How can Life Science Technology Providers Support the Pharmaceutical Industry in the Transition Toward More Digitally Connected Operations?

How can Life Science Technology Providers Support the Pharmaceutical Industry in the Transition Toward More Digitally Connected Operations?

June 24, 2024PAO-06-24-RT-02

Tim Tyson, Chairman and Chief Executive Officer, TriRx Pharmaceutical Services

Life sciences technology providers are essential in bolstering the pharmaceutical industry's transition to more digitally connected operations. They accomplish this through several key avenues. First, they develop and offer tailored digital solutions, including integrated data management platforms, cloud-based analytics tools, and artificial intelligence applications for drug discovery and development. These technologies streamline operations, foster collaboration, and expedite decision-making processes within pharmaceutical firms. Additionally, these providers assist in implementing digital transformation initiatives, offering expertise in data integration, cybersecurity, and regulatory compliance to ensure a seamless transition. They also support the integration of Internet of Things (IoT) devices and sensors into manufacturing processes, facilitating real-time monitoring of production parameters and quality control. Moreover, they provide training and support services, enabling pharmaceutical companies to optimize digital technologies for day-to-day operations. Through their innovative solutions and expertise, life sciences technology providers play a critical role in advancing the pharmaceutical industry's digital evolution, driving efficiency, agility, and competitiveness.

Amita Quadros, Ph.D., VP Commercial Operations, GBI Biomanufacturing

Life sciences technology providers can support the pharmaceutical industry in transitioning toward more digitally connected operations in several ways: digital Transformation in the pharma industry provides solutions to pharmaceutical companies, such as more flexible manufacturing processes and improved speed to market. Other aspects include real-time monitoring of manufacturing processes and supply chain optimization, thereby enhancing efficiency and compliance with regulatory requirements. Through AI and machine learning tools, life sciences technology providers can help pharmaceutical companies analyze vast amounts of data generated from clinical trials, manufacturing processes, etc. This information helps identify patterns, predict outcomes, and optimize processes from drug discovery to clinical trials and commercialization. Data integrity and intellectual property are two other critical aspects for pharma companies, and companies partnering with them should ensure they have systems in place to protect this information, including confidentiality, by developing software solutions that streamline regulatory compliance processes per regulations such as the FDA's 21 CFR Part 11. Overall, life science technology providers enable pharmaceutical companies to harness the power of digitization to drive innovation, accelerate drug development, improve operational efficiency, and deliver better outcomes for patients.

Andrew Lewis, Ph.D., Chief Scientific Officer, Quotient Sciences

AI is already having a notable impact on the pharmaceutical industry, particularly in drug discovery where several compounds have now made it into the clinic, and its potential to improve efficiency across the drug development process is being explored. With AI having the potential to positively impact almost every area of our business, life science technology providers can partner with companies to help prioritize investments and advise on feasibility of different use cases. At Quotient Sciences, we are working with technology providers on applications that are “quick wins” requiring minimal disruption but with short-term impact on efficiency or productivity, as well as transformational use cases we expect to provide benefits in the longer term, all aligned with our mission to accelerate drug development.

Chris Wiedel, Chief Business Officer, Nu-Tek Biosciences

One of the largest hurdles in achieving digital connectivity is, without a doubt, intellectual property concerns. Life science technology providers will have to develop resources that not only speak to each other but also do so without divulging sensitive information to other parties. This connectivity is not solely related to external parties but also internal groups that possess information critical to completing critical portions of a workflow, etc. Consider a scenario where materials are blinded to maintain anonymity but a glitch in the digital connection reveals sensitive information (e.g., Coca Cola’s formula). Technology providers will need to develop tools which incorporate clearing houses or firewalls that filter data in certain ways to protect sensitive information. If successful, this could enable cross-company information sharing that can improve workflows and increase productivity throughout the industry.

Michelle Hall, Vice President, Marketing, Mikart

Life science technology providers can help the pharmaceutical industry transition to more digitally connected operations by offering software solutions for data management and analytics and providing cloud-based platforms for collaboration and remote access to data. These technologies make operations more efficient, improve decision making, and facilitate communication across different stages of drug development and manufacturing.

