November 4-6, 2019 | North Bethesda, MD

SPEAKERS

Stacy Cline Amin, JD

Chief Counsel, Food and Drug Administration
Deputy General Counsel, Department of Health and Human Services

Stacy Cline Amin serves as Chief Counsel of the Food and Drug Administration and Deputy General Counsel of the Department of Health and Human Services. Stacy serves as the senior legal advisor to the Commissioner, FDA leadership, the HHS General Counsel and Departmental leadership on FDA regulatory and litigation matters. Stacy leads an office of 165 lawyers and support staff that provide counseling and litigation support to the agency.

Stacy previously served as Special Assistant to the President and Senior Associate Counsel to the President, serving as the senior legal advisor on matters relating to the Department of Health and Human Services. In that role, Stacy advised on critical matters arising under the Food Drug and Cosmetic Act, helped lead the Administration’s efforts to combat the opioid crisis, led multi-agency teams in the evaluation of high profile administrative actions, and successfully coordinated litigation strategy with the Department of Justice.

Prior to joining the White House, Stacy served as the Chief Counsel of the Senate Health, Education, Labor and Pensions Committee and as a Counsel for the House Energy & Commerce Committee. In Congress, Stacy frequently advised on Food Drug and Cosmetic Act issues and led bipartisan and bicameral investigations to promote patient safety and global public health. These efforts supported a number of legislative accomplishments, including passage of the Drug Quality and Security Act of 2013 and the 21st Century Cures Act of 2016.

Earlier in her career, she served as an Associate at Sullivan & Cromwell LLP and as a law clerk to the Hon. John R. Gibson on the U.S. Court of Appeals for the Eighth Circuit. She graduated cum laude from Harvard Law School and summa cum laude from The George Washington University.

Tahir Amin

Co-Founder and Co-Executive Director, I-MAK

Tahir Amin is an attorney with more than 25 years of experience in intellectual property law. He practiced as solicitor of the Senior Courts of England and Wales with two of the leading IP firms in the United Kingdom, as well as serving as in-house global IP counsel for multinational corporations. The son of a factory worker from a small, working-class mining town in the North of England, Amin was compelled to use the expertise he had developed to challenge a system in which intellectual property rights favored the powerful at the expense of those most in need.

In 2004, Amin left London for Bangalore, India, where he joined the Alternative Law Forum, a research collective and public-interest think tank. The HIV/AIDS epidemic had propelled the issue of high drug prices into the national consciousness, just as the country was in the midst of crafting new patent law that would give pharmaceutical companies exclusive rights over medicines. Amin quickly became highly sought-after by policymakers, workers groups, and the local media. For two years, Amin worked with grassroots activists to organize communities and educate the public about the need for public health safeguards in the new law. When the law passed, it included the protections that Amin and others had championed, making India among the first countries to consider public health in the granting of pharmaceutical patents.

In that win, Amin perceived an opportunity to advance treatment access using patent challenges, which had until then been used almost exclusively to advance private interests. He began winning patent oppositions on antiretrovirals to expand treatment of HIV on the basis of public health protections included in the new law.

On the strength of that work, he co-founded I-MAK in 2006, where he serves as a legal tactician and strategist to governments, foundations, multilateral organizations, and patient communities. He has been a trusted consultant to the World Health Organization, GAVI, UNITAID, the Clinton Health Access Initiative, Doctors without Borders, and the European Patent Office. His relentless and painstakingly researched patent oppositions have strengthened access in nearly 50 countries on drugs treating 8 different diseases. His work on HIV alone is estimated to have saved health programs in low income countries over a billion dollars.

More recently, he mobilized global efforts to block the granting of unmerited patent claims on a leading hepatitis C drug. His formidable behind-the-scenes leadership paved the way for an estimated 10 million patients in China to gain access to more affordable generic treatment. Amin’s pioneering work has established a new model for treatment access, one that restores balance to the system by upending the structural power dynamics that allow inequities to persist. He is a former Harvard Medical School Fellow in the Department of Global Health & Social Medicine and was a 2009 TED Fellow. Amin is a frequent speaker on and patent policy and rising drug prices, and has been featured in CNBC, Newsweek, The New York Times, Bloomberg, The Wall Street Journal, and Reuters.

Sameer Awsare, MD

Associate Executive Director, The Permanente Medical Group

Dr. Sameer Awsare is an associate executive director for The Permanente Medical Group (TPMG) where he oversees pharmacy, adult and family medicine, and opioid initiatives, among other operations. In addition to his clinical responsibilities, he is involved in resident teaching and serves as secretary and chair of the governance committee of the Mid-Atlantic Permanente Medical Group Board. Previously, he served as chair of the hospital ethics committee, chief of medicine at TPMGs Campbell medical facilities and held several roles on the TPMG Board of Directors.

Dr. Awsare is a board certified in internal medicine and holds a medical degree from the University of California, Irvine.

Molly Burich, MS

Director, Public Policy: Biosimilars and Reimbursement, Boehringer Ingelheim Pharmaceuticals, Inc.

Molly Burich, MS, is the Director, Public Policy – Biosimilars and Reimbursement at Boehringer Ingelheim, Inc. In her role she leads policy efforts at the federal and state levels impacting the franchises of Boehringer Ingelheim, with specific focus on biosimilars, oncology, pipeline products as well as reimbursement across the existing and pipeline portfolio for Boehringer Ingelheim.

Before joining Boehringer Ingelheim, Ms. Burich was an Associate Director of Mental Health Policy and Advocacy at Otsuka Product Development and Commercialization, Inc. In that role she focused on key mental health advocacy and policy issues at the state level. Prior to this role, Ms. Burich was a Senior Manager, Federal Government Affairs – Reimbursement and Policy at Otsuka. In that role, she focused on reimbursement and policy strategies to ensure patient access to products. Additionally, Ms. Burich focused on the implementation of healthcare reform and health policy strategies as they relate specifically to patient access and reimbursement. Prior to this role, Ms. Burich focused on strategic and operational considerations associated with reimbursement, patient access and patient hub programs within Otsuka.

