Arnold & Porter launches in Amsterdam with a Life Sciences Regs offer

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Arnold & Porter Kaye Scholer, headquartered in Washington, opened a third European office by integrating two new laterals in the Netherlands, further strengthening its global regulatory proposition.

Am Law 100 has played a strategic role for the growing life sciences market in Europe and has further strengthened its ability to provide global regulatory service by opening an office in Amsterdam. Along with London and Brussels, this becomes the firm’s third office in the region.

The office is launched with life science and biotech partners Carla Schoonderbeek and Bart Jong. For the past decade Schoonderbeek and Jong have practiced at Amsterdam-based Hoyng Rokh Monegier, having left Hogan Lovells in 2012 and NautaDutilh before that.

With a small but growing life sciences sector, the Netherlands has played an increasingly important role in European pharmaceutical regulation since the European Medicines Agency moved from London to Amsterdam following Brexit. . The United States Food and Drug Administration also moved a significant portion of its European operations to Amsterdam around the same time.

Jong said EMA’s presence in the Netherlands has made the country an increasingly attractive market for life science companies, even compared to traditional hubs such as Germany and the UK.

“We see a lot more pharmaceutical companies seeking marketing authorization in the Netherlands and having offices here.”

Schoonderbeek said that over the years Holland has also become increasingly attractive to the life sciences sector through Dutch government programs to promote industry growth.

As a result, demand for legal services in the practice area is expected to continue to grow, she said.

Richard Alexander, Chairman of Arnold & Porter, said the opening of the company’s new office is a good example of its commitment to joint global thinking and client services in the area of ​​regulatory general, and life sciences in particular.

“Our strategy is to be available in the markets where the customers have the needs, but we also focus on where the talents are. We are adding two amazing colleagues in Amsterdam to better serve our customers in European markets,” said Alexander.

When asked if he planned to further expand the company’s European presence, Alexander said Arnold & Porter’s goal was to secure the success of Schoonderbeek and Jong as an additional investment. in the company’s global life science practice.

“We consistently win business with our clients based on our talent and geography. Our geographic footprint is driven by the status of a walls business to meet the needs of our customers to ensure that we retain the talent necessary to serve these customers,” said Alexander, adding that Arnold & Porter “will continue to be opportunistic in other areas. to meet the needs of our customers. »

Schoonderbeek and Jong were already well known to the company, having worked for decades on cross-border issues with Ian Dodds-Smith – co-head of Arnold & Porter’s food, drug and medical device practice – and Jackie Mulryne, Cabinet Member. life science practice group, London.

“It’s been a long time coming,” said Schoonderbeek, looking forward to working more closely with her new colleagues at Arnold & Porter.

Schoonderbeek advises clients on European law and regulation of medicines, including pharmaceutical and biological products, as well as medical devices. She assists clients with EU marketing authorization issues, regulatory exclusivities such as data protection, orphan designation and pediatric research awards. Her job also includes assisting clients with EU market access and clinical trial issues.

Jong is a former Amsterdam District Court judge at the Ministry of Justice and now represents some of the largest companies operating in Europe. He specializes in European and Dutch regulatory issues regarding pharmaceuticals and biologics, including drug development, from marketing authorization procedures, manufacturing and distribution, regulatory exclusivities and enforcement, to pharmacovigilance, pricing and reimbursement. De Jong’s experience in administrative law includes handling cases involving administrative authorities such as the Dutch Ministry of Health, the Dutch Medicines Evaluation Council and the Dutch Health Authority, as well as reviewing decisions of the European Medicines Agency and the European Commission.

Daniel Kracov, co-president of Arnold & Porter’s life sciences and healthcare regulatory practice, said Schoonderbeek and Jong operated in a specialized practice area that was extremely important to clients.

“It’s a talented little bar of avocados and Carla and Bart are on top,” Kracov said, adding that Arnold & Porter has worked “very hard over the years” to gradually grow its regulatory offering by life sciences by attracting the best talent. that matches the needs of clients in key jurisdictions. “People tend to gravitate towards quality and exciting work. We are very happy to have Carla and Bart with us.

Kracov explained that the life sciences industry has become increasingly global in nature, requiring a global approach to regulation.

“Take clinical trials, for example. When I first started practicing, very few clinical trials for drugs approved in the United States were based on data developed outside. Today, approximately 60-70% of patients in clinical trials and data submitted to the FDA likely come from outside the United States. This forces law firms to provide their clients with a holistic approach and perspective.

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