Biologics & Advanced Therapies: AI-Powered Applications

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Regal Intel is a dedicated non-profit partner committed to helping innovators navigate the highly complex development, manufacturing, and regulatory landscape for biologics and advanced therapies. Our specialized guidance leverages AI-powered intelligence to address sophisticated challenges, from navigating intricate global pathways and designing appropriate clinical trials to ensuring rigorous post-market stewardship, ultimately accelerating patient access to these transformative therapies.

Successfully bringing biologics and advanced therapies for rare diseases to patients requires navigating multifaceted regulatory requirements. Our AI-driven platform provides solutions for:

• Expedited Pathways: We use AI to help secure and manage designations critical for rare diseases, including Orphan Drug Designation (ODD), Regenerative Medicine Advanced Therapy (RMAT), PRIME, Fast Track, and Breakthrough Therapy Designation.
• BLA/MAA Submissions: We guide manufacturers through the complexities of Biologics License Applications (US) and Marketing Authorisation Applications (EU) specifically for rare disease indications.
• Global Regulatory Strategies: We use AI-powered analytics to develop cohesive strategies for achieving patient access across international markets, tailored to the specific needs of rare disease biologics and advanced therapies.

Clinical development demands specialized expertise, particularly given the nature of these therapies and target populations. Our AI-driven platform provides guidance for:

• Clinical Trial Design: We leverage AI to develop protocols tailored for rare diseases, addressing challenges like small populations, immunogenicity, and long-term follow-up studies.
• Safety Monitoring: We help implement robust safety monitoring plans to manage unique potential risks (e.g., cytokine release syndrome, insertional mutagenesis) and ensure patient safety. Our AI models can help identify and analyze potential long-term adverse events.
• Data Management: We use AI to handle complex clinical data generated in specialized trials, ensuring the integrity and usability of data for regulatory submissions.

Manufacturing biologics and advanced therapies involves significant complexity. Our AI-powered solutions address these challenges, from manufacturing to post-market monitoring. We provide expert support for:

• cGMP Compliance: We assist in meeting stringent cGMP requirements, including specific guidelines for advanced therapy medicinal products (ATMPs).
• Process Development & Validation: We use AI to support the development, optimization, and validation of complex manufacturing processes (e.g., vector production, cell expansion, purification).
• Pharmacovigilance Systems: We help develop and implement robust pharmacovigilance (PV) systems tailored to capture unique long-term or delayed adverse events with AI-powered signal detection.
• Risk Management: We assist in creating and implementing comprehensive Risk Management Plans (RMPs) or Risk Evaluation and Mitigation Strategies (REMS) to address identified risks.

Our expertise is applied across various product types, always with a focus on applications targeting rare and orphan diseases. Our AI-powered platform provides support for:

• Biologics (e.g., monoclonal antibodies, recombinant proteins)
• Advanced Therapies (e.g., cell and gene therapies)
• Specialized Vaccines
• In Vitro Diagnostics & Companion Diagnostics