Drug Discovery Featured Articles & Applications

51. How To Ace Your FDA IND Submission (And How To Rebound If You Don’t) 3/20/2017

    Let's assume you have your pre-IND ducks in a row. Now you're ready to embark on preparing and submitting the IND application to the FDA, which, if approved, will allow you to test your drug in humans for the first time. 

52. What Outcomes-Based Contracts Mean For Drug Development And Drug Pricing 3/17/2017

    The mounting public outcry over drug prices — fueled by dramatic increases in cost for a few high-profile, older, life-saving drugs — has put intense pressure on the pharmaceutical industry to lower prices.

53. How Image Analysis Can Improve The Results Of Drug Development And Clinical Trials 1/24/2017

    In recent years there have been several potentially life-saving medications approved for cancer treatment, including targeted molecular entities and biologics such as Opdivo (nivolumab) and Keytruda (pembrolizumab). Oncology drugs remain a pharmaceutical priority and investments into cancer account for 30% of all pre-clinical and phase 1 clinical development expenditures. There is an impressive list of close to 800 drugs and vaccines currently in the industry-wide development pipeline, many with promising results in early-stage clinical trials. However by historical measures only 10% or fewer of these drugs will ever make it through FDA approval and become part of routine patient care.

54. Five Major Benefits of Tissue Phenomics 1/24/2017

    Seeing is believing – this is an important aspect of Tissue Phenomics, where cellular structures in tissue slides taken from patients are investigated in real space. Observing directly what type of structures form and what kind of interactions take place is in general of much higher value than concluding indirectly from other type of data. I experienced this factor very clearly thirty years ago when people speculated about the atomic structure on the surfaces of matter from indirect measurement.

55. 3 Ways Tissue Image Analysis Will Shape The Future Of Cancer Treatment With Immunotherapies 1/24/2017

    As healthcare continues its transition towards precision medicine, physicians are eager to maximize both the quantity and quality of data obtained from their patients’ tissue samples.  In the current “one drug, one test” paradigm, physicians struggle to balance the number of tests required to make a treatment decision with the limited amount of tissue that is available. 

56. Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare 1/11/2017

    If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.

57. Novartis’s Siponimod & Genentech’s Ocrevus: Challenges & Outlook For The Progressive MS Market 12/16/2016

    The first drug approval for primary-progressive multiple sclerosis (PPMS) may arrive by the end of March 2017, when the FDA is expected to render a decision regarding Genentech’s Ocrevus. Here, we will highlight recent positive data for Novartis’s siponimod in secondary-progressive MS (SPMS), explore key issues to watch as these medications enter the market, and look ahead at the commercial opportunity in progressive MS.

58. Genentech’s Ocrevus: Pioneering The Progressive MS Therapy Landscape 11/30/2016

    The last 12 months have brought about sought-after breakthroughs in the treatment of underserved progressive multiple sclerosis (MS) patients, and a landmark approval for one new therapy — Genentech’s Ocrevus (ocrelizumab) — may come in March 2017. In Part 1 of this two-part article, we will explore the landscape that Ocrevus will enter and the factors that will influence its uptake in progressive MS.

59. Trump And The FDA: What to Expect (And What’s At Stake) 11/22/2016

    Donald Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn about the agency, to help facilitate the transition from the Obama administration to the Trump administration. In this article, I describe what I expect the nascent 2017 agenda will be as Trump’s team walks in the door, and I offer a few thoughts as to why the Trump team would do well to consider the unique nature of FDA as transition planning takes shape.

60. Design Space Development — How (And When) To Get Started 11/2/2016

    Design space is a scientific concept used in the pharmaceutical/biopharmaceutical industry to support and assure product quality. The culmination of the information and knowledge gained during product development provides the foundation for the design space.