The goal of clinical development is to efficiently and effectively generate the evidence needed to support the intended label. Early regulatory agency alignment, strategic study and program design, and intimate knowledge of the regulatory, clinical, and competitive landscape ultimately support the successful launch of a product.
NGT BioPharma Consultants’ for clinical development and execution services supports both small molecules and biologics (e.g., mAbs, duobodies, proteins, cell/gene therapies, and other new modalities)
NGT BioPharma Consultants deliver clinical development and clinical-regulatory strategies and can lead or support execution, from first-in-human through Phase 3 and lifecycle management with a creative, risk-mitigated development approach. Our clinical leads Dr. Lee Techner and Dr. Amy Rachfal from Stage Gate Partners, LLC bring more than 45 years of combined experience leading integrated development programs, representing sponsors with FDA, EU regulators and Health Canada, including at FDA Advisory Committees, and providing clinical oversight within cross-functional teams.
Clinical plans are built in step with other NGT services areas, nonclinical, clinical pharmacology, CMC, and regulatory workstreams, all focused on the target product profile and regulatory pathway alignment.
