Articles By Ed Miseta

41. Are Regulators Providing The Right Quality Incentives? 9/8/2014

    If you want to get a horse to move, there are two schools of thought on how to get it done. One says stand behind the animal with a stick and hit it until it does what you want. This method is not the most humane, and would not do much to endear you to the horse. The other approach says hold a carrot in front of the horse, and get it to move of its own volition. The carrot would be a reward to the animal for doing the right thing.

    Looking at this situation in a different context, we all want quality outcomes in pharmaceutical manufacturing facilities. Good manufacturing practices will provide safe products to patients, prevent injury to workers, and minimize or eliminate plant shutdowns, which can ultimately lead to drug shortages. Guy Villax, CEO of CMO Hovione, believes the FDA and other regulatory agencies have many tools at their disposal that can be used to hit manufacturers for poor quality practices. In the future, he would like to see the oversight agencies make more use of carrots to get manufacturers producing to the standards that would benefit the entire industry.

42. Novartis' Heart Failure Medicine Cuts Cardiovascular Deaths by 20% In Landmark PARADIGM-HF Trial 9/2/2014

    At the European Society of Cardiology congress held this past weekend in Barcelona (and published simultaneously in the New England Journal of Medicine) Novartis revealed its investigational heart failure medicine LCZ696 was superior to ACE-inhibitor enalapril on key endpoints. The findings were the result of PARADIGM-HF, the largest heart failure study ever conducted. Findings showed patients with heart failure with reduced ejection fraction (HF-REF) who were given LCZ696 were more likely to be alive and less likely to have been hospitalized for sudden deterioration of their heart failure than those given ACE-inhibitor enalapril. Patients received LCZ696 or enalapril on top of current best treatment.

43. Is Life Sciences Media Helping Or Hurting The Industry? 9/2/2014

    If you’re like me, keeping up with news in the life sciences industry is an integral part of your day. I am especially interested in news relating to the pharma companies and their partners, and every day I get emails updating me on the latest news pertaining to drug discovery. But lately I have noticed a disturbing trend in many of those emails. It seems some media outlets are doing their best to promote all the bad news they can find. As a result, I am beginning to wonder why they seem to be lining up against the industry they are intended to cover.

44. The Supply Chain Of The Future: A Strategic View 8/26/2014

    Evolutionary theory teaches us it is neither the strongest nor the most intelligent of the species that survives. It is the one that is the most adaptable to change. Peter Bigelow, president of xcell Strategic Consulting, likes to mention this quote, widely attributed to Charles Darwin, when opening presentations on the future of the pharmaceutical supply chain. Ingredient suppliers, manufacturers, quality standards and audits, and logistics are just a few areas where we can expect to see many changes going forward. Adapting to these changes will be critical to everyone involved in the process, and in ensuring medicines are delivered to patients safely and effectively.  

45. Use Data To Find And Manage Your CRO Partnerships 8/5/2014

    According to Hurd, there are currently 9 billion devices connected to the Internet, a number that may reach 50 billion by the end of the decade. This will create an absolute explosion of data that businesses, including those in the life sciences, will have to manage. We know going in that a lot of that data will be worthless. Therefore, it will be incumbent upon companies to discern the valuable data from the noise.

46. Are You Properly Selecting Your CMO Partners? 8/4/2014

    At the 2013 WTG Global Pharma Manufacturing Summit in Boston, Angie Green gave a presentation on the steps sponsors should follow when selecting CMO partners. The CMO selection steps Angie reviewed are echoed in many of the conference sessions for Outsourced Pharma West—topics chosen by Life Science Leader readers.

47. How To Maximize The Value Of Your Attendance At Outsourced Pharma West 8/3/2014

    Outsourced Pharma West (OPW) will be here in just a few short months. Unlike conferences you have attended in the past, OPW will be a unique opportunity to learn and partner. The sessions were requested by you, our readers, via an extensive survey. In selecting speakers, we sought out the most qualified and experienced professionals in the pharma and biotech industries. Many top CMOs and manufacturing experts will be onsite for discussions and partnering opportunities. This is one show you won't want to miss.

48. Industry Insights From The Executive Director Of Compliance At Seattle Genetics 8/1/2014

    Kristin Rand always had a fascination with questions science had not yet answered, and she developed an interest in genetics while still in high school. She obtained an undergraduate degree in the Diagnostic Genetic Sciences program at UCONN. FDA law and bioethics were the focus of her graduate degree in law, and she later earned a master degree in industrial-organizational psychology.

    After serving in various positions at Wyeth and Genentech, she landed at Seattle Genetics, where she currently serves as executive director of compliance. In this piece she discusses trends in pharma compliance, and challenges companies can expect to face in 2014 and beyond.

49. WIB Profile: What Pharma Scientists Can Learn From A Lilly Specialty Sales Rep 7/30/2014

    When I first spoke with Laura McClung of Eli Lilly & Company about a Women in Bio (WIB) profile article, I almost wrote her off. Being involved in the sales force for Lilly, I initially felt she was too far outside the drug discovery process to contribute meaningful information to my readers. However, after having just one discussion with her, I immediately changed my mind.

    As McClung points out in this piece, many sales reps for Big Pharma have scientific or medical backgrounds. This makes them some of the most qualified individuals to advise doctors and clinicians on the medicines that will best meet the needs of patients. Their experience working with prescribers also makes them well qualified to provide feedback to those involved in the drug discovery process on what is needed by doctors and patients on the front lines.      

50. Four Essential Steps To Selecting The Right CMO Partner 7/23/2014

    If you are currently involved in outsourcing any of your pharmaceutical manufacturing, you know there are a lot of complexities around selecting the right CMO partner. It can be a daunting process to find a supplier that has the right level of quality, experience, is a good cultural fit, and has the right price.