Steve Sibley, Vice President Regulatory Strategy, Certara Drug Development Solutions
Accelerating drug approvals demands balancing speed with patient safety and regulatory rigor. High-quality regulatory writing is crucial to this process, offering clear and structured documentation like Clinical Study Reports (CSRs), Common Technical Document (CTD) modules, and Risk Management Plans (RMPs). These documents enable regulatory agencies to evaluate a drug’s benefits and risks with accuracy. Transparent patient narratives and lay documents further build public trust while meeting compliance standards.
On the regulatory operations front, leveraging solutions, such as electronic CTD (eCTD) submissions, automation, and structured content management, streamlines workflows, minimizes redundancies, and ensures consistency across global filings. Simultaneous multi-agency submissions and adherence to evolving guidelines like EMA Policy 0070 for data transparency play a critical role in reducing delays.
The synergy of precise regulatory writing and optimized operations ensures faster approvals without compromising patient safety. By integrating advanced technology, strategic submission planning, and comprehensive documentation, the industry can fulfill the dual goal of meeting regulatory expectations and providing timely access to life-saving therapies.
Joern Hoffmeyer, Ph.D., Head of Innovation and Portfolio Management, MilliporeSigma, the Life Science business of Merck KGaA, Darmstadt, Germany
The challenge of balancing faster drug approvals with patient safety and efficacy is critical in our life science industry. Innovations in rapid methods testing technologies that accelerate virus testing of bulk harvest material can significantly reduce biosafety testing timelines and deliver the highest quality standards, compared to traditional assay methods.
In addition, next generation sequencing (NGS) technology has the potential to unlock innovative capabilities for clients — reducing the time for traditional test results from weeks to just days, significantly enhancing this balance for efficacy and safety.
Siddhi Shah, Head of Strategy Development & Governance for Process Solutions, MilliporeSigma, the Life Science business of Merck KGaA, Darmstadt, Germany
Balancing speed with safety in drug approvals requires a multifaceted approach: leveraging adaptive trial designs, utilizing real-world evidence, and enhancing regulatory collaboration. Further guidance from the FDA, informed by the majority of approved products, provides valuable insights to refine processes and mitigate risks. Advances in artificial intelligence (AI), biomarkers, and real-time analytics enable continuous monitoring, ensuring patient safety while accelerating approvals. A risk-based approach — prioritizing high-impact innovations and robust post-market surveillance — can help the industry achieve both speed and efficacy.
Varta Patel, Regulatory Affairs Manager, Roquette
There are several strategies at drug producers’ disposal to expedite regulatory pathways, including processes like Fast Track Approval, Breakthrough Therapy, Accelerated Approval, and Priority Review. Used in combination with robust testing data, these programs provide a faster route to review and approval without compromising drug safety and effectiveness.
Manufacturers sometimes face a tradeoff between the efficacy or stability-enhancing features of incorporating novel excipients or processing technologies and the increased approval time which comes as a result. Regulatory initiatives, including the U.S. FDA’s PRIME (Pilot Program for the Review of Innovation and Modernization of Excipients) program, exist to overcome this dilemma, speeding up the evaluation of such excipients to accelerate approvals and remove barriers to innovation.
Strengthening pharmacovigilance strategies to proactively identify and mitigate post-market safety concerns is another key component of ongoing compliance. Effective surveillance systems capable of quickly detecting adverse events are producers’ most valuable tool for reinforcing patient safety and regulatory compliance, even within expedited approval frameworks.
This leads us to an often-overlooked factor in drug approvals — the patient perspective. To build a truly user-centric approach to pharma regulation, patient involvement needs to be integrated at every stage — from raw material selection, drug development and trial design to approval, labeling, and post-market monitoring. Strategic collaboration of this kind between regulatory agencies, pharmaceutical companies, and patient advocacy groups ensures treatments meet patient needs while remaining safe, efficacious and accessible.
Taeheui Lee, Vice President, Head of Antibody Cell Culture Process Development, Samsung Biologics
The path to drug approval, including Investigational New Drug (IND), is a crucial phase. Successful drug development requires technologies, platforms, and experiment designs tailored to accommodate the unique characteristics of a biologic, along with customized chemistry, manufacturing, and controls (CMC) strategies. Drug developers need a reliable partner who can facilitate transparent communication and use every resource possible to handle any inquiries in time.
The role of contract development and manufacturing organizations (CDMOs) is to be a reliable partner to those who may need the infrastructure and expertise for process/formulation development, GMP manufacturing, analytical validation, and stability studies. Biotechnology and pharmaceutical companies expect CDMOs to provide expertise in CMC, scalable productions, and regulatory compliance to help accelerate IND submissions without compromising quality.
By leveraging the expertise and experience of reliable CDMOs, drug developers can achieve efficacy and high quality for their projects. De-risked manufacturing and optimized technology transfers are also some of the essential services that CDMOs should provide.
Balancing the need for faster drug approvals while ensuring safety and efficacy calls for collaboration. That is in part why the industry’s reliance on CDMOs has become larger in recent years; the greater the role the industry expects from CDMOs, the greater the responsibility becomes for the contract service provider.
Samsung Biologics embraces such sense of responsibility; we call it a quality mindset. We work together from the client’s perspective, where advanced technologies and state-of-the-art facilities are the foundations from which we build our track record of client satisfaction.
End-to-end drug development and manufacturing cannot be done by one single entity, and we are continuously working to address the current and future needs of our clients.
Jennifer Cannon, Ph.D., President, Commercial Operations, Pharma Services, Thermo Fisher Scientific
CDMOS and Contract Research Organizations (CROS) are in a unique position to manage the relationship between rapid technical innovation and human-centricity that helps ensure patients have access to safe and effective medications. Our teams at Thermo Fisher Scientific are tackling that with a “360-degree” methodology, leveraging our comprehensive service offering to simplify and speed up the complex drug development journey. It’s all about providing customized solutions specific to the needs of our customers and, in turn, their patients.
For example, our teams deployed this methodology to help a biotech in the preclinical phase swiftly resolve assay development and active pharmaceutical ingredients (API) release issues — avoiding an 18-month project delay. By leveraging Thermo Fisher’s combined CDMO/CRO solutions, the biotech company was able to speed up time to clinic and advancement through the clinic to commercialization, streamline drug substance specifications and tests, enhance efficiencies and eliminate redundancies. This saved time and costs and enabled faster drug approval without negatively impacting safety or efficacy.
The ability to closely monitor and quickly adapt remains a critical component of overcoming potential challenges along the clinical development journey and, therefore, ensuring patients receive their drugs in a safe and effective manner.
Christine Allen, Co-Founder and Chief Executive Officer, Intrepid Labs
Balancing faster drug approvals with patient safety and efficacy is essential for advancing healthcare. At Intrepid Labs, we address this challenge by focusing on rapid and robust drug formulation optimization — an essential, yet frequently overlooked step in drug development. Effective formulations enhance therapeutic outcomes and reduce the risk of adverse reactions, directly contributing to patient safety and efficacy.
Our advanced modular self-driving laboratory leverages machine learning and robotics to accelerate the identification and characterization of optimized drug formulations. By reducing the formulation development timeline from months to days, we effectively tackle critical bottlenecks in the drug development pipeline. Given that formulation issues significantly contribute to clinical trial failures, our technology offers a transformative approach, enabling safer, more effective medications to reach patients more quickly.