NanOlogy nanoparticle production technology platform

About

Overview

NanOlogy, LLC is a clinical stage pharmaceutical development company formed by the collaboration of DFB Pharmaceuticals, CritiTech, and US Biotest to advance our patented submicron particle production technology platform for the treatment of cancer and other serious illnesses. Starting with the world’s most prescribed systemic chemotherapy agents, our technology platform reduces unprocessed paclitaxel and docetaxel API crystals by up to 400 times into patented, stable, naked submicron particles with tremendous surface area and unique geometry.

NanOlogy has developed these submicron particles into sterile injectable, topical, and inhalable products and has a clinical program underway to evaluate these products across multiple indications in cancer and related illnesses. The program includes clinical trials in ovarian, prostate, and pancreatic cancers, pancreatic cysts, cutaneous metastases, and actinic keratosis under affiliate, Soria. In addition, nonclinical studies via nebulized inhalation are underway for the treatment of lung cancer.

The NanOlogy Partnership

Nanology is a company formed by the collaboration of DFB Pharmaceuticals, CritiTech, and US Biotest to finance and develop a technology platform to produce unique, patented, naked submicron particle forms of paclitaxel and docetaxel for delivery directly to the site of disease in the treatment of cancer and other serious conditions.

DFB Pharmaceuticals, LLC is a private Texas investment group with an entrepreneurial drive for developing new products and businesses in healthcare. Founded in 1990, DFB has established a successful track record of creating value through start ups, strategic acquisitions of companies and technologies, internal product development, brand optimization, and operations in the pharmaceutical industry. DFB has realized more than $1.5 billion to date from the growth and sale of companies in the pharmaceutical industry.

Visit DFB.com

CritiTech, Inc. is private Kansas particle engineering company focused on developing new drugs and improving existing drugs. Using the company’s proprietary Supercritical Precipitation Technology (SCP Technology) CritiTech specializes in optimizing the delivery of challenging drug substances, potent molecules and poorly soluble compounds. In addition, CritiTech uses its SCP Technology to improve the efficacy, drug delivery options, dosing regimen and pharmacokinetics of wide variety of drugs, including oral, injectable, and inhaled drugs.

Visit CritiTech.com

US Biotest, Inc. is a private California company founded in 2000 that is dedicated to the development of therapeutics to address serious unmet medical needs. Building on strong relationships with industry experts, academic institutions, and leading physicians, the company provides product development strategy and support. US Biotest manages efficient delivery of programs from nonclinical through late-stage clinical trials.

US Biotest

The NanOlogy Team

Led by H. Paul Dorman of DFB, the NanOlogy team is comprised of eight executives across DFB, CritiTech and US Biotest, who work together to advance the NanOlogy clinical programs and business activities.

H. Paul Dorman, Chairman & CEO, DFB Pharmaceuticals

Paul is Chairman and CEO of DFB Pharmaceuticals.  In 1990, Paul and two partners founded DFB with the purchase of DPT Laboratories from Alcon. From there, Paul expanded DFB into a portfolio of healthcare companies growing from $18 million to more than $400 million in annual sales, with operations in Texas, New Jersey, Germany, and Canada. This growth was achieved with no shareholder dilution. By the end of 2012, DFB had sold major operating companies including Coria to Valeant, Healthpoint to Smith & Nephew, and majority interest in DPT to Renaissance Pharmaceuticals. In all, under Paul’s leadership, DFB has realized more than $1.5 billion of value to date.

In 2013, Paul and a remaining partner invested some of the proceeds into a new vision for DFB. This vision leveraged retained operating company, Phyton Biotech, to establish a foothold in oncology, and discover new investment opportunities in and around oncology. This led to the identification of an innovative nanoparticle production technology, and partnership with CritiTech and US Biotest in 2015, to develop a nanoparticle drug development platform under a newly created affiliate, Nanology, LLC. Through Nanology, Paul assembled a team of internal and external experts who has recently progressed this platform into multiple clinical trials across oncology, dermatology, and women’s health.

Today, Paul continues to lead DFB and is also involved in a number of philanthropic endeavors. Before founding DFB, Paul had nearly two decades of executive leadership experience with Johnson & Johnson and Baxter. He is also the past owner of three industrial distribution companies, which he turned around to profitability from Chapter 11 status at acquisition, and, ultimately, sold to a large, public corporation. 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 diZerega, MD,  CEO, US Biotest

Gere serves as Vice President of Clinical Affairs and Medical Director for NanOlogy. Gere is also CEO and Chairman of US Biotest, and played a key role in establishing the partnership with CritiTech and DFB to form NanOlogy. He, and his team at US Biotest, are responsible for regulatory affairs, clinical trial design, and oversight of clinical trials for all of NanOlogy’s programs.

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 MD 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 Mitchell, Chief Legal Officer & Managing Director, DFB Pharmaceuticals

Mark is 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 Executive Committee of Phyton Biotech and part of the Nanology management team.  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 lead 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, TableTop Media LLC, and holds a Bachelor of Business Administration from Texas A&M University and a Juris Doctor in Law from Southern Methodist University.

