About
About TFF
We are focused on developing innovative drug products based on our patented Thin Film Freezing, or TFF, technology platform.
Although intended for the lungs, many drugs are not given via the airway because drug properties make it too difficult to formulate for direct to lung delivery.
Administered systemically, these drugs often produce unwanted and potentially life-threatening side effects. To get around this, companies have tried to use microcapsules, carriers, and other agents to try to dose drugs direct to the lungs, but these other delivery agents often produce their own problems.
Using its proprietary technology, TFF can generate dry powder inhaler versions of many drugs using nothing but the drug itself and approved lung-friendly ingredients. This means that many drugs of all types – small molecules, biologics, even combinations – can be dosed direct to the lungs with fewer side effects.
Management
Glenn Mattes
President, Chief Executive Officer and Director
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Glenn Mattes
President, Chief Executive Officer and Director
Glenn Mattes joined the company in May 2018, bringing more than 30 years of business leadership, global therapeutics development expertise, and executive management experience to his role with the company.
In his capacity as Chief Executive Officer, Mr. Mattes, has oversight of the direction and strategy at TFF Pharmaceuticals, facilitating company activity in business development, marketing, investor relations, commercialization alliances and channels, and management support. He works to share the company’s vision and strategy with partners, investors and shareholders.
As Executive Chairman of Translational Sciences, Inc. the company consummated a global strategic collaboration in 2015 with Daiichi Sankyo for its lead cardiovascular asset. Prior to joining Translational Sciences, Mr. Mattes was CEO of Arno Therapeutics, a publicly traded company with a portfolio of development stage oncology therapeutic compounds, and a highly regarded group of founding investors.
From 2002 thru 2011 Mr. Mattes served as President of Tibotec Therapeutics, a Johnson & Johnson operating company, where he led, from inception, the organization responsible for the development, marketing, sales and business development of oncology and novel antiretroviral therapeutics. Tibotec’s revenues grew from zero to approximately $1 billion under Mr. Mattes’ leadership. During his Tibotec tenure, he led the successful launch of the first two Johnson & Johnson products launched into the HIV/AIDS market and presided over the growth of both Doxil and Procrit in the oncology therapeutic and supportive care categories.
From 1998 thru 2002 Mr. Mattes served as Vice President of Worldwide Commercial and Clinical Operations at Centocor Inc. He played a critical role in defining the company’s overall business direction as well as developing and implementing the strategy leading to the growth of ReoPro and the commercial launch of Remicade.
Prior to joining Centocor Mr. Mattes was at Rhône Poulenc Rorer, where he held positions of increasing responsibility, including President of RPR Canada and General Manager of U.S. pharmaceuticals. At Rhône Poulenc Rorer he built a market-leading asthma and allergy business with a focus on inhalation therapies. In addition, he was the General Manager of Advanced Therapeutics and Oncology, North America, and headed the successful launches of two blockbuster drugs, Taxotere and Lovenox.
In 2008 Mr. Mattes was honored with an appointment to the President’s Advisory Council on HIV/AIDS by President George W. Bush and the U.S. Secretary of Health and Human Services. In his service to the United States as a member of PACHA he was a key contributor to the committee responsible for counseling both the Bush and Obama administrations on domestic and global health and treatment issues.
Mr. Mattes serves on the Boards of Advantagene, Inc., Deck Therapeutics, Cornovus, Inc. and CannaMetrix. He is an advisor to the Gores Group and Clayton Foundation for Research, and served as an advisor to PTV Healthcare Capital. He is also an Operating Partner of Revival Healthcare.
Mr. Mattes received a Bachelor of Science degree from the City University of New York.
Chris Cano
Chief Operating Officer and Vice President, Business Development
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Chris Cano
Chief Operating Officer and Vice President, Business Development
Mr. Cano joined the company in 2018 with 20 years of corporate development experience in consultation, strategic planning, managing partnerships, and licensing expertise. Currently, he is the managing partner for consultation at C2 Strategic Solutions LLC, a company he founded, conducting business development and licensing for multiple life science and pharmaceutical companies. At C2, Mr. Cano oversees M&A, licensing, corporate growth, and strategic provision for organizations including Agile Therapeutics, Hitsamitsu, and Intec Pharma.
Prior to joining TFF Pharma, Mr. Cano held several upper business administration roles. While he was Vice President of Business Development at Aqua Pharmaceuticals, Chris managed corporate development strategy and business relationships. As Director of Business Development at Duchesnay USA, Inc., he was pivotal in the growth of the Women’s Healthcare Rx business in the US and Canada, and as Associate Director of Business Development at Noven Pharmaceuticals, he led the advancement of three separate business franchises.
