Program Sessions

Breakfast & Recap

8-8:30 a.m.

Human Clinical Trials

8:30-10 a.m. | Mathias Cousin

Human clinical trials are essential for understanding clinical benefits of medical products in subsets of human populations, in advancing medical knowledge and improving healthcare. They are the cornerstone of evidence-based medicine, providing critical insights into the safety and effectiveness of new treatments, therapies, and medical devices. This session will explore essential components of clinical trial design, implementation, and monitoring within a comprehensive product development program.

Learning Outcomes

• Describe key aspects of clinical trials: design, recruitment and retention
• Identify factors that may limit diversity and representation and understand key aspects of end-point selection.
• Outline regulatory compliance, guidelines, ethical considerations and requirements for informed consent.

CMC: A Critical Component of Drug Development

10-11:30 a.m. | Michele Dougherty

Aligning clinical development and product manufacturing activities is a key to successful commercial development. A successful regulatory strategy will take into consideration the timing of manufacturing milestones such as process scale ups and selection and implementation of commercial presentations to provide assurance of meeting regulatory requirements in support of licensure or approval. Accelerated clinical development can compound CMC challenges. This session will focus on development of biological products, exploring the complexities of aligning CMC and clinical development and discuss effective strategies to minimize risk and advance successful product development.

Learning Outcomes

• Analyze how CMC development activities influence clinical data generation and regulatory success.
• Identify key manufacturing milestones, including process development and commercialization strategies.
• Evaluate challenges and solutions for aligning accelerated clinical development with commercial manufacturing readiness.

Lunch

11:30 a.m.-12:30 p.m.

Cell and Gene Therapies: Challenges and Opportunities

12:30-2:30 p.m. | Mathias Cousin

Cell and gene therapies are revolutionizing medicine, offering life-changing treatments for patients with previously untreatable conditions. However, their development and commercialization present distinct challenges compared to traditional therapies. These complexities arise from intricate manufacturing processes, rigorous regulatory requirements, reimbursement barriers, and the need for scalable commercialization strategies. This session provides a comprehensive overview of cell and gene therapies, exploring strategies for demonstrating value, ensuring patient access, and overcoming key hurdles to drive long-term success.

Learning Outcomes

• Map the patient journey for cell and gene therapies, from development to treatment access.
• Differentiate cell and gene therapies from other treatment modalities and evaluate their impact on development and commercialization strategies.
• Identify critical success factors for launching and sustaining commercially viable cell and gene therapies.

Capstone Mastery Session: CEO of Me, Inc. Part I

2:30-5:30 p.m. | Rajshree Agarwal

Whether we are individual contributors or team leaders within organizations, creating value begins with personal and purposeful leadership. This mastery session will help you think and be the CEO of Me, Inc. It will foster you--an enterprising, purposeful individual with limitless potential. Starting with your own interests, abilities and aspirations, you will learn to develop collaborative trade relationships wherein you and your team members deliver on your unique value propositions by being aligned to a common objective and by creating strong organizational systems for success. Specifically, the session is designed to help you discover your "why," by thinking through the fundamental values and principles which define your purpose. It will also help you explore your "how," by leveraging your core skills and capabilities to effectively work with others and create productive and innovative solutions to problems in the world that you care deeply about.

Learning Outcomes

• Learn to use the four-question approach to define your purpose, success, value proposition and value network.
• Develop answers to the questions to determine what solutions to world problems you want to create and why these problems are important to you.
• Apply the "trader principle" to create collaborative relationships among individuals who have complementary capabilities and are aligned on a common objective.
• Understand how individuals and organizations can leverage the power of markets through purposeful leadership.

Dinner & Keynote: Coverage Is Everything! How Is It Done at CMS?

6-8 p.m. | Marion Couch, M.D., Ph.D., MBA

The Centers for Medicare & Medicaid Services (CMS) plays a critical role in shaping healthcare access and reimbursement in the United States, directly influencing innovation and service delivery. This session provides an in-depth exploration of how CMS establishes coverage policies, assesses medical necessity, and implements national and local coverage determinations (NCDs and LCDs). Participants will examine the intersection of policy, quality programs, and value-based care models, gaining valuable insights into the decision-making process and its far-reaching impact on healthcare stakeholders.

