M2Gen® is a health informatics solutions company focused on accelerating the discovery, development and delivery of personalized medicine. Our Company was founded in 2006 at the Moffitt Cancer Center to operationalize the Total Cancer Care® Protocol, a unique approach to studying patients throughout their lifetime. In this effort, we partner with the nation’s leading cancer centers via the Oncology Research Information Exchange Network (ORIEN).
Total Cancer Care®is one the world’s largest observational research studies in cancer. TCC represents a true partnership with patients who donate their clinical data and tissue so that we may learn from their experiences and develop evidence-based approaches to meet their needs. Consented patients agree to be contacted for future studies, playing an active role in the study of their cancer and improving care for future generations.
The Oncology Research Information Exchange Network ( ORIEN) is a unique research partnership among the nation’s leading cancer centers that recognize collaboration and access to data are the keys to advancing cancer discovery, and delivering improved cancer care. Members agree to use the Total Cancer Care protocol and share data to advance the discovery and development of new therapies.
M2Gen provides informatics-based solutions to accelerate the discovery, development and delivery of personalized medicine.
Using the information learned from patients through the Total Cancer Care® Protocol, and in partnership with our ORIEN Members, we work with biopharmaceutical companies to address the most challenging questions in drug development. Total Cancer Care provides a harmonized approach to link longitudinal clinical data with molecular information, enabling a much deeper understanding of a patient’s disease. This “opt-in” approach allows for patients to be re-contacted for further studies, creating an information-driven ecosystem to accelerate cancer research.
Our core solution, ORIEN Avatar TM is a pre-competitive informatics environment featuring a robust integrated clinical and molecular dataset combined with proprietary software tools to power discovery and development. We also work with leading biopharmaceutical companies on projects featuring informatics-based approaches to target and biomarker discovery, trial design and enrollment and post-market analysis.
Founder and Executive Chair of M2Gen.
Dr. William (Bill) S. Dalton is Founder and Executive Chair. He is the former CEO of M2Gen (2012-2017) and past President, CEO & Center Director of Moffitt Cancer Center, an NCI-Designated Comprehensive Cancer Center (2002-2012). During his tenure as CEO of Moffitt, he led the development of the Total Cancer Care program and creation of the Health Research Informatics platform designed to follow patients throughout their lifetime. He holds several patents in the area of personalized medicine and computer networking. In 2014, Moffitt Cancer Center, in partnership with the James Cancer Center at the Ohio State University, founded the cancer center alliance called ORIEN, Oncology Research Information and Exchange Network, with the goal of accelerating cancer research discovery by sharing information and delivering hope through collaborative learning and partnerships.
President and CEO of M2Gen
Timothy R. Wright is the President and CEO of M2Gen®. He was previously the Executive Vice President, Business Development, Strategy and Innovation at Teva. Mr. Wright is the founder and Chairman of the Drug Discovery and Development Institute for The Ohio State University Comprehensive Cancer Center, where he previously served as Director. He is a current a member of the Ohio State Innovation Foundation Board and the Ohio State School of Pharmacy External Advisory Board. Mr. Wright has served in executive leadership roles at several pharmaceutical firms, including Covidien, Elan, and DuPont Merck. He holds a B.Sc. from The Ohio State University.
Chief Scientific/Bioinformatics Officer of M2Gen.
Hongyue Dai, PhD, currently serves as M2Gen’s Chief Bioinformatics Officer / Chief Scientific Officer. In his role, he works with clients to understand their questions about biomarkers and patient populations, and develop novel solutions that add value and bring more effective, targeted drugs to right cancer patients sooner. Dr. Dai has over 15 years of data analysis experience in pharma and biotech, most recently as Executive Director, Informatics & Analysis at Merck Research Lab leading a group of 50 scientists. He has worked extensively on the analysis of genomic and genetic data to identify and validate novel drug targets and biomarkers, and to understand disease progression, mechanisms of compounds. He also has a strong publication record, including papers in Nature, Science and Cell.
Senior Vice President, Chief Financial Officer of M2Gen.
