CNS THERAPEUTICS XCHANGE
EUROPE 2023
Zurich, November 22

Welcome to hubXchange’s Europe CNS Therapeutics Xchange 2023, bringing together executives from pharma and biotech to address and find solutions to the key issues faced in developing CNS therapies.
Discussion topics will cover Novel Targets, Preclinical, Clinical Studies and Drug Delivery.
Take advantage of this unique highly interactive meeting format designed for maximum engagement, collaboration and networking with your peers.

Please note this is an In-Person meeting.

VENUE DETAILS: Hilton Zurich Airport Hotel, Hohenbuehlstrasse 10 – 8152 Opfikon, Switzerland

SNAPSHOTS OF DISCUSSION TOPICS

Track 1: Novel Targets

Novel therapies for complex neurological disorders: discovery of effective treatments
Oligonucleotides targeting microRNA: opportunities and challenges

Track 2: Preclinical

Methods to increase the success rates of drugs entering clinical phases
Novel strategies for reverse translation of temporal biomarkers for CNS drug development

Track 3: Clinical Studies

Fluid and digital biomarkers in neurodegenerative disorders
Utilizing clinical biomarkers to enhance drug development in neurodegenerative diseases

Track 4: Drug Delivery

Transcytosis-mediated brain delivery for proteins, antibodies, oligonucleotides, and small molecules
How AI can improve drug discovery

Full Xchange Agenda

Click on each track for detailed agenda

Novel Targets

Time

Titles and Bullets

Facilitator

8:00 – 8:30

Registration

8:30 – 9:00

Opening Address & Keynote Presentation by Cambridge Cognition

9:05 – 10:05

Exploring non-neuronal cells as therapeutic targets for CNS disorders

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings / Networking Break

11:10 – 11:20

Morning Refreshments

12:20 – 13:20

Networking Lunch

13:20 – 13:50

Spotlight Presentation

13:55 – 14:25

1-2-1 Meetings / Networking Break

14:25 – 14:55

1-2-1 Meetings / Networking Break

16:00 – 17:00

Evening Drinks Reception

Preclinical

Time

Titles and Bullets

Facilitator

8:00 – 8:30

Registration

8:30 – 9:00

Opening Address & Keynote Presentation by Cambridge Cognition

9:05 – 10:05

Skirting the cliffs in CNS drug development

Share experiences and „best practices“ in minimizing placebo response
What are the best methods for the early assessment blood-brain barrier penetration?
How should we deal with psychiatric disease heterogeneity (“DSM-5 vs. RDoC“)?

Carsten Spannhuth, Chief Scientific Officer, ATEKA Pharma

Dr Carsten Spannhuth is a senior pharmaceutical physician and strategy leader in CNS/neuroscience clinical development. He has worked successfully in senior positions over more than two decades at pharmaceutical companies such as Sanofi, Novartis, Idorsia and Lundbeck. He is a board-certified psychiatrist with extensive clinical experience in neurology, as well as experience in clinical development, business development and post-marketing lifecycle management in neurology and psychiatry in a global, innovation-oriented environment. He is also an innovative methodology facilitator, having implemented innovative study designs and endpoints, connected sensors and digital devices in clinical development; and co-founded both a pharma and a tech start-up company.

10:10 – 10:40

1-2-1 Meetings / Networking Break

10:40 – 11:10

1-2-1 Meetings / Networking Break

11:10 – 11:20

Morning Refreshments

11:20 – 12:20

Sponsor-led Roundtable by Synapcell

12:20 – 13:20

Networking Lunch

13:20 – 13:50

Spotlight Presentation

13:55 – 14:25

1-2-1 Meetings / Networking Break

14:25 – 14:55

1-2-1 Meetings / Networking Break

16:00 – 17:00

Evening Drinks Reception

Clinical Studies

Time

Titles and Bullets

Facilitator

8:00 – 8:30

Registration

8:30 – 9:00

Opening Address & Keynote Presentation by Cambridge Cognition

9:05 – 10:05

Novel endpoints and biomarkers in CNS clinical trials and real-world evidence

How can we construct an evidence-based framework to validate novel endpoints and biomarkers in CNS in a more efficient manner?
How can we leverage cutting-edge development in AI, digital health, and real-world evidence to establish regulatory-grade biomarkers?
How can we navigate regulatory and validation guidelines particularly for digital biomarkers?
How can we combine novel CNS biomarkers (clinical, radiological, and digital) to establish robust clinical trial endpoints?

