Articles By Ed Miseta

  1. Challenges In Managing Life Science Regulatory Submissions & Correspondence 10/17/2014

    Life science organizations produce large volumes of documents necessary for submitting applications to regulatory agencies. They need to have records of those documents as well as all related communications from sites around the world. This creates a situation that can be rather daunting.

    Sponsors must first make sure all documents are going through the proper review and approval cycle and that controls are in place to meet regulatory requirements such as 21 CFR part 11. Once the documents are published and ready for submission to the regulatory agency, they are typically stored on a file share. Although that file share has access controls in place, it will not have granular-level access controls.

  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. 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.

  7. 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.

  8. 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.

  9. Patient Demand, Vaccines, And Drug Delivery: Q&A With Steve Wick Of 3M Drug Delivery Systems 4/24/2014

    New technologies are changing the drug delivery approaches used for both small and large molecule manufacturers. Additionally, the more empowered patient is causing many pharma companies to re-evaluate their drug delivery strategies. We spoke with Steve Wick, Senior Technical Director for 3M Drug Delivery Systems, about these topics as well as how the drug delivery landscape might change over the next 5 to 10 years.  

    What technologies are currently changing drug delivery approaches for small molecules? For large molecules? How will these advances impact the pharmaceutical industry?

    For small molecules specifically, I believe that we will see two different trends in drug delivery. The first will be toward the targeting of drug delivery through the use of technology such as nanoparticles or even aptamers. 

  10. Patient-Centric Design: The Next Frontier In Drug Delivery 3/4/2014

    Patient-centric is one of those terms we suddenly seem to hear mentioned often. Everyone in pharma wants patients to know that it’s their comfort and well-being that are always at the forefront of development efforts for medicine and delivery devices.