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Early Drug Development

  January 15, 2020  
CfPA-The Center for Professional Advancement, Edison, NJ or Virtually
May 11-12, 2020

Who Should Attend?
This course is intended for professionals who participate in, or are responsible for, drug development in small or large corporations in the pharmaceutical or biopharmaceutical industries. It is particularly oriented toward individuals with relatively limited early development experience but also offers confirmation of currently accepted scientific practices for those more experienced in early drug development. Professional managers who oversee early development activities would additionally benefit by updating them to current approaches.

  • Non-clinical and clinical safety scientists
  • Pharmacokineticists
  • Chemists responsible for drug synthesis and supply
  • Regulatory affairs personnel
  • Lead biologists
  • Project managers
  • Physicians planning early trials
  • Budget managers

Read our latest Insights article by Course Director Dr. Stephen J. Newsholme on "Initial Planning for Early Drug Development" CLICK HERE TO READ.

Course Description
This intensive and interactive, 2-day course addresses that important period from entry of a selected potential drug into formal development through to filing a regulatory application for first administration to human (FIH). It is intended to inform all participants of their collective and individual contributions and to foster effective collaboration and decision making in this important and demanding period when multiple questions, choices and issues typically arise. Topics include the regulatory requirements, the studies and documentation needed, development planning for small molecules, biologicals and special indications, selection of alternative strategies and dealing with risks and issues. Active learning is a strong feature of this course: lectures are interspersed with Q&A sessions, discussions, case studies and other interactive elements.


Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Dr. Stephen J. Newsholme, Drug Development Consultant

Stephen J. Newsholme, currently a freelance drug-development consultant, has 30 years of experience in a large pharmaceutical company as a pathologist and director of non-clinical safety. This has provided him a deep and broad knowledge of drug development, particularly at the early end, and he has participated in selecting many new drug candidate molecules and in the planning, preparation, review and submission of numerous INDs and CTAs. He has steered early-stage development teams and trained and mentored many development team members. He has also designed and delivered drug-development courses to team representatives across multiple functional groups.

Dr. Newsholme’s experience is international in scope: He holds degrees in physiology and veterinary medicine from the University of London and a pathology degree from the University of Pretoria as well as being a Diplomate of the American College of Veterinary Pathologists. He has also chaired international, multidisciplinary research teams to investigate and resolve drug safety issues. He is a member of the American College of Veterinary Pathologists, Society of Toxicologic Pathologists, American Society for Investigative Pathology, the Royal College of Veterinary Surgeons and the Roundtable of Toxicology Consultants, and is a former member of ILSI/HESI where he chaired the Emerging Issues Committee. He has authored or co-authored more than 50 publications relating to pathology, toxicology and safety assessment.
Deadline for Abstracts: N/A
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
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