Ms. Burich was also an Assistant Director for Xcenda, an AmerisourceBergen Consulting Services company based in North Carolina. At Xcenda, Ms. Burich focused on reimbursement and health policy issues as they related to strategic reimbursement planning. Ms. Burich worked in collaboration with reimbursement, brand and managed markets teams across a variety of pharmaceutical and biotechnology clients across numerous disease states including, multiple sclerosis, hemophilia, oncology, mental health and rheumatoid arthritis. Prior to joining Xcenda, Ms. Burich worked for Avalere Health, a health care policy consulting firm based in Washington, DC. In that role, Ms. Burich specialized in reimbursement strategy and product commercialization for new pharmaceuticals and biotechnologies. In addition, she closely monitored ongoing legislative and regulatory changes for pharmaceutical, biotechnology, and medical device companies.

Ms. Burich received a master of science in public service management with an emphasis in public policy from DePaul University and a bachelor of arts in political science from the University of Northern Colorado.

Patrizia Cavazzoni, MD

Deputy Director for Operations, CDER, FDA

Dr. Cavazzoni received her medical degree at McGill University and completed a residency in Psychiatry and a fellowship in mood disorders at the University of Ottawa. She subsequently joined the faculty of medicine at the University of Ottawa as an assistant professor, where she was engaged in clinical work, teaching, and research on genetic predictors of mood disorders, authoring numerous peer-reviewed scientific publications. Following this, Dr. Cavazzoni worked in the pharmaceutical industry for several years, and held senior leadership positions in clinical development, regulatory affairs and safety surveillance.

Dr. Cavazzoni is certified by the American Board of Neurology and Psychiatry, a Fellow of the Canadian Royal College of Physician and Surgeons, a member of the Canadian College of Neuropsychopharmacology and recipient of the American College of Psychiatrists’ Laughlin Fellowship.

SALLY CHOE, PhD

Director, Office of Generic Drugs (OGD), CDER, FDA

Sally Choe, Ph.D., serves as Director of the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research. This office is responsible for the review and approval of Abbreviated New Drug Applications (ANDAs). Its mission is to ensure, through a scientific and regulatory process, that generic drugs are safe and effective for the American public.

From 2006 to 2011, Dr. Choe was leader of the metabolism and endocrinology team in CDER’s Office of Clinical Pharmacology, Office of Translational Sciences (OTS). Between 2011 and 2016, she served as senior director at PAREXEL International Corporation, overseeing the Asia-Pacific region and Japan offices, as well as managing the global Vice President Technical consultant group. Dr. Choe returned to FDA in January 2017 and served as deputy director of the Office of Study Integrity and Surveillance in OTS. With more than 18 years of experience in global drug development, Sally is a recognized expert in drug review, clinical pharmacology, biopharmaceutics, and pharmacokinetics.

She received her undergraduate degree in electrical engineering from Virginia Polytechnic and State University and her master’s and doctoral degrees in pharmaceutics from the University of Michigan.

Hillel P. Cohen, PhD

Executive Director, Scientific Affairs, Sandoz, Inc., A Novartis Division

Dr. Hillel P. Cohen PhD is Executive Director of Scientific Affairs at Sandoz, helping explain the principles of biosimilars and biosimilar policies to the healthcare community, patient advocacy groups, and health authorities. He has published and given presentations in the areas of biosimilar education, switching, interchangeability, naming and safety. Dr. Cohen led Sandoz efforts for the first biosimilar presentation (Zarxio®) to an FDA advisory committee and participated in BsUFA 2 negotiations on behalf of industry. Hillel is active on the Education Committees of biosimilar trade associations, including the Biosimilars Council (a division of the Association for Affordable Medicines) and the Biosimilars Forum.Prior to joining Sandoz he held multiple positions at Novartis Vaccines, including Head of Regulatory Affairs for North and Latin America and well as Head of Global Labeling. Dr. Cohen received a BA from New York University and a PhD in Biology from Dartmouth.

Alonza Cruse

Director, Office of Pharmaceutical Quality Operations
Office of Regulatory Affairs (ORA), CDER, FDA

Alonza Cruse is Director of the Office of Pharmaceutical Quality Operations within the FDA Office of Regulatory Affairs.  His office is responsible for all pharmaceutical inspections, working in conjunction with FDA’s Center for Drug Evaluation & Research and Center for Veterinary Medicine. From 2013-2015 Mr. Cruse served as the Director (Acting) of the Office of Medical Products & Tobacco Operations within ORA. From 2000-2015, Mr. Cruse was the Director of FDA’s Los Angeles District Office. Prior to this Mr. Cruse was Director of New York District Import Operations. Mr. Cruse first joined ORA in 1983 as a microbiologist. He received his Bachelor of Science degree in Medical Technology from York College (City University of New York). 

Chip Davis, Jr., JD

President & CEO, AAM

Chester “Chip” Davis, Jr. is the President and Chief Executive Officer of the Association for Accessible Medicines, the nation’s leading trade association for manufacturers and distributors of generic prescription drugs, manufacturers of bulk active pharmaceutical chemicals and suppliers of other goods and services to the generic drug industry. Appointed to the position by the AAM Board in summer 2015, Chip is responsible for ensuring that the Association fulfills its primary mission, which is to improve the lives of patients and consumers by providing timely access to safe, effective and affordable medicines.

Prior to joining AAM, Chip most recently served as Executive Vice President for Advocacy and Member Relations at the Pharmaceutical Research and Manufacturers of America (PhRMA), where he was responsible for leading PhRMA’s federal, state and international government relations and advocacy efforts, in addition to member company recruitment and retention. Prior to joining PhRMA, he was Vice President of Corporate External Relations for AstraZeneca, where he oversaw the company’s government relations, strategic alliances, community relations and employee volunteer efforts. He was a member of AstraZeneca’s Corporate Affairs Leadership team and Vice-Chairman of the company Political Action Committee. In 2007, Chip was one of the inaugural winners of the AstraZeneca CEO Award, given to global executives who best demonstrate AstraZeneca leadership capabilities in their accomplishments.

