Sponsored | The essential guide to drug commercialization: A manufacturer’s handbook for selecting solutions and partners
You have invested the time, expertise, and financial resources to develop a therapy that changes patient lives for the better. After all of your hard work and dedication, how can you ensure your product reaches patients? What are the key commercialization considerations for healthcare innovators, large and small? Learn how to unlock product potential in this step-by-step guide to making the most of your commercialization investments.
How to use this guide
This guide is designed to give manufacturers an inside look at critical success factors for each step in the commercialization journey. You’ll glean actionable insights from AmerisourceBergen’s Manufacturer Commercialization Strategy (MCS) team, a group of experts who regularly work with pharmaceutical manufacturers to bring products to market with tailored combinations of solutions that ensure therapies reach the patients who need them.
We’ve included five key sections:
The commercialization process
Drug development checklist
A model for success
The commercialization process
How to make the most of integrated commercialization solutions: Key considerations for each stage of the process
By Glen Martin, Vice President, Manufacturer Commercialization Strategy, AmerisourceBergen
For pharmaceutical companies, bringing a new therapy to market can be a long and expensive journey. Research and development alone can cost $2.6 billion, on average, and can take several years. Yet, developing a quality product and getting it approved for distribution is not enough to guarantee commercial success. A new product’s success can rarely be attributed to just one thing, such as good branding or quality patient support services, although both of these are important. Rather, success depends upon the many strategic decisions manufacturers make at different stages along the road to commercialization. The choices manufacturers make in the early planning and development stages impact a product’s commercial success as much as their choices after its launch.
Navigating clinical trials
At the clinical trial stage, manufacturers can face challenges with their supply chain planning and patient recruitment. They need to be able to recruit eligible patient populations, build a logistics platform that can scale up and out, acquire comparator drugs for testing, transport products across borders, and efficiently collect and analyze patient data. The suite of services needed at this stage includes everything from access to targeted provider networks to temperature-controlled, time-sensitive storage and transportation solutions and knowledge of international customs. With so many moving parts, having one dependable partner can make a big difference. The right commercialization partner should use digital platforms to track inventory while also managing clinical trial protocols and leveraging provider reach to access patients.
When to start planning
Start patient recruitment pre-trial and pre-development decision-making around packaging, temperature control, logistics platform, etc. up to 24 months pre-launch.
Pre-launch: Market access considerations
Once a product is approved to go to market, manufacturers have to take some time to evaluate the evidence they’ve collected (and any gaps in evidence) and establish their product’s value proposition, brand identity, and messaging strategy. The complex process of compiling information from multiple sources and gaining consensus on value messages from team members across varied job titles and perspectives is no easy task. Manufacturers have to develop different strategies to reach payers, patients, and providers. The right commercialization partner will have the experience and digital tools necessary to streamline this process and make it as efficient as possible, helping those involved avoid unproductive meetings and costly missteps.
When to start planning
12-24 months prior to launch.
Pre-launch: Patient services
Another critical component of the pre-launch stage is planning ahead to ensure patients will be able to access and afford the product, both of which are necessary for the therapy to reach its target patient population. At this stage, designing the right patient support program is key, as is ensuring that patients don’t experience cost barriers at the pharmacy or site of care.
When to start planning
3-6 months prior to product launch.
Once the product is launched, it will be critical to have a plan to raise awareness about the product among providers. It stands to reason that the same partner that helps a manufacturer optimize its patient assistance program should also be responsible for educating providers about that program and helping them address any reimbursement issues that may arise. A strategic partner that offers both patient support services and field reimbursement and access services can help facilitate communication, collaboration, and even data sharing between teams, making it possible to refine the patient assistance program and overall access strategy continually. It’s also crucial to track medication adherence and intervene to connect patients struggling with adherence to the necessary support from nurse educators and social workers based on the type of barrier(s) they’re facing. Plus, ongoing data analytics make it possible to identify early issues and refine the patient access strategy.
Manufacturers will also want to ensure they’re working with a partner whose continual commitment to global distribution excellence means channel strategy expertise coupled with reach into specialty provider networks, health systems, and everywhere patients present for care.
When to start planning
Up to 12 months pre-launch for field services.
What integration really means
The right commercialization partner is more than an aggregator of disparate services. True partnership, and true integration, is rooted in seeking solutions for today’s healthcare challenges and making investments where gaps exist.
Spotlight: Pre-launch Technology
When it comes to optimizing different aspects of the commercialization process, technology is also key. It’s important to look for a partner that offers wide-ranging expertise and a breadth of services that spans the entire commercialization journey, as well as the tools to make those services as effective and efficient as possible. The best partners have high-tech tools at their disposal that can add value at each stage of the commercialization process. For instance, a virtual meeting platform can help facilitate messaging and branding discussions. Modeling tools can help manufacturers map out the investment they will need to make in a patient assistance program. And leading patient support providers automate as many steps in the access journey as possible using artificial intelligence and predictive analytics to ensure quicker speed to therapy.
