President, CEO & Chairman

Michael K. Handley

Mike is successful life science business professional with over 23 years of cross-functional experience in drug/device commercialization, operations, mergers/acquisitions, regulatory/clinical affairs, venture formation/financing, market development and partnering/licensing. Mike has successfully assisted or led in the global commercialization of seventeen devices or drugs that account for over three billion dollars of sales annually. He has experience successfully leading management teams in a variety of capacities in high growth organizations and has secured millions of dollars in venture capital.

Currently, Mike is serving as Chief Executive Officer & Director of Statera Biopharma, Inc. (formerly Cytocom, Inc.) Statera has a pipeline of drugs that target immune disfunction, inflammation, cancer and viruses. Statera uses immune modulation as a cornerstone for mitigating and correcting disease. This new approach is focused on a systems biology approach in which multiple biological pathways are targeted simultaneously with the immune system thus increasing the efficacy and decreasing toxicity.

Prior to Statera, Mike was the CEO and Director of Armis Biopharma (aka CHD Biosciences). Armis is a multi-product development-stage healthcare company that has created a technology platform for the prevention and treatment of topical infectious disease. In his role, Mike was responsible for day-to-day operations, executing a profitable growth strategy, obtaining global product approvals, overseeing intellectual property strategy, product commercialization, business development and financing.

Prior to his work at Armis, Mike served in senior management roles at multiple life science companies. Specifically, Mike was one of the founders and on the management team of Vessix Vascular, Inc. in Laguna Hills California from 2011 to 2012. As a result of his work at Vessix Vascular the Company was acquired for $435M by Boston Scientific. Before his time at Vessix Vascular, Mike was Global Head of Regulatory at Acclarent that was acquired by Johnson & Johnson from 2010 – 2011 and assisted in the integration of the $785M acquisition of Acclarent and their five product lines and driving the global revenue growth of the Ethicon franchise for ENT products. Prior to working with Acclarent/J&J, Mike was the Global Vice President of Regulatory Affairs and Chief Compliance Officer at Spectranetics Corporation, a NASDAQ listed (SPNC) medical device company specializing in laser treatments of blocked arteries and removal of pacemaker leads from 2007 to 2010. Before his time at Spectranetics, Mike was the CEO and Vice President of Business development, Quality and Regulatory at a privately funded biosciences technology company, Accelapure Corporation, from 2005 – 2007. Mike expanded his executive skill set as a Senior Management Consultant in the healthcare field at Pittiglio Rabin Todd & McGrath (now PricewaterhouseCoopers) from 2004-2005. As a Senior Principal at PRTM, Mike assisted Genentech in the successful launch of Avastin (a multi-billion dollar bio-oncology drug) and Tarceva (a multi-million dollar cancer small molecule drug) and assisted in the successful commercial launch for these drug franchises.

Prior to his business career, Mike was a successful and active research scientist having developed multiple patents and written multiple peer reviewed publications. During part of his research career Mike worked at Amgen in their oncology group from 1999 – 2001 and was involved in the discovery and advancement of Motesanib or AMG706 (an oral, small molecule multi-kinase inhibitor that is currently in Phase III trials for lung cancer). Mike also worked at Gliatech (2006-2009), a public biotech company, in which he was instrumental the development of Cipralisant Maleate/Perceptin® (selective histamine H3 drug that is in development at Merck) that went from discovery to IND/Clinic in an industry record of 12 months.

Mike graduated cum laude from Colorado State University with Bachelor of Science degrees in Molecular Biology, Exercise Physiology and minors in Chemistry, and Neurobiology in 1995. Mike transferred to Colorado State University from University of Southern California (1989 – 1992) where he was a Presidential Scholar and Aerospace Engineering Major. Mike complemented his formal education by attending The Graziadio Business School at Pepperdine University Executive Management MBA Program 2000-2001. In Mike’s free time he is an avid triathlete, mountain biking enthusiast and burgeoning private pilot. He has two children, Regan and Mason.

Chris Zosh, EVP Finance

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Bob Buckheit CTO

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President, CEO & Chairman

Michael K. Handley

Mike is successful life science business professional with over 23 years of cross-functional experience in drug/device commercialization, operations, mergers/acquisitions, regulatory/clinical affairs, venture formation/financing, market development and partnering/licensing. Mike has successfully assisted or led in the global commercialization of seventeen devices or drugs that account for over three billion dollars of sales annually. He has experience successfully leading management teams in a variety of capacities in high growth organizations and has secured millions of dollars in venture capital.

