Dr. Windsor has spent the last 18 years in the formation and management of life science-based technology ventures and has led technology development and licensing to major pharmaceutical firms as well as public and private biotechnology companies. Dr. Windsor brings recent leadership experience in pharmaceutical drug development and most recently served as President of Enavail, LLC, a specialty pharmaceutical manufacturing company developing unique formulations for superior drug performance. While at Enavail, Dr. Windsor oversaw all aspects of pharmaceutical drug development, including drug selection, regulatory strategy, preclinical and clinical strategy, GMP manufacturing, and strategic partnering for pharma products.
Prior to his role with Enavail, Dr. Windsor directed portfolio company management for Emergent Technologies Inc. (ETI), an early stage technology venture creation and management company. During his tenure at ETI, Dr. Windsor has served as Managing Director or President for ten of ETI’s portfolio companies and has been involved in the conception, technology licensing, corporate and technical strategic planning, launch, and business development of all of these ventures. Applications areas of these companies span diverse segments within life and material sciences and include pharmaceutical development and manufacturing, drug delivery, and biotechnology.
Prior to joining ETI, he was Founder and Vice President of R&D for Texagen, Inc., a startup focused on genetic and chemical methods for overcoming mechanisms of drug resistance important to medicine and agriculture. At Texagen he directed outsourced research efforts at university labs and third party contract research companies, and he interfaced with corporate partners interested in feasibility studies and in-licensing discussions.
He holds a Ph.D. in Molecular Biology from The University of Texas at Austin, is an invited speaker for both scientific and technology transfer events, and is an inventor on multiple patents and patent applications.
Dr. Idell is a clinical investigator who has been continually funded over the past 30 years by the National Institutes of Health for his work in the areas of acute lung injury and pleural diseases. He is a board-certified internist and pulmonologist who has also directed the Intensive Care Units at Temple University Hospital in Philadelphia and at The University of Texas Health Science Center at Tyler, Texas. He is now Vice President for Research, a Professor of Medicine and Temple Chair of Pulmonary Fibrosis at UTHSCT and Director of an NIH-sponsored Program Project Grant to study the role of the fibrinolytic system in the pathogenesis of lung and pleural disease. Work from that project led to the development of scuPA as a treatment for pleural loculation and of a peptide-based approach to treat acute lung injury and pulmonary fibrosis.
Dr. Idell also continues to manage patients in the UTHSCT Pulmonary Clinic. He has successfully obtained over $27 million in grant support from agencies including the NIH, The American Heart Association, The American Lung Association and various foundations. He is the Director of the Texas Lung Injury Institute of UTHCT and has raised nearly $1 million of philanthropic support for lung injury research to develop novel experimental therapeutics from the community, grateful patients and various foundations in East Texas and has received commitment from the NIH RAID and SMARTT programs to perform IND-enabling studies with his lead therapeutic, LTI-01. In addition to his role as CSO, Dr. Idell also serves as Chair of the Scientific Advisory Board and a Member of the Board of Directors.
Dr. Mazar serves as Head of Product Development in addition to his current position as Director of the Center for Developmental Therapeutics and Entrepreneur-in-Residence at Northwestern University. Prior to this, Dr. Mazar was most recently the Chief Scientific Officer at Attenuon, LLC and has led three projects at Attenuon through IND and into phase II trials. He is currently managing an additional three projects at various stages of IND enabling development. Prior to Attenuon, Dr. Mazar had significant input in three projects that led two successful INDs, two of which made it through phase II trials and one of which is currently in phase II trials. One of these projects was the original development of scuPA for the treatment of myocardial infarction. Thus, Dr. Mazar has extensive expertise in translating early stage science into clinical projects through phase II clinical development and managing this entire process. He also has direct experience in the development of LTI-01 (scuPA) as a clinical therapeutic agent.
During his tenure in biotechnology, Dr. Mazar has led several projects that culminated in several out-license deals as well as funded collaborations. A new partnership deal with a large European venture group on all of Attenuon’s projects has closed. During the partnership process, Dr. Mazar led early and late stage discussion with most every large and mid-size biotechnology company interested in cancer therapeutics. During these discussions, terms sheets were obtained from five different suitors, all of them public companies. While at Attenuon, Dr. Mazar managed $63M of investment capital, the majority of this raised through a single investor, during his nine year tenure and led a road show managed by Bank of America.
John J. Koleng co-founded AlphaVektor, LLC, a life sciences development and industrialization consultancy focused on product development, manufacturing, scale up, commercialization, and supply chain management. He has more than 17 years of experience in the pharmaceutical industry, including over 8 years as a consultant. He specializes in product development, drug delivery technology, current Good Manufacturing Practice (cGMP) for clinical trial supplies and commercial products, facilities, project management, contractor engagement, Quality System requirements, and developing and directing corrective and preventive action (CAPA) initiatives.
During his career, he has guided and assisted numerous life-science client companies in the development of their technology enriched/enabled products, delivery systems, and processes for various clinical indications and commercial opportunities. John’s drug product development experience ranges from nasal/pulmonary products, trandermals, and abuse deterrent systems to liquid-filled capsules, hot melt extruded dosage forms, and nano-dose tablets. He has published numerous scientific research articles on topics including hot melt extrusion, pressurized meter dose inhalation, and aqueous film coating. He is an inventor on 6 issued US patents and numerous pending patent applications.
Prior to his consulting career, Dr. Koleng was Vice President of Industrial Operations at PharmaForm, a contract development and manufacturing organization (CDMO). John was part of the team that started the company in 1996. Over the next 11 years, his roles increased from Vice President of Pharmaceutical Research to Chief Operating Officer before selling the company to Akela Pharma, Inc. in 2007. At the time of the sale, he was responsible for ~ 120 individuals operating over a variety of disciplines in an FDA qualified 40,000 ft2 facility that he helped design and validate. Under his leadership, PharmaForm successfully navigated an FDA preapproval inspection (PAI) ~ 12 months after construction was complete.
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.