People

Our team members led the discovery and development of the Amadorins and offer extensive technical and operational experience in developmental stage drug companies.

 


Management

Pepper Landson

CEO & Co-Founder

Pepper Landson has been a driving force in novel therapeutics for critical healthcare needs for three decades. She has a proven record of creating value in early stage companies. Combining her skills in business development and operations with an extensive drug development background, she is championing disease modifying treatments for serious diabetic complications. She has worked exclusively on the Amadorin technology and diabetic complications for the last decade.

 

Raja G. Khalifah, PhD

Chief Scientific Officer

Raja G. Khalifah, PhD, is a broadly trained chemist and biochemist who transitioned from academia to directing research at three startups founded on discoveries from his research. He leverages his extensive experience in medicinal chemistry and drug design, pharmacokinetics and drug metabolism, and preclinical and clinical studies. Dr. Khalifah is the primary co-inventor on 15 issued US patents in Amadorins and related fields.

 

Katina Dorton

Strategic Business Advisor

Ms. Dorton is a life sciences financial executive with a consistent track record in business development and fundraising for biotechnology companies. She has served as CFO of public and private development stage biotech companies (Repare Therapeutics and AVROBIO) with responsibility for corporate partnerships. She is an established board director (Fulcrum Therapeutics), public company CFO and former Wall Street investment banker(Morgan Stanley) with earlier career experience as a corporate transactions attorney. Ms. Dorton draws from 25-year professional history advising corporate clients on capital markets, fund raising, mergers and acquisitions, and other strategic transactions with a significant focus on the life sciences industry.

 

JoAnn Giannone

Drug Development Advisor

Ms. Giannone is a seasoned executive with extensive expertise in advising senior management on defining product development strategies and leading the execution of those strategies. She specializes in building high-performance development teams and ensuring milestones are met. Ms. Giannone has over 25 years’ experience effectively leading companies through the drug and medical device development process. Prior to founding CSTI, Ms. Giannone, held leadership positions with Johnson & Johnson (RW Johnson Research Institute) and Pharmacia.

 

 

 

Scientific / Clinical Advisors

Our Advisors include world renowned experts providing guidance across the spectrum of diabetic complications and drug development.

Rayaz Malik, BSc. (Hons), MSc., MB ChB, PhD, FRCP

Weill Cornell School of Medicine

Dr. Malik graduated in Medicine from the University of Aberdeen, obtained his MRCP (London), PhD from the University of Manchester, and was elected to become a fellow of the Royal College of Physicians. In 2014 he was appointed as Professor of Medicine at Weill Cornell Medicine and remains an honorary Professor of Medicine at the University of Manchester and visiting Professor of Medicine at Manchester Metropolitan University. He was appointed as the Organizational Official in November 2016 and as the Assistant Dean for Clinical Research at Weill Cornell Medicine-Qatar in February 2019.

His research focuses on the pathogenesis, assessment and treatment of diabetic and other peripheral neuropathies and central neurodegenerative disorders. The research is funded by the NIH, JDRF, QF, ECTRIMS and MJFF. Over ~20 years he has pioneered the use of corneal confocal microscopy, a non-invasive ophthalmic instrument, to quantify diabetic and other peripheral neuropathies and more recently used CCM to assess neuronal damage in patients with Multiple Sclerosis, Parkinson’s disease, Stroke, Dementia and Autism.

 

Nigel Calcutt, PhD

School of Medicine, University of California at San Diego

Dr. Calcutt is a Professor of Pathology at the University of California San Diego. He began studying peripheral neuropathy in 1983 during his undergraduate studies with one of the scientific founders of the field, David Tomlinson. He has been involved in the preclinical/clinical development of multiple therapeutic programs and is a key opinion leader for companies engaged in drug development. He has consulted for many development programs: Biogen, Bristol Myers Squibb, Cebix, Epigen, GlaxoSmithKline, Impeto, Eli Lilly, Merck, Mitobridge, Neuralstem, Neurocrine, Novo Nordisk, Pfizer, Roche, Sangamo, Vertex, and Wyeth Ayerst, among many others. Dr. Calcutt also served as the lead preclinical contactor to the NIH NIDDK-RAID program and is a member of the Executive Committee of the EASD Neurodiab Study Group.

 

Peter McCullough, MD, MPH

Baylor University Medical Center

Dr. McCullough is a consultant cardiologist and Vice Chief of Medicine at Baylor University Medical Center in Dallas, TX. He is a Principal Faculty in internal medicine for the Texas A & M University Health Sciences Center. Dr. McCullough is an internationally recognized authority on the role of chronic kidney disease as a cardiovascular risk state with > 1000 publications and > 500 citations in the National Library of Medicine. His works include the “Interface between Renal Disease and Cardiovascular Illness” in Braunwald’s Heart Disease Textbook. Dr. McCullough is a recipient of the Simon Dack Award from the American College of Cardiology and the International Vicenza Award in Critical Care Nephrology for his scholarship and research. Dr. McCullough is a founder and current president of the Cardiorenal Society of America, an organization dedicated to bringing cardiologists and nephrologists together to work on the emerging problem of cardiorenal syndromes. His works have appeared in the New England Journal of Medicine, Journal of the American Medical Association, Lancet, British Medical Journal and other top-tier journals worldwide. He is the co-editor of Cardiorenal Medicine, Reviews in Cardiovascular Medicine, and associate editor of the American Journal of Cardiology. He serves on the editorial boards of multiple specialty journals. Dr. McCullough has made presentations on the advancement of medicine across the world and has been an invited lecturer at the New York Academy of Sciences, the National Institutes of Health, U.S. Food and Drug Administration (FDA), European Medicines Agency, and the U.S. Congressional Oversight Panel.