In his position at TFF, Chris continues to focus on developing and managing revenue-generating opportunities and strategic partnerships with potential partners by identifying, evaluating, and executing licensing transactions for new development and commercialization opportunities.
Mr. Cano holds a Master of Business Management degree from Rider University and a Bachelor of Finance degree from Villanova University.
Kirk Coleman
Chief Financial Officer
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Kirk Coleman
Chief Financial Officer
Mr. Coleman has served as our Chief Financial Officer since January 2018. Since 2012, Mr. Coleman has also served as an executive officer of Steelhead Capital Management, LLC and Bios Partners, LP, a venture capital firm focused on investment in early-stage and growth-stage biotech and medical device companies.
From 1998 to 2008, Mr. Coleman was Treasurer for EFO Holdings, LP, a family office. Mr. Coleman has over 20 years of financial and accounting experience. Mr. Coleman received a BBA in Accounting from Texas Christian University in 1995.
Anthony Hickey, Ph.D.
Chief Scientific Officer
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Anthony Hickey, Ph.D.
Chief Scientific Officer
Dr. Hickey is Professor Emeritus in Pharmacoengineering and Molecular Pharmaceutics at the Eshelman School of Pharmacy of the University of North Carolina at Chapel Hill and also Distinguished Fellow and Program Director in inhaled therapeutics in the Center for Engineered Systems at RTI International. Dr. Hickey is also Adjunct Professor of biomedical engineering at the University of North Carolina (UNC) School of Medicine.
He received the David W Grant Award in Physical Pharmacy of the American Association of Pharmaceutical Scientists (2015); Thomas T Mercer Joint Prize for Excellence in Inhaled Medicines and Pharmaceutical Aerosols of the American Association for Aerosol Research and the International Society for Aerosols in Medicine (2017) and the Ralph Shangraw Memorial Award for Excipient and Excipient Technology of the International Pharmaceutical Excipient Consortium Foundation (2018). In addition, he was recognized by the Triangle Business Journal (Raleigh, NC) in 2015 as Life Science Consultant of the Year, and in 2019 by RTI International with the Margaret Elliott Knox Excellence Award. He has edited/authored nine texts on pharmaceutical inhalation aerosols and coauthored seven others on pharmaceutical process engineering, particulate science, pharmaco-complexity and tuberculosis therapy.
Dr. Hickey is the founder of three pharmaceutical companies — Cirrus Pharmaceuticals Inc. (1997), Oriel Therapeutics Inc. (2001) and Astartein LLC (2013). He served as Chief Science Officer of Oriel Therapeutics from 2002 to 2007, which was acquired by Sandoz in 2010. He has also served as President and CEO of Cirrus Pharmaceuticals from its founding until its acquisition by Kemwell in 2013.
Dr. Hickey holds his Ph.D. and D.Sc. in pharmaceutical sciences from Aston University in Birmingham, UK. He is a Fellow of the American Association for Advancement of Science, American Association of Pharmaceutical Scientists, the Royal Society of Biology and Royal Society of Medicine.
John J. Koleng, Ph.D., R.Ph.
Vice President of Product Development and Manufacturing
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John J. Koleng, Ph.D., R.Ph.
Vice President of Product Development and Manufacturing
John J. Koleng has co-founded AlphaVektor, LLC and Axxis Innovations, Inc., life sciences development and industrialization consultancies focused on product development, manufacturing, scale up, commercialization, and supply chain management. He has more than 20 years of experience in the pharmaceutical industry, including more than 10 years as a consultant. John has been a founding member of three drug development companies, Oticara, Via Therapeutics, and CloXero Therapeutics, that are actively developing new products under an FDA 505(b)(2) approach.
During his career, John has guided and assisted numerous life-science companies in the development of their technology. His drug development experience ranges from nasal/pulmonary products, injectables, transdermals, and abuse deterrent systems to liquid-filled capsules, hot melt extruded dosage forms, and nano-dose tablets. He has published numerous scientific research articles and is an inventor on 16 issued U.S. patents and numerous pending patent applications. In addition to his other consulting work, John has a historic relationship working with TFF Pharmaceuticals as a consultant and is an inventor on several provisional patent applications filed on behalf of TFF.
Prior to his consulting career, Dr. Koleng was a founding member and served as Vice President of Industrial Operations at PharmaForm, a contract development and manufacturing organization (CDMO). His roles increased from Vice President of Pharmaceutical Research to Chief Operating Officer before the company was sold to Akela Pharma, Inc. in 2007. John has a B.S. degree in Pharmacy (1994), and a Ph.D. in Pharmaceutics (2002), both from the University of Texas at Austin where he currently holds an Adjunct Assistant Professor of Pharmaceutics appointment and serves on the UT College of Pharmacy Dean’s Advisory Council. He is a registered pharmacist.