Matthew Treagus, Chief Information Officer, Oxford Biomedica

Life sciences technology providers can support the pharmaceutical industry’s transition toward more digitally connected operations by:

Reducing integration complexity: Adhering to industry standards simplifies integration. Move away from offering complete ecosystems with proprietary connections. Customers have multi-vendor solutions and seek the best-in-breed answers tailored to each part of the puzzle. Without this, we see siloed systems with increased costs and complexities, which leads to inefficiencies and a slowdown in production.

Making a step change in user experience: Opt for user-centric design over process-centric approaches to minimize training needs, errors, and disinterest among users. Vendors often overlook design in internal GxP systems, neglecting usability and aesthetics.

Prioritizing security: Legacy applications born before the era of heightened cyber-security risk appear to have had a security retro-fit. While newer, rapidly growing software-as-a-service (SaaS) services boast robust infrastructure, relying largely on the underlying cloud provider for their credibility, concerns linger regarding application security and integrity.

Addressing qualification and validation: Despite vendors' confident claims of working with numerous large pharmaceutical businesses, having extensive experience in GxP contexts, and complying with various document references, many vendors leave these challenges to the clients. Few are willing to engage in the more difficult aspects or share best practice.

David O'Connell, Director of Scientific Affairs, PCI Pharma Services

One suggestion would be to develop and implement digital platforms that integrate various aspects of pharmaceutical operations, including research and development, manufacturing, supply chain management, and sales and marketing. This would serve to facilitate data sharing and collaboration across different departments and stakeholders, which in turn lead to improved efficiency and decision-making when developing, manufacturing, and packaging clinical and commercial drug products. Also, leveraging advanced analytics and data science techniques will help pharmaceutical companies derive valuable insights from the vast amounts of data generated throughout the drug development and commercialization process. This includes predictive analytics for identifying potential drug candidates, optimizing clinical trials, forecasting demand, and personalizing marketing strategies.

Hyeokgeon Kwon, Director of Information Strategy, Samsung Biologics

An all-in-one, digitized system that collects, filters, and analyzes realms of project data through a few clicks is now a must-have for CDMOs supporting global drug developers with the latter's patient-centric missions. So-called "digital connectivity," the transition from hands-based to data-based information gathering, optimizes the process of developing complex modalities, such as bispecific antibodies, reduces overall cost, and thus ultimately helps increase the development project viability. The all-in-one information system also enhances the data integrity of the biomanufacturing process, which is critical for on-time drug delivery. At Samsung Biologics, our fully digitized system makes mutual checks and balances with our biopharma partners possible, enhancing our accountability and facilitating trusted partnerships.

Kean Woodmansey, Senior Global Market Development Manager, Pharma, SCIEX

Technology providers like SCIEX, who offer advanced analytical systems like mass spectrometers and liquid chromatography systems, have a crucial role to play in guiding the pharmaceutical industry's journey toward digital integration. We need to prioritize the development of expansive digital platforms that seamlessly merge various systems and data sources and establish robust standards. Embracing innovative technologies, such as the Internet of things (IoT), and advanced analytics will allow us to implement real-time monitoring and predictive maintenance, ultimately optimizing operational efficiency for pharmaceutical companies.

Embedding compliance features into our solutions is crucial to ensure alignment with evolving regulatory frameworks. Equally important is a commitment to providing comprehensive training and continuous support to facilitate the smooth adoption of digital solutions within pharmaceutical companies. This proactive approach will empower these companies to navigate the complexities of digital transformation confidently and competently.

Ultimately, we should aim to drive the industry toward achieving operational excellence within the interconnected digital landscape. Through ongoing innovation and strategic partnership, life science technology providers can make a meaningful impact in shaping the future of pharmaceutical operations, ensuring agility, resilience, and efficacy in an increasingly digital world.

Nicolas Pivet, Vice President and General Manager, Technology Services, Cytiva

As technology providers within the life science industry, we can help drive measurable improvements by providing scalable digital solutions. The industry’s digital evolution varies based on organizational size, scale, and maturity. Scalable solutions allow us to meet organizations where they are. Innovative technologies, such as data lakes, digital twin technology and simulation tools, virtual and mixed reality (VR and MR), or advanced process control (APC), address a wide range of needs by placing data at the core.

