How Harvard Business School is Accelerating Precision Medicine

by Kathy Giusti and Richard Hamermesh

Accelerating Precision Medicine – We, the authors, are not scientists or researchers and don’t operate a lab or an incubator. We are businesspeople, entrepreneurs, and system thinkers with broad experience in areas such as finance, marketing, and operations.

Our mission is not to bring one specific drug to market faster. It is to act as a catalyst that accelerates the entire precision medicine ecosystem by connecting people, changing business processes, and disseminating best practices.

We aim to fulfill this mission by:

• Initiating a systematic approach to accelerate others in finding cures. This approach consists of:

1. Understanding the landscape by studying what exists and where gaps remain.

2. Identifying challenges through rigorous analysis of the landscape and roadblocks.

3. Convening thought leaders and solution teams who are the “best of the best” in relevant areas. These leaders – from across the precision medicine ecosystem – come together to identify best practices and actionable steps. Participants have included academics, scientists and researchers, investors, nonprofit foundation and registry leaders, community health system leaders, data experts, consumer engagement experts, government officials, and more.

4. Disseminating findings by publishing in places like the Harvard Business Review, Time, Forbes, and Fortune, creating a podcast, and conducting executive education.

5. Leveraging the concept of “collective impact.” This is a framework developed in part by Harvard Business School’s Mark Kramer. The idea is that solving complex problems requires diverse stakeholders working together. We have incorporated collective impact into the Kraft Accelerator and tapped into esteemed thinkers such as HBS Professors Michael Porter and Clayton Christensen.

Our philosophy is to identify and work with innovative first movers, understand the keys to their success, and then capture and convey these insights to second and third movers, thereby creating a ripple effect across the entire ecosystem – that accelerates progress and produces cures.

• Establishing focused workstreams. With numerous possibilities and limited resources, after the Kraft Precision Medicine Accelerator was established, we asked ourselves, “Where can we have the greatest impact? Where should we focus?” We initially identified the following four workstreams:

1. Direct-to-Patient (DTP). Since data is the key to unlocking promising therapies, the goal of this workstream is identifying best practices for engaging patients to share their data for research. The DTP workstream was led by an accomplished consumer marketing executive.

2. Data, Analytics, and AI. Once patients share their data, it needs to be aggregated, standardized, and analyzed, which has often not occurred. This workstream was guided by an expert in healthcare data and analytics.

3. Clinical Trials. Trials often run late or fail due to poor design or lack of enrollment. New trial designs are needed that increase efficiency and success. The trials workstream was overseen by an executive with extensive drug development clinical trial experience.

4. Investment & Venture. New investment approaches are required to align incentives, attract more capital, and accelerate progress. Richard Hamermesh leads this workstream.

Each workstream has involved intimate meetings with dozens of leaders in that area. Collectively, since the inception of the Kraft Accelerator, we have met with, listened to, and worked with about 300 of the most prominent leaders throughout the precision medicine space.

“The Pancreatic Cancer Action Network (PanCAN) was an active participant in all four workstreams of the Kraft Precision Medicine Accelerator. We shared insights with peers and industry experts about what PanCAN is doing and we learned from others about real‑world best practices. We continually apply these best practices across many elements of our business – from patient engagement to data sharing and venture philanthropy.”

– Julie Fleshman,
President and CEO, PanCAN

Descriptions of each workstream’s activity and progress are summarized below.

What We Have Done
Each workstream followed our approach of understanding, identifying challenges, convening leaders, and disseminating findings.

Workstream 1: Direct-to-Patient (DTP)

Precision medicine starts with patients, who control their data and are increasingly engaged in their care. A key to accelerating precision medicine is engaging large numbers of patients to provide access to their clinical data, genomic data, tissue, and other types of data on a longitudinal basis.
The DTP Workstream enlisted direct-to-consumer (DTC) experts – many of them HBS alums – from leading consumer marketing companies such as Marriott, Facebook, Peloton, Reebok, and Keurig. Beginning shortly after the Kraft Accelerator was founded, these DTC experts have convened in person and through regular conference calls to share insights on acquiring, engaging, and retaining consumers/patients. (See the summary of a May 15, 2019 roundtable1 with leading consumer experts on driving engagement.)

