It’s that time – the calendar shows that it is late December, when typically, we review the year behind us and look forward to the year ahead of us. For me, 2023 was a year of change and opportunity, as I started as Executive Director of CASSS in August. While I have over twenty years of experience managing nonprofit societies, this year represented an opportunity to learn a new staff team, a new Board of Directors, and a new professional society. As I look back over the last few months, and even more so to the start of the year 2023, I continue to be thankful for the opportunities of this new position and amazed at the productivity and achievements of CASSS, CASSS staff, and CASSS volunteers in 2023.
Facilitating Interactions Year-Round
For CASSS, the year 2023 started very well with a strong WCBP Symposium and the associated CMC Strategy Forum North America. WCBP alone had over 1300 attendees – in person and virtual – which represents the highest total attendance ever for WCBP. When we asked the attendees what is most important for CASSS to do to help them do their job better, the number one response – as it has been for over five years – is to facilitate interactions with regulatory agencies. Yet more evidence that this interaction between regulatory agencies, industry, and academics is the sweet spot for CASSS and our meetings.
Our success with meetings 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. Over 100 experts discussed important issues such as potency assay strategies, surface plasmon resonance, bioassays for vaccines and anti-infective therapies, and bioassays for cell and gene therapeutics. Clearly, the attendees thought the meeting was a success, as it generated an NPS (Net Promotor Score) of over 80, and over 84% of attendees thought that the content of this Symposium was better than other conferences in this field.
The CASSS portfolio of meetings continued to Rotterdam in May with the Analytical Technologies Europe (AT Europe) Symposium. Featuring sessions on important topics such as Mass Spectrometry of Oligonucleotides, Gene Therapies and Vaccines, Stability and Dynamics of Single Particles in Real Time, Control Strategies and Surrogate Assays, the AT Europe Symposium generated important discussions and wonderful reviews.
In June, CASSS convened our Cell and Gene Therapy Products Symposium (CGTP) and debuted the CGTP Summit in Rockville, MD to discuss critical challenges in the cell and gene therapy field. Our new CGTP summit focused discussions on a range of CGT modalities and new concepts in comparability required for certain CGT products. The CGTP Symposium itself featured plenary and parallel tracks as well as roundtable discussions designed to offer additional content and opportunities to engage in meaningful, powerful discussions. The Symposium drew in over 400 attendees, the most in the history of this meeting.
July continued to be an active month with our CMC Strategy Forum North America meeting in Gaithersburg, MD. The Forum has 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 2023 Forum lived up to these very high expectations, offering sessions and discussions around critical topics such as digital and cloud-based product approval processes, harmonization, the use of prior knowledge to accelerate product development, and statistical modeling approaches. Over 80% of attendees indicated that the content presented at this Forum was better than other conferences they have attended, further reinforcing the success and impact of the Forum.
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 session topics included quantitative proteomics, molecular design, developability, and biotransformation, hacking structural biology for drug delivery using protein footprinting, and mass spectrometry in gene and cell therapy. Once again, the content curated by our committee generated rave reviews as over 95% of attendees indicated they were satisfied or extremely satisfied with the content.
For the first time ever, CASSS doubled up on a good thing and 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 excellent sessions on HOS technologies, and new modalities, and met together with the Mass Spectrometry attendees to discuss emerging mass spectrometry technologies for HOS.
September continued to be a busy month for CASSS with the CE in the Biotechnology & Pharmaceutical Industries 2023: Symposium on the Practical Applications for the Analysis of Proteins, Nucleotides & Small Molecules (CE Pharm). The goal of this Symposium is to provide a forum for the discussion of recent developments in capillary electrophoresis (CE) analysis of protein, nucleotide, and small molecule pharmaceuticals. As in past years, the presentations and workshops were devoted completely to practical concerns to strengthen the use of CE within the biotechnology and pharmaceutical industries. The 2023 Symposium maintained our standard of excellence, as over 130 people attended and over 90% of attendees ranked the content as extremely or significantly satisfying.
In October, CASSS held the CMC Strategy Forum Europe and once again generated an impressive audience of thought leaders to discuss key emerging CMC issues that affect biotechnology in an open and transparent workshop format. The Forum once again 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 immunogenicity. After the EFPIA satellite session, CASSS held important in-person sessions and impactful discussions around the art of specification setting, characterizing and controlling modes of action, antibody-drug conjugates, stability, and collaborative approaches and reliance products followed. One of the highlights of the CMC Strategy Forum Europe was a welcome reception at the Vasa Museum, held underneath the hull of the great ship. Attendees will be talking about this meeting for many years.
CASSS continued our global impact with the 2023 CMC Strategy Forum Latin America. The Forum consisted of three virtual sessions: “Why Optimize the Submission and Review of CMC Post-Approval Changes?” in June, “Pathway to Optimizing Submission and Review of CMC Post-Approval Changes” in September, and “One Single Dossier for Global Submissions: How Far is Latin America From That?” in November. Were attendees happy with the content? Take a look at these scores: over 85% of attendees indicated that the content was extremely or very satisfying, and the Forum resulted in a Net Promoter Score of 73 (an NPS of over 50 is generally thought to be excellent).
CASSS held the 10th CMC Strategy Forum Japan on December 4-6 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, stability and ICH Guideline Q1/Q5C, regulatory expectations for CGT product comparability, and quality control of antibody drug conjugates. What we saw in Tokyo is a great example of what we expect to see in CASSS CMC Strategy Fora: a room full of intelligent people, working together to learn from one another and hold candid discussions in order to solve problems together.
Networking Around the World
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 May, August, and November. Similarly, the Netherlands Area Biotech (NLab) Discussion Group held meetings in June and December, and the DC Area Scientific Discussion Group (DCDG) held three meetings in February, May and September.
More Than Meetings
CASSS did more than hold meetings, however. A great example is the creation of the Emerging Leader in the Advancement of Scientific Knowledge Award (ELAA Award). Stay tuned for a separate recap in early 2024 on the ELAA Award and more.
Finally, the Board of Directors (BOD), led by President Julia Edwards, had a very busy year as well. Among the decisions and issues discussed by the Board in 2023 were the following:
- Designated John Dougherty and Reed Harris as new Distinguished Fellows of CASSS. Both John and Reed have provided CASSS with years of volunteer time and leadership and made many contributions to the biopharmaceutical industry. We are looking forward to honoring them and their accomplishments and contributions at the 2024 WCBP.
- Approved a new Code of Conduct for CASSS meetings, which will clearly state our expectations for attendees of our meetings and help to provide a safe, productive, and welcoming environment at CASSS events.
- Examined and refined the nomination process for the Board of Directors, which resulted in a process that maintains the ability of Associate Directors (ADs) to nominate candidates to the Board, but now also includes recommended candidates from the Board and nominating committee. This new process better matches best practices in professional societies and will help to meet the needs of CASSS strategic priorities via specific skills and backgrounds of recommended candidates.
- Most recently, elected Jamie Moore, Gilead Sciences as President and Mark Schenerman, CMC Biotech – MAS Consulting as Vice President & Secretary. Jamie and Mark will begin their services as new CASSS Board officers on January 1, 2024.
Looking Ahead
Wow – what a year! As I write this, we are heading into 2024 with WCBP and CMC North America, with registrations looking even better than last year. I am blessed to work with a talented 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 simply attend and contribute to the impactful discussions that CASSS is well known for.
Thank you for a great 2023 and here’s to looking forward to an even better 2024!