Life Sciences Advisory and Support Services

Continuous evolution of global commercialization strategies with an understanding of the dynamic risk environment.

The economics of specialty markets combined with the dynamic regulatory environment have contributed to rethinking aspects of the traditional commercialization model of the industry.  The complexity of these novel therapies now necessitates a greater focus on disease awareness and medical education, which has impacted the traditional roles of sales and medical affairs personnel.  For example, when promoting a curative therapy as opposed to a maintenance or management therapy the promotional message can be quite simple, while the medical support to identify and treat patients is not. 

Known for innovation, Life Sciences companies similarly need a partner who is committed to innovation. Baker Tilly Life Sciences Advisory and Support consultants are here to challenge legacy paradigms that make competing in today’s environment more difficult. Our team has the global business and compliance experience to support commercial enablement, medical affairs enablement, as well as the unique governance, risk and compliance requirements of the industry. 

As the commercialization model evolves it has become more imperative for executives to have more robust risk management programs. Risk management programs need to more uniformly support the identification, measurement and mitigation of risks across the spectrum including engagements with physicians and health systems, as well as product safety and quality processes. Corporate boards, and particularly the audit committee, must be educated and briefed and management’s risk mitigation activities. 

Global governance, risk and compliance programs

As the markets have become more complex so has the enterprise risk environment. The overall regulatory environment has continued to evolve with a myriad of new industry codes and laws that need to be managed. Enforcement activity has also not abated and in some areas the focus has begun to shift to the nuances of the specialty market commercialization model. The resulting risk portfolio is one that can quickly overwhelm the executive team and board.

There is a profound need for a comprehensive governance, risk and compliance program to identify, measure, mitigate and report on these dynamic risks across multiple areas, including:

  • Commercial compliance – sales, marketing and medical affairs activities
  • Quality Compliance – inspection ready clinical development, production and reporting process
  • Pharmacovigilance – comprehensive safety signal detection and reporting