Next Phase Newsletter

By Lucy Parkinson, VP of Investor Research, LSN

On November 5th, RESI is coming back to New York, and will bring an agenda full of investor discussions and content on key investor constituencies and life science technology verticals.

RESI NYC includes new panels on AI in Healthcare and Funding NYC’s Earliest Stage Companies, plus the return of the expert sessions on Investing in Oncology Innovation and Asia Cross-Border Investors.  RESI will also present panels on our core technology verticals of Early Stage Therapeutics, Medical Devices, Diagnostics, and Digital Health, and on key investor types such as Angels and Family Offices, Seed Funds, Corporate Venture Capital and Big Pharma.  You can view the entire agenda below.  If you’d like to here from experienced investors on these key topics and book face-to-face meetings with investors all day, you can register now.

By Karen Deyo, Investor Research Analyst, LSN

The FDA is working hard to modernize the agency to adapt to the rise of digital health. In his speech on April 26^th, FDA Head Scott Gottlieb noted that a clear FDA regulatory strategy for digital health is critical not only for maintaining patient safety, but to provide companies and investors a clear understanding of what, if any, regulatory requirements companies will need to meet before and after market entry. Additionally, the FDA is looking to modernize their own processes by adapting digital tools to help streamline pre-market review of therapeutic safety and for improved compliance with post-market study requirements.

When considering a digital health company for potential investment, investors will ask whether or not the tool will require any sort of FDA oversight. The FDA has determined that any digital health tool that does not have the ability to significantly impact patient safety does not require any regulation. This would include tools such as general wellness apps, tools to streamline doctor-patient communication or track patient care and records, as well as tools to ease patient access to medical records. Investors focused on technologies that don’t require regulatory approval will focus on companies developing these tools when looking for digital health portfolio companies.

Challenges for Digital Therapeutic Tools

The real challenge for the FDA will come in determining the regulatory requirements for digital health tools as part of medical devices, diagnostics and therapeutics. Digital health therapeutic tools, such as tools to monitor patient compliance with medication regimens or monitoring of side effects, would be reviewed in conjunction with drug development programs. Likewise, digital health tools that serve as a component of a medical device will be evaluated as part of the device, unless the FDA determines that the software component can have no effect on patient safety. However, given the difference in time and effort required to develop or alter these software components, the FDA is still determining how to ensure that the review process protects patient safety without delaying access to these tools for long evaluation periods. Since these tools are theoretically being developed side-by-side with a drug or device, they would already be part of the regulatory process and would simply be an added component to current reviews.

New Digital Health Pre-Certification Program Offers Faster Path to Market

Of highest importance to companies and investors is the Digital Health Software Pre-Certification Program that is currently being developed. Initially, this program will only apply to tools that qualify as software as a medical device (SaMD), which is defined as any digital health tool that is not part of a device with unique hardware. This includes software tools for diagnosing, determining treatment plans, imaging, monitoring etc. and any tool using AI or machine learning for these purposes. This is the class of digital health tools that can pose a higher risk for investors due to the uncertainty with regards to regulations and what evaluation will be required before they can be implemented in the clinic, despite their increasing traction among investors. Because of the drastically shorter development time required for these tools when compared with traditional medical devices, as well as the ease in releasing new iterations, the FDA is developing a new regulatory approach: pre-certifying the company as opposed to the digital health tool.

The premise to the FDA’s new approach is that by establishing the excellence of the company releasing the digital health tool, there is an assumption that any software platform the company releases to the market will meet FDA standards. Applying and receiving precertification will allow companies to release new digital health tools to market with little or no pre-market review. Instead, the FDA will rely on post-market studies to assess if any changes need to be made. The FDA has laid out five areas it will evaluate when assessing companies for precertification: the ability to demonstrate a commitment to product quality, patient safety, clinical responsibility (defined as conducting clinical evaluation of the software product), cybersecurity responsibility and maintaining a proactive culture. While this new program is still under development, investors can now evaluate companies by assessing how they plan to meet these guidelines. Once this program is in place, this method of evaluation can serve to mitigate risk when investing in companies before their product reaches the market. Once pre-certification is available, investors can use this as a differentiator when evaluating companies with software tools already on the market.

There are still a lot of unanswered questions with regards to the exact evaluation criteria, both for pre-certification, the delineation between technologies requiring no review, what information companies must provide during the expedited review process, and what data the FDA will require from post-market evaluation. The FDA is currently soliciting feedback from those involved in the industry to help the program take shape with a list of questions related to all aspects of the Pre-Certification Program. Companies and investors in digital health should watch for more updates from the FDA as these programs and regulations take shape.

