2025 Summer Scientific Forum Program Themes
Bioanalytical Track
Building for Change on a Dynamic Regulatory Foundation
In a rapidly advancing therapeutic landscape, regulatory frameworks and technological innovations should be seen as a symbiotic partnership. This dynamic relationship underscores the importance of developing and validating approaches that meet current regulatory demands and anticipating future ones. As new platforms, technologies, and guidances emerge, bioanalytical labs must adopt flexible strategies to ensure compliance from early development stages through licensure. Submit proposals that showcase the methods, technologies, and validation processes labs use to meet evolving regulatory expectations, especially within long follow-up and lifecycle management windows.
Theme 1: Building for Change
Keywords: Regulatory compliance, technical writing, SOP, ICH Q12, ICH M10, immunogenicity, AI, ML, DL, GAMP 5, data integrity, validation, case studies, lifecycle management, method design, DOE, automation.
Technologies, Modalities
As laboratories seek to maintain compliance while embracing innovation, flexibility is essential. Proposals should explore applying flexible thinking to the analysis of new therapeutic modalities and encouraging new regulatory strategies to address modern challenges. Presentations may include case studies of unique approaches to validating new technologies or bioanalytical approaches to new modalities that support and drive regulatory flexibility.
AI/Machine Learning/Deep Learning
AI, machine learning (ML), and deep learning (DL) are redefining bioanalytics, particularly in automation and data integrity. Submissions may include case studies of automated documentation/technical writing, leveraging frameworks such as GAMP 5, and AI-driven data management strategies. Examples of AI, ML, and DL applications in method design (including DOE), data interpretation, and maintaining data integrity are encouraged, particularly those emphasizing real-world applications and case studies.
Theme 2: Beyond the Analysis
Keywords: Pre-analytics, patient-centric, cell & gene therapies, cross-validation, immunogenicity, ARC, ADC, LNP, standardization, lifecycle management, compliance, case studies.
Pre-Analytics and Logistics
Presentations should examine the impact of pre-analytical factors, such as logistics and patient-centric considerations, on bioanalytical workflows in clinical settings. Topics may include strategies for cross-validation, statistical approaches, sampling, and data logistics in non-centralized clinical studies.
Immunogenicity and Beyond
As novel modalities like ADCs, ARCs, and cell and gene therapies emerge, immunogenicity profiles evolve. This poses unique challenges for validation and standardization. Proposals should discuss the use of reference materials, novel standardization tools, and compliance strategies for new modalities. Emphasis should be on examples of maintaining compliance and adapting for long-term study requirements, from early trials to licensure.
Pharmaceutical Analysis Track
Theme 1: Accelerating Analytical Development: Strategies and Case Studies
Keywords: Accelerating analytical method development & validation, streamlining analytical development for global regulatory filings, fit-for-purpose analytical methods, urgency, PAT tools for reducing offline testing, platform analytical procedures for novel modalities
CMC development timelines have emerged as a critical barrier to expediting drug approvals and commercialization for life-saving therapies. The key to accelerating analytical development lies in anticipating challenges earlier, employing efficient methods and technologies, and maintaining a flexible approach that allows for rapid adaptation as new data emerges.
Sessions should explore innovative strategies for accelerating analytical development that ensure critical therapies reach patients quicker. Case studies showcasing how risk-based approaches in analytical development can support accelerated CMC timelines are especially desired. These include strategies for streamlining analytical development to meet global regulatory requirements and perspectives on how advanced technologies and automation can enhance the efficiency of screening, developing, and validating analytical procedures. Additional topics include approaches for reducing offline testing by applying PAT tools such as online HPLC, NIR, and Raman spectroscopy, and applying platform analytical procedures to accelerate analytical development for novel modalities.
