As small to midsize biopharma organizations turn the preclinical corner with their assets, things start to get real—real fast. A rapid-fire queue of considerations can suddenly land in your lap, many of them topics you haven't thought much about before, from market access and brand strategy to pricing, manufacturing, and patient services.
It's a deluge of decisions all at once, and often, companies suffer analysis paralysis along the way. Maybe they're so overwhelmed by all the complexities of commercialization that they put launch planning on hold. Or perhaps they shift too quickly in an effort to conserve their investments without considering the ripple effects one chess-like move has on another.
In either case, that's risky. If you delay go-to-market planning, a competitor may not. Or the market might be unprepared to receive your product. And if you move too quickly, one wrong decision could jeopardize regulatory approval or revenue. Even so, managing the tidal wave of pre-launch considerations is hard to do alone—and even harder if you're a small to midsize organization. Regardless of whether you are launching a product to address an unmet need, or adding another option to an existing, competitive category, payers, patients, and providers all need to be prepared.
That's why emerging biopharmas often consult with partners like Cencora to help them navigate the complexities, including decisions they didn't know needed to be made. And indeed, there are a lot of them across different dimensions of the product lifecycle. Once decisions are made, the smaller headcounts in many emerging companies mean there may not be proper people power to pull those strategies through into tactics. A thoughtful commercialization launch plan can help you assess how much your infrastructure can support—and where assistance is warranted.
Here are the factors you should be considering as you navigate commercialization—and why approaching them in collaboration with a trusted partner can avoid analysis paralysis for a better, stronger, and more resilient commercialization plan.
Commercial viability
Even if a product is safe and effective, its viability in the market is not guaranteed. That's why accounting for viability complexities requires nuanced, upfront research. In particular, consider the targeted indication for product use, market size, intended customers and stakeholders, and product administration—as well as how those insights might interact with current market dynamics such as prescription trends and pricing expectations.
Clinical development
Clinical development activities include a wide range of things, from protocol design and trial execution to clinical logistics. Typically, some decisions will be more straightforward—such as developing endpoints that resonate with regulators—while others could be more nuanced, such as planning for those insights of most interest to payers.
Start by considering the clinical development strategy, which can inform factors such as study design, endpoints, and future commercial labeling. As with other areas, think through collaboration opportunities here too, including the need to select a CRO and clinical supply logistics partner. Consider conducting payer market research at this stage to test your protocol designs with critical payer audiences ahead of implementation.
Commercial operations
Commercial operations accounts for all the behind-the-scenes work involved in getting products from the bench to the bedside. It's infrastructure, financing, resourcing, contracting, and timelines—and especially for lean teams, can often be the most challenging part.
When approaching commercial operations planning, consider the financial resources and budgeting that may be required. As part of that process, factor in talent as well, including needs surrounding headcounts and roles, hiring and training, and whether to insource or outsource that support.
Evidence planning
As the footprint of real-world evidence continues to wrap around the product lifecycle—more than doubling among Phase IV trials between 2020 and 2022—biopharmas are thinking a lot more intentionally and expansively about their evidence story, and more specifically, what data is needed to support it.
Leaders will need to consider a variety of factors to ensure success here, from evaluating the data stakeholders may want to see outside the trial to auditing and assessing what data competitors may be generating across clinical and economic contexts, to communicating the evidence to stakeholders.
Pharmacovigilance
Pharmacovigilance is a nuanced and high-stakes field that leaves no room for error. Noncompliance can jeopardize commercial success—and more importantly, lives—so ensure any partners supporting pharmacovigilance are trusted, vetted, experienced, and knowledgeable about the product and patient population.
With that in mind, think about your plan for compliance with global requirements such as safety reporting. Additionally, evaluate local pharmacovigilance compliance needs such as signal detection, as well as how to assess product complaints and report them to applicable agencies.
Regulatory
As clinical trials become more complex and global, manufacturers can often get hung up on small details—from refining every last line on submission packages to ensuring regulatory documents account for the region-dependent nuances of various agencies.
Ultimately, regulatory readiness requires an understanding of the regulatory landscape for the target marketplace. This necessitates a global submission strategy that accounts for the needed resources to prepare agency submissions.
