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Novel Approaches to Developing Predictive Diagnostics
Decision Resources, Inc, July 2011
Just a 10% improvement in the ability to predict drug failures before embarking on clinical trials could save $100 million in R&D costs per drug, the FDA estimates. Currently, more than $50 billion is spent annually on drug R&D, but more than 90% of R&D projects fail to yield marketable drugs because of safety and efficacy issues. Biomarkers and diagnostics offer the tools necessary to predict drug failures before initiating clinical trials. Furthermore, biomarkers and diagnostics that can predict drug responsiveness are urgently needed to curb costs and enable wiser drug development and management.
Questions answered in this report:
- Roche/Genentech/Chugai’s Herceptin (trastuzumab), which is approved to treat a subset of breast cancer and gastric cancer patients with HER2-positive disease, had annual global sales exceeding $5 billion in 2010. How did predictive diagnostics fit into this picture, and what related strategies are other pharmaceutical companies adopting to mirror Roche/Genentech/Chugai’s success?
- Several new candidates for predictive diagnostics development were discussed at the most recent ASCO conference, including testing for drug targets in non-small-cell lung cancer, melanoma, and ovarian cancer. In what specific clinical trials are these diagnostics being evaluated? How do the results compare with existing capabilities to predict drug response in patients?
- The FDA has established a new personalized medicine group to improve the agency’s knowledge of genomic devices, pharmacogenomics, and proteomics and to introduce new approaches for validating complex devices. How do regulatory bodies perceive the use of predictive diagnostics in the context of drug development? What regulatory activities demonstrate support or neglect of predictive diagnostics?
- Novartis’s Prexige (lumiracoxib), Bristol-Myers Squibb/Merck Serono/Merck/Eli Lilly’s Erbitux (cetuximab), and Amgen’s Vectibix (panitumumab) are examples of drugs that have been rescued by predictive biomarkers used during regulatory approval stages. What circumstances surrounding these drugs enabled use of predictive biomarkers to gain regulatory approval? How can pharmaceutical companies exploit a predictive diagnostics strategy to strengthen regulatory applications?
- Reimbursement policies have been criticized heavily by drug/diagnostic developers because they rely on timelines that are at odds with the rapid pace of diagnostics development. What can industry players do to ensure payer support to optimize commercialization of predictive diagnostics? How have payers responded to the changing market dynamics?
Scope:
Indications: Non-small-cell lung cancer (NSCLC), breast cancer, colorectal cancer, Crohn’s disease, cardiovascular disease, Alzheimer’s disease, ovarian cancer, pain.
Clinical trials: I-SPY 2, BATTLE, BATTLE-2, DERMA, BRIM2, BRIM3, ERCC1, MARVEL, PRECEDENT, PROFILE 1005.
Dealmaking insight: Roche/Clovis Oncology, Clovis Oncology/Avila Therapeutics, DxS/Amgen, GlaxoSmithKline/Abbott, MDxHealth/Pfizer, Sanofi/Epistem, Ariad/MolecularMD, Pfizer/Abbott, Roche/Genentech/Daiichi Sankyo.
Future considerations: Forward-looking statements, including insight from Decision Resources analysts, that encourage the achievement of full potential and the practical realization of predictive diagnostics.
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