spacer
home > ebr > summer 2017 > organisation optimisation
PUBLICATIONS
European Biopharmaceutical Review

Organisation Optimisation

Mature products are often still sold in substantial numbers with a widespread global footprint, despite being long past their marketing exclusivity. They are critical to an organisation’s growth and revenue, alongside the development of new ones. Since they have been on the market for a while, they open up the possibility for marketing authorisation holders (MAHs) to manage processes in a more efficient and cost-effective manner – allowing them to consider an integrated safety, regulatory and benefit-risk model.

Their Importance


While at the end of their lifecycle, mature products are still likely to be sold well into the future and have a crucial role in the healthcare industry across different markets. Their proven effectiveness and safety profiles make them particularly significant in emerging markets where they can be introduced, manufactured and distributed more quickly. Since the cost of maintenance is substantially lower than that of a new product, pharmaceutical companies can focus on tailoring them to individual market needs, which is usually done through formula innovation, changing the dosage form or altering the packaging.

A blockbuster drug passing its patent exclusivity has a significant financial impact for the manufacturer. As generics enter the market, most firms have to re-evaluate the cost spent on product maintenance and minimise expenditure in order to sustain their profitability. As the industry has matured, the requirement for adequate documentation to maintain compliance with local regulations across many of the emerging markets has grown. Maintaining regulatory dossiers and managing labels is necessary to uphold licenses, along with pharmacovigilance (PV) activities. Noncompliance with any stipulations can result in serious penalties, often with significant financial implications.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
David Balderson is Global Vice President Safety Operations at Sciformix Coporation and has over 18 years of experience in safety and regulatory operations. Throughout his career, he has been a key driver of process improvement initiatives, from the development of processes to support the EU Clinical Trial Directive through to the development of an electronic interface between the study and safety databases. David holds a BSc in physiology and pharmacology as well as a PhD in neuroscience, both from the University of Manchester, UK.
spacer
David Balderson
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Destiny Pharma appoints MedPharm to develop new XF-platform drug formulations

Destiny Pharma, a clinical stage biotechnology company focused on the development of novel antimicrobial drugs, is pleased to announce that it has appointed MedPharm as its expert partner to develop new topical formulations of the Company’s novel XF-platform compounds. These new treatments for dermal and ocular infections are part of its second clinical programme to address the global problem of anti-microbial resistance (AMR). MedPharm is a world leading contract provider of topical and transdermal product design and formulation development services using sophisticated in vitro models to de-risk development programmes.
More info >>

White Papers
 
Industry Events

BioPharm America™ 2019—12th Annual International Partnering Conference

11-12 September 2019, Boston Convention and Exhibition Center (BCEC), Boston, MA 02210 USA

BioPharm America™ is a unique partnering event that forms the nexus of discovery and realization. Startup companies, established biotech and entrepreneurs from academia attend in search of finance, pharma and development partners. The event format highlights innovation and promotes new business relationships by bringing dealmakers from the life science ecosystem together to engage and de-risk the enormous task of drug development. Life science executives from around the world gather to identify, meet and to enter into strategic relationships facilitated by partneringONE®, the world’s leading web-based partnering system. BioPharm America is the only event in North America based on the same reputable formula as EBD Group’s acclaimed European events BIO-Europe® and BIO-Europe Spring®. BioPharm America annually attracts 800+ delegates from over 500 companies who participated in 2,300+ scheduled one-to-one meetings. BioPharm America is now part of Biotech Week Boston, and together they draw a total of over 4,500 life science leaders, scientists and innovators.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement