Opportunity Knocks: Expanding access to early stage life science investment opportunities and what Mammoth Scientific looks for in investable portfolio companies at Series A and beyond.

A Southeast Life Sciences Q&A with Mammoth Scientific COO Kimberly Mackrill. 

 

Mammoth Scientific occupies a unique position in the world of life science investing. Its founding team, which includes experts in medical, spinal, financial advisory and fintech all found venture investing cumbersome for most investors. Mammoth is built to fund quality companies, while seeking to provide a modern, transparent and quality experience to investors who previously found access to high potential, early stage life science innovators out of reach.

 

“Financial advisors are always looking for an edge to better serve their clients,” Mammoth COO Kimberly Mackrill told Write2Market’s Paul Snyder. “One way to do that is expanding offerings beyond what’s available in the public marketplace, especially in life sciences. Many of those opportunities don’t move into the public market because they’re ultimately acquired by large organizations who innovate through acquisition. But prior to that stage in their commercial life cycle, those companies are out there with world changing ideas and sufficient financial support to continue innovating and creating the future we want to live in.”

 

Essentially, Mammoth seeks to democratize early stage investment access, enabling wealth managers to access high potential VC opportunities in the life sciences. We hope you enjoy the following Q&A with Ms. Mackrill.

 

How did you get here?

I started in the nonprofit world, focusing on finding ways to motivate people without any financial compensation. I wound up working in marketing at a publicly traded company and then pulling back from working outside of my home while I had infants. I created my own boutique marketing firm and was highly selective about who I would work with during the early years of parenting. After my partner’s company was purchased by a PE firm, my partner and I founded Mineral – a fintech and financial advisory focused on design and marketing. Mineral received Best Advisor Innovation, Fuse 2017 and XYPN Fintech Award 2018 for software we created that helps advisors onboard clients. Mineral was acquired in 2018 by a national RIA. We worked inside their firm for two years – helping them redesign their client portal and accelerate their marketing offer. 

 

Our ability to brand build and create innovation technology contributed to over $3B in increased valuation across our portfolio of experience. 


Watching the impact of private equity on the firms we’ve served throughout our careers, gave us deep insight into the way both brand and technology influence valuations. We’ve seen how equity changes the game for both companies and individuals and believe that now is the time to bring the world of private investing – specifically venture capital, into this modern, accessible landscape.

 

Where is your sweet spot investment range?

Mammoth is built for accredited investors, qualified clients and the fiduciaries who serve them. We work with Registered Investment Advisors to help overcome the potential compliance hurdles and marketing pieces that their clients need to properly understand this level of investing and how it can impact not just their own portfolio, but the broader world for good. Additionally, Family Offices and Institutional Investors are all a part of the balanced mix of investment in our fund.

Mammoth is built to invest in innovative life science companies at the Series A level and beyond. We look for companies that have maturing revenue models and proven intellectual property who need to develop clear paths to regulatory approval and reimbursement. We currently do not invest with significance in the pharmaceuticals market, but everything else life science and medtech is in play with two surgeon GPs doing significant work in due diligence.

 

What are the should haves your invested companies bring with them?

Should Haves: A clear business model, quality research, a strong and experienced team and validated intellectual property.

 

Our Value Add: Our team includes members with extensive experience in FDA and EU regulation along with determining reimbursement pathways to help guide the long term market aspirations of our portfolio companies. 

 

What turns you off when exploring a new prospect?

  • Lack of a clear perspective and unfocused leadership,
  • Inability to drive revenue with their early stage business model, and
  • Lack of patience and grit necessary to build a lasting company. Being vulnerable, admitting non-alignment and a willingness to shift or pivot in order to move forward is an underrepresented strength in founders of life science startups that need help to realize their potential. Make-or-break activities and milestones like reimbursement pathways and strategies can take multiple rounds of discussions with regulators to advance. Ultimately, we feel success is rooted in a commitment to tackle adversity head-on. We all feel those moments of mettle testing. When teams successfully meet those moments to a positive result or outcome, it is powerful to witness them come through the other side.

