
Monday, September 28
Registration Open
IN PERSON ONLY: Pre-Conference Workshop: Inside the Portfolio Committee: Making R&D Investment Decisions under Uncertainty
Separate registration required.
Tuesday, September 29
Registration Open and Morning Coffee
Organizer's Welcome Remarks
MORNING MEET & GREET ICEBREAKER (IN PERSON ONLY)

Jumpstart your conference experience with a lively morning speed networking! This informal networking session is the perfect chance to meet fellow participants and connect with your conference peers right from the start. Grab a cup of coffee, engage in conversations, and kick off the conference with a bang. Don't miss out on this fantastic opportunity to make new connections, share insights, and lay the groundwork for a memorable conference journey.
Chairperson's Remarks
Michael Ferrante, Executive Director, Business Analytics, Global Regulatory Affairs & Clinical Safety, Merck , Executive Director, Business Analytics , Global Regulatory Affairs & Clinical Safety , Merck & Co
KEYNOTE PRESENTATIONS
Innovation Portfolio Management—Linking Strategy to Execution

Why do some pharmaceutical organizations consistently translate strategy into measurable outcomes, while others struggle with misaligned priorities, constrained resources, and stalled pipelines? In this keynote, Noel Sobelman shares key insights from his forthcoming book on innovation portfolio management, offering a pragmatic framework for improving decision-making, governance, and resource allocation across complex asset portfolios. Drawing on real-world experience, the session will highlight what differentiates high-performing organizations, common failure modes, and the structural and cultural enablers required to move from fragmented execution to disciplined, strategy-driven portfolio management.
Panel Moderator:
PANEL DISCUSSION:
From Framework to Reality—Operationalizing Innovation Portfolio Management

Panelists:



Coffee Break in the Exhibit Hall
STRATEGIC PRIORITIZATION & PORTFOLIO VALUE OPTIMIZATION
Sponsored by: Build the Target Product Profile for the Market at Launch, Not the Market Today



Every pipeline asset is aimed at a market that does not exist yet. Most Target Product Profiles, however, are assembled through weeks of manual benchmarking, captured in static documents, and already outdated by their first governance review.
Hear where TPP development breaks down across the asset lifecycle, from fragmented evidence collection and inconsistent formats to profiles that go stale as the competitive landscape moves
Understand why data and technology alone have not closed these gaps, and what changes when analytical platforms are paired with embedded therapeutic and methodological expertise
See how leading teams benchmark candidate profiles against today's standard of care and against the competitors most likely to be at market at launch
Leave with a practical framework for turning the TPP from a static document into a living, evidence-grounded strategy that stands up in governance reviews
Optimal End-in-Mind Thinking for R&D Programs & Portfolio Prioritization

What if the most dangerous moment in drug development is not a failed clinical trial—but the day a team starts work without a clear picture of the approved product they are trying to create? End-in-mind thinking forces R&D teams to define their destination before they chart the course. This session explores how the Target Product Profile, when treated as a living strategic tool rather than a regulatory formality, transforms program decision-making—and how portfolio prioritization frameworks built on the same principle allow organizations to invest with conviction, cut with confidence, and ultimately deliver more medicines to more patients.
Evaluating Asset Value across Multiple Indications

Early-stage development assets offer significant strategic flexibility in terms of indication selection and prioritization compared to those in late-stage development. This presentation explores the framing of strategic options when early-stage asset teams consider multiple indications to pursue, the implications on asset valuations, e.g., probability and value dependencies, and the appropriate valuation approaches to facilitate investment decision-making and cross-asset portfolio prioritization.
Luncheon Presentation: Sponsored by: LUNCHEON PRESENTATION: Beyond the Gantt Chart: Connecting R&D Strategy, Planning and Execution in Real Time


R&D teams still spend significant time translating strategy into plans, reconciling assumptions, and rebuilding scenarios as programs evolve. Agentic AI offers an opportunity to rethink this model by continuously connecting strategy, plans, resources, financials, risks, and decisions. This session will explore what this future could look like, the practical challenges, and a pragmatic roadmap for getting started.
Session Break
STRATEGIC PRIORITIZATION & PORTFOLIO VALUE OPTIMIZATION (CONT.)
Chairperson's Remarks
Michael Ferrante, Executive Director, Business Analytics, Global Regulatory Affairs & Clinical Safety, Merck , Executive Director, Business Analytics , Global Regulatory Affairs & Clinical Safety , Merck & Co
Implementing an Agile Portfolio Prioritization Process

Case example of a large Biopharma's journey implementing a quarterly portfolio prioritization (QPP) process that transformed R&D decision-making. By introducing an objective, data-driven framework aligned with strategic priorities we added significant portfolio value, fostered innovation, and created budget capacity to fund new value-adding development projects.
Building a Truly Global Program Management Function: Integrating China, Japan, and India Teams

