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Monday, September 30
 

8:30am EDT

Chair Opening Remarks
Monday September 30, 2024 8:30am - 8:45am EDT
Speakers
avatar for Tony Russell

Tony Russell

Executive Director, Head of New Product Commercialization, BioMarin
Monday September 30, 2024 8:30am - 8:45am EDT
Commonwealth Ballroom

8:45am EDT

PANEL: State of the Industry: Navigating Market Dynamics and Regulatory Changes in Biotech and Pharma
Monday September 30, 2024 8:45am - 9:30am EDT
Join industry leaders as they explore crucial trends and shifts in market access, economic conditions, and regulatory landscapes affecting the biotech and pharma sectors. This panel will provide insights into adapting business strategies in a rapidly changing environment and offer strategic advice for the coming year.
  • Regulatory Changes and Pricing Impacts: A healthcare policy expert will discuss recent regulatory changes, including those stemming from new legislation such as the IRA, focusing on their impact on drug pricing and market access strategies.
  • Market Access Challenges: An executive from a leading pharma company will address ongoing challenges in market access, detailing the evolving payer expectations and the importance of strategic pricing models to enhance patient access and affordability.
  • Economic and Market Trends: An industry analyst will provide an overview of current economic trends, investment patterns, and market conditions that are shaping the biotech and pharma industries, highlighting how companies can leverage these trends for growth.
  • Strategic Advice for the Next 12 Months: A seasoned pharma executive will offer practical advice on navigating the industry's complexities over the next year, emphasizing flexibility in operations, innovation in product pipelines, and effective stakeholder engagement.
This panel aims to give attendees a comprehensive view of the key factors driving changes in the biotech and pharma sectors, equipping them with the knowledge to make informed decisions and strategically position their companies for success.

Speakers
avatar for Agnes Yeboah

Agnes Yeboah

Executive Director, Global Regulatory Chemistry, Manufacturing and Controls (CMC), Cell and Gene Therapy, Bristol Myers Squibb
avatar for Tony Russell

Tony Russell

Executive Director, Head of New Product Commercialization, BioMarin
avatar for Wendy Cheung

Wendy Cheung

VP, Pipeline Commercialization Strategy, AbbVie
avatar for Steven Bloom

Steven Bloom

Chief Business Officer, Vincerx Pharma
Monday September 30, 2024 8:45am - 9:30am EDT
Commonwealth Ballroom
  General Session
  • QTAG NPPfeaturedsessionsHP

9:30am EDT

Innovating to Maximize Multi-Indication Potential
Monday September 30, 2024 9:30am - 10:00am EDT
The potential for novel drugs to be used across many types of diseases brings tremendous opportunity for biopharmaceutical companies. New product planning teams play a vital role in ensuring that these treatments deliver their full value not just to the companies that produce them but also to the patients who can benefit from them. Join us for a session on maximizing the lifetime value of drugs with multi-indication potential. We will discuss the pressures reshaping indication prioritization and sequencing, research on value-maximizing strategies and the ways companies can evolve new product planning—from capabilities and operating models to AI and machine learning applications.
Speakers
avatar for Joshua Hattem

Joshua Hattem

Pipeline & Launch Practice Lead, ZS Associates
Monday September 30, 2024 9:30am - 10:00am EDT

10:00am EDT

Interactive Ice Breaker
Monday September 30, 2024 10:00am - 10:30am EDT
Join us on Day 1 for a relaxed and fun-filled session designed to help you network with fellow delegates. Enjoy interactive activities and casual conversations that will set the stage for meaningful connections and collaborations throughout the conference. This is the perfect opportunity to meet industry peers, share insights, and start building relationships that will enhance your experience at the New Product Planning Conference.
Speakers
avatar for Tony Russell

Tony Russell

Executive Director, Head of New Product Commercialization, BioMarin
Monday September 30, 2024 10:00am - 10:30am EDT

