Jaylesh Jani

Regulatory Submission Manager – Rest of World Team Lead
Gilead Sciences

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My name is Jaylesh Jani and I am based in London, UK. I started working at Gilead Sciences 6 years ago, as my first role in the Pharmaceutical Industry, with my background prior being in Biomedical Science.
 
I am the team lead for Rest of World in Regulatory Submission Management, which falls within the wider Regulatory organisation at Gilead. My team and I work collaboratively with other functions such as, Regulatory Affairs and CMC, in order to successfully compile, submit and maintain drug product applications across several therapeutic areas to health agencies globally.
 
My role started more technical and operationally focused, with submission publishing for regions globally and has now evolved into a submission management role, with an added strategic responsibility. I have worked on many submission types including Initial MAAs (Marketing Authorisation Applications), across different submission formats (eCTDs, Non-eCTD Electronic Submissions (NeeS) and Validated NeeS) specific to the respective country.
 
During my time, I have developed experience in working with many markets and health authorities globally. Each with their own regional requirements and specifications, regulatory strategies and challenges. But the goal is always the same, to successfully and efficiently submit drug product applications and maintain these licenses, in order to provide patients with the life changing therapies they require.
 
Working with Rest of World Markets particularly pre COVID-19, during the pandemic and now after, has enabled me to gather an understanding of the different regulatory challenges within each region and what strategic solutions and pathways can be adopted by the regulatory industry in order to submit drug product applications in the most efficient way to these markets. While maintaining the completeness and integrity of the information submitted, regulations and requirements before market approval.

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Speech title & Synopsis

Evolution and Transformation of Global Drug Approval Pathways: Lessons from the COVID-19 Era and beyond – A Gilead Case Study

The COVID-19 pandemic presented an unprecedented global challenge, promoting an extraordinary and urgent response from the life sciences and pharmaceutical industries. It also forced regulatory agencies worldwide to adapt quickly to an evolving crisis, resulting in a regulatory environment unlike any previous experienced.
 
This presentation explores the evolution and transformation of global drug approval pathways through the lens of the pandemic, with a reference to the global availability of Gilead Sciences’ anti-vial treatment Veklury (Remdesivir). The presentation highlights the complexities faced in Rest of World markets, particularly in regions where regulatory agencies operate with limited resources, outdated technology or politically challenged environments.
 
Despite these challenges, innovative solutions have emerged and this presentation will examine regulatory reliance models, reference markets recognition and regional harmonisation efforts.
 
Using Veklury (Remdesivir) as a case study, the discussion will demonstrate the lessons learned during the COVID-19 era and how it can inform future regulatory strategies. Key themes will include, the sustainability of accelerated pathways, the importance of strengthening regulatory capacity, and opportunities to institutionalise reliance models, and harmonization mechanisms for future public health needs.
 
By reflecting on this unique period in regulatory history, the presentation will offer practical insights into how global regulatory systems can become more agile and efficient. Not only in terms of crisis but maybe as new standards for global health collaboration.