pharmaceutical managed markets summit
pharmaceutical managed markets summit
pharmaceutical managed markets summit
pharmaceutical managed markets summit
pharmaceutical managed markets summit
pharmaceutical managed markets summit



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Preconference | Day 1


Agenda: Day II
Thursday, June 9, 2016
7:30 am Registration Commences/Networking Breakfast
MORNING TRACK SESSIONS
TRACKS GROUP I (Choose one of the following Tracks)
TRACK A: 340B PROGRAM CONSIDERATIONS
8:00 am

Welcome, Introductions, Panel Discussions and Q&A

Anthony Greco, MBA
Director, Pharmaceutical & Life Sciences Advisory Services, PwC, Philadelphia, PA

    Speaker Bio

    Anthony S. Greco is a Director in the Advisory practice. He is a member of Pharmaceutical & Life Sciences sector with a focus on Governance Risk and Compliance with over 15 years of experience. He provides financial and business advice in connection with complex compliance and regulatory issues.
Ray Schroeder, MBA
Director, Pharmaceutical & Life Sciences Advisory Services, PwC, New York, NY

    Speaker Bio

    Ray is a Director within PwC's Pharmaceutical and Life Science practice with over 15 years of experience in providing consulting services in the Healthcare and IT space. Prior to coming to the firm Ray spent five years developing business intelligence and reporting & visualization analytical tools. For the past 10 years he has focused on Health Industries client projects spanning data assurance, data management consulting, business intelligence, data analytics, and process improvement. Ray was the Director on the team which performed the first manufacturer led OPA approved audit of a Covered entity. He continues to lead multiple reviews of other Covered Entities and provide compliance services to Covered Entities directly.

    Ray has worked with many of the top 50 Health Industries companies where he led audit and consulting engagements in various different capacities. Ray has expertise in developing solutions that leverage customized data analytics, advanced reporting initiatives, and process and compliance improvement programs.
Aaron Vandervelde, MBA
Managing Director, Berkeley Research Group, Washington, DC

    Speaker Bio

    Aaron Vandervelde is a Washington, DC based Managing Director in BRG's healthcare practice. His practice focuses on deriving strategic insight through the integration and analysis of large, complex data sets including claims data, internal and external sales data, and publicly available health data. Aaron is a nationally recognized expert on the 340B program and has broad experience working with all types of 340B stakeholders including pharmaceutical manufacturers, health insurers, covered entities, contract pharmacies, and TPAs.
    Presentation Material (Acrobat)
9:00 am Transition Break

TRACK B: REAL WORLD EVIDENCE AND IMPLICATIONS TO VALUE-BASED CONTRACTING
8:00 am

Welcome, Introductions, Panel Discussions and Q&A

BJ D'Avella, MBA
Senior Director, Huron Consulting Group, New York, NY

    Speaker Bio

    BJ D'Avella has worked with global life sciences companies for over 12 years in the areas of regulatory compliance and compliance-focused business operations improvement, and has experience in the design and deployment of RWE studies. BJ has a keen understanding of the challenges facing clients in operations, data analytics, and support functions, as well as in Commercial, Medical, and R&D operations; he has leveraged this understanding to deliver performance improvement, results, and improved regulatory compliance to his clients.
    Presentation Material (Acrobat)
Susan Lee, Esq.
Partner, Hogan Lovells LLP, Washington, DC

    Speaker Bio

    Susan Lee is a partner in the Washington, DC office of Hogan Lovells. She advises established and emerging pharmaceutical and biotechnology companies on a broad range of FDA legal and regulatory matters, with particular areas of expertise in advertising and promotion issues; interactions with healthcare professionals; approval standards; and FDA considerations that arise in the context of acquisitions, collaborations, licensing arrangements, and other transactions in the life sciences sector. Prior to practicing law, Susan was a consultant and manager in the life sciences practice of a leading strategic consulting firm and a vice president at a D.C.-based policy institute.
Mark DeWyngaert, MBA, PhD
Managing Director, Huron Life Sciences, New York, NY (Moderator)

