Philosopher Alan Watts once wrote, “The only way to make sense out of change is to plunge into it, move with it, and join the dance.” Well, clearly, 2025 was a year that CASSS “joined the dance” and moved with a lot of change affecting the biopharma community. As we all know, however, with change comes opportunity and, in this context, I’m pleased to share some highlights from CASSS in 2025.
2025 – Some Basic Numbers
Numbers are a great place to start. I’m pleased to share that CASSS planned and hosted 23 different meetings across the world, bringing 4207 attendees from 627 organizations and 39 countries together for thoughtful dialogue and impactful discussions. Without exception, the highly relevant and specialized programming for all of these meetings were curated by teams of expert and exceptional CASSS volunteers, working with a talented and experienced staff. CASSS meetings are developed by those who dwell in these topic areas, not second or third parties that host a conference, leave, and host another conference somewhere else on a different topic.
One of the key metrics we use at CASSS to measure the success of meetings is the Net Promoter Score (NPS). NPS is a commonly used statistic 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 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 the mean NPS of CASSS meetings in 2025 was an excellent 71.2, which was also an all-time average high for CASSS.
CASSS Officers and Board of Directors
The year started with two new CASSS Directors starting their terms in January: Markus Blümel (Novartis AG) and Yasuhiro Kishioka (Pharmaceuticals and Medical Devices Agency -PMDA). Jamie Moore (Gilead Sciences, Inc.), Mark Schenerman (CMC Biotech – MAS Consulting), and Joe Kutza (Eli Lilly and Company) returned as CASSS President, Vice President & Secretary, and Treasurer, respectively. Andrew Chang (Novo Nordisk, Inc.), Christof Finker (F. Hoffmann – La Roche Ltd.), Nomalie Jaya (Immunome, Inc.), Carmilia Jiménez Ramirez (Miliar BioPharma Solutions), Sarah Kennett (Genentech, A Member of the Roche Group), Andy Weiskopf (Sana Biotechnology), and Heidi Zhang (Tune Therapeutics) returned as CASSS Directors.
CASSS Meetings in 2025
CASSS had an extensive and diverse portfolio of meetings in 2025. The first CASSS meetings of 2025 were a strong WCBP Symposium and an associated CMC Strategy Forum North America. WCBP alone had over 1100 attendees – in-person and virtual – and featured a keynote presentation by Sonia Vallabh, Ph.D. Sonia co-leads the initiative to develop preventive drugs for prion disease at the Broad Institute of MIT and Harvard. She comes to this work with a personal mission. In 2010, Vallabh watched her 52-year-old mother die of a rapid, mysterious, undiagnosed dementia. One year later, Vallabh learned that her mother’s disease had been genetic prion disease, and that she herself was at risk. Vallabh underwent predictive genetic testing and learned that she had inherited the causal mutation, placing her at very high risk of developing the same disease. There was no prevention, treatment, or cure available. Vallabh quit her previous career in law and consulting, and, together with her husband, Eric Minikel, re-trained as a scientist in order to devote her life to finding a way to stop her disease before it starts.
WCBP provided an opportunity to celebrate Marjorie Shapiro as the recipient of the 2025 William S. Hancock Award, and Julia Edwards as a new CASSS Distinguished Fellow. The CMC Strategy Forum North America provided an opportunity to examine and discuss two critical subjects: Digital Transformation – AI and Data Analytics to Accelerate Development Timelines, and Advances Toward Patient-Centric Quality Standards.
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 met the high standard that has been set for this symposium. Ned Mozier, Ph.D. provided a keynote address on The Special World of Bioassay: Key Learnings, Special Situations and Keys to Success. The Symposium drew over 120 attendees to discuss topics such as potency assays, multispecific antibodies, antibody drug conjugates, emerging technologies, and more.
May featured CASSS’s newest event, Symposium on mRNA, which was co-produced by the Alliance for mRNA Medicines. The Symposium drew over 70 attendees, and featured presentations and discussions on topics including new advances that expand the therapeutic potential of mRNA beyond prophylactic vaccines, challenges and innovations in manufacturing, quality control and assay development, regulatory considerations, and more. This Symposium generated a stunning NPS of 94, the highest NPS of any CASSS event in 2025.
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. The one-day CGTP Summit, drawing 90 in-person attendees and 126 virtual attendees, comprehensively addressed CMC-related delays in the clinical development of CGT products with a primary focus on the development of a globally acceptable potency strategy. The CGTP Symposium included three days of impactful presentations, panel discussions, roundtable discussions, and rich discussions, including anamazing keynote presentation by Kiran Musunuru, Ph.D., who spoke about developing and deploying N-of-1 gene editing therapies. The Symposium also featured presentations and discussions on gene editing, the START Pilot FDA program, stem cell therapy development, development and characterization of viral vectors, platform development, analytical testing, regulatory perspectives, and more. The Symposium also featured “flash posters” and a fireside chat, and drew 203 attendees in person and 126 attendees online.
