NOVEMBER 9 - NOVEMBER 13
This is a must-attend event for the biopharma, medtech, diagnostic, and digital health industries wishing to do business in the region. This conference will feature the best companies from the southeast in the small company program and top-notch educational programming.
CEO, Ovid Therapeutics
Dr. Levin has been Ovid Therapeutic’s chief executive officer since March 2015 and chairman of the board since April 2014. Prior to joining that, Dr. Levin was president and chief executive officer of Teva Pharmaceutical Industries Ltd., the world’s largest generics drug company. Previously, he was a member of the Executive Committee of Bristol-Myers Squibb where he had global responsibilities for strategy, alliances, and transactions. Prior to BMS, Dr. Levin served as global head of strategic alliances at Novartis Institutes for Biomedical Research, Inc. Dr. Levin is the chairman of the Biotechnology Innovation Organization (BIO) and the recipient of numerous awards and was voted as one of the 25 most influential biotechnology leaders by Fierce Biotech in 2014. He has practiced medicine as a physician at university hospitals in England, South Africa, and Switzerland.
Head Eastern North America, Johnson & Johnson Innovation
Dr. Michal Preminger
Partner Kilpatrick Townsend
Tina McKeon, Board Co-Chair
Dr. McKeon contributes her talent and time to a number of bioscience and medical device organizations. She has served on the boards of Southeast Bio and Metro Atlanta Red Cross and is the current co-chair of Southeast Life Sciences. From 2005 until 2016, she taught in the TI:GER® Program, a collaboration between Emory University School of Law and Georgia Institute of Technology, that focuses on technology commercialization in a multidisciplinary context. She is also a frequent lecturer regarding the role of intellectual property in entrepreneurship and has served as adjunct faculty at Emory Law School. Dr. McKeon is the author of more than 14 scientific publications.
Dr. McKeon was named an “Atlanta Lawyer of the Year” in 2018 for Biotechnology Law and in 2012 for Patent Law by The Best Lawyers in America®. She was also listed in The Best Lawyers in America® for Patent Law and Biotechnology and Life Sciences Law in 2020 and each of the 11 years immediately preceding. Dr. McKeon has been recognized annually since 2009 by Chambers USA: America’s Leading Lawyers, which stated she “has a respected postdoctoral academic background and is highly regarding for her ‘great depth of knowledge’, particularly in biotech matters.” Dr. McKeon was named a Georgia “Super Lawyer” in 2020 and each of the 12 years immediately preceding, a “Top 50 Women Georgia Super Lawyer” in 2019 and each of the six years immediately preceding, and a “Top 100 Georgia Super Lawyer” in 2016 by Super Lawyers magazine. She is a recipient of the 2019 SEBIO Leadership Award and the 2013 Georgia Bio Community Award. Dr. McKeon was recognized by Georgia Bio for “being that rare combination of scientific expertise, legal acumen and sociability that affords her a broad role in the Georgia life sciences community.” She was named one of the “Top 10 IP Stars of the Top 250 Women in IP” in 2013 and 2016 and recognized as an “IP Star” in 2019 and the six years immediately preceding by Managing Intellectual Property magazine. Dr. McKeon was named as one of Georgia Trend‘s 2018 “Legal Elite” for Intellectual Property Law. She was named a top patent practitioner in 2014-2019 by IAM Patent 1000 – The World’s Leading Patent Practitioners. Dr. McKeon was named by Legal Media Group in its 2014 and 2016-2019 Expert Guide to the World’s Leading Women in Business Law. She was selected as a “Life Science Star” in the 2016 edition of LMG Life Sciences. Dr. McKeon is AV Preeminent® rated by Martindale-Hubbell.*
SVP, Strategy & External Affairs Kezar Life Sciences
Ms. Economides is Senior Vice President of Strategy and External Affairs at Kezar Life Sciences and has nearly 20 years of experience in the life sciences and biotech industries, spanning finance, corporate strategy, communications, patient advocacy, clinical, medical and government affairs. Prior to joining Kezar, Ms. Economides served as Vice President, Corporate and Public Affairs at Aurinia Pharmaceuticals, Inc, where she led the company’s investor relations, corporate communications, and patient advocacy efforts. Previously, Ms. Economides served as Director, Global Medical Affairs and Director, Clinical Operations at BioMarin Pharmaceutical, Inc. after the Company’s acquisition of Prosensa where she led IR and corporate communications. Earlier in her career, she led investor relations and program development at the Biotechnology Innovation Organization (BIO) and worked at a healthcare focused hedge fund and in financial services focusing on the biotech sector. Ms. Economides previously served on the Board of Directors of Altum Pharmaceuticals Inc, a private company focused on women’s health, until it’s merger with BetterLife Pharma in July 2020. She received her M.P.H. from Columbia University and a B.A. from McGill University.
