Tracks and Themes
Track 1: Predictive Translation and Decision-Grade Evidence
Predictive translation seeks to convert mechanistic biology, nonclinical pharmacology, biomarkers, and quantitative models into evidence that can confidently guide development decisions. As biotechnology expands across established and emerging modalities, the challenge is no longer to simply generate more data, but to determine which data are sufficiently informative, credible, and fit for purpose to support dose selection, early clinical hypotheses, regulatory interactions, and quantitative go/no-go decisions.
This track focuses on the scientific approaches that improve prediction and decision-making across the development lifecycle. Sessions highlight MIDD, human-relevant evidence generation, spatial and systems pharmacology, and translational biomarker and bioanalytical strategies. Across all three themes in this track, case studies should include examples that illustrate how predictive, science-generated, decision-grade evidence changes a development decision, strengthens a regulatory submission, or accelerates a therapeutic program toward patients.
Theme 1: Decision-Grade Translation: From Mechanism to Human Dose
Keywords: Human Dose Projection, First-in-Human (FIH), Recommended Phase II Dose (RP2D), Pharmacokinetic and Pharmacodynamic (PK/PD), Physiologically Based Pharmacokinetic (PBPK), Quantitative Systems Pharmacology (QSP), Model-Informed Drug Development (MIDD), In Vitro-In Vivo Extrapolation (IVIVE), Exposure-Response, AI, Minimum Anticipated Biological Effect Level (MABEL), Regulatory Strategy
The transition from mechanistic understanding to first-in-human testing is one of the most consequential points in development. At this stage, nonclinical PK/PD, translational biomarkers, mechanistic models, and prior knowledge must be integrated to predict human exposure, biological activity, safety margins, and an appropriate starting dose, RP2D, and regimen. The growing complexity of peptides, degraders, antibody-drug conjugates (ADCs), multi-specific biologics, and gene and cell therapy has increased the need for quantitative approaches that can connect drug properties and the mechanism of action to anticipated human responses.
This theme examines how decision-grade translation and quantitative dose/regimen can support first-in-human dose selection, early clinical hypotheses, dose optimization, and go/no-go decisions while reducing unnecessary studies through fit-for-purpose and least-burdensome development strategies.
Topics in this theme include human dose projection and first-in-human dose selection, RP2D, PK/PD, PBPK, QSP, MIDD, MABEL and IVIVE, exposure-response relationships, integration of mechanistic biology with nonclinical pharmacology for model credibility, dose selection, translational model refinement and decision thresholds for immunogenicity of peptides, degraders, antibody-drug conjugates, biologics, and gene and cell therapy, NAM-derived outputs for developing AI-assisted and systems-based models supporting clinically relevant dose selection, application of QSP to novel modalities with nonlinear or systems-level pharmacology FDA and global regulatory perspectives on model-informing drug development, and AI-assisted analysis that improves model building, parameter estimation, or decision-making.
Theme 2: Human-Relevant Evidence Without Defaulting to Animals
Keywords: New Approach Methodologies (NAMs), Microphysiological Systems (MPS), Organoids, Organ-on-Chip, Humanized In Vitro Systems, Replacement Reduction Refinement (3Rs), In Silico Models, AI-Enabled Toxicology, Evidence Credibility, Weight-of-Evidence, Regulatory Acceptance, Fit-for-Purpose Evidence, Context of Use
NAMs are rapidly changing how pharmacology and safety evidence can be generated before clinical testing. Organoids, microphysiological systems, organ-on-chip platforms, humanized in vitro models, and computational methods can provide more direct insights into human biology than some traditional animal models. These technologies also create opportunities to reduce, replace, or refine animal use while improving the relevance of evidence used to predict efficacy, toxicity, and therapeutic index.
