Health Connect South’s 11th Annual Gathering is Sept 18; 20% OFF for the SLS Ecosystem

“One of the region’s most influential health care conferences, underscoring the city’s role as an important health care hub in the Southeast.” – The Atlanta Business Chronicle

We are proud to share that our partners at Health Connect South will host their 11th Annual Gathering on Wednesday, September 18th, 2024, at the Georgia Aquarium.

Hilary Marsten, MD, MPH
Chief Medical Officer, U.S. Food & Drug Administration

The 2024 speaker lineup includes Hilary Marsten, MD, MPH, Chief Medical Officer, U.S. Food & Drug Administration (FDA) who will give the luncheon keynote address.

Get 20% off your registration by clicking here

The mission of Health Connect South is to serve the health community as a platform to promote health collaborations. It brings together the region’s top decision-makers, innovators and next-generation health leaders.

“We carefully craft an annual program to shine a very bright spotlight on some of the amazing ways our health community is working together. We hope that by bringing together the top innovators, decision-makers and next-generation of health leaders we can serve as a catalyst for forming new collaborations. As we have seen with pandemics and great health advances, we all count on health organizations to work together.” – Health Connect CEO Russ Lipari.

Click here to check out the 2024 Annual Gathering agenda and updated full speaker lineup.

A unique gathering of health leaders, Health Connect South expects to welcome over 1,000 attendees at The Georgia Aquarium. Included among the more than 50 speakers, panelists and presenters are:

  • Caylee Noggle, President & CEO, Georgia Hospital Association
  • Roland Illing, MD, Chief Medical Officer & Director Global Healthcare & Nonprofits, Amazon Web Services (AWS)
  • Judith Monroe, MD, President and CEO, CDC Foundation
  • Kathleen E. Toomey, Commissioner, Georgia Department of Public Health
  • Tim Denning, President & CEO, Georgia Research Alliance
  • Lisa C. Richardson, MD, MPH, Director, Division of Cancer Prevention and Control, CDC
  • Andy Miller, Correspondent, Kaiser Family Foundation Health News
  • Leigh Hamby, MD, Chief Medical Officer, Piedmont Healthcare
  • John Flavin, Founder & CEO, Portal Innovations
  • Ryan Collins, Principal, Noro Mosley Partners

Testimonials

  • “Simply a phenomenal experience. Taking what I learned from this experience, I am ready to act, to collaborate with others, and to serve.”
  • “Health Connect South is a meaningful gathering of healthcare leaders and change makers focused on driving solutions and relationships to advance health. What inspired me the most are the personal stories and challenges they have faced that fuel their passion to make a difference. A phenomenal platform for us to gather.”
  • “Being a small company, it’s crucial for us to carefully choose the events we attend. HealthConnectSouth continues to be a top choice for COR. This event allows us to identify areas of improvement, build valuable partnerships, and explore new avenues for optimizing healthcare.”
  • “An inspiring day at Health Connect South! Connecting with friends, exploring innovative approaches to challenges, and diving deep into the future of healthcare. The conversations and connections make events like these truly enriching.”
  • “A forum distinguished by its assembly of representatives from all cadres of public health, clinical, and management. It emphasizes the significance of networking, community building, and fostering dialogue.”

Thank you for giving your attention and consideration to our friends and colleagues at Health Connect South. Stay tuned for a message from Southeast Life Sciences leadership on our vision for the future in Q3 2024.

Where Are They Now? Expanding Partnerships, Including Arm-In-Arm Innovation with Optum Genomics Highlight Polaris Genomics’ Commercialization Pathway

“It’s one thing to have an exciting technology, even one with strong unmet clinical needs. It’s another thing entirely to get a code and convince someone to pay for it.”

In 2021, Polaris Genomics won the Inaugural SLS SE Color Pitch Competition for its novel approach to identify earlier, and more effectively diagnose and treat, mental health disorders.

From our 2021 spotlight, “The current system lets people fall off the cliff while the ambulance waits at the bottom,” Charles said. “We’re building guardrails to intervene ahead of the tragic outcomes that come from undiagnosed, untreated mental health disorders.”

In the past two years, the Polaris team continues to forge ahead through a variety of industry partnerships, including a direct approach to reimbursement strategy with Ilumina and Optum Genomics.

Rick Herrera, PhD, Chief Data Science Officer, Polaris Genomics

“We’ve been working hard to get our initial, 250 patient datasets analyzed, including our machine learning and AI component, to develop our model and algorithm for identifying the RNA pattern in those individuals most likely to have PTSD versus another condition,” Polaris Genomics Co-Founder and CEO Charles Cathlin said. “Last year we hired Dr. Rick Herrera as Chief Data Science Officer to lead these efforts, expanding our capabilities and accelerating our clinical and commercial pathways.”

“Partnerships with the Canadian Military, the United States Air Force and Army, organizations we certainly see as future customers, represent solid market validation for our technology and directly support additional validation next steps.”

In 2022, Polaris was selected to support the U.S. Department of Veterans Affairs “Mission Daybreak” suicide prevention grand challenge to support their path forward as well, with strong potential to add another VA [site or program] for a clinical validation study in the near future.

