Surviving the digital therapeutics graveyard—and thriving | David Benshoof Klein, Click Therapeutics

Christina Farr talks with David Benshoof Klein, Founder and CEO of Click Therapeutics, days after the FDA cleared Motivista, the first authorized treatment for the negative symptoms of schizophrenia. They discuss why so many digital therapeutics companies failed, and why an FDA-authorized app still has to fight for the coverage a drug would get automatically. David also explains why he thinks AI tools, not pharma sales reps, may be what puts treatments like Motivista in front of doctors.

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SPONSOR:
Click Therapeutics builds medical-grade patient software across digital therapeutics, software-enhanced drugs, wellness & wearables, and AI-enabled interventions. Its platform offers a library of 100+ validated modules backed by rigorous clinical testing, bringing biotech rigor to any condition with a neurological or behavioral component.
To learn more about Click: https://www.clicktherapeutics.com/
To learn more about Motivista: https://www.motivista.com/

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Join Christina for upcoming webinars:
10/13 - Verifying AI in Medicine: Is Healthcare AI Actually Ready for Deployment? https://streamyard.com/watch/GwsSXwdikhMw
10/28 - Type 2 Diabetes & Cardiometabolic Care: Wearables, AI & GLP-1s https://streamyard.com/watch/uAuwCzUEJTCF
11/3 - Is It Finally the Moment for Alternative Plan Design? https://streamyard.com/watch/ereM3aB58XK4

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LINKS:
FDA clears Motivista (CT-155): https://www.clicktherapeutics.com/news/fda-clears-motivista-ct-155-the-first-therapeutic-indicated-for-the-treatment-of-the-negative-symptoms-of-schizophrenia
CT-132, Click’s episodic migraine program: https://www.clicktherapeutics.com/products/ct-132
FDA draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (PDURS): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-prescript ion-drug-use-related-software
Click acquires Better Therapeutics’ assets, 2024: https://www.businesswire.com/news/home/20240522194752/en/Click-Therapeutics-Accelerates-Expansion-into-Obesity-and-Cardiometabolic-Disease-With-Acquisition-of-the-Assets-of-Better-Therapeutics-Inc

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David:
https://www.linkedin.com/in/davidbklein/
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https://www.linkedin.com/in/christinafarr/
https://x.com/chrissyfarr
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TIMESTAMPS:
(00:00) Lead in
(00:30) Intro
(01:46) First for schizophrenia
(02:20) What digital therapeutics means
(04:01) Software treats disease
(05:35) Drugs plus software
(06:55) Negative symptoms explained
(09:56) Designing adaptive goals
(13:50) Safety and autonomy
(16:03) Generative AI in care
(22:48) Regulation and evidence
(26:55) Digital therapeutics graveyard
(27:51) Digital therapeutics graveyard
(28:40) Why programs fail evidence
(29:38) Click survival playbook
(30:50) Commercialization and coverage
(31:46) Pharma launch gap
(33:42) AI driven prescribing wave
(36:37) FDA guidance and pharma cycles
(40:56) Pricing value and access
(43:48) Hiring for scrappy commercial
(46:38) Future of venture and consumers
(51:31) OTC migraine and AI assistants
(53:42) Text messaging engagement engine
(55:15) Wrap