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Product Development and Commercialization of Diagnostic or Life Science Products for Scientists and Researchers

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Molecular Profiling

Part of the book series: Methods in Molecular Biology ((MIMB,volume 1606))

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Abstract

Commercializing a diagnostic or life science product often encompasses different goals than that of research and grant funding. There are several necessary steps, and a strategy needs to be well defined in order to be successful. Product development requires input from and between various groups within a company and, for academia, outside entities. The product development stakeholder groups/entities are research, marketing, development, regulatory, manufacturing, clinical, safety/efficacy, and quality. After initial research and development, much of the work in product development can be outsourced or jointly created using public–private partnerships. This chapter serves as an overview of the product development process and provides a guide to best define a product strategy.

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References

  1. Lambert WJ (2010) Considerations in developing a target product profile for parenteral pharmaceutical products. AAPS PharmSciTech 11(3):1476–1481. doi:10.1208/s12249-010-9521-x

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  2. Rose LM, Everts M, Heller C, Burke C, Hafer N, Steele S (2014) Academic medical product development: an emerging alliance of technology transfer organizations and the CTSA. Clin Transl Sci 7(6):456–464. doi:10.1111/cts.12175

    Article  PubMed  PubMed Central  Google Scholar 

  3. Bishai DM, Champion C, Steele ME, Thompson L (2011) Product development partnerships hit their stride: lessons from developing a meningitis vaccine for Africa. Health Aff (Millwood) 30(6):1058–1064. doi:10.1377/hlthaff.2011.0295

    Article  Google Scholar 

  4. Mahoney RT (2011) Product development partnerships: case studies of a new mechanism for health technology innovation. Health Res Policy Syst 9:33. doi:10.1186/1478-4505-9-33

    Article  PubMed  PubMed Central  Google Scholar 

  5. Wells WA, Brooks A (2011) Adoption of new health products in low and middle income settings: how product development partnerships can support country decision making. Health Res Policy Syst 9:15. doi:10.1186/1478-4505-9-15

    Article  PubMed  PubMed Central  Google Scholar 

  6. Jahn R, Muller O, Bozorgmehr K (2015) Characteristics and determinants of knowledge transfer policies at universities and public institutions in medical research—protocol for a systematic review of the qualitative research literature. Syst Rev 4:110. doi:10.1186/s13643-015-0094-3

    Article  PubMed  PubMed Central  Google Scholar 

  7. Jekunen A (2014) Decision-making in product portfolios of pharmaceutical research and development—managing streams of innovation in highly regulated markets. Drug Des Devel Ther 8:2009–2016. doi:10.2147/DDDT.S68579

    Article  PubMed  PubMed Central  Google Scholar 

  8. Carroll MW (2015) Sharing research data and intellectual property law: a primer. PLoS Biol 13(8):e1002235. doi:10.1371/journal.pbio.1002235

    Article  PubMed  PubMed Central  Google Scholar 

  9. Pramod K, Tahir MA, Charoo NA, Ansari SH, Ali J (2016) Pharmaceutical product development: a quality by design approach. Int J Pharm Investig 6(3):129–138. doi:10.4103/2230-973X.187350

    Article  PubMed  PubMed Central  Google Scholar 

  10. Hakemeyer C, McKnight N, St John R, Meier S, Trexler-Schmidt M, Kelley B, Zettl F, Puskeiler R, Kleinjans A, Lim F, Wurth C (2016) Process characterization and design space definition. Biologicals 44(5):306–318. doi:10.1016/j.biologicals.2016.06.004

    Article  PubMed  Google Scholar 

  11. Ohage E, Iverson R, Krummen L, Taticek R, Vega M (2016) QbD implementation and Post Approval Lifecycle Management (PALM). Biologicals 44(5):332–340. doi:10.1016/j.biologicals.2016.06.007

    Article  PubMed  Google Scholar 

  12. Jain A, Taghavian O, Vallejo D, Dotsey E, Schwartz D, Bell FG, Greef C, Davies DH, Grudzien J, Lee AP, Felgner PL, Liang L (2016) Evaluation of quantum dot immunofluorescence and a digital CMOS imaging system as an alternative to conventional organic fluorescence dyes and laser scanning for quantifying protein microarrays. Proteomics 16(8):1271–1279. doi:10.1002/pmic.201500375

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  13. Gascon P, Fuhr U, Sorgel F, Kinzig-Schippers M, Makhson A, Balser S, Einmahl S, Muenzberg M (2010) Development of a new G-CSF product based on biosimilarity assessment. Ann Oncol 21(7):1419–1429. doi:10.1093/annonc/mdp574

    Article  CAS  PubMed  Google Scholar 

  14. Thomas JA, Collins CR, Das S, Hackett F, Graindorge A, Bell D, Deu E, Blackman MJ (2016) Development and application of a simple plaque assay for the human malaria parasite plasmodium falciparum. PLoS One 11(6):e0157873. doi:10.1371/journal.pone.0157873

    Article  PubMed  PubMed Central  Google Scholar 

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Correspondence to Meghan M. Alonso .

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Alonso, M.M. (2017). Product Development and Commercialization of Diagnostic or Life Science Products for Scientists and Researchers. In: Espina, V. (eds) Molecular Profiling. Methods in Molecular Biology, vol 1606. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-6990-6_26

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  • DOI: https://doi.org/10.1007/978-1-4939-6990-6_26

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  • Publisher Name: Humana Press, New York, NY

  • Print ISBN: 978-1-4939-6989-0

  • Online ISBN: 978-1-4939-6990-6

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