Bringing a new pharmaceutical product to market can cost billions of dollars and take many years to accomplish – sometimes more than a decade.
Clinical trials alone can take many years to complete.
Perhaps the main task in pharmaceutical life cycle management is identifying external opportunities and threats, such as foreign competition and regulatory demands. Pharmaceutical companies must manage the entire life cycle of a drug in order to make the smartest investment decisions and maximize ROI. Doing so not only ensures healthy revenues, it also increases competitive advantage and helps maintain strong R&D capabilities for future drug development efforts.
Technological advancements, a globally competitive environment, and an ever-changing regulatory world mean that life cycle management must now begin earlier, end later, and involve stakeholders in new ways.
Extended LCM and Identification of All Stakeholders
In earlier times, LCM started with product launch and lasted until the patent expired, but that is insufficient for today’s needs. Now, LCM starts earlier, in the discovery phase of pharmaceutical development. And it lasts until the end of the product’s life for the drug developer.
Among the many stakeholders in today’s pharmaceutical product development are governments, insurers, patients, physicians, and contract development and manufacturing organizations (CDMOs). Each of these wants more value from their investment in the product. The only way to ensure stakeholders gain maximum value from their stake is by comprehensive life cycle management, from discovery through end of product life.
With CDMOs, Collaboration Starts Earlier
Pharmaceutical companies can make use of CDMOs’ own LCM expertise, especially if they begin collaborating with CDMOs early in the discovery phase of a new product. For CDMOs, LCM is about quality and cost improvements during manufacturing, and when pharma companies collaborate with their CDMOs earlier, they can benefit from lower production costs and fewer process and production issues, right from the beginning. Often, collaboration with CDMOs leads to a two-pronged CDMO strategy: getting the product to launch quickly, then planning for process optimization to reduce the cost of goods.
Early collaboration with CDMOs can prevent process problems later.
Dedicated, Cross-Functional LCM Teams
Teams dedicated to life cycle management are standard now. The best LCM teams are cross-functional, with representatives from marketing, R&D, manufacturing, engineering, and legal departments. Including the CDMO in these cross-functional LCM teams is wise too. Assembling a dedicated LCM team early in the development process typically results in accelerated development, optimal manufacturing processes, lower cost of goods, fewer mistakes, and increased value for stakeholders. As a result, pharmaceutical companies can maximize profit during the market exclusivity period, and also optimize API manufacturing long before the product is scheduled to go off-patent.
Typical Tactics Used in Modern LCM Strategies
Technological advancement alone is helping accelerate time to market, with cloud technology offering drug manufacturers flexibility, security, and better regulation compliance, while allowing pharmaceutical companies to shrink their IT infrastructure costs and focus more fully on drug development and LCM.
Starting LCM planning early in the discovery phase of a drug is becoming standard practice. Working to create value for all stakeholders requires optimizing the active pharmaceutical ingredient manufacturing process, plus working on improvements like optimized logistics, better packaging, improved manufacturing processes, and optimized batch sizes.
After product launch, identifying new indications, improved formulations, and new drug delivery systems can address unmet customer needs. This can result in improving patient compliance by reducing side effects, simplifying dosing, and creating new drug delivery systems. Ultimately, pharmaceutical life cycle management is more than just a way to extend a product’s life and maximize value. It is ultimately about creating conditions for the business as a whole to grow and discover new opportunities.Copyright © DrugPatentWatch. Originally published at How Pharmaceutical Life Cycle Management Strategies Are Evolving