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.
How effectively will your asset meet patient needs? How will it fit into the market? And which of your assets will have the greatest impact? To answer these questions, you need to understand better how the new technologies, regulations and markets are evolving, since revenue will only come years in the future. So how will it generate value?
In collaboration with Health Advances, we’ll help you understand the possible clinical paths, what regulators will accept, and what commercial stakeholders will pay for. We’ll help you determine the asset’s lifetime potential so you can make those high-stakes go/no-go decisions on whether to develop or in-license an asset.
Acquiring assets is a key method of expanding and optimizing portfolios. Transferring an asset, however, is a complex operation, requiring data transfer in required formats, license transfer, full documentation, market authorization transfer, and regulatory certifications in the full range of intended markets.
Any mistakes can reduce asset value and impose regulatory and other expensive delays. We have extensive experience in time-sensitive, complex transfers, with an established reputation for operational efficiency and governance — so you can rest easy knowing your asset transfers will go smoothly.
You want any patient who can benefit from your drug to have easy and affordable access to it. To ensure this, you need to know why a physician would prescribe your drug, why a payer would cover it, and why a patient would choose it. The needs and responses of these stakeholders are often consulted too late to have the necessary effect on development choices.
Gathering evidence of prescriber and patient behavior is particularly vital for making smart market access decisions. Our recognized ability to reliably interview prescribers about their treatment algorithms, unmet needs, and competitive products provides a strong foundation for focusing on asset value.
To get maximum value from every asset, it’s important to understand the regulatory landscape for clinical trial and product licensing in every globally target market. Which assets on which geographical location are likely to meet with early approval? Which will face challenges from current and future competitor products targeting the same indication on the targeted market? Different regulators may have differing demands for data establishing toxicity, efficacy, research sample site, and ethical diversity.
Global products need a global perspective — and we provide it. We offer an understanding of the regulatory landscape in every national and regional market and can tell you where to anticipate roadblocks, what to do to avoid them, and how best to develop asset value. This may require, for example, choosing a regulatory regime where you can do first-in-human trials, get data while building asset value, and only then address more stringent concerns of other regulators. Whatever path is right for your project, we’ll provide it.