Accelerating Innovation Adoption Through “Arm-In-Arm” Payer Collaboration

Of significant interest to those following Polaris’ story, especially prospective investors, Polaris Genomics was selected as the inaugural participants in Illumina and Optum Genomics’ Clinical Catalyst Program.

“Launched in 2022, Illumina and Optum Genomics are collaborating to identify and accelerate new applications of genomics that have the potential to improve patient care and health outcomes. The Clinical Catalyst Program intends to identify promising applications, evaluate the test evidence for clinical validity and clinical utility, and support clinical readiness and patient access through evidence planning.

“The motivation for this program is the realization that companies utilizing Illumina’s technology for development of innovative applications face market access challenges. Often, coverage requests for genomic tests arrive at payer discussions with an incomplete or unclear value proposition or intended use. Through this program, Illumina aims to identify and assess the fitness of innovative clinical applications along with recommendations for more effective market access strategies.”

Charles Cathlin, Co-Founder & CEO, Polaris Genomics

“Medical reimbursement plays a huge role in our business model,” Cathlin said. “It’s one thing to have an exciting technology, even one with strong unmet clinical needs. It’s another thing entirely to get a code and convince someone to pay for it. Our work with Illumina, Optum and the Catalyst Program provides direct insight into what a payer wants and needs for successful entry and adoption into the commercial payer market.

“How is a new technology, especially a diagnostic, going to change existing clinical practices and flows? Will it translate into the best treatment pathway faster? Will it ultimately reduce costs to the system including the patient and payer? That’s what they want to know and that’s what we’re working to prove directly with a party potentially responsible for payment.”

Earlier this year, Polaris also entered JLabs@Washington, DC, Johnson & Johnson’s newest life science incubator, to explore ways Janssen’s neuroscience division can use Polaris’ technology for analysis of prospective depression therapeutics.

Fundraising To Ensure Life To Fight Another Day, As Many Days As Possible

“Beyond our clinical validation and reimbursement activities, we are currently raising a $10 million  price round intended to supplement our current revenue and non-dilutive funding sources like a recent AFWERKS Phase II $1.25 million award. The upcoming funding round will support continued product development efforts, regulatory and reimbursement efforts for product/market fit and personnel to generate additional revenue from our available Discovery Platform in advance of the ultimate availability of our clinical product for PTSD screening.”

Interested parties should contact info@polarisgenomics.com for more information.

Southeast Life Sciences applauds Polaris Genomics’ work and thanks the team for helping us share their story here.

AdvanSE at SLS Alumni OXOS Medical Announces $23 Million Series A Funding

OXOS Chief Medical Officer and Co-Founder Gregory P. Kolovich, MD

Earlier this month, Medical imaging and radiographics diagnostic innovator OXOS Medical announced a $23 million Series A funding round co-led by Parkway Venture Capital and Intel Capital. According to OXOS, this brings its funding raised total to $45 million.

From OXOS’ own media release,

“OXOS will use the funding to accelerate product innovation and expand availability globally” for its small form factor, high resolution imaging technology.

“We believe OXOS will have the same transformational impact on radiology as the iPhone had on mobile computing,” shared Gregg Hill, Parkway Venture Capital managing partner.

Founded in 2016 and based in Atlanta, OXOS was a presenting company in PitchRounds at AdvanSE 2022. 

Over the course of Southeast Life Science’s history, including the combined entities of the Southeastern Medical Device Association and SE BIO, more than 500 presenting companies have raised nearly $8 billion through 800 funding transactions. 

Late last year, fellow AdvanSE presenting alumni Acclinate and Embody announced $4.9 million and $10.4 million rounds respectively.

Images credit: OXOS Medical

Perspectives on The State of Medtech Funding: Insights from Industry Leaders Terri Burke and Shyam Parekh

Less than 24 hours had passed between the industrial jolt to the medtech and life science innovation ecosystem from the SVB news and my as-planned “state of medtech funding” interview with Epidarex Capital’s Terri Burke and Parekh Advisory Services Founder Shyam Parekh.

Thankfully, it appears a full-on crisis has been averted. While not intended at all as an analysis of what that event means for the medtech innovation ecosystem, it certainly does color the following Q&A with Terri and Shyam on the state of medtech funding, especially for early stage companies captured on March 10, 2023, we are proud to share below.

How would you describe the state of medtech funding, especially for early stage companies?

Terri Burke, Venture Partner, Epidarex Captal (Photo courtesy: Epidarex)

Terri:

Prior to the last 24 hours, medtech funding is in a pull back. Concepts are still getting funded, including some big rounds for late stage, pivotal clinical trials. But much of the funding for technologies with merit are of smaller sizes, seed and A rounds.

A sizable gap exists between what I would describe as late A and C or D rounds. That gap puts strain on technologies in cash intensive R&D stages trying to advance into pivotal clinical trials or 510(k) submissions. Some VCs are considering inside rounds to bridge portfolio companies through the next 18 months to avoid going out into the marketplace for a technology’s next round.

[A potential] SVB demise will likely put a pause on investing as both venture funds and portfolio companies take stock on exposure. This will almost certainly overhang the space while everyone digests its implications.

