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.

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.

Seeking high potential life science entrepreneurs – from startup through series B/C in the Southeast United States – for PitchRounds 2022 at AdvanSE

southeast life sciences pitchrounds

Southeast Life Sciences cultivates, convenes, and connects the Southeast entrepreneurial ecosystem to foster life science innovation in promising companies throughout the region from investors across the country. 

 

Our investor colleagues count on us to present to them the highest potential life science investments the southeast United States has to offer. 

 

For promising young companies from startups seeking six figures to more mature life science innovators seeking seven or eight figures, we introduce you to your next potential investors.

 

One of the key ways we do this is via PitchRounds at our annual flagship event AdvanSE. The 2022 edition is May 25-27 in Alpharetta, Georgia. AdvanSE is Southeast’s premier, must-attend event for the biopharma, medtech, diagnostic, digital health, and agriculture biotechnology industries wishing to do business in the Southeast region. AdvanSE attracts the best of the southeast’s innovation, research, and people.

 

PitchRounds 2022 at AdvanSE – APPLICATION DEADLINE EXTENDED TO APRIL 8.

 

We are ready for the most promising innovative life science companies – from startups seeking milestone-based funding at six figure levels from venture capital firms, corporate venture arms, family offices, and angel groups to more mature companies with institutional investors on board seeking future rounds at $1MM to $15MM plus – to apply for PitchRounds 2022 at AdvanSE.

 

Applicants should be planning to execute a funding round, supported by a strong commercialization plan and business strategy, within the next 12 months.

 

Why apply for PitchRounds 2022 at AdvanSE?

In the past 20 years, 501 PitchRounds presenting companies have raised $7.2 billion dollars. 70 companies subsequently executed M&A and IPO events and counting.

 

Kayla Rodriguez, MBA – Co-founder & COO, SweetBio

“Three weeks before the 2015 conference, SweetBio wasn’t even incorporated. Six months later, Innova and MB Venture Partners co-led a significant seed round to support FDA 510(k) clearance of our honey-incorporated advanced wound care product. From that first conference, gaining insights and feedback from Randy Scott, David Huizenga, Chris Hooper, and others helped shape our company. From investor insights to introductions to industry advisors and fellow peers, this event has us coming back year after year.” – Kayla Rodriguez Graff, Co-Founder and CEO, SweetBIo

 

“This conference provided us an incredible opportunity to connect with a large number of diverse life science professionals, which is not always easy to do for life science companies headquartered in the heartland. The exposure to investors and collaborators was instrumental to our early stage company.” – Vance Clement, CEO, Lineus Medical, Pitchrounds participant 2019 and 2021

 

“By attending AdvanSE, I get to meet some of the leading entrepreneurs and interesting companies in the Southeast.  AdvanSE offers exclusive opportunities to network with other investors and strategics and is the one-stop shop for innovation in the region.”  – Kyp Sirinakis, Co-Founder and Managing Partner, Epidarex Capital

 

HealthQuest partners are active participants in reviewing early stage businesses and investing across the healthcare spectrum – including medical devices, healthcare information technologies, diagnostics, novel delivery systems that improve patient outcomes and reduce costs. We find PitchRounds an early preview of companies that are rapidly growing and might become opportunities for investing as they seek growth capital.” – Tom Callaway, Venture Partner, HealthQuest Capital.


Who Will PitchRounds 2022 AdvanSE Presenting Companies Get to Meet?

  • Industry strategic partners (and acquirers) attending typically include AbbVie Ventures, AdvaMed, Amgen Ventures, Arbor Pharmaceuticals,, Avanos Medical, Braun Pharmaceuticals, Halyard / Owens and Minor, J&J, Lilly Venture , Medtronic, Merck, Moderna, Pfizer and Smith & Nephew.
  • Tom Callaway, Partner, HealthQuest Capital

    Recognized life science investors attending typically include Epidarex Capital, Foxboro Capital, Fulcrum Equity Partners, Hatch Medical, Hatteras Venture Partners, HealthQuest Capital, Kairos Ventures, Keiretsu Forum, Lumira Ventures, Mountain Group Partners, New Enterprise Associates, Osage University Partners, Pappas Capital, Solas Bioventures, Triangle Angel Partners, with top banks including Silicon Valley Bank, JP Morgan, Life Oak Bank, Pacific Western Bank, and large regional investors like CED (Center for Entrepreneurial Development), Georgia Research Alliance Venture Fund, NC Biotechnology Center, University Of Florida Innovate Venture, and UVA Licensing And Venture Group Seed Fund.

  • Top FDA consultants, intellectual property and business attorneys, the state BIOs of the Southeast, contract manufacturers, university tech transfer professionals from top southeastern universities, and more.

 

APPLY FOR PITCHROUNDS AT ADVANSE 2022 NOW – PRESENTING OPPORTUNITIES ARE LIMITED

 

For PitchRounds 2022 at AdvanSE we have 20 coveted spots available for young companies, 10 available for more mature innovators with at least one institutional investor on board.

Winners will pitch and compete against similar staged companies to an audience interested in your life science sector. No other programming, speakers, or panels will compete against the three pitch rooms running. Finalists in both early stage and late stage will compete in a “Shoot Out” before all AdvanSE 2022 patrons in attendance.

Companies selected to present during PitchRounds at AdvanSE 2022 further enjoy:

  • An assigned SLS board member or industry partner “guide” who will make critical introductions to investors, peers or solution providers based on need: think IP attorneys, design and development experts, industry leading preclinical service providers, business attorneys, FDA consultants, accountants and other aligned professionals in the ecosystem.
  • Focused attention – PitchRounds presentations will be the sole focus of morning sessions on May 25th and 26th. Presentations will not compete with any other conference programming. Finalists will compete in a “shootout” to determine the PitchRounds 2022 winners on the afternoon of May 26th. (Note: early stage companies will not compete directly with later stage companies.)
  • Investor access — In addition to the PitchRounds panel of judges, including a variety of qualified investors, we expect representatives from a variety of investor types including angels, VCs, institutional investors and a strong presence of strategics including J&J Innovations, Medtronic, Moderna, Pfizer and others.
  • A “Reality check” – Get feedback on your pitch content from neutral outside resources, especially for early stage companies – from a panel of experienced industry experts.
  • All access conference registration discount — you don’t have to pitch and run. Selected companies can extend their fundraising, networking and learning opportunities to the entirety of AdvanSE 2022 programming and events with all-access, 2 for 1, registration at the early bird rate of $549.
  • Awareness distribution of PitchRounds selection to more than 3,000 industry professionals in Southeast Life Science’s email CRM

Apply for PitchRounds 2022 at AdvanSE today.

 

We’re looking for the best the southeast life sciences’ innovation ecosystem has to offer. Apply for PitchRounds 2022 and your chance to accelerate your innovation’s pathway to commercialization today.

Header: Are race, social determinants or insurance types predictors of COVID mortality among hospitalized patients?

Jayne Morgan, MD, Executive Director, COVID Taskforce for Piedmont Healthcare and Southeast Life Sciences Board Member, along with Piedmont colleagues Jessica McCain, Xinyue Wang and Kate Connell sought empirical answers to these questions in a recently published paper in the Journal of the National Medical Association, “Assessing the impact of insurance type on COVID-19 mortality in Black and white patients in the largest healthcare system in the State of Georgia.”

 

From the paper’s key points:


Question: Does the relationship between race and COVID-19 mortality still exist when Black and White patients are equally insured?


Findings: In a retrospective analysis of hospital data for an equitably insured population, White and Black patients did not differ in odds of mortality from COVID-19. White patients were more likely to be older and on Medicare. Insurance type was a significant predictor in a logistic regression analysis, even when controlling for risk factors and laboratory results.


Meaning: Racial disparities in COVID-19 mortality in the US population may be partially explained by disparities in insurance.

 

Read the paper in its entirety here.

 

Jayne shared the following takeaway and action item for the Southeast Life Sciences community with Write2Market’s Paul Snyder.


What’s the one thing you hope readers will commit to memory?
 


“That Social Determinants of Health also determine downstream effects such as what type and quality of insurance you have.  This can serve to dissuade participation in the medical system and in the advocacy of one’s own health because of out of pocket expenses, caps, limitations, and bureaucracy. With regard to Covid diagnoses, when insurance was equitable, the inequity in health outcomes was no longer significant and equalized.


What’s the top opportunity for the SLS community to influence positive change in response to the paper’s findings?


“Where you live and what you earn should not impact whether you have access to health insurance and accurate health information. One of the ways in which we can influence positive change is by ensuring that people realize that medical care can also be accessed via clinical trials, regardless of one’s  economic and/or insurance status. Clinical trials can serve as a gateway toward removing barriers and providing access to healthcare for many.”

