Ross Tonkens, MD
Dr. Tonkens has over 30 years of experience as a practicing physician, senior executive in pharma and CROs, and consultant to biotechnology companies seeking funding. Prior to his most recent role as Vice President of Global Development and Regulatory Strategy at MDS Pharma, Dr. Tonken has served in the academic, private practice and pharmaceutical and biotechnology sectors.
In 1990, Dr. Tonkens established his own successful private equity fund focusing on computer technology in Henderson, NV. Simultaneously he established his own clinical research center, where he conducted numerous clinical trials in areas ranging from hy-pertension, diabetes, COPD, and infectious disease, to peripheral vascular disease, wound healing, and allergy and immunology. While in Nevada Dr. Tonkens also served on the teaching faculty of the University of Nevada School of Medicine's house staff training program in Las Vegas.
In 2001 Dr. Tonkens accepted the position of Global Scientific Head of the Cardiovascu-lar Therapeutics Division of Quintiles. In this role he directed a global team of cardio-vascular, pulmonary, and critical care physicians overseeing drug and device trials for Quintiles's customers. He also assessed investment opportunities for its NovaQuest venture capital division, which had over $1 billion in assets at the time of his departure.
In 2006 Dr. Tonkens left Quintiles to become Chief Medical Officer of Regado Bio-Sciences, which develops rationally designed and target-specific reversible drug-antidote pairs. As CMO, Dr. Tonkens shepherded REG-1, Regado's lead product, a drug/antidote replacement for heparin and protamine, from first in human trials through a successful proof of concept trial pitting REG-1 against current heparin standard of care, for placement of stents in diseased coronary arteries.
He then practiced invasive cardiology in Beverly Hills and taught as Assistant Clinical Professor of Medicine at UCLA before taking a position as medical editor for a national Lifetime network for a year.
He obtained both his bachelors and MD degrees at Yale University. While an under-graduate at Yale College, under a NASA grant, Dr. Tonkens developed the basic life de-tection system for the Mars Probe Viking, which soft-landed on Mars in the late 1970s. During his postgraduate training at UCLA and Cedars-Sinai Medical Centers, he also developed a computerized critical care management system, which was ultimately pur-chased and distributed by Hewlett Packard.
Dr. Tonkens has authored and coauthored numerous articles in peer reviewed journals (most recently in CIRCULATION, July, 2010) and has spoken globally on subjects run-ning the gamut from developments in cardiology to regulatory affairs and creative drug development financing options.
Roger Nolan, PhD
Dr. Nolan has over 25 years of experience in research and drug development both in the CRO and pharmaceutical industry. He has served in senior management roles in global clinical trials in cardiovascular disease, stroke, diabetes and oncology programs. He has participated as an author on regulatory submissions including INDs, NDAs, clinical study protocols, clinical study reports, pharmacology and toxicology sections, annual reports and has participated in numerous pre-IND and End-of-Phase II meetings with FDA.
Roger currently serves as the COO of BioKier, Incorporated, an early-stage pharmaceu-tical company developing new proprietary drugs for diabetes and related disorders. Dr. Nolan has extensive experience in drug, biologic, and device regulatory and clinical strategy. Dr. Nolan has also played a critical role in management, corporate venture and business development activities including direct FDA liaison.
Prior to BioKier, Dr. Nolan served in management roles for Calvert, Health Decisions, and Cato Research. He was an Assistant Professor of Biochemistry and Internal Medi-cine at Eastern Virginia Medical School and the Director of the Platelet Biochemistry Laboratory at the Diabetes Institute in Norfolk, VA.
Dr. Nolan was a Burroughs Wellcome Fellow as well as a Fogarty Fellow at the NIH. He obtained his Bachelors of Science in Biochemistry and Microbiology and his Doctorate in Philosophy. He has lectured at North Carolina State University, Eastern Virginia Medical School, Old Dominion University, University of North Carolina Chapel Hill, and Latrobe University in Melbourne Australia.
Peter Hammonds, PhD
Dr Hammonds has 27 years of international experience: 23 years of international as a research scientist, senior manager and independent consultant in the pharmaceutical (Glaxo), biotechnology (Encelle) and CRO (Cato Research, Chiltern International) industries; and 4 years post-doctoral research at Oxford University. His areas of expertise include clinical research, drug discovery and business development, combined with extensive therapeutic experience in diabetes and diabetes complications, and work in oncology, cardiovascular, HIV, CNS, respiratory, ophthalmology, and infectious disease.
Clinical research experience comprises the design and management of Phase 1-3 clinical trials, including site selection, Investigator meetings, and study management and monitoring. In addition, Pete has over 17 years of medical and regulatory writing experience, including over 60 clinical study protocols and clinical study reports, and several Pre-IND, IND, NDA and Orphan drug submissions. He has also authored several regulatory strategy reports, some as part of successfully funded corporate business plans and has participated in meetings with FDA.
As an independent consultant, Pete has worked with 19 biotechnology, pharmaceutical, venture, and CRO companies in clinical research, business development, and scientific, due diligence and licensing activities. He has lectured on medical writing as part of a Masters degree in clinical development at Duke University.