Quality
Quality should be documented and maintained with a quality management system (QMS). Considering all that can go wrong, manufacturers should think through their QMS planning of time to keep post-approval inspections and maintenance on track.
It's essential to determine whether the QMS is established and current for global markets, as well as maintained. Additionally, assess readiness for pre-approval inspection and put in place an oversight mechanism for compliance and stability programs.
Manufacturing
With inflation, supply chain shortages, and the labor crunch, some organizations have become increasingly concerned about their manufacturing readiness and resilience. As you approach these planning phases, consider broader decisions like insourcing versus outsourcing, manufacturing lead time expectations, and more granular details across the supply chain, such as whether to involve a separate packager.
Distribution
Organizations that fail to map out a comprehensive logistics plan can be caught off guard by unexpected hiccups, from a lack of infrastructure for temperature-controlled biotechnologies to difficulties getting trucks or containers for time-sensitive products. The best plans are built to be flexible and are made in collaboration with experienced logistics partners.
Considerations for distribution complexity depend on the unique handling and distribution needs of the product, from special handling (if applicable) and distribution data capture to the optimal distribution channels involved. Along the way, consider whether a third-party logistics partner (3PL) would be helpful...they often are.
Reimbursement and market access
Market access teams do much more than ensure products have a reimbursement pathway. They're also the ones accounting for different payer types—like private or government—as well as promoting payer awareness and identifying access barriers. When making hasty commercialization plans, it's those details that are among the most at risk of getting overlooked.
Considerations include payer types as well as the distribution and coverage among key players. As part of that plan, consider factors such as the need for payer awareness, field team requirements, sites of care, and reimbursement and access education materials that might be needed along the pathway to commercialization.
Pricing and contracting
The effects of pricing decisions can be immediate and long-lasting, emphasizing the need to plan out a pricing strategy that's well-informed and market ready. Even so, not developing that strategy fast enough can hold up other activities, so price planning should never take a backseat.
You'll need to know the preliminary pricing bands for the product, as well as details such as wholesale acquisition costs and impacts of pricing, discounts, and rebates on the average sales price. Knowing when or whether value-based contracts apply will also be critical.
Brand marketing
Marketing strategies are never cut and dry, and often require a depth of insights about prospective patients, prescribers, and payers. Compared with traditional activities like flyers and banner ads, today's marketers are much more adept at deploying personalized, compliant campaigns that tap into the greater psychology of consumer behavior.
As such, consider how, where, and to whom you intend to message. Some organizations benefit by onboarding an agency of record for this, while others may choose to develop materials and tools internally. Either way, think through those patient-, provider-, and payer-facing tools that may be necessary to ensure a successful launch, as well as a process for medical, legal, and regulatory (MLR) review for those developments.
Medical affairs and communications
The reason why entire teams focus on medical affairs and communications—and nothing else—is because of the vast requirements of those roles: You not only need sound science, but a way to explain that science to regulators, providers, peers, and the larger community.
When doing communication planning, consider the publication strategy, and whether there's a team to support it. Additionally, factor in the need to communicate data to decision-makers as well as answer medical questions from patients and providers.
Patient services
How you support access, affordability, and adherence is critical, and often spans a variety of activities across enrollment, onboarding, shipments (when applicable), education, and ongoing support. One wrong or poorly planned decision in one area could have repercussions for patients getting on—and staying on—therapy, so take heed.
Consider the needs of the product's patient population and pay particular attention to any special access situations they may have. In turn, factor education, resources, and financial assistance programs into the patient services plan.
Making the right decision, every time
Every biopharma launch has its ups and downs, but if you're not thinking through every choice with purpose and a long-term plan, you might encounter more hard times than not.
Across the many dimensions of commercial considerations—from medical affairs to manufacturing, regulatory to reimbursement and beyond—there's a lot that can fall through the cracks. Or worse, a lot more that can paralyze biopharma leaders from making a decision at all.
Cencora's Commercialization Blueprint can help
This article is intended to communicate Cencora’s capabilities which are backed by the author’s expertise. However, Cencora strongly encourages readers to review the references provided with this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto as the article may contain certain marketing statements and does not constitute legal advice.