The central challenge is not whether these technologies are innovative, but whether the resulting evidence is sufficiently credible for a defined context of use. Sessions in this theme examine how NAMs can be characterized/validated for context-specific use, combined with conventional animal-derived evidence, and incorporated into development programs in a manner that is scientifically rigorous, fit for purpose, and acceptable to regulators. Considerations for AI-enabled toxicology and in silico approaches can strengthen evidence packages without overstating model performance or replacing biological judgment.
Topics can include examples of NAMs such as 2D and 3D human relevant immune assays, microphysiological systems, healthy and diseased state-derived organoids, and organ-on-chip applications; human-relevant pharmacology and safety models; humanized in vitro systems; 3Rs; AI-enabled toxicology and in silico prediction models built using NAM outputs; historical nonclinical data and translational clinical data, assay and model qualification; evidence credibility and fit-for-purpose evidence packages; weight-of-evidence regulatory strategies; integration of NAMs with traditional nonclinical studies; use of human-relevant models to investigate target biology, tissue-specific toxicity, or modality-specific risk; integration of multiple NAM-based models to capture pathway-level and inter-tissue communication relevant to drug disposition and toxicity; reverse translation from clinical findings to improve preclinical models; least-burdensome and risk-based development strategies; FDA and international regulatory perspectives on NAM implementation; recent feedback to guidance provided by industry; and case studies demonstrating how NAMs reduced, replaced, refined, or have substantially improved the interpretation of animal studies.
Theme 3: Translational Biomarkers and Bioanalytical Strategies for Tissue, Cellular, and Functional Evidence
Keywords: Spatial Biology, Single-Cell Analysis, Multi-Omics, System Pharmacology, Target Engagement, Receptor Occupancy, Intracellular Exposure, Bioanalysis, Imaging biomarkers, Immunogenicity, Translational Biomarkers
Understanding whether a therapeutic reaches the relevant tissue, engages its target, and produces the intended biological effect requires measurements that extend beyond conventional plasma concentration data. Advances in spatial biology, single-cell analysis, multi-omics, and systems pharmacology now make it possible to characterize drug action at the tissue, cellular, and molecular levels. These approaches can reveal heterogeneity that is obscured in bulk measurements and can provide more direct links among exposure, target engagement, pharmacodynamic response, and clinical outcome.
This theme emphasizes measurement technologies, assay readiness, biomarker validity, bioanalytical strategy and implementation. Sessions focus on the resulting data integration in spatial and systems pharmacology and how to transform this information into coherent strategies appropriate for the modality and stage of development. Speakers should also address regulatory expectations for minimum viable biomarkers and bioanalytical strategies that support clinical development.
Other topics include spatial biology; single-cell analysis; multi-omics; systems pharmacology; target engagement and receptor occupancy; tissue and intracellular exposure; cellular and functional biomarkers; risk-based, streamlined immunogenicity assessment; in silico and bioanalytical methods for detecting clinically relevant outcomes across established and emerging modalities; translational biomarker strategies; wearable and digital biomarker technologies that support regulatory decision-making; real-world evidence generation and postmarketing surveillance; AI-assisted interpretation of complex multi-omics or spatial datasets; and case studies showing how advanced bioanalysis, spatial measurements, or decision-grade biomarkers can integrate their outputs in a systems-based model to support clinical development or regulatory submissions.
Track 2: Product Design, CMC, and Regulatory Enablement for Biologics and Novel Therapies
Novel therapies require the integration of innovative science, technology, manufacturing, and regulatory strategies to address unmet medical needs and advance patient-centered care.
This track dives into the convergence of product design, CMC, advanced manufacturing, and regulatory science to enable robust, scalable, and effective development of biologics and novel therapies.
In addition, sessions showcase innovations and best practices across development, manufacturing, commercialization, and lifecycle management of complex therapeutic modalities. Emphasis is placed on AI/ML, digital twins, advanced analytical technologies, innovative drug delivery, novel formulation approaches, and modern manufacturing platforms. The track also explores evolving global regulatory landscapes, regulatory intelligence, platform technologies, regulatory harmonization, and strategic partnerships.
