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Learn. Adjust. Implement.

The CTIS regulations alongside FDA regulations has given the clinical data disclosure and transparency landscape a renewed interest for professionals and requires a space for discussing best practices regarding global regulations going forward. This summit will explore how to quickly create experts in any sized organization on these clinical data disclosure policies and discover how to be confident in earlier disclosure of clinical trials.

Speakers

Erik Lakes

Position: Director and Head of Data Disclosure and Transparency
BEIGENE
Categories: Speaker
Location: Speaker

Erik Lakes

Director and Head of Data Disclosure and Transparency
BEIGENE

J.R. Meloro

Position: Global Head, Disclosure, Publications & Transparency
PFIZER
Categories: Speaker
Location: Speaker

J.R. Meloro

Global Head, Disclosure, Publications & Transparency
PFIZER

Oladayo Oyelola, PhD, SC(ASCP)

Position: Senior Director and Head, Clinical Trial Information Disclosure, Global Regulatory Operations, Information & Compliance
DAIICHI SANKYO
Categories: Speaker
Location: Speaker

Biological Sketch

Dr. Oladayo Oyelola is Senior Director and Global Head, Clinical Trial Information Disclosure at Daiichi Sankyo, Inc. He is responsible for corporate strategies and operations for global clinical trial information disclosure and clinical data sharing compliance activities. He also manages and coordinates internal trial disclosure operations’ training, process improvements and clinical trial transparency regulatory policy intelligence.

He has also served in the same capacity and as Head of the R&D Clinical Medical Writing Platform at Sanofi Pasteur Inc., the Vaccine Division of Sanofi during which he led regulatory medical writing activities on clinical projects and clinical study teams for novel vaccine and pharmaceutical products for the US, EU and other international regulatory submissions and marketing approvals.

Dr. Oyelola holds a BS degree in Biochemistry, MS in Applied (Nutrition) Chemistry, and PhD degree in Clinical Chemistry. He received The Rockefeller Foundation Special Postdoctoral Fellowship Award with tenure at the University of Cincinnati and Cardiovascular Research Center 1991 – 1993; and the National Mentor Role Model Award/Citation of the Minority Access Inc. / Office of Minority Health, National Institutes of Health in 2001.

He has over 35 years’ experience in clinical and pharmaceutical R&D activities along with professional certifications of the National Registry of Certified Chemists and the American Society for Clinical Pathologists.

He is a member of the American Association for Clinical Chemists, the American Society for Clinical Pathology, and the Drug Information Association.

Contact Information

Oladayo Oyelola, PhD, SC(ASCP)

Senior Director and Head,

Clinical Trial Information Disclosure

Global Regulatory Operations, Information & Compliance

Daiichi Sankyo, Inc.

211 Mt. Airy Road

Basking Ridge, NJ 07920 USA

Direct Line:    +1 (908) 992-6478

Email: ooyelola@dsi.com

Biological Sketch – 800 

Dr. Oladayo Oyelola is Senior Director and Head, Clinical Trial Information Disclosure at Daiichi Sankyo. He is responsible for corporate strategies and compliance operations on clinical trial transparency/data sharing; and coordinates internal disclosure operations’ training, process improvements and transparency policy intelligence. He held the same position at Sanofi Pasteur – 2005 to 2016.

He holds a PhD degree in Clinical Chemistry, 1990. He received The Rockefeller Foundation Postdoctoral Fellowship, 1991 and National Mentor Role Model Award of Minority Access Inc/Office of Minority Health, NIH, 2001.

He has over 35 years’ experience in clinical and pharmaceutical R&D: Professional certifications of the National Registry of Certified Chemists and the American Society for Clinical Pathologists.

Biological Sketch – 750 (748)

Dr. Oladayo Oyelola is Senior Director and Head, Clinical Trial Information Disclosure at Daiichi Sankyo. He oversees corporate clinical trial transparency/data sharing strategies and compliance activities; coordinates internal disclosure operations’ training, process improvements and trial transparency policy intelligence.

He holds a PhD in Clinical Chemistry from Obafemi Awolowo Univ. Ile-Ife, Nigeria, 1990 and received The Rockefeller Foundation Postdoctoral Fellowship, 1991 and National Mentor Role Model Award of Minority Access Inc/Office of Minority Health, NIH, 2001.

Dr. Oyelola has over 35 years’ experience in biomedical R&D, and certifications by National Registry of Certified Chemists and American Society for Clinical Pathologists.

Operations activities

Biological Sketch Dr. Oladayo Oyelola is Senior Director and Global...

Oladayo Oyelola, PhD, SC(ASCP)

Senior Director and Head, Clinical Trial Information Disclosure, Global Regulatory Operations, Information & Compliance
DAIICHI SANKYO

Adian Talib

Position: Manager of Chinese Center for Drug Evaluation Clinical Trial Registration
BEIGENE
Categories: Speaker
Location: Speaker

Adian Talib

Manager of Chinese Center for Drug Evaluation Clinical Trial Registration
BEIGENE

Laura Troast

Position: Director of Clinical Data Disclosure and Transparency
MERCK
Categories: Speaker
Location: Speaker

Laura Troast has been working in the disclosure and transparency space at Merck & Co., Inc. since 2006. She is a director within their Clinical Data Disclosure & Transparency (CDD&T) group, currently operating as Head of Medical Writing. Laura holds a B.S. in Biochemistry and Molecular Biology from Penn State University and an M.S. in Regulatory Affairs from Northeastern University.

Laura Troast has been working in the disclosure and transparency...

Laura Troast

Director of Clinical Data Disclosure and Transparency
MERCK
Interested in speaking at the event?
Please contact Cayti Weber-Vowell at
cayti@momentumevents.com

Who Should Attend

This event is developed for professionals from Pharmaceutical, Biotech, and Medical Device Companies with the following titles (Director to C-level):

  • $Clinical Disclosure
  • $Clinical Transparency
  • $Clinical Registration
  • $Regulatory Affairs
  • $Clinical Operations
  • $Data Privacy
  • $Clinical Development
  • $Medical Publications
  • $Medical Writing
  • $Medical Affairs
  • $Clinical Pharmacology
  • $Corporate Communications
  • $Corporate Operations
  • $Intellectual Property
  • $Statistical Programming
  • $Investor Relations
  • $Epidemiology
Secondary Market:
  • $Disclosure and Transparency Consultants
  • $Transparency and Disclosure Cloud Platforms
  • $Regulatory Services
  • $Data Anonymization Services
  • $CRO Pharma Solutions/Data Management Services
  • $Healthcare Communication Solutions
  • $Clinical Trial Disclosure Solutions
  • $Medical Writing and Editing Consultants

Group Discount Available!

If you’re interested to learn more, please contact Arianne Leclair at
arianne@momentumevents.com

Key Takeaways

Achieve elevated confidence in clinical disclosure practices for US and EU standards on both a company and team level.
Construct a transparency team that will allow efficient clinical data disclosure practices for internal and external relations.
Discuss how to prepare clinical data for disclosure in the earliest and most compliant way to appeal to all governments involved in regulation and compliance.
Guarantee compliance documents are future-proofed for disclosure compliance and protection.
Understand clinical data disclosure enforcement and how to best avoid penalties.

Sponsors

Sponsorship Opportunities Now Available!
If you’re interested to learn more, please contact Lauren Arcady at
laurenb@momentumevents.com

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