Caligor Broadens Leadership Team to Support International Growth

Stephanie Smith Appointed as Director, US Operations – Global Access Programs;

Kelly Fearn Appointed as Global Head of Regulatory Affairs – Global Access Programs

SECAUCUS, N.J. & DARTFORD, United Kingdom--()--Caligor Rx, a leader in global specialty pharmaceuticals services, today announced the appointments of Stephanie Smith as Director of US Operations for Global Access Programs and Kelly Fearn as Global Head of Regulatory Affairs for Global Access Programs (GAP).

“Stephanie and Kelly bring complementary skills, experience and relationships to our senior leadership team”

“Stephanie and Kelly bring complementary skills, experience and relationships to our senior leadership team,” said Caligor Managing Director Tammy Bishop. “Both women are operationally driven, strategy-minded leaders who will be instrumental in the expansion of our GAP division at Caligor.”

GAP is Caligor’s term for programs also referred to as “named patient,” “expanded access,” “early access,” or “compassionate use” programs. These are not clinical trials, but rather targeted programs specifically intended for patients who have exhausted their treatment options and for whom appropriate therapies exist outside normal commercial channels. A GAP program can be established for an individual patient or for a group of patients. For pharmaceutical and biotechnology companies, GAP provides a solution for effectively meeting patient demand in markets around the world, throughout the product lifecycle.

In her role, Ms. Smith is responsible for leading all key operational aspects of Global Access Programs at Caligor, collaborating with the Head of Global Regulatory Affairs, UK Director, and the Global Head of QA. Prior to joining Caligor, she served as the Head of US Operations for the Managed Access Programs division of Idis. She brings more than 20 years of pharmaceutical industry experience to Caligor, including clinical trial expertise in program/operations management from early-to-late-stage drug development and expanded access programs at companies including, Pharmacia, Schering-Plough, Johnson & Johnson and sanofi. She received a Bachelor’s degree from The University of Texas at Austin.

In her role, Ms. Fearn is responsible for overseeing all regulatory aspects of the Company’s Global Access Programs. Prior to joining Caligor, she served as Senior Manager of Global Regulatory Information at Idis, where she was responsible for country-specific expanded access intelligence and regulatory training as well as serving as the subject matter expert for all external stakeholders as well as internal functions, including business development.

Ms. Fearn has more than 16 years of regulatory affairs experience. Previously she was Director of Global Regulatory Affairs at I3 Research and Associate Director at Orion Clinical Services, and held positions with Parexel and J & J Ortho Clinical Diagnostics. She graduated from Warwick University with a BSc Honours degree in Chemistry and Medicinal Chemistry and is a member of The Organisation of Professionals in Regulatory Affairs.

About Caligor Rx

Caligor Rx is a global specialty pharmaceuticals services business focused primarily on sourcing and supplying drugs for worldwide clinical trials. The Company is dedicated to serving the pharmaceutical and life science industries as well as patients with specialty needs.

Caligor’s Global Access Program (GAP) is an ethical, innovative and compliant platform to create global customized solutions that facilitate patient access to unlicensed medicines that address unmet medical needs. Caligor bridges the gap for physicians, patients and pharmaceutical and biotechnology companies through collaboration, development and implementation of programs that incorporate the appropriate access solutions to meet the needs of markets around the world, throughout the product lifecycle.


Sharon Merrill Associates
Scott Solomon, 617-542-5300