The life sciences industry has gone through a profound evolution as the focus has shifted away from primary care therapies to specialty markets.
Commercialization in these specialty markets is markedly more difficult than primary care and the challenges are often characterized by:
Supply constraints necessitating high-cost distribution through specialty-pharmacies and/or specialty-distributors
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.
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:
The Baker Tilly Life Sciences Advisory and Support team is broadly experienced in designing and implementing commercialization strategies, as well as comprehensive governance, risk and compliance programs. Our professionals understand the unique nuances and demands of the global life sciences industry.
We support clients in designing decision-support solutions that ensure risk awareness and measurement.
Our team can help organize market facing operations (i.e., sales, medical affairs, key account managers, patient support, reimbursement support, etc.) to align objectives with market needs and integrate compliance requirements.
We have the expertise to design and support innovative programs to support the strategy including market access and real-world evidence generation, publication planning, medical education needs assessment, and speaker bureau optimization.
With respect to governance, risk and compliance, our team has industry specific expertise in enterprise risk management. Our team can support initiatives to increase risk awareness of the board and preparedness of management.
Clients can rely on us to design and implement all aspects of their risk management and compliance programs.