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Kate Lumpkin

“If you don’t know where you are going, any road will get you there.” -  Lewis Carroll   

 I was recently involved in a “mock OPDP” meeting (a meeting of internal and external experts some companies utilize to assess the viability of the proposed launch claims – usually about 6 months before the PDUFA date) where the ad/promo review team informed commercial that virtually none of their essential differentiating claims, other than stating the actual indication, were supported by substantial evidence, the historical regulatory standard. They would be able to market their product with only a very few of the claims they “needed.” The product was not developed to even test those critical claims because they were not pre-identified.

Imagine the pall cast over the room. The commercial team clearly was devastated they could not make the claims they had projected. Other team members were equally as distressed to have to say “no.” But there simply was no supporting data to the level required to support the claims. The draft PI was over inspirational. And draft claims were designed based on that over-reaching draft PI. This was a moment of true corporate crisis.

That meeting reminded of the very first training program I delivered as a consultant for a pharmaceutical company, some 15 years ago. In that program, I coined the phrase “Backwards Planning.” My message was predicated on thecriticality of developing a product with the end goal of including the pre-determined, essential claims in the package insert. Fifteen years ago, the concept was important. 

Fifteen years later, I am more convinced than ever of the business imperative to do so.

The Case for Backwards Planning

I define “Backwards Planning” as developing the product with the end goal as the imperative. Of course, there is no “one size fits all.” And, there are many changes and challenges occurring in the drug development and commercialization world. The drug development road is winding, for sure. However, if there is no clear destination, there is also no clear success.

The end goal is the inclusion of essential data in the package insert, such as the most appropriate indication language, patient subgroups, and a robust clinical trials section, among others. In addition to providing the most beneficial data for patient selection and treatment, this approach provides objective development milestones, maximizes potential commercialization, and minimizes short-term and long-term risk management (compliance) considerations. It is no longer acceptable to just get the drug approved. We must be smarter. We must think strategically. We must get the right product approved with the right attributes. When possible, we must obtain differentiating claims. We must have more metrics to inform us to cut our losses when appropriate. We must do this for our patients, for maximizing commercial success, for risk mitigation, and for the business as a whole. This development strategy is essential, whether developing a NME or using the 505(b)(2) pathway.

Backwards Planning Considerations

 There are many considerations to creating an effective product development strategy using “Backwards Planning”. This takes real courage, requires enlightened leadership, and is certainly not easy. But drug development is expensive, complicated, and long. This method can be a vital tool in mitigating some of the ultimate commercial challenges. Though far from complete, and recognizing space limitations and the fact I am oversimplifying a very complicated process, here are some observations on working from a “Backwards Planning” platform. 

Involve the right people from the beginning

 Form a team charged with defining the global/US development strategy. The team must include all appropriate disciplines, including: clinical, medical, regulatory, market intelligence, legal, compliance, commercial, regulatory, ad/promo regulatory, etc. This team should work with the development team throughout the process to establish “needed” data/claims, to design appropriate studies to test them, to assess the strategy for compliance considerations, to assess the feasibility of inclusion in the final PI, and to provide accurate advice on the likelihood of the data to support a promotional claim.

Clearly define the needed product attributes

 Utilizing market intelligence, demographic knowledge, illness evolution, and predicted payer data and information needs, among other factors, clearly define the desired indication (use) of the asset, the desired patient population, the desired delivery pathway, etc. Determine whether to develop this drug/biologic for a broad indication or a more targeted and focused one. Determine whether or not it is critical to have a superiority claim at launch. Determine whether or not you need to gather data to support patient reported outcome claims, adherence claims, or patient preference claims. If at all possible, work strategically to determine the actual desired claims, using the actual desired language.

Work futuristically, and determine a future-thinking development strategy early. What additional indications or patient groups will be important to study in the future?  Plan for this now.

Design a development strategy to objectively test the desired claims

 After defining the desired product attributes, the team should develop a TPP(Targeted Product Profile) to guide the overall development process and create a best possible development/claims “wish list.”

 If data supports conducting Phase III trials, design trials to effectively test the pre-determined claims. Realizing the numerous business and financial considerations to drug development, including time and need for “first to market”, the more closely the final PI reflects language and data (substantial evidence) to support the essential claims, the better chance for successful commercialization and the more characterized the product will be for patient selection and potential clinical response.

The team should effectively utilize an end of Phase II meeting with the appropriate review division. This is especially essential if the team desires to use an unusual study design, desires to study patient adherence or preference, use an unfamiliar scale, etc. Acknowledging the limitations of this request and commitment, as possible, gain agreement that the study design actually supports the claim testing you have identified as vital.

 No matter how it is done, drug development is an arduous, expensive, and winding road. Having a clear destination in mind, and strategically planning accordingly, is essential for patient and market success.