CMC STRATEGY & TECHNICAL SUPPORT
Overcome the Challenges of New Drug and Biologic Development
The continuously evolving CMC regulatory landscape presents a steady challenge to the development of new drugs and biologics.
Research and development is based on science and product development, taking up to 15 years from discovery to launch. One reason is the FDA’s expectation that companies adopt new paradigms of drug development (e.g., QbD/PAT), which increase testing and controls while adding major CMC challenges. Our strategic CMC regulatory solutions are designed on a case-by-case basis by evaluating each client’s scientific and technical situation.
SERVICE OVERVIEW
CMC Strategy & Technical Support
Ayd Group offers stage-appropriate technical support for each phase of development from first-in-human clinical trial material through optimized finished drug product for commercial approval. In certain situations, challenges come into play, such as when building the CMC based on third-party CDMO-supplied information. Particular attention to detail is needed when developing criteria for incoming, in-process and release specification limits for the API — all active and inactive ingredients in the formulation — as well as the container and closure, etc. Not to mention evaluation of process validation data, etc., and all of this as production quantities scale.
Here are some examples of what we do:
- Define the “Right Content” for All Regulatory Submissions
- Investigational applications (IND/CTA)
- Marketing application (NDA/MAA)
- Type II Drug Master Files (DMF)
- Manage Critical Quality Issues during Development
- Genotoxic impurities/degradants, stability
- Materials, process controls, specification
- Formulation/process changes during development
- “Right-Size” the CMC Content
- Build, as needed, for different phases of clinical development
- Update content, tighten limits and validate methods and processes in step with technology advances and scale
- Regulatory Agency Meetings (Pre-IND, EOP-2, Pre-NDA, Type C, Scientific Advice)
- CMC Regulatory Due Diligence (for In-license or out-license)
RESOURCES
US FDA Web-based Training Course: “Chemistry, Manufacturing, and Controls (CMC) Perspective of the Investigational New Drug Application (IND)” CLICK TO VIEW
US FDA Presentation: “Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations” DOWNLOAD
Sample Engagements
Provided CMC strategy, pre-clinical/clinical development and regulatory strategy road map for a South Korean company developing a novel microneedle combination product in the US for USFDA approval. In scope will be a pre-IND meeting request.
Provided support to an early-stage oncology cell and gene therapy company by translating FDA nonclinical guidances into a roadmap which will help them identify their lead candidate. Assisted client to conceptualize proof-of-concept study details and plan for other toxicology studies required to support a pre-IND meeting request.
Provided non-clinical and regulatory support to a not-for-profit research entity pioneering novel treatments for acute myeloid leukemia (AML). Performed a gap analysis on nonclinical studies conducted and their outcomes against FDA regulations. Provided client with a written report of findings and recommendations.
A physician conceived to use an FDA-regulated food component as a Sars-COVID-2 treatment due to its demonstrated anti-viral properties. The treatment is indicated in mild-to-moderate cases where the patient is deemed unlikely to get worse. In an IND meeting facilitated by Ayd Group, the FDA gave Fast-Track status, and the client went directly into Phase 2 clinical study. There is potential for the FDA to grant Emergency Use Authorization (EUA) within the year. The physician wants to create a virtual pharma company that can outsource critical functions to third parties. This will put him in a position to manufacture and distribute the therapeutic treatment if EUA is granted. Ayd Group was retained in the first phase of work to develop a strategic plan to enable the new pharma company to operate in a regulation-compliant fashion on Day 1. Day 1, defined as the earliest conceivable date when the FDA would issue the EUA, was arrived at by making “best case” assumptions and reverse-engineering goals the company needed to complete. Phase 2 of the project is in progress. Ayd Group has been retained as the company’s Acting EVP, Regulatory Affairs, as well as role of “Integration Specialist” to help build the infrastructure needed to operate.
Assisted a client whose already FDA-approved product is a “510k Device” to pursue FDA approval for the same product but as a drug via an ANDA submission. Interestingly, there is a reference listed drug, and so the client’s goal was to provide the same product as a drug and device (with different indications) simultaneously. Ayd Biopharma oversaw the entire reverse engineering process and their development of a generic equivalent of the RLD. Additional support will be to author the entire ANDA and assist the client’s submission.
Don’t Let Regulatory Changes Overwhelm Your Development Efforts.
We’ll help you gain control and be prepared for the challenges that you face now and those that lie ahead. Contact us to arrange a free consultation.