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
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here