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Key Sessions

Sukhanya Jayachandra, Ph.D.

Regulatory Perspective on Analytical Characterization and Bioassay Development for Cell and Gene Therapies

CBER-FDA

Sudhakar Agnihothram, Ph.D.

Product Characterization for Adjuvanted Vaccines

CBER-FDA

Nadine Ritter, Ph.D.

FDA Town Hall

Global Biotech Experts, LLC

7:00am - 8:00am

Coffee & Registration

More
8:00am - 8:05am
Chairperson’s Remarks

Chairperson’s Remarks

More
Showing of Streams
9:45am - 10:10am

Networking Refreshment Break in Poster and Exhibit Hall

More
Showing of Streams
Showing of Streams
Showing of Streams
Showing of Streams
2:30pm - 2:55pm

Networking and Refreshment Break in Poster and Exhibit Hall

More
Showing of Streams
4:30pm - 5:00pm

Panel Discussion: Bioassays for Cell and Gene Therapies - What Kind of Assays are Relevant? What are the Analytical Challenges?

  • Moderator Bhavin Parekh, Ph.D. - Research Advisor, Bioassay Group Leader, BioProduct R&D, Eli Lilly and Co.
  • Panelist Marina Feschenko, Ph.D. - Principal Scientist, Analytical Development- Biologics & Gene Therapy, Biogen
  • Panelist Nancy Sajjadi, MSc. - Consultant, Independent Quality Consultant
More
5:00pm - 5:05pm
Close of Conference – See you in 2019!

Close of Conference – See you in 2019!

More
7:00am - 8:00am 60 mins
Coffee & Registration
8:00am - 8:05am 5 mins
Chairperson’s Remarks
8:05am - 8:35am 30 mins
Plenary Session: FDA Perspective – Physical and Functional Characterization
Regulatory Perspective on Analytical Characterization and Bioassay Development for Cell and Gene Therapies
  • FDA Speaker Sukhanya Jayachandra, Ph.D. - OTAT, Division of Cellular and Gene Therapies, CBER-FDA
8:35am - 9:05am 30 mins
Plenary Session: FDA Perspective – Physical and Functional Characterization
Product Characterization for Adjuvanted Vaccines
  • Sudhakar Agnihothram, Ph.D. - Reviewer, CBER-FDA
9:05am - 9:45am 40 mins
Plenary Session: FDA Perspective – Physical and Functional Characterization
FDA Town Hall
  • Moderator Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
  • Panelist Lokesh Bhattacharyya, Ph.D. - Lab Chief, CBER - FDA
  • Panelist Alfred Del Grosso, Ph.D. - Team Leader, Analytical Chemistry, Division of FDA/CBER/OCBQ/DBSQC, U.S. FDA
  • Panelist Muhammad Shahabuddin, Ph.D. - Chief, Laboratory of Biochemistry, Virology and Immunology, CBER - FDA
9:45am - 10:10am 25 mins
Networking Refreshment Break in Poster and Exhibit Hall
10:10am - 10:15am 5 mins
Modality Specific Characterization & Strategies for Diverse Products: Stability Studies and Specification Setting
Chairperson's Remarks
10:10am - 10:15am 5 mins
Areas & Applications of Characterization: Upstream/PAT
Chairperson's Remarks
  • Wei Chen, Ph.D., - Chief of CMC Operations, BioAtla
10:10am - 10:15am 5 mins
Biological Assays: Monitoring Performance, Controls and Reference Management Programs for Bioassays
Chairperson's Remarks
10:15am - 10:45am 30 mins
Modality Specific Characterization & Strategies for Diverse Products: Stability Studies and Specification Setting
Case Study - Comprehensive Characterization of Charge Variants of Therapeutic Protein Revealing Novel Modification
  • Weitao Jia, Ph.D. - Protein Analytical Chemistry-2, Pharma Technical Development, Genentech Inc
10:15am - 10:45am 30 mins
Areas & Applications of Characterization: Upstream/PAT
Process Analytical Technologies in Upstream Bioprocessing - A Regulatory Perspective
10:15am - 10:45am 30 mins
Biological Assays: Monitoring Performance, Controls and Reference Management Programs for Bioassays
Monitoring Performance of Bioassay to Avoid Out of Specification Investigations
  • Emma Reyes, PhD, MBM - Senior Scientist, Pfizer, Inc.
10:45am - 11:15am 30 mins
Info
Modality Specific Characterization & Strategies for Diverse Products: Stability Studies and Specification Setting
Getting to the Same End in Half the Time: Strategies for Efficient Analytical Development from Veterinary Pharma
  • Agatha Feltus - Principal Research Scientist, Pharmaceutical and Vaccine Science & Technology, Elanco, an Eli Lilly Company

Shorter clinical studies in veterinary pharma put development on the critical path to submission. The analytical challenge is to quickly develop, transfer, and validate appropriate stability-indicating methods. Principles of Quality by Design, platform methods, and upfront forced degradation studies are strategies that enable meeting shorter timelines.

