Lessons from innovation in drug-device combination products

Advanced Drug Delivery Reviews

Volumn 64, Issue 1, 2012, Pages 69-77

  Couto, Daniela S ^a,b   Perez Breva, Luis ^a,c   Saraiva, Pedro ^d   Cooney, Charles L ^a  

^a USA   (United States)

^b INSTITUTO SUPERIOR TÉCNICO   (Portugal)

^c MASSACHUSETTS INSTITUTE OF TECHNOLOGY   (United States)

^d UNIVERSITY OF COIMBRA   (Portugal)

Author keywords

Controlled drug delivery; Drug eluting stents; Primary mode of action; Transdermal patches

Indexed keywords

COMBINATION PRODUCTS; DRUG DELIVERY DEVICES; DRUG-ELUTING STENTS; LEARNING OPPORTUNITY; MEDICAL DEVICES; PRIMARY FUNCTIONS; PRIMARY MODE OF ACTION; TRANSDERMAL;

ARTIFICIAL ORGANS; CONTROLLED DRUG DELIVERY; PRODUCT DEVELOPMENT; STENTS;

DRUG INTERACTIONS;

BIOMEDICAL TECHNOLOGY ASSESSMENT; DRUG DELIVERY SYSTEM; DRUG ELUTING STENT; INTERMETHOD COMPARISON; MARKETING; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; REVIEW; TRANSDERMAL PATCH;

DELAYED-ACTION PREPARATIONS; DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; DRUG DELIVERY SYSTEMS; DRUG DISCOVERY; DRUG INDUSTRY; DRUG-ELUTING STENTS; HUMANS; MARKETING; TRANSDERMAL PATCH; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84858449673     PISSN: 0169409X     EISSN: 18728294     Source Type: Journal    
DOI: 10.1016/j.addr.2011.10.008     Document Type: Review

References (33)

