Strategic Challenges in Neurotherapeutic Pharmaceutical Development

NeuroRx

Volumn 1, Issue 1, 2004, Pages 165-180

  Gallen, Christopher C ^a  

^a PFIZER INC   (United States)

Author keywords

disease models; Neurotherapeutics; pharma; proteins; small molecules

Indexed keywords

ARTICLE; CENTRAL NERVOUS SYSTEM DISEASE; CHEMICAL MODIFICATION; CLINICAL RESEARCH; DISEASE MODEL; DRUG INDUSTRY; DRUG SPECIFICITY; ECONOMIC ASPECT; GENOMICS; INVESTMENT; NEUROLOGIC DISEASE; OUTCOME ASSESSMENT; ANIMAL; BIOLOGICAL MODEL; CENTRAL NERVOUS SYSTEM; DRUG DESIGN; DRUG EFFECT; ECONOMICS; HUMAN; METHODOLOGY; PHARMACEUTICS; REVIEW;

ANIMALS; CENTRAL NERVOUS SYSTEM; CENTRAL NERVOUS SYSTEM DISEASES; DISEASE MODELS, ANIMAL; DRUG DESIGN; HUMANS; MODELS, NEUROLOGICAL; TECHNOLOGY, PHARMACEUTICAL;

EID: 23844492857     PISSN: 15455343     EISSN: 15455351     Source Type: Journal    
DOI: 10.1602/neurorx.1.1.165     Document Type: Article

References (47)

