What is a Pre-IND Meeting?

Docuply - Herausforderungen rund um das Pre-IND-Filling für Biotech- und Pharma-Start-Ups

As a pharma or biotech start-up, one of the most important steps in bringing a new drug to market is the pre-IND meeting. This meeting, which takes place between the start-up and the FDA or EMA, is an opportunity to discuss the proposed drug development programme and receive feedback from the FDA or EMA on the proposed IND application.

One of the most important aspects of the pre-IND meeting is preparation. It is important that you come to the meeting with a well-prepared and organised presentation that clearly outlines your planned drug development programme. This includes information about your preclinical data, planned clinical trial design and your plans for manufacturing and quality control. Proper document management is essential for collating the required preclinical data and for quality management. Electronic document management systems, such as Docuply, can help here.

Another important aspect of the pre-IND meeting is communication. It is important to communicate clearly and effectively with the FDA or EMA during the meeting and to be open and transparent about your plans and any potential challenges or concerns. It is also important to listen carefully to their feedback and take their comments and suggestions into account as you move forward with your drug development programme.

In relation to the pre-IND meeting, it is equally important to mention regulatory compliance. The FDA and EMA have strict guidelines for IND applications and it is essential to ensure that your proposed drug development programme complies with these guidelines. This may require working closely with regulatory experts to ensure that your plans comply with their requirements.

Funding is also an important consideration for pharmaceutical or biotech start-ups in the context of the pre-IND meeting. Developing a new drug can be an expensive process and it is crucial that you have sufficient funding to support your development programme. This includes presenting a solid business plan to investors and demonstrating the potential value of your drug.

Finally, time management is an important aspect of the pre-IND meeting. The IND application process can take several months and it is important to plan ahead and allow sufficient time for each step of the process. This can include setting realistic timelines and milestones and ensuring that all team members are aware of their responsibilities.

In summary, the pre-IND meeting is an essential step in bringing a new drug to market as a pharmaceutical or biotech start-up. If you are well prepared, communicate effectively with the authorities, ensure compliance, secure funding and use time effectively, you can successfully go through this process and move your new drug into clinical trials.

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Quality management in the pharmaceutical and biotech industry: Current challenges in the cooperation between pharmaceutical companies and CROs, CMOs and CDMOs

"The increasing decentralization of the supply chain in the pharmaceutical industry poses major challenges for companies. In a regulated environment, regulatory requirements must be implemented in a compliant manner while adhering to "Good Documentation Practice" with business partners in a global environment. The global networking and faster availability of information in large numbers are pushing our existing document management systems to their limits in terms of timely processing in compliance with GMP requirements. Therefore, we need to rethink our current way of working to enable effective and efficient document management with new IT solutions."

Timur Güvercinci
Timur Güvercinci