Currently, Mike is serving as Chief Executive Officer & Director of Statera Biopharma, Inc. (formerly Cytocom, Inc.) Statera has a pipeline of drugs that target immune disfunction, inflammation, cancer and viruses. Statera uses immune modulation as a cornerstone for mitigating and correcting disease. This new approach is focused on a systems biology approach in which multiple biological pathways are targeted simultaneously with the immune system thus increasing the efficacy and decreasing toxicity.

Prior to Statera, Mike was the CEO and Director of Armis Biopharma (aka CHD Biosciences). Armis is a multi-product development-stage healthcare company that has created a technology platform for the prevention and treatment of topical infectious disease. In his role, Mike was responsible for day-to-day operations, executing a profitable growth strategy, obtaining global product approvals, overseeing intellectual property strategy, product commercialization, business development and financing.

Prior to his work at Armis, Mike served in senior management roles at multiple life science companies. Specifically, Mike was one of the founders and on the management team of Vessix Vascular, Inc. in Laguna Hills California from 2011 to 2012. As a result of his work at Vessix Vascular the Company was acquired for $435M by Boston Scientific. Before his time at Vessix Vascular, Mike was Global Head of Regulatory at Acclarent that was acquired by Johnson & Johnson from 2010 – 2011 and assisted in the integration of the $785M acquisition of Acclarent and their five product lines and driving the global revenue growth of the Ethicon franchise for ENT products. Prior to working with Acclarent/J&J, Mike was the Global Vice President of Regulatory Affairs and Chief Compliance Officer at Spectranetics Corporation, a NASDAQ listed (SPNC) medical device company specializing in laser treatments of blocked arteries and removal of pacemaker leads from 2007 to 2010. Before his time at Spectranetics, Mike was the CEO and Vice President of Business development, Quality and Regulatory at a privately funded biosciences technology company, Accelapure Corporation, from 2005 – 2007. Mike expanded his executive skill set as a Senior Management Consultant in the healthcare field at Pittiglio Rabin Todd & McGrath (now PricewaterhouseCoopers) from 2004-2005. As a Senior Principal at PRTM, Mike assisted Genentech in the successful launch of Avastin (a multi-billion dollar bio-oncology drug) and Tarceva (a multi-million dollar cancer small molecule drug) and assisted in the successful commercial launch for these drug franchises.

Prior to his business career, Mike was a successful and active research scientist having developed multiple patents and written multiple peer reviewed publications. During part of his research career Mike worked at Amgen in their oncology group from 1999 – 2001 and was involved in the discovery and advancement of Motesanib or AMG706 (an oral, small molecule multi-kinase inhibitor that is currently in Phase III trials for lung cancer). Mike also worked at Gliatech (2006-2009), a public biotech company, in which he was instrumental the development of Cipralisant Maleate/Perceptin® (selective histamine H3 drug that is in development at Merck) that went from discovery to IND/Clinic in an industry record of 12 months.

Mike graduated cum laude from Colorado State University with Bachelor of Science degrees in Molecular Biology, Exercise Physiology and minors in Chemistry, and Neurobiology in 1995. Mike transferred to Colorado State University from University of Southern California (1989 – 1992) where he was a Presidential Scholar and Aerospace Engineering Major. Mike complemented his formal education by attending The Graziadio Business School at Pepperdine University Executive Management MBA Program 2000-2001. In Mike’s free time he is an avid triathlete, mountain biking enthusiast and burgeoning private pilot. He has two children, Regan and Mason.

Director

Satish Chandran Ph.D

Satish Chandran is a biotechnology veteran with nearly 30+ years in leadership positions at early and mid-stage biotech, and at large pharmaceutical companies where he has formed. He has led teams to develop novel concepts into commercially viable products. Satish has been a serial entrepreneur over the last nearly 30+ years. He founded and led several biotech companies, and at leadership positions at large pharma (Pfizer and Wyeth) brings additional large pharmaceutical experience to the team in vaccines, drugs, biologics and medical devices. Lay Sciences is his latest venture focused on advancing novel technologies into late-stage commercial ready products.