Dale J. Christensen, Ph.D.
Head of Clinical Development
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Dale J. Christensen, Ph.D.
Head of Clinical Development
Since the formation of TFF Pharmaceuticals, Dr. Christensen has successfully translated three programs from concept to Phase 1 clinical trials and leads the non-clinical and clinical development activities for TFFP. He is a biotech executive and consultant with over 25 years of R&D experience at the therapeutic interface of chemistry and biology experience managing research and early development across respiratory, inflammation, CNS, anti-infective, and oncology indications.
Dr. Christensen also holds an appointment as Adjunct Associate Professor of Medicine at Duke University Medical Center. He has held senior positions at Spyryx Biosciences, Oncotide, Cognosci, Affinergy Inc., Aryzun Pharmaceuticals, and KaroBio USA (formerly Novalon Pharmaceuticals).
In addition to running research programs for each company, he has also provided oversight of clinical trial design and execution; biomarker development; toxicology study design and execution; and CMC activities for multiple compounds, filing IND/CTA/CTNs, and early-stage trials.
Dr. Christensen has been involved in companies that have raised more than $100M in funding from venture capital groups and $50M in public markets. In addition, he has negotiated strategic partnerships with large pharma and managed external alliances with both large pharma and academic labs.
Dr. Christensen received his B.S. in Chemistry from Utah State University, and a Ph.D. in Organic Chemistry from the University of Utah. He was an NIH Postdoctoral Fellow at Texas A&M University. He has published many papers and is an inventor on numerous patents and patent applications in drug discovery.
G.J. Davenport, Ph.D.
Vice President of Government and Strategic Initiatives
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G.J. Davenport, Ph.D.
Vice President of Government and Strategic Initiatives
Dr. Davenport brings over 28 years of pharmaceutical product development and government contracting experience as a C--Level Executive with both biotech and life science companies. Greg is a founding partner of Dport Federal Group, LLC, a consulting firm that assist various clients in the life science and pharmaceutical industries seeking to conduct business with the Federal Government.
Dr. Davenport oversees TFF’s academic, government, and industry infectious disease and biodefense collaborations and pursues non-dilutive funding to advance TFF’s technology platform and products to address government and commercial needs.
Prior to joining TFF, Dr. Davenport was Vice President at a Washington, DC government relations firm where he secured federal contracts and non-dilutive funding for various Fortune 100 companies, academic institutions, and non-profit organizations. Previously, Dr. Davenport served as an executive with Tunnell Consulting, where he was instrumental in establishing Tunnell Government Services that currently provides scientific and technical support to several federal agencies including the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Health Integrated Research Facility (IRF) at Fort Detrick. He has also held roles as President of the biodefense division of DOR Biopharma, Inc.; Director of Vaccine Technology and new business development at Dynport Vaccine Company, a General Dynamics Information Technology Company; and CEO of Dport and Associates, LLC, a broad-based consulting firm.
Dr. Davenport earned a Bachelor of Science degree from Dillard University in New Orleans, Louisiana and received his Ph.D. in Molecular Biology from Howard University in Washington, D.C.
Paul F. Manley
Head of Regulatory Affairs
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Paul F. Manley
Head of Regulatory Affairs
Paul F. Manley, has accumulated 30+ years of business and senior management experience in regulatory affairs, compliance and overall drug development, across a range of therapeutic areas within the pharmaceutical, biologic and consumer products industries. Mr. Manley’s corporate career encompassed senior management and technical leadership positions within the US and Europe in both large corporations (VP, Global Regulatory Affairs – Oncology, Johnson & Johnson) and start-up-like entities (VP, Regulatory Affairs and Compliance, Genta Incorporated). In 2007 Mr. Manley established Orvieto Consulting, LLC, providing strategic advice to numerous companies across a wide range of scientific disciplines and through all phases of development through to post-marketing.
Robert O. (Bill) Williams III, Ph.D.
Technology Inventor/Special Advisor
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Robert O. (Bill) Williams III, Ph.D.
