Agenda - MTECmtec-sc.org/wp-content/uploads/2016/07/3.1.16-Slides-For-Posting.pdf · • Lauren...

8:15 – 8:30 am Welcome and Overview of the Day• Stacey Lindbergh, MTEC Executive Director

8:30 – 9:00 am U.S. Army Medical Research & Materiel Command - MTEC Overview & Upcoming Plans• James B. Phillips, Ph.D., PMP, Program Manager, Medical Technology Support Center, USAMRMC

9:00 – 9:45 am USAMRMC Funding, Programmatic Processes and Available Intellectual Property Collaboration Opportunities• Jonathan S. Miller, Ph.D., J.D., Deputy for S&T, Medical Technology Support Center, USAMRMC• Sara B. Langdon, M.B.A., Senior Program Analyst, Medical Technology Support Center, USAMRMC

9:45 – 10:15 am MTEC Member Intellectual Property Policies • Alysia Bridgman, MTEC Contract Manager

10:15 – 10:30 am BREAK

10:30 – 11:15 am MTEC Project Solicitation Process Overview• Polly Graham, MTEC Program Manager• Alysia Bridgman, MTEC Contract Manager

11:15 – 11:40 am Market and Technology Assessment Overview• Lauren Macri-Palestrini, Ph.D., MTEC Director of Research Programs• Rick Satcher, MTEC Director of Commercialization

11:40 – 11:55 am Philanthropic Approach • Susan Raymond, Ph.D., MTEC Director of Strategic Funding

11:55 – 12:00 pm Next Steps and Closing Remarks • Stacey Lindbergh, MTEC Executive Director

Agenda

MTEC Leadership

Board of Directors

Dr. Lester Martinez Lopez, MPH, Major General (Ret), U.S. Army

MTEC President and Chairman of MTEC Board

Dr. Anthony AtalaUniversity/Not-for-Profit

Board Representative

Mark D. BreyenDevice Manufacturer Board

Representative

Leslie H. ShermanSmall Business Board

Representative

Dr. Kent Kester,FACP, FIDSA, FASTMH

Vice President and Head, Translational Science & Biomarkers

Dr. Lauren Macri-PalestriniDirector of Research Programs

Julia MartinChief Financial Officer

Natalie CorellaContracts & Compliance

Stacey Lindbergh, MHAExecutive Director

Officers

MTEC Leadership

Richard SatcherDirector of Commercialization

Dr. Susan RaymondDirector of Strategic Funding

Dr. Bradford WaltersChief Medical Officer

William HowellChief Operating Officer

Alysia Bridgman MTEC Contracts Manager

Intellectual Property Plan

• Posted on the mtec-sc.org website• Currently being revised, pending review by MTSC and

legal counsel• All prospective Consortium members have agreed in

advance to contribute (by license or otherwise) Background Intellectual Property on projects where relevant and appropriate

• Will be superseded by the terms of the Base Agreement entered into by MTEC and Members

• Intended to balance the interests of the government, Consortium, and Consortium Members, while offering maximum flexibility between the parties to negotiate specific IP terms appropriate for a particular collaboration

Intellectual Property (IP)

The legal rights associated with technical know-how, technical data, discoveries, materials, samples, software, software programs, documentation, reports, regulatory filings, any and all other copyrightable materials, any invention or discovery that is or may be patentable or otherwise protectable under title 35 of the U.S. Code and any other intellectual property rights of any kind or nature whatsoever.

Background IP

Rights that are controlled, owned, developed or licensed by a party to which such party has rights prior to the date of an applicable MTEC Research Project Agreement, or that is conceived or first reduced to practice by such party during the term of such MTEC Research Project Agreement but not in the course of the performance of such party’s activities thereunder nor their use of MTEC IP, relating to the subject matter of such MTEC Research Project Agreement.

Background IP (continued)

• Each Member shall retain all rights to its Background Intellectual Property; the decision to make available any such Background Intellectual Property for use in a Member’s Research Project Award shall be at the sole discretion of each Member. MTEC, as part of its project solicitation, will require proposers to identify all Background IP required for performance of a research project.

Consortium-Developed IP

Individually and collectively all IP which is conceived or first reduced to practice solely or jointly by any Member(s) of the Consortium as a part of and during the performance of an MTEC Research Project Agreement funded in whole or in part by the Government or other third party.

CDIP shall be owned by the respective inventing or creating Members, subject to any Government rights and/or any pre-existing rights of any third party.

