QCLT) and the Worldwide Group Operating Committee for the pharmaceuticals businesses. Prior to her current role, Liz was Vice President Quality Systems and Strategy for Johnson & Johnson. She had direct leadership for Enterprise Quality Management Systems, was a member of the Johnson & Johnson QCLT and the Supply Chain Operating System (SCOS). She had responsibility for the development of Quality Standards, strategy and business plans for Johnson & Johnson Quality & Compliance.

Liz returned to Johnson & Johnson after four years with GE Healthcare as Senior Vice President, Global Quality Assurance where she was responsible for establishing one global quality management system across more than 100 sites. Prior to joining GE Healthcare, Liz worked at LifeScan, Inc., Ethicon Endo-Surgery, Inc., Ethicon, Inc., and Johnson & Johnson Corporate QCS. Her last position at Johnson & Johnson before joining GE Healthcare was Worldwide Vice President, Quality, Regulatory and Medical Affairs, LifeScan, Inc.

Liz holds an A.S. in manufacturing technology from Keene State College, a B.S. in mechanical engineering from the University of Lowell and a M.S. in management from Lesley College. She also serves on the U.S. FDA GMP Advisory Committee and is a voting member of ISO TAG 176 Quality Systems Standards.

Paul C. Brooks

Senior Vice President, Healthcare Solutions

BSI Group

Bio

Paul qualified with BSI as an electro-mechanical technician engineer and progressed to a Senior Certification Officer responsible for certification of products and registration of quality management systems to BS 5750 (UK predecessor of ISO 9000).

In 1993 Paul joined BSI’s US subsidiary and work as the local expert on CE Marking under the Medical Devices Directive. During his 6 years with BSI Inc Paul worked with over 400 US medical device manufacturers that were selecting a notified body and beginning the CE Marking process for complying with European regulations. He also led on programs to raise awareness of the new European CE Marking regulatory approach in North America.

In 1998 Paul return to London to be Head of Notified Body for BSI’s Medical Devices Group, and was regularly involved in European Medical Devices Notified Bodies meetings and technical groups, interacting with UK Competent Authority, trade / industry groups and in Brussels at Notified Body meetings with the European Commission.

Paul relocated back to BSI’s Washington DC office in 2001 and is now responsible for leading BSI activities in the medical devices regulatory sector for the Americas region including EU Notified Body, ISO 13485 Certification, Health Canada / SCC CMDCAS accreditation and MDSAP Auditing Organization recognition.

Paul is a long standing member of the Regulatory Affairs Professional Society (RAPS), serving as a Board member for six years and 2013 Chairman, he is also a long-term member of American Society for Quality (ASQ) – Biomedical Division and routinely presents and trains at sessions organized by both of these societies as well as other sector focused meetings/conferences.

Blair Childs

Senior Vice President of Public Affairs

Premier Inc.

Bio

Blair Childs is Senior Vice President of Public Affairs for Premier, leading the Advocacy, Communications, Safety and thought leadership units and serving on the company’s executive team. He works with the Congress, White House, and other policymakers involved in health policy.

Childs has been at the center of policy issues for more than two decades, playing a leading role on issues impacting medical devices, pharmaceuticals, insurers, and hospitals. Childs has held senior management positions in professional, trade, and advocacy associations and a Fortune 25 company.

Petra Dörr, Ph.D.

Head of Communication and Networking and Deputy Director

Swissmedic, Swiss Agency for Therapeutic Products, Switzerland

Bio

Since January 2014, Petra Dörr holds the position of Head of Communication and Networking and Deputy Director at Swissmedic, Swiss Agency for Therapeutic Products. Amongst other responsibilities in external relations, she oversees the international activities of Swissmedic with other agencies and international organisations. She is a member of the ICH Management Committee and of the Scientific Advisory Council of the Centre for Innovation in Regulatory Science and has served as the chair of the International Pharmaceutical Regulators Forum (IPRF) since June 2013.

She received her approbation as a pharmacist in 1990 and was awarded her PhD at the Institute of Pharmaceutical Chemistry, Faculty of Pharmacy at the University of Heidelberg in 1995. She has ten years of experience in international regulatory affairs. Before joining Swissmedic, she held the position of Vice President Regulatory Affairs in Europe, Africa and Asia at Valeant Pharmaceuticals, Inc. In October 2004, she started at Swissmedic as the Head of International Affairs. She has been Head of Management Services & Networking and Member of the Management Board at Swissmedic, Swiss Agency for Therapeutic Products, since July 2007.

