Anne Chappelle, Ph.D. DABT

SafeBridge Regulatory and

Life Sciences Group

• Unintended Exposures in Medical Device and Drug Development

   

  ABSTRACT:

   

  The focus of medical device and drug development is to solve a problem for a specific target.  Improve the design of an implanted pacemaker to control the human heartbeat.  Produce an IV bag that protects the contents from photodegradation but is also biodegradable.  Modify an insoluble drug so that it can be delivered intact across the blood brain barrier.  

  Occupational toxicology (OccTox) is the application of toxicology to chemical hazards in the workplace, focusing on substances/mixtures and conditions where inhalation and/or dermal exposure may happen.  This lecture will focus on the role of OccTox in successful drug/device development, with a review of hazard and risk assessment frameworks.  Case studies will be presented to highlight challenges and provide insight into how early collaboration can speed product development while maintaining a safe and productive workplace.

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  BIOGRAPHY:

   

  Dr. Chappelle is a Senior Managing Toxicologist at SafeBridge Regulatory and Life Sciences Group and has 25 years of experience as a toxicologist in the pharmaceutical and chemical industry performing risk assessments and generating data that serves to minimize potential adverse outcomes to workers, consumers, and the environment. She is a proud Blue Hen (AS’91), certified by the American Board of Toxicology and holds a Ph.D. in Pharmacology and Toxicology (St. Joseph’s University).  Anne is passionate about science communication; she is the current co-host of the Society of Toxicology interview podcast Adverse Reactions (www.adversereactionspodcast.com), and has appeared in Tech Support answering poison questions from Twitter for Wired Magazine.)