Evidence-Based Digital Health in Pharma Agenda

Registration, Breakfast & Networking 

Chairs Opening Remarks

Alisan Atvur, Principal UX Researcher, Design Thinking Catalyst, Novo Nordisk

Keynote Presentation: An Introduction into Evidence-Based Digital Health in Pharma

To set the scene for the day, this presentation led by a leading expert of the industry, will lay the groundwork for evidence-based digital health in pharma by exploring the current efforts, impact and challenges faced by the pharmaceutical industry and explore how we can overcome these hurdles for improved clinical, economic and health outcomes.

• What are the current efforts within pharma for evidence-based digital health adoption and implementation?
• An overview of the key challenges faced by the pharmaceutical industry in utilizing digital health solutions.
• What are the successes we’ve seen in this field and how can we continue building on these?

Shoibal Datta, Head of Digital Health Sciences, Takeda

Presentation: Defining, Aligning and Preparing Pharma for Evidence-Driven Digital Health

In recent years, there has been an explosion of digital health solutions within the healthcare system. As a result, it’s important to establish a clear definition of digital health and determine which opportunities have the most potential for the pharmaceutical industry. This session will set the scene for what evidence-based digital health is and what success looks like, especially for pharma. We’ll discuss:

• Where does pharma have a right to play in evidence-based digital health?
• Who are the stakeholders and what are their expectations and objections?
• Where have we seen successful integrations of digital health technologies with pharmaceutical therapies?
• What steps or evidence must be taken to support the combination of digital health and pharma therapies?
• What are the most important lessons learned from real-world evidence generation?

Ahmed Albaiti, Principal, Digital and Connected Health, ZS
Jim Joyce, CEO and Co-Founder, HealthBeacon 

Keynote Panel Discussion: Defining the Need for Evidence-Based Digital Health | A Multi-Stakeholder Perspective

Over recent years, the adoption of clinically-validated digital health solutions within the therapeutics industry have continued to grow. However, its place within pharma is still uncertain and undefined. Key challenges around where this new technology sits within pharma, who owns the processes and understanding its true potential remain unanswered. This panel discussion will explore the need for evidence-based digital health and its prospective effect on the healthcare system.

• What opportunities can evidence-based digital health tools offer the current healthcare system and its patients?
• How are pharma, payers and providers viewing the prospect of digital health tools within healthcare?
• How can we begin to pivot the traditional healthcare system to include digital health solutions as the norm? Meri Kay
• What are the potential challenges of utilizing digital health?
• What role should pharma play in collaborating with other stakeholders to make sure the full benefits of digital health can be realized?

James Williams, Head & Executive Director, Biogen Digital Health External Innovation and Alliances, Biogen
Meri Kay Scott, Associate Vice President, Digital Health R&D – Clinical Operations, Eli Lilly and Company 
Basker Gummadi, Head of Digital Health, Gilead Sciences
Celine Marquez, Global Medical Director of Digital Health, Genentech

Morning Refreshments & Networking

Presentation: Quantifying Product Development Risks 

Developing innovative and more holistic digital medicines comes with a high degree of risk. How can we balance and quantify this risk whilst developing these novel digital medicines? How does this risk differ from more traditional efforts of therapeutic development?

Mar Santamaria, Clinician, Director, Pfizer

Panel Discussion: What Evidence is Needed to Inform Decision Making Concerning the Adoption of Evidence-Based Digital Health Solutions?

The pharmaceutical industry traditionally involves a great deal of risk around product development. With digital health becoming more implemented within Pharma there is a need to address the risks and impact in the adoption, use and development of digital health solutions as well as quantifying this risk with the great value that the implementation of digital technologies can bring. This session will outline how we can approach and manage the risk that comes with the implementation of digital health, by deciphering what evidence is needed to inform decision making concerning its adoption. 

• What type and strength of evidence and data (e.g. from clinical trials or real-world data [RWD]) are needed to enable the adoption of digital health solutions in healthcare?
• What are the current challenges with collecting large sets of RWD to generate real-world evidence (RWE) from digital applications?
• What are the issues around protected health information (PHI) under data privacy when using big data, for example, in the US, EU and other parts of the world?
• How can we ensure that evidence generated by digital health solutions is collated from diverse data sets? E.g. representativeness of the patient populations, across gender, race, and ethnicity variables, as well as interoperability for complementary information.
• How can data science (e.g. artificial intelligence, machine learning and deep learning) improve the adoption and application of digital medicine?

