Kean Woodmansey, Senior Global Market Development Manager, Pharma, SCIEX
Advancements in technology, particularly in mass spectrometry, have significantly transformed the capabilities and roles of contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) in the drug development life cycle. High-resolution mass spectrometry (HRMS) has advanced the characterization of complex molecules, enabling precise identification of potential drug candidates and a deeper understanding of their mechanisms of action. Techniques like tandem mass spectrometry (MS/MS) and advanced fragmentation methods such as electron-activated dissociation (EAD) from SCIEX allow for detailed structural elucidation and quantitation of biomolecules, facilitating the development of more targeted and effective therapies.
Integrating artificial intelligence (AI) and machine learning (ML) algorithms with mass spectrometry data enhances the potential of CDMOs and CROs by providing predictive insights and optimization strategies for drug discovery and manufacturing processes, improving efficiency and decision-making.
Advanced techniques like native mass spectrometry allow the study of biomolecules in their natural state, aiding research on protein complexes and interactions critical for biologics and personalized medicine. As technology continues to evolve, mass spectrometry will further enhance the efficiency, accuracy, and scope of services offered by CDMOs and CROs, driving innovation in drug development that can lead to the discovery of novel new medicines.
Delara Motlagh, Ph.D., Vice President, Global CT & Plasmids, Catalent
The personalized nature of cell therapies allow developers to harness the power of the cell to target a wide range of diseases. While these living therapies support broad applications, they also bring complexity in manufacturing. CDMOs play an important role in scaling the manufacture of these advanced therapies by leveraging best-in-class automated technologies to standardize the process and deliver a consistent product. CDMOs have experience optimizing processes using design of experiments (DoE) principles to define critical process parameters (CPPs) and critical quality attributes (CQAs) for each process. These advancements support quicker quality control release, bioreactors that shorten the expansion phase, real-time feedback, and technologies optimizing cryogenic logistics and the digital supply chain. CDMOs also reduce timelines through a detailed assessment of the regulatory landscape and considering key components such as comparability studies, CMC framework, and master protocols to avoid delays. Finally, CDMOs improve the commercial model by defining a manufacturing strategy, establishing a plan to scale the process to meet growing demand, and managing raw materials to ensure a sustainable supply chain. CDMOS have shifted to taking on a much bigger role in accelerating the delivery of these potentially lifesaving treatments to patients.
Diane Lacroix, Vice President - Clinical Data Management, eClinical Solutions
Modern clinical trials face significant challenges, from trial design to operational intricacies and data management. Technology and scientific innovation have made it easier to collect increasing amounts of data, but this not only places critical burdens on patients and sites — it complicates the data operations of research. Biometrics teams must now possess technical skills, therapeutic-area-specific data expertise, and an adaptable mindset to navigate this data-heavy environment. Traditional full-service outsourcing models often downplay the priority of data in trials and lack the flexibility required for complex, data-driven studies.
Biopharma companies are more focused than ever on data as the critical asset of their studies and organization. As a result, sponsors are emphasizing several key priorities in their outsourced strategies: efficient management of data complexity, the ability to leverage technological advancements, and a move beyond operational execution to technology optimization (including adoption of AI and risk-informed approaches).
Outsourcing partners offering domain and function expertise around clinical data can address sponsors’ priorities to streamline data operations. This reshaping of a data-focused outsourcing strategy addresses widespread trial efficiency needs while helping life sciences organizations advance toward a comprehensive clinical data science framework, establish the foundation for AI-enabled productivity, and gain study and program-wide effectiveness.
Jeanne Hecht, Chief Executive Officer and Executive Chairwoman, Lexitas Pharma Services
Enhanced data analytics, AI, and machine learning are transforming drug discovery and development by enabling more accurate predictions of drug efficacy and safety. Automation and robotics enhance manufacturing precision and efficiency, reducing time-to-market and production costs. Cloud-based platforms facilitate seamless collaboration and data sharing among global teams, improving operational efficiency and decision-making. Advancements in personalized medicine and biomanufacturing allow CDMOs and CROs to offer tailored and scalable solutions for complex biologics and gene therapies.
