Southeast Life Sciences Launches SE Color

Southeast Life Sciences Launches SE Color
SE Color will initiate “We Are In” Campaign to encourage minorities to participate in Clinical Trials.

On September 9, Southeast Life Sciences announced the formation of SE Color, an organization dedicated to support minority life science entrepreneurship, increase investment in minority-owned life science businesses, and improve minority access to information and clinical opportunities.

The founding advisory board members are Jayne Morgan MD, Clinical Director, Covid Task Force at Piedmont Healthcare, Kornelius Bankston, Managing Partner with techPLUG, and John Newby, Chief Executive Officer for Virginia BIO. As executive director of Southeast Life Sciences, Jason Rupp will staff the organization.

SE Color’s initial effort will focus on increasing the number of minorities in clinical trials. In an article published in Healthcare Tech Outlook, Dr. Morgan notes that, “African Americans make up 13.4 percent of the US population, yet only 5 – 7 percent of clinical trial participants nationally.”

Dr. Morgan further states, “Nearly every advance in medicine today was first evaluated in a clinical trial. Clinical trials offer our best and most forward thinking and can be the gateway to provide earlier access to life saving medicines and therapies years ahead of FDA approval. Equitable participation in clinical trials is therefore a critical call to action in ensuring that medicines, devices, and vaccines that are developed are relevant to all populations.”

Although there are many aspects to facilitate minority recruitment in clinical trials, SE Color will initially focus on education through the “We Are In” campaign. The initial priority will be to share information on clinical trials available throughout the southeast. SE Color will partner with state associations in the region to ensure we have updated information and extend the network.

Southeast Life Sciences recognizes the great need for effort in these areas and though we will only be one part of the solution, we will be part of it. In closing, Bankston adds “I believe the greatest social injustice in modern history is health inequalities which disproportionately impact people of color. We can create more effective therapeutics, applications and medicines for all populations- by addressing the systemic issues in clinical research.”

Insights and full recording from our recent Southeast Life Science investor panel and webinar

On Tuesday, April 13, Southeast Life Sciences convened a panel of industry leading medtech and life science investors to discuss how activities have shifted and what the mid-long term ramifications will mean to early stage innovators. 

Bob Crutchfield moderated the discussion including insights from:

Gerry Brunk of Lumira Ventures, Joe Cook III of Mountain Group Partners and Kyparissia Sirinakis of Epidarex Capital.

A few of the top takeaways included:

  • There are, and will continue to be, significant disruptions in GLP preclinical work required to achieve an IND or entry into clinical trials. 
  • New medical technologies with ‘capex’ implications for hospital budgets will be at a significant funding and commercialization disadvantage for at least 12 to 24 months.
  • Telehealth and remote monitoring should be poised well for structural changes including adoption and reimbursement.
  • High net worth family offices have plenty of capital to invest. They will ‘lean in’ on increasing stakes in existing investments and in sectors or stages least likely to be impacted. The telehealth genie, for example, will not likely go ‘back into its lamp.’ Opportunity: What is going to really make it sing? 
  • Innovators need to adjust timelines to reflect new realities and resources required. Runway extension is the current name of the game, especially for technologies requiring clinical studies. Break up your pathway into ‘bite size’ milestones and discontinue using any pre-COVID-19 valuation and structure analogs.
  • Keep the conversation going. Investors are now considering technologies they may have passed on previously. They are continuing to do their due diligence. Many are focused more highly on solutions so transformative on patient benefit and cost reduction than they ever have been before. Early stage companies’ funding rounds will take longer, but great companies will always find funding.
  • The translational aspect of new medtech and life science innovations needs to be stronger than ever before.

We encourage everyone, especially early stage medtech and life science companies, to give the full session a watch or listen HERE.

Paycheck Protection Program Starts today – April 3, 2020

Today the Treasury Department is launching the Payment Protection Program that was created as part of the CARES Act. The program authorizes up to $349 billion in forgivable loans, up to $10M per company, to small businesses to pay their employees during the COVID-19 crisis.

The program is intended to be a simple process that will be implemented through your banks. Below is more for your review.

