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Appendix M of the NIH Guidelines

47 minutes

Recorded on Tuesday, June 05, 2018


Clinical research expert Daniel Kavanagh discusses registration and reporting requirements for gene therapy research under the recently revised NIH guidelines. He covers:

  • NIH reporting compliance;
  • The Office of Science Policy registration process; and
  • Progress and safety reporting requirements.

Speaker: Daniel Kavanagh, Senior Director of Biosafety and Gene Therapy, WCG Biosafety

Cutting the Costs of Clinical Trial Subject Recruitment

62 minutes

Recorded on Wednesday, May 30, 2018


Patient recruitment expert Steven Pyffer discusses ways to reach potential research subjects through both tradition and digital avenues. He covers:

  • Insight on the factors that determine the actual outreach cost of a randomized patient;
  • Ways to reduce patient outreach cost; and
  • Improved expectations to patient outreach performance.

Speaker: Steven Pyffer, Senior Director of Patient Outreach, ThreeWire

Managing Safety Reporting for Advanced Therapies

53 minutes

Recorded on Tuesday, May 22, 2018


Pharmacovigilance expert Angela Pitwood looks at compliance challenges for gene therapies and other novel treatments in personalized medicine. She discusses:

  •  Cutting-edge therapies that offer hope for conditions for which there are limited or no therapeutic options now;
  • Development of advanced therapies; and
  • FDA safety reporting requirements, both now and in the future.

Speaker: Angela Pitwood, Vice President of Pharmacovigilance, Vigilare

Clinical Trials and Assessment of Suicidal Ideation and Behavior

60 minutes

Recorded on Tuesday, May 15, 2018


Suicide treatment experts Larry Alphs, Jennifer Giddens and David Sheehan present latest trends and developments in measuring suicidal ideation and behavior. They discuss:

  • Drug development targeting suicidality;
  • What’s new in design and execution of studies of suicidal ideation and behavior;
  • Phenotypes in suicidality; and 
  • Assessments in clinical trials for anti-suicidality treatments

Speakers: Larry Alphs, Therapeutic Area Leader, Ortho-McNeil Janssen; Jennifer Giddens, Co-founder & Co-director, Tampa Center for Research on Suicidality; and David Sheehan, Distinguished University Health Professor Emeritus, University of South Florida College of Medicine