10:45am - 11:45am 60 mins
Areas & Applications of Characterization: Upstream/PAT
Process & Analytical Approaches Toward Problem Solving - Case Studies From A Dual Perspective
  • Jimmy Smedley, Ph.D. - Director, Analytical Development, KBI Biopharma, Inc.
  • Yuan Chang, Ph.D. - Director, Downstream Process Development, KBI Biopharma, Inc.
10:45am - 11:15am 30 mins
Biological Assays: Monitoring Performance, Controls and Reference Management Programs for Bioassays
Reference Standard Management
  • Matthew Borer, Ph.D. - Senior Research Scientist, Corporate Reference Standards, Eli Lilly and Company
11:15am - 11:45am 30 mins
Modality Specific Characterization & Strategies for Diverse Products: Stability Studies and Specification Setting
Panel: Why Forced Degradation Studies Are Important and How do they Add Value in BLAs and INDs?
  • Moderator Santosh Yadav, Ph.D. - Principal Scientist, GVBC-BA, Merck & Company Inc
  • Panelist Huijuan Li, Ph.D. - Head, Analytical Development, Moderna Therapeutics
  • Panelist Chris Rankin, Ph.D. - Associate Director, R&D, MedImmune
11:15am - 11:45am 30 mins
Biological Assays: Monitoring Performance, Controls and Reference Management Programs for Bioassays
Building the Foundation for Future BIoassay Expansion
  • John Lehrach - Leads, Discovery & Optimization, Bristol-Myers Squibb
12:15pm - 1:25pm 70 mins
Luncheon Roundtable A
Challenges in Capillary Electrophoresis Methods Development for Complex Fusion Proteins
  • Francesco Cristofaro, Ph.D. - Junior Researcher, EMD Serono
12:15pm - 1:25pm 70 mins
Luncheon Roundtable B
How to get quantitative CMC regulatory updates for Biologics
  • Wei Chen, Ph.D., - Chief of CMC Operations, BioAtla
12:15pm - 1:25pm 70 mins
Luncheon Roundtable C
Appropriately Leveraging Resources for Potency Bioassay Programs - Avoiding the Pay Me Later Scenario
12:15pm - 1:25pm 70 mins
Luncheon Roundtable D
Managing Critical Reagents
12:15pm - 1:25pm 70 mins
Luncheon Roundtable E
Strategies for Switching Assays
1:25pm - 1:30pm 5 mins
Modality Specific Characterization & Strategies for Diverse Products: New Modalities
Chairperson's Remarks
  • Suzanne Hudak, M.S. - Scientist, MedImmune
1:25pm - 1:30pm 5 mins
Areas & Applications of Characterization: Immunogenicity
Chairperson's Remarks
1:25pm - 1:30pm 5 mins
Biological Assays: Phase-Appropriate Method Validation for Biological Assay & Requirements for Quality Compliance
Chairperson's Remarks
1:30pm - 2:00pm 30 mins
Modality Specific Characterization & Strategies for Diverse Products: New Modalities
Analytical Method Overview for Cellular Therapy Drugs
  • Michael Bowen, Ph.D. - Former Head of Analytical Development, Juno Therapeutics, a Celgene Company
1:30pm - 2:00pm 30 mins
Info
Areas & Applications of Characterization: Immunogenicity
Non-Clinical Assessments of Immunogenicity
  • Wojciech Jankowski, Ph.D. - Commissioner's Fellow, CBER - FDA

Immunogenicity (development of anti-drug antibodies) is a significant impediment to development and licensure of any therapeutic-protein. Recent progress in the development and use of non-clinical and pre-clinical assessments of immunogenicity will be presented along with examples demonstrating good predictive outcomes. I will illustrate how judicious application of these tools can permit better decision making during drug-development, licensure, and clinical-trials.

1:30pm - 2:00pm 30 mins
Biological Assays: Phase-Appropriate Method Validation for Biological Assay & Requirements for Quality Compliance
Taking it to Another Level: Phase Appropriate Validation of Bioassays
  • Michael Sadick, Ph.D. - Principal Scientist, Catalent Pharma Solutions
  • Michael Merges - Director of Strategic Growth, Biologics Analytical Services, Catalent Pharma Solutions
2:00pm - 2:30pm 30 mins
Info
Modality Specific Characterization & Strategies for Diverse Products: New Modalities
Characterization of Critical Quality Attributes of mRNA, A Novel Therapeutic
  • Huijuan Li, Ph.D. - Head, Analytical Development, Moderna Therapeutics

Using mRNA to create new therapeutics is complex and requires overcoming novel scientific and technical challenges. mRNA production process heavily relies on in vitro enzymatic synthesis instead of chemical synthesis due to its length. Recent advances towards mRNA production and delivery prompt a need for robust analytical methods capable of characterizing this new class of drugs. mRNA product-related impurities include short mRNAs resulting from either premature termination of transcription or in-process degradation, uncapped mRNAs, and point mutations, insertions/deletions. Multiple case studies utilizing a combination of biochemical and biophysical methods will be discussed on characterization of mRNA product- related impurities and variants for successful development of mRNA therapeutics.

