Ours is a diverse industry ecosystem. We have much to offer life science innovators of all shapes and sizes, investors, solution providers, institutions of higher education including tech transfer offices and more.

In the interest of building and sharing knowledge across the ecosystem, we hope you will find these recent insights, curated and contributed by the Southeast Life Science team, useful.

One perspective from JPM23

“It’s always interesting to track sentiment and overall vibe for the healthcare innovation economy coming into and out of healthcare week in SF every year. In general, 2023 definitely felt like a smaller group [compared to 2022]. Speaking for SVB, we did have a packed calendar with many high quality meetings so it was time well spent.

“The meetings with many growth-stage investors indicated multiple active deals under term sheet (finally), which could be taken as an early sign of settling valuations and the potential for funds with significant dry powder to start putting money to work at some point this year. 

“This difficult fundraising environment may not be entirely over, but sentiment was that there could be light at the end of the tunnel, and hopefully well before the end of 2023.

“Healthcare innovation companies with healthy balance sheets will continue to be able to ride out the storm, and many are becoming more acquisitive due to reduced valuations and market caps of public companies (especially in the biotech sector) which could result in increased opportunistic M&A activity in 2023.

“Only time will tell but it should be an interesting year!” – Scott McCarty, Southeast Life Sciences Co-Chair and Director, Silicon Valley Bank

FDA guidance on clinical decision support software

“People should know that the FDA made significant changes to the Clinical Decision Support Software Guidance so if a product is in that category, the product should be reviewed against the guidance again,” Grace Powers, Founder and Principal Consultant of Powers Regulatory Consulting wrote us.

From Medtech Dive, “…the final guidance goes into more detail about how the FDA interprets the term “intended for the purpose of supporting or providing recommendations to an HCP [healthcare provider or professional] about prevention, diagnosis, or treatment of a disease or condition.” The text now features examples and a discussion of two aspects of software functionality that may affect whether it is used to support or provide recommendations.

“The FDA has also rewritten and simplified a section focused on examples. In the final text, the section is broken into three parts that cover examples of device software functions and two types of non-device software functions. The agency has also created a graphic to help companies determine if their clinical decision support software is a device.”

Sensor technologies continue to reveal impact in innovation, focus on flexibility

From Georgia Tech News, “So many of our current systems for monitoring and diagnostics rely on bulky machines that enmesh motionless patients in a snarl of wires and sensors, [Dr. W. Hong] Yeo says. Cardiac tests like the electrocardiogram can’t provide continuous data, and they only work if patients remain still and do nothing. Sleep studies, on the other hand, subject patients to uncomfortable, atypical environments prone to yield suspect data. These dependencies on motionlessness and unnatural settings activity make the tests highly susceptible to error and limit the value and trustworthiness of their data. 

“To address these challenges and limitations, Yeo’s group designs and manufactures nano-biosensors and bioelectronics. Completely wireless and easy to wear, these “biopatches” look like small stickers or bandages — soft and tiny, flexible and imperceptible — and a single device can track heart rate and other cardiac activity, respiration, blood oxygen concentration, body temperature, brain activity, and more.

“As we begin 2023, Georgia Tech is looking at six young, pioneering researchers who are tackling some of the world’s most complicated issues and working on solutions ranging from feeding an ever-growing population to controlling wheelchairs via wireless brain wave patches.”

Read on. 

For bioscience and pharma: Preclinical implications for novel cell & gene therapies (ICYMI)

Our colleagues at GCMI report, [preclinical implications for novel cell and gene therapies] are a significant departure from the typical preclinical testing requirements to which the manufacturers of these therapies, almost exclusively pharmaceutical companies, are accustomed.

“On the ‘back end’ of a preclinical study for a novel cell or gene therapy, the endpoints may not look like endpoints common to many device studies, predominantly safety and efficacy. Regulatory bodies will require preclinical study endpoints not commonly considered in medical device evaluation including demonstration of the mechanism of action to show how they work, as is required for drugs, not just safety and efficacy.” – Evan Goldberg, Director of Scientific Affairs, GCMI

Read on.

Partner resource available for marketing, SEO and lead generation

Our colleagues at Write2Market have told us they have room to add 1-2 clients to the healthcare practice of their B2B digital marketing and PR agency. As solution providers to Southeast Life Sciences and SEMDA collectively for the past seven years, as well as to our partner GCMI for nearly a decade, we recommend you give them a look as responsible, results-driven custodians of your digital marketing including web and SEO, audience development and awareness resources.

“Based on the high value they provide GCMI in awareness, industry leadership, marketing and lead generation, we confidently recommend our colleagues across the life science ecosystem consider and engage Write2Market for their awareness, engagement, marketing and business development needs,” said GCMI CEO Sherry Farrugia. “In just one specific example, their ability to use storytelling to brand is unique and helped us achieve #1 search return for ‘preclinical CRO.’”

“Like so many of our clients, we run lean. And because our clients tend to remain clients for extended periods, we cycle in new clients as others depart due to acquisition or pure, internal growth. When we aggressively pursue new client opportunities, we believe it is as meaningful an opportunity for the right client as it is for ourselves.” – Write2Market VP, Healthcare, Paul Snyder

Thanks for reading!