Abstract
Modeling and simulation is poised to transform drug development across the entire life cycle from discovery to commercialization. For the biopharmaceutical industry, this transformation will enable knowledge-based decision making and foster new collaborative ways of working that will translate into more high-value treatments and increased development efficiencies. In the health care arena, where value for money is paramount, modeling and simulation will inform future health care planning and practice.
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References
1.
Sawcer
S
Hellenthal
G
Pirinen
M
. Genetic risk and a primary role for cell-mediated immune mechanisms in multiple sclerosis . Nature . 2011 ;476 (7359 ):214 –219 .
2.
Gelfand
A
. Dogs, doses and devices: FDA’s ambitious plans for computational modeling . Biomedical Computational Review . Fall 2011 , pp 20 –26 . http://biomedicalcomputationreview.org/7/2/10.pdf.
3.Archimedes Inc . Case study: comparative effectiveness analysis . http://www.archimedesmodel.com/sites/default/files/Cost-Effectiveness-Archimedes.pdf. Accessed December 21, 2012 .
4.Cray Inc . News release. Cray supercomputers play key role in designing Boeing 787 Dreamliner . http://investors.cray.com/phoenix.zhtml?c=98390&p=irol-newsArticle&ID=1022899. Published July 5, 2007.
5.
Parks
M.
Biggest challenges sponsors face in diabetes trials. Podcast, Applied Clinical Trials Online . http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=641256. Published November 12, 2009 .
6.
Kaitin
KI
DiMasi
JA
. Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009 . Clin Pharmacol Ther . 2011 ;89 (2 ):183 –188 .
7.
DiMasi
JA
Grabowski
HG
. The cost of biopharmaceutical R&D: is biotech different? Manage Decis Econ . 2007 ;28 (4-5 ):469 –479 .
8.
Gilbert
J
Henske
P
Singh
A.
Rebuilding big pharma’s business model . In Vivo, The Business and Medicine Report . 2003 ;21 (10 ).
9.
Munos
B
. Lessons from 60 years of pharmaceutical innovation . Nat Rev Drug Discovery . 2009 ;8 (12 ):959 –968 .
10.Centers for Medicare and Medicaid Services . National Health Expenditure Projections 2010-2020, Table 1 . http://www4a.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/proj2010.pdf. Published 2011 . Accessed December 21, 2012.
11.
Markham
H
. The Blue Brain Project . Nat Rev Neurosci . 2006 ;7 :153 –160 .
12.
13.OpenBUGS software for performing Bayesian Inference Using Gibbs Sampling . http://www.openbugs.info/w/. Accessed December 21, 2012 .
14.
Ambrosiano
N.
Largest computational biology simulation mimics life’s most essential nanomachine. National Nuclear Security Administration Newsletter . http://nnsa.energy.gov/sites/default/files/nnsa/newsletters/10/nl_2005Dec_NNSA_News.pdf. Published December 2005 .
15.Food and Drug Administration . The Sentinel Initiative July 10 report . http://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM233360.pdf. Published July 10, 2010 .
16.
Terdiman
J
. PS1-39: The Kaiser Permanente Northern California Oracle Research Database . Clin Med Res . 2011 ;9 (3–4 ):168 –169 .
17.General Practice Research Database (GPRD) . http://www.erskinepractice.scot.nhs.uk/website/S11486/files/GPRD_PatientLeaflet.pdf. Published October 2012.
18.The Health Improvement Network (THIN) . http://www.inps4.co.uk/vision/extending-vision/thin/. Accessed December 21, 2012.
19.Food and Drug Administration . Innovation or stagnation? Challenge and opportunity on the critical path to new medical products . http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm. Published March 2004 .
20.Food and Drug Administration . Guidance for industry: end-of-phase-2A meetings . http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/ucm079690.pdf. Published September 2009 .
21.National Institute for Health and Clinical Excellence (NICE) . Single technology appraisal (STA): specification for manufacturer/sponsor submission of evidence . 10 2009 .
22.