AI/ML in CROs streamline administrative tasks like drafting CDAs, proposals, and contracts, allowing experts to focus on review and editing. They also create templates and first drafts of key documents (e.g., ICF, protocols) in real time and support patient identification and safety reporting through advanced analytics. This shift reduces manual processes, addressing resource constraints. AI-driven solutions also enhance patient identification and reduce prescreening activities, often required in radiological exams and genomic testing.
Ultimately, these advancements demand that the current and future workforce be technology-forward thinkers and data science experts, moving beyond traditional tools like Excel and Word.
Ian Scanlon, Fiber Development Lead, Astrea Bioseparations
The development of advanced therapeutics has led to an increasing trend in stable expression systems for vector production. Many CDMOs now offer stable, inducible, packaging, or producer cell lines, providing higher density expression, higher functional titres, and better impurity profiles. For example, in the adeno-associated vector (AAV) space, improved packaging cell lines have increased yields and, in some cases, eliminated the need for affinity purification due to cleaner AAV production from the harvest step.
This trend extends to lentiviral vectors (LVV) as well. The complex nature of LVVs poses challenges in producing fully formed infectious particles, but recent reports show increasing functional titres with packaging cell lines, making commercial LVV production processes more efficient.
Advances in upstream production of larger, delicate targets necessitate changes in downstream processing (DSP) steps due to changing impurity profiles. Many CDMOs are exploring new DSP technologies, such as the novel electrospun fiber, AstreAdept, which operates with low shear, low delta pressure, and high flow rates to match advancements in upstream expression.
Michael Nonnenmacher, Ph.D., Director Global Business Development Differentiating Technologies, Evonik
CDMOs and CROs are using technological advancements to offer more specialized and customized solutions. With over 30 years of leadership in drug delivery systems and expertise in manufacturing highly potent and controlled APIs dating back to the 1960s, Evonik is a great example of how CDMOs continue to evolve and transform to meet the needs of the pharmaceutical market.
For parenteral drug delivery systems, Evonik is the only CDMO that can make or take your active pharmaceutical ingredient (API), supply our own bioresorbable excipients for extended release, develop the formulation, and then manufacture and fill the final drug product. Another example is our cGMP manufacturing of lipid nanoparticle–based drug products to support entry into early-stage clinical studies, using a range of highly customized process technologies for drug product manufacturing, and Evonik-made lipids tailored to our customers’ requirements for a fully integrated clinical development service.
CDMOs with a strong track record in the manufacture of diverse complex drug substances must offer a portfolio of technologies to ensure a smooth, right-first-time launch. Our differentiating technologies, such as chemistry in water, flow chemistry, high-throughput screening, and AI-supported process development demonstrate how technology has elevated the role of a CDMO to an indispensable partner to the pharmaceutical industry.
Ryan Guest, Ph.D., Senior CMC Translational Consultant, eXmoor Pharma
Advancements in technology are significantly enhancing the roles and capabilities of CDMOs and CROs in the drug development life cycle for cell and gene therapies (CGTs). At a fundamental level, the CGT space has blossomed with RNA-based vaccines, clinical POC for allogeneic therapies, BLA/MA approvals for AAVs, and expansion of therapeutic modalities/populations for autologous cell therapies.
Automation and AI-driven data analytics streamline research and development, accelerating the identification of viable therapeutic candidates enabling rapid prototyping and optimization of therapies. Enhanced bioprocessing technologies and real-time monitoring systems improve manufacturing precision, scalability, turn-around time, and compliance, ensuring higher-quality and consistent CGTs. Innovations in next-generation sequencing and gene editing tools, such as CRISPR, aligned with clinical POC data, have transformed genetic analysis and more efficient and accurate gene modification.
Digital platforms for clinical trial management enhance patient recruitment, data collection, regulatory compliance and reduce time-to-market. Additionally, advanced logistics, blockchain and cold chain management technologies ensure the integrity and viability of sensitive CGT vein-to-vein logistics.