Chip earned an undergraduate degree in Accounting from the University of Delaware, and a Juris Doctor from the University of Baltimore School of Law. He is a licensed attorney in Maryland, Virginia and the District of Columbia. He currently serves on the Board of Directors for the Washington, DC area Chapter of Autism Speaks, the University of Delaware Alumni Association, the St. Mary’s High School Royal Blue Club, and the Member Advisory Board for the National Journal.

Charlie DiLiberti

President, Montclair Bioequivalence Services, LLC

Charlie DiLiberti has over 30 years’ experience in the pharmaceutical industry, the majority of which (17 years) were at Barr Laboratories (later acquired by Teva Pharmaceuticals). Charlie built and oversaw Barr’s cutting-edge bioequivalence and pharmacokinetics program for generic drugs, small molecule proprietary drugs, and biologics. Charlie left his position as Vice President of Biopharmaceutics at Teva Women’s Health Research in 2010 to start his own firm, Montclair Bioequivalence Services, LLC, which provides strategic consulting services around the world in generic, innovative, and biological drug development, biostudy planning/risk management, formulation development guidance, and advanced troubleshooting methods, with a focus on difficult/complex products. Charlie has given numerous public presentations, in the US and internationally, on a wide variety of topics, including pharmacokinetics, bioequivalence, BCS waivers, biosimilars, highly variable drugs, narrow therapeutic index drugs, complex drugs, locally-acting drugs, adaptive sequential bioequivalence designs, analytical chemistry, physicochemical characterization of biological products, generic drug development, etc.

Charlie holds a BA in Biochemical Sciences from Princeton University and an MS in Chemistry from Stevens Institute of Technology.

Ronny Gal, PhD

Senior Analyst, Sanford C. Bernstein & Co

Aaron (Ronny) Gal is the Senior Analyst at Bernstein covering Global Specialty Pharmaceuticals. Prior to joining Bernstein in 2004, Ronny spearheaded Canon’s business development in life sciences. He also spent six years with the Boston Consulting Group, advising clients in the pharmaceuticals and healthcare delivery industries. Ronny was awarded a PhD from the Massachusetts Institute of Technology and holds a BSc from Emory University. Ronny has been a top analyst in Institutional Investor’s All-America Research Team survey for the past seven years; ranking either No. 1 or No.2 in his sector.

Scott Gottlieb, MD

Former Commissioner, FDA

Scott Gottlieb, MD is a physician and served as the 23rd Commissioner of the U.S. Food and Drug Administration. Dr. Gottlieb’s work focuses on advancing public health through developing and implementing innovative approaches to improving medical outcomes, reshaping healthcare delivery, and expanding consumer choice and safety.

Dr. Gottlieb is an aggressive advocate for advancing the health of patients, promoting healthcare access, and driving innovation. The agency’s historic and prolific advances in new policy distinguished his tenure as the FDA’s commissioner, in addition to a record-setting number of approvals of novel drugs, medical devices, and generic medicines.

Under his leadership, the FDA advanced new frameworks for the modern and safe and effective oversight of gene therapies, cell based regenerative medicines, targeted drugs, and digital health devices. The agency implemented new reforms to standardize drug reviews and make historic improvements of post market data collection and the use of real world evidence. They promoted policies to reduce death and disease from tobacco, improve food innovation and safety, and aggressively confront addiction crises.

Previously, Dr. Gottlieb served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and before that, as a Senior Adviser to the Administrator of the Centers for Medicare and Medicaid Services, where he helped advance policies to improve healthcare quality and promote the effective use of new medical technologies. A healthcare futurist, he has worked as a venture capitalist and founder and board member to companies that have developed new medicines and advance the delivery of healthcare.

Dr. Gottlieb is widely published in leading medical journals and periodicals, including The Wall Street Journal, The New York Times, and The Washington Post. He has held editorial positions on the British Medical Journal and the Journal of the American Medical Association and appears regularly as a guest commentator on CNBC. Fortune Magazine recognized him as one of the “World’s 50 Greatest Leaders” in 2018 and again in 2019. Modern Healthcare named Dr. Gottlieb as one of the “Most Influential Physician Executive and Leaders” in its annual survey of 50 physician executives, and Time magazine named Gottlieb one of its “50 People Transforming Healthcare in 2018.”

Dr. Gottlieb was a practicing hospitalist and a Clinical Assistant Professor at the New York University School of Medicine. He is a member of the National Academy of Medicine and a Resident Fellow at the American Enterprise Institute in Washington, DC.

Amy Gutierrez, PharmD

Senior Vice President, Chief Pharmacy Officer, Kaiser Permanente National Pharmacy

Dr. Amy Gutierrez is the Senior Vice President and Chief Pharmacy Officer for Kaiser Permanente National Pharmacy Programs and Services. In this role, she oversees pharmacy practice and policy across eight US national regions, including California, Hawaii, Washington, Oregon, Mid-Atlantic States, Colorado, and Georgia service regions. Pharmaceutical contracting, medication safety, pharmacy operations, managed care benefits and overall strategic planning are areas of responsibility. Prior to this position, she served as the Chief Pharmacy Officer for the Los Angeles County Department of Health Services, the second largest public health system in the US.

Dr. Gutierrez obtained her Doctor of Pharmacy degree from the University of Southern California, and completed a California Healthcare Leadership Fellowship in 2005. She is currently an assistant professor of clinical pharmacy at the University Of Southern California, as well as a member of the Dean’s Board of Councilors. From 2012-2018 she served as a governor-appointed board member of the California Board of Pharmacy.

Robert Iser, MS

Vice President, Regulatory & Access, Parexel International

Bob Iser is currently a Vice President in Parexel’s Regulatory & Access Consulting group, providing technical leadership and expertise including development of global regulatory strategies on behalf of clients interfacing with Regulatory Agencies and through leading a team of global regulatory experts. 

Prior to joining Parexel, Bob spent 14 years with the U.S. FDA (most recently as the Director of the Office of Process and Facilities in CDER) with experience in CMC review, pre-approval inspections, CGMPs, guidance & policy development, and training.   

