1 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.org Welcome to the PMI Houston Conference & Expo and Annual Job Fair 2015 • Please put your phone on silent mode • Q&A will be taken at the close of this presentation • There will be time at the end of this presentation for you to take a few moments to complete the session survey. We value your feedback which allows us to improve this annual event.
Transcript
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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
• Please put your phone on silent mode
• Q&A will be taken at the close of this presentation
• There will be time at the end of this presentation for you to take a few moments to
complete the session survey. We value your feedback which allows us to improve
this annual event.
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
8
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
3
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
