Transitioning from Bench into Clinical Phase
In over the decade, the pharmaceutical industry is continuing to face a number of challenges – high attrition rate, low productivity, patent expiry, rising costs of research and development, high regulatory hurdles, increasing concern about adverse side effects. It has also become clear that the traditional business model of pharmaceutical companies is no longer sustainable. The pharmaceutical companies are now seeking to find better ways to reduce operational costs, increase output of new drugs through innovation within research and development. Drug research and development is a dynamic process, requiring integration of activities across a number of preclinical scientific disciplines for successful progression of therapeutic candidates.
The presentation will review the deep analysis data of what are the critical challenges in pharmaceutical R&D and highlight how innovative approaches can help to overcome these challenges. Dr. Yan will also share some cases to illustrate how Covance applied its “Seamless and Strategic Approach” to help its partners to bring the miracles of medicine to market sooner.
James Yan, PhD, MD, DABT, Executive Director, Early Development, Covance
Dr. James Yan is Site Lead and Executive Director of Covance Early Development (ED) Shanghai Site and Covance Pharmaceutical R&D (Shanghai) Co., Ltd. James is responsible for all activities of Covance ED business in Shanghai.
James has over 20 years of research experience in academics and the Pharmaceutical industry with extensive training in the fields of Pharmacology, Toxicology, Molecular Biology, and Oncology. He started his career in industry with Pharmacia and was responsible for the development of a variety of new technologies for drug safety evaluation and non-clinical safety assessments. Then he worked in Pfizer and Hospira, where he headed toxicology group and focused on toxicology programs supporting drug development and regulatory submissions. James has over 12 years working experiences in non-clinical safety assessment of both small molecules and biologics in drug research and development. He is well versed in multiple industry regulations such as FDA, EMEA, CFDA, OECD, ICH as well as other international guidelines for drug development. In 2009, James moved back to China and serviced as the head of Drug Safety Evaluation in Hutchison MediPharma. Over the course of his career, he was involved in IND and NDA filings for multiple drug candidates and gained substantial experience working with global regulatory agencies, including the US FDA, EMA and China FDA (CFDA).
James received his PhD degree from Peking Union Medical University in China and did his post-doctoral training at the Ben-May Institute for Cancer Research, University of Chicago in the United States. He is a Diplomate of the American Board of Toxicology (DABT).
Covance, with headquarters in Princeton, New Jersey, is one of the world’s largest and most comprehensive drug development services companies, with annual revenues greater than $2 billion and more than 12,000 employees in more than 60 countries. Covance has the people, processes, client service, and global resource capabilities to respond to biotechnology and Pharmaceutical clients’ toughest drug development challenges.