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A PMP Among PhDs: Applying Program

Management to Biotechnology Research and

Commercialization

Speaker: Jill Almaguer, PE, MBA, PMP

Company: Texas Heart Institute

Website: www.texasheart.org, www.ccobtexas.orgWelcome to the PMI Houston Conference & Expo and Annual Job Fair 2015

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Agenda

• CCOB Objectives (Program Management

by Moonshot)

• CCOB Stakeholder Characteristics

• Commercialization Opportunities

• Summary and Acknowledgements

• Q&A

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The Center for

Cell and Organ Biotechnologyat TAMU and THI

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Executive Summary

• Recruit the globally renowned scientist,

Dr. Doris Taylor, and others to Texas

• Establish joint research Center for Cell and Organ Biotechnology (CCOB) at TAMU and THI – a unique national center to develop and commercialize cell based therapeutics and personalized organ replacements

• Utilize resources of both institutions synergistically to support and grow research capacity in both and commercialization of technologies from both

• Catalyze future growth of “One Health” at TAMU through collaborations at Texas Medical Center

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• Inextricable link:

– Human health

– Animal health

– Ecosystem health

Develop, test, and commercialize disruptive cell & organ

biotechnologies and molecular tools;

build the medicines of tomorrow

• Diagnostics. Blood-based cell profiling that allows evaluations

of health status & identification of treatment “responders” vs.

“non-responders”

• In vitro therapeutics. Personalized, customizable matrix-based

drug test beds that incorporate a patient’s own stem cells

• In vivo therapeutics. Patches that effectively deliver

autologous adult stem cells to repair damaged hearts; CVD cell

therapy for veterinary patients

• Solutions for end-stage organ failure. Biological scaffolds to

grow organs for replacement using a patient’s own stem cells

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CCOB Specific Objectives:

Aligning Projects to Moonshots

• Build a Heart in the Lab

• Develop New Treatments for

Cardiovascular Disease

• Increase Life Expectancy by 50%

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We Choose:• “We choose to go to the moon and do the other

things, not because they are easy, but because

they are hard.” *

• Who? Stakeholders: Sponsors, Participants

• What? Requirements – moonshot projects

• Where? TAMU and THI

• When? Milestones Critical Path

• Why? Change the World

• How? Triple Constraint

* President Kennedy at Rice University

TAMU-CVM/THI Partnership• TAMU-CVM will provide Dr. Taylor

commercialization support, lab space, research

collaborators, graduate students & post-docs.

• THI will provide renovated lab space, equipment,

research staff & collaborators, commercialization

support, & clinical trial capacity.

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• Veterinary Medical Teaching Hospital

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Unique Resources at TAMUTranslational and Commercialization

The CCOB will have access to a patient caseload of >20,000/yr

with care given to >80,000 animals/year and over 145 clinical

faculty specialists in a wide variety of disciplines, making

available spontaneously occurring diseases for clinical trials and

onsite expertise to collaborate.

One Health

Unique Resources at TAMUTranslation and Commercialization

GMP Facility for Human

Cell /Tissue/Organ

Based Therapeutics

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Texas A&M Institute for Preclinical

Studies

GLP animal studies &

advanced imaging for

preclinical translation

Accelerates translation of cell based therapies from the bench

through human clinical trials to commercialization

National Center for Therapeutics

Manufacturing

One Health

Unique Resources at THI

• 70,000 sf contiguous lab space in Cooley Building

• Research collaborators

• First in human clinical studies

• World-renown transplant and artificial heart programs

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Unique Resources at THI• Focus on clinical relevance and application

• Hospital affiliations

• Access to patients

– CHI Baylor St. Luke’s Medical Center Hospital

– Texas Children’s Hospital

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Commercialization

• Establishing Sr. Licensing Associate dedicated to CCOB technologies

• Targeting companies – licensing agreements– Spin out companies in Texas - create jobs

– Existing small companies

– Existing large companies

• New, dynamic, burgeoning commercial opportunity

• A target rich environment needs portfolio program management

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Commercialization Potential - Human Market

Technology Value Proposition Market

Diagnostics.

Blood-based

• biomarkers of:

- disease

- response to

treatment

• indicators of

cell physiologic

vs. biologic age

• cell product

potency

Define individuals’ capacity

to respond to drugs, genes,

cells by changes in blood.

Define “health and capability

” of patient specific cells

prior to use in clinical trial

Fewer non-responders

enrolled in clinical trials;

Fewer subjects required for

Phase 2 & 3 trials.

