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1.
Ther Innov Regul Sci ; 53(3): 332-339, 2019 05.
Article in English | MEDLINE | ID: mdl-29916261

ABSTRACT

BACKGROUND: Over the past decade, biopharmaceutical companies have been progressively establishing global frameworks across their capabilities. It is well recognized that the Medical Information (MI) department is a key externally facing function that needs to maintain a consistent focus on optimizing its capabilities of addressing product medical inquiries worldwide. METHODS: In the United States, a consortium named Pharma Collaboration for Transparent Medical Information, phactMI, a collaboration of pharmaceutical company MI departments dedicated to supporting health care professionals in their commitment to provide quality patient care, has provided a forum to benchmark and share best practices across the companies. In May 2017, phactMI conducted a survey inclusive of 25 biopharmaceutical companies to gain insight into the globalization of respective MI departments and relevant trends. RESULTS: We found increased trends in various aspects of globalization across large, mid, and small size companies, and identified key drivers for success. Overall, 16 of the 25 companies had globalized their MI department, 5 had only partially globalized, and the remaining 4 had not globalized. CONCLUSION: The findings of this survey will further help inform the MI community as to globalization approaches for a successful outcome.


Subject(s)
Benchmarking/trends , Drug Industry/organization & administration , Benchmarking/organization & administration , Humans , Internationality , Medical Informatics , Quality of Health Care , United States
2.
Ther Innov Regul Sci ; 48(6): NP6-NP14, 2014 Nov.
Article in English | MEDLINE | ID: mdl-30227466

ABSTRACT

Over the past 25 years, biopharmaceutical companies have faced and adapted to an external landscape that has grown increasingly complex and challenging. Medical information departments have played a fundamental role in the globalization process through their development of multichannel customer-facing resources that address the complexities with innovative solutions. The authors conducted a survey to determine key components of the globalization of medical information departments in large biopharmaceutical companies. In this article, they present survey findings and propose key components to the globalization process in medical information. Finally, they offer considerations for providing more patient-focused responses and processes for evaluating the impact of the medical information department in a global framework through the multifaceted measurement of customer satisfaction.

3.
Ther Innov Regul Sci ; 48(4): 488-493, 2014 Jul.
Article in English | MEDLINE | ID: mdl-30235563

ABSTRACT

Biopharmaceutical contact centers are expanding core skill sets when it comes to addressing inquiries regarding combination products. An inside look at how biopharmaceutical companies are handling this increasingly common scenario is provided through a benchmark survey, which was conducted between December 2012 and January 2013. The purpose of this survey was to collect and share contact center best practices on the handling of combination products in the biopharmaceutical industry. Eleven biopharmaceutical companies participated in the survey, 10 of which were listed in "The Top 50 Pharmaceutical Companies," by Pharmaceutical Executive. The information gathered from the survey responses is reported anonymously and provides perspectives on the trends and best practices that will serve as a practical resource for those involved in establishing or expanding contact center services.

4.
Pharmacotherapy ; 24(3): 313-23, 2004 Mar.
Article in English | MEDLINE | ID: mdl-15040644

ABSTRACT

STUDY OBJECTIVE: To evaluate the efficacy of darbepoetin alfa 200 microg subcutaneously every 2 weeks after therapeutic substitution for epoetin alfa. DESIGN: Retrospective multicenter chart review. SETTING: Three US Oncology-affiliated outpatient sites. PATIENTS: Three hundred thirty anemic patients with nonmyeloid malignancies, of whom 174 had been treated previously with epoetin alfa (switched group) and 156 had not been treated recently with epoetin alfa (naive group). INTERVENTIONS: Therapeutic substitution with darbepoetin alfa was started according to the US Oncology Pharmacy and Therapeutics Committee's recommended dosing guidelines: anemic patients with cancer received a starting dosage of darbepoetin alfa 200 microg every 2 weeks regardless of whether or not they had previously received epoetin alfa. Hematologic and darbepoetin alfa usage data were abstracted from consecutive medical records dated from May 2002-March 2003. MEASUREMENTS AND MAIN RESULTS: Median exposure to darbepoetin alfa was 10 weeks (25th quartile 6 wks, 75th quartile 17 wks) and 10 weeks (25th quartile 5 wks, 75th quartile 18 wks) for the naive and switched groups, respectively. The week before the switch to darbepoetin alfa, the 174 patients receiving epoetin alfa were administered the following weekly doses: less than 40,000 U (9%), 40,000 U (50%), or 45,000-90,000 U (41%). Mean hemoglobin level increased from baseline (wk 0) in both the naive and switched groups. The proportion of patients receiving a red blood cell transfusion in the darbepoetin alfa treatment phase was low (15% in each group). No variation in transfusion rates was observed across weight categories in patients who received a fixed dosage of darbepoetin alfa. Darbepoetin alfa was well tolerated. A detailed usage algorithm was validated by these results and is being used in these three US Oncology-affiliated practices. CONCLUSION: A darbepoetin alfa starting dosage of 200 microg subcutaneously every 2 weeks administered according to US Oncology-recommended dosing guidelines is effective in treating chemotherapy-induced anemia in both epoetin alfa-naive patients and those switched from epoetin alfa.


Subject(s)
Erythropoietin/analogs & derivatives , Erythropoietin/therapeutic use , Practice Guidelines as Topic/standards , Therapeutic Equivalency , Aged , Anemia/chemically induced , Anemia/complications , Anemia/therapy , Antineoplastic Agents/adverse effects , Darbepoetin alfa , Drug Administration Schedule , Epoetin Alfa , Erythrocyte Transfusion , Erythropoietin/administration & dosage , Female , Hemoglobins/analysis , Hemoglobins/drug effects , Humans , Injections, Subcutaneous , Male , Neoplasms/complications , Recombinant Proteins , Retrospective Studies , Time Factors , Weight Gain
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