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Voices of the Board

Embracing the Future of Cell and Gene Therapies

by: Rebecca Devine, PDA Chair

If you have read the news lately, you probably are aware of some of the recent developments in cell and gene therapies. These innovative products offer potential life-saving treatments for cancer, genetic disorders, neurodegenerative diseases, etc. While a few have been approved in the United States and Europe, more remain in the pipeline. And as these therapies become mainstream, manufacturing will help bring them to light.

At the same time, cell and gene therapies present unique manufacturing and supply chain issues when compared to traditional large molecule drug products. PDA is excited to expand our involvement in this growing area. Last year saw PDA host its 10th Advanced Therapy Medicinal Products conference in Amsterdam in the spring. Later in 2018, PDA hosted a successful Cell and Gene Therapy Conference in the United States. In addition, our new Cell and Gene Therapy Interest Group held its first meetings.

We will continue to embrace cell and gene therapies even more in 2019. For the first time ever, PDA appointed a board member with a specific focus on cell and gene therapies. We welcome Michael Blackton, Vice President, Quality, CMC, Adaptimmune, to the board this year. He has been one of our leading volunteers in this area. He co-chaired the 2018 PDA Cell and Gene Therapy Conference and is also the co-leader of the Cell and Gene Therapy Interest Group. I look forward to working with him on the board to advance PDA’s efforts in this area.

This year you can expect a technical report on cell and gene therapy manufacturing. In April, the Advanced Therapy Medicinal Products conference will be held in Vilnius, Lithuania. During our 2019 PDA Biopharmaceuticals Week, we will also hold the 2019 PDA Cell and Gene Therapy Conference, May 6–7. In addition, we plan to expand our courses in this area. Cell and gene therapy manufacturing will continue to be a topic explored in PDA Letter articles and “On the Issue” videos as well as in the PDA Journal of Pharmaceutical Science and Technology.

This is an exciting area that is surely the future of pharma. We look forward to offering more to our members in this area. If this topic interests you, I encourage you to volunteer and get involved.

President's Message: PDA Adapts to Changing Future

by: Richard Johnson

This new year marks the 73rd anniversary of PDA. Last year saw a surge of activity across our various focus areas and we will continue our focus on Connecting People, Science and Regulation®.

Much like the pharmaceutical community, our focus is on, first and foremost, people. While pharma companies and others throughout the supply chain focus on enhancing value to patients, PDA’s role is to help them achieve this. Our members, and the larger community, benefit from our education, communication and scientific leadership. We completed our biannual customer survey of more than 1,600 individuals (member and nonmember) worldwide, and while the data showed that PDA is valued most highly in our credibility and value, we continue to strive for improvement.

We continued to grow, adding young professionals and regulators to our community. We offered 36 conferences and workshops in 2018, along with more than 110 training courses in locations around the world.

We also adapted our use of technology to better serve customers. Some examples of this include:

  • Complying with data protection and privacy requirements enacted in several countries around the world
  • Redesigning PDA’s website to increase usability, expand mobile compatibility and allow users to navigate by topic
  • Simulcasting key meetings to enhance the ability of attendees to hear from and interact with speakers across the globe
  • Increasing the use of audience response systems to gather input from attendees
  • Developing an e-learning platform anticipated to launch in early 2019 so we can begin to offer computer-based training
  • Enhancing the PDA newsfeed, our news uPDAteSM, which employs artificial intelligence to fine-tune topics based on readers’ preferences; we provide this at no cost to members and nonmembers
  • Expanding our offering of online articles and videos to keep up with the continuing migration from print to electronic access
  • Increasing our efforts to translate technical reports into other languages
  • Improving PDA ConnectSM with a new platform and expanding it to all interest groups and chapters

We hope you have found these new technology features valuable, and we will continue to explore ways to use technology to enhance member and customer value.

All of this has been accomplished through the work of our dedicated staff and volunteers on committees and task forces, who collaborate with colleagues around the world to advance PDA’s important mission. We look forward to your integral role in maintaining PDA’s position as an industry leader.

We continue to value and appreciate your contributions! Remember, PDA is your association! We value your input. If you happen to be in Berlin or Bethesda and have the time, please feel free to stop by. We would love to meet you.