7th Pharma Pricing, Reimbursement & Market Access 2023
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• 30+ Speakers from Sanofi Genzyme, Mallinckrodt, Alkermes, Abbvie, Novartis, BeiGene, Supernus Pharma, Eisai, Horizon Therapeutics, UCB Pharma, Julz Pharma, GE Healthcare, ICER & many more
• 100 + attendees expected from Pharma, Biotech & Payers/HTA’s
• In-Person networking - Reconnect with old faces and meet newbies as we connect face-to-face
• Meet Global Pharma & Healthcare leaders, leading solution providers, patient experts, and industry heavyweights - from Pricing, Reimbursement, Market Access and RWE, HEOR, HTA/Payer, commercial, marketing, medical affairs and patient engagement, - who’ll unlock unrestrained innovation and drastically improved health outcomes.
Sanofi
DAVID BOWER, Senior Director - U.S. Value & Access – Dermatology, Sanofi
David is Senior Director of Value & Access for Dupixent at Sanofi. David brings 12+ years of pharmaceutical and life sciences experience. Previously, David was at Clarion (now part of Lumanity) where he was Head of Market Access Excellence. At Clarion he led a team of market access colleagues dedicated consulting professionals to inform and develop strategic access initiatives in both US and ex-US markets and across therapeutic areas.
Prior to Clarion, David was the Global Value & Access Lead for DUPIXENT Atopic Dermatitis, but also supported workstreams across Dermatology LCM indications at Sanofi during 2018-2021. David also has prior market access consulting leadership experience from Guidehouse (formerly Navigant) where he helped to build the firm’s market access and pricing capabilities, as well as at Simon-Kucher & Partners where he worked across markets and therapeutic areas.
David began his career in life sciences at Cook Medical where he worked in regulatory affairs within the Latin America region. David received an MBA with a concentration in Finance from the Kelley School of Business while on full scholarship as a Life Sciences Fellow. He received a BS in Biology, with honors, from Indiana University – Bloomington, where he was a Life Sciences Scholar, also on full scholarship.
Alkermes
BeiGene
BOXIONG TANG, Executive Director, Health Economics and, Outcomes Research (HEOR), BeiGene
• Dr. Tang has over 23 years experiences in medicine, public health, and health economics and outcomes research.
• Currently, he is the Executive Director, Head ofHealth Economics and Outcomes Research (HEOR) at Beigeneex-China Medical Affairs, responsible for developing HEOR function and implementing health outcomes researchstrategies globally. He established HEOR function to support the product launches and reimbursement globally.
• Before joining Beigene, he served as a Sr. Director of Global HEOR, and Growth Markets at Teva Pharmaceutical. Dr. Tang has established the newly created Growth Markets Market Access and HEOR team within Teva.
• Previous, Dr. Tang was a Senior Director of Health Outcomes Research at Pfizer Emerging Markets supporting Asia region. His responsibilities includes developing and implementing research strategies in clinical development (specialized in health economics assessment and patient reported outcomes, product value dossiers), and post market products (real world and large database creation and analysis). Dr. Tang is specialized in therapeutic areas of oncology, hematology, and immunology (biologics), and women’s health.
• Prior to Pfizer, Dr. Tang was the director of Health Economics and Clinical Outcomes Research in Johnson & Johnson and GlaxoSmithKline, where he was responsible for health outcomes research in biologics and oncology.
• He was also an adjuvant professor of China Fudan University and faculty of Zhejiang University Medical School. Meanwhile, Dr. Tang was the Chair of the HTA (Industry) Committee, Asia Consortium of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR), and a member of Asia Consortium Executive Committee.
• Dr. Tang’s training includes a MD in Preventive Medicine, a PhD in Health Services Research, and a MPH in Health Planning and International Health.
• Dr. Tang serves as the chair of Industry Committee of International Society of Pharmacoeconomics and Outcomes Research (ISPOR) Asia Consortium. He has published more than 30 manuscripts in peer review journals, 100+ abstracts and numerous speeches and presentations in major scientific congresses including ISPOR. He is knowledgeable in the development of Health Technology Assessment around the world. In addition, he served at Scientific Committees of International Health Economics Association (iHEA),Society for Medical Decision Making (SMDM), and a Peer Reviewer of America Journal of Managed Care.
Bayer
RICHARD LINER, Senior Assistant General Counsel, Bayer
Richard Liner is Senior Assistant General Counsel for Bayer’sPharmaceuticals Division. He advises on a broad spectrum of complex fraud and abuse and compliance issues, including anti-kickback, anti-corruption, off-label promotion and HIPAA privacy. He routinely works on the development of policies, procedures and guidance for the Bayer pharmaceutical business and manages both external and internal compliance investigations.
Richard graduated from Boston University’s School of Law with a concentration in healthcare law and received a Master’s degree in Public Health from The Harvard School of Public Health.
Bristol-Myers Squibb
SUVINA AMIN, Director, Worldwide HEOR, Hematology, Bristol-Myers Squibb
Biogen
RITU NADKARNI, Commercial Director, SouthEast US, Biogen
Ritu is a Global Sales/Business Development leader and a Strategic Marketer with 22 years of experience working with some of the top Healthcare systems including Mayo Clinic, Merck vaccines and Biogen. Currently she is the commercial regional director for Southeast Market, leading a team of sales, reimbursement, and account management professional responsible for one fourth of the division’s revenue. She is passionate about population health initiatives and nurturing high performing diverse teams. Her work has resulted in multi-million-dollar revenue and has been acknowledged by numerous President and Industry awards.
Ritu credits her cultural sensitivity and ability to work well with various constituencies to her experiences of living and working in three different continents and growing up in a multi-generational household. She holds a Master of Business Administration degree from the Thunderbird School of Global Management, Glendale, AZ from where she graduated as a Beta Gamma Sigma honor society member. She also holds a master’s degree in International Business from the Symbiosis Institute of Foreign Trade, Pune, India.