    Speaker Bio

    Mark is a Managing Director in Huron's Life Sciences. He has provided operational, clinical, managerial, consulting, and litigation services to various segments of the healthcare industry. Mark trained as molecular biologist and has ben actively involved in both research and business development roles for over 30 years. Mark specializes in assisting pharmaceutical manufacturers, biotechnology, and medical device companies with identifying and mitigating regulatory risks and valuing intellectual property.
9:00 am Transition Break

TRACKS GROUP II (Choose one of the following Tracks)
TRACK C: INDICATION-SPECIFIC PRICING -- THE GOOD, THE BAD AND THE UGLY
9:15 am Welcome, Introductions, Panel Discussions and Q&A
Susan Asante-Abedi, MS
Senior Principal, IMS Consulting Group, New York, NY

    Speaker Bio

    Susan is a senior principal in the IMS Consulting Group where she focuses predominantly on pricing and market access strategy for new pharmaceutical products and medical devices. Susan has been working with IMS Consulting Group for more than 11 years collaborating with clients to develop pricing and market access strategies.

    Her experience developing payer strategies extends across numerous therapeutic areas with particular focus on specialty products and oncology. Susan has global and US expertise with launch pricing, innovative pricing, contracting, and value communications strategy.

    Susan recently published "Defining Value: The Payer Perspective" in Pharmaceutical Executive - a thought piece that provides an overview of how we can use a broader understanding of stakeholders' differing definitions of value to support new commercial engagement approaches.

    Prior to IMSCG, Susan worked for two boutique consulting firms and spent time at Pfizer. Susan has an MS from the Harvard School of Public Health and a BA in Chemistry.
    Presentation Material (Acrobat)
10:15 am Transition Break

TRACK D: LEGAL AND REGULATORY CHALLENGES REGARDING RISK-SHARING ARRANGEMENTS IN THE JOURNEY TO VALUE-BASED CARE
9:15 am

Welcome, Introductions, Panel Discussions and Q&A

Vasiliki Kalaitzidis, Esq.
Associate General Counsel, Managed Markets and Operations, EMD Serono, Rockland, MA

    Speaker Bio

    EXPERIENCE
    Vasiliki (Viki) Kalaitzidis serves as Associate General Counsel at EMD Serono managing the team responsible for providing legal support to the Managed Markets organization (including support for all managed care contracting), as well as legal support for all commercial operations of EMD Serono (including the Human Resources function). From 2009-2014, Ms. Kalaitzidis was Clinical/Medical Affairs Counsel, and then Senior Counsel, providing support to the Development and Medical organizations, including Global Clinical Development, Clinical Operations, Clinical Trial Management, Medical Affairs, Medical Operations, US Medical Information, US Drug Safety, Quality Assurance and Regulatory. In August 2014, Ms. Kalaitzidis was promoted to her current position of Associate General Counsel Managed Markets and Commercial Operations. Ms. Kalaitzidis joined EMD Serono in February 2009.

    Prior to EMD Serono, Ms. Kalaitzidis worked at Nixon Peabody LLP, an international law firm, where she focused her practice on clinical trials and FDA, HIPAA and regulatory compliance for health care, pharmaceutical, medical device, and biotechnology companies, as well as mergers, acquisitions, private equity and venture capital transactions both within and outside the pharmaceutical industry.

    In 2011, Ms. Kalaitzidis was recognized by Massachusetts Lawyers Weekly as a Top Woman of Law for her dedication to the mission of the Women's Bar Association, where for 10 years she served as a member of the WBA Board of Directors and/or Chaired a number of the WBA's many Committees (most recently the In-House Counsel Committee).

    Ms. Kalaitzidis is admitted to practice in Massachusetts.