Addressing the manpower and skill set disparities across smaller biotech firms and larger pharmaceutical companies is also needed. As digital capability and usage matures, companies will need expertise in areas that they may not be able to provide in-house. Recruitment and retention can be tough, especially for smaller firms. That's where partnership can make a significant difference, leveraging the technical expertise of suppliers. By fostering collaboration across the value chain, the industry can realize digital’s full potential in delivering therapeutics efficiently and cost-effectively.

Matthew Bio, Ph.D., Chief Scientific Officer, Cambrex

Supporting the pharmaceutical industry’s digital aspirations will require that technology providers already be fully digital in data acquisition and management. For CDMOs serving the industry, supporting the digital aspirations of customers requires a fully digital solution from lab to manufacturing via integrated data management platforms. In development, CDMOs should be able to provide data-rich experimentation in a fully digital environment. The adoption of low-cost IoT technologies in the laboratory connected to a common data-acquisition platform can provide real-time visibility into multiple process parameters and support the development of digital process models. With IoT-enabled lab development platforms, rapid algorithm-driven optimization, and automated process characterization become possible, reducing development time while providing highly robust development data. Ideally, development data can be shared in real-time via digital collaboration platforms facilitating seamless communication and collaboration with external partners. Such an environment would facilitate collaboration and accelerate decision-making. In manufacturing, mapping the engineering specifications of all components of the process line and enabling real-time data acquisition from sensor arrays monitoring process parameters would allow for development of highly accurate digital twins.

Chris Brown, Operations Director, Astrea Bioseparations

Pharmaceutical companies are experts in their own processes, but imagine what could be done if process data could be shared with their suppliers –– the experts in the component parts of the pharmaceutical process.

Suppliers could aid significant process improvement, adding value to both parties and changing the approach of looking at suppliers as a cost (to be reduced as far as possible). This win/win approach would obviously need infrastructure and trust to really work, but if suppliers had a stake in the gains made and live process data made available, the monitoring and process improvements can be continuous rather than waiting until issues arise before involving their supply chain technical and operations teams.

Chris Black, Ph.D., Senior Vice President, ADME-Tox Division, BioIVT

Speaking to the absorption, distribution, metabolism and excretion (ADME) industry, we’ve seen challenges focused on improvements in the consistency, quality, and characterization of our enzyme and cell systems. However, we know that while the current inventory and quality of cells is better than ever, there are still questions that require innovation and likely will require technology improvements, data, and informatics, as well as more advanced model systems. Putting these solutions together will take time, but once we do, we can begin to tackle questions around cell-to-cell interactions, immune responses, and understanding adverse outcome pathways. Given that, the changes and advancements that are happening around organ modeling and modelling disease states should be top of mind. Technology providers in the pharmaceutical industry should ask themselves how to integrate different cell types together to better mimic organ functionality or disease outcomes. It’s an area that the industry is only scratching the surface on but is ripe for innovation and enhancement.

Alan Marcus, Chief Growth Officer, LabVantage

Life science technology providers can significantly support the pharma industry in its digital transformation journey by offering advanced laboratory information management systems (LIMS) that go beyond basic data digitization. Traditional methods (e.g., Excel spreadsheets) present numerous challenges, including regulatory risks, data integrity issues, and inefficiencies. Tech providers can help drug developers circumvent these pitfalls by providing modern, integrated LIMS solutions with advanced analytics that ensure reliable data management, collaboration, workflow automation/optimization, and cybersecurity.

A contemporary LIMS facilitates the management of vast amounts of data generated during drug development by providing a secure, scalable platform that integrates data from disparate sources, including clinical trials and research labs. This integration can be supported by AI-powered tools and can simplify data accessibility and analysis, ensuring a streamlined flow of information.

In terms of efficiency, automating routine tasks like data entry reduces human error and increases productivity. Robotics and AI play crucial roles here, helping to optimize workflows, supporting decision-making throughout drug development, predicting clinical trial outcomes, and providing deeper insights into patient data.

What’s more, enhancing collaboration through a secure cloud-based LIMS platform enables seamless communication and data sharing among researchers and stakeholders. As a technology provider, LabVantage prioritizes robust cybersecurity and data privacy measures to protect sensitive information and comply with regulatory standards.