Ritu resides in Houston, TX with her husband Kunal and their son Ayan (12) and daughter Avya (9). In her spare time, she enjoys activities with her family – traveling, participating in half-marathons, long distance bike rides (MS 150) and writing for business publications including the Huffington Post. She is an active contributor in her community and is involved with multiple initiatives related to Education and Diversity & Inclusion. She along with husband founded “Empowering kids for future”, to support and provide opportunities to children from her community. She currently serves on the board of Ronald Mc Donald House (RMHC), Child Rights and You (CRY), and is a fellow of the prestigious American Leadership Forum class XLIX.Equally, Ritu has been an impactful mentor and an ally to many aspiring leaders and was an active participant in mentoring programs such as TENT that supports LGBTQ Refugees.
BeiGene
LAURENE REDDING, Global Head Strategic Pricing, BeiGene
• With over 25 years of experience of progressively senior roles within the pharmaceutical industry, Laurene is currently the Global Head of Value, Access & Pricing at BeiGene. BeiGene is a global biotechnology company co-founded in 2010 by John Oyler, an American entrepreneur, and Dr. Xiaodong Wang, world renowned biochemist and youngest ever U.S. Academy of Science member, to deliver cancer medicines more broadly and improve the lives of patients worldwide.
• Laurene’s experience spans both public and private healthcare, having worked early as her career as a health economic consultant, in the hospital system, as the head of the pharmaceutical division of Canada’s largest private insurer, and in various pharmaceutical companies. Laurene has also served as the industry representative on the Patented Medicines Prices Review Board (PMPRB), responsible for championing the industry’s views on price reform and modernization.
NAHPC
MARGARET REHAYEM, Vice President, National Alliance of Healthcare Purchaser Coalitions
Margaret Rehayem is an experienced healthcare leader that brings care and enthusiasm to her role with the National Alliance. As Vice President, she provides leadership for national initiatives that support member collaboration, helping coalitions leverage their regional efforts at the national level to drive health, innovation, equity and value. Her focus has been in health & wellbeing, total person health as well as various areas in delivery & payment reform such as hospital pricing, drug management and high cost claims.
Margaret has over 20 years' experience working with employers in various areas of healthcare strategic planning. She has developed and executed projects with continuous improvement frameworks, national employer roundtables and multi-stakeholder learning collaboratives that support organizational improvement and business/community partnerships. She also oversees a number of grant activities that have partnered with national organizations such as CDC Foundation, Patient-centered Outcomes Research Institute (PCORI), Robert Woods Johnson Foundation (RWJF) and United Health Foundation. She serves as a main contact for member coalitions; fostering relationships, and supporting regional coalition members through networking and capacity building opportunities. She also helps drive the direction of the organization’s National Health Leadership Council and engages with both public and private employers of different industries through the National Purchaser Leadership Council (NPLC). She also coordinates the Race, Health & Equity Council that meets throughout the year.
Margaret is a national speaker on a number of healthcare topics including business performance & leadership, health benefits, medical & pharmacy drugs, biosimilars, employee engagement, & organizational culture, and the impact of health equity, social needs, and wellbeing in organizations.
Before joining the National Alliance, she was on the leadership team at the Midwest Business Group on Health, a leading business coalition in Chicago. Early on in her career, she created and managed an award-winning employee health and wellness program for 11 years at a community college. She has been involved with various Advisory Boards including with the National Health Council, the Innovative Value Initiative and the Act4Biosimilars. She has been an adjunct faculty professor since 2008 and most recently taught corporate health and entrepreneurship at the University of Illinois at Chicago.
Cormedix
ERIN MISTRY, SVP, Head of Payer Strategy, Gov’t Affairs & Trade, Cormedix
• Erin Mistry is EVP and Chief Commercial Officer at CorMedix – where she leads the company’s commercial strategy and execution with an expected approval late this year. CorMedix is biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life- threatening conditions.
• Erin brings over 18 years of industry experience at the executive level from consulting to in-house executive management. Prior to joining CorMedix, Erin held roles in health systems, industry and consulting – managing the global P&L for the Value Access practice at Syneos Health. During her career she has worked with and for emerging, mid, and large biopharma across a broad range of therapeutic categories and advises various stage companies on commercial viability, policy implications, reimbursement and valuation to optimize their portfolio.
• Erin holds an undergraduate and Masters degree in Biomechanical Engineering from North Carolina State University
Deallus
PETER BARSCHORFF, Vice President, Deallus
• Peter Barschdorff is Vice President and Head of the U.S. consulting business at Deallus, a global boutique pharma consultancy serving half of the world’s top-25 pharmas as well as select emerging biopharmas.
• Peter’s experience spans more than two decades, both in management consulting and in industry senior executive positions, most recently as GSK’s U.S. Pharma Chief Analytics Officer, and member of the Pharma Executive team at Bayer U.S. Previously, he served as global Head of Complexity Reduction at Bayer, and as deputy Head of the global inhouse consulting function, which brought him to oversee consulting projects from Mexico, across the U.S., and to China.
• He started his career in the pharmaceutical industry as an analyst in market access consulting, mainly focused on several of the world’s top blockbuster drugs of the early 2000s. His project experience ranges from the creation of pharmaco-economic models to contracting process design, from pricing to national accounts operating model improvement, and from establishment of one of the first managed care departments in biotech to devising employer strategies for big pharma.Most recently, he oversaw payer research for an innovative digital solution as well as about payer values and barriers for access to launch an innovative CAR-T therapy in U.S. market.
• Peter originally trained as defense analyst; his Doctorate is from the Free University of Berlin (Germany) and his MBA from Columbia Business School. He has chaired a number of industry conferences, most recently the 6th Annual Pharma Pricing, Reimbursement & Market Access conference, 2022, in Boston.
