The Digital Health Revolution · informa | Pharma Intelligence 6 Key Digital Health Deals 2017-2019...

B u s i n e s s Tr e n d s , R e g u l a t i o n s a n d M o r e

The Digital Health Revolution

Information Classification: Generalinforma | Pharma Intelligence

PRESENTED BY:

Lucie EllisExecutive Editor, In VivoPharma IntelligenceE: [email protected]

Derrick GingerySenior Writer, Pink SheetPharma IntelligenceE: [email protected]

Ferdous Al-FaruqueSenior Reporter, Medtech InsightPharma IntelligenceE: [email protected]

Zach RothsteinVP of Technology and Regulatory Affairs, AdvaMedE: [email protected]

Webinar Discussion

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Digital Health Today

The Role of Real-World Evidence

AI and Cyber Security

Regulatory Landscapes

Q&A

Digital Health Today

Lucie EllisExecutive Editor, In Vivo

Setting The Scene


The Future Will Be Shaped By Digital Technologies

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• Traditional pharma and medtech models need to reboot

• More pharma and medtech deals are focused on digital technologies

• Alliances are more commonplace than acquisitions

Three frequent deal types:

• AI and machine learning for drug discovery

• Patient apps

• Digital medicines

Information Classification: Generalinforma | Pharma Intelligence 6

Key Digital Health Deals 2017-2019 Highlights in pharma deal making for Al technology, apps and digital medicines

Videogame Novartis agreed in 2019 to partner with Tilak Healthcare to exclusively co-promote to ophthalmologists Tilka'sOdySight prescribed therapeutic mobile videogame

AI$550m: Potential deal value from Atomwise from its 2019 artificial intelligence-driven drug discovery partnership with Eli Lilly

AppsIn 2019 Otsuka Pharma paid $10m upfront for Click Therapeutics mobile software app CT152 for major depressive disorder

Machine Learning Vertex Pharma and Genomics PLC in 2018 agreed to collaborate in a 3-year deal using Genomics' machine learning platform for discovery of precision medicine targets

Digital Drugs Propeller Health and Aptarsigned an agreement in 2018 to co-develop and co-market digital medicines across multiple disease areas

Discovery In 2017 Sanofi signed a deal with Exscientia for the discovery of new bispecific small molecule therapies for metabolic diseases; the deal is worth a potential $273.9m to Al firm Exscientia


Digital Leadership Several companies have appointed C-suite executives specifically responsible for digital evolution


Benefits Already Being Realized

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• Speed to market

• Reduction in headcount

• Cuts in service costs with smart maintenance applications

• Digital manufacturing functions

• Better use of data

• The ability to fail faster with new drug or device candidates

Real World EvidenceUsing Digital Health to Approve Drugs

Derrick GingerySenior Writer, Pink Sheet

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• What is Real World Evidence?

• Questions Abound

• What’s already in place to increase RWE use?


A Cross-Cutting Issue For Drugs and Devices

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All that data coming through Apps and wearables is meant for something

Real-World Data: Clinical information derived from sources such as electronic health records, insurance claims, registries or mobile devices.

Real-World Evidence: Clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data.

Increasingly drug sponsors want to use real-world data and real-world evidence to support drug approvals.


Questions, Questions, And More Questions

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• December 2018: FDA releases its framework for using data generated outside a clinical trial to demonstrate efficacy.

• May 2019: FDA releases additional guidance suggesting sponsors flag their real world data submissions in applications.

Many sponsors remain skittish:

• Statistical questions

• Sourcing questions

• Even FDA officials have questions


FDA Questions Real World Evidence Readiness

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• Principal Deputy Commissioner - Amy Abernethy recently told an industry gathering that she was not entirely confident about the use of real-world evidence.

• “I came from that space and I’m cautious” Abernethy said.

• Office of New Drugs Director - Peter Stein: believability and robustness of data a concern.

• More use cases needed.


FDA Leading The Way Increase Real-World Evidence Use

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Several Projects in the Works

• Clinical Trial Replication: Using claims data to reproduce results of randomized clinical trials.

• MyStudies Mobile Phone App: Open-access software for collecting patient data.

• Sentinel Expansion: Includes real-world evidence test bed known as FDA Catalyst, also real-world evidence trials.

• FDA internal training planned.


Just Do It

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FDA Leading, But Sponsors Need To Pitch In Too

• Agency officials want to engage with sponsors on real-world evidence uses, early and often.

• Best way to advance the field may be to just try it: Abernethy said pilot projects a good idea in this setting.

Digital HealthFDA Regulations, Cybersecurity and AI

Zach RothsteinVP of Technology and Regulatory AffairsAdvaMed


FDA Regulation of Software: An Evolutionary Approach

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2015 2016 2017 2018 2019

Mobile Medical Apps

General Wellness Devices

Clinical Decision Support (draft)

Software Modifications

Medical Device Accessories

Interoperable Devices

SaMD Clinical Evaluation

Precertification Pilot

Artificial Intelligence (draft)


Medical Device Cybersecurity

• Guidances

- 2014: Premarket Submission Requirements

- 2016: Postmarket Management

• Safety Communications

• Information Sharing


Artificial Intelligence / Machine Learning

2018: Xavier White Paper

2018: AMA Position

2019: FDA Proposed Regulatory Framework

Digital Health Latest Developments in Digital Health

Ferdous Al-FaruqueSenior Reporter, Medtech Insight


Pre-Certification Program (Trust)

• Digital Medtech Conference in March 2017 (Precheck)

• Opened pilot to nine participants July 2017

• NIH Pre-Cert Meeting

• Pilot participants picked by April 2018 along with publishing new working model

• Mid-year review of pilot participants July 2019

• Finding: Excellence appraisal may be sufficient to evaluate products


Legal Concerns

• Does US FDA have the authority to move forward with the pre-cert program without new laws?

• Shuren talks about “regulatory Legos”

• HIPPA impact on digital health products and specifically AI products

• Dividing liability


Future Factors

• Consumer v medical device technology

• Is it patentable (Alice)

• Cybersecurity (use total product lifecycle)

• Reimbursement potential

Thank You!Questions?

The Digital Health Revolution · informa | Pharma Intelligence 6 Key Digital Health Deals 2017-2019...

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