Before joining FDA, Bob worked for seven years in the biopharmaceutical industry. 

Timothy J. Keeler, JD

Partner, Mayer Brown LLP

Timothy J. Keeler is a partner in the Government and International Trade Group at Mayer Brown LLP. Tim previously served as the Chief of Staff of the Office of the U.S. Trade Representative, as a senior official at the US Treasury Department, and on the international trade staff of the Senate Finance Committee. Tim provides legal and strategic advice to clients on matters including the consistency of various legal regimes with World Trade Organization (WTO) rules and other international legal obligations; Committee on Foreign Investment in the U.S. (CFIUS) filings on proposed transactions of foreign investment; international trade negotiations in the WTO and bilateral or regional fora; WTO and other international trade agreement litigation; international economic, political, and legal events and actions that effect businesses and investors; the U.S. economic decision making process in the Administration and Congress; the political climate in various countries that are pertinent to clients’ business activities; and advocacy on behalf of clients to the U.S. government and to foreign governments. Tim is also an adjunct professor at the Georgetown University School of Law, co-teaching a course on U.S. and WTO law, policy, and politics, and is a Director on the Board of the Washington International Trade Association (WITA).

Jonathan Kimball

Vice President, Trade & International Affairs, AAM

Jonathan Kimball is the Vice President of Trade and International Affairs at the Association for Accessible Medicines (AAM). He serves as senior strategist and advocate in partnership with the SVP, General Counsel, to direct the international trade strategy of AAM and represent the association and its member companies’ interests before the U.S. Trade Representative, the Department of Commerce, Congress, The White House and other stakeholders. He identifies public policy priorities and implements strategies to advance AAM’s trade and international affairs agenda.

Before joining AAM in February 2019, Jonathan was Managing Director, Healthcare Policy at Burson Cohn & Wolfe (formerly Burson-Marsteller). In this role he collaborated with pharmaceutical companies, medical device companies, trade associations and other clients to develop public affairs and advocacy campaigns aimed at influencing the policy and regulatory environments in the United States and international markets. Previously he was Deputy Vice President at Pharmaceutical Research and Manufacturers of America (PhRMA), for which he developed and advanced external advocacy and communication efforts in partnership with senior U.S. and foreign government officials, Congressional staff, patient organizations and other trade associations.

Jonathan’s earlier career took him to Budapest, Hungary, for Freedom House and other NGOs. He earned a master’s degree in International Affairs/International Political Economy from American University and a BA from San Francisco State University.

Andrew Kish, MSPPM

Office Director, Office of Program and Strategic Analysis (OPSA), CDER, FDA

Andrew is the Director of the Office of Strategic Programs and Analysis (OPSA) in the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA). Andrew oversees projects that span the application of economics, program evaluation, decision science, operations research, and policy analysis focused on enhancing the policy and operational decision making and performance of CDER. Andrew has served as a lead negotiator for the Agency in multiple user fee negotiations with regulated industry over the past eight years, including PDUFA V and VI and BsUFA I and II.

Andrew has a Master of Science in Public Policy and Management from Carnegie Mellon University.

Michael Kopcha, PhD, RPh

Director, Office of Pharmaceutical Quality (OPQ), CDER, FDA

Michael Kopcha, Ph.D., R.Ph. is the Director of the FDA’s Office of Pharmaceutical Quality (OPQ). This office has over 1,300 staff responsible for assuring the availability of quality medicines for the American public through assessment, inspection, surveillance, research, and policy. OPQ contributes to the assessment of nearly every type of human drug marketing application including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs), including 351(k) applications (i.e., biosimilars). OPQ also performs the quality assessment of Investigational New Drug Applications (INDs) and establishes quality standards for over-the-counter drug products and facilities.

Prior to joining the FDA, Dr. Kopcha amassed more than 25 years of experience in major and mid-sized innovator, generic, drug/device, and over-the counter (OTC) pharmaceutical and consumer health companies. He developed expertise in areas including formulation and process development, product scale-up, process validation, technology transfer, project management, change management, and off-shoring/outsourcing. Dr. Kopcha most recently served as Vice President, and global research and development franchise head, for cough, cold, and respiratory products at Novartis Consumer Health, Inc.

Dr. Kopcha earned his doctorate and master’s degrees in pharmaceutical science, and a bachelor’s degree in pharmacy from Rutgers University. He also served as an adjunct assistant professor in the Department of Pharmaceutics at Ernest Mario School of Pharmacy at Rutgers.

Suzette Kox, M.Sc., Pharm.

Secretary General, IGBA

Suzette Kox has been nominated Secretary General of the International Generic and Biosimilar Medicines Association, after 17 years in various functions at Medicines for Europe.
Suzette is very committed to support IGBA, which is at the forefront of preserving sustainable competition within the generic and biosimilar medicines industry, by stimulating competitiveness and innovation in the pharmaceutical sector; thereby, ensuring millions of patients around the world have access to high quality medicines.

Kiran Krishnan, PhD

Senior Vice President, Global Regulatory Affairs, Apotex Inc.

Kiran began his career at Apotex in 2006, holding roles of increasing responsibility within Global Regulatory Affairs. Today, he is responsible for overseeing the global regulatory function for Apotex. In addition to creating and executing the company’s global regulatory strategy, he also manages a worldwide team of regulatory professionals.

Dr. Krishnan has more than 18 years of regulatory experience in the generic pharmaceutical industry, integrating regulatory strategy into drug development. He was part of the American Association for Accessible Medicines (AAM) team that actively engaged with the US FDA to develop the commitment letter to support the Generic Drug User Fee Act II. Dr. Krishnan has a Master’s degree in Pharmacy with a specialization in Industrial Pharmacy and a PhD in Pharmacy.

