News & Insights

Observations. Experiences. Opinions. Events

Featured Case Study
Rare & Orphan

The task was straightforward, though extremely difficult: Get the FDA to consider a different efficacy endpoint for approval.

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Rare & Orphan

A Natural History Study Poses a Distinct Enrollment Challenge

With a target population of 1 in 5,000 and no therapeutic benefit for participants, filling a 200-person study posed a serious challenge. Yet, Precision’s multitiered approach to recruitment, enrollment, and retention produced a sufficiently robust study to generate the data necessary to design a phase 2/3 study.

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Oncology

From Pediatric to Adult Indication: Expanding a Product Life Cycle

Developing an oncology franchise can be a challenge. Launching with an acquired drug initially approved only for pediatric patients required Precision expertise.

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Rare & Orphan

Securing Enrollment for a Complex Phase 2 Trial in Eosinophilic Esophagitis Ahead of Schedule

A rare disease. An accelerated enrollment timeline. And a patient cohort suddenly limited to adults. By developing targeted strategies to address each of these challenges, Precision was able to meet enrollment goals 2 months ahead of schedule—and sites reported that success was directly due to effective communication and ease of implementation.

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Oncology

Careful Site Selection Bolsters Enrollment in Adaptive Study, Accelerating Proof of Concept

Exploring multiple tumor types concurrently should speed proof of concept. But when the target patient population is limited to 2% to 8% of all solid tumors, and genomic profiling is a requisite for enrollment, recruitment can be a challenge—one that Precision met through long-standing expertise.

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Rare & Orphan

When the FDA Has Questions: Finding Answers in the Data

After planning a study to assess typical measures of sensitivity and specificity, our sponsor was asked by the FDA to modify the primary endpoint used to interpret whether the new diagnostic was sufficiently comparable to the existing gold standard. The sponsor turned to Precision for Medicine Oncology and Rare Disease to navigate the request.

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Oncology

Experience With Multiple Myeloma Rescues a Global Phase 3 Trial

When the sponsor of a global phase 3 registrational trial realized their CRO had insufficient expertise in multiple myeloma, they turned to Precision to get the study back on track. We were able to re-engage qualified sites and implement detailed patient enrollment plans, resulting in full enrollment of 780 patients at 155 sites in 20 countries a full month ahead of schedule.

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Oncology

Harnessing Flow Cytometry Data to Keep
a Phase 1 Trial on Track

The task: ascertain the optimal dose of a novel therapeutic for maximized response while remaining tolerated and safe.
The issue: no clinical data—and considerable time pressure, with enrollment on hold, pending results. Precision succeeded by relying on biomarker and immunohistochemistry data, analyzing flow cytometry data to provide initial results within 1 week.

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Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, adaptive clinical trial execution to regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.