2:00pm - 2:30pm 30 mins
Info
Areas & Applications of Characterization: Immunogenicity
Controlling galactose-alpha-1,3-galactose(a-Gal) glycan in a highly sialylated Fc-Fusion Biotherapeutics during Commercial Process Development
  • Barry Drew, Ph.D. - Sr. Scientist II, Bristol-Myers Squibb

To mitigate immunogenicity risk from non-native antigens, it has become imperative to understand, control and quantitate the amount of Galactose-alpha-1,3-galactose (α-Gal) making up the glycan profile in Fc-Fusion proteins. As a result, a novel LC/MS solution was employed to quantitate α-Gal in a highly sialylated Fc-fusion protein.

2:00pm - 2:30pm 30 mins
Biological Assays: Phase-Appropriate Method Validation for Biological Assay & Requirements for Quality Compliance
Lab Quality and Data Integrity for Non-GMP Labs
  • Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
2:30pm - 2:55pm 25 mins
Networking and Refreshment Break in Poster and Exhibit Hall
2:55pm - 3:00pm 5 mins
Modality Specific Characterization & Strategies for Diverse Products: Biosimilar Comparability and Interchangeability
Chairperson's Remarks
  • John Schiel, Ph.D. - Research Chemist, IBBR, National Institute of Standards and Technology
2:55pm - 3:00pm 5 mins
Biological Assays: Development for Challenging Modalities
Chairperson's Remarks
3:00pm - 3:30pm 30 mins
Modality Specific Characterization & Strategies for Diverse Products: Biosimilar Comparability and Interchangeability
FDA Draft Guidance on Interchangeability - Industry Perspective
  • Hillel Cohen - Executive Director, Scientific Affairs, Sandoz Inc.
3:00pm - 3:30pm 30 mins
Biological Assays: Development for Challenging Modalities
Bioassays for a Bispecific Adntibody Drug Conjugate
  • Ashley Mullan - Scientist, Development, Analytical Sciences, MedImmune
3:30pm - 4:00pm 30 mins
Modality Specific Characterization & Strategies for Diverse Products: Biosimilar Comparability and Interchangeability
The Role of Higher Order Structure in the Assessment of Comparability
  • Mats Wikström, Ph.D. - Principal Scientist, Group Leader, Higher Order Structure, Amgen
3:30pm - 4:00pm 30 mins
Biological Assays: Development for Challenging Modalities
Comparability Assessment Using SPR Method and How to Avoid the Pitfalls Associated with the Increased Precision of the Method Compared to Other Bioassays
  • Jeongsup Shim, Ph.D. - Scientist, Analytical Development and Quality Control - Biological Technologies, Genentech
4:00pm - 4:30pm 30 mins
Info
Modality Specific Characterization & Strategies for Diverse Products: Biosimilar Comparability and Interchangeability
Understanding Deficiencies Identified During the Biosimilarity Exercise
  • Nitisha Pyndiah, Ph.D. - Consultant, HartmannWillner

For a product to be demonstrated to be biosimilar to a reference product it must be highly similar and have no clinically meaningful differences but when are differences considered not highly similar and clinically meaningful? How do you proceed when biosimilarity is not demonstrated? In this presentation, we aim at providing ample information about challenges associated with the demonstration of biosimilarity. We propose to present two case studies of monoclonal antibody biosimilars to highlight deficiencies identified during the biosimilarity exercise. From analytical data with differences in charge variants and purity to potency data and manufacturing changes, targeting the most common deficiencies regarding biosimilarity will help your product reach patients faster. FDA considers the totality of evidence approach when evaluating biosimilars and sponsors/applicants are advised to make the most of this approach.

4:00pm - 4:30pm 30 mins
Info
Biological Assays: Development for Challenging Modalities
How Far Should we go to Demonstrate Potency of Gene Therapy Drugs In Vitro?
  • Marina Feschenko, Ph.D. - Principal Scientist, Analytical Development- Biologics & Gene Therapy, Biogen

Potency of the drug is the most critical quality attribute and needs to be assessed for lot release and stability. The potency assays have to be reflective of the mechanism of action, specific, and quantitative. These assays are usually more difficult to develop and not possible to share between different programs. Potency of gene therapy drugs can be assessed in animal models and cell-based assays. The lack of relevant animal models for human diseases coupled with large variability and high cost of testing makes them a rare choice for drug release. The cell-based assays can measure three different activities of the viral vector: ability to penetrate cells (infectivity), target protein expression, and functional potency. Do we need to have all three or we can justify selecting one or two assays for release? Our approach for two different AAV-based programs will be presented and discussed.

4:30pm - 5:00pm 30 mins
Panel Discussion: Bioassays for Cell and Gene Therapies - What Kind of Assays are Relevant? What are the Analytical Challenges?
  • Moderator Bhavin Parekh, Ph.D. - Research Advisor, Bioassay Group Leader, BioProduct R&D, Eli Lilly and Co.
  • Panelist Marina Feschenko, Ph.D. - Principal Scientist, Analytical Development- Biologics & Gene Therapy, Biogen
  • Panelist Nancy Sajjadi, MSc. - Consultant, Independent Quality Consultant
5:00pm - 5:05pm 5 mins
Close of Conference – See you in 2019!