    EDUCATION
    JD, Suffolk University Law School (1999, cum laude)

    BA, Major in International Relations, Minor in French, Boston University, Boston, MA (1995, cum laude)
    Presentation Material (Acrobat)
Stephen Paul Mahinka, Esq.
Partner, Morgan, Lewis & Bockius LLP, Washington, DC

    Speaker Bio

    Stephen Paul Mahinka is a partner in the Washington office of Morgan Lewis. He has practiced in the both the antitrust and FDA regulatory areas throughout his career. He is the founder and former leader of the firm's Life Sciences industry group, the founder of the firm's FDA practice, and a former leader of its Antitrust practice. He has co-authored several books, including Food and Drug Law and Regulation (3d ed. 2015) and Life Sciences Mergers and Acquisitions (2008), and published over 70 articles on FDA and antitrust issues. He is a graduate of Johns Hopkins University and the Harvard Law School.
    Presentation Material (Acrobat)
10:15 am Transition Break

TRACKS GROUP III (Choose one of the following Tracks)
TRACK E: OPTIMIZING CONTRACT OPERATIONS THROUGH TECHNOLOGY: HARNESSING INSIGHTS THROUGH ANALYTICS TO DRIVE STRATEGY AND COMPLIANCE
10:45 am

Welcome, Introductions, Panel Discussions and Q&A

Katherine Buckley, MBA
Principal, PwC Risk Consulting, Philadelphia, PA
Erinn Hutchinson
Principal, PwC Risk Consulting, Philadelphia, PA

    Speaker Bio

    Erinn Hutchinson is a Principal in PwC's Pharmaceutical and Life Sciences Advisory Practice. Erinn's focus is working with clients to assess existing and build and implement new compliance and risk management programs. Her expertise includes providing comprehensive risk assessment services on a broad range of health care and pharmaceutical operational issues including corporate compliance, monitoring and auditing, corporate integrity agreements, commercial regulations, reimbursement, anti-kickback, conflicts of interest, and due diligence for mergers and acquisitions. Erinn has significant experience working with pharmaceutical companies to assess global sales and marketing and pricing practices and regulatory compliance issues. In addition to extensive experience in the U.S. and China, Erinn has performed compliance assessment reviews in Brazil, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Italy, Mexico, Poland, Portugal, Russia, and the Ukraine.
    Presentation Material (Acrobat)
11:45 am Transition Break

TRACK F: STRATEGIC & OPERATIONAL REQUIREMENTS FOR VALUE-BASED CONTRACTING: WHAT CONDITIONS MUST BE MET IN ORDER FOR RISK CONTACTING TO BE SUCCESSFUL?
10:45 am Welcome, Introductions, Panel Discussions and Q&A
David Blaszczak
Founder and Partner, Precipio Health Strategies, Washington, DC

    Speaker Bio

    David Blaszczak, Principal at Precipio Health Strategies, is recognized as one of the leading reimbursement experts in life sciences and healthcare services, with almost 20 years of experience. He has been a consultant to many of the largest and most successful investment firms in the U.S. for nearly the past decade. This mainly includes advising private equity firms and lenders on leveraged buyouts across the healthcare spectrum. He also works with the management of healthcare companies by incorporating reimbursement and health policy into a successful growth strategy.

    In 2013, Mr. Blaszczak was an advisor to the Food and Drug Administration's Entrepreneurs in Residence Program regarding commercial insurer collaboration.

    Prior to Mr. Blaszczak's experience among healthcare companies and private equity firms, he previously worked for the government at both the state and federal level. At the U.S. Department of Health and Human Services (HHS), he helped advise the Secretary of HHS and the Administrator of the Centers for Medicare and Medicaid Services (CMS). This included implementation of the Medicare Modernization Act and also development of policy in areas, such as: managed care, health IT, provider reimbursement, and other key policy areas.

    His first foray into public policy was through the Maryland Office of the Attorney General followed by the Maryland Department of Insurance where he focused his efforts on regulation of insurers and working with medical societies.

