January’s Regulatory Focus: Leadership in RA, expanding diversity, and more

Feature articles during January focused on regulatory leadership, a novel approach to hiring regulatory professionals, expedited programs for reducing time to approval for certain drugs, and the Cuban biotechnology industry and its response to COVID-19. Keywords – assessment aid, breakthrough therapy, Cuba, diversity, ILAP, leadership, PRIME
 

Leadership, hiring, and expanding diversity

Effective leadership in regulatory affairs is rooted in an understanding and appreciation of team members as well as the broader regulatory and business environments. In The leadership role in regulatory affairs, Rushabh Patel, Siddhi Rasam, Darin Oppenheimer, and George A. Cusatis examine some of the important aspects of leadership, including critical thinking, business acumen, emotional intelligence, and mentorship. All are vital in being a self-aware and emotionally intelligent leader who can build a committed, contented team and make sound regulatory decisions around strategizing and meeting goals. These skills are not quickly or easily acquired and need to be taught and honed over time. Moreover, while they help leaders gauge and adapt to change and address challenges and needs in a timely manner, these skills are most effective when leaders also share their learned experiences with others.
 
In How regulatory affairs can expand its capabilities and increase diversity, Holly Drake, Ginny Hu, and Brent Eliason describe how “hidden workers,” who are individuals who are unemployed or underemployed because of systemic problems, might help address the shortage of regulatory professionals while bringing unique value to a team and possibly strengthening efforts to improve workplace diversity, equity, and inclusion. Those considering tapping this pool of workers should be prepared to develop and offer flexible onboarding and training programs to help bridge the gap in regulatory and organizational knowledge.
 

Review aids and expedited pathways

The US Food and Drug Administration’s assessment aid (AAid) for streamlining reviews of oncology drug applications is now widely used and its benefits have been recognized globally. In Maximizing the potential of the FDA assessment aid: Genentech’s experience, Simin Yazdanpanah and colleagues share Genentech’s experience in using the AAid and recommend tips for preparing the package. They emphasize the importance of early and continued communication between the agency and sponsor to further streamline the process and maximize its potential and benefits.
 
In Expedited pathways: Breakthrough therapy designation, PRIME, and innovative licensing & access, Maurice Bancsi compares the three initiatives introduced in the US, EU, and UK, respectively, to cut the time to approval for drugs that address an unmet medical need. The pathways’ eligibility requirements and benefits are comparable, although the breakthrough drug designation focuses more on data quality while the PRIority MEdicines (PRIME) scheme and the innovative licensing and access pathway (ILAP) focuses on the promise of data and early and close cooperation between the relevant parties. Common perceived, but not verified, risks or disadvantages for all three initiatives center on the robustness of the data package and concerns about generating supporting real-world evidence after initial approval.
 

Biotechnology and regulation in Cuba

In Cuba’s biotechnology industry and its response to the COVID-19 pandemic, Silvia Bendiner examines Cuba’s biotechnology and pharmaceutical industries and their roles, along with the and the National Regulatory Agency for Medicine, in supporting the country’s national healthcare strategy and responding to the COVID-19 pandemic.
 

Upcoming in Regulatory Focus

What’s coming in February?

Articles during February will examine the impact of noncompliance. Look for this topic and more throughout February at Regulatory Focus. The submission due date for articles has been extended to 14 February 2022. To contribute, email rmatthews@raps.org

 

And March?

For the March issue, the topic will be Regulatory intelligence. The submission due date for articles has been extended to 1 March 2022. To contribute, email rmatthews@raps.org

 

Call for articles

April 2022 issue

In April 2022, the topic will be Specialist or generalist: Which is the path for you? The submission due date for articles is 15 March 2021. To contribute, email rmatthews@raps.org

 

Also see 2022 Editorial Calendar.

 

Upcoming in RF Quarterly

Each issue of RF Quarterly is comprised of original content, developed around a theme, as a member-exclusive benefit. The most recent issue, focusing on selected takeaways from the RAPS Convergence 2021, is available.

 

Topics through 2022 will be:

• Software as a medical device (March)
• Regulatory history (June)
• Strategy in regulatory affairs (September)
• Artificial intelligence (December)

To contribute to the upcoming issues, email rmatthews@raps.org
 
Previous issues of RF Quarterly

 
For more information about monthly articles and RF Quarterly, see Guidelines for Authors and the 2022 Editorial Calendar.