Pharma sector needs better data infrastructure, experts say
The pharmaceutical industry needs a centralised data platform so companies can share data easily, a panel of experts has advised.
This was one of the topics discussed at a virtual roundtable by The Pistoia Alliance, a global, not-for-profit alliance that works to lower barriers to innovation in life science and healthcare research and development.
Leaders from pharma giants including Gilead and Roche were among the attendees at the event, which focused on learnings to date from the COVID-19 pandemic. The panel highlighted the power of collaboration in an emergency and called for continued co-operation post-pandemic.
Attendees heard a call to action from the president of the Alliance, Dr. Steve Arlington, on the need for more companies to invest in and build on the work of the pharma and life sciences world so far. Participants discussed their increased willingness to share data among companies but drew attention to the need for a better collaboration infrastructure to make widespread data-sharing a reality.
“During COVID-19, collaboration has been the lifeblood of R&D" Dr. Merdad Parsey, Chief Medical Officer at Gilead Sciences said. "From the outset, we’ve been dependent on working together – initially diagnostics in vivo and in vitro could only be done through government laboratories, and we also worked with the I-SPY network, the NIH and WHO to conduct trials.
"We couldn’t have got to where we are now if we didn’t all work together. There is an opportunity for us all to get much better at data sharing and to develop this ethos, because we also need the expertise of those outside the industry to advance the causes we are working on right now and in the future.”
Several of the panel members agreed that getting data ‘back’ from partners due to a lack of infrastructure had been a challenge. There was also consensus on the need to remove barriers to sharing information outside of the pharma ecosystem – for example to encourage data sharing between pharma companies and those in chemicals, technology, manufacturing, and supply chain, amongst others.
This was underlined by the discussion between the panel that all nations have faced huge challenges pulling together the various moving parts needed to get national testing programs up to speed.
Participants also referenced the long-term impact that COVID-19 is set to have by discussing its influence on plans for the “next pandemic” that are currently being made.
“2020 has been a hugely challenging year for all of our members, but I’ve been blown away by the outstanding efforts to help humanity overcome the COVID-19 crisis" Dr Arlington added.
"Between our members and beyond, the fruits of collaborative projects have underlined the very reason behind the founding of the Alliance. We now need to bring other industries into the fold and be willing to work with those outside of our immediate circle, as well as create a long-term infrastructure for sharing data.
"Though it’s an unprecedented time, we need to carry this momentum forward and ensure this collaborative instinct continues post-pandemic. We also need governments around the world to lead the charge; the importance of following the science remains paramount but a spirit of openness is required that allows us all to work together to understand the real reasons why we take a certain path and avoid the trap of politically motivated actions being blamed on science.”
Digital technologies will be key to further breakthroughs and particularly important to help overcome the limitations caused by social distancing. The Pistoia Alliance launched a collaborative project this summer to explore technology for collecting data during clinical trials.
The panel discussed how other digital technologies that can be applied during COVID-19 must also be investigated. Data collection and symptom monitoring will be critical to efforts to treat COVID-19 they said, particularly as the virus isn't fully understood yet.
The future of pharma: personalised healthcare
Ever since the very first healthcare systems were created, the earliest documented being in ancient Egypt, medical professionals have had a reactionary approach to finding cures for ailments. That is to say that a solution is sought after someone has become sick, using whatever methods were thought to work at the time. Thousands of years later, with advances in genomics and molecular modelling, emphasis is starting to shift towards preventative, personalised healthcare rather than "sick care".
This move is led by data analytics as well as genetic sequencing to inform decision-making, which can ultimately lead to more individualised care. "Identifying the right data will support personalised health outcomes", explains Chris Easton, who is Takeda’s Senior Director and Global Commercial Lead, specialising in personalised health and innovation and applying this to rare blood disorders. "It's about how we can empower patients, interpret data and then apply it."
"The historic pharma model, in a very simplified form, is: a patient has symptoms, gets diagnosed, and gets given drugs for symptoms", Easton says. "Now, with holistic patient care in mind, it's much more about the additional components to care that would make a difference. Yes, drug therapy is one of them, but likewise, it's okay to talk about mental health, as the impact of chronic diseases means often there is a mental health challenge. So what can we do to build a mental health and physical health support package, both of which have data associated with them, that we can use together?"
