Pharma Launch Excellence Summit Conference Day 1: Wednesday September 30

7:30 am - 8:15 am Breakfast & Registration

8:15 am - 8:30 am Chairs Opening Remarks - Aligning the Enterprise & De-Risking Launch

Day 1: Aligning the Enterprise & De-Risking Launch

In 2026, launch excellence is moving beyond product positioning to shaping the disease space, building ecosystem readiness, and aligning development, access and commercial execution earlier.

8:30 am - 9:00 am Opening Panel Discussion: Where Do Launches Actually Fail, and Why? Fixing the Gaps Between Strategy, Access, Insight and Execution

Launch strategies are more sophisticated than ever, yet outcomes remain inconsistent. Some organizations point to execution gaps, others to strategy, alignment, or external market dynamics. So where do launches really break down? Attend this session to delve into:

• Exploring where launches fail across strategy, execution and alignment

• Understanding the role of cross-functional coordination in outcomes

• Identifying the biggest drivers of successful vs underperforming launches

9:00 am - 9:30 am ‘Too Late’ is Too Expensive. How to Spot Early Signals, Challenge Launch Assumptions, and Adjust Before Performance Suffers

Market share rarely moves all at once. It shifts as access barriers harden, competitive narratives gain traction, and HCP confidence or behavior begins to change. By the time traditional reporting confirms it, the launch is no longer adjusting to the market - it's chasing it. The warning signs appear much earlier, but they are scattered across conversations, functions, and systems - easy to miss and difficult to validate in time.

Erin Mistry, CEO of Within3, will show how launch teams can recognize change while it is still forming, identify the voices shaping it, and align around a compliant view of what to do next. She'll explore how connected, always-on intelligence gives teams the confidence to challenge launch assumptions and make precise adjustments before small shifts demand major corrections.

Attendees will learn how to:

• Recognize when emerging market signals challenge a critical launch assumption

• Look beyond the usual KOL list to identify who is actually shaping adoption decisions

• Connect what Medical, Commercial, Market Access, and Field teams are each seeing into one compliant view of the market

• Turn that clearer view into focused adjustments before delayed action becomes lost market share

9:30 am - 10:00 am Morning Panel Discussion: AI in Launch - Where Can It Actually Create Value?

AI is rapidly entering launch planning, but many teams are still working out where it meaningfully improves speed, quality and decision-making. Across medical, commercial, access, analytics and field teams, the opportunity is not just automation, it is using AI to improve insight generation, content development, stakeholder engagement and launch execution without losing rigour, compliance or human judgment. Attend this session to delve into a range of perspectives on:

• Identifying where AI can reduce launch workload and accelerate readiness

• Applying AI to insight synthesis, content development and customer engagement

• Balancing speed, compliance and quality in AI-enabled launch workflows

• Supporting leaner teams while maintaining launch performance and impact

10:00 am - 10:30 am Morning Coffee Break & Networking

10:30 am - 11:00 am Panel Discussion: Demystifying AI to Maximize Commercial Launch Impact

AI is more accessible today than ever before and is rapidly becoming a critical launch enabler. While emerging biotech companies have the opportunity to embed AI into new operating models from day one, established organizations often face the challenge of integrating AI into existing processes, systems, and ways of working. This panel brings together leaders from emerging and established biopharma and AI strategy firms to explore where and how AI is creating real value in launch planning and execution, what remains overhyped, and how organizations can move from experimentation to practical impact. Attend this session to:

Identify where AI can most effectively improve launch efficiency, insights, and decision-making
Understand how AI strategy, enablement and adoption differs between emerging launch organizations and established commercial teams
Learn a practical AI framework for characterizing AI opportunities and overcoming common barriers to implementation

11:00 am - 11:30 am Panel Discussion: Who Owns Launch Excellence? Building the Operating Model, Governance and Tools for Cross-Functional Execution

As the role evolves, definitions and responsibilities vary widely. Without clarity, ownership and accountability can quickly break down. This roundtable session will cover:

• Defining launch excellence across organizational models

• Clarifying ownership across commercial, medical and operations

• Positioning launch excellence as a strategic function

11:30 am - 12:00 pm Roundtable Discussion: Medical Earlier, Not Later: How Pre-Approval Strategy Shapes Launch Outcomes

Medical Affairs is too often brought into launch as a supporting function, rather than a strategic partner shaping evidence, education and market readiness from the start. For first-in-class therapies in high-unmet-need diseases, earlier medical involvement can reduce downstream friction, strengthen scientific positioning and prepare the field before commercial execution begins. Drawing on a multitude of launch experience, as well as the current pre-launch strategy including current experience bringing a first-in-class therapy to market in a competitive rare disease landscape, German will explore how medical can establish scientific presence, build KOL engagement, align evidence generation and partner cross-functionally with commercial, market access, clinical development and regulatory before launch.

• Bringing Medical Affairs into launch planning earlier

• Translating clinical data into evidence, education and positioning

• Building KOL, investigator and scientific engagement before approval

• Aligning Medical, Commercial, Access, Clinical and Regulatory execution

12:00 pm - 1:00 pm Networking Lunch

1:00 pm - 1:30 pm Presentation/Case Study: From Performative to Performance: Overcoming Pervasive Barriers to Drive Successful Launch

With $200B+ in revenue at risk from loss of exclusivity by 2030, the margin for launch error has never been thinner. The data suggests the industry is systematically over-investing in the factors that matter least and under-investing in the ones that determine outcomes. Combined with a performative process orientation and common organizational dynamics leading up to launch, key internal barriers to success are not addressed, and external barriers to uptake are missed. This session presents the evidence and the path forward.