Drug development checklist: Seven success factors during the drug development stage
Long before any therapy goes to market, manufacturers must make decisions that will ultimately influence commercial success. In the early days of drug development, manufacturers are navigating the near-term logistics of patient recruitment, clinical trial participation, compliance with regulatory requirements, and data collection. With the right commercialization partner involved from the start, manufacturers can feel more confident that the drug development process establishes the best possible foundation for market entry—even when that may be months or years away.
It’s never too early to find the right partner. Start your search by looking for someone who covers these critical needs:
- Time-sensitive, temperature-controlled logistics for clinical trials: Look for near-perfect execution of storage and transport solutions.
- Reaching eligible patient populations for clinical trial participation: The right partner will offer direct to-patient solutions for in-home trials and access to specialty provider networks for hard-to-reach patient populations.
- Data collection and clinical journey insights: Seek out a robust, scalable logistics platform with powerful inventory management, ordering, and tracking tools.
- Ability to move treatments across borders: The ideal partner will offer global reach with local expertise on customs and credentials.
- Comparator sourcing: Look for efficient access to (and transportation of) comparator products.
- Navigating the regulatory process: You’ll need to leverage expertise in regulatory strategy, dossier authoring, submission preparation, and lifecycle management integrated with expert publishing and quality assurance solutions.
- Ensuring drug safety and compliance with continually evolving regulatory requirements: Make sure you have access to comprehensive pharmacovigilance and medical information services.
Pre-launch checklist: Nine questions to ask yourself and your commercialization partner
The pre-launch phase of the drug commercialization journey is a mission-critical time that weighs heavily on product and patient outcomes. Manufacturers invest in and align on the building blocks of a successful therapeutic debut during this pre-market period — developing the unique value proposition, defining distribution channel strategy, and designing patient support services. Finding the right integrated commercialization solutions partner can help position your product for success. The right partner will help you simplify the extremely complex pre-launch process. That partner will help you answer the tough questions as you navigate market access, distribution decisions, and patient services. Simply put, they’ll check all the right boxes.
Position yourself for optimal market access — and start your search for a commercialization partner — by asking these questions.
- What can I do to address evidence gaps? Even after preclinical and clinical phases, knowledge gaps can persist — particularly within specialty medication trials. Look for partners who recommend practical solutions, such as real-world evidence studies, to fill in what’s missing.
- How can I apply HEOR to deliver a compelling value story? Health economic outcomes research (HEOR) studies can help showcase a drug’s full economic value and convince payers of its potential impact. If a partner doesn’t apply HEOR insights to demonstrate a therapy’s worth, it might be time to find someone who does.
- How can I gain internal consensus on my product’s value message? As teams become more remote, it can be challenging to get pre-market feedback from internal stakeholders. The right partner will help take on that burden. In particular, look for someone with technology that solicits and streamlines internal feedback.
- What are my business process and order infrastructure needs? Not all manufacturers can or want to build out their own business processes and logistics infrastructure. Knowing this, effective commercialization partners provide outsourced solutions in storage, staffing, customer service, payment processing, and more so that logistics becomes a scalable and predictable expense.
- Can I get more visibility into the ordering process? Just because manufacturers don’t handle orders directly doesn’t mean they shouldn’t have insight into them. Look for a partner who offers web-enabled reporting tools that make orders viewable in real-time to stay informed on changes in inventory, distribution, and finances.
- How can I give payers information where and when they need it? Getting payers on board with formulary considerations takes a nuanced approach, and hard-copy dossiers just don’t cut it anymore. An effective partner’s web-based platforms encourage collaborative exchange between manufacturers and payers.
- How can I help provider offices overcome reimbursement and access hurdles? Even with a strong value proposition and formulary placement, drugs can’t succeed if doctors don’t know how to prescribe them or how they’ll get reimbursed. Commercialization partners who offer field reimbursement and access services can fill those education gaps with reimbursement, prior authorizations, and claims support.
- What can I do to break down access, adherence, and affordability barriers better than anyone else? Ensuring that patients get and stay on therapy with as few obstacles as possible requires a human touch, along with technology. The right partner balances both for the sake of medication adherence — from staffing up with social workers and nurses to investing in machine learning tools that verify benefits and predict adherence risk in time to intervene.
- How can I make sure my product is available wherever patients present for care? Manufacturers benefit from a partner with a distribution network and provider reach that ensures product is available wherever patients choose to receive care — whether that’s a health system, community practice, specialty or retail pharmacy. Consider the size and range of the partner’s distribution network, and ask about their alignment with major GPOs.
Post-launch checklist: Four success factors for post-launch product success
You’ve seen your new therapy through to its official launch, but the work doesn’t end there. Once in-market, product logistics and patient needs fluctuate in real-time, requiring a post-launch strategy that can pivot. What should your commercialization partner focus on post-launch? Effective partners optimize programs and solutions as needed to remove access and adherence barriers and ensure products reach their full potential.
Look for a partner who leads the way in these key post-launch areas:
Education and support for providers and patients
The right partner will offer: targeted marketing, education, and other engagement solutions to resolve concerns around reimbursement, coverage, and affordability; patient education on administration, side effect management, and adherence measures delivered by a qualified nurse.
An action plan for removing access barriers
The right partner will offer: strategies to enroll new patients into the patient support program, ongoing payer negotiations for formulary expansion, and ever evolving hub services that keep pace with patient needs.
Ongoing global distribution excellence
The right partner will offer: distribution infrastructure and network innovation, frequent touchpoints to optimize channel strategy—accounting for current and projected inventory volumes, shipping troubleshooting, and demand forecasting/allocation expertise.
Real-time insights and analytics
The right partner will offer: analysis of uptake data and patient engagement metrics, measuring against key performance indicators and recommending realtime adjustments to improve the patient support and reimbursement strategies.
The hidden value of integrated commercialization services: A manufacturer’s perspective
The AmerisourceBergen Insights team recently sat down with one of our manufacturer partners to gain perspective on what it’s like to work with our manufacturer commercialization strategy (MCS) team. We learned just how valuable it is for manufacturers to work with a single partner for integrated commercialization solutions — and what’s missing when they don’t.
Q: What do you find most valuable about working with the AmerisourceBergen MCS team?
Working with the AmerisourceBergen team is like having a dedicated quarterback to help you plan and execute your commercialization strategy. That quarterback is able to look at the manufacturer’s commercial needs from a holistic perspective and bring the appropriate solutions and subject matter experts into the conversation. This is what truly differentiates AmerisourceBergen. Whatever a manufacturer’s need or challenge is — from market access to logistics to HEOR (health economics and outcomes research) and beyond — there is one person you can count on to connect you to the right people immediately.
Q: What is the big “payoff” when you work with one partner to deliver several different commercialization solutions?
Accountability. Just as every division or vertical for a manufacturer ultimately reports up to the same P&L, so do the AmerisourceBergen businesses. This creates a more interdependent culture in which all the businesses hold each other accountable. The accountability culminates in higher service levels, greater efficiencies, and better response times.
Q: When bringing a new product to market, how does the initial conversation with an integrated commercialization services partner like AmerisourceBergen start?
A drug commercialization discussion will typically begin with distribution. A manufacturer will want to know how the product distribution process is going to work. Will they be working with third-party logistics (3PL) or an integrated logistics solution? Who will be handling state licensures, and how quickly can that be set up?
Next, it’s important to address whether you’re looking at specialty distribution or one that is going to go through full-line wholesale. What fees will be involved in the commercialization? For a specialty product, what hub services, such as specialty pharmacy, will you have access to? For a hospital product or an oncology product, it’s important to find out which services will help get the therapy to the right patient population.
I’ve been working with AmerisourceBergen long enough that the conversation simply begins with me saying, “here’s the type of product we want to commercialize. Here are our goals.” A manufacturer who is working with AmerisourceBergen for the first time can lean on the MCS team to connect the dots for them and connect them to the right areas of the AmerisourceBergen business.
The nice thing is that whether you are a smaller manufacturer bringing one product to market or a large manufacturer with a portfolio of products, AmerisourceBergen helps you develop the right commercialization strategy to meet the needs of your unique product or product line.
For me, working with AmerisourceBergen is like one-stop shopping. Each of the verticals is on the same email system, and they hold each other accountable. My MCS contact brings the right people to us when we need them.
Q: When there is no point person – no MCS contact – what’s at risk?
What is the potential worst-case scenario? Without a point person to help manage integrated commercialization services, a manufacturer may end up working with multiple MSAs, companies, and vendors. In this scenario, you end up in a situation where everyone is not really on the same sheet of music, which brings significant risk to the entire process.
Communication is fragmented and can completely break down. From a budget standpoint, the most detrimental thing is the lack of a streamlined process. The manufacturer cannot capitalize on where it has business within an organization, leaving money on the table. Another risk is lack of consistency of data. If you are dealing with six specialty pharmacies or six GPOs or three hubs, everyone is reporting data differently. Someone on the manufacturer end must manage all those disparate data feeds, which can be disastrous.
The worst-case scenario is when something crucial falls through the cracks. Maybe one vendor contract expires, and it had to do with getting the patient on a critical therapy in the shortest time period. There are all kinds of important details that can be overlooked in a disjointed process.
Q: What is a key takeaway you would want someone who is not familiar with AmerisourceBergen’s commercialization approach to know?
I would want that person to understand that when it comes to bringing a pharmaceutical therapy to market, AmerisourceBergen touches pretty much anything that has to do with that process. The MCS team ties all the integrated commercialization services together, customizes a solution based on the manufacturer’s and product’s unique needs, and truly simplifies the entire process.
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