Chad Landmon

Partner, Axinn, Veltrop & Harkrider LLP

Chad Landmon is a partner at Axinn, Veltrop & Harkrider LLP, where he chairs the FDA and IP Practice Groups. Chad has nearly 20 years of experience in food and drug law and patent litigation and counseling. He has served as lead trial counsel in high stakes patent and FDA litigation throughout the United States, handling over 50 cases in numerous federal district and appellate courts, involving products with over $100 billion in sales. His practice involves client counseling and petitioning FDA and litigating issues relating to the Biologics Price Competition and Innovation Act (BPCIA), including the requirements for the demonstration of biosimilarity and the patent resolution provisions, and issues relating to the Hatch-Waxman Act, including marketing exclusivities, patent listing, certification and notification requirements, bioequivalence, labeling, and other issues. Chad’s practice also includes matters involving the intersection of the antitrust and patent laws, such as issues arising from the settlement of patent and FDA exclusivity disputes.

Robert Lionberger, PhD

Director, Office of Research Standard (ORS), Office of Generic Drugs (OGD), CDER, FDA

Robert Lionberger, Ph.D. serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads OGD’s implementation of the GDUFA science and research commitments including internal research activities and external research grants and collaborations to ensure the therapeutic equivalence of generic drug products. ORS also provides pre-submission advice on complex generics through pre-ANDA meetings, product specific guidance and correspondence responses.

He received his undergraduate degree from Stanford University in Chemical Engineering, and a PhD from Princeton University in Chemical Engineering. After his Ph.D., he conducted post-doctoral research in Australia in the Department of Mathematics and Statistics at the University of Melbourne. Prior to joining the FDA 15 years ago, he was an Assistant Professor of Chemical Engineering at the University of Michigan.

Rosario Lobrutto, PhD

Head of Scientific Affairs, Sandoz, Inc. (A Novartis Division)

Rosario has over 20+ years of experience in driving R&D, commercial, and operational excellence through business acumen and scientific leadership with roles of increasing responsibility in development, scale-up, transfer, and launch preparation of generic, complex generic and branded products as well as products following a 505b2 regulatory pathway at Merck, Novartis, TEVA and Sandoz.   This includes development of active pharmaceutical ingredients and drug products including small molecules, synthetic polypeptides and proteins in various dosage forms (Parenterals, solid oral dosage forms, transdermals, films, etc) and drug-device combination products for a wide gamut of therapeutic areas.

Currently at Sandoz Rosario is Head of Scientific Affairs based in Princeton, NJ responsible for external partnership product development (NDAs, 505(b)(2)s, and ANDAs).  Rosario oversees technical due diligence evaluating CMC and bio-analytical aspects of new product opportunities amenable to co-development, in-licensing or acquisition.  Moreover, he advances pipeline strategy and leads team for identification, evaluation and prioritization of internal/external assets and robust tuneable technology platforms.

Prior to joining Sandoz, Rosario worked at TEVA Pharmaceuticals as Site Head / Head of Development for Sterile Products in Pomona, New York. He also worked at Novartis as global project leader for API/drug product, Global Quality by Design Network Leader, and led various global teams: QbD training, Specification Setting Strategy and Regulatory CMC team focused on streamlining CMC processes for small molecules/ biologics development projects. In addition, he worked at Merck Research Laboratories API Division supporting the development of synthetic pathways and scale-up of chemical processes for early- to late-stage drug candidates.

Recognized for scientific innovation: 35 research publications, 100+ presentations, and book contributions on formulation, analytical and physical chemistry, process analytical technology (PAT), Quality by Design (QbD), and other topics. Co-Editor (Book): HPLC for Pharmaceutical Scientists.

Markham C. Luke, MD, PhD

Director, Division of Therapeutic Performance and Supervisory Physician
Office of Research and Standards, OGD, CDER, FDA

Since 2016, Markham serves as the Director of the Division of Therapeutic Performance in the Office of Research and Standards at FDA’s Office of Generic Drugs and FDA Supervisory Physician. The Division of Therapeutic Performance is responsible for facilitating pre-application development of generic drugs by conducting and promoting regulatory science research to establish standards, including Product Specific Guidances, to ensure therapeutic equivalence of new generic drug products. Markham has been at the FDA for 21 years.

Markham has research interests in the pharmacology of complex drugs (including dermato-pharmacology), clinical study design and endpoints assessment (including patient-reported outcomes) for medical, surgical, and aesthetic products. Markham is a strong advocate for drug access and medical product development for rare diseases and special populations. In addition, Markham serves in the role of consultant dermatologist to various parts of FDA. Markham was born and raised in New York City, attended Stuyvesant HS, and majored in Biochemistry at New York University. He obtained his MD and PhD, Pharmacology, degrees at Johns Hopkins University. Markham interned at Hopkins in Internal Medicine and was a dermatology resident at Washington University/Barnes Hospital, St. Louis, Missouri. He served as PHS Fellow and Clinical Associate for Dermatology at the National Cancer Institute, NIH, beginning in 1997, and as a PHS Medical Officer at FDA, CDER’s Office of New Drugs. In 2001, he was selected as Lead Medical Officer for dermatology at FDA. Markham served as attending dermatologist at Bethesda National Naval Medical Center (now the Walter Reed Medical Center – WRMC), is currently an Associate Professor at the Uniformed Services University of the Health Sciences. From 2008 to 2016, Markham served as the Chief Medical Officer and Deputy Office Director in FDA’s Office of Device Evaluation (ODE) in CDRH, where he was responsible for clinical oversight of the medical device evaluation process, evaluating and overhauling the Advisory Committee process. He was also the Center liaison for Emergency Preparedness and senior champion for appropriate regulation of UV indoor tanning devices.

Carol Lynch

President, Head of North America, Sandoz US

Carol Lynch was appointed President, Sandoz US, Head of North America in March 2018. In this role, Carol leads Sandoz’ largest commercial and country organization – the United States – which is responsible for over 35% of Sandoz’ global revenue. Carol also oversees Sandoz’ commercial operations in Canada. She continues as a member of the Sandoz Executive Committee, having sat on Sandoz’ global governance body since her prior role, and is a board member of the Association for Accessible Medicines (AAM) in the US.

