8th Annual Pharma Pricing, Reimbursement & Market Access USA 2024
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• 30+ Speakers from Sanofi, Sandoz, Takeda, Bayer, Agenus, CSL Behring, Pfizer, Deallus, Merck, AVEO Oncology & 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 Genzyme
DAVID BOWER, Senior Director - U.S. Value & Access – Dermatology, Sanofi Genzyme
Bayer
JARED WORFUL, Global Integrated Evidence Generation Lead, Inflammation & Immunology, Bayer
Jared Worful is currently the Global Integrated Evidence Generation Lead for Bayer’s Inflammation & Immunology portfolio. His team maximizes asset value through the utilization of broad real-world data sources and the development of cross-functionally aligned evidence plans. He also leads the development of data science and automations applications in Bayer which utilize real-world evidence to solve business critical needs. Over his ten plus years at Bayer, he has served in multiple roles across the Commercial and Medical organization at Bayer including Marketing, Market Access, Oncology Strategy, New Production Commercialization and Operational Excellence.
Agenus
BOXIONG TANG, AVP, Head of HEOR & Medical Value Access, Agenus
• Dr. Tang brings over 25 years experiences in medicine, public health, and health economics & outcomes research (HEOR).
• Currently, he is the Associate Vice President, Head of HEOR and Medical Value Access at Agenus, responsible for developing HEOR function and implementing health outcomes research strategies globally. He established HEOR function to support the product launches and reimbursement globally.
• Before joining Agenus, Dr. Tang has served as an Executive Director of HEOR at BeiGene, Sr. Director of Global HEOR at Teva Pharmaceutical. Senior Director of Health Outcomes Research at Pfizer Emerging Markets, Director of HEOR in JNJ and GSK.
• He was also an adjuvant professor of China Fudan University and faculty of Zhejiang University Medical School. Meanwhile, Dr. Tang was the 2016-2018 Chair of the HTA (Industry) Committee, Asia Consortium of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR), and a current member of Asia Consortium Executive Committee. Also, he served as a Sr. Fellow at Thomas Jefferson University, School of Population Health.
• 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.
• He has published more than 40 manuscripts in peer review journals, 100+ abstracts, speeches and presentations in major scientific congresses. 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/ASHE), Society for Medical Decision Making (SMDM), and a Peer Reviewer of America Journal of Managed Care, and Cancer Research Journal.
Jazz Pharmaceuticals
ANASTASIA JOSECK, Associate Director, Patient Advocacy, Jazz Pharmaceuticals
Boehringer Ingelheim
KATYE GEMMA, Director & Senior Counsel II - Market Access, Boehringer Ingelheim
“Katye Gemma is the Director and Senior Counsel at Boehringer Ingelheim. She is a key Value and Access team member, providing critical legal support for market access. With over 20 years of experience as in-house counsel in the Life Sciences industry, her areas of expertise include market access, government pricing, policy, and contracting.”
Merck
ANKA G. EHRHARDT, Director, Cell-Based Assays / Analytical Research & Development, Merck
Dr. Ehrhardt is a biophysicist with a Ph.D. in human physiology. Throughout her career, she focused on driving biomedical research through efficient application of innovative technology strategies. She built and led successful teams in industry. At Merck, she headed a laboratory providing leading technologies for cell-based research from early discovery through manufacturing. At BMS, Dr. Ehrhardt led and grew an international clinical assay team to robustly cover large scale registrational and translational clinical analysis generating clinical decision-driving data and mechanistic insights for studies across disease areas.
Recently, Dr. Ehrhardt fulfilled one of her scientific aspirations at CHDI Foundation, designing and implementing successful clinical biomarker strategies for Huntington’s disease. Currently, at Merck, Dr. Ehrhardt is providing strategic and technical leadership for the development and implementation of industry-leading and QC-friendly cell-based assays and models for potency determination that reflect the unique mechanisms of biologics products in clinical studies and beyond.