Simon Wagschal, Ph.D., Associate Director of Small Molecules R&D, Lonza

Life science technology providers play a pivotal role in facilitating the pharmaceutical industry's transition to more digitally connected operations. One key avenue is by development of computer-aided synthesis planning tools (CSPTs), which are being used by discovery chemists to address the growing complexity of small molecule drugs. These tools, using advanced deep-learning models, devise synthesis routes for target molecules, aiming to rapidly devise new or alternative approaches to a given target active pharmaceutical ingredient (API). However, these CSPTs do not meet the needs of process chemists; often, an elegant synthetic route to a target compound is not feasible at the production scale.

Lonza’s Small Molecules division has overcome this limitation by combining its proprietary supply chain database with a leading CSPT. By considering the availability and pricing of chemical building blocks, Lonza ensures synthesis routes are not only theoretically sound but also commercially scalable. Lonza’s route scouting offering can thus help customers identify and prioritize the best routes from the start, saving them time, effort, and resources. This integration enables Lonza to navigate digital transformation successfully, delivering cost-effective, scalable solutions from discovery to market.

Avi Nandi, Head of U.S. Cell & Gene Therapy, SK pharmteco

Life science technology providers can act as catalysts for the pharmaceutical industry's shift toward digitally connected operations by offering a suite of solutions that bridge inefficiencies and enhance transparency across the entire drug life cycle, such as:

  • Integrated Digital Platforms to streamline communication and collaboration between researchers, developers, manufacturers, and distributors through a unified digital platform.
  • Equipe pharmaceutical companies with real-time data analytics tools to gather and analyze real-time data, leading to optimized decision-making and process improvement.
  • Implement digital solutions that provide complete visibility into the pharmaceutical supply chain, enabling companies to track materials, ensure timely delivery, and optimize logistics.
  • Integrate automation and robotics into manufacturing processes to boost efficiency, minimize errors, and expedite production timelines.
  • Enable remote monitoring and control of manufacturing operations via IoT-enabled devices and cloud platforms, fostering greater flexibility and agility in response to market fluctuations.
  • Offer digital tools and services that streamline regulatory compliance, such as electronic batch records and e-signatures, to expedite drug approvals.

William (Bill) Goodman, Senior Director of Product Management, Digital Science, Thermo Fisher Scientific

Life science technology providers play a pivotal role in supporting the pharmaceutical industry on the journey to digital connectivity. Today, cutting-edge technologies are revolutionizing laboratories, streamlining processes, and accelerating the pace of scientific breakthroughs. However, according to McKinsey Life Science and Data Analytics’ Digital Maturity Index, life science leaders still trail behind cross-industry leaders in digital adoption. Those that have implemented comprehensive digital solutions saw a 15% bottom line improvement over the past five years.

To support the pharmaceutical industry in adopting digital solutions, life science technology providers can deliver digital ecosystems that orchestrate complex workflows, optimize resource allocation, and foster collaboration across multidisciplinary teams by integrating diverse lab instruments, software, and data management systems, which ultimately drive innovation in drug discovery. These digital systems also facilitate automation of administrative lab tasks allowing scientists to focus on value-adding scientific discoveries.

As new instruments, techniques and next-generation technologies propel life sciences research to the pinnacle of pharmaceutical innovation, life science technology providers must remain in lockstep with industry partners, providing digital solutions that help them expedite the drug discovery process, from target identification and compound screening to lead optimization and preclinical development.

Rich Gliklich, M.D., Chief Executive Officer and founder, OM1

One impactful way will be through platforms that enable data and study automation. In recent remarks, FDA Commissioner Dr. Robert Califf argued that there is tremendous opportunity to simplify and digitize data collection to create more pragmatic and less burdensome approaches to evidence generation: “Technology is no longer our limitation.”

The automation of data collection, from electronic medical records and other systems, is emerging as a key means to simplify and improve clinical studies. Some of the advantages of automation include accelerating study timelines, reducing costs, generating external control arms, reducing site burden, and increasing the diversity of participants who are enrolled.