1. Drews J. Drug discovery: a historical perspective [comment]. Science 287 (March 17, 2000) 1960-1964
2. Hensley S. Proteins-not genes-could be clue to human complexity, disease. Wall St J (2001)
3. Pharmaceutical Research and Manufacturers of America (PhRMA). New medicines in development for mental illness (2002), PhRMA, Washington, DC
4. Pharmaceutical Research and Manufacturers of America (PhRMA). The value of medicines 2001. Washington, DC http://www.phrma.org/publications/
5. Ashton GA, Joshua PJ, Industry Success Rates 2002-including trends in success rates, ref number CMR02-175R. Surrey, United Kingdom: Centre for Medicines Research International Limited.
6. Grabowski H., Vernon J., and DiMasi J. Returns on research and development for 1990s new drug introductions. Pharmacoeconomics 20 Suppl 3 (2002) 11-29
7. Tufts Center for the Study of Drug Development (Tufts CSDD). R&D efficiency. Outlook 2003. 2, 2003
8. DiMasi J., Hansen R., and Grabowski H. The price of innovation: new estimates of drug development costs. J Health Econ 22 (2003) 151-185
9. Tufts Center for the Study of Drug Development (Tufts CSDD). Impact report. 5(3)1, May/June,2003
10. Peck C. Drug development: improving the process. Food Drug Law J 52 (1997) 163-167
11. Ogg M., van den Haak M., and Halliday R. Activities of the international pharmaceutical industry in 2000: pharmaceutical investment and output. CMR International. http://www.cmr.org/index.htm
12. Grabowski H., and Vernon J. Returns to R&D on new drug introductions in the 1980s. J Health Econ 13 (1994) 383-406
13. A plan to ensure taxpayer interests are protected. NIH response to the conference report request for a plan to ensure taxpayers' interests are protected. Department of Health and Human Services, National Institutes of Health (2001). http://www.nih.gov/news/070101wyden.htm
14. The Pharmaceutical Research and Manufacturers of America (PhRMA). Annual Survey, 2001. Pharmaceutical Industry Primer 2001, p 5. 2001
15. The Pharmaceutical Research and Manufacturers of America (PhRMA). Annual Survey, 2001. U.S. FDA. Global Market Res & Analysis 2001
16. IMS Health, 2001 in Pharmaceutical Industry Primer 2001, PhRMA p 8, 2001
17. Peakman Franks T., White C., and Beggs M. Delivering the power of discovery in large pharmaceutical organizations. Drug Discovery Today 8 (2003) 203-221
18. Beggs M. HTS -where next?. Drug Discov World 2 (2000) 25-30
19. Beggs M., and Long A. High throughput genomics and drug discovery-parallel universes or a continuum?. Drug Discov World 3 (2002) 75-80
20. Lin L. Betaseron. Dev Biol Stand 96 (1998) 97-104
21. U. S. International Trade Commission, Global Competitiveness of U. S. Advanced-Technology Manufacturing Industries. Pharmaceuticals, Report to the Senate Finance Committee (September 1991), ITC, Washington, D.C.
22. Industry perspectives: U. S. outpaces Europe in growth of emerging biotech market. IMS Health (2002). http://www.imshealth.com/ims/portal/front/articleC/0,2777,6599_40183890_ 40053441,00.html
23. Drews J. In: Drews J., and Ryser S. (Eds). Human disease: from genetic causes to biochemical effects (1997), Blackwell, Berlin 5-9
24. Drews J., and Ryser S. Classic drug targets. Nat Biotechnol 157 (1997) 1
25. Doull Iolo J. Recent advances in cystic fibrosis. Arch Dis Child 85 (2001) 62-66
26. Fucharoen S., and Winichagoon P. Thalassemia and abnormal hemoglobin. Int J Hematol 76 Suppl 2 (2002) 83-89
27. Schreiber S. Target-oriented and diversity-oriented organic synthesis in drug discovery. Science 287 (2000) 1964-1969
28. Horrobin D. Realism in drug discovery: could Cassandra be right?. Nat Biotechnol 19 (2001) 1099-1100
29. Willner P. Methods for assessing the validity of animal models of human psychopathology. In: Boulton A., Baker G., and Martin-Iverson M. (Eds). Animal models in psychiatry, I (Neuromethods, No 18 (1991), Humana Press, Clifton, NJ 1-23
30. Horrobin D. Modern biomedical research: an internally self-consistent universe with little contact with medical reality?. Nat Rev Drug Discov 2 (2003) 151-154
31. Pearson H. Surviving a knock-out blow. Nature 415 (2002) 8-9
32. Arlington S., Barnett S., Hughes S., and Palo J. Pharma 2010: the threshold of innovation: future series executive summary (2002), IBM Corporation, Somers, NY
33. Rowland M., and Tozer T. Clinical pharmacokinetics: concepts and applications. ed 3 (1995), Williams & Wilkins, Baltimore 142
34. Cutler N., Sramek J., Kurtz N., Murphy M., and Carta A. Accelerating CNS drug development (1998), Wiley, New York 143-149 Chap 5
35. Feng D., Weidong C., and Fulton R. FIPS: a functional image processing system for PET dynamic studies. In: Gjedde A., Hansen Soren B., Knudsen G., and Paulson O. (Eds). Physiological imaging of the brain with PET (2001), Academic, San Diego 35-38
36. Carson R., Channing M., Vuong B.-K., Watabe H., Herscovich P., and Eckelman W. Amphetamine-induced dopamine release: duration of action assessed with [11 C]Raclopride in anesthetized monkeys. In: Gjedde A., Hansen S.B., Knudsen G., and Paulson O. (Eds). Physiological imaging of the brain with PET (2001), Academic, San Diego 205-209
37. Smith D., Gee A., Hansen S., Moldt P., Nielsen E., Scheel-Kruger H., et al. Serotonin release and reuptake studied by PET neuroimaging using fenfluramine, water, oxygen, fluorodeoxyglucose, NS2381, and its enantiomers in living porcine brain. In: Gjedde A., Hansen Soren B., Knudsen G., and Paulson O. (Eds). Physiological imaging of the brain with PET (2001), Academic, San Diego 237-247
38. Stix G. Reverse-engineering clinical biology. A peacetime dividend yields drug trials on virtual patients. Sci Am 288 (2003) 28
39. McKenna C., and Sudbeck B. Assessing the impact of predictive biostimulation on pharma R&D, Entelos, Inc. In: Mathieu M. (Ed). PAREXEL's pharmaceutical R&D statistical sourcebook 2003/2004 (2003), PAREXEL International, Waltham 128-129
40. Michelson S, Scherrer D, Assessing the impact of predictive biosimulation on lead optimization current drug discoveryhttp://www.currentdrugdiscovery.com 23, 26 http://www.entelos.com/news/publications.html
41. Dutton G. Modeling software for speeding discovery and reducing attrition. Genet Eng News (2002) 22
42. Tolman K., and Chandramouli J. Hepatotoxicity of the thiazolidinediones. Clin Liver Dis 9 (2003) 369-379
43. Zipkin I., and Michael A. BioCentury 7 (1999) 1
44. IMS Health. Growth in new active substances: how biotechnology drugs are making inroads. http://www.imshealth.com/public/structure/dispcontent/1,27779,1203-1203- 144043,00
45. Marshall S., Lazar G., Chirino A., and Desjarlais J. Rational design and engineering of therapeutic proteins. Drug Discov Today 8 (2003) 212-221
46. Marshall S., Lazar G., Chirino A., and Desjarlais J. Rational design and engineering of therapeutic proteins. Drug Discov Today 8 (2003) 212-221
47. Asoh S., Ohsawa I., Mori T., Katsura K.-I., Hiraide T., Katayama Y., et al. Protection against ischemic brain injury by protein therapeutics. Proc Natl Acad Sci USA 99 (2003) 17107-17112