Introduction to Enkrisi: Learn about Enkrisi, a full-service regulatory and product development consulting firm, specializing in biologics, pharmaceuticals, and medical devices. Understand their mission to help companies bring innovative and safe products to the U.S. market.

The Complexities of Product Development: Explore the challenges faced by emerging biotech companies in navigating the regulatory landscape. Understand the importance of establishing a concise CMC development and regulatory strategy to ensure successful product development.

Optimizing Spending and Mitigating Risks: Discover Enkrisi's approach to helping companies make informed decisions while keeping spending to a minimum until critical clinical milestones are met. Learn how they identify and mitigate associated risks to ensure a smooth regulatory process.

Engaging with Regulatory Agencies: Gain insights into the expertise of Enkrisi's team in approaching regulatory agencies. Understand the importance of having a strong regulatory package to achieve approval and bring products to market.

The Enkrisi Difference: Delve into the philosophy behind Enkrisi's founding and their commitment to a better future through innovative approaches, world-class science, and regulatory know-how. Learn how they become trusted partners in the journey toward regulatory success and product development excellence.

Closing Thoughts: Recap the key takeaways from the episode and highlight the value of Enkrisi's services for emerging biotech companies seeking regulatory approval for their products.

Join us in this episode as we dive into the world of regulatory challenges and gain valuable insights from Enkrisi, your trusted partner in navigating the complex realm of biologics, pharmaceuticals, and medical devices.

When developing modified-release oral solid dosage forms, important considerations include selecting the appropriate release mechanism, establishing the optimal release profile, understanding regulatory requirements, addressing CMC considerations related to formulation, manufacturing, and testing, considering BCS classification and biowaiver, developing a clinical development plan, and protecting intellectual property. API characterization and pre-formulation work provide benefits such as improved understanding of API properties, identification of formulation challenges, support for regulatory submissions, enhanced process understanding, better manufacturing control, and improved prediction of product performance in the human body. Health authorities expect to see key CMC development data, including formulation details, manufacturing processes, analytical method development and validation, stability information, in-vitro release studies, BCS classification and biowaiver status, clinical development plan and data, and comparative data. These data are necessary to demonstrate the suitability and quality of the modified release product for regulatory approval.

Quality-related issues, adverse events, product complaints, and recalls are common in the pharmaceutical industry, occurring at any stage of manufacturing. Issues can arise from raw materials, equipment, or processes, leading to contamination, labeling errors, or deviations. Adverse events include allergic reactions and side effects, while product complaints involve problems reported by customers. Recalls involve the voluntary or mandatory removal of products due to safety concerns. Handling and reporting these issues require steps such as identification, containment, root cause analysis, reporting, and record-keeping. Regulatory requirements may vary, so consulting with relevant agencies is recommended.

This audiocast discusses the impact of Artificial Intelligence (AI) and Augmented Intelligence on regulatory strategies and submissions in drug development. AI methods, such as predictive analytics and machine learning, can aid in quality control decision-making, cost reduction through corrective action plans, and identifying data requirement issues early on. The audiocast presents an example of an emerging biotech company using AI-powered software to generate a CMC submission for a new drug candidate, resulting in time savings and reduced errors. It emphasizes the importance of understanding drug development goals, selecting appropriate AI tools, and assembling a capable team to leverage AI's potential in improving the regulatory CMC process.

This audiocast discusses the guidelines for designing drug substance and product stability studies, which can be complex and challenging. The FDA provides general principles, but interpretation and uncertainty can arise regarding meeting FDA requirements. The International Conference on Harmonisation (ICH) provides guidelines for stability testing, including storage conditions, duration of testing, statistical analysis, and establishing shelf life. The audiocast explains the process of stability testing, which involves developing a protocol, conducting accelerated and long-term testing, monitoring stability, analyzing data, and reporting results. It emphasizes the importance of using validated methods and following regulatory guidance to ensure the safety and quality of drug products.

This audiocast focuses on tech transfers in contract manufacturing projects. The success of a tech transfer depends on factors like product lifecycle stage, communication, and risk assessment. Thorough documentation and collaboration are crucial. Customers evaluate success based on cost, milestones, and quality. Choosing the right CMO is important.

This audiocast discusses navigating CMC guidance, meeting regulatory requirements, drug substance/product information, FDA expectations, and quality requirements for progressing from Phase 2 to Phase 3.

This audiocast highlights the importance of setting specifications for FDA-regulated products to ensure quality and safety. The FDA provides guidance on scientific-based specifications that should be regularly reviewed. Specific requirements exist for various dosage forms, and testing should follow validated methods and established specifications. Compliance with FDA regulations allows for tailored specifications while meeting federal law.