Work by the DTP Workstream has included:

• Building Your Base: We defined foundational expertise needed by nonprofits that want to acquire and retain patients as participants in clinical research and registries. Elements include understanding the patient journey, adopting a modern CRM, using social media to acquire patients, and having scorecards and dashboards to measure performance.
• Driving Value and Engagement. The DTP Workstream worked with five leading cancer organizations – which had never previously collaborated – on research to identify patients’ knowledge gaps about the patient journey. Based on insights from this research, the Kraft Accelerator developed the Right Track (see Figure 1), a valuable framework that nonprofits can use to build patient engagement.
  Some organizations, including the MMRF, contributed to the development of the Right Track and have now made it a central organizing principle. And, while developed with a focus on a cancer diagnosis, the Right Track is applicable for other diseases.

Figure 1 – Right Track

Understanding Registries with Biospecimens. The DTP Workstream’s current focus is understanding the complexity of registries with biospecimens. Consumer experts continue to advise the team on creating frictionless programs with high-impact visuals and clear return of results.

Workstream 2: Data, Analytics, and AI

Data is the key to answering critical questions regarding new targets, potential biomarkers, and clinical pathways and workflows. This includes clinical, molecular, genomic, and immune data collected longitudinally. The main data-related problems? Many datasets are siloed, restricting access to data that may be crucial to finding cures; and, organizations face challenges ensuring privacy and security of data for the organization, patients, or subjects of a trial.

The Data Workstream has focused on ensuring that data required for precision medicine is aggregated, harmonized, and analyzed. This workstream has brought together leaders from major data suppliers and aggregators, as well as from the worlds of machine learning and AI to share their knowledge.

Early on, the Kraft Accelerator engaged PwC to conduct a landscape survey to identify organizations that collect and analyze oncology data sets. We found a vast system of unconnected data archipelagos. In 2018, we updated our Data Landscape (see Figure 2).

In creating this updated landscape, we found: real-world data assets are growing in size and sophistication; sharing and linking models are winning; the willingness to share and link data assets is rising; and the frontiers of real-world data are advancing. Our survey also identified companies involved in the analysis of this data and sorted these companies based on their type of analytics, including AI.

This workstream has launched a podcast series titled Under the Datascope2 showcasing business models, technologies, and analytics leaders in precision medicine. Recent episodes include discussions of using AI to avoid wasteful treatments, how R&D needs to change to cure disease, who owns a patient’s data, and genomic registries.
The work of the data workstream is continuing with a tiger team currently looking at business models for the monetization of data.

“As an organization intensely focused on changing how cancer is treated, we enjoyed sharing our knowledge and experiences with other healthcare leaders. Through our experience with the Kraft Accelerator, we cultivated relationships with data partners and advocacy organizations that will help us build new precision medicine care models and pathways.

– Lincoln Nadauld, MD, PhD,
Vice President, Chief Precision Health, Intermountain Healthcare

Workstream 3: Clinical Trials

Clinical trials are a major issue in drug development. They are necessary, but are inefficient, slow, and costly. A better approach that accelerates trials is needed.
As part of this workstream, we brought in Quintiles/IMS to develop a landscape of platform studies to identify leaders in the space, best practices, and opportunities in clinical trial design and operations. We identified clinical trial models that may be more conducive to precision medicine.
This workstream convened leaders with extensive trial experience from pharmaceutical and biotech companies, as well as nonprofits and academic centers. Participants convened multiple times to examine innovative trial approaches, understand advantages and challenges of platform trials, and share best practices around master protocols. This group concluded:

• Master protocols offer the promise of more productive clinical trials.
• There is a “sweet spot” for master protocol partnership between industry and nonprofits.
• Proactive risk mitigation gives a master protocol the best chance of operating smoothly and working successfully.

As part of this workstream the Kraft Accelerator facilitated collaboration among cancer groups working on clinical trials to share progress, challenges, and metrics, and identify solutions. The Kraft Accelerator has held conversations with the FDA about innovative trials and has disseminated findings by publishing articles such as Master Protocols in Oncology: A Review of the Landscape.3

“As a biotech company focused on precision therapies, we aim to significantly improve and extend the lives of patients by delivering the right drug to the right patient at the right time. In working with the Kraft Accelerator, we gained valuable new perspectives on the interdependencies of external stakeholders such as patient advocacy organizations, community health systems and lab diagnostic partners. Taking a holistic view to these stakeholders will definitely help us advance our programs and optimize patient outcomes through precision medicine approaches.”