Head of Inclusion Strategy & Partnering, Chief Diversity Officer, Genentech
Gerren Wilson, PharmD
Gerren is a clinical pharmacist and biopharmaceutical enterprise leader who brings a deep understanding of patient care, healthcare disparities, managed care strategy, and marketing leadership from various roles across the healthcare industry. Gerren developed broad clinical pharmacy expertise at Rhode Island Hospital where he practiced both general inpatient and specialized oncology clinical pharmacy services. He later expanded his capacity as a care provider and deepened his commitment to serving diverse populations by transitioning to the Veterans Affairs (VA) Medical Center, where he managed the outpatient ambulatory care clinic.
Following clinical pharmacy practice, Gerren joined the biopharmaceutical industry 10 years ago to improve patient access to specialized medication and disease outcomes. Since joining Industry, he has held roles of increasing responsibility in Medical Affairs, Commercial, and Government Affairs. Gerren is currently Head of Inclusion Strategy and Partnerships at Genentech where he leads efforts to advance inclusive research and transform society by harnessing the power of the increasingly diverse world surrounding the Industry the company serves. Gerren is the recipient of numerous awards for collaboration, innovation and ability to deliver value to patients. Recently he was named as one of the Top 30 leaders under 40 transforming US healthcare by Business Insider.
Gerren contributes time and energy to professional and community organizations on local and national levels. He is a member of the American Pharmacists Association and American Society of Health System Pharmacists. Gerren is also a 15+ year member of Kappa Alpha Psi Fraternity, Incorporated. He has held several local officer positions, coordinated fundraisers, organized community outreach and led several youth programs. Gerren received his PharmD from Massachusetts College of Pharmacy and Health Sciences (MCPHS) and holds a bachelor’s degree from Morehouse College.
Chief Operating Officer – AdvaMed
Mr. White serves as the Association’s Chief Legal Officer and manages AdvaMed’s Legal Committee to develop and promote legal policy positions enhancing patient access to medical technology. Mr. White also leads the Association’s global working groups on legal policy and compliance, including over 1500 in-house medtech lawyers. He testified before state and federal legislative committees on priority legal policy issues; led the drafting team revising the AdvaMed Code; and led the multinational negotiating team to draft the Kuala Lumpur Principles, harmonizing industry Codes of Ethics in Asia.
He is a frequent speaker on health law and policy issues, and has guest lectured at Northwestern, UPenn, Wharton, GWU School of Medicine and Health Sciences and is an Advisory Board Member to the GWU School of Medicine and Health Sciences. He serves as a frequent speaker and author on industry legal and compliance issues.
As Chief Operating Officer, he manages the Association’s HR, IT, Facilities, and, governance and provides counsel on contract, corporate, tax exemption, HR, and legislative and regulatory matters. Mr. White is a graduate of Wake Forest University where he studied cell biology, and Catholic University Law School. He is an avid sailor, cyclist and beekeeper.
Director of Cardiovascular Research – Piedmont Heart Institute
Jayne Morgan, Vice Chair
Dr. Jayne Morgan is a Cardiologist with extensive experience in clinical patient management, as well as pharmaceutical and biotech research. For the past 2 decades she has focused on improving the care and quality of life measures for patients from heterogenous populations, including end-of-life patients without further medical options.
