Precision for Medicine Builds FDA ‘Dream Team’ for Oncology Trials

BETHESDA, Md. – May 21, 2026 – In a strategic move that underscores the increasing complexity of cancer drug development, Precision for Medicine has assembled a formidable trio of former high-ranking U.S. Food and Drug Administration (FDA) officials. The company announced today that Paz Vellanki, MD, PhD, a recent Associate Director from the FDA’s oncology division, has joined as Vice President, Clinical Development, Oncology.

Dr. Vellanki’s arrival solidifies a unique concentration of regulatory expertise, placing her alongside two other former FDA oncology leaders: Chief Medical Officer Harpreet Singh, MD, and Vice President of Clinical Development Nicholas Richardson, DO, MPH. This team's collective experience, spanning solid tumors, hematologic malignancies, and the very latest in biomarker science, signals a significant power play in the competitive contract research organization (CRO) landscape, promising clients an insider’s map to navigate the labyrinthine process of bringing new cancer therapies to market.

An Unprecedented Concentration of Regulatory Power

The creation of this internal regulatory brain trust is a direct response to the evolving challenges in oncology. Drug development is no longer a one-size-fits-all endeavor; it is a hyper-specific field driven by biomarkers, complex trial designs, and a constant push for faster, more efficient pathways to approval. Precision for Medicine is betting that embedding top-tier regulatory experience directly into its clinical development teams will provide a decisive advantage.

Dr. Vellanki joins from her role as Associate Director of the FDA's Division of Oncology 2, where she was a key decision-maker for drugs treating lung cancer, head and neck cancer, and rare tumors. She joins Dr. Singh, a former Director of the same FDA division, who is known for spearheading initiatives like “Project Pragmatica” to streamline clinical trials and for her expertise in geriatric oncology. The trio is completed by Dr. Richardson, who served as Deputy Director of the Division of Hematologic Malignancies 2, where he was instrumental in shaping regulatory strategy for cutting-edge treatments like CAR-T cell therapies and developing novel endpoints such as minimal residual disease (MRD).

“Paz's arrival is a defining moment for Precision for Medicine,” said Daisy DeWeese-Gatt, President, Clinical Solutions at Precision for Medicine, in a statement. “Having three former FDA oncology leaders embedded in our team directly reflects that mission and unequivocally sets us apart from other CROs. Together, Harpreet, Nick and Paz bring an unmatched depth and breadth of regulatory and clinical insight that will benefit every client navigating an increasingly challenging and rapidly evolving environment.”

The Cutting Edge: From ctDNA to Biomarker Strategy

Dr. Vellanki’s expertise is particularly timely. She was the technical lead on the FDA’s recently finalized guidance for the use of circulating tumor DNA (ctDNA) in early-stage solid tumor trials. ctDNA, often called a “liquid biopsy,” allows researchers to detect and monitor cancer through a simple blood draw, offering a non-invasive way to assess treatment response and detect molecular residual disease (MRD) — microscopic traces of cancer left after treatment that can signal a high risk of recurrence.

The potential for ctDNA to serve as an early endpoint in clinical trials could revolutionize drug development, allowing companies to get a faster read on a drug's effectiveness. However, its use requires careful validation and a deep understanding of regulatory expectations. Dr. Vellanki’s direct experience shaping FDA policy in this nascent field is a powerful asset.

“Her expertise in lung cancer, head and neck cancer, rare tumors and novel endpoints like circulating tumor DNA, combined with her years of experience shaping regulatory decisions inside the FDA, make her an extraordinary asset to our clients and to this organization,” stated Chief Medical Officer Harpreet Singh.

This focus on advanced biomarkers aligns with the company's broader strategy. Recent partnerships, such as one with SOPHiA GENETICS to integrate AI-driven analytics for biomarker discovery and another with Agena Bioscience to improve mutation detection in lung cancer, demonstrate a clear commitment to building a comprehensive, biomarker-driven platform. This new hire adds a critical layer of regulatory acumen to that scientific and technological foundation.

The Industry's Gravitational Pull on Top Regulators

The move of high-level officials from the FDA to the private sector—a phenomenon often dubbed the “revolving door”—is a well-established trend in the life sciences industry. While it raises perennial questions about talent migration from public service, the strategic benefit for companies is undeniable. Hiring former regulators provides not just technical knowledge of the rules, but invaluable institutional knowledge of the agency’s culture, priorities, and decision-making processes.

This insight is a critical de-risking tool for drug developers, from small biotechs with a single promising molecule to large pharmaceutical giants managing global portfolios. Understanding how to design a trial that will meet the FDA’s evidentiary standards, how to present data effectively, and how to anticipate agency questions can save millions of dollars and, more importantly, years of development time.

For companies working in the most complex and competitive areas of oncology—such as those developing therapies for rare cancers with small patient populations or pioneering novel cell therapies—this level of expert guidance can be the difference between a stalled program and a successful submission.

From Regulatory Strategy to Patient Reality

Ultimately, the strategic hires and focus on regulatory efficiency are aimed at a single, vital goal: delivering more effective treatments to patients faster. The complexities of the regulatory system, while essential for ensuring safety and efficacy, can create a formidable barrier between a scientific breakthrough and a patient in need.

By streamlining this process, experts like Vellanki, Singh, and Richardson can help accelerate the availability of precision therapies that target the specific molecular drivers of a patient's cancer. This is particularly crucial in areas of high unmet need, a point Dr. Vellanki emphasized in her statement.

“I look forward to bringing my FDA experience to Precision for Medicine and to serving as a true thought partner to the life sciences companies working to advance meaningful, life-saving therapies — particularly in disease areas like rare tumors, where numerous patients are still waiting for better options,” she said.

As the war on cancer becomes increasingly personalized and data-driven, the ability to navigate the path from laboratory to clinic is paramount. With its newly formed trio of regulatory veterans, Precision for Medicine has made it clear that mastering this path is not just part of its service, but the very core of its strategy to shape the future of oncology.