Articles By Ed Miseta
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WIB Profile: Emerging Markets Drive Growth In Biologics
2/12/2015
I was able to catch up with Daniella Kranjac, integration leader and head of commercial operations, to discuss her position with GE Healthcare and the trends she sees occurring in the biologics market.
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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.
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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.
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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.”
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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.
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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.
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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.
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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.
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7 Essential Steps To Hiring A Pharmaceutical Consultant
2/26/2014
In preparation for the spring 2014 hiring season, The CECON Group has recently developed guidelines for choosing the best consultant for a project. Selecting and managing a technical consultant can be a challenge, especially if the subject matter is well outside of the hiring manager’s field of expertise. In the pharmaceutical industry, consultants can help companies of any size to deal with various aspects of drug development, including the selection of suppliers and outsourcing partners.
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Cobra Biologics Extends GMP Certification
2/11/2014
In December 2013, business growth necessitated CMO Cobra Biologics install a new Thermo Scientific 1000L HyClone Single-Use Bioreactor (SUB) at the company’s centre of excellence for mammalian antibody and recombinant protein production. In announcing the expansion, the company cited a ten-fold increase in antibody business over the prior two years, growth in contract manufacturing services, and its continued commitment to single-use disposable technologies.