Serving in the roles of both Clinical Development and Medical Affairs for global pharmaceutical and device companies for the past 10 years, she has successfully led Phase II and III programs globally, and Phase IV programs in Europe. In these roles, her background includes leadership and accountability for research projects with oversight of a $52 million dollar budget within a $4.5 billion company.
As the driver of the cardio-renal and heart failure programs (sponsored and funded by Solvay Pharmaceuticals), and providing the scientific guidance as a consultant to the MitraClip programs (funded and sponsored by Abbott Vascular), her experience in the design and execution of large international clinical trials for both devices and pharmaceuticals is well established. Acknowledged with both the Solvay Cardio-Metabolic Strategic Paper Award and People to People Ambassadorship for vulnerable global populations, she has selected and led many scientific panel experts including Steering Committees, Adjudication Committees, and Data Safety Monitoring Board Committees, and has also served on regulatory panels for both the FDA and EMA.
Following high school graduation as Valedictorian, Dr. Morgan went on to complete her B.S. degree in Biology and Biochemistry from Spelman College; her M.D. degree from Michigan State University; Internal Medicine Residency from George Washington University; and Cardiology Fellowship at Mount Sinai Medical Center including completion of a Pacemaker Sub-Fellowship. She has treated patients in both rural primary care settings, as well as within academic institutions as the Associate Professor of Medicine at the Cleveland Clinic Florida, and is published in both the American Heart Journal and recognized by the Heart Failure Society for her work on Adenosine Receptor Antagonists. Further, Dr. Morgan has received numerous distinctions in Principles of Radiation Physics, and RadioPharmaceuticals and Chemistry in Nuclear Medicine. In fact, most recently, she served as the CMO (Chief Medical Officer) of the American Chemistry Council where she introduced new stakeholders, advocated for senate bill reforms, and developed a strategy and new direction for their research program including securing funding from the Board of $5 million dollars annually for 4 years.
Dr. Morgan has also served as a 6 year Board member of the Make-A-Wish Foundation of Georgia and Alabama and the Calvary Childrens Home (orphanage). Currently, she is a Founding Member of Biotechnology for Women, member of the AHA (American Heart Association), AMA (American Medical Association), AWMA (American Womens Medical Association), and the ABC (Association of Black Cardiologists). Additionally, she is recognized as an Industry Fellow for the GRA (Georgia Research Alliance) focused on the development and commercialization of biotech and pharma innovations into viable companies and partnerships here in the state of Georgia.
Currently, she is the Director of Cardiovascular Research at the Piedmont Research Institute where she is responsible for all drug, device, and drug/device combination trials in both the Cardiovascular and Peripheral Vascular space. Bringing to an organization over 20+ years of clinical and industry experience, and a demonstrated record of strategic planning, management, and execution of trials to support the medical and scientific platform of an organization, Dr. Morgan is able to leverage a wealth of qualifications in business development, scientific rigor/conduct, medical education, and communication.
President – Silver Spire Consulting; Executive Mentor-in-Residence – Duke University; Member – Triangle Angel Partners
Fred Kornahrens, a Mentor-in-Residence (MIR) with Duke New Ventures, brings 28+ years of experience in medical device technologies that spans large company, startup and turnaround ventures with a proven record of building company value. In addition to working as a Duke MIR, Fred is President of Silver Spire Consulting, a medical device consulting firm. He is also a member of Triangle Angel Partners II Fund (TAP II) serving on the screening committee and is a Venture Mentoring Service (VMS) Mentor for the Council for Entrepreneur Development (CED) in Durham.
