Last year at this time, having just served my first four months as CASSS Executive Director, I wrote that 2023 was a year of change and opportunity. Now, at the conclusion of 2024, I remain optimistic that positive change and opportunity persist but moving into 2025 they are strengthened by a successful 2024 of thoughtful discussion, amazing meetings, and new friendships. Let’s take a few minutes to review what CASSS achieved in 2024.
First, some numbers for the year. I’m pleased to share that CASSS planned and hosted 21 different meetings across the world, bringing 3716 attendees from 471 organizations and 46 countries together for thoughtful dialog and impactful discussions. Of these attendees, 1303 were first-time attendees of a CASSS event, and 356 were speakers or panelists generously sharing their ideas, expertise and perspectives. Healthcare authorities and regulators made up 458 of these attendees. One of the key metrics we use at CASSS to measure the success of meetings is the Net Promoter Score (NPS). NPS is said by many to be the best way to measure customer satisfaction, and in turn, customer loyalty. It is a simple score between -100 to 100 that helps organizations rank themselves within their industry and independently. Creators of NPS Bain & Company suggest that a score above 20 is favorable, above 50 is excellent, and above 80 is world class. I’m pleased to report that all CASSS meetings in 2024 resulted in an NPS above 60.
Let’s take a look at some of the highlights of the year. The year started with CASSS President Jamie Moore (Gilead Sciences) taking office, along with Vice President & Secretary Mark Schenerman (CMC Biotech – MAS Consulting). Four new CASSS Directors started their terms in January 2024: Christoff Finkler (F. Hoffmann-La Roche Ltd.), Nomalie Jaya (Immunome, Inc.), Andy Weiskopf (Sana Biotechnology) and Heidi Zhang (Tune Therapeutics). Joe Kutza (Eli Lily & Company) returned as Treasurer, and Andrew Chang (Novo Nordisk, Inc.), Carmilia Jiménez Ramirez (BioMarin Pharmaceutical Inc.), Sarah Kennett (Genentech, A Member of the Roche Group) and Hansjörg Toll (Sandoz) returned as CASSS Directors.
The CASSS portfolio of meetings started in 2024 with a strong WCBP Symposium and associated CMC Strategy Forum North America. WCBP alone had over 1200 attendees – in person and virtual – and featured a keynote presentation by Donald Ingber, the Founding Director of the Wyss Institute for Biologically Inspired Engineering at Harvard University. In his keynote, Dr. Ingber described how single human Organ Chips and multi-organ human Body-on-Chips systems have been used to model complex diseases and rare genetic disorders, study host-microbiome interactions, quantitatively predict drug pharmacokinetic and pharmacodynamic parameters, recapitulate whole body inter-organ physiology, and reproduce human clinical responses to drugs, radiation, toxins, and infectious pathogens. WCBP provided an opportunity to celebrate Wassim Nashabeh as the recipient of the 2024 William S. Hancock Award, and two new CASSS Distinguished Fellows: John Dougherty and Reed Harris. The CMC Strategy Forum North America provided an opportunity to examine and discuss two critical subjects: best practices for in-use stability and compatibility studies and establishing and leveraging platforms to support product development.
Photographed from left to right: Jamie Moore, CASSS President, Wassim Nashabeh, Hancock Award Winner and Julia Edwards, Past CASSS President
After a short break in our meeting schedule, CASSS continued with our Bioassays Symposium in April in Gaithersburg, MD. Designed to provide an opportunity for engagement among key industry thought leaders and discussion around topics such as current perspectives, strategies, and technologies used for bioassays, the Symposium more than lived up to its promise. Dean Smith from Health Canada started the symposium with an excellent presentation on the gains and losses regarding the harmonization of specifications during the Covid-19 pandemic. The symposium drew over 134 attendees to discuss topics such as potency assays, bioassays lifecycle management, similarity, comparability and equivalence, variant characterization, automation, automated liquid handling, and more.
In June, CASSS convened our Cell and Gene Therapy Products (CGTP) Summit and Symposium in Rockville, MD to discuss critical challenges in the cell and gene therapy field. Focusing on the topic of advancing comparability understanding of cell-based medicinal products, the one-day CGTP Summit drew 109 attendees in person and 66 virtual attendees and featured 13 speakers and panelists. The summit yielded a Net Promoter Score of 73, which is rarely attainable and considered to be an excellent score. The CGTP Symposium included three days of impactful presentations, panel discussions, roundtable discussions and rich discussion, including an FDA cell and gene therapy regulatory update by keynote speaker Dr. Nicole Verdun from CBER, as well as a closing global regulatory update and panel discussion including Yoshiaki Maruyama from PMDA, Steven Oh from CBER and Ilona Reischl, from Austrian Medicines and medical Devices Agency. The symposium drew 250 attendees in person and 68 virtual attendees and yielded an amazing Net Promoter Score of 75.
