Navigating the Future of Contract Research and Manufacturing Organizations

In an exclusive interaction with India Pharma Outlook, Dr. Mahesh Bhalgat, CEO and MD of Veeda Clinical Research Limited, discusses key trends in the CRO/CDMO industry, such as digital transformation, niche specialization, global expansion, compliance, sustainability, and personalized medicine—factors shaping roles and strategies in an evolving market. Dr. Bhalgat, an accomplished leader with over three decades of experience in global biopharma, CRO, CDMO, and CRAMS sectors, is known for his strategic expertise in operations, quality, and regulatory functions, having held senior roles with Syngene, Sanofi, and Biological E Limited.

What are the current key trends shaping the landscape of CROs and CDMOs in the global pharmaceutical industry, and how are these trends influencing their roles and strategies?

The CRO/CDMO sector has always been an important part of the pharma industry. Recently, with cost and time pressures, the role of this sector has further been enhanced, as seen by the growth of the pharma-biotech outsourcing industry. For players in the CRO/CDMO space to continue significant contributions, there is a need to keep up with the evolving trends, some of which are identified below:

The COVID-19 pandemic accelerated the adoption of digital technologies in CROs and CDMOs. This includes the use of artificial intelligence (AI) and machine learning (ML) for drug discovery, process optimization, and predictive maintenance. One notable case study involves the AI-powered platform AIDDISON, used by a CRO to enhance drug discovery. AIDDISON integrates AI and machine learning (ML) with computer-aided drug design (CADD) tools to streamline the identification and optimization of drug candidates. This platform allows scientists to perform virtual screening, predict ADMET properties, and conduct molecular docking experiments efficiently. By leveraging AI, the CRO can accelerate the drug discovery process, reduce costs, and improve the success rate of identifying viable drug candidates.

In the realm of process optimization, AI and ML are used to enhance manufacturing processes.  For instance, in additive manufacturing, AI algorithms can optimize parameters to ensure high-quality production with minimal waste. This involves analyzing large datasets to identify patterns and make real-time adjustments, leading to improved efficiency and reduced costs. Through AI-driven predictive maintenance, ML algorithms can predict potential failures by analyzing data from machinery and equipment before they occur. This proactive approach minimizes downtime and extends the lifespan of equipment.

This is a very important criterion when it comes to manufacturing.  Specifically for biologics, cell lines that give high yields can significantly improve the cost of goods. High-yielding cell lines produce more of the desired product (like proteins or antibodies) per batch resulting in saving time and resources. High-yielding cell lines allow CDMOs to scale up production more easily to meet market demand without a proportional increase in costs

How have recent technological advancements, such as AI and digital transformation, impacted the operational efficiencies and service offerings of CROs and CDMOs?

AI and digital transformation have revolutionized CROs and CDMOs by enhancing data analysis, predictive modeling, and process automation. These technologies streamline drug discovery, development, and manufacturing, leading to faster and more cost-effective operations.

AI-powered automation streamlines routine tasks such as data entry, monitoring, and reporting. This reduces manual intervention, minimizes human error, and allows staff to focus on more complex and value-added activities.

CROs and CDMOs can leverage AI to analyze large datasets quickly and accurately, leading to more informed decision-making and improved outcomes in clinical trials and manufacturing processes. AI-driven predictive analytics help in forecasting demand, optimizing supply chains, and predicting potential issues before they arise. This proactive approach enhances operational efficiency and reduces downtime.

Digital transformation facilitates the development of personalized medicine by enabling the analysis of genetic, clinical, and lifestyle data. CROs and CDMOs can use this information to develop tailored treatments, improve patient outcomes and expand their service offerings.

AI and digital tools help ensure regulatory compliance by automating documentation and reporting processes. This reduces the burden of compliance and helps organizations stay up to date with evolving regulations.

What are the primary challenges that CROs and CDMOs face in maintaining regulatory compliance across different regions, and how are they addressing these challenges?

There are several examples of challenges faced by CROs/CDMOs which need to be addressed on an ongoing basis.

Diverse Regulatory Framework:The changes in the regulatory landscape are important for CRO/CDMOs to understand and adapt to. Along with robust regulatory surveillance, it’s important to have team members (and/or local regulatory experts) present in important jurisdictions. Through such a global presence, CRO/CDMOs can interact with regulatory authorities more efficiently and help in both interpretation and implementation of regulations.

Data Privacy and Cybersecurity: Data privacy laws, such as GDPR in Europe, require stringent measures to protect personal data. Ensuring compliance with these laws across multiple regions is complexand has to be achieved through a combination of different approaches.

Language, Cultural, and Ethical Differences: Differences in language, culture, and ethical standards can add complexity. Misunderstandings or misinterpretations of regulations can lead to non-compliance. CROs/CDMOs are hiring multilingual staff and providing cultural competency training to ensure clear communication and understanding of local regulations. They also engage local consultants to bridge cultural and ethical gaps.