OTA Data Rights

Category Description Allocation of Rights under OTA

Category A Data Data developed and paid for by totally private funds

Government has “limited” or “restricted” rights

Category B Data Data developed previously or with mixed funding

Rights negotiated under a prior agreement. Government shall normally have immediate unlimited or Government purpose license rights upon project completion

Category C Data Data developed exclusively with Government funds through MTEC

Government has unlimited rights except as provided in separate agreement

Category D Data Specifically-negotiated data rights by agreement of the parties. Sufficiently flexible to meet the needs of the parties.

Specifically-negotiated data rights agreement should be included in a research project award

OTA Patent Rights

Government Contribution

Government Rights to Subject Invention under OTA

0-49% of Research Project Award

Nonexclusive, nontransferable, irrevocable, paid up license to practice, or have practiced on its behalf, for Government purposes

50-100% of Research Project Award

Nonexclusive, nontransferable, irrevocable, paid up license to practice, or have practiced on its behalf, for Government purposes, plus the ability to transfer the license for commercial purposes

Only GovernmentEmployees on Invention

Government has initial option to retain title; Government agrees to enter into good faith negotiations to license invention to Consortium Member(s)

Joint Invention involving Government Employee

Joint title to invention between Government and other entity(ies); Consortium Member(s) have initial option to file patent applications

Differing Patent Rights

• Differing patent rights may be negotiated between the parties to each individual Research Project Award on a case-by-case basis

• This provides the parties maximum flexibility

OTA Terms and Conditions

• Will be flowed down to Members in the MTEC Base Agreement

• Article 9. Rights in Technical Data, Computer Software, and Copyrights

• Article 10. Inventions• “Use, duplication, or disclosure is subject to the

restrictions as stated in the Agreement between U.S. Government and the Consortium, Agreement Number W81XWH-15-9-0001, Proposal Title with [company]…”

Questions?

Polly GrahamMTEC Program Manager

Alysia Bridgman MTEC Contracts Manager

Statutory Requirement Prototype OTA

Section 815, National Defense Authorization Act of 2016

Section 815 of the National Defense Authorization Act (NDAA) for Fiscal Year 2016, authorizes Department of Defense organizations to carry out prototype projects that are directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components, or materials in use by the armed forces.

Definition of Prototype Project

According to the DoD OT Guide:• A physical or virtual model used to evaluate the technical or

manufacturing feasibility or military utility of a particular technology or process, concept, end item, or system.

• Quantity limited to amount needed to determine feasibility• Prototype Projects are NOT: Services, Maintenance,

Production (including LRIP) and Construction.• Usually will result in delivery of prototype

deliverables• Could be a final report of a prototype process, physical

model, virtual model

Medical Materiel Prototypes (ex)

• Devices• Vaccines

Use of Authority/Requirements

(A) There is at least one nontraditional defense contractor participating to a significant extent in the prototype project(B) All significant participants in the transaction other than the Federal Government are small businesses or nontraditional defense contractors“(C) At least one third of the total cost of the prototype project is to be paid out of funds provided by parties to the transaction other than the Federal Government(D) The senior procurement executive for the agency determines in writing that exceptional circumstances exist (uncommon)

Definition of Nontraditional

Per National Defense Authorization Act of Fiscal Year 2016:A nontraditional defense contractor is a business unit that has not, for a period of at least one year prior to the issue date of the Request for Project Proposals, entered into or performed on: • any contract or subcontract that is subject to full

coverage under the cost accounting standards (CAS) prescribed pursuant to section 26 of the Office of Federal Procurement Policy Act (41 U.S.C. 422) and the regulations implementing such section

“Nontraditional” (continued)

Nontraditional defense contractors can be at the prime level, team members, subcontractors, lower tier vendors, or "intra-company" business units; provided the business unit makes a significant contribution to the prototype initiative (i.e., is a key participant).

Significant Participation

No statutory definition of Significant Participation• Per the DoD OT Guide, rationale to justify asignificant contribution include:

• Supplying a key technology or products,• Accomplishing a significant amount of the

effort• Use of unique skilled personnel, facilities

and/or equipment• Causing a material reduction in cost or

schedule, and/or• Improvement in performance

Warranties and Representations

• Used along with statement of work and proposal to ensure project meets OTA statutory authority

• Specifically addresses whether criteria regarding non-traditional participation to a significant extent has been met

• Opportunity for proposer to make case that contributions of nontraditional defense contractor are significant.

