by Jim Anthony - Global Head, Parexel Biotech
Happy new year! I think we are all glad to have 2020 in the rearview mirror. It was certainly a year like none other. But thanks to the incredible dedication and scientific expertise of our community, 2020 ended on a hopeful note with the Emergency Authorization of two new vaccines for the novel virus that were developed in less than 12 months.
Normally this week, I would be in San Francisco for JP Morgan Healthcare Conference, talking with colleagues across hundreds of companies about the opportunities and challenges in sight as they look to the future. Because the event is being held virtually this year, I thought I’d “put pen to paper” and share some thoughts about the state of the industry, along with how Parexel Biotech has evolved since our launch in January 2019.
Biotech: A Powerful Force in Driving the Industry Forward
Biotech companies are the driving force behind the industry’s R&D pipeline as they develop and launch increasingly complex treatments. With more than 80% of the assets in development managed by small and mid-sized biopharma companies, it is a thrilling time to be working in this field.
A Rugged Landscape to Navigate
That said, the challenges for biotechs are steep. The global healthcare landscape is changing rapidly, affecting the way in which companies are navigating their clinical development journey. R&D is extraordinarily costly, and competition for funding is intense. While efficiency is paramount, safety and quality are more so: how is it possible to balance the two? In addition, trial complexity is mounting, along with the associated patient and site burden. What is the optimal protocol strategy keeping the patient central to the design? What are the right sites for patient recruitment – especially amidst the pandemic? What is the right development and post-launch path, and how can the latest innovations be applied to improve the likelihood of launch? Layered around these considerations is a complex regulatory and reimbursement landscape with stringent demands for a compelling proof of concept and clear demonstration of efficacy, safety and value.
A Partner Along the Clinical Development Lifecycle
Thinking back to when we launched Parexel Biotech, we did so with our customers’ needs in mind. We knew that the need to be fast and nimble was, and continues to be, hardwired into the DNA of these companies.
For a small or emerging company to realize value and ROI from a contract research organization (CRO), they need to access and harness all the services the CRO can offer. As a large CRO, Parexel delivers through our global network of industry-leading capabilities, services and expertise.
At the same time, we understand that these companies have limited time and resources. To make this wealth of expertise more accessible to them, we would need to redesign our service offerings to support their way of working throughout the clinical development lifecycle. We could leverage Parexel’s strengths to their benefit if we built our services from within.
As such, Parexel Biotech has evolved our operating and relationship models to better collaborate side-by-side with our biotech customers. The concept is to partner with them throughout their development journey, from the early stages of planning and initiation of trials, and then to be there to execute and adapt the plan along the way. This requires a working model with single points of contact, enabling them to harness all of Parexel’s strengths in a simpler way.
A Reimagined Internal Culture with the Patient at Heart
In parallel, we have updated our internal company culture to put patients at the center of everything we do. We made a commitment to this approach, both publicly and internally, making sure that our culture reflects the fact that patients are part of our DNA. We reached out to patient advocacy groups, and directly to patients themselves, to better understand their experience with disease. And we also partnered with the healthcare organizations to bring the whole patient to the work we do. I believe this is reflected now not only by our company culture, but in the clinical trials we deliver today.
A Journey of Many Steps
The journey from Pre-IND to Post-Approval is a complex one and encompasses literally hundreds of different steps. We stay focused on simplifying that journey for our small and emerging biotech companies by working side-by-side with them to break it down into a series of connected decisions and milestones. Because when each step is approached strategically, connected to other steps, and executed with the patient in mind, that’s when we see breakthroughs that can make an exponential difference in patients’ lives.
I welcome the chance to meet with you – virtually, of course – to learn more about where you are in your journey, and how we can help you achieve your goals.
Email me if you would like to connect.
Happy new year and stay safe!