Prior to this, Carol was the Global Head of Biopharmaceuticals at Sandoz, responsible for the development, manufacturing and commercialization of biosimilars, including its contract manufacturing. In her four years in this role, Carol grew the biopharma business reaching 1bn USD in sales annually, and delivered a portfolio with five biosimilar approvals. Under Carol’s leadership, Sandoz achieved the first approval and launch of a biosimilar in the US, and last year saw the launch of the next wave of biosimilars in the EU. With the recent announcement of the collaboration with Biocon, Carol leaves the biopharma team with the promise of continual replenishment of our pipeline. Carol also operated as the Chair of the Biosimilar Medicines Group, a Medicines for Europe sector group, and will continue to do so until her committed term is over.

Carol has more than 25 years of global pharmaceutical and generics industry experience. Prior to joining Sandoz in 2014, Carol held several Commercial and Development leadership positions in Novartis Pharmaceuticals both globally and in country organizations, including the United States.

Brian McCormick

Vice President and Chief Regulatory Counsel, Teva Pharmaceuticals

Brian McCormick is Vice President and Chief Regulatory Counsel for Teva Pharmaceuticals. Brian and his team provide regulatory law, intelligence, and policy advice to Teva’s specialty, generic, biologic, and biosimilar businesses. They counsel clients on a wide range of FDA regulatory matters through all phases of the product lifecycle, and provide strategic advice on the Hatch Waxman Act, the Biologics Price Competition and Innovation Act, the Orphan Drug Act, the Best Pharmaceuticals for Children Act, and other laws. His team provides global regulatory intelligence and R&D transactional support, oversees the development of approved and promotional labeling, and represents Teva in various trade associations. Previously, Brian was an Assistant General Counsel at GSK and a Partner in the FDA regulatory group of Hogan Lovells LLP. Brian earned his law degree from Georgetown and has a master’s degree in health policy from Johns Hopkins and a bachelor’s degree in government from Franklin & Marshall College.

Clark Packard, Esq

Trade Policy Counsel, Finance Insurance & Trade, R Street Institute

Clark Packard researches and writes about international trade and investment policy, and does outreach work for the Finance, Insurance & Trade team at R Street.

Clark joined R Street from the National Taxpayers Union, where he spearheaded the organization’s work on trade and financial services policy and provided legal counsel to the organization’s senior officers.

Previously, he was an attorney and policy adviser for former South Carolina Gov. Nikki Haley. Earlier in his career, Clark worked in private practice, where he advised financial services companies on federal and state financial regulation. During law school and shortly thereafter, he worked as a budget and policy adviser to then-South Carolina Gov. Mark Sanford.

He holds a bachelor’s degree in political science from the University of Dayton and is a graduate of the University of South Carolina School of Law. Clark is a member of the South Carolina bar.

Sang-Jin Pak, MD, MSc

Senior Vice President and Head of Commercial Division

Dr. Sang-Jin Pak is a Senior Vice President of Commercial Division at Samsung Bioepis. He is a medical doctor with more than 20 years of experience in healthcare and pharmaceutical industry, patient care, marketing and sales, strategic planning, talent management and organizational development, sales force excellence and new product launches.

Dr. Pak has proven track record of leading global, regional and local strategy development and implementation with cross-functional and cross-cultural teams.

Prior to joining Samsung Bioepis, Dr. Pak served as a General Manager of GlaxoSmithKline (GSK) Germany from 2013 to 2018 and Country President of AstraZeneca Korea 2010 to 2013.

Sang-Jin is fluent in three languages (German, English and Korean) with extensive overseas experience across three continents.

Donal Parks, MBA, MPM

Division Director, Division of User Fee Management and Budget Formulation (DUFMBF), Office of Management (OM), CDER, FDA

Donal Parks works for CDER’s Office of Management, where he oversees the collection of revenue from the PDUFA, GDUFA, BsUFA, and pharmacy compounding user fee programs. His division also prepares CDER’s annual budget request to Congress.

Ronald T. Piervincenzi, PhD

Chief Executive Officer, United States Pharmacopeial Convention

Ronald T. Piervincenzi, Ph.D., has served as Chief Executive Officer of the United States Pharmacopeia since February 2014. Dr. Piervincenzi provides strategic leadership to USP’s global staff of over 1,400 across 10 global sites. His transformative vision has launched key USP initiatives in bringing quality across the healthcare spectrum, upholding USP’s reputation as a quality leader since its founding in 1820. Under his leadership, USP has modernized its operations and launched innovative new science, including in the areas of digital medicine, cutting-edge manufacturing technologies and advanced biologics. USP is also better connecting to its stakeholders and customers through new initiatives including the Hyderabad Training Institute in India, the Quality Institute, and USP’s new Impurities for Development service. Dr. Piervincenzi served as Chair of the Council of Experts, USP’s scientific standards-setting body of 24 Expert Committees and over 750 standards-setting experts until June 2015, when he transferred this responsibility to USP’s new Chief Science Officer.

Dr. Piervincenzi brings more than 20 years of industry experience across pharmaceutical sciences, research and business strategy. Before joining USP, Dr. Piervincenzi served as Vice President of Development Sciences with Biogen Idec, Inc., where he designed and launched Biogen’s value-based medicine group. Dr. Piervincenzi was a partner and leader in McKinsey & Company’s global pharmaceutical and medical products practice for over 12 years. Dr. Piervincenzi earned his M.S. and Ph.D. from Duke University in Biomedical Engineering, with research focused on protein engineering. He is the proud co-founder and chairman of the board for the Newark Mentoring Movement.

Robert W. Pollock, RPh, MS

Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.