AGENAS
MARCO MARCHETTI, Director HTA Unit, Agenzia Nazionale per i Servizi Sanitar Regionali (AGENAS)
• Marco Marchetti has graduated in medicine at Università Cattolica del Sacro Cuore (Rome) and postgraduate in Hygiene and Public Health and Legal Medicine.
• Since November 28th 223 he is Co-chair of the Member State Coordination Group on Health Technology Assessment (HTACG) set up by Regulation (EU) 2021/2282 on Health Technology Assessment. - https://health.ec.europa.eu/latest-updates/flash-report-member-state-coordination-group-hta-htacg-28-november-2022-2022-11-28_en
• Since April 2021 up to now he is the Director of the HTA Unit of the National Agency for Regional Health Care Services that have the responsibility to support Italian National and Regional Government.
• Since January 2017 up to February 2022 he has been the Director of the National Center for the 'Health Technology Assessment of the Italian National Institute for Health.
• He has been Director of Health Technology Assessment and Innovation Unit until December 2016 of the Fondazione Policlinico Universitario “Agostino Gemelli”, Università Cattolica del Sacro Cuore.
• He has been experts and referees for Health Technology research proposal in the period 2033-2008 by The NHS Health Technology Assessment Programme. - National Coordinating Office for Health Technology Assessment - UK.
• He has been treasurer and member of the Executive Committee of the Health Technology Assessment International from 2018 to 2021 - https://htai.org/
• He has been the Co-Chair of Local Organizing Committee of the 2017 Health Technology Assessment Meeting in Rome in the next June 2017.
• He has been advisor of the National Agency for Drugs in Italy for more than 10 years from 2005 to 2015.
• He has been also advisor for the Regional Authorities of Lazio and Lombardia Regions for more than 5 years since 2010 to 2015 on the topics of drugs and medical devices policies.
• He has been since June 2023 co-chair of Interest Subgroups of HTA international – Htai www.htai.org - “Hospital based HTA”.
• He participates since the beginning to the activities of the EUNETHTA.
• His expertise area are on the following fields: hospital management, quality assurance, risk management, HTA, drug epidemiology, evidence based medicine, digital medicine impact evaluation.
• He published more than 160 paper on national and international on the subject he interested in.
Equideum Health
HEATHER LEIGH FLANNERY, Founder & Chief Executive Officer, Equideum Health
Heather Flannery is Founder and Chief Executive Officer of Equideum Health, a spin-off from ConsenSys AG effective March 2nd, 2020 focusing at the intersection of federated AI, advanced privacy technology, and blockchain/web3. ConsenSys Health rebranded to Equideum Health on January 18th, 2022. Equideum Health is a Microsoft and ConsenSys partner and a ConsenSys Mesh portfolio company.
Heather is a member of the Board of Directors of the Equideum Foundation, Co-Chair of the IEEE SA Open P2418.6 Standards Development Working Group (blockchain and AI convergence in healthcare and life sciences), served as FY19 and FY20 Co-Chair and FY21 Chair of the global HIMSS Blockchain in Healthcare Task Force, Chairs the Healthcare Interest Group at the Enterprise Ethereum Alliance (EEA), and is a member of the Board of Directors of the World Business Angels Forum (WBAF) USA Country Office. Ms. Flannery is an active consultant, advisor, and keynote speaker.
Equideum Health
ROBERT POPOVIAN, VP Health Economics & Policy, Equideum Health
Dr. Robert Popovian is the Founder of the strategic consulting firm Conquest Advisors. He also serves as Chief Science Policy Officer at the Global Healthy Living Foundation, Senior Healthy Policy Fellow at the Progressive Policy Institute, and Visiting Health Policy Fellow at the Pioneer Institute. He previously served as Vice President of U.S. Government Relations at Pfizer. As an advisor, Dr. Popovian serves on the Board of Councilors of the University of Southern California School of Pharmacy and to the Value of Life Sciences Innovation program at the Schaeffer Institute.
Dr. Popovian has published extensively and referenced on the impact of biopharmaceuticals and health policies on costs and clinical outcomes in the most prominent medical sources and media publications. He is also a sought-after speaker and has been invited to provide detailed presentations, briefings, and expert reviews for the U.S. Congress, dozens of state legislatures, and at conferences and medical symposiums throughout the country and worldwide.
Dr. Popovian completed his Doctorate in Pharmacy and Master of Science in Pharmaceutical Economics and Policy degrees at the University of Southern California with honors. He has also completed a residency in Pharmacy Practice/Adult Internal Medicine and Infectious Diseases at the Los Angeles County-USC Hospital and a fellowship in Pharmaceutical Economics and Policy at USC.
Equideum Health
SEAN MANION, CSO, Equideum Health
Chief Scientific Officer, Equideum Health, is a creative thinker who dissects problems to build solutions. He is an inspiring leader who enhances people and teams by understanding the factors that can create environments for innovation and the value of diverse perspectives as a guide for people, ideas, and organizations through all phases of development.
Sean is a neuroscientist and research administrator with 20+ years’ experience in federal and academic health research. As an entrepreneur, advisor, and thought leader, he currently focuses on applying emerging tech to healthcare and science for better science, cheaper research, and faster miracles.
Red Nucleus
Kyle Clifton, Senior Director, Red Nucleus
• Kyle has 15 years of experience in the healthcare industry with significant expertise in commercial and market access strategies. Over this time, he has been increasingly responsible for leading the access planning and value development activities for pharmaceuticals across many therapeutic areas and orphan diseases.
• He has expertise in assessing healthcare policy, developing stakeholder-specific value messages, conducting market assessments and indication prioritizations, developing evidence-generation strategies, and assessing the price/value relationship. He has delivered presentations to physician offices on payer management, reimbursement support, and financial assistance programs to increase on-therapy patient pull-through.
• Kyle earned masters degrees in business administration and health sector management from the W. P. Carey School of Business at Arizona State University, and a bachelor of arts in business administration with a minor in English from Rhodes College in Memphis, Tennessee. He also completed the Project Management Professional certification through the Project Management Institute.
