JACK DOWNEY - Virtue Insight

20th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 2

09:00 – Chairperson Opening Remarks

20th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 2

DIGITAL ACCESSIBILITY

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

20th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 2

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

20th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 2

10:20 – Morning Coffee / Tea & Networking

20th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 2

WORKING TOGETHER

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

20th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 2

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

20th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 2

12:10 – Networking luncheon

20th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 2

CHALLENGES & OPPORTUNITIES

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

20th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 2

REGULATION OVERVIEW & UPDATE

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

20th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 2

15:00 – Chairperson’s closing remarks and end of conference

20th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 2

15:40 – Afternoon Tea / Coffee & Networking

19th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 1

09:00 – Chairperson Opening Remarks

PETER BARSCHDORFF, Vice President, Deallus

19th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 1

HTA

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

19th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 1

09:50 – Drug price negotiation under the IRA

KATYE GEMMA, Director & Senior Counsel II - Market Access, Boehringer Ingelheim

19th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 1

10:30 – Morning Coffee / Tea & Networking

19th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 1

RWE

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

19th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 1

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

19th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 1

12:20 – Networking luncheon

19th September 8th Pharma Pricing, Reimbursement & Market Access 2024 – Day 1

PATIENT ACCESS

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

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

08:00 – Coffee and registration

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

08:50 – Morning Chair’s opening remarks

RAM BALANI, CEO / Founder, eSTARHelper (USA)

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

INTELLECTUAL PROPERTY

09:00 – “Securing a Resilient Supply Chain Through Dynamic Partnerships – Introduction to the Intellectual Property Rights Coordination Center”

BRIAN ANDERSEN, Special Agent / National Program Manager, Homeland Security Investigations (HSI)

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

DSCSA REGULATORY PREPAREDNESS

09:30 – “Boosting DSCSA Regulatory Preparedness for FDA’s Drug Supply Chain Security Act Compliance with Microsoft Copilot Integrated Generative ChatGPT - 4 AI / ML”

• Why DSCSA was created by US Congress, brief history, overview of FDA DSCSA pilot project final assessment reports
• Who’s who and what’s what with DSCSA trading partner roles, some mandates apply to all drug industry stakeholders others not, l earning requisite trading partner roles challenging!
• Discuss why many remain unprepared highlighting the search gauntlet with US FDA.Gov website hosted regulatory contents (Guidance & 21 CFRs, abysmal metadata searching) vs. the fallback alternative with Google search -there’s better ways now
• Illustrate Microsoft Copilot & chatbot platform / technology with underlying OpenAI generative AI/MLLLM under the hood- also Microsoft Bing boosted (RAG-Retrieval Augmented Generation) emphasizing cautionary caveats on inherent AI/ML bias
• Extending Microsoft Copilot with proprietary enterprise data including hosted on Sharepoint Online tenant sites, utilizing Microsoft Search Full-Text search (.e.g. Smart-Search+) to fact check or verify generative response accuracy by You-the-Human !

RAM BALANI, CEO / Founder, eSTARHelper (USA)

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

10:00 – FDA’s Office of Criminal Investigations - Online Pharmacies and Counterfeit Drug Investigations

• Overview of FDA OCI
• Overview of a Rogue Online Pharmacy Network
• Case Examples of Online Pharmacy Network and Counterfeit Drug investigations

DEREK ROY, Resident Agent in Charge, FDA Office of Criminal Investigations

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

10:50 – Morning Coffee & Networking

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

11:20 – Product Authentication in a Counterfeit World

• Advanced technologies and the ease of knowledge transfer has fostered a more difficult environment for authentication solution providers and users.
• Effective solutions need consumer engagement and participation in the authentication process, requiring easy to recognize yet hard to replicate tamper-evident or destructive overt features, along with covert or forensic features known only to your company.
• Ease of implementation into the existing supply chain and manufacturing process is possible with even the most advanced solutions.

