Combination Product Industry News & Guidance
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Commercial Considerations for a Pharma Company Strategically Transitioning to Combination Products
Congratulations, on becoming a combination product company!
There is a trend for injections to be self-administered with new innovations in drug delivery, and a move away from treatments in facilities to treatments at home. In response, many pharma and biotech companies are moving to self-administered drugs that patients can give themselves at home.
In general, we at Suttons Creek have seen two approaches entering the combination product arena:
1) Companies that require a responsive fix for their immediate needs to get a product to the market. 2) Companies that are seeking a strategic long-term solution.
Both are viable approaches, depending on your company’s goals, growth plans and available budgets, though the latter, in the end, will set you up for greater efficiency and an infrastructure design for durable success. Either way:
Getting an outside perspective from experts with combination product knowledge and experience can help your internal drug team break through these challenges to effective methods that will better serve your new direction. Having had extensive experience coaching pharmaceutical and biologic companies into the world of combination products, we understand the activities, milestones, critical decision points, and strategic differences for a commercial organization to consider in the development and launch of a combination product vs drug development alone.
When a pharmaceutical company decides to add a device delivery system to their portfolio, thereby becoming a combination product company, there are many things for the Commercial Marketing team to consider. The underlying question to ask across the board is:
“How significant are the differences between drug and device development and commercialization?
This question will help inform the Commercial Marketing teams about how they must show up differently to combination product tasks. One can then filter this question into the challenges and opportunities that fall into 3 key categories: Product, People and Process.
Does the company have a strategy for the combination product that starts at the top?
It is integral to the success of the program that strategy and support starts at the executive level, and that appropriate budgets are allocated, training is available across divisions, and stakeholder goals and processes are aligned. They need to consider the combination product as a new product category that needs cross-company support, as combination products require a new way of thinking.
We have seen that, for the pharmaceutical company, the focus is on the drug, its pharmacology, side effect profile, and its therapeutic effect. For the pharmaceutical company that is in the business of developing a product which includes a device delivery system, they now must ALSO become a device company focused on the patient experience. The focus must shift from being exclusively on whether the therapeutic effect of the drug was efficacious to including whether or not the device meets the user needs for delivering the drug.
At the end of the day, the goal for a combination product is to create a patient-focused product. One that is efficacious but can also be delivered safely and effectively. A patient has to be able to use the device. For the device design to maximally meet the needs of the end user, the commercial team must get involved earlier in the device development process than they are accustomed to with drug development alone. We’ve learned that there needs to be a strategic shift in thinking from the development process of an individual drug or a device. Anyone that has gone through this process will attest to the fact that when you create a combined drug delivery device, a new unique product development process emerges.
Does the company currently contain the expertise and experience among their talent to accomplish effective combination product development?
A company not only needs device development and drug development experience and expertise to bring a successful combination product to market. They also need experience and expertise in combination products, which is more than the sum of its two parts. It has its own unique DNA, processes, challenges and opportunities.
New core competencies within your team need to emerge for drug delivery devices to be brought to the market in a timely, cost effective, and efficient way. For this to happen, device experts need to get more exposure to the drug aspects. Similarly, drug experts need to get more exposure to the device aspects. New trainings at all levels and across divisions need to occur, and executive leadership must possess the expertise to shepherd their teams to new possibilities.
There also needs to be mutual understanding, cooperation and alignment among stakeholders. Over time, the silo’s that have built up need to break down. Egos need to be put aside. Executive leadership needs to appreciate the differences and make corporate attitude and infrastructural adjustments to guide their team toward success. Every department needs to collaborate and make adjustments to their own approaches, with a new focus on a user-driven combination product.
What are the variances of current processes and systems? What new processes are needed? What processes need to be adapted? What are the timelines?
While there are many departments in the mix, this article focuses on the Commercial Marketing Team. So, we will focus on answers for these many questions, as they relate to them. The Commercial Team is the backbone of a successful commercial launch. And, in a user-driven combination product program, the voice of the user is crucial to success. The Commercial Team must bring the voice of the customer to the table during combination product development, even more so than they are used to with drug development and drug launch alone. At every phase, they should insert their knowledge of the end user’s needs to make sure they are being met.
Following are examples of the key roles, responsibilities, and timing considerations of the Commercial team throughout the combination product development, launch and post-market processes.
