Conference Agenda
14th Biosimilars Global Congress 2022 Europe
Day 1: Monday 7th November 2022
08:00 am - Conference Registration and Continental Breakfast
08:50 am - Chairperson’s Welcome and Opening Remarks
Challenges, Trends and Opportunities
09:00 am - Opening Keynote Panel Discussion: Current trends and strategies to access biosimilar industry
- Critical aspects of the global Biosimilar market such as vendor landscape, competitive strategies, market drivers and challenges
- Changing market dynamics within the Biosimilars market
- What are the recent biosimilar market trends and development to date
- Useful guidelines for players to understand and define their strategies more efficiently in order to keep themselves ahead of their competitors
- Emerging new ventures who are creating an impact on the global market with their latest innovations and technologies.
Moderator:
Yariv Hefez, VP, Global Head Oncology Marketed Products, Merck Group
09:40 am - Global Biosimilars Trends and Insights
- Performance of latest biosimilars
- Challenges facing the sector
- Future Biosimilar Opportunities
Aurelio Arias, Senior Consultant, Thought Leadership, IQVIA
10:20 am - Education, Implementation and Administration: Understanding issues around physician, healthcare professional and patients to increase uptake of biosimilars.
- National and International developments in biosimilar medicines
- How well versed are pharmacists today in the world of biosimilars?
- Importance of Physician and Patients input in shaping international standards for biosimilars
- Policies in place to encourage physicians / pharmacist collaboration
- Harmonizing global standards to ensure safety and efficacy of biosimilars
10:40 am - Morning Networking& Refreshment Break
Challenges, Trends and Opportunities
11:30 am - The evolution of Biosimilars and its impact on Healthcare
- What impression does recent changes in regulation, science & production technologies on future patterns of production
- Issues to overcome to increase uptake of biosimilars
- How to generate enough interest and enthusiasm for biosimilars
12:10 pm - SPONSORED SPOTLIGHT PRESENTATION
12:40 pm - Biosimilars litigation and patent challenges: What is there to come?
- Most common approach for challenging the RBP’s patent
- Biosimilars Patent strategies and considerations
- What are the anticipated new litigations?
1:10 pm - Networking Lunch
Innovations, Clinical Considerations and Manufacturing
2:10 pm - Using SPOT™ and SLIM™ technology in our CHOBC® platform to reduce cost of goods for biosimilar development
- USP technology for efficient DSP
- Accelerating specific productivity by SPOT™ for titre increase
- Extending sustainability of CHOBC® by SLIM™ technology
- Advantages of SLIM™ technology developed by metabolic engineering
Louis Boon, Chief Scientific Officer, Bioceros
2:40 pm - Data Analytics Strategy for Digitalization in Biosimilar development
- An overview on data analytics and digitalization
- Discuss what are the challenges
- User cases that we have implemented
Syu-Yi Su, Principal Scientist, Novartis
3:10 pm - Current Challenges for Demonstrating Analytical Similarity and Data Quality for Manufacturers of Biosimilars
Anita Krishnan, Director and Head, Analytical R&D and CMC, Kashiv Biosciences LLC
3:40 pm - Afternoon Networking & Refreshment Break
4:20 pm - Addressing significant challenges in Pharmacovigilance and risk management
- Identifying specific product associated with adverse events
- Importance of product naming for biosimilars traceability
- Establishing full characterization of immunogenicity profile
- Continues post-post marketing surveillance is critical for effective risk management
Rene Anour, Sr. Clinical Expert, Head of National Scientific Advice, AGES*
4:50 pm - Rational Selection, Criticality Assessment, and Tiering of Quality Attributes and Test Methods for Analytical Similarity Evaluation of Biosimilars
- The importance of a careful design of the analytical similarity study program
- A state-of-the-art analytical similarity study meeting current regulatory requirements
- Scientific and methodological considerations on the process of attribute
- Case Examples
5:30 pm - Panel Discussion: Addressing developmental challenges to maximize biosimilars market growth
- Challenges and obstacles faced by manufacturers in developing biosimilars
- How to overcome challenges, increase development success and optimize result
- Techniques in bringing the next generation of Biosimilars to the market
- Reducing capital investment and creating cost effective and scalable manufacturing operations
6:10 pm - Chairperson's Closing Remarks
6:00 - 7:00 pm - Networking Drink Reception