Sooner or later – and we argue sooner – a European biotech or life science venture needs to set out its U.S. strategy. From round to round CEOs will need to raise increasing amounts of capital from U.S. investors and, if an IPO is part of the roadmap, the going public will happen on NASDAQ more likely than not.
The U.S. market represents the single largest commercial opportunity for every European entrepreneur. This therefore also means: (i) designing your target product profile (TPP) for the U.S. markets; (ii) getting your market access work right, (iii) maximising your freedom to operate with a commercially strategic IP strategy, (iv) navigating the U.S. regulatory regime with the FDA, (v) developing traction with the key sites for clinical trials, (vi) developing business development and commercial operations and much more.
The range of challenges asks demanding questions of a European CEO: what language do you need to speak to U.S. investors at the different stages, how do you recruit and retain the best U.S. talent, which functions need to be run from where and when, how do you evolve your board.
What does going “stateside” entail?
Rodger Novak, M.D. Rodger is a serial entrepreneur, long-time pharmaceutical and biotechnology senior executive. In 2013 he co-founded CRISPR Therapeutics together with Shaun Foy and Emmanuelle Charpentier, led the team that IPO’d the company in 2016 and served CRISPR as CEO until December 2017. He then became President and Chair of Board until his departure in September 2023. During his tenure at CRISPR Therapeutics, Rodger was responsible for the two landmark deals with Bayer and Vertex, and the definition of the early-stage portfolio strategy, which ultimately led to the approval of the very first CRISPR-based therapy, CasgevyTM, for the treatment of sickle cell disease by FDA and MHRA as well as conditional market authorization by EMA end of 2023.
Before CRISPR Therapeutics, Rodger was Global Head Infectious Diseases at Sanofi, based in Paris, France. In 2006, Rodger co-founded Nabriva Therapeutics, an antibacterial development company in Vienna, Austria, where he acted as COO. Nabriva was a spin-out from Sandoz/Novartis, where Rodger worked as Vice-Head of the Antibiotic Research Institute. Rodger is currently the Executive Chair on the boards of Xap Therapeutics and Econic Biosciences. He co-founded the companies in 2020 and 2022, respectively. He is the Chairman of AiRNA Therapeutics and a director of ERS Genomics he cofounded in 2014. Rodger is a venture partner at SR One Capital since 2019.
Rodger received his M.D. from the Philipps University, Marburg, Germany and was a postdoctoral fellow in the US at the Rockefeller University, the Skirball Institute, and St Jude Children’s Research Hospital. In 2001, he was appointed as tenured Professor for Microbiology at the Vienna Biocenter, Austria. Rodger authored numerous publications, among them articles in Nature, Nature Medicine and Molecular Cell, including authorships in scientific textbooks in the fields of anti-infectives, genetics and personalized medicine. He is also a co-inventor of several patents.
Shaun Foy, CFA is a biotech entrepreneur with significant startup experience and a strong investment track record as a former partner of a leading venture capital firm. He has spent more than 25 years working with emerging healthcare companies as an entrepreneur, investor and advisor. Shaun co-founded CRISPR Therapeutics and ERS Genomics, two of the leading companies commercializing the breakthrough CRISPR/Cas9 technology. At CRISPR Therapeutics he served as Chief Business Officer and Chief Financial Officer leading it through its company creation phase and early financings. He was the CEO of ERS Genomics, leading the company through its startup phase and negotiating the company’s initial licensing deals. More recently, Shaun co-founded and is an Executive Director of Econic Biosciences, a company focused on developing new cancer therapies that target ecDNA. He also co-founded and is a director of Xap Therapeutics, a company developing an iPSC-derived delivery platform for a broad spectrum of therapeutic payloads, including genetic medicines. Shaun previously served as a Partner and one of the founding team members of Nomura Phase4 Ventures, a London-based venture capital group investing in emerging healthcare companies in North America and Europe. He received an M.Sc. in Cell Biology & Immunology from the University of British Columbia and is a CFA® charterholder.