11:00am EDT

How to Execute a Modern Launch in a Brave New World: Success 2.0
Monday September 30, 2024 11:00am - 11:30am EDT
The launch environment is more pressurized than ever before. The convergence of legislative requirements, payer expectations of price and evidence, and meeting patients’ needs means an aligned launch strategy is mission critical. Launch is no longer a mad dash to return on investment during year one on the market. It requires thoughtful, strategic action throughout the first three years on the market. A successful modern launch plans for success early and maintains a watchful eye as they move through the three phases of Launch: Acquire, Optimize, and Grow. By focusing on building a successful, sustainable trajectory the goal of reaching as many patients as possible can become a reality.
  • The new definition of launch success and how to plan for a sustainable three-year growth trajectory, not just immediate ROI.
  • Examine how to execute the three phases: Acquire, Optimize, and Grow and which core metrics to track to ensure success
  • How to align strategies and optimize resources to effectively engage providers, patients and payers.
Speakers
avatar for Dr. Elyse Muñoz

Dr. Elyse Muñoz

Director of Thought Leadership, IQVIA
avatar for Brian Lasky

Brian Lasky

Senior Principal, IQVIA
Brian Lasky is the Practice Lead of IQVIA’s Launch Center of Excellence. He has over 28 years of pharmaceutical experience, with over 19 of those at IQVIA. Brian focuses on the study and detailed assessment of the Launch Excellence process. His areas of expertise include pre-launch... Read More →
Monday September 30, 2024 11:00am - 11:30am EDT
  General Session
  • QTAG NPPfeaturedsessionsHP

11:30am EDT

PANEL: Best Practices for Effective Drug Launch Planning
Monday September 30, 2024 11:30am - 12:15pm EDT
Join this panel discussion to hear the critical components of successful launches and actionable, real-life learnings from commercial operations, marketing, regulatory, and digital experts. 
We’ll discuss new challenges facing emerging biopharma leaders, and how to drive success by combining traditional launch best practices with new methods underpinned by data, analytics, and technology.

Key Success Factors: Panelists will identify and discuss the essential factors that contribute to a successful drug launch, including timing, commercial infrastructure, market readiness, and stakeholder engagement.

Topics include:  
 
  • Building a commercial engine that powers a successful launch with the flexibility to iterate in response to fast-moving customer and competitor dynamics 
  • Crafting compelling product narratives and value-add resources to that build relationships and drive adoption among complex customer sets 
  • Integrating digital marketing strategies with traditional engagement methods, including the benefits and challenges of blending these approaches in modern drug launches. 
Speakers
avatar for Dennis Fournogerakis

Dennis Fournogerakis

Partner, Beghou Consulting
avatar for Heather DeMyers

Heather DeMyers

Vice President, US Innovative Medicines Marketing, Teva
avatar for Brian Powl

Brian Powl

Chief Commercial Officer, Kura Oncology
avatar for Ethan Galloway

Ethan Galloway

Head of Marketing and New Product Planning, Orca Bio
Monday September 30, 2024 11:30am - 12:15pm EDT
  General Session
  • QTAG NPPfeaturedsessionsHP

12:15pm EDT

Translating Research to Revenue: Forecasting for Clinical Development Planning and Go-to-Market Strategy
Monday September 30, 2024 12:15pm - 12:45pm EDT
A roadmap for how strategic forecasting can help you take your lab wins and convert them to market triumphs by prioritizing your clinical development opportunities and leaning in on your go-to-market strategy. At the intersection of science and commercial lies the keys to unlocking true asset value.  This presentation will dive into how forecasting and market research helps us navigate this crucial overlap with confidence.


  • Indication Prioritization – Understanding the therapeutic applications of the science and how to sequence them strategically for clinical development.
  • LCM Strategy – Balancing odds across clinical, therapeutic, regulatory, and commercial dimensions, and factoring for environmental macros such as the IRA, etc.
  • Financial Forecasting – Putting together a robust forecast story for validating investment theses, raising capital, seeking partnerships, etc. to drive the program ahead.




