Extending Precision’s Capabilities Into One of the Fastest Growing Areas of Drug Development

Bethesda, MD and Carlsbad, CA – September 6, 2017 – Precision for Medicine, part of the Precision Medicine Group, announced today it has acquired Agility Clinical (“Agility”), the leading contract research organization (CRO) focused specifically on clinical development of rare disease and orphan therapies. The acquisition creates the first comprehensive, fully integrated orphan therapy clinical development services provider, combining the highest standards in global clinical trial execution and biometrics expertise with sophisticated biomarker and specialty lab capabilities.

Agility was founded in Carlsbad, California in 2012 with a mission to help companies bring innovative rare disease treatments to market more effectively for patients and their families. New treatments being developed for rare diseases present fundamentally different regulatory and operational challenges compared with other areas of clinical development. Agility has assembled an experienced operational and clinical team to support the advancement of these products, as well as complex development programs in broader disease areas. Overall, Agility has supported over 100 clients in the past 5 years.

“Agility’s expertise in rare and orphan research and its heritage in biostatistics and data management for complex trials are perfect complements to our existing research capabilities,” said Precision for Medicine President Chad Clark. “Agility’s operational strength in California enhances Precision’s ability to support the vast number of dynamic biotech companies throughout the West Coast. Together, Precision and Agility can deliver sophisticated global studies and help innovative life sciences companies achieve their clinical development goals faster.”

Nearly half of all medications approved by the FDA in 2016 were orphan drugs, and 73% of those approved benefited from one of the FDA’s programs to expedite the process of drug review, such as breakthrough therapy designation. Acquiring rare and orphan expertise not only expands Precision’s capabilities into one of the fastest growing areas of drug development, but also complements Precision’s core offerings, as many rare disease patients are screened through a “precision medicine” biomarker-based test.

Additionally, clinical development programs for treatments of rare diseases require specialized expertise in regulatory, statistical design, and global clinical operations to support studies with narrow and difficult-to-recruit populations. Precision’s rapidly expanding EU footprint will be immediately available to support Agility’s clients.

Agility will continue to be led by Ellen Morgan, co-founder and CEO. Prior to founding Agility, Ms. Morgan was the founder and CEO of Synteract, a full-service CRO serving biopharma companies.

“We could not be more pleased to join the Precision for Medicine family,” explains Morgan. “We see Precision’s biomarker expertise, growing global footprint, and focus on precision medicine as a perfect complement for our clients’ needs. Agility and Precision share very similar company cultures, including our goal of delivering new therapies to patients who need them most, and we see this as the right next step for our employees and our valued clients.”

Agility Chairman and Co-founder David F. Hale added, “Precision is an ideal match for Agility, and we are gratified that Precision is committed to supporting the continued growth of Agility’s business in our Southern California base of operations. This thriving biotech market now has an even stronger partner for new drug and diagnostic development.”

About Precision for Medicine
Precision for Medicine supports life sciences companies in the use of biomarkers essential to targeting patients more precisely and effectively. Precision applies novel biomarker approaches to clinical research that take advantage of the latest advancements in science and technology, focusing predominantly around genomics, immune-response assays, global specimen logistics, biomarker analytics, and companion diagnostics solutions. For more information, visit precisionformedicine.com.

About Agility Clinical
Agility Clinical is a contract research organization (CRO) focused on the needs of preclinical and clinical stage companies and specializes in rare disease and complex clinical trials. Agility has a successful track record of preparing data for regulatory submissions leading to product approval. Founded in 2012 and headquartered in Carlsbad, California, Agility claimed consecutive ROAR (Rare and Orphan Advocacy and Research) awards for best CRO. For more information, visit www.agility-clinical.com.

# # #

Media Contact:
Louis Landon, Precision Medicine Group Media Relations