Culture Development Featured Articles
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Preventing Culture Clash In The Changing Healthcare Landscape
11/1/2013
Increasingly, Big Phamra is partnering with smaller drug developers to create new, innovative products, but unfortunately these unions end up being far from harmonious. The problem? Culture clash.
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Selecting Strategic Partners – The Lilly Way
10/31/2013
As VP of Lilly Research Laboratories’ (LRL) operations and LRL Europe, Andy Dahlem puts his reputation on the line every day. When Eli Lilly and Company implemented its new outsourcing strategy several years ago, he was tasked with implementing it. The transformation took Lilly from a fully-integrated pharmaceutical company (FIPCO) to a fully-integrated pharmaceutical network (FIPNET) with numerous external partners.
In this position, Dahlem carries much of the responsibility for work done by external partners. If he seems very serious when discussing breakdowns in quality and reliability, it’s because he holds himself personally accountable for those lapses. “When I make a deal with a service provider to do the work, it’s my reputation that is at risk,” he states. “That is not a responsibility I take lightly.”
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Lilly’s Success Depends On Strategic Partnerships
10/29/2013
Eli Lilly and Company developed several new products in 2003. By 2009 the company had invested six years of R&D into building the portfolio, and the products were ready to move from Phase I to Phase II. That is when Lilly created its Development Center of Excellence (DCOE), with the idea that it would help the company be prepared when the products were ready to move into Phase III. The DCOE is now responsible for clinical development, product R&D, toxicology, and project management. Today, to say the DCOE is critical to ensuring the success of its pipeline would be an incredible understatement.
“John Lechleiter’s (Lilly president, chairman, and CEO) vision for the DCOE was to aggregate these disciplines together under one roof,” says Tom Verhoeven, SVP and co-leader of the Development Center of Excellence, Lilly Research Labs (LRL). “Success will be measured by the number of molecules getting through Phase III, as well as the data generated. The idea behind the DCOE was to become more reliable when getting data and to have the portfolio moving in a predictable way through the different phases of development.”
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Global Trials Roundtable – Controlling Cost And Mitigating Risk
10/24/2013
The current economy, patent expirations of multibillion dollar drugs, and the rising cost of clinical trials (and drug development in general) has many in the pharma industry placing an increased emphasis on controlling costs. Companies must do this while continuing to take more trials to a global market and seeking out more strategic relationships with clinical partners.
To gain a better understanding of the current trends in clinical outsourcing, and what can be done to control the cost of trials, Clinical Leader conducted a roundtable discussion with executives from several CROs. The panel included: Paula Brown Stafford, president of clinical development at Quintiles; Wendel Barr, CEO of SynteractHCR, James D. Esinhart, CEO of Chiltern, Wanda Dobrzanski Nisiewicz, VP of Clinical Operations Latin America & North America at inVentive Health Clinical; Silvia Zieher, VP, Clinical Development, Latin America Operations at INC Research; and Ramita Tandon, SVP and general manager at inVentive Health Clinical.
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New Application Of TAP’s ambr Microscale Bioreactor As Perfusion Mimic
10/15/2013
TAP Biosystems, a leading supplier of innovative cell culture and consumables for life science, recently announced a new application of its ambr micro bioreactor system as a perfusion mimic, enabling scientists to rapidly and easily develop large scale perfusion culture processes of unstable, low producing or minimally expressing proteins or antibodies.
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New Microplate Hotel For TAP’s CompacT SelecT Extends Screening System Support
10/3/2013
TAP Biosystems, a leading supplier of innovative cell culture systems and consumables for life science applications, recently introduced a new microplate hotel for use with its CompacT SelecT automated cell culture system.
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Next Generation Single-Use Bioreactor Improves Cell Culture Performance
9/18/2013
The next-generation HyPerforma Single-Use Bioreactor has been redesigned to provide improved ergonomics while retaining traditional stainless steel bioreactor design principles to enhance cell culture performance.
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Thermo Fisher Scientific Opens Its First Dry Powder Media Facility In APAC Region To Support Growing Biopharmaceutical Market
8/16/2013
Thermo Fisher Scientific Inc., the world leader in serving science, today announced it is expanding its global cell culture and bioprocessing capabilities by opening a new manufacturing plant in Singapore to produce dry powder media (DPM), a crucial cell culture raw material used to manufacture biologics, including vaccines, anticancer therapeutics, and others. The facility is the first-ever cell culture DPM production site in Singapore and is designed to address the increased global requirements from biopharmaceutical companies to mitigate critical raw material supply risks.
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Roche And BioLamina Start Collaboration To Develop Novel Cell Culture Systems
3/6/2013
BioLamina, Stockholm, Sweden and Roche recently announced the signing of a research and development agreement to jointly develop new cell culture systems for various applications, including stem cell research.
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7 Keys To Establishing A Quality Culture Your Senior Management Will Love
2/5/2013
Executive Management participation and support is key to the successful development, implementation, and management of pharmaceutical quality systems. The FDA guidance document (Quality Systems Approach to Pharmaceutical CGMP Regulations) defines the expectations for management with executive responsibility (MWER). These expectations for MWER are aligned with the Q10 Guideline, published by International Conference for Harmonization (ICH). By Christine Park, Quality Architech