SBA overview of the program
More Information

Find eligible lenders
More Information

Dept of Treasury Fact Sheet
More Information

 Application
The application process is meant to be easy – fill in the application and take it to your bank.
Application Link

Venture-backed companies
 Uncertainty remains whether venture-backed companies would be eligible for the program, however there is a commitment from Congress and the Treasury Department to fix this problem. Due to the “affiliation rule” that was intended for companies owned by private equity, there is concern that venture-backed companies would not be eligible for the program. According to senior leaders in Congress, this has been or will be clarified by the Department of Treasury and venture-backed companies will be eligible.
Read More

If you would like more information, the Washington Post has a comprehensive FAQ to the program. Unlike most Washington Post articles, this is not restricted behind a paywall.
Read More

 

Southeast Life Sciences signs coalition letter on behalf of small businesses with equity investors

This week, Southeast Life Sciences joined a national coalition to encourage the federal government to clarify that small businesses with equity investors will be included in the Keeping Workers Paid and Employed Act provision included in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. 

The imminent fate of hundreds of thousands of jobs across the Southeast and America hinges on the implementation of these rules.  In order to survive, these companies must make difficult decisions over the course of the next several days. Rapid clarity on how these rules will be interpreted for purposes of the program can provide confidence to these vital small businesses that resources will be available and will mitigate the layoffs beginning to sweep across the startup ecosystem.

The Keeping Workers Paid and Employed Act is one of the most powerful small business recovery programs ever passed by the United States Congress.  This program will provide loans of up to $10 million dollars to small businesses up to 500 employees.  The benefits are carefully crafted to encourage the retention of middle-class jobs through the economic crisis caused by the COVID-19 pandemic.  If this is effective then millions of jobs across America will be preserved, potentially preventing the downward spiral in economic activity created by widespread layoffs.

Most American startups are below 500 employees and are not yet profitable.  Like other small businesses, these companies survive on a month-to-month basis, meaning their workforces are also particularly vulnerable in an economic downturn.  Startups commonly take equity financing, and in an economic crisis, that capital must be used to keep the entity in operation.  Companies must make difficult decisions fast on whether to lay off some of their workforce or run the risk of exhausting their available capital and destroying the business.  Every single one of these companies are currently looking through their books to better understand how far they can stretch their current available capital to preserve the entity through the economic crisis.  This timeline is often colloquially referred to as “runway.”  Because such a high percentage of the capital is spent on payroll, often the only way for startups to extend their runway is furloughs and layoffs.

Thankfully, Congress responded to the crisis with the Keeping American Workers Paid and Employed program that is designed to prevent mass layoffs at small businesses.  But how the Department of Treasury and the Small Business Administration (SBA) will apply the rules in upcoming guidance to implement the program is a central question to program access for startups and other small businesses with equity investors.  If the current SBA rules on affiliation are applied, they will create significant confusion about eligibility, delay the application process, render many small businesses ineligible, and cause many more to forego the process.  Each of these challenges will exacerbate layoffs.

In the last few days a brief survey of a cross-section of venture investors was conducted to gauge what the impact would be on their portfolio companies if they do not have access to the small business lending facility.  The responses were dramatic, with many companies considering layoffs between 25 and 50 percent of their workforce.  To provide a perspective of the impact of these layoffs on the workforce, about 34,000 companies in the United States have raised venture funding since 2015.  Of the approximately 20,000 of these companies for which the employee count is captured, 97% have fewer than 500 employees. 1   As noted above, about 2.27 million Americans work at these companies, with many more people employed in support roles at other companies.

Failure to provide clarity that small businesses with equity investors are eligible for the loan facility will cost jobs not only at startups, but at many of the independently owned service oriented small businesses in communities across America.  These startup workers, who include engineers, customer service representatives, and human resources professionals, are the very customers that service-oriented small businesses such as restaurants and coffee shops rely on for sales making an economic comeback post crisis even more difficult.

Finally, if the affiliation rules are not applied appropriately, our country will experience incalculable cost to our science and technology leadership.  Venture capital backs the world’s most innovative companies, but without support from the government hundreds of research projects across the country are at risk of being shelved.  This is potential progress that will pause overnight, and just as important, will set back American competitiveness in an increasingly global race for innovation leadership back by years.

Full Coalition Letter Here

About Southeast Life Sciences

Southeast Life Sciences is a regional non-profit organization dedicated to the growth of the life sciences industry. It was formed in 2019 through the merger of Southeast BIO and the Southeast Medical Device Association (SEMDA).

The mission of Southeast Life Sciences is to efficiently, effectively connect our industry’s innovators and entrepreneurs with the right investment and partners be they institutions, corporations, venture capitalists or angels.

We facilitate connections, conversations and capital investments through continuous networking, education and funding opportunities for life-science innovators of all shapes and sizes.