Time flies in the life sciences – and nowhere more so than at BIO-Europe with its whirlwind of blind date partnering sessions complemented by exotic national and regional pavilions, giveaway laden supplier stalls and increasingly provocative sessions.
Am I going a bit too far? Well, BIO-Europe itself has certainly come a fair distance – “We’re celebrating 25 years since we started with just 80 delegates in Hannover when the talk was all about small molecules and partnering was arranged via post-it notes!” EBD Founder and Managing Director, Pam Putz reminded us in the opening session in Hamburg.
This year set new records with 4,400 delegates from 61 countries holding a scarcely believable 27,400 meetings. You could then probably at least double the number of interactions if you add on exhibit visits and networking discussions. Thus my overriding impression was that what was started as a Baby Bio has really come of age.
Conference organizers always have a delicate balancing act to play matching the needs of delegates and sponsors. How to ensure for example that exhibitors get footfall, partnering meetings are productive and the program is interesting. In this respect BIO-Europe seems on the cusp – most of the delegates I met managed to do all three, but it was a struggle mainly due to the sheer number of partnering requests received – up to 30 in some cases. To lose this would be a shame. Starting with the program – see the Top 10 sidebar (below) – the opening plenary alone gave me enough food for thought to last at least through till BIO-Europe Spring in Paris in March.
A bolt-on de-risked M&A approach
To take just a few nuggets, David Thomas of BIO started by warning the industry not to be complacent. In the US, investors are clearly holding back with the Biotech Index down 14%. This could be due to the political climate says Thomas: “We’re hearing policy makers saying “We’re fine with less innovation, we’re fine with less medicines for patients, as long as prices come down.””
However, he went on to note that deals are continuing, predicting they would end close to where they were last year. R&D-stage out-licensing deals are running at 126 at the start of November compared to 160 in 2018. “We are also seeing a pick-up in clinical-stage deals, with up-front payments – already running at $11.9 billion – set to create a new record.”
Finally, Thomas noted a much bigger emphasis on acquisitions of newly emerged companies with regulatory approval and less than $1 billion in sales – such as Novartis and Spark, Pfizer and Array Biopharma, and Eli Lilly of Loxo Oncology. Most interesting was that big pharma easily has sufficient buying power if they want to continue this bolt-on de-risked M&A approach – the top 22 have $200 billion in cash and the 48 potential targets Thomas has identified would cost “only” $100 billion.
The real transformation
Mike Ward’s Top Ten provided the perfect warm-up for the opening panel discussion chaired by Kate Bingham of Schroeders. Points that particularly resonated for me were Fredrich von Bohlen of Molecular Health GmbH predicting that the challenge of digital technologies and encroachment of Google and Amazon means that the sector will need to “inhale” precision medicine. “Roche to me were the forerunner 25 years ago. But the future will involve an increasingly dense analysis of individuals’ health and disease data and new and as yet unknown models of data sharing and monetization to incentivize individuals to share their information. Computing is essential to that transformation to a truly preventive vision of healthcare, but it is not the main driver. I think the real transformation is biology.”
“I think the real transformation is biology”
Jane Osbourn, chair of the UK’s BIA agreed, adding that studying the transformation from a person’s healthy to disease state will be crucial: “The UK’s Biobank has had initial success in this area and the missing part of jigsaw is now to engage earlier with wellperps (her term) and gather data earlier.”
Finally, in a neat full circle to Pam’s opening remark, Paul Stoffels of J&J stressed that it was not all about biologics and since access to them was currently restricted to only the richest societies, the industry also must retain small molecules and stay relevant for the world.
Despite my best efforts, I only managed a couple of other therapeutic area sessions, but can confirm they were equally challenging. Overall, I hope BIO-Europe continues to invest in the program – that industry publications such as Biocentury, Scrip, Bioworld, Fierce and others continue to flourish is a sure sign that there is an appetite for informed comment and analysis. Good panels, fireside chats and keynotes at conferences provide the perfect complement. Furthermore, compared to other industries I’ve worked in, we do have a wealth of people prepared to share their experience and insights honestly and modestly.
I also believe exhibits play an important role. Walking the halls, I got a real feel for the global nature of biotech and opportunities on offer – from new precision medicine players close to home such as Lithuania to the growing attraction of Australia for clinical trials from the increasing influence of Asia to the continued attraction of the US. Lithuania is starting to reap the benefits of a concerted promotional drive over the last five years, according to Monika Glinskyte. “We have had to explain the backstory of why Lithuania, referring back to the Soviet heritage of biotech and medtech research, but now have a strong group of international companies such as ThermoFisher, Hollister, Teva and MOOG to complement our research base. This in turn has already led to a flourishing crop of eight start-ups. Now we believe we are on the global biotech map and being here has been integral to that success.”
Australia was represented by a State of Victoria booth because as assistant trade and investment manager Ellen Walsh explains Melbourne is a major life sciences hub with over seven universities including Monash.
“The key attraction we believe is how easy it is do clinical trials – on average three months with no review to set up and coming some 60% cheaper than US at current dollar rate. We’ve been getting customers from all over – the US, Korea, Europe, India – and the trend has continued here.”
Korea has long been a feature at European biotech conferences and now according to BioKorea project manager Merian KJ Kim, there is a renewed effort from the government to grow the sector (including medtech) to be 6% of economy by 2030. “We find that with our focus on Europe, all players at the conference. So we come in force – 28 companies + 50 delegates.”
