DISCLAIMER: PLEASE NOTE THAT THIS CONTENT IS THE VIEW OF THE AUTHOR AND DOES NOT ENGAGE OR REPRESENT THAT ONE OF TAKEDA PHARMACEUTICAL CO. LTD.
Future of Bioethics!
The pharmaceutical sector is essential in advancing healthcare through rigorous research, innovation, and the development of new treatments. With the integration of artificial intelligence, the industry is now reshaping its approach to drug discovery, patient care, and diagnostics, adding a transformative layer to its traditional methods. This technological progress not only accelerates the potential for more precise therapies, such as genomics and personalized medicine but also introduces new ethical considerations around patient data privacy and the broader implications of AI. As these advancements unfold, the sector increasingly focuses on establishing guidelines to address these intricate ethical dimensions, ensuring that progress aligns with patient welfare and public trust.
Caroline Petit, Global Director of Advertising and Promotions in Regulatory Affairs, brings a unique perspective on ethical standards. She is committed to ethics and patient-first principles and demonstrates a balanced approach that places regulatory compliance and moral integrity at the heart of pharmaceutical innovation. Her leadership is marked by a dedication to transparency, advocacy for responsible AI integration, and nurturing collaborative dialogue on bioethics. Pursuing a Master of Bioethics, she combines her expertise with understanding the nuanced legal and ethical challenges in healthcare, reflecting her drive to shape a more conscientious approach to medical technology and patient care.
Let’s explore Caroline’s journey of addressing AI’s role in patient care:
Addressing Ethical Challenges in AI and Medicine
Caroline believes innovation is key in the pharmaceutical and medical fields today and goes hand in hand with the Era of Artificial Intelligence. Topics such as genomics, precision medicine, patients’ data use and ethical limits, legal frameworks, and ethical challenges related to the use of AI in pharmaceuticals are shaping the future of innovation in pharma.
She highlights, “We enter an area where artificial intelligence can improve precision medicine, diagnosis, and care for patients and human beings in general. Yet, clear guardrails, both in the US and Europe, are currently being worked on to guide and protect patients and the entire population against potential ethical drifts with the use of AI.”
Currently, she is pursuing a Master of Bioethics at Harvard and works within that remit in close collaboration with the Harvard Center of Bioethics. The learnings she received have been tremendous, and, at the same time, she still sees the long road to spreading awareness in a satisfactory manner around bioethical concerns and their associated remedies.
It is just the beginning of the story, and she has noticed that there is a strong need to push for more multi-disciplinary bioethical committees in the world of health. People still struggle worldwide to integrate the notion that bioethics is at the frontier of many different disciplines, such as law, compliance, regulation, medicine, philosophy, sociology, psychology, ethics, sciences, public health, and much more. This is a challenging topic and discipline that deserves more and more attention to help address unresolved questions brought by AI in terms of limits.
Guiding Principles for Ethical Leadership
As a leader, these personal values guide Caroline’s decisions and strategy:
- Ethics: Ethics has been one of her guiding principles since she dived into her passion related to helping patients and working in the medical field.
- Patients first: As a child, she was always led by the passion to cure and find new treatments. Sciences, medicine, and law are Caroline’s favorite topics. With that in mind, her everyday work is guided by this motto and is of great inspiration.
- Loyalty: Loyalty is a broad topic that does not only tackle a personal attribute but a general behavior. Loyalty can be extended to patients, colleagues, and the industry and is a general mindset in life.
- Kindness: Practicing kindness is an essential element for her in the healthcare environment. Working to help patients in their health journey and practicing acts of kindness with colleagues is an essential quality for her.
- Ownership of one’s mistakes: As a leader and professional, it is key to recognize when things do not go as expected, embrace it and address it. As human beings, we are not perfect, and things don’t always go as planned.
- Genuine: Being truly engaged in her cause with authenticity resonates as another key principle guiding her work since it also impacts interactions with others.
- Vulnerability: Showing that one can make mistakes and being aware of them is an important way to connect with others. We are not robots, and genuinely sharing one’s own weaknesses can make everyone feel more comfortable.
Understanding and Bonding with Team Members
(Care to Dare to Unleash Astonishing Employee Potential-George Kohlrieser Professor of Leadership and Organizational Behavior-Insights at IMD, vol 18)
She cultivates a culture of collaboration and innovation among her teams in the following ways:
- Listening carefully: Caroline feels active listening is important as it shows working partners that their input is valued and noted.
- Getting to know and understand every individual: Understanding their sources of inspiration, motivation, and what they care for.
- Bonding genuinely: Connecting on a human level is also an important aspect of the partnering principle.
- Understanding the business and culture.
- Playing to “win”: Thinking about how to compromise so that both parties get what they need and the outcome is favorable for everyone.
- Discussing challenging topics: Essential for growth, even if it may lead to disagreement. Agreeing to disagree and coming to a positive outcome and resolution outside of emotions.
