Facet Life Sciences was recently featured in Life Sciences Review, spotlighting the firm’s entrepreneurial approach to FDA regulatory strategy for emerging biotechs.
Life Sciences Review recently sat down with Dr. Tom Hallam, Ph.D., MBA (President & COO), and Tom Meyer (VP & Head of Business Development) on how Facet challenges the industry’s assumed trade-offs between quality, speed, and cost — and what it looks like when regulatory strategy is built around your program, not a standard playbook.
Facet was also recently recognized by Life Sciences Review as the exclusive recipient of the Top Regulatory Services Provider 2026 award, based on a proprietary methodology, and was named among the Top Regulatory and Compliance Services leaders.
A new client came to Facet Life Sciences with a problem. For years, their CRO had advised them they needed additional Phase 3 clinical trials. The Facet team reviewed the data and saw a better way.
Facet determined that the existing data was already sufficient to support an NDA submission. They reframed the regulatory strategy, engaged with the FDA, and secured agreement to move forward. The result: savings of millions of dollars and two to three years of development time — for a single client, in a single engagement… and a new product to patients!
It wasn’t luck. It’s what they do. It is the Facet model in action. They take nothing as a given, are creative, and find the best path to FDA approval.
Better by Design: Purpose-Built for Emerging Biotech Companies
Emerging biotech companies, operating with limited capital and compressed timelines, must identify the most efficient path to approval. Aggressive regulatory strategy, clinical study design and evidence planning are key to achieving value-building milestones.
Facet was built with one need in mind: the emerging biotech company operating with limited resources and compressed timelines. They have one “shot on goal” and need it to be right 100% of the time.
Purpose-built for small biotech companies, Facet intentionally recruits senior-level professionals with deep, domain-specific expertise — scientists who have run these programs before, met with the FDA, and know how to build a compelling story. Facet’s clients get a team who can apply a breadth of experiences directly to their program.
“We leverage our knowledge of the science behind the drug or medical device under development to help clients navigate regulatory, clinical or nonclinical hurdles with speed and efficiency.”
Whether the goal is early proof-of-concept data for out-licensing to large pharma companies or the fastest path to full-scale commercialization, Facet’s experienced industry veterans tailor strategies in line with the clients’ business objectives. Facet’s focus is on maximizing ROI for every R&D spend.
“We leverage our knowledge of the science and deep experience with the FDA to help clients navigate regulatory, clinical and nonclinical hurdles with speed and efficiency,” says Tom Hallam, President and COO.
Facet provides guidance across the full drug development lifecycle — from initial IND through NDA approval, and across regulatory, clinical, statistical, and commercial domains. For Sponsors with deep in-house capability in any of these areas, the firm provides an independent second set of eyes. For Sponsors without these skillsets, Facet can fill in almost any knowledge gap – as an internal check on the work being done by CROs, a sounding board, or handling all the activities needed through FDA approval.
Facet’s statistical team is particularly valued in this role. Many emerging biotechs rely on their CROs to provide analytical insight without any internal capability to validate it. Facet’s statisticians close that gap.
Integrating commercial insight early in the process helps clients understand market dynamics and determine the drug’s value potential upfront. These decisions have cascading effects on the trial count and approval timelines, saving time and resources.
Challenging Industry Norms for Enhanced Outcomes
For decades, the biotech industry has assumed that companies must trade off between quality, speed and cost during candidate development.
Facet challenges this belief. In each engagement, it brings the right scientific expertise and planning to deliver high-quality outcomes while reducing timelines and controlling costs.
Emerging biotechs need expert advisors who understand their constraints, share their urgency, and bring the kind of creative, innovative thinking that can make a real difference to timeline and cost. They need partners who act like fiduciaries, like Facet.
Facet’s message is simple: a smarter path to FDA approval exists. It starts with asking the right questions and having the right partner to answer them.
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