An innovative operational model can work perfectly well in combination with "niche" areas like the development of orphan & rare disease drugs
Springfield, MA & Wilmington, NC (PRWEB) September 23, 2012
CRMi’s President Stephen Cincotta summarized CRMi’s future in rare disease development strategy for 2012 and beyond:
“There is an unmet need in the marketplace for a global CRO that focuses exclusively in Orphan and Rare Diseases. Strategic research alliances and outsourcing are, in the end, aimed at bringing innovative medicines to patients. Innovation and flexibility are at the core of our approach as a research consortium. We have an alignment of vision, an understanding of what rare disease research needs in order to achieve milestones and have built a relationship on trust that will be a driver of success for OrphanReach and rare disease patients.”
QED’s CEO Thomas Ogorka commented:
“I am delighted that CRMi will be joining the OrphanReach consortium and become a part of this first of its kind global CRO Alliance. Orphan and rare disease drug development requires out of the box thinking and dynamic teams that can provide tailored solutions. Joining forces with CRMi means that two companies that have a lot in common will be working together towards one goal: to help accelerate drug development in an area where patients’ unmet medical needs have to be urgently addressed.”
In 1983, Congress passed the Orphan Drug Act, which allows the FDA to provide incentives for pharmaceutical and biotech companies to bring such drugs to the market. The Orphan Drug Act defines a rare disease or condition as one affecting fewer than 200,000 people in the US. There have been over 1,800 orphan designations and over 300 orphan drug approvals, leaving over 1,500 orphan drugs in development or abandoned for various scientific or business reasons.
OrphanReach capitalizes on CRMi’s and QED’s shared global infrastructure, with offices in over 40 countries including the United States, Europe, Latin America, India and the Pacific Rim. OrphanReach will employ a flexible, adaptive approach, providing an excellent fit with orphan drug development needs for government, pharmaceutical and biotech industries.
It is through the experience of the global network of clinical research professionals within rare indication trials that OrphanReach can command confidence that trials will yield high quality data thus increasing the confidence of the Regulatory Authorities when reviewing the Clinical Trial Application. Furthermore, trials are led by experienced project management teams, who understand the importance of critical milestones being met on time and on budget.