Shyam:

Building on that, from the strategic buy side, my observations are consistent with Terri’s. The current lay of the land is such that patients, providers and payers have learned to expect more from the medtech industry in general. For a majority of mainstream MedTech, simple ‘widget sales’ is not sufficient. New technologies from startups or earlier stage companies need to think hard about “solutions.”  The Go-To-Market plan needs a solid, robust roadmap to achieve ‘level 1’ evidence and a well-defined burden of proof requirements as evidence from a set of case studies will be unlikely  to encourage someone to buy.

From the buyers’ side, emphasis continues to move further downstream as more risks need to be retired; e.g. engineering v&v (verified and validated product development) are the table stakes for most investment considerations. It helps enormously, if the sellers can articulate a clear roadmap as to what needs to get done to complete pivotal clinical trials along with robust reimbursement strategy including how to achieve new codes if needed.

Has the high emphasis on fully de-risked technologies by investors eased, increased or stayed about the same?

Terri:

It is probably increasing some. Strategic buyers can afford to be more cautious. They won’t likely pick up a technology early on clinical promise because not only are they reevaluating their risk situation specifically and holistically, but also they don’t need to move quickly. This is where longer-term funding, revenue sharing and creative development partnerships – Orchestra Biomed and Revival Healthcare are good examples – these more differentiated models will be interesting to watch in the short to mid-term.

Shyam:

This is the current status, as Terri described it well. We all in the industry need to think through business model innovation; e.g. Go-To-Market models, how aggregating multiple inputs can improve the offering, “a total solution” as buyers of the solution want to reduce their own cost burden. This approach would help with the pathway to commercial success. The ‘lone wolf’ strategy (our offering alone) is not likely to be a winning one for medtech startups for the foreseeable future.

What should readers infer from the SVB “news?”

Terri:

A fascinating case study is unfolding right in front of our eyes. If equity investors are expected to take business risks in banks, they should understand the risks or strengths. Should depositors be doing that as well? Absent significant, systemic financial regulatory action, it appears the answer is yes.

Should startups have or require more than one business bank account? The answer in hindsight appears to be yes as well.

What seems particularly remarkable is that the incredible reputation of that bank, one of a true ‘trusted partner,’ still didn’t keep depositors from quickly withdrawing, or attempting to withdraw, their deposits en masse.

Shyam:

It’s too early to say just 24 hours later, particularly given SVB’s benchmark examples on so many deals across the spectrum. They fill such an important void that something different will emerge.

What do the spate of “tech layoffs” in light of interest rates and return to pre-pandemic life mean for medtech? Is the opportunity to add from a deeper talent pool significant?

Terri:
If a company is flush with cash in their funding cycle, yes. If the company is in cash preservation mode, I think that is uncertain to doubtful. Bigger medtech companies will be more opportunistic in this regard.

Startup companies, especially CEOs and management teams with boards of directors, should be looking closely at cash burn, inflection points, milestones and pressure testing budgets. Hiring needs to focus sharply on critical talent profiles most capable of efficiently achieving the next critical milestone, and ensuring operations ‘map’ to that outcome.

Companies in those heavy R&D phases, the phases that suffer from the funding gap we discussed above, should already have the requisite talent and third party support on-board. The most pressing question for them to answer is, how do we expedite critical milestone achievement or at least minimize the potential for that achievement to take 20, 30 percent or longer than forecast to achieve; a common occurrence with outcomes no one enjoys.

Shyam Parekh

Shyam:

The way I’ve seen it, execution roadmaps and system architecture become critical. When engaging vendors for verification and validation testing, for example, young medtech companies need to test and retest the roadmap and milestones and match them against the funding necessary for those activities so that the capital is deployed the right way with the right vendors for the right set of activities.

As we know, talent and effective team structure are, undoubtedly, critical inputs for any development program. The nuance I can underscore is capital efficiency. This comes from clearly understanding what due diligence we have done and what needs to get done so that financial stakeholders will have the the confidence that it’s been done correctly. Companies have a well defined stage gate approach to manage R&D projects. As companies tighten the belt and re-evaluate checks and balances along the development milestones and activities and allocate resources as we all want to limit  the number of “$10,000 days.” All of these reevaluations will bring more efficiency and give young companies and the boards of directors, more confidence to forge ahead.

How far down the development and commercialization pathway should earlier stage companies be prepared to depend on other funding sources like NIH grants?

Shyam:

As far down that pathway as they can while achieving as many meaningful milestones in the path to pivotal trials or satisfaction of activities that lead to a regulatory submission as possible.

Terri:

In general young companies need to be scrappy, but at the same time they need to be thoughtful about the investment of time and energy compared to how much money they’re chasing with those investments. NIH grants can be very long cycles before funding decisions are made and those funds become accessible, assuming the application was successful. Just how much time, and at what cost, will those activities really take? Will it take two or three people to successfully unlock a $50,000 NIH grant?

If a young company’s CEO is a researcher or physician adept at writing grant applications, those might be a good use of his or her time because they can do so with high efficiency. A company without that resource, or a CEO whose strength is operations, team building or raising venture capital would have to pay for that resource or risk the cost of the time required for grant writing, which could outweigh its net benefit.

