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Novo Nordisk’s Klaus Henning Jensen on trends in medical affairs

PMLiVE speaks to the head of clinical, medical and regulatory for Novo in the UK and Ireland

It's more than six years since the global financial crisis hit, but the austerity measures that followed in its wake continue to challenge all of Europe when it comes to healthcare spending.

For those at the sharp end of this within pharma there is a sense of not so much a transient crisis, but a shifting market reality that has to be dealt with by an ever-greater number of departments.

One of the functions evolving to address the impact of tighter budgets and greater scrutiny from health technology assessment (HTA) bodies is medical affairs.

“It goes without saying that health technology assessments have been on the rise for a long time,” explains Novo Nordisk's head of clinical, medical and regulatory for the UK & Ireland Klaus Henning Jensen. “They have become very important in very many markets and the HTAs, and especially those who live close to the government or other reimbursement bodies, are the strongest stakeholder we have in pharma today.

“I see a clear trend for medical affairs, where I'm coming from, to work much more closely according to this new set of stakeholders. Of course, the world is changing and we have to change the function accordingly. Industry-wide we see a general slowing of access for any new innovative premium product - products are having to drag themselves through mud to get there, whereas previously you would come flying out.”

It's a change to which Jensen brings a global perspective, having moved from Novo's headquarters to the Danish firm's UK affiliate in January. He says market requirements have broadened the focus of medical affairs from just making sure specialists understood the science behind a product. “Now we have to focus much more on the market side of things - medical affairs needs to align more to the new state we have. I think the UK - with its very strong devolution of the healthcare system - is a good example of how that's developed very fast.”

With the onus on pharma to lower its prices or receive less access to new, expensive drugs, global strategies have to be made fit for local application. “Our global development programmes are designed primarily to ensure that we get regulatory access. That means, of course, that the process tends to be clear in terms of what the authorities need, and when they need it by.” The same cannot be said, Jensen says, of health technology assessment bodies like NICE, whose requirements are harder to predict on anything like the same kind of long-term basis.

“When it comes to all the access challenges and restrictions, we may not know what NICE or Wales' AWMSG or the SMC in Scotland will want five years from now,” says Jensen. “So we need to look much more ahead and we need to fit that into the global development programmes.

A call for closer collaboration

When it comes to working with HTA bodies, a more productive model, Jensen says, would be something closer to that followed by the EMA's scientific advisors in the CHMP, which takes a more collaborative approach in terms of discussing data. “You get a good opportunity to have a dialogue and explain the data - and I assure you, the CHMP will not approve anything that is not safe, but they do collaborate with you because they recognise the complexities of these drugs.”

But that level of collaboration is difficult to have with the UK's multiple HTA bodies and numerous NHS decision-makers, such as those at the local Clinical Commissioning Group level. Their timelines are also far more squeezed than on a European level - leading them to take what many in pharma might argue is a simplified view of a large amount of available data.

novo nordisk klaus henning jensen 

Klaus Henning Jensen has served at Novo Nordisk since 2005

“I would love to have a strong collaboration with them, both in advance in terms of figuring out what kind of data are they expecting to see and also in terms of their ways of evaluating the data,” says Jensen, who sympathises with the size of the task for HTA bodies. “The fact is that we are talking about huge data sets, and they have to go in and maybe review a whole therapy area where they compare the different drugs in that therapy area. So that task is also huge, and that has to be recognised.”

He adds: “Additional dialogue as a company with these bodies along the way might help smooth that process to make sure there are no misunderstandings.”

Innovating healthcare

It is an issue that must be frustrating at times, given the perspective Jensen's role leading Novo's UK clinical, medical and regulatory functions affords him. The job - “a huge opportunity”, he notes, given the UK's importance to Novo - sees him work with colleagues in clinical, regulatory, medical, safety, customer care and medical information functions.

In terms of how he came to this role it's a journey that encompasses a spell in clinical practice at a Danish hospital, an entrepreneurial diversion and then a move to pharma and a series of global roles.

Jensen started out as a doctor in Bispebjerg hospital - a large teaching hospital that's part of Copenhagen University Hospital, but found himself torn about his future direction. “I didn't know whether I wanted to do orthopaedics, which I found extremely fun, or whether I wanted to do internal medicine which I found scientifically stimulating. You can say one is a craft and the other thing is a science. I love both elements, so I decided something completely different.”

When you work for a pharma company you can improve patients' lives on a much wider scale than you were able to do in clinical practice

The impetus for that decision came when Jensen and a colleague were operating on an old lady with a broken hip and both noticed the poor state of the hip screws they had at their disposal. These were often not strong enough for the job, with the result that further, more extensive surgery would be needed later on. The two doctors had an idea for a new type of hip screw and, collaborating with Copenhagen University and winning venture capitalist backing, the pair started work on their product.

Ultimately the company's patent strategy would not prove robust enough, but Jensen's experience as the start-up's CEO sparked a desire to learn more about product development. He was able to channel that interest when an opening came up in 2005 in medical devices as an international medical adviser at Novo Nordisk, where he has been ever since.

“I saw joining the industry as an exciting opportunity. When you work as a doctor you can do a lot for the patient you're seeing right now, and also the other patients that you will be seeing, one by one. But when you work for a pharmaceutical company, then suddenly you can actually do a lot for a lot of patients at the same time. You can improve their lives on a much wider scale than you were able to help in clinical practice. That was attractive to me.”

An exciting time

It was in many ways a fortuitous decision. Devices are a vital part of Novo's injectable product portfolio and it's an area that has seen sustained innovation. It's also, unsurprisingly, an area where the company looks to carve out a competitive advantage over its rivals.

“Even the needles are important,” Jensen explains, “because you want to have a needle where it doesn't hurt when you inject. The needles we have available today, due to the continuous innovation from both Novo Nordisk and other companies, they are so damn thin that people actually don't feel them in the majority of injections.”

“I loved that job. I was offered on several occasions to come and work with drug products, devices may be seen a little bit as a support product to a real product, but I loved working with devices.”

It was also an area that afforded Jensen his first leadership experience when a position as the director for the area came up. He brushes aside any notion of challenges in that role, saying: “It's the same kind of thing that any manager faces when you suddenly don't only have to perform for yourself, but you have to move your previous strong performance to performing through the people you manage.”

But he does note, wryly given his own medical background: “Managing medical doctors who are trained to be extremely independent in their views and independent in their work is interesting, because you have people who are extremely highly educated and very independent in their mindset and opinions.”

Novo Nordisk Victoza liraglutide diabetes

Novo Nordisk's Victoza (liraglutide) is a GLP-1 receptor agonist

It was around this time that Novo began gearing up for launch of its future blockbuster diabetes treatment Victoza (liraglutide), a product deemed so important for Novo that entire functions - such as Jensen's area of medical affairs - were restructured in preparation for the GLP-1 receptor agonist's arrival on the market.

“The launch of Victoza has been the most exciting ride so far at this company in terms of the amount of energy and what we did there.” But there is a huge amount of drive at company about the products it has coming through to expand the base created by Victoza - and there will be more about those products and the therapy area in next month's PME when we take a closer look at diabetes.

Article by
Dominic tyer

is editorial director at PMGroup

4th November 2014

From: Research, Sales, Regulatory



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