2022 looks to be an exciting year for the Platform. We successfully weathered the pandemic, grew our membership significantly in 2021, and built on our relationship with the Food and Drug Administration. Of equal importance, several issues that the Platform identified during the pandemic have evolved to the point that they will directly benefit the Platform and its members in the immediate future. Our goals then are to solidify our bases and then build in these new issues. We also have a three-minute survey link at the bottom for members to help focus our priorities.
(b)(2)’s are the catamarans of the pharma industry. They are sleek, more rapidly developed products that move with less institutional resistance than new chemical entities. They are the next practical generation of products i.e., the beta versions. The pandemic has induced changes in the drug product development systems, and new opportunities have been revealed. Everyone is looking for newer, faster, more efficient way to develop drug products. Plodding along the traditional pathway will be much harder and less lucrative. Reimbursement, the coin of the realm, will require more sophistication to obtain. Scores and scores of applications that were dumped into FDA to help deal with the pandemic proved not only fruitless but were wasteful of Agency resources. The efforts revealed a naiveté of irrational exuberance that continues to be exposed as the Agency deals with these applications. Moreover, fall out shows that applicants will require more sophistication about reimbursement when dealing with investors and payers.
2022 will culminate in the user fee negotiations. We must remember that the increased demands for accountability placed on the Agency in these negotiations have historically led to increased Agency demands for improved application quality from industry. These demands can increase development costs. With all this in mind, we summarize and identify the issues for 2022 and beyond.
Patient Centricity and Decentralized Trials
From our regular interactions and meetings with FDA, it is also clear that these efforts provide direct insights into the Agency’s concerns, problems and thinking. These interactions also provide members with the opportunity for unfiltered contact with the Agency
As we move forward, addressing the Agency’s concerns is vital, and the new user fees will yield more demands by the Agency for quality (b)(2)’s submissions. Accordingly, in 2022, we will continue meeting with CDER (at least twice) to educate ourselves about the 505(b)(2) issues most important to FDA and communicate the findings out to our membership.
Dealing with Payers and Investors
It is very clear that a strategic plan explaining how you will deal with the payers for your (b)(2) is essential from Day 1. Showing how you will make money for your investors is paramount. So we will work with the members to help guide them in addressing the product launch plan and designing ways to improve the corporate value such as using a multigenerational product approach to combat generic competition.
We plan to have 2 meetings in 2022. We are planning to hold the annual meeting as a hybrid in person and virtual event in New York during the week of March 22-24 in New York City. The time frame will correlate with the DCAT meetings to permit as many people as possible who will be in the city to attend. We have more details in mid-February as the pandemic picture becomes slightly clearer.
We also plan to have our second annual Value Added Medicines Week in October to build on the economic interests that came to light this past Fall. During that week, we plan to explore partnering meetings for our members with other companies and investors. More on that to come during the year.
As noted above, to ensure that we once again focus on your priorities in 2022, we would like you to take a few minutes to complete our survey.
Go to: https://www.surveymonkey.com/r/NY8L3LG