Category: Supply Chain

The lack of access to personal protective equipment is an ongoing issue in the U.S., particularly among smaller, non-hospital facilities. But doctor-led PPE collection and distribution groups are tackling the problem head on.

BioNTech may be deeply ensconced in the latter stages of its bid to bring a COVID-19 vaccine to market, but it’s still pushing forward on other fronts, including a partnership with InstaDeep to deploy artificial intelligence and machine learning across its business.

The two companies have been working together in this area since 2019, but BioNTech has opted to double down on the alliance with a revised agreement focusing on new immunotherapies for cancer and infectious diseases.

The headline news in the new agreement is the formation of a joint AI Innovation Lab – split between InstaDeep’s headquarters in London in the UK and BioNTech’s site in Mainz Germany – that will focus on drug discovery and design, protein engineering, manufacturing and supply chain.

One of the main research areas for the new lab will be the development of new vaccines and biologic drugs for the treatment of cancer and prevention and treatment of infectious diseases, including COVID-19.

InstaDeep – which was founded in Tunisia – has built its business across a range of sectors, mainly helping small- and mid-sized companies to develop bespoke apps harnessing computer vision, predictive analytics, 3D imaging, augmented and virtual reality, and deep learning. It was recently nominated by CB Insights as one of the 100 most promising AI start-ups in the world

With BioNTech, the company will focus on three main areas. The duo will apply InstaDeep’s protein design platform – called DeepChain – to engineer new mRNA sequences against protein targets, and also collaborate on sifting through anonymised patient data to identify new drug targets and biomarkers.

They will also use AI and machine learning to find ways to make manufacturing and supply chain processes more efficient, tapping into technologies like robotics and autonomous decision-making algorithms.

“Pairing BioNTech’s deep knowledge of the human immune system and scientific data-driven development approach with our AI platform could transform the way we discover and develop new drug classes for patients all over the world,” said Karim Beguir, InstaDeep’s chief executive.

A recent study by Kearney revealed that 68% of global industry leaders in the healthcare sector see AI and advanced analytics as major value drivers.

All attention at the moment is on BioNTech’s Pfizer-partnered coronavirus vaccine BNT162b, but it has a packed pipeline of earlier-stage projects, including a Roche-partnered mRNA-based drug for melanoma in phase 2 and several other cancer therapies in phase 1.

“We see a significant opportunity at the intersection of AI and immunology by computational design of new precision immunotherapies,” said BioNTech chief executive Ugur Sahin. “This collaboration will expand our digital capabilities and optimise our operations across the value chain.”

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COVID-19 is proving to be the perfect storm in terms of the supply of pharmaceutical products. But learning how to overcome the challenges of 2020 will serve the industry well for years to come. As part of our EU Leader series, Christian Pawlu, head of strategy, portfolio and BD&L at Sandoz, told us about how securing supply in a time of crisis will ensure future access, build resilience, and transform relationships.

Since the start of the year, pharmaceutical companies have been riding a rollercoaster of challenges. Pawlu describes a “perfect storm” as the various strands came together to threaten supply chains.

“First, we saw a doubling or tripling of usual demand for a lot of our products. At the same point, there were big worries about supply chains in China.

“Then, as we went further into the crisis, there were some almost protectionist moves in some countries, as they placed or considered export bans on active pharmaceutical ingredients (API).”

Navigating this rapidly evolving landscape presented a challenge, but not an insurmountable one, Pawlu says.

“The industry, and our company in particular, always has business continuity plans in the drawer. But never in recent history have we had to pull out strategies for so many of our products and subsidiaries at the same time and put them into place.”

Daily calls with supply chain colleagues, activating second sources and alternative supply chains, along with strategic API and finished product stockpiling, all contributed to an absence of any major disruptions.

“For us, the crisis was also a reminder of our purpose as a company: to provide and pioneer access to the patient. We were the first company to commit to keeping prices stable for drugs seen as essential treatments for COVID-related symptoms.

“We made a commitment early on that we would not want to benefit from any shortages. In addition, we have made a commitment to provide 15 drugs to low-income countries at cost.”