 

What do you wish more founders knew? 

First, the amount of time it will take for them to achieve their long term goals. Depending on the technology, life science innovations can take several years and millions of dollars to realize their exit or commercial potential and the associated returns for investors.

 

Second, the dimensions they have to understand to really see the potential of their business. 

Pure startups using friends or family for branding is often not strong or specific enough, for example. Those startups have strength and early success in other areas, but that branding and marketing dimension often does not mature at the same pace as other pieces. As such, valuations suffer, or are not indicative of real potential, because branding and marketing is lacking.

 

We look at these dimensions for our portfolio companies and investors. What needs to mature, or ‘grow up’ to play in the same space as the rest of your life science technology has to offer?

 

What common mistakes have been around too long for life science startups seeking Series A investments and beyond?

  • Lack of unique research,
  • Underinvestment in marketing and brand,
  • Failure to build a strong advisory team, and 
  • Lack of detail in long term vision and strategic roadmap. At series A and beyond, we expect potential portfolio companies to have a well developed strategic road map including product market fit, IP, regulatory pathway confidence and in some cases a pre-submission meeting with, and feedback from, regulatory bodies like the FDA. Iterating and adjusting potential process and pathway refinements and acceleration is where we can come in. 

 

What are the hallmarks of young companies that should be getting to know you?

Proven leaders, deep research, a strong understanding of the health sciences market, protected intellectual property and a vision for building a strong business.

AdvanSE 2021 is fast approaching! Will you join us?

Southeast Life Sciences thanks Ms. Mackrill for sharing her insights with us. We look forward to her keynote presentation on Thursday, October 28th at AdvanSE. Come see the best of what the southeastern U.S. life science ecosystem has to offer at the 2021 edition of our flagship event October 27 – 29 in Charleston, SC.

 

About Mammoth Scientific
Mammoth Scientific is a venture capital company that specializes in health science and technology funds. Co-founders Dr. Jay Yadav, Tommy Martin, Kim Mackrill, Dr. Matthew McGirt and Jud Mackrill provide venture capital for health science and technology companies maturing beyond seed rounds. The Mammoth team includes seasoned physician entrepreneurs and highly successful operational managers, representing a twenty-year track record of creating and investing in multiple successful start-ups with large exits to major global companies (e.g., Abbott Laboratories, Boston Scientific, Johnson & Johnson) or to the public markets. To learn more about Mammoth Scientific and its $100 million Mammoth Health and Tech Fund, visit Mammoth.vc.

Pulling research out of higher ed and into a high potential commercial pathway: Q&A with Bayer’s Hanna Eilken

No matter the brilliance of the research, or researcher, life science innovation relies on a rigorous regulatory and commercialization pathway before its potential to improve lives can enter patient care, at almost any scale.

 

Universities rely on their technology transfer offices and commercial entities like Bayer to pull high potential research and technologies out of the academic or research environment into clinical utility.

 

Dr. Hanna Eilken, strategic alliance manager with Bayer, provides insights into her organization’s red flags, processes, requirements and what she wishes more researchers knew about Bayer’s methodology for pulling research out of a university setting and into your commercialization pathway in the following Q&A. 

 

Enjoy!

 

  • What attracts you to research coming out of a higher education setting?

 

Drug discovery and development becomes increasingly challenging with long development times, increasing costs, growing competition, and insufficient predictability of translation of preclinical data. Thus, engaging with universities and associated research institutions, to join forces and complement competencies is an important pillar to drive innovation in pharmaceutical companies. Academic research provides access to scientific excellence, disruptive technologies and cutting-edge approaches that are a source of creative solutions which are required to successfully develop effective treatment options, and to bring innovation to patients. 