Breakfast & Recap

9-9:30 a.m.

Capstone Work: Time to Work with Deloitte Mentors

9:30-10:30 a.m.

The Capstone Innovation Lab is an integrated, hands-on experience that spans the entire week-long Program, providing participants with ongoing opportunities to apply their new-found kno-how to real-world healthcare challenges. Through structured touchpoints, working sessions, and expert mentorship, teams will refine strategic approaches and develop actionable solutions to pressing industry issues. 

Ethical Crossroads: A CEO’s Case Study

10:30 a.m.-12:30 p.m. | Kenneth Moch

A child is dying, and the family is pleading for access to your still-unproven experimental medicine. As a CEO or senior executive, how do you navigate this impossible decision? Expanded access programs present profound ethical dilemmas, balancing the immediate needs of a critically ill patient against the broader impact on a drug development program and future patients. While the urgency of compassionate use is undeniable, companies must also consider scientific integrity, regulatory compliance, and long-term consequences.

This interactive session will explore the ethical, regulatory, and strategic challenges surrounding experimental medicine access. Through real-world case studies, participants will examine the perspectives of patients, companies, regulators, and the broader healthcare system to assess how leadership can responsibly navigate these high-stakes decisions.

Learning Outcomes

• Analyze the intersection of drug development, bioethics, and patient advocacy in expanded access decisions.
• Evaluate the perspectives of all stakeholders involved & consider whether a universally “right” decision exists.
• Develop strategies for organizations to proactively prepare for expanded access requests while maintaining ethical and regulatory integrity.

Lunch

12:30-1:30 p.m.

Corporate Venturing: Igniting Entrepreneurial Spirit from Within

1:30-3:30 p.m. | Oliver Schlake

This session explores the skills, strategies, and challenges of fostering entrepreneurial behavior within organizations (“intrapreneurs”), including both corporate and, where applicable, government settings. Participants will examine how companies identify and develop intrapreneurs, create internal ventures, and navigate barriers to corporate entrepreneurship. The session also introduces a “venturing readiness” assessment tool, enabling participants to evaluate their organization’s capacity for innovation and internal venture development.

Learning Outcomes

• Understand corporate venturing as a strategic driver of growth and innovation, highlighting the role of intrapreneurship in maintaining long-term competitiveness.
• Develop strategies to identify, support, and leverage intrapreneurs, fostering a culture of innovation within organizations.
• Analyze common obstacles to corporate venturing and apply practical approaches to overcome challenges and enhance innovation capacity.

Capstone Work: Time to Work with Deloitte Mentors

3:30-5 p.m.

Guided by industry mentors and medical experts, cross-functional teams will engage in “Innovation Sprints,” leveraging critical thinking skills and best practices in leadership. Throughout the week, teams will continuously refine their approaches and define their unique value proposition within the life science and healthcare ecosystem. The experience culminates in a final reports from all teams that will be posted for the benefit of all participants, after the Program culminates.

Field Trip: Sunset Sightseeing Tour of D.C.

6-8 p.m.

Breakfast & Recap

8-8:30 a.m.

Product Launch & Commercialization

8:30-9:30 a.m. | Candy Lurkin

A successful product launch requires meticulous cross-functional planning and a deep understanding of the needs of multiple external stakeholders. Retrospective analysis has repeatedly shown that you only have one chance to make a strong first impression, making it critical to execute a launch strategy effectively from the outset. With the increasing trend of launching multiple indications for a single product within short timeframes, organizations must develop a strong Launch Excellence (LX) capability to ensure efficiency versus disruption and hecticness which was the norm when launches happened every few years. This session explores effective launch strategies for a new product or product extensions/new indications, including some international differences, particularly in the EU and Japan, driven by domestic laws and regulations.

