Dr. Michelle McMurry-Heath Headlines Medtech Women Conference

We are very excited to announce that our Keynote Speaker this year will be Dr. Michelle McMurry-Heath, President & CEO of the Biotechnology Innovation Organization, who took over the CEO position at BIO in June, replacing Jim Greenwood. I’ve spoken to many of my former colleauges at BIO, who say she is a dynamic leader who’s hit the ground running. BIO recently annouced a new diversity & inclusion program, The Right Mix Matters, so we’re thrilled that she will close our event this year!

 

Dr. Michelle McMurry-Heath

President & CEO
Biotechnology Innovation Organization

Michelle McMurry-Heath assumed the leadership of the Biotechnology Innovation Organization (BIO) as President and CEO on June 1, 2020. A medical doctor and molecular immunologist by training, Dr. McMurry-Heath becomes just the third chief executive to steward the world’s largest biotechnology advocacy group since BIO’s founding in 1993.

The common thread in McMurry-Heath’s work across academia, government and industry has been her focus on broadening access to scientific progress so more patients from diverse backgrounds can benefit from cutting-edge innovation. Driven by her own past family experiences navigating clinical trials and funding uncertainties within the rare disease community, McMurry-Heath calls “the distribution of scientific progress the social justice issue of our age.”

She comes to BIO from Johnson & Johnson where she served as Global Head of Evidence Generation for Medical Device Companies and then Vice President of Global External Innovation and Global Leader for Regulatory Sciences. She was also instrumental in bringing J&J’s incubator, JLabs, to Washington, DC. She led a global team of 900 with responsibilities in 150 countries around the globe.

Prior to her time at J&J, Dr. McMurry-Heath was also a key science policy leader in government. The Obama-Biden transition team tapped her to conduct a comprehensive analysis of the National Science Foundation’s policies, programs and personnel. President Obama then named her associate science director of the FDA’s Center for Devices and Radiological Health under Commissioner Peggy Hamburg. In that role, she championed clinical trial evolution, the use of real-world evidence in product evaluation, and an embrace of the patient’s voice in health research so new medical products deliver outcomes that matter to them.

McMurry-Heath was the founding director of the Aspen Institute’s Health, Biomedical Science, and Society Policy Program, where she promoted personalized medicine and bolstered international preparation for pandemic disease threats. She received her early training in science policy from the Robert Wood Johnson Foundation and later served as Senator Joe Lieberman’s top legislative aide for science and health. In that role, she drafted legislation to protect the country from biological attacks.

McMurry-Heath received her MD/PhD from Duke’s Medical Scientist Training Program, becoming the first African-American to graduate from the

August 5 Covid-19 Update

Most of the trends from two weeks ago continue, with a couple of notable exceptions. Cases in Florida and Louisiana appear to be leveling off, with some decline over the last week or so in both states. With universities (potentially) opening in the next month, that trend will be tested. If cases continue to level and/or drop, this is tremendous news for this Fall. 
 
Also notable is Alabama’s continued dramatic surge of hospitalizations remains puzzling. As you’ll see in the chart below, hospitalizations are so high that it would mean nearly everyone who tested positive over the last couple of weeks ended up in the hospital. I was skeptical two weeks ago and now I find it almost impossible to believe. Again, I checked the numbers with Alabama’s health department and the totals add up, but I remain convinced that hospitalizations were inaccurately counted for weeks or months and the data is now catching up to reality. 

Covid Numbers for the Week

 

7-Day Moving Average for Southeastern States
New Cases & New Hospitalizations 

(LA & NC do not report hospitalizations)
Alabama
Arkansas
Florida
Georgia
Kentucky
Louisiana
Mississippi
North Carolina
South Carolina
Tennessee
Virginia
Linear Case Growth

7-Day Moving Average for Southeastern States
New Tests & Positive Tests

Alabama
Arkansas
Florida
Georgia
Kentucky
Louisiana
Mississippi
North Carolina
South Carolina
Tennessee
Virginia

<!-- Global site tag (gtag.js) - Google Analytics --> <script async src="https://www.googletagmanager.com/gtag/js?id=UA-162914190-1"></script> <script> window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'UA-162914190-1'); </script>
April 6 Covid-19 Newsletter

July 22 Covid-19 Update

Covid Numbers for the Week

 