Where are some other funding resources earlier stage companies should be exploring beyond what we’ve discussed?

Shyam:

To build on that, I have seen the Office of Naval Research issue RFPs on specific medtech problem statements along with the Department of Defense, the national labs, including even the FDA give funding for some specific innovations that may treat rare diseases or technologies that can help FDA panels better evaluate cell therapies.  There are other government programs that award funding to its Prime Contractors where industry can come in as a subcontractor and leverage its expertise by securing a portion of the total grant. This an example of some other ways funding streams can come about for some earlier stage medtech companies.

Terri:

There are a significant number of tech transfer offices that have funding support available for technologies and startups that emanate out of institutes of higher education.  There are also some funding opportunities available from pitch competitions like Medtech Innovator, incubators like Ignite in Houston, and with organizations rooted in pediatric innovation like NCC-PDI.

The team at Southeast Life Sciences thanks Shyam and Terri for their insights. Stay tuned for a follow on considering the following:

  • If you’re a young company working on THIS … watch out.
  • If you’re a young company working on THIS … consider a pivot.
  • If you’re a young company working on THIS … keep going or go faster.

PitchRounds Alumni Acclinate and Embody Close New Funding Rounds

According to industry sources and confirmed by Crunchbase, PR Newswire and Silverwood Partners, two PitchRounds at Southeast Life Sciences (or SEMDA) alumni recently raised seven and eight figure funding rounds.

Acclinate, a PitchRounds 2020 presenting company, raised $4.9 million for its endeavors to achieve diversity in clinical trials, while Embody, a two-time PitchRounds presenting company (2018 and 2020) raised $10.4 million.

Jeff Conroy, Founder & CEO, Embody (Image credit: Embody)


From PR Newswire, “Embody, Inc., a privately-held medical device company focused on soft tissue healing, announced today that it closed a $10.4 million Series C funding round led by Genesis Innovation Group’s cultivate(MD) Capital Funds LP. The financing will enable Embody to expand its world-class operations, post-market clinical studies of the recently launched Tapestry RC System for rotator cuff and prepare for the commercial launch of ActivBraid™ high-strength collagen-based suture technology in 2023.

“This financing represents a notable step in the continued growth of Embody,” said Jeff Conroy, Embody’s Founder and Chief Executive Officer. “We are thrilled to have the continued support of our highly seasoned investor base, further illustrating the opportunity and need of our soft tissue healing technology portfolio.”

Acclinate, Silverwood Partners briefly reported, “…raised $4.9 million of venture funding from undisclosed investors on October 19, 2022. The company is a developer of a digital health analytics platform designed to assist biopharmaceutical research organizations in increasing the representation and diversity of their genomic research and clinical trials.”

Crunchbase’s profile of Acclinate appears to confirm the recent transaction.

Scott McCarty

“One of Southeast Life Science’s core missions is to introduce investors, including large strategic enterprises that frequently innovate through acquisition, to their next investable opportunities,” said SLS Co-Chair and Silicon Valley Bank Director Scott McCarty. “While we certainly can’t take too much credit for these funding rounds, we are always proud to see PitchRounds presenting companies follow on their participation with funding rounds like these.

“The southeastern United States has all of the elements needed for high value life science innovation and investment.”

Something for Everyone: A Holistic, Yet Specific, Look Inside the Life Science Innovation Ecosystem

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!

The Impact We Make: Our spotlight interview with Ibraheem “Ib” Badejo

“My story starts out much like Shyam’s,” Ib said.

True, but from one continent and an ocean away at its genesis.

Born in Takoradi, Ghana of Nigerian parents and immigrated to Nigeria when he was eight years of age, Ibraheem Badejo earned his undergraduate degree in chemistry in just three years under scholarship from Avila University in Kansas City. But difficulties in PhD studies at Kansas State University manifested in a second chance, like Shyam’s, at the University of Toledo. Ib earned his PhD in organic chemistry from that institution where he was the Robert Whiteford Memorial Scholar for Outstanding Graduate Research and a Petroleum Research Fund Fellow.

It’s true, Ib and Shyam Parekh worked in the same lab at the same time at the University of Toledo on their journeys to careers in life science. By the time Ib completed his graduate studies, he had published 12 scientific papers.

His first industry gig was in the automotive industry developing automotive coating and colorants, but Ib knew he had more to offer humanity than beautiful, colorful cars.

Taking a chance on eagerness and desire

Transition from automotive coating to healthcare occurred after two years of adjunct research and volunteer work at the Medical University of South Carolina School of Pharmacy in the evenings, Closure Medical Corp was recruiting for an organic chemist with polymer experience under Jeff Clark, then Head of RD, Closure Medical Corp. About a week or so later, he called to offered Ib the job, Ib thought he was joking.

“I had very little direct medtech experience for the position,” Ib said. “When I asked him, ‘Why me?’ He cited my eagerness, willingness to learn, prolific inventions at Bayer and strong desire to improve outcomes for those needing care.

“Patients were waiting then, and patients are still waiting today,” Ib said.