Particular attention is given to practical approaches for topics including but not limited to CMC challenges, microbiological control, technology transfer, scale-up, and regulatory expectations. Through real-world case studies, this track highlights how scientists are transforming data and innovation into actionable strategies.
Theme 1: Advancing Biologics and Novel Therapies: Development, Delivery, and Analytical Characterization
Keywords: Biologics, Proteins, Monoclonal Antibodies, Bispecific Antibodies, ADCs, Vaccines, mRNA, LNPs, Cell Therapy, Gene Therapy, CRISPR, Radio conjugates, targeted radiopharmaceuticals, peptide-drug conjugates, immune-cell targeting platforms, High-Concentration Biologics, Drug Delivery, Analytical Characterization, QbD, risk-based approaches, AI/ML, Combination Products
This theme focuses on advances and challenges in the development, formulation, delivery, and analytical characterization of biologics and novel therapies, including peptides, proteins, antibodies, ADCs, PDCs, vaccines, mRNA/LNPs, cell and gene therapies, CRISPR-based products, radio-conjugates, targeted radiopharmaceuticals, and immune-cell targeting platforms. Sessions explore developability, novel excipients, product development strategies, and emerging delivery technologies, and combination products that improve product performance, patient access, and administration. The theme also highlights advanced analytical approaches, patient-centric technologies, and CQAs, offering practical case studies demonstrating AI/ML enabled acceleration of formulation, characterization, delivery, and product development.
Theme 2: CMC Attributes, Bioprocessing, Manufacturing, and Microbiological Control
Keywords: CMC, Control Strategy, Upstream Processing, Downstream Processing, Bioprocess Development, Process Characterization, Scale-Up, Process Validation, Commercialization, Fill-Finish, Aseptic Processing, Microbiology, Contamination Control, Sterility, Endotoxin, Mycoplasma, Adventitious Agents, Environmental Monitoring, Single-Use Systems, PAT, Digital Twins, Advanced Manufacturing, Automation, AI-Enabled Manufacturing
This theme emphasizes CMC implementation, manufacturing, and microbiological control to enable consistent and scalable production of biologics and novel therapies from clinical development through commercialization. Sessions explore control strategies, process development, scale-up and scale-out, technology transfer, process validation, and commercialization readiness, with emphasis on practical case studies, risk mitigation, and supply resilience. The theme also covers modern fill-finish technologies, including but not limited to robotics, isolators, flexible manufacturing, small-batch filling, lyophilization, high-viscosity products, ADC containment, and device assembly, as well as microbiological strategies for contamination control, sterility assurance, and rapid microbial testing. Emerging technologies such as digital twins, PAT, advanced process control, predictive maintenance, and AI-enabled manufacturing will be featured through implementation-focused case studies and measurable outcomes.
Theme 3: Strategic Initiatives, Emerging Partnerships, Global Regulatory Landscape
Keywords: Regulatory Strategy, Global Regulatory Landscape, AI-Assisted Regulatory Submissions, Platform Technologies, Regulatory Innovation, Global Regulatory Harmonization, Strategic Partnerships, China Regulatory Strategy, Regulatory Intelligence
This theme focuses on strategic initiatives, partnerships, and evolving regulatory landscapes of biologics and novel therapies. Sessions offer a window into innovative approaches to regulatory submissions, including but not limited to AI-assisted filing, leveraging prior knowledge, platform technologies, and regulatory intelligence, as well as strategic partnerships and global collaborations, including emerging opportunities in China, India and other markets. The theme highlights phase-appropriate, innovative, global platform, and modality-specific regulatory pathways, along with regulatory strategies. Case studies discuss agency interactions, regulatory expectations, deficiencies, major objections for approval, clinical holds, remediation strategies, and post-approval lifecycle management, including manufacturing changes, additional sites or suppliers, and global change management.
2027 Programming Submission FAQ
Q: What types of programming can I submit?
