Well over half of the pre-IND meetings requested of the FDA in 2011 were from “Emerging Sponsors,” not the traditional Pharmaceutical Companies.  More than ever before, companies need to be focused and prepared to work with the FDA to position for a successful launch.

This week, Joe D’Ambrosio from Clarkston Consulting moderated a panel of industry experts at the most recent CED Biotech Forum.  The topic was working with the FDA during the process of developing a new drug and the audience consisted of start-up drug companies, traditional big pharma, companies that provide pharmaceutical development services, and even venture capital.

Companies Requesting Time from the FDA is Growing at a Rapid Pace

A key theme that ran through the entire session was that clearly the number of companies requesting time from the FDA is growing at a rapid pace – especially what are defined as “Emerging Sponsor” products or those that are not coming from the traditional big pharma/biotech companies.  With the field getting more and more crowded, the FDA is experiencing further strain on being able to accommodate all the requests being made.  This is evident in the backlog of NDA, ANDA, and other types of approvals at the agency.  The collection of users fees is designed to help in this matter, however, it is Clarkston’s opinion that the challenges and wait times are likely to increase before they get better.

During the session, various types of drug evaluation / approval pathways were discussed.  There was much emphasis placed on the 505(b)(2) approval pathway.  505(b)(2) is defined by the FDA as an NDA containing investigations of safety and effectiveness that are being relied upon for approval but that were not conducted by or for the applicant, and for which the applicant has not obtained a right of reference.

Applications Differ from the Typical NDA

These applications differ from the typical NDA, in that they allow a sponsor to rely, at least in part, on the FDA’s findings related to a previously approved drug, also known as the “reference drug”.  Whereas the 505(b)(2) evaluation / approval pathway can be utilized for a wide range of products, especially for those that represent a limited change from a previously approved drug, sponsors should get help from those knowledgeable and experienced with the regulations, pitfalls, and limitations or they could find themselves having invested a great deal of time without a positive outcome.

Meetings with FDA

Another major topic and point of conversation was around preparation for teleconferences and face to face meetings with the FDA.  There are a series of meetings of various types.  These include Pre-IND meetings, End of Phase 1 Meetings, End of Phase 2 / Pre-Phase 3 Meetings, and Pre-NDA/BLA Meetings.  The key theme around meetings was to make sure you are prepared.  It’s not supposed to be a “dog and pony show”, but rather a sound scientific meeting with excellent preparation.  This is the drug company’s opportunity to ask questions of the FDA and the FDA to respond.  The drug company is responsible for knowing the science behind their drug and explaining to the FDA how it will meet requirements for safety and effectiveness.

The FDA will not grant all meetings requested, and in some cases will respond to questions in a written manner.  So the requesting company needs to make sure they are prepared with follow-up questions as good as the first set.  You never want to give the FDA the impression that you are “meeting just to meet” or are wasting their time.  This can cause issues then and into the future.  Good meetings are critical for successful go-to-market.  Good meetings are characterized by:

• good scientific preparation,
• roll-playing / scenario planning in advance,
• being face to face (or at least having everyone on a teleconference in the same room), and
• especially providing the FDA with a summary of the actions and notes both during (verbally), and immediately after in written form.

The FDA is required to provide their summary back within 30 days of the meetings themselves.  So getting your notes to them promptly and accurately helps both them and you.

Successfully Managing Interactions

In summary, successfully managing interactions with the FDA during drug development is critical for success:

• Plan and prepare for meetings with people who know what to expect.
• Be thorough and sound in your scientific basis.
• Plan, prepare, and dry run.
• Don’t leave anything to chance.

A good meeting will leave you with questions answered, as well as the FDA feeling confident you know your stuff.