Color of device: The marketing team should provide early input on color. This generally needs to be done much earlier than you expect. As the device is developed further, there will be a design freeze and changes won’t be possible. Stay in the loop on your development team’s calendar.
Market research: Market research is critical in understanding how patients will accept and use the product. It tells the Commercial team what users desire, need and preferences. It provides insight to drive strategy. Giving this input on patient needs to the development team is necessary to ensuring you have a useable and saleable combination product at launch time.
Human Factors: In device development there is also Human factors testing. Human Factors differs from market research in that it focuses on the patients’ interactions with the device, how they use it, and whether they can use it safely and effectively. Ultimately Human Factors support whether initial strategic choices meet requirements of regulatory bodies. Human factors may be a new concept for pharma companies who have not needed to teach patients how to use their products before, and the Commercial team should work closely with the Human Factors specialists to ensure usability and user needs align.
Commercial Package: Management needs to ensure that this is a commercially viable product in addition to an effective medical solution. The user purchasing decision factors of a self-administered product impacts the reimbursement strategy, distribution channels and the supply chain. In light of this, input into the design of the eventual device and packaging is Commercial Department’s responsibility.
Instructions for Use (IFU): The IFU is part of the device package and must be available for all drug-device combinations. A good IFU will assist with regulatory approval as well as a positive user experience, facilitating product launch and assisting with market growth. To ensure users can follow the IFU safely and effectively, the commercial organization should ensure that proper resources are given to the IFU development and that Human Factors testing is applied.
Final Labeling: The final labeling must be specific and built before the Human Factors summative studies. This includes several important coordinated tactics, including Commercial’s input on what will make the product profitable.
Promotional Materials: Commercial role is to create and produce promotional and training materials that summarize benefits and risks of the new combination product device for HCP’s, patients and the sales force. The focus of the launch goes beyond the drug, and now includes the device, the patient, and possible advantages compared to other existing product offerings. To increase comfort and excitement, there should be attention to the ease of how it works and is used and the benefits to the patient.
Training of Patients and HCPs: Comprehensive training on the device aligned with the IFU can reduce the number of complaints and inquiries. It is the Commercial team’s responsibility to create training materials (documents, videos, phone scripts, etc.) and have the sales and support team trained in them prior to launch.
Patient Hub Support: Organizing a Patient Hub for support can reduce complaints, returns and safety issues. A comprehensive patient support hub with the right pre-decided services and support materials (such as the training materials mentioned above) must be provided and prioritized prior to launch. Inquiries become an important part of the early interaction with patients and must be handled proactively and supportively.
Complaint Handling: Complaint handling differs from those for drug, and the complaint volumes for a combination product may be 10-fold compared to drug-only during the initial introduction of the product. Commercial needs to plan for this, working to mitigate product complaints by thoroughly knowing the patients and by providing training to reduce complaints based on misunderstanding the device.
Reimbursement Considerations: A new device will result in some market access changes and possible barriers for patients. Commercial needs to perform market research to understand and lower these barriers, whether that be during development or in their promotional and post-market support efforts.
While we have pointed out many differences in the commercial development of a combination product compared to a drug-only product, many companies have made the transition successfully…it is feasible! A focused effort to understand the changes in mindset will set your company on the right track. Best practices by our clients suggest two key takeaways:
- Multiple engagement opportunities with the patient supports more successful therapy, adherence and launch.
- The commercial organization should plan to provide much needed input earlier when a device is involved than they are used to with drug alone. Changes requested late into the development process can impact timelines, cost and rework, or even not be possible in the case of design freeze. Commercial teams should emphasize to management the importance of their early strategic involvement in the combination product development.
Our team at Suttons Creek has done this before and can help you chart a strategic plan and execute for a successful launch of a combination product. We are happy to assist your organization with advice and wisdom on marketing strategy, activities and timeline considerations customized to your particular goals.
Stephanie Sobel: Director, Sales & Marketing, Client Consultant – Stephanie Sobel is a strategic leader in the biopharmaceutical industry with 20 years of experience in Big Pharma and other business development ventures. She has led teams across diverse rolls in the Commercial Organization of AstraZeneca in Sales, Marketing, Commercial Operations and other business development rolls.
Stephanie says the key to her commercial leadership success has been prioritizing process, cadence and culture. And, she is implementing those effective tactics as she builds Suttons Creek’s own marketing programs and works to define, develop and execute effectual commercialization strategies for Suttons Creek clients.