Theme 2: Transferring Analytical Methods - Challenges and Opportunities
Keywords: Method validation and transfer, deviation management, risk assessment, compliance and data integrity, method comparability, strategic outsourcing
Transfer of analytical methods to external testing sites (e.g., CDMOs) is essential for maintaining consistency in drug quality and safety. At the same time, this process struggles with analytical discrepancies, resource limitations, and equipment incompatibilities. Accelerated timelines, new technologies and enhanced regulatory standards add layers of complexity. Strategic outsourcing and partnerships to advance analytical capabilities and ensure that methods are designed with the specific capabilities and limitations of the manufacturing site in mind can significantly reduce the time needed for method development and validation. This includes but is not limited to lean method validation (phased appropriate) and transfer strategies (bridging studies), early implementation of forced degradation studies to enable the development of stability-indicating methods, predictive and digital modeling tools, and partnerships with specialized CROs for complex analyses (e.g., chiral methods, trace analysis).
Efficient method transfers offer substantial opportunities to enhance collaboration between laboratories, integrate approaches to drug development, standardize quality control, and structure risk assessments. These sessions focus on how knowledge sharing and innovation can enhance the analytical method transfer process while ensuring global regulatory and quality compliance.
Theme 3: Recent Developments in Techniques for Pharmaceutical Analysis
Keywords: Analytical, spectroscopy, method development, artificial intelligence, machine learning, continuous manufacturing, PAT, quality control
Advances in analytical techniques for pharmaceuticals have resulted in enhanced sensitivity, improved selectivity, and better capabilities for analyzing new modalities as well as existing drugs and drug products. Translating these advancements to pharmaceutical research and development and the QC environment is crucial, especially as AI and Machine Learning (ML) become integrated into analytical laboratories.
This session highlights these new applications in analytical technology along with the challenges and opportunities of their implementation. This includes incorporating PAT tools (e.g., NIR, Raman spectroscopy) during manufacturing to provide real-time data on critical quality attributes (CQAs), as well as reducing the need for extensive offline testing and accelerating decision-making. Sessions will also discuss analytical methods related to continuous manufacturing that are enabled by methods that integrate seamlessly into continuous systems while also ensuring precision, efficiency, and reliability. Additionally, key areas of focus include predictive models, real-time analytical tools, and feedback control systems optimizing process performance and mitigating risks through data-driven decision-making.
Theme 4: Ensuring Patient Safety through Analytical Control of Impurities across Modalities
Keywords: Impurity identification, impurity control, impurity guidance, analytical methods, ICH Q3, control strategy, safety
A robust analytical control strategy for drug substance and drug product impurities is essential for ensuring patient safety across clinical and commercial spaces. Understanding the identity, origin, and risks associated with these impurities, however, often requires solving a number of challenges, particularly as novel synthetic approaches are developed across current and new modalities. These impurities may also require applying advanced analytical technologies as well methods for simultaneous assessment of multiple quality attributes. Furthermore, the continuously evolving regulatory landscape and associated requirements often require a balance between technical feasibility and internal and external capability to address impurity control.
These sessions examine the strategies and methods through which analytical teams build and apply fundamental knowledge in establishing analytical control of impurities across modalities.
Bioanalytical and Pharmaceutical Analysis Thursday Joint Session
Scientific Programming Committee
Scientific Programming Committee
Lynn Kamen, Ph.D., BioAgilytix (Chair)
Landon Greene, Ph.D., Vertex Pharmaceuticals (Vice-Chair)
Bioanalytical Track
Mark Wissel, Ph.D., Eurofins Viracor BioPharma Services (Chair)
Indiwari Gopallawa, Ph.D., AstraZeneca (Vice-Chair)
Catherine Brockus, Ph.D., Eli Lilly and Company
Suk Hyung, Ph.D., Genentech
Linlin Luo, Ph.D., Merck & Co., Inc.
Jayharsh Panchal, Ph.D., Asklepios BioPharmaceuticals
Jennifer Vance, Ph.D., Recursion Pharmaceuticals
Kun Yang, Ph.D.
Pharmaceutical Analysis Track
Eric Munson, Ph.D., Purdue University (Chair)
Xiuli Li, Ph.D., Eli Lilly and Company (Vice-Chair)
Galina Bernstein, Ph.D., Azure Delta Consulting
Nathan Contrella, Ph.D., Merck & Co., Inc.
Dhara Patel, Ph.D., Cosette Pharmaceuticals, LLC
Gregory Sacha, Ph.D., Simtra BioPharma Solutions
Beata Sweryda-Krawiec, Ph.D., Boehringer Ingelheim Pharmaceuticals, Inc.