NanOlogy, LLC formed in 2015 as a clinical-stage oncology company advancing a particle engineering technology platform designed to enhance the efficacy of intratumoral therapy while minimizing the serious adverse effects associated with systemic cancer agents.
Technology: The NanOlogy commercial scale GMP production platform precipitates dissolved drug substances with sonication and compressed supercritical carbon dioxide to form stable large surface area microparticles (LSAMs) of pure drug containing no excipients or coating agents. LSAMs have a disproportionately large surface area to particle size ratio that enables retention of particles at the disease site and continuous local drug release over time with gradual systemic clearance at subtoxic levels. Initial investigational drugs are LSAM-PTX and LSAM-DTX, which have completed clinical trials in multiple solid tumors with excellent tolerability and promising signs of tumor response and immunomodulation. NanOlogy has established feasibility of forming LSAMs in multiple drug classes including taxanes, cisplatin, TKIs, and PARPIs.
Therapeutic Potential: Therapeutic potential exists across the cancer disease spectrum with NanOlogy intratumoral investigational drugs. In local disease, the potential to delay or prevention of solid tumor progression as an alternative to organ removal or other invasive procedures as the only curative options. In metastatic disease, the potential for immunomodulation by sustained primary tumor cell death to boost the local and systemic response to immunoncology therapies without adding systemic toxicity.
Paul is Chairman and CEO of NanOlogy and DFB Pharmaceuticals. In 1990, Paul and two partners founded DFB growing annual sales from $18 million to more than $400 million across multiple companies, with operations in Texas, New Jersey, Germany, and Canada. This growth was achieved with no shareholder dilution. DFB sold major operating companies by 2012 realizing more than $1.5 billion of value.
In 2013, Paul and a remaining partner invested some of the proceeds into a new vision for DFB. This vision leveraged a retained operating company, Phyton Biotech, to establish a foothold in oncology. This led to the identification of an innovative large surface area microparticle (LSAM) production technology, and collaboration with CritiTech in 2015, to develop the technology under a newly created venture, NanOlogy, LLC. NanOlogy has now progressed investigational drugs based on the technology into clinical research across multiple solid tumors.
Before founding DFB, Paul had nearly two decades of executive leadership experience with Johnson & Johnson and Baxter, and owner of several industrial distribution companies culminating in successful turnarounds and divestitures. Paul serves on the board of directors of Renaissance Acquisition Holdings LLC, Multicultural Alliance, and RXi Pharmaceuticals Corporation. He holds a Bachelor of Science degree in Mechanical Engineering from Tulane University and a Juris Doctor of Law from Loyola University.
Gere leads medical affairs for NanOlogy. Gere is also CEO and Chairman of US Biotest, and played a key role in establishing the collaboration with CritiTech and DFB to form NanOlogy. He, and his team, are responsible for medical and regulatory affairs, preclinical research, and early clinical trial research for NanOlogy.
Gere’s aptitude for drug development was demonstrated while a professor at the University of Southern California, where his research received funding from the NIH, Department of Defense, National Science Foundation, and BARDA. This work led to the elucidation of the renin-angiotensin system in epithelial tissue repair and preovulatory follicle development in the ovary. Projects initiated at the discovery level in Gere’s laboratory at USC were advanced to US Biotest, a drug development company he founded to support regulatory activities and perform clinical trials.
Gere has since contributed to development and regulatory approval of many products sold worldwide, and has collaborated with several “big pharma” companies in creating successful products. He has been recognized for this work by many professional societies in the United States and around the world.
Gere graduated from the University of Kansas, majoring in comparative physiology and cell biology. He received his Doctor of Medicine from Baylor College of Medicine, completed his residency at Keck School of Medicine, University of Southern California-Los Angeles County Medical Center, and completed his fellowship at NIH and Walter Reed Army Medical Hospital.
Mark leads legal and regulatory affairs for NanOlogy. Mark is also Chief Legal Officer and a Managing Director of DFB and has over 25 years of experience as an executive in the pharmaceutical industry. In addition to serving as DFB’s General Counsel, Mark is on the DFB and Phyton Biotech Executive Committees.
As outside counsel, Mark joined the DFB board of directors in 1990, and joined DFB as its Chief Legal Officer in 1993. He has also established and led Quality, Regulatory Affairs and Compliance functions across multiple pharmaceutical businesses in the DFB family of companies. Prior to joining DFB, Mark spent twelve years as a corporate lawyer in private practice. He currently serves on the board of DFB Pharmaceuticals LLC and TableTop Media LLC. Mark holds a Bachelor of Business Administration from Texas A&M University and a Juris Doctor in Law from Southern Methodist University.
Maxwell leads finance and corporate development for NanOlogy. Maxwell is also a Managing Director of DFB. He is part of a team that manages DFB’s business interests in pharmaceutical manufacturing and product development. Maxwell serves on the DFB and Phyton Biotech Executive Committees and plays a lead role in developing, evaluating, structuring, and executing new business and investment opportunities.
Prior to his current role, Maxwell was Vice President of Corporate Development for DFB, where he led strategic planning, acquisition and growth initiatives across multiple life science and medical technology businesses. For four years prior to its sale, he was a member of the senior management team of Healthpoint Biotherapeutics, leading business development and international sales and marketing. He initially joined DFB as Director of Corporate Finance with responsibility for capital raising and financial planning and analysis for DFB and its portfolio of companies.
Before joining DFB, Maxwell was an investment banker with Bank of America Securities, where he was responsible for the execution of capital raising and M&A transactions in a variety of industries. He currently serves on the boards of Renaissance Acquisition Holdings LLC, TableTop Media LLC, Bio NorthTX, and Trinity Valley School.