Red Nucleus
Shiv Shan, Director, Red Nucleus
Shiv is an experienced consultant focused on solving challenges related to commercial strategy within the life science industry. Across his time at Red Nucleus (previously Jupiter Life Science Consulting) and Windrose Consulting Group, Shiv has worked on a wide variety of engagements including, asset valuation, value story development, pricing and market access strategy, payer and provider contracting strategy, and launch strategy.
He has deep experience in the rare diseases, inflammation and immunology, among other therapeutic areas (i.e., oncology, T2D, hematology). He is passionate about developing strategies to effectively communicate the value of therapies launching across global markets (i.e., US, EU, Asia-Pacific).
AVEO Oncology
JASON M. NOTO, Senior VP, US Market Access, AVEO Oncology
Jason Noto serves as Senior Vice President of US Market Access at AVEO Oncology, an LG Chem Company. Since 2019, Jason has led all aspects of Market Access (Trade & Distribution, National Accounts, HUB Services, Federal Channels, and Pricing / Contracting) and spearheaded the commercial buildout of the Function for the launch of FOTIVDA (tivozanib) for advanced Renal Cell Carcinoma in March, 2020. Prior to his time at AVEO, Jason spent 12 years in US Marketing roles with increasing responsibility at Bristol-Myers Squibb, Alkermes, and Sunovion Pharmaceuticals and has led the commercial launch of 7 specialty products over the span of his marketing tenure. Jason started his career in 2000 in sales and sales management roles spanning oncology, rare disease, and CNS therapeutic areas.
Jason graduated from LeMoyne College with a Bachelor’s Degree in Marketing and earned his Masters of Business Administration (MBA) from the Carroll School of Management at Boston College.
ICER
ELLIE ADAIR, Deputy COO, Institute for Clinical and Economic Review (ICER)
With over 10 years of experience in health care policy and social justice, Ellie is a member of the senior leadership team at the Institute for Clinical and Economic Review, a leading non-profit health policy research organization, as Deputy Chief Operating Officer. In that role, she is responsible for overseeing ICER’s public programs, stakeholder engagement, and business operations. Prior to coming to ICER, Ellie was the Director of Membership for the Network for Excellence in Health Innovation (NEHI), a national health policy think tank working to break down the silos in health care.
Previous to that, she was the Executive Director at the Massachusetts National Organization for Women (Mass NOW), which works to advance intersectional justice for all those who identify as women in Massachusetts. Ellie received her MPA from Brown University and her BA from the University of Rochester. She is originally from Rochester, New York and currently lives in Arlington, Massachusetts.
Novartis
SCOTT HOWELL, Former US Pharma Chief Strategy Officer, Novartis
• Scott Howell, MD currently advises a number of healthcare, technology, and biopharmaceutical firms. He also teaches, researches and writes about healthcare and biopharmaceutical industry strategy.
• Scott retired in 2022 as Chief Strategy Officer for US Pharmaceuticals at Novartis. In this role, Scott led a US Commercial Model Transformation, including implications for sales, marketing, and drug development and portfolio management. He also headed US Business Development & Licensing and a Pricing & Access Innovation team and served as a member of the US Pharmaceuticals Executive Committee. Scott joined Novartis in 2017 as VP & Head of US Market Access, where he was responsible for US pricing and contracting, channel management, managed care, and hospital systems, as well as patient support services. In this role he led very successful transformations placing Novartis at the forefront of the industry in these domains. Prior to joining Novartis, Scott was Vice President of Market Access at Jazz Pharmaceuticals, a rare disease and orphan drug company, and had worked for Cardinal Health as Senior Vice President of Manufacturer and Clinical Services, Specialty Pharmaceuticals. Scott also spent a number of years at Genentech where he held a variety of leadership positions in market access and clinical development. Earlier in his career, Scott was Vice President of Pharmacy at Highmark Blue Cross Blue Shield and before Highmark, he held a variety of medical affairs and managed care leadership roles at GlaxoSmithKline.
• Scott began his career as a general internist and worked several years in private practice before entering academic medicine at The Ohio State University. While at Ohio State, Scott also held positions in group practice administration and health plan administration.
• Scott earned his undergraduate degree at Notre Dame and his medical degree at Ohio State. He completed his medical internship and residency and also earned an MBA at Duke University. Scott has been teaching health policy and industry strategy for more than 15 years, primarily in the graduate programs at UC Berkeley, and has authored and contributed to a number of industry-related papers. Scott is a recognized national thought leader in the area of value-based pricing and access for biotech and pharmaceutical products.
Magnolia Market Access
AMANDA O’HORA, Senior VP, Magnolia Market Access
• Amanda O’Hora, is Senior Vice President of Reimbursement & Market Access at Magnolia Market Access. She has more than 24 years’ experience conceptualizing and implementing a broad range of commercialization activities for manufacturers of drugs, biologicals, cell and gene therapies, devices, diagnostics, and digital therapeutics. In addition to life science manufacturers, she also supports trade associations, health plans, and health systems.
• Her areas of expertise include reimbursement (coding, coverage, and payment), manufacturer patient support services, health policy, and market access for payers, providers and patients. She is adept at integrating data analytics, market insights, and personal experience into developing strategies, putting them into action and enhancing them in response to market changes. She is a nationally recognized speaker on reimbursement, patient support services and market access, having presented at numerous conferences, the Centers for Medicare and Medicaid Services (CMS), state Medicaid offices, health systems, national sales meetings, and other events.
• Prior to joining Magnolia, Amanda consulted for more than 20 years with life sciences companies on market access, reimbursement, health policy, and patient support services engagements. She also advised manufacturers on the design and development of their patient support services programs and managed the day-to-day operations of multiple outsourced patient services programs.
• Amanda received her Bachelor of Arts in History from the Florida State University.
