The power of a digital thread in life sciences
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Read how lessons of the last year can help power development of treatments for health conditions.
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The power of a digital thread in life sciences
- 1. October 13, 2021 Stuart Henderson Dan Sheeran Barry Heavey Chris Kopinski The power of a digital thread in life sciences
- 2. Setting a new pace of change The lessons of the last year can help power the discovery, development and delivery of new treatments for all health conditions. • Phase II and III protocol procedures have increased 44% since 2009, • Patient stratification and novel biomarkers/endpoints driving a rise in trial complexity. More treatments in development + market stratification • AI-based methodologies reduce time spent for discovery from 4.5 years to a year. • Virtual clinical trials grew by over 50% in 2020. • Average treatment duration of decentralized trials was 36% (140 days) faster Treatments are coming to market faster than ever • Driving 81% of biopharma revenue growth and 61% of all revenues (2021-2026). • The average NPV of New Science treatments to be launched from 2022-2026 will exceed traditional counterparts by 69%. New Science is more important than ever
- 3. COVID-19 highlighted many orthodoxies within life sciences that have now been dispelled Orthodoxy 1 We can’t change the way we discover medicine Orthodoxy 2 We can’t deviate from in-person clinical trials, at premier sites Orthodoxy 3 We can’t rapidly scale manufacturing for new modalities
- 4. What if we could… Accelerate early process development Accelerate filing and approval of the CMC dossier Execute flawless tech transfer of manufacturing process between teams Optimize and speed the manufacturing process
- 5. Digital thread in life sciences A digital solution thataccelerates thescale up in supply of complex treatmentsfrom clinical trials through commercial launch and production. By building upon established tools, this creates better collaboration for faster decisions and lower risk of non-compliance or under-performance in supply.
- 6. Putting the digital thread in life sciences (DTLS) to use A biopharma client with one of the most exciting pipelines in the industry. Looking to create a digital bridge between R&D through manufacturing to enhance new product launch capability. New product introduction and technology transfer is historically paper driven, time and effort intensive and error prone. This creates risk of delays in product launch and ripple effects in wider portfolio. Leveraged and enhanced existing IT platforms to create a digital product profile and digitization of the manufacturing control strategy. Initial pilot on a biologic tech transfer resulted in more than 20% reduction in effort. The opportunity The typical challenges The DTLS outcome
- 7. Migrate and free-up resources Accelerating the digital thread with cloud Adopt modern application development practices Gain faster, deeper insights with analytics Ensure security, compliance and resiliency Organize for speed and agility Bridge skills and experience gaps rapidly
- 8. Technical Outcomes Creating end-to-end integration with DTLS Rapid drug discovery and accelerated clinical development Smart factories for small and large molecule drugs Holistic view of data Interconnected global network Lifesaving treatments reach more patients Rapidly scale up manufacturing to support new clinical and commercial launches Quickly evaluate manufacturing feasibility with rapid feedback to development cycle Create end-to-end visibility by integrating operational manufacturing information from disparate systems Seamlessly bring data together across data lakes and source systems to enable additional processing or transfer of information
- 9. The unique business relationship between Accenture and AWS delivers deep technicalexpertise, extensive life sciences domain experience and investments in breakthrough innovations Powering the new frontier of a connected data- driven life sciences industry. What makes our partnership special? Helping clients achieve a new level of innovation and efficiency across their operations and value chain. Access to a vast portfolio of cloud services combined with unmatched reliability, security and data privacy.