    He earned a Bachelor of Arts in Health Administration and Master's in Public Policy from the University of Maryland Baltimore County.
Mark DeWyngaert, MBA, PhD
Managing Director, Huron Life Sciences, New York, NY

    Speaker Bio

    Mark is a Managing Director in Huron's Life Sciences. He has provided operational, clinical, managerial, consulting, and litigation services to various segments of the healthcare industry. Mark trained as molecular biologist and has ben actively involved in both research and business development roles for over 30 years. Mark specializes in assisting pharmaceutical manufacturers, biotechnology, and medical device companies with identifying and mitigating regulatory risks and valuing intellectual property.
Marc Tomassi
Managing Director, Huron Consulting Group, New York, NY

    Speaker Bio

    Marc brings 25 years' experience in the healthcare and life sciences sectors to Huron. Prior to joining Huron in 2014, Marc spent 18 years with Frankel Group, initially as a Consultant. His work spans the industry value chain, encompassing early research & technology strategy, portfolio management, clinical development planning and commercial strategy. Industry clients include major global pharma, biotech, specialty pharma, med tech, generics, life science services and healthcare informatics. Investment community clients include private equity and banking firms engaged in equity & debt financing at venture and commercial stages.

    Prior to joining Huron, Marc spent 18 years serving The Frankel Group, initially as a Consultant, and later as a Managing Director. In these roles, he focused on strategy consulting and transactions in the life sciences industry. Marc also worked as Director of Corporate Marketing at Empire Blue Cross Blue Shield, where his responsibilities included strategic planning, marketing services, and market research.

    Over the years, Marc has leveraged his payer background focused on market analytics and strategic planning acquired through previous work in the managed care sector. He also has worked extensively in life science transactions, assisting clients in LM&A planning, forecasting / valuation and execution.

    Marc has a BA in Comparative Government from Syracuse University, and an MBA from Carroll School of Management at Boston College.
    Presentation Material (Acrobat)
11:45 am Transition Break

JOINT KEYNOTE LUNCHEON WITH ACO SUMMIT AND BUNDLED PAYMENT SUMMIT
Noon Joint Keynote Luncheon With ACO Summit and Bundled Payment Summit
12:20 pm

Keynote Address/Discussion: Centers for Medicare and Medicaid Services Perspectives on Payment Reform

Patrick H. Conway, MD, MSc
Deputy Administrator for Innovation and Quality, Chief Medical Officer and Director, Center for Medicare and Medicaid Innovation and Director, Office of Clinical Standards and Quality, Center for Medicare and Medicaid Services, US Department of Health and Human Services, Baltimore, MD

    Speaker Bio

    Patrick Conway, MD, MSc, is the CMS Acting Principal Deputy Administrator and Deputy Administrator for Innovation and Quality & CMS Chief Medical Officer. As the CMS Acting Principal Deputy Administrator and CMS Chief Medical Officer, Dr. Conway is responsible for overseeing the programs that serve the over 130 million Americans that access health care services through Medicare, Medicaid, the Children's Health Insurance Program, and the Health Insurance Marketplace. He and the CMS team focus on health system transformation by improving quality, affordability, access to care, and health outcomes.

    Dr. Conway is also Director of the Center for Medicare and Medicaid Innovation (CMMI) at CMS. The CMS Innovation Center is responsible for testing numerous new payment and service delivery models across the nation that reward quality and value. Models include accountable care organizations, bundled payments, primary care medical homes, state innovation models, and many more. These models involve millions of people and hundreds of thousands of providers across the nation. Successful models can be scaled nationally.
    Presentation Material (Acrobat)
1:15 pm Luncheon Adjournment
AFTERNOON CLOSING PLENARY SESSION: THE FUTURE OF THE US PHARMACEUTICAL MARKETPLACE
1:25 pm

Welcome and Introductions

Mark DeWyngaert, MBA, PhD
Managing Director, Huron Life Sciences, New York, NY (Moderator)

