AGENDA - Main Workshop DAY 2 - 7am to 6:45pm, Wednesday April 3, 2019

"LCMS & LBA, Common Topics, and Regulators Inputs DAY"

07:00am-08:00am:  Start your day at WRIB with Networking Continental Breakfast in the Exhibition Room
 

Day 2 Session 1: LBA & LCMS Orthogonality/Complementarity
Chair: Dr. Renuka Pillutla, Executive Director Bioanalytical Sciences, Bristol-Myers Squibb
 

08:00am-08:25am: Dr. Renuka Pillutla, Executive Director Bioanalytical Sciences, Bristol-Myers Squibb
"LBA and LCMS Go Hand in Hand to Tackle Complex Bioanalytical Challenges in Biotherapeutic Development"
 
08:25am-08:50am: Dr. Surinder Kaur, Director & Senior Scientist in BioAnalytical Sciences, Genentech/Roche
"State-of-the-art Orthogonal LBA & LCMS Advanced Strategies for Biotherapeutics in a Fully Integrated Bioanalytical Lab"
 
08:50am-09:15am: Dr. Petia Shipkova, Principal Scientist, Bristol-Myers Squibb
"Tissue Protein Biomarkers: Orthogonal LCMS & LBA Approaches for Quantitation of Target Levels"
 
09:15am-10:00am: Networking Morning Break with Snacks and Coffee/Tea in the Exhibition Room
 
10:00am-10:25am: Dr. Susan Spitz, Senior Director, Incyte
"Assessing Tumor Microenvironment with Orthogonal/Complementary Bioanalytical Techniques: LBA & LCMS & Flow Cytometry"
 
10:25am-10:40am: Dr. Renuka Pillutla, Executive Director, Lead, Bioanalytical Sciences, Bristol-Myers Squibb
Dr. Surinder Kaur, Director & Senior Scientist in BioAnalytical Sciences, Genentech/Roche
Dr. Petia Shipkova, Principal Scientist, Bristol-Myers Squibb
Dr. Susan Spitz, Senior Director, Incyte
"Panel Discussions on LBA & LCMS Orthogonality/Complementarity"
 

Day 2 Session 2: Most Recent Regulators’ inputs on Bioanalysis, BMV Guidance/Guidelines
Chair: Dr. Fabio Garofolo, Head of Research, Angelini Pharma
 

10:40am-11:00am: Dr. Sean Kassim, Director Office of Study Integrity and Surveillance, US FDA
"KEYNOTE: A Question of Surveillance Evolution of the Office of Study Integrity and Surveillance and FDA’s Bioavailability/Bioequivalence Inspection Program"
 
11:00am-11:10am: Dr. Stephen Vinter, Operations Manager GLPMA and Laboratories Group, UK MHRA
"Transparency in Study Reporting: Inspections outcomes and issues with the final bioanalytical report"
 
11:10am-11:20am: Dr. Catherine Soo, Senior Clinical Evalulator, Health Canada
"Health Canada: Regulatory Experience with Large Molecule Review – a Clinical Perspective"
 
11:20am-11:30am: Ms Thais Correa Rocha, Specialist in Sanitary Regulation and Surveillance, Brazil ANVISA
"ANVISA Perspectives on ICH M10 Guidance"
 

Ask the Regulators!
Interactive Panel Discussion with Regulators on Bioanalysis, BMV Guidance/Guidelines

