Preclinical feature articles

51. 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? 

52. 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.

53. 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.

54. Outsourcing Insights From The President Of A Virtual Drug Discovery Company 4/16/2013

    Carolyn Green, is the President and Director for Atreaon, Inc., a privately held biopharmaceutical company developing a novel engineered protein called Atsttrin, for the treatment of inflammatory diseases such as rheumatoid arthritis. Having recently completed a $20 million Series A financing to support the pre-clinical development of Atsttrin, Green took time out from her busy schedule to share some of her thoughts and insights regarding the outsourcing of clinical research.

55. A Chief Scientific Officer's Opinion On Clinical Outsourcing 4/16/2013

    Dr. Kenneth Burhop is the chief scientific officer of Sangart Inc., a biopharmaceutical company that engages in the research, development, and commercialization of oxygen therapeutics. He joined Sangart in January 2011, after serving as the global scientific lead/CSO for Baxter Healthcare’s Medication Delivery division and VP of R&D for Baxter's Biopharmaceutical Technologies business, including the company’s second generation recombinant hemoglobin program. He has authored over forty publications, more than seventy abstracts, several book chapters, and has been invited to speak at various international meetings and symposia, and is a recognized international expert in the field of hemoglobin therapeutics. Burhop shares his opinions on clinical outsourcing.

56. Outsourcing Perceptions From The CEO Of An Early Stage Start-Up 4/1/2013

    Leslie Williams is President, CEO, and founder of ImmusanT, Inc., an early stage company focused on peptide treatments for auto-immune diseases. Williams has over 20 years of industry experience in healthcare, management, commercial product development and marketing. Williams took time out from her managerial duties to share her perceptions on outsourcing and working with CROs.

57. Outsourcing Insights From The Executive Director Of Medical Research Operations For Purdue Pharma 4/1/2013

    Dr. Mitchell Katz, Ph.D. is the executive director of medical research operations responsible for leading activities across all clinical programs for Purdue Pharma. He has 26 years’ experience in the pharmaceutical and biotech industries, including preclinical research, pharmaceutical operations, and regulatory affairs. Katz, a key opinion leader within the clinical trial space, often speaking at key industry events such as Partnerships in Clinical Trials, and DIA. He recently shared his insights regarding outsourcing in the clinical universe.

58. Former Acorda Chief Medical Officer Discusses Benefits And Pitfalls Of Outsourcing 3/18/2013

    Dr. Thomas C. Wessel, former chief medical officer for Acorda Therapeutics, recently shares his expertise acquired from working with the clinical development and operations, regulatory affairs, biostatistics, data management and drug safety functions.

59. Increased Adoption Of iPSC-Derived Human Cells For Use In Drug Discovery And Toxicity Testing 10/1/2012

    Traditionally, discovering a pharmacological therapy for a disease involves first investigating the underlying biological processes of that condition and then identifying drug candidates that interfere with those processes.  From here, the most promising compounds are advanced to pre-clinical and clinical development. The goal of this “bench to bedside” approach is to translate bench research to point-of-care patient outcomes as quickly and safely as possible. With dwindling drug pipelines, pharmaceutical companies need new approaches that can re-energize their discovery efforts. By Chris Parker, Vice President and Chief Commercial Officer, Cellular Dynamics International

60. March Madness - Coast To Coast To Attend SOT And DCAT 3/20/2012
    I recently had the opportunity to attend two different events — the Society of Toxicology ToxExpo (SOT) and the Drug, Chemical, and Associated Technologies Week (DCAT). By Rob Wright, Chief Editor, Life Science Leader magazine