Making a Difference Motivates New Leader of MDS Pharma Services’ Late Stage Clinical Trial Management Unit

“It occurred to me that I could continue to treat patients one at a time,” he recalls, “or I could make a greater impact on more people by helping to develop new treatments and medicines as part of the healthcare research industry.” After a medical career that included service on the staffs of four London hospitals after earning Bachelor of Medicine and Bachelor of Surgery degrees from London University’s Royal Free Hospital School of Medicine, he chose the latter, and hasn’t looked back.

Today, he is Vice President and General Manager for the Global Clinical Development unit of MDS Pharma Services (www.mdsps.com), a leading provider supporting every phase of the drug discovery and development process. The path that brought him to the business’ executive office in King of Prussia, Pennsylvania, included more than 25 years of experience in medicine, international clinical trial management, contract research organization (CRO) services, and global pharmaceutical sales, marketing and operations.

His first stop following his intensive care epiphany was South East Asia, where he spent two years as an International Medical Advisor for The Wellcome Foundation. Dr. Pusey managed foreign marketing, registration and anti-viral drug development trials, with responsibility for Hong Kong, Malaysia, Taiwan, the Philippines and Sri Lanka. Knowing that he needed to add business management to his medical background, he then returned to London as a full-time MBA student at the London Business School. The degree was his ticket to several positions with SmithKline Beecham, where the New Zealand citizen worked for four years as General Manager of Pharmaceuticals & Consumer Healthcare for that country. He ultimately became Vice President and General Manager of the Clinical Trials Center (CTC), a global CRO owned by the company.

SmithKline Beecham’s CRO was successfully sold at the time of the merger with Glaxo, and subsequently Dr. Pusey was recruited by AstraZeneca USA Inc. to become Vice President of Marketing, and following a promotion, Vice President and Therapeutic Area Leader for Central Nervous System, Pain and Infection. After four years with AstraZeneca, Dr. Pusey sought biotechnology experience and joined Serono as Executive Vice President for Neurology, where he was accountable for commercial operations, and late stage drug development, including co-development projects with Pfizer. Two years later, and prior to joining MDS Pharma Services, Dr. Pusey augmented his biotechnology experience with a role as President and CEO of the publicly traded biotech company OrthoLogic, Inc.

What brought him to MDS Pharma Services?

“I was attracted by the MDS opportunity in the rapidly developing CRO industry. We have an innovative process for improving the project management of clinical trials, and this will help us realize our potential for market leadership,” Dr. Pusey says. “MDS Pharma Services is a recognized early stage player in the pre-clinical and Phase I space, and we are increasingly achieving well-deserved recognition in the late stage development, or Phase II through Phase IV studies. We were ranked the Top CRO in Europe in the 2006 Thomson CenterWatch survey of investigators, and the Most Promising CRO in Asia by Frost and Sullivan that same year.

“With therapeutic focus areas that include Oncology and Metabolic Disorders (endocrinology),” he continues, “our Global Clinical Development team is helping to address some of the world’s most pressing medical needs, as is our work in infectious diseases and specifically with pediatric clinical trials.”

Pediatric assessments are becoming a regular part of the drug development process. In the past five years, MDS Pharma Services has conducted more than 40 pediatric trials, including a large-scale vaccine trial involving more than 2,000 pediatric participants in Europe and Latin America. By doing so, the organization has gained valuable experience in addressing the scientific, logistical, ethical and psychological challenges inherent in such trials.

“Patient recruitment in pediatric trials is both a sensitive and challenging issue,” Dr. Pusey says. “The process of informed consent must be appropriately handled to take heightened parental anxiety into account. Key therapeutic areas in pediatric drug development include Oncology, Vaccines, Respiratory, Dermatology, Metabolic Disorders, Psychiatry and Infectious Diseases such as HIV and malaria.”

Malaria – a deadly disease spread by infected mosquitoes – is the focus of Phase III clinical trials that are being managed by the MDS Pharma Services Global Clinical Development in China, Laos, India, Thailand (at left), Burkina Faso, Kenya, Mozambique, Uganda, and Zambia,. Nearly 40 per cent of humanity, chiefly pregnant women and children under 5, are at risk for malaria. A child dies of malaria every 30 seconds, and the disease kills one to three million people each year. According to the U.S. Centers for Disease Control and Prevention, between 350 and 500 million clinical episodes occur every year, fueled by malaria’s growing resistance to existing drugs.

MDS Pharma Services is managing a Phase III trial of a first-line treatment against malaria: Eurartekin™ or “Artemisinin Combination Therapy.” The trial is being conducted on behalf of an international public and private collaboration of four groups: Sigma-Tau, a leading pharmaceutical company based in Italy; the non-profit Medicines for Malaria Venture, which is part of the World Health Organization; China's Chongqing Holley pharmaceutical company; and Oxford University.
“Through its management of pivotal studies such as this one, MDS Pharma Services is helping to set the standard for conducting clinical trials in malaria-endemic countries,” Dr. Pusey concludes. “MDS Pharma Services is honored to have been chosen to conduct this study with world renowned experts such as Professor Nick White of Oxford University and Professor Umberto D'Allesandro of the Institute of Tropical Medicine in Antwerp. Our involvement in this effort to find affordable and effective treatments for malaria in developing countries supports the MDS core purpose to make a distinctive contribution to the health and well-being of people. And the opportunity to make a positive difference is what motivates me and my team every day.”