Nick Milazzo and Jyoti Bansal

A deep dive into advanced IRP topics, their impact on pricing, and evolving rules. This session covers cutting-edge IRP techniques and hands-on exercises with NAVLIN IRP to tackle complex challenges, including:

- Identifying informal rule behaviors

- Portfolio forecasting

- Developing a list price policy with IRP

- Assessing in-line BD&L opportunities

Gain expert insights and practical skills to navigate the complexities of IRP effectively.

Gerardo Peccia

Featuring a revamped, more challenging bidding format for our interactive tender game, plus expanded content on negotiation and bidding theory.

Dr. Richard Wenzel and Shivani Shah

The speakers take all participants onto the journey of estimating PICOs as used in the EU JCA process. All steps will be illustrated with hands-on examples.

Alan Crowther and Heather Rae Martin

A review of current policy changes, upcoming proposals, and insights on the future of healthcare policy under the Trump administration.

Dr. Richard Wenzel, Dr. Ray Gani, Shivani Shah

This session explores the role of data in enhancing the planning and creation of HEOR models, including CE, BIM, and ITC. Our co-moderators from HEOR and PMA Consulting will talk about current data challenges developing state-of the art HEOR models, their impact on HTA submissions, and commercial outcomes. Several case studies will allow attendees to gain practical knowledge on leveraging data for improved planning and implementation in HEOR models.

Alan Crowther, Charles Moun, Gary Watson and Gustav Ando

Engage with our leaders to review key accomplishments over the past year, upcoming changes, product direction, and roadmap insights. Exclusive to NAVLIN customers.

An update on NAVLIN, Global Value, Evidence, Price & Market Access environment to kickoff to our event.

Insights into our progress—what we’ve built, what’s in development, and how we’re making it happen. We’ll highlight key milestones, upcoming initiatives, and the strategies driving our success.

This session explores the impact of recent policy shifts across global markets, including IRA implementation, inflation-linked rebating, HHS pricing policy, tariff and tax reforms, preferential pricing for local manufacturing, R&D-based price guardrails, manufacturing incentives for foreign investment, and many others. Attendees will learn about some of the strategic responses the industry is considering and implementing, such as supply chain diversification and product innovation, to navigate these evolving challenges. Additionally, they will understand how these changes can impact your roles within your companies. Gain insights into adapting through upskilled teams, agile planning, and leveraging technology to ensure strategic alignment and maintain competitive advantage across diverse markets.

A well-executed global Early Access Program (EAP) can accelerate revenue, expedite approvals, and enhance market access. However, missteps can create significant pricing and policy risks. This session will explore how to develop and implement a strategic EAP while effectively managing potential challenges to ensure long-term success.

In its second year, this enhanced survey provides deeper insights, refined metrics, and a more comprehensive view of pricing operations. Learn how to improve benchmarking accuracy and deliver greater value for strategic decision-making.

Learn how to efficiently create comprehensive product price and access landscapes while streamlining competitive tracking. This session will showcase strategies and tools to enhance speed, accuracy, and ease in monitoring market dynamics.

Prof. Schlander will explore the strategic importance and benefits of early advise consultations for pharmaceutical manufacturers. Focus will be on the key agencies G-BA, HAS, NICE with examples of global trends. Topics will include: choice of surrogate endpoints and targeted subpopulations for HTAs, and the optimal use of Patient Reported Outcomes (PROs) data in the context of international HTA trends, including the relevance of socioeconomic burden.

Join a dynamic roundtable featuring former payers and key industry influencers as they tackle your questions on access, reimbursement, and other critical topics in a fast-paced, open forum. Gain rapid insights across multiple markets in this unique opportunity for direct discussion. Space is limited—additional registration is required.

Payers:

• Omar Ali, U.K.
• Jaime Espin, Spain
• Dr. med. Detlev Parow, Germany
• Jean-Claude Castanier, France
• Fabrizio Gianfrate, Italy
• JL (Hans) Severens, Netherlands

Smaller biotech launches, whether from a smaller organization or a narrowly targeted therapy at a large organization that does not get the same resources, is a critical aspect of launch. This session covers how to enable smaller launches and what the implications are more broadly for the organization and how to communicate efforts to all stakeholders.

Join a dynamic roundtable featuring former payers and key industry influencers as they tackle your questions on access, reimbursement, and other critical topics in a fast-paced, open forum. Gain rapid insights across multiple markets in this unique opportunity for direct discussion. Space is limited—additional registration is required.

Payers:

• Omar Ali, U.K.
• Jaime Espin, Spain
• Dr. med. Detlev Parow, Germany
• Jean-Claude Castanier, France
• Fabrizio Gianfrate, Italy
• JL (Hans) Severens, Netherlands

Quick review of current state of AI in price & market access and a discussion with several panelists and their view of where AI is going in Price & Access.

