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West is proud to announce that Diane Paskiet, Director, Scientific Affairs will serve as Co-chair at the upcoming PDA Packaging Conference in Baltimore, MD. In her leadership role for the meeting, Diane will moderate several sessions, including Repackaging – Problems and Solutions and The Future Direction of Devices and Patient Adherence/Compliance.
This year’s conference—an update on current challenges and future directions—promises to take on a wider breadth of topics, including human factors and systems engineering and how to leverage this data to drive patient adherence in the years to come.
“The annual packaging conference is intended to provide solutions for both pharmaceutical companies challenged with developing and manufacturing quality products to meet patients’ needs, as well packaging suppliers faced with meeting the ever-increasing standards for container closures and delivery systems,” said Diane. “I look forward to seeing decision-makers from across the industry take a deeper dive into tough regulatory and scientific issues by examining various case studies and learning about best practices from some of the biggest names in healthcare.”
Diane will be joined at the meeting by colleagues John Chippari Vice President, Regulatory Affairs and Andrea Straka, Senior Technical Account Specialist.
John’s session will raise awareness about the unique challenges related to licensing in China, compared to other developed and developing countries around the globe. “Most pharmaceutical companies don’t realize that licensing in China is a three to four year endeavor,” said John. “It is important for manufacturers and suppliers to understand this complex process from the earliest stages of development so that the timeline for commercialization is accurately defined.”
Finally, on Tuesday afternoon, Andrea will address Rubber and Seal Nonconformities – An Update and Sample of the Upcoming PDA Technical Report and provide her perspective as co-Chair for the PDA Elastomers Technical Report Taskforce focused on creating a lexicon of stopper and aluminum seal defects. Andrea has spent the last 12 years working closely with West customers to guide decisions for appropriate container closure systems, troubleshoot issues and solve complex challenges for their drug products.
For a chance to hear from West’s experts on topics that go beyond packaging and manufacturing and into the patient experience, join Diane, John and Andrea in Baltimore from May 18-19. More details can be found on the PDA website.
Employees from The Tech Group’s Phoenix, Rockford, Scottsdale and Tempe West facilities raised more than $72,000 for Upward Children and Families as part of the 2013 West without Borders fundraising campaign.
Research in the area of cell and gene therapies started almost 40 years ago, however recently there has been a been a surge of activity including landmark regulatory approvals for therapies treating chronic and rare diseases. In 2017 and 2018 the FDA approved the first two CART-T cell therapies for cancer treatment and the first two gene therapies for rare diseases. All four of these cell and gene therapies were approved under the FDA Accelerated Approval Program, aimed at expediting approvals for life saving drug therapies. These regulatory programs have the potential to shorten drug development as much as 1-3 years. Currently, there are more than 1,000 regenerative medicine clinical trials underway globally<sup>1</sup>, and the market is expected to grow rapidly over the next 10+ years.
Seeking technical support? Need a little information about fill-finish manufacturing technology? How about advice from the experts on extractables and leachables? These answers, and more, are available in the new West Knowledge Center.
Particles in drug products can come from many sources—extrinsic (from outside the process), intrinsic (from within the process) and even inherent (as part of the drug formulation)<sup>1</sup>.
Each June, West recognizes Pride Month, which promotes and supports the self-affirmation, dignity, equality, and increased visibility of the Lesbian, Gay, Bisexual, Transgender and Queer or Questioning (LGBTQ) community.
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