Speakers
avatar for Anindya Roy

Anindya Roy

Principal, Viscadia
Monday September 30, 2024 12:15pm - 12:45pm EDT

1:45pm EDT

PANEL: Advanced Forecasting - Organizing the Forecasting Process, Future Impact of IRA and AI
Monday September 30, 2024 1:45pm - 2:30pm EDT
Forecasting in large organisations faces a number of challenges that go beyond the forecast itself. The bigger the number of stakeholders and assets, the bigger the need for assumption consistency and transparency and alignment on an agreed forecasting process. As much as Excel is capable of supporting very complex forecasting models, additional layers of functionality are required to meet the operational and organisational challenges in this situation. In absence of an obvious gold-standard, which strategies do different types of organisations pursue to make the forecasting process most efficient?
 
It appears that the topics of IRA and the impact of AI rank high in influencing forecasting both near term and long term. How do forecasters deal with the impact and uncertainties around the IRA? Where do experienced forecasters see the most opportunity for AI to either improve forecast accuracy, help with demand planning or support insightful analytics?
 
Join our panel of experienced forecasting professionals to discuss the above questions and hear their vision of the future in forecasting.
Speakers
avatar for Deepak Wadhwa

Deepak Wadhwa

Forecasting Director - US Respiratory Biologics, AstraZeneca Pharmaceuticals
avatar for Mayank Misra

Mayank Misra

VP, Commercial Strategy, Analytics & Operations, Soleno Therapeutics
avatar for Aaron Furtado

Aaron Furtado

Executive Director, Forecasting & Performance Optimization, Bayer
avatar for Erik Holzinger

Erik Holzinger

Founder and Director, groupH
avatar for Ashley Robinson

Ashley Robinson

Associate Director, New Product Commercialization, BioMarin Pharmaceuticals
Monday September 30, 2024 1:45pm - 2:30pm EDT

2:30pm EDT

Leveraging Generative AI to Expedite Market Landscaping and Commercial Forecasting
Monday September 30, 2024 2:30pm - 3:00pm EDT
Explore the transformative potential of generative AI in enhancing market and competitive intelligence workflows, delivering faster and more accurate insights. This presentation will provide an overview of cutting-edge AI technologies, including Large Language Models (LLMs) and AI Agents, and their practical applications for understanding R&D pipelines and bringing treatments to market.

Key Topics Include:

  1. Generative AI and AI Agents: Transforming market analysis and forecasting
  2. Advanced AI tools: Smarter data extraction 
  3. AlphaSense: The largest source of equity research and clinical trial reports
  4. Gen AI: Risks and benefits ahead

    AlphaSense, an AI-powered market intelligence platform, enables executives to make confident, data-driven decisions with unparalleled speed. With the industry’s most comprehensive collection of equity research alongside company presentations and clinical trial data, AlphaSense delivers robust solutions for drug pipeline analysis, forecasting, and due diligence.

Speakers
avatar for Craig Farrell

Craig Farrell

Director of Go-To-Market Strategy, AlphaSense
Monday September 30, 2024 2:30pm - 3:00pm EDT

3:30pm EDT

PANEL: Navigating Market Access and Pricing Strategies in the Post-IRA Era
Monday September 30, 2024 3:30pm - 4:15pm EDT
This panel will provide a comprehensive examination of the evolving landscape of market access and pricing strategies in the wake of the Inflation Reduction Act (IRA), featuring insights from experts across the pharmaceutical industry.

  • Disrupting the Status Quo - Panelists will explore how the IRA fundamentally shifts the balance of power in pharmaceutical pricing and market access, highlighting the strategic challenges and opportunities for companies navigating Medicare Part D changes.
  • Strategies for adapting business models under the IRA, focusing on new pricing strategies, transparency, and innovation within fiscal constraints.
  • An examination of the IRA's impact on innovation and smaller biotech firms, addressing funding, investment, and regulatory challenges.
  • Discussion on international market trends and their influence on drug pricing and access strategies.
  • Effective strategies for engaging with payers to enhance drug accessibility and affordability in the context of new global policies and economic pressures.
Speakers
avatar for Jason Xenakis

Jason Xenakis

Senior Director of Value and Evidence, Pfizer
avatar for Leora Schiff

Leora Schiff

Moderator
avatar for Narin Yasar

Narin Yasar

Director, Global Oncology Market Access, New Products, Merck
avatar for Rosa Yoon