1. Wu P., Grainger D.W. Drug/Device Combinations for Local Drug Therapies and Infection Prophylaxis. Biomaterials 2006, 27:2450-2467.
2. Public Law 107-250 107th Congress, Medical Device User Fee and Modernization Act (MDUFMA) of 2002 2002.
3. Office of Combination Products Performance Report FY 2009 2010, U.S. Food and Drug Administration.
4. Combination Products Approvals FDA U.S. Food and Administration - Office of Combination Products 2011.
5. Food and Drug Administration Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) 2011, U.S. Department of Health and Human Services. 31st ed.
6. U.S. Food and Drug Administration Drugs FDA database 2011.
7. Serruys P.W., de Jaegere P., Kiemeneij F., Macaya C., Rutsch W., Heyndrickx G., et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N. Engl. J. Med. 1994, 331:489-495.
8. Fischman D.L., Leon M.B., Baim D.S., Schatz R.A., Savage M.P., Penn I., et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. N. Engl. J. Med. 1994, 331:496-501.
9. Acharya G., Park K. Mechanisms of controlled drug release from drug-eluting stents. Adv. Drug Deliv. Rev. 2006, 58:387-401.
10. Hara H., Nakamura M., Palmaz J.C., Schwartz R.S. Role of stent design and coatings on restenosis and thrombosis. Adv. Drug Deliv. Rev. 2006, 58:377-386.
11. Moses J.W., Leon M.B., Popma J.J., Fitzgerald P.J., Holmes D.R., O'Shaughnessy C., et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N. Engl. J. Med. 2003, 349:1315-1323.
12. Morice M.-C., Serruys P.W., Sousa J.E., Fajadet J., Ban Hayashi E., Perin M., et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N. Engl. J. Med. 2002, 346:1773-1780.
13. Turco M.A., Ormiston J.A., Popma J.J., Hall J.J., Mann T., Cannon L.A., et al. Reduced risk of restenosis in small vessels and reduced risk of myocardial infarction in long lesions with the new thin-strut TAXUS liberté stent: 1-year results from the TAXUS ATLAS program. JACC Cardiovasc. Interv. 2008, 1:699-709.
14. John M.L., David A.C., Morris D.L., Jeffrey A.B., Paul D.M., Phillip A.H., et al. Two-year results of paclitaxel-eluting stents in patients with medically treated diabetes mellitus from the TAXUS ARRIVE program. Am. J. Cardiol. 2009, 103:1663-1671.
15. Mahmud E., Ormiston J.A., Turco M.A., Popma J.J., Weissman N.J., O'Shaughnessy C.D., et al. TAXUS liberté attenuates the risk of restenosis in patients with medically treated diabetes mellitus: results from the TAXUS ATLAS program. JACC Cardiovasc. Interv. 2009, 2:240-252.
16. Prausnitz M.R., Mitragotri S., Langer R. Current status and future potential of transdermal drug delivery. Nat. Rev. Drug. Discov. 2004, 3:115-124.
17. Arora A., Prausnitz M.R., Mitragotri S. Micro-scale devices for transdermal drug delivery. Int. J. Pharm. 2008, 364:227-236.
18. Prausnitz M.R., Langer R. Transdermal drug delivery. Nat. Biotech. 2008, 26:1261-1268.
19. Chen H., Zhu H., Zheng J., Mou D., Wan J., Zhang J., et al. Iontophoresis-driven penetration of nanovesicles through microneedle-induced skin microchannels for enhancing transdermal delivery of insulin. J. Control. Release 2009, 139:63-72.
20. Karande P., Mitragotri S. Enhancement of transdermal drug delivery via synergistic action of chemicals. Biochim. Biophys. Acta Biomembr. 2009, 1788:2362-2373.
21. Martanto W., Davis S., Holiday N., Wang J., Gill H., Prausnitz M. Transdermal delivery of insulin using microneedles in vivo. Pharm. Res. 2004, 21:947-952.
22. Prausnitz M.R., Mikszta J.A., Cormier M., Andrianov A.K. Microneedle-Based Vaccines. Vaccines for Pandemic Influenza 2009, 369-393. Springer Berlin Heidelberg, London/New York. R.W. Compans, W.A. Orenstein (Eds.).
23. Christensen C.M., Grossman J.H., Hwang J. The Innovator's Prescription: a Disruptive Solution for Health Care 2009, McGraw-Hill, New York, NY.
24. Burgelman R.A., Christensen C.M., Wheelwright S.C. Strategic Management of Technology and Innovation 2008, McGraw-Hill/Irwin, New York, NY. 5th ed.
25. Cordis a Johnson-Johnson company Cordis Celebrates 50 Years of Transforming Cardiovascular Care Website:, assessed online on January 2011. http://www.jnj.com/connect/news/all/20090326_090000.
26. Alza Corporation Alza Corp 10-K Report 1996.
27. Johnson & Johnson Johnson & Johnson to Merge With ALZA Corporation In $10.5 Billion Stock-for-Stock Transaction 2001.
28. Alza Corporation Alza Corp 10-K Report 1993.
29. Henderson R.M., Clark K.B. Architectural innovation: The reconfiguration of existing product technologies and the failure of established firms. Adm. Sci. Q. 1990, 35:9-30.
30. Burt H.M., Hunter W.L. Drug-eluting stents: A multidisciplinary success story. Adv. Drug Deliv. Rev. 2006, 58:350-357.
31. Gopalaswamy S., Gopalaswamy V. Conclusions. Combination Products: Regulatory Challenges and Successful Product Development 2008, 221-224. CRC Press, Taylor & Francis Group, Boca Raton, FL.
32. J.A. Schumpeter, Capitalism, Socialism, and Democracy, First Harper Perennial Modern Thought ed., HarperCollins, New York, NY, 1942.
33. Teece D.J. Profiting from technological innovation: Implications for integration, collaboration, licensing and public policy. Res. Policy 1986, 15:285-305.