The recipient of 25 U.S. patents with others pending, Ib is now Sr. R&D Director, Ethicon External Front End Innovation. Prior to this role, (Nov 2013-June 2021) – Ib was Sr. Dir, New Ventures at Johnson & Johnson Innovation,  focusing on identifying and investing in early stage medtech companies with strategic alignments to Johnson & Johnson MedTech priorities.  Several of such early stage investments led by Ib are now acquired/on-boarded or part of JJDC portfolio.  From his bio, “From 2010 to 2013, Ib was a Research Fellow at Global Surgery Group of Johnson & Johnson, where he was responsible for external and front-end innovations and intellectual property for Ethicon Biosurgery. From 2006 to 2010, he was the Director of Applied Research & New Technology Assessment of novel biomaterials. Prior to that, he was the Chief Scientist of Closure Medical Corp (acquired by J&J in 2005). Prior to joining Closure, he held various positions at Bayer, North Carolina State University, College of Charleston. He currently serves as an Adjunct Professor of Biomedical Engineering at Drexel University.”

What his bio has not yet caught up with is that Ib is currently in his first year studies in the Northeastern University School of Law. Yes, despite all of his experience and accomplishments, Ib is currently a law school student.

Always learning

“I do have a desire to learn constantly,” Ib said. “But more importantly, I’m always reading contracts, trying to get deals done and negotiating. My fluency there is good, but the nuances of intellectual property (IP), like the differences between discovery and invention and what freedom to operate means can easily be the difference between failure and successful commercialization of new medical technologies for the innovator. Earning a patent is one thing. Being able to commercialize the patent is something else.

“Being fluent in the nuances of IP and how those nuances translate into the business of life science innovation should help me be more effective and efficient in my current role and prepare me for possible future ventures helping early stage companies pick the right projects to focus their limited resources.”

Given Ib’s considerable experience in medtech innovation, we hope you find the following Q&A useful.

What advice would you give early stage medtech innovators or startups?

Ib shares insights on a keynote panel at AdvanSE 2022

“Failure is an option. We so often are told that the sky is the limit. That is true, but it rarely comes without important learning that comes from taking risks that ultimately fail to achieve the goal. Try not to let fear of failure get in the way of trying to begin with. Fail fast, learn from the failure and move on. Do your best, then let the chips fall where they will.  When I have a new idea, start a project or new product development , I always ask myself “what must be true” for this project to move forward.  Another way to think about it – What are 2 critical questions that I must answer for this idea to move forward?  What are two or three showstoppers that must be overcome to move the idea forward?

“Equally important is understanding exactly what you are creating and who is going to pay for it. Can you get a CMS code? Will it be grouped with other products in the same code even if the product is superior? Who are your key stakeholders for a successful commercialization? What’s the regulatory pathway for approval? Critically important is the clinical study design and future reimbursement for the technology.  Answering those questions early and at multiple way-points in the technology’s development and commercialization pathway can increase the odds for successful commercialization or preservation of scarce resources.”

What advice would you give those mid-career professionals, especially regarding inclusivity?

“We all need mentors and sponsors. They are critical to our individual career advancement. Be open to suggestions including criticism that might feel negative. Mentors and sponsors, don’t sugar coat those suggestions. Honest and candid discussions help keep the focus for improvement in the right places. Serving on boards and foundations, and giving back to your community is a privilege and a blessing. I have also pledged to my nieces and nephews back in Nigeria that money needed for their education will never be an impediment for them as long as I can help it.”

What needs to change most urgently in the industry and for what effect?

“Covid-19 highlighted a major issue in our delivery of care for diverse populations. The Black community was hit disproportionately hard. This will almost certainly improve if we increase the number of Black innovators in the life sciences and healthcare because they will much more intimately understand the healthcare journey of Black patients, which is far different from others’. The industry needs to be intentional about building trust in diverse patient communities and funding Black and minority innovators, early stage companies and engineers.”

If someone was going to commit one or two things to memory from this, what would it be?

Image credit to Ib, @IbraheemBadejo

“Our lives should be measured by the impact we make. And, yes, patients are still waiting. We should constantly focus on solving big healthcare problems. In just one specific, personal example, my wife passed from sickle cell disease, a predominately Black disease. We can and should use our talents and resources more intensively to reduce the mortality rate of sickle cell disease.

“We focus on delivering solutions for the future. But in many cases the ‘future’ is always upon us.”

We are grateful for Ib’s contributions to the life science and medtech ecosystem including his time to make this spotlight possible and his service as a member of the Southeast Life Sciences Board of Directors.

Taking a Holistic View: Lessons from a ‘Circuitous’ Career in Life Sciences

Our interview with Shyam Parekh, Strategy and Corporate Business Development, Avanos Medical (NYSE: AVNS)


Since 2005 Shyam Parekh has been primarily focused on inorganic growth initiatives for Kimberly Clark Healthcare, Halyard Health and eventually Avanos Medical as the enterprise’s healthcare business evolved. 

“Where can we go from here, two years or five years out from Avanos’ innovation roadmap? That’s been my focus,” Shyam says of his role.

But how did he get “here” and what can others learn from his circuitous career journey?

Shyam was born and raised in Gujarat, India, 7,729 miles – give or take – from Toledo, Ohio. As unlikely as the match seemed, Shyam earned his Ph.D. in organic chemistry from the University of Toledo in 1989 following degrees in chemistry, physics, business and a masters degree in industrial (applied) chemistry from MS University in Gujarat.