Rosa Yoon

Senior Director, Global Oncology New Product Planning, Sanofi
Monday September 30, 2024 3:30pm - 4:15pm EDT
  General Session
  • QTAG NPPfeaturedsessionsHP

4:15pm EDT

Rethinking Asset Development: The Power of Commercial Insights
Monday September 30, 2024 4:15pm - 4:45pm EDT
Asset development is often highly centered around obtaining regulatory approval. This clinically-minded lens puts market adoption at risk. In this session, we’ll discuss how new approaches to asset development which wholistically integrate both clinical and commercial considerations can de-risk development costs, maximize uptake, and help support a better value creation narrative for investors or other key stakeholders. We’ll look at a case study of how an early stage biotech used this approach to successfully prove their asset’s worth, secure capital, and advance development. Join us as we share with you our thoughts on Rethinking Asset Development: The Power of Commercial Insights.
Speakers
avatar for Carl Sailer

Carl Sailer

Global Go-To-Market Lead, Syneos Health
Monday September 30, 2024 4:15pm - 4:45pm EDT

4:45pm EDT

PANEL: Successful Collaboration Strategies Across R&D, Clinical, and Commercial Teams
Monday September 30, 2024 4:45pm - 5:30pm EDT
  • Explore strategies for enhancing integration and communication between R&D, clinical, and commercial teams.
  • Discuss the importance of aligning these teams early in the development process to ensure successful asset progression.
  • Share case studies demonstrating successful cross-functional collaboration and its impact on project outcomes.
Speakers
avatar for Erica Paine

Erica Paine

Vice President, Value & Market Access, Chiesi
avatar for Sue Nemetz

Sue Nemetz

Founder & CEO, Corval
avatar for John Harlow

John Harlow

Chief Commercial Officer, Melinta Therapeutics
avatar for Cathi Ahearn

Cathi Ahearn

Senior Vice President, Worldwide Commercial Portfolio Strategy, Bristol Myers Squibb
avatar for Josh Meidenbauer

Josh Meidenbauer

Senior Director, New Product Planning, Intellia Therapeutics
Monday September 30, 2024 4:45pm - 5:30pm EDT
  General Session
  • QTAG NPPfeaturedsessionsHP
 
Tuesday, October 1
 

9:00am EDT

Day Two Kickoff & Chairperson’s Remarks
Tuesday October 1, 2024 9:00am - 9:15am EDT
Speakers
avatar for Tony Russell

Tony Russell

Executive Director, Head of New Product Commercialization, BioMarin
Tuesday October 1, 2024 9:00am - 9:15am EDT

9:15am EDT

Strategic Early Positioning for Successful Drug Development
Tuesday October 1, 2024 9:15am - 9:45am EDT
  • We will emphasize the necessity of early positioning in the drug development process and its cross-functional nature.
  • Discuss the common mistake of late positioning and the benefits of integrating positioning strategies before designing phase three trials.
  • Hear real-world examples to illustrate the impact of early positioning on product success.
  • Understand how early positioning is a critical precursor to a successful product launch, avoiding rigid phase three protocols that limit strategic flexibility.
Speakers
avatar for Guru Muralimohan

Guru Muralimohan

Executive Director, Early Pipeline Commercialization, Oncology, Bayer
Tuesday October 1, 2024 9:15am - 9:45am EDT

9:45am EDT

From Pipeline Prioritization to Commercialization Strategy: How IRA is Transforming New Product Planning
Tuesday October 1, 2024 9:45am - 10:15am EDT
As Medicare’s Maximum Fair Prices (MFPs) for the first ten selected drugs have finally been released, IRA is again at the forefront of forecasting, market access, patient services, and BD/portfolio strategy teams' minds as they grapple with the future prospects of their lead development programs. Strategically setting price and cost of access as assets approach launch is no longer enough to realize the full value of a program – teams must now consider how to maximize value even as they select candidates for clinical development. Join Triangle Insights Group for an interactive presentation where our Pricing and Market Access and New Product Planning leadership outlines potential approaches to maximize near-term ROI and long-term revenue potential in the age of IRA drug pricing provisions, including:

  • A general overview of key updates to IRA drug pricing provisions from the most recent guidance
  • The evolution of strategies for candidate selection and development in the context of the IRA drug pricing provisions
  • An interactive product profile selection and design process based on characteristics favorable to the IRA landscape

Speakers
avatar for Sarah Jims

Sarah Jims

Partner, Triangle Insights Group
avatar for Matt Haynes

Matt Haynes

Pricing & Market Access SME, Triangle Insights Group
Tuesday October 1, 2024 9:45am - 10:15am EDT

10:15am EDT

PANEL: Mastering the Art of Target Product Profiles in Drug Development
Tuesday October 1, 2024 10:15am - 11:00am EDT
Delve into the strategic importance of Target Product Profiles (TPPs) in pharmaceutical development with a panel of industry experts. This discussion will explore advanced strategies, key considerations, and real-world applications of TPPs to optimize drug development outcomes.
  • Discuss the role of TPPs in facilitating smoother regulatory reviews and negotiations, and preparing for market access challenges.
  • Strategies for updating TPPs in response to new clinical data, regulatory feedback, and changes in the competitive landscape to keep the development process agile.
  • Real-World Applications: Analyze case studies that highlight both successful implementations and common pitfalls of TPPs in drug development, offering practical insights and actionable strategies.
Speakers
avatar for Marsha Pelletier

Marsha Pelletier

Global Product Strategy, Strategic Insights, BioMarin Pharmaceuticals
avatar for Laryssa Wozniak

Laryssa Wozniak

Senior Director, Global Marketing, Immunovant
avatar for Vincent Fisher

Vincent Fisher

Executive Director, Global Marketing & New Product Planning, Unicycive Therapeutics
avatar for Aziz Mottiwala

Aziz Mottiwala

Chief Commercial Officer, Tarsus Pharmaceuticals
Tuesday October 1, 2024 10:15am - 11:00am EDT
  General Session
  • QTAG NPPfeaturedsessionsHP

11:30am EDT

Research-Backed Winners: See What The Top 3 Value-Added Programs in Oncology Are According to the Customer
Tuesday October 1, 2024 11:30am - 12:00pm EDT
Join us for an exciting and interactive session where we reveal the top three value-added oncology programs, identified through our research study with oncologists and payers. These insights are essential for pharmaceutical companies looking to enhance their product offerings.

What to Expect:

  • Industry Perspectives: Ray Gomez, who has spearheaded transformations at leading pharmaceutical companies like Bristol Myers Squibb and Novartis, will provide expert commentary and industry insights.
  • Get Past 'Planning' – See Tangible Examples: Sherif Salti, Founder and Global Managing Partner of SALTI, will showcase the top three customer engagement journeys that stand out based on our research.
  • Interactive Experience: This session isn’t just a presentation—you’ll have the chance to ask questions, share ideas, and see real examples in action.

Come ready to engage, learn, and walk away with clear, actionable steps to elevate your new product planning strategies in oncology.
Speakers
avatar for Ray Gomez

Ray Gomez

VP Worldwide Omni-Channel Capabilities, Bristol Myers Squibb
avatar for Sherif Salti

Sherif Salti

Global Managing Partner, SALTI
Tuesday October 1, 2024 11:30am - 12:00pm EDT
  General Session
  • QTAG NPPfeaturedsessionsHP

12:00pm EDT

Maximizing Financial Efficiency and Optionality Through a First-in-Class Product Launch
Tuesday October 1, 2024 12:00pm - 12:30pm EDT
Michelle Robertson, EVP, CFO and Treasurer of Geron, will present a case study on how to prepare a company for the transition from a clinical development to a commercial organization based on her experiences launching a first-of-its-kind medicine.

In June 2024, Geron received FDA approval for RYTELO™ (imetelstat), the first-ever telomerase inhibitor, for the treatment of certain adults with lower-risk MDS with transfusion-dependent anemia, following a multi-decade scientific and drug development journey to bring the potential of telomerase inhibition to patients. Key takeaways will include how and where to invest your resources; mitigating risks as a company doubles in size; and making strategic investments to set your company up for success.

