The perfect storm

John Hall tells NGP of the burning issues in the biopharmaceutical industry.

There is a new health landscape in which the rules are changing on all fronts. Patients are taking more control over decision-making about their treatments, with access to a wealth of information available at their fingertips on the web. There is also a greater emphasis on safety on the part of both regulators and consumers. Furthermore, there is a greater value consciousness on the part of both patients and payers. This means that there is a heightened need for different types of data for the changing stakeholder groups that goes beyond the data traditionally gathered for the regulatory authorities. It is now vitally important to consider these needs and to do so early in the drug development process.

These drivers have contributed to 'the perfect storm' for biopharma companies. Going forward, it is easy to envision how the impending 'patent cliff' that is unfolding will serve to heighten the pressure that the biopharma industry faces. Specifically, from 2009 through 2014, an estimated $128 billion of branded revenues will go generic. At the same time, funding for biotechs remains under heavy pressure in a capital constrained environment. Pharmaceutical companies need to re-examine the way they manage the lifecycle of their drugs, in particular the role of late phase studies if they are to differentiate their products and build a comprehensive value proposition in an increasingly saturated and payer-dominated marketplace. If they don't take up this challenge, the payers themselves will be only too happy to step into the breach and, in the end, it will largely come down to price.

Ultimately it comes down to real life-cycle development. The concept of value has widened to encompass not just whether a drug is safe and 'works' but other key factors such as how it performs against the current gold standard of care, cost-effectiveness, long-term risk management and satisfying reimbursement criteria. While elements of value creation, such as patient-reported outcomes (PROs) or quality-of-life measures, can be incorporated into phase II or III clinical trials, the real goal of these studies remains getting the drug licensed and it is imperative that this goal is not compromised by building in too many more objectives. Hence the need to have a longer term strategic clinical plan that includes post-marketing studies.

These studies are concerned with what the product actually looks like in real life, rather than in the highly selective context of a mainstream clinical trial. For example, in a real-world setting patients may have several diseases and be taking several therapies at once. To pursue late-phase development effectively, though, requires specific expertise that goes beyond that employed in the traditional phase III setting. Expertise is required in areas such as PROs, health economics, statistics and outcomes research and, as with all forms of research, the key success factor is designing the studies correctly from the outset.

Nurses and patients can also help to fill out a drug's profile post-approval. Sponsored nurses not only play a crucial role in patient education and compliance with therapy, they can also collect outcomes data from hospital databases under contract. Patients can also contribute through media such as the iGuard online medical monitoring service, which was launched in 2007 with start-up funding from Quintiles. The service now has over two million users.

Ultimately however what is required is a major change in thinking to ensure there is a continuum of studies, which encompass both the more traditional and the more innovative approaches, which will provide the right data at the right time to satisfy the needs of the increasing stakeholder groups. It is only by thinking strategically early on in the development process that the biopharma industry will be able to continue to develop new and better medicines that deliver real patient benefits.

John Hall is Vice President, Global Medical Affairs, Epidemiology and Outcomes Research for Quintiles. A former practicing physician, Dr. Hall brings over 25 years experience in development and commercialization strategy, having served in medical affairs with Eli Lilly, Glaxo, Allen and Hanburys and an independent consulting company.