Julz Pharma
USMAN IQBAL, Chief Medical Officer, Julz Pharma
• Usman Iqbal MD, MPH, MBA is the Chief Medical Officer at Julz Pharma. He is a medical executive with a portfolio career entailing 15 + years of diverse experience spanning R&D, Medical Affairs, Value and Access across both large and small cap biopharmaceuticals. His experience spans a number of therapeutic areas including Neuroscience, as the Senior Medical Affairs Leader at AstraZeneca Innovative Medicines Group (IMG), and in Oncology, as former Head of Sanofi Oncology, Global Evidence & Value Development (GEVD). With positions of increasing responsibilities across both R&D and Medical Affairs in different organizations, Dr. Iqbal has successfully led several development programs with a strategic focus on innovation, operational excellence, and end in mind approach driven by medical value and patient centricity.
• As a medical leader, he has led numerous organizational transformations, built integrated and transversal medical platforms, and led the execution of integrated Medical Affairs strategy for several launched products. His area of expertise also includes harnessing big data science, real world evidence, advanced analytics and digital medicine to optimize R&D portfolios, Trial designs, Medical Affairs delivery and Patient Access. Prior to working in the industry that also includes Amgen, Trevena, and Acer Therapeutics, Dr. Iqbal was at the Boston University Health Outcomes Technology Group where he served as a senior research fellow at the Center for Assessment of Pharmaceutical Practices (CAPPs) and Veterans Affairs Pharmacy Benefit Management (VA-PBM).
• Dr. Iqbal has authored 50+ publications and serves as an industry consultant & thought leader on “end to end” clinical asset development, evidence & value generation, and 3P (physician, patient, payer) driven integrated medical affairs operating models. He received his MD from Allama Iqbal Medical College, Lahore, Pakistan and MPH and MBA degrees from Boston University.
Eisai
ANGELINA IRIZARI-POLICARPIO, Head of the U.S. HEOR & RWE Field Communications Team, Eisai
• Angelina is currently the Head of the U.S. HEOR and RWE Field Team at Eisai, leading the team that supports the portfolio for Oncology and Neurology including Alzheimer’s. Sheis a graduate of MIT Sloanin addition to havingextensive clinical and healthcare experience. She was a member of the MIT NEWDigs Global Collaborative creating a Financial Model for the Future of Healthcare Innovation. She has held executive level positions in the Life Sciences industry, National Health Plans and Consulting.
• In these roles, she spent a significant amount of time around initiatives and projects that require complex collaborations with internal and external stakeholders. Having received her training in Systems Dynamics and in Systems Thinking at MIT, she designed collaborative work, and executed largescale transformation initiativesand built infrastructure for enduring results with impact.Her clinical training from a Masonic based- program was also rooted in the Systems view of the patient and the healthcare ecosystem, which ultimately led her to earn the distinguished Dr. Deutsch award in clinical practice.
• Her work in implementing innovation through intrapreneurial programsin 2018 has been featured in the MIT Innovation for Corporations courses and led Real World Evidence and Informatics collaborations in addition to demonstration projects with several health systems in the US.
• She brings her deep understanding of the US Health Care Ecosystemand her experience in using the Systems Dynamics Principles to her role as a moderator for our segment The Importance of Working Together: Stakeholders- Patients, Physicians, Industry and Payers
Mitsubishi Pharma
LOUISE ST-ONGE, Head of Pricing, Market Access & Government Affairs, Mitsubishi Tanabe Pharma (Canada)
Louise St-Onge is the Head of Pricing, Market Access & Government Affairs at Mitsubishi Tanabe Pharma Canada. She is an accomplished Pharma Leader with >25 years executive experience in Specialty Pharma, Oncology & Rare Diseases.
Louise brings unique perspectives with her strong ability to solve complex issues and from her broad experience in Sales, Marketing and Patient Access, including in setting up Canadian Operations.
Takeda
SAMUEL ANG, Global Access Lead, Takeda
Sam Ang is the global patient value and access lead for oncology in Takeda. He has 17 years of industry global and region market access experience in five biopharma companies Pfizer, Abbott, Lilly, Amgen and Takeda. Within market access, Sam’s expertise includes payer value strategy, pricing & reimbursement, health policy, patient access and key account strategy. He has led market access strategy in each stage of product lifecycle from pipeline development, through launch, indication expansion to loss of exclusivity lifecycle management.
Previously, Sam was a legal counsel for the Singapore government and a strategy management consultant with Bain & Company. Sam has a law degree from Singapore, MBA from Imperial College London, and MPA from Harvard University.
KPMG
RYAN CLEMENTS, Managing Director, KPMG
Background
• Ryan has over 15 years of advisory experience focused on the life sciences and healthcare sectors serving a varied client base from Fortune 20 to early stage and pre-commercial market entrants as well as mid-market and leading global financial services companies. Lindsey pulls from her strong analytical background and experience working with a variety of healthcare organizations in diverse markets to deliver data-driven advisory services.
• Prior to KPMG, Ryan was a Managing Director at Avalere Health, a boutique life sciences and healthcare focused Advisory firm based in Washington DC, well known for government affairs, corporate affairs and both state and federal policy strategy work. Ryan led many of the firms operations including a variety of initiatives to acquire and expertly deploy various data assets into the firm’s advisory offerings. Ryan led many of the firm’s premiere biopharma and life sciences client relationships, with oversight for the work his teams executed related to health economics and advanced analytics, market access and government affairs.
• Ryan was a Director and founder of Red Oak Sourcing, a joint venture between CVS Health and Cardinal Health. Ryan and his team at Red Oak were responsible for managing the generic drug portfolio on behalf of both parent companies, including negotiating dead net cost with generic drug manufacturers, understanding competitive dynamics on generic launches and break opens, developing inventory management strategies, mitigating supply risk and optimizing supply chain strategy, and understanding regulatory, FDA and government affairs dynamics in play for the generics industry
• Before his time at Red Oak, Ryan worked for PwC focused on life sciences and medical device clients
Example Experience
Phillips
Aetion
ASHLEY JAKSA, Market Access Scientific Strategy Lead, Aetion
Ashley Jaksa is the Market Access Scientific Strategy lead at Aetion. Her role at Aetion focuses on partnering with regulatory and HTA agencies to to support their use of RWE in decision-making, and to help set methodological guidance for RWE generation.
