Managing Compliance Risk in a COVID and Post-COVID World

Tatiyana Akers, Corporate Compliance Consultant, Independent Consultant, USA
Fabiana Lacerca-Allen, SVP Compliance, Aimmune Therapeutics, USA
Laura Hamm, Director, Corporate Compliance, Aimmune Therapeutics, USA
Brenda Crabtree, Associate Director, Compliance Auditing and Monitoring, Aimmune Therapeutics, USA

Managing risk can be complicated in the best of times, and the challenges associated with risk management become even greater when combined with the tremendous disruption caused by a global pandemic. In 2020, the world was hit by a global coronavirus disease (COVID-19) pandemic. This pandemic has created many challenges for governments, businesses, and individuals, and created new risk considerations for companies relating to workplace health and safety, privacy, security, employee oversight, and general health and wellness. In managing these new risk considerations associated with the pandemic and ensuring preparedness for future calamitous and yet unforeseen events, companies need to ensure that their own policies and processes relating to crisis management are updated to reflect our new reality. As part of this planning process, companies should consider contingency plans for various potential disasters, both natural and man-made. These plans should include a clear communication strategy, as well as guidance to employees on what actions to take in such situations. With proper planning and preparation, companies will be ready to mitigate the damage that will inevitably come with the next unexpected crisis.

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USA Management Pharmaceutical November 2020 Vol.13, No. 53, Autumn 2020

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.

Fabiana Lacerca-Allen

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Biography M. Fabiana Lacerca-Allen has over 30 years of experience in legal and compliance roles, working for leading American companies such as Aimmune, 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. About your organization 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.

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.

USA Management Pharmaceutical November 2020 Vol.13, No. 53, Autumn 2020
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