Red Nucleus
KYLE CLIFTON, Senior Director, Market Access & Commercialization Services (MACS), Red Nucleus
Kyle has over 15 years’ experience in the life sciences industry with expertise in commercial and market access strategies, access planning, and value communication. At Red Nucleus, he has robust experience in assessing value, setting price, and developing innovative contracts, with specific focus on therapies for rare diseases and oncology. He has also focused on payer strategy, evidence generation, patient and provider access, and reimbursement strategies across settings of care
Certara
CAITLIN VERRILLI, Director, US Access Strategy, Certara
Caitlin Verrilli, MBA, is a Director, US Access Strategy at Certara. She brings experience from across the healthcare industry, including pricing and contracting, market access planning, value-based care, and advanced modelling skills. Caitlin’s specialties include data visualization, Medicaid and Medicare policy and innovation, reimbursement strategies, and modelling.
Prior to Certara, Caitlin worked at Ipsen, where she was a member of the Pricing & Contracting group. She also brings experience from the provider side, helping to implement the NYS Medicaid redesign and as a project manager at NYC Health & Hospitals. She began her career at Simon-Kucher & Partners where she helped develop market access strategies. Caitlin holds an undergraduate degree from Columbia University and an MBA from Columbia Business School.
AstraZeneca
Merck
Magnolia Market Access
AMANDA O’HORA, Senior Vice President, Magnolia Market Access
Amanda O’Hora, is Senior Vice President of Reimbursement and Market Access with Magnolia Market Access. She has more than 26 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. 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 Market Access, Amanda consulted for more than 20 years with life sciences companies on market access, reimbursement, health policy and patient support services engagements. She also managed the day-to-day operations of multiple, outsourced patient services programs, and worked in hospital, physician office and IDTF billing departments. Amanda received her Bachelor of Arts in History from the Florida State University.
Invisible Economics
Dr. Reddy’s Laboratories
DINAKARAN BALASUBRAMANIAN, Head, Commercial Strategy & Insights, Biologics, Dr. Reddy’s Laboratories
Dinakaran is an accomplished commercial professional with rich experience of over 12 years in the pharmaceutical industry. He has an extensive understanding of the US commercial landscape and its key economic drivers, specifically in generic injectables and biosimilars. He is currently serving as the Head of Commercial Strategy & Insights for Biologics in North America for Dr Reddys Laboratories. His role extends to leading pricing strategy for Biosimilar launches, providing insights into the go to market strategy, competitive intelligence, crucial for driving product adoption and profitability objectives.
During his long tenure, he has handled multiple roles across Sales, strategy, pricing, and product management. And has commercial expertise in various areas of pharmaceutical value chain like manufacturing, active ingredients and finished drug products.
Pfizer
Population Health Partners
LISA MOSTOVOY, Senior VP, Next Gen Commercialization, Population Health Partners
Lisa Mostovoy, PharmD, MBA is the SVP, Next Gen Commercialization, at Population Health Partners (PHP). Prior to joining PHP, Lisa led Payer Partnership at EQRx. Lisa’s team was responsible for building meaningful, long-term, strategic partnerships with US payers and developing innovative commercial contracts. Prior to EQRx, Lisa served in a number of leadership positions at Blue Cross Blue Shield Association (BCBSA) and was responsible for pharmacy strategy and innovation across the Blues. Prior to BCBSA, Lisa managed national employer groups at CVS Health focusing on overall clinical strategy, management of complex custom formularies, utilization management, and benefit design.
Lisa completed a managed care residency with CVS Health, holds a Bachelor of Biology from Stevenson University, Doctor of Pharmacy from University of Maryland, and Master of Business Administration from University of Baltimore. Throughout Lisa’s professional career, her passion has been and remains - lowering the cost of and making life-saving therapies accessible for all.
NAHPC
AI MINDSystems
HEATHER LEIGH FLANNERY, CEO & Co-Founder, AI MINDSystems Foundation
Heather Leigh Flannery is an applied futurist, policy and patient advocate, and complex systems theorist. She is CEO at AI MINDSystems Foundation, a nonprofit she co-founded in March 2024 with Chief Scientific Officer, Sean Manion, PhD, and other industry leaders with a timely vision for structural interventions for humanity's health, safety, prosperity, and privacy. Heather is also the Chair of the Healthcare & Life Sciences Working Group at the Government Blockchain Association (GBA), Chair of the Washington, DC Chapter of AI 2030, develops standards at IEEE, and serves as the Women Economic Forum G100 USA Northeast Regional Chair for Humanity, Technology & Innovation.