• More detail and specificity is better

Cost Share

Without significant participation of a nontraditional defense contractor, project can still be awarded under OTA if 1/3 of the project cost is provided as cost share:

Project or program costs not borne by the Federal Government• Proposed cost share is defined in terms of source

and applicability to the performance of the project. • Offeror must demonstrate determination

(methodology) of cost share value

Types of Cost Share

• Cash: Outlays of funds to perform the ResearchProject Awards. Cash includes labor, materials, andrelevant subcontractor efforts. Sources include newIndependent Research & Development (IR&D)funds, profit or fee from another contract, overheador capital equipment expense pool. New IR&Dfunds offered to be spent on the Research ProjectAward SOW and subject to the direction of theinitiative management may be utilized as costshare.

• In-Kind: Reasonable value of in-place equipment,materials or other property used in performance ofthe Research Project Award.

Cost Share Requirements

• Must be part of the project scope• Would otherwise be an allowable project cost• Will be subject to review to cost reasonableness

review• Proposals that contain cost share cannot include

fee• May only be proposed on cost type agreements• Offeror will be required to provide financial

reporting with appropriate visibility into expenditures of Government funds vs. cost shrefunds

Acquisition Process

Acquisition Cycle without White Papers

Proposal Submission

• Project Proposal documents will be posted on MTEC “Members Only” website

• Proposal Preparation Guide – PPG• Request for Project Proposals - RPP

• Members can submit question regarding project calls to [email protected]

• Q&As will be posted on MTEC “Members Only” website

mailto:[email protected]

Proposal Preparation Guide

• Describes contents of white papers (if required)• Includes requirements for separate Technical

Volumes and Cost Volumes • Describes potential award types and process

for making Research Project Awards• Describes proposal compliance screening

process

Request for Project Proposals

• Presents specific Technology Objectives• Presents Commercialization Plan requirements• Describes Military Relevance requirements• Addresses any unique requirements (page

numbers, etc.)• Includes evaluation criteria and adjectival merit

ratings

Research Project Awards

• Negotiate Base Agreements• Includes Terms and Conditions from MTEC OTA• All projects approved for funding immediately or in

the Basket Provision

Questions?

Lauren Macri-Palestrini, Ph.D.MTEC Director of Research Programs

7/19/2016 MTEC Proprietary 37

Clinical Needs

Technology Assessment

Market Assessment

Funding Analysis

Specific interest areas included in the RFP

• Dual use markets• Industry interest• IP protection• Leveraged funding• Technology maturity

Overview


Clinical Needs


Market Assessment

Funding Analysis


• Dual use markets• Industry interest• IP protection• Leveraged funding• Technology maturity

Overview

Clinical needs

• Understand the military’s technology needs• Understand the clinical user’s requirements• Conduct meetings with the Army to identify the

breadth of technology targets for MTEC• Maintain communication with DoD focus area

leads• Build target product profiles• Speak with experts to fully understand the

potential for dual use




• Identify all approaches to solve a clinical need

• Conduct literature searches

Gather background info

• Speak with subject matter experts

• Interview inventors

• Interview technology users

Interviews

• Review IP ownership

• Evaluate status of protection

• Status of industrial interactions

Technology protection

• Identify major technology gaps

• Determine technology readiness level

• Recommend technology areas to include in RFP

• Generate report of findings

Analyze info

• Understand military requirements

• Define clinical requirements

Clinical need


Patients

Payers

Regulators

Risk capital

Commercial partners

IP

Better value

Project Selection

Rick SatcherMTEC Director of Commercialization


Clinical Needs


Market Assessment

Funding Analysis


• Dual use markets• Industry interest• IP protection• Leveraged funding

Overview

Market Assessments

Why conduct the assessment?


Industry interest in tech objective

ID potential market

applications

Help complete target product

profile

Market characteristics

Understand technology status

in the market

Market Assessments


• Incidence and prevalence • Market overview, growth rate• Industry sector overview• IP landscape

Secondary research

•Informed market feedback•Technology-specific feedback•Better assessment of commercial potential

Primary research

Ex questions we ask industry

• What is the size of the potential market? Where are the growth trends?

• What is the current state of development of the technology (in-house and in the market)?

• What are the development barriers you envision?• Where would you like to see funding focused to address these

barriers?• Are there complementary technologies that should be

developed/funded to make the technology more effective in meeting the need?

• What are potential applications and markets outside the primary one being considered?


