15th Biosimilars Congregation 2021
Share
Now
WHY SHOULD YOU ATTEND?
Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.
Event Speakers
MICHAEL S R
Alliance for Safe Biologic Medicines
MICHAEL S R
Alliance for Safe Biologic Medicines
MICHAEL S REILLY, Executive Director, Alliance for Safe Biologic Medicines
MIGUEL N O
STADA Arzneimittel
MIGUEL N O
STADA Arzneimittel
MIGUEL NAVARRETE OLMEDO, Hospital & Biosimilars Commercial Director, STADA Arzneimittel
NIKLAS EKMAN
Finnish Medicines Agency
NIKLAS EKMAN
Finnish Medicines Agency
NIKLAS EKMAN, Head of the Biological Section, Finnish Medicines Agency (Vice-Chair of the Biosimilar Working Party (BMWP), EMA)
RENE ANOUR
Austrian Medicines & Medical Devices Agency (Member of BMWP)
RENE ANOUR
Austrian Medicines & Medical Devices Agency (Member of BMWP)
RENE ANOUR, Sr. Clinical Expert/Head of National Scientific Advice, Austrian Medicines & Medical Devices Agency (Member of BMWP)
MICHEL MIKHAIL
MICHEL MIKHAIL, International Expert in Biosimilars Global Expert in Regulatory Affairs
LENNEKE D W
Polpharma Biologics
DEEPA ARORA
CLINEXEL Life Sciences
DEEPA ARORA
CLINEXEL Life Sciences
DEEPA ARORA, Chief Executive Officer, CLINEXEL Life Sciences
Deepa is an Experienced Clinical Development and Drug Safety physician. She served in leadership positions in pharma companies for almost two decades, leading global clinical research and pharmacovigilance activities. Currently she is the Chief Executive Officer of Clinexel Life Sciences Pvt Ltd.
CLINEXEL is an agile, customer focused full service, Clinical Research Organization, that provides clinical research, pharmacovigilance, regulatory, auditing and medical writing services to pharma, biotech and medical device companies. At CLINEXEL, our mission is to partner with early-stage pharma and biotech companies for fast and efficient clinical development of their innovations.
SANDY EISEN
Frontline Pharma Consulting
SANDY EISEN
Frontline Pharma Consulting
SANDY EISEN, Chief Medical Officer, Frontline Pharma Consulting
ALEXANDER R
Arnold & Porter
ALEXANDER R
Arnold & Porter
ALEXANDER ROUSSANOV, Life Sciences Regulatory & Privacy Lawyer, Arnold & Porter
"Unleashing the bold era of IoT, AI & Blockchain innovation”
Event Schedule
Learn, meet and network with your conference colleagues.
09:30 – Welcome Address & Virtual Conference Platform Instructions
MARKET OVERVIEW & ANALYSIS
09:40 – The biosimilar business case - A Growth formula for generics biosimilars
• Generics and Biosimilars: Industrial Strategy
• Globalization of Biosimilars
• GMP, GCP, QC & R&D
• Innovation and Technology for Biosimilar Development
• Licensing of biosimilars
PAYER’S PERSPECTIVE
10:20 – Biosimilars – Bringing it into the market quickly
• Strategies in overcoming obstacles in Biosimilar development
• Effective strategies for product design
• How Payers are aligning biosimilars?
• Global impact of biosimilars over generics
• Requirements for product development program
• Bridging the ‘uncertainty gap’ between payers & pharma - the shifting paradigm
• What to expect in the next 2 years?
OMAR ALI, Pharmacist Consultant, QIPP Adviser Payer Network
11:00 - Morning Coffee/Tea & Discussion
CHALLENGES & OPPORTUNITIES
11:20 – Keynote Panel Discussion: Understanding the biosimilars opportunity for pharma companies
• Latest developments, Trends and Future of Biosimilars
• Looking at sustaining growth through pandemic
• Current Challenges and Research trends in Biosimilars & Biologics
• Issues to overcome to increase uptake of biosimilars
• Generate enough interest and enthusiasm for biosimilars
• Lack of stakeholder confidence – what does this lead to?