7-Day Moving Average for Southeastern States
New Cases & New Hospitalizations 

(LA & NC do not report hospitalizations)
Southeast Covid-19 Updates. Alabama 7-Day Moving Average, New Cases and New Hospitalizations
Alabama
Arkansas
Florida
Georgia
Kentucky
Louisiana
Mississippi
North Carolina
South Carolina
Tennessee
Virginia
Linear Case Growth

7-Day Moving Average for Southeastern States
New Tests & Positive Tests

Alabama
Arkansas
Florida
Georgia
Kentucky
Louisiana
Mississippi
North Carolina
South Carolina
Tennessee
Virginia

<!-- Global site tag (gtag.js) - Google Analytics --> <script async src="https://www.googletagmanager.com/gtag/js?id=UA-162914190-1"></script> <script> window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'UA-162914190-1'); </script>
April 6 Covid-19 Newsletter

Allyson Bower-Willner succeeding Tiffany Wilson as chair of Medtech Women AdvanSE at Southeast Life Sciences

During the 2020 Medtech Women AdvanSE of Southeast Life Sciences (formerly Medtech Women@SEMDA) virtual event on September 8, 2020, Founder, Chair and GCMI CEO Tiffany Wilson will pass the gavel to Allyson Bower-Willner. Willner, Marketing Director for Strategic Accounts with Molynlycke Health Care, has served on the MW@S board since its inception in 2016.

“We founded Medtech Women to serve as a strong advisory network for mentoring and professional development for female professionals and innovators across the medical technology industry in the Southeast,” Wilson said. “There is a meaningful gender gap in the C Suite. We know this. At the same time we are seeing more female technologists — doctors and engineers — with their names on patents, but we are not seeing a corresponding jump in the number of women involved in medtech startups.”

“Our goal is to continue our work making the southeast a world-class region for the medical device industry,” Willner said. “Medtech Women can play an integral role in that mission by enhancing the opportunities for female inventors, entrepreneurs, and other industry professionals in the southeast.”

Since its inception, Medtech Women@SEMDA has evolved to include an advisory board of 20 medtech and life science executives, physicians and successful entrepreneurs. The group has added educational programs, webinars and is now positioned to expand its capabilities and reach in large part thanks to the merging of the Southeastern Medical Device Association (SEMDA) with SE BIO in the new combined entity Southeast Life Sciences.

“The convergence of medical technologies, including devices, with bioscience technologies including drugs, data, digital and combination products necessitates the convergence of these entities,” former SEMDA Executive Director and now Southeast Life Science Executive Director Jason Rupp said. “In order to respond to the combined needs of stakeholders in both ecosystems, the time arrived for SEBIO and SEMDA to come together under one roof.”

“We have given Medtech Women life and validated its reason for being: creation of opportunities for women in medtech and life sciences for growth, leadership and professional development,” Wilson says. “Shifting from start-up mode into growth mode and maturity is an exciting time for any organization, particularly in an ever evolving industry like medtech and the life sciences.” 

“Thanks to the chair and the board’s leadership to date, and the remarkable environment in which we all find ourselves, the impact potential for Medtech Women AdvanSE is high,” Willner said. “We encourage all members of the southeast life science ecosystem to engage with us. Registering for the 5th annual Medtech Women AdvanSE virtual conference is an excellent place to start.” 

 

Those interested in serving on a committee like programming, conference, sponsorship or other should contact Jason Rupp at jrupp@southeastlifesciences.org or (202) 438-4960

July 7 Covid Newsletter

Covid Numbers for the Week

 

7-Day Moving Average for Southeastern States
New Cases & New Hospitalizations 

(LA & NC do not report hospitalizations)
Alabama
Arkansas
Florida
Southeast Covid-19 Updates. Georgia 7 day moving average new cases and new hospitalizations.
Georgia
Kentucky
Louisiana
Mississippi
North Carolina
South Carolina
Tennessee
Virginia
Linear Case Growth

7-Day Moving Average for Southeastern States
New Tests & Positive Tests – with R-Squared Values 

Alabama
Arkansas
Florida
Georgia
Kentucky
Louisiana
Mississippi
North Carolina
South Carolina
Tennessee
Virginia

<!-- Global site tag (gtag.js) - Google Analytics --> <script async src="https://www.googletagmanager.com/gtag/js?id=UA-162914190-1"></script> <script> window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'UA-162914190-1'); </script>
April 6 Covid-19 Newsletter

June 30 Covid Newsletter

Seven-Day Moving Average – New Cases & New Tests by State

The spike continues for most of the southeast, with Florida looking really bad. In the last week, Florida’s total cases grew by 45%, from 97,000 to 141,000. The numbers there are so high, it skews all the other states, so I had to take them out of the linear growth chart for the region.