She also works with Aetion’s biopharma clients to ensure their RWE studies meet decision-makers' evidence standards. Previously, she has worked at CVS Health and Context Matters, Inc. She holds a bachelor's degree from the University of Michigan-Ann Arbor and a MPH from Yale University.
Karnezis Consulting
TED KARNEZIS, Owner, Karnezis Consulting
• Ted Karnezis, RPh BSPharm, President of Karnezis Consulting LLC, established in October of 2020.
• Graduate of University of Illinois in 1992 (BS Biology) and St. Louis College of Pharmacy (now known as University of Health Sciences & Pharmacy in 1995 (BSPharm).
• Registered Pharmacist in Illinois 1995 - present
• Registered Pharmacist in Florida 2008 - present
• Experienced with dispensing in both community and acute care hospital settings in Illinois from 1995 through 2018.
• In 2007, transitioned into the Department of Veterans Affairs (“VA”), while remaining part time at St. Mary’s Hospital Pharmacy on weekends.
• Ted’s experience spans a decade at the Department of Veterans Affairs Pharmacy Benefits Management working with the pharmaceutical industry across various aspects of Government pricing, FSS contracts and the Veteran’s Healthcare Act of 1992 (“VHCA”) compliance.Ted has worked directly with the Offices of Inspector General (OIG) to ensure the pricing was accurate, current, and complete while assisting with confidential matters in pre & post contract award reviews and pricing calculation methodologies.
• While at the VA, Ted’s primary responsibility was to manage the Veteran’s Healthcare Act of 1992 (VHCA), also known as Public Law 102-585, which assured discounted pricing on covered drugs for the Department of Defense (DOD), Department of Veterans Affairs (VA), Indian Health Service (IHS) and Coast Guard (CG). Procurement was through established Federal Supply Schedule (FSS) contracts, which also lists published pricing. Pricing would be adjusted annually during the VA’s “Public Law Season” as interpreted by VHCA. Ted was an integral part of ensuring the Public Law season ran smoothly and streamlined the annual reporting process and tightened program requirements.
• Acting as a voting member of the VA’s Public Law 102-585 Policy Group, Ted was involved with industry’s difficult questions and outcomes regarding contract pricing, compliance, calculation methodologies and market access concerns from the lens of the VA.
• Ted departed the VA in 2018 and landed with KPMG where he received broader government pricing to other CMS programs (Medicaid, Medicare, Best Price and ASP).
• In 2020, Ted launched Karnezis Consultingto providing compliance solutions to pharma industry and assisting with Government Pricing compliance.
• In 2022, Ted joined AMSUS (https://www.amsus.org/about-amsus/) and has been invited to be part of a PHS sub-committee. Ted has also presented at many industry conferences including Medicaid Drug Rebate Plan (MDRP), ACI’s Big Four Pharmaceutical Boot Camp and VA/DoD Joint Committed in Contracting. Karnezis Consulting website provides additional information.
Wiggin and Dana
JOLIE APICELLA, Partner, Wiggin and Dana
Jolie is a Partner in Wiggin and Dana’s Litigation Department and Health Care Practice Group. A seasoned attorney and skilled negotiator with extensive experience in healthcare regulations, investigations and litigation, Jolie has successfully handled complex matters in the areas of health care oversight, civil rights enforcement, contractual disputes, white collar federal investigations, environmental matters, intellectual property disputes and employment litigation. Jolie’s practice focuses on complex civil litigation, alternative dispute resolution and trial practice.
Jolie represents individual and corporate clients in internal and government investigations and white collar criminal defense, with a particular focus advising on the False Claims Act, federal Anti-Kickback Statute, Stark Law, and other health care fraud and abuse laws. Previously, Jolie was an Assistant United States Attorney (AUSA) in the Eastern District of New York, where she served as Chief of Healthcare Fraud. Drawing upon her background in investigating and prosecuting fraud matters against pharmaceutical companies, pharmacies, hospital systems, laboratories, physician practice groups and individual providers, Jolie advises clients on government investigations.
Winston & Strawn
PDCI Market Access
N. DYLAN LAMB-PALMER, Associate Director, Pricing and Data Analytics, PDCI Market Access (Division of McKesson Canada)
• As a member of PDCI’s Pricing and Policy team, Dylan has lead dozens of strategic pricing assessments, leveraging his PMPRB expertise in assisting clients with business cases for pricing strategies for new launches and in-market patented medicines. Dylan is a trusted PMPRB Pricing expert to his many clients, providing strategic pricing plans, ensuring regulatory compliance, assessing and advising on “willingness-to-pay” in public and private markets, and leading clients’ negotiations through Voluntary Compliance Undertakings. Dylan has worked with many key industry stakeholders in estimating the impact of the 2020 PMPRB Regulatory reforms.
• Working in the PDCI’s Data Innovation team, Dylan helps develop and maintain PDCI’s data analytics services including PDCI’s Market Access Toolkit, national public claims data, private claims data, and price trends. Dylan leverages this experience to assist with PDCI’s whitepaper publications on topics including National Pharmacare and the Impact of COVID-19 lockdowns on market access and reimbursement.
• Prior to joining PDCI’s Pricing and Policy Team, Dylan developed health economic models (cost-utility, cost-effectiveness, and cost-consequence) and budget impact analysis (BIA) models for submission to Canadian HTA agencies (CADTH CDR & pCODR, INESSS) and private payers.
