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Wednesday, June 21 • 4:00pm - 5:15pm
#383: Safety Issues in First-in-Human Studies

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

The session deals with overcoming or assessing safety concerns and issues early in development and exploring some of the safety issues that you can address in early clinical trials with a focus on biomarkers. It showcases where preclinical and clinical meet demonstrating a variety of organ markers. Examples of different organ systems impacted or assessed may include use of markers in renal toxicity, testicular safety or cardiac assessments as examples.

Learning Objectives

Identify methods that are useful to address early safety issues in FIH studies which is originally seen in toxicity data.

Chair

David R. Jones, MS

Speaker

The New EU Guidance for First-In-Human Clinical Trials
David R. Jones, MS

Safety Issues in First-in-Human Studies
Charu Gautam, MD

First-In-Human Nonclinical Testing and Starting Dose Considerations
Paul Baldrick, PhD


Moderators
avatar for David Jones

David Jones

Expert Pharmacotoxicologist, Clinical Trials Unit, Medicines and Healthcare products Regulatory Agency (MHRA)
David R Jones Expert Scientist (Pharmaco-Toxicologist). I have been a Toxicologist for over 30 years. I am responsible for the Safety Assessment of Clinical Trials Applications within the UK. I am the UK's representative on the EU's Safety Working Party (SWP). I also represent the... Read More →

Speakers
avatar for Paul Baldrick

Paul Baldrick

Executive Director, Regulatory Strategy, Covance Inc.
Paul Baldrick is Executive Director, Nonclinical Regulatory Strategy within the Global Regulatory Affairs Department at Covance; he has a PhD from Durham University, UK. Professor Baldrick is also Visiting Chair (Regulatory Toxicology) of the School of Pharmacy, University of Lincoln... Read More →
avatar for Charu Gautam

Charu Gautam

Head- Early Clinical Development, Asia Pacific, QuintilesIMS
Charu Gautam is a Physician with 17 years experience in research and academics. Been associated with leading companies in India to lead the clinical operations and medical teams. Qualified as MBBS, MD followed by a board certification, she is also a lead faculty at various GCP workshops... Read More →
avatar for David Jones

David Jones

Expert Pharmacotoxicologist, Clinical Trials Unit, Medicines and Healthcare products Regulatory Agency (MHRA)
David R Jones Expert Scientist (Pharmaco-Toxicologist). I have been a Toxicologist for over 30 years. I am responsible for the Safety Assessment of Clinical Trials Applications within the UK. I am the UK's representative on the EU's Safety Working Party (SWP). I also represent the... Read More →

Wednesday June 21, 2017 4:00pm - 5:15pm
S405b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  09: TranslSci-Preclin-Clin-ProdDev, Session