Hydrocephalus Research Workshop
April 12-13, 2024
Cincinnati, OH
Developing Non-Invasive Hydrocephalus Therapies: Advancing Towards Clinical Trials
Presented By:
Program Highlights Include:
- Building consensus in the field: experimental endpoints and animal models of hydrocephalus
- Lessons from current and past clinical trials
- Roadmap to advancing to clinical trials: regulatory aspect
- Funders: NIH, DOD, venture capital group
- Industry perspective
- Patient perspective
When:
April 12-13, 2024
Where:
Cincinnati Children's T building
240 Albert Sabin Way
Cincinnati, OH 45229-3039
Attendees are kindly reminded that they are responsible for booking and covering the cost of their hotel room and travels.
Hotel:
Graduate Cincinnati Hotel
Hydrocephalus Association Research Workshop
151 Goodman Street
Cincinnati, Ohio 45219
*Walking distance to workshop venue
Event Block Dates Available to Book:
April 11-15, 2024
*Above dates will auto populate – please adjust stay dates accordingly to your stay.
Reservations Direct: 844-888-4723
Hotel Direct: 513-487-3800
Hotel Sales Direct: 513- 487-3802 (issues with the link please give us a call to assist with your reservations)
Reservation Web Link: Hydrocephalus Association Research Workshop
Travel:
Graduate Cincinnati is about a 30-minute drive (17 miles) from CVG Airport
PROGRAM
Day 1, April 12
8am Breakfast
8:20am Opening and welcoming remarks
Francesco Mangano, DO, Cincinnati Children's Hospital Medical Center
Diana Gray, MA, Hydrocephalus Association
Monica Chau, PhD, Hydrocephalus Association
Session: Creating scientific consensus in the field
What are the ideal animal models and techniques to induce hydrocephalus?
9:25am Moderator: Pat McAllister, PhD, Washington University in St. Louis; Introduction to the round tables
9:30am Marc del Bigio, MD, PhD, University of Manitoba; Animal models of hydrocephalus: what is their translational utility for development of therapies?
9:45am Acquired hydrocephalus models overviews:
Pat McAllister, PhD, Washington University in St. Louis; Kaolin-induced hydrocephalus models
Jose Peiro, MD, PhD, Cincinnati Children's Hospital Medical Center; Fetal intracisternal Bioglue for a new model of obstructive hydrocephalus in large animal research
Lauren Jantzie, PhD, Johns Hopkins University; The essential role of inflammation in modeling PHHP secondary to IVH
Brandon Miller, MD, PhD, UTHealth Houston; Using blood vs. hemoglobin for IVH research
10:15am Consensus building: open discussion
10:40am Break
10:55am Genetic models overviews:
June Goto, PhD, Cincinnati Children's Hospital Medical Center; Genetic insights into models of congenital hydrocephalus
Mark Johnson, MD, PhD, UMass Memorial Health; Decoding iNPH: Mechanistic Insights from Genetically Engineered Mice
11:10am Consensus building: open discussion
Endpoint measurements in hydrocephalus studies
Moderator: Bonnie Blazer Yost, PhD, IUPUI
11:25 am Endpoint measurements
Harriet Kamendi, PhD, Kandih BioScience – FDA toxicology expectations
Charles V. Vorhees, PhD, University of Cincinnati - Behavioral testing paradigms as hydrocephalus endpoint measures
Diana Lindquist, PhD, Cincinnati Children's Hospital Medical Center - Translating MRI to the preclinical realm: advanced rodent neuroimaging for the evaluation of hydrocephalus
11:45am Consensus building: open discussion
12:10pm Lunch
Patient perspective: What motivates patients to participate in clinical studies?
