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How to Do Clinical Trials with a Cancer Drug Partner Insights

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How to Do Clinical Trials with a Cancer Drug Partner Insights 1 6th Issue | Spring 2018 Building an Ant ibody Innovat ion Pow erhouse Exclusive interview with Genmab CEO, Jan van de Winkel PAGE 3 How t o do Clinical Trials w it h a Cancer Drug Interview with Dorte Klokker, Head of Clinical Operations at Roche PAGE 6 Part ner Insight s Featuring Accelerace, Novo Nordisk Regulatory Affairs and Roche PAGE 10 1 2 Cont ent s Main Art icles In Ot her New s 3 Building an Ant ibody 20 Doing Business In Innovat ion Pow erhouse Synapse was fortunate to have two team members attend Doing Business In 2018. Jan van de Winkel, CEO of Genmab, attended the Copenhagen Life Science Summit as a speaker. We caught him for an 21 The 13t h Danish interview. Conference on 6 How t o do Clinical Trials Biot echnology Coverage of the annual conference organized w it h a Cancer Drug by Danish Biotechnological Society A video interview about the purpose of clinical trials with Dorte Klokker, Head of Clinical Operations at Roche Denmark. Career Help & Advice 22 Synapse Career Aid Kit Event s & Short New s Tips and tricks for students attending 7 Event Announcem ent s conferences List of events to attend. 24 Synapse Says 8 Short & Sw eet Industry professionals answer magazine readers' questions Short news in life science. Synapse Part ner Insight s Ext ras 10 Part ner Insight s 27 iLAB - Int erdisciplinary Featuring Accelerace, Novo Nordisk Life-Science Applicat ion Bus Regulatory Affairs and Roche. The winner essay of the Copenhagen Life Science Summit 2018 competition Synapse Wit hin 16 Synapse Mem ory A look back at our past events. 17 Synapse Insider Emily Barot opens up about the SCUK team. 18 Synapse Connect UK 2018 Andreas Obers from Synapse shares his experience with Synapse UK Connect. Cover photo designs by Mark Out ridge [email protected] Pictures taken by Jonas Krøner [email protected] 6th Issue | Spring 2018 2 3 Building an Ant ibody Innovat ion Pow erhouse steps.? How does Genmab stay in touch with the scientific Written by Sven Hollmann Team Member of Synapse community and collaborate with academia? ?We are organizing a lot of lectures and At the Copenhagen Life Science Summit 2018, Jan van de Winkel, the Chief Executive Officer symposiums, next month we will open up a new (CEO) of the international biotech company R&D facility in Utrecht. Before the official opening, Genmab A/S, held an inspiring presentation we have already organized an international about building an innovative powerhouse. After the presentation, Synapse had the symposium earlier this week with amazing chance to talk with him. speakers, as a clear signal that we want to communicate with the outside world and attract Thank you for a great presentation here at the people from academic institutes, to really help us CLSS 2018. We are curious to know what it is like to think about how we can address treatment of be a CEO when you have a background in life diseases in a better way. So we are very actively science? working together with academia. Furthermore, as a ?I think it actually helps, because biotech is about global company, we have great interactions with both having an eye for the details, as well as for the different teams in Denmark, the Netherlands and broader picture. The fact that I was the CSO for the the US as well as academic interactions across first eleven years helps, because I also learned a lot Europe and the US. These academic interactions about the business in those years, and it actually are always focused on certain disease targets or gives a better, clearer, and more transparent way to certain scientific approaches. So we are already understand the business and think about the next involved in a lot of collaborations, and we will in 3 4 fact intensify our efforts for collaboration in the been very clear and transparent on the fact that we coming time.? want to create an independent business. There are not many hostile takeovers in our industry. Usually What have been the biggest challenges for companies are acquired when they have signaled Genmab in the company?s relatively short that there may be better prospects for the existence? company by being part of a bigger entity. I believe ?The challenge is that you are developing drugs that we can build far more substantial value by over a 10-year time frame and sometimes the staying independent as an innovation powerhouse, market does not give companies that time. Events that is what our strength is. I do not see a scenario occur in the market; economic crises or other where Genmab has thousands of employees, I see crises, which then can make it very difficult for a a scenario where the company has maybe several company to recapitalize. In the early days Genmab hundred very talented employees. Our motto is: needed a number of funding rounds, but keep the brains inside and hands outside of the sometimes funding was not available due to the company. What we mean by that is that we can macroeconomic situation. So the biggest challenge outsource some of the operational tasks, but keep was to ensure continued market support to help the knowledge and the strategy ? the intellectual develop the products and ultimately the company. part ? inside the company. A good example is the Like any other industry, it is all about the products deal we have with Janssen [ Janssen in the end. The challenge with biotech products is Pharmaceuticals obtained the exclusive global that it takes such a long time to develop them, so rights to commercialize daratumumab from what you need is a very strong business plan, which Genmab in 2012]. Janssen is the military machine gives the business clear direction and focus. for development and commercialization, and they Obviously there needs to be flexibility in that do that really well ? I have the deepest respect for business plan, because things do change over time, how they execute the development of especially in an industry such as ours with long daratumumab and commercialization of the drug. development timelines. So for Genmab, we have The Genmab team is not set up to do that, but I am recognized that we need to be well capitalized at all very proud of the fact that we created the times, so that the business is independent of the molecule. This is also our future strategy. To have market. Right now the company is in a state where manufacturing and large clinical trials carried out it is sustainably profitable with a growing income by CROs [Contract Research Organisations] and stream, so from here we can build a stronger and other organisations under our guidance. I can see a better company. To create this situation has scenario where we would have a number of sometimes been challenging during the past preferred relationships with partners we know decade.? really well. With CROs and CMOs [Contract As you said, Genmab is now very well-funded, but Manufacturing Organisations] so we have solid how did Genmab avoid getting acquired by a relationships with them and really get to know the bigger player during the company?s early years? employees from those companies that we work with.So we create real relationships as you would ?I think it is a combination of being very focused on with colleagues in the same company.We have 16 our future development and very clear in our partnerships, 6 with pharma companies and 10 communication that our aim is to build an biotech company partners. Our aim is to be a independent strong biotech company. I think it preferred partner, that is, to be a partner of choice helps to ensure you are well capitalized, so as a for companies because we create such good company you are less vulnerable to potential working relationships in our interactions. That is takeover attempts especially during the early years. how I see a future for our industry. That we are The best defense for a takeover is a high share connected and partnered so that biotech and price and Genmab?s stock did really well. We have academia can build on ideas and processes 4 5 together.? stress? To remain an innovative powerhouse, Genmab ?Of course there is a level of stress, but I don?t feel it will... has much of an impact on me. I create more energy from my work than I actually put into it. I believe ?Focus on what we are really good at and connect that if you can say that, you are in very good shape. with the outside world. For example on academic I relax at the weekends by swimming and I would groups for access to scientific knowledge and love to be able to do that more often. Swimming partners for manufacturing of kilograms of benefits all the muscles in your body and it has this antibody, and for help in running clinical trials repetitive aspect, which allows me to think and (CROs). Then our own employees can concentrate relax, whilst also keeping my my body in shape. on specific critical work and strategy. We will be the Hard work comes with the job, and by now I am connector, we will be the spider in the web used to it. If I were not able to handle it, then I basically.? would not do it and as I said, I still generate a lot What advice would you give to your younger self? more energy from my work than I put into it, and ?To young Jan as a student; believe in yourself, that makes me able to keep going and be energized follow your heart, and focus on where you can about the future.? make a difference.
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