FDA’s OTP Super Office Set to Take on 500 Jobs!

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CEBR), is confident in the OTP’s progress towards filling their 500 vacancies. He believes it’s a positive step towards ensuring patient safety and that potential treatments are verified through rigorous standards.

Under the guidance of Gerald Marks, the Organizational Transition Plan at OTP is well underway. He is confident that the majority of leadership roles have been filled, though there is still room for a few talented individuals to join the team. By reorganizing the office, OTP seeks to maximize efficiency and provide a better experience for its employees and clients.

The creation of the Office of Tissues and Products (OTP) in March 2023 marked a watershed moment in the history of the Center for Biologics Evaluation and Research (CBER). It is the FDA’s first super office since its establishment, boasting six sub-offices, 14 divisions and 33 branches that promise to improve discipline alignment, increase review capacity and bring a new level of expertise to cell and gene therapy reviews. Welcome to the future of biotech regulations.

At the end of July, the FDA’s Center for Biologics Evaluation and Research (CBER) welcomed Nicole Verdun as its new director. Taking over the top role from Acting Director Celia Witten, Verdun brings with her a wealth of experience from her time in CBER and the Center for Drug Evaluation and Research (CDER). FDA spokesperson Paul Richards stated that Verdun had played a pivotal role in many matters vital to both national and global public health, making her the perfect selection for the director’s position.

To find the piece of the puzzle that will bring the organization together, Marks is beginning the search to fill the critical role of Head of the Clinical Office. Because of its importance, Marks is taking the necessary time and care to ensure the right person is chosen.

Marks is confident that with the super office’s guidance, the OTP will maintain the foundational consistency in the regulatory advice it provides, as well as ensure that all recommendations from junior staff align with FDA’s expectations. This promises a tighter, more reliable supervision.

Industry stakeholders have long been eager for the Office of the Trade Representative (OTP) to become more consistent and timely in providing guidance. OTP’s backlog of informal meetings further underlines the need for them to become increasingly responsive. According to OTP’s Director, David A. Marks, this has always been an area of interest for industry.

In order to grow and better serve its sub-offices, the OTP is looking to hire up to 500 entry- and mid-level staff. “We’re in the process of filling positions from a broad spectrum of related scientific fields and medical specialties, many of which will be fulfilled by candidates with advanced degrees”, said Richards. Marks revealed that this hiring process will take place over the next year or two.

Drawing In New Staff

Are you looking for a job that will put your scientific and medical knowledge to the test? Joining the FDA’s Office of Therapeutic Products (OTP) is the perfect opportunity to get your hands on the cutting edge of science and medicine. By tapping into our extensive portfolios of products, you will gain a truly comprehensive understanding of cross-product knowledge that publications just can’t give you. Come explore the future with us!

The OTP is embracing a combination of hybrid and remote work settings to attract the right team members for the job. By leveraging the best of both worlds, the organization is ensuring that employees have the flexibility and autonomy they need to do their job effectively.

Recently, the market climate has been favorable for the OTP’s staffing needs. Physician professionals are evaluating non-traditional career paths, while CMC reviewers formerly employed by venture capital-backed companies are available as those organizations close their doors. With a wealth of talent on offer, the OTP has utilized the opportunity to expand its teams with qualified talent.

Staff turnover could be detrimental to the OTP’s ambitions if new CMC reviewers take too long to become proficient and reach the mastery level of expertise. It often takes six months for reviewers to become competent, and up to two years to master the craft, unless they come in with prior experience in the industry, extending up to 10 years.

With the ever-changing job landscape making it simpler than ever to switch positions without having to move, I’m slightly concerned that the FDA won’t see the same level of stability. Traditionally, people used to stick around for a long time, and I’m worried this could be a thing of the past.

The 21st Century Cures Act has revolutionized staffing for Rahm’s team by allowing the FDA to offer salaries that are significantly higher than what was traditionally permitted. However, these salaries are still not quite on par with the levels offered in the private sector. Despite allowing his team to more conveniently hire and retain staff, this creates a unique challenge that Rahm’s team must work around.

Organizing the Staff to Maximize Productivity

Today, Dr. Marks revised down his original estimates of 10-20 cell and gene therapy products getting approved by the FDA annually by 2025, citing the disruption caused by the COVID-19 pandemic and complexity of the regulatory process. Nevertheless, Dr. Marks aims to have 25-40 such products approved in the coming five years – a major leap forward in the field of medicine!

Rather than structuring its six sub-offices by specialities, the OTP has now changed to a system where expertise is distributed to wherever the application workload lies at any given time. This ensures that teams are better balanced, even if one area has more applications than another – such as the FDA dealing with a particularly large volume of applications.

The OTP’s new project structure is being adopted by multiple leading pharmaceutical corporations to ensure their departments all operate in a cohesive, efficient manner. This project management approach provides a comprehensive solution to connecting multiple functional areas and allows for an improved user experience.

The US Office of Technology Policy is harnessing the power of artificial intelligence (AI) to boost its efficiency, leveraging its capabilities to analyze genome sequences and use safety surveillance. OTP head Michael Kratsios suggested that AI may even be used for more of their processes in the near future. With this technology helping out, the agency is expecting promising results.

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