Technology Inventor/Special Advisor
Robert O. (Bill) Williams is the Johnson & Johnson Centennial Chair and Professor of Pharmaceutics and the Division Head of Molecular Pharmaceutics and Drug Delivery at the College of Pharmacy, University of Texas at Austin. He earned a B.S. in Biology from Texas A&M University, a B.S. in Pharmacy from the University of Texas at Austin, and a Doctor of Philosophy in Pharmaceutics in 1986 from the University of Texas at Austin. Dr. Williams worked nine years in the pharmaceutical industry in the United States and France before returning to the University of Texas at Austin in 1995. He was named the Inventor of the Year by the University of Texas at Austin in 2017. He is the co-founder of several pharmaceutical companies. Dr. Williams’ research interests include development of novel drug delivery systems for oral, pulmonary, nasal, injectable, buccal, and topical applications, development of novel particle engineering technologies for low molecular weight drugs, peptides and proteins, and analytical technologies to characterize actives, excipients, and polymers. He has published over 500 peer-reviewed research articles, reviews, abstracts and book chapters, and co-edited two books in the fields of pharmaceutical technology and drug delivery. He is an inventor on over 60 patents and patent applications.
Board of Directors
Glenn Mattes
President, Chief Executive Officer and Director
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Glenn Mattes
President, Chief Executive Officer and Director
Glenn Mattes joined the company in May 2018, bringing more than 30 years of business leadership, global therapeutics development expertise, and executive management experience to his role with the company.
In his capacity as Chief Executive Officer, Mr. Mattes, has oversight of the direction and strategy at TFF Pharmaceuticals, facilitating company activity in business development, marketing, investor relations, commercialization alliances and channels, and management support. He works to share the company’s vision and strategy with partners, investors and shareholders.
As Executive Chairman of Translational Sciences, Inc. the company consummated a global strategic collaboration in 2015 with Daiichi Sankyo for its lead cardiovascular asset. Prior to joining Translational Sciences, Mr. Mattes was CEO of Arno Therapeutics, a publicly traded company with a portfolio of development stage oncology therapeutic compounds, and a highly regarded group of founding investors.
From 2002 thru 2011 Mr. Mattes served as President of Tibotec Therapeutics, a Johnson & Johnson operating company, where he led, from inception, the organization responsible for the development, marketing, sales and business development of oncology and novel antiretroviral therapeutics. Tibotec’s revenues grew from zero to approximately $1 billion under Mr. Mattes’ leadership. During his Tibotec tenure, he led the successful launch of the first two Johnson & Johnson products launched into the HIV/AIDS market and presided over the growth of both Doxil and Procrit in the oncology therapeutic and supportive care categories.
From 1998 thru 2002 Mr. Mattes served as Vice President of Worldwide Commercial and Clinical Operations at Centocor Inc. He played a critical role in defining the company’s overall business direction as well as developing and implementing the strategy leading to the growth of ReoPro and the commercial launch of Remicade.
Prior to joining Centocor Mr. Mattes was at Rhône Poulenc Rorer, where he held positions of increasing responsibility, including President of RPR Canada and General Manager of U.S. pharmaceuticals. At Rhône Poulenc Rorer he built a market-leading asthma and allergy business with a focus on inhalation therapies. In addition, he was the General Manager of Advanced Therapeutics and Oncology, North America, and headed the successful launches of two blockbuster drugs, Taxotere and Lovenox.
In 2008 Mr. Mattes was honored with an appointment to the President’s Advisory Council on HIV/AIDS by President George W. Bush and the U.S. Secretary of Health and Human Services. In his service to the United States as a member of PACHA he was a key contributor to the committee responsible for counseling both the Bush and Obama administrations on domestic and global health and treatment issues.
Mr. Mattes serves on the Boards of Advantagene, Inc., Deck Therapeutics, Cornovus, Inc. and CannaMetrix. He is an advisor to the Gores Group and Clayton Foundation for Research, and served as an advisor to PTV Healthcare Capital. He is also an Operating Partner of Revival Healthcare.
Mr. Mattes received a Bachelor of Science degree from the City University of New York.
Aaron Fletcher, Ph.D.
Chairman of the Board
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Aaron Fletcher, Ph.D.
Chairman of the Board
Dr. Fletcher is Managing Director of Bios Partners, a life sciences venture firm based in Fort Worth, TX and founded and serves as President of Bios Research, a financial services firm that provides public equity research in the healthcare space tailored to institutional firms and large family offices. Bios Research provides fundamental healthcare industry research focused in the biotech and med-tech sub-sectors and through this research, Dr. Fletcher has a strong understanding of commercial viability in the marketplace.
Dr. Fletcher holds a PhD in Biochemistry from Colorado State University and currently serves as a visiting professor at Dallas Baptist University. Dr. Fletcher has worked as an independent consultant for the biotech/healthcare equity industry for over 10 years.
Robert S. Mills
Director
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Robert S. Mills
Director
Mr. Mills is a 39-year veteran in the pharmaceutical industry. Bob’s expertise ranges across GMP Operations, Clinical Research, Regulatory Affairs and Commercial Operations as well as R&D, IT, Product Development, Technical Services, Manufacturing, Engineering and Quality Assurance. Mr. Mills has a large network of industry relationships, as well as a very strong track record successfully managing businesses, delivering quality products, successfully interacting with the FDA, and generating attractive growth through expanding market share and launching exciting new products.
