Masterclasses

The evolving landscape of digital measures in pharma is a complex and dynamic field with emerging challenges and opportunities.

Despite ambitious goals, innovative in-pipeline and on-market products, Pear Therapeutics faced go-to-market challenges and revenue difficulties.

In the pursuit of reinvention, it is crucial to consider the underlying principles and foundations upon which the wheel was originally built

What does the future hold for digital therapeutics (DTx) in 2024? holds. The past year has taught the industry that the marketplace for digital therapeutics, especially those requiring a prescription, remains precarious.

As pharmaceutical and digital health companies continue to innovate and develop new technologies, it's important to understand how to effectively work with hospitals to bring these products to market.

2020 was a period of optimism in the investment market, with companies receiving large amounts of capital and investors expecting returns.

Large, self-insured employers are the main buyers of digital health solutions for employee benefits. For many digital health solutions, it has proven to be a good starting point to acquire customers, observe the product in the real world, and establish a revenue stream. 

DTx has faced numerous challenges in the past year.

The evolving landscape of digital measures in pharma is a complex and dynamic field with emerging challenges and opportunities.

The transformation of obesity management is at an interesting crossroads, with both the utilisation of digital solutions and GLP-1 blockbusters taking off rapidly.

Digital twins are digital replicas of physical objects, systems, or processes.

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The transformation of obesity management is at an interesting crossroads, with both the utilisation of digital solutions and GLP-1 blockbusters taking off rapidly.

Proving clinical efficacy is one of the biggest challenges for digital therapeutics (DTx) companies.

Real-world evidence (RWE) plays an increasingly important role - as a complement to traditional clinical trial data - in informing the safety, effectiveness and value of healthcare interventions.

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Obtaining SaMD approval is no easy task, as it requires rigorous evidence generation and efficacy demonstration to ensure patient safety and usability.

“Digital twins” are creating a buzz in the healthcare industry, sparking excitement with their potential in diverse applications, from early warning systems to clinically actionable health changes.

Navigating the ever-evolving landscape of CMS coverage (Centers for Medicare & Medicaid Services) for digital therapeutics (DTx) in the US is challenging.

Identifying and developing impactful, high-quality digital health solutions that are truly impactful for patients, yet meet different stakeholder requirements is an incredible task.

Achieving patient-centricity is vital to the success of any digital health solution. Spaces are limited so apply now to secure your place.

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This year, France established a pioneering, fast-track reimbursement pathway for digital devices — the PECAN program. Join this Masterclass where Aymeric Perchant, eHealth Projects Director at the French Ministry of Health, will outline the key components of the PECAN framework. Seats are limited so apply now to secure you place.

Are your Digital Health innovations being slowed or even derailed by regulatory, security, privacy or legal compliance considerations? Apply now to join HealthXL in this expert led Masterclass to deep dive into this topic.

The regulatory landscape for any medical device can be difficult to navigate. Join this Masterclass to learn more about this topic and discuss with experts in this field.

Earlier this year, the digital health industry was rocked by the news that Pear Therapeutics had become insolvent and was looking for a lifeline, which never materialised. Spaces are limited so apply now to secure you place.

Would you like to learn more about value-based health care models (VBHC) and the interplay between these systems and digital health solutions? Join HealthXL in this Masterclass led by Matt Hickey to deep dive into this topic. Seats are limited so apply now to secure your place.

We all know that it's important to choose "measures that matter" when selecting and developing digital measures for evidence generation in clinical trials, but how do we put these good intentions into action? Join us in this expert led Masterclass to learn more about this topic. Seats are limited so apply now to secure your place.

Do you need guidance on the best practices for gaining regulatory approval for your digital health solution? Then this masterclass is the perfect fit for you! Apply now to secure your place.

Are you working on developing an evidence-based digital health/digital medicine solution with the goal of obtaining payer reimbursement? Apply now to join this Masterclass led by Todd Greenwood and Craig Buell from the ZS Digital Connected Health Group where they will discuss this topic further.

Despite the rapid expansion of the digital therapeutics (DTx) market in the US, DTx companies are still facing challenges in establishing a foothold and making an impact in the digital health industry. Join this masterclass with Jonas Duss (Co-Founder at Kaia Health) to discuss the key challenges facing DTx companies seeking to enter the US market. Seats are limited so apply now to secure your place.

One-size-fits-all approach is outdated; every patient is different. Apply now to join this Masterclass led by Jason Foster who will deep dive into this topic.