Fred offers company formation, device technology, and executive management expertise from experience with Telectronics Pacing Systems, Datascope and Zimmer Spine along with small company/pure start-up experience with IntraTherapeutics (sold to Sulzer Medica), Raymedica, Kspine (sold to K2 Medical Group) and Cardiosolutions. Multiple technologies taken from concept through regulatory approvals and to market that include pacing leads, vascular/endovascular grafts, peripheral stents, spinal orthopedics and structural heart devices. Fred progressed through the technical ranks reorganizing/building companies, leading R&D, Product Development, Clinical, & Regulatory functional areas to include COO, President, CEO and Board Member responsibilities. Fred has directly/indirectly raised $50M+ across several companies, recruited high performing teams and led companies to key value-driving milestones.
A veteran US Air Force pilot serving as a B-52 Crewmember. Fred earned a BS Engineering, US Air Force Academy and MBA, Rensselaer Polytechnic Institute.
Kathryn Cole Becker
Kathryn Becker established Charleston, SC-based Translational Science Solutions LLC in 2014 to facilitate the commercialization of innovative medical device and digital health products at all stages of development. She utilizes her in-depth knowledge of science, regulatory affairs, business planning, and product management to develop, coordinate, and execute business-minded regulatory strategies that help clients anticipate, meet and exceed FDA regulatory requirements. Services include the analysis of complex regulatory challenges, development of regulatory strategies for new products, and the preparation and stewardship of related submissions and interactions with FDA on behalf of clients.
Deputy Chief Patient Officer / Executive Director, Patient Insights / Diversity Leader, Merck & Co.
Luther T. Clark, MD, FACC, FACP
Dr. Luther T. Clark is Deputy Chief Patient Officer and Global Director, Scientific Medical and Patient Perspective in the Office of the Chief Patient Officer (OCPO) at Merck. In this role, his responsibilities include (1) collaborating across Merck to increase the voice of patients, directly and indirectly in decision-making; and (2) collaborating with key internal and external stakeholders in development of a systematized approach for collecting and incorporating patient insights across the patient journey and product lifecycle. Luther leads Merck’s Patient Insights Team, is co-leader of the team that champions Health Care Equities (including promotion of health literacy and research diversity) and chairs the Patient Engagement, Health Literacy & Clinical Trials Diversity Investigator Initiated Studies (MISP) Research Committee. Prior to joining the OCPO, Luther was the Cardiovascular Global Director for Scientific Affairs (GDSA).
Prior to joining Merck, Luther was Chief of the Division of Cardiovascular Medicine at the State University of New York Downstate Medical Center (SUNY Downstate) and founding Director of the National Institutes of Health (NIH) funded Brooklyn Health Disparities Research Center. He earned his Bachelor of Arts degree from Harvard College and his Medical degree from Harvard Medical School. He has authored more than 100 publications and edited and was principal contributor to the textbook Cardiovascular Disease and Diabetes (McGraw-Hill).
Dr. Clark has received numerous awards and honors, including the Harvard University Alumni Lifetime Achievement Award for Excellence in Medicine.
Director - Life Sciences, Silicon Valley Bank
Scott is currently working as a Director on the National Life Sciences Team for SVB, covering the Mid-Atlantic and Southeast markets. Through his 12 years with Silicon Valley Bank based in the Atlanta office, Scott has been focused on providing specialized banking and lending services to the innovation economy with specific focus on growing the Bank’s healthcare practice. Previous to SVB, Scott was a sales executive for an emerging healthcare IT company. Scott graduated from the University of Georgia with a major in Finance from the Terry College of Business.
Partner, Hutchison PLLC
Dan’s practice focuses on the business transactions important to pharmaceutical and biotech companies, including licensing and commercial transactions, FDA-related regulatory matters, asset acquisitions and divestitures, supply agreements, product development agreements and strategic alliances. Dan previously served as outside counsel to life sciences companies and in in-house counsel roles for Eli Lilly and Company, AAIPharma, Inc., Xanodyne Pharmaceuticals, Inc. and Xcellerex, Inc.
Medical Doctor at Piedmont Healthcare
Dr. Bronwen Garner
Co-Founder & Chief Development Officer, Acclinate
Tiffany is an innovator and entrepreneur with 10 years of business management expertise. She’s experienced in all aspects of business formation, operation, strategic messaging, and marketing. In addition, she is a lifelong learner committed to staying on top of the best current and emerging business practices. She works hard to continue strengthening communities while fostering civic engagement through service and volunteering. At Acclinate Tiffany is able to utilize her relentless drive for diversity, equity, and inclusion to transform clinical research.