A lifelong interest in science, chemistry in particular, drove his studies and his career, but did not come without its challenges.

“I failed miserably in the first semester as a graduate student at Kent State, clearly prior to Toledo, and lost my financial support,” Shyam told Write2Market’s Paul Snyder. “I guess I was right in my hunch that I was not quite prepared when I started my graduate studies in the United States. Do I go back to India or keep trying?

“Somehow, I could not accept defeat. That experience strengthened my resolve to earn a Ph.D. in Organic Chemistry, publish papers and teach chemistry.

“Thankfully, the University of Toledo gave me an opportunity – and I believe the benefit of doubt for my poor performance or experience at Kent State – at least in part because of my complete absence of experience and study in ‘English medium schools.’” 

Like many, Shyam worked hard, overcame the challenges of language, maintained good grades and, as mentioned, earned his Ph.D. in Organic Chemistry from the University of Toledo.


A “No Contest” Post-Doctoral Opportunity 

Subsequently, he had a decision to make between industry or post-doctoral work; a much more predictable, easily-chosen fork in the road to navigate.

“When Professor Barton invited me to join his research group to work on reaction mechanisms at Texas A&M, it presented a ‘no contest’ situation,” Shyam said.

Sir Derek H.R. Barton won the Nobel Prize in Chemistry in 1969 for adding a third dimension to chemical analysis. He served as professor of chemistry at Texas A&M from 1986 until the time of his death in 1989.

“Working with Dr. Barton was a metamorphic transformation in my path,” Shyam said. “It taught more about what an academic research career requires and how research translates into applications beyond the academic corridors than I would have imagined. It also brought out an aptitude for developing research proposals that had me very seriously considering a career in academic research.”

Alas, Shyam transitioned from academia to industry in 1993 upon accepting a chemical research position with Abbott Laboratories (now Abbvie). 


The Intersection of Science and Industry

“I had a wonderful opportunity to work on HIV protease inhibitors in the thick of the AIDS epidemic,” Shyam said. “Over time, I had an opportunity to work in the area of API development; for numerous drug targets such as anti-angiogenesis (oligopeptide based oncology) targets, GERD and anti-infective agents based on macrolide chemistry and many other pharma process research initiatives. This work also involved scale up, technology transfer to various vendor sites, and transfer of manufacturing technologies.

Shyam’s experience as a line management functional lead with Abbott required him to ‘represent the franchise’ to leadership, commonly a Venture Head (SVP level leader) that had the  soup-to-nuts responsibilities from concept to commercial launch, after which the franchise’s project or product would transfer to the commercial operations under the President of Pharma division.

“A holistic view of business, especially how money meets the market, has held high interest for me for a very long time,” Shyam said. “Generally, corporate executives in medium to large enterprises, including the life sciences, ask you to play your position and play it very well. My innate desire to see the whole picture including how basic research in chemical sciences leads to drug programs, how the external innovations are progressing and how all of the ‘parallel journeys’ impact millions of lives motivated me to validate the ability to speak both the languages of business and science fluently by earning an MBA.”

He did so at the University of Chicago in 2003.


Where Corporate Strategy Meets Business Development Through Open Innovation

When Kimberly Clark created a function and opportunity to combine corporate strategy and business development that previously had not existed, he pursued it with vigor.

“Joining acquisition targets with investment rationale and ‘owning’ those transactions fit my holistic interest in business and linked it directly to my life-long interest in science and medicine,” Shyam said. “Ever since, including through Kimberly Clark’s spin out of the health business into Avanos Medical, my interest and focus on innovation in medical technologies has been very, very high. What criteria make a sound business decision for investments in life sciences – where does the money meet the mind and the market – is a question I find continually interesting. Put another way, ‘Is the juice worth the squeeze?’ ‘Is the view worth the climb?’

“Building and continuously refining an open innovation program – one that starts with our own strategic initiatives and then leverages others’ work in the area through strategic alliances like option agreements, joint development & commercialization agreements, structured deals like distribution agreements with metrics for acquisitions – whatever works for both sides – has been highly fulfilling work. Developing and executing on those agreements, undertaking investments in promising early stage companies – whatever is possible to advance innovation from a very wide variety of sources is always an exciting enterprise.”

We hope you will enjoy Shyam’s insights and answers to a few questions in his own words.


What surprised you as you navigated through multiple stages within your medtech career?

“Accountability to the rigor of all aspects of diligence, deadlines, budgets and cross-functional teams is endlessly more intensive in industry than academia. Industry seeks prudence in resource commitment, alignment and goals, not science for the sake of science as there are always competing priorities for corporate resources. 

“Those transitioning from academia to industry are generally not accustomed to thinking this way. They will likely find themselves facing questions like, ‘What have you done for me lately?’ with surprising frequency.

“Beyond measurable results, career growth in industry has just as much to do with perception as potential. Perceptions are like snapshots of you in the minds of your peers or superiors. Who you are, including your true potential, can never be fully known to others until you spend significant time in an organization with them working, contributing and engaging in dialogue with you on multiple fronts.

