Dr. Celia Witten – Former Deputy Director of FDA’s Center for Biologics – Joins ELIQUENT

ELIQUENT Life Sciences today announced that Celia Witten, M.D., Ph.D., former Deputy Director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics, has joined the firm. Dr. Witten’s appointment reflects ELIQUENT’s to supporting innovators developing advanced therapies across the development lifecycle.

“Dr. Witten’s vision and leadership at the FDA played a pivotal role in shaping the regulatory pathways that drive innovation in cell and gene therapy (CGT), rare disease programs, patient engagement, and human tissue regulation,” said Tim Dietlin, Chief Executive Officer, ELIQUENT Life Sciences. “Her deep regulatory insight and scientific perspective gives our clients a distinct advantage as they pursue groundbreaking therapies with confidence and clarity.”

Dr. Witten brings nearly three decades of regulatory leadership and scientific expertise to her role at ELIQUENT, including nine years of service as Deputy Director of the FDA’s Center for Biologics Evaluation and Research (CBER) where she oversaw the restructuring of the Office of Tissues and Advanced Therapies into the Office of Therapeutic Products. In this role, Dr. Witten enhanced the agency’s review capacity for CGT products, launched strategic initiatives like the START pilot to improve industry communication, and led key programs in advanced manufacturing, international collaboration, and horizon scanning. Prior to that, Dr. Witten served as Director of the Office of Cellular, Tissue, and Gene Therapies, helping to catalyze the growth of investigational studies and product licensure during a transformative period in CGT.

Dr. Witten joins a multidisciplinary team of scientific, regulatory, and quality professionals supporting sponsors who work across the development lifecycle to help clients align with regulatory expectations, accelerate progress, and bring transformative therapies to patients. Learn more about Dr. Witten.

About ELIQUENT Life Sciences

ELIQUENT redefines regulatory consulting with a full-service platform that delivers integrated solutions across the product lifecycle. The firm’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to advise clients on the complex process of bringing new therapies to market and manufacturing them to quality standards. ELIQUENT’s platform of regulatory solutions feature the following integrated service offerings:

• Regulatory Affairs Solutions: From the earliest phases of innovation through regulatory submissions, to post- approval support, ELIQUENT guides companies to approval and beyond.
• Pharmacovigilance & Risk Management Solutions: With an approach that includes both strategic direction and hands-on global support, customized PV solutions empower companies to operate with confidence.
• Quality & Compliance Solutions: Highly specialized compliance experts build customized solutions that equip companies with best- in-class strategic support, technical expertise, and project-based solutions.
• Remediations Solutions: Respected professionals and global experts bring an unmatched level of credibility and trust when interacting with regulators and guiding companies to remediation solutions.
• Talent Solutions: Whether you need a team of one or 100+, ELIQUENT’s talent solutions gives clients the ability to rapidly scale teams to the right size, with the right level of expertise, in the right locations.

THE ­­ELIQUENT team works cross-functionally to deliver the global solutions that pharmaceutical, biotechnology, and medical device companies need to gain and maintain authorization for the products. ELIQUENT’s comprehensive services support innovators across therapeutic modalities, phase-based pathways, and major global markets. ELIQUENT’s continued growth is supported by GHO Capital, the European specialist investor in healthcare.