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IP & Tech Transfer

Intellectual Property & Tech Transfer

Case Study: Group Discussion

Valuation
Assessment of Value of a
New Medical Product

Accelerating MDD in an Academic Setting

Resources and Strategies for Enhancing


Translational Product Development: Exploring the
Local Ecosystem
CHALLENGE: Translating biomedical research findings into clinical
and public health applications that improve human health is a
slow and complex process with high costs and high failure rates.

Harvard Catalyst brings together the intellectual force,


technologies, and clinical expertise of Harvard University
and its affiliates and partners to facilitate the translational
process and reduce the burden of human illness.
https://www.ctsacentral.org/
6/24/2016 CTSA_consortium_map_1_2_14_resized.jpg (588×385)
Harvard Catalyst supports translational research by enabling collaboration and by
providing training, tools, and technologies.

• Find collaborators
• Learn new skills and mentors
through live and through Profiles
online courses.

Workforce
Collaboration • Gain access to
• Longitudinal Development: expertise through
programs for Education & Training biostatistical or
mentored projects regulatory
and skills consultations

Tools and
Technologies
• Research resources -
• Funding - pilot grants
access to technologies,
clinical research facilities,
and the community
Harvard Catalyst leverages resources and networks across its 26 affiliates and serves as a
hub for existing but otherwise disparate information.

Example: Profiles is a tool to search contact, publication, and social network information for Harvard
affiliated investigators

Geographical map of Dr. Elliott Antman’s co-authors


Radial map of Dr. Fred Schoen’s co-authors and their networks
Harvard Catalyst Education structures its content and delivery to better prepare
faculty to engage in interdisciplinary translational research.

Overview Courses Fundamentals of Clinical and Translational Research: online


Cover entire T-spectrum

T-domain overview
T1 T2 T3 T4
offerings

Applied Biostatistics
Network Medicine
Advanced Courses: Understanding Biomarker Science
Often covering more Medical Device Development
than one T-space;
technical learning Imaging Modalities in C/T Research
Introduction to ‘Omics

Team Science
Cross-Cutting
Learning: Adaptive Ethics
skills that are woven Mentoring
throughout AND
offered as Leadership Skills
independent courses
Grant Writing and Communications
Regulatory
CIMIT Introduction

Resources and Strategies for Enhancing


Translational Product Development: Exploring the
Local Ecosystem

Contact:
John Collins, COO
jcollins11@parners.org
Cell: +1-617-899-3364
CIMIT: Consortia for Improving Medicine with Innovation
and Technology

CIMIT Founders CIMIT Members National Affiliates

NIBIB
VA Boston NHLBI
A Center at

1998 2000 2002 2004 2006 2008 2010 2012 2014 2016

International
Affiliates
Competitive
Cooperative
Agreements Page - 2
CIMIT’s Mission:

Accelerate the healthcare


innovation cycle
by:
Facilitating collaboration
among:
Clinicians, technologists,
entrepreneurs & Co’s
in:
Creating novel “HealthTech”
products, services and
enabled procedures
to:

Improve patient care


Page - 3
CIMIT Process:

Find Facilitate
➢ Site Miners ➢ Experienced
➢ Program entrepreneurs from
Leaders network
➢ CIMIT Forums ➢ Find collaborators &
➢ Conferences refine proposals
➢ Courses
Fund ➢ Anticipate and
address issues (e.g.
➢ Request for ➢ Innovation Grants
regulatory, IP
Proposals ➢ Accelerator Awards
compliance, etc.)
➢ Needs ➢ Adoption & Diffusion
Awards ➢ Create options and
Solicitations
➢ Prizes plans for funding &
➢ Growing profile commercialization
➢ Young Clinician
Awards ➢ CRAASH Course
Page - 4
The Healthcare Innovation Cycle:

10 - Standard of Care (SoC) 1 – Need


The Solution is Recognized Insights into unmet clinical needs
as the Standard of Care. and available solutions
SoC Need
9 - Clinical Use (Use) 2 – Idea
The Solution is Used Successfully Use Idea Potential Solution Described
in Day-Day Clinical Practice Progress: to an Unmet Need
- Clinical
8 – Approval & Launch (A&L) A&L PoC 3 - Proof of Concept (PoC)
- Market/Bus.
Institutional and Regulatory Approval Key Component Concepts Validated in
Received and Sales Launch - Regulatory Models and Value Proposition Articulated
- Technical
7 - Validation of Solution (VoS) VoS PoF 4 - Proof of Feasibility (PoF)
The Solution is Shown to be Effective and
Feasibility of Whole Solution Demonstrated
its Value to all Stakeholders is Validated ICT PoV in Models and with Stakeholders

6 – Initial Clinical Trials (ICT) 5 - Proof of Value (PoV)


