Hydrocephalus  Research Workshop

April 12-13, 2024
Cincinnati, OH

Developing Non-Invasive Hydrocephalus Therapies: Advancing Towards Clinical Trials

Presented By:

Hydrocephalus Association Logo
(PRNewsFoto/Cincinnati Children's Hospital)
HANDS_Logo2022_CMYK

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

Via Vite Ristorante

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

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