The only exception in the spikes is Virginia, which has reduced new infections significantly since their spike peaked a month ago. Below are charts for Florida and Virginia, with some commentary.

Before I get there, one major assumption on my part as I interpret this data is that testing needs to outpace cases. When testing is higher, and growing faster, than new infections, the state has a good grasp on the overall impact of the virus. It means more healthy people are getting tested and the overall percentage of positives is low. As new cases catch up to testing, it’s showing that more people are getting tested because they are sick. If the growth rate of cases is outpacing testing, then it’s getting out of control.

This assumption becomes important in causation vs. correlation. When I look at these charts, there is some obvious correlation between testing and cases, but only when there are spikes in cases. When the states had more strict guidelines in place, testing far exceeded new cases. In that case there is no correlation and certainly no causation would exist. When the cases start ramping up, which they are now, the testing ramps up equally. Are we getting more cases because there is more testing; or are we getting more testing because there are more cases? 

Covid Numbers for the Week

 

7-Day Moving Average of New Cases for Southeastern States

Alabama
Arkansas
Southeast Covid-19 Updates. Florida 7 day moving average. New cases and new tests
Florida
Southeast Covid-19 Updates. Georgia 7-Day Moving average. New cases and new tests
Georgia
Kentucky
Louisiana
Mississippi
North Carolina
South Carolina
Tennessee
Virginia
May 24 Linear Case Growth

7-Day Moving Average of New Hospitalizations for Southeastern States

Alabama
Arkansas
Florida
Georgia
Kentucky
Mississippi
South Carolina
Tennessee
Virginia

<!-- Global site tag (gtag.js) - Google Analytics --> <script async src="https://www.googletagmanager.com/gtag/js?id=UA-162914190-1"></script> <script> window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'UA-162914190-1'); </script>
April 6 Covid-19 Newsletter

June 24 Covid Newsletter

Covid Numbers for the Week

 

7-Day Moving Average of New Cases for Southeastern States

Alabama
Arkansas
Florida
Georgia
Kentucky
Louisiana
Mississippi
North Carolina
South Carolina
Tennessee
Virginia
Southeast Covid-19 Updates. Covid-19 Linear growth rate for southeast states.
May 24 Linear Case Growth

7-Day Moving Average of New Hospitalizations for Southeastern States

Alabama
Arkansas
Florida
Georgia
Kentucky
Mississippi
South Carolina
Tennessee
Virginia

<!-- Global site tag (gtag.js) - Google Analytics --> <script async src="https://www.googletagmanager.com/gtag/js?id=UA-162914190-1"></script> <script> window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'UA-162914190-1'); </script>
April 6 Covid-19 Newsletter

June 7 Covid Newsletter

Covid Numbers for the Week

 

7-Day Moving Average of New Cases for Southeastern States

Alabama
Arkansas
Southeast Covid-19 Updates. Florida new covid cases per day growth chart.
Florida
Georgia
Kentucky
Louisiana
Mississippi
North Carolina
South Carolina
Tennessee
Virginia
May 24 Linear Case Growth

Upcoming Free Content

The Future of Medical Devices: How COVID-19 and the rise of digital health has changed regulatory, clinical, and reimbursement  dynamics in the medical device industry, June 23 
PhRMA: COVID-19 Bending the Curve, May 28 – June 11
DeviceTalks Tuesday, Weekly discussions and workshops for Medtech companies who want to ensure their teams are atop of this changing world. Starting May 19
 

<!-- Global site tag (gtag.js) - Google Analytics --> <script async src="https://www.googletagmanager.com/gtag/js?id=UA-162914190-1"></script> <script> window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'UA-162914190-1'); </script>
April 6 Covid-19 Newsletter

May 27 Covid Newsletter

Covid Numbers for the Week

 

7-Day Moving Average of New Cases for Southeastern States

Alabama
Arkansas
Florida
Georgia
Kentucky
Southeast Covid-19 Updates. Louisiana new covid cases per day growth chart.
Louisiana
Mississippi
North Carolina
South Carolina
Tennessee
Virginia
May 24 Linear Case Growth