Prior to AI MINDSystems Foundation, Heather was the Founder and CEO at Consensys Health, which began in 2018 incubated within Consensys. Consensys Health was spun-off March 2020, and rebranded to Equideum Health January 2022. Equideum Health focused on blockchain-facilitated, multi-party decentralized AI and analytics, collaborative (federated) machine learning, privacy enhancing technologies (PETs), and web3 identity and verifiable credentials for granular, dynamic consent. Initiatives include veterans health, decentralized trials (DeSci) and Clinical Research as a Care Option (CRAACO).
Prior to Equideum Health, in 2009 Heather founded Obesity Prevention, Policy, and Management, Inc. ("Obesity PPM"), a digital health tech-enabled services company with innovations in capitated, multi-specialty chronic disease and acute care management, population health, research administration, and market access for new United States FDA-approved treatments.
From 2015, Obesity PPM sought to adopt blockchain to improve its "Managed Ecosystems for Integrated Obesity Treatment." Heather became an expert on the barriers to blockchain adoption in health, and co-founded a trade association for industry self-regulation and evidence-based policy, Blockchain in Healthcare Global (BiHG) under IEEE ISTO. She continues as a patient advocate for ending discrimination against people with obesity. Obesity PPM focused on weight bias and evidence-based treatment as primary prevention of obesity's comorbidities, including 16 hormone-sensitive cancers and the full cardiometabolic disease spectrum.
Heather has driven business model innovation throughout her 30-year career. She builds organizations through values-alignment: impact, inclusion, sustainability, and a global focus informed by her work in global health, development, and deep tech diplomacy.
IMRSV Insights
GREGOR BENDER, CEO and Co-founder, IMRSV Insights
Gregor Bender, Pharm.D., is the CEO and Co-founder of IMRSV Insights, where he leads innovations in decentralized and personalized pragmatic clinical trials. With experience at major pharmaceutical companies, including Pfizer, GSK, and Wyeth, Gregor has specialized in pharmacometric modeling and simulation across various therapeutic areas in preclinical and clinical research. He holds a Pharm.D. from the University of Pittsburgh and completed a prestigious postdoctoral fellowship at the Leiden/Amsterdam Center for Drug Research.
Under his leadership, IMRSV Insights aims to revolutionize the industry through AI-driven spatial computing solutions, enhancing cost management, improving patient access, and enabling pharmaceutical companies to leverage real-world data. His work aims to reduce the costs of clinical research while empowering individuals with efficient solutions that deliver actionable insights to drive personalized healthcare.
Avalere Health
AYESHA AZAM, Associate Principal, Avalere Health
Ayesha Azam is Associate Principal at Avalere Health, a strategic advisory firm and commercialization partner. She advises life sciences clients on policy, commercialization, and patient access strategies in response to a complex, evolving healthcare landscape. Before joining Avalere, Ayesha served on the executive leadership team at the Patient Access Network Foundation, leading programmatic and clinical strategy and building sustainable, strategic partnerships.
Her areas of expertise include industry outlook, patient-centered outcomes, and health equity. Ayesha began her career at the Cystic Fibrosis Foundation where she developed programs and tools to increase access to care for patients. Ayesha holds an MS in health administration informatics from the University of Maryland and is a certified Lean Six Sigma Black Belt.
CLF
SUSAN THORNTON, CEO, Cutaneous Lymphoma Foundation
Susan Thornton serves as the CEO of the Cutaneous Lymphoma Foundation, a worldwide nonprofit that empowers, educates and supports people diagnosed with this rare cancer. In addition, she serves as Board Chair for the Lymphoma Coalition and has held leadership positions as Vice Chair of the International Alliance of Dermatology Patient Organizations (IADPO) and Vice Chair of the Coalition of Skin Diseases. She also served on the planning committee that hosted the first International Dermatology Patient Organization Conference held in Vancouver, BC and was a founding member of IADPO. Susan has recently been elected to serve as Vice Chair of the newly created World Skin Health Coalition which brings together patient organizations, industry and the clinical community to bring focus to the impact of skin conditions around the world.
Prior to joining the CL Foundation in a professional capacity, Susan served on the Board of Directors and provided consulting services to the Foundation. Her professional career before coming into the nonprofit sector, was in healthcare technology where she spent over 25 years in various consulting, marketing and sales positions.