Bernadette Dunham

Visiting Professor at GW

Former Director

Former Director, Center for Veterinary Medicine

US FDA

Bio

On April 4, 2016 Dr. Bernadette Dunham joined the Milken Institute School of Public Health at the George Washington University as a Visiting Professor, where her focus is on One Health issues. Dr. Dunham also serves as the Senior Science Advisor to the Deputy Commissioner, OFVM, U.S. Food and Drug Administration.

Dr. Dunham served as the Director of the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) from 2008 -2016. As Center Director, she oversaw the regulation of the manufacture and distribution of drugs, medical devices and food additives that are given to animals. These include animals from which human foods are derived, as well as pet (or companion) animals and minor species which include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats. Dr. Dunham was responsible for assuring that animal drugs and medicated feeds are safe and effective and that food from treated animals is safe to eat. Dr. Dunham coordinated the outreach to educate consumers as well as the regulated industry; the careful evaluation of data on proposed veterinary products before permitting them to be marketed; the discovery of violative marketed products through surveillance programs; the initiation of legal action, if necessary, to bring violators into compliance with the law; and the research to support Center activities.

Prior to becoming CVM’s Director in 2008, Dr. Dunham had been CVM’s Deputy Director. Dr. Dunham also served as the Director of CVM’s Office of Minor Use and Minor Species from August 2006 to January 2008. She came to CVM in December 2002 as the Deputy Director of CVM’s Office of New Animal Drug Evaluation. Dr. Dunham has served as an Adjunct Professor in the Department of Biomedical Sciences and Pathobiology at the Virginia-Maryland Regional College of Veterinary Medicine from 1996 to 2012. She lectured on a variety of topics from emerging issues and opportunities in veterinary medicine to the role of consensus building in policy development.

Prior to joining FDA, Dr. Dunham was Assistant Director for the American Veterinary Medical Association’s Governmental Relations Division in Washington, D.C. from 1995-2001. In that position, she participated in the formation and execution of AVMA policies, objectives and programs, with emphasis on Federal legislation and regulatory issues. Dr. Dunham’s work also involved identifying Congressional and regulatory issues that might impact the veterinary medical profession, as well as developing strategies for response to these issues. From 1989 to 1995, Dr. Dunham was the Director of Laboratory Animal Medicine and Adjunct Professor of Pharmacology at the State University of New York Health Science Center in Syracuse, N.Y. Dr. Dunham’s research focused on the molecular regulation of cardiac gap junction proteins. She participated in a post-doctoral residency program in the Department of Pathology at the New York State College of Veterinary Medicine, Cornell University, Ithaca, N.Y., from 1987 to 1988. Dr. Dunham was a Research Assistant Professor at Boston University from 1984 to 1987. Prior to returning to academia to pursue her Ph.D., Dr. Dunham was in private clinical practice in Ontario, Canada from 1975 to 1979.

Dr. Dunham received the degree of Doctor of Veterinary Medicine in 1975 from the Ontario Veterinary College at the University of Guelph in Ontario, Canada and her Ph.D. in cardiovascular physiology in 1984 from Boston University in Boston, Massachusetts.

Dr. Dunham is a member of the American Veterinary Medical Association, the American Academy of Veterinary Pharmacology and Therapeutics, the National Academies of Practice, and an Honorary Diplomate of the American Veterinary Epidemiology Society. She has served on peer review panels for the National Academies of Science, the American Heart Association - New York State Affiliate, United States Department of Agriculture-Cooperative State Research, Education and Extension Service, Competitive Programs, and the National Institutes of Health. Dr. Dunham also served as the Chairperson for the 18th Session of the Codex Alimentarius Committee on Residues of Veterinary Drugs in Foods.

Ruth Lopert

Deputy Director, Pharmaceutical Policy and Strategy

Pharmaceuticals and Health Technologies Group

Management Sciences for Health

Bio

Ruth Lopert, a public health physician and pharmacoepidemiologist/pharmacoeconomist, is currently Deputy Director, Pharmaceutical Policy & Strategy, in the Pharmaceuticals & Health Technologies Group at Management Sciences for Health in Arlington VA. She also holds an adjunct professorial appointment in the Department of Health Policy & Management at George Washington University, where she was Visiting Professor in 2011-12 and a Harkness Fellow in Health Policy in 2006-07. From 2008-11 Ruth was the chief medical officer in the FDA’s Australian counterpart agency, the Therapeutic Goods Administration. Previously she established and directed the pharmaceutical policy unit in the Australian Department of Health; prior to that Ruth managed the day-to-day operations of the national drug benefit program, the Pharmaceutical Benefits Scheme and was a clinical and policy advisor to the national formulary committee. In 2003-04 Ruth was also primary negotiator on pharmaceuticals during the Australia US Free Trade Agreement negotiations.

