Articles By Ed Miseta

  1. FDA Regs Help Secure The Global Supply Chain 10/27/2014

    A better strategy, coordination, and additional tools will help keep medicines and ingredients safe.

  2. ISPE Releases Drug Shortages Prevention Plan At Annual Meeting 10/15/2014

    ISPE has released its Drug Shortages Prevention Plan at a media conference held during its annual meeting at Caesars Palace in Las Vegas. Present at the conference were new president and CEO John Bournas, strategic advisor John Berridge, and Drug Shortage Prevention Plan leaders Joe Famulare, Paul D'Eramo, Donna Gulbinski, and Sam Venugopal.

  3. ISPE Set To Address Drug Shortages At Annual Meeting 10/6/2014

    Drug shortages continue to plague the pharmaceutical industry. According to a GAO report on shortages, dated February 2014, the number of shortages continues to increase in the U.S., as well as around the world. In 2007 there were 154 shortages, 114 new shortages and 40 ongoing from a prior year. In 2012, there were 456 shortages, 195 news ones and 261 ongoing. As of June 30, 2013, there were already 73 new shortages and 288 ongoing.

    The public health importance of these shortages cannot be overemphasized. Shortage situations have included zinc for parenteral nutrition in neonates and premature infants, doxorubicin for ovarian and other cancers, and Propofol for anesthesia.

    Clearly something needs to be done. “ISPE believes efforts to address this complex and multi-faceted problem of drug shortages requires close collaboration and clear communication between the pharma industry and global health authorities,” says Francois Sallans, VP and chief quality officer for Johnson & Johnson, and presenter at the 2014 ISPE-FDA CGMP Conference. “We believe The Drug Shortages Prevention Plan being assembled by ISPE will provide guidance to pharma and global health authorities to manage drug shortages more effectively. But more importantly we are looking into ways for the two groups to manage these shortages more proactively as well. That is an important component that we need to have in place in order to make these shortages rare, but short-lived.”

  4. Pfizer Issues A Challenge – Cook Pharmica Delivers 9/24/2014

    When Pfizer approached Cook Pharmica about producing a monoclonal antibody, Cook saw it as an opportunity to demonstrate its ability to deliver a product to the specifications the sponsor desired. Cook was fairly new at the time, and had been working with clients for just over four years. The company looked good on paper, and was one of a few facilities that could produce ingredients as well as final drug products in the same facility. Still, Cook executives knew they needed to prove they could measure up to the five driving principles (quality, cost, adaptability, timeliness, and risk) that were crucial to Pfizer.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. What Can Be Done To Change The Reputation Of Pharma? 7/3/2014

    Thinking back on the week I spent at the DIA 2014 Annual Meeting, I was able to reflect on many enjoyable and informative meetings. None, however, was as memorable as the opportunity I had to be part of the reporter roundtable session and to speak alongside two knowledgeable members of the pharma press: Ben Comer, senior editor of Pharmaceutical Executive and Mandy Jackson, west coast editor for Scrip Intelligence.