iSpeak Blog

Driving Excellence, Modernization, and Harmonization in Pharmaceutical Science & Manufacturing

Lisa J. Graham, PhD, PE
Driving Excellence, Modernization, and Harmonization in Pharmaceutical Science & Manufacturing

The needs of patients provide the impetus to challenge the notion of “this is the way we’ve always done it.”

It is a great honor and pleasure for me as Chair of the 2023 ISPE Annual Meeting Planning Committee to give you an overview of the upcoming conference including information about the knowledge that will be shared, a look at keynote speakers, and details about a few of the networking opportunities.

First, this conference has been developed by the best possible program committee: the committee members have deep knowledge of the content areas, are attuned with the latest industry trends, and come from all aspects of the broad pharma and life sciences community. We know that for both new therapies and traditional therapies, there is opportunity to leverage innovative manufacturing processes, collective guidance, and an agile mindset to adapt to the current needs of patients. These experts have been working all year round to bring you the latest and greatest on delivering what’s needed most to meet the ever-changing needs of society!

2023 ISPE Annual Meeting & Expo

We received a record number of submissions this year, and it is evident that your colleagues are taking on the challenges of rethinking “the way we’ve always done it.” These submissions show even more collaboration happening, not only with each other, but with regulatory agencies on a global scale. Why? To ensure we are adapting with the needs of our world to drive reliable delivery of effective medicines. These emerging needs of patients deserve a responsive life sciences community and that is what we will focus on at the meeting this fall.

In the spirit of driving excellence, modernization, and harmonization, we have reshaped the conference agenda to focus on the following content areas:

  • Digital Transformation
    • Digitalization and the management of big data plus its analytics enables the control, prediction, and optimization of related biopharmaceutical business management trends and processes. The organizational requirements, cultural change, workforce training and infrastructure required for Digital Transformation are captured in the 4 principles of Pharma 4.0: Resources, Organization, Culture, and Information Systems.
  • Manufacturing, Quality Control & Operational Excellence
    • Applying harmonized approaches to innovative design solutions and project delivery strategies to ensure that quality therapeutic products are brought to market in an efficient manner to improve patient health.
  • Regulatory, Compliance & Quality
    • Regulatory and quality challenges, learnings, and opportunities which might include the current speed to market expectations, regulatory harmonization initiatives (ICMRA / PQKMS initiatives and Q12) and guidance updates, drug shortages, and the regulatory focus on data integrity.
  • Supply Chain Resiliency
    • The robustness and adaptive capability of the pharmaceutical manufacturer’s supply chain to prepare for unexpected events, respond to disruptions, and recover from them by maintaining continuity of operations at the desired level of connectedness and control over structure and function.
  • Advanced Therapy & Manufacturing
    • Advanced manufacturing is a collective term for new medical product manufacturing technologies that can improve drug quality, address shortages of medicines, and speed time-to-market.

Interestingly, while digital transformation is increasingly common across industrial organizations globally, LNS Research survey data shows that “two-thirds of companies surveyed have implemented, are currently implementing, or plan to implement an Industrial Transformation program. That research also shows that 75% of companies are not yet seeing any value from their programs”.1 Come join us to learn about where your peers are having success, including the stories of how they are utilizing people, processes, and technologies to affect change – whether in supply chain, on the manufacturing floor, or in all other aspects of the launch of new medicines.

Building on the success of 2022, the conference speakers come from all corners of the globe. They provide unique, multi-faceted experiences on the topics, with emphasis on real-world tested solutions. As we get closer to the conference, keep an eye out for more blogs from the leaders of each content area where they will dive into the exciting details about the specific plans for each one.

While the conference continues with traditional events, such as educational sessions with five focused content areas, global regulatory town hall, vendor exposition, facility tours, etc., you will see few changes to the conference layout this year.

  • This year's hybrid experience allows you to choose how you participate, whether you join us live at the Mandalay Bay Resort in Las Vegas, NV, USA or virtually from anywhere in the world. These new options include pre-and-post event networking opportunities and the Virtual All-Access Pass. As before, the Virtual Essentials Pass is FREE to all ISPE Members. You can learn more about this at the link here.
  • The main events will be held over a period of three, i.e., Monday, 16 October through Wednesday, 18 October. This arrangement is expected to improve attendance for educational sessions and the vendor exposition, while allowing attendees flexibility to travel over the weekend and depart Wednesday afternoon.
  • The FOYA education sessions and Banquet will take place Sunday, 15 October.
  • Breaks/dedicated time has been allotted for attendees to network and visit the Expo Hall.
  • For this year’s event, we are working to grow our Emerging Leaders (ELs) engagement. There are several ways ELs can contribute to the educational sessions and workshops – co-lead educational sessions, session presentations, moderate focused topics/Q&A sessions, and facilitate panel discussions or breakout sessions, to name a few. The ISPE Annual Meeting committee recognizes the importance of this connectivity and we are so pleased to include them even more in the program!

Last, but not least, we have an amazing keynote speaker lineup! This year, we are excited to have the following keynote speakers who will be kicking off our Annual Meeting:

Celia Lourenco
Associate Assistant Deputy Minister
Health Canada
Flavius Martin
Executive Vice President of Research
Gilead Sciences

The needs of patients must provide the impetus to challenge the notion of “this is the way we’ve always done it”. New transformative therapies inherently bring new challenges, but they also present us with new opportunities. For both these new therapies and the traditional therapies, there is opportunity to leverage innovative manufacturing processes, collective guidance, and an agile mindset to adapt to the current needs of patients.

Above all, the ISPE Annual Meeting conference provides ample opportunities to network with your peers, learn about new products in the exhibit hall, and socialize with peers. In addition to the content areas shared above, there will also be several workshop-type discussions, the Hackathon, and great networking at the Emerging Leader and Women in Pharma socials happening!

It takes the commitment of our pharmaceutical community to work together: To challenge the old ways. To embrace new thinking. To make it real.

I’ll wrap with a big “Thank You” to all the participating speakers, vendors, sponsors, and committee members – your contributions are critical to the success of this largest platform for our industry.

Check out the 2023 ISPE Annual Meeting & Expo, to get a glimpse of what we have in store!

Learn More & Register