A PMP Among PhDs: Applying Program Management to Biotechnology Research and Commercialization Speaker: Jill Almaguer, PE, MBA, PMP Company: Texas

Transcription

1 A PMP Among PhDs: Applying Program Management to Biotechnology Research and Commercialization Speaker: Jill Almaguer, PE, MBA, PMP Company: Texas Heart Institute Website: 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. 1

2 Agenda CCOB Objectives (Program Management by Moonshot) CCOB Stakeholder Characteristics Commercialization Opportunities Summary and Acknowledgements Q&A 2

3 The Center for Cell and Organ Biotechnology at TAMU and THI 3

4 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 4

5 Inextricable link: Human health Animal health Ecosystem health

6 CCOB Specific Objectives: 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 6

7 Aligning Projects to Moonshots Build a Heart in the Lab Develop New Treatments for Cardiovascular Disease Increase Life Expectancy by 50% 7

8 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

9 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. 9

10 Unique Resources at TAMU Translational and Commercialization One Health Veterinary Medical Teaching Hospital 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. 10

11 Unique Resources at TAMU Translation and Commercialization GLP animal studies & advanced imaging for preclinical translation Texas A&M Institute for Preclinical Studies One Health GMP Facility for Human Cell /Tissue/Organ Based Therapeutics National Center for Therapeutics Manufacturing Accelerates translation of cell based therapies from the bench through human clinical trials to commercialization 11

12 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 12

13 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 13

14 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 14

15 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 15

16 Commercialization Potential Cont d Technology Value Proposition Market Human 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 16

17 Commercialization Potential - Human and Vet Markets Technology Value Proposition Market In vivo therapeutics. Matrix-based cardiac gels & patches Human and Veterinary M Gels increase retention of stem cells delivered to injured organs; patches used to repair areas of heart damaged by MI or HF. Market for VADs ~$7B. Veterinary cell therapy for CVD Genetic predisposition for CVD in dogs and cats Expand beyond CVD market 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 antirejection drugs Market for organ transplants ~$28B 17

18 When? = Milestones Critical Path ExtraCellular Matrix - Cells - Recell Decell: sterile, storage, speed 1 8 Cells: prepare, select type, production 2 4 Recell: sterile, assays, cells delivery, media, location, route, mixtures

19 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

20 Triple Constraint 1 Science Scope: Cardiac Patch Requirements 2 Schedule: Critical tasks Non-critical tasks Risks 3 Resources: People Equipment Materials Science Scope: Scale Up Decellurization 4 Schedule: Critical tasks Non-critical tasks Risks 5 Resources: People Equipment Materials 6

21 Program Management Desired Outcomes Team building Shared Moonshot Goals, CCOB, Bioartificial Heart, Papers 1 Develop shared plans that will predict critical path to moonshot goals 2 Integrate calendar for projects to enable completion by year end without impacting critical path on program moonshots 3

22 Know your Predecessors Predecessor Links Start to Finish Start to Start Finish to Finish Finish to Start Example We must build the house before we can move in.

23 Setting Priorities Leadership Team Communications as easy as 1, 2, 3 II. NOT URGENT and IMPORTANT Regular cleaning of lab areas Going to lunch or scheduled PTO Complete mandatory training Reading , journals Professional society meetings Communicate 1 update/week III. NOT URGENT and NOT IMPORTANT Time wasters Unproductive activities Long term general interest tasks Communicate updates monthly Summary I. URGENT and IMPORTANT Focus on these items Top Priorities Critical path tasks/risks Recruiting Providing lab tours Communicate 1-2 updates/week II. URGENT and NOT IMPORTANT catch the 6pm bus to parking Take the train Communicate 1 update/week

24 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. 24

25 Acknowledgments: 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 25

26 Contact Information Speaker: Jill Almaguer, PE, MBA, PMP Company: Texas Heart Institute Website: Phone: Thank You 26