Clinical Development & Trial Design

We counsel on FDA regulatory strategy, from preclinical planning and IND development through clinical trials, NDA/BLA approval, labeling, and post-approval commitments.

Drug and biologic development turns on a series of consequential decisions: which indication to pursue, what endpoints and comparators to select, what evidence FDA will expect, and what trial design can support approval. These choices have wide-ranging impacts, affecting FDA's view of the evidence, negotiating posture at key meetings, the approvability of the application, and the label and commercial opportunities.

We help sponsors make those decisions with FDA precedent, reviewer expectations, patient need, and commercial reality in view from the start. We also help clients engage with FDA throughout development to test assumptions, refine strategy, and push back when appropriate.

We advise on:

• Target indication and patient-population strategy
• Clinical development planning and trial-design strategy
• Protocol review and regulatory-risk assessment
• Endpoint selection and evidentiary strategy
• Pre-IND meetings, FDA meetings, and IND submissions
• Type A, B, C, and D meetings, including end-of-Phase 2 and pre-NDA/BLA meetings
• Special Protocol Assessments and alignment on pivotal-study design
• NDA and BLA submission strategy and FDA review issues
• Labeling strategy and negotiations
• Postmarketing requirements and commitments
• Expanded access and Right to Try
• Device-related issues in drug and biologic development, including combination products, diagnostics, cross-labeling, digital health, and software

Selected Experience

• Helped sponsor overcome IND clinical hold issues related to nonclinical safety margins and trial design, resulting in an IND granted letter without the need for additional nonclinical studies.
• Advised on the strength of clinical evidence for possible NDA submission based on a single Phase 2 trial, including whether existing informed consent permitted the additional analyses needed to support the marketing application. Sponsor received approval without conducting an additional clinical study or requiring reconsenting patients.
• Helped sponsor design its pivotal clinical trial in a complex rare disease, including choice of endpoints, considering FDA advice and leveraging regulatory precedent.
• Advised on the likelihood of approval based on existing studies, including right-of-reference issues, ultimately leading to a successful marketing application based largely on significant unmet need.
• Advised on pre-IND briefing document and regulatory strategy for personalized oncology product development, resulting in a rapid pathway to IND acceptance.