Skip to main content
SpringerLink
Log in

Pharmaceutical Industry Perspective Regarding Imaging Techniques

  • Chapter
  • First Online:
Medical Imaging in Clinical Trials

  • 2167 Accesses

Abstract

Product development within the pharmaceutical and medical device industries is shaped by market and regulatory forces. Patients and payers are only willing to pay for products that represent true innovation and value. As good branded products lose exclusivity, the bar with respect to product performance is raised for new products. The healthcare industry has successfully demonstrated value for new products by identifying populations with significant unmet need through companion diagnostics or orphan diseases. The regulatory hurdle for product approval has steadily increased with the key metric being the product benefit compared to its risk. Clinical trial size and complexity has increased markedly in order to meet the regulatory hurdles for risk assessment. Imaging can document the pathophysiology of many disorders. Through various methods, imaging can be employed as a biomarker in early development, as a tool for identifying a population for a specific product, or as an endpoint in registration trials. This chapter reviews the changing landscape of product development and the role for effective implementation of imaging technology within clinical development.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 119.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 159.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Sarac SB, Rasmussen CH, Rasmussen MA, Hallgreen CE, Soeborg T, Colding-Jorgensen M, Christensen PK, Thirstrup S, Mosekilde EA. Comprehensive approach to benefit-risk assessment in drug development. Basic Clin Pharmacol Toxicol. 2012;111(1):65–72.

    CAS  PubMed  Google Scholar 

  2. Ramaswami U. Update on role of agalsidase alfa in management of Fabry disease. Drug Des Devel Ther. 2011;5:155–73.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  3. Elstein D, Cohn GM, Wang N, Djordjevic M, Brutaru C, Zimran A. Early achievement and maintenance of the therapeutic goals using velaglucerase alfa in type 1 Gaucher disease. Blood Cells Mol Dis. 2011;46(1):110–23.

    Article  Google Scholar 

  4. van Capelle CI, van der Beek NA, Hagemans ML, Arts WF, Hop WC, Lee P, Jaeken J, Frohn-Mulder IM, Merkus PJ, Corzo D, Puga AC, Reuser AJ, van der Ploeg AT. Effect of enzyme therapy in juvenile patients with Pompe disease: a three-year open-label study. Neuromuscul Disord. 2010;20(12):775–82.

    Article  PubMed  Google Scholar 

  5. Rabe E, Schliephake D, Otto J, Breu FX, Pannier F. Sclerotherapy of telangiectases and reticular veins: a double-blind, randomized, comparative clinical trial of polidocanol, sodium tetradecyl sulphate and isotonic saline (EASI study). Phlebology. 2010;25(3):124–31.

    Article  CAS  PubMed  Google Scholar 

  6. Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, Smolen JS, Weisman M, Emery P, Feldmann M, Harriman GR, Maini RN. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-tumor necrosis factor trial in rheumatoid arthritis with concomitant therapy study group. N Engl J Med. 2000;343(22):1594–602.

    Article  CAS  PubMed  Google Scholar 

  7. Ross JS, Slodkowska EA, Symmans WF, Pusztai L, Ravdin PM, Hortobagyi GN. The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine. Oncologist. 2009;14(4):320–68.

    Article  CAS  PubMed  Google Scholar 

  8. Ballestrero A, Garuti A, Cirmena G, Rocco I, Palermo C, Nencioni A, Scabini S, Zoppoli G, Parodi S, Patrone F. Patient-tailored treatments with anti-EGFR monoclonal antibodies in advanced colorectal cancer: KRAS and beyond. Curr Cancer Drug Targets. 2012;12(4):316–28.

    Article  CAS  PubMed  Google Scholar 

  9. Debergh I, Vanhove C, Ceelen W. Innovation in cancer imaging. Eur Surg Res. 2012;48(3):121–30.

    Article  CAS  PubMed  Google Scholar 

  10. Nishino M, Jagannathan JP, Krajewski KM, O’Regan K, Hatabu H, Shapiro G, Ramaiya NH. Personalized tumor response assessment in the era of molecular medicine: cancer-specific and therapy-specific response criteria to complement pitfalls of RECIST. AJR Am J Roentgenol. 2012;19(4):737–45.

    Article  Google Scholar 

  11. SteriPET. Summary of product characteristics. www.mhra.gov.uk/home/groups/l-unit1/documents/websiteresources/con025955.pdf.

  12. Herceptin® Prescribing information. www.gene.com/gene/products/information/pdf/herceptin-prescribing.pdf.

  13. Avastin® Prescribing information. www.gene.com/gene/products/information/pdf/avastin-prescribing.pdf.

  14. Erbitux® Prescribing information. http://packageinserts.bms.com/pi/pi_erbitux.pdf.

  15. LoRusso PM, Weiss D, Guardino E, Girish S, Sliwkowski MX. Trastuzumab emtansine: a unique antibody-drug conjugate in development for human epidermal growth factor receptor 2-positive cancer. Clin Cancer Res. 2011;17(20):6437–47.

    Article  CAS  PubMed  Google Scholar 

  16. Torres L, Ribeiro FR, Pandis N, Andersen JA, Heim S, Teixeira MR. Intratumor genomic heterogeneity in breast cancer with clonal divergence between primary carcinomas and lymph node metastases. Breast Cancer Res Treat. 2007;102(2):143–55.

    Article  PubMed  Google Scholar 

  17. Shah RB, Mehra R, Chinnaiyan AM, Shen R, Ghosh D, Zhou M, MacVicar GR, Varambally S, Harwood J, Bismar TA, Kim R, Rubin MA, Pienta KJ. Androgen-independent prostate cancer is a heterogeneous group of diseases: lessons from a rapid autopsy program. Cancer Res. 2004;64:9209–16.

    Article  CAS  PubMed  Google Scholar 

  18. Iacobuzio-Donahue CA. Epigenetic changes in cancer. Ann Rev Pathol Mech Dis. 2009;4:229–49.

    Article  CAS  Google Scholar 

  19. Kapty J, Murray D, Mercer J. Radiotracers for noninvasive molecular imaging of tumor cell death. Cancer Biother Radiopharm. 2010;25(6):615–28.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Strategy and Regulatory Affairs, TherapeuticsMD, Boca Raton, FL, USA

    Joel Krasnow MD, MBA

Authors
  1. Joel Krasnow MD, MBA
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Joel Krasnow MD, MBA .

Editor information

Editors and Affiliations

  1. Medical Affairs, BioClinica Inc., Newtown, Pennsylvania, USA

    Colin G. Miller

  2. Department of Strategy and Regulatory Affairs, TherapeuticsMD, Boca Raton, Florida, USA

    Joel Krasnow

  3. Dept. of Radiology, Columbia University Medical Center, New York, New York, USA

    Lawrence H. Schwartz

Rights and permissions

Reprints and permissions

Copyright information

© 2014 Springer-Verlag London

About this chapter

Cite this chapter

Krasnow, J. (2014). Pharmaceutical Industry Perspective Regarding Imaging Techniques. In: Miller, C., Krasnow, J., Schwartz, L. (eds) Medical Imaging in Clinical Trials. Springer, London. https://doi.org/10.1007/978-1-84882-710-3_16

Download citation

  • DOI: https://doi.org/10.1007/978-1-84882-710-3_16

  • Published:

  • Publisher Name: Springer, London

  • Print ISBN: 978-1-84882-709-7

  • Online ISBN: 978-1-84882-710-3

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation