Nordic Life Science 1
ADVERTORIAL BUSINESS PRESENTATION RegSMART Life S
cience AB She understands that working with these kinds of projects requires changes to the regulatory mindset, as well as increased interaction between regulators, health technology bodies and payers. “Considering the type of products in the pipeline today, there will be a limited amount of data for the authorities and payers to evaluate. This puts pressure on both authorities and companies.” MAKE SURE WE ARE PREPARED Together with CTR, Marie Gårdmark wants to contribute to competency development within Life Science in Sweden. She believes that the positive collaboration climate and strong scientific heritage supports an expanding Swedish Life Science. Marie Gårdmark, CEO, RegSmart Life Science “I sometimes meet those who see regulaREGSMART LIFE SCIENCE tory experts as naysayers. In my experience we are the opposite. Guidelines and regulations are constantly emerging, driven by research from the pharmaceutical and medical device industries.” Center for Translational Research (CTR) has established a new regulatory company, RegSmart Life Science, with a focus on pharmaceuticals and medical devices. To meet today’s regulatory challenges, Marie Gårdmark (CEO), sees the need for a closer relationship between companies and authorities. EGSMART’S AIM is to help scientists and companies navigate through a complex regulatory landscape. “The conditions for the development of pharmaceuticals and medical devices are rapidly changing and to find the most successful way forward, profound regulatory competence is needed. We understand how the authorities reason and that regulatory guidelines do not always give you a straight answer. There are hardly simple yes or no’s,” Marie Gårdmark says. A CHANGE IN CLINICAL RESEARCH Marie Gårdmark has extensive regulatory experience as Director of Licensing at the Swedish Medical Products Agency and has had several regulatory strategic roles within 24 NORDICLIFESCIENCE.ORG the pharmaceutical industry. She sees a change in clinical research with, for example, much focus on treatments targeting small but urgent need patient populations. “The patients understand their own needs and are important in the development of new products, for example to determine what endpoints are most important to them.” Marie Gårdmark believes that the development of advanced therapies (ATMPs) will continue in the future. “As a society, we are challenged by these types of products and we may need to review both regulations and business models to make sure that we are prepared.” Medical devices such as digital apps and diagnostics tools are also an emerging market. RegSmart will help identify gaps in the development of pharmaceuticals and medical devices and suggest how to move forward. “We will guide companies in understanding the current view of the regulators. We will help in risk and opportunity assessment and in the development of the project strategy.” CENTER FOR TRANSLATIONAL RESEARCH AB is a holding company that was founded in 2016. CEO is Mats Lindquist. The company partly owns RegSmart Life Science AB and CTC Clinical Trial Consultants AB. WWW.REGSMART. SE KNOW THE CHALLENGES Marie Gårdmark believes that the regulatory plan is an important part of a product’s developmental plan. With her scientific background and experience from both big and small sized pharma, she knows the challenges. “It’s important to understand the scientific, regulatory and commercial issues at an early stage. My role as a regulatory expert is to read between the lines and visualise the perspectives of the authorities.” NLS