Validated systems, such as OM1’s automated study platforms, collect and process data directly from electronic health records for clinical studies from hundreds of practices and health systems. This includes the traceable and auditable transformation of unstructured clinical narratives and reports into standardized data points and using AI to identify computable phenotypes and to estimate and amplify key outcomes. These platforms are significantly changing the burden and costs of registries, large studies, and external control arms to name a few. By showing measurable benefit and ROI in evidence generation, technology providers can help the industry digitize data collection.

Anna Codina, Ph.D., Senior Director Biopharma & Strategic Market Development, Bruker BioSpin

The pharmaceutical industry needs a technology partner that can support them on their digitalization journey throughout the entire life cycle of a drug from discovery and development to manufacture and commercialization –– an end-to-end solution provider who offers connectivity across all platforms and that can automate processes and data analysis, freeing up research and development time to focus on higher value tasks. Increasing throughput in laboratories and commercial settings will help bring drugs to market faster and more cost-effectively.

Many companies have multiple electronic laboratory notebooks (ELNs), LIMS, and diverse archiving solutions, including legacy systems, resulting in a wealth of very valuable information, which is often difficult to be fully utilized. Having connectivity between disparate instrumentation, accessibility to new and legacy systems, format standardization, and data that is findable, interoperable, reusable and can be preserved, will enable the biopharmaceutical industry to prepare their data in a way that is AI ready and to make autonomous data-driven decisions based on the insights provided by the data collected.

Bruker has recently acquired two companies that are helping our pharma customers move toward a digitally connected lab: ZONTAL and Chemspeed. Both platforms streamline operations and accelerate innovation within drug discovery, development and manufacturing workflows using vendor-agnostic scientific software and automation.

Sebastian Arana, Head of Process Solutions, MilliporeSigma, the Life Science business of Merck KGaA, Darmstadt, Germany

As solutions providers, we facilitate the transition to digitally connected operations by offering innovative solutions that enhance operational efficiency, productivity, flexibility, data management, and compliance. At MilliporeSigma, we are dedicated to delivering solutions that assist our partners in achieving their goals of digitally connected operations. Understanding the digital maturity model is crucial in developing and producing solutions for digitally connected operations. This model provides a characterization of an organization’s digital state. As our partners evaluate their strategic objectives and align them with digital initiatives, they can create a step-by-step roadmap to achieve their ambitions. And this is where we can support our partners. Contrary to misconceptions, “Facility of the Future” or “Bioprocessing 4.0” is not a distant vision but rather a phased journey toward future objectives. At MilliporeSigma, we are committed to delivering solutions in a stepwise manner, ensuring that we effectively meet the present needs and future ambitions of our customers, recognizing that each partner’s ambitions are unique.

Christopher Bouton, Ph.D., Senior Vice President and Head of AI, Certara Drug Development Solutions

In order to really support the transition to more digitally connected operations, the pharmaceutical industry must take a dual-pronged approach. So, what does that mean? The first is the establishment of data architectures that enable the surfacing, cleaning, normalization, and management of the data relevant to any given pharma use case. Then the second is the deployment of novel analytics like AI analytics that helps to derive greater insight from that data. The bottom line is that you cannot do one without the other. It’s crucial to have both an architecture capable of handling this data at scale but then also access to the analytics that are specifically focused on the types of things that need to be done with that data.

Katrina Rice, Chief Delivery Officer, Biometrics Services, eClinical Solutions

Our industry often expects results from technology without enough upfront attention to the problems we’re trying to solve and the anticipated outcomes. Taking time for this advance work is critical to operationalizing digital technologies for meaningful impact. As a clinical biometrics services organization using our own data cloud, elluminate, and many other digital technologies to produce ROI for clients, we’ve been through this tech adoption journey internally and help biopharma clients do the same. The reason to keep coming back to your problem statement is to use that as a driver for defining success –– is it efficiency, quality, speed? We want all of the above, but you need starting metrics to measure how digitally connected operations will improve outcomes. Developing incremental but high-impact ways to produce results that matter to each biopharma organization will accelerate industry-wide goals of high-quality data and faster cycle times. Technology providers can help the industry digitally transform by working with clients on a metrics-first approach, advising on impacts of non-technical factors like misalignment and communication silos, and offering expertise to tackle these derailers. Jointly working to embed metrics across the data life cycle can help the pharmaceutical industry move beyond acceleration goals to downstream impacts.