Most recently, he was the President and CEO of Scientific Protein Labs (SPL), the US’s leading manufacturer of heparin and pancreatin. Recently, Mr. Mills sold SPL to a Chinese pharmaceutical company for 3 times the original purchase price and with milestone payments over the next several years could be as high as 5 times the original purchase price.
Prior to SPL, Mr. Mills was President of Qualitest Pharmaceuticals, a leading manufacturer and distributor of generic pharmaceuticals. He joined Qualitest in early 2010 with the specific charge to grow the business at a quicker pace. In less than one year, monthly net sales increased by over 50 percent. In late 2010, Qualitest was acquired by Endo Pharmaceuticals for $1.2 billion or 15 times EBITDA.
Prior to Qualitest, Mr. Mills was recruited to Columbia Laboratories, Inc. in 2001 to solve a worldwide recall issue for the principal product and re-launched the product to the marketing partner within 4 months. He was also responsible for a product with a completely new delivery system being approved on its PDUFA date and after becoming CEO in 2006 more than doubled sales to $36 million in two years. As Vice President and General Manager of Watson/Schein’s solid dose division, after correcting a number of quality and regulatory issues through a voluntary corrective action plan with FDA, the Company received 5 new product approvals. The launch of these products coupled with operational efficiencies resulted in an improvement of profitability in one year by $60 million which was instrumental in Schein being acquired by Watson.
Mr. Mills served as Vice President of Operations at Alpharma, Inc. from 1993 to 1996. Prior to Alpharma, Mr. Mills held various positions with Sanofi including Director-Plant Operations, Rhone-Poulenc Rorer. His business development experience has led to multiple product acquisitions, joint ventures and product divestitures. He was recognized as a finalist for Entrepreneur of the Year for New Jersey in 2009 by Ernst and Young. Mr. Mills holds a B.S. Degree from Grove City College and numerous graduate business credits from Temple University.
Stephen Rocamboli
Director
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Stephen Rocamboli
Director
Mr. Rocamboli is an experienced business and legal executive with a record of adding significant value for investors and companies in the life sciences arena. In his role as Chief Business Officer for Advantagene, he helps direct corporate strategy, leads corporate finance activities and strategic partnering transactions, manages legal affairs, and drives certain operational initiatives. He also serves as Advantagene’s corporate secretary.
As a member of the Paramount BioCapital executive team he participated in the completion of nearly $1 Billion in private financing transactions (debt and equity) as well as the launch and operation of several investment funds with collective assets in excess of $1 Billion. This also included the founding of more over 20 life science companies, many of which are publicly traded or have been sold, including ZioPharm Oncology (ZIOP), Chelsea Therapeutics International (acquired by Lundbeck), Cougar Biotechnology (acquired by J&J), Javelin Pharmaceuticals (acquired by Hospira), Velcera (acquired by Perrigo), and Cutanea Life Sciences (acquired by Maruho). Ultimately becoming Senior Managing Director & General Counsel at Paramount, Mr. Rocamboli’s expertise includes M&A, strategic partnering and licensing, and corporate finance. Mr. Rocamboli then led Pear Tree Pharmaceuticals as President until its sale to Daré Bioscience. Immediately prior to joining Advantagene, Mr. Rocamboli worked as a strategic consultant and legal counsel to life science entrepreneurs, companies and investors throughout the world. Mr. Rocamboli has been a member of the board of directors of numerous public and private companies and is currently a member of the board of directors of Cortice BioSciences (New York, NY) and Androvia Life Sciences (New York, NY) and was a member of the board of directors of Foresight Therapeutics until its sale to Shire Pharmaceuticals in 2015.
Mr. Rocamboli is a graduate of the State University of New York at Albany (B.A) and Fordham University School of Law (J.D).
Harlan Weisman, M.D.
Director
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Harlan Weisman, M.D.
Director
Harlan F. Weisman, M.D. has 30 years’ experience as a senior healthcare executive responsible for the discovery, development, regulatory approval and launch of pharmaceutical, biopharmaceutical, medical device and diagnostic products. He is currently Managing Director of And-One Consulting, LLC, advising medical product companies, investment firms, and government and non-government healthcare organizations in formulating and implementing strategies for driving innovation in healthcare products and services. Dr. Weisman is also on the Board of Directors of ControlRad, Inc. and 3DBio Therapeutics. He is a Senior Advisor to CRG, a healthcare investment firm and a Venture Advisor to the Israel Biotech Fund. He is on advisory committees to the Johns Hopkins University Institute for Basic Biomedical Sciences, Memorial Sloan Kettering Cancer Center and BioMotiv, a medical product accelerator company.