Remote pharma

COVID-19 has fundamentally changed the way all sectors work on a day to day basis, but pharma did not have the luxury of time in allowing these changes to bed in.

Within a week, all 100,000 employees at Sandoz and parent company Novartis had transitioned from office to remote working, a process Pawlu describes as relatively “frictionless”.

“The biggest challenge was the interaction with our customers, because we weren’t able to see healthcare providers physically anymore. But, in the end, that turned out to be an opportunity.”

Before the pandemic, Sandoz was able to reach around 15% of its customers digitally, but that has now increased to around 70%.

As people adjusted to connecting digitally, through Zoom, Microsoft Teams, and other video-based software, in their private lives, this expanded into their professional lives, says Pawlu.

“Traditionally, the way we interact with our customers has been a big barrier to conveying messages, particularly in off-patent pharma.”

While using digital channels will not necessarily be easier, it will make companies think differently about how best to interact with healthcare professionals, Pawlu believes.

He says: “The key question we need to ask ourselves is, if we have more access to physicians, how do we want to use it? More reach? More efficiency?

“We are working through this as we speak and are thinking how we complement or even replace the traditional channels, and how we can reach customers we haven’t reached so far. It’s exciting.”

As the industry moves from a face-to-face to digital communication model, it needs a change of mindset, he adds.

“A physical person showing up in a physical office is the old normal.

“As an industry, we will have to be a bit more honest with ourselves. We’ll be much better able to see where we get access, where we have a really deliverable message, and when we elicit a response or an active request for follow up, rather than measuring it by the time people spend with the customer.”

Resilient future

Another change Pawlu hopes is here to stay is the increased communication and collaboration between industry and policy makers.

This is, in part, thanks to a greater appreciation of the importance of resilient supply chains, he says.

“Over the last 30 years, the volume of products produced in Europe versus Asia has flipped. The majority of APIs and an increasing share of FDF is currently being manufactured in Asia,” explains Pawlu, adding that this was driven, particularly in generics, by price.

“I think the balance we need to keep in mind is cost, quality, and resilient supply. You can optimise all three, but you can only maximise two at the same time.

“If you can go for the highest quality and resilient supply, you will have to pay a higher cost, or you do it the other way around – of course we never want to compromise on quality.”

Supply chain issues during the pandemic have brought this argument into sharp focus, and it is now “on the radar” at an international level.

“Sandoz has been in contact with heads of governments across Europe, and I’m extremely happy that this topic has gained so much attention,” he says, adding that the European Commission has committed to developing a continent-wide pharma strategy.

Back in July, Sandoz announced that it had entered a partnership with the Austrian government to keep production of penicillin at the company’s Kundl facility – the last remaining integrated production chain for antibiotics in the western world.

“Austria is something that’s been very visible, but we’re having similar discussions on other product areas with other governments,” Pawlu says.

Ultimately, 2020 has been a challenging time for pharma, but it has also presented a myriad of opportunities to learn and evolve.

For Pawlu, COVID-19 has highlighted how we transform the way the industry works – from manufacturing and supply chains, to sales and detailing – in a way that ensures everyone can access the high quality, affordable medicines they need to live happier, healthier lives.

About the interviewee

Christian Pawlu is the global head, strategy, portfolio and BD&L for Sandoz and a member of the global Sandoz Executive Committee. Christian studied medicine in Germany, Canada and France and is a licenced physician. Before he joined Sandoz, Christian was a start-up entrepreneur.  He was a partner at McKinsey & Company where he specialised in pharmaceuticals and medical products with a focus on generic drug manufacturers. Prior to joining McKinsey, Christian was a neuroscience researcher at the university of Freiburg, Germany. Christian is married to a professor of medicine and they have three children.

About the author

Dr Paul Tunnah founded pharmaphorum in 2009, which combines industry leading publications (www.pharmaphorum.com) with a specialist strategy and content marketing/communications consultancy (www.pharmaphorumconnect.com). He is a recognised author, speaker and industry advisor on content marketing, communications and digital innovation, having worked with many of the world’s leading pharmaceutical companies and the broader ecosystem of healthcare organisations.