Upcoming Free Content

RTI Covid-19 Webinar Series: Webinar 4: Vaccination, May 27
Life Science Tennessee Beer & Biotech – Covid-19 Latest Research and Innovations, May 28
PhRMA: COVID-19 Bending the Curve, May 28 – June 11
DeviceTalks Tuesday, Weekly discussions and workshops for Medtech companies who want to ensure their teams are atop of this changing world. Starting May 19

<!-- Global site tag (gtag.js) - Google Analytics --> <script async src="https://www.googletagmanager.com/gtag/js?id=UA-162914190-1"></script> <script> window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'UA-162914190-1'); </script>
April 6 Covid-19 Newsletter

Where are they now? We caught up with 2019 PitchRounds winner RCE Technology’s CEO Atandra Burman

Atandra and RCE will be presenting June 16 at 2:20 during the Southeast Life Sciences Virtual PitchRounds

When we spoke last year RCE CEO Atandra Burman told us, “Our goal in 2019 is clinical validation and submit to FDA this fall. As our pilots materialize towards key insights, we look forward to setting up 2020 for commercialization efforts. we are currently raising $800k to support our immediate needs in completing our compliance testing and FDA sub, as well as supporting clinical pilots for 2019.”

RCE Technologies is following a commercialization pathway to reduce major adverse cardiovascular events and healthcare costs via instant risk stratification and remote monitoring via “non-invasively detection of cardiac protein biomarkers. Continuous streams of these early clinical data points enable our cloud based AI models in detecting characteristic learned patterns of early changes in the heart, thereby empowering clinicians in making an instant early assessment and proactive intervention”

How did the balance of the year unfold for the 2019 SEMDA PitchRounds winner? Atandra recently shared an update with us.

“2019 was a successful year for RCE in product innovation both with the ECG wearable vest and Non-invasive protein sensor,” Atandra said. “We successfully completed our pilot studies for the ECG wearable vest along with product certification requirements. We also demonstrated early feasibility of our non-invasive protein sensor in cardiac biomarker measurements. 

“On the funding side, we completed a round of promissory notes enabling us to fast track our clinical feasibility track.” 

What have you learned in the past 12 months about fundraising?

“Our focus on physician investors has been highly productive. It seems the market has been waiting for this innovation for years. Many physicians we have spoken to, including our investors, expressed some surprise this hadn’t been done yet.

“Our studies have demonstrated positive outcomes, allowing those physicians to extrapolate the clinical and economic value propositions by using our technology in present workflows. We intend to publish some of those outcomes data by year’s end.”

Have you shifted course at all?

“Not fundamentally. We solved the first problem, which was wearables to collect non-invasive biomarkers. Now we are solving our second problem, to conduct clinical validation efforts and collect data from diverse demographics for accurate AI prediction models.”

“The feedback from the clinical pilots has been well received by key opinion leaders who have told us they have not seen anything like it. We are able to demonstrate early feasibility of our non-invasive protein sensor in measurement of cardiac biomarkers allowing risk stratification of chest pain patients. We see the market in point of care diagnostics in the hospitals and urgent care clinics.

“We are currently conducting multi-site clinical trials of the non-invasive protein sensor. We expect those trials to conclude in September. We reinforced our lean product development and kept our focal efforts on track towards our vision. We are much closer to ‘product market fit’ than we were 12 months ago.”

What is the current status of your FDA submission and market entry?

“We are currently working closely with the FDA on both of our submissions this year, including fast tracking the non-invasive device submission this year. We will use a combination of partnerships and salesforce for hospital and outpatient clinic device sales.

“Employing a partnership model drives initial revenue with lower investment in salesforce out the gates. This allows us to assess the market segments to establish a product market before scaling. This also justifies spend on data collection efforts for our AI models that are core to our value provision and mission.”

What does the balance of 2020 hold for RCE?

“We will continue clinical validation and market development efforts for our wearables, AI data collection efforts, and formalizing our regulatory pathways with anticipated product launch in 2021.”

What is particularly advantageous about innovating in the southeast, particularly Atlanta? 

“There is outstanding access to “voice of the customer” and patient populations for clinical trials through the robust networks of hospitals, health systems and research institutions like Emory University, and Wellstar Health System. Advancing our technology requires significant time spent with both patients and physicians. Georgia Tech’s ATDC facilities, and access to highly qualified local services in product prototyping and quality verification has been advantageous as well. Lastly, low cost of operations here compared to places like Boston and San Diego, extends the capital runway, and the opportunity to accomplish more with less.”