Our 2022 Plan

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 

• Patient centricity has become a watchword during the pandemic within the healthcare community as providers, institution, and payers realize the power of patients. But patient centricity has been a pillar of (b)(2) development from the inception of the “paper NDA”, the (b)(2) antecedent, in the 1980’s. Oral extended-release products are the essence of patient centricity and were among the first such products. Alza and Elan built an industry in the late 80’s and ‘90’s using controlled release technology to make daily dosing of oral drug products routine. Dosing regimens were easier to follow.  Patient adherence was better, and payers realized a cost benefit from the adherence.  
• Combinations of new drug entities and new dosage form delivery systems are now evolving to assist the scores of patients of all ages who need more sophisticated types of therapeutic assistance, and the new technologies will facilitate patient adherence and cost benefits. Many more patients need, or benefit from, more refined therapeutic regimens and treatments because insurers move patients out of hospitals as soon as possible, and patients prefer treatment at home or in a local environment. Identifying, treating and maintaining these disparate patients are a large future business opportunity. New technologies and products are blossoming to treat these patients. Developing and working with payers to show cost effective distribution and therapy is opening the doors to new channels of revenue. We discussed these issues initially in our annual meeting and during our Value Added Medicines Week conference. These issues will be more prominent in 2022 and beyond.  
• Local health care providers and groups are being squeezed by insurers and healthcare systems. They are seeking ways to increase their revenue. Thus, a confluence of factors can be keys to accelerate the development of products and facilitate reimbursement. New multi component clinical development programs can offer great economic opportunity. And decentralized trials can be pivotal in this process. They check all the boxes. They can lower your clinical trial costs through faster enrollment, through consistent patient participation and follow up, all of which can lead to improved application submission and processing. Such studies can also help demonstrate your credibility and gravitas, which is becoming more important as FDA emerges from the bolus of inadequate COVID applications. This issue has been vital to not only Dr. Janet Woodcock the Acting Commissioner, but also to the current nominee. Dr. Robert Califf.   
• At our annual meeting, we will feature an FDA presentation on decentralized clinical trials to provide insight and guidance. 

Continued FDA Meetings and other Interactions  
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.   
 
Meetings 
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.  
 
Survey 
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