• Dylan holds a Master’s degree in Applied Science from McGill University in Montreal, and a Bachelor’s degree in Science with and Honor’s Specialization in Genetics from University of Western Ontario in London Ontario.
Covington & Burling
Porzio Bromberg & Newman
Meet and to network with your conference colleagues.
09:30 – Chairperson opening remarks
PETER BARSCHORFF, Vice President, Deallus
09:40 – “Policies, Portfolios and Commercial Viability”
ERIN MISTRY, SVP, Head of Payer Strategy, Gov’t Affairs & Trade, Cormedix
10:20 – Value based reimbursement
• The importance of demonstrating product value stories.
• What are product values from a payer perspective.
• How to generate scientific evidence and demonstrate product values.
• Importance of clinical and economic evidences in supporting product reimbursement.
• Develop a strong market access and data generation strategy to support value proposition.
BOXIONG TANG, Executive Director, Health Economics and Outcomes Research (HEOR), BeiGene
11:00 – Morning Coffee / Tea & Networking
11:20 – Keynote Panel Discussion: Pharma pricing and market access in the US: From Dream to Reality
• Latest developments in pharma pricing and market access in the US, including Inflation Reduction Act (IRA)”
• Evidence driven pricing and reimbursement strategy
• Market access strategic planning - Steps and logical sequencing for market access strategy development
• The new normal: HTA & Reimbursement challenges in a post-pandemic world
• Innovator strategy and investor due diligence
• Recent changes - Market access and pricing policy and how we navigate them?
• Staying ahead in the race - Update on pricing and market access in USA, EU & RoW –
• Implications for companies – What to Prepare for 2025
Moderator
PETER BARSCHORFF, Vice President, Deallus
Panellists
MARGARET REHAYEM, Vice President, National Alliance of Healthcare Purchaser Coalitions
GREG APOSTOL, Vice President & Head of Market Access, Alkermes
SUVINA AMIN, Director, Worldwide HEOR, Hematology, Bristol-Myers Squibb
SAMUEL ANG, Global Access Lead, Takeda
12:10 – Leveraging Insights Across the Patient Access Journey to Inform Decision Making
• Identifying opportunities and risks across the patient access journey
• Leveraging analytics and the cross-functional team to identify bottlenecks, validate challenges, and overcome obstacles
• Quantifying impact to optimize commercial & market access strategic and tactical plans (i.e., payer and/or channel contracting, patient fulfillment, etc.)
• Building a centralized, data collection infrastructure to enhance knowledge management, cross-functional collaboration, and stakeholder engagements
KYLE CLIFTON, Senior Director, Red Nucleus
SHIV SHAN, Director, Red Nucleus
12:40 – Networking luncheon
13:40 – Panel Discussion: Prioritizing patient-centred care - Adding value through an innovative patient-centred approach
• Drive for better patient centricity from a pharma perspective
• Patient centricity in value and price assessment
• The role of the patient voice in market access
• Always remembering patients during policy making
• Opportunities for meaningfully engaging patients in medicines research, development & delivery
• Best practices for collecting and incorporating patient insights
• Driving next generation patient-centric platforms and engagement
• Examining the barriers and the solutions to access to medicines for patients
Moderator
PETER BARSCHORFF, Vice President, Deallus
Panellists
USMAN IQBAL, Chief Medical Officer, Julz Pharma
ELLIE ADAIR, Deputy COO, Institute for Clinical and Economic Review(ICER)
YAOZHU (JULIETTE) CHEN, Global Evidence and Outcomes Lead, Takeda
JOLIE APICELLA, Partner, Wiggin and Dana
14:30 – Can the patient access hurdles for rare disease drugs be overcome in Canada to create a viable marketplace?
• The reimbursement landscape
• Payer trends and the NEW National Strategy for Rare Disease
• Considerations for manufacturers to optimize the patient access journey
• Is your value proposition strong AND sustainable?
• Designing your Patient Support Program (PSP) so that it helps elevate your long-term value proposition and plays a critical role in the broader healthcare decision making
LOUISE ST-ONGE, Head of Pricing, Market Access & Government Affairs, Mitsubishi Tanabe Pharma (Canada)
15:00 – Afternoon Tea / Coffee & Networking
15:20 – Biopharma Deal Trends
• Trajectory of deal volumes and deal values
• What’s fueled deal making
• Evolving deal making rationale
• Impact of IRA on deals activity
• ’23 deal market implications
RYAN CLEMENTS, Managing Director, KPMG
15:50 – Key US life sciences markets trends and their implications
• Understand the key US market trends in pricing, access, and promotion that are impacting life sciences companies
• Understand the critical implications and need to adapt for life sciences companies related to these trends
• Learn about a novel proposed alternative for the drug pricing and access system
SCOTT HOWELL, Former US Pharma Chief Strategy Officer, Novartis
16:20 – HTA and decision making in the reimbursement decisions
LAURENE REDDING, Global Head Strategic Pricing, BeiGene
17:00 – Chairperson’s closing remarks and end of conference day 01
17:05 – 18:10 – Networking Drinks Session
09:30 – Chairperson opening remarks
PETER BARSCHORFF, Vice President, Deallus
09:40 – Patient-centered approach to value based healthcare
This presentation will introduce the concept of patient-centric value-based healthcare, and how it will be involved in next-generation massively multilateral value-based agreements, real-time real world evidence gathering, novel financing structures in the context of precision medicine, and reducing cost of putting digital diagnostics and therapeutics through regulatory approval. It will also provide some examples of how patient-centric value-based healthcare is implemented in different settings and contexts, such as primary care, chronic disease management, cancer care, etc. Finally, it will discuss some of the challenges and opportunities for adopting this model in the current healthcare system.
