Setting the Curve in Consulting to the Biopharmaceutical Industry

I had the pleasure of working with Michael on development of a clinical strategy for a novel biologic in the oncology arena, where Mike was the clinical lead. Michael brought rational clinical design skills to the project, in combination with a flexible, operationally feasible approach. Michael interacted with equal ease with leading global physicians, senior company management and cross-functional project team members. This level of flexibility, combined with Mike’s deep scientific knlowledge and excellent communication skills truly differentiates him as a senior clinical consultant.” 

Simona Cipra, Sr Director Clinical Operations, Eisai Pharmaceuticals (formerly MGI Pharma, INC.), Lexington, MA

Case History: Strategic Success Dimention

A large Scandinavian healthcare company elected to explore diversification into the ethical pharmaceutical business.

BioStrategics Consulting Ltd was selected as part of the broad management consulting team.

We extensively evaluated the corporate assets, opportunities, and growth potential in the global pharmaceutical arena.

The project led to the development of a small, innovative, “intrepreneurial” unit. It had the mission of developing a highly focused portfolio of proprietary pharmaceutical products.

In its capacity as a longstanding consultant to the unit leader, BioStrategics Consulting Ltd has assisted in strategic planning not only at the corporate level but also at the level of individual clinical development programs.

At one point, the unit was presented with the opportunity to license a technology closely aligned with its mission.

As part of an intensive 6-month evaluation effort, Dr. Silverman was named to serve on the project steering committee as well as to head its development assessment team.

In this capacity, Dr. Silverman undertook the following tasks:

  • led the scientific, clinical, and regulatory due diligence efforts
  • met with US and European thought leaders
  • helped elaborate both preclinical and clinical development plans
  • assisted the client in ultimate decisions regarding licensing and commercialization

Strategic success, in this instance, depended upon a thorough understanding of the new technology, its relationship to the corporate mission, and a realistic view of the clinical pathway that would bring the product to market.