Regulated Production of Prototypes and The Potential of the Solution to Work and Create
Collection of Clinical and Economic Data. Value for All Stakeholders is Demonstrated

“Translation”

Page - 5
What often really happens … Inexperienced teams make
mistakes that doom, derail or stall promising innovations
Lack of
Awareness
Too Too Good,
Expensive Too Special
SoC Need
Use Idea Does not fit
Resistance to
Progress: Workflow
Change
- Clinical
A&L - Market/Bus. PoC
Published &
- Regulatory Lost IP
Regulatory “Wall” - Technical
VoS PoF Too Complicated

No Advocates, ICT PoV


No IP “Freedom to
“Lead Users” Operate”
No
Wrong Data Team/ Plan

Need Filled by CIMIT:


Find, Fund and Facilitate multi-disciplinary teams to
navigate the complex healthcare innovation journey
GAITS Approach

The Healthcare Innovation Cycle


(10 Deliverables and 4 Domains)

4) Analyzing: Studying & 1) Guiding: Deliverables and


Sharing Best Practices Descriptive Resources

3) Reporting: Projects 2) Planning & Tracking:


and Portfolio Roll-Ups Deliverables and Metrics

© CIMIT 2018
Page -7
DIGITAL TRANSFORMATION

CREATING
IMPACT

Confidential – do not copy or distribute © 2017 Brigham Digital Innovation Hub. All Rights Reserved.
BRIGHAM INNOVATION JOURNEY

First Hackathon Partnerships


Collaborations with MIT Evidation Health
H@cking Medicine, HBS, Rock Health
Startups and Industry Microsoft, Apple and others…

2014 2015 2016

Launch 2013 Scaling Beyond


Brigham and Women’s Digital Health central to BWH strategy
iHub Launches MA Governor Baker Council
DHIG Infrastructure Process
Community Engagement
Collaboration Nights Open Innovation Studio
Shark Tanks
Start up Pilots

Confidential – do not copy or distribute © 2017 Brigham Digital Innovation Hub. All Rights Reserved. 2
IMPACT SINCE 2013

5 iHUB SUPPORTED
BWH SPINOUTS 21 2 BWH HACKATHON
PROJECTS WENT ON
TO FORM COMPANIES
• BrainSpec by Alexander Lin, PhD DEPARTMENTS
• Volalytix by Sophia Koo, MD ENGAGED
• Fertilex by Hadi Shafiee, PhD with “Frequent Flyers” from
Pulmonary/Critical Care,
• Astarte by Kate Gregory, PhD, RN Radiology and OB/GYN
• Postercast by Rick Kaufman, MD

1000+ ATTENDEE
S@ 25+ EVENTS

Guest presenters have included executives from companies such as


71 PROJECTS REVIEWED BY DHIG
(DIGITAL HEALTH INNOVATION GUIDE)

The DHIG governance committee and process


improves likelihood of project success by ensuring
proper approvals and pilot best practices are followed.

Confidential – do not copy or distribute © 2017 Brigham Digital Innovation Hub. All Rights Reserved.
iHub: A DIGITAL HEALTH INNOVATION ENGINE
Our mission is to drive more seamless, efficient, patient-centered and safe care for our patients
through the development, evaluation, use and commercialization of digital health platforms and tools.

We make it easy for BWH to test out digital innovation by supporting a bi-directional flow of innovation…

Confidential – do not copy or distribute © 2017 Brigham Digital Innovation Hub. All Rights Reserved. 4
LEADING INFRASTRUCTURE
ACCELERATING DIGITAL INNOVATION
“Open for Business”

Onboarding Digital Enterprise Access


Help onboard new technologies Developed a Research & Innovation
to test and accelerate pilots. Portal to simplify adding applications
into Epic and clinical workstations.

Integration Care Setting Delivery


BWH is developing a platform to BWH provides a broad digital testing
connect outside applications to arena for inpatient, ambulatory, post-
streamline integration with acute/home and more through various
enterprise IT systems. technology end points (Computer,
tablets, mobile, etc…)

Confidential – do not copy or distribute © 2017 Brigham Digital Innovation Hub. All Rights Reserved. 5
iHub: WAYS TO ENGAGE
iHub supports all levels of engagement, whether you’re a tech-savvy clinician, a seasoned innovator
who wants to learn about digital health, or an operations manager in search of a solution.

I’d like to learn about I’m exploring an I have a project I’d


digital innovation. idea. like iHub to support.