Kaitlyn O’Connor, Partner, Nixon Gwilt Law
Bhaskar Dutta, Head of Digital Health Program Management, Alexion Pharmaceuticals
Rose Purcell, U.S. Lead (Director), Global Regulatory Policy & Innovation, Takeda
Kelly Zou, Head of Global Medical Analytics and Real World Evidence, Viatris

Lunch & Networking

Presentation and Discussion: Outlining the Methods Pharma can add Digital to their Portfolio

There are various ways that Pharma companies can add digital products to their portfolio. In this session, we will discuss the pros and cons of three of the most common models:

• Acquisition of a digital asset altogether
• Contracting with a digital health/DTx company or other product shop as a vendor, to produce a bespoke product
• Building an internal product team and creating products in-house

Each of these approaches has pros and cons, which we will discuss from the perspective of panelists in Pharma using each of these approaches. This discussion will help disentangle some of these factors to understand where each of these models shines.

Acacia Parks, Digital Health Expert & Advisor

Panel Discussion: How can Digital Health Solutions improve the Efficacy, Adherence and Patient Outcomes when Partnered with Traditional Therapeutics?

A leading approach from pharmaceutical companies, when utilizing digital health within their central efforts, is to combine these novel digital therapies with longstanding traditional drugs. However, with very few current in-market examples, it’s difficult to understand the true impact this can have on the efficacy, adherence and ultimately the outcomes of the patient. This panel, led by leaders across the pharma field, will explore this perspective, define its approach and compare it with other pharma-led digital efforts.

• Why are pharmaceutical companies looking to combine novel digital solutions with traditional therapeutics?
• What are the different approaches in which digital can be implemented alongside traditional therapeutics?
• Are there specific disease areas that can benefit the most from this strategy and what alignment is necessary for a success story?
• What is the increased value for pharma companies in building these ‘digitally-augmented therapies’?
• How do patient outcomes differ in combination therapies compared with digital-only or drug-only cases?
• What is necessary and where do we expect to see reimbursement when combining a digital solution and a traditional drug as a single therapeutics method?

Amir Lahav, Head of Strategic R&D, Digital Health Innovation & Corporate Strategy, Mitsubishi Tanabe Pharma US
Ainslie Forbes, Executive Director, Head of Digital Health R&D, Otsuka
Geoffrey Eich, Chief Executive Officer, Blue Note Therapeutics

Afternoon Break & Refreshments

Panel Discussion: Defining the Digital Health Treatment Pathway 

There is a great deal of ambiguity on how to clearly define a treatment pathway for digital health and how this differs from traditional treatment pathways. This session will look at the challenges underpinning the development of a digital health treatment pathway and look at how the industry can strategize and work alongside other stakeholder groups to ensure a seamless adoption of digital solutions within healthcare. 

• How can we define the different types of digital health solutions being developed and used?
• What are the challenges of implementing digital health solutions into patient treatment pathways?
• How can we support and motivate physicians providing digital medicine?
• What is the role of pharma in providing digital health solutions to patients, providers, and payers?
• Who has the obligation to care for patients using digital health continuously and who is responsible for patient data produced by these digital solutions?
• How do we handle the misalignment of incentives around the development and implementation of digital health solutions?

William Rush, Senior Director, Value and Access, Digital Healthcare Solutions, Sanofi
Joanna Kemp, Senior Director, Digital Health Commercialization Lead, Hematology and Cell Therapy, Bristol Myers Squibb
Lauren Bataille, Head of Digital Patient Health & Innovation – Cardiovascular, Renal & Metabolism, AstraZeneca
Jessica Lipschitz, Associate Director, Digital Behavioural Health & Informatics Research Program, Brigham & Women’s Hospital

Presentation: Partnering with Digital Health Companies to Guide Decision-Making, Improve Health Outcomes and Encourage Digital Innovation

• Dive deep into how digital health can address the disconnect between large pharma and the patient journey.
• Explore how real-time data insights can help inform decision-making. 
• Learn how Ada partners with pharmaceutical companies to increase access to care and improve patient journeys.

Eran Desheh, SVP, Corporate Development & Strategic Partnerships, Ada Health

Panel Discussion: Exploring Different Avenues into Evidence-Based Digital Health for Pharma

There are a variety of different avenues by which pharma has and can take into digital health. The 4 main avenues are 1) investing in digital health companies, 2) adopting the development of digital health solutions into their main pipeline efforts, 3) partnering with digital health companies and 4) licensing digital health solutions from an external company. This panel will outline these different avenues and explore the ranging benefits and challenges of each.

• Build, Buy or Partner – Which strategies are best suited for pharma?
• In the current digital health ecosystem, is there a preference as to which avenue pharma companies are looking to integrate digital health into their therapeutic efforts?
• How does the maturity and quality of evidence impact the structure or nature of the approach pharma takes in acquiring or partnering or accelerating these relationships?
• What are the varying considerations needed when evaluating digital solution adoption across disease states?
  