11:30pm-12:00pm: Ask the Regulators on Bioanalysis, BMV Guidance/Guidelines
 Regulatory Panelists:
  • Dr. Sean Kassim (OSIS Office Director, US FDA)
  • Dr. Sam Haidar (Senior Science Advisor, US FDA)
  • Dr. John Kadavil (Deputy Director, US FDA)
  • Dr. Arindam Dasgupta (Deputy Director, US FDA)
  • Dr. Brian Booth (Deputy Director, US FDA)
  • Dr. Nilufer Tampal (Division Director, US FDA)
  • Dr. Theingi Thway (Senior staff fellow, US FDA)
  • Dr. Sriram Subramaniam (Pharmacologist, US FDA)
  • Dr. Jan Welink (Senior Pharmacokinetic Assessor, EU EMA)
  • Dr. Olivier Le Blaye (Inspector, France ANSM)
  • Mr. Stephen Vinter (Operations Manager, UK MHRA)
  • Ms. Emma Whales (Inspector, UK MHRA)
  • Dr. Anna Edmison (Senior Clinical Assessment Officer, Health Canada)
  • Dr. Catherine Soo (Senior Clinical Evaluator, Health Canada)
  • Mr. Gustavo Mendes Lima Santos (Head of Bioequivalence, Brazil ANVISA)
  • Ms. Thais Correa Rocha (Regulatory Specialist, Brazil ANVISA)
  • Ms. Dulcyane Neiva Mendes (Regulatory Specialist, Brazil ANVISA)
12:00pm-01:00pm: Networking Sit-down Buffet Lunch in the Lunch Room - Storyville Hall
Note: Desserts and Coffee/Tea from Lunch are served in the Exhibition Room

 
12:30pm-12:45pm: 13th WRIB AWARDS presentation: Outstanding Contribution Award & Best Poster Award from Day 1-2
 

Day 2 Session 3: Most Recent Regulators’ inputs on Immunogenicity Final Guidance and Biomarker Guidance/Papers
Chair: Dr. Fabio Garofolo, Head of Research, Angelini Pharma
 

01:00pm-01:20pm: Dr. João Pedras-Vasconcelos, Senior Staff Fellow, US FDA
"Immunogenicity Testing of Therapeutic Protein Products - The Final Guidance has landed!"
 
01:20pm-01:30pm: Dr. Elana Cherry, Division Manager Clinical Evaluation Division, Health Canada
"Unwanted Immunogenicity Updates from Health Canada Biologics and Genetic Therapies Directorate"
 
01:30pm-01:40pm: Dr. Nirjal Bhattarai, Principal Investigator, US FDA
"Gene Therapy: Evaluation of Risk of Immunity and Current Regulatory Expectations"
 
01:40pm-01:50pm: Dr. Yow-Ming Wang, Co-Director of Therapeutic Biologics Program, US FDA
"Use of Biomarker Data in Support of Regulatory Submissions – a Clinical Pharmacology Perspective"
 
01:50pm-02:00pm: Dr. Kevin Maher, Regulatory Scientist, US FDA
"Pre-market Regulatory Review for Flow Cytometry"
 
02:00pm-02:10pm: Dr. Heba Degheidy, Staff Scientis, US FDA
"Standardization & Validation Strategies in Flow Cytometry "
 
02:10pm-02:20pm: Dr. Shirley Hopper, Medical Assessor, UK MHRA
"Update on Co-development of Medicines and Predictive Biomarker-based Assays: MHRA Perspective"
 
02:20pm-02:30pm: Dr. Abbas Bandukwala, Biomarker Qualification Program, US FDA
"21st Century Cures Biomarker Qualification: Updates on Biomarker Qualification and their limits"
 
02:30pm-02:40pm: Dr. Shashi Amur, Scientific Advisor, US FDA
"Regulatory Science at CDER, US FDA"
 

Ask the Regulators!
Interactive Panel Discussion with Regulators on Immunogenicity, Biomarkers and Gene Therapy

02:40pm-03:10pm: Ask the Regulators on Immunogenicity Final Guidance and Biomarker Guidance/Papers and Gene Therapy
 
