Without doubt, biotech startups and smaller pharmaceutical companies have become the major drivers of innovation in the pharmaceutical industry. In 2020, 63% of approved new therapeutic drugs in Europe and the US came from small-to-medium enterprises. Yet for every success, there are countless tales of defeat. How do investors and executive managers bridge the gap between identifying a promising drug candidate and turning out a commercially successful product? While there is no simple answer to this question, one thing is certain: behind every successful new drug, there is a well-crafted product development plan (PDP). In this article, we explore why and how to use this pivotal tool to formulate a winning drug development strategy.
What is a Product Development Plan (PDP)?
The PDP is a strategic document that creates a detailed and comprehensive picture of the development strategy. It serves as a step-by-step guide to arrive at the envisioned drug product. For each stage of the development process, the PDP clarifies the major goals and critical success factors, specifying how success will be measured and what needs to be done to mitigate any risks.
A well-designed PDP not only increases the chances of success, it also plays an important role in helping the program teams reduce cost of goods, maximize efficiency and shorten time to market.
The PDP: Where Opportunity Meets Reality
Bringing a beneficial new drug or therapy to patients is an exciting opportunity and a worthy goal, but not without significant risks. For the best chance of success, it is imperative to start out with a realistic understanding of what lies ahead, and a solid plan of how to arrive at an end product that is not only marketable but will give a healthy return on investment.
Even with sound science and technology as the starting point, turning a lead candidate into a commercially viable drug is no easy feat. It is a multidisciplinary effort that requires extensive planning and coordination, as well as a clear vision of the end goal.
As we saw previously, partnering with more experienced industry players who have been there before and know what to expect is one way that smaller biotech companies can improve their chances of success. Another is to make sure there is a sound product development plan (PDP) in place from the start.
The News No CEO Wants to Hear
Imagine having spent several years and several million investor dollars to get a drug candidate successfully through phase 1 clinical trials, only to learn that your manufacturing process is not suitable for commercial scale production or that the COGS is too high.
Or perhaps your new gene therapy turns out to be the next Zolgensma, with a price tag of over $2M per patient. Will the benefit to patients justify the price of your product? Will insurers agree to cover it? If not, it may mean going back to the drawing board to rework the formulation or the manufacturing process.
What if you had to tell stakeholders that there would be a massive delay in bringing your product to the market because you did not correctly anticipate pivotal next steps and investments?
All of these scenarios are catastrophic for any company, but in particular for smaller companies that pursue a product strategy rather than a technology platform strategy.
For companies relying on Big Pharma partnerships, Menzo Havenga, President & CEO of Batavia Biosciences offers these additional words of caution:
“If at the heart of your company strategy a big pharma partner is imperative, then please note that they will take a meticulous look at the manufacturing process underlying your Phase I clinical data. Should there be any risk that the process cannot be scaled to final commercial volume, they may find the return on investment disappointing.”
Scenarios like this happen far more often than you might think, especially when developing complex biological products or advanced therapeutics, where there may be no established manufacturing or commercialization paradigms, and the path to regulatory approval is uncertain.
Where does it all go wrong? More often than not, the cause of costly delays and roadblocks can be traced back to inadequate planning or failure to fully appreciate the commercial aspects of the program and their implications in product development.
What is the Role of the PDP and Who Will Use It?
Given that a typical drug can take over a decade and more than $2 billion to develop, business leaders need to be fully aware upfront, before spending money, of what they’re getting themselves, their teams and their stakeholders into. The PDP lays everything out on the table from the start, so that the chance of success can be accurately assessed. This starts with being brutally honest about capabilities, weaknesses and deficits, as well as any challenges and risks they face.
As the program unfolds, executive management, potential partners and investors need to be presented with all the relevant facts and information required to decide whether the investment is a viable one, and whether all the criteria have been met to progress to the next stage gate.
In addition, teams executing on the plan will need to have clear guidance on strategy and know what steps to take at every stage of the development process in order to gather the right information and achieve the end goals. They will need to follow the metrics to success, understand what contingency plans are in place, and know when to act on them should things go wrong. A good PDP helps ensure timely action so that there is a smooth transition between phases. In particular, it helps your teams understand how any proposed changes will impact the program as a whole, so that they can make mission-critical decisions without delay.
On this point, Christopher Yallop, COO of Batavia Biosciences comments:
“As any cyclist knows, if you are on your bike and looking only at the tarmac you will not see the bus coming around the corner! It’s imperative when developing a drug that you see the road ahead and steer when needed. That’s where the PDP is essential.”
Finally, Program leaders must of course have sight of the big picture to be able to delegate responsibilities and coordinate the activities of all the relevant teams—including finance, marketing, non-clinical and clinical development, quality assurance, and regulatory affairs. They can refer to the plan to check whether teams are on track to meet important milestones and deliver to specification and within budget.
The PDP is the central command station that makes all of this possible.
The Benefits of Creating a PDP for Your Drug Candidate?
A PDP should meticulously map out the journey of a drug candidate, from early-stage research through commercialization. By charting the course, it paves the way for smoother navigation, optimal resource allocation, and informed decision-making.
A PDP is more than just a roadmap – it’s a strategic compass guiding drug developers to achieve the desired outcomes efficiently. Here are some compelling reasons to consider crafting a PDP for your drug candidate.
- Provides clear guidance at each stage
- Serves as a reality check
- Facilitates communication
- Improves alignment
- Drives agility and sound decision-making
- Increases efficiency
What Should Be in the Product Development Plan?
In practice, the PDP is not one strategy, but many. The key to creating a well-integrated program is to ensure that the PDP encompasses all stages and aspects of the drug development program. While the structure and content may vary, most drug development plans include these components:
A high-level overview of the drug product and target patient, the market position, as well as a summary of the financial figures and projections needed to support investment and stage gate decisions.
Marketing Strategy and Business Case
This section focuses in more detail on the commercial aspects of the program, plotting the strategy for achieving the necessary market penetration and expected return on investment. Intellectual property and trademark strategy – plays a crucial role in maintaining competitive advantage, ensuring protection in major markets, and responding quickly to any changes in the IP landscape.
Target Product Profile (TPP)
Often described as the backbone of the PDP, the TPP details the target product attributes needed to obtain regulatory approval and to satisfy commercial goals; these specifications are crucial in determining what can be claimed on the product label, and they also drive the design and evidence gathering strategies for other critical program elements.
Comprising of the ‘meat and bones’ of the PDP, laying out the most effective strategies for non-clinical and clinical development, CMC, manufacturing, regulatory affairs, and quality assurance, project organization, planning and budget considerations.
How to Get it Right First Time
Having a PDP in place as early as possible lays a solid foundation for success, but only if it has the right structure and content. To see what a typical PDP looks like, request our free PDP template, which you can access after completing the form below. In the next and final article of this series, we’ll discuss how to put together the most effective PDP for your drug development program.