In July CASSS convened our CMC Strategy Forum North America meeting in Gaithersburg, MD. The topic of this Forum was innovations and lifecycle management of bioconjugate therapies. The Forum started with an overview of bioconjugates: The Wide World of Bioconjugates; Stories of Successes and Challenges from Discovery to First in Human Studies. Other topics included control strategy and potency, analytics and case studies of post approval change management. The CMC Strategy Fora have established an excellent reputation for being the premier scientific meeting that brings together regulatory, industry, and academic professionals to discuss key emerging CMC issues that affect biotechnology in an open and transparent workshop format. The 2024 Forum lived up to these very high expectations, bringing 128 attendees and speakers together and yielding an outstanding NPS of 67.
Next up in our tour of the CASSS portfolio was the CMC Strategy Forum – Latin America, which was held in two sessions in August. The Forum was again held virtually to optimize access and ease of attendance. The title of the first session was “Convergence of Regulatory Variation Category Assignment and Defined HA Review Timelines Through Risk-Based Assessment of PACs” and featured five different speakers and panelists. The second session, held a week later, was titled “Streamline Management of Product Life Cycle Changes and Build Regulatory Efficiencies Leveraging Reliance” and featured six speakers and panelists. The Forum was a great success, yielding 198 virtual attendees and an amazing NPS of 82.
In September, CASSS hosted the Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry (Mass Spec). The goals of this Symposium are to communicate best practices and innovative approaches for mass spectrometry applications in biopharma, as well as to promote colleague networking and open discussions. The symposium featured two amazing keynotes: the first by John Valliere-Douglass (Pfizer, Inc.) speaking on the topic of “Integration of Mass Spectrometry into ADC Release and Stability Methold Development and Process to Product Characterization.” The second keynote was given by Joshua Coon (University of Wisconsin–Madison), who spoke about “Technology for Rapid Peptide Mapping with Direct Infusion Mass Spectrometry.” Other topics included molecular design, developability and biotransformation, Mass Spec in cell and gene therapy, Mass Spec technologies in higher order systems, new techniques and technologies, and multispecifics and ADSs characterization. With an attendance of 164, the symposium drew a diverse array of experts in the field and generated an NPS of 68.
As in 2023, CASSS co-located the International Symposium on Higher Order Structure of Protein Therapeutics (HOS) with the Mass Spectrometry Symposium in September. Protein higher-order structure (HOS) and dynamics are essential to protein function. For protein-based therapeutic products, HOS is a critical quality attribute that needs to be monitored to ensure the safety and efficacy of drug products. HOS can be monitored by a multitude of biophysical and structural characterization tools. This Symposium featured an opening keynote by Steven Berkowitz, whose presentation was titled “The Evolution & Challenges of HOS Analysis in Biopharmaceutical Development: Past, Present and Future. Other topics included NMR, small angle scattering, AI, electron density topography, mass photometry instruments, and regulatory perspectives on structural characterization of gene therapy products.
September was a busy month for CASSS with the CE in the Biotechnology & Pharmaceutical Industries 2024: Symposium on the Practical Applications for the Analysis of Proteins, Nucleotides & Small Molecules (CE Pharm). The goal of this three-day Symposium is to provide a forum for the discussion of recent developments in capillary electrophoresis (CE) analysis of protein, nucleotide, and small molecule pharmaceuticals. The CE Pharm symposium also featured two keynotes: Robbert Kennedy from University of Michigan opened the symposium with a keynote titled “Affinity Interactions by CE: The Western Blot and More” while Neil Kelleher from Northwestern University provided a closing keynote titled “Proteoform-Enabled Workflows Maturing for Robust Characterization of Biopharmaceuticals and Endogenous Antibodies.” Immediately after his keynote, Robert Kennedy was also presented with the 2024 CE Pharm Award, which is presented in recognition of sustained and significant contribution to the application of CE in the analysis of biopharmaceuticals and/or pharmaceuticals. The CE Pharm Symposium generated 127 attendees and the best NPS of any CASSS meeting in 2024: an amazing 83.
