Articles By Ed Miseta

61. Handle Challenges And Avoid Common Mistakes In Drug Product Packaging 10/11/2013

    Michael Rooney, Business Support Manager for Almac, has spent over 12 years working in the pharmaceutical industry. Prior to joining Almac, he spent time working as an associate scientist at ABC Laboratories and an analytical chemist at Nicobrand. In his current position, he assists clients with guidance and advice on packaging issues. I spoke with Rooney about the challenges companies in the pharmaceutical industry face with regard to packaging.

62. Six Essential Tips For Developing Orphan Products 9/20/2013

    Developing orphan products is not an easy endeavor, but one that pharma may be getting more involved with as a result of the patent cliff and erosion of the blockbuster model. Knowing how to select the right development partner can greatly accelerate the approval of orphan products, reduce the cost, and result in a better sponsor/CRO relationship. David Shoemaker, SVP of R&D for contract research firm Rho, notes Pharma firms may not be looking for a blockbuster, but would still like to find drugs that can serve a large population. 

63. What Influences Your Buying Decision? 9/19/2013

    What most influences your buying decision? When presented with a buying opportunity, is your decision based more on the company, the product or service, or the salesperson? Do scientists evaluate products or services and approach buying decisions differently than most people?
    
    Those are just a few of the questions that the Association of Commercial Professionals – Life Sciences (ACP-LS) hoped to answer via a survey conducted by marketing research firm Life Science Strategy Group along with SCORR Marketing. The survey questioned 220 scientists in the life science industry on the importance of a sales representative in the buying/decision process for contract research services. The results will be presented at the ACP-LS Annual Meeting September 19. Chuck Drucker, president of ACP-LS, provided me with a sneak-peek at a couple of the findings.

64. Will A New Diagnostic Platform Be The Key To Early Cancer Detection? 9/10/2013

    Accurately exploring biomarkers is instrumental to detecting cancer early. As long as there are markers linked to a specific type of cancer, early detection is significantly simplified. “Markers help to detect certain cancers, and are also critical after the surgery, to detect whether the cancer is returning,” says Paul Chapman, CEO of diagnostics measurement firm Quanterix. “Since curing patients of cancer is all about early diagnosis, detecting it earlier rather than later is critical to saving patient lives.”

65. Should Russia Be Your Choice For Clinical Trials? 8/27/2013

    Years ago, being a CRO in Russia was not an easy endeavor. Politics, as well as the state of medicine and healthcare in the country, made it a difficult place to perform trials. With improvements that have been made in both medicine and technology, and the changing political landscape, the country is now a very different place. This has significantly improved the job of the CRO, and has made the country a growing and successful area to conduct clinical trials.  

66. Industry Executive Responds To API Trends Report 8/19/2013

    I recently had the opportunity to speak with Brian Scanlan, president and CEO of pharmaceutical chemical producer Cambridge Major Laboratories, Inc., to get his perspective on the state of API manufacturing. I asked Scanlan for his thoughts on a report recently released by CPhI Worldwide and global online community CPhI Pharma Evolution thst looked into the current state of the formulation and ingredients market. The findings in the report, obtained via interviews conducted with 123 high-level executives and experts from the industry, noted challenges and shortcomings faced by the industry.

67. Will Pharma And The FDA Act To Control Opioid Abuse? 8/13/2013

    The Centers for Disease Control and Prevention estimates that 16,000 Americans die each year from opioids. While some may be the result of suicide, many are accidental overdoses by both addicts and non-addicts. In an attempt to address the abuse of opioid drugs such as OxyContin, New York City recently announced it would begin restricting patients to a three-day supply of these painkillers. But Dr. Lynn Webster, president of the American Academy of Pain Medicine and medical director of specialized research organization CRI Lifetree, believes more needs to be done.

68. Four Ways To Avoid Clinical Monitor Burnout 8/2/2013

    Anyone involved with clinical research knows the world of drug trials can be demanding, especially for trial monitors. These individuals spend long hours on the job and are generally required to travel extensively. Lynn King, AVP of clinical operations for contract research firm Rho, understands the stress all too well. King has been involved in clinical research for more than 20 years and has spent some of that time working as a trial monitor. She now works closely with monitors, spending time on-site with them and discussing the challenges they face.

69. How Is Risk Changing The Relationship Between Sponsors And CROs? 7/30/2013

    There are many risks faced by companies operating in the clinical trial space. Jamie Macdonald, CEO of global CRO INC Research, has been a keen observer of risk in the industry with deep experience managing through changing approaches in clinical development. He has taken time to speak with customers, colleagues, and competitors in the CRO space about their business relationships. He believes changes currently occurring in risk management are driving many sponsors and CROs to reevaluate the nature of their relationships, and in many cases, changing those relationships for the better.

70. Your CRO Just Acquired Another CRO – Now What? 7/27/2013

    A year ago, Wendel Barr, CEO of CRO Synteract, was frustrated. His company was profitable, he had talented personnel, Synteract was managing a wide variety of projects, and his clients were satisfied with their level of service. Despite this success, his potential to grow the business was constrained. Synteract was a U.S.-based firm with limited presence overseas. As a result, his company often found itself forced to leave money on the table, especially as its customers moved to larger, Phase 3 trials. “It became clear to us that in order to provide the range of services our customers required, we had to have more offices in Europe, beyond our office in Prague,” he says. “If you want to be a full service provider from Phase 1 to Phase 4, you have to be global.”