10 Molecule to Market The drug development process from lead generation to patent expiration is complex, fraught with risk, and extremely time and cost intensive. 16 Drug Discovery Pharmaceutical companies are using state-of-the-art technologies to understand the basis of disease as a way to bring product candidates to the clinic. 20 Preclinical development Most product candidates often fail in the preclinical stage. High-quality toxicology studies and companies’ ability to address unexpected events are critical to managing preclinical timelines. 22 Phase I More rigorous and more complex Phase I trials can be more costly and time extensive, but they can also provide an opportunity to see proof of concept sooner. 26 Phase II New trial designs are helping pharmaceutical companies execute more efficient trials. This is also the time to begin thinking about the commercial aspect of a product candidate. 30 Phase III Technology solutions that improve patient recruitment and data collection and management may be just what the industry needs to reduce costs and improve efficiency. 34 Registration and Launch The expanding global market is creating hurdles within the registration process, requiring long-term views and solutions to bring a product successfully to launch. 40 PostLaunch REMS, adverse events, postmarketing research, and patient recruitment are just a few of the challenges drug sponsors face in this late-stage phase. in every issue 3 Letter from the Editor 8 UpFront 46 What’s New 50 E-media 52 On the Calendar 54 Talent Pool 58 Last Word Mark Swindell discusses the integration of Wyeth’s vaccines. Only in the Digital Edition of the March 2010 issue of PharmaVOICE A Long and Winding Road: R&D models Drug Discovery: Biomarkers Across Drug Development: Personalized medicine CROs and Preclinical Development: Outsourcing Phase I: Patient Recruitment: Communicating the value Phase III: Market Preparation: Brand adoption Launch: Safety Counts: Long-term concerns Phase IV: Technology Solutions: Real-time data Special Issue: Molecule to Market Bonus Content A Drug Development Timeline A Long and Winding Road By addressing failing R&D models, collaboration issues, complex global trials, development bottlenecks, and changing regulatory landscape, sponsors and their partner companies can improve development efficiency. Why science is greater than the economy Rebalancing risk to transform cost and productivity in drug development Driving site performance: The investigator perpective Drug Discovery Biomarkers Across Drug Development As personalized medicine becomes more of a reality, biomarkers are becoming increasingly more important to help identify patients and develop customized therapies. Preclinical Development CROs and Preclinical Development As lab budgets remain constricted, pharmaceutical and biotech labs are outsourcing preclinical and drug discovery services to CROs. Considerations when selecting an early-phase CRO and clinical research facility Phase I Trials Phase I: Patient Recruitment While the emerging markets constitute around 15% of global pharmaceutical sales, the emerging countries attract only around 1% of the global R&D spend. Performance-based pricing in patient recruitment Leveraging online social media for clinical trial patient recruitment Phase III Trials Phase III: Market Preparation An important step during Phase III trials is preparing the market for eventual adoption. Reducing clinical regulatory risk for the development of drugs, biologics, and devices Firecrest Clinical’s training modules and productivity tools Registration and Launch Launch: Safety Counts Once a drug is approved, companies also have to consider postmarketing safety requirements. Postlaunch Phase IV: Technology Solutions Technology solutions that integrate clinical research with clinical care are critical as the demand for data in a real-world setting accelerates. IN EVERY ISSUE PharmaTrax Trends from industry analysts Talent Pool More industry appointments On the Calendar More industry events and conferences Last Word Pfizer prioritizes development programs