Southeast Life Sciences would like to thank Jayne for her continuing support and leadership. 

Readers can keep up with the latest from Southeast Life Sciences by following us on LinkedIn and Twitter.

It’s a Big House and There’s Room for Everyone

Alexandria Henry-Smith, Morehouse School of Medicine researcher and PhD candidate on the southeast life sciences and Women@SLS community means to her, and can mean to others.

 

Alexandria Henry-Smith’s mother made a highly intentional effort to expose her daughter to science, including in her homeschooling through the third grade. Her pediatric dentist also went out of his way to demonstrate new tools, technologies and techniques during her visits.

 

While initial ambitions toward dentistry didn’t fully manifest, the intentional exposure to science, including new fields opened to her through a high school medical program, forged a foundation of knowledge and curiosity that made a career in the life sciences likely, if not inevitable. It’s a bit of a family affair as well. Her uncle is a biologist and currently the head of the environmental science department for a leading engineering company. 

 

Ms. Henry-Smith is now a PhD candidate in biomedical science with a focus on neurology at the Morehouse School of Medicine. Her research into ways of decreasing neural injuries covers zinc and its effects on ASIC during ischemic stroke.

 

In 2019, Ms. Henry-Smith discovered Southeast Lifesciences and Women@SLS (previously Medtech Women @ SEMDA) on LinkedIn, which she followed for awareness, networking and potential opportunities for operational roles in life science and biotech startups. When her research hit a ‘hard hold’ in early 2020, she found herself desperate for interaction with the southeast life science ecosystem. She found a piece of that in the 2020 Women @ SLS Annual Conference.

 


Discovering more of what’s possible

 

“I met women performing roles and doing work I had not yet realized was actually attainable or possible,” she told Write2Market’s Paul Snyder. “As the only graduate student in that virtual event, it turned into an incredibly valuable personal advice session.

 

“An undergraduate professor once said pretty women can’t be surgeons or leaders. While I was solid in my self confidence, for many women that was completely discouraging. But when we see women in leadership roles like so many in the Women @ SLS group, it shows an executive level career in life sciences is an actionable, attainable goal. It’s something you can really do. 

 

“It does take dedication, a competitive spirit and strong backbone to the rigors of scientists, researchers, but these women are proof that there are more roles and more routes to careers in the life sciences than legacy pathways to them.

 

“It’s also immensely valuable to pick the brains of women in life science leadership roles that have transitioned from academia to industry,” she said. “Their advice on specific activities like boards to join and introductions to others whose pathways look a bit like mine or those whose needs might align with my skills, research, knowledge and experience is invaluable as well.”

 

An environment and community of encouragement

 

She said the 2021 edition of AdvanSE reinforced the highly collegial spirit of the southeast life science community.

 

“In every conversation I had at the event in South Carolina, each person was happy to advise and encourage,” she said. “Everyone was very, very kind. This is not always expected coming from the highly competitive academic research side of the life sciences.”

 

She told Paul she aspires to be a chief innovation or operations manager officer for a startup or early growth stage life science entity.

 

“I would love it if that entity had a strong focus on neurologic disorders, but I have learned flexibility is key when things present themselves. It’s important to be ready to jump. Before getting more closely engaged and active within the Southeast Life Sciences and Women @ SLS communities, I would not have aspired so high.”

 

When asked why one should get actively involved with SLS and Women @ SLS, she said, “Whether you are focused on marketing, communications, research or development, there are connections to be made that are highly beneficial for the future. You may well speak to your next employer. If you are a young regulatory professional, for example, you will meet people doing that work, many in leadership or influential roles that can help you get where you want to go. You can find champions, those who advocate for you when you’re not in the room, and mentors, your advocates there for you when you are in the room. 

 

A big house with a place for everyone

 

“Young life science professionals, including startup founders, have so much to gain by engaging closely with the Southeast Life Sciences community. You can speak directly to those with the ability to advance or jump start your career in ways or places you might not have anticipated, especially because the pathway into these careers is not always clear.

 

“Engineering, marketing, operations, biomedical research, manufacturing… they’re all critical elements to the life science industry. It’s a very large house, and there’s so much to do in it, anyone can find their place.” 

 

We thank Ms. Henry-Smith for taking the time to share part of her story with us.

 

The 2022 edition of Southeast Life Sciences’ flagship event, AdvanSE, is May 25 – 27 at the Avalon Hotel and Conference Center in Atlanta. Follow Southeast Life Sciences on LinkedIn and Twitter for all of the latest including 2022 dates for the Women@SLS Conference.