- 10. Multi-disciplinary engagement can help drive end-to end innovation and transformation in life sciences How do I get started? Connect with your Accenture and AWS team to co-create a solution for an industry-wide challenge. Am I right for this? We are looking for those responsible for clinical supply, tech operations, commercial supply and CMC regulation. Accenture.com/DigitalThread
Notas do Editor
- MODERATOR (1MIN)
- STUART (4MIN) 1 min: Introduction (Why are we here and what do we want to leave you as as take-home message) Acceleration in pace of innovation is great but purpose of this talk is to discuss how we can help avoid bottlenecks in the E2E journey from bench-to-beside We will “lean in” particularly to the potential challenges in supply (clinical and commercial) and propose approaches to avoid supply being on the critical path of continued innovation 1 min: Talking points on the “lessons of last year” We moved on from sequencing of the CoronaVirus to developing and supplying a multitude of diagnostics, vaccines and therapeutics We saw the validation of an entirely novel modality in the form of mRNA 2 min Talking points on the pace of innovation: New Science is here and driving growth (81%), revenue (61%) and ROI (69% higher NPV – in part due to speed and higher success rates) (beyond Covid, look at what is happening in Oncology, Alzheimers, Inflammatory disease and gene therapy for rare diseases) Number of treatment candidates in clinical trials are increasing (44%) and trials are becoming more complex as use of biomarkers and novel endpoints become more common Evidence of acceleration everywhere: AI in drug discovery reduces time from 4.5 years to 1 year, virtual clinical trials increased by 50% and treatment duration decreaing by 36%
- STUART (3MIN) The pharma industry has long-held orthodoxies around the time and cost required to bring new treatments to patients buit we are seeing these orthodoxies challenged Drug discovery is being enabled by AI tools that help a) more completely understand the complex biology of disease and b) identify the most promising target and candidate molecules to impact on the biology Example 1: Example 2: 2) Clinical trials can be moved away from in-person settings and can be orchestrated away from premier sites through, for example, use of advanced remote patient monitoring technology Example 1 3) Many doubted whether, even if a vaccine was approved it could be scaled up fast enough for the pandemic, based on previous experience in scale up of supply. But through a Herculanean effort we have seen administration of over 3.6Bn doses of vaccine However Vaccine supply has not been without challenges for all the players with successfully approved products and we have seen a number of strains in the launch and supply of other novel treatments (such as Car-T cells, novel recombinant protein-based treatments and gene therapies) in the years running up to and through the pandemic . While we believe that the industry can do more to challenge and disprove all these orthodoxies, today we will focus primarily on how we can continue to challenge orthodoxy three – utilize digityal tools to accelerating the clinical and commercial supply of novel treatments Barry is now going to talk you through some of the ongoing challenges, opportunities and progress in orthodoxy 3 in more detail
- BARRY (2MIN) Thanks Stuart…. etc Accelerate development: Moderna’s scientists could rapidly design mRNA candidates coding for different parts of the covid spike protein and put them into production and testing. What if we could routinely do similar rapid early development and scale up of a wide variety of products across the spectrum of modalities To do this we need to utilize data to better understand and control the complexity of the products attributes and how ther are impacted by the process parameters Optimise process Biology in the manufacturing process brings complexity, but also enormous potential for improvements. Companies who have led in using data to control the biology of their manufacturing processes (like Regeneron, Amgen, Sanofi) are starting to achieve 500-1000% higher yield of drug from their manufacturing processes compared to industry laggards. Imagine if a car company reported that could increase productivity ten fold from a facility through digitalisation! Accelerate filing In 2019 The FDA launched an initiative called KASA, (knowledge aided assessment & structured applications) to help pharma companies interact in a more digital way with the FDA in submission of dossiers and on topics like manufacturing/quality controls and risks. This is a great example of a regulatory body embracing innovation and really being ahead of industry. Many companies are now envisioning a “turbo-tax” like approach to making their filings on the manufacturing and control of their processes but they are still being held back in achieving this by the large amount of paper and static documents that their various teams use Tech Transfer is a common stress point in the industry where a delicately controlled process is moved to a new location and a new team (even new companies), creating risks that subtle changes or poor exchange of knowledge may create unforeseen impacts on productivity or product quality. The more complex the process the greater the risk. In contrast, the greater the depth & sharing of knowledge of the process and all its interdependent variables, the lower the risk of unforeseen problems
- BARRY (2MIN) Digital Thread for life sciences is a tool that can help achieve all of these goals by helping to the appropriate teams (internal and third party) to collate and share deep knowledge on the product and process from the very start of R&D through scale up approval, launch and ever maturing supply This is about harnessing enormous complex and disparate scientific and engineering data around the product and the process, surfacing insights on how the process influences the product quality and ensuring this data and knowledge is available to all the relevant personas However we are not talking about a new “magic bullet” piece of technology but rather about more effectively harnessing existing investments in well-established tools in the industry such as ERP and GxP systems like manufacturing and quality management systems combining them with modern digital tools like AI/ML and cloud computing. This approach provides a exciting opportunity to lower complexity and risk so lets talk about an example …
- BARRY (4MIN) Earlier I discussed the challenges and risks around tech transfer and this is a case study of a client who had become something of a victim of the success of their R&D pipeline - which was regarded as one of the hottest in the industry (they have had a number of shortlisted by our Friends in Fierce Pharma as “most exciting” new launches in recent years The wanted to enhance and digitalise the bridge/handoff between R&D because historically that process was paper based and extremely labor intensive, distracting both teams from day-to-day activities as they tried to mitigate risks We worked with a multidisciplinary team in the client from R&D, regulatory affairs, manufacturing, quality. We utilized their existing ERP and manufacturing and quality systems and took account of the regulatory guidance emerging from the international congress of harmonization to convert a Quality Target Product Profile to a digital product profile. We utilized the S88 standard for batch manufacturing process control processes to create a digital process profile.
