Articles By Ed Miseta

41. Data Support Clinical Validity Of Pharmacogenomic Testing 3/21/2014

    In 2007, a technical review by the Evaluation of Genomic Applications in Practice and Prevention group (EGAPP) conducted testing that concluded there was insufficient evidence at the time to determine the clinical value of pharmacogenomic testing for adults beginning treatment with SSRI antidepressants.  Since then, extensive new published evidence is available to refute those findings. C. Anthony Altar, chief science officer of personalized medicine company Assurex Health, is the lead author of a study published last fall in the International Review of Psychiatry, which validates the clinical use of pharmacogenomic testing to help predict patient response to psychiatric medications.

    Dr. Altar, who has a Ph.D. in psychology with an emphasis in neuroscience, has spent over 30 years working in the life science industry dealing with pharmaceuticals and drug discovery. He was instrumental in the discovery of Abilify, one of the most commonly prescribed antipsychotic medications, and has done extensive work in developing drugs for the nervous system.      

42. Life Science Leader Presents CMO Leadership Awards In NYC 3/21/2014

    Life Science Leader magazine, a publication dedicated to executives involved in pharmaceutical and biopharmaceutical drug development, presented its 2013 CMO Leadership Awards during a ceremony and reception at the W Hotel in New York City. Rob Wright, chief editor of Life Science Leader, served as master of ceremonies for the event while Ed Miseta, chief editor of Outsourced Pharma, presented the awards to the recipients. The event, attended by over 300 industry professionals, was sponsored by Federal Equipment Company.

43. TransCelerate Advances Risk-Based Monitoring 3/3/2014

    November 2013 marked several noteworthy events for TransCelerate BioPharma, the industry group attempting to bring drug sponsors together to collectively identify and address broad industry issues. The non-profit organization achieved milestones on several of its original projects, expanded its membership to 19 sponsors and launched its second year initiatives. Three new initiatives, Common Clinical Trial Protocol Templates, Special Populations Clinical Trial Networks, and an Investigator Registry will be added to the original five initiatives. The group also announced it will expand on two successful projects – Site Qualification and Training and the Comparator Network.

44. mHealth Ready For Primetime In Clinical Trials 2/25/2014

    mHealth is suddenly a popular buzzword in the pharmaceutical world. What started out as a term referring to mobile and digital programs to help patients and their caretakers has now morphed into a more general term being used in clinical trials to describe the use of mobile technology in research programs.

45. DIA Identifies Trends To Watch In 2014 2/21/2014

    DIA has released the 2014 version of its annual What Lies Ahead report. The report, first published in 2013, attempts to predict the trends that will have the greatest impact on the pharma, biotech, and medical device markets in the coming year. In assembling the report, DIA interviewed industry leaders from all sectors of life sciences including industry, patient organizations, government, and academia. According to DIA, this year’s responders were well aligned in their opinion of the most influential trends.

46. Putting The Patient At The Center Of Drug Delivery Technology Formulations 2/19/2014

    Rising healthcare costs are a concern to everyone from the president down to the patient. One way of controlling those costs is to involve the patient in as much self-administration as possible. Doing so would reduce hospital and clinic stays, and the cost of nurses visiting patients at home. Patient-friendly formulations would also serve to increase patient adherence to their medications.

    To facilitate this, drug delivery technologies need to be formulated in such a way as to facilitate easy use and patient acceptability. One example would be an orally disintegrating tablet (ODT), which does not require water and is easy to swallow for the elderly, the very young, and patients who have dysphagia.

47. LabCorp Enhances Genomics Portfolio With Acquisition 2/14/2014

    LabCorp Clinical Trials, already a leading provider of late-state core genomic services including mutation analysis, pharmacogenetics, and pharmacogenomics, has expanded its offerings with the acquisition of Covance Genomics Laboratory (CGL). The additional offerings will allow LabCorp to meet client needs with a more comprehensive set of services ranging from preclinical/early development all the way through to late stage development.

48. New Models Will Drive New Approaches To Clinical Trial Data 2/12/2014

    PwC’s Health Research Institute (HRI) has released a report analyzing the top issues and trends that will impact pharma companies and the health care industry in 2014. Covering everything from the Affordable Care Act to venture capital outlays, the report details the trends and health issues for pharma professionals to watch in the coming year. I spoke with Anup Kharode, director of pharmaceutical R&D advisory services for PwC, about two of those trends, which involve healthcare innovation and clinical trial data/site selection.

49. New Program Prepares To Target Novel Antibiotics 2/12/2014

    It’s no secret to anyone in the life science industry that the world is facing new strains of infection that are growing increasingly resistant to existing antibiotics. This would not be a problem if new drugs were being developed and making their way to physicians. Unfortunately, in the last 30 years, only two new classes of antibiotics have made it to market. Gram-negative bacteria, such as E-coli, are able to resist antibiotics, making effective treatment difficult. These bacteria make development of effective medicines difficult.

50. "Your Journey, Our Mission": PAREXEL Launches New Brand Platform To Strengthen Client Relationships 2/12/2014

    Attempting to simplify the journey of sponsors from the drug discovery process through to new treatments for patients, biopharmaceutical services provider PAREXEL is announcing the launch of a new initiative. The company’s promise to bio and pharma firms, “Your Journey, Our Mission”, was put in place to demonstrate its commitment to enhance client opportunities.

    PAREXEL has been working on this rebranding idea for more than two years. According to the company’s founder and CEO, Josef von Rickenbach, the process involved a lot of soul searching and examining of where the company and the industry were evolving, as well as the expectations of its clients. The goal was to understand how the strategies and visions of pharma could be best served by the companies it selected as partners.