Clinical Regulatory Roundtable: Accelerating drug development

Reserve your space now for the informative discussion hosted by industry experts in Clinical Regulatory discussion and successful strategy development.

Make this a time to join your fellow Toronto based biotech peers for an engaging discussion to accelerate drug development.

Caidya provides the cocktails and appetizers at the Marriott Downtown CF Toronto Eaton Centre September 5th. Please come join us.

Who should attend: Biotech and biopharma drug development executives, management, and scientists with assets in pre-clin, IND enabling studies, early phase clinical development, and CEOs interested in Regulatory Accelerated Approval Programs.

Thursday September 5th

Marriott Downtown at CF Toronto Eaton Centre
525 Bay St., Toronto, ON M5G 2L2, Canada
• 5:30pm – meet and greet
• 6:00pm – Clinical Regulatory Presentation
• 6:30pm – Round Table Discussion
• 7:30pm — Adjourn

Leading the discussion:

Bani Tchekanova MS, PhD

Vice President of Regulatory and Strategic Development

• Over 25 years of Regulatory experience across diverse therapeutic areas including oncology (small molecules, and biologics), dermatology, infectious disease, and cardiovascular
• Expertise in FDA-required quality standards and clinical research management
• Extensive experience in IND, NDA, BLA, MAA development for health authority, FDA, EMA, PMDA and Health Canada submissions
• Member of FDA Advisory Committee for the Pharmaceutical Science and Clinical Pharmacology
• Mentoring few ASCO physicians on clinical trials and regulatory affairs
• Mentoring Students on Regulatory Affairs
• Member of DIA, RAPS, ASCO, OCRA and SDRAN

Blaine Van Leuven, MS, RAC

Executive Director, Regulatory and Strategic Development

• Over 18 years of experience in pharmaceutical product development and global regulatory affairs with expertise in CMC strategy for small and large molecules and combination products
• Serves as Regulatory CMC Lead during FDA and global health authority interactions
• Authors, reviews, and/or manages CMC sections for clients’ IND, CTA (IMPD), and global marketing applications including ANDAs