Ruth is a Fellow of the Faculty of Public Health of the Royal Australasian College of Physicians, was recently appointed to membership of l’Academie Nationale de Pharmacie of France, and is a former member of the WHO Expert Advisory Panel on Drug Policies and Management. Over the last 5 years she has also worked as an external consultant to WHO, the World Bank, PAHO and NICE-International, mainly in former Soviet bloc countries. Her research interests include medicine and therapeutics regulation; pharmaceutical policy and pricing; health technology assessment (HTA); pharmaceutical intellectual property (IP); and issues at the intersections of trade, IP and access to medicines.

Mark Mansour

Partner

Mayer Brown LLP

Bio

Mark Mansour is a Litigation & Dispute Resolution partner in Mayer Brown’s Washington DC office. He focuses his practice on FDA regulatory matters.

For more than two decades, Mark has worked with clients in the food, pharmaceutical, medical device, dietary supplement and cosmetic industries to develop and implement strategies for regulatory approvals, compliance and enforcement actions, crisis management, rulemaking and public policy issues.

He counsels corporations and organizations on how to negotiate effectively with government agencies in the US and key global markets.

James W. (JW) McBlane, Ph.D.

MHRA Assessor and UK’s Alternate Delegate

European Medicines Agency's Committee for Advanced Therapies (CAT)

Bio

After degrees in pharmacology at the universities of Dundee and Aston in Birmingham, Dr McBlane worked in the pharmacology research laboratories for the British pharmaceutical company, Wellcome, before moving to the UK’s Medicines Control Agency to work in pharmacovigilance. After a short period there, he moved to the Japanese biopharmaceutical company, Chugai, where he worked for almost 10 years in several roles, latterly specialising in preclinical development. He returned to the Licensing Division of the UK’s Medicines & Healthcare Products Regulatory Agency and is now a preclinical assessor in the Licensing Division, assessing marketing authorisation applications for biological products. He also has experience of assessing clinical trial applications for every kind of product, as well as having hundreds of meetings with companies or academics developing pharmaceutical products. For the last 4 years, he has been the UK’s alternate delegate to the European Medicines Agency's Committee for Advanced Therapies (CAT).

Michael Morton

Vice President, Corporate Regulatory Affairs

Medtronic, Inc.

Bio

Michael C. Morton is Vice President for Global Regulatory Affairs, at Medtronic, Inc. Michael is responsible for public health policy advocacy and for internal regulatory policy within corporate regulatory affairs.

Michael has over twenty five years of experience in the medical device industry, including quality, clinical, and regulatory affairs. Before joining Medtronic, Inc., Michael worked with CarboMedics, Inc.; W.L. Gore and Associates; Alcon Labs; and Sorin Group.

Michael has been recognized as a Fellow of the Regulatory Affairs Professional Association (RAPS). He is active in industry groups, including the Advanced Medical Technology Association (AdvaMed). He chairs the AdvaMed PMA Working Group, co-chairs the Pediatric Devices Working Group, and is a member of the Heart Valve Task Force. Michael represented industry within Study Group 1 (Premarket) of the Global Harmonization Task Force. He served as the industry representative to the FDA Circulatory System Devices Advisory Panel from 2001 to 2005.

Steven Niedelman

Lead Quality Systems & Compliance Consultant

King & Spalding LLP

Bio

Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act.

He joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Previously, he was executive vice-president of Quintiles Consulting.

Mr. Niedelman consults with manufacturers, importers, new product developers, as well as with firms involved in or facing enforcement actions. He helps firms develop corrective action plans so their business needs are properly balanced with regulatory requirements in order to achieve compliance without compromising objectives. He provides training and guidance to industry professionals on all FDA requirements, including quality systems requirements, inspection preparedness, post-market obligations and to executives about their management responsibilities as well as FDA’s expectations.

Mr. Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of the Office of Regulatory Affairs (ORA), including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. Additionally, Mr. Niedelman assisted in the day-to-day management of FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations.

