AGENDA - Specialized Session M2
June 15, 2020, 11am to 4pm ET: Part 1
June 16, 2020, 11am to 3:30pm ET: Part 2

"BMV Guidance Day:
Interpretations & Training on ICH M10 before its Adoption; Audits Outcome using 2018 FDA; Transition from Local Guidelines to ICH M10 with Gap Analysis on Controversial Issues"

How can you be prepared for the transition from local FDA, EMA, MHLW, ANVISA Guidance/Guidelines to ICH M10? What do you need to do for the ICH M10 adoption & Global Harmonization of Bioanalytical Guidance? An in-depth gap analysis on controversial BMV issues after the public consultation of the ICH M10

BMV Guidance Day Part 1: June 15, 2020 (EDT time listed)

11:00am-11:10am: Drs. Jan Welink, Sr. Clinical Assessor, EU EMA
"Introduction of BMV Guidance Day - Part 1"

Understanding the Scope of new Guidance/Guidelines based on the Regulatory & Science Evolution

Chair: Drs. Jan Welink, Sr. Clinical Assessor, EU EMA
11:10am-11:25am: Dr. Arindam Dasgupta, Deputy Director of the Division of New Drug Study Integrity, US FDA
"Underlying Causes for Internal Standard Variation and its Impact on Quantitation: An Update"
11:25am-11:45am: Dr. Wenkui Li, Director of Bioanalytics, Novartis
"Evaluation, Identification, and Impact Assessment of Abnormal IS Response Variability in Regulated LC-MS Bioanalysis for Compliance with the FDA Guidance"
11:45am-12:05pm: Mr.Phillip Sundman, Director of Business Informatics & Systems Validation, Pfizer
"Design, Data Integrity, and Regulatory Factors to Consider when Utilizing the Cloud for Instrument Data Storage"
12:05pm-12:25pm: Dr. Eric Woolf, Executive Director Regulated PK Bioanalytics Group, Merck
"Regulated Bioanalysis on Cloud and Large Networks"
12:25pm-12:40pm: Dr. Tahseen Mirza, Assoc. Director Regulatory Affairs Office of Study Integrity and Surveillance, US FDA
"Cloud Computing and Data Integrity - a Regulatory Perspective"
12:40pm-01:10pm: Social Networking - Time to "Visit" Exhibitors and Posters
01:10pm-01:40pm: Dr. Arindam Dasgupta, Deputy Director of the Division of New Drug Study Integrity, US FDA
Dr. Wenkui Li, Director of Bioanalytics, Novartis
Mr.Phillip Sundman, Director of Business Informatics & Systems Validation, Pfizer
Dr. Eric Woolf, Executive Director Regulated PK Bioanalytics Group, Merck
Dr. Tahseen Mirza, Assoc. Director Regulatory Affairs Office of Study Integrity and Surveillance, US FDA
Moderator: Drs. Jan Welink, Sr. Clinical Assessor, EU EMA
"Panel Discussion on Internal Standard and Data Integrity"

Recent Regulatory Findings from Different Regulators

Chair: Dr. Anna Edmison, Senior Clinical Assessment Officer Division of Biopharmaceutics Evaluation, Health Canada
01:40pm-01:55pm: Dr. Diaa Shakleya, Principal Investigator Office of Testing and Research, US FDA
"A Practical Laboratory Perspective on the Application of 2018 FDA Bioanalytical Method Validation (BMV) Guidance: Understanding the scope of the new guidance based on the regulatory & science evolution"
01:55pm-02:10pm: Dr. Suman Dandamudi, Staff Fellow Office of Generic Drugs, US FDA
"Regulatory Findings from Generic Bioequivalence Submissions"
02:10pm-02:25pm: Dr. Catherine Soo, Sr. Clinical Evaluator Clinical Evaluation Division, Health Canada
"Health Canada: Challenges Experienced During Review of Large Molecule Drugs"
02:25pm-02:40pm: Mr. Stephen Vinter, Operations Manager GLPMonitoring Authority and Laboratories Group, UK MHRA
"Recent Inspections in Regulated Bioanalysis"
02:40pm-02:55pm: Dr. Mohsen Rajabi Abhari, PharmacologistOffice of Study Integrity and Surveillance, US FDA
"Recent FDA Observations of Biologics PK Assays"
02:55pm-03:25pm: Social Networking - Time to "Visit" Exhibitors and Posters