Motivating Diverse Teams
Being an avid learner and very demanding with Caroline’s own performance and learning objectives, Caroline thought at the start of her career that learning leadership would be a question of a few months. (laugh). In the beginning, she was trying to inspire herself with role models and apply them like a magic recipe. Well, this is a good start, yet when practicing leadership, she understood quickly that she had to find her own style.
Getting to know the one in front of her and the group with whom she is bonding is critical to finding her style and her own path. People don’t get motivated for the same reasons. Leading is a big topic in the business world as it involves human beings, and everyone is different.
When she started to understand the importance of people’s way of learning and their source of inspiration, she managed to start talking heart-to-heart with them, and this was the biggest lesson she learned: being genuine in her interactions and showing she truly cares was the most transformative step she took.
Addressing Privacy Concerns in Patient Data Use
According to Caroline, “We are currently living in a space where patients’ studies and the increasing use of artificial intelligence become the central piece of scientific progress. Technology and digital initiatives are key to embarking on the next level in pharma and to fully take on the new era.”
On that topic, it remains critical that health authorities and companies create safeguards around patients’ involvement and data use in this context. For instance, privacy concerns are approached worldwide, and regulatory agencies work on regulations to protect patients’ data. Those steps are a good start, but there still seems to be a long way to go to completely embrace the use of AI ethically in such a context.
Mainly, she strongly advocates the defense of ethical and legal guidelines within the digital transformation journey.
Importance of Ethics in Patient Care
Healthcare companies are highly regulated in Europe and the US. The FDA, EMA, IFPMA, EFPIA, and PhRMA are key in providing the path forward in terms of regulations and ethical guidelines for the pharmaceutical industry. Rules and laws are currently well-developed in the industry. Also, ethics is a critical element present and put forward in the everyday care of patients.
Moreover, additional scrutiny is brought by the observance of companies between themselves: in the industry, everyone is very careful of following the rules and respecting the regulations as FDA and European complaints are taken very seriously and investigated with care. Caroline believes professionals are respectful of the strongly regulated environment, and this is to the benefit of patients.
Creating a Collaborative Cloud of Ideas
Caroline’s first advice is to keep up with global actors such as pharmaceutical organizations, health authorities, public health agencies, patient associations, and other biotech and healthcare firms.
Then she thinks looking at partnerships among other pharmaceutical groups, not only focusing on one’s own group, enables the strengthening of knowledge and skills brought by AI, as well as understanding the potential ethical and legal challenges by observing the challenges faced by others in different therapeutic areas or organizational matrices. Learning from each other and creating a bigger cloud of ideas and projects could benefit the global top-tier pharmaceutical group.
Other industries started learning from the AI journey a long time ago, especially in the B-to-C environment. Although those firms may not have the same business model or objectives, their knowledge of how to steer AI challenges could also greatly benefit the pharmaceutical environment.
Ensuring Ethical Practices in Pharma Research
She highlights that often, pharma companies have a mission to help patients improve their quality of life. On this topic, many of them launch large-scale reports and clinical studies showing the evolution of patients’ quality of life following different treatment guidelines and the improvements compared to their lives before.
Caroline believes that if AI guardrails are protected and respected to ensure that studies are conducted ethically, quality of life for patients will be the result. They can also help create a culture of awareness and help the overall population understand the challenges faced by patients and the specific stigma that may be associated with some diseases, such as mental health conditions, for instance.
Key Principles for Personal and Professional Growth
Caroline has always believed that following one’s passion, heart, and intuition is the best guide in professional life. Also, starting a journey with a mission is her advice. A mission that goes far beyond professional ambition and guides life, like a life purpose.
Here are some fundamental principles that can help:
- Be brave, bold, and humble.
- Follow your heart.
- Follow your passion.
- Be curious.
- Keep Learning.
- Fulfill your dreams.
- Don’t listen to those who try to ruin your dreams.
- Try, fall, make mistakes, and go back.
- Surround yourself with people that help you grow.
- Adopt the growth mindset: never stop learning.
- Most important: love what you do!
Focusing on Patients Quality of Life
She always had in mind to help patients in their journey to alleviate their pain. When she started working in the medical world, experiencing different angles, she noticed that regulation and ethical topics could be more broadly discussed across industry functions. That is what pushed her to take the stance of exploring deeper in that direction.
Caroline is now really engaged with bioethical topics, and this is also featuring the main contents of her presentations while participating in global healthcare summits as a speaker. She will continue to spread awareness around the topic of ethical boundaries and legal frameworks surrounding the use of AI in patients’ projects; this is the core of her capstone project at Harvard.
She wishes to highlight the latest directives and regulations surrounding AI in the US and EU from a legal perspective. She would also like to provide some ethical grounds and associated tools to enable a positive outcome in the revolutionizing era of digital projects in pharma.
