Product Development Strategy: Defining the Road Ahead

Developing a sound product development strategy requires full knowledge of where we are starting from, a clear understanding of where we want to be at various time points (milestones), and what constraints or requirements have to be addressed along the way.

Each of these three elements will evolve over time. New study results add to our knowledge; understanding of specific medical needs evolves. Regulatory milestones are addressed, thus directing efforts toward the next step with increased understanding and consensus. New regulations or market changes may affect the context in which the product is developed or will be launched.

The implications of these two paragraphs are vast. First, an array of skills is necessary to conceive sound strategies. Such skills can be provided only by multiple individuals working in product development teams. The necessity of product development teams is widely recognized. The secret, however, is not whether a given development “team” has a catalog of the necessary skill sets. Gathering personnel with proper resumes is easy enough. Rather, the secret behind efficient product development teams is in how the assigned individuals actually team up in a dynamic, effective manner, thus making the skill sets functionally available to the project. When this happens, the product development team becomes a reliable, productive unit, with one voice and one identity. Unfortunately, we have probably all been part of more or less dysfunctional product development teams. Fortunately, most of us have probably been lucky enough to experience the alternative: teams where the ultimate goal is the success of the product in the market place. With such a clear goal, team members remain focused on the essential objective, with a goal that is placed well above any personal gains, thus recognizing the futility of personal promotion relative to the fully successful development of the product.

Second, a clear development goal is critical to success. Medical products are developed to address medical needs. The fundamental nature of the product development plan is to define the path, demonstrating that the product actually meets these medical needs. Ultimately, all products that come to market are assessed against the expectations of physicians and the realities of the medical market. Regardless of the reasons, products that fail to meet the actual needs of patients for which they are seemingly indicated also fail to address the needs of their physicians and the corresponding medical reality. Ultimately, these products also fail to meet their business goals essentially because adoption falters. Thus, it is essential to define clearly and fully the medical needs that a given product should address.

What need(s) is/are addressed, and how, must be defined at the start of product development. This is a critical step, as it will guide all future actions of the product development team and of the company.

Often, priority is given to defining the product profile. “Product profile” is quite often dictated by business objectives rather than the expectations of the world as a whole. Medical reality, however, is outside the company and is defined by the needs of patients and physicians. Product profiles that aim at maximizing the apparent potential market size with limited regard to the medical reality have a high potential to derail development efforts, to make regulatory and reimbursement negotiations difficult, or to lead to disappointing results when the product reaches the market.

The following examples reflect the aggregated experience based on observing the development of several products (drugs, devices, biologics) over the years, and should not be seen as referring to a single product.

Example 1

Let’s assume that we have the license to a new drug that would be perfect for heart failure. It’s potentially a first in class, with a unique mechanism of action that addresses a known challenge in the treatment of patients with chronic heart failure or acute worsening of their condition. It addresses a clear unsatisfied need for a potentially huge market. A few competitors are pursing compounds of the same class. The race is on! Our data package supports short-term use with an IV formulation. If we accept this fact, we can start the few missing trials shortly, and run in parallel a Phase IIb trial, which, with the appropriate design, could become our first Phase III pivotal study. Time to submission can be 2 to 3 years, thus ensuring that launch should occur with limited delay. However, the potential indication is limited to the acute care setting, thus limiting the market size significantly.

In order to appeal to a larger market, management decides to pursue an oral formulation, suitable for the desired indication of long-term treatment of heart failure. The short-term advantage is obviously that the potential of the product, and thus of the company, now appears much larger. The issue is that it is also much more challenging. Indeed, significant pre-clinical research must be performed, in addition to multiple clinical studies that are required to support chronic use. Finally, it is not known that manufacturing a commercially viable oral formulation is feasible. Marching orders being what they are, the product development team marches as directed.

Fast forward 2 years.

Unexpected formulation issues have delayed the initiation of multiple trials. Unforeseen safety issues have lead to additional regulatory requirements. There is no consensus among the medical community that the intended action of the drug would be of significant benefit in the context of chronic use for this indication. A competing agent has been approved. Money is running out.

Why do we arrive, after two years of very hard work, at this disappointing result? Well, after the fact, it’s easy to see. Management failed to assess the gap between a data package suitable for acute use and the regulatory requirement that must be satisfied for the approval of a chronic indication. Management also failed to assess thoroughly that the medical relevance of the drug in acute care settings, which remains unchallenged, could be extrapolated to chronic care.