While at ORA, Mr. Niedelman served as the principle liaison to the Center for Devices and Radiological Health, and was a member of the Global Harmonization Task Force (GHTF) Steering Committee, FDA/Medical Device Industry Grassroots Initiative Steering Committee and the CDRH Post Market Initiative Steering Committee. He also served on the Steering Committee to the Pharmaceutical “cGMP for the 21st Century” initiative as well the Counterfeit Drug Task Force. Prior to joining the Office of the Associate Commissioner, he was the Director and Deputy Director of FDA’s Office of Enforcement, where he was responsible for oversight and consistency of compliance policy, enforcement and recall activities to ensure fair implementation by FDA’s five product centers. During his tenure, Mr. Niedelman presided as the Chairman of FDA’s Compliance Policy Council. He currently participates as a member of the Medical Devices Committee at the Food and Drug Law Institute and as a member of the Editorial Review Board for FDA News GMP publications directed at the pharmaceutical and medical device industries. Mr. Niedelman has also served as Vice President of the FDA Alumnae Association.

Before joining the Office of Enforcement, Mr. Niedelman spent nearly 24 years throughout the Office of Compliance at the Center for Devices and Radiological Health (CDRH) in a number of management positions. During those nearly 24 years at CDRH he was responsible for implementing many of the newly created statutory requirements and drafting and shaping many of the regulations and policies affecting the sale, distribution and promotion of medical devices. He began his FDA career in 1972 as an Investigator in FDA’s New York District Office.

Marcia Nusgart

Executive Director

Alliance of Wound Care Stakeholders

Bio

Marcia Nusgart R.Ph. is the founder and Executive Director of the Alliance of Wound Care Stakeholders (“Alliance”) a non-profit interprofessional association for clinical organizations whose members treat patients with wounds. It addresses regulatory and legislative issues impacting wound care. She also serves as Executive Director for the Coalition of Wound Care Manufacturers (“Coalition”) and President of Nusgart Consulting LLC.

As Executive Director of the Alliance and the Coalition, she is viewed as a highly visible, respected and credible source of industry information for the Centers for Medicare and Medicaid Services and their contractors, Food and Drug Administration and the Agency for Healthcare Research and Quality as she advocates for appropriate public policy processes. As the Alliance’s Executive Director, she organized its efforts in writing the article, “Consensus Principles for Wound Care Research Obtained Using a Delphi Process (Wound Repair and Regeneration May/June 2012), submitted wound care quality measures to the Centers for Medicare and Medicaid Services (CMS) and tackled issues relating to coverage, coding and payment for wound care procedures and products.

Ms. Nusgart is an industry leader in providing comprehensive strategies to medical device and pharmaceutical manufacturers regarding coding, coverage and reimbursement issues under Medicare and Medicaid. Her accomplishments range from advocating successfully, in her coalition capacity, for CMS to modernize the HCPCS coding process to make it more timely, transparent and understandable for manufacturers; to, in her consulting role, obtaining new HCPCS codes along with appropriate coverage and payment for manufacturers' products.

She is highly regarded in the wound care industry through her numerous published articles and is a highly sought after speaker, appearing at various conferences such as the Symposium on Advanced Wound Care Conferences, European Wound Management Association, World Union of Wound Healing Societies, American College of Tissue Healing and Wound Repair, American Professional Wound Care Association, MEDTRADE shows, FDA and NIH Meetings, and the Medical Device Manufacturers Association Reimbursement Conferences. She has received numerous honors ranging from the 2011 Distinguished Alumni award by the Ohio State University College of Pharmacy to the AAWC Leadership Award to the designation of Master from APWCA, both honoring key opinion leaders who have made significant contributions impacting wound care.

Ms. Nusgart founded her own business, Nusgart Consulting LLC, in 1998. Prior to that she worked in two associations-- the Advanced Medical Technology Association (AdvaMed) and the National Community Pharmacy Association. She has also served in senior positions for Super X Drugs (now CVS) and worked for Merck. She holds a Bachelors of Science in Pharmacy from the Ohio State University. She currently serves on the Boards for four distinct organizations: Women Business Leaders of the U.S. Healthcare Industry Foundation, the Ohio State University College of Pharmacy, Kestrel Wound Care Wound Source and Premier Homecare.

Amra Racic

Principal Regulatory Affairs Policy & Advocacy Specialist

Medtronic, Inc.

Bio

Amra Racic is currently employed at Medtronic as a Principal Regulatory Affairs Policy and Advocacy Specialist. She has been in the healthcare industry for over 16 years, the majority spent with the Medtronic regulatory group doing a variety of US FDA and international submissions for low risk, high risk and in-vitro medical devices. Prior to Medtronic, she has also worked on regulatory submission projects at Bayer AG and also had responsibility for patient care management at a local hospital in Minneapolis.

Prior to moving into her current role, Amra spent a couple of years working in the corporate group at Medtronic tracking and interpreting worldwide new and changing regulations. She has led internal teams of experts through various exercises of assuring compliance to a variety of global regulatory requirements.

Today she primarily focuses on identifying, leading and executing on Medtronic global regulatory advocacy initiatives through venues such as training of regulatory authorities, seminar presentations, development of position/white papers. Amra also heavily participates in trade association working groups, including the Advanced Medical Technology Association (AdvaMed) and various harmonization working groups.

Amra holds a B.A in Business Administration and an MBA with focus on Business Management from Walden University in Minneapolis.

Nancy Singer

President

Compliance-Alliance

Bio

Nancy Singer founded Compliance-Alliance LLC in 2004 to specialize in the professional development for government, association, and business professionals. She has taught over 1700 people how to improve their communication practices. She is on the faculty of George Washington University Medical School and Health Science Program, and she has taught classes at Johns Hopkins University, University of Southern California, and Harvard Symposia.

She presently teaches classes for FDA Staff Colleges and FDA District Offices, Previously she served as Special Counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation.

She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. Nancy is a retired commander in the Naval Reserve.

Donna-Bea Tillman

Senior Consultant (Medical Devices)

Biologics Consulting Group

Bio

Dr. Donna-Bea Tillman is a senior consultant at Biologics Consulting Group with 17 years of medical device regulatory experience at the US Food and Drug Administration, Center for Device and Radiological Health. She held numerous positions within FDA CDRH, culminating in her 2004 appointment to the position of Director of the Office of Device Evaluation, where she oversaw the medical device premarket review program for non-IVD devices. During her tenure at FDA, she played a pivotal role in the development of guidance documents, standards, and policy frameworks for medical device software and health IT.

In 2010 she joined Microsoft’s Health Solutions Group as the Director of Regulations and Policy, where she was responsible for obtaining the appropriate global premarket registrations and managing Microsoft’s postmarket safety programs. Donna-Bea received her B.S.E. in Engineering from Tulane University, her Ph.D. in Biomedical Engineering from the Johns Hopkins University, and her Master’s in Public Administration from the American University.

Frank F. Weichold

Director, Office of Critical Path and Regulatory Science Initiatives

Chief Scientist and the Office of the Commissioner for the FDA

Bio

Dr. Weichold is director for the Office of Critical Path and Regulatory Science Initiatives in the office of the Chief Scientist and the Office of the Commissioner for the Food and Drug Administration. He also chairs the FDA Senior Science Council and he represents FDA at the Maryland Life Science Advisory Board. The expertise he brings to the regulatory agency builds on his ability to advance, coordinate, and integrate scientific resources for FDA by addressing mission critical scientific regulatory challenges in a global environment. The FDA Centers of Excellence in Regulatory Science and Innovation (CERSI) network is being built under Dr. Weichold’s leadership in collaboration with academic institutions to leverage scientific expertise, resources and capacity toward FDA’s mission. He is leading strategic partnership arrangement and value generation at the agency, including intellectual property development and technology transfer.

Dr. Weichold’s experience includes execution of strategic and operational initiatives across the sciences’ value chain. Dr. Weichold has led the development of international collaborations and public private partnerships for discovery and early medical product development, implemented global operating and development models, and executed large-scale business model transformations. He has accumulated more than a decade of industrial research and medical product development experience while leading teams in Clinical Pharmacology, DMPK, as a Director at MedImmune LLC, and AstraZeneca. Prior, he directed research and clinical development of vaccines at the Aeras Foundation (founded by The Bill and Melinda Gates Foundation)

As a tenured Professor in the University of Maryland system, he developed and managed independent research programs and trained graduate students. He also held faculty positions at the University of Maryland Biotechnology Institute to study signal transduction pathways that affect immune responses, as well as at the Humboldt University, Berlin (Germany) to teach and study microbial immune modulation. During the five years of postdoctoral education, Dr. Weichold worked at the National Institutes of Health in Bethesda, Maryland, first at the National Cancer Institute where he researched immune pathologies in HIV infection, then at the Hematology Branch of the National Heart Lung and Blood Institute where bone marrow pathologies, transplantation immunology and gene therapy were the focus of his clinical research studies. His medical practice and clinical experience include Infectious Diseases and Immunology/Rheumatology.