As biopharma R&D increasingly serves a global market, asset development must account for the need for several regions, each with development strategies tailored to specific regulatory requirements, healthcare-system realities, and market access approaches. Program management functions therefore need to move beyond a headquarters-centric model toward an integrated global operating approach. This session explores how organizations can get the balance right: enabling regionally tailored development strategies and strong leadership of regional execution, while maintaining global alignment, efficient ways of working, and integrated operations across the full asset-development lifecycle. We will discuss the practical needs that emerge when regional realities meet global development priorities, and how program management can connect local execution, cross-regional coordination, and enterprise-level decision making to accelerate development without compromising strategic coherence.
Refreshment Break in the Exhibit Hall
Panel Moderator:
PANEL DISCUSSION:
Portfolio Ownership Models—Resolving the Portfolio-Finance Tug of War

Panelists:




Breakout Discussions Session Block
INTERACTIVE ROUNDTABLE DISCUSSION
IN-PERSON ONLY:
Beyond the Data: The Human Side of Governance
Kundini Amin, Head, Portfolio Leadership, Analytics & Insights (PLAI), Biogen , Senior Director/Head , Development Portfolio Leadership, Analytics, & Insights , Biogen
Elena Spencer, Head of Research Governance & Portfolio Management, Biogen , Head of Research Governance , Biogen
As portfolio management practices continue to mature through advanced data, analytics, and tooling, this session focuses on the equally critical human and structural elements that enable those insights to translate into real decisions. Using a People + Process + Data governance framework, the session explores how trust, facilitation, meeting design, and decision documentation shape what actually happens in governance forums. During this interactive discussion, participants will examine the behavioral and operational realities that influence decision quality - such as whether stakeholders feel safe to speak up, whether shared understanding is truly achieved in the room, and how decisions made collaboratively are accurately reflected in outcomes and follow‑through. Through real‑world examples and facilitated breakout discussions, participants will explore practical techniques for strengthening governance design so that portfolio decisions are not only well‑informed, but also clearly understood, aligned, and effectively executed.Â
Session Objectives
By the end of the session, participants will be able to:Â Â
- Recognize common human and process failure points in portfolio governance - even when data is strong Â
- Apply practical techniques to improve psychological safety, shared understanding, and decision clarity Â
- Identify 1–2 changes they can make immediately to their governance forums, meetings, or decision artifacts​
Networking Reception in the Exhibit Hall
Close of Day
Wednesday, September 30
Registration and Morning Coffee
BUILDING & EVOLVING THE PORTFOLIO
Chairperson's Remarks
Stephen Smith, Senior Program Director, Corcept Therapeutics , Sr Program Dir Oncology , Oncology , Corcept Therapeutics Inc
Origination to Opportunity: Translating Early Exploration into Therapeutic Hypotheses and Value-Creating Portfolios


Flagship Pioneering founds and builds innovative biotechnology companies around novel platform technologies. Each platform is capable of addressing many therapeutic areas, creating a vast opportunity space to navigate under compressed timelines. To meet this challenge, Flagship built a dedicated, centralized team combining scientific, strategic, and analytical expertise with a unique mandate: develop bespoke pipeline strategies that identify the highest-value therapeutic directions before a traditional pipeline exists. This presentation describes our framework for translating platform capabilities into clearly defined therapeutic opportunities ready for investment decisions, the role of AI-enabled tools in supporting this process, and key learnings and future directions.
Sponsored by: A ROADMAP FOR BUILDING TRUST IN AI-POWERED PRODUCT PORTFOLIOS: From connected PPM foundations to strategic autonomy


Explore how organizations can intentionally move from AI experimentation to practical value in portfolio management by connecting strategy, resources, risks, and outcomes. Examine a progression from on-call assistance and always-on portfolio monitoring to explainable gate decisions and actions within defined boundaries. Gain insights into how AI, human judgment, governance, and connected data can increase portfolio revenue and accelerate product delivery.
The Other Half of the Deal: R&D Integration from Pipeline to People

Once the deal team delivers at signing and closing, the integration challenge takes center stage: integrating pipelines, preserving scientific momentum, and retaining the people who built them. Whether the value resides in a single asset, a platform, or a full portfolio, this session explores the operational complexities of integration—from protecting regulatory submissions to rebuilding team structures—and what it takes to protect what you paid for.
Panel Moderator:
PANEL DISCUSSION:
Competitive Intelligence as a Strategic Input to Portfolio Decisions

Panelists:




