Articles By Ed Miseta

  1. What Is Holding Up Adoption Of Continuous Flow? 7/11/2013

    If you went into an automobile assembly plant in the 1960s and compared it to a factory of today, you would see two very different places. Significant advancements in technology have dramatically changed the way vehicles are produced. Unfortunately, if you went into a small molecule manufacturing facility in the 1960s and compared it to today’s facilities, they would look virtually identical. Many of the advances in manufacturing technology seem to have completely bypassed the pharmaceutical industry.

  2. Sharing Knowledge To Solve Manufacturing Challenges 7/1/2013

    Innovation is important in the pharmaceutical world. So much so, in fact, that it was difficult to find a booth at the 2013 BIO International Convention that did not seem to mention it in one form or another. New technologies and processes can often make or break a manufacturing firm. For that reason, contract manufacturer Aesica created the Scientific Advisory Board several years ago. Its purpose was to develop new technologies the company could take to customers. When Aesica realized others could innovate just as well, if not better, it disbanded the Advisory Board in 2011 and formed the Aesica Innovation Board (AIB). To continue to advance the efforts of the board, Aesica recently agreed to join process manufacturing think-tank Britest.

  3. Five Technology Trends That Will Impact Clinical Research 6/11/2013

    Zikria Syed, CEO of enterprise software company NextDocs, has seen many technology advancements in life sciences, including open standards, mobile access, tablets, and cloud computing. However, despite the cost and compliance advantages offered by many of these advancements, clinical research firms are still slow in adopting them. Research conducted by his firm shows this dynamic is about to change.

    “Our sales and marketing personnel talk to clinical researchers and their CIOs every day,” he says. “I believe there is a message we are delivering to them that they are finally starting to understand: There is a technology shift going on that your peers are starting to take advantage of. If you do not embrace these changes as well, you will soon be operating at a costly productivity disadvantage.”

  4. What Should You Look For When Auditing A CMO? 5/23/2013

    Veda Walcott is no stranger to audits. As the VP of quality for contract manufacturer Cook Pharmica, she often hosts clients performing their annual manufacturing audits of the Cook facility. Last year her company hosted more than 40 such visits by its clients or their partners, and she believes it is only a matter of time before the organization is accommodating at least one audit per week. In her position as VP of quality, Walcott reviews every audit response that goes out. This has made her a bit of an expert on manufacturing audits. She was willing to share some of her insights on the importance of audits in the contract manufacturer selection process.

  5. Pennsylvania's Tom Corbett Named BIO Governor Of The Year 5/3/2013

    On April 23, 2013 The Biotechnology Industry Organization (BIO) announced Pennsylvania Governor Tom Corbett would be honored with its Governor of the Year award. Governor Corbett received the recognition for his leadership and commitment to strengthening the biotechnology and public health sectors within Pennsylvania. Corbett was presented with the award at the 2013 BIO International Convention in Chicago, IL.

  6. Six Ways You Can Avoid Malpractice Risk In Clinical Trials 5/2/2013

    When choosing a partner to participate in your human clinical trial, does it matter if you select a state- or federally chartered clinical facility versus a privately operated clinic or hospital? David Shuey, North America life sciences practice leader for insurance brokerage firm Willis Group Holdings plc., believes it does. In fact, if you are not aware of the differences, it could cost you dearly should a problem arise. The issue is sovereign immunity, an ancient carryover from England that is designed to protect the government from lawsuits.

  7. Russian Federation Makes Case For Pharmaceutical Investment 5/2/2013

    At the 2013 BIO International Conference the Russian Federation made its case for pharmaceutical firms to invest there, while pushing its Pharma 2020 strategy. One of the forum’s sessions, Spotlight on the BRICS: Russia, consisted of two blocks. The first focused on the role of biopharm clusters while the second was an overview of Pharma 2020.

    At the opening ceremony of the Russian exposition, a Memorandum of Understanding was signed between Russian biopharmaceutical company Nanolek and U.S. biotechnology Lentigen. The hope is for Nanolek to become the first manufacturer of a VLP (virus-like particle)-based flu vaccine in Russia. Sergey Tsyb, Head of the Department of Ministry of Industry and Trade of the Russian Federation, expects the project to provide access to efficient, high-quality and affordable vaccines for Russian patients.  Nanolek would manufacture the vaccine at its production facility in Kirov, Russia.

  8. Outsourcing Insights From The President Of A Virtual Drug Discovery Company 4/16/2013

    Carolyn Green, is the President and Director for Atreaon, Inc., a privately held biopharmaceutical company developing a novel engineered protein called Atsttrin, for the treatment of inflammatory diseases such as rheumatoid arthritis. Having recently completed a $20 million Series A financing to support the pre-clinical development of Atsttrin, Green took time out from her busy schedule to share some of her thoughts and insights regarding the outsourcing of clinical research.

  9. A Chief Scientific Officer's Opinion On Clinical Outsourcing 4/16/2013

    Dr. Kenneth Burhop is the chief scientific officer of Sangart Inc., a biopharmaceutical company that engages in the research, development, and commercialization of oxygen therapeutics. He joined Sangart in January 2011, after serving as the global scientific lead/CSO for Baxter Healthcare’s Medication Delivery division and VP of R&D for Baxter's Biopharmaceutical Technologies business, including the company’s second generation recombinant hemoglobin program. He has authored over forty publications, more than seventy abstracts, several book chapters, and has been invited to speak at various international meetings and symposia, and is a recognized international expert in the field of hemoglobin therapeutics. Burhop shares his opinions on clinical outsourcing.

  10. Economic Freedom And Innovation – Why We Should All Be Worried 4/15/2013

    Are you concerned about the ranking of the United States in regard to the Economic Freedom of the World Annual Report? If not, you should be – and here’s why. Economic freedom is not just about politics or tariffs or regulations. It is about people. It is about being able to work where you want, when you want, trade the way you want, and live in a society where you are protected from others. It is also about the level of your health and your life expectancy.