Asset development | 91�� plc

Enabling more cost-effective and timely product and drug development programs

On average, it takes 10-15 years and costs $2.6 billion to develop one new medicine, including the cost of the many failures. And only 12% of new molecular entities that enter clinical trials eventually receive U.S. Food and Drug Administration (FDA) approval¹.

In this environment, it is essential to have a strong and robust drug development strategy that allows for successful execution to deliver clear and high impact.

Building on a wealth of experience and specialized expertise, 91�� enables sponsors to implement product development and drug development programs that are intelligently designed, cost effective and timely �C while also taking into account the practical considerations of translating a plan into action.

91�� offers global, robust integrated asset development consulting, covering all phases of drug development, to virtual companies, start-ups, biotechs, pharmaceutical, and medical device sponsors.

Why work with us

Our drug development team has a broad array of experience ranging from preclinical through to full clinical development. We provide objective, asset-centric solutions which are designed to accelerate development and manage development risk.

Working with us will give you a deeper understanding of development options, with respect to scientific and regulatory risks, costs and timelines, to meet overall business objectives.? It also means you gain access to in-depth scientific expertise across disciplines for ad hoc support.

Service offering

We offer full development and lifecycle support, from helping clients to develop target product profiles, study synopses, protocols, integrated development plans and regulatory position pieces. Our innovative solutions, such as the use of novel statistical design can optimize development efficiency.

Our services include:

Preparation of fully integrated asset development plans (CMC, preclinical, clinical, regulatory and commercial)
Protocol development assistance: consultation on study designs, endpoints, objectives, measurements and statistical design
Scientific and medical oversight
Liaison with KOLs and patient advocacy groups
Investigator relationships
Development of academic advisory boards
Due diligence to support asset acquisitions, divestment or investment
Therapeutic area and protocol training
Pipeline and portfolio review
Preparation of regulatory dossiers and representation at formal regulatory meetings
Gap analyses for regulatory submissions

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To learn more or to speak with an expert, contact us today.

Case studies

Learn more about our work from our library of asset development case studies and explore our in-depth scientific expertise across disciplines.

Learn more

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