Ivan John Clement, Associate Director, RWE & Innovative Evidence, Novartis

Ivan Clement is currently the Global Associate Director, RWE & Innovative Evidence in Neuroscience in Novartis, where he is responsible for the development and implementation of scientifically robust Integrated Evidence Strategies that drive successful launch, access, and clinical adoption of portfolio drug assets. He brings over 10 years of experience in evidence generation across the pharma lifecycle and in multiple therapeutic areas – starting in Eli Lilly where he supported key clinical development programs in neuroscience, oncology, and immunology, and then subsequently in MSD where he led digital health, access, and RWE analytics activities for their immuno-oncology, neuroscience, and vaccines portfolio. He then established RWD collaborative partnership ecosystems in Asia-Pacific while in IQVIA, prior to leading portfolio data and evidence generation strategic initiatives in Roche.

Ivan holds an MSc in Management of Health Industries from ESSEC Business School and a BSc in Computational Biology from the National University of Singapore. He also completed a research fellowship in biological engineering at MIT, and currently undergoing further studies in Precision Cancer Medicine at the University of Oxford.

10:10 – 10:40

1-2-1 Meetings / Networking Break

10:40 – 11:10

1-2-1 Meetings / Networking Break

11:10 – 11:20

Morning Refreshments

11:20 – 12:20

Sponsor-led Roundtable Discussion by Cambridge Cognition

12:20 – 13:20

Networking Lunch

13:20 – 13:50

Spotlight Presentation

13:55 – 14:25

1-2-1 Meetings / Networking Break

14:25 – 14:55

1-2-1 Meetings / Networking Break

15:00 – 16:00

Late communication with the FDA cost a lot of research waste in addition to delays in delivering new modalities to patients

While the FDA is encouraging and facilitating communication at the earliest possible, we are still hesitant to take this step as an opportunity.
We start producing literature reviews, look for endpoints, design registry and natural history studies before having any communication, resulting and resources and research waste.

Dima Martini-Drew, Early-Stage Medical Affairs Lead, Mitochondrial and rare disease, Astellas Pharma

With 26 years of experience in the Biotechnology and Pharmaceutical industry, as an executive leader, Dima has gained extensive knowledge of Rare Diseases, especially in-born errors of metabolism that involve Lysosomal Diseases and Mitochondrial Diseases. Her expertise covers a range of modalities, including small molecules, enzymes, and gene therapy. Furthermore, She is well-versed in the specialized modeling for Rare Disease operations across all functions within the Biotech and pharmaceutical industry.

16:00 – 17:00

Evening Drinks Reception

Drug Delivery

Time

Titles and Bullets

Facilitator

8:00 – 8:30

Registration

8:30 – 9:00

Opening Address & Keynote Presentation by Cambridge Cognition

9:05 – 10:05

Drug response prediction: Multi-target drug discovery and multi-indication development for CNS diseases

How can we develop drugs that need to address several targets for optimal efficacy and safety?
How can we develop drugs with similar mechanisms of action in several indications?

Frank Tennigkeit, Senior Clinical Program Director Pediatric Development, UCB Biosciences

Drug Development Expert with > 15 years of pharmaceutical industry/biotech experience.
Medical background in Pharmacology and Neuroscience. Strong experience in clinical development and real world evidence generation, especially in Neurology (Alzheimer’s Disease, Epilepsy, Parkinson’s Disease and PSP) and orphan autoimmune disorders.
Pediatric Development expert (pediatric development plans, studies, submissions and approvals).
Extensive experience in planning, executing, publishing and submitting clinical development programs for new chemical entities, biologics, and vaccines. NDA and submission experience, 5 successful approvals (US, EU, J, CN).
Medical/Clinical Team Lead and manager of cross-functional teams.
Publication of > 40 papers and abstracts in scientific medical journals.
Business Sustainability support for large non-profit research networks.
Love teaching, coaching, connecting.
Patient-centric mindset “Excellent medical science to help patients”

10:10 – 10:40

1-2-1 Meetings / Networking Break

10:40 – 11:10

1-2-1 Meetings / Networking Break

11:10 – 11:20

Morning Refreshments

12:20 – 13:20

Networking Lunch

13:20 – 13:50

Spotlight Presentation

13:55 – 14:25

1-2-1 Meetings / Networking Break

14:25 – 14:55

1-2-1 Meetings / Networking Break

15:00 – 16:00

Advancements in CNS drug formulation and manufacturing

TBC

16:00 – 17:00

Evening Drinks Reception

CNS THERAPEUTICS XCHANGE
EUROPE 2023
Zurich, November 22