For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
With our in-depth understanding of the relevant biological and chemical mechanisms, we can define a target product profile (TPP) that articulates an asset’s likely clinical advantages. The target profile also provides guideposts around key efficacy and safety endpoints, creating a foundation for more efficient animal and later clinical testing. Our regulatory group examines this data for early evidence review and will advise on which jurisdictions will allow you to proceed and which will require further data, to keep the project running smoothly.
With every asset, we focus on its ultimate market performance goals throughout development. This requires planning for the best market positioning while taking regulatory and development feasibility into account. You’ll need to understand what you need for your asset at every stage of development, so you’ll be ready with the story needed to gain investor confidence.
With a team that understands the science and the clinical path, what regulators in every market will accept, and what the reactions of payers, providers, and patients will be, we’ll get you from a scientific concept to an asset with patient impact.
You want to get to a commercially viable product as quickly as you can while reliably substantiating outcomes to demonstrate its value — but there are potential obstacles. It can be difficult to recruit the right population, analysis might require difficult and expensive imaging that goes beyond the reach of most sites, and more.
At Parexel, we know what you need before you even write the protocol. We provide early site services to locate sites that provide you with the necessary patient population, both individually and in larger geographies. We investigate biomarkers that may replace the need for imaging. We look at the development and regulatory feasibility considerations, work through the TPP , and test it with payers, market stakeholders, and KOLs so you know how it resonates.
A new treatment for a disease with previously limited or nonexistent therapeutic options may have side effects that need monitoring. Marketing that kind of drug requires a clear strategy.
Our translational group can help you manage tests to demonstrate how your drug’s benefits outweigh its risks, and to maintain patient access through appropriate use. Our regulatory group has managed many such drugs through the FDA’s Risk Evaluation and Mitigation Strategies (REMS) program, EMA’s risk-management plan (RMP), and other global risk-mitigation regulations.