Maxwell holds a Bachelor of Arts degree from Vanderbilt University, and a Master of Business Administration from The Fuqua School of Business at Duke University.
Marc leads product and business development for NanOlogy. Marc is also a Managing Director of DFB and is part of a small talented team responsible for identifying new healthcare investment opportunities and leading them through development to value creation. Marc helped establish NanOlogy in 2015 to advance tumor-directed drug therapy. Prior to his current role, Marc led the transformation of Phyton Biotech, a company wholly owned and operated by DFB, to a standalone commercial API business.
Marc has been with DFB since 1993 with leadership roles in business development, marketing, project management, and operations across the DFB family of companies. Earlier in his career, Marc worked for Procter & Gamble as a market analyst, Merck as a pharmaceutical representative, and as a clinical pharmacist in Ohio and Texas.
A graduate of the Ohio State University with a Bachelor of Science in Clinical Pharmacy, Marc received his Master of Business Administration from the University of Texas at Austin.
Mike leads up formulation development and CMC activities for NanOlogy. Mike is also the Chief Scientific Officer of CritiTech, Inc. He joined CritiTech in 2014 and has over 40 years of experience in in the development of pharmaceutical products including 10 years with Sandoz, 13 years with Marion Laboratories and successor companies, 7 years with Quintiles, 4 years with Cardinal Health and 9 years at the University of Kansas.
During his career, Mike contributed to the development and launch of several new and reformulated products including Gris-PEG® tablets, Triaminic® cold medications, Tavist® syrup, Tavist-D® tablets, Mellaril® suspension and tablets, Parlodel® tablets, Zinecard® injectable solution, Cardizem QD® capsules, Anzemet® tablets and injectable solution, Allegra D® tablets, Allegra® suspension, Pentasa® capsules, Silvadene® cream, and Chlora-Prep®. Most recently, Mike spent 9 years at KU helping early-stage oncology compounds advance from research into clinical trials.
Mike received his Bachelor of Science in Chemistry in 1972 and an honorary PhD in 2005 from Missouri Western State University. He received Master of Science and Doctor of Philosophy in Pharmaceutics and Pharmaceutical Chemistry in 1977 from the University of Kansas.
Sam is Chairman of CritiTech and has been with CritiTech in leadership roles since 2003 and serves on the board of NanOlogy. He played an integral role in establishing and advancing CritiTech’s large surface area microparticle technology, which now forms the basis for the NanOlogy drug platform.
Sam has been involved in funding and development of early-stage life science and technology companies for over three decades. He has been extensively involved in supporting life science and technology commercialization and has held a variety of roles with the Kansas Technology Enterprise Corporation (KTEC). KTEC is now managed by the Kansas Board of Regents through the Kansas Epscore program, and Sam continues to serve on the advisory committee. In addition, Sam has held leadership roles with the Kansas University Center for Research and is currently a member of the Board of Trustees. Sam is also President of TerraMetrics Agriculture, Inc., a satellite remote sensing company with several applications in the agriculture industry.
Upon earning a Master of Business Administration, Sam entered the banking business and served with several organizations beginning with First National Bank of Topeka. He returned home to join First National Bank of Lawrence and eventually Douglas County Bank. He left Douglas County Bank to establish his own investment group and was one of the founders of University National Bank where he still serves on the board of directors.
Matthew is the president of CritiTech, Inc. where he is responsible for leading corporate strategy, strategic partnerships, and business operations and serves on the board of NanOlogy. He has nearly two decades of executive leadership and investment management experience with early-stage life sciences companies. Start-up technology companies with whom Matthew has worked for or assisted have raised over $200,000,000 in private equity capital. Under his guidance, CritiTech has successfully utilized its Supercritical Precipitation Technology to develop numerous drugs, including the oncology drugs being developed by NanOlogy. Matthew also serves as the president of CritiTech Particle Engineering Solutions, a pharmaceutical contract development and manufacturing organization, customers of which include “Top 15” pharmaceutical companies. Matthew started his professional career as a senior consultant with Deloitte Consulting, where he provided strategy and information technology consulting services to Fortune 1000 companies.
Matthew serves on the boards of CritiTech, CritiTech Particle Engineering Solutions, and NanOlogy. He also serves on the board of Truity Credit Union, founded in 1939, that now serves over 69,000 members and manages more than $800 million in assets. Phillips 66, Conoco Phillips, and Tyson Foods are among the many Select Employee Groups served by Truity.
Matthew received a Juris Doctor in Law and Master of Business Administration from the University of Kansas and a Bachelor of Business Administration (summa cum laude) from Benedictine College.
Mike is an independent advisor to NanOlogy and has acted in this capacity since participating in the formation of the company in 2015. From 2010 until 2022, he was a member of the Board of Directors of DFB Pharmaceuticals, the largest shareholder of NanOlogy. As a director of DFB, Mike was actively involved with a range of strategic initiatives, including the divestments of Healthpoint Biotherapeutics and DPT Laboratories. Following these major transactions and the dissolution of the DFB board, Mike remained with DFB to assist the ownership and management team with the next phase of the company.
Before joining DFB, Mike was a senior investment banker focusing on companies in the pharmaceutical, biotechnology and medical devices sectors. He had leadership roles at various firms, including Wells Fargo, Wachovia Securities, CIBC World Markets, Oppenheimer & Co., and L.F. Rothschild, Unterberg, Towbin.
Mike’s areas of expertise include business strategy, capital markets, M&A and corporate governance developed through his 35+ years as an investment banker, independent advisor and board member for U.S. and international public and private companies.
Mike earned a Bachelor of Science degree in Business Administration from The Pennsylvania State University.