By way of example, Easton cites the approach taken by elite athletes and astronauts. "Their model is to keep as healthy as possible. If someone on a space mission gets a cold, they're off the mission - it's not affordable to send someone to space that might have a health issue. If you look at footballers and runners, their coaches maintain them at the highest level, and they're using technology and wearables to help monitor their health so that they can make adjustments to stay at peak level for as long as possible."
The aim is to provide a complete, holistic package of care, which Easton acknowledges will pose some challenges to the pharmaceutical sector. "Our model is not necessarily that of a total care package. It's drug therapy or device and technology support therapy. So some things will need to evolve, and that's part of what my role is about."
One way of effecting this change is by collaborating with other organisations, not necessarily limited to healthcare and life sciences. "I'm a big advocate of partnerships and joint ventures. For the pharma sector, these are traditionally through universities and research houses, but I think we need to be willing to look outside the box and look for scalable and transferable technology that is used in everyday life."
"An example is the smartphone you probably have sitting on your desk or the smartwatch you're wearing. These are gathering data all the time. There are probably hundreds of data points that we could use, just from our everyday technology", Easton adds.
While apps like Apple Health, Google Health, and devices like Fitbit collect data, they could be linked to WhatsApp, WeChat or Telegraph to connect to members of a user's care team if a health issue arises. "It's using technology that is already embedded in our lives, that would enable us to share information and photographs. For example, if your knee is swelling and you want to ask a doctor for their opinion, you can send an image, then share the log from your treatment, and it becomes a way of integrating and sharing information."
Shifting towards preventative medicine is one of Takeda's strategic goals for the next few years. An example of how this could work is how people affected by Von Willebrand disease could be supported. This lifelong bleeding disorder prevents blood from clotting and particularly affects girls and women, causing menstrual bleeding to be excessively long and heavy, which has a big impact on their quality of life.
"It's a hereditary disorder, so many women in a family can be affected, but it's hard to diagnose", Easton explains. However, using existing technology that tracks the menstrual cycle via a smartphone perhaps an alert can be issued to let the user know when it's time to start taking replacement therapy for Von Willebrand.
"This means that by the time a period begins, Von Willebrand levels are normalised, and menstrual flow goes down to normal levels. That's actually a massive outcome for someone who has been living with two-week-long periods that bleed through clothing every month. Suddenly for just four or five days, they can use regular tampons and pads. That's a huge improvement to life."
The field of rare blood disorders typically hasn't seen the same amount of attention focused on it - at least in terms of tech innovation - as other chronic illnesses like diabetes. "Rare blood disorders are difficult to show returns on because you've got small patient numbers and often high costs. But if we think about the total patient journey, we could use technology to triage vast numbers of patients and data into more specific diagnosis boxes, so that what is then presented to physicians are smaller groups, of the more likely issues."
Data analysis could, for instance, show that the combination of headaches, nausea and lethargy equates to a specific type of bleeding disorder. "You can start to put these things in categories", Easton says. "And then you're able to do differential diagnosis. But ultimately, what you're trying to do is get a faster, more accurate diagnosis, leading to a specific therapy."
This would be more efficient than administering plasma-based treatments, for example. "A lot of bleeding disorders are caused by a deficiency of something", Easton explains. "There is a lot of combination therapy in blood disorders when you give people plasma-based products because plasma is like the golden chalice of medicine. It has a bit of everything you need. In some cases, when you don't know what the disorder is, this can help patients, but it's not the most precise way of doing it."
"That's one of the ways having very clear diagnostic support linked to advanced direct therapy can help, only treating what you need to. From a payer's perspective, it's very targeted, and there's no wasting money and resources on patients being hospitalised for things that are not necessary."
"If you go back 15-20 years, market access to the pharmaceutical industry was the emerging trend", Easton adds. "We saw all these diagrams of physician decision-making coming down and payer decision-making going up. Now we have another divergence of change, which is the application of technology to support personalised care. This is one of the transformative pieces of pharma right now, and there are a lot of good companies, big and small, being very intelligent about how they're approaching it and investing in those spaces. There's definitely a community building."