Corporate Counsel Q&A: Life Sciences
Raegan McClain, the deputy general counsel and global compliance director at Novocure, talks about a range of mattters, including her role at the burgeoning global oncology company, legal issues with R&D, the criteria for instructing a law firm and what makes a leading life sciences lawyer.
Novocure is a global oncology business with over 200 employees in six countries and subsidiaries in the US, Europe and Japan. The company’s goal is to effectively treat cancer patients through the development and administration of tumor treating fields (TTFields), a novel antimitotic therapy that uses low-intensity alternating electric fields to target solid tumors. The therapy was first developed in 2000 by Yoram Palti, MD, PhD, who founded Novocure in Haifa, Israel. Since then, the company has achieved growth on a global scale to include operations in New York, Portsmouth (New Hampshire), Lucerne and Tokyo.
Since 2000, Novocure has treated over 1,700 patients, and in December 2014 the company reached a milestone of certifying more than 150 treatment centres in the US to prescribe its FDA-approved medical device for adult patients with recurrent glioblastoma.
Raegan McClain is the company’s deputy general counsel and brings strong experience to the role, having been active in the life sciences sector for several years: first as a private practitioner advising on pharmaceutical licensing deals and R&D matters at DLA Piper, and subsequently with in-house positions at Sanofi-Aventis and Aptalis Pharma. Since moving to Novocure in 2014, she has advised on a wide range of regulatory and compliance matters relevant to the company’s ongoing work. Who’s Who Legal spoke with McClain about her role within Novocure, recent projects, the current state of the pharmaceutical and medical device sectors, and the company’s interaction with the legal industry.
Tell us about your role at Novocure.
My primary role at Novocure is to implement and monitor Novocure’s global compliance programme. In addition to my compliance role, I also advise Novocure’s global business and support teams on legal, regulatory and compliance matters and serve as Novocure’s privacy officer overseeing data protection matters.
The company’s main focus is currently on the development and commercialisation of TTFields as a major treatment modality for cancer. What legal challenges have been faced throughout the R&D?
Due to the novel treatment modality of our commercial product, it has been challenging to navigate the global legal landscape. Additionally, in a dynamic emerging company, where resources are limited, there are a lot of balls in the air. It is particularly challenging to manage and sustain legal and compliance acumen with respect issues that arise in multiple countries.
What criteria do you use when deciding which firms/lawyers to instruct in relation to a TTFields or medical device issue?
Given my global responsibilities, when looking for firms/lawyers for support ex-US matters, my goal is to find a one-stop shop, where a multitude of issues can be managed by one firm that has representation and expertise in the global markets where we operate.
Given the relative youth of Novocure as a business, has the company taken any steps to develop its own in-house legal function? Is there an aim to become more self-dependent in terms of the legal issues faced by the organisation?
Yes. In 2012 Novocure brought in Todd Longsworth for the role of general counsel. I was brought in as the second attorney in April 2014 to build and support the compliance-related needs of the organisation at a global level. Although the general counsel and I cover a broad range of issues, we often rely on outside counsel in the ex-US markets. In addition to utilising outside counsel to ensure we are in compliance with global regulations, in many circumstances we are faced with a language barrier that requires us to rely on external support.
What is the greatest challenge – legal, practical or political – facing the international medical devices and pharmaceutical field?
Keeping up with the evolution of laws on a global level and ensuring harmonisation of laws, especially with respect to information that is centralised in information technology systems, is our biggest challenge right now as a small global medical device company.
What makes a leading life sciences lawyer?
Broad expertise in issues facing life sciences companies during the life cycle management of products, the ability to manage issues across different areas of expertise and responsiveness.
What are your relationships with other members of the executive leadership at Novocure, and does the board of directors advocate a particular approach to deciding which firms or lawyers the company consults in relation to a legal matter?
As a global function, I support many areas of the business and interface with the executive leadership team at Novocure to ensure continuity of compliance matters across the organisation. As with the selection of any service providers, the board ask us to select effective and efficient providers.
Are there any recent regulatory changes or cases in the sector that have caught your attention?
Nothing in case law stands out, but I have been following guidance and regulatory changes issued by the FDA over the past six months with respect to promotional and development activities in the life sciences industry.
How do you see Novocure developing in the next five years?
The greatest change for Novocure over the next five years will be to scale up its internal infrastructure to support globalisation and growth, and to drive efficiency.
Are there any technological advances which might have an effect on the way the sector operates?
I think the shift to IT cloud-based systems will have a big impact on global life sciences companies who need to ensure compliance with data privacy and security regulations.
What prompted you to move in-house in the sector, and what do you enjoy most about working as deputy general counsel in the life sciences field and at Novocure?
I moved in-house because I wanted to learn and understand the business from the inside, and have an impact as a strategic partner in supporting the business. In my current role, I enjoy being part of building the foundation for a growing company and building cross-functional relationships to collaboratively address the legal and compliance needs for our global organisation.