In 2017, Tiffany founded, Driven Solutions, where she continuously works to find solutions for the everyday needs of clients while helping them maximize their full potential in order to reach goals. At a young age Tiffany made a name for herself here in Rocket City by being a dedicated volunteer to United Way of Madison County and a hard worker. After managing a well known dental practice for 5 years Tiffany worked for the Huntsville/Madison County Chamber of Commerce. Through the years she has established herself as a trustworthy, dedicated and diligent young professional. She was recently recognized as one of the top 40 young professionals under the age of 40 by 256 Magazine and a finalist for the 2018 & 2019 Entrepreneur Awards by al.com and the Catalyst Center for Business & Entrepreneurship.
Tiffany has strong affiliations in the business community where she serves as an active board member of Urban Engine, Vice President of the Board of Directors for Nexus Energy Center, Advisor to the United Way of Madison County, Community Partner to Monrovia Middle School and Hampton Cove Middle School, A member of the National Space Club, A Kids to Love advocate and community partner, TRC Volunteer for the Decatur/Morgan County Chamber of Commerce, a member of the Women’s Economic Development Council, and a member of Mayor Battle’s Diversity & Inclusion Council. She works hard to form bonds with businesses to promote different perspectives which encourage the leaders, employees and our entire community to evolve.
CEO, Advanced Catheter Therapies
Paul has a very diverse entrepreneurial & executive leadership background in the medical device, healthcare, consulting & hospitality services arenas. He has led teams which have taken innovated services and technology from ideation through, funding to commercialization and exit. His experience includes 10+ start-ups, turnarounds, roll-ups, integration of acquired companies, multi-site & international operations. Specific industry sectors include: EMS/ambulance advanced life support emergency medical services, physical therapy and rehabilitation services, international nurse recruiting & staffing, breast cancer risk screening, complex Point of Care molecular DX testing and endovascular catheter-based drug delivery medical devices. Ventures ranged from pre-revenue to $250M revenue, completing over $50 million of private and venture backed financings and completing over 20 M&A transactions with a combined value in excess of $100 million. Paul currently serves as CEO and Director of Advanced Catheter Therapies, Inc., (ACT) in Chattanooga, TN www.acatheter.com a research and development medical device company with a portfolio of innovative endovascular catheter based technologies focused on vascular disease including its novel next generation FDA cleared & patented universal targeted liquid drug delivery platform the Pressana® Occlusion Perfusion Catheter. Paul has been responsible for developing and executing the Companies business model, strategy and completing $9 million in grant & equity financings. Paul has taken ACT from ideation to revenue generation of $7.9 million in licensing fees & product sales to date. In addition, Paul provides fractional C-level and board engagements along with advisory services to startups and small companies. He serves as a volunteer board member, provides pro bono mentorship to startups and early stage companies and is a member of several professional and industry associations. Paul is a graduate of the Northeastern University degree paramedic program and was an adjunct faculty in the paramedic program for 10 years”
Senior Assistant General Counsel, PhRMA
Julie Ritchie Wagner
Mentor in Residence,
Andrew Krouse has over a decade of biotech investing and leadership experience with a track record of success as the founder and CEO of Tau Therapeutics, LLC, Xdynia LLC, and venture backed Cavion, Inc. He has been recognized for his leadership in the industry as a CIT GAP 50 Entrepreneur in the Commonwealth of Virginia, a member of the Board of SEBIO, and is the immediate past Chairman of the Virginia Biotechnology Association. Prior to his experience in the pharmaceutical industry, he worked as an analyst for Goldman Sachs, NYC, and served as Vice President of the UVA Darden Graduate School of Business. Most recently, he led the acquisition of UVA startup, Cavion, to industry leader Jazz Pharmaceuticals.