Bryan Katz, Chief Strategy Officer/Head of Corporate Development, ProPharma

The main challenge in increasing the connectedness of things is in adoption and change management. New technologies live and die by the degree users experience and demonstrate value across meaningful use cases. Life science technology providers are critical in this regard, helping to advise and build digitally connected workflows, designing easy-to-use interfaces, and ensuring any advantage from either drives a user’s productivity and/or enhances decision making.

Second only to adoption is the integration and interoperability of disparate data sources. The proliferation of new advanced technologies (e.g., AI and similar) have on the one hand created a great forcing function for companies looking to leverage the tech to get their data in order –– in many regards, their data strategy essentially shapes their AI strategy. On the other hand, such proliferation has also led to a land grab by service providers, increasing complexity to an already fragmented market. Smart life science technology providers will help innovators solve their problems.

Josh Ludwig, Global Director, Commercial Operations, ScaleReady

Digital integration without proper preparation is guaranteed to disappoint. Before adding in new layers of complexity, technology providers need to offer simple tools with simplified use. This not only reduces cost and time overruns during the transition but can lead to long-term efficiencies as well.

To transition, the pharmaceutical industry needs to develop streamlined operations with efficient information technology systems, which will allow companies to quickly integrate digital data for decision making in things like inventory control, purchasing, quality systems management, equipment management, and facilities management. In manufacturing, this will require tools with highly repeatable procedures, minimal training requirements, and an ability to produce accurate data in a timely manner, all within GMP settings.

Even if the technology is highly simplified, the workflow will remain complex. Technology providers will need to function as partners, providing optimal support and consultation to ensure companies understand how to integrate and use these platforms with minimal need for customization, along with plug-and-play standard operating procedures. Providers can also help ensure the technology is operating properly once installed, producing the minimum amount of data needed and keeping operations like manufacturing progressing normally and within standard process controls.

Joel Eichmann, Co-Founder and Managing Director, Green Elephant Biotech

Fostering collaboration and ensuring interoperability across devices is essential. By advocating for standardized APIs, technology providers can dismantle the existing silos that hinder communication between devices within the pharmaceutical ecosystem. This approach not only streamlines process development but also enhances efficiency, enabling any device to seamlessly integrate and communicate with another. Such connectivity is fundamental in constructing a cohesive digital infrastructure that supports more agile and responsive manufacturing processes.

It is also imperative to build trust with stakeholders through education and by demonstrating the robustness of digital systems. New digital structures, such as electronic batch records, often introduce apprehensions related to perceived risks — if systems fail, production halts. Addressing these concerns involves not only implementing resilient systems that can withstand various challenges but also ensuring that all parties understand the benefits and safeguards associated with these digital advancements. Education and clear communication are thus key in mitigating fears and fostering an environment where digital transformation is embraced rather than feared.

Stella Vnook, Chief Executive Officer, Likarda

Technology providers are proving most helpful with a focus on facilitating interoperability and data integration. Pharmaceutical companies still struggle with data silos, a problem that is not getting easier as the already vast amounts of data generated throughout development explodes through the use of new technologies like single-cell ‘omics. Solutions that enable the industry to make better use of these data, especially by integrating disparate data sources, will have a crucial impact on better and faster drug development.

Artificial intelligence, particularly machine learning (ML) algorithms, are regularly explored as tools to facilitate drug development, and in that role are a significant contributor to the exponential growth in data generation –– but they are also crucial for unlocking its utility. Through optimized data integration, predictive analytics can increasingly improve every step of the value chain.

This is particularly true in relation to cell and gene therapies, where standardization is still a long-term goal for the industry. Here, many processes are traditionally paper-based, but tools like supply chain management are expected to help these difficult-to-make medicines more accessible through faster, less expensive manufacturing. In addition, these digital integration technologies are simplifying quality assurance and regulatory compliance.

Dalip Sethi, Ph.D., Commercial Leader, Cell Technologies, North America, Terumo Blood & Cell Technologies

Data management is a clear area where enabling technologies can improve digital connectivity, especially for cell and gene therapies. As more processes are automated throughout the value chain, it will be critical to integrate different platforms. We have seen the opportunities with our own platforms, like the Quantum Flex Cell Expansion System and our Finia Fill and Finish system, which are enhanced for fleet management through process monitoring, using the Cell Processing Application (CPA). The systems are designed for electronic data reporting capabilities. The output could be fed into other data systems for ease of analysis –– enabling, for example, automated data collection that could help cell-based therapy developers and manufacturers to optimize their processes, generating more starting material for patients in less time.

