Ed Miseta

ARTICLES BY ED MISETA

• UPS Pain In The Chain Survey: Pharma Makes Gains In Compliance, Partnerships

  UPS' Pain in the Chain survey is one of the best ways to understand where life science companies stand on the issues making logistics a headache and keeping executives up at night. Since 2008, the survey of healthcare and life science supply chain professionals has attempted to determine the needs of these companies.

• Should You Outsource Your Pharma Supply Chain?

  Have you thought about taking the bold step of outsourcing some or all of your pharma supply chain? If so, you won’t be the first company to consider it. But is outsourcing the best option?

• Lilly Banks On Equity Investing To Grow Pipeline

  Lilly continues to partner with academic institutions and biotech companies, and more recently has been entering into a greater number of collaborations with other Big Pharma companies. But one area where the company has devoted significant resources, and which is certainly a big part of Lilly’s partnering strategy, is equity investing.   

• WIB Profile: Sponsors And CMOs Require Production Flexibility

  Drug manufacturers today are increasingly demanding flexibility in their manufacturing processes. So who better to provide those solutions than someone who has spent her career dealing with change.

   

• Is The Orphan Drug Act Hurting The Patient Population?

  The intent of the Orphan Drug Act was a good one. The problem is the success of the act may now be discouraging pharma companies from pursuing medicines that would be more beneficial to the patient population as a whole, in order to pursue a more profitable treatment for an orphan disease with a much smaller number of patients. 

• Opdivo And Praluent Expected To Lead The Class Of 2015

  Which pharma offerings should you keep an eye on in 2015? Thomson Reuters has released its 2015 Drugs To Watch report, with insights into those medications expected to enter the market this year and make a big splash for their developers.

• Hiring A Chief Medical Officer May Sound Good, But…

  Laurie Halloran has seen many firms succeed where others have failed. She will tell you she started her company after speaking to many executives about how to grow their companies, get funding, make it through clinical testing, and finally going commercial.

• 21st Century Cures Gets Closer To Revolutionizing The Pharma Industry

  If you’re a regular reader of my articles, you know my background is in economics, and I tend to favor free markets over more central control. But when I first became aware of the 21^st Century cures initiative last year, I felt it was something the industry needed.

• FDA Regs Help Secure The Global Supply Chain

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

• Challenges In Managing Life Science Regulatory Submissions & Correspondence

  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.