Market Analysis

7/19/2016

MTEC Proprietary 48

• Industry overview

• Identify potential market applications

• Identify applicable technologies

Gather background info

• Speak with industry experts

• Determine areas of industry interest

• Understand market growth trends

Interviews

• Review IP landscape

• Licensee/ licensor partnerships

Technology protection

• Industry interest• IP landscape• Stage of

development• Competitive

advantage• Market

characteristics• Outside funding

potential• Generate report

of findings

Analyze info

• Understand military requirements

• Define market requirements

Market need

Susan Raymond, Ph.D.MTEC Director of Strategic Funding

The Objective of Philanthropy in MTEC

• Align the research and development priorities of MTEC with the interests of philanthropic leaders, thereby lifting the awareness of MTEC and its work among sources of private support

• Attract support for research initiatives, in collaboration or coordination or in parallel with public funders

• Develop opportunities for social finance that can bridge between traditional philanthropy and new mechanisms for social investing

• Contribute to the growth and sustainability of MTEC

The Structure of Philanthropy

Traditional Philanthropy

FoundationDonations Grants Nonprofit

Charitable Giving by Source 2014 – $358.58 billion

Charitable Giving by Sector2014 – $358.58 billion

Remember that Traditional Model? Well times change.

Source: S. Raymond. Finance for Hard Times. Wiley, 2008

The Arc of Innovation in Philanthropy

Traditional resource transfers

Traditional philanthropic resources at efficiency and scale

Traditional philanthropic resources demanding market-like results

Philanthropic resources moving in new ways onto the societal commons

Entirely new kinds of resources moving onto the societal commons

Social stock exchanges

Impact investingMRIs

Equity-like flowsBond-like flowsSocial business

Blended investments

CollaborativesInteractive hubsMultiple-funder

partnerships

Venture philanthropy

PRIsMicro-

insurance poolsEmbedded transfers

Charitable grants

What Changes?The Money: Grants vs loans vs equity vs bondsResults Expectations: Demonstrating the outcomes and their scalabilityTimeframes: From short to longFunder Role: From passive to engagedExpected Nonprofit Consequences: Scale

Source: S. Raymond. Recession, Recovery, Renewal. Wiley, 2013

Our Approach to Philanthropy

Key Components for Fundraising Success

The framework for any successful fundraising program includes these four (4) elements:

• A strong case for support

• Committed leadership with the ability to open doors and influence philanthropy

• A sufficient number of cultivated prospects necessary to achieve the campaign goal

• A comprehensive and well thought-out plan

For “public-private partnerships” the fundraising success elements are the same. But the philanthropist needs to see a clear distinction in roles. No philanthropist is interested in doing the government’s job. Hence,

• the case must pay particular attention to value propositions and roles; and, • governance must ensure a role for private funders in decision making.

This project requires us to plan and execute strategy that is BOTH Traditional AND Innovative

• We are developing strategy in terms of• Support for MTEC in general• Support for issues or constituencies• Support for specific research projects• Long-term continuous flows for a pipeline of research and technology development

• And we are developing tactics that are • Focused on institutions• Focused on philanthropic leaders• Focused on new technologies and crowdfunding

Motivations and Value Propositions

There are several value propositions embedded in MTEC that can speak to the interests of funders, both in terms of their own resources and in terms of supporting membership for their research grantees. The latter may also apply to associations or other organizational aggregators of companies or nonprofits.

Ability to proffer potential research areas for support, participate in RFP process, and/or co-fund research areas as leverage

RFP/White Paper Process

Intrinsic Issues Alignment

Offering opportunities to support the target group (veterans and military) or the issue (burns or blindness) for those that view this as a

primary philanthropic motivator

Inside knowledgeAccess to knowledge about relevant research and technology

regarding DOD and other Federal funders as well as dimensions of commercial markets

Commercialization Access

Access to systems and skills that improve project management on the commercialization pathway; ability to bring those skills to grantees

There are Four Market Segments

Leadership cuts across all segments and often ties them together. High net worth individuals, for example, are often heads of corporations and have family foundations as well as make individual gifts and serve on boards of nonprofits which may be focused on diseases of interest to MTEC. Therefore,

while institutional and individual donors are important, individuals as LEADERS of the process are absolutely critical to success.

Foundations

Private Independent

Family

Corporations

R&D Depts

Corporate Giving

Foundations

Employee Giving

Individuals

Donor Advised Funds

Medical Issue Interest

Military/ Veteran Interest

Nonprofits

Veterans/ Military NPs

Associations

Medical NPs

Universities

Summary of Value Propositions Against Markets

Next Steps

Develop fundraising policies, procedures and systems Develop funds that are topic-oriented Focus on priorities for Leadership Traditional research funding Awareness and market positioning Begin to explore innovative alternatives

Email Questions to [email protected] Contact Info Stacey Lindbergh, MTEC Executive Director 843.760.3566

[email protected] Allison Moody, MTEC Program Assistant 843.760.3344

[email protected]

Contact Information




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