Conducting RCTs is a significant undertaking that requires substantial investments and financial resources. Apply now to join your peers in this expert led Masterclass.

Clinical efficacy is a crucial factor for the commercial success of Digital Health solutions. Apply now to join HealthXL in this session as we deep dive into this topic.

Digital health solutions can be commercialized in various ways depending on factors such as value proposition, stakeholders, and regulatory requirements. Join this expert led Masterclass to dive deeper into this topic.

Regulatory clearance and the right commercialization model for a digital health product are key components of success in this rapidly growing space. Apply now to join this Masterclass led by Jonas Albert (Digital Health Expert at fbeta) and Hans-Holger Bleß (Partner at fbeta).

Industry is from Mars. The Government is from Venus. How can digital health companies get R&D and commercialization US government funding? Apply now to join this Masterclass led by industry leaders.
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The healthcare industry is undergoing a digital transformation and extended reality (XR) technologies such as virtual reality (VR) and augmented reality (AR) are expected to play a significant role in this change in the next few years. Apply now to join this Masterclass led by Nemanja Kovačev, MedTech Expert at HTEC Group.

Proving clinical efficacy is one of the biggest challenges for DTx companies. Apply now to join HealthXL in this session to dive deeper into this topic with leaders in this field.

The digital health industry has seen a decline in funding in recent times, as investors have become more knowledgeable and selective to where they allocate their capital. Seats are limited so apply now to secure your place.

Are you trying to increase adoption and use of your Digital Health solution across the UK's National Health Service? Join your peers in this meeting as they deep dive into this topic. Apply now to secure your place as seats are limited.

Getting regulatory clearance/approval for DTx can be challenging, and it requires a learning curve to define the best regulatory strategy for a specific solution. Join this Masterclass to deep dive into this topic further.

Digital health companies need to show economic evidence for their solutions, but building that evidence can be very difficult, especially for small companies that are new in the market. Join this meeting to deep dive into this topic with other senior leaders in this field.

In this masterclass, we will touch on different case studies of human-centered design in digital health. Spaces are limited so apply now to secure your seat.

Are you seeking reimbursement of a DTx solution in the US? Join this Masterclass led by Mike Pace to deep dive into this topic with your peers working in this space.

Are you trying to commercialize AI-based digital health solutions in the European Union (EU)? Would you like to learn practical steps on how to navigate the EU regulations for AI in medical devices? Join us in this masterclass led by Erik Vollebregt (Partner at Axon Lawyers) to deep dive into this topic.

How do DTx products get listed on a formulary? And what happens next? Join this masterclass to hear from Mark Bini, the visionary who helped devise Evernorth's Digital Health Formulary.

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Are you working in digital health and looking for successful partnerships with health systems? Join this meeting to deep dive into this topic with other senior leaders in this field.

The reimbursement path for digital health solutions in Europe has always been complex to navigate. Join this Masterclass led by Aymeric Perchant to deep dive into this topic.

Proving clinical efficacy is one of the biggest challenges for SaMD manufacturers. However, it is key to getting buy-in from stakeholders. Join this Masterclass led by Shaheen Lakhan (Chief Medical Officer, Click Therapeutics) to depp dive into this topic with other senior leaders in this area.

Real-World Data (RWD) can be highly valuable for many stakeholders in healthcare, such as pharma, MedTech, payers, or hospitals. Join this Masterclass, led by Philip Russmeyer (Founder, FITFILE) to discuss this topic further.

Regulatory clearance and the right commercialization model for a digital health product are key components of success in this rapidly growing space. Join us in this interactive masterclass led by Dr. Victor Stephani (responsible for Market Access and Chief of Staff at HelloBetter) to discuss this topic further.

Join this masterclass led by Tahir Rizvi (Head of Quality Assurance and Regulatory Affairs at Caption Health) and Armen Vidian (Digital Health Venture Capitalist) to learn more about the regulatory considerations for AI-based solutions in the US.

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Are you a digital therapeutics (DTx) company seeking reimbursement in the US market? Join this masterclass led by the biopharma and DTx reimbursement expert Mike Pace to dive deeper into this topic.

Are you a digital health company looking to fundraise, acquire new customers or hire key executives? If so, crafting a story that inspires, builds trust, and drives credibility is critical. 

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Healthcare is one of those areas that one would expect to be more human-centric, at the end of the day, what is more human than getting sick? Join HelathXL in this masterclass led by Kellee M. Franklin, PhD, Founder of Mindful Innovation Labs, and Carole Tremonti, VP Clinical Strategy at Project Cronin, where they will discuss how we can be more human-centric when creating digital health solutions for patients and the care team.

