A development stage biotechnology company was engaged in the development of a novel anti-cancer vaccine.

While the product had proved safe in Phase 1 trials, the sponsor had no physician on staff and only a minimal clinical research infrastructure. There was no clear plan in place for advancing the vaccine into efficacy trials.

Essential questions about dosing, trial design, and clinical endpoints were yet to be answered.

At that point, BioStrategics Consulting Ltd was engaged.

Working with the company’s excellent senior scientific staff, Dr Silverman was part of the team that organized an expert advisory panel to explore critical clinical, market, and regulatory issues relating to the efficacy trials program.

Dr. Silverman then spearheaded the effort to translate this information into a Phase 2 protocol design that addressed the key clinical questions in a sound, scientifically rigorous manner.

The protocol design and conduct had to incorporate a number a unique features, including:

• special blinding procedures;
• sensitivity to ethical considerations related to the delay of definitive treatment in patients with potentially pre-malignant lesions; and
• the incorporation of a surgical procedure considered to be the standard of care for most patients.

Through a lengthy process of consultation and negotiation with expert clinicians on 2 continents, clinical investigators, and FDA reviewers, BioStrategics Consulting Ltd helped produce a protocol that satisfied all concerns as well as met the central scientific efficacy objectives.

During the course of the protocol conduct, we further assisted by presenting the program, on numerous occasions, to potential investors, licensees, governmental regulatory and funding agencies, and strategic partners.

In every instance, the fact that the protocol had a very high probability of meeting its scientific objectives was clearly beneficial in contributing to the client’s business goals and strategic success.

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