In October, CASSS held the CMC Strategy Forum Europe, this time in Rotterdam in The Netherlands. As in past years, the Forum started with a presentation and discussion by the EFPIA Biomanufacturing Group – not only a summary of current concept papers but also presentations and discussion on the topic of alternative & rapid microbiological methods. After the EFPIA satellite session, CASSS held important in-person sessions and impactful discussions around the ICH regulatory landscape, platforms and prior knowledge, artificial intelligence and machine learning, PACMP’s, and analytic similarity & comparability. One of the highlights of the CMC Strategy Forum Europe was a welcome reception at the Euromast, one of the tallest buildings in Rotterdam. The evening featured beautiful views of Rotterdam, delicious food, and good discussions among old and new friends and colleagues. The CMC Strategy Forum Europe had 164 attendees, with 30 speakers and panelists sharing their knowledge, experiences and perspectives.
In November, CASSS debuted a new Fall Virtual CGTP Summit: Accelerating the Development of Adeno-Associated Viral Vector Gene Therapies - Innovations in Chemistry, Manufacturing, and Control. Designed to be easy and convenient to attend, 61 people attended the program and 12 speakers and panelists shared their expertise and perspectives. The day was broken into two sessions with multiple presentations and two associated panel discussions. In keeping with the high expectations set by CASSS, the summit generated good dialog, excellent reviews and an NPS of 62.
Finally, CASSS held the CMC Strategy Forum Japan on December 9-10 in Tokyo, Japan. As in previous years, the Forum was the result of a strong partnership between CASSS, the Pharmaceuticals and Medical Devices Agency (PMDA), as well as the Japan Pharmaceutical Manufacturers Association (JPMA). The Forum brought in the highest in person attendance since 2019 and generated excellent presentations, discussions, and reviews. Topics discussed included recent trends in the regulation of biopharmaceutical products, ICH Guidelines M4Q revisions, regulatory landscape and changes in the ICH guideline Q6 for biological products, and key strategies and harmonization efforts on raw materials managements of cell therapies. This Forum generated an attendance of 95, with 24 of these attendees serving and speakers and/or panelists.
Large-scale meetings are not the only CASSS opportunities that provide important, timely content and impactful discussions. The CASSS Consultants’ Network held three virtual meetings in April, August, and November. Similarly, the Netherlands Area Biotech (NLab) Discussion Group held meetings in June and October (a short course in association with the CMC Strategy Forum Europe), and the DC Area Scientific Discussion Group (DCDG) held three meetings in April, June and October.
Commitment to DE&I
CASSS is committed to diversity, equity, and inclusion in all aspects of what we do. It is our belief that diverse perspectives drive innovative thinking and better solutions that advance our mission of regulatory capacity building, knowledge-sharing and global access. As a result of this commitment, CASSS staff, leaders, and volunteers, constantly strive to advance the growth and development of DE&I programming initiatives. In 2024, this included:
- The continued presence of roundtable discussions focused on DE&I topics at the WCBP, Cell & Gene Therapy Products, Mass Spec and CE Pharm Symposia.
- The growth of the trailblazing Emerging Leaders Award program in the Higher Order Structure and WCBP Symposia programs.
- The introduction of the Out of the Shadows leadership development cohort at Mass Spec - a joint effort between CASSS, SCIEX and FeMS+.
- Company-wide DE&I training for all staff, which highlighted best practices for building inclusivity and belonging in the workplace and serves as an initial step in the establishment of a continuous DEI education and professional development program.
- The expansion of the CASSS Diverse Voices: Breakfast Chats series; a unique and impactful session that highlights the compelling stories and inspirational anecdotes from members of the CASSS community.
Looking Ahead
As I write this, we are heading into 2025 with great programs for both WCBP and CMC North America. Registrations are trending significantly better than last year. CASSS leadership has developed an exciting portfolio of meetings for 2025, including two brand new meetings: A symposium on mRNA therapy products co-produced by the Alliance for mRNA Medicines (AMM), and a brand new European CGTP Symposium to be held in Basel, Switzerland immediately after the CMC Strategy Forum Europe. Clearly, 2025 will be an exciting and productive year for CASSS and CASSS members.
I am blessed to work with a talented and hard working staff team, but the heart and soul of CASSS has always been our generous and brilliant members – those who take an active role in committees and the Board of Directors, those who speak at our meetings and share their knowledge, and those who attend and contribute to the impactful discussions that CASSS is well known for.
To these leaders, thank you for a great 2024. To the rest of the CASSS community and biopharma community, I hope you join me and the rest of the CASSS staff and leadership team at an event in 2025. I promise you this: you will come curious, enjoy the meeting, and leave inspired.