In June 2020, he became chief content officer for Healthware Group, a next-generation integrated consulting group that operates at the intersection of the transformation of commercial operations and digital health, offering a unique range of services combining design, strategy, communication and innovation with technology and corporate venturing.

Connect with Dr Tunnah at https://www.linkedin.com/in/paultunnah/ or https://twitter.com/ptunnah

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Supplies of swabs for coronavirus and other critical NHS tests for diseases like cancer, diabetes and heart disease have been threatened by a failure at a facility operated by Roche.

The company said the problems – which also include other items like reagents and screening kits – have resulted from a switch to a new warehouse, which ironically is intended to make production quicker and more efficient through the use of automated processes.

The issues have led to a significant drop in processing capacity that could impact testing for two to three weeks – just as daily cases of coronavirus in the UK are continuing to escalate with more than 14,500 new infections reported yesterday.

Roche is one of the major suppliers of testing equipment for the NHS, with most of its materials for the UK market coming from a single distribution facility in Newhaven, East Sussex.

A BBC report says that at least one NHS trust has advised doctors to ration non-urgent tests and prioritise supply of swabs for coronavirus testing, and there are concerns some essential items could be out of supply within a few days.

North Devon Healthcare NHS Trust says it is expecting a delivery of swabs next week, adding if that doesn’t materialise it will have a big impact on its ability to carry out COVID-19 testing.

In an emailed statement, Roche told us that: “We deeply regret that there has been a delay in the dispatch of some products. We are prioritising the dispatch of [coronavirus diagnostics] and antibody tests and doing everything we can to ensure there is no impact on the supply of these to the NHS.”

The company adds that since then it has “worked around the clock to prioritise and manage orders as well as increase this capacity.”

It goes on: “As well as extending working hours, we have recruited extra staff and, where they can, our dedicated teams on the ground are working with customers to distribute products and minimise service disruption.”

Antibody test order

Roche’s issues affect the supply of swab tests used to detect if someone is currently infected with SARS-CoV-2, but there was better news on the supply of antibody tests that detect whether a person has been exposed to the virus in the past.

This week the UK government signed a contract with Abingdon Health for the supply of a million AbC-19 rapid antibody tests, which use a small drop of blood from a finger-prick and deliver results in 20 minutes without the need for a specialised lab.

The government said the testing kits will be used to “help build a picture of how the virus has spread across the country and further develop our understanding of how antibodies work.”

Antibody testing was trumpeted in March as the UK’s ticket to emerge from lockdown, but that view was soon undermined by the proliferation of tests that didn’t meet regulatory guidelines.

There are three main approved blood tests for COVID-19 in the UK – from Roche, Abbott and Ortho Clinical Diagnostics – but these require a full venous blood sample rather than a fingerpick and have been in limited supply, reserved mainly for healthcare workers.

That hasn’t stopped a myriad of companies from offering fingerprick tests – including claiming to be based on these technologies – directly to the public. against Public Health England (PHE) and Medicines and Healthcare products Regulatory Agency (MHRA) guidance.

Abingdon says its test has undergone an independent evaluation commissioned by the UK government that will be published in full in due course by PHE, after peer review.

The post Roche working “around the clock” to tackle UK test supply problems appeared first on .

Supplies of swabs for coronavirus and other critical NHS tests for diseases like cancer, diabetes and heart disease have been threatened by a failure at a facility operated by Roche.

The company said the problems – which also include other items like reagents and screening kits – have resulted from a switch to a new warehouse, which ironically is intended to make production quicker and more efficient through the use of automated processes.

The issues have led to a significant drop in processing capacity that could impact testing for two to three weeks – just as daily cases of coronavirus in the UK are continuing to escalate with more than 14,500 new infections reported yesterday.

Roche is one of the major suppliers of testing equipment for the NHS, with most of its materials for the UK market coming from a single distribution facility in Newhaven, East Sussex.

A BBC report says that at least one NHS trust has advised doctors to ration non-urgent tests and prioritise supply of swabs for coronavirus testing, and there are concerns some essential items could be out of supply within a few days.

North Devon Healthcare NHS Trust says it is expecting a delivery of swabs next week, adding if that doesn’t materialise it will have a big impact on its ability to carry out COVID-19 testing.

