Pharmaceutical Training HealthAs Dr Kevin Robinson compiles the post-event media coverage, it seems that, once again, Pharma Integrates was challenging, lively and full of debate

At the 2016 Pharma Integrates conference, wrote Michela McMullan, PhD, GlobalData’s analyst covering cardiovascular and metabolic disorders, industry leaders across the UK and Europe gathered to take part in interactive discussions surrounding key topics on the challenges and opportunities faced by the industry today. The evolution of the pharmaceutical ecosystem was a key topic at the conference, highlighting the complexity of dynamic innovation by trying to connect and satisfy all stakeholders in this network, including pharma, physicians, patients, payers, regulators, investors and many more.

“The optimistic slogan, bringing medicine to life, was echoed throughout this year’s conference; but, in reality, the pharmaceutical ecosystem model requires extensive work to bring drugs to market both faster and more efficiently, and at affordable prices for all patients. Industry leaders who spoke at the conference do not believe that there is any one business model that will achieve this goal for Big Pharma,” she noted.

With an impressive line-up of more than 70 speakers, senior level delegates from every part of the pharmaceutical industry and an incisive agenda of debate-led content, Pharma Integrates 2016 offered a packed programme of breakthrough thought leadership that challenged established paradigms and put new operational models for pharmaceutical production up for discussion. “The pharmaceutical industry is a sector of strategic importance, standing on the threshold of innovation,” said Mike Thompson, Chief Executive, ABPI, as he welcomed 350 delegates to the event. Panellists and delegates tackled issues such as the rise of precision medicine, disruptive thinking in pharmaceutical regulation, achieving patient compliance, future pharmaceutical supply chains and more during 2 days of deliberation and insight.

Setting the stage, Prof. Trevor Jones, CBE, member of the board of eTherapeutics and Chairman of Simbec Orion Research, observed: “Involving the patient at every stage of the drug discovery and development process is critical to the future of the pharmaceutical industry.” Putting the patient first was a recurring theme during the content-packed 2-day event in London, UK, with many stakeholders offering different visions about what patient centricity actually means.

Pfizer’s Bev Nicol suggested that Big Pharma needs to supply patients with what they want and need, and actually ask them what they think. Another delegate opined that industry should think about patients as real human beings and assess how their products and services fit into how people live and work. Targeting the condition is paramount, added a panellist, but we must also address the symptoms that matter to the patient.

AstraZeneca’s Andy Jones advised the capacity crowd to “Follow the science,” saying that “It will show you the path to market.” Although not universally supported as a business concept, the theme became a mantra. “We need to redefine the role of the clinician and the patient to identify and address unmet medical needs,” added Lonza’s Jesus Zurdo, and Gary Acton of Pirates of Oncology went even further: “It’s time for a complete deconstruction and revision of pharma’s regulatory framework,” he stated.

Jones agreed, saying “Pharma R&D is too compartmentalized. We need to identify the unmet medical need and work towards it.” Furthermore, Martin Lush, President, NSF Health Sciences, Pharma Biotech Consulting, advised the audience that “Unless we simplify, we won’t see the next punch coming!”

Professor Guido RasiEMA in the Spotlight
In the newly introduced one-on-one interviews, Prof. Guido Rasi, Executive Director, European Medicines Agency (EMA), was quick to dismiss the possibility of a common EU pricing policy and reiterated that EMA has no role at all in drug pricing. He also stated that a post-Brexit move for EMA’s headquarters was not a foregone conclusion and expressed concern about disruption and the loss of experts pending a departure from London.

“The head of Europe’s drugs regulator is braced for disruption following Britain’s vote to leave the European Union (EU) and said he feared losing expert staff if, as widely expected, the regulator is forced to decamp from London,” reported Reuters. The EMA approves treatments for all EU countries from its headquarters among global banks in London’s Canary Wharf. It’s the largest EU body in Britain.

“My concern is that we’ll lose experts, lose staff,” said Rasi. Most industry watchers believe Britain’s decision to leave the EU will mean Europe’s equivalent of the US Food and Drug Administration is forced to move to a city within the Union, although there has been no official announcement on this, noted Reuters. Countries including Spain, France, Poland, Italy, Sweden, Denmark and Ireland have already offered to host EMA, instead of Britain, and the tussle regarding its future location is expected to form part of some complex political horse-trading.

