Navigation Links
Successful Strategies and Innovative Practices for Bringing FDC Products to Market
Date:3/24/2011

CHAPEL HILL, N.C., March 24, 2011 /PRNewswire/ -- The pharmaceutical industry has turned to lifecycle planning as one of the strategies to offset lackluster pipelines and patent loss. Fixed dose combination (FDC) products not only offer an opportunity to extend patent life for branded products but also the chance to offer payers and patients a differentiated product with a therapeutic benefit.

Unfortunately, getting to market quickly with an FDC is more myth than reality. On average, it takes between five and eight years to go from decision-to-develop to launch and costs an average of $80 million, according to a new Best Practices, LLC report. Thus, successful FDC products require thoughtful planning, beginning early in the product development and lifecycle management process.

"If you want either to expand an indication or go to a second generation launch, you've got to think about that right when your initial Phase III is done or shortly after you've launched the product that you're going to be including in that fixed dose," one R&D veteran noted in the report.

To identify a potentially successful FDC it's important to understand that commercial success depends on the product offering a differentiated medical benefit, according to "Fixed Dose Combination Products: Successful Strategies for Developing and Bringing FDC Products to Market." Focusing on value and differentiated benefit is a critical lesson learned, according to executives working with FDC products.

Some of the issues addressed in this research include:

- Chief reason for pursuing FDC development

- Measures used to evaluate success

- Years from decision to develop through launch

- Cost of FDC product development Approximate

- Difficulty areas for bringing FDC product to market

- Reasons for partnering with another company to develop FDC product

- Time lapsed from initial contact to signed contractual agreement with partner

- U.S. filing routes used

- EU filing routes used

- Months from filing to approval

- Pre-launch marketing challenges

- Specific reimbursement challenges

- Strategies, tactics, practices to help accelerate or impede launch progress

- Lessons learned from executives

- Metrics for effectively communicating business value

The full 55-page report contains more than 150 benchmark metrics, providing executives with the tools, tactics and techniques to help organizations successfully develop and commercialize fixed dose combination products. Review a complimentary summary of the study at http://www3.best-in-class.com/rr1047.htm. The summary includes selected best practices drawn from extensive primary research with 51 representatives from 34 leading companies, including eight of the Top 20 pharma companies. 

ABOUT BEST PRACTICES, LLC

Best Practices, LLC serves 48 of the world's 50 top pharmaceutical companies.  For 17 years, we have conducted work based on the simple yet profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies.  For more information about the company, go to www.best-in-class.com.


'/>"/>
SOURCE Best Practices, LLC
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
2. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
3. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
4. New Study Proves That Minimally Invasive Aneurysm Treatment Yields Successful Long-Term Results
5. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
6. GeoVax Successful HIV/AIDS Vaccine Trial Data Presented at AIDS Vaccine 2007 Conference
7. EpiCept Announces Successful Completion of Enrollment for Phase I Trial of EPC2407
8. Researchers Report First Successful Treatment of Chronic Traumatic Brain Injury
9. Nabi Biopharmaceuticals Announces Successful Completion of NicVAX(R) Phase 2b Trial; Drug Shows Statistically Significant Rates of Smoking Cessation and Continuous Long-Term Smoking Abstinence at 12 Months
10. PLC Systems Achieves Successful Early Conclusion of RenalGuard(TM) Pilot Safety Trial
11. YMed, Inc. Successfully Completes First Clinical Cases With Innovative VascuTraK(TM) II PTA Dilatation Catheter
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 Revolutionary ... Oticon , industry leaders in advanced audiology ... of Oticon Opn ™, the world,s first internet ... possibilities for IoT devices.      (Photo: ... introduces a number of ,world firsts,: , ...
(Date:6/23/2016)... , June 23, 2016 The vast ... an outpatient dialysis facility.  Treatments are usually 3 times ... hours per visit, including travel time, equipment preparation and ... patient, but especially grueling for patients who are elderly ... a skilled nursing and rehabilitation centers for some duration ...
(Date:6/23/2016)... 2016  Experian Health, the healthcare industry ... patient payment and care experience, today announced ... and services that will enhance the breadth ... These award-winning solutions will enable healthcare professionals ... in an ever-changing environment and redefine front-office ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned by ... to enhance the health of felines. The formula is all-natural and is made from ... the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract ...
(Date:6/25/2016)... ... 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due to ... a new, often overlooked aspect of head lice: the parasite’s ability to live away from ... common occurrence, but a necessary one in the event that lice have simply gotten out ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary ... Work award to iHire in recognition of their exemplary accomplishments in worksite health promotion. ... Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, ... at his family verbally and physically. , “When something upset him, he couldn’t control his ... it. He would throw rocks at my other children and say he was going to ...
(Date:6/24/2016)... ... ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for ... $12 an hour by 2020 and then adjusting it yearly to increase at the same ... wage, assure the wage floor does not erode again, and make future increases more predictable. ...
Breaking Medicine News(10 mins):