EUCOPE Member Spotlight: Q&A with Beigene

Every month, EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. In May, we spoke with Gerwin Winter, Senior Vice President – Head of Europe at BeiGene.

Gerwin Winter joined BeiGene in March 2021 as Senior Vice President, Head of Europe. Driven by a passion to unlock patient access to the best care, Gerwin is responsible for building and leading the team in Europe that will bring BeiGene’s innovative medicines to patients across the continent. With a master’s degree in pharmacy from the University of Munich, Gerwin has worked in the pharmaceutical industry for nearly three decades, with a strong focus on haematology and oncology.

 

 

 

 

Tell us about your organisation and its mission and how you drive innovation internally?

BeiGene is a global biotechnology company with a mission to create impactful medicines that are affordable and accessible to far more people facing cancer and life-threatening diseases. BeiGene was founded in 2010 to develop high-quality, innovative medicines and bring them to the greatest number of patients possible, because we accept that it is not enough for new treatments to simply exist without reaching the people who need them.

Our European story so far is in its early stages, but with over 400 employees currently based here, and the regional team doubling in 2022, our expansion plans are already going from strength to strength. We have been able to draw from the best science, talent and collaborations, wherever they exist through a combination of key offices in Europe, including our Hub in Basel, Switzerland, and remote employees based across the continent. Continuing and building on this legacy is our primary goal.

At BeiGene, we embrace change, new ideas, and diverse points of view to support a more resilient, forward-thinking and innovative company. Historically, the pharmaceutical industry has been slow to innovate its processes and ways of working. At BeiGene, this ‘change’ mentality has helped us spearhead a new model for the biotech industry that allows us to deliver science focused on greater patient impact.

In practice, this new model approach is demonstrated by our uniquely comprehensive internal capabilities. Our 950+ strong oncology research team, representing 10% of the entire company, is one of the largest in the industry, while our clinical development and medical affairs team of 2,700+ people means that we are able to conduct the vast majority of our global clinical trials internally. This allows us to develop cost-effective innovative medicines faster, while retaining high quality science.

How do your organisation’s activities help patients now and into the future?

BeiGene’s motto is ‘Cancer has no borders; neither do we.’ We operate in an industry where new medicine has historically been available in higher-income markets to maximise economic gains before seeking delivery to patients in middle- and lower-income markets. This has created inequalities, even within Europe. The emphasis in our strategy on affordability and broader access is a strategic priority and commitment for us to reduce health inequalities and maximise patient impact.

To turn this commitment into a reality, we have invested heavily into expanding our internal research team, which includes 950+ researchers, and our global clinical development and medical affairs functions, which include 2,700+ colleagues. This includes building expertise and capacity for conducting clinical trials internally. We are largely contract research organisation (CRO)-free and run trials in 45+ countries across EMEA, the Americas, China and Asia/Pacific, with 20,000+ patients enrolled across 110 clinical trials which have been initiated.

We like to move with speed and efficiency, not just in development, but also to get medicines faster to patients around the world. We have driven a collaborative approach to market access, which has helped get medicines to patients quicker, often faster than industry averages. We avoid reliance on the traditionally premium-priced markets and instead focus on broad availability. Delivering this broad access for patients as quickly as possible has been instrumental for building BeiGene and we have already managed to achieve availability for our medicines in record time in Europe and globally.

Ultimately, our goal is to deliver our 2030 strategy; namely to discover, develop, and provide more high quality, innovative and affordable medicines to far more patients globally.

What do you see as the biggest challenge facing the life sciences industry today?

Creating a new medicine is one of the most R&D-intensive and complex processes across all industries, requiring increasingly heavy investment. The industry is extremely high risk. At pre-clinical stage, out of 10,000 compounds screened and assessed, only around 10 will become investigational drugs entering the clinical stage. Subsequently, only 1 out of 10 drug candidates successfully passes clinical trial testing and regulatory approval. This reality means that despite the estimated average cost of developing a drug being nearly $2.3 billion in 2022, the average projected return on investment (ROI) in R&D is typically just 1.2%.

It is very important that we better explain this risk and challenge to those outside the industry so there is a greater understanding that ROI is what, in turn, supports the significant investments required to deliver further innovative medicines.

The perception of the pharma industry is still far too negative and we must do more to showcase the positive impact that this industry has.

What are the major health policy issues and themes that you are most focused on in 2023?

Like many within the European market, the reforms to the EU General Pharmaceutical Legislation (GPL) are a core focus. BeiGene recognises the opportunity that now exists to update and improve the GPL. We welcome proposals that embrace the latest scientific knowledge and advances in regulatory practice. We also share the European Commission’s aspiration to ensure that all patients in Europe, no matter where they live, have access to medicines that have a marketing authorisation.

However, given the complexity and shared competencies involved in achieving price and reimbursement, we are concerned that the proposal disproportionally places the patient access onus on the marketing authorisation holder and have concerns about linking regulatory data protection to launch conditionality.

We believe that the GPL should incorporate a gated approach to launch conditionality, recognising that in many Member States it is simply not possible to begin price and reimbursement negotiations at the time of marketing authorisation. It must be possible to file for price and reimbursement simultaneously across all EU Member States before a punitive deadline is considered.

BeiGene would welcome a structured dialogue, facilitated by the European Commission, on launch conditionality where the MA holder and the national competent authorities have a genuine shared responsibility to ensure patient access.

When the EU GPL reforms come into practice, our overarching goal is to ensure that BeiGene is as prepared as possible. We are doing everything we can to help overcome any challenges by collaborating with access regulators and health systems as efficiently as possible for the benefit of patients in Europe.

We are committed to achieving patient access in all 27 EU Member States as fast as possible – the EU is an important strategic region for BeiGene and accelerating equitable access beyond the larger markets is integral to our global mission. This month, we announced our partnership with Swixx to help expand access in 13 countries across Central and Eastern Europe (Croatia, Slovenia, Czech Republic, Slovakia, Hungary, Romania, Bulgaria, Lithuania, Latvia & Estonia) as well as Greece, Cyprus, and Malta.

What attracted you to join EUCOPE and how can we help you achieve your business goals?

As a new company building our presence in Europe, we wanted to join a trade association that understands the challenges of small and medium-size biopharmaceutical companies. We were attracted to EUCOPE because it has an established record of representing the interests of companies like ours with key stakeholders in Brussels. We look forward to being an active participant and working with EUCOPE to help navigate the changing regulatory and access environment in Europe.

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For more information about EUCOPE membership

Visit our Benefits of Membership Page, or schedule an introductory call with our Business Development Manager Dante Di Iulio diiulio@eucope.org