– Kate Haviland, COO,
Blueprint Medicines

Workstream 4: Investment/Venture

Curing a disease requires significant funding and narrow focus. However, while disease-focused groups have historically had a narrow focus, most haven’t raised enough money to make a difference. And venture capital firms, which have significant capital, have focused broadly to avoid concentrating their risk. These traditional approaches will not provide adequate funding for cures.

To find solutions, this workstream has studied multiple funding options, spoken with numerous investors and organizations launching innovative investment vehicles, and convened investors pursuing a wide range of models. On February 28, 2019, the Kraft Accelerator convened leaders from banks, venture firms, biotech companies, disease-focused organizations, and other funding innovators. (See the meeting summary4).

A snapshot of the landscape for precision medicine investments is shown in Figure 3.
The types of organizations funding precision medicine include disease foundations, venture capital funds, universities, and newly emerging healthcare investment vehicles. Models ranges from philanthropy to mixed models such as venture philanthropy to for-profit investments. Investors also differ in their focus, with some having a narrow focus – in an area like multiple myeloma or diabetes – and others having a broad focus. Innovative new models show great promise. Examples include:

• An oncology fund of almost $500 million created by multinational bank, UBS. UBS raised $500k to $1M each from high net worth individuals. Funds are invested by MPM, a venture capital firm with oncology expertise.
• The Dementia Discovery Fund raised $350 million from leading pharma companies, Bill Gates, and AARP. Venture firm SV Health is managing the investments. Initial results are promising.
•  A venture capitalist has raised more than $500 million to invest in therapies for rare diseases.
• The Juvenile Diabetes Research Foundation has launched the T1D Fund, venture philanthropy fund to catalyze investment by other investors in type 1 diabetes treatments.

The Kraft Accelerator’s Investment/Venture Workstream is continuing to identify innovative funding models and is connecting organizations to learn from each other.

This workstream has published articles (such as Impact Investing: A New Way to Fund Cures for Cancer5) and been interviewed about new approaches to investment, including this piece in the Wall Street Journal: In Quest for Cures, Medical Nonprofits Seek to Wield Their Own Venture Funding Power.6

Disseminating Findings

Through these working groups we have solicited and identified numerous best practices from the hundreds of precision medicine leaders and first movers the Kraft Accelerator has convened. Fulfilling our mission involves disseminating these insights throughout the precision medicine ecosystem to second and third movers and to nonprofits and foundations that are just getting started. Ways we disseminate findings include:

• Publications. We have published broadly in business publications like the Harvard Business Review, Forbes, Fortune, and the Wall Street Journal; mainstream media including Time, the Boston Globe, and Huffington Post; and healthcare publications such as STAT and Applied Clinical Trials.

5 Selected Publications

Among the many publications created by the Kraft Accelerator, examples of articles include:

• 4 Important Steps to Take After a Cancer Diagnosis, Time, February 12, 20197
• What Cancer Researchers Can Learn from Direct-to-Consumer Companies, Harvard Business Review, January 12, 20178
• A New Approach to Safely Sharing Cancer Patients’ Data, Harvard Business Review, June 21, 20179
• Impact Investing: A New Way to Fund Cures for Cancer, STAT, February 25, 201910
• What Precision Medicine Can Learn From the NFL, Forbes, April 13, 201711
• Executive education on Accelerating Innovation in Precision Medicine. This offering, held at Harvard Business School in 2018 and 2019, brought together more than 150 leaders from dozens of organizations from all parts of the precision medicine ecosystem. Through presentations, case studies, and discussions, participants learned from the Kraft Accelerator’s findings about how to accelerate their organization’s precision medicine activities. Participants also built relationships and strengthened their network.
• Case studies are part of Harvard Business School’s DNA. Among several relevant case studies on precision medicine, examples are Intermountain Healthcare: Pursuing Precision Medicine, Dementia Discovery Fund, and Breakthroughs at Blueprint Medicines.

Videos, webinars, and podcasts from several workstreams on multiple topics. This webinar video on Exploring the Frontiers of Data and Analytics for Precision Medicine12 is an example.

Where the Kraft Accelerator is headed

After more than three years of intensive efforts and contributions from hundreds of experts, the Kraft Accelerator has developed a significant base of knowledge on engaging patients, aggregating data, improving trials, attracting investment, and more.

We see an opportunity to accelerate the entire precision medicine ecosystem by democratizing the knowledge and insights we have gained. Our aim is to become a trusted resource of precision medicine expertise that helps propel the thousands of nonprofits that lack the scale and expertise of the first movers we have convened and of Harvard Business School.

We are currently an online collection of insights, best practices, resources, frameworks, and tools. Our plan is to make these assets available to all entities focused on using precision medicine to accelerate cures.

Also, while our initial efforts focused mainly on cancer, the knowledge we have gained and the tools and resources we have developed are relevant beyond oncology to organizations using precision medicine in other therapeutic areas.

Our work will continue to align with the Kraft family’s goal of removing the obstacles in the healthcare system to accelerate cures through precision medicine.

A Transformative Approach to Curing Diseases

THE KRAFT FAMILY understands from personal experience the promise and challenges of precision medicine. When Myra Kraft, wife of Robert and mother of Jonathan Kraft, was diagnosed with ovarian cancer, the Krafts learned from Dr. Eric Lander, director of the Broad Institute, about the remarkable progress in understanding how genes work and potential cures arising from precision medicine.

They also experienced the broken, fragmented healthcare system where breakthrough discoveries do not reach patients fast enough and where collaboration among stakeholders is often lacking. Harvard Business School Dean Nitin Nohria explained, “Many of the challenges facing the advancement of precision medicine are business challenges.”

The Kraft family agreed. Having experienced these challenges, they concluded great impact could come by accelerating precision medicine to cure diseases. In 2016, they donated $20 million to establish the Kraft Precision Medicine Accelerator to catalyze breakthrough business models.

Robert and Jonathan Kraft believed Harvard Business School could bring about disruptive, systematic changes to move precision medicine from the lab to patients much faster. They chose Harvard Business School because of its entrepreneurial leadership and resources, and because of the School’s ability to convene leaders, act as a trusted third party, and catalyze change.

Dean Nohria asked us – Richard Hamermesh, a longtime HBS professor, and Kathy Giusti, an HBS graduate – to co-chair the Kraft Accelerator. Kathy, a multiple myeloma patient, established and led the Multiple Myeloma Research Foundation (MMRF), which has been instrumental in bringing 11 drugs to market and extending patients’ life expectancy. Richard, also a cancer survivor, was the founding Faculty Chair of HBS’s Healthcare Initiative, and has been involved in numerous healthcare ventures and organizations.

Kraft Accelerator Team: Kathy Giusti, Nitin Nohria, Robert Kraft, Richard Hamermesh (from left to right)

Kathy Giusti, Faculty Co-Chair of the Kraft Precision Medicine Accelerator and the Henry & Allison McCance Family Senior Fellow at Harvard Business School. Kathy established the Multiple Myeloma Research Foundation (MMRF) in 1998, shortly after being diagnosed with the disease. She has led MMRF in establishing collaborative research models in tissue banking, genomics, clinical trials, and data sharing. Recognized as a leader in precision medicine, Kathy has been named by Time as one of the world’s 100 most influential people and by Fortune as one of the World’s 50 Greatest Leaders.

 

 

 

Richard Hamermesh, Faculty Co-Chair of the Kraft Precision Medicine Accelerator and Harvard Senior Fellow, is also a cancer survivor. Richard was the founding Faculty Chair of the HBS Healthcare Initiative. Richard is an active investor and entrepreneur, having participated as a principal, director, and investor in the founding and early stages of over 20 organizations. Richard is the author or co-author of five books and has published numerous articles and case studies.

 

 

Additional Information
For more information about the Kraft Precision Medicine Accelerator, contact kraft_accelerator@hbs.edu or call 1.617.495.1782.

Figure 1: Right Track

Figure 2: Data Landscape

Figure 3: Investment Landscape for Precision Medicine