Leaders in Life Sciences: Hilary Baldwin, Vice President of Regulatory and Quality at SimBioSys

SimBioSys is a technology company deploying a combination of artificial intelligence and biophysical simulations to improve our understanding of cancer. By virtualizing cancer, SimBioSys aims to empower clinicians and patients with a better understanding of the disease and the ability to assess all available options computationally to truly individualize treatment.

Read on for more insights from Hilary Baldwin …

Robert Fenton: How many years have you been in the life sciences, and what are the three most notable changes that you’ve seen and experienced in your career?

Hilary Baldwin: I have been in the life sciences industry for roughly 20 years, with a career spanning from biotechnology to diagnostic companies in regulatory and quality. The three most notable changes I have seen during my career are:

• AI tools performing less invasive techniques by analyzing radiological images for a more detailed understanding of how a disease progresses;
• Personalized medicine which is tailoring therapy to the individual patient to reduce risk and ensure better care; and
• Collaboration with healthcare providers and industry for real world data sharing.

Rob: In what specific ways do you see the life sciences evolving in the next decade?

Hilary: I think there will be a major shift in the skill set of the workforce in life sciences. Increased complexity of technologies such as AI, automation, and data analytics will shift the focus of healthcare. There will need to be an upskilling of the employees needed to work with these new technologies.

Rob: What do you see as the biggest challenges to innovation and digital transformation in the life sciences?

Hilary: The biggest challenge facing life science innovation is the ever-changing regulatory environment. Businesses must hire skilled workers and put a compliant system in place, all while regulations continue to evolve. This creates an increased need for companies to stay ahead of ongoing changes to compliance requirements and the Code of Federal regulations.?

Rob: If you had to name two companies that have fundamentally changed the life sciences for the better in the last 5 years, who would they be and why?

Hilary: Illumina and GRAIL (now part of Illumina) have changed life sciences over the past 5 years by continually innovating to provide better speed and access to genomic sequencing. The company continues to release sequencing tools that drive down the cost of genetic sequencing.?

Rob: How can the life sciences industry more broadly apply lessons learned from the pandemic to accelerate innovation?

Hilary: One of the fundamentals of innovation is answering an unmet need once identified. During the pandemic, there was a need to move as quickly as possible to get a product to the market, and all while still ensuring compliance. This lesson can be more broadly applied to life sciences in order to accelerate innovation.?

Rob: Where are you seeing the most innovation today in the life sciences ecosystem?

Hilary: I think the most change is happening in relation to regulation catching up with innovation.? For example, digital health platforms are increasingly being used to collect real-world data for use as real-world evidence in regulatory decisions. Also, new regulatory frameworks that cover AI and digital health are also fast approaching in the U.S., China, and Europe.???

Rob: How do you stay on top of trends and innovations in the life sciences?

Hilary: Being part of industry groups such as RAPS, following thought leaders on LinkedIn including current and former FDA leaders, and subscribing to industry pages like Precision Oncology News.?

Rob: What advice or words of wisdom do you have for early-stage life sciences companies that are looking to disrupt the status quo while accelerating innovation and safeguarding quality?

Hilary: My advice would be to start early with educating the organization on compliance. Regulatory compliance is critical to the market authorization process for any device. Building a compliant, user-friendly quality system will help set a life sciences company up for success.?