OR WAIT 15 SECS
ProductLife Group’s new CEO, Xavier Duburcq, talks about his hopes and ambitions, and his industry predictions, as global life sciences squares up to a more dynamic and digital future.
Xavier Duburcq is ProductLife Group’s new CEO. He joins the organization after 13 years at Altran, where he was Group VP of Life Sciences. A pharmacist, with a Ph.D in Immunology, Xavier was involved in his early career in the development of new medical devices for the detection of hepatitis, HIV, malaria and other blood viruses at Sedac Therapeutics and Biorad. At Altran Life Sciences, Duburcq led a team that has delivered substantial international development across Europe, Asia and North America over the last decade. As he takes the helm at ProductLife Group in these uncharted times, Duburcq talks to Pharm Exec about his hopes and ambitions, and his industry predictions, as global life sciences squares up to a more dynamic and digital future.
Xavier Duburcq: ProductLife Group is a leading provider of regulatory, safety and compliance outsourcing and consulting services to the global life sciences industry. We’re headquartered in Paris but operate internationally, serving more than 100 countries today. The organization has been around for nearly three decades, and its client base includes 75 per cent of the world’s top pharmaceutical companies who rely on ProductLife Group’s support and services across the regulated product life cycle – from development to post marketing.
I see some major trends which are having an impact on the way life sciences manufacturers need to behave, and organize and optimize their operations. The first is the drive for organizations to make an innovative contribution to patient healthcare. Beyond traditional drug innovation, more work is being focused on specialized medicine, as well as cell and gene therapies. What characterizes these new areas beyond their scientific value is that the drugs are continuously evolving across their lifecycles, enhanced by patient feedback. This has a direct impact on a company’s pharmacovigilance (PV) activities, which must now be more proactive and adaptable.
There’s also a growing emphasis on “value-added medicine” – for instance enhancing existing drug assets to improve efficiency, reduce adverse events, and improve patient adherence and the patient experience. This is giving rise to new follow-up protocols or approaches, and can involve new regimes such as taking drugs based on medical device innovation (for example, as sensors detect a need or suggest a dose adjustment) – an area known as “digital therapeutics.” Large pharmaceutical and medical devices companies are working intensively to develop these new type of heath solutions - switching from a simple drug delivery model to a fuller service for patients. Crucially, their differentiation tends to be linked to the service around the medicinal product/medical device, rather than the item itself.
All of these developments place new emphasis and pressure on Regulatory and Safety processes. By that I don’t just mean the speed, accuracy/completeness and continuous nature of feedback mechanisms. It also demands a rounded knowledge of the organization’s entire product portfolio and associated assets - enabling all possible synergies to be exploited, and the acceleration of market through confident re-use of already validated information.
On top of all this, Regulatory and Safety teams must also keep abreast of new regulations and technologies, while enriching their practices to meet rapidly-evolving compliance requirements, as the life sciences industry seeks to progress its transformation agenda; reflect the highest manufacturing standards; and improve patient safety.
It is developing and changing companies’ industrial mind-set. Even before the crisis, Big Pharma organizations were starting to rethink their manufacturing and supply-chain approaches (Earlier this year Sanofi announced some re-localization of operations to the EU, for example.) The dependence on China/East Asia/ India for compounds and drugs has led to a number of issues which have been magnified as the Covid-19 situation has unfolded, including stock disruption and uncontrolled circulation of falsified medicines. This has created new urgency around operations planning.
The crisis has also highlighted the need for the pharma industry to review how it manages regulatory and safety information, as it strive to become more responsive and agile, and more focused and efficient. Regulators’ increasing preference for electronic submissions, and eventually the use of standardized data rather than static documents, paves the way for manufacturers to manage information in new ways – for instance, leaning on trusted partners to take over more of their compliance activities.
The prioritization of core activities has never been more crucial. Unless manufacturers can refocus their skills and resources, they will struggle to achieve the dynamism, efficiency and speed to market they need to keep pace with the demands of the global market.
Like other innovative industries (aeronautics, automotive, food, electronic devices, nuclear, and so on), pharma is rapidly evolving from sub-contracting tasks to outsourcing entire elements of their business processes. Organizations were already embracing managed services such as tech-enabled regulatory process outsourcing with mounting zeal, and over the months and years ahead we can expect this trend to accelerate at a tremendous rate. This is because it makes no sense at all for highly sought-after and deeply-skilled scientific teams to give over so much of their time to the mandatory and demanding regulatory, safety and compliance-related administration. Not when there are service provides with all the latest skills, technologies and regulatory knowledge to take care of these activities for them.
In the context of what we’ve already discussed, artificial intelligence’s potential lies in two main areas - in distilling new intelligence and insights; and in enabling automation - for instance in completing and checking routine documents.
The possibilities are numerous and some applications are already implemented. These include tools supporting PV safety monitoring and adverse event detection across social networks and research literature. Or, in a regulatory intelligence context, gathering data from regulators around the globe. Combining the two approaches will allow companies to profile drugs from a variety of angles - from adverse signal identification, to informing optimized regulatory strategies for each country.
AI will continue to help us balance our responsibilities across the “three Ps:” profits, people and the planet. While striving to grow our business in a healthy and sustainable way, we will be looking at how we can go the extra mile to take care of our people, stretch them and enhance their skills. That includes giving them access to the latest AI tools and techniques to optimize processes. In this way we will make our work more interesting, and create new value-added services and experiences for our clients. Harnessing the latest digital facilities will also help us bridge distances and collaborate in more advanced and efficient ways with clients and partners internationally, reducing the need for travel.
Of course it is not ideal, especially as I was expecting to travel around our offices to meet our people and our partners. But I prefer to focus on the opportunities it creates. And the good news is that, in 2020, we have all the digital tools in place to progress conversations and meetings remotely. Our first priority is the safety of our people and those of our partners, and I will ensure that all measures are in place to support this, particularly as the lockdown is gradually eased across the countries in which we operate.
As well as “meeting” all of my new colleagues, I want to build up a deeper understanding of the company culture and DNA, and the specific challenges I will be managing. In parallel, I will be looking to meet our main customers and partners and find out more about their perception and expectations of ProductLife Group and discuss our mutual ambitions for the coming months.
All of this preliminary activity will support the design of our roadmap, our strategic plan and our actions for the remainder of 2020.
The goal is for ProductLife Group to become the global leader in Regulatory & Compliance outsourced services for pharmaceutical and medical device manufacturers. To this end, the strategic plan for 2020-2025 will include expanding our current footprint - first deeper within North America, then across Asia. We will also diversify our market coverage, across more of the medical devices industry and additional areas of Quality & Compliance.
Innovation is an important priority too, and this will see us continue to enhance our value proposition, integrating AI and the latest digital technologies and process automation tools and techniques into our service portfolio.
I believe it’s crucial to keep questioning and challenging what we do, so that we are always striving to be better – through a process of continuous improvement, and empowerment of our governance and project management methods and practices. We will do this for the benefit of staff engagement as well as customer satisfaction. I am pleased to say that I am supported in this journey by a fantastic team of senior leaders and investors.
Related Content:Regulatory |