Articles By Trisha Gladd

  1. HDMA Conference Examines A Holistic Approach To DSCSA Preparation 10/30/2014

    As the first Drug Quality and Security Act deadline approaches, pharma professionals around the globe are offering insight and advice in order to help with preparation for this legislation. While any Google search will return pages of helpful articles, the most beneficial information will be offered in real time at conferences and seminars arranged by industry organizations. One example of this is the 2014 Healthcare Distribution Management Association (HDMA) Education Traceability Seminar taking place in Arlington, VA from November 10th to the 13th. According to its site, the seminar will “include valuable insights, innovative approaches, and lessons learned as distributors and manufacturers successfully implement serialization and traceability technologies.”

  2. 2nd Draft Guidance Under DSCSA Offers Clarity For 3PLs As January Deadline Approaches 10/28/2014

    Earlier this month, the FDA announced the availability of the second draft guidance under the Drug Supply Chain Security Act (DSCSA), titled The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers. While clarifying information is provided, the guidance is still in draft form and more information from industry will need to be collected in order to drive it to a finalized state.   

  3. Supply Chain Security: 3 Visions To Prevent Fraud And Safeguard The Patient 10/27/2014

    The vulnerability of the pharmaceutical industry’s supply chain has been talked about in great depth, especially since the passing of the Drug Quality and Security Act (DQSA) last November. Millions of stolen, counterfeit, and illegal medications infiltrate pharma’s shipping lanes every year, and despite all of the buzz, experts are pumping out viable solutions at a much slower rate than criminals are distributing contaminated and/or fake drugs.

  4. Supply Chain Management Of Temperature-Sensitive Products At Novartis: Advice From An Expert 9/11/2014

    Gone are the days when pharma can depend on blockbuster drugs to carry them to financial heights; instead, successful pharmaceutical companies are taking a different approach and looking to demand to determine their next step in drug development and supply chain management. For Novartis’ Michael Trocchia, this demand has resulted in a new role as the Global Supply Chain Lead for Cell Therapy Products. In this article, he discusses the challenges associated with managing the supply chain for a temperature-sensitive product and what best practices he applies in order to contribute to Novartis’ ability to maintain a top spot in big pharma.

  5. BPI Offers A Look Into QbD At Genentech 8/19/2014

    Brian Horvath, Scientist and Technical Development Team Leader, Late Stage Cell Culture at Genentech, says the company’s QbD approach has been evolving over the past several years. It is used in a number of ways in the bioprocess areas—cell culture, purification, and formulation—which allows validation that the process as a whole reliably produces product with the desired critical quality attributes. In October, Horvath, will present a case study at the BioProcess International Conference and Exhibition outlining how QbD was used at Genentech during the characterization of a CHO-based monoclonal antibody.

  6. How To Prepare A Facility For The Biopharmaceutical Revolution 7/8/2014

    Drug discovery is an inherently inefficient process. It takes thousands of failed compounds before one can get approved as safe and efficacious, and this effort does not come at a low cost. Because of this, the industry is constantly looking for ways to bring safe, compliant, and profitable drugs to market faster and cheaper. Patheon facility in Brisbane, Australia, exemplifies the facility needed to survive the future of pharma. But how did they do it?

  7. Analytical QbD at Teva: Knowledge Is Power Only When You Share It 7/3/2014

    Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.

  8. FDA's First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn't 6/23/2014

    On June 10th, the long-awaited first draft guidance under the DSCSA was released by the FDA. For those holding high expectations that the guidance would offer specific direction on how to handle suspect/illegitimate products internally, you may come away feeling a little shortchanged. However, in the past, the FDA has come under scrutiny for using guidance to replace rule making, since this requires legislative involvement, so the lack of detail in the draft may be an effort to make room for flexibility that industry felt they weren’t getting before. Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action. I recently spoke with David Colombo and Dawn Wang with KPMG Life Sciences Advisory to find out what can be learned from this draft and where we go from here.

  9. FDA Approval Pushes Novartis Into 21st Century Vaccine Development 6/18/2014

    In 2009, the world experienced a global threat in the form of H1N1. Despite a prompt response to the need for a vaccine in the United States, it was still not available until six months later and not enough doses were even produced to cover all Americans. During the year-long battle with the deadly virus, the CDC estimates between 8,870 and 18,300 people died due to H1N1-related complications. In the world of influenza vaccine production using chicken eggs, the response experienced during the H1N1 outbreak is not uncommon. Is this the best our industry can do? Novartis says NO.

  10. Where Do Ideas Come From? How To Transform An Idea Into A Product 5/30/2014

    Shabbir Dahod, president and CEO of TraceLink, has been working in the pharmaceutical industry for over 11 years, and in the last 30 years, has founded three companies prior to launching Tracelink. When asked how he comes up with the ideas that have brought him so much success, Dahod credits a very specific approach he learned about during the commencement speech at his wife’s college graduation. The speaker was the president of John Hancock at that time, and Dahod says he made a comment that sticks with him to this day. “He said what you need to do is look for connections and patterns from one segment to another,” says Dahod. “What it forces you to do is think a little bit more about what’s happening at the meta level. How could that pattern be applied somewhere else?”