Matthew Wetzel

Vice President & Assistant General Counsel

Advanced Medical Technology Association (AdvaMed)

Bio

Matt Wetzel is Vice President & Assistant General Counsel of the Advanced Medical Technology Association, or AdvaMed. At AdvaMed, Mr. Wetzel advocates on behalf of the medical device industry with respect to several key legal issues, including health care fraud and abuse concerns, anti-bribery/anti-corruption measures, and physician-industry transparency initiatives, among others. He also oversees the Association’s amicus program.

Prior to joining AdvaMed, Mr. Wetzel served as Senior Counsel, Global Compliance and Ethics at Boston Scientific Corporation. While there, he played an integral role in overseeing several critical elements of the company’s global compliance and privacy programs and advised on a variety of legal issues.

Previously, Mr. Wetzel was as an Associate in the health care practices of Reed Smith LLP and Latham & Watkins LLP, both in Washington, D.C. Mr. Wetzel is also a member of the American Health Lawyers Association Diversity & Inclusion Council, a Fellow of the Leadership Council on Legal Diversity, and a member of the LGBT Bar Association of Washington, D.C. He received his J.D., cum laude, and his A.B., magna cum laude, from Georgetown University. He spends his spare time spoiling his English Bulldog, Boris.

Christopher L. White

Senior Executive Vice President, General Counsel and Secretary

Advanced Medical Technology Association (AdvaMed)

Bio

Christopher L. White, Esq. is Senior Executive Vice President, General Counsel and Secretary of the Advanced Medical Technology Association (AdvaMed).

Mr. White serves as the Association’s Chief Legal Officer and manages AdvaMed’s Legal Committee to develop and promote legal policy positions enhancing patient access to medical technology. Mr. White also leads the Association’s global working groups on legal policy and compliance. He testified before state and federal legislative committees on priority legal policy issues; led the drafting team revising the AdvaMed Code; and led the multinational negotiating team to draft the Kuala Lumpur Principles, harmonizing industry Codes of Ethics in Asia.

He serves as a frequent speaker and author on industry legal and compliance issues. As Chief Legal Officer, he also manages the Association’s HR, governance, and provides counsel on contract, corporate, tax exemption, and legislative and regulatory matters.

Mr. White is a graduate of Wake Forest University where he studied cell biology, and Catholic University Law School.

He is an avid sailor, cyclist and beekeeper.

Robert E. Yocher

Senior Vice President of Regulatory Affairs

HeartWare International Inc.

Bio

Bob Yocher is currently the Senior Vice President of Regulatory Affairs at HeartWare International Inc. of Framingham, Massachusetts. Previously he was the Vice President, Regulatory Affairs and Corporate Quality Compliance, Genzyme Corporation, Cambridge, Massachusetts.

Bob holds a B.A. in Microbiology and Biochemistry from the University of Connecticut and a Masters Degree in Health Science in Public Health Microbiology and Epidemiology from the School of Allied Health, Quinnipiac University. He is Regulatory Affairs Certified and is a Certified Quality Engineer (E-8448) and Certified Quality Auditor (US001168). Bob was elected a Fellow of the Regulatory Affairs Professional Society in 2008 and a Senior Member of the American Society of Quality in 2005. He brings over 46 years of experience in the medical products business. Bob has held many senior executive management positions in QA, Regulatory Affairs, Clinical Affairs and Marketing.

Bob was an adjunct faculty for Health Product Regulation at Regis College Graduate School of Nursing and a guest lecturer at the Mass. School of Pharmacy and Northeastern University from 2002-2012. He was also on Regis college graduate school advisory board from 2002 -2014.

He has participated as a working group member on the Secretary's Advisory Committee on Genetic Testing (SACGT) and was the Working Group chair for AdvaMed's IVD Task Force on Genetics and BIO's working group on Research Tools and Molecular Diagnostics. He has been an active member of many professional organizations including Regulatory Affairs Professionals Society, The American Society for Quality / Biomedical Division, AdvaMed, PhRMA, NEMA, MassMedic and the American Clinical Laboratory Association.

Bob was the Boston Chapter Chair for RAPS 2008-2010, and the Fellows Chair at RAPS 2009-2011. Bob has been a member of the Board of Directors for RAPS since 2010.

He has also published many professional articles including “Regulatory Considerations for Promotional Material of Medical Products on the Internet”, in the Journal of Commercial Biotechnology, (Vol.7, Number 2, October 2000) and " HIPAA and Data Privacy", in Focus, The official Journal of Regulatory Affairs Professionals Society (March, 2002) and the “The RAPS Fellow” in Focus The official Journal of Regulatory Affairs Professionals Society (April, 2010).