Ultimately, these advancements have increased global CDMO/CRO capacity, specialization and with interest/adoption across new geographies, such as South America, Eastern Europe, and Asia, have enabled market expansion.
Adriano Leuzzi, Ph.D., Head of Process Development, and Angelo Raggioli, Ph.D., Head of Technology Development, ReiThera
In gene therapy and viral vector manufacturing, CDMOs are increasingly focusing on developing stable cell lines and refining chromatographic conditions to enhance scalability and product purity. Specifically, the production of viral vectors now emphasizes stable cell lines and advanced purification and analytical techniques to address challenges like partial capsids and improve product quality. Additionally, the integration of single-use bioreactors and the transition to suspension culture technologies have improved scalability and process consistency, enabling the efficient large-scale production of viral vectors.
Moreover, technological innovations, such as process automation or AI, continuously drive success in the CDMO landscape. They support development from the early determination of target product profiles in preliminary phases to process optimization and product characterizations throughout the entire product life cycle management phases. This facilitates fast-track, quality-oriented transitions to pilot production. The ongoing optimization of transfection methods, including efforts to develop high-yield producer cell lines, further exemplifies how technological advancements are driving efficiencies and reducing costs in gene therapy manufacturing.
These technological innovations and process improvements collectively empower CDMOs to deliver cutting-edge solutions, enhancing their capabilities in the bioproduction landscape and driving scientific progress.
Stella Vnook, Chief Executive Officer, Likarda
Advancements in technology are fundamentally transforming the roles and capabilities of CDMOs and CROs in the drug development life cycle. Many are leveraging enhanced data analytics and AI to predict drug efficacy and safety profiles, optimizing the entire drug development process. These advanced tools enable manufacturers to manage and interpret large volumes of data more effectively, improving decision-making and significantly reducing time-to-market.
In addition, continuous manufacturing technologies are now well-entrenched within CDMOs, offering more efficient and consistent production processes compared with traditional batch manufacturing, thus reducing costs and time. Advanced tools like automated compliance systems and real-time software updates on regulatory changes are also allowing CDMOs and CROs to stay compliant and adapt strategies swiftly as needed.
This technological transformation comes with a high upfront cost, as many contract manufacturers operate with legacy systems that are not easily integrated with new technologies, making upgrades challenging — especially when existing approved products are already in production. Ongoing maintenance, training, and upgrades also require continuous investment. Overcoming economic, as well as regulatory and technical barriers, requires a strategic, well-coordinated approach that balances innovation with practical considerations and fosters strong collaboration with clients
Trevor Smith, Senior Manager, Regional Marketing - Cell & Gene Therapy, Terumo Blood & Cell Technology
Next-generation manufacturing technologies for cell and gene therapies have been making their debuts from both incumbent and emerging players. These advancements put more pressure on CDMOs and CROs to be familiar with the latest and greatest, so they’re not caught off guard by customer requests. In particular, these can include new platforms that enable data analytics and automation to improve on and optimize manufacturing processes.
Furthermore, advanced therapy developers continue to demand proof points: relevant data sets on modified cells that more accurately capture how this technology may benefit their own processes. To that end, technology providers would do well to collaborate with CDMOs and CROs to generate this data, proving not only that the devices work for their customer needs, but also that the CDMO/CRO has the expertise in operating them — potentially saving time during tech transfer within the drug development life cycle.
Natalia Elizalde, Ph.D., Chief Business Development Officer, VIVEbiotech
Advancements in technology are continually reshaping the capabilities of CDMOs, especially as CDMOs are increasingly moving toward platform-based approaches, which significantly reduce timeframes while ensuring scalability and productivity up to commercial phases.
Additionally, continuous automation and monitoring is shortening development times while guaranteeing the ability to predict behaviors in later stages, due to enhanced data collection.
At VIVEbiotech, as a GMP CDMO, we are following this approach through a very well-established versatile plug-and-play manufacturing platform specialized on lentiviral vectors that is scalable, regulatory compliant, and cost-effective, allowing shorter set-up phases and covering all stages to commercial.