Bob retired from Lachman Consultants at the end of 2012 as Executive Vice President and is currently Senior Advisor and Outside Director to the Board at Lachman where he provides support and counsel to the Lachman regulatory team and other Lachman practice areas and provides regulatory services for the industry. In addition, in July of 2014 he accepted the position of President and Chief Scientific Officer of Melbourne Laboratories, a drug development firm. Formerly, Mr. Pollock was the Acting Deputy Director of the Office of Generic Drugs (OGD), Center for Drug Evaluation and Research, Food and Drug Administration. Bob was in the generic drugs program shortly after the passage of the Drug Price Competition and Patent Term Restoration Act (Waxman-Hatch Act). Prior to transferring to the FDA in 1985, he held various field and headquarters assignments with the Health Resources and Services Administration of the Public Health Service. He retired from the PHS in January 1995 with over 20 years of service at the rank of Captain. Mr. Pollock received his B.S. degree in pharmacy and his M.S degree in pharmacy administration at the University of Rhode Island where he studied as a Fellow of the American Foundation for Pharmaceutical Education. Mr. Pollock has numerous publications and presents extensively on the drug approval process as well as issues regarding strategic alliances.

Juliana Reed

Vice President, Corporate Affairs Lead – Immunology, Inflammation (I & I) and Biosimilars, Pfizer, Inc.

Juliana Reed is the Vice President, Corporate Affairs, for the Pfizer global Immunology, Inflammation and Biosimilars business. Ms. Reed has been engaged in global biosimilar policy for over 15 years through her current position as well as her previous work as Vice President of Global Government Affairs for Hospira, Inc. Ms. Reed has direct pre and post approval market experience in multiple countries across at least 9 biosimilars on the market today. She is an internationally recognized expert on biosimilars.

In addition to her corporate positions, Ms. Reed has previously served on the board of the Generic Drug Association (GPhA/AAM) in the US, the board of Medicines for Europe, and was a co-founder of the US Biosimilars Forum where she is currently serving as the Forum’s President for the 5 of the past 6 years.

Jonathan Resnick

Project Management Officer, OBI, OSP, CDER, FDA

Jonathan Resnick is a member of CDER’s Electronic Submissions Team, with a focus on eCTD and has been with FDA for eight years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.

Gautier Sala, PharmD

Executive Director, US Head Biopharmaceuticals Regulatory Affairs, Sandoz Inc. (A Novartis Division)

Gautier Sala is the Executive Director heading the Sandoz US Biopharmaceutical Regulatory Affairs team in Princeton, NJ . His team is responsible for the management of Sandoz biosimilars’ portfolio from early development, through registration and post approval activities. He has also been actively involved in US regulatory affairs policy matters and comments to FDA draft and final guidance documents, in particular through his participation to Industry Trade Association including the Biosimilar Forum where he acts as the Chair the Regulatory Committee and the Association for Accessible Medicine (AAM).

Prior to joining Sandoz, Gautier held roles of increasing responsibilities for over 10 years in Novartis Pharma Global Regulatory Affairs in Basel, Switzerland. He led the global regulatory strategy for the development and registration of key small molecule and biological assets across a various therapeutic areas (cardiovascular and metabolism, neurosciences, immunology). He also served as Head RA Global Drug Development Strategic Affairs & Communication with responsibilities over portfolio transfers and organizational design & change management. Gautier holds a Pharmacy Degree from the Pharmacy School of Strasbourg (France).

Paul Schwartz, PhD

Director, Division of Post -Marketing Activities II, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, CDER, FDA

Dr. Schwartz received a Ph.D. in chemistry from the City University of New York. He did post-doctoral research in the Biophysics Department of Michigan State University in the area of anticancer cisplatin drugs. He continued research in this field on a National Cancer Institute contract with the pharmacology department at Veterans Administration Medical Center in Charleston, South Carolina. His work led to a number of patents and publications and he was presented with the Inventors Award for Federal scientists by the Department of Commerce. In 1990, Dr. Schwartz joined the Office of Generic Drugs as a CMC reviewer and has served as Branch Chief, Deputy Division, and Division Director in OGD and now in OPQ. Dr. Schwartz was the manager of the manufacturing research component of a University of Maryland School of Pharmacy contract with FDA to identify critical manufacturing variables. On the International level, Dr. Schwartz was CDER’s expert at meetings in South Africa and Botswana to help initiate the PEPFAR program and was a lecturer at an International Generic Pharmaceutical Alliance in Mumbai, India. Recently, Dr. Schwartz represented OLDP at meetings in Australia with the TGA and in Canada with Health Canada to discuss common regulatory issues.

Dr. Schwartz was an FDA representative on the USP expert Committee on General Chapters-Dosage forms from 2010-2015.

Edward “Ted” Sherwood, MA

Director, Office of Regulatory Operations, OGD, CDER, FDA

Ted Sherwood returned to the Office of Generic Drugs (OGD) to serve as the Director, Office of Regulatory Operations (ORO). ORO consists of four different divisions: the Division of Project Management, the Division of Filing Review, the Division of Labeling Review, and the Division of Quality Management Systems. Previously, he served as the Associate Director of Immediate Office Operations, Office of Pharmaceutical Science [now the Office of Pharmaceutical Quality (OPQ)]. Prior to joining OPQ in 1999, he spent a dozen years in OGD. He held various positions including, reviewing new submissions for determination of fileability, conducting program analyses, and coordinating congressional activities. Ted received his bachelor’s degree from the University of Maryland in 1992.

Aloka Srinivasan, PhD

Vice President, Regulatory Practice, Lachman Consultant Services, Inc.

Aloka Srinivasan, Ph.D. is Vice President, Regulatory Practice at Lachman Consultants who brings more than two decades of experience in the pharmaceutical industry, including nine years of progressive experience with the U.S. FDA’s Office of Generic Drugs. Prior to FDA, Dr. Srinivasan was a Senior Scientist at National Cancer Institute working on nitrosamines and nitric oxide donors. Prior to joining Lachman, Dr. Srinivasan was the Vice Regulatory Affairs at Lupin Pharm. Inc.  At FDA, Dr. Srinivasan was part of the team that developed the QbR-QOS at Office of Generic Drugs and a significant contributor to the examples related to QbR in the FDA website. Dr. Srinivasan also spearheaded the establishment of a DMF review division at CDER based on GDUFA I and was the primary author of the Completeness Assessments for Type II API DMFs under GDUFA. Dr. Srinivasan has presented and published FDA’s and industry’s perspective related to generic review process on several occasions. Currently, Dr. Srinivasan is the representative of International Generics and Biosimilar Medicines Association (IGBA) in ICH Q11 Q&A Implementation Working Group (IWGI). Dr. Srinivasan champions the regulatory efforts of the generic industry based on her experience and knowledge of U.S. regulatory requirements.  Dr. Srinivasan holds a Ph.D. in Chemistry from University of Missouri.