Sarah Cohen joined Global Center for Medical Device’s design and development team in 2017, bringing more than a decade of medical device experience from the perspective of both large corporations and small startups. At GCMI, she provides technical and program leadership for a variety of product development programs, leading clients through the engineering process within the constraints of a regulated industry. Prior to joining GCMI, Sarah worked in design and evaluation of cardiovascular devices, including implantable left ventricular assist devices (LVADs) and cardiac electrophysiology mapping catheters. She also has experience in vascular catheters, brachytherapy, ophthalmic implants and orthopedic tissues, with a particular interest in tissue-device interactions. Sarah has been directly involved with many aspects of the product lifecycle, from concept development to device testing to supporting manufacturing and clinical trials.
Senior Vice President, Investor Relations, MacDougall Bio Communications
Sara Michelmore is Senior Vice President, Investor Relations at MacDougall. Sara joined the agency in 2018 to oversee the Investor Relations practice, where she utilizes her extensive Wall Street and consulting experience, insights and relationships to advise clients on the strategic positioning and communication of their science and technology to the investment community. She enjoys helping companies increase their visibility and credibility to the Street and strategically navigate evolving capital needs and maximize valuation in the context of ever changing market dynamics. Past experience includes 25 years in the Health Care industry in various roles. She spent 15 years working as a Wall Street Sell Side Analyst, including 12 years at Cowen and Company, where she established strong relationships with both private and public investors. Her background also includes over 5 years in Healthcare management consulting and advisory, focused on market assessment, forecasting, valuation analysis, investor position and outreach. Most recently she served as a Client Leader & Executive of Human Care Systems, a fast growing HCIT company focused on solutions for Therapy Management & Adherence. Sara graduated from Bowdoin College with a bachelor’s degree in Biochemistry, and minor in Economics.
Audit Partner, Hughes Pittman & Gupton
Tom is currently the leader of the Firm’s life science practice and has 24 years of experience, 18 in public accounting and six in private practice. He started his career at PricewaterhouseCoopers as an audit associate. Tom was previously a controller and CFO with a sports travel company. Tom joined Hughes Pittman & Gupton, LLP in November 2006, and became a partner in January 2014.
Tom works with both public and nonpublic companies. Tom’s primary focus is life science clients. In addition to being an audit partner, Tom provides interim chief financial officer services to private companies and SEC reporting services for public companies. Tom has experience with biotechnology, pharmaceutical, medical device, contract research organizations, software, professional services, distribution, and venture capital funds.
CEO, Georgia Arrhythmia Consultants and Research Institute
Felix Sogade, MD
Dr. Sogade serves as Chief Executive Officer (CEO) for Georgia Arrhythmia Consultants and Research Institute (GACRI), Director of Electrophysiology and Physician Co-Management with Navicent Health, as well as Associate Professor of Medicine, Mercer University School of Medicine. He initiated the ablation and EP lab based device programs at both Navicent Health and HCA Coliseum. He is a Fellow of the American College of Cardiology and Heart Rhythm Society with appointment as HRS ambassador to Africa for 2018-2019. He served as 2016- 2018 Chairman of the Board of Directors for the Association of Black Cardiologists (ABC).
Dr. Sogade is impassioned about community service both locally and abroad. GACRI host various community education events including the S.C.A.R.E. (Sudden Cardiac Arrest Research and Education) Project, he also serves as Chair to Georgia Arrhythmia Consultants Africa Project.
Following his MB, BS with distinction degree from University of Ibadan College of Medicine in Ibadan, Nigeria, Dr. Sogade completed his Internal Medicine and Cardiovascular Diseases Residency and Fellowship at State University of NY at Stonybrook. He subsequently completed his fellowship in cardiac electrophysiology at Duke University Medical Center
Amber Schmidtke, PhD
Partner – HealthQuest Capital
Todd has spent the last nine years as a healthcare CFO, helping build several successful companies to profitable exits. He joins HealthQuest excited to bring his operations and financial experiences to innovative companies that are primed for growth with the right plan and execution.
