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
Mike Silverman has provided key support to Pharmalucence as both strategic advisor and Medical Director for two new product programs. Mike's impact was immediate and included clinical trial design, clinical site qualification, FDA submission preparation/review and fulfillment of the Medical Expert role in FDA meetings. Beyond his extensive expertise in the pharmaceutical field, Mike brings a personal touch that encourages productivity and collaboration from his colleagues. I strongly recommend BioStrategic Consulting.” 

Glenn Alto, Private Investor and Business Advisor
Our company has retained Michael as an expert consultant to our drug development and clinical trialing activities since 2001. He is highly valued member of our 'team' and a consummate professional in all that he does for us. We particularly value his ability to work with a wide range of people, located in time zones across the globe, to help achieve the strategic outcomes that are important to us. Michael carries with him our strongest recommendation.” 

Simon Wilkinson, CEO at Innate Immunotherapeutics

Transform your molecule into a significant corporate asset

We are committed to your success

A large part of the value that we add emerges from our ability to understand and integrate the 3 critical dimensions of clinical trial success:

  • strategic
  • scientific
  • operational

First, we bring a strategic perspective to your clinical development planning.

Our experience can lead to your strategic success

Time and again our experience has shown us that, to be successful, every clinical trial must contribute to long-term corporate objectives.  This is where we come in.  

Companies just like yours -- early-stage biotech, pharmaceutical, or drug delivery companies - engage us to help them in the year before an IND application filing in anticipation of "first-in-man" and "proof-of-principle" human testing.  

Our efforts begin by striving to envision - and, most importantly, integrate - the scientific, clinical, regulatory, and market factors that will transform a molecule into a corporate asset. 

In order to achieve the first step in this strategic success, we work closely with your senior management team:

  • Chief Executive Officer
  • Chief Operating Officer, and/or
  • Chief Scientific Officer

In short, we assist you in crafting a clinical development program that succeeds at the level of corporate business strategy.

Read a brief case history illustrating the Strategic Success dimension.

But a clinical protocol cannot succeed on a strategic level unless it also succeeds at the scientific level. 

Our experience can lead to your scientific success

First trials can be "make-or-break" events for a young company like yours. These trials tend to be subjected to enormous internal and external scrutiny, time and cost pressures, and scientific scrutiny. BioStrategics Consulting Ltd evaluates critical path issues on the road to scientific success of your initial clinical protocols.

In such a setting, clinical protocols must be meticulously designed to address the threshold questions that need to be answered for internal decision-making, clinical relevance, and regulatory acceptance. 

We have extensive experience working with expert clinicians (both domestic and international) and regulatory bodies (including the US FDA).  We'll help you ensure that your clinical protocols not only ask, but also are designed to clearly answer the threshold scientific questions. 

Read a brief case history illustrating the Scientific Success dimension.

Ultimately, a sponsor must forge the third link in the success chain - by implementing the protocol and seeing it to completion. 

Our experience can lead to your operational success

Like scientific success, operational success is a sine qua non for corporate strategic success.  BioStrategics Consulting Ltd has assisted numerous sponsors in the following ways:

  • screening and selecting contract research organizations
  • providing oversight and guidance for monitoring and clinical operations staff
  • qualifying and educating clinical investigators
  • providing medical monitoring services for Phase 1 and Phase 2 clinical trials.

We are particularly comfortable with the placement and management of first-in-man trials, and have assisted several sponsors (both US and European) in conducting normal volunteer clinical trials in the United Kingdom. 

Read a brief case history illustrating the Operational Success dimension.

Begin to maximize your return on clinical development efforts

BioStrategics Consulting Ltd is committed to helping you realize the potential of your portfolio assets by maximizing your return on clinical development efforts. We bring a deep understanding of new product development; a proactive, problem-solving orientation; and a strategic perspective to every engagement. 

To begin a dialogue about how we may be able to contribute to your company's strategic, scientific, and/or operational success, contact us today.