  • Regulatory Panelists on Immunogenicity:
    • Dr. Joao Pedras-Vasconcelos (Senior Staff Fellow, US FDA)
    • Dr. Haoheng Yan (Lead Chemist, US FDA)
    • Dr. Susan Kirshner (Review Chief, US FDA) - remote
    • Dr. Venke Skibeli (Senior Advisor Clinical Assessment, Norway NoMA)
    • Dr. Therese Solstad Saunders (Senior Scientific Advisor, Norway NoMA)
    • Dr. Elana Cherry (Division Manager Clinical Evaluation Division, Health Canada)
    • Dr. Akiko Ishii (Director, Japan MHLW)
  • Regulatory Panelists on Biomarkers:
    • Dr. Yow-Ming Wang (Co-Director of Therapeutic Biologics Program, US FDA)
    • Dr. Abbas Bandukwala (Biomarker Qualification Program, US FDA)
    • Dr. Kevin Maher (Regulatory Scientist, US FDA)
    • Dr. Shashi Amur (Scientific Advisor, US FDA)
    • Dr. Shirley Hopper (Medical Assessor, UK MHRA)
    • Dr. Yoshiro Saito (Director, Japan MHLW)
  • Regulatory Panelists on Gene Therapy:
    • Dr. Nirjal Bhattarai (Principal Investigator, US FDA CBER)
    • Dr. Heba Degheidy (Staff Scientist, US FDA CBER)
03:10pm-04:10pm: Networking Afternoon Break with Snacks & Wine and Beer Reception in the Exhibition Room
Reception
 

Day 2 Session 4: ICH M10 BMV Draft Guideline - Common Topics
Chair: Dr. Brian Booth, Deputy Director, US FDA / M10 EWG Regulatory Chair
 

04:10pm-04:25pm: Dr. Jan Welink, Senior Pharmacokinetic Assessor, EU EMA
"ICH M10- Bioanalytical method validation"
 
04:25pm-04:50pm: Dr. Olivier Le Blaye, Inspector, France ANSM
"Bioanalytical method robustness: A European inspector's perspective (Small molecules)"
Mr. Charles Hottenstein, Scientific Leader, GlaxoSmithKline
"Validations Tests to Support Method Robustness Claim for LBA PK Assays: How to Demonstrate to Regulatory Agencies Inspectors that your Assay is Robust"
 
04:50pm-05:10pm: Dr. Corey Nehls, VP Bioanalytical Labs, PPD
"Whole Blood Stability & Lipemic Matrix Testing"
 
05:10pm-05:30pm: Dr. Chad Briscoe, Executive Director, PRA
"Harmonization of Certificate of Analysis (CoA) for Chromatographic & Ligand Binding Assays"
 
05:30pm-05:45pm: Dr. Charles Hottenstein, on behalf of Working Dinner Expert Panel
"Consensus & Conclusions from Working Dinner Expert Panel on ICH M10 BMV Draft Guideline Common Topics"
 

Open Forum - Panel Discussion on ICH M10 BMV Draft Guideline - Common Topics
Chair: Dr. Brian Booth, Deputy Director, US FDA / M10 EWG Regulatory Chair
 

05:45pm-06:45pm: Industry Recommendations to ICH M10 Major Participating Regulatory Agencies
EWG Regulatory Panelists:
  • Dr. Brian Booth (US FDA / EWG Regulatory Chair)
  • Dr. Jan Welink (EU EMA / EWG Member)
  • Dr. Anna Edmison (Health Canada / EWG Member)
  • Dr. Akiko Ishii (Japan MHLW / EWG Rapporteur)
  • Dr. Yoshiro Saito (Japan MHLW / EWG Member)
  • Ms Dulcyane Neiva Mendes (Brazil ANVISA / EWG Member)
  • Ms Thais Correa Rocha (Brazil ANVISA / EWG Member)

 

 

Please Note: Since WRIB has been always fashionably running late in the past years due to too many interesting interactive discussions in the sessions and in the panel, fewer people had the energy to attend the evening reception. Since 2015, we have moved the Evening reception to be in conjunction with the afternoon break (extended to 1 hour) so everyone can have a good time and be reenergized for continuing the key panel discussions!

 

 

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