 

Bayer has recognized that complementing its in-house expertise with the know-how of academic scientists is mutually beneficial for both partners. We set up and execute co-operations in a collaborative fashion with shared risks and rewards. For example, Bayer has established the Joint Precision Cardiology Lab with the Broad Institute of MIT and Harvard which aims to combine Broad’s innovative methods for basic science discovery such as single cell sequencing and clinical expertise, with Bayer’s long experience in drug development to discover new potential therapeutics in cardiovascular diseases. Thus, we combine our expertise to jointly enable the development of new therapies for patients with cardiovascular diseases such as heart failure.

 

  • What are the top red flags when engaging with academic institutions?

 

Usually, scientists in a university setting have the same motivation as pharmaceutical companies: bringing innovative therapeutics to patients. However, bringing together academia and industry also means – for both parties – accepting different cultures, mindsets and approaches. Often, both partners have the same goals but different ways of achieving them. A red flag would be to not: be open for new ideas, willingness to adapt, constant alignment, collaboration and personal interaction on the scientist and leadership level. From my perspective, it is very important to invest time to understand each other and build a healthy relationship. 

 

  • Where do your interactions begin and how do they progress especially regarding the people and what you need from them? 

 

Interactions begin through various channels, e.g. through Bayer scientists, BD&L, Open Innovation and Leaps teams who are pro-actively scouting for technologies, assets and expertise that synergize with our in-house activities. In addition, we are often approached by academic researchers who wish to discuss their innovation with Bayer. We ask them to present their data and invite them to jointly discuss opportunities and potential challenges of the technology in non-confidential conversations. In the event there is mutual interest, we align on details of how a collaboration should look like and what partnership model we would pursue. 

 

  • At what point do you closely examine IP and what do you require to proceed?

 

Patent protection is a prerequisite for drug development in a company like Bayer, and it is essential that the patent term is sufficiently long after commercialization. We review the prospective patent portfolio early in the due diligence process. 

 

  • What do you wish more tech transfer officers knew about your methodology for pulling research out of a university setting and into your commercialization pathway? What do you wish more researchers in higher education knew about what’s needed to successfully transfer their work into a commercialization pipeline? 

 

While many scientists do have a basic understanding of the drug development process, it is important to understand how they need to tailor their program towards commercialization. Talking to investors, big pharma or other potential partners can help to resolve some of the open questions and better understand how these potential partners are thinking. Many Tech Transfer Offices possess a solid understanding of what big pharma is looking for and they work with their investigators to identify gaps and shape a program towards commercialization. 

 

Bayer has recently launched a few programs which are tailored to bring innovators from academia and young start-ups closer to big pharma, for example mentoring programs, Bayer-Access and the Center for Regulatory Excellence. In the Bayer Access program, Bayer offers expert guidance from multiple business and scientific perspectives, e.g. preclinical pharmacology, data science, drug discovery sciences, formulation and BD&L, and we jointly mentor the scientists, providing expertise and recommendations in a 1:1 session. 

 

The Center for Regulatory Excellence is a novel initiative by Bayer and MassBio enabling academic scientists and young start-ups to learn from regulatory experts. We offer Think-Tank, educational sessions where we share our knowledge, expertise and experience when working with the FDA and other regulatory authorities. In addition, innovators can also apply for a selective 1:1 mentoring session with Bayer regulatory experts to discuss their project-specific questions.

 

In depth conversations as described above are extremely valuable for scientists and help to understand the complexity of the drug development process.

 

AdvanSE 2021 is fast approaching! Will you join us?

Southeast Life Sciences thanks Hanna for sharing her insights with us. Come see the best of what the southeastern U.S. life science ecosystem has to offer at the 2021 edition of our flagship event, AdvanSE, October 27 – 29 in Charleston, SC. 

On “Optionality,” Exits and Giving Science the Best Chance to Save Lives

A Southeast Life Sciences Q&A with AskBio Co-Founder and CEO Sheila Mikhail

 

“The field of gene therapy was in a nuclear winter in 2001,” said AskBio Co-Founder and CEO Sheila Mikhail. 