Moderator: Jin Lee, Former Director of Digital Health, Rx+ (Global), Formerly at Astellas Pharma
Ofer Waks, Director, Digital Strategy & Innovation, Pfizer
Jeff Weness, Head of Digital Opportunities and Investments, Otsuka 
Krista Russell, Head of Digital Health Solutions, Takeda
Amir Lahav, Head of Strategic R&D, Digital Health Innovation & Corporate Strategy, Mitsubishi Tanabe Pharma US
Steffanie Bristol, Head of Biogen Digital Health Ventures Strategy and Innovation, Biogen

Chairs Closing Remarks

Alisan Atvur, Principal UX Researcher, Design Thinking Catalyst, Novo Nordisk

Close of Evidence-Based Digital Health in Pharma Summit Day 1

Registration, Breakfast & Networking 

Chairs Opening Remarks

Alisan Atvur, Principal UX Researcher, Design Thinking Catalyst, Novo Nordisk

Keynote Panel Discussion: Evidence Assessment for Digital Health Interventions: A Multi-Stakeholder Perspective

Rapid evolution is occurring across a wide range of digital health technologies. Such development is exciting but brings questions around evidence standards for regulated and non-regulated digital health products. Dozens of frameworks have been proposed to assess evidence in digital health, creating ambiguity for product developers. How can we harmonize and optimize evidentiary standards in this rapidly changing space? How should we assess digital health evidence for effective translation in real-world settings?

The Digital Medicine Society organized a multidisciplinary workgroup with leading industry experts to develop a careful and efficient framework for evidence assessment in digital health. The multi-sector collaboration included representation from payers, academic medical centers, digital health solutions, providers, pharma, and others.

In this session we will share key findings from the workgroup, with a focus on:

• The current state of evidence standards in digital health.
• Proposed best practices to assess clinical evidence for digital health interventions.
• Concrete steps that may help digital health solutions providers “future proof” their evidence generation strategy.
• Common pitfalls in evidence generation for digital health interventions.
• Key gaps and opportunities to advance the field.

Moderator: Sarah Valentine, Partnerships Manager, Digital Medicine Society
Jordan Silberman, Director of Clinical Analytics and Research, Elevance Health
Isaac Rodriguez Chavez, Independent Consultant, Clinical Research (Scientific, Clinical, Regulatory Affairs) and Digital Health Technologies
Madalina Sucala, Director, Digital Health Oncology R&D, AstraZeneca

Morning Refreshments & Networking

Panel Discussion: What Will it Take for Pharma to Invest in Evidence-Based Digital Health Therapies?

This panel will look at how Pharma are investing in Digital Medicine and what Pharma Venture Partners are looking for from Digital Therapeutics Companies in order to invest. 

• What are pharma looking for from evidence-based digital health companies when looking to invest?
• How do pharma venture partners differ from venture capitalists?
• To all panelists – what criteria do you look for in digital health companies to show value and justify continued investment? And how has that been influenced by the current economy?

Adam Kundzewicz, Executive Director, Venture Fund, Boehringer Ingelheim 
Cris De Luca, Partner, Sanofi Ventures
Rakhshita Dhar, Senior Director of Health Venture Investments, Leaps by Bayer

Panel Discussion: Looking into the Future and it’s Innovation for Evidence-Based Digital Health 

Closing off the Summit, this panel discussion will look at the furthest and most recent innovations within Digital Medicine showing promise to become implemented within the future. This panel will also explore the importance of involvement, future innovation, investment in the realm of digital for pharma.

• Which recent innovations within Digital Medicine are showing the most promise to become implemented within Pharma in the future?
• What is the role of investors in the future of Digital Medicine? Which areas have investors identified within Digital Medicine for pharma that will have success and longevity?
• What is Personalized Medicine’s place within Digital Medicine and how might Digital Medicines become increasingly personalized within the Future? Where is the limit for this?
• How might behavioral understandings help develop future Digital Medicines?
• What is the future for Digital Medicine? What key hurdles need to be overcome at present to ensure successful future implementation of Digital Medicine?

Andrew L’Huillier, Associate Director, Global Regulatory Affairs, Precision Medicine and Digital Health, GSK
Zarina Shameer, R&D Health Tech Expert

Chairs Closing Remarks

Alisan Atvur, Principal UX Researcher, Design Thinking Catalyst, Novo Nordisk

Close of Evidence-Based Digital Health in Pharma Summit Day 2