Xavier Duburcq, CEO at ProductLife Group

1) What inspired ProductLife to join EuropaBio?
Europe has a complex biotech landscape: thousands of companies, multiple paths to innovation and financing, and marked differences among countries. Europe’s strength as a global powerhouse for scientific research and publication does not yet translate into new medicines as it should be. From conception and development to approval and launch, each stage of the commercialization process requires individuals with specific expertise, in areas ranging from clinical data collection to capturing and reporting adverse events. With today’s ever-changing laws and regulations, there’s a growing demand for well-rounded professionals who understand the overall regulatory landscape and can help companies effectively bring products to market. Developing that understanding requires staying up-to-date on emerging trends within the industry. PLG will share its expertise at EuropaBio across National Associations Council and the SME platform in order to improve the regulatory ecosystem for increasing European biotech companies’ competitiveness in Europe.

2) How has ProductLife changed over the years as technologies advance?
Since 1993, ProductLife Group (PLG) has made dramatic changes in its philosophy. From a fully European company, we became in a few years’ time a European company with a global footprint. Today, PLG is supporting its clients through the entire life cycle of medicines and MedTech products, combining local expertise with global reach and spanning more than 130 countries. In the specific field of biotech, PLG has set up a team of biopharmaceutical regulatory experts, with an extensive experience and a strong understanding of biopharmaceutical product development, registration, market access and commercialization. PLG is providing flexible and tailored, pre-clinical, clinical and market access solutions designed to notably - but not only - help mid-size and small biopharmaceutical companies move forward in their effort to get treatments to patients – from helping to define the development plan, to implementation of all stages of product development, through launch and commercialization – in order to deliver compelling results to regulatory authorities, investors, and stakeholders.

3) What are your plans for expansion?
First of all, PLG will pursue its international expansion. On a regulatory stand-point, there is an increasing demand for the faster approval process, changing regulatory landscape, growth in emerging fields, such as specialty therapies, new vaccines, orphan drugs, and personalized medicines. At PLG, we will continue to assist our customers : 1) to file the important gap in translational research, 2) to accelerate the development of regulatory sciences that reflect the new integrated approaches to R&D and healthcare delivery that are transforming healthcare, 3) to create new businesses placing our customers at the forefront of cross-sectorial benefits for patients, and 4) to increase partnerships worldwide in order to operate in an efficient and flexible way.

4) How do you see ProductLife being able to transform the regulatory and pharmacovigilance services?
Biopharmaceutical companies are actively involved in the development of innovative molecules that fulfil the unmet needs of patients. The biopharmaceutical market is anticipated to witness substantial growth in the future. For biopharma innovators with so much opportunity ahead of them, there is a lot to think about. Considerations must include strategies for product development, and the need to fulfil regulatory obligations at all stages of development as well as pre- and post-market. To maximise their potential, these companies must ensure they are targeting the right markets with the right medicines, that they have access to the scale of funding they need at the right stages, and that they are able to safely fast-track delivery of much-needed treatments at an affordable and sustainable price point, harnessing the right partnerships as they go. In order to reach this goal, Real world data that better supports scientific or commercial analysis. as well as Digital health (AI) will be more and more integrated into new medicine development at PLG.