 

Motivated by belief in the science of gene therapy in order to give the blind a chance to see or give more children a chance to live full, healthy lives, AskBio used creative financing, grants and selective scientific technology sales (or exits) to keep its vision and work alive. It would be more than 15 years later that the company took on its first round of funding, $235 million.

 

In October 2020, Bayer acquired AskBio in a deal worth up to $4 billion including potential milestones. As reported by BioSpace, “Under terms of the deal, Bayer will own full rights to AskBio’s pipeline of treatments for Pompe disease, Parkinson’s disease, as well as therapies for neuromuscular, central nervous system, cardiovascular and metabolic diseases.”

 

The AskBio team does a much better job telling their story and explaining their science than we ever could. We encourage you to read the pioneering story of Jude Samulski story as published on their website.

 

What we at Southeast Life Sciences want to share with this community are Sheila’s insights into what mature, late stage life science “startups” need to know when an IPO or exit to a large “strategic” like Bayer looks like it could be the next milestone in the company’s journey. 

 

Sheila graciously shared her insights with Paul Snyder, VP of Healthcare for Write2Market. We hope you find these insights in the Q&A below informative and useful.

 

Q: How long had potential acquirers been looking closely at AskBio?

 

A: “We had long standing connections with large life science companies through collaboration or colleagues. Pfizer’s acquisition of Bamboo Therapeutics was a significant moment for us, and for gene therapy’s maturation into a new pillar of medicine.”

 

Editor’s note: Bamboo is an AskBio spinout focused on gene therapies for four severe diseases: 

 

  • Giant axonal neuropathy, a disorder of neurofilaments, the structural framework that helps define the shape and size of nerve cells.
  • Friedreich’s ataxia, a progressive degeneration of nervous tissue in the spinal cord.
  • Canavan’s disease, a progressive deterioration of nerve cells in the brains of infants.
  • Duchenne muscular dystrophy, a progressive degeneration of muscles.

 

“We realized in 2020 that we had to take more cash for the tools we needed to address the myriad varieties of complex diseases with the synergy of small molecules and gene therapy. Things heated up at JPMorgan 2020 because acquiring our technology and pipeline was almost certainly going to have a higher ROI before an IPO than after.”

 

Q: What can other innovators, including those that look like AskBio just prior to 2020, learn from your experience as Bayer closed in on acquisition?

 

A: “Investment bankers talk a lot about ‘optionality.’ It’s a key driver of transaction completion. You are more attractive with multiple options available like an IPO, multiple bidders, the ability to continue to go it alone if needed, or investors willing to put more money into the company.

 

“If you’re backed into a corner, desperately seeking an exit partner or seven-figure or greater investment, the transaction probably won’t happen. But if you do find yourself in a corner, learn how to bluff really well and never let them see you sweat.”

 

Q: What, if anything, do you wish you had known before?

 

A: “I wish I’d had a better idea of just how hard it would be. I kept thinking I might have been making a mistake, that I wasn’t experienced enough, that I wasn’t good or capable enough. But I believed in the technology’s life saving potential and had to give these transformative therapeutics a chance to make lives so much better.”

 

Q: What advice would you give aspiring women in life sciences, including students at almost any level or clinician innovators with ‘an idea?’

 

A: “Try to not spend time worrying about other people’s opinions. You will find yourself alone more often than you might like. Continue to advance your science, your therapies. Get them to the clinicians, watch the impact and keep your eyes on the objective. Be true to who you are and do the best you can by the science, by the patients, by the employees and by the science and technology.”

 

Southeast Life Sciences thanks Sheila for sharing her insights with us. We hope to see you at the 2021 edition of our flagship event, AdvanSE, October 27 – 29 in Charleston, SC.

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.

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

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

On the frontline of connecting patients to their providers via blockchain: a quick catch up with Patientory Founder and CEO Chrissa McFarlane

As we recently recognized in a conversation with Florence Hudson, there is a LOT to unpack when it comes to blockchain in health care. But the industry has definitely taken notice of Patientory, whose team and distributed ledger technology is starting to revolutionize EHRs and the way doctors and patients interact with each other and their data.