Importantly, while recognizing that automation and a platform-based approach is key to the reshaping of the roles and capabilities of CDMOs, I also consider that keeping a high degree of specialization and expertise both in virology and bioprocess is essential to be a real strategic contributor in the drug development life cycle in very innovative fields, such as cell and gene therapy.
Carol Houts, Chief Strategy Officer, GermFree
Digital platforms for quality management systems and process controls are a critical advance, enhancing efficiency and regulatory compliance while providing for more data sharing between CDMOs and their clients. This improves outsourcing models for pharmaceutical innovator companies and makes manufacturing in these models more feasible. These platforms integrate data and utilize analytics for process optimization and provide quality management systems that drive efficiencies and quality improvements.
For CROs, decentralized clinical trials have revolutionized patient engagement by leveraging advanced electronic date capture, telehealth, and wearable devices, improving recruitment and data accuracy. Decentralized healthcare models expand access to care, especially in remote areas, supported by scalable manufacturing solutions from CDMOs for access to medicines.
Technologies like blockchain, ML, and AI enhance data transparency, security, and analysis, optimizing trial design and patient matching. Additionally, advancements in flexible manufacturing and personalized medicine allow CDMOs to adapt rapidly to changing demands, ensuring the production of personalized treatments at scale.
Overall, these technological innovations drive greater efficiency and flexibility, and keep patients at the center of drug development, leading to improved patient outcomes and more effective treatments.
Priya Baraniak, Ph.D., Chief Business Officer, OrganaBio
Through adoption of digital technologies and data analytics, from R&D to manufacturing and clinical trials, data-driven insights are enabling more efficient processes, faster decision-making, and improved outcomes. Automation and robotics are streamlining operations by increasingly handling repetitive tasks, leading to increased productivity, reduced operator errors, enhanced safety, and lower regulatory burden. In research, automated high-throughput screening systems are accelerating drug discovery processes.
Advanced therapies demand specialized expertise and capabilities from CDMOs and CROs. These therapies require complex manufacturing processes and unique regulatory considerations, prompting these organizations to invest in cutting-edge technologies, including new bioreactor platforms and AI/ML, and develop specialized skills to meet the evolving needs of drug developers. This rapidly evolving landscape is fostering a more collaborative and integrated approach to drug development, ultimately accelerating the delivery of innovative therapies to patients.
Matthew Hewitt, Ph.D., Vice President, CTO Manufacturing, Charles River Laboratories
The pace of technological advancement has only been gaining steam. One reason for this, therapeutics are becoming more complex. Two areas in particular, second-generation biologics and advanced therapeutics (cell/gene therapy and nucleic acids), use pieces of biology or complete biology (e.g., CAR-T cells/AAV viral vectors) to elicit a therapeutic effect in patients. Even as these therapies get more complex, the overarching goal is to make the CGMP manufacturing processes approachable via closed, automated processing so manufacturing staff don’t need specialized training/tribal knowledge. At the same time, these processes must maintain their robustness, so a high-quality therapeutic product is provided to patients. The path to CGMP manufacturing for all programs starts in process and analytical development, where technology has been evolving to support more streamlined, predictive product development. There are systems which allow process development staff to use scaled-down manufacturing platforms (i.e. AMBR) to simulate larger-scale manufacturing. We have sufficient confidence in these small-scale systems and how they will translate to the larger-scale manufacturing processes required for clinical and commercial activities. Even as these technological advanced have streamlined therapeutic development to clinical and commercial, there remains a need for staff with the tribal knowledge/understanding to appropriately apply these systems in the right use-cases.
It’s something our CDMO teams do frequently when chatting with partners. The conversation typically begins by asking what the success criteria are for manufacturing, how many doses (biologics/viral vectors) or what dose (autologous cell therapy) are required for dosing a specific patient then working backwards to determine the best-fit technology. The best summation to the question is while technology continues to advance at a rapid pace, human input and expertise are still required to properly utilize these new technologies, and choosing the right CDMO team to advance a therapy to clinical and commercial is critical.
Beate Mueller-Tiemann, Ph.D., Chief Technology Officer, Cytiva
Advancements in digital, AI, and biological platforms have revolutionized the ways service providers support the industry. The core competencies of drug development, once reserved for leading pharmaceutical companies, can now be achieved by leading CDMOs and CROs.