For the last year, he has been the acting CFO for Femasys, a medtech company developing and selling devices targeted at women’s health issues. Prior to that, he was CFO and Treasurer of ZS Pharma (IPO in 2014 and sold to AstraZenaca in 2015; a 30x increase in valuation from when he joined in 2013). Todd was the CFO and led business development activities for Sarcode which developed lifitigrast, the first dry-eye pharmaceutical to be approved (2016) for both signs and symptoms of dry eye (sold to Shire in 2013). He was also the CFO of Sirion Therapeutics, an ophthalmic company that successfully developed and received approval for two products (Durezol and Virgan) and sold to Alcon and Bausch and Lomb in 2010. During his CFO tenure he has raised more than $500m in equity and debt, helping to build operations and companies that generated over $3.5b in exits.
Earlier in his career, Todd did healthcare venture investing for Quintiles and worked with SRI International. He has also co-founded two companies; a spectroscopy platform spinout of Duke University (Centice) and a specialty pharmaceutical company (TLC Pharma).
Todd holds bachelor’s degrees in Finance and Accounting from Miami (Ohio) University where he was also a scholarship baseball player, and an MBA from Duke University. He is an Executive-in-Residence for Moffitt Cancer Center and sits on the Healthcare Advisory Board for Duke’s Fuqua School of Business. He and his wife live in Tampa, Florida with their two sons.
COO, VP of Clinical Development, Jackson Medical
Kamil Makhnejia, MBID
Kamil Makhnejia helped start Jackson Medical in 2016 and has since served as Chief Operating Officer and Vice President of Clinical Development. He has worked on a number of different medical device technologies in a variety of sub-specialties over his 5+ years of experience in the industry.
Chief Executive Officer at Basking Biosciences
Vice President of Engineering and R&D, Rhythmlink International
Gabe Orsinger is Vice President of Engineering and R&D at Columbia, SC-based Rhythmlink International. Rhythmlink designs, develops, and manufactures medical devices connecting patients to machines. Most notably, this includes subdermal needle electrodes for intraoperative neuromonitoring, and EEG electrodes for continuous brain monitoring. Driven by improving patient care and accessibility, Gabe has been innovating in the biotech and med device space for 15 years. At Rhythmlink, he leads R&D, New Product Development, and Manufacturing Engineering which together sustain an evolving product pipeline of new medical devices, from concept though commercialization. Notable recent 510(k) clearances include MR Conditional Quick Connect™ EEG Electrodes, BrainHealth™ Headset, Rhythmlink EEG Template, and Guardian Needle™. In addition to medical device commercialization, Gabe has an extensive multidisciplinary background in 3D tissue cultures, engineered nano-capsules, medical imaging instrumentation, and ophthalmic drug delivery systems. Gabe earned his Ph.D. and M.S. in Biomedical Engineering from University of Arizona, and his B.S. in BME from University of Virginia.
Senior Director US Government Affairs, Medtronic
Todd Gillenwater joined Medtronic in 2017 and his portfolio includes Medicare coverage and payment-related issues, value-based healthcare, and U.S. government agency procurement policy matters. Todd also serves as the Government Affairs Federal Business Liaison for the Diabetes and Restorative Therapies Group (RTG) businesses, as well as the Americas Liaison for Medtronic Care Management Services (MCMS) and Value-Based Partnerships.
Todd joined Medtronic following 13 years with the California Life Sciences Association [CLSA; previously the California Healthcare Institute (CHI)], California’s life sciences trade association. He served in a number of capacities with CLSA and CHI, including as Executive Vice President for Advocacy and External Relations, leading the organization’s Washington, DC office. Prior to that, Todd served as Legislative Director for former Congressman David Dreier (CA) and was an associate at The Heritage Foundation.
Todd has a BS in International Relations from the Georgia Institute of Technology and MS in Management from The Catholic University of America.