You may recall Patientory was the winner of the 2018 SEMDA Medtech Conference PitchRounds competition.

After raising $7.2 million in mid-2017 through its ICO (initial coin offering), Patientory launched its consumer-facing app in late 2018. But what’s needed to accelerate blockchain technology deployment in the healthcare continuum?

“We need brave, forward looking health systems for use cases in large patient populations,” Patientory founder and CEO Chrissa McFarlane told us. “We need to see an adoption by a large company on a day-to-day basis that includes 1 million covered lives. The space is filled with great startups, but adoption and implementation is the next mountain to climb.”

Beyond an individual’s EHR, blockchain for healthcare can improve processes in supply chain management of medical devices or opioids or even claims processing and adjudication. But large scale adoption in highly centralized provider IT networks is unlikely in the short term given clinical workflow disruption and technical proficiency ramp up requirements.

“There are payer and provider CIOs or IT architecture leads fluent in blockchain, but very few of them,” McFarlane says. “Ultimately the end users, the patients, physicians and their bosses will drive systemic adoption of secure, distributed ledger technology that enables them to truly own and access individuals’ electronic health records. This is why the launch of our app was so important.”

As tech giants like Google and Apple wade deeper into the healthcare pool collecting more and more personal health data, will blockchain be the technology that carriers and secures it?

“It’s inevitable,” McFarlane says. “Blockchain’s potential spans the entirety of the continuum, which tends to cloud its greatest value potential: securely placing patient data in the right hands at the right time to improve outcomes while reducing cost.”

What’s next for Patientory?

“We remain focused on our core deliverables from our 2017 product roadmap including the enterprise distributed application solution and the PTOYNet storage network,” McFarlane says. “We are also eager to analyze the results from our ongoing pilot programs to learn what works, what doesn’t and what’s needed next to place millions of lives under care through the Patientory platform. Do they have a long term tech strategy to incorporate distributed ledger technology into their stack?

“We need more market validation and to learn more about health systems’ financial structures and operations along with their perception of the emerging opportunities and potential for blockchain in healthcare.”

Ms. McFarlane will share further thoughts on the future of blockchain in healthcare during a panel conversation following Florence Hudson’s keynote on Wednesday, April 9th at the 2019 SEMDA Medtech Conference. Register today!

Where are they now? Our 2019 deep-dive Q&A with SweetBio CEO & Co-founder Kayla Rodriguez Graff

Three years, two rounds and one ‘market reprioritization later,’ SweetBio is poised to enter the $10 billion wound care market this year. While FDA work continues on a first in kind pre-implant dental application of its Manuka honey and collagen derivative membrane product Apis, the company has pivoted to a planned, but previously secondary market. Why? A faster regulatory pathway and larger addressable market.

SweetBio Co-founder and CEO Kayla Rodriguez Graff was kind enough to share nearly an hour with Write2Market VP of Healthcare Paul Snyder. They talked about the company’s progression, ‘market reprioritization,’ learnings and more in the nearly four years since we first featured them following SEMDA 2015.

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

Paul: “What drove your reprioritization from a first in kind dental implant regenerative product to wound care in general?”

Kayla: “Our baseline technology, which we call MXTECH, is a true platform. While the first manifestation of MXTECH was a regenerative membrane for dentistry, we quickly discovered the direct translatability and extreme market demand in adjacent markets, including wound care. As honey has never been cleared for use in dental, the regulatory pathway became more difficult. Because we had already examined the wound care market and heard from early customer discovery that our product is ‘exactly what they have been looking for,’ we were confident in this pivot.