Susan holds a business degree from The University of Pennsylvania Wharton School and completed the Non-Profit Certification Program at the University of Pennsylvania. In addition to her CL Foundation Board service, she served on the boards of the Leukemi & Lymphoma Society, Eastern Pennsylvania Chapter, Tristate Multisport Association and the Sierra Club, Philadelphia Chapter. A native of Philadelphia, Susan has completed 17 triathlons, including a 1/2 Ironman in 2004, raising money for cancer research.
Winston & Strawn
Wiggin and Dana
LATHAM & WATKINS
CHRISTOPHER H. SCHOTT, Partner, LATHAM & WATKINS
Chris primarily advises on price reporting and other compliance obligations related to the Medicaid, Medicare, and 340B drug pricing programs, with a focus on market access. He combines extensive regulatory insight with deep industry knowledge to support pharmaceutical clients at all stages of the product life cycle. Market entrants and investors also seek Chris’s advice when evaluating potential opportunities and strategies.
The drug pricing policy landscape is ever evolving. For example, the Inflation Reduction Act is significantly impacting the pharmaceutical industry, and clients turn to Chris to put these developments into perspective and provide strategic advice.
Chris assists clients through policy advocacy, such as by evaluating legislative and policy proposals, drafting white papers, and meeting with stakeholders. Chris also helps pharmaceutical manufacturers proactively engage with federal regulators through in-person advocacy and comment drafting. Additionally, he frequently advises drug manufacturers seeking guidance from regulators regarding specific issues or commercial proposals.
Methodologies and reasonable assumptions that support the periodic certification and submission of price reporting metrics are at the heart of compliance with the federal programs, and Chris frequently advises clients in connection with reporting Average Manufacturer Price and Best Price under the Medicaid
Drug Rebate Program, Average Sales Price under Medicare Part B, and the 340B ceiling price. The definitions of the price types and how the federal programs use the data are relevant to many different facets of the pharmaceutical business, which is why Chris bases his counsel on a full consideration of the client’s product portfolio, distribution model, and strategic goals.
Chris draws on his regulatory knowledge and understanding of the pharmaceutical industry to support a range of corporate transactions, including acquisitions and divestitures, as well as licensing and copromotion arrangements. He regularly helps clients evaluate the impact of price reporting requirements on proposed mergers and acquisitions, as well as to navigate due diligence matters and the post-closing transition of regulatory responsibilities.
Meet and to network with your conference colleagues.
JACK DOWNEY
09:00 – Chairperson Opening Remarks
PETER BARSCHDORFF, Vice President, Deallus
JACK DOWNEY
09:10 – New Trends of Health Technology Assessment (HTA) in Supporting Reimbursement Decisions around the world (EU & US) and Applications
• Updates of US & EU HTA Process and Policies for Market Access and Reimbursement
* New Development of Joint Clinical Assessment (JCA) in EU
* New Development of Drug Reimbursement in the US (IRA & ICER)
• Key role of Patient Reported Outcomes (PRO) and Clinical Outcomes Assessment (COA) in Patient Focused Drug Development Programs
• Importance of developing a value-based market access and reimbursement strategy
BOXIONG TANG, AVP, Head of HEOR & Medical Value Access, Agenus
JACK DOWNEY
09:50 – Drug price negotiation under the IRA
KATYE GEMMA, Director & Senior Counsel II - Market Access, Boehringer Ingelheim
JACK DOWNEY
10:30 – Morning Coffee / Tea & Networking
JACK DOWNEY
11:00 – Panel Discussion with experts: Optimizing market access and commercialization of new drugs through Real-World Evidence
• Are you set up for success? Let’s get real about building insightful real-world evidence
• Build integrated RWD and analytics solutions to generate actionable insights and improve patient outcomes
• Navigate the use of RWE to educate payers on treatment effectiveness and guide their reimbursement decisions
• Refine your RWD strategy based on emerging feedback from stakeholders to continue maximizing patient value
• Accelerate medical excellence by leveraging RWE and tech advancements