Previously, Dr. Weisman was Chairman and CEO of Coronado Biosciences, Inc., a biopharmaceutical company that was developing novel immunotherapies for autoimmune diseases and cancer. Prior to Coronado, he was a senior executive at Johnson & Johnson for over 20 years. Dr. Weisman was the Chief Science and Technology Officer of the J&J Medical Devices and Diagnostics Group from 2006-2012. He served on the Board of Directors of J&J Development Corporation (JJDC) and as Chairman of the J&J Worldwide R&D Council. Preceding these roles, he was Company Group Chairman, J&J Pharmaceutical Research & Development, and before this he was President of Centocor R&D. Prior to joining industry, Dr. Weisman was Assistant Professor of Medicine at Johns Hopkins University School of Medicine and Consultant Cardiologist at Johns Hopkins Hospital. He has a B.A. from the University of Maryland and M.D. from the University of Maryland School of Medicine. Dr. Weisman completed an Internal Medicine residency at Mount Sinai Hospital in New York and a fellowship in cardiovascular disease at Johns Hopkins Medical Institutions. He has authored more than 100 articles and book chapters about cardiovascular disease, medical product development, healthcare policy and organizational development.
Randy Thurman
Director
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Randy Thurman
Director
Randy Thurman has been an operating partner and senior advisor in private equity since 2008 and brings over 30 years experience in executive leadership, M&A and corporate governance. As a CEO, his background has focused in the healthcare technology industry specifically biopharmaceuticals, medical devices and clinical diagnostics. Additionally, he brings a global perspective having started and operated businesses in North America, Europe, Asia, the Middle East and Latin America. Early in his career he was Director and President of Rhone-Poulenc Rorer Pharmaceuticals. Subsequently, he became Chairman and CEO of Corning Life Sciences and then was Founder, Chairman and CEO of VIASYS Healthcare Inc., a global leader in respiratory and neuro diagnostics, critical care systems and orthopedics.
Randy has extensive experience working with private equity firms and has participated in transactions globally. He is currently Executive Chairman, Outlook Pharmaceuticals Inc. Vice Chairman, Syntone BioPharma Inc. and Director, TFF Pharmaceuticals and chairman of the audit committee. He is also on the Advisory Board of Villanova University Law School, Scarpa Center for Law and Entrepreneurialism. Randy has served on numerous boards and has published a number of articles on corporate governance. Prior to his corporate career he served as a fighter pilot in the U.S. Air Force.
Randy graduated from Virginia Polytechnic Institute with a BS in Economics; Webster University with a MA in Management; and is a graduate of the USAF Air Command and Staff College.
Malcolm Fairbairn
Director
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Malcolm Fairbairn
Director
Mr. Fairbairn was the Co-Founder, President and Chief Investment Officer for Ascend Capital, a multi-billion dollar Long-Short Equity fund for almost 20 years. In particular, he led vertically specialized teams that invested across all market sectors. Prior to Ascend, Mr. Fairbairn established a successful track record as a Managing Director for Citadel, LLC, and as a portfolio manager for Strome Susskind LLC.
Mr. Fairbairn holds an MBA from Harvard Business School and an MS and BS from MIT in Chemical Engineering.
Brandi Roberts
Director
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Brandi Roberts
Director
Ms. Roberts has over 25 years of public accounting and finance experience, including 22 years at publicly traded pharmaceutical, medical technology, and life science companies. Ms. Roberts has served as the Chief Financial Officer of Longboard Pharmaceuticals, Inc. (LBPH) since January 2021. Previously, Ms. Roberts served as Chief Financial Officer of Lineage Cell Therapeutics, Inc. (LCTX) from January 2019 to January 2021. Prior to joining Lineage, she served as Chief Financial Officer of REVA Medical, Inc. Ms. Roberts previously served as Chief Financial Officer of Mast Therapeutics, Inc. from January 2013 to April 2017, and as its Senior Vice President, Finance, from March 2011 to January 2013. Previously, she held senior positions at Alphatec Spine, Inc., Artes Medical, Inc., Stratagene Corporation, and Pfizer, Inc. Ms. Roberts currently serves as Chair of the Southern California Chapter of the Association of Bioscience Financial Officers and has served on the Board of Temple Therapeutics BV since November 2019. Ms. Roberts is a certified public accountant with the State of California and received her B.S. degree in business administration from the University of Arizona and her M.B.A. from the University of San Diego.