“We were grateful to be working with world renowned wound care clinicians, including Dr. Lillian Nanney and Dr. Jeffrey Davidson at Vanderbilt University, who provided incredible feedback as we prepared for the wound care industry. Because of the background work completed on the safety and efficacy of MXTECH, and because there are currently over a dozen Manuka honey wound care products commercially available, we were able to translate our dental regulatory documentation into over a 1,000 page wound care 510K application in just 40 days. We expect to our first product to enter the $10 billion wound care market – with solid, existing reimbursement opportunities in place – this year.”

Paul: “SweetBio recently closed a new funding round. What messages resonated most with your investors?”

Kayla: “A $10 billion market and an investable opportunity with high growth return potential. There is also strength in our multiple bottom line message. We are able to demonstrate a proven record of delivering on dollars received including spending plans, accountability, clear messages and consistent communication with our investors. We are an investable company with high growth potential and a diverse, woman-led company.  

“Because we stand for better healing, everyone has a relatable story, which usually involves witnessing a painful healing experience with an aging loved one or even a beloved pet. We are also tackling a problem with an on-trend natural solution without having to sacrifice performance for ingredients.”

Paul: “What have you learned about the FDA process that could be useful to very early stage innovators – like yourselves three years ago?”

Kayla: “First, understand your claims and pathway. Word choice is monumentally important. Just one or two words in your claims can push a 510k to a PMA. Next, find the right partner, especially regulatory consultants that are experienced in your product class and FDA branch to communicate that word choice. Then, finalize your product design in a way that enables you to manufacture at scale with economics that make sense. The last thing you want to learn is that you have $100 product COGS that can only retail for $20.

Paul: “What would you do differently?”

Kayla: “Hire full-time, high quality consultants up front. Pay them to work every day as early as possible with complete focus on, and enthusiasm for, what you are doing. Conversely, move faster on removing bad partners. They might not be bad people, but if they are misaligned with your vision, remove them swiftly.”

Paul: “What makes clinicians (potential customers) more likely to engage with a pre-FDA healthcare startup?”

Kayla: “Referrals are the way we get early interest from clinicians. We don’t succeed at cold calling. Even clinicians follow the common diffusion of innovation curve – people are either innovators, early adopters, in the majority or laggards. Understand your value proposition for each group, then find early adopters willing to try something different and are excited about it. The value proposition and strategic alignment with innovators or early adopters lies in an existing interest in innovation and industry leadership, which includes being part of the research and publishing.

Paul: “How did you get to be part of Prudential’s ‘State of Us’ commercial happen?”

Kayla: “That was absolutely amazing. Their own team picked cities with statistics that drove unique financial decisions. They picked Memphis due to its massive increase in the number of  women owned businesses. We had no contact with them prior to being asked to participate. I believe that our visibility in the entrepreneurial and life sciences ecosystems, serving on boards including Epicenter and New Memphis Institute, participating in community activities as mentors, our mission and diversity helped them find us. After eight rounds of interviews, we got the gig!

Paul: “What’s the lesson there?”

Kayla: “When you serve, good things happens. What happens outside of your office or lab is equally as important as what happens inside of it. You won’t see immediate results. Do it from a different place, a place of service. In our case, our commitment to our community and service ultimately helped raise money, connect to clinicians, gain access to more boards and other resources like our new office at the University of Memphis CommuniTech Research Park initiative.”

Paul: “What has been most surprising about your journey to date?”

Kayla: “How my role has changed. Each day, I focus on identifying the right work that aligns with strategic objectives and putting the right people on that right work. It has shifted from putting processes in place for projects with more partners and help the business run more efficiently. Axel Strombergsson, our new chief operating officer, was built for that. With Axel on operations and myself on the future activities of the company, it frees up our co-founder and Chief Science Officer, Dr. Isaac Rodriguez, to soar at his strengths – reinforcing the scientific credibility of SweetBio. The culture of our company is strong and I am proud of it – we each have the opportunity to soar at our strengths while we drive incredible progress for the company.

“We plan on doubling our team in next 12 months while ensuring we’re operating in a way that’s energizing. I’ve been spending and enjoying more time focusing on the team and our culture – different and surprising for me – and I’m highly energized by it.”