1:10pm Moderator: Samantha Lanjewar, PhD, Hydrocephalus Association
Denise Berman, MA
Alejandro Rojas, PhD, Ananke Therapeutics
Lynn Beirl, BS, Flourishing in Mid-Life Women’s Hydrocephalus Group
Lessons from current and past clinical trials
Moderator: David Limbrick, MD, PhD, Virginia Commonwealth University
1:50pm David Limbrick, MD, PhD, Virginia Commonwealth University - ESTHI trial and lessons learned
2:15pm Francesco Mangano, DO, Cincinnati Children's Hospital Medical Center; Governance in clinical trials: DSMB
2:30pm Robin Ohls, MD, PhD, University of Utah - Phase I-III trials in preterm infants using Darbepoetin
2:55pm Bonnie Blazer Yost, PhD, IUPUI – Perspectives from kidney disease clinical trials and navigating the patent process for hydrocephalus treatment
3:20 pm Break
3:35pm Shenandoah (Dody) Robinson, MD, Johns Hopkins University - Overcoming regulatory barriers on the way to Phase I: A clinical trial of EPO+MLT in preterm infants with severe IVH
4pm Mark Luciano, MD, Johns Hopkins University - Minority access to Neurosurgery: iNPH as a case study
Industry perspective
Moderator: Francesco Mangano, DO
4:25 pm Mike McBreen, Integra LifeSciences- How we partner to help patients: an industry perspective
Synthesis discussion
Moderator: Lauren Jantzie, PhD
5pm Topic: How can we better design preclinical trials with a focus towards clinical translation?
5:20pm End of program day
6:30pm Group dinner (by invitation only), hosted by Integra LifeSciences
520 Vine Street
Cincinnati, OH 45202
(513) 721-8483
Day 2, April 13
8am Breakfast
8:15 Opening remarks
Roadmap to advancing to clinical trials and beyond
Moderator: Ramin Eskandari, MD
Regulatory aspect:
8:30am FDA speaker, Center for Drug Evaluation and Research (CDER)- Advancing to clinical trials
9am Bruce Mackler, PhD, JD- The Drug Discovery Process and the Role of the Academic Researcher
9:25am Harriet Kamendi, PhD- Kandih BioScience, FDA toxicology: planning preclinical studies
University IP offices:
9:50am Carole Burns, PhD, UMass Chan Medical School BRIDGE Office of Innovation and Business Development; Bridging the Gap – A new paradigm for advancing academic innovation
10:15am Justin Levy, JD & Jon Brophy, MSE, Cincinnati Children’s Innovation Ventures; Technology Licensing Basics for Medical Devices and Therapeutics in Hydrocephalus
10:40am Break
Funders' Support
Moderator: Carolyn Harris, PhD
Government Funding:
11:00am Jill Morris, PhD, NINDS, NIH - NINDS Funding Opportunities Supporting Translational Research
11:25am Cecilia Dupecher, PhD, CDMRP, DOD - DOD and Congressionally Directed Medical Research Programs (CDMRP) and support for clinical trials
Private funding:
11:50am Scott Davis, PhD, The Sontag Foundation
12:15pm Monica Chau, PhD, Hydrocephalus Association
12:35 pm Lunch and networking
2:00pm End of workshop program
FROM THE SPEAKERS
Active Hydrocephalus NOSIs
Notice of Special Interest (NOSI) for Hydrocephalus Research
Session 1: Creating Scientific Consensus
Animal Models:
Jose Peiro, MD, PhD- Fetal intracisternal BioGlue for a new model of obstructive hydrocephalus in large animal research
Session 6: Roadmap to Advancing to Clinical Trials and Beyond
Bruce Mackler, PhD, JD- The drug discovery process and the role of the academic researcher
Harriet Kamendi, PhD- FDA toxicology: planning preclinical studies
Jill Morris, PhD- NINDS funding opportunities supporting translational research;
>> Access hydrocephalus NOSIs here <<
NIH Grants and Programs:
Current Translational Research NINDS Funds
Cecilia Dupecher, PhD- Department of Defense, Congressionally Directed Medical Research Programs and support for clinical trials
(Click links to download)