Learning Outcomes

• Evaluate the capabilities and investments required to launch a product
• Synthesize key learnings from past product launches
• Understand the key differences when launching ex-US and the market entry options to consider

Reimbursement: The Achilles Heel of Medical Product Adoption

9:30-10:30 a.m. | Jayne Little

Bringing a new medical technology from concept to widespread clinical adoption requires more than just innovation—it demands a strategic reimbursement and market access plan. Without a clear reimbursement pathway, even the most groundbreaking products can struggle with affordability, market viability, and adoption. Success depends on navigating the complexities of clinical trial design, coding, coverage, and payer policies in what can often be a reimbursement-resistant environment.

This session will explore the critical elements of reimbursement strategy, including how clinical trial outcomes impact payer decisions, the processes required to secure provider and facility reimbursement, and the role of specialty societies inshaping market access. Participants will gain insights into overcoming common barriers and ensuring financial sustainability for new medical products.

Learning Outcomes

• Analyze how clinical trial outcomes influence payer coverage and reimbursement policies.
• Evaluate the processes necessary for securing adequate reimbursement for physicians and healthcare facilities.
• Examine the role of specialty societies in advocating for reimbursement and shaping market access.

Overview of Real-World Data & Real-World Evidence

10:30 a.m.-12:30 p.m. | Reid D’Amico & Nicole Duran

In an era of rapid medical advancements, real-world data (RWD) and real-world evidence (RWE) are playing an increasingly vital role in regulatory decision-making and medical product development. These data-driven insights support regulatory submissions, post-marketing surveillance, and market access, helping to bridge gaps between clinical trials and real-world patient outcomes. This session provides a comprehensive overview of RWD/E principles, evolving regulatory frameworks, and practical applications. Through case studies, participants will explore how to efficiently capture, analyze, and leverage RWD/E to drive innovation, meet regulatory expectations, and unlock new opportunities beyond traditional regulatory interactions.

Learning Outcomes

• Examine key RWD/E regulatory guidance and recent global regulatory developments.
• Evaluate various regulatory pathways that leverage RWD/E for medical product development and approval.
• Analyze case studies to understand how sponsors engage with the FDA to optimize the use of RWD/E.

Lunch

12:30-1:30 p.m.

Clinical and Patient Adoption of Breakthroughs

1:30-3:30 p.m. | Judy Frels

Every medical innovation must gain acceptance from two key stakeholders: the prescribing physician and the patient. The Diffusion of Innovations theory provides a framework for understanding how these stakeholders assess and adopt new medical advancements. By identifying potential barriers to adoption early in the development process, organizations can refine their innovations to enhance market success. This session will examine two case studies of FDA-approved products that failed to achieve widespread adoption, offering valuable insights into the challenges of diffusion and strategies to improve uptake.

Learning Outcomes

• Identify the five key factors that influence the diffusion of medical innovations.
• Evaluate an innovation using these five factors to determine potential adoption challenges.
• Propose strategic modifications to an innovation during development to increase its likelihood of market success.

Capstone Applied Session: CEO of Me, Inc: Part II

3:30-5 p.m. | Jacqueline Manger

In this interactive session, teams will apply the “Be the CEO of Me, Inc.” framework to their organization, refining their collective mission, assessing key success strategies, and sharpening their unique value proposition. Through structured discussions and collaborative exercises, participants will evaluate their organization’s current and future activities, ensuringalignment with long-term strategic goals. Using feedback loops and peer insights, teams will refine their organizational success matrix, identify key partnerships, and develop actionable strategies for sustainable growth and impact. By the end ofthe session, participants will have a clearer roadmap to enhance their organization’s effectiveness and value.

Learning Outcomes

• Define a clear, concise, and specific purpose that aligns with the organization’s strategic goals and impact.
• Assess current and future initiatives using success and value proposition frameworks, identifying strengths, gaps, and opportunities for growth.
• Articulate the organization’s distinct contributions, develop strategies to enhance competitive positioning, and identify key partners to drive mission success.

Dinner & Keynote: Infectious Disease Disasters: Pandemics, Ebola and Anthrax

6-8 p.m. | Boris Lushniak, MD, MPH

Infectious disease disasters can arise from bioterrorism, pandemics, or outbreaks of emerging and reemerging diseases. Understanding how to effectively mitigate, prepare for, respond to, and recover from such disasters is critical to public health resilience. This keynote session will explore lessons learned from past infectious disease crises, including the anthrax attacks, the 2009 H1N1 influenza pandemic, the Ebola outbreak, and with particular emphasis on COVID-19 pandemic.