“Most of your colleagues, including those senior-to-you, know you from brief interactions around program reviews and ‘water cooler’ conversations. Impressions get left behind and those drive perceptions and perceptions drive career development, at least in some part.

“‘I’m about to schedule a meeting. We are going to talk about X. Someone from regulatory will be there,’… those details do not matter in those brief, yet perceptively impactful interactions.

“Better sounds like, ‘The last EU-MDR update that needed to happen is complete. We now have updates from engineering and clinical, but still need input from regulatory.’ Don’t say ‘hopefully.’ Instead say, ‘I anticipate these updates by X and will report to the team accordingly.’ Don’t ask questions to satisfy your own curiosities. Ask questions that move the conversation forward in a team setting.

“Intentionally synthesize your thoughts into succinct, consumable snippets or refined progress reports in a succinct manner. Don’t embellish, don’t ramble, be succinct, state facts and deliver what they seek to understand. These are the marks of an effective communicator, especially in the life science industry.”


What did you learn as you went that you put into action to some very positive effect?

“The hard learnings came later than I would have preferred. This was just my reality. Inside an industry enterprise others’ interest in how your work serves their career is often intense.

“Don’t use jargon or heavy scientific language. Identify and clearly communicate challenges, uncertainties, risks and the mitigation approach. This shift in communication goes hand in hand with a transition from a role deeply embedded in R&D to corporate strategy including mergers and acquisitions.”


What, if anything, would you like to share about diversity, equity and inclusion in the field?

“Inclusion of diverse perspectives is just as important as all other facets of DE&I. Every individual is looking for respect and an opportunity to prove that they too can contribute, that they are vital to a purpose, an organization, a charter. Give sufficient opportunity for the entirety of a team’s perspectives to be heard.”


What needs to change most urgently in the industry and for what effect?

“Giving credit where it’s due, I agree strongly with Boston Consulting Group’s insights on the need for a material change in medtech’s commercial model. One of the key focus areas for the industry is to improve on SG&A allocations and selling costs as the profit pool continues to shrink in most major medtech market segments. This is needed to meet the investor expectations and the changing market demands. The incremental model is not in any way gaining market adoption by taking the price as the requirements for acceptance of new innovations by the practitioners continues to be intensely competitive and demanding due to changes in payer policies. This is another challenge the industry must address. 


If someone was going to commit one or two things to memory from this, what would it be?

“As we know change is the only constant. Business is no different and frequently change happens at very high speed. Economies change and evolve. Markets change and evolve. Thus, organizations need to evolve with varying degrees of speed. 

“Therefore we all have to learn to evolve with it. If you see an opportunity where you may be sidelined or ignored or otherwise ‘boxed in’ based on perceptions that have driven the reality, ask for an opportunity to prove yourself. Seek out opportunities to be helpful in others’ initiatives. It’s hard for anyone to turn down an offer of more help that can advance their work with the potential to shift their own perception – and career reality – in a positive direction.

“Lastly, own your own deliverables. Your future is in your own hands and you need to learn to manage it.”


Thank you, Shyam!

Shyam has recently shared his plans to retire from Avanos in the next 18-24 months.

We wish Shyam all of the best in his future endeavors and thank him for sharing his story, his energy and his insights with the Southeast Life Sciences ecosystem. He has been an active member of SEMDA, Southeast Life Sciences and the broader southeast medtech innovation community for decades. He also serves, and plans to continue to serve, on the Biolocity Oversight Committee and GCMI’s Industry Advisory Board. 

Ecosystem Partner Insights on the Current State of Medtech Design and Development

Southeast Life Sciences’ approach to innovation is embodied in continuous networking, education and funding opportunities that encourage the life science industry to grow.

Our colleagues at the Global Center for Medical Innovation (GCMI) help direct the development, testing, training and commercialization of innovative medical products that improve quality based outcomes and delivery of healthcare for patients. They are also regular publishers of insights intended to keep the ecosystem abreast of the latest in the life science design, development and commercialization landscape.

GCMI Medical Director Dr. Emily Blum and Director of Research and Development Engineering Saylan Lukas recently shared their insights on “State of Medtech Design and Development” including the hot technologies, high demand services, regulatory evolution and common hiccups for innovators to avoid.

  • “What’s critical for new technologies currently in development that lean on AI, is to ensure collection of clean, correct, and unbiased data, and then storing and processing it properly.”

  • “More frequent, routine feedback from the FDA’s experts will always limit expenditures and risks a project might take heading down the wrong pathway.”

  • “Even the most basic “ back of the napkin” drawings for a novel medical device contribute to a robust design history file and can be of value to regulators in understanding a device’s origins and intentions. Rule of thumb: if it’s not documented, it doesn’t count.”

We invite you to take a deeper dive into the current state of the medtech design and development ecosystem in the detailed post on the GCMI news and blog.

In It for the Long Haul: The story of Nephrodite’s quest to radically transform care for kidney failure and dialysis patients.

When deep seated, long-unmet clinical needs for a very large patient population meet one particular young patient’s journey, opportunity for innovation knocks. Loudly.

