Achieving Breakthrough Innovation in Biotechnology through R&D Productivity

With Advanced Clinical’s Executive Vice President, Rosemarie Truman, attending the 2010 Mid-Atlantic Biotech Conference, we would like to provide you with our ideas on achieving breakthrough in biotechnology through R&D Productivity. The following abstract will be presented at the Conference today, and we are giving you an sneak peek online in case you can’t make it to the conference!

With recent announcements of significant budget cuts in the R&D workforce and spending, it is clear the R&D model has changed for biotech companies and an innovative turnaround in R&D is needed. Advanced Clinical’s poster presentation will demonstrate a codified framework for biotechnology companies to achieve true R&D productivity.

Through a strong framework and approach, biotech companies can ensure their product has market adoption and is differentiated; they can ensure operational efficiency in the clinical trial and they can make sure the medical/scientific focus is correct.

The comprehensive framework will assess the “what,” the “how” and the “why” of R&D productivity.

1. What is needed for effective R&D productivity? First, the right medical / scientific focus is required. This includes, but is not limited to:
Protocol
Target label claims
Doses and routes
Enrollment and drop-out rates
Heterogeneity of the population
Precision endpoints

2. How can R&D productivity be achieved? Clinical trial operational execution factors to assess include, but are not limited to:
Clinical operations, enrollment, investigators and sites
Regulatory management
Data management
Biostatistics
Drug supply
Labs
Medical writing
Medical safety and monitoring

3. Why should the drug reach the market? Will it have adoption? Market viability and comparative effectiveness are critical to a drug’s success.

By providing a framework for biotech companies to ensure their product is successful, they gain a higher probability of success in getting much needed products to market.

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