Breakfast & Recap

8-8:30 a.m.

Revolutionizing Healthcare: Harnessing AI for Effective Decision-Making

8:30-9:30 a.m. | Balaji Padmanabhan

Artificial Intelligence is revolutionizing many industries and has the potential to unleash a new era of productivity and discovery in the life sciences sector. However, there are several challenges that organizations need to properly manage to harness its capabilities appropriately. This session will provide an overview of AI’s capabilities as it stands right now and lay out both promises as well as risks. Participants will gain insights into governance practices that can increase the likelihood of seeing the benefits while mitigating the risks. The discussion will focus on examples of AI in the life sciences sector and provide a forward-looking perspective on AI’s role in shaping healthcare decision-making.

Learning Outcomes

• Understand the capabilities of today’s AI systems, and their origins, in order to distinguish current possibilities and limitations within the life sciences and healthcare sectors.
• Describe various AI risks and governance practices that can help increase the chances of maximizing benefits from AI use while mitigating harm.
• Develop a perspective on AI applications in the healthcare sector using real-world examples.

From Drug Discovery to Diagnosis to Death: How AI is Transforming Healthcare, Life Sciences, and Research

9:30-10:30 a.m. | Juergen Klenk

Artificial intelligence and data-driven technologies are transforming the healthcare continuum, from drug discovery to diagnosis and treatment. These advancements are driving efficiencies, improving precision, and reshaping patient outcomes in unprecedented ways. This session will explore key applications of AI in accelerating drug development, enhancing diagnostic accuracy, and optimizing treatment pathways. Participants will gain insights into real-world innovations, ethical considerations, and the future impact of AI on healthcare and public health.

Learning Outcomes

• Understand the evolution and impact of AI in drug discovery, diagnostics, and treatment, recognizing its role in transforming healthcare decision-making.
• Differentiate between AI-driven tools, data analytics, and machine learning applications in healthcare, and explain how they contribute to improved patient outcomes.
• Develop effective strategies for integrating AI into healthcare systems, fostering trust-based collaborations that enhance clinical decision-making and public health initiatives.

Intellectual Property (IP) & Technology Transfer

10:30 a.m.-Noon | Steve Ferguson

Intellectual property (IP) and technology transfer are critical components of the biomedical industry, shaping how innovations move from research labs to real-world applications. As the landscape of life sciences R&D and commercialization evolves, understanding how to strategically manage and leverage IP is more important than ever. Despite frequent interactions with IP and technology transfer, many professionals lack a comprehensive grasp of how to maximize their potential to align with institutional or organizational goals.

This session will provide a detailed exploration of IP fundamentals, technology transfer processes, and commercialization strategies. Participants will engage in an interactive case study, applying key principles to real-world licensing scenarios to better understand how IP and technology transfer drive innovation and business success.

Learning Outcomes

• Develop a deeper understanding of IP and technology transfer and their strategic roles in biomedical innovation.
• Analyze the interaction of technology transfer within the broader process of bringing new discoveries to market.
• Apply IP and technology transfer principles in an interactive licensing case study.

Lunch

Noon-12:30 p.m.

Leadership Under Pressure

12:30-4:30 p.m. | Subra Tangirala & Jennifer Marr

Effective leadership in a high-stakes environment is essential for managing uncertainty, making informed decisions, and fostering team resilience. The goal of this session is to critically examine and reflect on leadership and team dynamics in high pressure situations through a live interactive simulation. Participants will work in teams to confront a series of leadership challenges that will test their ability to work together in situations characterized by uncertainty in the life sciences industry. The session will conclude with a reflection of team experiences and a discussion of best practices for navigating these situations in real life.

Learning Outcomes

• Experience and examine leadership challenges in uncertain situations within the life sciences industry
• Assess the team dynamics that arise in high pressure situations
• Understand how to manage team processes (e.g., conflict) in uncertain situations

Graduation & Certificate Presentation

4:30-5 p.m.