Pre-Conference Workshop Day
11th September
Pre-Clinical Workshop Day
Clinical Workshop Day
9:00 AM-12:00 PM
Deep Dive into Preclinical Modelling to Overcome the Complexities of the Complement Cascade & Improve Better Translation into Humans
This workshop provides you the opportunity to delve into preclinical modeling of heterogeneous diseases where pathomechanisms aren’t clearly defined, improving translational efficacy into humans. Hear testimonials and opinions from developers working on a range of diseases and how they are navigating these pressing challenges.
Hear from the experts and discuss:
• Current preclinical models in use, the benefits, and drawbacks of these models
• Modelling the complement pathway in animals including mouse and NHP
• Discuss whether the differences in sequence homology and expression patterns are too great to recapitulate human
complement biology
• Modelling complement dysregulation and disease pathology in animal models
• How well our current models translate to humans, what can we do better?
Workshop leaders:
Abraham Scaria, Chief Scientific Officer, AGTC
Alberto Cruz-Martin, Assistant Professor, Boston University
Guillemette Masse Ranson, Associate Scientific Director,
Immunology Research, Moderna
1:30 PM- 4:30 PM
Complement Activation Biomarkers & Sensitive & Specific Assays to Reliably Detect Them
Advancements in development of biomarkers which sensitively and specifically detect complement activation undoubtably goes hand in hand with the development of next generation complement therapeutics.
This intimate session will discuss:
• Upstream activation signals as activation biomarkers
• How to detect and quantitatively measure complement activation
Share your thoughts and opinions to assay developers on the need for sensitive and specific assays which:
• Allude to the activation route
• Accurately predict or measure tissue levels of complement
• Overcome human activators for rodent species
• Better account for the differences between human and rodent serum components
Workshop leaders:
Ruchi Sharma, Staff Scientist, OGVFB, National Eye Institute
Xaria Li , Research Officer, Woodruff Group of
Neuroinflammation, University of Queensland
9:00 AM-12:00 PM
Prognostic & Predictive Biomarkers in Clinical Development to Better Inform Patient Populations
With increasing opportunity for complement therapeutics there is now a greater need to identify accurate and non-invasive biomarkers that improve measurement of complement levels in clinical settings.
In this workshop expect to discuss:
• Improving sample collection enabling us to move away from biopsies
• Tackling the need to develop biomarkers which better identify patients, enriching clinical trials and predict prognosis
• Earlier biomarkers which predict onset of disease preventing tissue injury
Workshop leader:
Donna Flesher, Vice President, Biomarker & Bioanalytical Sciences, HIBio
Ketan Thakar, Research Scientist II, Biomarker Development, Alexion, AstraZeneca Rare Disease
Joseph Manimala, Director, Diagnostics Alexion, AstraZeneca Rare Disease
1:30 PM- 4:30 PM
Assessing the Regulatory Landscape in Complement Therapeutics to Identify Strategies to Progress Candidates to the Shelf
With recent approvals from Apellis and Iveric Bio’s NDA acceptance, the regulatory landscape is changing and the future for
complement therapeutics looks promising
Join this intimate discussion-orientated session to:
• Objectively review strategies to overcome challenges of regulatory approval regardless of disease type when working with complement therapeutics
• Hear expert opinions on navigating regulatory approval to better
inform your regulatory strategies
Workshop leaders:
Aude Gobert, Director of Global Regulatory Affairs, UCB
Michael Storek, Head of Complement Cluster, Sanofi
Lori Taylor, Senior Vice President, Portfolio Strategy & Operations Biology, Annexon Biosciences