AGENDA - Training Session T1
June 17, 2020, 11am to 4:30pm ET: Part 1
June 18, 2020, 11am to 4:30pm ET: Part 2

"Large Molecules Method Development by LBA: Solving Challenges with Innovative Approaches on Critical Reagents, Learning from Vaccine Assays, Multi-Domain Biotherapeutics, Emerging Technologies"

What’s new in Critical Reagents and impact on method development? What can we learn from Vaccine Assays experience? How Multi-Domain Biotherapeutics (MDB) are changing traditional method development strategies? How can Emerging Technologies (ET) help in method development?

LBA Method Development Part 1: June 17, 2020 (EDT time listed)

11:00am-11:10am: Dr. Rocio Murphy, Senior Principal Scientist Bioanalytical, Merck
"Introduction of LBA Method Development Part 1"

Vaccine Assays - What can we Learn from Vaccine Assays Experience?

Chair: Dr. Rocio Murphy, Senior Principal Scientist Bioanalytical, Merck
11:10am-11:30am: Dr. Rocio Murphy, Senior Principal Scientist Bioanalytical, Merck
"Strategies in Vaccine Clinical LBA Development and Validation"
11:30am-11:50am: Dr. Ivo Sonderegger, Assoc. Director Clinical Serology Strategy, Takeda
"Scientific & Regulatory Differences/Similarities between Vaccine and Biotherapeutics LBA"
11:50am-12:10pm: Mr.Francis Dessy, LeadClinical Assays Validation,GlaxoSmithKline
"How to Connect Assay Variability, Critical Reagents, Bridging Criteria and Assay Intended Use?"
12:10am-12:30pm: Dr. Holger Koch, Global Head Clinical Serology & Assay Strategy, Takeda
"Bioanalytical Performance of Vaccine Assays: Assay Maintenance, Critical Reagent Qualification, Trending, and Proficiency Panel Use"
12:30pm-01:00pm: Social Networking - Time to "Visit" Exhibitors and Posters
01:00pm-01:40pm: Live Quiz on Vaccine Assays
01:40pm-02:10pm: Dr. Rocio Murphy, Senior Principal Scientist Bioanalytical, Merck
Dr. Ivo Sonderegger, Assoc. Director Clinical Serology Strategy, Takeda
Mr.Francis Dessy, LeadClinical Assays Validation,GlaxoSmithKline
Dr. Holger Koch, Global Head Clinical Serology & Assay Strategy, Takeda
"Panel Discussion on Vaccine Assays"

Large Molecules by LBA Method Development Challenges & Emerging Technologies - Part A

Chair: Dr. Christine Grimaldi, Head Biotherapeutic Bioanalysis Group,Boehringer Ingelheim
02:10pm-02:30pm: Dr. Andrew Mayer, Group Leader Pharmacokinetic Assay Development, GlaxoSmithKline
"Single Well Analysis (“Singlicate”) in LBA"
02:30pm-02:50pm: Dr. Matthew Andisik, Assoc. Director Clinical Bioanalysis Group, Regeneron
"Functional (Free) vs. Total Pharmacokinetic Assays: Choose Your Own Adventure"
02:50pm-03:10pm: Dr. Seema Kumar, Assoc. Director DMPK, EMD Serono
"Considerations for Bioanalytical Support for Multi-Domain Biotherapeutics"
03:10pm-03:40pm: Social Networking - Time to "Visit" Exhibitors and Posters
03:40pm-04:10pm: Live Quiz on LBA Method Development Challenges
04:10pm-04:40pm: Dr. Andrew Mayer, Group Leader Pharmacokinetic Assay Development, GlaxoSmithKline
Dr. Matthew Andisik, Assoc. Director Clinical Bioanalysis Group, Regeneron
Dr. Seema Kumar, Assoc. Director DMPK, EMD Serono
Dr. Christine Grimaldi, Head Biotherapeutic Bioanalysis Group,Boehringer Ingelheim
"Panel Discussion on LBA Method Development Challenges"


LBA Method Development - Part 2: June 18, 2020 (EDT time listed)

11:00am-11:10am: Dr. Rocio Murphy, Senior Principal Scientist Bioanalytical, Merck
"Introduction of LBA Method Development Part 2"

Large Molecules by LBA Method Development Challenges & Emerging Technologies - Part B

Chair: Dr. Rocio Murphy, Senior Principal Scientist Bioanalytical, Merck
11:10am-11:30am: Dr. Florian Neff, Lab Head, Roche
"Can Ella Platform be Used for PK Assays in Regulated Bioanalysis? Pros/Cons and Method Development and Validation Challenges"
11:30am-11:50am: Dr. Mitra Azadeh, Assoc. Director Bioanalytics, Takeda
"Importance of QC Trending in Method Development, Validation and Sample Analysis for PK Assays by LBA"
11:50am-12:10pm: Dr. Marcela Araya, Group Leader BioMedicine Design, Pfizer
"Common Issue with LIMS Based Software for LBA Support: Sharing Pharma Experience"
12:10pm-12:40pm: Social Networking - Time to "Visit" Exhibitors and Posters
12:40pm-01:10pm: Live Quiz on Method Development & Emerging Technologies Challenges
01:10pm-01:40pm: Dr. Florian Neff, Lab Head, Roche
Dr. Mitra Azadeh, Assoc. Director Bioanalytics, Takeda
Dr. Marcela Araya, Group Leader BioMedicine Design, Pfizer
Dr. Rocio Murphy, Senior Principal Scientist Bioanalytical, Merck
"Panel Discussion on Method Development & Emerging Technologies Challenges"

What’s new in Critical Reagents and Impact on Method Development?

Chair: Dr. Christine Grimaldi, Head Biotherapeutic Bioanalysis Group,Boehringer Ingelheim
01:40pm-02:00pm: Dr. Nisha Palackal, Director Protein Biochemistry, Regeneron
"Critical Reagents Generation, Characterization, Troubleshooting, and Life-cycle Management: Updates & New Case Studies"
02:00pm-02:20pm: Dr. Christine Grimaldi, Head Biotherapeutic Bioanalysis Group,Boehringer Ingelheim
"Defining and Bridging of Critical Reagents in ADA Assays: Case Studies"
02:20pm-02:40pm: Ms. Alison Joyce, Group Lead Discovery Bioanalytical and Critical Reagents Group Biomedicine Design, Pfizer
"State-of-the-Art Strategies for Rapid Critical Reagent Screening and Assay Optimization"
02:40pm-03:00pm: Dr. Weili Yan, Scientific ManagerBioanalytical Sciences, Genentech
"Critical Reagent Strategies for Maintaining LBA Assays at CROs during Clinical Development: Practical Case Studies from Pharma"
03:00pm-03:30pm: Social Networking - Time to "Visit" Exhibitors and Posters
03:30pm-04:10pm: Live Quiz on Critical Reagents
04:10pm-04:40pm: Dr. Nisha Palackal, Director Protein Biochemistry, Regeneron
Dr. Christine Grimaldi, Head Biotherapeutic Bioanalysis Group,Boehringer Ingelheim
Ms. Alison Joyce, Group Lead Discovery Bioanalytical and Critical Reagents Group Biomedicine Design, Pfizer
Dr. Weili Yan, Scientific ManagerBioanalytical Sciences, Genentech
"Panel Discussion on Critical Reagents"




Final Agenda Agenda at a Glance