Experience builds expertise. Sometimes reaching the most effective outcome means doing things differently or doing things that may not be immediately intuitive. These principles, simple in nature and drawn from our deep experience, are at the core of every complex program we undertake.
Resources and capabilities are never infinite. We concentrate on our unique advantage: niche dermatology-focused drug development. Organizations stand to benefit from focusing on a few good opportunities versus every “interesting” one that presents itself. It’s better to consistently hit singles and doubles than to be the home run hitter who frequently strikes out. And getting two or three successful drugs approved during a five-year period trumps constantly failing to deliver on the promise of a blockbuster.
While it’s true that good development is based on science, answering all interesting scientific questions detracts from the main objectives. The goal of development is gaining approval of a commercially successful product. Rather than jeopardize development by asking non-critical questions, we help our partners focus on what’s important. We suggest leaving those intriguing scientific questions to your research colleagues.
We believe products have “personalities,” and the personality of the product should determine its clinical use and positioning in the market. Recognizing your product’s personality and accepting it is critical. We advise against trying to make a product be something it is not. Recognizing the product’s personality enables the organization to protect and guide it. Therapeutics will help you identify and nurture your product’s personality. We can leverage the product’s strengths and support its weaknesses through thoughtful market research and carefully considered non-clinical and clinical evaluations.
In today’s market approvability does not guarantee profitability. In addition to the clinical performance of the drug, successful drug development must reflect a clear understanding of the market, competitive technologies, customer demands, reimbursement issues, regulatory requirements, etc. Therapeutics will carefully evaluate the myriad of influences and develop considered responses to maximize the potential of your product.
While a New Chemical Entity (NCE) with clear advantages can be really great, creative adaptation of established compounds can also be great. Today, there is precious little discovery activity directed toward identifying unique dermatologic therapies. The majority of new product introductions in dermatology are not based upon NCEs, but rather improved formulations or new delivery systems dependent upon decades old active moieties. Whether you are developing an NCE or an “improved” product, expert design and execution are required to give you a competitive edge in the market.
It used to be that the doctor was the sole decision-maker in determining which drug the patient received. Now, the doctor’s choice in conjunction with patient mindset, healthcare policies, regulatory requirements, the competitive landscape, and the effectiveness of your marketing and sales groups combine to influence the positioning and use of your product. One must be prospectively aware of these drivers and respond appropriately with relevant development program design and execution.
More than 70% of the pharmaceutical products approved in the last decade have no sustainable point of differentiation. Consequently, the value of a product’s “brand equity” cannot be overestimated. To fully leverage brand equity the product must be properly positioned, consistent with “product personality.” The brand message must be consistent across all materials, media and venues, and all spokespersons (including R&D professionals) must accept and speak “The Brand Story.” Positioning, messaging, and branding evolve with the lifecycle of the product. New studies and findings should be used to enhance the brand; not obscure it. The relatively small size and relationship-driven nature of the dermatology product market is conducive to the execution of a strong branding strategy.
Lifecycle-management (LCM) planning for your product should begin long before regulatory approval. Effective LCM planning provides a relatively low risk, cost-effective method of leveraging your initial product development investments. LCM products often possess subtle, but unique points of differentiation that can be leveraged through brand equity. LCM products generally offer a better return on investment (ROI) than the primary product and are usually the key defense against generic substitution. Through thoughtful management of your product’s lifecycle it is possible to maintain a proprietary position years after the composition of matter patent expires. Therapeutics can help you evaluate your product’s lifecycle opportunities and develop and execute a custom LCM plan.
Drug development is a high risk endeavor. Few products that enter clinical trials make it to market. Companies in the drug development race should run to win. Sometimes that may mean crossing the finish line with a great new drug during a triumphant moment. Other times that may mean asking if you are in the ”right race” to begin with or recognizing that there may be times when it is better to withdraw rather than complete the race and not win.
Therapeutics does not advocate allocation of valuable drug development resources to commercially non-viable product development efforts. Instead, we suggest primary market research to assess the product’s commercial potential at the outset and continued monitoring of the product’s viability throughout its development and entire lifecycle. Regularly monitoring the product’s viability, even as it matures, is necessary to confirm that it is appropriate to complete the race. Closure of what was once a promising development effort may be disconcerting, but overall, it may be necessary to maximize the development portfolio ROI.
Pharmaceutical product development timelines are measured in years. Success can be managed, but is never guaranteed. Maintaining a portfolio of rationally-staged development projects is essential to long-term success. Progressing multiple opportunities to the “proof-of-concept” stage enables an organization to have programs that can be readily moved into full development if one of the lead projects fails to meet expectations.