Moderator
LOUIS BOON, CSO, Polpharma Biologics
Panellists
CLAUDIA LOUATI, Policy Advisor, FDA
JULIE MARECHAL JAMIL, Director Biosimilar Policy & Science, Medicines for Europe
MATTHEW TURNER, Senior Director Government Affairs and Policy Biosimilars Europe, Asia, Latam & Canada, Fresenius Kabi
RENE ANOUR, Senior Clinical Expert/Head of National Scientific Advice, Austrian Medicines & Medical Devices Agency (AGES)
JOHAN DE MUNTER. Assistant Nurse Manager Cancer Center University Hospital Ghent, President, European Oncology Nursing Society
SANDY EISEN, Chief Medical Officer, Frontline Pharma Consulting Ltd
12:00 – Topic TBC
BER OOMEN, Executive Director, ESNO (European Specialist Nurses Organisations)
12:40 - Networking luncheon
PATIENT’S PERSPECTIVE
13:50 – Analysing Physicians and Patients perspective
• National and International developments in biosimilar medicines
• Physicians education - Challenges
• Importance of Physician and Patients inputs to shape the international standards for biosimilars
• Encouraging physicians - Policies
• Physicians / pharmacist collaboration
• Harmonizing global standards to ensure safety and efficacy of biosimilars
14:30 – Reducing time to market: Fast track process development towards biosimilarity
• Accelerated high-titer cell line generation
• Upstream process modulation to obtain biosimilarity
• Biosimilar cell line portfolio for out-licensing
LENNEKE DE WINTER, Senior Scientist USP, Polpharma Biologics
15:10 – Afternoon Tea/Coffee
15:30 – Solution Provider Presentation
For sponsorship opportunities please contact, info.uk@virtueinsight.com
COMMERCIALISATION & MARKET ACCESS
16:00 - Panel Discussion: Commercial landscape & market access for Biosimilars: Predicts to prepare for a successful tomorrow
• Comparison of US/EU biosimilar developments, policies and guidelines
• The impact of Biosimilars on the competitive landscape of biological products
• Challenges and obstacles faced by manufacturers in developing biosimilars
• Bringing the next generation of Biosimilars to the market
• Ensuring market access and reimbursement
• Evidence generation will be the key to future success
• Stakeholders approach in successfully bringing Biosimilars to the market
Moderator
RAJESH DESIKAN, Vice President & Head, US Marketing, Oncology, & Immunology Biosimilars, Fresenius - Kabi
Panellists
ROBERT A. JOHNSTONE, Board Member, International Alliance of Patients Organisations
MIGUEL NAVARRETE OLMEDO, Hospital & Biosimilars Commercial Director, STADA Arzneimittel
BERT THOMAS, Senior VP, Business Development, Bio -Thera Solutions
ANNA AILLERIE, Brand Management Lead, Europe, Dr Reddy’s Laboratories SA
MICHEL MIKHAIL, International Expert in Biosimilars, Global Expert in Regulatory Affairs
16:40 – End of Day 1 of conference
09:30 – Welcome Address & Virtual Conference Platform Instructions
MANUFACTURING
09:40 – Overcoming Development Challenges for Biosimilars with Effective Bioprocessing and Analytics Quality by Design
• Current market and manufacturing challenges
• Cost-effective manufacturing approaches, quality-by-design and rapid quality control
• Novel analytics and regulatory strategies for bringing next generation Biosimilars to market
FREDRIK SUNDBERG, Global Director, Strategic Technology Partnership, Cytiva (Formerly GE Life Sciences)
10:20 – Pricing & Market access
• Best Practices for a competitive Market
• Impact of pharma pricing over innovation
• Biosimilars influence on pricing and reimbursement
• Market access success rate
• Biosimilar Milestone
11:00 – Morning Coffee/Tea & Discussion
CLINICAL
11:20 – Clinical Data Requirements for Biosimilars: Have the regulators got it right?
• Residual uncertainty after demonstrating similarity at the structural and biological activity level
• Are studies in patients needed?
• What concerned are addressed by patient data
• The position of different regulatory agencies
CECIL NICK, Vice President, Parexel
BUSINESS MODELS
12:00 – Solution Provider Presentation
For sponsorship opportunities please contact info.uk@virtueinsight.com
12:40 - Networking luncheon
CLINICAL
13:50 – A Clinician’s Guide to Biosimilars in Oncology: Understanding the Science of Extrapolation and Interchangeability
HANMANT BARKATE, Vice President & Head Medical Services (India, MEA), Glenmark
14:30 – Leanbio capabilities and pipeline
• Lean Development for Biosimilars
• Lean bioproduction
• Cost effective CMC development
• Reduced non clinical and clinical program
ANDREAU SOLDEVILA, Founder & CEO, Syna Therapeutics
15:10 – Afternoon Tea/Coffee
15:30 – Self-injection devices for biosimilars – overview and market trends
• Introduction to devices for self injection with market overview
• Particular needs for the biosimilar area including IP aspects
• Recent trends from the market place 1 – larger volumes
• Recent trends from the market place 2 – carbon neutrality and renewable materials
JAKOB LANGE, Senior Director Delivery Systems, Ypsomed
REGULATION OVERVIEW & UPDATE
16:10 - Panel Discussion: The developing regulatory framework in advanced and developing markets
• Market and regulatory developments in the Europe and globally
• Predicting the post Brexit changes in biosimilars regulation in UK
• EMA’s act on switching & interchangeability?
• How regulators, payers and policy makers take initiatives to make healthcare more sustainable
• Collaboration with HTA’s for patients benefit
• CMC regulatory considerations for Biosimilar products development
• Regulatory changes necessary to maximize biosimilars potential
• The way forward
Moderator
LOUIS BOON, CSO, Polpharma Biologics
Panellists
INGRID SCHWARZENBERGER, Senior Regulatory Consultant, Independent Consultant (Former Head Global Regulatory Policy, Sandoz)
NIKLAS EKMAN, Head of the Biological Section, Finnish Medicines Agency (Vice-Chair of the Biosimilar Working Party (BMWP), EMA)
SWEETY MATHEW, Regulatory Affairs, Biocon
ZIQUN HAN, Director, Zen Medical Science
MARIE MANLEY, Partner, Head of the UK Life Sciences, Sidley Austin
ALEXANDER ROUSSANOV, Life Sciences Regulatory & Privacy Lawyer, Arnold & Porter
16:50 - End of conference
Share
Now
Event Sponsors & Partners
Revealer
Revealer Global Solutions Private Limited helps organizations create, implement and support a Scalable, Actionable and Reliable Enterprise Analytics Solution defining their current and future business plans.
The challenges of the future for tomorrow’ management will be predominantly data related. The only way for Management to be decisive in overcoming these future challenges is to change to an aggressive insight-driven approach to strategy and decision making from a mere static perception-driven implementation of operational variables
Virtue Insight
CONCEPTUALISED BY
Virtue Insight
CONCEPTUALISED BY
Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.
Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.
Testimonials
Jakob& Partners Senior Business Analyst
Regulatory Affairs Sanofi Senior Manager
LUPIN BIOTECH BUSINESS DEVELOPMENT & PM
JAKOB & PARTNERS INDIA PVT LTD BUSINESS ANALYST
Quantimmune Solutions Senior Research Scientist
Presentation