• Examine diverse methodologies and models employed in data collection to derive real-world evidence
• Developing and implementing an approach to using RWE in HTA
• Complexities surrounding data ownership and utilization, while implementing optimal strategies
• Improve your submissions and decisions through better collaboration on gathering real world evidence
Moderator
PETER BARSCHDORFF, Vice President, Deallus
Panelists
JARED WORFUL, Global Integrated Evidence Generation Lead, Inflammation & Immunology, Bayer
BOXIONG TANG, AVP, Head of HEOR & Medical Value Access, Agenus
YONG CHEN, Sr. Director, Real World Evidence, Oncology, Pfizer
YAOZHU (JULIETTE) CHEN, Outcomes Research Lead, AstraZeneca
JACK DOWNEY
11:50 – Impact of Product Characteristics on Evidence, Value, Access, & Pricing Strategy in the US
• Overview of key elements involved in product development strategy
• Evaluation of specific product/asset development situations (including same product with same dosing in multiple indications, same product with varied dosing in multiple indications, same product with variable dosing in multiple indications) and how they impact evidence planning and generation, value, access, and pricing strategy
• Review recent real-world examples of each situation
• Key learnings that manufacturers can incorporate into their own development strategy/pipelines
KYLE CLIFTON, Senior Director, Market Access & Commercialization Services (MACS), Red Nucleus
JACK DOWNEY
12:20 – Networking luncheon
JACK DOWNEY
13:30 – Panel Discussion with experts: Improve patient access - Accelerating patient access to innovative interventions
• Prioritizing patient-centred care - Adding value through an innovative patient-centred approach
• How patient perspectives add value to access decisions
• Partner with patients / Develop value-based relationships with reimbursement stakeholders
• Patient centricity in value and price assessment
• Drive for better patient centricity from a pharma perspective
• Role of healthcare ecosystem in bringing treatment closer to patients.
• The role of the patient voice in market access
• Are you really listening to your patients? - Explore new feedback models
• Good collaboration between payers and pharma companies to ensure patient access
Moderator
AYESHA AZAM, Associate Principal, Avalere Health
Panellists
ANASTASIA JOSECK, Associate Director, Patient Advocacy, Jazz Pharmaceuticals
SUSAN THORNTON, CEO, Cutaneous Lymphoma Foundation
MARGARET REHAYEM, Former VP, National Alliance of Healthcare Purchaser Coalitions
JOLIE APICELLA, Partner, Wiggin and Dana
LISA MOSTOVOY
14:30 – Payer and Other Stakeholder Prospectives – An Actuarial View
• Understand how Part D and commercial payers value formulary financial decisions while balancing clinical considerations
• Describe the financial liability and risk differentiation between PBMs, GPOs, and payers
• Learn how Part D and commercial payers examine selection and utilization risk in determining formulary access
• Review a case study on how drug manufacturers establish pricing that aligns with payer net liability concerns
STEPHEN GEORGE, Senior Consultant, Milliman
PAMELA LABOY, Consulting Actuary, Milliman
LISA MOSTOVOY
15:00 – Afternoon Tea / Coffee & Networking
LISA MOSTOVOY
15:30 – WAC Marketing: The Potential for Price Messaging in the Pharmaceutical Industry
• Several case studies indicate a need for framing pricing with clear and transparent communication
• Recent examples demonstrate a variety of strategies in price-focused messaging
• There are both benefits and challenges of proactive and/or reactive approaches
• Some considerations: potential obstacles and limitations to price-focused messaging
ERIC BACHMAN, Founder, Invisible Economics
LISA MOSTOVOY
16:00 – What does Digital Accessibility Mean for Pharma
With the Americans with Disability Act (ADA) in place for nearly 34 years (July 26, 1990), the awareness and practice of digital accessibility has experienced a remarkable crescendo in recent years – becoming a central tenant of Diversity Equity & Inclusion (DE&I), Environmental Social & Governance (ESG), and the Social Determinants of Health (SDOH). With the rising tide of global legislation (the nice-to-have becoming the must-have), explore the potential implications to clinical trial drug development, manufacturing, and commercial for the inclusive patient and consumer experience.
STEPHEN FRAMIL, Corporate Global Head of Accessibility, Merck
LISA MOSTOVOY
16:40 – Chairperson’s closing remarks and end of conference day 01
LISA MOSTOVOY
16:50 – 18:00 – Networking Drinks
JACK DOWNEY
09:00 – Chairperson Opening Remarks
JACK DOWNEY
09:10 – Reinventing the Digital Formulary: Decentralized Science (DeSci), Data Economics, and Ethical AI
• Understand challenges that have prevented Digital Formularies from being adopted at scale, their potential value-based agreement (VBA) interactivity with drug formularies, and the new business models that can be enabled for digital diagnostics, digital therapeutics, and drug companion apps;
• Understand the burgeoning new field of DeSci, and the potential of the reinvented Digital Formulary to manifest the vision of DeSci - from decentralized and adaptive trials, to pragmatic trials, registry sciences, and real-time, real-world evidence;
• Understand the current data economy at a high level, and the vital role that new data economics and market architectures play in creating, scaling, and sustaining the reinvented Digital Formulary
• Understand ethical AI fundamentals and a series of key innovations, and the role of the reinvented Digital Formulary in bringing about the spirit and intent of emerging AI regulations while creating new distribution, contracting, and person-centered demand-generation digital diagnostics and digital therapeutics.
HEATHER LEIGH FLANNERY, CEO & Co-Founder, AI MINDSystems Foundation
JACK DOWNEY
09:50 – Boost or bust? Evaluating the impact of the IRA’s enhanced reimbursement on biosimilars uptake
• Trends in oncology biosimilars uptake and market share
• The relationship between awareness of IRA enhanced reimbursement and utilization of biosimilars at oncology treatment sites
• Facility characteristics associated with level of biosimilar utilization
• What’s next? Expectations over the final years of the initiative as a wave of new biosimilars enter the market
CAITLIN VERRILLI, Director, US Access Strategy, Certara
JACK DOWNEY
10:20 – Morning Coffee / Tea & Networking
JACK DOWNEY
10:50 – Keynote Panel Discussion: Working & staying Connected for better health – Stakeholders / Industry / Payers / Physicians / Patients
• Pharma market access & pricing environment - Current challenges and solutions as seen by payers, employers and providers
• Increase your product’s value proposition to payers to accelerate access
• Role of HEOR teams to navigate policy transformations
• Impact of IRA on strategic pricing and contracting
• Aligning your pharma’s strategy to payer priorities
• Importance of creating long-lasting relationships with payers and advocacy groups
• Effective communications stakeholders and its importance
• Improve your market access strategy by understanding what private payers want
• From PI to Payer to Patient: RWE From the Perspective of Each Key Stakeholder
• Rise of Payors - Collaborating with them to achieve market access
• The new normal - Pioneering digital stakeholder engagement
• Multi-stakeholder collaboration for access to drugs
Moderator
ANKA G. EHRHARDT, Director, Cell-Based Assays / Analytical Research & Development, Merck
Panellists
JOAQUIN F. MOULD, Global HEOR & Value Strategy Director, CSL Seqirus
CHERYL ROCHE ALEXANDER, Account Experience Specialist, UCB
LISA MOSTOVOY, Senior VP, Next Gen Commercialization, Population Health Partners
DINAKARAN BALASUBRAMANIAN, Head, Commercial Strategy & Insights, Biologics, Dr. Reddy’s Laboratories
JACK DOWNEY
11:40 – Cracking the Code: Developing and Implementing Coding Strategies for Your Product
• Regardless of what kind of product you have, understand why you need a coding strategy
• Review the key medical coding systems used in the U.S., what they are used to report, who uses them, and how to apply for them
• Discuss key considerations for developing a coding strategy
• Examine research findings and case studies that illustrate coding challenges that need to be addressed
AMANDA O’HORA, Senior Vice President, Magnolia Market Access
JACK DOWNEY
12:10 – Networking luncheon
JACK DOWNEY
13:20 – Keynote Panel Discussion: Successful pricing strategy to widen your market access
• Global market access trends predicting the future
• U.S. Inflation Reduction Act, and its implications
• Considerations for a successful drug launch in today’s environment
• Strategies to improve a better payer relationship
• Latest developments in pharma pricing and market access in the US
• Evidence driven pricing and reimbursement strategy
• The new normal: HTA & Reimbursement challenges
• Staying ahead in the race - Update on pricing and market access in USA, EU & RoW
• Implications for companies – What to Prepare for future
Moderator
HEATHER LEIGH FLANNERY, CEO & Co-Founder, AI MINDSystems Foundation
Panellists
DAVID BOWER, Senior Director - U.S. Value & Access – Dermatology, Sanofi Genzyme
RODNEY EMERSON, Vice President, Pricing & Contracts, Sandoz
MARTIN ROST, Former Vice President, Market Access (Global), Pfizer
GREGOR BENDER, CEO and Co-founder, IMRSV Insights
JACK DOWNEY
14:10 – Panel Discussion with experts: Recent regulatory updates & development – Making the best of the situation
• Updates to the regulatory system - An insight into the future US pricing and market access environment
• Collaborating closely with regulatory authorities to expedite the approval process and aligning with payer requirements
• The differing approaches of the healthcare systems of the EU and the United States, and how the changes in HTA regulations can affect all parties involved
• 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?
