Wyss DxA Industrial Participant Program

Austere Environments Consortium for Enhanced Sepsis Outcomes (ACESO)
ACESO is a consortium consisting of U.S. Government, non-profit, academic and industry partners with a mission to improve survival for patients with severe infections through development of rapid, point-of-care diagnostics & prognostics and evidence-based clinical management.

Contact: Danielle Clark, Co-Founder and Director, dclark@aceso-sepsis.org

BioDot
BioDot specializes in low volume fluid dispensing systems (picoliters to microliters) for product development and manufacturing in the diagnostic and life sciences industries. Every Drop Has A Story.

Contact: Debbie Bowers, Senior VP of Commercial Development, debbie.bowers@biodot.com

bioMérieux
In 160 countries, bioMérieux provides diagnostic solutions (systems, reagents, software, services) which determine the source of disease and contamination to improve patient health and ensure consumer safety.

Contact: Mahala Burn, PhD, Corporate Development and Strategic Financing, mahala.burn@biomerieux.com

Program Leads

Trey Toombs is the Head of Operations and Outreach for the Wyss DxA Industrial Participant Program, applying his program management experience to help develop, launch and operationalize this new endeavor and facilitate collaborations that will accelerate the advancement of diagnostics. Trey also serves as a Program Director for the Brigham Research Institute, where he works closely with faculty and institutional leaders to create and execute initiatives to foster new interdisciplinary and interdepartmental research and raise the visibility of the broader research enterprise. Previously, Trey was a research fellow at Massachusetts General Hospital, received his Ph.D. in biochemistry and molecular biology from Colorado State University and his B.S. from Virginia Tech. Contact: james.toombs@wyss.harvard.edu

Gretchen Fougere has a passion for and a track-record of building bridges between the academic and industrial worlds to solve problems. In academia for a decade, she led the development of strategy and programs that she launched, funded, and scaled globally, as well as raised millions for faculty research. Most recently, she was a leader in an innovation institute using AI and ML to advance computational medicine translation and life science discovery, and she raised millions for faculty in this startup. In industry for a decade, she focused on new product development as an inventor, innovator, and leader of cross-functional teams. At the Wyss, Gretchen works closely with faculty and research teams to build bridges with industry to translate cutting-edge ideas into new products, such as medical devices and diagnostics. She earned her Ph.D. in Materials Science/Nanotechnology from Northwestern University and two bachelor’s degrees in Mechanical Engineering and Biomedical Engineering from Vanderbilt University. Contact: gretchen.fougere@wyss.harvard.edu

Advisory Team

Members of the Wyss DxA IPP Advisory Team bring their broad experiences and diverse backgrounds to help guide and grow the program to benefit its participants.

Elliot P. Cowan, Ph.D., is Principal and Founder, in 2013, of Partners in Diagnostics, LLC, providing consulting on the regulation of in vitro diagnostics to IVD manufacturers, and is the Chief Regulatory Officer of TestZone, dedicated to making spaces safer in the midst of pandemics. This followed a 20-year career at the US Food and Drug Administration, where he led the regulation of all blood donor screening tests and retroviral diagnostics. Elliot was also a member of the Laboratory Technical Working Group for the President’s Emergency Plan for AIDS Relief (PEPFAR), providing technical assistance for laboratory quality assurance issues in PEPFAR focus countries, advised the World Health Organization on the development of its Prequalification of Diagnostics Programme, and assisted in building regulatory systems for diagnostics in Sub-Saharan Africa. Elliot received a B.A. from Williams College and a Ph.D. in Biology and Biomedical Sciences from Washington University in St. Louis.

David Levine, M.D., M.P.H., M.A., is a practicing general internist and clinician-investigator at Brigham Health and Harvard Medical School. He is active in clinical and translational research through a focus on optimizing quality time at home by shifting care home, decentralizing care, digital health technology, and measuring the quality and experience of health care. He is medical director for strategy and innovation for the Brigham Health Home Hospital and co-chair of the Hospital at Home Users Group. He sees his role as helping patients achieve the right care at the right time in the right place by designing, implementing, and evaluating innovative interaction spaces among a care team, technology, caregiver, and a patient. David received his undergraduate degree from Pomona College in biology and politics. He earned his master’s in teaching in special and secondary science education and served as a high school chemistry teacher and science department chair in Chicago Public Schools. He received his medical degree from Washington University in St Louis and completed his residency at New York University and Bellevue Hospital in internal medicine – primary care. He completed a general internal medicine fellowship at Brigham Health and Harvard Medical School and received his master’s in public health at the Harvard School of Public Health.

Jim Niemi has over 25 years of experience in medical device research, development, and commercialization. His prior interests and experience include neuromuscular stimulation and control, stochastic resonance for human neuromotor applications, advanced medical imaging, implantable smart sensors and materials, as well as bioreactor and automation design. Jim is currently the Lead Staff Engineer for the Living Cellular Devices focus area of the Wyss Institute focusing on applications of synthetic biology, in conjunction with traditional devices, for primarily diagnostic applications. Jim received his B.S. in Biomedical Engineering from Boston University and his M.S. in BioEngineering from Brown University. Contact: james.niemi@wyss.harvard.edu

Richard Novak, Ph.D., is the founding CEO of Unravel Biosciences, Inc., which he spun out from the Wyss Institute at Harvard University to develop therapeutics for orphan CNS diseases using a novel AI drug prediction and in vivo screening platform. Prior to Unravel Bio, he was a Lead Engineer at the Wyss Institute at Harvard University where he managed the Microengineering Team and led development of human Organ Chips, Organism-on-Chip screening platforms, and analytical and diagnostic instrumentation for accelerating therapeutics discovery and precision diagnostics. Richard received his PhD in Bioengineering from UC Berkeley/UC San Francisco where he developed microfluidic single cell analytical and diagnostic platforms for forensic, therapeutic, and basic research applications. He is the founder of Future Scientist, a nonprofit that works with resource-poor communities to design sustainable solutions through their prototyping and development hub in Panama. Richard also is a founder and director of Rhinostics Inc., a medical consumables company that has developed an automatable sample collection platform that accelerates and expands access to respiratory, blood, and genomic laboratory testing through integration with existing lab automation instruments.

Mac Strafford is a healthcare professional with a background in management consulting. She currently oversees population health projects at Optum and previously served as a consultant at Bain & Company in the private equity practice. Throughout 2020, Mac also led Testing & Therapeutic efforts at a COVID-19 relief nonprofit called Stop the Spread. In this role, Mac supported over 100 diagnostic companies by connecting them with resources to accelerate their development timeline and enable greater scale.