In July, CASSS convened our CMC Strategy Forum North America meeting in Gaithersburg, MD. The topic of this Forum was Bioconjugates & Multispecifics: Technologies, Analytics, Developability, and Scalability. Topics and sessions included novel bioconjugates and multispecifics, radioconjugates, new approaches to analytics, global regulatory considerations, integrated control strategies, risk management, and more. 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 2025 CMC Strategy Forum North America Summer lived up to these very high expectations, bringing together over 100 experts to have impactful discussions on this important topic.
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 facilitate access and ease of attendance. The overall theme of the Forum was Driving Regulatory Convergence Across Latin America. The Forum sessions explored the current regulatory scenario, global initiatives that will shape the future of regulatory requirements and practices, and how regulators and industry in Latin America and the Caribbean can better prepare for this future. Sessions and topics included reliance, PGMP implementation, building regulatory expertise and capacity, AI drug development, and cloud-based submissions. The Forum was a great success, yielding 267 virtual attendees and an amazing NPS of 84.
September was a busy month for CASSS, starting with the CE in the Biotechnology & Pharmaceutical Industries 2025: 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 featured two keynotes: J. Michael Ramsey from the University of North Carolina, Chapel Hill, opened the Symposium with a keynote titled “Microtechnologies for Acquiring Biological Information” while Joel Welch from the Center for Drug Evaluation and Research (CDER), FDA from provided a closing keynote titled “CE’ing into the Future: The Role of Capillary Electrophoresis in Innovation for Biological Products”. Immediately after his keynote, J. Michael Ramsey was also presented with the 2025 CE Pharm Award, which is given 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 214 attendees (73 virtual) and an amazing 71 NPS.
In late 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 Ping Hu (Johnson & Johnson) speaking on the topic of "Advancing Protein Analytics with Mass Spectrometry". The second keynote was given by Joseph Loo (University of California, Los Angeles), who spoke on “Advanced Mass Spectrometry and Structural Biology Strategies to Characterize Therapeutic Proteins”. Other topics included MS applications for research and early stage development, MS in cell and gene therapy, EAD fragmentation, MS trends in regulatory research, review and standard, new technologies, high throughput sample preparation methods for MS-based proteomics, multispecifics and ADCs characterization, MAM for product and process characterization and quality control, multi-omics, and more. With an attendance of 218 (152 in person and 66 virtual), the Symposium drew a broad array of experts in the field and generated a very strong NPS of 70.
In October, CASSS held the CMC Strategy Forum Europe in the beautiful city of Basel, Switzerland. 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 the design, development, and future opportunities of multispecific antibodies. After the EFPIA satellite session, CASSS held important in-person sessions and impactful discussions around the global reliance, CMC post approval changes, analytical procedures and platform methods, reference materials, regulatory updates, bridging strategies during clinical development, ICH M4Q & SPQS, and more. One of the highlights of the CMC Strategy Forum Europe was a welcome reception at the Sandoase Basel, a beautiful waterfront venue overlooking the Rhine. The CMC Strategy Forum Europe had 198 attendees, the highest attendance ever for this event, as well as an outstanding NPS of 71.
Immediately after the CMC Strategy Forum Europe, CASSS debuted our newest meeting: CGTP Europe - Manufacturing, Quality and Regulatory Considerations. This new Symposium was also held in Basel. The content was exceedingly strong in this first version of our newest symposium. Luigi Naldini from the San Raffaele Telethon Institute for Gene Therapy gave a terrific keynote presentation titled “Genetic Engineering of Hematopoietic cells: From Lentiviral Gene Replacement to Targeted Gene Editing”. Other topics included a matric approach to control potency of cell and gene therapy modalities, data management in cell and gene therapy, comparability, AAV gene therapy vectors, regulatory considerations in cell and gene therapy, and more. Over 80 experts convened at this first-ever CGTP Europe Symposium.
To cap off a busy year, CASSS held the CMC Strategy Forum Japan on December 8-9 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). Topics discussed included recent trends in the regulation of biopharmaceutical products, AAV technology, advanced stability testing, innovative approaches in biopharmaceutical manufacturing, AI, and more. This Forum generated an attendance of 100, which was the highest attendance since 2019.
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 March, June, and September. Similarly, the Netherlands Area Biotech (NLab) Discussion Group held meetings in May, October, and November, the DC Area Scientific Discussion Group (DCDG) held two meetings in June and October, and the Virtual Europe Discussion Group (VEDG) held two meetings in May and November. All of these meetings are free to biopharma and regulatory professionals and include not only presentations and panel discussions but invaluable networking opportunities.
