RARE featuring Caroline Petit

Please note that the speaker’s interview is based on their own experience and view ONLY and does not engage the one of Takeda under any circumstances. This interview?is for display use only.

For this episode of RARE, I had the pleasure of speaking with Caroline Petit. Caroline is trained in Law, Sciences and UE/EU Regulatory policies and has been working in the pharmaceutical industry for more than 15 years. She has a history of successfully leading US and International cross-functional teams and is well versed in providing strategic policies and regulatory guidance and is driven by a passion to help patients.

Caroline is currently taking part in an executive part-time Master in Biosciences with a Major in US Law at Harvard Medical School. She wishes to focus more specifically on the ethical use of Artificial Intelligence in large scale pharmaceutical projects and related legal considerations and policies protecting patient’s boundaries which is a topic she will tackle on this episode of RARE.

The full interview can be accessed here:

https://youtu.be/ARhWC7al7KM

Key Takeaways

Caroline starts by talking about where her passion for medicine and healthcare began with her grandfather who suffered from a rare cardiovascular condition and unfortunately never recovered from it. This was the moment she decided she wanted to help patients and put them first in the work she did as an adult.

Caroline made the move into pharma gaining experience in multiple departments: research, marketing, medical, patients’ services and then regulatory. When she joined regulatory and even a few years before, she realized that ethical boundaries, patients’ rights and laws and regulations can dramatically help protect patients’ role and positions in sciences and pharmaceutical big scale projects. She then took on extensive training both academically and on the job in the field of compliance, law and regulations in the US and EU.? Caroline gradually became enrolled in more and more compliance, legal and ethical issues across projects and was invited to conferences on the topic, to raise awareness on how to make sure ethical boundaries and patients’ privacy rights are respected when impactful studies including large patient datasets and information are conducted in EU/ US.

Harvard Medical School – Master in Bioethics

Caroline goes on to talk about the Master in Bioethics program she is partaking in. It has a main focus on US Health Law at Harvard Medical School and so with belongs to the Harvard Bioethics Medical Center. Caroline is working on how to ensure the healthcare sector respects ethical boundaries when developing patient initiatives whilst leveraging AI, particularly with the focus on data management and privacy rights for patients. More specifically, Caroline wishes to delve into both US and EU perspectives as it is critical to highlight the differences.

Thanks to the resources of the Bioethics Centre, Caroline is working on both regions to leverage two frameworks, along with the legal boundaries of machine learning to be able to highlight the differences between the two regions and clearly identify how different mechanisms can work globally. In the rare disease area in particular, the database tends to be thinner and more tailored as cases are fewer and tend to be more specific. Hence it is critical within this field in particular to be more cognizant especially with compassionate use practices, which are often in high demand in the rare disease area. Coupled with the strict legislative framework that pharmaceutical companies need to abide by in order to enable compassionate use, “out of box” solutions become more and more important which Caroline believes AI will be able to help move in this direction in the future.

Caroline’s Motivation

Caroline always had this motivation to support the treatment of patients. When she started working in research and then closer to patients through different projects from various angles (clinical, medical, marketing), she realized that even though the compliance and ethical stance is always present in the work she does, sometimes they are left in the background and not specifically highlighted. Now she is working across functions and it is more than a framework, it is a partnership, not just to abide by certain regulations but to meet certain patient goals in a successful way.

AI tools are now scrutinized in various legislation frameworks to make sure proper guardrails are in place to leverage them in the pharma industry while protecting patients. Particularly I am convinced the ethical perspective is becoming increasingly critical with this digital transformation journey.

Rare Disease

Rare disease and related treatments will be inevitably embracing AI tools to improve medical research in the field. Nowadays, the global legal and ethical framework related to the use of AI is quite weak and vague, struggling with its premises. We are currently reaching a stage of a formalised AI EU act and we are seeing multitude US state directives trying to tackle the topic without clear directions. Yet, this will be critical in the near future to have a clear framework setting strong guardrails for the use of AI tools, and especially for the rare disease patients as medical experience is limited for them and so is funding for research. Those patients are usually looking for solutions outside of the usual medical research frame and clinical studies or trials, they can sometimes advocate for compassionate use and outside of the box solutions. Left alone with a few patients’ associations they can be at risk of trying innovative solutions that, when not properly framed in a clear legal and ethical scheme, could become life-threatening for them. Hence the topic I am currently working on came as fundamental in my eyes to support them.

Thank you to Caroline for taking the time to feature.

For any questions or if you are interested in being featured on a future episode, please feel free to reach out to Laura at [email protected]