The rise of AI and mechanistic modelling also opens significant innovation opportunities for new service offerings. Using these technologies, providers assist in designing target proteins for their developability and manufacturability, adding value throughout the customer journey from discovery to commercialisation. The move toward in silico process development can also speed up the creation of chemistry, manufacturing, and controls (CMC) packages, with the opportunity to leverage historical data set.
The rise of complex protein therapies, such as multi-specific monoclonal antibodies (mAbs) and antibody–drug conjugates, underscores the need for advanced biological platforms. These therapies involve multiple mechanisms within a single drug molecule, presenting production challenges like consistency of quality. To address this, service providers are developing proprietary technologies for protein design and production, aiming to reduce or eliminate such issues.
Wade Macedone, Chief Executive Officer, Andelyn Biosciences
Advancement in science, whether in research or in biomedical applications, has always been closely wedded to the latest enabling technologies. We have a standalone 42,000 square foot Andelyn Development Center (ADC) that houses our Process Development and Analytical Development teams, who are constantly evaluating new technologies and how they can be applied to gene therapy manufacturing.
Manufacturing gene therapies for clinical and commercial use is governed by extremely rigorous standards of quality and consistency in the highly regulated GMP environment. Having that sandbox in place at the ADC provides an avenue for safely adopting new technologies that are thoroughly vetted not only for the required reproducibility and reliability but also for the higher degree of accuracy and efficiency they provide for streamlining and optimizing the end-to-end process.
This approach has informed everything from how we developed our high-performing HEK293-derived AAV CuratorTM cell line to adapting innovative analytical methodologies, like moving from quantitative PCR to digital PCR, or evaluating the use of mass spectrometry for empty/full viral vector characterization.
Atul Mohindra, Ph.D., Head of R&D, Biologics, Lonza
There have been a number of advancements in recent years, especially in the areas of cell expression, bioprocessing, and analytical technologies, to better enable the CDMO industry to support customers in different ways throughout the life cycle of drug development. For example, at Lonza, we have invested in new predictive tools and expression platforms, such as our bYlok® technology, which has enabled us to develop more diverse molecular formats. This has allowed us to change the paradigm from being a transactional services provider into more of a solutions provider where we can use our unparalleled expertise to guide our customers to reach their milestones successfully. Similarly, innovation in process intensification and in-line testing technologies has allowed us to improve our capabilities to support our customers’ needs in reducing cost of goods, especially in late-phase development.
Looking ahead, we see the entire industry adapting novel digitalization technologies, robotics, and AI machine learning tools. These new technologies can help address the growing demand to develop therapies faster and more efficiently, thus reducing customer timelines and costs. Lonza is adopting digital technology and automation to streamline operations, decrease manual involvement, and improve data-driven decision-making. Staying at the forefront of these trends is crucial to delivering exceptional value to our clients.
Kevin Wysocki, President, Clinical Research, ProPharma
AI and ML technology are disrupting business processes across industries, and the role of CROs in the drug development life cycle is no exception. With greater volumes of clinical data available, CROs are tasked with helping sponsors understand the data as efficiently and quickly as possible to drive more informed decision-making throughout the drug development life cycle.
Precision is key to finding the signals in the noise. Here are two examples:
Clinical trial design: CROs can leverage AI to determine inclusion and exclusion criteria and identify subjects most likely to respond to a specific treatment. Such precision can accelerate the results and reduce the risk of not having sufficient participants to complete the trial.
Clinical correlation: Multimodal algorithms can better identify clinical correlation by ingesting multiple and varied data sets, including omics data, medical images, and other relevant medical record information.
With increased investments in rare diseases and orphan drugs, digital twins — a data science method for developing synthetic control arms using real-world data — are another emerging technology CROs are adopting to accelerate clinical research.
