Biologics and Biosimilars

Biography

Candida is a Founder and President of BBCR consulting. Leveraging extensive experience leading early clinical development and developing regulatory strategy, BBCR consulting is a valuable asset for a company requiring advisory related to life science product development; specifically, pipeline and clinical plan assessments, clinical trials, GTM strategy, safety, or biomarker. BBCR team areas of expertise include rare diseases, immune-oncology, immunology, inflammation, risk-benefit management, regulatory compliance, and FDA issues. BBCR team is a specialized in Orphan, Autoimmune, Oncology, and CNS indications for innovator, biosimilar, and repurposing products. BBCR team has contributed innovative clinical regulatory strategies and trial design for products, directed regulatory compliance across international government entities for drug, device, and combination products. BBCR team leads evidence-based trial strategies, cost-effective solutions, reduces risks and facilitate patient centricity, recruitment and retention Candida is an accomplished Senior Executive MD with more than 25 years of success spanning biotechnology, pharmaceuticals, and device. She led market approval for five major products, improved endpoint achievability, and designed Natural History studies and registry protocols. An industry leader, she is a sought-after speaker presenting at international industry summits. Candida attained her MD and an higher degree in Immunology and trained at The Johns Hopkins University and The Harvard University.

Research Interest

• Biosimilars: Clinical Plan and regulatory strategy • Rare disease: Clinical Plan and regulatory strategy • Safety and Pharmacovigilance • Regulatory submissions (IND, IMPD, etc) • Clinical Hold Resolution • Re-analysis data for failed clinical trial • Patient registry • Natural History study rare disease