“All Holly wanted was to be ‘normal,’” said Nephrodite Co-Founder and Urologic oncologist Nikhil Shah, DO, MPH. “After years of living in fear, in constant sickness, full of stress, constantly in and out of dialysis centers, she did at last receive a kidney transplant. Ultimately the transplant failed and she succumbed to kidney failure.”

In the 1940s and 50s, pioneering dialysis technology extended the lives of patients with renal disease and kidney failure, previously a veritable death sentence. That technology has changed little in the past seven decades or more.

“Advancements in technologies for other high volume, high impact diseases like heart disease and heart failure, like LVAD [left ventricular assist devices], have improved the lives and outcomes by leaps and bounds in the past 10 years,” Dr. Shah said. “It is past time for new technologies to do the same for millions of patients who rely on dialysis for their very lives.”

Nephrodite co-founder and Pediatric Urologist Hiep Nguyen, MD, specializes in surgical advances in kidney disease and urinary reconstruction, including kidney transplantation. Almost 10 years ago, Drs. Shah and Nguyn set out to create a technology “to restore freedom, function and independence to individuals with end stage kidney disease.” 

Enter Holly(™), a continuously functioning dialysis device, one of only a few technolgies in the artificial kidney space to ever be developed. the nearest technology to an artificial kidney ever developed.

Given Holly’s potential impact across its patient population to improve outcomes and reduce cost for a disease with very high priorities for global health organizations, and very high investability potential, Nephrodite earned the winner’s position in the PitchRounds at AdvanSE 2022 device category in May of this year.

 

COMMITMENT

As a U.S. FDA Class III technology, Holly’s commercialization pathway is the most rigorous, time consuming and costly in the medtech innovation discipline. It is not unreasonable to assume total concept-to-commercialization costs for Class III devices to approach, or exceed $100 million.

“Our work started many years ago; trying to miniaturize a common, quite large dialysis machine to about the size of a small child’s fist, implantable in humans,” Dr. Shah said. “It has been no small task, but we have ensured our technology is sound and all these years later now have a functional prototype. 

“We have had many opportunities to walk away, which I suppose is not uncommon for an implantable technology that requires PMA (premarket authorization) as an FDA Class III device.

“But we have done a tremendous amount of de-risking, we have close ties to the unmet need, the patient population and the technology itself. Our team is dedicated, passionate and we intend to see this technology all the way through to commercialization.

“We are, without question, in it for the long haul.”

Current status

Nephrodite relocated its headquarters to Atlanta earlier this year where it entered into Georgia Tech’s Advanced Technology Development Center.

“We relocated to Atlanta in order to leverage the abundance of talent and resources not just in Atlanta, Georgia but in the Southeast,” Dr. Shah said. “But we were not aware at the time of just how robust the life science ecosystem is including the ATDC, Georgia Bio, SEMDA – now Southeast Life Sciences – and supporting entities like the Global Center for Medical Innovation on top of all the scientists, clinicians, regulatory experts and others. 

“We have been working to both make our presence known and avail ourselves of the local and regional assets and resources, which are plentiful.”

Nephrodite has recently accepted an invitation to be part of the Center for Medtech Excellence, which “will provide a reimagined, comprehensive approach for concept to commercialization and sustainable innovation, which is crucial for cultivating more agile healthcare organizations. Georgia Tech will develop the Center for MedTech Excellence – a three-year collaboration with the Advanced Technology Development Center (ATDC), the Georgia Manufacturing Extension Partnership (GaMEP), and the Global Center for Medical Innovation (GCMI).”

What’s next

In addition to its recent FDA application for a breakthrough technology designation, the company intends to raise Series A funding starting in Q2 2023 to complete development of a clinically appropriate, human-ready device in order to then initiate requisite preclinical testing in chronic models sometime in 2024. (Prospective, interested investors should contact Nikhil Shah, nshah@nephrodite.com).

“In the very near-term, we intend to raise awareness for our cause and its associated burden, in addition to forming a community advisory board for those on dialysis or those passionate about kidney disease to improve treatment options, outcomes and lives for patients worldwide,” Dr. Shah said. “We will be seeking volunteer based input on the device’s design and functional attributes with particular attention devoted to patient-centric needs for day-to-day living with our device.

“We welcome interested parties, be they patients, care givers, family members, clinicians or members of the scientific and research communities to contact Niraj Khurana, our Director of Operation (niraj@nephrodite.com) to learn more about participating in the community advisory board.

Lessons to Learn: Engage regulators early, often and never underestimate the importance of team acumen, timing

When asked what advice he would give to other medtech innovators, Dr. Shah shared the following:

“Try to include and understand what it’s going to take [to meet] regulatory requirements, milestones and inflection points as early as possible.

“Engage the formal regulatory body early and often. They will only help you. They are much more accessible, much more understanding and supportive of innovation and innovators with more available resources to help you verify actions or assumptions than people know. 

“Telling your story in a few minutes is an art that needs development and practice. It is important to understand your audience and your value proposition for them, but do not exclude your overarching value to the larger community, to everyone ‘in the room.’

“Assemble your team, internally or otherwise, carefully. Investors do indeed look closely at team members, their acumen, accomplishments and fit for function and timing.”

Southeast Life Sciences thanks Dr. Shah for sharing his insights with us.