Satish is the founding Director, President and CEO of Lays Sciences, and concurrently is also the CEO and Director of Prodigy Bio. Prior to Lay Sciences, he was the was the Chief Technology Officer, President and Chief Operating Officer of Marizyme, following the acquisition of Somahlution – a medical device company that he founded, and where he served as its Director and CEO. Prior to Somahlution, Satish was the Chief Technology Officer at Pfizer Biotherapeutics (OTU), and the CSO and COO of Nucleonics-an RNAi-based therapeutics company founded and previously headed the DNA vaccine division of Wyeth Vaccines (now Pfizer Vaccines).

In addition to his tenure in Pharma and biotech he served as faculty at several universities and research institutions; Thomas Jefferson University as Associate professor, Professor at IHVR (Institute for Hepatitis and Virus Research – now Blumberg Institute) and Professor at North Dakota State University, and also serves as a Board member and Advisor to several biotech companies. 

Dr. Uday Saxena

Dr. Uday Saxena is a pharma Executive who has held C level positions in large and small multinational companies. He is vastly experienced in preclinical drug discovery and development

He has a PhD from memorial University of Newfoundland, Canada and a Post-Doctoral Fellowship from Columbia University in New York. He has since then held positions of increasing responsibilities at Parke-Davis/Pfizer, Michigan, AtheroGenics Inc, a NASDAQ listed Company where he was Vice President of Research. He then became Chief Scientific Officer of Dr. Reddy’s Laboratories in USA and India, a Company listed on NYSE since 2000.

He is currently Cofounder and CEO of a start-up Company working on 3D Bioprinting platform for COVID, Inflammation and diabetes products. He is an inventor on 30 plus granted or filed patents and over 60 peer reviewed publications. He was elected Fellow of American Heart Association and Member of American Diabetes Association and Alzheimer’s Association. He is an invited speaker on several International Pharma forums.

Dr Blake Hawley

Dr Blake Hawley is an entrepreneur with a deep classical Fortune 50 background in the fast-moving goods sector.  He founded Cleopatra Life Inc, a direct-to-consumer women’s health telemedicine enabled platform delivering bio-identical hormone therapy to women on patent-pending platform technology.  His acquisition of a 40 year old lab has allowed product licensing of novel and patented products in human health and foods through Motega Holdings, Inc dba Motega Health.  He also founded SBH Nutrition Science, LLC which develops nutritional formulations for companies in the pet food and treat space both domestically and globally as well as Cedoga Consulting, LLC which works with companies to help develop and commercialize veterinary and pet heath products.  His background includes  30 years in the health and nutrition space including the development and launch of brands which sell in excess of $2 Billion annually, plus start-up formulation work for companies like Petaluma, FreshWoof, Doggy Dish Club, and the veterinary therapeutic PureNatural line as well as many more.

Prior to these companies, Dr Hawley worked in animal health, pharmaceuticals, and foods of multimillion-dollar businesses.  He served as the President & CEO for an Australian founded animal health start-up.  During his tenure there, the company grew from 3 technologies to over 30, with distribution agreements in 10 countries. He has successfully raised angel funding, participated in road shows as part of a secondary offering for a publicly traded company and has also received a USDA SBIR grant.

Prior to this, Dr Hawley was Chief Commercial Officer for Kindred Biosciences, where he helped investigate and commercialize multiple new animal drugs and therapeutic foods.  He held various senior management roles at Colgate-Palmolive’s division Hill’s Pet Nutrition Inc, working across 23 countries and 3 continents.  He holds an MBA from the University of Kansas, and a doctorate in veterinary medicine and zoology degree from NC State.  He conducted a post-doctoral stint at Utrecht University in the Netherlands.  

Dr Hawley has served on multiple advisory boards, including the KU MBA Advisory Board and the Lawrence Humane Society.  Dr Hawley is a 2017 graduate of Pipeline Entrepreneurs, and a graduate of the Village Capital Agricultural 2016 Entrepreneur Cohort and the 2020 Black & Veatch Covid IgniteX accelerator. 

He sits on the Board of Directors for Torigen Pharmaceuticals, CytoNest Inc and serves as the commercial officer for TRIM-edicine, Inc.