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

Fabiana Lacerca-Allen, SVP Compliance, Aimmune Therapeutics, USA
Tatiyana Akers, Corporate Compliance Consultant, Independent Consultant, USA
Laura Hamm, Director, Corporate Compliance, Aimmune Therapeutics, USA
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.

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USA Compliance Healthcare November 2019 Vol.12, No. 49, Autumn 2019

Fabiana Lacerca-Allen

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M. Fabiana Lacerca-Allen has had more than 20 years of experience working for leading American companies such as Elan, Mylan, Bristol-Myers Squibb Company, Microsoft, Merck and AT&T. She has counseled and litigated in the field of international business transactions and international environmental law. She has extensive experience in the pharmaceutical industry in leadership roles in charge of legal and compliance teams. She has counseled and represented clients on a broad range of questions, including strategic business initiatives ensuring compliance with laws and regulations, and corporate policy. Ms. Lacerca-Allen has provided legal support and strategic advice on opportunities and trends in law particularly within the government sector, as well as with major and strategic corporate accounts. Fabiana has established policies and oversight on key areas of compliance affecting international markets, and she has been able to positively impact the perception of compliance, creating compliance training programs and relevant standard operating procedures and has been involved in validating and aiding due diligence in the compliance industry, frequently being requested as speaker and participant in forums. She has been recognized in the industry by Hispanic Executive Magazine in 2013, http://hispanicexecutive.com/2013/fabiana-lacerca-allen/; recognized as 2015 Women in Leadership, Inspiring Leaders: http://www.theguardian.com/women-in-leadership/2015/may/12/know-who-you-want-to be-kidnapped-with-and-four-more-tips-for-leaders; served as Chair to the Bay Area Ethics & Compliance Association (BECA); and served as Co Chair for CBI, an Advanstar company serving the Life Sciences industry. Ms. Lacerca-Allen was invited to join the Gioja Research Institute while she was a student researching on environmental law. She was recipient of 1992 UCLA’s tuition waiver based on merit and recognition, and she represented UCLA in the Roscoe Foundation National Essay Contest submitting a paper on Global Warming.

Tatiyana Akers

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Tatiyana Akers is a Corporate Compliance Consultant with over 12 years of Legal, Financial Services, and Compliance experience, specializing in the development and implementation of global ethics and compliance programs within the Pharmaceutical Industry. She has assisted pharmaceutical companies with the successful implementation and management of Office of Inspector General (OIG) mandated Corporate Integrity Agreement (CIA) obligations, including the development of CIA specific training; policy development; annual Independent Review Organization’s (IRO) system and transaction reviews; management and accountability certifications; board of directors resolutions; disciplinary guidelines; conflicts of interest, exclusion screening, and disclosure programs; as well as implementation/annual reports to the OIG. Mrs. Akers is also an experienced compliance investigator, partnering with various business functions to respond to, identify, and remedy potential compliance violations. She has a strong desire to integrate compliance initiatives and ethical practices cross functionally and via corporate leadership to ensure optimal compliance and operational efficiencies within organizations.

Laura Hamm

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Laura Hamm is the Compliance Director at Aimmune Therapeutics. Before joining Aimmune, Laura was the Compliance Officer of medical device manufacturer Stryker’s Neurovascular division, a nearly $1B business, and Stryker’s only global division. At Stryker, Laura oversaw all elements of Neurovascular’s compliance program. As a global Compliance Officer, Laura has witnessed the evolution of international regulations, and recognizes the importance of cross-border collaboration to meet global business goals. Laura is passionate about integrating compliance into business DNA, and empowering business partners to achieve objectives with high integrity. Prior to industry, Laura was an educator in the California public school system, focusing on literacy in low-income communities.

Brenda Crabtree

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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 Therapeutics

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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.

Independent Consultant

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Tatiyana Akers' works as an independent consultant to pharmaceutical companies in the San Francisco Bay Area assisting with the implementation of comprehensive compliance and ethics programs.

Aimmune Therapeutics

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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.

USA Compliance Healthcare November 2019 Vol.12, No. 49, Autumn 2019
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