EXTON, Pa.--(BUSINESS WIRE)--Frontage, a full service contract research organization (CRO), today announced the appointment of Michael S. Willett, PharmD., RAC as President of its clinical business unit.
Dr. Willett is a seasoned industry professional with more than 25 years of experience in clinical research involving new chemical entities, biologics, biosimilars, medicines targeted for new therapeutic uses (505(b)(2) programs), consumer health, and generic drugs. In 1994, Dr. Willett established Advanced Biomedical Research, Inc. (ABR), a Phase I-II clinical CRO which was later acquired by Frontage in 2008. He left Frontage in 2009 to start a clinical and research consultancy, Ready Clinical LLC, where he provided strategic regulatory, clinical and pharmacokinetic consultation and analysis services in support of early phase clinical development programs. He has been involved in fast-track programs with drugs treating rare diseases and has performed site audits, best practice evaluations and training to academic and non-academic investigative sites. Dr. Willett has been a sub-investigator on over 400 Phase I-II clinical trials involving a wide range of compounds and has been involved in regulatory submissions for multiple new product approvals. Dr. Willett will leverage this extensive scientific and regulatory expertise to lead the Company's clinical business.
“I am very excited to work with Michael once again as he leads our clinical operations. He is an exceptional scientific, operational and regulatory expert with more than two decades of thought leadership in pharmaceutical clinical research. I believe his leadership skills will take our clinical business to greater levels of success and improved performance for our valued clients,” said Dr. Song Li, CEO of Frontage Laboratories.
“I am delighted and sincerely appreciative to have this opportunity. Song has built a phenomenal, versatile organization and the new state-of-the-art 160-bed Phase I-II unit in Secaucus will allow us to better serve our valued clients. I look forward to leading the clinical operations team to even greater success,” said Dr. Willett, President of Frontage’s Clinical Operations.
Frontage is a full service CRO assisting biopharmaceutical organizations in their research and product development efforts. Spanning from the discovery stages through late-stage clinical trials, our full service offerings include bioanalysis using more than 50 LC-MS/MS instruments, preclinical and clinical studies, analytical testing, product development support, DMPK and biometrics. Our company also provides turnkey product development, bioequivalence and analytical services to generic and consumer health pharmaceutical companies to support ANDA, and 505(b)(2) new drug application submissions.
Founded in 2002, the business has grown to state-of-the art research facilities in the US and China. Our experienced teams provide study management services for all phases of clinical research, including monitoring, data management, biostatistics and medical writing.
Frontage has enabled biopharmaceutical and generic companies of all sizes to advance hundreds of molecules through clinical development to commercial launch in global markets. For more information, visit www.frontagelab.com