Outcomes That Speak for Themselves

Challenge

A mid-size oncology company had a promising PD-L1 inhibitor but faced a fragmented regulatory strategy after their internal team turned over mid-program. With a PDUFA date approaching and unresolved FDA information requests, they needed experienced leadership fast.

Approach

We embedded a senior regulatory lead within 72 hours, resolved all outstanding FDA queries, and restructured the NDA response strategy. We also prepared the team for a pre-approval inspection and coordinated labeling negotiations.

Outcome

The NDA received first-cycle approval under Priority Review — four months ahead of the original internal timeline. The product launched as a first-line therapy for NSCLC patients with high PD-L1 expression.

Challenge

A biotech startup developing a gene therapy for a rare pediatric metabolic disorder had never filed with FDA before. Their CMC package was incomplete, their pre-IND meeting had surfaced significant questions, and their timeline to first patient was under pressure from investors.

Approach

We took over full IND preparation — restructuring the CMC section, writing the pharmacology/toxicology summary, and developing a Phase I protocol designed to satisfy FDA's safety concerns while enabling meaningful early efficacy signals.

Outcome

The IND cleared without a clinical hold in 30 days. The Phase I trial enrolled its first patient eight weeks later — the fastest first-patient timeline in the company's history.

Challenge

A neurology-focused biotech had compelling Phase II data for an ALS candidate but had been advised by outside counsel that Breakthrough Therapy Designation was unlikely given the competitive landscape and FDA's historical caution in the space.

Approach

We conducted a deep analysis of FDA's prior BTD decisions in ALS and related neurodegenerative diseases, identified the specific data elements most likely to resonate with FDA's review division, and built a BTD request that reframed the clinical evidence around unmet need and preliminary clinical evidence criteria.

Outcome

FDA granted Breakthrough Therapy Designation within 60 days of submission — enabling more frequent FDA interactions, rolling review eligibility, and a significantly accelerated development timeline.

Challenge

A cardiovascular drug developer received a Complete Response Letter citing deficiencies in their cardiovascular outcomes data and a request for an additional post-marketing study. The internal team was demoralized and uncertain how to respond without triggering a second CRL.

Approach

We led a structured CRL response strategy — analyzing FDA's specific concerns, identifying existing data that addressed the outcomes questions, and negotiating the scope of the post-marketing commitment to a feasible design. We prepared the Type A meeting request and briefing document.

Outcome

The Type A meeting resulted in a clear path to resubmission. The NDA was resubmitted as a Class 2 response and approved six months later with a manageable post-marketing commitment — no additional clinical trial required.

Challenge

A Phase III trial in moderate-to-severe psoriasis was 14 months behind enrollment projections. The sponsor had activated 45 sites but 60% were underperforming. A competitive trial had launched in the same indication, further tightening the patient pool.

Approach

We conducted a rapid site performance audit, identified the top-performing sites and the root causes of underperformance at the rest, and implemented a targeted rescue plan — including site-specific recruitment support, protocol amendment to broaden eligibility, and a digital patient identification campaign.

Outcome

Enrollment was back on track within five months. The trial completed enrollment three months ahead of the revised timeline, and the sponsor avoided a costly protocol extension that would have added an estimated $8M in trial costs.

Challenge

A specialty pharma company was planning a full 505(b)(1) development program for a reformulated analgesic — a path that would have required a complete Phase III program and an estimated seven-year timeline to approval.

Approach

We identified a viable 505(b)(2) pathway leveraging existing safety and efficacy data from the listed drug, designed a bridging study program that satisfied FDA's requirements, and negotiated the development plan in a Type B meeting.

Outcome

The 505(b)(2) NDA was approved in 18 months from IND filing — saving an estimated three years and $40M in development costs compared to the original 505(b)(1) plan.