Proof of Concept - Year in Review

Mission: The mission of the Proof of Concept Office (POC) is to empower Cleveland Clinic caregivers to transform promising research and novel ideas into medical products that significantly advance human health. The POC Office collaborates with Cleveland Clinic Innovations (CCI) and directly with inventors to identify projects stemming from new invention disclosures that promise clinical benefits, potential for intellectual property, and commercial viability. These projects may require assistance with prototyping or initial demonstrations. Before filing an invention disclosure, inventors seeking to develop compelling medical products and explore funding opportunities for product development are encouraged to consult with the POC Office.

Ideas are referred to the POC Office from Cleveland Clinic Innovations (CCI) or through engagements directly from inventors. POC projects come from new invention disclosures that can make a positive clinical impact and show an opportunity for new intellectual property and commercial outcomes but need help with prototyping or initial demonstration. Inventors can also approach the POC Office before filing an invention disclosure, for guidance on creating a compelling new medical product and to learn how to access product development funding.

Therapeutics

PAI-1 Inhibitors as Therapeutics and Diagnostic Indicators

Inventors: Thad Stappenbeck, MD PhD; Vara Prasad Josyula, PhD

Mobius Care, Inc., a CCI portfolio company, uses PAI-1 inhibitors to personalize Inflammatory Bowel Disease (IBD) therapeutic and diagnostic care, through its proprietary AI tool, applied to targeting host and microbiome pathways that infect gastrointestinal (GI) tract wounds. Vara Prasad Josyula PhD and Juliana Woda PhD from the POC team worked with the inventors to define a business model and growth plan to help make Mobius Care a new CCI startup company. The Company’s technology can also identify subsets of patients who are likely to respond favorably to an existing arsenal of well-characterized drug candidates. Additionally, Mobius is developing therapeutics to treat the dysfunctional wound healing and dysfunctional microbiome associated with IBD.

https://mobius.care/

Devices

Autoregistration for Stereotactic Procedures

Inventors: Rafi Avitsian, MD; Pablo Recinos, MD

This invention disclosure was originally disqualified due to a lack of invention enablement. Dr. Erik Waldorff worked with the Inventors in a series of Ideation Clinics, resulting in a new invention disclosure and a SPARK award. The funding was used for enablement and to define features. The new Invention was admitted into the Innovation’s system less than 10 months later, a patent was filed for the new invention, and a Joint Development Agreement was established with an external partner to help further enable the invention.

Devices

Modular Needle Valve for Injection Flow Control

Inventor: Michael Forney, MD

This initial Invention Disclosure arrived with few details about implementation or product features. To define the product features, the POC team conducted Ideation Clinics, voice-of-the-customer sessions, and prototyping experiments. This led to intellectual property filing, and the invention was successfully transitioned to CCI for active development of a minimal viable product.

Temporally-Corrected Dose Accumulation (Jacob Scott, MD)

This invention disclosure arrived lacking a proof-of-concept demonstration and details regarding the algorithms needed for enablement. The POC team and Innovation Fellows worked with the inventor to define critical path experiments, which resulted in a white paper defining the algorithms and subsequent invention qualification.

An Ideation Clinic includes a panel of field experts from the POC team, Innovations, Medical Device Services and the inventor’s institute(s). who provide iterative constructive feedback to Cleveland Clinic medical device inventors to refine their ideas and arrive at well-founded inventions. Ideation Clinics facilitate two-way discussions of commercialization roadblocks and potential effects through considerations including:

- Technical feasibility and engineering
- Reduction-to-practice
- Regulatory
- Clinical evidence
- Reimbursement
- Market Adoption

Working with CCI Engagement Partners and Institute Innovations Leads, the POC team helps new inventors better understand the technology development process from "Ideas-to-Inventions (I-2-I)." Using the inventor’s great new ideas as the starting point, the POC team and Innovation Fellows help inventors understand the market, define objectives and value propositions, plan next steps, and identify internal and external development partners and sources of funding. This support enables inventors to develop "great ideas" into "great inventions."

Since 2018, the Innovation Fellows program has trained Cleveland Clinic caregivers in the healthcare technology development and commercialization process, from invention-creation through regulatory approval and marketing. It is a 2-year program and requires a 20% time commitment (with salary offset). Innovation Fellows receive didactic training and hands-on project management and, in their second year, they help train the incoming class. Fellows manage I-2-I and Catalyst SPARK projects. Graduates have gone on to new careers in CCI, joined Cleveland Clinic portfolio companies, become consultants, and have roles in industry. Fellows moving on to industry often facilitate collaborative partnerships between their company and Cleveland Clinic.