• The specific investment patterns that separate the 67% overperformers from the rest and how to diagnose whether your own launch is on the right side of the data

• Why the gap between what physicians say and what they do should change your pre-launch engagement model, your budget allocation, and your success metrics

• The common organizational dynamics that repeatedly contribute to launch challenges

• Advice for breaking through the internal and market barriers to propel successful launch outcomes

• Where AI can create a real edge in launch and where it remains premature

1:30 pm - 2:00 pm Panel Discussion: Defining Launch Success - Speed, Access or Impact?

With competing priorities across functions, defining success is increasingly complex.

This session will delve into how a range of pharma companies are redefining launch success through:

• Balancing speed, access, engagement and revenue

• Aligning KPIs across teams

• Measuring short and long-term success

2:00 pm - 2:30 pm Presentation / Case Study: Ready Isn't Ready: How Mock Launch Exposes the Gaps Before Go-Live

Most launch teams have plans, playbooks and checklists, but many still discover too late that assumptions have not been pressure-tested, roles are unclear, decision rights are missing, or critical handoffs are weaker than expected.

This session will explore the common launch readiness mistakes companies make before going to market, and how mock launch exercises can expose gaps early, strengthen cross-functional alignment and turn launch planning into real operational readiness.

• Identifying hidden gaps in launch readiness before they become launch risks

• Using mock launch to pressure-test assumptions, roles and decision-making

• Aligning commercial, medical, access, supply and field teams around execution

• Turning rehearsal insights into practical launch improvements

2:30 pm - 3:00 pm Roundtable Discussion Groups

Small groups. No slides. No spectators.

Each table is built around a problem teams are actively trying to solve:

• Fixing weak uptake in the first 90 days post-launch

• Getting Medical, Access and Commercial aligned before approval

• What to cut when launch budgets tighten

• Where AI is actually saving time in launch execution

• Dealing with payer pushback on high-cost therapies

You'll leave with:

• How others are approaching it

• What's working vs failing

• Practical ideas you can take straight back

Rountables Include:

AI in Launch: Turning Experimentation into Measurable Impact
Access, Pricing and Affordability as Launch Strategy]
Medical Affairs, Evidence and Scientific Engagement Before Launch
Turning Launch Strategy into Launch Performance
Field Execution, Commercial Ops and Launch Infrastructure

3:00 pm - 3:30 pm Afternoon Refreshment Break

3:30 pm - 4:00 pm Presentation/Case Study: Precision Launch: Winning the Moments That Matter Most

Launch success is increasingly determined by the quality of a small number of critical decisions made under uncertainty. This session introduces the concept of

Precision Launch 'must-win moments': the unique set of choices and conditions that disproportionately influence a specific launch trajectory. At the heart of a Precision Launch strategy is precision archetyping. By understanding the specific launch archetype, and the dynamics that make it distinctive, teams can

move beyond generic launch excellence to identify the moments that matter most and the decisions that carry the greatest weight for impact. Archetyping creates the lens through which teams can focus effort where it will make the greatest difference.

We will explore how a Precision Launch strategy uses this foundation to expose and stress-test the assumptions behind must-win moments and determine the signals that should trigger action. Moving beyond traditional readiness, the session will examine how benchmarking, scenario thinking and decision rehearsal can de-risk the choices that matter most before reality tests them, while agile governance and learning loops enable rapid adaptation afterwards. The goal is to understand what kind of launch you are facing, be exceptionally ready for what matters most, and be prepared to adapt when it changes.

4:00 pm - 4:30 pm Panel Discussion: Rare Disease & Specialty Launch: Solving the Access, Patient Identification and Engagement Challenge

Rare disease launches require fundamentally different approaches, with smaller populations, higher costs and more complex access pathways. Join this session to delve into a range of perspectives on:

• Designing strategies for highly targeted patient populations

• Navigating pricing, access and reimbursement challenges

• Engaging patients, advocacy groups and specialist clinicians

4:30 pm - 5:00 pm Panel Discussion: Inside Medical Affairs: Aligning Evidence, Data, Field Medical, HEOR and Engagement for Launch

Medical Affairs is not one function, it is a connected ecosystem of teams shaping evidence, stakeholder engagement, field readiness, medical intelligence and scientific credibility before, during and after launch. As products become more complex, launch success depends on aligning Medical Strategy, Field Medical, HEOR, Medical Information, Scientific Communications, Medical Operations and data-driven insight earlier and more deliberately.

• Aligning medical strategy, field medical and scientific communications

• Connecting HEOR, RWE and evidence generation to access needs

• Using data and medical intelligence to guide launch decisions

• Preparing Medical Information and field teams before approval

5:00 pm - 5:30 pm Presentation/Case Study: Launch Excellence 2035: Winning in an Era of Exponential Change

Many studies, including the THRIVE Launch Success Code™, show that roughly half of new pharmaceutical aunches miss their forecast, and the industry has learned a great deal about why. But every study of launch, THRIVE's included, is built on the market as it is. That market is being remade in front of us. AI, genomics, and other exponential technologies are advancing and converging at extraordinary speed, and together they will reshape how therapies are

discovered, evidenced, approved, prescribed, paid for, and adopted. What makes a launch succeed in 2035 will not be what makes one succeed today. Some of today's drivers and barriers to launch success will still matter. Others will become obsolete. And some of the factors that will decide the winners are not on

anyone's list yet.

Attend this session to:

• Explore several plausible worlds for pharmaceutical launch in 2035, each reshaping who decides, who prescribes, who pays, and how quickly markets move

• Understand what launch excellence looks like in each of those worlds, and which no-regret moves to

start now

• Leave with a way of thinking about uncertainty that applies to your next launch, not only the one a decade from now