In this new episode of the Life Sciences — In Focus podcast, hosted by Karen Tkaczyk, we welcomed a genuinely remarkable guest, Aman Khera, Vice President of Regulatory Science, Strategy, and Innovation at Worldwide Clinical Trials. With a career spanning nearly three decades, Khera is a force of innovation and a staunch advocate for diversity and patient inclusion in clinical research. Her journey from a curious student in the UK to a leading executive in the clinical research organization (CRO) space is a testament to her passion, resilience, and dedication to making healthcare better for all.

From Biochemistry to Regulatory Science

Khera’s origin story is as inspiring as it is unique. Her academic background in medical biochemistry ignited a curiosity that couldn’t be satisfied by the confines of a laboratory alone. Her exploratory spirit led her to the field of Regulatory Affairs, where she found her true calling. Despite initial discouragement, Khera’s determination saw her break into the industry, proving that with the right mindset and preparation, one can carve out their own path in the life sciences sector.

A Career Built on Innovation and Authenticity

Throughout her career, Khera has not only witnessed but also contributed to the evolution of the regulatory landscape in clinical trials. Her work at Worldwide Clinical Trials underscores the importance of personalized attention in a rapidly consolidating industry. With over 3,000 employees across more than 60 countries, Worldwide Clinical Trials embodies the spirit of innovation and commitment to patient-centric solutions that Khera champions.

Championing Diversity and Patient Inclusion

A significant focus of Khera’s work involves promoting diversity and inclusion in clinical trials. The conversation around diversity in clinical research is not new, but the approach to genuinely integrating diverse patient populations into clinical trials requires innovative thinking and strategic action. Khera shed light on the necessity of engaging regulatory bodies early and strategically to ensure that clinical research is as inclusive as possible.

Khera’s involvement with initiatives like Sikhs in Clinical Research and her advisory roles in organizations like emTruth, Inc., and Vation Ventures demonstrates her commitment to bridging the gap between diverse communities and the clinical research industry. Her efforts are not just about fulfilling regulatory requirements but ensuring that clinical trials reflect the diverse populations they aim to serve.

Looking Ahead: The Future of Regulatory Affairs

As the life sciences industry continues to evolve, driven by advancements in technology, medicine, AI, and global health challenges, Aman Khera’s role and vision become increasingly crucial. Khera, with her extensive experience and forward-thinking approach, remains at the forefront of this transformation, advocating for a regulatory environment that is not only more inclusive and innovative but also fundamentally patient-focused.

Khera envisions a future where regulatory affairs extend beyond compliance and become a cornerstone of strategic planning in drug development and clinical trials. In this future, regulatory professionals are not gatekeepers but facilitators, working hand-in-hand with scientists, clinicians, and patients to ensure that the pathway to bringing new therapies to market is as efficient and effective as possible. This involves a deep understanding of the scientific innovations at play, as well as the ever-changing global regulatory landscape.

Anticipating Regulatory Hurdles

Aman Khera champions the idea that regulatory strategies should be designed with the end goal of enhancing patient access to innovative treatments. This means anticipating regulatory hurdles and working proactively to address them, ensuring that new therapies can reach the patients who need them most without unnecessary delays. It also means embracing new technologies and methodologies, from digital health solutions to advanced data analytics, to improve trial design, patient recruitment, and outcomes measurement.

In Khera’s view, the future of regulatory affairs is deeply intertwined with the push for greater diversity and inclusion in clinical research. This entails meeting regulatory mandates for diversity and actively seeking to understand and dismantle the barriers that have historically excluded specific populations from participating in clinical trials, including language barriers. By doing so, the industry can ensure that clinical research reflects the diversity of the patient populations it serves, leading to more effective and equitable health outcomes.

Khera also sees the potential for regulatory affairs to lead the way in fostering collaboration across the industry, breaking down silos between different functions and encouraging a more holistic approach to drug development. This includes working closely with patient advocacy groups, healthcare providers, and payers to align on common goals and leverage collective expertise for the greater good.

Finally, Khera emphasizes the importance of education and mentorship in preparing the next generation of regulatory professionals. By nurturing talent and encouraging a mindset of innovation, collaboration, and patient advocacy, the field of regulatory affairs can continue to evolve and adapt to meet future challenges.

Aman Khera’s vision for the future of regulatory affairs is transformation and empowerment. By placing patients at the heart of regulatory strategy, embracing innovation, and fostering collaboration, the life sciences industry can navigate the complexities of the modern world to bring life-saving therapies to market faster and more efficiently than ever before.

About Life Sciences — In Focus
Life Sciences — In Focus Podcast by Vistatec features fascinating conversations with global life sciences experts. Follow Life Sciences — In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple and Google podcasts. Life Sciences — In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.

About Vistatec

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