May 17, 2020

Novartis Social Business: Blending profit with purpose

antibiotics
Novartis
Innovation
antibiotics
Catherine Sturman
7 min
purpose
Bacterial infections remain a leading cause of death in children five years and under. Following a call from the World Health Organization (WHO) to deve...

Bacterial infections remain a leading cause of death in children five years and under. Following a call from the World Health Organization (WHO) to develop affordable and improved formulations for young children which are also heat-stable, Novartis’ generic division, Sandoz, has led the way in developing essential treatments on a global scale.

With a mission to cure, discover, develop and successfully market innovative products to prevent and cure diseases, its division, Novartis Social Business (NSB) has combined its social and business aspirations to drive both profit and purpose.

“This sounds like how businesses should be run but in fact aren't,” explains Dr Harald Nusser, Head of NSB. “That's what makes NSB special. Usually, investments are evaluated on a discounted cash flow financial analysis, but we will put equal weight also on a monetisation of societal returns. We want to monetise our societal impact, so that we can make investment decisions based with equal weight, both on social return and financial return.”

One of the largest generic antibiotics’ manufacturers worldwide, its Sandoz division works to ensure supply availability, but strives to utilise adaptive research and development (R&D) tools to make sure that adults, children and the most vulnerable are able to access proper medicines. This Dr Nusser states, is vital to support those in tropical conditions.

“It’s not only about substance, but whether it will remain stable. Oftentimes children are almost a different species in relation to drug development. It requires us to have a more thoughtful evaluation of what they really need and require, particularly in countries where we are responsible.”

Through a recent, non-financial collaboration with the Global Antibiotic Research & Development Partnership (GARDP), NSB has worked to develop a dispersible tablet formulation of what is the most impactful antibiotics currently in the pipeline. Beyond this, the company is brainstorming with GARDP and is looking at ways to increase paediatric development for deadly diseases such as sepsis. Most importantly, the partnership focuses on sharing knowledge, information and gaining insights on improving generic antibiotic formulations for children.

Although paediatric clinical trials remain limited, presenting significant challenges, NSB’s adaptive R&D approach within Sandoz has allowed the business to anticipate demand and gain a further understanding of where to add supplies and develop further applications.

“We have a certain strength in Sandoz to develop new formulations. For example, we underwent a specific development of Amoxicillin as a dispersible tablet with interest from UNICEF. Based on this positive experience we decided to do this for other medicines as well,” says Dr Nusser.

Not only facing challenges within paediatric drug development, the pharmaceutical industry is tackling the rise of antimicrobial resistance as a result of the increased use of over the counter (OTC) drugs to treat common ailments, such as coughs and colds worldwide. Resistance to common antibiotics is becoming a significant public health issue, leading Novartis to develop its stewardship programmes which work to educate the public on how to use antibiotics responsibly.

“We also work with big institutions and governments on the ground to make sure that we truly live our responsibility beyond just the commercial access of commodities and medicine,” says Dr Nusser.

Following the success of its community-led malaria initiative in India over a decade ago, which has since spread to Vietnam and Kenya, Novartis has launched its more recent programme, Novartis Access, to address noncommunicable diseases (NCDs) for those in low and low-middle income countries. The initiative has also been developed to also look at the company’s NGO supply capabilities, as it continues to sell essential medicines to international institutions, such as the WHO, The United Nations Children's Fund and more.

“Our role in going beyond what is usually expected from a pharma company is saying we need to at least spot opportunities where and how the private sector can engage - what should need to be done and how this could be done going forward,” states Dr Nusser.

Through its aim to improve access to medicine on a global scale, the company has identified three main areas of non-commercial engagement through the initiative. Whilst monetary evaluation, supply chain strengthening and the integrity of distribution chains all remain vital, another area has been developing its awareness and diagnosis capabilities in order to support health practitioners worldwide through essential training. This will enable communities to interpret signs and symptoms in order to seek medical support when required.

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Strengthening its supply chain, particularly for interventions around NCDs which require chronic and steady treatment and availability at local dispensaries has remained vital, where proper forecasting and availability of treatments on a continuous basis has been a key focal point under the initiative.

“What we started almost three years ago in Kenya where we have the first Novartis Access product, is the establishment of Management Scientists for our supply chains. This focuses not only on the first level customer, but second level customers as well. For example, faith-based hospitals are also public pharmacies.

“There was no proper implementation of first in, first out products, so they had to risk their products running out of shelf-life. Management Science for Health has developed a close relationship with the government in Kenya, where our results have been conducted together with the government. Based on this, we can improve health and develop jointly.

“I was also confronted with the fact that legally we could also not claim our malaria programme to be a success. Despite the fact that we now know that we have shipped more than 900mn life-saving or potentially life-saving treatments of our antimalarials, the proof individually measured was not there because we never engaged so far into proper and independent monitoring and evaluation,” he says.

“We have changed this with through the use of Novartis Access. Together with Boston University, we have also established a methodology on how to go about monitoring this, which has led to an industry wide commitment via Access accelerators, that at a certain taxonomy for different access to medicine interventions shall be used, which Boston University has also developed.”

Housing a number of different interventions, such as engaging in awareness-building in communities, the company’s products can also be donated or sold at lower prices.

“Oftentimes companies have only focused on measuring input and output parameters. For example, input could be writing a grant of US$2mn with an NGO and then output would be how many trainings have been conducted, yet we and the public would not know the impact and the outcome of those training sessions. Have people really learned something? With that broader taxonomy framework, we have significantly contributed to what Boston University has developed and set a standard for the industry. Right from the beginning, we said that everything we do needs to be public, but the question is with the methodology.”

Through engaging in a number of strategic partnerships, Novartis is acutely aware that as business and consumer needs evolve, so will its relationships. Signing a Memorandum of Understanding (MOU) for one year with GARDP, NSB will continue to have regular meetings, hold internal working groups, enabling both the company and its Sandoz arm to share knowledge and expertise whilst looking at further areas of collaboration to ensure a successful, long-term strategic partnership. It will therefore be imperative for the business to remain willing to learn, while sharing dilemmas and overcoming obstacles which may arise.

Dr Nusser reflects that whilst in the past, the interest of the pharmaceutical industry was not so much on curing people but more on selling treatments – such a paradigm is changing. Novartis’ CART-T 19 cancer programme and subsequent stem cell approach is a further example of this, where the use of data and collaboration will largely increase and reshape the industry.

“There's also another important role to play, and that is to focus on the prevention of diseases and not just treatment or cure,” he says.

“It's particularly vital for NCDs; real lifestyle changes and healthy diets are all essential. The pharma industry with all this knowledge has a role to play and a certain responsibility to be active here as well.

“In Asia and the Middle East, the rise of diabetes, for example, is everywhere. In Pakistan, if the incidents rate doesn’t change, then 30 years from now every second person will have diabetes. We need to join forces, beyond industry and sectors, public and private, to really have an impact.”

Novartis Social Business’ long-term vision to discover, market and most importantly, cure diseases will continue to drive its aim in blending profit with purpose. Making a social impact in Rwanda, Uganda, Cambodia, Nepal and more, the company will work to enter into a lower income strata to further gain increased visibility of an entire spectrum of different commercial needs, pricing and purposes to develop key treatments worldwide cementing its position as one of the most advanced pharmaceutical companies today.

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Jun 10, 2021

The future of pharma: personalised healthcare

#pharma
#personalisedmedicine
#genomics
#diagnostics
6 min
Chris Easton, Global Commercial Lead at Takeda, tells us how the pharmaceutical sector can help deliver more personalised care

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." 

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