Lee
JY
Garnett
C
Gobburu
J
. Impact of pharmacometric analyses on new drug approval and labelling decisions . Clin Pharmakinet . 2011 ;50 (10 ):627 –635 .
23.
Cannon
B
Hede
K.
Making medicine more scientific: using data and technology to get the most from personal and clinical tools . Scientific American Pathways . Published 2012 . http://www.sa-pathways.com/data-and-technology/making-medicine-more-scientific. Accessed December 21, 2012.
24.
Sharp
M.
No more science fiction—HIV gene therapy delivers. HIV and Hepatitis.com coverage of the 18th Conference on Retroviruses and Opportunistic Infections (CROI 2011) . http://www.hivandhepatitis.com/2011_conference/croi2011/docs/0304_2010a.html. Published March 2011 .
25.
May
M.
Simulating structures . Scientific American Pathways . Published 2012 . http://www.sa-pathways.com/a-healthier-tomorrow/simulating-structures. Accessed December 21, 2012.
26.
Smith
M
Marshall
A.
Importance of protocols for simulation studies in clinical drug development . Stat Methods Med Res . 2011 ;20 :613 –622 .
27.
Gaydos
B
Anderson
K
Berry
D
. Good practices for adaptive clinical trials in pharmaceutical product development . Drug Inf J . 2009 ;43 :539 –556 .
28.Food and Drug Administration . Guidance for industry: adaptive design clinical trials for drugs and biologics [Draft Guidance] . http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf. Published February 2010 .
29.
Gosling
J
O’Hagan
A
Oakley
J
. Nonparametric elicitation for heavy-tailed prior distributions . Bayesian Anal . 2007 ;2 (4 ):693 –718 .
30.
Holford
NH
Kimki
HC
Monteleone
JP
Peck
CC
. Simulation of clinical trials . Annu Rev Pharmacol Toxicol . 2000 ;40 :209 –234 .
31.Archimedes Inc . Case study: prioritizing prevention activities in the Medicare population . http://www.archimedesmodel.com/sites/default/files/Policy-Impact-Analysis-Archimedes.pdf. Accessed December 21, 2012.
32.HHS enlists Archimedes Inc . to expand government’s use of health care modeling for forecasting quality and cost outcomes: HHS agencies can now use ARCHeS tool to conduct large scale analyses to evaluate health spending, treatment and effectiveness . BusinessWire . May 3 , 2012 . http://www.businesswire.com/news/home/20120503006421/en/HHS-Enlists-Archimedes-Expand-Government%E2%80%99s-Health-Care.
33.Health Information and Quality Authority . Health technology assessment (HTA) of a population-based colorectal cancer screening programme in Ireland . http://www.hiqa.ie/publication/health-technology-assessment-population-based-colorectal-cancer-screening-programme. Published March 2009 .
34.
Cross
J
Lee
H
Westelinck
A
. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999 . Pharmacoepidemiol Drug Saf . 2002 ;11 (6 ):439 –446 .
35.Food and Drug Administration . Guidance for industry: exposure-response relationships—study design, data analysis, and regulatory applications . http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072109.pdf. Published April 2003 .
36.
Sheiner
LB
. Learning versus confirming in clinical drug development . Clin Pharmacol Ther . 1997 ;61 (3 ):275 –291 .
37.Food and Drug Administration . Guidance for industry: population pharmacokinetics .http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM133184.pdf. Published February 1999 .
38.
Garnett
C
Beasley
H
Bhattaram
V
. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review . J Clin Pharmacol . 2008 ;48 (1 ):13 –18 .
39.
Lalonde
R.
Application of modeling and simulation in drug development at Pfizer . Presented at: American Conference on Pharmacometrics; March 9, 2008; Tucson, AZ .
40.
Stone
J
Banfield
C
Pfister
M
. Model-based drug development survey finds pharmacometrics impacting decision making in the pharmaceutical industry . J Clin Pharmacol . 2010 ;50 (9 suppl ):20S –30S .