FDA looking externally and internally to develop future IT leaders

Regulatory NewsRegulatory News | 16 January 2023 |  By 

Jessica Berrellez, FDA ODT executive officer. (Source: FDA)

The US Food and Drug Administration (FDA) recently published a report on its plans to prioritize developing a cadre of leaders who can streamline its information technology infrastructure and develop plans to make their systems more efficient. According to a top agency official, some of the work is already underway as the agency looks internally and externally for future IT leaders.
For years, the FDA has dealt with decentralized IT systems that were unable to work with each other, which often means information in one IT system used to review and track products would need to be duplicated in another. Under the leadership of former FDA Principal Deputy Commissioner Amy Abernethy IT modernization was given top priority and the position of FDA chief information officer (CIO) was elevated to the commissioner’s office.
Though Abernethy left the agency in 2021, the issue has continued to be a focus under the leadership of FDA CIO Vid Desai and the Office of Digital Transformation (ODT). In December, the ODT published the Leadership Modernization Action Plan (LMAP) detailing the need for IT modernization and developing a pipeline of leaders who can guide the agency’s thinking.
Given the FDA’s wide-ranging public health mission, the agency traditionally has taken a program-based approach to IT planning and investment, resulting in program-specific systems and custom solutions that are costly and don’t play well together, according to Jessica Berrellez, ODT executive officer. Now, the agency acknowledges hat data interoperability is critical to its regulatory decision-making process.
“There are multiple functional areas impacted by system fragmentation,” Berrellez told Focus. “One area of ongoing focus is related to FDA’s regulatory inspectional oversight activities. By consolidating data systems and migrating to a secure hybrid cloud environment, the FDA can simplify inspectional workflows, decrease the cost of maintaining data and network security, and improve our ability to efficiently prioritize, conduct, and evaluate oversight activities.”
The LMAP also emphasizes that IT leaders at the FDA need to have a business mindset similar to how medical industries are increasingly looking to technology leaders to also function as business partners.
“This is a departure from historical perceptions of information technology as a secondary or ‘backdoor’ function,” Berrellez said. “In today’s digital environment, technology and data are now delivering business outcomes like operational effectiveness and workforce performance.
“Technology leaders must expand their bench beyond technical domains to understanding (and co-creating) business strategy,” she added. “Leading successful digital transformation also requires new ways of leading and strong soft skills, or what I would reframe as ‘smart’ skills.”
While the LMAP was released in December, much of the work has been under way since ODT reorganized its leadership and operations in September 2021. Berrellez said the agency saw it as an opportunity to make foundational changes to recruiting and retraining its IT, data, and cybersecurity leadership. She added that the first component of the LMAP, which focuses on creating an environment that enables collaborative decision-making and business alignment, is already at work.
“The establishment of ODT in September 2021 and alignment under the [FDA] commissioner cleared the path for increased IT and senior leadership engagement,” said Berrellez. “We continue to strengthen the FDA Technology Council as part of our ongoing modernization work and are utilizing this collaborative forum to advance our agency-wide Technology Business Management (TBM) Framework development.”
LMAP also calls for developing an enterprise IT strategic plan to have effective governance and collaboration at the FDA. This is the “natural evolution” of the agency’s efforts under the Prescription Drug User Fee Amendment (PDUFA VII) commitment, Berrellez said, adding that  the agency is actively focused on advancing pilot projects to build out its people operations, leadership capabilities, and change resiliency.
Many of the goals and use cases referenced in the LMAP also are outlined in the ODT Strategic Plan for 2023-2025, according to Berrellez. She noted that the LMAP also intersects with the Organizational Excellence, Governance and Operational Excellence strategic priorities set out by the FDA.
“This recently released plan will guide our LMAP implementation efforts over the next two years,” said Berrellez. “It includes related objectives and key performance indicators across different areas of ODT’s portfolio.”
As an example, Berrellez noted the FDA recently launched Project Elixir to shift its ODT workforce and future vacancies to the hiring authority under the 21st Century Cures Act starting this year. She s this should allow the ODT to hire and retain top IT talent to build a strong leadership pipeline.
“We will also launch a new Strategic Leader Program Pilot to support leadership and organizational effectiveness,” Berrellez added. “This complements our efforts to support technology workforce upskilling as part of our Project UpTech work.”
The agency also recently published the FDA Academy and ODT Academy learning resources to support its efforts to develop IT leadership and will continue to develop role-specific and competency-based training curricula.
“Whether hiring IT leaders externally or growing future leaders from within, developing robust and diverse talent pipelines is a high priority,” said Berrellez. “We are increasingly rethinking our approach to hiring and compensation strategies to increase our competitive advantage while building a workplace that attracts top talent. We are also investing in technology workforce upskilling and leadership development initiatives to keep pace with the rapid advances in this field.”
FDA officials hope LMAP will put people in place at the agency who will increase its efficiency and avoid past mistakes. The agency’s two major remits – to provide marketing authority for healthcare products and to monitor those on the market for safety – mean that it has  huge volumes of data to track and analyze. i“These processes depend entirely on timely and secure access to science-based information and data,” Berrellez emphasized. “IT is closely intertwined with all regulatory approval and oversight activities, and no process operates without it.
“Today, everything is driven by IT and technological innovation will continue to reshape our agency and healthcare industry,” she added. “When we improve IT leadership, IT works better, the agency works better and industry and the public benefit.”


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