NEIL IVEY, VP, Authentication Solutions, SICPA Securink

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

SERIALIZATION / DSCSA

11:40 – Panel Discussion with the experts – Serialization and track & trace - DSCSA compliance and 2024 implementation timeline

• DSCSA compliance and 2024 implementation timeline
• Complying With the DSCSA
• Current operational issues associated with traceability implementation
• The long-term data advantage of Track & Trace
• Technology and the future of drug traceability.
• Progress in packaging and serialization.
• When misalignment happens, what do you do?
• The road ahead for pharmaceutical track-and-trace.

Moderator
RAM BALANI, CEO / Founder, eSTARHelper (USA)

Panellists
SEBASTIEN MAUEL, Head of Serialization & Product Security, Ferring Pharmaceuticals
JOSE CAMARA SANTIAGO, CEO, Camara Validation & Consulting Services
JACK DOWNEY, Solutions Architect Manager, Systech
GLENN TAMIR, President, Biomedical Enterprises

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

12:30 – SATT PLATFORM in Azure protected by Microsoft - Inside look at the development of the most secure Тrack and Тrace system

• Global track and trace compliance – ensure a swift response to market demands;
• Reduction of supply chain complexity – optimize the processes and procedures;
• Seamless integration with other hardware/software vendors;
• Data security – advanced reliability and availability directly through Azure;
• Unparalleled scalability and flexibility – enable seamless scaling of services;
• Cost-efficiency – improve operational effectiveness and maximize the investment;
• Efficient resource management – ultimately enhancing productivity.

VENELIN DIMITROV, CEO, SoftGroup

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

13:00 – Networking luncheon / Exhibition Visit

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

14:00 – Assessing Serialization Readiness and Compliance in M&A situation.

• Create awareness among the technical experts (the audience) the significance of serialization in the bigger picture; engaging in a conversation with the M&A generalist (me); opening slides from me, open up for discussion- if there is interest create a white paper out of it.
• Pay top dollars to buy, can lose the business quickly if shipment to customers is at risk, any factors that put this at risk, last few years Serialization has been the elephant in the room
• Two parts of the processes - Diligence pre buying / Integration post buying
• Either situation assess, factor in Serialization – infrastructure, quality of documentation, processes, people from a seamless business continuity perspective in - Own Plants / Partner Plants
• INTEGRATION - Switch or not to switch packaging lines
• Serialization Workstream how it would fit into the other Integration workstreams.
• Executing, seamless to the customer.

RAHUL SAIKIA, Head of M&A, Chief Strategy Officer, Rising Pharmaceuticals

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

14:30 – Drug Enforcement Administration - Diversion Control Operations

TODD BOYETT, Chemical Investigations Section, Diversion Control Division, Drug Enforcement Administration (DEA)

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

SMART TECHNOLOGIES

15:00 - Use of Smart Technologies to Improve Track and Trace of Pharmaceuticals

• An overview of the Axia Institute Smart Research Platform
• RFID as an enabler of pharmaceutical traceability required by DSCSA
• RFID and NFC as enablers of anti-counterfeit and medication adherence

BAHAR ALIAKBARIAN, Sr. Director, R&D, Axia Institute, Michigan State University

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

REGULATORY

15:30 – Panel Discussion: Regulatory Perspective-Recent DSCSA updates and Global developments

• Organisations and agencies work together and its importance / maintaining visibility and transparency
• Recent evolving regulatory frameworks towards counterfeit drugs
• Most recent track and trace regulations
• Online counterfeits – working together with the regulators to overcome this issue
• Update – Enforcement policies and guidelines
• Role of the Pharmaceutical Companies / Regulators
• What’s the way forward?

Moderator
RAM BALANI, CEO / Founder, eSTARHelper (USA)

Panellists
CEM AYDIN, Associate Director - Team Lead Logistics and Warehouse, MorphoSys
BAHAR ALIAKBARIAN, Sr. Director, R&D, Axia Institute, Michigan State University

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

16:10 – Chairperson’s closing remarks and end of conference

27th June 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024 – Day 2

16:15 – Networking Tea / Coffee & End of 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024