CMC Strategy Forum Global Steering Committee
Among the most impactful things that CASSS has done is to create and establish the CASSS CMC Strategy Fora. CMC Strategy Fora are perhaps the cornerstone of CASSS, and are designed to foster collaborative technical and regulatory interactions on current and emerging CMC elements of biotechnology/biological product development and commercialization. The goal of each CMC Forum is to encourage the exchange of technical, quality, and regulatory information among industry, academics, and regulatory agencies to assist them in merging good scientific and regulatory practices. To facilitate this goal, the outcomes of the Forum meetings are recorded and/or published in a manner to be publicly available. Ideally, these outcomes will help assure that biopharmaceutical products manufactured in a regulated environment will continue to be safe and efficacious.
In 2025, the CMC Strategy Forum Global Steering Committee was re-formed by the CASSS Board of Directors, and was charged by the CASSS Board of Directors with advancing the mission and objectives of CASSS by ensuring the production of high-quality interactive forums worldwide for the discussion of relevant CMC issues throughout the lifecycle of a biopharmaceutical product. Among the responsibilities of the Global Steering Committee are to 1) develop and establish Regional CMC Forum Committees as appropriate to further the mission and objectives of the CMC Strategy Forum worldwide; 2) assure that established Regional CMC Forum Committees operate in alignment with the Global CMC Strategy Forum mission and objectives; and 3) assure that each Regional CMC Strategy Forum develops content and format to achieve their stated goals and objectives, including interactive discussions and attendee satisfaction. This important committee is chaired by Wassim Nashabeh and Julia Edwards.
New CASSS Webinar Program
CASSS debuted a new Exhibitor Webinar program in 2025, designed to provide live, just-in-time learning in an easy virtual format on critical topics in biopharma. Two companies partnered with CASSS to pioneer these meetings in 2025: SCIEX, who hosted Jessica Taylor from Teva Pharmaceuticals speaking on "Advancement of Capillary Gel Eletrophoresis through the use of Native Fluorescence Detection”, and Millipore Sigma, who hosted Manjula Aysola and Alison Armstrong, speaking on "Navigating Regulatory Complexities Along the Cell and Gene Therapy Lifecycle”. CASSS has partnered with several other companies to provide similar webinars in 2026, so please watch your email for additional information.
New CASSS Bylaws
Often considered an agreement between the Board and the members of an organization, bylaws are the agreed-upon rules that outline authority, rights, and broad processes and structures of the governance and operations of a nonprofit association. Bylaws are an important fundamental framework to guide our actions, decisions and basic processes. After consultation with staff and legal counsel, the CASSS Board of Directors agreed that the current CASSS bylaws were in need of revision. Legal counsel suggested, and the Board agreed, that it would be cleaner and easier to start from scratch with a new set of CASSS bylaws that were shorter and clearer, yet still preserved the crucial CASSS structures and processes that help to make CASSS unique and successful. CASSS legal counsel and staff constructed a new set of bylaws, which were reviewed and approved by the Board of Directors. These new bylaws were distributed to Associate Directors in September 2025 and will again be presented to Associate Directors for approval at the January 2026 meeting of Associate Directors preceding WCBP.
CASSS Foundation for Science
One of the most important achievements of CASSS was the formation of the new CASSS Foundation for Science. Many of you reading this report know that CASSS is a 501(c)(6) tax exempt organization: an association of people sharing a common vision and often a common business interest. Often, 501(c)(6) associations like CASSS will form a separately incorporated but affiliated 501(c)(3) organization, with a related mission, but better positioned to obtain funding from additional sources. For over a year, the CASSS Board of Directors has been researching and discussing the possibility of forming such an affiliated 501(c)(3) organization for the purpose of finding alternative funding streams to help us meet our mission of bringing together professionals from industry, academia, and regulatory agencies to solve scientific and technical problems to advance the field of biopharmaceutical development. I’m pleased to share that this new foundation – the CASSS Foundation for Science – has officially been incorporated. The first meeting of the Board of Directors occurred in November 2026, at which bylaws were approved, officers were elected, and new policies passed. The CASSS Foundation for Science has just been born. Watch for more information on this exciting new foundation in 2026.
Looking Ahead
As I write this, we are heading into 2026 with a lot of appreciation, a lot of excitement, and a lot of anticipation. Our volunteer leaders and staff team have partnered to create terrific programs for both WCBP and CMC North America. Registrations for both are trending better than last year. CASSS leadership has developed an exciting portfolio of meetings for 2026, including two brand new virtual summits, our first-ever CMC Strategy Forum in Canada, a new Foundation to launch, and plenty of needs to meet in the biopharma community. Clearly, 2026 will be an exciting and productive year for CASSS and CASSS members.
I work with a wonderful, 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 2025. 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 2026. I promise you this: you will come curious, you will enjoy the meeting, and you will leave inspired. Just as we are leaving 2025 – curious, inspired, and excited for 2026.