The Frontier of Precision Based Behavioral Health: SE Color Winner Spotlight: Polaris Genomics

Improving the antiquated,  inadequate “Gold Standard” for PTSD diagnosis and treatment

 

Charles Cathlin wanted to be a pilot. With a sister serving in the U.S. Air Force and a predisposition for science and technology, Colorado Springs was calling. But…

 

“It seemed like everyone knew I was color blind except me,” he said. 

 

Nevertheless, Charles served six years in the Air Force as a bioenvironmental engineer working to mitigate or eliminate environmental hazards in industrial arenas like aircraft maintenance facilities. After deployments to Albania, Mozambique and the Middle East, Charles joined the United States Public Health Service Corps’ division on emergency response and preparedness in August 2001. His department was responsible for the medical response to the terror attacks on New York and Virginia the very next month.

 

“We knew how to protect first responders and uniformed service members from the myriad environmental hazards they faced in response to the events of September 2001,” Charles said. “But there was no protection at all from the mental health impacts responders inevitably faced.”

 

In 2016, he learned of pioneering PTSD biomarkers and genomics research conducted by Dr. Rachel Yehuda at the Icahn School of Medicine at Mt. Sinai in conjunction with Dr. Florian Holsboer at the Max Planck Institute.

 

An aging, inadequate “Gold Standard” for PTSD diagnosis

The current gold standard for PTSD diagnosis is a self-reporting survey, Charles stated in his winning pitch to the Southeast Life Sciences 2021 SE Color panel. Bias, stigma and the variety of symptoms are just three challenges to diagnosing PTSD. Currently, there are 22 veteran suicides daily.

 

“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 behavioral health disorders.”

 

Charles co-founded Maryland-based Polaris Genomics to identify earlier and more effectively diagnose and treat mental health disorders. Polaris licensed the PTSD biomarker patent from Mt. Sinai and expanded its capability from 3 genes to more than 1,000 with correlating mental health conditions. The team then built the TruNorth Platform, a bioinformatics engine to ingest genomic information, analyze it and apply AI for predictive modeling and reporting for clinical use.

 

Editor’s note: At the end of his service with USPHS, Charles spent 10 years at the FDA including serving as the Chief of Neurology and Radiology Devices.

 

The frontier of precision based behavioral health 

Polaris is a veteran-owned business that remains committed to its founding mission of improving the lives of U.S. military service members and veterans living with behavioral health conditions such as PTSD. Over the last 18 months, an evolving behavioral health landscape amid the Covid-19 pandemic highlighted the urgency for advances in diagnostics and treatment for many more populations. Answering a calling to serve, Polaris officially launches with an expanded mission addressing:

 

  • Veterans and active-duty US military service members,
  • First responders, frontline workers, and individuals in high-risk occupations, and
  • Trauma-exposed communities at large.

Building on research into the biological basis of PTSD and other neuropsychiatric conditions, the team at Polaris is working to develop the frontier of precision behavioral health with the first objective and evidence-based diagnostics and therapeutics.

 

“Experiencing PTSD is not exclusive to veterans,” Charles said. “Just look at the hand that healthcare workers and first responders have been dealt in dealing with Covid-19 and the mental health repercussions they will continue to face in the foreseeable future.”

 

As of this publication date, Polaris is completing validation on a clinical product in partnership with Sanford Health, while laying out a Series A funding strategy for an early 2022 push. 

 

Charles Cathlin

“We have goals set for science and product development, finance fundraising, team building, marketing and business development,” Charles said. “We want to form a company with the right people. Failing to do so can cause a lot of chaos with the wrong people in roles necessary to move the company forward. We spend a great deal of time on team building and development because we know how important it is to get it right.”

 

“Scientifically, unlike cancer, you can’t see or biopsy within mental health conditions. We’re doing some of the work needed to identify the biological underpinnings of those conditions with validation and research partners at Sanford Health and Defense Research and Development Canada.”

 

In addition to the fundraising plan mentioned previously, Polaris’s marketing and business development efforts center around gathering as much input from their network, including KOLs, as possible to position the technology for successful commercialization.

 

Finding the right, ripe markets for early commercialization, while building a path to providers

“Commercialization is a top area of focus at the moment,” Charles said. “We are talking to potential customers for feedback and input. There are some interesting therapeutic products being developed by the pharmaceutical companies. But identifying patients for clinical trials is proving difficult for them. Adding a genomic component to the PTSD diagnosis pathway could provide a significant boost for their recruitment efforts.”