    Speaker Bio

    Mark is a Managing Director in Huron's Life Sciences. He has provided operational, clinical, managerial, consulting, and litigation services to various segments of the healthcare industry. Mark trained as molecular biologist and has ben actively involved in both research and business development roles for over 30 years. Mark specializes in assisting pharmaceutical manufacturers, biotechnology, and medical device companies with identifying and mitigating regulatory risks and valuing intellectual property.
1:30 pm

Managing Communications between Manufacturers and Payers: Promotional Messages, Financial Contracting Negotiations, and Commercial Free Speech

Ayman Chit, MBA, MSc, PhD
Senior Director, Health Economics Modeling and Market Access, North America at Sanofi Pasteur, Assistant Professor, University of Toronto, Swiftwater, PA

    Speaker Bio

    Ayman Chit is a senior director with Sanofi Pasteur where he currently heads up economic assessments and epidemiological research focusing on new vaccines for the North America business. Prior to joining Sanofi, Ayman held multiple roles with in industry, most notably establishing and heading up the health economics and outcomes research group responsible for oncology medicines and vaccines at GlaxoSmithKline (GSK) Canada. During his tenure at GSK he also spent time working in research and development where he led clinical development operations teams and interfaced with commercial teams advising them on product launch and life cycle strategy. In conjunction with his interest in business, Ayman keeps an active academic affiliation teaching on research methodologies and the pharmaceutical industry as an assistant professor at the University of Toronto's (UofT) school of pharmacy.

    Ayman holds an honors bachelor of science (HBSc) degree in Chemistry, a master in biotechnology (Mbiotech) and a doctoral degree (PhD) in health economics all from UofT. His doctoral thesis was focused on the economics of vaccine and drug development.
Torrey Cope, Esq.
Partner, Sidley Austin LLP, Washington, DC

    Speaker Bio

    TORREY COPE is a partner at Sidley Austin LLP who helps clients address a wide range of matters involving FDA regulatory issues. He is an experienced advisor with scientific training and a passion for helping pharmaceutical, biotechnology and medical technology companies solve their most challenging regulatory problems. He counsels clients on regulatory issues and represents clients in the full range of litigation, enforcement, transactional, and other matters in which FDA issues arises. In both contexts, he has knowledge and experience related to clinical trials, marketing authorization, promotional and non-promotional communications, good manufacturing practice (GMP), product safety and other issues.
John E. Osborn, JD, MIPP
Senior Advisor, Hogan Lovells, Executive-in-Residence and Industry Advisor, Warburg Pincus LLC; Former Senior Vice President, Global Corporate Affairs, Onyx Pharmaceuticals, Inc., an Amgen subsidiary; Former Executive Vice President, General Counsel and Secretary, Dendreon, Washington, DC

    Speaker Bio

    John E. Osborn is a Senior Advisor with Hogan Lovells, based in Washington, DC. Mr. Osborn advises clients on corporate, commercial, public policy and regulatory matters with a particular focus on the life sciences and healthcare industry. For more than twenty years, Mr. Osborn worked as a senior executive and general counsel with leading life sciences and healthcare companies, including Cephalon, US Oncology, Onyx Pharmaceuticals, Dendreon, and a Merck joint venture company. He is the author of an influential, frequently cited article published in 2010 in the Yale Journal of Health Policy, Law & Ethics entitled "Can I Tell You the Truth? A Comparative Perspective on Regulating Off-Label Scientific and Medical Information".
2:15 pm

PhRMA's Perspective

Randy Burkholder
Vice President of Policy and Research, Pharmaceutical Research and Manufacturers of America (PhRMA); Former Associate Vice President for Public Affairs, AdvaMed, Washington, DC

    Speaker Bio

    Randy Burkholder is Vice President of Policy and Research at the Pharmaceutical Research and Manufacturers of America. Mr. Burkholder leads PhRMA work on policy solutions for supporting continued biopharmaceutical innovation and high-quality, patient-centered health care, including payment and delivery reform, quality measurement, appropriate use and patient adherence, evidence-based medicine and health technology assessment, value of innovation and personalized medicine. Mr. Burkholder represents PhRMA at federal agencies and advisory bodies including the Medicare Evidence Development and Coverage Advisory Committee, CMS' Technical Expert Panel on oncology, and the Federal Coordinating Council for Comparative Effectiveness Research. He also is a former member of the Board of Directors of the Personalized Medicine Coalition and serves on the Steering Committee of the Partnership to Improve Patient Care and the advisory committee for the Turning the Tide Against Cancer initiative.