Paul: “What do you need next?”

Kayla: “Two things. First, interview around 100 wound care experts for customer discovery. Second, identify and learn from business mentors who have done what we are hoping to do: to build, launch and scale a company both nationwide and globally.”

Paul: “What are you interested in learning from the collective ‘medtech’ community?”

Kayla: “The New Memphis Institute, a community leading nonprofit in Memphis, does a ‘speed mentoring’ event. I’m interested in more one-on-one knowledge sharing from the Randy Scotts and Bob Crutchfields of the world in a low-risk environment. There are always questions about reimbursement, resource recommendations and what are the top questions to ask distributors in contracts? Having access to mentoring from these inspirational leaders can be company altering for a scale-up company.”

Follow SweetBio on LinkedInTwitter and Facebook.

SweetBio uses SEMDA as springboard to medical device startup growth

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

Three weeks before SEMDA 2015, SweetBio wasn’t even incorporated. Six months later, Innova and MB Venture Partners co-led a $900,000 seed round to support FDA 510(k) clearance and commercialization of the company’s Guided Tissue Regeneration Membrane (GTR).

A graduate of ZeroTo510, listed among TechCrunch’s Top 20 U.S. Accelerators, SweetBio has created a patent-pending dissolvable membrane that uses honey to encourage healing and produce better outcomes. While currently used in hospitals to treat ulcers and burns, SweetBio is the first company to leverage this naturally antibacterial and wound-healing ingredient in oral procedures.

SweetBio COO Kayla Rodriguez recently shared with us a few insights about the company’s SEMDA 2015 experience and plans for SEMDA 2016.

Why did you decide to invest in SEMDA 2015?

“A few weeks before SEMDA 2015, I was in San Francisco and we hadn’t even settled on a name for the company. When we heard about SEMDA, we realized it would be the perfect opportunity to determine if our pitch, our business model and our value proposition are worth something.

“In less than 3 weeks, we incorporated the company, put our first investor pitch deck together, practiced, practiced and practiced some more to get ready for PtichRounds.”

What was your experience at SEMDA 2015 like?

“It was the most wonderful experience. Gaining insights and feedback from David Huizenga, Chris Hooper, Randy Scott and others helped shape our company. They also introduced us to dozens of colleagues including other investors that have been instrumental in SweetBio’s growth. Having the undivided attention of seasoned medtech investors in a low-risk environment is something I had never experienced before attending the SEMDA conference in 2015.”

What were the results?

“We got to know more about who we are as a team. And while we don’t have all the answers, we have the grit and grind. Our experience at SEMDA 2015 helped refine our strategic direction, improved our pitch, opened new doors and helped validated our business.”

What advice would you give medtech startups considering attending?

“If you are not planning on pitching, no matter how early or young your company or idea, get it ready and just go pitch. Do whatever you can to take steps forward. Redefine winning. Winning PitchRounds is not all about coming in first. Winning PitchRounds is also in relationship building. Allow yourself to be social, be bold. The collective crew at SEMDA is most welcoming.”

What are your goals for SEMDA 2016?

“We are participating in PitchRounds again and we are treating it as a benchmark. We are proud of our progress, and this is a perfect opportunity to do a ‘temperature check.’ Having just celebrated our first year as a company we need to ensure we are focused on what’s critical to our continued development: de-risking our marketing plan and de-risking our trials plan.”

“We hope the investors will challenge us and poke holes in our pitch, so that in year two we focus on initiatives that continue to add value – especially to our go-to-market strategy.”

Thank you, Kayla! We can’t wait to see you and what you have in store for us at SEMDA 2016 and beyond!

Applications for PitchRounds at SEMDA 2016 open through May 2, 2016

PitchRounds and its corresponding online platform connect medical device startup companies with venture capitalists and angel investors who are seeking new investments. If you have a medical device or health IT company and you’re looking for venture funding, PitchRounds is for you.