Compliance Red Flags: What Companies Should Look Out For in Times of Change

Brenda Crabtree, Associate Director, Compliance Auditing and Monitoring, Aimmune Therapeutics, USA

Although we know that compliance is everyone’s responsibility, we also understand that company personnel are focused on their primary roles and responsibilities, and because of this, compliance requirements may not be at the top of everyone’s priority list. Addressing the myriad of compliance requirements can be challenging for any company, and especially so for those undergoing significant change.

Brenda Crabtree is the Associate Director, Compliance Auditing and Monitoring at Aimmune Therapeutics. Prior to this, Brenda worked as an intellectual property attorney for biotechnology and pharmaceutical companies and advised pharmaceutical and medical device companies on various compliance matters including corporate policy and strategy, privacy, transparency, and fair market value. Brenda is a humanitarian who began her career in public service as a U.S. Naval Officer, and she applies her strong sense of ’doing the right thing” to her work as a compliance professional.

Aimmune was created in response to a united call to action from the leading minds and key stakeholders in food allergy who met at an advocacy-sponsored research retreat in 2011 to reach consensus on the direction of food allergy treatment research. Among the outcomes of the retreat, the group concluded that a standard oral immunotherapy (OIT) approach needed to be established, and associated products needed to be developed. When no pharmaceutical company showed interest in developing an OIT treatment, the food allergy community formed Aimmune. Today, Aimmune is working to fulfill the 2011 shared vision of developing a peanut allergy treatment and making it available to allergists for patients worldwide.