Cell and gene therapies (CGTs) are quickly emerging as valuable approaches for the treatment of complex diseases. The development of these treatments, especially Advanced Therapy Medicinal Products (ATMPs), requires careful planning and collaboration to accelerate the path to Investigational New Drug (IND) application. By understanding regulatory standards and improving management of strategic partnerships, biopharma organizations can better navigate this pivotal stage of R&D and accelerate the delivery of life-changing therapies.
Maintaining regulatory standards in IND applications
IND applications are a critical milestone in the development of new therapies, as they serve as a regulatory gateway in the transition from preclinical research to clinical trials. For CGTs, the IND process involves coordination of preclinical, clinical and Chemistry, Manufacturing and Controls (CMC) timelines. Each of these components must adhere to strict regulatory standards, enforced by agencies such as the FDA, to ensure the safety of the drug candidate.
In the preclinical phase, comprehensive data must be gathered to demonstrate the potential benefits and safety of the drug through in vitro and in vivo studies. These studies must be carefully designed and executed to meet regulatory expectations, often requiring advanced technologies to provide reproducible results. These highly technical studies are often completed by leveraging external partnerships specializing in the required methodologies. Identifying high-quality vendors and maintaining regulatory standards across these partnerships is a key challenge in successfully progressing to clinical trials.
Clinical timelines add another layer of complexity, involving multiple phases of trials, each with specific regulatory requirements for enrollment, data collection and reporting. The transition from preclinical to clinical stages must be handled carefully, often done by utilizing external vendors, to ensure compliance with Good Clinical Practice (GCP) guidelines.
The CMC activities of the IND application present a unique set of challenges. This component must demonstrate that the drug can be consistently manufactured to meet quality standards. It involves detailed information on the drug’s composition, manufacturing process, quality control measures and stability. Aligning these aspects with regulatory expectations requires Good Manufacturing Practice (GMP) standards and frequent communication with a range of stakeholders.
Managing multiple vendors and partnerships
A successful IND application requires a well-coordinated approach internally as well as a one that leverages strategic partnerships with CROs and CDMOs across preclinical, clinical and CMC timelines. While these partnerships present the opportunity for efficiency, the process of identifying and comparing potential vendors, coordinating legal agreements, managing communications and standardizing project management and quality across all parties is rife with its own set of challenges.
With more than a decade of experience connecting researchers in the biopharma industry with external service providers, Scientist.com presents a complete procurement solution that enables companies to identify, evaluate and manage strategic partnerships on a single platform under one legal agreement. Scientist.com leverages years of business intelligence, data and in-house industry experts and SMEs to facilitate productive partnerships between the world’s leading researchers and 5,000+ catalog and service providers, including BioIVT, Charles River Laboratories, Precision for Medicine and VectorBuilder amongst many others in the CGT space.
What’s next in CGT?
CGT will undoubtedly continue evolving and play an increasing role in drug discovery in the coming years. To learn more about streamlining cell and gene therapies through IND application, join Scientist.com on Thursday, October 17 for the live webinar, From Bench to Clinic: Decoding the IND Roadmap for Innovative Cell and Gene Therapies. Here, Grace Lee, PhD, MBA, CQA, Founder of Elevalue Consulting LLC, will share how to best navigate the intricacies of CMC development for IND applications. She will be joined by Scientist.com’s Vice President of Pharmaceutical Development and Manufacturing, Frederik Deroose, PhD, who will explain how organizations can easily manage all aspects of IND applications, from preclinical studies to clinical trials.
To register for the live webinar, or to receive an on-demand recording, please click here.
- SEO Powered Content & PR Distribution. Get Amplified Today.
- PlatoData.Network Vertical Generative Ai. Empower Yourself. Access Here.
- PlatoAiStream. Web3 Intelligence. Knowledge Amplified. Access Here.
- PlatoESG. Carbon, CleanTech, Energy, Environment, Solar, Waste Management. Access Here.
- PlatoHealth. Biotech and Clinical Trials Intelligence. Access Here.
- Source: https://www.biopharmadive.com/spons/streamlining-ind-applications-for-cell-and-gene-therapy-innovations/727187/