Bridging the gap between translational research and new therapeutics, Cleveland Clinic’s Center for Therapeutics Discovery (C3TD) was established in 2018 work with investigators to de-risk promising approaches using small molecule chemical probes. Part of an advanced research technology facility housed in Lerner Research Institute, C3TD includes a state-of-the-art small molecule screening library, X-ray crystallography, computational tools, and target validation to generate starting points for nascent hit-to-lead and lead optimization campaigns. Staff members comprise structural biologists, medicinal chemists, and pharmacologists. In addition to guiding and collaborating on projects that are referred by Cleveland Clinic Innovations, the POC team helps researchers interact with the C3TD as they are planning their drug discovery programs. C3TD also works with POC to secure and optimally utilize contract research organization (CRO) resources.

Medical Device Solutions

Medical Device Solutions (MDS) develops innovative prototypes and equipment to enhance research and solve unmet clinical needs. The MDS team includes experts in 3D printing, bio-robotics, mechanical testing, electronics, engineering design, instrument refurbishing and repair, prototyping, nitinol, and polymer fabrication. MDS team members participated as panel experts in POC Ideation Clinics.

In 2023, POC and MDS implemented a project tracking system and collaborated on 15+ projects including:

- Medical device design iterations

- Enablement planning

- Proof-of-concept prototype developments

Catalyst SPARK

In 2023, Cleveland Clinic’s Philanthropy Institute launched Catalyst SPARK, a part of the Caregiver Catalyst Grant Program. This program equips new inventors with strategic funding, effective project management, mentoring, and inventor education to help enable new technologies. The POC team helps validate and develop inventions selected for the program, including proof of concept, demonstration and prototyping. Participating inventors are partnered with a POC field expert, who guides the inventor through “Idea to Invention” milestones. Successful new inventions are then transitioned to Cleveland Clinic Innovations (CCI) for further development and commercialization.

Strategic Partnerships

The POC team works with external partners to provide resources to support research and development. Our objective is to combine the resources and talents of the partners to deliver mutually beneficial outcomes greater than what either partner could produce alone. Highlights from 2023 include:

Moderna
- $1.6M educational partnership
- Emerging Research co-development
ThermoFisher
- Consulting and Equipment for Cleveland Clinic Cell Therapy Facility
- Exploring diagnostics research & development opportunities

Emerging/expanding relationships with pharmaceutical, medical devices, and materials companies

Our Team

Bryan Williams, PhD​

Scientific Advisor

Elizabeth Sump

Senior Director,Strategic Alliances

James D. Ellis, JD, MBA​

Managing Director, Pre-Market Innovations

Catherine Teringo, MHA​

Program Manager

Julie Woda, PhD​

Senior Director & Domain Lead,Therapeutics & Diagnostics

Vara Prasad Josyula, PhD​

Senior Director,Therapeutics & Diagnostics

Erik Waldorff, PhD, MBA​​

Senior Director,Medical Devices

Snehal Chokhandre​

Senior Principal Research Engineer Biomedical Engineering, Senior Project Manager for Proof of Concept

Technology Highlights

By the Numbers: 2023 Projects Managed

62

total projects

5

projects advanced to Innovations

49

active projects

Education & Development

Ideation Clinics

10

total clinics

8

new inventions resulted

Invention Support/Idea-2-Invention (I-2-I)

Innovation Fellows Program

22

total Fellows

9

current Fellows

4

graduated to expanded Cleveland Clinic roles

9

graduated accepted in tech transfer or industry

45k

square feet

17

staff members

20+

drug targets

12+

therapeutic areas

Funding

18

applications

$6.1M

awarded

$185M

total asks

$8.5

pending

Strategic Fundraising Support

Catalyst SPARK

14

awards

$800K

total funding

65%

translation rate from idea to commercialization

Strategy

Strategic Partnerships

Cleveland Clinic Ventures Support

$9.3M

total non-dilutive funding

9

CCI portfolio companies with POC involvement

7

portfolio companies with POC board members

1

portfolio company with POC co-founder

Bryan Williams, PhD

Senior Director,
Strategic Alliances

James D. Ellis, JD, MBA

Managing Director,
Pre-Market Innovations

Catherine Teringo, MHA

Julie Woda, PhD

Senior Director & Domain Lead,
Therapeutics & Diagnostics

Vara Prasad Josyula, PhD

Senior Director,
Therapeutics & Diagnostics

Erik Waldorff, PhD, MBA

Senior Director,
Medical Devices

Snehal Chokhandre