Immunogenicity MasterClass - EU edition
13-14 March, 2024
A phenomena for complex therapeutics – Biologics, Biopharmaceuticals, Biosimilars & ATMPs
An important topic for complex therapeutics like Biologics, Biopharmaceuticals, Biosimilars & ATMPs Wanted for different kind of vaccines, unwanted for a variety of complex Large Biological Entities (LBEs)
13-14 March, 2024, Virtual
Time Zone : UTC/GMT+1 /CET
With the increasing complexity of today’s therapeutics like Biologics, Biopharmaceuticals, Biosimilars & especially ATMPs, the unique issues have emerged especially in managing immunogenicity in clinical practice and during drug development. Understanding regulatory and quality requirements as well as applying the appropriate analytics and effective clinical monitoring to detect ADAs (Anti-Drug-Antibodies) are becoming essential for successful drug development & patient safety.
Distinct approaches to control ADAs & safeguard human subjects need to be considered. This unique course brings practical & in-depth understanding of immunogenicity in pre-clinical and clinical development, and brings clarifications on regulation, requirements, and quality concerns.
Join us to find solutions for your immunogenicity challenges and learn from case studies on mAbs, ATMPs & Biosimilars.
#masterclass #pharmaonlinemasterclass #glceurope #globalleadingconferences #immunogenicity
Meridian Biopharmaceuticals, Austria
He has a management consulting education and holds a doctorate degree in immunology/biochemistry from the Technical University of Graz, Austria. Markus started his carrier at a Novartis “Spin off” in Vienna in 2006, later on he has acquired the oncology division from Novartis and founded 2 Biotech companies VelaLabs & Meridian Biopharmaceutics.
Besides serving as a CEO and formal Managing Director, Markus has also taken responsibilities as a Head of Regulatory Affairs within the Quality Operations team.
Markus was previously Head Quality Control at Igeneon / Aphton Biopharma where he was responsible for all QC aspects of pre-clinical and clinical projects such as stability studies, specifications, method validation, and product release.
Before he was Group Leader of Immunology and Product Development at Biomin GmbH, Head Biochemical Control at Baxter AG and Head Quality Operations at Octapharma AG.
2 years Biomin AG
Lab Head, Cell culture lab, development of immune enhancer drugs
6 years Baxter Inc.
QC Manager, Quality control of vaccines & coagulation factors
2 years Octapharma AG
Head of Quality Operations & Quality Control
3 years Novartis AG
Head QC, Oncology, cancer immune therapy, product development of mAbs
15 years Management Buy-out VelaLabs & Meridian Biopharma
Founder & Managing Director of 2 Biotech companies
2020-now: Mfi Bio-Consulting GmbH
Founder & CEO, Consultancy & training
Products: Biologics, Biopharmaceuticals, Biosimilars, ATMPs, Monoclonals, Vaccines
Focus: Analytics, Quality Control, Process & Clinical Development, Regulatory Affairs Member
of advice team for ATMPs (ECA) and EMA Working Group
Who should attend?
• Clinical trial manager
• Product development specialists
• CSO/COOs in Biotech industry
• Analytical development heads
• Members of QC departments
• Members for product analytics
• Clinicians & Principal investigators
• Personal from CROs
• R&D scientists for complex drugs
• Members of agencies & authorities
"High attention to detail in course content and very well delivered"
Product Development Manager
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
USP PD Team Manager
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Manager, Senior Investigator
MT Sword Laboratories (BMS)
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Years of experience