Managing Product Supply Risks - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Managing Product Supply Risks
How to use geographic diversification and legacy technology transfers to avoid product shortages.


Pharmaceutical Technology
Volume 36, Issue 4, pp. 102-109

Conclusion

Systematically identifying risks to product supply and taking the necessary steps to mitigate these risks allows a company to proactively avoid product shortages. Multiple options to mitigate risk are available. Diversification by establishing backup manufacturing facilities in geographically distinct areas is one strategic approach to avoid product shortages in the event of an emergency situation at the primary manufacturing site. By carefully laying out the strategy for and potential challenges of conducting legacy technology transfers, companies can successfully implement diversification. It remains to be seen how companies and regulatory agencies such as FDA can work together to move forward in preventing and avoiding such product shortages and thus ensuring safe treatments for patients.

Acknowledgments

The author wishes to express sincere thanks to Arleen Paulino, Bill Keefe, Dan Rathman (Amgen), Ali Siahpush (Dendreon), and David Clark (MedImmune) for their active support and insightful comments in preparation of this paper.

Sushil Abraham is director of technology transfer at MedImmune, 636 Research Drive, Frederick, MD 21703, tel. 301.228.5183,
. At time of acceptance of this paper, the author was at Amgen, 4000 Nelson Road, Longmont, CO 80503.

References

1. J. Wechsler, BioPharm Intl., 24 (11), 12–14 (2011).

2. A. Federgruen, The Wall Street Jrnl., Mar. 2, 2011.

3. The White House, "Executive Order 13588–Reducing Prescription Drug Shortages," Press Release (Washington, DC, Oct. 31, 2011).

4. Johnson and Johnson, "Johnson & Johnson Provides Update on McNeil Consumer Healthcare Remediation; Announces Completion of Internal Assessment Phase of Comprehensive Action Plan," Press Release (New Brunswick, NJ, Jan. 14, 2011).

5. L. Bush, BioPharm Intl Bulletin, June 17, 2009.

6. M. Wiebe, presentation at West Coast Chapter of the PDA meeting (June 17, 2010).

7. B. Obsoj-Cardwell, The Pharma Letter online, http://www.thepharmaletter.com/file/96470/emea-recommends-replagal-as-alternative-fabry-treatment-due-to-fabrazyme-shortage-fda-approves-shires-daytrana-for-adolescents, July 7, 2010.

8. J. Woodcock, MD, Statement, House Committee on Energy and Commerce Hearing, Apr. 29, 2008.

9. FDA, Information on Heparin, http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM112597, accessed March 5, 2012.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here