2024 ARCHIVES

2024 Short Courses* (In-Person Only)

*Separate registration is required.

Short courses at CHI's 16th Annual Immunogenicity & Bioassay Summit are designed to be instructional, interactive, and provide in-depth information on a specific topic with opportunities for Q&A throughout. The courses include introductions for those new to the fields and those looking to learn more, as well as explanations on more technical aspects than time allows during our main conference presentations. Instructors are drawn from industry and academics alike, and many are recognized authorities in the fields or have teaching experience.

Tuesday, October 15, 2024 9:00 - 12:00 pm

SC1: Development of NAb Assays, Technical Considerations, Case Studies

Detailed Agenda

The development of neutralizing antibody assays is a daunting task that is complicated by the specific nature of each biotherapeutic. Many factors must be assessed to choose the proper assay format, to develop a robust assay, and choose when to invest in the development and implementation of these assays. This short course will focus on these topics and provide examples of current industry practices and publications.

Lynn Kamen, PhD, Scientific Officer, Executive Director, BioAgilytix

Jim McNally, PhD, CSO, BioAgilytix

9:00 am

Development of NAb Assays, Technical Considerations, Case Studies

Lynn Kamen, PhD, Scientific Officer, Executive Director, BioAgilytix

Jim McNally, PhD, CSO, BioAgilytix

Topics to be Covered Include:

Current regulatory guidance
NAb assay strategy – Immunogenicity risk assessment
Special focus on assay format selection – Mechanism of action-based approach
Validation and implementation of NAb assays
Relevant case studies

INSTRUCTOR BIOGRAPHIES:

Lynn Kamen is a Scientific Officer at BioAgilytix. She earned her PhD in Immunology at the University of Michigan and completed a postdoctoral fellowship in immunology at the University of California, San Francisco. Lynn has over a decade of experience working in drug development, from early target discovery through clinical development for both large and small molecules at several companies including Portola Pharmaceuticals, and Alector. More recently, Lynn was a principal scientist at Genentech where she supported the in vitro biological characterization of large molecules and lead the development of immunogenicity assays including ADA, NAb and immunogenicity risk ranking assays. She is co-lead of the AAPS NAber working group and member of the AAPS NAb drug tolerance sub-team.

Dr. McNally has an extensive background in bioanalytical assay development and program leadership spanning nearly 20 years working in the pharmaceutical and biotechnology industry. Prior to joining BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics, where he lead a team of scientists to develop a portfolio of assays to support development of gene-based therapeutic candidates throughout their lifecycle. He has also previously held roles at Genzyme, Pfizer, EMD Serono, and Shire which have given him broad experience in the development of large molecule, gene therapy, and cell therapy biotherapeutics. Dr. McNally is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and is specifically skilled in progression of biotherapeutics from research through clinical development. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance. Dr. McNally obtained his B.S. in Biology from Mississippi State University, his Ph.D. Viral Immunology from Louisiana State University School of Medicine in Shreveport, and his Post-Doc in Viral Immunology from University of Massachusetts Medical School.

Tuesday, October 15, 2024 2:00 - 5:00 pm

SC2: Overcoming Drug and Target Interference in ADA and NAb Assays

Detailed Agenda

Soluble drug, drug target, and matrix can often interfere in the detection of anti-drug antibodies, including neutralizing Abs. Although not always straightforward, it can be addressed and mitigated in a properly designed immunoassay. This short course will give an overview of the different types of interferences, and current methodologies and approaches being utilized to resolve or reduce them.

Lynn Kamen, PhD, Scientific Officer, Executive Director, BioAgilytix

Weifeng Xu, PhD, Director, Bioanalytical, Merck

2:00 pm

Overcoming Drug and Target Interference in ADA and NAb Assays

Lynn Kamen, PhD, Scientific Officer, Executive Director, BioAgilytix

Weifeng Xu, PhD, Director, Bioanalytical, Merck

Topics to be Covered Include:

Types of Interferences:

> Soluble Target

> Drug

> Matrix

Immunogenicity Assay Designs and Susceptibility to Interference
Competitive Ligand-Binding Immunoassays Bridging Immunoassays
Cell-Based Immunoassays Mitigation Strategies
Sample Pre-Treatment BEADACEBEHD
Heat Inactivation
Case Studies

INSTRUCTOR BIOGRAPHIES:

Weifeng has been in the field of immunogenicity for biologics for about 10 years. He had developed cell-based neutralization Ab assays for multiple key product at BMS including Opdivo and Yervoy. He is an active member in AAPS NAb work group as well as EBA NAb team; he is also co-leading the NAb assay drug tolerance subteam at AAPS. After join Merck at the end of 2018, Weifeng is now leading Cell Assay group within PPDM Regulated Immunogenicity to develop neutralizing assays for both biologics and vaccines.

Tuesday, October 15, 2024 5:30 - 8:30 pm

SC3: Validation of ADA Assays and Cut Point Calculations

Detailed Agenda

This short course will focus on the validation of ADA assays and cut-point evaluations. We will provide an in-depth overview of the basic considerations around ADA assay validation, with significant focus on the process of evaluating different types of cut-points, and the translation of the cut-point established during validation to the real-world implementation during a preclinical or clinical study.

Kavitha Akula, PhD, Principal Scientist, Bristol Myers Squibb Co.

Krupa Ramani, Manager, Johnson & Johnson

Jiangbo Tang, PhD, Principal Scientist, Bristol Myers Squibb Co.

5:30 pm

Validation of ADA Assays and Cut-Point Calculations

Kavitha Akula, PhD, Principal Scientist, Bristol Myers Squibb Co.

Krupa Ramani, Manager, Johnson & Johnson

Jiangbo Tang, PhD, Principal Scientist, Bristol Myers Squibb Co.

Topics to Be Covered Include:

Tiered testing strategy: Basic issues regarding screening, confirmatory, and titer assays
ADA assay validation strategies: Experimental design to execute a validation
Step-wise process for calculating different types of cut-points
Practical challenges for the in-study implementation of cut-points
Case studies related to the implementation of validation and study-specific cut-points

INSTRUCTOR BIOGRAPHIES:

Dr. Kavitha Akula is currently a Principal Scientist at Bristol-Myers Squibb (BMS) in the Non-clinical Disposition and Bioanalysis Group. Kavitha joined BMS in 2019 as Research Investigator-II with about five years of experience in regulated bioanalysis from different contract research organizations (CRO). She received her PhD from Temple University, Philadelphia in Organic Chemistry in 2017. Kavitha has extensive experience in regulate bioanalysis of large molecule drugs and new treatment modalities in support of PK and Immunogenicity. She recently took co-lead position in the Early Career Bioanalytical Scientists (ECBS) sub-team in AAPS.

Krupa Ramani is a Manager in the department of Bioanalytical Discovery and Development Sciences at Johnson and Johnson (J&J). Krupa has been in the field of immunogenicity for over 20 years. She joined J&J in 2015 as an Associate Scientist and assumed progressively greater responsibilities supporting biologics therapeutics from preclinical through post-market studies. She oversees the immunogenicity validation and laboratory bioanalysis teams, managing a group of five scientists. Prior to joining J&J, Krupa worked at Strategic Diagnostics, Inc (SDIX). She earned a B.S. degree from M.G Science Institute and Medical Tech degree from The Gujarat Cancer & Research Institute in India.

Jiangbo Tang is a Principal Scientist in the Department of Clinical Pharmacology, Pharmacometrics & Bioanalysis at Bristol Myers Squibb (BMS). He leads regulated PK and immunogenicity bioanalytical development to support programs in CAR T, ADC, and antibody therapeutics. Prior to joining BMS, for several years he led a team at a CRO and provided regulated bioanalytical support for clinical programs. He also worked as a Staff Scientist in the QC Department at Regeneron, where he automated potency assays in support of stability, and lot release of drug products. Jiangbo received his PhD in Human Genetics from the University of Pittsburgh and completed his postdoc training at the University of Pennsylvania, where his published research in cancer biology and immunology has been widely cited with over 1,500 citations.

