Preclinical feature articles
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WIB Profile: CROs Must Have The Ability To Deliver
9/3/2015
Zhaoqing (Ching) Ding has been involved with the sciences for more than 15 years. She earned a B.S. in Microbiology and a M.S. in Immunology, both from the University of California, San Diego. She then earned a Ph.D. in Immunology from the Stanford University School of Medicine before rounding out her education by attending the program in Innovation and Entrepreneurship from the Stanford University Graduate School of Business. She started her career performing research in academia before joining The Janssen Pharmaceutical Companies of Johnson & Johnson as a scientist in 2013. In this WIB profile article she shares her experience in working in academia versus pharma, the challenges of working with CROs, and the future potential of biotherapeutics.
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Why Do Most Clinical Trials Fail?
7/8/2015
According to the latest industry research, about 90 percent of drugs that reach clinical stage development never make it to FDA approval and commercialization. At first glance, one could conclude that the reason is the stringent FDA review process designed to ensure that only products that deliver an acceptable efficacy and safety profile ever reach consumers. But a more detailed analysis of the results of many clinical research programs tells a different story.
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Understanding Key Early Phase Clinical Trial Cost Drivers
5/19/2015
Pharmaceutical companies have been implementing intensive cost–saving efforts in the recent years through mergers, reducing overheads, and trimming down of entire business units for efficiency. These efforts have increased the need to outsource services to external vendors throughout the R&D value chain. The early phase clinical trial market in 2014 saw an approximate outsourcing rate of 56 percent with most of the patient studies being externalized to both global and specialist CROs. As cost efficiency is the main focus for pharma, it is important to understand the cost behavior of outsourcing services.
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Signal Management In Drug And Biosimilars Development
5/7/2015
Signal management in drug development has been ongoing, evolving, and improving for many years. For the European Medicines Agency (EMA), Food and Drug Administration (FDA) and other regulatory bodies immunogenicity is a major area of safety concern for biosimilars as well as for peptide, protein, and drug therapeutics, all of which have the potential to trigger some level of antibody response.
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ACRES: Ready To Improve The Conduct And Quality Of Clinical Trials
2/18/2015
The nonprofit ACRES operates in the public interest, taking a multi-stakeholder approach, forming a true alliance united behind the goal of collaboratively building a system for the clinical research process, based in principles of Accountable Research™.
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Improve Clinical Sites By Bringing Together Pharma, Biomedical R&D and CROs
2/18/2015
How do you take pharma, and other biomedical R&D, as well as CROS, which for years have operated as separate entities, and get them to come together and create standards and an accreditation process to benefit the entire industry, indeed, the entire enterprise of a complex of multiple stakeholders, including regulators and the public?
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MPI Research And Jasper Clinical: Getting Decisions To Sponsors Faster
11/13/2014
The Upjohn Company was founded in 1886 in Kalamazoo, MI to make friable pills, which were easily digested and could be “reduced to powder under the thumb.” In 1984, the company decided it needed an internal Phase 1 testing unit and felt Kalamazoo would be the best place to construct it. In 1995, Upjohn merged with Pharmacia. A subsequent merger in 2003 made Pharmacia a part of Pfizer. That same year, the Phase 1 testing unit became Jasper Clinic, an independent operation. In October 2014, that facility, now known as Jasper Clinical Research and Development with more than 80 staff members, became a part of the MPI Research family.
That acquisition by MPI includes the Jasper Clinic, a 50-bed clinical trial unit providing early-stage study services, including pharmacokinetic and pharmacodynamics, drug interaction and methodology studies, and biomarkers. The 25,000 square-foot facility is located on the campus of Bronson Hospital and is physically connected to the hospital’s Level 1 Trauma Center.
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Will Pharma Talent Help Transform CROs Into CSOs?
11/5/2014
It's no secret that Big Pharma is shedding scientific talent. Large layoffs, which have traditionally involved management, sales, and marketing personnel, are increasingly affecting scientists and researchers as well. "This scientific talent has to end up somewhere, and more and more they seem to be migrating to smaller biotech companies and CROs," says Emily Hickey, DVM, Ph.D. and VP for In Vivo Discovery at Charles River. "As Big Pharma continues to shrink, they will rely even more on those two segments. Biotech firms will assist them with target discovery while CROs will assist with efficiently interrogating such targets, be it through chemistry or in vitro and in vivo studies. With more scientific talent in those areas, it can be a win/win situation."
Hickey has first-hand experience with this trend. She herself worked for a top 10 Big Pharma company prior to migrating to the CRO side of the house. In her previous position she was part of a team that evaluated CROs, deciding which ones had the best qualifications and would be the best fit with her company. Working in this capacity, and dealing with all of the challenges that came with it, gave her a lot of the experience she now uses to ensure her company can best meet the needs of pharma clients. As other scientists from Big Pharma make that same transition, both pharma and CROs stand to benefit.
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BRIC Nations: Divergent Patterns in the Clinical Trials Landscape
6/12/2014
The clinical trial landscape in BRIC countries is changing. Long heralded as a low-cost alternative to Western markets, Brazil, Russia, India and China are experiencing a shift in trial initiation by global sponsors.
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Former Big Pharma R&D Exec Shares Thoughts On Outsourcing
5/2/2013
Jim Hauske is President and founder of Sensor Pharmaceuticals, a company focused on the nexus of inflammation and metabolic disease. A virtual company, Sensor has established business relationships with AMRI, Absorption Systems, MPI, RenaSci, Ricerca and SciLucent. These relationships provide the means to synthesize, screen and assess, in disease models, new chemical entities designed by Sensor. The company has pre-clinical compounds representing several chemo types versus GPR119, GPR120 and TLR-4. All these molecules have demonstrated in vivo activity in relevant animal disease models.