In summary, as the digital capabilities of the systems increase, we expect greater integration with wider ranges of data types will increase the benefits exponentially, enabling the industry to further mature and standardize.

Lindsay Davies, Ph.D., Chief Scientific Officer, NextCell Pharma

Digitalization is currently a buzz word in the biotech arena, for good reason. There is a growing recognition that investment in enabling digital technologies can strengthen and streamline processes in drug development, manufacturing, and distribution.

Specifically within the area of cell and gene therapy, scalability in the production of these niche drugs will improve their commercial potential, drive down costs, and increase accessibility for patients. Doing so will require automated production techniques and the potential for future decentralized manufacturing, as well as storage and distribution of products. Each of these areas will be positively impacted by improved digitally connected operations. Activity in Europe provides a perfect example to demonstrate the importance of compatible digital infrastructure and traceability for transport, cross border controlling of drug products, and storing at multiple sites for fast access to the drug by clinicians.

Natalia Elizalde, Ph.D., Chief Business Development Officer, VIVEbiotech

In recent times, manufacturing equipment as well as associated tools have shifted toward a more digital and automated environment, in effect becoming significantly more intelligent. The primary aim of this trend is the ability to increase productivity, reproducibility, and cost effectiveness, also improving sustainability as a consequence.

Life science technology providers like VIVEbiotech, which has been involved in the manufacture of more than 150 batches in reactors on lentiviral vectors, have a clear role in contributing to the transition to more digitally connected operations. Companies like ours can leverage big data and increasingly sophisticated analytical tools, with a focus on integrating artificial intelligence and robotics.

VIVEbiotech considers the transition towards digital operations as a strategic project to be executed in a multidisciplinary manner by all the technical areas in the company, with an awareness that there is still a way to go.

Priya Baraniak, Ph.D., Chief Business Officer, OrganaBio

Our industry has a reputation for slow, cautious integration of new technologies, given the unique challenges of biopharma development and the failed promises "outsiders" have made in the past. But over the last decade, we have the seen substantial growth of tech companies taking on some of the biggest bottlenecks in biopharma development, relying on digital connectivity to handle large and disparate data sets. Initial skepticism has begun to give way as these technologies demonstrate their worth.

Perhaps most impressive, an increasing number of AI and ML platform companies are accelerating the discovery process, with clear benefits specifically in drug target identification, lead optimization, and clinical trial design. In addition, big data is being brought to bear via cloud-based platforms for efficient clinical trial design and data collection, management, and analysis, helping ensure easier regulatory compliance and faster trial completion.

As these technologies further mature, they will enable and improve real-time monitoring and optimization of manufacturing processes, along with blockchain-powered supply chain management systems, for better transparency and drug traceability. This included real time, non-invasive, non-destructive monitoring enabled by AI/ML.

Stuart Ward, Head of Platform Strategy, Digital Products Development, IDBS

Life science technology providers are vital partners in the pharmaceutical industry's transition toward more digitally connected operations. Pharmaceutical companies are already starting to leverage digital tools, such as AI and ML to accelerate drug discovery and development, but they still struggle with strategies to manage their huge volumes of complex R&D data.

To fully harness the potential of AI & ML, it is essential to have well-organized, high-quality R&D product and process data that is:

  1. Complete – encompassing both successful and failed experiments.
  2. Contextualized – to facilitate historical and predictive analyses.
  3. Accessible – for enhanced analyses and reporting.

The next generation of cloud-based R&D informatic platforms have evolved past ELN and LIMS systems to compliantly capture and structure product and process data from all sources across the full drug lifecycle. This single data source enables AI/ML tools to use the data, often without the need to further extract and transform the data.

Wherever a pharmaceutical company is in its digital maturity journey, building the right data foundation is crucial. With the right technology partnership, the pharmaceutical industry can drive operational efficiency, ensure regulatory compliance, and maintain data integrity throughout its digital transformation.

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