Scientific Advisory Board
David N. Cornfield, M.D.
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David N. Cornfield, M.D.
Dr. Cornfield is the Anne T. and Robert M. Bass Professor of Pulmonary Medicine at Stanford University and the Director of the Center for Excellence in Pulmonary Biology at Stanford, and Chief of the pediatric pulmonary, asthma, and sleep medicine divisions at Stanford University and Lucile Packard Children’s Hospital.
Annually recognized, both regionally and nationally as “Best Doctor” and “Top Pediatrician,” Dr. Cornfield has received numerous professional honors including the Daniel C. Darrow Award from Children’s Mercy Hospital, the Richard B. Rowe Award for outstanding achievements in perinatal cardiology from the Society for Pediatric Research, and the Established-Investigator and Clinician-Scientist Awards from the American Heart Association.
Dr. Cornfield serves on the National advisory committee for the Burroughs Wellcome Foundation Physician-Scientist task force and co-Director of the Chan-Zuckerberg Biohub Physician-scientist program. He serves on the editorial boards of the American Journal of Physiology, Pediatrics, and Pulmonary Circulation.
Continuously funded by the NIH since 1998, the Cornfield lab focuses on the development of blood vessels in the lungs and the molecular mechanisms responsible for sensing changes in oxygen tension, providing significant insight into the cellular and subcellular mechanisms that determine pulmonary vascular tone and lung development. His clinical research has focused on methods to treat acute lung injury in infants and children and other areas of research include clinical lung injury, violence prevention in developing countries, microlending in Africa, optimizing the electronic medical record, and preserving physician-scientists in pediatrics.
Dr. Cornfield earned his medical degree from the University of Wisconsin School of Medicine and completed his residency at Children’s Mercy Hospital in Kansas City, Missouri where he was recognized as a Chief Resident and as the Most Outstanding House Officer.
Prof. David Denning, FRCP FRCPath DCH FMedSci
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Prof. David Denning, FRCP FRCPath DCH FMedSci
David Denning is an infectious diseases clinician with expertise in fungal diseases. Now retired from clinical practice, he is currently a Professor of Infectious Diseases in Global Health at the University of Manchester. He is also the Founding President and Chief Executive of the Global Action Fund for Fungal Infections and the Executive Director of Leading International Fungal Education. He founded two University spinout biotechnology companies – F2G Ltd (antifungal drug discovery and development) and Myconostica Ltd (molecular diagnostic tests for fungi).
Professor Denning’s research efforts are directed at improving clinical outcomes for patients with fungal infections and more recently fungal allergy. He has published more than 600 papers, books and book chapters and lectures worldwide. In addition to serving on the advisory board of TFF Pharmaceuticals, he acts or has recently acted as a consultant to Pulmatrix, Pulmocide, Zambon, Biosergen, Bright Angel Therapeutics, Cipla, Pfizer and Fujifilm.
Professor Denning graduated from Guys Hospital in London in 1980 and was trained in London and Glasgow in internal medicine and infectious diseases. He completed additional research training at the MRC Clinical Research Centre in Harrow, UK as well as a three-year fellowship at Stanford University, Santa Clara Valley Medical Center.
Jay Peters, M.D.
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Jay Peters, M.D.
Dr. Jay Peters is the Chief of Pulmonary and Critical Care Medicine at the University of Texas Health Science Center at San Antonia and Adjunct Professor of Molecular Pharmaceutics and Drugs Development at University of Texas in Austin.
Currently, his clinical research and basic science focuses mainly in the areas of asthma, COPD, interstitial lung disease and non-tuberculous mycobacterium. He has been investigating Mycoplasma pneumonia’s role in the initiation and persistence of chronic asthma which has been supported by the National Institute of Health, the Department of Defense, the Gates Foundation and through Clinical Translational Science Awards.
Dr. Peters received his undergrad from the University of Texas at Austin. He attended Baylor College of Medicine where he received his MD and where he stayed for his residency and postdoctoral fellowship.
Ted M. Ross, Ph.D.
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Ted M. Ross, Ph.D.
Joining with over 20 years of experience in research and immunology, Dr. Ross is a tenured Professor at the University of Georgia in the Center for Vaccines and Immunology and the Department of Infectious Diseases. During his tenure, he worked as the Director of the Center for Vaccines and Immunology and Georgia Research Alliance Eminent Scholar and Professor of Infectious Diseases at the University of Georgia. He explored new vaccine technologies intended to protect against various influenza strains and applied this strategy to other serious viruses.