Director of Corporate Development, Cumberland Emerging Technologies
Jim Stefansic is the Director of Development at Cumberland Emerging Technologies (CET). His responsibilities include sourcing, evaluating, and negotiating for new biopharmaceutical product and technology opportunities, in addition to contributing to the management and expansion of CET’s university collaborations.
Stefansic was previously COO of Pathfinder Therapeutics, Inc., a company he co-founded, where he led FDA regulatory submissions and business development activities. While there, he raised more than $17 million in venture capital and Small Business Innovation Research (SBIR) funding. He also previously served as the director of commercialization at Launch Tennessee, where he was instrumental in leading the acquisition of funding to develop and support the statewide SBIR program. He earned an undergraduate degree in biomedical engineering from Johns Hopkins University, a doctorate from Vanderbilt, and his MBA from Belmont University’s Jack C. Massey Graduate School of Business, where he currently serves as an adjunct professor of business and was named the distinguished alumnus of the year in 2011. Stefansic started his career as a research professor at Vanderbilt University Medical Center. He was also co-founder and CEO of Raiven Healthcare.
President – Southern Metrics
Principal – The Pinnacle Group
David is a principal and founding member of MRC Global, the result of a merger between Pinnacle and MRCx, and serves as a member of the leadership team where he directs growth strategies for the organization including service line expansion and new company development. Known as a creative thinker and problem solver, David’s professional focus is geared toward building stronger provider relationships and identifying shared business opportunities.
With more than 25 years’ experience in health care organization management and consulting, David’s expertise is extensive and includes new business development, health services valuation and financial analysis, health care market research, medical staff partnership planning, and physician practice management consulting.
David has managed thousands of fair market value analyses for a broad array of clients located across the country including health systems, medical device/pharmaceutical companies, community/rural hospitals, specialty health service providers, and single/multi-specialty medical groups. He has also worked with national health plans on provider contracting and medical management issues and is viewed as a leading expert in the dialysis industry with more than 18 years’ experience as a valuation and management consultant.
In addition to his leadership role with Pinnacle, David has been part of management teams developing and launching a wide variety of services including urgent care access and delivery, outsourced medical coding solutions, telemedicine technology and support services, an insurance brokerage offering tailored provider solutions, and an insightful approach to credentialing for physician thought leadership.
Prior to Pinnacle, David was a health care consultant with Milliman USA and a co-founder of Physician and Hospital Solutions. He also served as Director of Planning and Practice Management for Eisenhower Medical Center in Rancho Mirage, California, and started his career in Cleveland, Ohio with Orion Consulting/New Health Management. David received his BS in Finance from the University of Colorado (Boulder) and his MBA with a focus in health care management from Cleveland State University.
On a personal note, David has been married to his best friend for 27 years. They have three children and two grandchildren. David enjoys skiing in the Rockies, reading a good sci-fi or action thriller, golfing whenever he can and travel with friends and family.
Partner – Baker Hostetler
Kristen McDermott Woodrum concentrates her practice in the area of healthcare law, including regulatory compliance and transactional matters. Well-versed in the nuances of healthcare law, Kristen anticipates potential issues and provides practical counsel while working with clients to structure complex transactions, including acquisitions, joint ventures and other strategic affiliations.
Kristen also advises clients on day-to-day operational and compliance matters, including fraud and abuse laws, such as the federal Stark Law and Anti-Kickback Statute, and the HIPAA; Medicare/Medicaid billing and reimbursement, licensure and accreditation; third-party payor issues; and state fee-splitting, fraud and abuse; and corporate practice of medicine laws.
- Represented a multicampus hospital system in its acquisitions of ancillary facilities, including imaging centers, ambulatory surgery centers, laboratories, urgent care centers and radiation therapy facilities.
- Assisted a community hospital in the development of a clinically integrated network of providers, including evaluation of corporate structure and healthcare regulatory issues, and preparation of key documents, such as participation agreements and CIN policies and procedures.
- Advised a multicampus hospital system regarding physician-hospital arrangements and provided transactional representation in connection with practice acquisitions; employment, medical director, response and call coverage agreements; and other professional services arrangements.