Quintiles has announced the launch of its Integrated Asset Development Plan (IADP) offering. This new suite of services combines development strategy, regulatory strategy, market and patient access and commercial expertise, with in-depth therapeutic knowledge, a facilitated strategic-planning process, data analytics and modeling to deliver an integrated asset-development plan.
IADP brings together cross-functional strategies and operational delivery to enable more informed decisions that speed market access, fulfill regulatory requirements and help optimize commercial potential. Potential assets that could benefit from this new offering include small molecule drugs, biologics, medical devices, combination therapies and novel technologies.
“In today’s increasingly complex healthcare market, a successful asset must meet key value objectives and evidence needs for a variety of stakeholders, including patients, providers, regulators and payers,” said Rick Sax, M.D., senior vice president, Quintiles Advisory Services. “A successful asset development plan considers the dynamic requirements of stakeholders to enable better decisions during development. With IADP, we bring an objective view of commercial viability, a structured design process and robust technology to create an approach that helps our customers improve their probability of success.”
As part of the IADP offering, Quintiles advises biopharmaceutical companies on considerations for an asset’s value proposition, Target Product Profile (TPP), regulatory plan, and a Clinical Development Plan (CDP) which optimizes trial design and protocol development.
The IADP also includes market access planning, evidence generation plan, commercial launch plan, lifecycle management and real-world evidence risk management plans, in keeping with the stage of development for the asset.
“Based on our experience, having a viable, integrated plan for asset development increases the likelihood of success,” said Sax. “When combined with an in-depth understanding of the cross-functional dependencies and operational requirements, it’s a very powerful approach.”