Major contributions:

  • Senior leadership and oversight of clinical, education, and research operations at major academic medical centers in Detroit, Kansas City, and Dallas
  • Led observational studies and randomized trials of therapies for acute kidney injury, hypertension, acute coronary syndromes, heart failure, and cardiorenal syndromes
  • Chaired and participated on 20 data safety monitoring committees for large randomized trials
  • Advised sponsors and the FDA resulting in approval of 17 new drugs and 3 novel in vitro diagnostic tests used today around the world

 

John Buse, MD, PhD

University of North Carolina – Chapel Hill, School of Medicine

Dr. Buse’s practice combines clinical care, research, and education. He has received international recognition for innovative clinical care and efforts at prevention of type 1 and type 2 diabetes and their complications. He practices patient-centered care focusing on developing treatment programs in collaboration with patients that meet their needs and expectations. He works with teams of investigators in diabetes clinical trials, comparative effectiveness research, and translation of basic science research towards clinical application. Current projects focus on novel treatments including development of glucose-responsive insulin, cardiovascular safety and efficacy of diabetes drugs, and developing the evidence-base for treatment guidelines of the future in diabetes care. Dr. Buse also plays a significant role in research administration, having been Executive Associate Dean for Clinical Research at UNC-Chapel Hill since 2011 and Director of the NC Translational and Clinical Sciences Institute since 2015.

 

Jamie Dwyer, MD

Vanderbilt University Medical Center

Dr. Dwyer’s clinical expertise centers around kidney disease (in general) but specifically diabetic kidney disease and other glomerular lesions, including glomerulonephritis. He has developed expertise in the evaluation, management, and prevention of kidney stones (nephrolithiasis). His clinical research has focused on these areas as well, particularly on the design, conduct, and analysis of large-scale randomized clinical trials (RCT) in nephrology and hypertension, particularly in delaying the progression of chronic kidney disease (CKD). Dr. Dwyer is the Co-Director of the Vanderbilt Nephrology Clinical Trials Center, a founding part of the Vanderbilt Center for the Study of Kidney Disease. Additionally, he is an Officer of the Collaborative Study Group (CSG), an international, non-profit organization dedicated to the exceptionally rigorous design and analysis and safe conduct of pilot and multinational, large-scale, pivotal RCTs in relevant therapeutic areas, including CKD, diabetic nephropathy, lupus, lupus nephritis, and end-stage renal disease. Dr. Dwyer’s expertise centers around protocol design, medical monitoring, trial conduct, and safety.

 

George Bakris, MD

University of Chicago School of Medicine

Dr. Bakris specializes in the diagnosis and reduction of high blood pressure, particularly in complicated and refractory cases. He is also skilled in the treatment of kidney disease, with special expertise in diabetes-related kidney disease and slowing its progression. As director of the Comprehensive Hypertension Center he oversees the interpretation of Ambulatory Blood Pressure Monitoring (ABPM) for the institution, a technique that provides information about blood pressure over the 24 hour period, including during sleep.

In his research activities, Dr. Bakris explores why the rate of kidney disease is significantly higher in the black population than it is in other ethnic groups. He also evaluates specific markers of kidney disease progression and heightened cardiovascular risk, as well as how changes in the artery (central pressure) affect the heart and kidney.

Dr. Bakris has been extensively involved as either a principal investigator or on the steering committees of national and international trials involving diabetic kidney disease progression and resistant hypertension. He is the principal investigator of the FIDELIO trial evaluating a novel agent on progression of diabetic kidney disease. He is also on the steering committee of two other international trials involving agents that lower blood pressure or blood sugar and assessing effects on diabetic kidney disease progression. He recently completed studies on renal denervation for resistant hypertension and use of a recently FDA-approved agent, patiromer, for controlling serum potassium in high-risk people with advanced kidney disease. And, he has served on many guidelines committees over the past 15 years and is currently the chair of the American Diabetes Association Blood Pressure Consensus Panel, and a member of the American Heart Association panel updating resistant hypertension guidelines.

Dr. Bakris received the Irvine Page-Alva Bradley Lifetime Achievement Award to acknowledge his lifetime of outstanding achievements in the field of hypertension.

 

Alexander ‘Zan’ Fleming, MD

Dr. Alexander Fleming is Founder and Executive Chairman of Kinexum. Dr. Fleming received his M.D. and internal medicine training from Emory. He completed fellowship training in endocrinology at Vanderbilt and metabolism at National Institutes of Health, where he was a senior fellow.

At the US Food and Drug Administration from 1986-98, Dr. Fleming was responsible for the therapeutic areas of diabetes, other metabolic and endocrine disorders, growth and development, nutrition, lipid-lowering compounds, and reproductive indications. He led reviews of landmark approvals, including metformin and the first statin, insulin analog, PPAR-agonist, and growth hormone for non-GH deficiency indications. Dr. Fleming oversaw clinical review of the earliest biotech products, including human insulin and growth hormone. He also helped to shape FDA policies and practices related to therapeutic review and regulatory communication.

Dr. Fleming has frequently published scientific articles and book chapters. The most recent chapter, Regulatory Considerations for Early Clinical Development, is in Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development, published by Springer in October 2018. Dr. Fleming is also lead author of the book, Optimizing Development of Therapies for Diabetes. He has been a member of many corporate and advisory boards to academic and commercial institutions and professional societies. He serves on the joint technology working groups of the European Association for the Study of Diabetes and American Diabetes Association.