  • Best practices to maximize capital use and minimize waste across development phases and launch.
  • Flexible and robust budgeting techniques that adapt to unexpected changes and regulatory shifts in development.
  • Long-term financial strategies that align with business goals and maintain investor confidence. 


Speakers
avatar for Michelle Robertson

Michelle Robertson

EVP, CFO and Treasurer, Geron Pharmaceuticals
Tuesday October 1, 2024 12:00pm - 12:30pm EDT

1:30pm EDT

Revitalizing the Traditional NPP Model
Tuesday October 1, 2024 1:30pm - 2:00pm EDT
  • Better prepare your organization to effectively evaluate the commercial potential of early-stage assets and have greater confidence in the key strategic decisions you need to make for your early pipeline
  • Reimagine the traditional prioritization of activities when exploring a new asset’s viability globally
  • Explore the key stage-gates to a successful product life cycle, including what to do, when to do it, and how much investment is “worth it”
  • Rethink how more effective cross-functional collaboration can advance your new product planning team
Speakers
avatar for Amanda Francis

Amanda Francis

Partner, Trinity Life Sciences
avatar for Amanda Cassidy

Amanda Cassidy

Associate Principal, Strategic Advisory, Trinity Life Sciences
Tuesday October 1, 2024 1:30pm - 2:00pm EDT

2:00pm EDT

Launching Products, Regardless of the Unmet Patient Need, Face Similar Challenges
Tuesday October 1, 2024 2:00pm - 2:30pm EDT
Gene therapies are a promising new class of medicines known as advanced-therapy medicinal products. While there is a lot of excitement in the scientific and medical community around the promise of these therapies, the reality is that bringing any new innovation to market is challenging.  
 
Ferring Pharmaceutical’s David Bell, Vice President of the Uro-Oncology Business Unit, can talk about how biopharma companies can overcome these challenges to successfully bring innovative products such as gene therapies to market at scale. This presentation will discuss:

  • The importance of launching a product right the first time. 
  • The evolution of prelaunch activities and launch planning. 
  • Establishing strong and diversified manufacturing capabilities to meet the growing needs of patients beyond launch.  
  •  Value strategies that drive the efforts needed to ensure coverage and reimbursement.  
  • How to reduce the financial burden on patients through access programs and partnerships – especially for oncology patients.  
  • Working with and educating healthcare providers to help disrupt standards of care for the betterment of patients.  
  • Commercialization strategies and considerations for engaging providers and patients around breakthrough, novel therapeutics.  






Speakers
avatar for David Bell

David Bell

Vice President, Uro-Oncology, Ferring Pharmaceuticals
Tuesday October 1, 2024 2:00pm - 2:30pm EDT

2:30pm EDT

PANEL: Is There Such Thing as Too Early: Integrating NPP with Early-Stage R&D
Tuesday October 1, 2024 2:30pm - 3:15pm EDT
  • Assess the risks and rewards of involving NPP in the early stages of R&D, including case studies that highlight the outcomes of various timing strategies.
  • Explore effective strategies for fostering strong relationships and thought partnerships between NPP and R&D teams to enhance collaborative efforts.
  • Delve into the development and implementation of stage-appropriate assessments and process "road maps" in a collaborative, cross-functional environment.
Speakers
avatar for Sonal Das

Sonal Das

Senior Director, Global Commercial, argenyx
avatar for Cathy Garabedian

Cathy Garabedian

Executive Director, New Product Planning, Keros Therapeutics
avatar for Kathleen Davenport

Kathleen Davenport

Vice President, Strategy, Omega Therapeutics
avatar for Mike Conlon

Mike Conlon

Consultant, BioMarin
avatar for Tony Russell

Tony Russell

Executive Director, Head of New Product Commercialization, BioMarin
Tuesday October 1, 2024 2:30pm - 3:15pm EDT

3:15pm EDT

Closing Remarks
Tuesday October 1, 2024 3:15pm - 3:30pm EDT
Speakers
avatar for Tony Russell

Tony Russell

Executive Director, Head of New Product Commercialization, BioMarin
Tuesday October 1, 2024 3:15pm - 3:30pm EDT
 
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