SC4: Recent Advances with Cell and Gene Therapy

Detailed Agenda

Topics to be covered in this course include: Immunogenicity assessment of cell therapies, examining recent developments with CAR T cells & edited stem cell, immunogenicity assessment of gene therapies, recent data on pre-existing reactivity for AAV, advances with redosing, application of current guidance to novel modalities, and what is your product, the vector, the expressed product?

Jim McNally, PhD, CSO, BioAgilytix

5:30 pm

Recent Advances with Cell and Gene Therapy

Jim McNally, PhD, CSO, BioAgilytix

Topics to be Covered Include:

Immunogenicity assessment of cell therapies
Examining recent developments with CAR T cells and edited stem cells
Immunogenicity assessment of gene therapies
Recent data on pre-existing reactivity for AAV Advances with redosing
Application of current guidance to novel modalities
What is your product, the vector, the expressed product?

INSTRUCTOR BIOGRAPHIES:

Thursday, October 17, 2024 6:00 - 9:00 pm

SC5: Advice on Putting Together an Integrated Summary of Immunogenicity

Detailed Agenda

The purpose of this workshop is to share experience gained in preparing and reviewing the “Integrated Summary of Immunogenicity (ISI)” for submission in regulatory filings. We will overview examples of the multi-disciplinary information that is most useful for the regulator assessing the scale of risk of undesirable immunogenicity for overall clinical benefit vs. risk. We will also examine the sponsor team's role, the general format of an ISI, and provide examples of how to anticipate and address potential issues (and how to avoid introducing any new ones!) by generating a well-thought-out and constructed integrated summary.

Bonnie Rup, PhD, Biotechnology Consultant, Bonnie Rup Consulting

6:00 pm

Advice on Putting Together an Integrated Summary of Immunogenicity

Bonnie Rup, PhD, Biotechnology Consultant, Bonnie Rup Consulting

Background

Information relevant to the assessment of the impact of undesirable immunogenicity of therapeutic proteins on overall clinical benefit vs. risk balance is distributed across many different sections of the regulatory dossier. This has made it difficult for regulatory reviewers to locate the requisite data. Moreover, essential background information to describe the intrinsic immunogenic potential of the molecule, and how extrinsic factors (product quality, patient variables, dose regimen, etc.) might interact to influence clinical manifestations, is often missing. Although there might be valid reasons for applying a particular strategy for evaluating immunogenicity, the sponsor’s rationale is often not clearly explained. For this reason, recently issued FDA and EMA guidance has recommended submitting integrated summary documents in regulatory submissions with the objective of collating the essential information required by the regulatory assessor.

Who Should Attend?
This short course is relevant to anyone who is involved in generating and compiling the input data for immunogenicity-related sections of regulatory dossiers, including CMC, bioanalytical, non-clinical, clinical, and regulatory specialists.

Topics to be Covered Include:

Regulatory expectations
The iterative process
Risk assessment and study planning
Identifying relevant information for the ISI
ISI structure, level of detail and analysis, suggestions for presenting the data

INSTRUCTOR BIOGRAPHIES:

Bonita Rup is a biopharmaceutical development consultant, providing expert advice on bioanalysis, immunogenicity risk assessment, and related regulatory strategy aspects of biopharmaceutical development. Previously she was Research Fellow and lead for the Immunogenicity Discipline at Pfizer, Assistant Vice President of Protein Bioanalytics in Wyeth, and held various positions directing development and application of immuno-ligand binding assay technologies for PK, immunogenicity and protein impurity analysis, and other aspects of biopharmaceutical development. During her career, she has been involved in multiple regulatory filings during preclinical, clinical development and marketing approval of biopharmaceutical products. She has been a member of AAPS, EIP, European IMI ABIRISK consortium, and Biosafe; with these organizations, she has been a co-author for multiple publications related to monitoring immunogenicity and bioanalysis of therapeutic proteins. Bonnie received her B.S. from University of Massachusetts, Amherst, Ph.D. from University of Texas, Austin, and conducted postdoctoral research at Duke University and University of Rochester, NY.