Whether you plan to out-license or commercialize your product, getting the label right matters.

When putting together a comprehensive drug development plan, it’s important to remember one of Premier Consulting’s key approaches to drug development: “Begin with the end in mind.” This is a multifactorial mindset that considers the patient journey, physician prescribing practices, marketing, insurance reimbursement, and more. From a regulatory perspective, this approach is borne from consideration of the eventual product labeling, beginning in early stages of product development.

Labeling goals have a deep impact on a development strategy, and failing to take them into account is often costly. Here are a few keys to optimizing a product’s labeling to bring value to its sponsors, partners, and investors:

Consider the labeling early

A sponsor has only one opportunity to design the appropriate study to achieve certain labeling claims. The more a sponsor thinks about the ultimate program goals during the early stages of development, the better it can weave these considerations into a comprehensive, concise program. This program then can be discussed with the FDA during development, ensuring Agency agreement and avoiding redundancies in studies conducted.

When a sponsor waits to consider the labeling until after development plans have already been discussed during a pre-IND, it can lead to inadvertent commitment to study designs or elements that are not in direct alignment with its goals. Often in this situation, a drastic change in the development program is required. Such a move is risky and time consuming in that a sponsor no longer has Agency buy-in, and additional interactions (read: more time and money) become necessary to re-align the program.

Prioritize value over speed

Pharmacokinetic (PK-only) programs for products developed via the 505(b)(2) pathway are one example that illustrates why focusing on speed alone can limit commercial success. Generally considered the “holy grail” of 505(b)(2) development programs, PK-only programs minimize the costs associated with running supplemental safety or efficacy studies and accelerate the timeline between opening an IND and filing an NDA.

However, the “fastest to market” approach will not necessarily allow the product to be positioned in the most advantageous way in a saturated, competitive pharmaceutical landscape. For instance, PK-only programs do not allow for incorporation of new comparative statements in labeling.

When outlining the development plan for a product, a sponsor needs to consider several questions about how to bring added value to the program:

• In what ways can the product be differentiated in the market, and how will those factors be reflected in the eventual product labeling?
• What will insurance companies be willing to pay for this product, and how will they reimburse the drug companies based on the clinical advantages of the drug?
• What capabilities does the product need to have for a physician to preferentially prescribe it and for patients to gain added value from it?

Take other stakeholders into account

In many cases, it is not a sponsor’s goal to bring a product to market but rather to enter into a sales or licensing agreement. Often, if a sponsor won’t be responsible for marketing a product, a development plan which will get the product to market by the fastest possible route with the lowest up-front cost seems the most desirable. A sponsor is more likely to attract investors and licensing partners with a development plan that takes into account how the eventual product label will be perceived in the market.

For example, a sponsor with a licensing agreement with another company for post-approval marketing may be tempted to pursue NDA approval by the most efficient means available. However, if the plan fails to consider the eventual product labeling and to align the development strategy with the licensor’s values, the cost for both parties in terms of time and money can be enormous.

While the “end” for the sponsor in this scenario differs from that of a sponsor aiming to bring its own product to market, both should consider the commercial value of their products and pursue development plans that will produce optimized labels.

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At Premier Consulting, we have experience outlining programs that are time- and money-conscious, while ensuring that the end product is valuable to drug developers, investors, patients, and physicians. Contact us to find out how we can assess your regulatory needs and help develop a streamlined program that will produce a differentiated, marketable product.