It was also good to see the US not being complacent. The first BIO-Europe came from an initiative by Morrie Ruffin then at BIO bringing over a delegation of 20 US companies. The North Carolina Biotechnology Center were among several organisations who see Bio-Europe as more important than ever.
“It’s an increasingly competitive and global sector,” said VP Robin Deades. “We believe we have strong advantages – quality of life, an established hub of 700 companies employing 64,000 and featuring start-ups to large corporations such as Merck, Novo, Grifols and Pfizer. We attract a large amount of NIH funding to our universities including Duke and North Carolina. And we are involved in new areas such as precision medicine with Locus Biosciences and their CRISPR therapeutics. But we have to get out and tell people, so BIO-Europe is a must.”
Finally, what about the quality of partnering. Over the three days I ran into several Nordic companies who are longstanding BIO-Europe fans including Sprint, Follicum and Bioinvent. However, the best measure came from a chance meeting with a first-time start-up attendee.
“I was amazed to be asked for 20 meetings with leading pharma and biotech companies and have already signed several CDAs as a result”
Dr Oommen Varghese is CSO of RNAi therapeutics company Uppsala Therapeutics and was delighted with the results: “This is the first time I have attended such a meeting and had little time to prepare being so busy in the lab. However, I was amazed to be asked for 20 meetings with leading pharma and biotech companies and have already signed several CDAs as a result.”
I’ve always been a strong advocate of BIO, but revisiting BIO-Europe after a few years, I am now convinced it should be on every budding Nordic biotech’s agenda. And I firmly believe the Nordics should be on the list of potential venues.
“We were delighted with the success of Copenhagen last year,” says Putz. “We would love to return to the region and Stockholm is definitely on our radar.”
Biotech’s Top Ten
Mike Ward has established himself as one of the most astute and colorful commenters on the life science sector and to celebrate BIO-Europe’s 25th came up with this Top of The Pops list of key drivers. See if you agree – and can think of an appropriate Abba/Cardigans/A-ha, Roxette tune for each!
Sequencing of human and other genomes
Underpinned by increasingly efficient gene sequencing technologies and advances in ‘omics capabilities, industry now has a growing understanding of underlying genetic links and biological pathways associated with diseases. The recent discovery and development of gene-editing techniques is expected to further enhance industry’s ability to improve human health.
Policy & Regulatory initiatives supporting development of innovative medicines
Initiatives established by governments and regulatory agencies have had a major role in nurturing the development of biotech. Introduction of orphan drug policies supported the development of drugs to treat rare diseases; increased spending in basic science has underpinned advances in core biosciences and drug discovery; introduction of increasingly pragmatic regulatory processes such as breakthrough medicines and adaptive clinical trials is having an impact on both the economics of drug R&D and the delivery of innovative medicines to patients.
Value-based pricing initiatives
Healthcare spending accounts for an increasingly large proportion of global GDP. To ensure that patients get access to the best medicines, all stakeholders – healthcare payers and pharma companies alike – are having to be more creative in developing sustainable and affordable reimbursement models. This is allowing patients to get access to medicines that are both efficacious and cost-effective.
Shift in medicine focus from treatment to cure… to prevention?
Better understanding of the underlying biology of diseases and disorders has catalysed a shift from symptomatic treatment towards cures and potentially preventative options. Moreover, in the past two and a half decades a number of killer acute diseases, such as HIV and some cancers, have been changed to more chronic conditions, while others are now curable. While early efforts in gene therapy in the mid-1990s fell on stony ground, advances in recent years heralds a new treatment paradigm for some diseases.
Biologics underpin best-selling drugs
Twenty five years ago, the world’s best selling drug was the proton pump inhibitor Prilosec omeprazole with sales of just over $4bn. Therapeutic monoclonal antibodies, which back them were still an aspiration, now dominate the best sellers list – with 8 of the top ten being Mabs, led by Humira adalimumab at $20bn. Many of the early blockbusters are now going off patent, so opening the door for more affordable biosimilar options.
Opportunities and challenges of precision medicines
Advances in understanding the genetic basis of diseases has underpinned the identification of biomarkers, patient stratification for clinical trials and treatments, and the development of precision medicines leading to the delivery of the right treatment, to the right patient at the right time.
Transformational nature of computing power
Use of “omics” technologies and large sample sizes have generated massive amounts of data sets, a wealth of information for different diseases and their links to intrinsic biology, which have driven the development of sophisticated computational and statistical methods for their analysis. Healthcare applications of AI and machine learning are attracting both VC and corporate investments with earliest results in imaging with drug discovery and development opportunities on the rise.
Globalization of biotech industry
In the mid-1990s, the US accounted for approximately two thirds of the global biotech industry, with Europe being home to about 25% the total. Today, the US share of the global biotech community is just under 50%, Europe now accounts for 28%, with the Asia-Pacific growing to 18%. Ambitious companies now need to have a truly global view when looking to access innovation. The fact that 2300 biotech companies from 61 different nations are attending this meeting is testament to that.
Investor willingness to put more money to work
In its early days, biotech was funded almost exclusively by specialist venture capitalists, mostly based on the US West coast. In the past two and a half decades, the availability of funding has grown dramatically both geographically and from new sources including corporate venture arms, mutual funds, and charitable organizations. In 1995, the global biotech industry raised $Xbn. In 2018, the industry raised $XXbn.
Evolution of partnering strategies & biotech business models
Big pharma started to look outside its own R&D for innovation in the 1990s and imported innovation from biotechs; that initial outreach has now been extended to include other stakeholders such as academic organizations, manufacturing and formulation businesses, data-handling companies, clinical trials experts and patient advocacy groups.