Five key questions for anyone new to contraceptive R&D
Post written by Elizabeth Knippler, FHI 360
When I joined a team of researchers working in contraceptive technology in May 2020 through the FHI 360/UNC Gillings fellowship program, I was relatively new to the world of contraceptive research and development (R&D). When my colleagues published an article on “The new contraceptive revolution: developing innovative products outside of industry” in a special issue of Biology of Reproduction over the summer, it was the perfect orientation to the larger landscape of contraceptive R&D.
Here are 5 key questions this article helped to answer for me:
1. What are potential contraceptive users looking for?
This might seem like an obvious question to ask when developing any sort of new product, but it is particularly important in the case of contraceptives. Because contraceptive methods are often used by young, healthy individuals as a way to prevent pregnancy over long periods of time rather than as a treatment for a disease like many other pharmaceuticals, they face a higher safety bar and require a cleaner side effect profile for approval. Additionally, potential users may be more selective or have higher expectations for their products. While effectiveness at preventing pregnancy may be the most important factor for some users, others may carefully consider non-contraceptive “side benefits” or side effects.
Callahan et al. point out the importance of collecting user preference data beyond typical market research, particularly in varying contexts, including low- and middle-income countries. Understanding what product characteristics are important to potential users can help inform product design and early decision-making. Even more nuance can be captured with the development of user profiles, which move beyond traditional categorization of users (e.g., adolescents, rural users) and focus on unique contraceptive needs. The Contraceptive Technology (CT) Innovation Lab is one example of how human-centered design approaches and participatory data collection can help generate ideas to be applied to contraceptive product development. NGOs and other organizations outside of the pharmaceutical industry who have a strong history in social and behavioral research may be uniquely positioned to help answer the question of what potential users are looking for.
2. What leads to higher effectiveness?
Decades of contraceptive clinical trials have all pointed to a consistent takeaway: “consistently high effectiveness in preventing pregnancy requires longer-acting methods.” This is in many ways due to issues of compliance. Long-acting methods can circumvent some of the typical gaps between perfect use and typical use that shorter-acting methods experience. Typical use effectiveness acknowledges that methods may not always be used consistently and correctly, and that inconsistent or incorrect use of a contraceptive method can still lead to unintended pregnancy. Long-acting reversible contraceptive (LARC) methods like IUDs and implants allow users to “forget about” their method, and have higher typical use effectiveness rates. While higher effectiveness is a goal to strive for, consideration must also be given to users’ access to removal services if new methods require providers for removal as do current LARCs. User preference data, in addition to research that explores user experiences with LARC removals and access to services, can be ways to continually center users in the development process.
New contraceptive development or alternative ways of administration can also increase contraceptive method choice for potential users, allowing them to consider more longer-acting contraceptives that can help them achieve high effectiveness in addition to meeting their other needs and preferences. For instance, several research efforts have focused on products with the potential for self-administration, such as a microneedle patch and subcutaneous injectables, which can improve method continuation rates and potentially make methods more attractive for users.
3. How can R&D partners collaborate?
Callahan et al. describe FHI 360’s unique outsourcing model of collaboration for early-stage contraceptive product development. While organizations outside the pharmaceutical industry may have particular strengths in helping to identify potential users’ preferences as mentioned above, they may be restricted in other ways, such as having limited laboratory-based facilities. An outsourcing model allows these organizations to partner with academia, the pharmaceutical industry, small biotech companies, and Clinical Resource Organizations (CROs), as well as to engage the technical expertise of consultants. These collaborative research efforts take advantage of the collective strengths, expertise, and capacity of partners; however, they also come with unique challenges. The authors provide several lessons learned from their experiences in order to maximize success, including good communication and collaborative, proactive goal-setting. Although such partnerships may require oversight, negotiation, and quality checks, an outsourcing model allows for the collective success of groups who may have been previously left out of the traditional drug development space.
4. What considerations should go into the regulatory strategy?
A lot of product development time is spent planning for and meeting regulatory requirements, which can seem considerably less exciting than some of the other phases of development. However, Callahan et al. discuss the importance of identifying key markets in order to select the appropriate regulatory pathway, as well as the need to engage with regulatory authorities early and often. Having a regulatory strategy in mind from the beginning helps frame the design of preclinical studies and the ultimate development path. The authors’ experience shows that regulatory engagement and investment of time and effort in goal-setting can help the entire development process proceed more smoothly.
5. Why make business development a priority?
Even the best-developed products can’t reach their full potential without effective product marketing and other business development activities. While often market development activities are postponed or given less attention than preclinical work, Callahan et al. encourage initiation of business development activities and engagement with potential manufacturing and commercialization partners early in the process… as they say, “[it] cannot come too soon”! They point out that scientists often lack the skills required for sales and negotiation, making this an area where consultants or other experts can play an important role. Unsurprisingly, good relationships, clear communication, and transparent goal-setting are important in this phase too, especially when navigating challenges that may arise when developing low-cost products intended for distribution in low- and middle-income countries.
With dwindling interest from the pharmaceutical industry coupled with current scientific and technological advances, the opportunity for non-traditional groups to emerge as players within the contraceptive R&D landscape is great. Novel partnerships between the academic sector, small biotech companies, foundations, NGOs, and federal governments can play an increasing role in advancing contraceptive innovation. It is certainly an exciting time to start in contraceptive R&D and witness this “contraceptive revolution” firsthand.