Scientific Symposium Presentation: A 90-minute session consisting of three themed, 30-minute presentations. A submitter can propose one 30-minute presentation for inclusion in the program, or submit multiple presentations that when combined form a session. The Scientific Programming Committee (SPC) will select and assemble submissions for the program. There can only be one speaker per 30-minute presentation. All speakers are subject to approval by the SPC.
Rapid Fire Presentation: A 10-minute presentation that is followed by 3 minutes of Q&A on the latest scientific topics. New research, insights, and ideas are especially appropriate for this program. There can only be one speaker per rapid fire presentation.
Hot Topic: A 60-minute session that explores the latest science and innovation in a field and discusses its pain points and challenges. Each of the two scientific tracks offers two Hot Topic sessions, which may be delivered as a symposium, discussion panel, roundtable, debate, case study, or other format that engages the topic in depth.
Q: When are programming submissions due?
Proposals for Symposia, Hot Topics, and Rapid Fires are due Friday, September 25th , at 5:00 pm ET.
Q: What information do I need to submit with each proposal?
Presentation Title: A submission must have a short, specific presentation title (containing no abbreviations) that indicates the nature of the presentation.
Scientific Tracks: All submissions must align to a specific track. Proposals that do not relate directly to a track will not be considered.
Gap Analysis: What gap in a pharmaceutical scientists' knowledge does this program fill? Why do you believe there is a gap? Not required for rapid fire submissions.
(max 500 words)
Learning Format and Audience Engagement Details: Does your content lend itself to an interesting delivery? Could this be a panel or debate? How can we best engage the attendee during this session? (max 250 words) Not required for rapid fire submissions.
Target Audience: Who will benefit most from attending this session? (max 250 words) Not required for rapid fire submissions.
Presentation Description: A brief description of what would be covered in this talk. Additionally, if you are submitting this as one piece of a larger, 90-minute symposium, please note that here and submit each 30-min talk separately. (max 500 words)
Learning Objectives: Complete the sentence, “Upon completion, participant will be able to….” When writing learning objectives. Use action words to begin each objective, such as list, describe, define, demonstrate, conduct, etc.
Three learning objectives are required for Symposia, and Hot Topics. One learning objective is required for Rapid Fires.
Proposed Speaker(s): First Name, Last Name, Email, Affiliation, and Job Title are required fields.
Q: What are the two tracks around which NBC is organized?
Track 1: Predictive Translation and Decision-Grade Evidence
Track 2: Product Design, CMC, and Regulatory Enablement for Biologics and Novel Therapies
Q: How do I withdraw my proposal?
If you have submitted a proposal but would like to withdraw, log into the submission site, click on your session, and select “Edit Session.” You may then use the dropdown to change the submission status to “Withdrawn.” All withdraws must be completed by the submission deadline. Proposals that are not withdrawn will be reviewed.
Q: When will submitters be notified regarding acceptance/rejection?
Submitters will be notified in November 2026. If you submitted a session idea and have not received an accept/reject by that time, contact [email protected].
You do not have to be a member to submit a proposal. Non-members may create accounts without joining in order to submit a proposal.
If you do not have an account with AAPS, click “Create Account” under the New Users tab. Once you create an account, you may be taken to the Communities Page, depending on how you entered the account-creation process. Return to https://members.aaps.org/programming and sign in under Existing User with your new username and password to begin your submission.
2027 Scientific Programming Committee
Steven Louie, MS (Conference Chair)
Weiping Shao, Ph.D. (Conference Vice Chair)
Shuhua Bai, Ph.D. (Past Conference Chair)
Yanmei Lu, Ph.D. (Track Chair)
Steven Eck, Ph.D. (Track Leader)
Vibha Jawa, Ph.D., FAAPS (Track Leader)
Nirav Shah (Track Leader)
Bhasker Sambar (Track Chair)
Guizhi (Julian) (Track Leader)
Tamara Hodge (Track Leader)
Jing Zhu(Track Leader)
Russ Weiner, Ph.D., FAAPS (Board Liaison)