Communications During Drug Development
Helping physicians and patients get access to new drugs and medical devices requires more than showing that a product works. In this article, we focus on the hurdles that the biopharmaceutical industry faces. Similar challenges face the medical device industry; however, as they say, the devil is in the details.
Typically, the first hurdles facing the biopharmaceutical industry are demonstrating that the product is safe and effective and that it can be consistently and reliably manufactured. However, a successful product launch also requires surmounting the hurdles of reimbursement and commercialization.
Each hurdle requires developing and communicating data essential to inform a variety of decision makers and payers to do this efficiently and effectively, we must get the right information to the right audience at the right time and in the right way.
The right information includes data on how well a product works, how safe it is, and how it is manufactured, and its use in in treating or diagnosing a disease. The right information also includes the justification for paying for the product.
Knowing the right audience and understanding their requirements is critical. Audiences may include regulators, opinion leaders, payers, physicians, nurses, medical and disease-related societies, and patients. Their requirements vary with respect to content, to timing, and to manner of delivery. For example, some information cannot be legally communicated until the drug is approved, and a presentation at a scientific meeting would be appropriate for communicating to a group of physicians, but not to regulators or patients.
Stages of Communication
Beginning early in drug development we need to consider where and when to communicate to our audiences. These decisions need to be continually updated in light of the evolving clinical drug development program and a potentially changing treatment paradigm. At each stage, various types of communication vehicles, including advisory boards, publications, and conference activities, may be appropriate ways of communicating with the target audiences.
Early in development, we need to communicate why a product is needed in the treatment paradigm. There may be gaps in current standards of care, unaddressed populations or need for improved treatment options, an improved patient experience, or a more economic treatment.
Once the stage is set, we need to explain what the product does and where it might be effective. If, for example, a drug has a unique pharmacokinetic or pharmacodynamic profile, we may decide that that is important information for the public to be aware of. Data about safety and efficacy can be used to explain how this product might fit into clinical practice. It will also be used to support applications for marketing authorization by regulators. Throughout the development process, we also must decide when to engage with opinion leaders, including regulators, payers and physicians.
Peri- and post-approval, we need to determine and communicate the economic value of the product, including health care resource utilization, establishing its value as the biopharmaceutical company begins discussions with payers. Specific data may be required, depending on the regions of the world where the product will be marketed. Tools such as a global value dossier and health economics models facilitate presentation of the requisite evidence in peer-reviewed publications and in other documents such as reimbursement dossiers.
Additional regulatory hurdles may arise post approval. These can include a variety of post-marketing commitments either volunteered by the biopharmaceutical company or mandated by a regulatory authority.
Writing Styles for Our Audiences
Each audience requires a very different writing style and different content, but the writing should always be interesting to read!
Regulators must review long documents that capture a huge amount of data with a high degree of scientific and medical complexity. Because this audience is expert, we do not usually present a great deal of background explanation of the disease or the class of drugs. Data should be presented in an accessible format, with a focus on clarity. As writers, we want to make sure that regulators understand exactly what we're saying, and minimize industry opinion.
Payers such as reimbursement agencies are looking at somewhat smaller but still very data-intensive documents. We need to present different types of data, depending on the payer in question, and generally include data related to health economics and non-clinical outcomes. Typically, we also exclude or limit industry opinion, allowing payers to draw their own conclusions.
For key opinion leaders, who have a very high level of scientific and medical expertise, we want to present synthesized data in a concise format. We can include moderate amounts of sponsor opinion for this audience.
When we write for treating physicians, we must be accurate, but we should not overwhelm them with data. We may need to include some background explanation about the use of the drug and the disease state.
When we write for patients, we want to keep the scientific complexity low while maintaining a high degree of accuracy, a difficult type of writing to do well.
The Value Proposition
One of our major goals as communicators is to use the information gained during drug development and post-marketing studies to build the long-term story of the product, into what is known as the Value Proposition.
This is the total sum of information that will help decision makers, be they health care providers or payers, make an informed judgment about the use of the product. It may also provide insight into what is not known about the product, and identify the research that may still be needed to answer questions from the scientific and payer communities. This insight may be gained through exercises such as gap analyses or discussions with experts at advisory boards and in turn may be used to help inform future research programs.
Covance Integrated Communications
Our Integrated Communications services provide synchronicity, consistency and efficiency in communications. We develop one value story across all activities, including drug approvals, commercialization, reimbursement, and all facets of data dissemination. You can find more information on our website about the ways in which we can help you communicate, including additional details about the types of writing that we provide.