In an emailed statement, Roche told us that: “We deeply regret that there has been a delay in the dispatch of some products. We are prioritising the dispatch of [coronavirus diagnostics] and antibody tests and doing everything we can to ensure there is no impact on the supply of these to the NHS.”

The company adds that since then it has “worked around the clock to prioritise and manage orders as well as increase this capacity.”

It goes on: “As well as extending working hours, we have recruited extra staff and, where they can, our dedicated teams on the ground are working with customers to distribute products and minimise service disruption.”

Antibody test order

Roche’s issues affect the supply of swab tests used to detect if someone is currently infected with SARS-CoV-2, but there was better news on the supply of antibody tests that detect whether a person has been exposed to the virus in the past.

This week the UK government signed a contract with Abingdon Health for the supply of a million AbC-19 rapid antibody tests, which use a small drop of blood from a finger-prick and deliver results in 20 minutes without the need for a specialised lab.

The government said the testing kits will be used to “help build a picture of how the virus has spread across the country and further develop our understanding of how antibodies work.”

Antibody testing was trumpeted in March as the UK’s ticket to emerge from lockdown, but that view was soon undermined by the proliferation of tests that didn’t meet regulatory guidelines.

There are three main approved blood tests for COVID-19 in the UK – from Roche, Abbott and Ortho Clinical Diagnostics – but these require a full venous blood sample rather than a fingerpick and have been in limited supply, reserved mainly for healthcare workers.

That hasn’t stopped a myriad of companies from offering fingerprick tests – including claiming to be based on these technologies – directly to the public. against Public Health England (PHE) and Medicines and Healthcare products Regulatory Agency (MHRA) guidance.

Abingdon says its test has undergone an independent evaluation commissioned by the UK government that will be published in full in due course by PHE, after peer review.

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Achieving Standardization & Operational Excellence in Vein-to-Vein Supply

As an increasing number of candidates enter the clinic and promise to be a mainstay in the future of cancer treatment, cell therapies pose unique supply chain challenges.

From temperature and time sensitivity, to patient-facing delivery and chain of identity, these supply chain challenges must be overcome to ensure the delivery of safe and efficacious cell therapies at scale.

The Patient-to-Patient Supply for Cell Immunotherapies Summit (October 29-30, 2020) is a unique two-day digital platform discussing best practises in implementing robust vein-to-vein supply chains.

Our community of supply chain experts are looking forward to connecting with you in the digital world, including:

• Christopher Baldwin, Supply Chain Director, Cell & Gene Therapy¸ GSK
• Reggie Foster, Senior Director Labelling, Logistics & Packaging, Kite: a Gilead Company
• Sheng Lin-Gibson, Chief, NIST Biosystems & Biomaterials Division
• Jean Stanton, Director Commercial Apheresis, Johnson & Johnson
• Richard McFarland, President, Standards Coordinating Body
• Neeraj Shah, Director Supply Chain Excellence, Bristol-Myers Squibb
• Kawa Chiu, VP CMC Supply Chain, Lyell Immunopharma
• Alexandra Gomez, Associate Director, Patient Services Operations, bluebird bio

Get your copy of the brand-new agenda for the full list of speakers and sessions.

Join the key speakers sharing industry-leading expertise and reconnect with your community to ensure your team is equipped to navigate this pandemic with robust, commercially ready supply chains.

Join this timely discussion by registering online today.

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The COVID-19 crisis has accelerated the shift to a more resilient, agile and innovative digitally-enabled world within healthcare and pharma. But the best companies are going further – by enhancing and expanding their digital channels they are using this as an opportunity for enduring change. Continuing our series on digital health and COVID-19, David Reilly examines major shifts in patient care and healthcare provision resulting from the pandemic and explores which of these changes are likely to stay.

Neurologists say that it takes around 90 days for new bridges to form between synapses in our brain. If we interpret this as the time for new habits to emerge, then we have now had long enough for our new behaviours in the COVID-19 world to become entrenched habits, and for these to have meaningful consequences and enduring impact.

Here are just a few behaviours that have emerged and evolved during the pandemic, and are likely to stick around once we are out of lockdown.

Mobile apps

Mobile devices initially showed great promise, with UK health secretary Matt Hancock saying that the “tide” of digital technology approaching the NHS should be “embraced”.

However, the UK government was forced to abandon its widely-hyped ‘track and trace’ mobile app – which collected personal information to try and mitigate the risk of spread – in favour of using services developed by Apple and Google.

While showing great potential, the app also exposed wider concerns with privacy and data collection. Post COVID, the UK government needs to understand the challenge of trust and capturing mobile data.

As Paul Dixey, multichannel lead at Novartis explains, “People are still very anxious about the UK government or private companies, e.g. Google, capturing and using personal data.”

Remote view consultations

The adoption of remote telemedicine has been immediate and at unprecedented levels throughout lockdown, and there has been a notable accelerated trend towards virtual care.

NHS doctors have been encouraged to hold consultations via video to avoid putting themselves, and vulnerable patients, in danger. But this move has not been without its challenges. Having access to the internet can be difficult for those on low incomes or older demographics who do not routinely use technology. In addition, virtual consultations with first-time patients can be limited when assessing treatments, reading body language or recognising key symptoms.

Overall, many clinicians and HCPs believe the practice of remote virtual consultations accelerated during COVID-19 will become a valuable tool for them in the long term – for example in triaging new patients and especially those that live a long way from the hospitals.

In addition, many businesses outside of healthcare, from Twitter to BT call centres, have already announced that their employees can have the option to work from home permanently. This step is likely to further support the case for more remote video consultations between patients and HCPS.

Digital remote engagement access

As COVID has increased the use of remote access by HCPs through secure digital platforms, a priority for the future will be delivering quality experiences through new tools like Microsoft Teams, Zoom or webinars.

The key is in the execution and the need to deliver consistent, high-quality digital content experiences to HCPs in the front line. If executed correctly, this can deliver very positive results for pharma clients.

“We have seen very high webinar engagement with HCPs,” says Dixey. “The challenge is to keep content highly relevant, engaging and up to date. Healthcare professionals still need to learn, and will still need to access medical education and scientific content, especially as we are seeing in-person conferences drastically reduced.”

Novartis has also used the lockdown to re-invent its relationship with start-ups and the NHS through the development of its Biome, a global network of innovation hubs aimed at strengthening the connection and interaction between Novartis and tech partners.

Irfan Mohammed, strategic partnerships lead for Biome, explains: “The pandemic challenged our agility in pivoting around the changing needs of the NHS and co-create effective sustainable solutions while in isolation. It has also helped us clarify what we are good at and where we can strengthen our digital and data capability through collaboration.

“I think we will see a different relationship between pharma and the NHS in the future, and the Biome provides a dedicated environment in which to ask the right questions and build long term sustainable digital solutions.”

Agile by default

The seeds of agile thinking, process and more outside collaboration have been a central strategic thread pre-COVID – and the pandemic has merely accelerated its vital importance.

Angus Evans, marketing manager at Galen explains, “Being Agile is now of paramount importance to Galen and I am seeing a lot more internal collaboration and use of agile thinking in lockdown.

“Agile helps marketing teams become more innovative, respond to marketplace trends and customer behaviours faster, and I can foresee more agile working across the industry as we emerge out of lockdown.”

The deployment of agile will continue and it will become more and more vital throughout the pandemic.

Supply chains

Having a full-functioning and robust supply chain has taken on special importance throughout the lockdown, and this will endure as a strategic priority.

Taking an end-to-end view across the value chain to assess the implications from the pandemic has also highlighted the vital importance of emerging technologies like blockchain and AI in enabling the process to work more efficiently with greater transparency.

We can foresee a massive restructuring generally of supply chains for strategic products such as drugs, diagnostics, personal safety and equipment driven by national governmental actions with this forming a key element of lessons learned from the lockdown.

The COVID-19 pandemic, and the global disruption it has caused, has demonstrated the vital need for pharma organisations to adopt agile, innovative and digitally-focused services for HCPs, payers and patients that will endure and evolve as we emerge out of lockdown.

About the author

David Reilly is founder of Let’s Learn Digital, delivering training in digital sales strategy, corporate innovation, and emerging technologies to the pharma industry.

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