    Mr. Burkholder has over 20 years experience in health care policy, advocacy and communications in the medical technology and pharmaceutical industries. Prior to joining PhRMA, Mr. Burkholder was Associate Vice President for Public Affairs at AdvaMed, the leading association of the medical device and diagnostics industries.
    Presentation Material (Acrobat)
2:45 pm Breaking Down the Hurdles to Value-based Arrangements for Pharmaceuticals
Samuel R. Nussbaum, MD
Chair, Alternative Payment Model Framework and Progress Tracking Work Group, Health Care Payment Learning and Action Network, Centers for Medicare and Medicaid Services; Former Executive Vice President and Chief Medical Officer, Anthem, Indianapolis, IN

    Speaker Bio

    Dr. Samuel Nussbaum serves as a Strategic Consultant to EBG Advisors, consulting arm for Epstein Becker and Green, where he advises life science companies, health care systems and provider organizations.

    From 2000 until 2016, Dr. Nussbaum served as Executive Vice President, Clinical Health Policy, and Chief Medical Officer for Anthem. He oversaw clinical strategy and corporate medical and pharmacy policy. During his tenure at Anthem, he was responsible for over $100B in annual health care expenditures through business units focused on care management, health improvement, and provider network contracting. Nussbaum was instrumental in developing contracting approaches that link hospital reimbursement to quality, safety and clinical performance; and patient-centered medical homes. Under his leadership, HealthCore has built partnerships with Federal agencies and academic institutions to advance drug safety, comparative effectiveness and outcomes research.

    Dr. Nussbaum is a Professor of Clinical Medicine at Washington University School of Medicine and a Senior Fellow at the USC Schaeffer Center for Health Policy and Economics.
    Presentation Material (Acrobat)
Alonzo Weems, Esq.
Vice President and Deputy General Counsel, Lilly USA, LLC, Eli Lilly and Company, Indianapolis, IN

    Speaker Bio

    Alonzo Weems holds the position of Vice President and Deputy General Counsel, Bio-Medicines Business Unit and General Counsel for Lilly USA, LLC. In this role, Alonzo and his team are responsible for partnering with business leaders in the US, Europe, Japan, Canada and Australia to operate our Bio-Medicines business consistent with applicable laws and ethical standards. Prior to assuming this role in the beginning of 2013, Alonzo served as General Counsel and Corporate Secretary for Eli Lilly Canada. In this role, he was a member of the ACE legal heads leadership team and provided supervisory responsibility for the legal team in Australia.

    Since joining Lilly in 1997, Alonzo has held several positions within Lilly, including Assistant General Counsel for the global and US cardiovascular teams, Director of Global Workforce Diversity and Counsel for the Oncology Global Product Team and US Business Unit.

    Prior to joining Lilly, Alonzo was an Attorney with the National Labor Relations Board from 1995 to 1997.

    In 1995, Alonzo received his Doctor of Jurisprudence from Indiana University School of Law. In 1992, he graduated Cum Laude with a Bachelor of Arts in English from Wabash College which included studying at the University of Nairobi in Kenya.

    Alonzo is a current member of the Governor's Early Learning Advisory Committee, a member of the Ready to Learn, Ready to Earn Committee of the United Way of Central Indiana and is a past Co-Chair of the Success by Six Leadership Council. Alonzo also is past President and member of the Indiana State Board of Law Examiners. He is a member of the American Bar Association.

    Alonzo is married and is the father of two children.
3:30 pm Summit Adjournment


Go to Agenda:
Preconference | Day 1





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