ASK THE REGULATORS!
Interactive Panel Discussion with All the Regulators

03:25pm-04:00pm: Address any questions you have directly to the Regulators
 Regulatory Panelists:
  • Dr. Tahseen Mirza (US FDA)
  • Dr. Arindam Dasgupta (US FDA)
  • Dr. Mohsen Rajabiabhari (US FDA)
  • Dr. Suman Dandamudi (US FDA)
  • Dr. Diaa Shakleya (US FDA)
  • Drs. Jan Welink (EU EMA)
  • Mr. Stephen Vinter (UK MHRA)
  • Dr. Anna Edmison (Health Canada)
  • Dr. Catherine Soo (Health Canada)


BMV Guidance Day - Part 2: June 16, 2020 (EDT time listed)

11:00am-11:10am: Dr. Anna Edmison, Senior Clinical Assessment Officer Division of Biopharmaceutics Evaluation, Health Canada
"Introduction of BMV Guidance Day - Part 2"

Gap Analysis on Controversial Issues after the Public Consultation of the ICH M10

Chair: Dr. Anna Edmison, Senior Clinical Assessment Officer Division of Biopharmaceutics Evaluation, Health Canada
11:10am-11:30am: Dr. Rachel Palmer, Head Biomarkers and Clinical Bioanalysis, Sanofi
"Parallelism Evaluation in Regulated Bioanalysis for PK LBA: If “30% criterion is rubbish” what to do from a regulatory perspective?"
11:30am-11:50am: Dr. Allena Ji, Director Clinical Mass Spectrometry Laboratory Biomarkers and Clinical Bioanalyses, Sanofi
"Practical Consideration on How to Evaluate Parallelism in Chromatographic Assays, Differences from LBA, Gap Analysis and Slope Acceptance Criteria"
11:50am-12:10pm: Ms. Rebecca Elliott, Sr. Scientific Manager Bioanalytical Sciences Genentech
"Partial & Cross Validation for PK LBA and Chromatographic Assays"
12:10pm-12:30pm: Ms. Parya Nouri, Assoc. Director Clinical Assay Group, Pfizer
"Hybrid LBA/LCMS Assays Supporting Clinical Development: Regulatory Rigor & Acceptance Criteria while awaiting for a Guideline"
12:30pm-01:00pm: Social Networking - Time to "Visit" Exhibitors and Posters
01:00pm-01:30pm: Dr. Rachel Palmer, Head Biomarkers and Clinical Bioanalysis, Sanofi
Dr. Allena Ji, Director Clinical Mass Spectrometry Laboratory Biomarkers and Clinical Bioanalyses, Sanofi
Ms. Rebecca Elliott, Sr. Scientific Manager Bioanalytical Sciences Genentech
Ms. Parya Nouri, Assoc. Director Clinical Assay Group, Pfizer
Moderator: Dr. Anna Edmison, Senior Clinical Assessment Officer Division of Biopharmaceutics Evaluation, Health Canada
"Panel Discussion on Controversial Issues"

Interpretations & Training on ICH M10 before its Adoption

Chair: Drs. Jan Welink, Sr. Clinical Assessor, EU EMA
01:30pm-01:50pm: Dr. Michael Buonarati, Sr. DirectorBioanalytical Lab, Intertek
"Interpretations & Training on ICH M10 Chromatographic Assays"
01:50pm-02:10pm: Dr. Christina Satterwhite, Senior Director, Global Laboratory Sciences, Charles River
"GCC Recommendation - ICH M10 Guidelines: Ligand Binding Assays"
02:10pm-02:30pm: Mr. Rafiq Islam, Executive Director Bioanalytical Services, Celerion
"GCC Recommendations - ICH M10 Guidelines RSM, New Technologies, Endogenous Compounds, Documentation"
02:30pm-03:00pm: Social Networking - Time to "Visit" Exhibitors and Posters
03:00pm-03:30pm: Dr. Michael Buonarati, Sr. DirectorBioanalytical Lab, Intertek
Dr. Christina Satterwhite, Senior Director, Global Laboratory Sciences, Charles River
Mr. Rafiq Islam, Executive Director Bioanalytical Services, Celerion
Moderator: Drs. Jan Welink, Sr. Clinical Assessor, EU EMA
"Panel Discussion on ICH M10 Interpretations before its Adoption"




Final Agenda Agenda at a Glance