Andelyn Biosciences Board of Directors Announce New CEO
(COLUMBUS, Ohio) – Andelyn Biosciences Chief Operations Officer Wade Macedone has been promoted to CEO of the gene and cell therapy manufacturing company following a national search. He will begin his role as CEO immediately.
“Following an engaging and productive search, we found the right leader here within the leadership team at Andelyn. Wade brings a wealth of knowledge in clinical manufacturing with a more than 30-year industry track record of leading operations for medical devices, biologics, pharmaceuticals, and cell and gene therapies. His experience in all aspects of clinical manufacturing and business operations will advance the already exciting momentum of Andelyn Biosciences,” said Tim Robinson, Chair of the Board of Directors for Andelyn Biosciences and CEO of Nationwide Children’s Hospital.
“Andelyn Biosciences is the original gene therapy pioneer, where the first FDA-approved systemic gene therapy was produced while operating out of NCH. We offer a wide portfolio of capabilities and services that are game-changing for our clients and life-saving for patients,” said Macedone. “Andelyn’s mission-driven history and proven track record is making a meaningful impact on the world of novel gene therapies. I’m honored – and energized to have the opportunity to lead this organization where our clients’ innovative discoveries are advanced in a timely and reliable manner to benefit patients who need those breakthrough therapies.”
Macedone has had a distinguished career working in the cell and gene industry to include positions covering analytical development, quality operations, validation, process development and manufacturing. From 1996 to 2018, he held various leadership roles at Boehringer Ingelheim/Roxane Laboratory Inc. where he was responsible for overall business performance including site strategy, product development, quality, business growth, commercial manufacturing, and product launch for world-wide distribution.
Following a brief role in consulting, Macedone became the general manager and executive director of ATMP (Advanced Therapy Medicinal Products) clinical manufacturing operations at the Abigail Wexner Research Institute at Nationwide Children’s Hospital. In September of 2020, Macedone became Chief Operations Officer at Andelyn Biosciences when it spun out of Nationwide Children’s GMP (Good Manufacturing Practices) clinical manufacturing facility as a for-profit affiliate.
Macedone has a Bachelor of Science degree in Chemistry from the University of Pittsburgh, with additional areas of study including polymer sciences, business management and mathematics. He also achieved a lifetime certificate in project management from Xavier University.
With over 20 years of experience in clinical manufacturing, Andelyn’s scientific expertise has produced 450+ GMP clinical sublots in support of more than 75 worldwide clinical trials. Andelyn’s advanced quality systems, full regulatory support, and supply chain vertical integration are accelerating the development and manufacturing of innovative therapies to bring more treatments to more patients.
In the Spring, Andelyn Biosciences will celebrate the grand opening its new 185,000 sq. ft. manufacturing and corporate headquarters located in The Ohio State University, Carmenton Innovation District. Now operating in three facilities for plasmids, pre-clinical, and GMP clinical and commercial manufacturing, the opening of the new Andelyn Corporate Center completes a network of flexible and scalable sites that support end-to-end cell and gene therapy contract development and manufacturing.
About Andelyn Biosciences
Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on developing, characterizing, and producing viral vectors for gene therapy. With more than 20 years of experience, Andelyn’s deep scientific expertise has resulted in the production of cGMP material for more than 500 clinical batches and 85 global clinical trials. Operating out of its development and manufacturing facilities in Columbus, Ohio, Andelyn supports its clients in developing cell and gene therapies from concept through plasmid engineering and manufacturing, process and analytical development, and cGMP clinical and commercial manufacturing. Andelyn can accelerate programs and deliver high-quality products by developing and manufacturing processes on its configurable, data-driven Curator® Cell and Gene Therapy Platforms, or by tech transfer within an established client program. Capabilities include cGMP manufacturing for suspension and adherent processes. A rigorous, commercial-grade quality system, phase-appropriate manufacturing, and supply chain vertical integration further help clients bring critical therapies to market.
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