Maxwell Lea, Managing Director, DFB Pharmaceuticals

Maxwell is a Managing Director with DFB, and is part of a team that manages DFB’s business interests in pharmaceutical manufacturing and product development.  He also 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 (a DFB company), 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, Table Top Media LLC, Bio NorthTX, and Tech Fort Worth.  He has earned the Chartered Financial Analyst designation, and graduated with a Bachelor of Arts degree from Vanderbilt University and a Master of Business Administration from The Fuqua School of Business at Duke University.

Marc Iacobucci, Managing Director, DFB Pharmaceuticals

Marc is a Managing Director of DFB and serves on the executive committee of Phyton Biotech, a company wholly owned and operated by DFB. He is part of a small team responsible for identifying new healthcare investment opportunities and leading them through development to value creation for DFB. Currently, he is primarily involved in advancing a broad clinical program in oncology, dermatology, and woman’s health for DFB affiliate, Nanology, LLC, which was formed in 2015.  Prior to his current role, Marc led establishment of Phyton as a commercial operation.

Marc has been with DFB since 1993 with leadership roles in business development, marketing, project management, and operations across DFB’s 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 degree in Clinical Pharmacy, Marc received his Master of Business Administration from the University of Texas at Austin.

Sam Campbell, Chairman, CritiTech

Sam is Chairman of CritiTech and has been with CritiTech in leadership roles since 2003. He played an integral role in establishing and advancing CritiTech’s nanoparticle production technology, which now forms the basis for NanOlogy’s 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 graduation with an MBA he 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 also was one of the founders of University National Bank where he still serves on the board of directors.

Matthew McClorey, President, CritiTech

Matthew is the president of CritiTech where he is responsible for leading the company’s strategy and managing its operations. He also serves on the CritiTech board of directors.

Prior to joining CritiTech, Matthew was the president of the Bioscience & Technology Business Center (“BTBC”) at the University of Kansas where he helped entrepreneurs create and grow early-stage life sciences and other high-technology companies. He consulted with dozens of start-up businesses on corporate strategy, operations management, sales, marketing, financial management, and capital fundraising. BTBC’s clients raised $190,000,000 while Matthew served as its president.

Before leading BTBC, Matthew was vice president of business development and portfolio management for the Kansas Technology Enterprise Corporation (“KTEC”), where he managed a multi-million-dollar fund of debt and equity investments in early-stage technology companies, and provided management consulting services to those companies. Earlier, Matthew was with Deloitte Consulting, where he served as a senior consultant providing strategy and information technology consulting services to Fortune 1000 companies.

Matthew earned his J.D. and M.B.A. from the University of Kansas and his B.A. in Business from Benedictine College.

Michael Baltezor, PhD, Chief Scientific Officer, CritiTech

Mike is 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.  This includes 10 years with Sandoz, 13 years with Marion Laboratories and successor companies, 7 years with Quintiles, 4 years with Cardinal Health and 7 years at the University of Kansas.  In addition to the CSO role with CritiTech, Mike continues to run the Biotechnology Innovation and Optimization Center (BIOC) at the University of Kansas which conducts drug delivery projects in support of the development of new drugs.  Mike also serves as the Deputy Director of the institute for Advancing Medical Innovation (IAMI) and the Director of the Lead Development and Optimization Shared Resource (LDOSR) for the KU Cancer Center.

Mike received his BS degree in Chemistry in 1972 and an honorary Ph.D. in 2005 from Missouri Western State University.  He received his MS and Ph.D. in Pharmaceutics and Pharmaceutical Chemistry in 1977 from the University of Kansas.

NanOlogy Advisors

Maurie Markman, MD, MS, FACP, FASCO
President, Medicine & Science, Cancer Treatment Centers of America®

A nationally-renowned oncologist, Dr. Markman is President of Medicine and Science at Cancer Treatment Centers of America (CTCA). Previously, he was Senior Vice President of Clinical Affairs and National Director of Medical Oncology.

Dr. Markman has more than 30 years of experience in cancer treatment and research at some of the country’s most recognized facilities, with a particular focus on new drug development and exploring novel management strategies in the area of female pelvic cancers.  Dr. Markman has been the primary author or co-author on over 1,500 published peer-reviewed manuscripts, reviews, book chapters, editorials or abstracts, and has written, edited or co-edited 24 books on various topics in the management of malignant disease.

In June 2011, he received the esteemed American Society of Clinical Oncology (ASCO) Statesman Award. Presented annually, the Statesman Award recognizes individual ASCO members who have shown extraordinary volunteer service, dedication and commitment to ASCO, their hospital community and the patients they serve for at least 20 years.

He is widely regarded for his knowledge and expertise as a practicing clinical oncologist and is frequently asked to be a visiting professor and guest lecturer at universities and medical schools across the country. He has served as a member of numerous national and regional oncology committees.

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