Target clinical research

organizations; High

gross margin potential

(est. 80%);

Market size >$3B

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Commercialization Potential Cont’d

Human MarketTechnology Value Proposition Market

In vitro

therapeutics.

Matrix-based drug

test beds;

• Genotype

specific

• Vulnerable

populations

(e.g., pregnant

women,

children)

• Patient specific

Lower costs for drug testing;

reproducible & more indicative

of human response;

Decreased use of animals in

research studies.

Decreased post approval

withdrawal (e.g., Vioxx)

Target pharmaceutical

companies; High gross

market potential (est.

80%); Market size ~$2B

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Commercialization Potential - Human and Vet Markets

Human and Veterinary MTechnology Value Proposition Market

In vivo

therapeutics.

Matrix-based

cardiac gels &

patches

Veterinary cell

therapy for

CVD

Gels increase retention of

stem cells delivered to

injured organs; patches

used to repair areas of

heart damaged by MI or

HF.

Genetic predisposition for

CVD in dogs and cats

Expand beyond CVD

market…

Market for VADs

~$7B.

Market for pet

therapies

Solutions for

organ failure.

Biological

organ scaffolds

+ stem cells

Create fully functional

organs using 3D tissue

matrix & autologous stem

cells; eliminate tissue

rejection & need for anti-

rejection drugs

Market for organ

transplants ~$28B

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When? = Milestones Critical Path

ExtraCellular Matrix - Cells - Recell

Decell: sterile,

storage, speed

Cells: prepare, select type, production

Recell: sterile, assays, cells delivery,

media, location, route, mixtures

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2

1

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2

4

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How? = Teamwork• Hire the best people

• Give them the training, tools, and environment to

do their best work (MBO)

• Estimate activities and duration based on

experience

• Check critical path status frequently = scope,

schedule, resources (people, equip, material)

• Escalate issues early

• Celebrate successful milestones

1Science Scope:

Cardiac Patch Requirements

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Science Scope:

Scale Up Decellurization

2Schedule:

Critical tasksNon-critical tasks

Risks

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Schedule:

Critical tasksNon-critical tasks

Risks

3Resources:

PeopleEquipmentMaterials

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Resources:

PeopleEquipmentMaterials

Triple Constraint

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2

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Team building – Shared Moonshot Goals, CCOB, Bioartificial Heart, Papers

Program Management Desired Outcomes

Develop shared plans that will predict critical path to moonshot goals

Integrate calendar for projects to enable completion by year end without

impacting critical path on program moonshots

Example

We must build the

house before we

can move in.

Predecessor Links

• Start to Finish

• Start to Start• Finish to Finish• Finish to Start

Know your Predecessors

II. NOT URGENT and IMPORTANT I. URGENT and IMPORTANT

III. NOT URGENT and NOT IMPORTANT II. URGENT and NOT IMPORTANT

• Regular cleaning of lab areas• Going to lunch or scheduled PTO• Complete mandatory training• Reading email, journals• Professional society meetings• Communicate 1 update/week

• Focus on these items• Top Priorities• Critical path tasks/risks• Recruiting• Providing lab tours• Communicate 1-2 updates/week

• Time wasters• Unproductive activities• Long term general interest tasks• Communicate updates monthly• Summary

• catch the 6pm bus to parking• Take the train• Communicate 1 update/week

Setting Priorities – Leadership Team Communications as easy as 1, 2, 3

Summary

• Cutting edge biotechnology research takes time and cross-functional

resources to go from pre-clinical and clinical trials to

commercialization.

• Texas Heart Institute (THI) and Texas A&M University (TAMU)

System Office of Technology Commercialization are leveraging

program management expertise to start-up the collaborative Center.

• The CCOB includes grant funded staff and leadership from TAMU

College of Veterinary Medicine and Biomedical Sciences and THI

Regenerative Medicine Research.

• First year Emerging Technology Fund grant milestones have been

met, and continued growth of the collaborative center requires

program management coordination to ensure resources applied to

proposed new projects are aligned with the future milestones.

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Eleanor M. Green, DVM, DACVIM, DABVP The Carl B. King Dean of Veterinary Medicine

Texas A&M University

Doris A. Taylor, PhD, FAHA, FACC

Director, Regenerative Medicine Research Department, THI

Director, Center for Cell and Organ Biotechnology

Adjunct Professor, TAMU College of Veterinary Medicine and

Biomedical Sciences

Acknowledgments:

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Contact Information• Speaker: Jill Almaguer, PE, MBA, PMP

• Company: Texas Heart Institute

• Website: www.texasheart.org, www.ccobtexas.org

• Phone: 832-355-9489

• E-mail: jalmaguer@texasheart.org

Thank You