• Risk-sharing agreements – what works and what doesn’t?
• Possible increased synergy between HTA and regulatory agencies – Opportunity or challenge for medical devices?
• Effects of upcoming regulatory changes on your access, pricing and reimbursement efforts
• Working closely - Payers and Gov – What is the way forward?
Moderator
PETER BARSCHDORFF, Vice President, Deallus
Panellists
HEATHER LEIGH FLANNERY, CEO & Co-Founder, AI MINDSystems Foundation
REED STEPHENS, Partner, Winston & Strawn
CHRISTOPHER H. SCHOTT, Partner, LATHAM & WATKINS
JACK DOWNEY
15:00 – Chairperson’s closing remarks and end of conference
JACK DOWNEY
15:40 – Afternoon Tea / Coffee & Networking
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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
Certara Evidence & Access
An exponential rate of innovation, increased competition, and the growth of cost containment pressures create a greater need to comprehensively establish the value of health care interventions. Certara’s integrated approach allows global market access teams to optimize product value, positioning, and evidence synthesis across all stages of the reimbursement journey. Our combination of strong science as well as empathy with public health decision-makers’ challenges is the key to effective market access and the central philosophy of the Certara Value & Access consultants.
Assessing and optimizing therapeutic value are central to all our activities. Through our work with regulatory agencies, ICER organizations, payers, biopharma, med-tech and investment funds, we have developed an array of methods to assess the value of health interventions. This enables Certara to address the variety of situations and points of view faced by stakeholders of the healthcare systems.
www.certara.com
Today’s ever-growing healthcare complexity only increases the financial burden being passed on to patients and risk-bearing entities. At Milliman, we work with clients across the healthcare spectrum to control costs, expand coverage, and untangle regulatory complexity to improve the health and well-being of people everywhere.
Navigating today’s most pressing health industry challenges with a leading global expert by your side.
• Top 50 largest US health plans engage Milliman
• Milliman performed more than 50% of the MAPD and PDP bids
• Milliman is involved in over 70% ACA health plan filings
• Milliman has access payer claim line data; 80 million commercial lives and 7 million Part D lives
We pair real-world payer data with world-class actuarial methodologies to empower the biotech industry with unprecedented clarity and insight into their product access decision process—resulting in:
• Deeper patient understanding
• Optimized market strategies
• Access to the financial implications of all stakeholders
Answers to key questions like:
• How does my formulary and access strategy fare in my market?
• What is the evidence-based burden of care of my target population?
• How do my target patients compare to patients with other conditions or characteristics?
• How will potential legislative changes affect my asset?
For more information contact Stephen George PharmD MS stephen.george@milliman.com TAMPA OFFICE
Visit our website: www.milliman.com
For professionals in the pharmaceutical, biotech, and consulting sectors aiming to deepen their understanding of US market access, resources are often limited. Experts with a decade of experience in this field frequently receive requests for mentorship, insights on critical topics, and foundational guidance. While there is a clear demand for enhanced education in these areas, placing additional burdens on those in market access leadership is not a viable solution. This need inspired the creation of Invisible Economics.
Invisible Economics seeks to bridge the gap between theory and practice across seven essential domains of US market access. Our meticulously designed curriculum adapts to the ever-evolving landscape, uncovering the intricate nuances of healthcare and highlighting the significant influence of market access on decision-making. Through our courses, industry professionals can gain vital knowledge and skills in US market access—knowledge that has traditionally been acquired only through lengthy apprenticeships.
Whether you are building a consulting team, training a healthcare field team, or developing the next generation of market access leaders in your organization, we look forward to partnering with you to provide the most robust educational opportunities in the industry.
Visit our website : www.invisibleeconomics.com
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