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Rapid Regulatory Approvals for Digital Therapeutics
Join the second webinar of our series: Demystifying clinical trials for digital therapeutics and healthtech companies.

We will be joined by an expert panel:

Jason Brooke, Attorney and Managing Member at Brooke Consulting LLC
Acacia Parks, Chief Behavioural Health Officer at Found
Athena Robinson, Chief Clinical Officer at Woebot Health

And hosted by…
Paul Wicks, Digital Health Consultant at Wicks Digital Health

This excellent panel will be addressing the following hot topics:
- How DTx companies can build expertise and a competitive advantage in regulatory affairs
- Which regulatory pathway to follow in the US (and why a 510k isn't always your best bet!)
- Whether regulatory approval in European markets is *ever* a priority
- How new trial designs like adaptive clinical trials might shorten timelines to approval by years
- Common mistakes to avoid when designing clinical trials and working with CROs

Paul will also host a live Q&A to let you ask your own questions and connect with the panel!

Looking forward to seeing you there.

01:09:00

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Speakers

Acacia Parks
Chief Behavioural Health Officer @Found
Acacia Parks is behavioural health executive with expertise in research, coaching operations, and behaviour change strategy in mental and physical health conditions. Acacia joined Found, a modern weight care platform, in 2021 as the Chief Behavioural Health Officer. Prior to this Acacia worked as the Chief Science Officer at Happify Health, for over 10 years.
Athena Robinson
Chief Clinical Officer @Woebot Health
Dr Robinson is a clinical psychologist, published author and editor, with treatment outcome research expertise in evidence-based psychotherapeutics for a wide array of psychological concerns. She joined Woebot Labs in 2017 as Chief Clinical Officer after over a decade at Stanford University's School of Medicine.
Jason Brooke
Attorney and Managing Member @Brooke Consulting, LLC
M. Jason Brooke, MSE, JD, CSQE is the Managing Member at Brooke Consulting, LLC—a digital health legal and regulatory advisory firm. Jason offers a unique, multi-disciplinary perspective on the digital health industry as a regulatory attorney, scientist, technologist, and quality consultant. He brings a focused expertise in the medical device industry that combines nearly 20 years of experience ranging from science and technology design, development, implementation, and testing; to business strategy and operations; to legal and regulatory compliance.
Paul Wicks
Digital Health Consultant @Wicks Digital Health
Paul Wicks, PhD, is an independent consultant who helps life sciences companies generate evidence, revenue, and awareness. Prior to consulting, for 13 years, he led innovation at PatientsLikeMe, an online community for over 750,000 people living with medical conditions. Paul has over 180 peer-reviewed publications including decentralized trials, patient-reported outcome (PRO) measures, and a “dose-response” curve for the benefits of friendship.