Fady Boctor, President and Chief Commercial Officer, Petros Pharmaceuticals
CDMOs and CROs are currently undergoing significant operational shifts toward expediency and efficiency under the auspices of technological advancements that will continue to potentiate the truncating, strengthening, and enrichment of sponsor drug development life cycle initiatives. Operational capabilities especially, such as study recruitment, seamless tool integrations, fully virtual or remote trial designs, voluminous data analytics, and the ability to illustrate real-time study progress, trends, and analyses (a sponsor favorite), are only a few of the enhancements dominating the industry.
However, with these developments, it has been our experience and the experience of many industry colleagues to note that these advancements should never be implemented without an onboarding season. In other words, through the art and science of technological advancements, especially around automation and analyses, a learning curve must be scheduled, constantly assessed, and tirelessly mitigated prior to fully trusting the advancement as a “hands-free” or fully autonomous utility. Those that implement such an onboarding and “perfecting” of their advancements will likely rise as industry leaders in the future.
Jaewon Mun, Director of Drug Development Project Management, Samsung Biologics
Above all considerations, CDMOs cannot take on their evolving role unless trust is built into partnerships with their clients. Like sherpas helping mountaineers reach the desired summit with know-how and preventive measures in place, CDMOs should offer expertise and enable their clients to leverage resources in their best interests.
Resources, like cell lines yielding high-titer, versatile development platforms, analytical tools, and intensified modes of manufacturing, need to be readily available in CDMO operations. Such capacity of CDMOs helps pave the route for the client's journey to bring drugs to patients. In other words, a competitive CDMO should voluntarily invite its client to open discussions, embracing challenging inquiries from its counterpart. Such discussions are vital for both parties to establish a drug development and commercialization strategy through comprehensive CMC solutions customized for the client’s unique molecules.
On a more intimate level, the interactions between CDMOs and their clients are becoming transparent and contemporaneous with digitalization. CDMOs' statistics-ready data are exchanged in real time and can be easily integrated into client supply chain management systems. This makes the CDMO–client relationship more cohesive than ever, generating synergy between the two as it bears a greater chance of overcoming challenges around quality, time, and cost.
Overall, the new technology, morphed with customizable models, will enhance the service capabilities of CDMOs and their influence in the drug development life cycle.
Jason Bock, Ph.D., Co-Founder and Chief Executive Officer, CTMC
Biotech companies in the emerging cell therapy space can benefit from partnering with an organization that offers more than manufacturing capacity. Access to technology platforms and solutions can significantly advance the development of these innovative modalities to create a better, more efficacious product.
CTMC’s differentiated TIL (tumor-infiltrating lymphocytes) platform, for example, enables manufacturing to start from a less invasive biopsy versus a full surgical resection requiring a larger tissue sample, which can be challenging for patients with fragile health. Reduced surgical risks and shorter recovery times from a minimally invasive procedure result in a more accessible option for patients who might have previously been excluded from TIL therapy.
Autologous cell therapy is especially complex since each product begins and ends with the patient. The complicated logistics of managing patient samples can require substantial resources; however, our unique relationship with MD Anderson Cancer Center allows us to streamline this process,eliminating the middlemen, so biopsy specimens can immediately progress to the manufacturing stage reducing tumor to vein time.
The collaborative process between biotech partners and CTMC allows for customization of our platform based on their innovative research. Ultimately, this accelerates the development and manufacturing process while increasing efficiency and improving scalability.
Peter Freed, Ph.D., Head of Global Pharma Customer Technical Support (CTS), Roquette
Rapidly advancing technologies are transforming the role of CDMOs and CROs from suppliers to true partners in innovation, empowering them to guide their customers through shifting sector needs while radically improving efficiencies.
A good example is the increasing prevalence of continuous manufacturing (CM) techniques. CDMOs were among the early adopters of CM, helping to push the benefits of streamlined processes and the faster release of products to the market (and into the mainstream). We can see a similar pattern in the rise of 3D printing technology, with many CDMOs and CROs exploring its capacity to unlock personalized medicine, rapid prototyping, and customized delivery systems. It’s not all about all-new solutions though — contract manufacturers can also play an important role in pioneering improvements to existing production lines, such as incorporating in-line process monitoring or automated drug candidate screenings.
