Fierce New Product Planning 2024: Full Schedule

8:45am EDT

Chair Opening Remarks

Monday September 30, 2024 8:45am - 9:00am EDT

about Geoff is the Chief Commercial Officer for Ensysce Biosciences. Ensysce is a clinical stage company which employs transformative chemistry to improve prescription drug safety using two technology platforms. Their lead compound is designed to deliver strong analgesia while reducing the risk of abuse and overdose. Geoff’s experiences range from leading development teams in phase 1 to propelling products through launch and life cycle management. He studied at INSEAD and Henley Business Schools and started his career in Biochemistry in Newcastle, England. He began working in the Pharmaceutical Industry for Eli Lilly and then moved to Lundbeck where he ran the UK sales and Marketing division. Following Lundbeck, Geoff moved to ICI Pharmaceuticals as a global marketing manager and spent 15 years with ICI and AstraZeneca. He ran several business units including global pricing and strategic communications; he also led the AZ merger process in all markets outside the USA. Geoff moved from the UK to the US in 1999 to lead the Neuroscience division and, when he left AZ, he was Global SVP for CNS and Oncology drugs, an $8 Billion dollar business. Geoff transitioned into Biotech and consulting where he assisted many major companies on launch strategy, leadership development, and positioning. Geoff has held leadership roles in the UK, the US, Germany, and Global businesses. He led the development and launch of several market leading brands in the CNS/ pain and addiction areas including Nicorette, Seroquel and Zomig.

8:45am EDT

Panel: State of the Industry: Navigating Market Dynamics and Regulatory Changes in Biotech and Pharma

Monday September 30, 2024 8:45am - 9:15am 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.

Monday September 30, 2024 8:45am - 9:15am EDT

9:15am EDT

Presentation

Monday September 30, 2024 9:15am - 9:30am EDT

Case study presentation.

Monday September 30, 2024 9:15am - 9:30am EDT

9:45am EDT

Strategic Early Positioning for Successful Drug Development

Monday September 30, 2024 9:45am - 10:30am 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.

Guru Muralimohan, PhD, Executive Director, Early Pipeline Commercialization, Oncology, Bayer US

Monday September 30, 2024 9:45am - 10:30am EDT

10:30am EDT

Networking Break

Monday September 30, 2024 10:30am - 11:00am EDT

Networking Break

Monday September 30, 2024 10:30am - 11:00am EDT

11:00am EDT

Presentation

Monday September 30, 2024 11:00am - 11:30am EDT

Case study presentation.

Monday September 30, 2024 11:00am - 11:30am EDT

11:30am EDT

Key Practices for Effective Drug Launch Planning

Monday September 30, 2024 11:30am - 12:15pm EDT

Explore the critical components of successful drug launches in this panel discussion where experts from marketing, regulatory, and digital strategy fields share their insights. The panel will delve into how companies can effectively leverage traditional and digital marketing tools to enhance market adoption and navigate the competitive landscape of pharmaceuticals.

Key Success Factors: Panelists will identify and discuss the essential factors that contribute to a successful drug launch, including timing, market readiness, and stakeholder engagement.
The role of marketing in crafting compelling product narratives and driving adoption among target demographics will be a major focus.
Experts will explore the integration of digital marketing strategies with traditional methods, discussing the benefits and challenges of blending these approaches in modern drug launches.

Monday September 30, 2024 11:30am - 12:15pm EDT

12:15pm EDT

Partner Presentation

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

Case Study presentation.

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

12:45pm EDT

Lunch Break

Monday September 30, 2024 12:45pm - 1:45pm EDT

1:45pm EDT

Advanced Forecasting: Driving Decisions with Data

Monday September 30, 2024 1:45pm - 2:30pm EDT

Join industry experts as they explore the cutting-edge of predictive analytics and artificial intelligence in pharmaceutical forecasting. This panel will delve into how these technologies are reshaping decision-making processes in drug development.

Panelists will compare the effectiveness of various forecasting models, discussing the integration of machine learning and traditional statistical methods.
Experts will debate the benefits and challenges of incorporating real-world data into forecasting models, including data integrity and privacy concerns.
The panel will address ethical issues arising from AI in forecasting, such as biases in data sets and the implications of predictive decision-making.

Monday September 30, 2024 1:45pm - 2:30pm EDT

2:30pm EDT

Presentation

Monday September 30, 2024 2:30pm - 3:00pm EDT

Case study presentation.

Monday September 30, 2024 2:30pm - 3:00pm EDT

3:00pm EDT

IRA Latest Developments: Detailing the Inflation Reduction Act’s Impact on Pharma

Monday September 30, 2024 3:00pm - 3:30pm EDT

We will review the latest IRA developments, focusing on those aspects directly impacting pharmaceutical pricing and regulatory policies.
Delve into the specific provisions of the IRA that affect drug pricing, examining potential impacts on pricing strategies and overall industry profitability.

Monday September 30, 2024 3:00pm - 3:30pm EDT

4:00pm EDT

Decoding the IRA: Strategic Impacts and Adaptations

Monday September 30, 2024 4:00pm - 4:45pm EDT

We will explore the complex landscape of the Inflation Reduction Act and its profound implications on the pharmaceutical industry in this in-depth panel discussion. Experts from different facets of the industry will dissect how the IRA influences pricing structures, market access strategies, and overall business models, providing actionable insights for navigating these changes.

