About the MTIG
The MTIG Mission
The Microbiome Therapeutic Innovation Group (MTIG) is an independent 501(c)(6) coalition of companies leading the research and development of FDA-approved microbiome therapeutics and microbiome-based products to address unmet medical needs, improve clinical outcomes, and reduce health care costs. The human microbiome is one of the new frontiers of medical innovation that has the potential to benefit patients suffering from numerous diseases afflicting millions of patients and consuming billions of dollars of healthcare resources. Through a collective voice, the MTIG membership works together to enhance the regulatory, investment, and commercial environment to accelerate microbiome therapeutic drug product development and expand availability of life-changing and life-saving FDA approved microbiome therapies to patients. MTIG is committed to working with stakeholders who share in our mission and seek to collaborate with patients, patient advocates, professional societies/organizations/public health officials, scientists, government policymakers, healthcare providers and payers who seek tangible policy and regulatory solutions to issues in the emerging microbiome arena.
Through the strength of its collective membership, MTIG promotes regulatory policies and legislation that support innovation in the microbiome arena. Currently MTIG is focused on advancing the following policy initiatives:
- Streamlining the regulatory process to increase clarity and decrease the amount of time needed for new microbiome therapeutics to reach the market.
- Key areas include: regulatory clarity on clinical trial design, endpoint selection and biomarker selection, use of expedited review pathways, and product nomenclature.
- Educating policymakers, clinicians, patients and the public about the role of the microbiome in human health, and opportunities with products that augment and modulate the microbiome to address unmet medical needs.
- Working with clinical leaders, patient advocates, and other stakeholders to support FDA regulation of microbiome-based drugs and encourage FDA to finalize its draft guidance “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies” issued in March 2016.
- MTIG supports continuing access to physician prepared FMT with donor controls and patient informed consent, as described in the FDA guidance. However, MTIG believes these standards should not be applied to unregulated commercial-scale FMT that have not established safety and efficacy under FDA regulated clinical trials.
- MTIG believes FDA regulation is necessary to ensure that commercial scale FMT products implement and adhere to the rigorous controls and testing necessary to ensure the quality of the drug product meets regulatory requirements.
Board of Directors
Thomas J. DesRosier, Esq.
Chairman of the MTIG Board
Executive Vice President, Chief Legal Officer and Secretary
Thomas J. DesRosier is the Executive Vice President, Chief Legal Officer and Secretary of Seres. He brings more than 30 years of experience in the biopharmaceutical industry. Prior to joining Seres, he served as Chief Legal and Administrative Officer at ARIAD Pharmaceuticals, and prior to that held the same position at Cubist Pharmaceuticals where he led the negotiation of the acquisition of Cubist by Merck. Previous to that, he served as Senior Vice President and General Counsel, North America of Sanofi, a position he assumed in 2011 after Sanofi acquired Genzyme Corporation, where he was Senior Vice President and Chief Legal Officer. Prior to his 12-year tenure at Genzyme, Mr. DesRosier held senior legal positions at Wyeth Pharmaceuticals, predecessor Genetic Institute, and E.I. DuPont de Nemours. He received his J.D. from Wake Forest University School of Law and his Bachelor of Arts in chemistry from the University of Vermont.
Founder, President and Chief Executive Officer
Lee Jones is the founder, president, and chief executive officer of Rebiotix, a results-oriented biotechnology company revolutionizing the treatment of challenging gastrointestinal diseases by harnessing the power of the human microbiome.
Lee has over 30 years of experience as a medical technology executive and entrepreneur in large and small companies and academia. With Rebiotix as her first foray into biotechnology, Lee is leading a fast-paced effort to develop a new way of treating disease through Microbiota Restoration Therapy (MRT). The company’s first MRT is a biologic drug targeted at recurrentClostridium difficile infection.
Before joining Rebiotix, Lee was the chief administrative officer of the Schulze Diabetes Institute at the University of Minnesota. She is also the former president and chief executive officer of Inlet Medical, a privately held medical device company that she grew to profitability prior to its sale to CooperSurgical in 2006. Prior to Inlet, she spent 14 years at Medtronic where she developed and commercialized several innovative products, including InterStim – a surgically implanted neurostimulation device for urinary incontinence that opened up new markets for the company.
Lee has served on several public and private boards and is currently on the board of Electromed Inc., on the University of Minnesota’s Office of Technology Commercialization advisory board, and on the board of LifeScience Alley, an industry association. She is a member of the Sofia Angel Investment Fund and is an advisor to several small companies.
Ms. Jones has a BS in Chemical Engineering from the University of Minnesota and an Executive Management degree from the Carlson School of Management at the University of Minnesota.
Bernat Olle, Ph.D
Co-founder and Chief Executive Officer
Dr. Olle is a co-founder and Chief Executive Officer of Vedanta Biosciences. He has been a member of the founding teams of several companies of the PureTech portfolio and served as a member of the Board of Directors of Vedanta Biosciences and Follica Biosciences.
In 2013 Dr. Olle was named “Innovator of the Year” in MIT Technology Review Spain’s “Innovators under 35” awards. He completed his doctoral work at the Chemical Engineering Department at MIT, where he developed a novel method for large-scale bacterial culture. During his graduate work, Dr. Olle was awarded the “la Caixa” fellowship. Dr. Olle received his B.S. in Chemical Engineering from Universitat Rovira i Virgili, in the Republic of Catalonia, his M.S. and PhD. in Chemical Engineering Practice from MIT, and his M.B.A. from the MIT Sloan School of Management. He has published his work in journals including Nature and Nature Biotechnology.