 

“The provider community in the PTSD arena will be slower to adopt this technology,” Charles said. “Shifting from self-reported surveys, observation and conversation to utilization of genomic, bioinformatic data and AI will be a heavy lift in the clinical community. The research market and potential pharmaceutical market will support our work while we continue to educate clinicians.”

 

We applaud Charles and his team’s noble, novel approach to an unmet need that may well save thousands of lives and improve the lives of millions more that suffer PTSD. From their own story, “The team has garnered numerous awards, ranks, titles, and accomplishments, ranging from captain to engineer, Purple Heart recipient to medical doctor, virologist and immunologist, 9/11 responder to Iraq War veteran, and PhD to Homeland Security Public Health Officer amid the threats of SARS and anthrax.”

 

Watch Charles’s winning pitch here.

 

About Southeast Life Sciences

Southeast Life Sciences cultivates, convenes, and connects the Southeast entrepreneurial ecosystem to foster life science innovation & investment across the region for the greater good.

 

We’re the network that brings all southern life science innovation together in one place: for investors, we bring your next investable opportunity; for young companies, we introduce you to your investors and potential partners; universities & corporations, move your research or innovation into the commercialization pathway; for solution providers, we bring your next clients.

 

We are the proud creator and producer of the AdvanSE Life Sciences Conference, an annual gathering of the most innovative life sciences companies, researchers and discriminating, accomplished investors and corporations that want to do business with them. 

 

The 2021 AdvanSE Life Science Conference, Southeast Life Science’s flagship event, will be October 27-29, 2020 in Charleston, SC. 

 

In 48 hours at AdvanSE, investors can see the very best of what the southeast life sciences innovation ecosystem has to offer.

 

Register.

Here are the Highlights from the Virtual 2021 SE Color Pitches/Women@SLS Conference

On Thursday, June 24, Southeast Life Sciences hosted the virtual SE Color Pitches and Women@SLS Conference that featured a dynamic group of presenters and speakers discussing some of the biggest challenges that women and minorities continue to face in the industry today. 

Here are some of the key insights and takeaways from this year’s event. 

 

SE Color Pitches Summary

Keynote with Dr. Melanie Ivarsson 

Dr. Melanie Ivarsson, Senior Vice President & Chief Development Officer with Moderna, kicked off the SE Color Pitch event in a fireside chat with Dr. Jayne Morgan, Executive Director of the Covid Task Force at Piedmont Healthcare. 

Melanie and Jayne started with an overview of Melanie’s career, spanning her childhood to her current position at Moderna. Melania recounts her childhood through her PhD and path to Moderna. She makes a note to compare her parent’s education opportunities, particularly for her mother, stating that education for women has moved “from a luxury, to being in the room but the minority, to where we are today.” 

The discussion then turned to Moderna’s path from a relative start up to creating one of the most important products in our lifetimes. When Melanie first started at Moderna she was told that she would work on a “side project” on Covid, but within three weeks it would become the focus of the company. 

Moving on, Melanie and Jayne discussed Moderna’s leadership role in health equity in their Covid vaccine clinical trial, finishing with the highest percentage of minority enrollment of any company. Melanie noted, “ you don’t have to be one of the big giants to be the one who changes the way we do things” 

There was much more to the fireside chat, so be sure to watch it all here

SE Color Pitches 

The meeting continued with seven presentations from minority-led organizations based in the southeast. The winner of the event and the $10,000 prize was TruGenomix, led by Charles Cathlin. You can see the TruGenomix pitch here

To view all of the presentations, check out our YouTube page

 

Women@SLS 

Mentorship vs. Championship

Deanne Kasim, Executive Director of Health Policy for Change Healthcare, touched on the key differences between having a mentor and having a champion in the workplace during her opening keynote. While mentors are always good to have, champions go above and beyond when it comes to your success. In addition to sharing advice and giving guidance as a mentor, champions are there to open doors for you and put your name in the running, playing a much more active role in your success. 

“Men have evolved into natural champions and I feel like they’ve had more opportunity to do so, while women have become aces at mentoring each other,” Deanne explained. 

So, how do we cross-pollinate these roles and connections between men and women? Deanne’s number one answer was networking, whether it be in-person or online. Opportunities are increasing for women in the life sciences despite the fact that it’s still a male dominated industry, so it’s crucial to continue moving forward and challenging biases by building a community of allies for the current and future generation of leaders. You can watch the opening keynote here. 