Joseph R. Smith, CPA, CGMA, currently serves as the Senior Vice President and Chief Financial Officer for M2Gen, a wholly owned for profit subsidiary of Moffitt Cancer Center. In this role, Joe is responsible for the financial, marketing and sales aspects of M2Gen and provides leadership for the day to day financial and operational aspects of the business. Prior to joining M2Gen Joe served as Chief Operating Officer and Chief Financial Officer for Bisk Education and also was the CFO, Secretary and Treasurer for a private then public dental practice management company. Joe started his career in public accounting at Deloitte, rose to the level of Partner and was in charge of the middle market practice in the Tampa, Florida office. He holds a BSBA in Accounting with Honors from University of Florida.
VP/ Chief Administrative Officer of M2Gen
Administrator, Oncology Research Information Exchange Network (ORIEN)
Odalys Capote currently serves as Vice President/Chief Administrative Officer & Administrator for the Oncology Research Information Exchange Network (ORIEN) at M2Gen. She also serves as Administrator of the DeBartolo Family Personalized Medicine Institute at Moffitt Cancer Center. Odalys has over 30 years of experience in healthcare, including such roles as: Chief of Staff, Compliance & Privacy Officer, cost accounting/decision support implementation, project management and consulting. She holds a Bachelor’s degree in Marketing from the University of South Florida School of Business.
Vice President of Strategy and Business Development, M2Gen
Naveen Kumar currently serves as Vice President, Strategy and Business Development for M2Gen, and is primarily responsible for supporting M2Gen’s growth through partnership with life science and technology companies, as well as cancer centers via ORIEN. Prior to joining M2Gen, Naveen held various management consulting and financial advisory roles serving the health care industry. He holds a B.A, with Honors, from New York University and a M.Sc. in Finance and Economics from the London School of Economics.
Vice President of Medical Informatics, M2Gen
Judy Barkal is the VP of Medical Informatics at M2Gen. She brings deep experience in strategy, innovation and complex business and technology transformation. Judy’s most recent role was Head of Information Strategy and Innovation at Knight Cancer Institute, Oregon Health and Science University. At OHSU, Judy established a cancer informatics strategic roadmap and, as PI, led the creation of a clinical data repository integrated with genomics data to serve multiple cancer researchers and programs. Judy and her team selected and deployed a Natural Language Processing (NLP) platform. After engineering a robust pipeline, they successfully used NLP to process physician notes, pathology reports and radiology reports and extracted staging, tumor characteristics, biomarkers, medications and mutations in patients across multiple disease groups. Judy established new informatics concierge services that worked directly with researchers to understand needs and ensure solutions were intuitive and useful. Judy and her team delivered over seventy data sets and informatics tools releases in eight months. Deliveries integrated clinical and genomics data to create patient time-line views that included diagnoses, procedures, specimens, medications and doses, lab results, and comprehensive genomics panel results to help researchers explore cohorts. Deliveries to the clinical trials office helped identify patients eligible for clinical trials using key inclusion, exclusion criteria and integrated clinical visits to community care and clinics beyond oncology. Judy also selected and deployed an imaging platform to convert proprietary microscopic images for web display. The imaging platform also provided tools for custom coloration and text annotations as well as a Galaxy pipeline plug-in for executing specialized image analytics. Judy was formerly a Partner in IBM Global Business Services and specialized in leading clients through complex transformations and adoptions of First-of-A-Kind (FOAK) technologies. She has led complex business and technology transformation programs in North America, Asia and Europe for healthcare, financial services, transportation, energy, retail and consumer electronics. As a business leader, Judy has led a large Application Innovation Services organization and was responsible for the complex solution and services delivery portfolio of P&L results for IBM North America and IBM Italy. In recognition of her deep technical expertise and leadership, Judy was elected to the IBM Academy of Technology. Prior to IBM, Judy specialized in clusters and high performance computing at Sequent Computer Systems. In her early career, she developed safety-critical, real-time flight control systems at Rockwell Collins.
Chairman - University Commercial Center
Vice Chair - Former Senator, United States Congress; Partner, Liberty Partners Group
Founder & CEO, M2Gen
Former Speaker, Florida House of Representatives; Founder, Moffitt Cancer Center
Chairman, Atlantic Merchant Capital Investors
President, Hospital Corp.; Executive Vice President & COO, Moffitt Cancer Center
Founder & CEO, Florida Institute for Human & Machine Cognition
President & CEO, Black Diamond Capital Corporation
Managing Director, Toucan Capital Fund II; Chief Executive Officer, Northwest Biotherapeutics
Chief Medical Officer, M2Gen; Executive Vice President & Associate Center Director for Clinical Science