Was there a viable alternate scenario? Yes indeed! First, we believe that the product should have been developed aggressively for an indication in acute care. It would have been superior to its competitors, potentially first to launch, thus having a serious chance at making good on being the first mover. Although the target market would have been limited in size, pricing could have been optimized, thus allowing for significant cash inflow early on. Second, we also believe that the development of the chronic formulation should have been pursued, but in parallel and not instead of acute care. This strategy would have provided us with a viable (if not great) business early on (acute care) and a great potential for growth (chronic use) as well as a solid ground to build both businesses.

Example 2

Sometimes, reality is actually better that expectation. However, when reality is so much beyond expectations that the best plans are eventually overwhelmed, the risk of failure is real. Indeed, this situation results in demand overwhelming supply capabilities as well as the resources available for sales and support.

Company X faces a typical life-cycle management issue. The flagship product is coming off patent. Within 2 to 3 years, sales will be taken over by generics. Another product with some potential is under development. The corporate goal is to replace the sales lost to generic competition with the income generated by the new product. Consequently, all plans call for sales of the new product to match those projected lost sales. Business as usual makes everybody happy. No new analysis challenges this plan.

While executing pivotal trials, multiple indices call the attention of the project team to the fact that the existing projections may be too conservative, and by a large margin. The team goes back to the drawing board aiming for a significant increase in projected sales.

The development plans are thus optimized to support a new, more aggressive regulatory and launch strategy The company assigns all the resources needed for success. After a year in the market, all the milestones and goals defined in the new plan are met or exceeded , with a ctual sales exceeding initial projections by more than 3 times.

Lesson learned? Plans are only good as far as they serve two purposes. First, of course, is to provide sound basis for resource planning. The second and, in my opinion, the most important purpose of plans is to offer a basis for reflection, an objective reference from which better strategies may be built. In the example above, the plans being challenged, critically reviewed, revised, then supported by management proved instrumental to success.

Example 3

A promising blockbuster drug with potential for multiple indications is well under development. Among the indications, priority has been given to a first claim. A first Phase III trial in under way, with several interim analyses planned. A first interim analysis suggests serious safety concerns in this chronic indication. Management decides to close the program and discontinue developing the drug altogether.

This decision may actually have been the correct one, ultimately. However, other promising indications were at earlier stages of development, addressing other significant medical conditions. No effort was made to verify that the issues observed in the initial Phase III trial, aimed at the priority indication, were relevant for the other indications, although there was reason to doubt that they were.

Nobody will ever know whether the decision was ultimately sound or resulted in significant opportunities being missed.

In Summary

The role of management is critical, as these examples illustrate. Leadership must promote the objective analysis of all information available, real team work, acknowledge input from product development teams, and challenge business as usual.

Product development teams, for their part, must embrace the fact that the team is responsible and accountable to all parties for the future of the product. Its duties can be listed as follows:

To corporate management, the team is responsible for optimizing the product to the maximum possible within the confines of the market place (defined on the basis of actual medical needs).

To all entities that are represented in the product development team, the team is responsible for proving the information and guidance to ensure that operational decisions are sound and coordinated, and that resources are properly allocated.

To regulatory reviewers, the product development team is expected to provide all the information that is needed to support the clearance or approval of the product. The information must be complete and accurate. It should also be focused. Regulatory requirements should be followed, challenged as needed (new therapeutic modalities may dictate new standards), but not supplemented with information that may distract from the primary goal of regulatory review.

Finally, the product development team is accountable to the community of physicians and patients for developing a product that addresses their needs effectively and safely. Key to this is an indication that matches the medical needs as exactly as possible and that is not inflated to address a market much bigger that it really is.

About Paul-André de Lame

Paul-André de Lame, MD, currently president and CEO of Anabase International Corp., has more than 20 years of industry experience and a broad knowledge of product development, clinical research, and related regulatory issues. He has made critical contributions to a number of new product launches while organizing multiple research projects at the domestic and international levels. His team-based approach to global project management proved extremely efficient in organizing complex projects with short and long-term business relevance. Building on this industry experience, Dr. de Lame and Dr. Lemaire co-founded Anabase International Corp. in 1996. Anabase is dedicated to providing strategic consulting, clinical research services, regulatory affairs support, and information management systems to the Pharmaceutical, Medical Device and Health Care Industries. Prior to founding Anabase, Dr. de Lame obtained his MD degree from the Catholic University of Louvain (Belgium) with a specialization in anesthesiology and intensive care medicine. He spent several years as Head of Intensive Care in a private hospital in Brussels (Belgium) before joining Merck Sharp & Dohme, Belgium. He then joined Warner Lambert Parke-Davis, where he was a critical contributor to the successful launch of atorvastatin.

About the company
Anabase International Corp. provides consulting services for clinical development and regulatory strategies, services including medical and safety monitoring, and integrated study and data management systems and processes. Information regarding Anabase International Corp. can be found on the web at www.anabase.com.