As precision medicine reshapes therapeutic development, the road to patient access grows increasingly complex. Diverging global approaches to companion diagnostics and NGS reimbursement are redefining how we plan, collaborate, and deliver innovation. This session offers a strategic lens on navigating these evolving dynamics—and challenges you to rethink how access can be embedded from development through lifecycle management.

JCA is now live in the EU, and companies are already actively submitting dossiers. But the impact of Joint Clinical Assessment goes far beyond added complexity during EMA approval—it spans the entire product lifecycle. From early PICO planning and leveraging AI to accelerate insights, to strategic decisions about Joint Scientific Consultations before Phase III, and executing the JCA itself with a focus on indirect treatment comparisons (ITCs), a strategic approach is essential.

Join our experts Pamela Vo, Dr. Richard Wenzel, and a special guest from industry as they discuss how to navigate JCA with foresight and impact.

Effectively measuring and communicating price and market access success to senior executives, boards, and investors is more critical than ever. This session explores strategies for showcasing P&MA impact, the growing presence of these discussions in board meetings and investor calls, and how P&MA teams can proactively prepare themselves to meet the opportunity.

Join us for a discussion on assessing early asset valuation through a price and market access lens. We’ll explore the role of AI in predicting asset value, key considerations for early-stage evaluation, and strategies to drive informed decision-making.

Explore key tender pricing trends and discover how AI-powered analytics can enhance the analysis of real-world tender data for deeper market insights. This session will showcase strategies for leveraging NAVLIN Tender Data and AI-driven tools to drive smarter pricing and market access decisions.

Horizon scanning is essential for staying ahead of policy changes, access and reimbursement shifts, and competitive market dynamics. This session explores cutting-edge approaches to horizon scanning and how to leverage it for strategic decision-making.

Learn how to forecast, prepare for, and execute a successful strategy around loss of exclusivity. Whether defending the value of your asset or planning a biosimilar launch, this session will provide key strategies, best practices, and examples of how AI and modeling can help you stay competitive in a dynamic market.

Explore new ways to think about early launch planning and sequencing beyond major markets. This session will provide fresh perspectives and strategies to optimize pricing decisions and maximize market success.

Join us for a session on innovative ways to use IRP and NAVLIN IRP Express to address challenges beyond "mandatory price changes." Discover how these tools can enhance Business Development & Licensing (BD&L), competitor insights, and more to drive strategic decision-making.

Global Gross-to-Net forecasting is evolving, and pricing teams must ensure their approach aligns with finance, internal processes, and external policy changes. This session will focus on how to adapt forecasting strategies to avoid surprises and maintain accuracy across the organization.

A review of key trends in oncology pricing and access - the dominant therapeutic area for new drug approvals and major driver of payer budgets.

Gene therapy now represents 10% of new approvals, with a growing pipeline and increasingly complex launches. This session will explore the future of gene therapy and provide insights on how Price & Market Access professionals can prepare as their companies enter gene therapy licensing deals for the first time.

Discover the all-new version of NAVLIN Mobile and how it’s designed to meet all your needs, directly from your mobile phone. Experience the convenience of accessing key tools and insights wherever you are, whenever you need them.

Speed and Insights have become the ultimate competitive advantage in market access and reimbursement. Every delay in deciding on and securing an access agreement or payer approval means lost revenue, missed market opportunities, and—most importantly—patients left waiting for life-saving treatments. But how can pharma companies accelerate decision-making in an increasingly complex and data-driven environment? In this session, Girisha Fernando, CEO of Lyfegen, will unveil game-changing Data Insights and AI-powered approaches that dramatically speeds up drug pricing and reimbursement strategy.

From the upcoming U.S. election to evolving EU pharmaceutical legislation, ongoing changes in Japan, and mounting pressures in China, the pharmaceutical landscape is in flux. This session will explore what lies ahead during this time of significant policy uncertainty, offering expert insights and fearless forecasts on global pharmaceutical policy trends and their implications.

Join us for cocktails in the foyer following Closing Remarks!

Gary Watson, et. al.

Deep dive into NAVLIN Software's emerging Launch Excellence tools, going beyond Launch Sequence and outlining everything that the NAVLIN product managers are developing and how they are incorporating AI.

Smita Joseph, Vice President of Support & Customer Success

In-depth review of NAVLIN Data support and customer success, including in-depth statistics and insights on usage, plans for enhancing customer success, programs to drive value, and a chance to spend time with the tireless and fearless leader of NAVLIN's customer support program

Anna Smith and Team

Join for a discussion of NAVLIN Daily News, introduction of new in-depth NAVLIN Policy trackers, and overall landscape plans and directions for use of Generative AI to help support research and tracking of news & policy within Price & Market Access

In-depth discussion of the Insights market access metrics and KPIs platform, its roadmap plans, and its incorporation of AI.

In-depth discussion of the new tender platform features, evolution of its new ultra modular design and incorporation of AI into both Tender Management Software and Tender Data.