Are you trying to commercialize a digital therapeutics (DTx) solution in the European Union (EU)? Would you like to learn practical steps on how to navigate the European regulatory landscape? Keep reading, this masterclass is for you!

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The right commercialization model for a digital health product is a key component of success in this rapidly growing space. Join this masterclass led by Steven Vandeput, PhD, to discuss this topic further.

Are you trying to get your DTx solution regulated in the US? Would you like to learn from the experiences of a real company? Join HealthXL in this masterclass led by Michelle Rubin-Onur from Blue Note Therapeutics to dive deeper into this topic

Digital Health solutions are top of mind for biopharma companies in 2022, and Software as Medical Device (SaMD) is a crucial cornerstone for top-tier companies. Join this Masterclass led by BrightInsight to dive deeper into this topic and discuss this further with your peers working in this space.

Are you a DTx or Pharma company seeking wide-spread reimbursement of a DTx product in the US? Join this Masterclass led by Mike Pace to learn more about this topic and share your experiences with others working in this space.

How to successfully take a DTx product through the regulatory pathways in the US? Join this Masterclass led by Jason Brooke, medical device attorney and regulatory/quality advisor, as we dive deeper into this topic.

Spotify, Disney, Amazon, what do all of these organizations have in common? Top class customer experience. Join this Masterclass led by Sutherland to learn more about successful customer experience strategies and how pharma and medtech companies can improve their customers' experience.

How can we leverage technological advancements to drive an explosive evolution in pathology? Join this Masterclass led by Bill Taranto to dive deeper into this topic.

How can we design trials for our digital health tools so they are rigorously validated and regulated? Join this Masterclass led my Akili Interactive to learn more about this topic.

Regulatory clearance and the best commercialization model for a digital health product are among the key components for success in a rapidly growing sector. Join this Masterclass led by Flying Health to dive deeper into this topic.

Are you struggling with trial design for your digital health products? Join this meeting to discuss this further with others working in this space.

Are you trying to get your SaMD product regulated in the European Union (EU)? Join HelathXL in this meeting to discuss this topic further with others working in this space.

Are you a DTx or Pharma company seeking coverage of your DTx in the US market? How should we be thinking about value-based agreements (VBA) in the context of DTx reimbursement in the US? Join this masterclass led by biopharma and PDT outcomes-based contracting pioneer, Mike Pace, to dive deeper into this topic.

Regulatory clearance and the right commercialization model for a digital health product are key components of success in this rapidly growing space. Join this interactive masterclass led by Dr Victor Stephani to dive deeper into this topic and discuss the matter further with your peers in this field.

Are you a DTx or Pharma company seeking to successfully navigate both fully-insured and self-insured health plan segments to get your DTx products reimbursed in the US? Join this interactive masterclass led by biopharma and DTx reimbursement expert Mike Pace to learn more about this topic and share your experience with the group.

Digital health vendors often seek payer collaborations, and solid clinical evidence is often needed to support this pathway. Join this interactive masterclass led by Jordan Silberman (Director of Clinical Analytics and Research, Digital Care Delivery, Anthem, Inc.) to engage with your others in this field and discuss this matter further.

Regulation is an absolute essential for companies who want to get their SaMD accepted into clinical and payer groups. Join this US-focused Masterclass led by Jason Brooke, medical device attorney and regulatory/quality advisor, to discuss the do’s and don’ts when attempting to take your SaMD through regulatory pathways in the US.

Are you struggling with trial design for your digital health products? Join this Masterclass led by Suzanne Clough (Chief Medical Officer, AmalgamRx) to discuss this topic further.

There are many DTx companies who are at the forefront of shifting care into the hands of empowered patients, reducing the healthcare system cost. However, the question remains: who pays for DTx? Join this Australia-focused masterclass led by Bronwyn LeGrice, CEO and Managing Director at ANDHealth to dive deeper into this topic.

Are you trying to get your SaMD product regulated in Europe? Join us in this Masterclass led by S3 Connected Health to learn all about the do’s and don’ts when attempting to take your SaMD product through regulatory pathways in Europe. Apply now to secure your place.

Are you a DTx or Pharma company seeking Payer Reimbursement of a DTx product in the US? Keep reading, this masterclass is for you. Join us for this masterclass led by Mike Pace, where we will focus on demystifying US Payer Access Negotiations.