Resource and Supply Chain Constraints: Regulatory compliance often requires significant resources, including time, money, and personnel. Supply chain disruptions can also impact compliance, especially when sourcing materials from different regions. Organizations are adopting digital tools and automation to streamline compliance processes and reduce resource burdens. They are also diversifying their supply chains to mitigate risks and ensure a steady supply of compliant materials.

How is the evolving demand for personalized medicine and biologics influencing the services and capabilities of CROs and CDMOs?

The rising demand for personalized medicine and biologics is driving CROs and CDMOs to enhance their capabilities in precision drug development and specialized manufacturing. They are investing in advanced technologies and expanding their expertise in biologics, including cell and gene therapies. This shift also necessitates navigating complex regulatory landscapes and adopting sustainable practices to meet industry standards.

Enhanced Technological Integration

Integrating Artificial Intelligence and Machine Learning with analytical data helps in predictive insights and optimization strategies, improving efficiency in drug discovery and manufacturing processes.  Especially in biologics manufacturing, it is important to build systems that take upstream data and build predictive models on product quality.  This helps in avoiding downstream batch failures due to product quality issues.

Focus on Personalized Therapies

CROs and CDMOs are offering more tailored and scalable solutions for biologics and gene therapies. The uniqueness of personalized medicine requires a specific design of clinical trials, so it’s important for CROs to work with sponsors and design clinical trials for such a focused group of patients, which provides for strong scientific bases and regulatory compliance at the same time.

Data Management and Analytics

The ability to handle large volumes of data efficiently is becoming a priority. Advanced data analytics, supported by AI, are transforming clinical trials and drug development by enabling more accurate predictions of drug efficacy and safety.

These platforms facilitate seamless collaboration and data sharing among global teams, improving operational efficiency and decision-making.

Regulatory and Quality Control

CDMOs are playing a crucial role in navigating the complex regulatory landscape for personalized therapies. They help in optimizing processes to meet regulatory requirements and ensure quicker quality control release.

Defining critical process parameters (CPPs) and critical quality attributes (CQAs) is essential for maintaining the quality of personalized therapies. CDMOs use design of experiments (DoE) principles to optimize these parameters.

In what ways are CROs and CDMOs adapting their business models to respond to the increasing need for integrated and end-to-end solutions from pharmaceutical companies?

Many CROs/CDMOs are expanding their capabilities to offer comprehensive services that cover the entire drug development lifecycle, from early-stage research to commercial manufacturing. This approach helps pharmaceutical companies streamline their processes and reduce the complexity of managing multiple vendors. The primary motivations for vendor consolidation include cost efficiency, streamlined operations, and improved quality control. As a result, pharmaceutical companies are increasingly partnering with integrated CROs and CDMOs. These integrated entities offer a comprehensive range of services, from research and development to manufacturing, allowing pharma companies to consolidate their supply chain, enhance collaboration, and accelerate time-to-market for new drugs. Integrated organizations offer more & better services from the same location, as well.

Technological Advancements:CROs and CDMOs are investing in digital technologies that help in optimizing clinical trials, improving data management, and accelerating drug development timelines.The adoption of automation and robotics in manufacturing processes is helping CDMOs increase production efficiency, reduce human error, and ensure consistent product quality.

 Flexibility and Scalability: To accommodate the varying needs of different projects, CDMOs are investing in modular and flexible manufacturing facilities that can be quickly adapted to different production scales and processes. With scalable solutions CROs and CDMOs are able to support pharmaceutical companies from small-scale clinical trials to large-scale commercial production, ensuring a smooth transition as the project progresses.

Looking ahead, what are the anticipated future developments and innovations that could transform the role of CROs and CDMOs in the pharmaceutical industry over the next decade?

Biologics and Advanced Therapeutics: The demand for biologics, including vaccines and immunotherapies, will continue to grow, requiring specialized CDMO capabilities. The rise of oral solid dose (OSD) forms for cancer treatments is a key trend taking place across the pharma industry, serving as a more patient-centric alternative to parenteral administration.

Innovations in Regulatory and Compliance Practices: Smaller scale manufacturing will be more essential for precision medicine. Therefore, a collaborative approach between the technology developers, the CDMOs, and the regulators will be crucial. Regulatory bodies are expected to develop more adaptive frameworks to keep pace with rapid technological advancements, facilitating faster approvals for innovative therapies.

Technology-led Clinical trials: Several aspects of technology-led innovation are likely to be in the future of clinical trials.  Targeted patient matching through real-world data, inclusion of diversity in trial design, use of digital twins and the AI-ML-based approach to biomarker identification for clinical trials are some of the trends that will continue to drive transformation for CROs in the future. CROs will be a key contributor to the data-led revolution through their rich data-driven experience.