“I’m flattered that so many different nations want us, but my concern is workability,” Rasi told the Pharma Integrates. “EMA employs nearly 900 people and, as the agency has been based here for the past two decades, many of them have made a long-term home in London,” he said. Losing Britain could also leave a big hole in the EMA’s scientific capability, as British experts are among the biggest contributors to its drug assessment system. Rasi said the EMA had set up a task force to address the challenges arising following the Brexit vote, but noted that the decision on if and when the agency would move was up to European politicians, Reuters concluded.

When Sir John Bell, Regius Professor of Medicine, University of Oxford, was in the hot seat, he commented: “We have the best science base in EU, but we need to maintain a good talent flow and embrace disruption. The UK pharma industry has added 9 years to male life expectancy and 8 years to females in the last 30 years, he added. He also acknowledged that “the data revolution is real,” but admitted that the next big challenge will be managing patient information in the context of Big Pharma, security, trust and confidentiality.

Professor Trevor Jones CBE

Professor Trevor Jones CBE

Focus on the patient
Under the overarching theme of Shaping Pharma’s Future, Martin Price, Janssen, said: “We should be rewarded for the health outcomes we deliver, not the packages we sell.” Andy Jones, agreed, adding: “Pharma should be paid on outcomes and not volume … and that change is coming. The pharmaceutical industry needs to rediscover its ethical core.” Richard Seabrook of The Wellcome Trust confirmed that “Outcomes-based drugs are the way forward, but more work needs to be done.”

If there was a single take-home message from the event, it was partnership. Trevor Jones said that it’s not part of our past, but it has to be part of our future. And, throughout the sessions, collaboration was proposed as the new pharma business model. Can it be done? Can pharma escape its own silos? As one observer noted: “Collaboration often feels like hot air when examples and substance are hard to prove.” In theory, a well co-ordinated supply chain collaboration cuts out time and, ultimately, benefits the patient. So, the importance of strategic partnerships between the sponsor, vendor and everyone else in the supply chain is essential.

The problem with true collaboration is that it requires transparency, openness and trust. “The sector is so worried about confidentiality and IP protection that it’s stifling creativity, collaboration and innovation,” quoted a source: “Unless pharma can work this out, it will forever be talking the talk about great collaboration … but with the shackles firmly on.”

“People think Big Pharma is out to steal IP. In fact, collaboration is key to kick-starting R&D,” Andy Jones added: “How we combine data sets will be fundamental to R&D progress.” Terminology can often cloud thinking, offered Chas Bountra, Chief Scientist (SGC) and Professor of Translational Medicine, University of Oxford, stating: “The future of pharma R&D is data driven. We should use global academia to crowd source R&D &and derisk drug development … and share everything!” Furthermore, patient and charity voices are not being leveraged effectively enough, even in the pre-competitive space, the panelists agreed. The road to high performance R&D is to share and collaborate bravely, be optimistic and realise just how far we’ve actually come, concluded Duncan McHale of UCB Pharma.

According to his blog, Raman Sehgal of Ramarketing & PR Ltd, noted: “The most positive theme that came out of this year’s Pharma Integrates was the focus on the end user, the patient, which I have never seen to be so prominent before.” Instead of centring on ‘what we can do’ as researchers, manufacturers and suppliers etc., the debate was all about what the patient needs. “This shift in focus can only be a good thing for the sector as a whole,” observed Raman, “which ultimately exists — in my view — to make people healthier.”

It also ties in nicely with the evolution of precision and personalised medicine, which is an untapped niche for the pharmaceutical and biotechnology firms that will hugely benefit small patient populations with rare diseases that have otherwise been overlooked in the past as they didn’t — in reality — make economic sense to target. “I learnt that there are 7000 rare diseases and only 400 orphan drugs, so if there was ever an incentive, this is it. Medicine is no different to other products in that it’s all about satisfying the needs of the patient. It’s as simple as that,” he concluded.

Pharma Integrates 2017 will take place on 15–16 November in London, UK.