Finding the right seat at the table 

Tiffany Wilson, President & CEO of The Science Center, moderated the panel discussion on expanding the representation of women in the boardroom. Although there is some room for improvement in the number of women on life sciences boards, there are opportunities out there.

Tara Kochis-Stach, Slone Partners President, shared that networking is critical to find these kinds of opportunities. Being bold about what you want to do and reaching out to the people that can help you get there will create opportunities for yourself. However, making sure you’re joining the right board for you is just as crucial. 

“Don’t pick whatever board offers you a position just because you want to be on a board,” stated Valerie Darling, CEO & Chief Business Officer of Life Science Management Consultants. “It needs to match with your lifestyle and current job in terms of time commitment.” 

Arlene Morris, Board of Director Member for the MUSC Foundation for Research & Development, also suggested, “Interview with everyone on the board to make sure you gel with them and get along. If you know people on the board already, reach out to them to see what the environment is like.” 

Watch the full panel here. 

Identify the champions of your technology, and fast  

The panel discussion on what early-stage companies should know as they begin sourcing their first customers, moderated by Jesse Goodwin, PhD, featured insights from Vice President of Client Success at Pieces Technologies Lehanne Doyle, Senior Director of Clinical Operations at Moterum Technologies Lauren Rashford and ASKBio CEO Sheila Mikhail

Lehanne stressed the importance of finding several key champions in the facility to help support the change in process when your new technology is implemented. Identifying the procurement or IT personnel is also critical, as projects can easily fail because they weren’t involved early on. 

Lauren agreed that relationship management is key during this process. Finding these individuals that will be doing the day-to-day tasks and having their support will help leverage and drive your technology through the system smoothly. Click here to watch the full panel. 

Breast cancer treatment has come a long way, but there is always room for improvement 

This year’s conference ended with a closing keynote on the evolution of care and opportunities for improvement in breast cancer, featuring presentations from Regina Hampton, MD, FACS, Medical Director of Breast Center at Doctors Community Hospital, and Nikki Jensen, Vice President at Essentially Women. 

While Dr. Hampton illustrated the progress made in breast cancer treatment with the shift to patient-centered care and the passing of the Women’s Health and Cancer Rights Act in 1998, Nikki touched on some of the necessary steps that have not yet been taken when it comes to fully protecting and accommodating breast cancer patients and survivors. This includes breast prostheses and how they have not yet gotten the same treatment from the CMS that other breast cancer treatments have received. Watch the closing keynote in its entirety here. 

Southeast Life Sciences would like to thank everyone who participated in or attended this year’s SE Color Pitch/Women@SLS Conference, and the event sponsors who made it all possible. If you were unable to attend the live event, visit our YouTube channel to watch the recordings.

Southeast Life Sciences Announces the winner of the SE Color Pitch

se-color-pitchrounds-logo

July 6, 2021 – The first SE Color Pitch event, hosted by Southeast Life Sciences, was held on June 24, 2021, featuring top minority-led, early-stage life science companies from the southeast United States.

We’d like to congratulate the winner of the SE Color Pitch event, TruGenomix, which will receive the $10,000 prize, sponsored by Moderna. Presenting for TruGenomix was Charles Cathlin. CEO & Founder.

TruGenomix is a precision behavioral health company focused on advancing the diagnosis and treatment of mental health conditions such as post-traumatic stress disorder (PTSD). Our behavioral health platform incorporates our core products, TruGen-1and TruBase. TruGen-1 is a 1000 gene neuropsychiatric panel, designed in collaboration with Illumina, that includes our patented markers for PTSD predisposition. TruBase is our custom-built machine learning and bioinformatics engine, which is designed to support behavioral health research, clinical decision-making, and biomarker discovery.

See the presentation HERE

Congratulations Charles & TruGenomix!

About SE Color

SE Color, a division of Southeast Life Sciences, was established in 2020. SE Color is an organization designed to support minority life science entrepreneurship, increase investment in minority-owned life science businesses, and improve minority access to information and clinical opportunities. 

 

About Southeast Life Sciences

In 2019, the Southeastern Medical Device Association (SEMDA) and Southeast BIO (SEBIO) officially merged to form Southeast Life Sciences. The merger created a single, unified platform for medtech and bioscience innovation, partnering and investor relations.