By Dennis Ford, Founder & CEO, Life Science Nation; Creator of RESI Conference Series

My Boston-based company, Life Science Nation (LSN), was basically frozen out of Biotech Week Boston (BWB) last year. I wrote an article in response to the treatment LSN, and our Redefining Early Stage Investments (RESI) Conference Series September event, received from the London-based owners of BWB. Yes, a London-based company owns Biotech Week Boston!  The article tried making the case that it was in the best interest of everyone to make BWB inclusive instead of exclusive if it really wanted to be a JPM-like east coast event.

As a result of writing the article, I and my company staff were told we were subsequently banned from any and all EBDGroup.knect365 events. Then, a few months ago, I was approached by one of their senior marketing staff with an offer.  First, she told me LSN and RESI could be part of the BWB this year’s event, but that LSN would have to pay a fee per RESI attendee which would have amounted to over $100K. Basically, the offer was to list LSN and RESI in their web-based event marketing collateral and have access to some event functions. Next, after my explicit refusal, I was shocked to learn that upon entering “RESI Boston,” LSN’s premier September event (since 2013) as a search term on Google, a paid advertisement appears, redirecting prospective RESI Boston attendees to EDBGroup’s BioPharm America conference “Register Now” page at BWB (see below). In my eyes this is a very dirty trick.

Do the Massachusetts Life Science stalwarts and luminaries who are supporting this BWB conference know that these type of shenanigans are part and parcel of what they are endorsing and sponsoring? 

I founded LSN and the RESI Conference Series to help move the needle in life science – to get early-stage life science companies funded and get badly needed treatments and cures to patients who currently have none. If you are a fundraising life science CEO or scientist-entrepreneur looking to fund a new drug, medical device, diagnostic test or digital health product, there will be over 300 global investors and partners that will be attending RESI Boston. Feel free to check out the program guide; https://blog.lifesciencenation.com/wp-content/uploads/2018/08/resi-boston-program-guide-8-24-2018_digital_100-compressed.pdf  Life Science Nation’s RESI event is being held on September 6^th at the Boston Marriott Copley Place. 

It may be time for another Boston tea party.

By Nono Hu, Director of Marketing, LSN

In just a week’s time, Life Science Nation will be bringing the Redefining Early Stage Investments (RESI) Conference back to the Marriott Copley Place in downtown Boston. Over 700 attendees from the early stage life science world will be at RESI, including startups at the earliest stages of development representing tech hubs from all around the US Northeast in the new RESI Innovator’s Gathering, plus over 300 investors. You can read the program guide below to plan out your day at RESI and see who else will be there. We look forward to seeing you next week.

By Dennis Ford, Founder & CEO, Life Science Nation; Creator of RESI Conference Series

In November 2017, RESI came to New York for the first time and gathered together investors from all over the world to meet scientist-entrepreneurs from the rising life science hub in the city.  With hundreds of partnering meetings based on fit, RESI NYC allowed these entrepreneurs to start dialogues with global investors drawn from LSN’s established network.

RESI NYC will feature a full day of partnering, panel and workshop content, networking and more.  Startups from the biotech, medtech, diagnostics and digital health verticals are now welcome to register for RESI NYC to join the global investor dialogue.  We hope you will join us again there.

By Lucy Parkinson, VP of Investor Research, LSN

The Boston area is known worldwide as a hub for early stage biotech companies, and this year’s RESI Boston event will also feature young biotech spinouts from tech hubs and universities from all around the biotech ‘First Coast’ in the US Northeast.  To commercialize their discoveries, these young companies will need to access capital.

This panel of Early Stage Therapeutic Investors aims to bring a diverse group of experts and senior decision making staff from VCs, corporate pharma, and other investor types together to discuss topics such as:

• • How they make decisions
  • What can startups do to be more attractive?
  • Areas of high need
  • Overcrowded areas
  • Common mistakes/red flags

The participants are:

• Kuldeep Neote, Senior Director – New Ventures, Johnson & Johnson Innovation
• Scott Weiner, Partner, Pappas Ventures
• Bibhash Mukhopadhyay, Principal, New Enterprise Associates
• Marta New, Partner, Agent Capital
• Imran Babar, Chief Business Officer, Cydan

The discussion will cover topics including how the investors source and vet novel therapeutic assets, what kinds of technology are of interest to them right now, and how they as investors work with a startup to move a new drug toward commercialization.