There is a broad variety of digital health solutions, but in order to thrive and be successfully adopted, prescribed and reimbursed, it is essential to clinically prove their efficacy and safety. Join us in this Masterclass led by Akili Interactive to learn all about the above and hear insights from thought leaders in this space.

Join this masterclass led by Justin Norden (Partner at GSR Ventures) and Dr. Nirav R. Shah (Chief Medical Officer at Sharecare), as they walk us through 'Business Models for Digital Health Companies targeting Medicaid.' Apply now to secure your place in this exclusive Masterclass.

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What do you need to know to navigate the DiGa framework? Join us in this interactive masterclass led by Flying Health to learn from key thought leaders in this space. Apply now to secure your place.

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Join us in this US-focused Masterclass led by Clay Anselmo and Bernhard Kappe, As they walk us through the regulation of SaMD in the US. Apply now to secure your place.

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Join us in this Masterclass led by Click Therapeutics, as we discuss Clinical Trials Design for Digital Health Products. Our Masterclass sessions are the perfect opportunity to hear from thought leaders in the space and share your own thoughts and experiences.

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Join our Masterclass led by Mike Pace, where we will focus on Pharmacy Benefit Managers (PBMs) as an entry point to DTx reimbursement in the US. Apply now to hear industry insights from a thought leader in this space.

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Join this masterclass led by Redox and Orthogonal, where we will focus on the interoperability of digital health solutions in the US. Apply now to hear invaluable insights from thought leaders in the industry.

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Join us in this Masterclass led by AmalgamRx to learn more about the regulation of DTx in the US. Our Masterclasses are the perfect opportunity to hear valuable insights from thoughts leaders in the industry while also having the chance to share your own thoughts and experiences on the topic.

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Are you a DTx company seeking reimbursement in the US? Then this masterclass is for you. Join us in this US-focused interactive masterclass led by Mike Pace, who will walk us through how to get your DTx product reimbursed in the US.

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Join us in this Masterclass led by Curebase to learn more about Clinical Trials Design for Digital Health products. our Masterclass sessions offer you the opportunity to learn valuable insights from thought leaders in this space and answer any questions you may have on the topic.

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Join this masterclass to hear from the visionary who helped devise Evernorth's Digital Health Formulary, Mark Bini. We're extending an invitation to investors, digital health entrepreneurs and digital health pharma leaders in the USA to join and learn from and share your experiences with Mark.

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Join us in this interactive masterclass led by Flying Health, as they discuss what you need to know to navigate the DiGa framework. Apply now to learn valuable insights from thought leaders in this space.

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Join our Digital Health Meeting as we discuss commercialisation models for Virtual Care in Respiratory Diseases. Apply now to hear from fellow peers in this space and share your own thoughts and experiences on this topic.

In this masterclass, Zachary Tan (Advisor at CancerAid; Venture Creation Partner at Aegis Ventures; more info here) & Lisa Zhu (Research Fellow of the Center for Eye Research Australia) will walk us through the key learnings from their latest article in Scientific Reports (Nature) on real-world AI-based screening for diabetic retinopathy in Australia. This early-stage study is one of the first globally to describe the real-world implementation of AI in healthcare.

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Join us in this interactive masterclass led by Antidote where they will walk us through how to use digital tech to improve Clinical Trials Recruitment. Apply now to secure your place and hear from thought leaders in this space.

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Join us in this masterclass led by ANDHealth to learn about the opportunities and challenges in the Australian Digital Health market. ANDHealth will also share insights from their latest report on digital health market trends in Australia, due to be published in the next few months so apply promptly to avoid missing out.

Join us in this masterclass, convened by Orthogonal.io in partnership with UCLA Biodesign, to discuss the regulation of Artificial Intelligence and AI/ML Software as a Medical Device. By participating in this conversation you will hear valuable insights from thought leaders in this space.

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Join us in this interactive masterclass led by FITFILE where we will focus on the opportunity for RWE, in the European context, in a world of growing patient data sources to support market access objectives. Great opportunity to hear valuable insights from thought leaders in the industry.

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Join us in this Masterclass led by Akili Interactive to learn more about Clinical Trials Design for Digital Health products. Our Digital Health Masterclasses are the perfect opportunity to hear valuable insights from thought leaders in the industry.

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Join this Masterclass led by BrightInsight to learn more about the regulation of DTx in the US. Apply now to hear valuable insights from thought leaders in the industry.