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Ibett Romero

By: Ibett Romero on March 19th, 2020

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Phase I Oncology PD-1 Inhibitor Enrolled 78 Days Early

Pharm-Olam Insights | Oncology-Hematology Disease

Pharm-Olam is a mid-sized, global CRO that provides clinical research solutions for rare diseases, oncology, hematology, autoimmune conditions, allergies, and infectious diseases. Our organization was hired to support a Phase I, first-in-human study of a programmed cell death receptor (PD-1) inhibitor monoclonal antibody (mAb) drug treatment for solid tumor malignancies. The research is in its final stages. Pharm-Olam is proud to have supported this critical research, the patients and the sponsor involved.  

The company [Pharm-Olam] managed six dosages over four sites, all based in the United States. While there are challenges to enrolling patients in a first-in-human oncology study, we completed enrollment 78 days ahead of schedule thanks to strong relationships with our investigators and the effective deployment of our checkpoint approach to cohort management.

In response to the recruitment success, Pharm-Olam had to escalate the study timeline and leverage their cohort management skills (read more about Pharm-Olam’s approach to effective cohort management here). The company had to flex its staff and its resources to accommodate rapid patient enrollment. Ultimately, this meant adding additional days on site and adding resources where necessary to respond to the study demands and ensure timely data review to support study and cohort progression. 

Pharm-Olam managed the fast recruitment because of our agility and flexibility to meet demand. As a result, the company is wrapping up the PD-1 mAb study after enrolling all subjects 78 days early.

We are grateful to our patients, our sites and our sponsor for the work done in support of furthering PD-1 inhibitor research and the drive to find a cure.  

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About Ibett Romero

Ibett is a Project Manager at Pharm-Olam, with over 13 years of experience in oncology-related research, including work on clinical trials that have contributed to FDA approvals in the oncology setting. With a background in site management, Ibett has the ability to assess clinical trials from the physician and site staff perspective, in an effort to make processes associated with clinical trials as efficient as possible for both the site and the patient. Impacted by cancer within her family, Ibett brings passion to her work with clinical trials, with the goal of connecting those who have embarked on their cancer journey, with innovative and new treatments. When Ibett is not at work, Ibett divides her time between earning her Masters of Science in Organizational Leadership, trying new food from around the globe, and traveling with her husband.