Scott D. Tomsky

Vice President, Regulatory Affairs, Generics, North America, TEVA

Scott D. Tomsky is currently Vice President, Regulatory Affairs, Generics, North America for TEVA and is based in Horsham, Pa.

Prior to joining Teva, the world’s leading provider of generic medicines in July 2013, Scott worked for Ranbaxy in Princeton, NJ for nearly 12 years.  While at Ranbaxy Scott held several positions in RA and when he left he was head of Regulatory Affairs and Pharmacovigilance for North America.   Scott has also worked at Johnson & Johnson in Regulatory Affairs at McNeil, and over his 20 years in the industry has also held positions in R&D and Quality.

His regulatory experience includes filings and strategy for DMFs, ANDAs, and NDAs.  He has experience with many dosage forms including steriles, solids, liquids, transdermals, inhalation products, and drug-device combination products.  In addition, Scott has worked closely with cross functional teams on compliance matters, as well as pharmacovigilance activities.

Scott has been actively involved in AAM and served on the AAM GDUFA II negotiating team. He also remains closely involved with GDUFA II implementation as a member of the AAM implementation team.  He holds a B.S. in Biology and a Minor in Chemistry from Trenton State College in NJ and a M.S. in Quality Assurance and Regulatory Affairs from Temple University.

Siva Vaithiyalingam, PhD

Vice President of Regulatory Affairs, Cipla LTD

Siva Vaithiyalingam is Vice President of Regulatory Affairs, Cipla LTD. He is responsible for both Generic and New Drugs at Cipla. He served at Barr Labs, BMS, Teva and FDA, at various capacities. His expertise includes Technical, Regulatory and Quality aspects of drug development, approval and life cycle management. He graduated with a master’s degree in Pharmaceutical Sciences from Institute of Technology, BHU and PhD in Pharmaceutical Sciences from Texas Tech University Health Sciences Center.

Jeff Watson

President & Chief Executive Officer, Apotex Inc.

Jeff is President & Chief Executive Officer (CEO) of Apotex. Appointed in 2018, Jeff oversees the day-to-day operations of Apotex, including research and development, manufacturing, packaging and distribution of products across three Lines of Business to more than 115 countries around the globe.

Prior to this role, Jeff served as President & Chief Operating Officer, Apotex, as well as President, Global Generics, the largest line of business at Apotex, where he provided leadership for the Commercial and Strategic Operations and was instrumental in delivering significant growth. A 25-year veteran of Apotex, Jeff has held progressively senior positions with Sales and Marketing since 1993 when he joined the company.

Before joining Apotex, Jeff spent time working in the retail pharmacy sector for Shoppers Drug Mart, Canada’s leading pharmacy chain.

Jeff has been a member of the Association for Accessible Medicines (AAM) Board of Directors since 2012 and served as Chair in 2017. He was re-elected as Chair in 2018. In 2008 he became an Executive Member of the Canadian Generic Pharmaceutical Association’s (CGPA) board. From March 2015-February 2017, he served as Chair of CGPA’s board following three years of service as Vice Chair. Jeff is a former Chair of the US Healthcare Distribution Alliance’s (HDA) knowledge partner, the HDA Research Foundation. He is also the Chair of the Board of Directors for TruLeaf Sustainable Agriculture, Nova Scotia, Canada.

Billie Wiltison, MS

Consultant, Wiltison Regulatory Consulting

Billie Wiltison is a regulatory affairs professional with over 18 years of industry experience. Extensive experience with Chemistry, Manufacturing, and Controls for US and Global submissions. Experience in managing Regulatory projects, including strategy, project planning, and implementation. M.S. Regulatory Science from the University of Southern California. Currently an independent consultant. Previous positions include Sr. Director RA for Impax Laboratories, Sr. Consultant for Parexel, and Associate Director Special Projects for Mylan Pharmaceuticals.

Geoffrey Wu, PhD, PMP, CPH

Associate Director, OLDP, OPQ, CDER, FDA

Commander Geoffrey Wu, Ph.D., PMP, CPH, is a scientist officer in the United States Public Health Service. He is currently the Associate Director for Science and Communication, and a Supervisor for the Immediate Office Review Staff in the Office of Lifecycle Drug Products (OLDP), Office of Pharmaceutical Quality (OPQ). Geoff has been deeply involved, leading or co-leading regulatory review and research for controlled correspondence, ANDAs, and supplemental ANDAs and NDAs in the past eight years. Between 2013 and 2017, he served on the OPQ Emerging Technology Team (ETT). Also he is a core member in multiple policy development efforts, such as emerging technology, continuous manufacturing, and comparability protocols.

Geoff has training and education in pharmacy, pharmaceutical science, protein chemistry, polymer chemistry, and process analytical technology. His professional specialization is mainly in product design, manufacturing and process analytical technology. He has more than 20 peer reviewed publications, and has been invited to multiple national and international conferences to present or discuss the above related topics. Geoff holds a Ph.D. degree in Pharmaceutics and Pharmaceutical Chemistry, M.S. degree in pharmaceutics, and B.S. degree in pharmacy.

Sarah Yim, MD

Director of the Office of Therapeutic Biologics and Biosimilars, CDER’s Office of New Drugs (OND), FDA

Sarah Yim, M.D. is the acting Director of the Office of Therapeutic Biologics and Biosimilars, in CDER’s Office of New Drugs (OND), FDA. Prior to that, she spent 2 years as Director of the Division of Clinical Review in the Office of Generic Drugs, and 11 years in various roles in rheumatology drug review in OND. She received her undergraduate degree from Stanford University, her Doctor of Medicine degree from the Uniformed Services University of Health Sciences, and completed a postdoctoral fellowship in rheumatology at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), at the National Institutes of Health.