Takashi Takenoshita was a London-based healthcare partner in a leading global strategic consulting firm. During his 19 years consulting career, he served 14 pharmaceutical and biotech companies as well as a number of hospitals, payors and the National Health Service. Most recently, he was the founding CEO of a Japanese pharmaceutical company's European arm, where he built a full-scale pharmaceutical company and oversaw clinical trials, registration and commercialisation.
Ben Brickell: Why is out-licensing typically the default position for US Biotechs when it comes to launching a new drug in Europe? Why do many hesitate to launch it themselves?
Takashi Takenoshita: Historically speaking, it was true that most US biotechs preferred out-licensing when entering the European market. They needed to focus their capital and management resources on the US market. Recently, however, more and more biotechs are choosing to launch their products in the European market on their own. This is certainly the case for the companies with products targeting rare diseases and niche markets. Several factors have contributed to this change. The market access issues have become global and companies are opting to have direct control over pricing and reimbursement in key world markets. In addition, there are experienced people and suppliers that biotechs can tap into. Finally, nowadays, few large or regional pharma companies in-licence products for the European market alone.
What are the main things to consider when launching in Europe things to think about if you’re an American or Asian-headquartered Biotech looking to commercialise in Europe for the first time?
First and foremost, the company has to have a product that they can afford to launch themselves, i.e., not overly resource intensive – typically a rare disease or specialist product, with a strong clinical value proposition vs an alternative in the clinical practice.
So, the first thing the aspiring new entrant has to do is an opportunity assessment with a focus on clinical positioning and market access. It is important to do this very early - at least by six months before the start of Phase 3 trial, if not at the start of Phase 2b, of the first programme.
Understand how the product might be used and differentiated
Set the target label and study pricing / reimbursement
Clarify data requirement
Consider tax and IP location strategy
Devise a high-level road map for building the European franchise
There are independent consultants and specialist firms that can support this part of the journey. Hire/transfer a reliable executive and run a series of projects. Make sure that consultants are local and have an up-to-date functional domain expertise in the European context. Then, once the end of Phase 3 is near, the company can start investing in in-house launch capabilities: supply chain, registration, market access, medical, commercial and supporting functions.
The key here is not to build the overhead too early as there are always delays and setbacks in clinical trials. In addition, the business environment for smaller biotech is unpredictable and corporate direction can change quickly. Companies are best advised to refrain from hiring too many people until it is ready commit to the build out and launch in Europe. The team on the ground have to manage a vertical take-off and an extremely busy period during the twelve months up to the launch. Finding experienced senior leaders and delegating authorities would be the key to get the work done well and quickly.
Finding the right talent quickly is crucial in such a situation. You have built a great team around you in the past– what 3 qualities were most important to you when you were building your leadership team?
There are many people with significant professional experience. However, in my experience, the set-up stage of a European business requires a particular type of profile. For me, the most important traits for such profile are:
Confidence: the first set of leaders need to feel comfortable in making judgements with limited information and taking appropriate risks. They also need to come across credible in the face of the colleagues at HQs to get sufficient autonomy.
Conviction: circumstances change and there will always be sceptical voices. The leaders need to be fully bought into the cause and potential of the journey and keep marching on together as a team with resilience.
Resourcefulness: everyone has to be hands-on and play multiple roles to fill the gap in the organisation. The mentality of ‘let’s make do with what we’ve got’ is essential.
What would have been helpful for you to know before you started building businesses in Europe? Knowing what you do now, what advice would you give to your younger self?
I did not see Brexit coming… at least, I did not give a serious thought to the consequence of it. But who did?
On a more practical note, one thing I learned over the last two decades working on European business launch is the importance of being connected with the global leadership of the company. The European leadership team can get consumed in day-to-day business especially during the demanding pre-launch period. This creates a ‘long-distance relationship’ type of dynamics with the decision makers in the HQs. The regional leadership needs a full backing of their global counterparts and must fully align their direction with that of the other parts of the company, in substance and perception. So, it is important to allocate enough time and mindshare for the global communication, no matter how busy one might be.
You recently Co-founded a new Biotech company in Oxford. Can you tell us a bit about that?
I build businesses that deliver good products to patients and that is why I have been helping many companies in Europe and Japan.
I am also passionate about innovations and get inspired when I work with academics who have full of energy and ideas. The academia continues to be the main source of truly innovative ideas for new therapeutics and in recent years, there is a new big wave of innovations in life sciences. So, since 2012 I have been working with tech transfer offices of UK universities to building businesses around promising therapeutic ideas. Recently, I helped to set up an oncology-focused company with the University of Oxford and Oxford Sciences Innovation. The company, called Dark Blue after the University colour of Oxford, is developing a new R&D model based on a symbiotic academic–industry collaboration. We scout world class academic ideas coming from Oxford labs and provide professional grade drug R&D capability and capital to develop innovative therapeutics. BMS and Evotec are our strategic partners. We are working on three ground-breaking programmes and excited about the potential of these drugs for cancer patients.
We are looking for professionals that are passionate about our project, so please get in touch if you would like to know more.