There’s the hot topic of AI, too. As in other industries, advanced AI analytics have allowed CROs and CDMOs to process large amounts of data — quickly. This has allowed for the advent of highly accurate predictive monitoring, easier identification of promising new drugs and optimized clinical trial designs. When paired with other tools, such as digital twins, AI can offer manufacturers unprecedented insight into their processes, without the expense or hassle of process interruptions.
Sonya Schermann, Ph.D., Senior Director, Analytics, Ascend Advanced Therapies
The rate of technology development in the gene and cell therapy field is expanding in line with the current increases in clinical trials and approvals for these modalities.
Improvements in yield are always important for sponsor companies, and technologies that allow CDMOs to build high-performing platforms will be key. Developments in cell lines, plasmid design, alternative DNA delivery technologies, and upstream development will be particularly important.
However, productivity will always need to be balanced by quality. As gene therapies are being developed for indications with larger patient populations and lower risk–benefit ratios, quality will become an ever more important factor for sponsors. Key technologies will be those that improve the quality of the therapy, either by improving potency to lower the dose or by reducing the levels of impurities in the product.
This requires not only improved technologies with respect to product and process development but also improved methodologies which can be used to analyze the product quality and therefore truly understand the impact of process improvement.
Anil Kane, Ph.D., Senior Director, Global Technical Scientific Affairs, Pharma Services, Thermo Fisher Scientific
While related technology is advancing at a rapid pace, drug discovery and development remains a long, high-risk process that takes several years and an average cost of $2.3 billion for the development alone. Biotech, biopharma, and pharmaceutical companies rely on having a trusted partner to take them through that complex life cycle with success — and leveraging the latest technological advancements to overcome challenges along the way is imperative.
That’s where having CDMO and CRO capabilities under one roof is a gamechanger. Drug developers increasingly look for a partner with comprehensive, end-to-end solutions — enabled by cutting-edge technology — to accelerate their path to market. For example, in the pre-clinical phase — moving toward an ecosystem of connected clinical trial services, technologically enabled infrastructure helps enable efficient collaboration and holistic program management. This not only provides real-time visibility on program health across services but also establishes centralized accountability and a hub of communication, keeping internal departments aligned throughout the process. Co-creating these customized solutions with a CDMO/CRO partner helps to accelerate drug development goals, while setting new standards for managing clinical trials.
Emily Gateau, Innovation Manager, Exothera
Advancements in technology are transforming the roles of CDMOs and CROs in drug development by enhancing efficiency, precision, and collaboration. The progress of AI-based tools, large data models, and digitalization has significantly impacted data management practices and collaboration between service providers and product developers. As regulatory frameworks evolve, CDMOs and CROs are adopting advanced manufacturing and analytical technologies to enhance the robustness and precision of drug products manufacturing through standardized manufacturing platforms. To reduce costs, automation and robotic strategies are being developed to improve precision and speed in drug testing via automated labs and high-throughput screening. These technological advancements are accelerating the delivery of new therapies.
Jordi Robinson, Chief Commercial Officer, Navin Molecular
Customers working with CDMOs are now expecting the relationship between parties to be a partnership, rather than only transactional, and so CDMOs need to differentiate themselves in a crowded marketplace through high-quality service backed up by a broad range of technical capabilities. Whereas service providers could previously market themselves as “niche suppliers,” constant re-evaluation of supply chains by large pharma companies has seen the necessity for partners to have a wider range of capabilities to meet all of their diverse requirements. The nature of new drugs is the greatest driver for change. The increased number of biologics in the pipeline is impacting the emerging small molecules, with the need for them to be more targeted and having fewer side effects. This means molecular complexity is increasing and has led to CDMOs investing in new technologies: be it for manufacturing to ensure consistent supply of products; or in tools to aid novel drug design to access new molecular space. These challenges are part of the ongoing evolution of new drug development and are offset against the constant need for shorter timelines at every stage, and the economic pressures of having potentially smaller patient populations. Investment is vital for CDMOs to keep pace with these demands, with a view to securing and maintaining the long-term relationships with customers.