In 2003, Dr. Ross began his own laboratory as Principal Investigator at East Carolina University which eventually moved to the University of Pittsburgh in the Department of Medicine-Infectious Diseases, Microbiology and Molecular Genetics, and as a founding member of the Center for Vaccine Research where he stayed for 10 years. Dr. Ross explores new vaccine technologies intended to protect against all strains of influenza – an endeavor that could potentially eliminate the need for seasonal flu shots. Dr. Ross and his colleagues are applying similar strategies to fight other serious viruses such as, Dengue, Zika, Ebola, Chikungunya, and HIV Type-1 viruses.
Dr. Ross earned his undergraduate and graduate studies in Zoology and Microbiology at the University of Arkansas, and he received a Doctorate in Microbiology and Immunology from Vanderbilt University in 1996. He performed his post-doctorate fellowship at Duke University on HIV biology of viral entry. He also worked at Emory University on vaccine development for HIV and influenza viruses. He has published more than 220 papers and book chapters on infectious disease and vaccine development.
Mike Saag, M.D.
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Mike Saag, M.D.
Dr. Saag is a physician and prominent HIV/AIDS researcher at the University of Alabama at Birmingham (UAB). He is currently a Professor of Medicine at UAB School of Medicine and Director of the UAB Center for AIDS Research. He is also an attending physician in the Department of Medicine, UAB School of Medicine and Secondary Appointment to Epidemiology, UAB School of Public Health.
Listed by many prominent publications as one of the best doctors in America since 1994, and a recipient of numerous accolades including Castle-Connelly Physician of the Year, Dr. Saag has over 40 years of research experience, and recently served as a member of the COVID-19 Task Force for Congress by the Federation of American Scientists. Dr. Saag is currently on the Board of Directors for the International AIDS society and is a member of the President’s Advisory Council on HIV/AIDS (PACHA).
He has published over 500 articles in peer reviewed journals, including the first description of the use of viral load in clinical practice (Science, 1993), the first description of the rapid dynamics of viral replication (Nature, 1995), the first guidelines for use of viral load in practice (Nature Medicine, 1996), the first proof of concept of fusion inhibition as a therapeutic option (Nature Medicine, 1998), and directed the ‘first-in- patient’ studies of 7 of the 25 antiretroviral drugs currently on the market (including indinavir, efavirenz, abacavir, and enfuvirtide).
Dr. Saag earned his medical degree from University of Louisville.
Drew Weissman, M.D., Ph.D.
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Drew Weissman, M.D., Ph.D.
Drew Weissman, M.D., Ph.D., is a physician-scientist and pioneer in the science of immunology, with major contributions to the field. He is the Roberts Family Professor in Vaccine Research at the Perelman School of Medicine at the University of Pennsylvania. Dr. Weissman’s laboratory is centered on the study of ribonucleic acids (RNA) and innate immune system biology, as well as the applications these areas have to vaccine research, therapeutic proteins, and gene therapy. Most notably, his research on messenger RNA (mRNA) biology, conducted with collaborator Katalin Karikó, Ph.D., helped pave the way for the first two FDA-approved mRNA vaccines to treat COVID-19.
Dr. Weissman and his lab team continue to conduct basic scientific research to understand how nucleoside-modified mRNA could be used to advance safe and effective vaccines and therapeutics for various diseases. He is a co-author of numerous publications related to vaccines for infectious diseases including flu, herpes and HIV and is the recipient of multiple accolades in medicine and research, including the NIH Merit Award, NIH Special Achievement Award, and the 50th Rosenstiel Award for Distinguished Work in Medical Science.
Dr. Weissman earned his B.A./M.S. in Biochemistry/Enzymology from Brandeis University and his M.D./Ph.D. in Immunology/Microbiology from Boston University.
Collaboration Opportunities
We continue to work with the inventors of the TFF platform through a series of Sponsored Research Agreements, or SRAs, with UT. Pursuant to those agreements, the research scientists, together with their labs and collaborators, provide expertise and initial development work, including:
- the preliminary development and in vitro evaluation of our drug candidates;
- the determination of the key characteristics influencing performance of our product candidates;
- the determination of the formulation and manufacturing parameters that influence the key characteristics of our product candidates;
- supply of bulk dry powders for initial good laboratory practice, or GLP, and non-GLP toxicity studies;
- supportive stability for future GLP and GMP studies; and
- the evaluation of the in vivo performance of our product candidates in various animal models.
Pathway to Market
Because our dry powder drug candidates will represent a new formulation of an existing drug, we will need to obtain FDA approval of the TFF prepared drug candidate before we can begin commercialization. However, because we begin our formulation with a drug that has previously received FDA approval in another form, we believe that in most cases we should qualify for the FDA’s 505(b)(2) regulatory pathway, which potentially will take less time and investment than the standard FDA approval process.
