Omni-HC Driving Innovation in Scientific Commercialization

7/1/2025

The Power of Pre-Launch: A rolling Start

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Setting Your 505(b)(2) for a Rolling Start
Lets continue our series on commercializing 505(b)(2) products. Last month, I introduced the analogy of a "rolling start" versus a "standstill start" for a small-engine car. A smaller engine (representing the 505(b)(2) with its often more limited IP and shorter commercial runway) can accelerate much faster and more smoothly from a rolling start, avoiding undue stress. This month, I will delve deeper into why pre-launch commercialization efforts are absolutely critical for giving your 505(b)(2) that essential rolling start, ensuring a rapid path to peak sales from the outset and preventing costly "repairs" down the line.

Why Pre-Launch is Non-Negotiable for Your 505(b)(2)
Many product developers, captivated by the promise of faster regulatory approval, view commercial planning as something that can wait until closer to launch. For a 505(b)(2), this mindset is a significant pitfall. The commercial engine of a 505(b)(2) product simply isn't designed to bear the immense stress of a "standstill start" in a highly competitive market.
Here's why commercialization planning and pre-launch efforts are critical:

1. Market Research: Pinpointing Your Niche and Understanding the Landscape
Before you can even think about your "rolling start," you need to know where the road is and who else is on it. The first step is to do effective market research to allow you to:

Identify specific unmet needs: Even if the active ingredient is known, your 505(b)(2) must solve a unique problem or offer a distinct advantage. Deep research helps pinpoint these gaps.
Understand the competitive environment: This isn't just about direct competitors, but also alternative therapies, existing standards of care, and even the "do nothing" option. Knowing the competitive landscape informs your entire strategy.
Segment your audience: Which physicians, patient populations, or institutions will value your specific "value-add" the most? Establishing a beachhead in a market niche is often key for 505(b)(2) success.

2. Early Value Proposition Refinement: Honing Your Message
As I have mentioned previously, the "brandability" of a 505(b)(2) is its biggest asset. But you can't brand effectively if you haven't precisely defined what you're branding. Pre-launch allows for:

Iterative messaging development: Refine how you articulate the problem your product solves and its unique benefits. This isn't a one-and-done task; it requires some testing and iteration long before launch.
Stakeholder-specific messaging: The value proposition will sound different for a physician, a payer, and a patient. Early refinement ensures you have compelling, tailored messages ready.
Countering "Glorified Generic" Perceptions: By clearly defining your value early, you proactively arm your brand with a narrative much needed to allow positioning beyond a mere generic.

3. Influencer Mapping and Engagement: Building a Foundation of Support
Just as every car preforms better on a clear road without roadblocks, your 505(b)(2) needs champions to overcome market hurdles. Identifying and engaging influential healthcare providers before launch is vital to setting your product in motion, developing awareness:

Establishing credibility: Influencer can lend significant credibility to your product and its unique benefits within their professional networks.
Gaining early insights: The influencers can provide invaluable feedback on your product's real-world utility and help refine the commercialization strategy.
Building advocacy: Early engagement fosters a network of advocates who can help expedite adoption once your product is available.

4. Payer Strategy Development: Unlocking Market Access
In todays environment, perhaps one of the most critical pre-launch efforts for any pharmaceutical product, and especially for a 505(b)(2), is the payer strategy. Without access and reimbursement, your product simply won't reach patients. Pre-launch payer development includes:

Value story development for payers: Crafting a compelling reason the value-add is important. This can be done both economically and clinically. The argument should focus on the value the product is bringing to their membership to justify a favorable formulary placement.
Engagement with key payers: Initiating discussions with major health plans and pharmacy benefit managers (PBMs) at least 1 year in advance helps understand their requirements and gives the company time to address potential barriers.
Anticipating reimbursement hurdles: Identifying potential challenges related to coding, coverage, and pricing, allowing time to develop solutions proactively rather than reactively post-launch.

The Cost of a Standstill Start
Failing to undertake these pre-launch efforts is like demanding that your small-engine car go from 0 to 60 mph instantly from a dead stop. The "extreme stress" on the commercial engine translates to:

Delayed market uptake: Slow adoption by prescribers and limited patient access due to reimbursement issues.
Suboptimal peak sales: Missing the narrow window to maximize revenue before competitive pressures intensify.
Long-term revenue erosion: The "costly repairs" significantly reduce your products peak sales potential by creating issues such as persistent market access issues, brand confusion, and the inability to fully capitalize on your product's potential over its lifecycle.

In the coming months, we will explore each of these areas in more detail, providing practical insights into how your 505(b)(2) can achieve that crucial rolling start and transform into a consistent revenue generator.

Is your 505(b)(2) ready for a rolling start? Omni-HC specializes in navigating the unique commercialization challenges of value-added medicines. Contact us today to discuss how our expertise can accelerate your product's path to peak sales and sustained success.

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6/20/2025

Introduction to 505(b)(2) Commercialization

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Throughout my career I have worked with 505(b)(1) (innovative), 505(b)(2) (value-added) and 505(j) (generic) products. Because of their unique nature, 5 years ago, I co-founded the first business alliance for 505(b)(2) developers and marketers, which is now being renamed the Value-Added Medicines Alliance. From now through the end of the year I plan to write a blog about commercializing 505(b)(2) products and the unique challenges associated with this class of pharmaceutical products.

505(b)(2)s are often thought of in terms of easier/less risky products to develop by product developers. While in the market 505(b)(2)s are often labeled as glorified generics. In actuality, 505(b)(2)s are products that require a great deal of commercialization expertise to launch and successfully market. In baseball terms, the vast majority of 505(b)(2) products never become home runs, but they can make a good single or double.

The biggest asset of a 505(b)(2) is its brandability. Far too often 505(b)(2) product developers overlook the commercialization process needed to properly advantage a 505(b)(2) in the market so it can maximize speed to peak sales. When it comes to launch and marketing the lack of proper commercialization development is akin to the difference of a stand still start to a rolling start in a small engine car. A car with smaller engine can get up to speed faster with a rolling start than from a standstill start. In fact, the pressure put on the small engine to get up to speed from a stand still can put extreme stress on the engine that can require costly repairs in the future.

A 505(b)(2) product that does not create and implement a commercialization plan well before launch is creating a long-term issue that will result in less than optimal revenues for the life of the product. Throughout the next few months I will continue to blog on this topic and get into more specific areas including the importance of pre-launch efforts, product velocity, value-add differentiation, and marketing efficiency in commercializing a 505(b)(2) product.

Is your 505(b)(2) ready for commercialization? Omni-HC specializes in navigating the unique commercialization challenges of value-added medicines. To learn more go to www.omni-hc.com/505b2commercialization.html.

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