Experts will succinctly break down the critical aspects of the IRA affecting pharmaceutical pricing and access, including government negotiations, Medicare Part D changes, and spending caps.
Business Model Adaptations: Panelists will discuss the transformation of pharmaceutical business models under the IRA, focusing on new pricing strategies, the necessity for transparency, and innovation within fiscal limitations.
Effects on Innovation and Small Firms: The panel will examine the IRA’s potential impact on innovation, especially its effect on funding for research and development, and its implications for smaller biotech firms facing investment and regulatory challenges.
Insights will be shared on adjusting to the IRA’s evolving regulatory landscape, with emphasis on strategic planning to manage market shifts and maintain competitiveness.

Monday September 30, 2024 4:00pm - 4:45pm EDT

4:45pm EDT

Presentation

Monday September 30, 2024 4:45pm - 5:15pm EDT

Case Study presentation.

Monday September 30, 2024 4:45pm - 5:15pm EDT

5:15pm EDT

Successful Collaboration Strategies Across R&D, Clinical, and Commercial Teams

Monday September 30, 2024 5:15pm - 6:00pm 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.

Monday September 30, 2024 5:15pm - 6:00pm EDT

6:15pm EDT

Fierce 15 Awards Ceremony

Monday September 30, 2024 6:15pm - 6:30pm EDT

6:30pm EDT

Fierce 15 Networking Reception

Monday September 30, 2024 6:30pm - 7:30pm EDT

8:00am EDT

Networking Breakfast

Tuesday October 1, 2024 8:00am - 8:45am EDT

The Westin Boston Seaport

Tuesday October 1, 2024 8:00am - 8:45am EDT
The Westin Boston Seaport 425 Summer Street Boston, MA 02210

8:45am EDT

Day Two Kickoff & Chairperson’s Remarks

Tuesday October 1, 2024 8:45am - 9:00am EDT

Geoff Birkett, Chief Commercial Officer, Ensysce Biosciences

Tuesday October 1, 2024 8:45am - 9:00am EDT

9:00am EDT

Keynote - TBD

Tuesday October 1, 2024 9:00am - 9:30am EDT

Case study TBD.

Tuesday October 1, 2024 9:00am - 9:30am EDT

9:30am EDT

Presentation

Tuesday October 1, 2024 9:30am - 10:00am EDT

10:00am EDT

Market Access Mastery: Timing and Impact in the Era of Change

Tuesday October 1, 2024 10:00am - 10:45am EDT

Explore the multifaceted challenges of market access with leading experts from various sectors of the healthcare industry. This panel will discuss how to strategize around the evolving global policies and economic pressures.

Panelists will discuss the impact of international market trends on drug pricing and access strategies.
Experts will debate the implications of recent policy changes on market access and how companies can best adapt.
The panel will provide insights into effective strategies for engaging with payers to enhance drug accessibility and affordability.

Tuesday October 1, 2024 10:00am - 10:45am EDT

10:45am EDT

Networking Break

Tuesday October 1, 2024 10:45am - 11:15am EDT

11:15am EDT

Maximizing Financial Efficiency in Drug Development: Strategic Budgeting and Cost Management

Tuesday October 1, 2024 11:15am - 11:45am EDT

Explore efficient allocation of financial resources to maximize capital use and minimize waste across development phases.
Discuss flexible and robust budgeting techniques that adapt to unexpected changes and regulatory shifts in development.
Examine long-term financial strategies that align with business goals and invest in cost-reducing, sustainable practices to enhance ROI.

Tuesday October 1, 2024 11:15am - 11:45am EDT

11:45am EDT

Presentation

Tuesday October 1, 2024 11:45am - 12:15pm EDT

1:15pm EDT

Panel Discussion: Reviving Shelved Pharmaceutical Assets for New Therapeutic Applications

Tuesday October 1, 2024 1:15pm - 2:00pm EDT

Many promising drug candidates often face de-prioritization due to financial constraints, strategic shifts, or resource allocation decisions. This panel will dive into the transformative journeys of shelved assets that have been resurrected and developed into FDA-approved treatments. Featuring expert insights from leaders who have successfully navigated the complexities of in-licensing and repositioning these drugs, the discussion will highlight strategies for identifying potential, overcoming challenges, and ultimately delivering new therapies to patients in need.

Key Discussion Points:

Learn how companies pinpoint promising drug candidates that have been previously set aside and assess their viability for new therapeutic applications.
Explore the processes and strategies involved in in-licensing shelved assets, including the negotiation, planning, and development stages that lead to successful outcomes.
Gain insights into the challenges faced during the advancement of these assets, including clinical trial design, regulatory approvals, and navigating the complex landscape of drug development.
Hear from industry leaders who have successfully brought shelved assets to market, sharing their experiences, key takeaways, and the impact these drugs have had on patients' lives.

Tuesday October 1, 2024 1:15pm - 2:00pm EDT

2:00pm EDT

Presentation

Tuesday October 1, 2024 2:00pm - 2:30pm EDT

2:30pm EDT

Panel Discussion: Mastering the Art of Target Product Profiles in Drug Development

Tuesday October 1, 2024 2:30pm - 3:15pm 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.

Vincent Fisher, Executive Director, Global Marketing & New Product Planning
Unicycive Theraputics

Tuesday October 1, 2024 2:30pm - 3:15pm EDT

3:15pm EDT

Closing Remarks

Tuesday October 1, 2024 3:15pm - 3:30pm EDT