- CHRIS (2MIN) For those of you in Clinical Development, CMC, or Manufacturing, you know the importance of focusing on strategic value drivers that are most important to your organization’s success whether it be accelerating clinical development, speeding up your filings and approvals, optimizing and creating more efficient manufacturing operations, or executing flawless tech transfer between team. COVID has proven we can move quickly as an industry; however, portfolio and product complexity and the pace of new product introduction is demanding a new paradigm or new way of operating. The digital tools and capability that enable that now exists that 5-10 years ago were not even possible. Customers that innovate with digital thread do so by leveraging the best that cloud brings. By moving to cloud, our customers are able to Migrate applications such as LIMS, MES, and QMS to free up IT resources. This additional capacity allows your teams to ceate an environment of innovation, such that you leverage data generated in the process of bringing new therapies to market in order to scale your manufacturing process globally while ensuring the necessary security, compliance and resiliency measures are in place. In doing so, companies are able to evolve their business policies in order to help break down silos between functions and create and end-to-end data strategy.
- CHRIS & DAN (8 MIN) Barry shared earlier the story of Moderna and what they were able to achieve in accelerated development. This is an incredible story. But this is only half the story. This same company is on track to make and distribute over a billion doses in just 1 year. If someone told you this 2 years ago, you would have said this is impossible? While there are many factors that contributed to the success of the industry’s response to COVID-19, companies that start by basing their technology stack in the cloud, give their teams a competitive advantage by accessing technologies that provide the agility, scalability, and responsiveness that’s needed to capitalize on such market changes. Our customers are innovating across the value chain, which is enhanced by the Digital Thread. Of the half-dozen or so leading COVID vaccine, anti-viral, and therapeutic companies supporting the pandemic, AWS is playing a key role with two of these companies in scaling key parts of their SAP environment in order to meet the scale and volume anticipated for their production. This not only helps these companies quickly respond to the market changes, but also creates a path for introducing new approaches such as an integrated digital product profile linking clinical development to technical operations to commercial supply. AWS is also working with companies that are specializing in new science, such as CAR-T or Biologics, where manufacturability is often on the critical path. At one of our customers, AWS is helping their clinical development team combine near real-time data capture with machine learning to quickly evaluate manufacturing feasibility in order to rapidly feedback critical information needed for establishing control strategies so that scientists can improve the process in just a fraction of the time that’s needed than with the traditional scale-up approaches. And its not only the Biotechs and Startups. AWS is also working with established, multi-nationals, who have a broad portfolio of small molecule to gene and cell therapy and development and manufacturing facilities around the world. AWS is helping two of the top 10 Biopharma companies integrate their supply chain to create visibility from start-to-end, from raw materials to shop floor operations to commercial demand in order to predict outcomes such as batch performance or be able to mitigate risks resulting from deviations to normal operations which can have a significant impact on delays or incur unwanted costs. A vast majority of our customers are preparing for the new normal by bringing data together across data sources within their own silos and across partners to allow data scientists to work with process scientists in order to co-create the solutions needed to deliver new product introductions with speed from benchtop to bedside DAN -
- DAN (3MIN) We bring together Accenture’s mastery in combining technology and human ingenuity to drive extraordinary outcomes with AWS’s pioneering platform technologies to accelerate the path to value for life sciences companies. Accenture’s strength across the value chain matched with AWS’s experience creating innovative solutions matched with each of our deep technical expertise, extensive life sciences domain experience and investments in breakthrough innovations makes this partnership so special. There is no compression algorithm for experience. There is clear advantage of working with the Life Sciences experience of Accenture and AWS versus risking it on your own. The Accenture AWS Business Group is committed to our customer obsession in helping you and patients in only successful outcomes. Think about where you are in your journey to solving more patient diseases or therapies. Think about the power of what you heard today to speed those goals. And then, contact a business partner at Accenture or AWS to enable your plan.
- DAN (5MIN) If you are responsible for 1) clinical supply, 2) technical operations, 3) commercial supply or 4) CMC regulatory affairs and are feeling excitement and trepidation from developments in New Science ... then we want to collaborate with you and multidisciplinary teams from your company