PHILADELPHIA— January 25, 2023 — Today, The 505(b)(2) Platform announced the scheduling of its first Webinar for 2023. This webinar is part of a planned series of webinars to be delivered in 2023 and developed through an ongoing collaboration between The 505(b)(2) Platform and Scientists for Advancement of Affordable Medicines (SAAMnow™). The initial webinar, Commercialization Differences Between Value-Added medicines and Innovator Products, will be held on February 22, 2023 at 12 noon (EST).
 
The free one-hour webinar will engage, educate and empower attendees on the differences between value-added medicines (VAM’s) and innovator products. The faculty will present and discuss the importance of building clinical and payer value before, during, and after launch to optimize market success. Scheduled speakers include industry experts in development and regulatory, commercialization, and market access. The webinar will help attendees understand how to best prepare and execute commercialization of value-added medicines, especially 505(b)(2) products.
 
“We are very excited to launch this series of webinars to help companies and life science professionals better understand the commercialization differences between value-added products and innovator products,” said Stephen Casey co-founder of The 505(b)(2) Platform and co-owner of Omni-HC, “To often companies commercialize a 505(b)(2) product as if it is an innovator product, when in actuality successful 505(b)(2) product commercialization requires a customized targeted approach to overcome significant market forces that sideline and derail value-added products.”

About the The 505(b)(2) Platform™
The 505(b)(2) Platform is a non-profit 506(c) business league. Its purpose is to educate and advocate for manufacturers of 505(b)(2) products on best practices in drug development and commercialization. Our mission is to enhance the understanding and acceptance of 505(b)(2) products in the development, regulatory and commercial arenas. WWW.505b2.org

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 

​We had a banner year in dealing with FDA/CDER.  Further, at the request of our members this year, we focused on teaching companies how to tell their stories to potential investors in multiple forums. 
 
FDA Interactivity
We had had multiple interactions with FDA and CDER.  Our principal meetings involved James Myers, Maarika Kimbrell, and Elizabeth Goldstein for discussions concerning the basics of (b)(2) filing and development issues. We also met with Dr. Kevin Bugin on the issue of decentralized clinical trials which is becoming a bigger issue as we move toward a post COVID world.  This issue can be of particular concern for 505(b)(2) development because these applications often deal with drug products intended for unique, but limited, patient populations. Further this approach provides access to a greater number of patients. At our 2022 annual meeting we will have more discussion on this issue.
 
Meetings and Symposia 
At the annual meeting, which was held virtually in July, we had invaluable presentations on telling your story.   The first was by the head of FDA’s Office of (b)(2)’s, James Myers, who discussed FDA’s applications and need for application comprehensiveness.  That was followed by presentations from very successful 505(b)(2) entrepreneurs, and investors, who discussed how to make money in the (b)(2) space.  That program was attended by over 200 high level pharma executives. 
The success of that event led us to the ambitious creation and launch of Value Added Medicines Week, late October which was a weeklong virtual event for people in this spaces.  It was co-sponsored with SAAMNow, the association of scientists and regulatory professionals in this space with whom we have worked closely for several years. We firmly established the event as the premier conference on all things current on 505(b)(2)’s and highlighted critical (b)(2) issues.
The weeklong event had the unique concept of independent commercial and regulatory tracks.  It was extremely well received. 
In our “Regulatory with a Commercial Mindset session” FDA panelist, Elizabeth Goldstein, provided a tutorial on the issues that have hindered FDA review and approval of (b)(2)’s in recent years.
Marketing approved (b)(2)s, and fund raising were the intertwined next commercial discussions. Comments found the candor of the sessions invaluable.
Investors in this space have certain basic assumptions of 505(b)(2)’s:

1. >70% of Annual NDA filings are (b)(2)’s and they have a >60% Approval Rate
2. Potential market exclusivity of 3, 5, or 7 years – the more the better
3. Strong IP Protection
4. Voracious Generic Competition will occur
5. Avaricious Payers

With these points as the foundational mindset, our panelists distilled the real issues facing companies as follows:

1. How do you make money for your investors?
   

• Marketing is the first order risk. You need to focus on this from day 1. You must Add Value by Design into your product pitch
  
• The market is a potentially Large Market Channel, but it is not a Glorified Generic Market

 2.  The importance of Payers and a Market Access Strategy was emphasized.

• Time Frames must include time for Addition to Formularies
• What is your product Distribution Strategy
• Who is providing you with support in the market, policy, political arenas - Supra -Regulatory Support

For Platform members, the presentations are available on the members' site.

Summary and 2022
We continued to build rapport with CDER as the prime voice for 505(b)(2)s applicants.

1. We add value to CDER by educating on the issues facing the evolving industry and developers of (b)(2)’s.  We are helping to minimize unreviewable files, which became an even greater issue during the early stages of the pandemic.

Over 95% of the preferred pandemic solutions were (b)(2) and were not geared to generate any meaningful data
FDA had to shift the unreviewable files to the side to avoid waste of reviewing resources
Known commodities were considered credible and received more comprehensive consideration
This area is not for novices.
Grew our membership by over 400% this year.
Finally we are beginning to generate cross-border interest, particularly from Indian generic drug companies who are looking to expand beyond the deflationary generic market.
We will be circulating a questionnaire to learn issues of concern for 2022. We hope that you had a great holiday season, and join the Platform by going to 505b2.org. 

The 505(b)(2) Platform proudly hosted a breakfast meeting with Buchanan Ingersoll & Rooney Life Sciences practice and Cumberland Consulting in conjunction with the 2020 JP Morgan Healthcare Conference in San Francisco. This years breakfast speakers discussed the political landscape, existing FDA issues and how they relate to healthcare product pricing and commercialization. We thank all the speakers and co-hosts. Our next event will be March 24th in New York City.

We wanted to update you on some exciting news from The 505(b)(2) Platform.  Our initial dialogue with FDA on behalf of The Platform has led to a positive working relationship with senior CDER officials.  They are happy to work with us on issues that are important to our membership, including ensuring that available guidance documents address the 505(b)(2) industry’s needs. 
 
To help FDA better understand these needs, the Agency has asked us to do two things.  First, they would like The 505(b)(2) Platform to identify the guidance documents that are relevant to this segment of the drug industry.  Second, they ask that we identify which documents are the most useful and which are inadequate or need updating.  Once we do so, we plan to request a meeting with FDA to discuss our members’ collective thoughts.  We hope that these discussions will then lead to the development of brand new guidance documents in areas where they are most needed.
 
While the FDA has The 505(b)(2) Platform and our recent discussions at the top of mind, please help us with the following:

• Which guidance documents are of primary importance to you and your organization?
• Which guidance documents need to be amended or expanded to reflect the current state of technology or science?
• Which topics would you like to see FDA address in new guidance documents?

Please send your thoughts via the contact form or comment below so that we may collate and curate responses.   

This initial effort to engage with FDA on guidance documents that are relevant to The 505(b)(2) Platform membership represents just the beginning of our Platform efforts.  We will need to prioritize other topics that are of concern to our members, and we welcome your feedback on topics that your organization would like addressed.