HEATHER LEIGH FLANNERY, Founder & Chief Executive Officer, Equideum Health
10:20 – Panel Discussion: From Generative AI to Evidence Generation: How to jump the clinical quality chasm with emerging tech
Generative AI, for example Chat GPT, is a branch of artificial intelligence that can create new content or data based on existing data. It has many potential applications in various industries, including pharma. Chat GPT can be used in drug discovery in many ways such as to analyse vast amounts of data from various sources and identify new drug targets and predict drug efficacy and safety, or to help with regulatory affairs by providing information about regulations in different countries. One challenge is that to date, this technology is only designed for casual or conversational use, lacking the language specificity for clinically relevant applications. This panel will explore the rapid rise in use of AI and explore some of the key steps that will be required to safely and productively employ these new tools in clinically relevant and validated ways.
HEATHER LEIGH FLANNERY, Founder & Chief Executive Officer, Equideum Health
SEAN MANION, CSO, Equideum Health
ROBERT POPOVIAN, VP Health Economics & Policy, Equideum Health
11:10 – Morning Coffee / Tea & Networking
11:30 – Keynote Panel Discussion: Importance of working together - Stakeholders- Industry, Payers, Physicians and Patients
• Pharma market access & pricing environment - Current challenges and solutions as seen by payers, employers and providers
• Collaborations and working together – What have we learnt from the pandemic?
• Rise of Payors - Collaborating with them to achieve market access
• The New Normal - Pioneering Digital Stakeholder Engagement
• Multi-stakeholder collaboration for access to drugs
• Value Assessment, navigating the global landscape
• Launch success for products in today’s managed markets environment
• Developing and implementing an approach to using RWE in HTA
Moderator
ANGELINA IRIZARI-POLICARPIO, Head of the U.S. HEOR & RWE Field Communications Team, Eisai
Panellists
DAVID BOWER, Senior Director - U.S. Value & Access – Dermatology, Sanofi
RITU NADKARNI, Commercial Director, SouthEast US, Biogen
JASON M. NOTO, Senior VP, US Market Access, AVEO Oncology
12:30 – Emerging Issues for HTA – EU HTA Regulations What about the next scenario
MARCO MARCHETTI, Director HTA Unit, Agenzia Nazionale per i Servizi Sanitar Regionali (AGENAS)
12:50 – Networking luncheon
13:40 – The Inflation Reduction Act: What Payers Think? How You Should Prepare?
How will the sweeping changes of the Inflation Reduction Act impact payers? Magnolia Market Access recently completed a survey of top payers and actuaries across the US to see how payers are adjusting their plan designs, formularies, and expectations on rebates because of this new regulation. In this presentation we will review top-line survey results and explore what pharma companies need to do to ensure product coverage and patient access to appropriate care.
• Expand knowledge about the components of the IRA and identify which ones are important to payers
• Examine payer perceptions of the IRA and what they are planning to do in response to the IRA
• Identify what manufacturers can do to support or address payer responses to the IRA
AMANDA O’HORA, Senior VP, Magnolia Market Access
DONNA SHUFORD LANDIS, Senior Director, Patient Support Services, Magnolia Market Access
14:10 – Pharmaceutical Price Regulation Reforms in Canada: Implications for USA and beyond
• Overview of Pharma Price Regulation in Canada
• Update on significant changes at the Patented Medicine Prices Review Board (PMPRB)
• PMPRB: new basket of 11 reference countries
• Canada / USA cross border trade (separating facts from fiction)
• Outlook and implications
N. DYLAN LAMB-PALMER, Associate Director, Pricing and Data Analytics, PDCI Market Access (Division of McKesson Canada)
14:40 - The evolving role of real-world evidence in HTA decision-making
• Understand the current and future role that RWE is playing and will play in international HTA agencies
• Understand the landscape of RWE guidance and what “good looks like” to HTA bodies
• Considerations for manufacturers when developing real-world evidence generation strategies for reimbursement
ASHLEY JAKSA, Market Access Scientific Strategy Lead, Aetion
15:10 – Afternoon Tea / Coffee & Networking
15:30 – Keynote Panel Discussion: Recent regulatory updates & development
• Updates to the regulatory system - An insight into the future US pricing and market access environment
• Complex regulatory and reimbursement pathways, varied evidence requirements and long procedural timelines pose risk to successful access and launch
• What patient advocacy can do for you?
• Policy issues that affect pricing and reimbursements - Ways to overcome issues
• Effects of upcoming regulatory changes on your access, pricing and reimbursement efforts
• Risk-sharing agreements – what works and what doesn’t?
• Possible increased synergy between HTA and regulatory agencies – Opportunity or challenge for medical devices?
• Working closely - Payers and Gov
Moderator
TED KARNEZIS, Owner, Karnezis Consulting
Panellists
RICHARD LINER, Senior Assistant General Counsel, Bayer
REED STEPHENS, Partner, Winston & Strawn
RUJUL DESAI, Partner, Covington & Burling
SARA SIMON, Attorney at Law, Porzio Bromberg & Newman
16:20 –Market Access & Reimbursement: Best Kept Secrets
Questions every Reimbursement, Trade, and Market Access team members should be asking their service providers to ensure strategies and tactics are in place to overcome access barriers
EMILY PHILLIPS, Founder, Phillips Reimbursement Consulting, LLC
16:50 – Chairperson’s closing remarks and end of conference
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Red Nucleus (RN) are your global strategic partner trusted to deliver transformative solutions across the entire product life cycle.
We have strategically assembled a global team across nine countries, bringing a wealth of diverse expertise across the life science industry to support our clients as they navigate the market realities of today and tomorrow. By integrating RN’s deep scientific, process, training, and market access knowledge with unmatched creativity and digital innovation, we are your trusted partner in developing meaningful strategies, products, and solutions that provide actionable insights and measurable results.
Specifically, the RN Market Access and Commercialization Services (MACS) team partners with pharma and biotech innovators on broader commercial strategy initiatives as well as projects encompassing shaping value, optimizing price and navigating market access. The senior-led MACS team leverages a data-driven and solutions-oriented approach to maximize the commercial success of our client partners.
Visit our website: www.rednucleus.com
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