Attend monthly events Request a market scan Work with iHub to match a
(Speaker Series, Digital challenge to a market
Research Forum) Workshop your idea at Open solution, and facilitate
Office Hours (Thursdays) collaboration and testing

Join a Startup Have iHub facilitate an Refine your prototype,


Screening Session Innovation Series for business model and pitch in
(Fridays, 30 min.) your team our Accelerator

Confidential – do not copy or distribute © 2017 Brigham Digital Innovation Hub. All Rights Reserved. 6
Resources and Strategies for Enhancing Translational
Product Development:
Exploring the Local Ecosystem

Monique Yoakim-Turk, PhD


Partner, Technology Development Fund

October 2018
Resources for Boston Children’s Translational Endeavors

Innovation &Digital Health Accelerator Simulator Program Technology Innovation and


(IDHA) (SIMPeds) Development Office (TIDO)
Technology & Innovation Development Office

TIDO Services
• Identify research and discoveries with commercial potential
• Build commercialization strategy
Patents and
• Manage intellectual property Licensing
• Fund proof-of-concept
• Structure commercial deals
• Manage alliances
• Support research Business Technology
Development/ Development
Marketing Fund
Technology Development Fund
TDF is a seed-stage academic catalyst fund dedicated to translating high-impact academic
technologies into the independently-validated, later-stage opportunities sought by industry
partners and investors.

Academic Research Company Research &


Development
Proof of
Basic concept Licensee
Translational Opportunity Clinical Product
research research •Product development •Startup validation
Concept company

Tech Dev
Fund

23
Technology Development Fund
TDF Model
TDF Award

Funding Technical
Mentoring / Project
($50K- Support
$150K)
Coaching Management
(CRO)

Technology Development

Technology Licensing and


Product Commercialization
Selection Process
RFP BCH Executive Committee

Initial Evaluation Final Evaluation Project Plan


Defer Defer
PI PI
PI TDF PI Presents PI Meets
No Submits Presents Project
submits Triages to Ad No With
Full Project Begins
LOI LOI Invitation to Board Mentor
Proposal Plan
submit full
proposal Award

EVALUATION CRITERIA
• BCH mission: pediatric impact
• Medical need, research significance
• Technical feasibility
• Impact of funding on translation
• Clear commercial potential
• Will the project generate or strengthen IP?
TDF 2017: Mentoring

David Roberson, PhD


Clifford Woolf, MD, PhD
TDF 2017 awardees TDF Advisors/Mentors

Broader
network/market
BCH TIDO/TDF research
Supporting Development with TDF Funds/
Defining business model and business plan
TDF History 2009-Present

TDF since launch in 2009:

• 9 fund years completed


• 359 applications
• 74 awards
• approx. $8.5 M allocate

$4.7M invested to date


$38M follow-on funding
14 licenses
11 start-up companies
$104M in VC investment
40+ co-development partners
Discussion

Thank you!

Monique Yoakim-Turk PhD


Partner, Technology Development Fund
Technology Innovation and Development Office
monique.yoakim@childrens.harvard.edu
617-919-3027
What is B-BIC?
• B-BIC is a consortium of 14 member institutions in Boston
Beth Israel Deaconess Medical Center Boston Children’s Hospital
Boston Medical Center Boston University
Boston VA Medical Center Brigham and Women’s Hospital
Draper Laboratories Forsyth Institute
Harvard Medical School Massachusetts General Hospital
Massachusetts Institute of Technology Northeastern University
Partners HealthCare Tufts University

• Funded by NIH | NHLBI cooperative agreement beginning 2013


• One of three National Centers of Accelerated Innovation (NCAIs)

• Includes domain experts and advisers from across institutions,


industry, and venture
Resources Available Through B-BIC
• Non-dilutive Funding
• Pilot - Proof of Concept Studies – up to $88,750 total cost
• DRIVE - Validation Studies – up to $350,000 total cost

• Project Managers and Coaches from Industry

• Access to External Partners


• Local Venture Community
• Federal Partners including CMS, FDA, USPTO, Kaiser Permanente

• Customized Skills Development and Broad Offerings


Coaching and Project Management
• Coaching
• Pre-award - Provides PI’s with high level strategic assessment of market,
competition, differentiation, regulatory and reimbursement strategies

• Post-award - Engages Pilot awardees at start, middle, and end of project period

• Project Management
• Pre-award - Identifies key decision points and milestones in project plans,

• Post-award - ~35% FTE for DRIVE awardees to capture milestones/outputs


achieved as project progresses, connect PI’s with external resources and
expertise, including SDC training in support of project plans
Targeted Outcomes
• SBIR / STTR Awards

• Co-Development Deals

• License to Existing Companies

• New Companies with Financial Support

• Follow-on Funding Multiplier (as of September 2018): 11.3x


How would you best help these people?

Persona #1 Persona #2 Persona #3

“I have…” “I have…” “I have…”

• A team • Intellectual property


• An idea for an
• Intellectual property • Substantial funding
invention
• Modest funding • Technical validation

“I need…” “I need…” “I need…”


• Help designing clinical
• Help designing bench
trials
• Guidance on what to and animal studies
• Guidance toward
do next • Guidance securing
acceleration and
more funding
commercialization
@HarvardCatalyst

#hcatpge

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