Managing Compliance Risk in a COVID and Post-COVID World

November 2020

Abstract

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.

Authors

Brenda Crabtree

Director, Compliance Auditing and Monitoring, Aimmune Therapeutics, USA

Brenda Crabtree is the 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.

Laura Hamm

Sr. Director, Corporate Compliance, Aimmune Therapeutics, USA

Laura Hamm is the Senior 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.

Fabiana Lacerca-Allen

Chief Compliance Officer, Cipla, USA

M. Fabiana Lacerca-Allen is a senior compliance and legal executive with over 30 years of experience leading global compliance, legal, and governance programs across the pharmaceutical, biotechnology, and technology sectors. She currently serves as Chief Compliance Officer for Cipla USA and has held senior leadership roles at Aimmune Therapeutics, Elan Pharmaceuticals, Mylan, Bristol-Myers Squibb, Microsoft, Merck, and AT&T. She brings deep expertise in risk-based compliance program design aligned with DOJ and OIG expectations, including third-party risk management, global investigations, data integrity, ethical culture transformation, and crisis preparedness. She regularly advises boards and executive leadership teams on international operations and enterprise governance. Fabiana serves as a Board Director and Audit Committee Member of Shield Therapeutics and holds a risk and governance advisory position with the International Federation of Red Cross and Red Crescent Societies (IFRC). She is also Adjunct Professor at Fordham University School of Law, teaching compliance, ethics, and governance. She is author of Crisis Capable and a frequent international speaker. She previously served as Chair of the Bay Area Ethics & Compliance Association and Co-Chair for CBI (Advanstar). She holds a JD and LLM and conducted academic research in international environmental law through the Gioja Research Institute.

Tatiyana Akers

Associate Director, Compliance, Aimmune Therapeutics, USA

Tatiyana Akers, Associate Director, Compliance has over 14 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.

Companies

Aimmune Therapeutics

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. Aimmune is on a mission to transform the lives of patients and their families by developing pharmaceutical therapies to prevent, manage, and treat food, GI, and metabolic-related diseases.

Aimmune Therapeutics

Cipla

Cipla Limited is a leading Indian multinational pharmaceutical company, founded in 1935, focused on developing high-quality, affordable medicines across various therapeutic areas, including respiratory, cardiovascular, and HIV/AIDS. With 46 global manufacturing sites, it produces 1,500+ products and operates in 80+ countries.

Managing Compliance Risk in a COVID and Post-COVID World

Abstract

Authors

Companies

Aimmune Therapeutics

Aimmune Therapeutics

Cipla

Aimmune Therapeutics

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