A well-crafted product development plan (PDP) can play a pivotal role in the development and commercialization of a new drug product, but creating one takes time, commitment, and a lot of hard work. After all that effort, will your PDP be the magic bullet that builds investor confidence and steers you on the path to success—or will it end up being filed away and forgotten? We tapped into the wisdom of Batavia’s president and CEO, Menzo Havenga, for his advice on how to create an effective PDP. True to form, he had some refreshing insights that turn conventional thinking on its head.
Start with the end goal and work backwards
Perhaps the piece of advice that comes least naturally to those who are new to commercial drug development is the suggestion to work from the finish line backwards. Especially in cases where a drug candidate is coming out of an academic setting, the development strategy tends to focus first on the technical and scientific aspects, because this is the entrepreneur’s comfort zone.
“This can get you into a lot of hot water when constructing a product development plan,” says Havenga. “Instead of thinking from the bottom up, emerging biotech companies need to learn to plan from the top down, starting with the commercial drivers, and drilling down from there. Otherwise, they risk developing a product that fails to satisfy regulators, is not cost-effective to produce, or that no one will buy.”
For example, you might start by asking what is the ultimate business goal – will you out-license to a partner or take it all the way through to product launch? If it’s the latter, then in what countries will you launch first? What are the main market assumptions and the competitive landscape in those regions? What do these imply for the target product profile and the clinical development strategy? What does that mean for the manufacturing process? And so forth. By working backwards from the end, you have the distinct advantage of being able to answer any question from any stakeholder along the way.
As a manufacturing partner, this is typically where we help our clients to create value immediately, by challenging them to think that way.
Lay all your cards on the table
In the enthusiasm to secure financial backing and move forward with development partners, another common temptation is to put a positive spin on everything you communicate. When it comes to a drug development plan, however, it’s important to do the exact opposite. Now is the time to ruthlessly expose every potential threat, obstacle, risk and weakness you can possibly identify. Only then can you get the experts thinking about these problems and formulating strategies to address them.
For example, if you suspect you may have to swap out an animal-origin product for a more expensive non-animal derived alternative, schedule in some detailed cost modelling as early as possible. Far better to spend the extra time and research dollars upfront to find a technical work-around, than to have difficult conversations down the road on regulatory compliance or how your drug is going to cost $1M per dose.
Involve the experts early
Commercial drug development is a multidisciplinary undertaking, which means that to create an all-encompassing PDP that reflects reality, you will need to gather input from all of the relevant functions. While it may seem expedient for one leader or manager to work up the first draft of the PDP before pulling in the experts to review it, involving those experts from the start creates a shared sense of ownership and helps the author avoid imposing his or her own views and bias on the process. In the end this can save a lot of time, because you are more likely to get it right the first time.
Honesty also comes into play again here, as companies need to admit to themselves when they need outside help in areas where they have less experience. It’s also important to recognize that all of the components of the PDP are interdependent, so if there is expertise lacking in one element, it will have knock-on effects on the others.
“After all, if you aren’t well versed in commercial manufacturing,” says Havenga, “how can you advise on the chemical manufacturing and controls (CMC) strategy? And if you cannot advise on the CMC, how can you propose a suitable process development plan?”
The bottom line is that the earlier you can reach out and get input from experts—both internal and external—the more time you’ll save and the less risk there is that you will overlook something critical.
Increasingly, biotech companies are seeking the help of specialized “center of excellence” CDMOs at the early stages of drug development to bypass the steep learning curve and accelerate strategic planning.
Batavia Bioscience is one such CDMO that offers strategic planning services and will work with clients to co-develop a sound PDP.
What does the PDP development process look like?
Developing an effective drug development strategy is an intensive process that can’t be rushed. When a client turns to Batavia for help in creating a PDP, they set aside a full 5 days for the workshop. This ensures there is ample time to cover the entire process comprehensively and dig deep into areas of ambiguity or concern.
“The whole experience can be very enlightening,” says Havenga. “As our subject matter experts drill down into the specifics, we almost inevitably uncover areas that need more thought. It’s very rewarding to see how together we can then find practical solutions to serious obstacles.”
Ready to kick-start your drug development strategy?
Batavia Biosciences is a Center of Excellence for viral vaccine and viral vector development with extensive experience in the field of infectious diseases and oncology. If the prospect of putting together an effective PDP is making your head spin, reach out and talk to one of our experts. We’re here to help you succeed.