Coffee Break in the Exhibit Hall
DECISION INTELLIGENCE & PORTFOLIO ANALYTICS
Applying AI to Portfolio Decisions: Real-World Use Cases across TPP, Timelines, Competitive Landscapes, Development Scenarios, and PTRS

AI and machine learning are increasingly being applied to support portfolio and asset-level decision-making—but where do they truly add value? This session shares real-world use cases across both early and late-stage drug development, including target product profiles (TPP), timelines, competitive landscape assessment, development scenarios, and probability of technical and regulatory success (PTRS). The discussion will highlight where AI/ML has been successfully deployed, where it has fallen short, and the practical ways of working between portfolio teams and data science functions. Attendees will gain a grounded perspective on how to apply AI to improve decision quality, evaluate trade-offs, and strengthen portfolio outcomes.
Design and Implementation of an AI Agent for Pharmaceutical Portfolio Analytics

AI agents have the potential to significantly increase the efficiency of routine tasks in the workplace as well as extract additional value from disparate sources used in these workstreams. In this presentation we review a real-world example of design and implementation of an AI agent in the context of pharmaceutical portfolio analytics. We also discuss key challenges encountered and lessons learned for future applications.
The Portfolio Dilemma: Why Smart Systems Fail to Drive Smart Decisions


Pharma organizations invest heavily in building robust pipelines and sophisticated project management systems, yet many still struggle to convert execution insights into effective portfolio decisions. The root cause isn’t a lack of data—it’s the behavioral and decision dynamics that undermine how that data is interpreted, governed, and acted upon. Misaligned incentives, delayed insights, and fragmented governance structures create a persistent disconnect between strategy and real-time project realities. This session examines why good systems fail to produce good decisions, where portfolio decision-making breaks down, and how leading organizations overcome these barriers. Attendees will gain a clearer understanding of the human and structural factors driving the portfolio dilemma.
Enjoy Lunch on Your Own
REAL-WORLD DECISION-MAKING UNDER UNCERTAINTY
Chairperson's Remarks
Stephen Smith, Senior Program Director, Corcept Therapeutics , Sr Program Dir Oncology , Oncology , Corcept Therapeutics Inc
Designing Decision-Ready Dashboards: Bridging Data and Human Judgment in Pharma

In US commercial pharma, we rarely have the full picture. Regulations shift, markets move, and data remains fragmented, so some level of unknown is always present. Yet most dashboards are built as if completeness is achievable, creating a gap between what systems show and how decisions are made. In practice, leaders fill these gaps with judgment, often outside dashboards in Excel or PowerPoint. This session challenges the idea of “complete†dashboards and explores how to design systems that incorporate human insight and work effectively with uncertainty.
Bridging Governance from Discovery Research to Late Phase Development

Establishing governance across the breadth of drug development and associated stakeholders can be a challenge. Lilly has two primary governing bodies: Early Phase, Discovery through Phase 2; and Late Phase, Phase 3 and beyond. Lilly leverages a Commercial Decision Process as the primary bridge between the two. Additional measures established to ensure seamless transitions and efficiencies will be presented.
Refreshment Break in the Exhibit Hall
Breakout Discussions Session Block
INTERACTIVE ROUNDTABLE DISCUSSION
IN-PERSON ONLY:
Execution Under Pressure: Identifying Failure Points in Development and Change Initiatives
Shawn Malloy, Director, R&D Portfolio Management, Biogen , Director, Asset & Portfolio Analytics , Portfolio Leadership, Analytics, & Insights , Biogen
Mike Myers, Founder & President, ID4 Consulting , Associate Vice President , LRL Due Diligence , ID4 Consulting
Even the most well-designed development programs and strategic initiatives can fall short in execution. This interactive working group will focus on understanding why implementation fails—and how to identify risks early before they derail outcomes. Participants will break into small groups to explore:
- The most common drivers of execution failure in development programs and portfolio initiatives
- “Unicorn†or unpredictable events that can disrupt even the strongest plansÂ
- Early warning signs that a program or initiative is at risk, from unrealistic assumptions to emerging operational or safety challengesÂ
Through facilitated discussion, attendees will share real-world experiences, compare patterns across organizations, and identify practical approaches to improving execution and mitigating risk. The session will conclude with a synthesis of key takeaways and actionable insights that participants can bring back to strengthen execution across their own programs and portfolios.​
Close of Summit
For more details on the conference, please contact:
Bridget Kotelly
Senior Conference Director
Cambridge Healthtech Institute
Phone: (+1) 781.264.5249
Email: [email protected]
For sponsorship information, please contact:
Kristin Skahan
Senior Business Development Manager
Cambridge Healthtech Institute
Phone: (+1) 781.972.5431
Email: [email protected]







