ccp2011 ludlow
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Welcome to the Community College Program Day
BIO 2011Washington D.C.
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Regenerative Medicine –Today and TomorrowRegenerative Medicine –Today and Tomorrow
John W. Ludlow, Ph.D.Senior Director, process Research & Assay Development
Eighth Annual Community College Program DayBIO International Convention, Washington, DC, June 2011
John W. Ludlow, Ph.D.Senior Director, process Research & Assay Development
Eighth Annual Community College Program DayBIO International Convention, Washington, DC, June 2011
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Certain statements in this presentation may constitute forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although Tengion believes that these statements are based upon reasonable assumptions within the bounds of its knowledge of its business and operations, there are a number of factors that may cause actual results to differ from these statements.
For instance there can be no assurance that: (i) the Company's Neo-Urinary Conduit clinical trial will not be placed on clinical hold by the Food and Drug Administration, or FDA; (ii) patients enrolled in the Company's Neo-Urinary Conduit clinical trial will not experience additional adverse events, which could delay clinical trials or cause the Company to terminate the development of the Neo-Urinary Conduit; (iii) the Company will be able to successfully enroll patients in its clinical trials, including its initial clinical trial for the Neo-Urinary Conduit; (iv) the results of the clinical trial for the Neo-Urinary Conduit will support further development of that product candidate; (v) data from the Company's ongoing preclinical studies will continue to be supportive of advancing its preclinical product candidates; and (vi) the Company will be able to progress its product candidates that are undergoing preclinical testing, including the Neo-Kidney Augment, into clinical trial and (vii) the Company will be able to obtain the capital it needs to develop its product candidates and continue its operations.
For additional factors which could cause actual results to differ from expectations, reference is made to the reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward looking statements in this presentation are made only as of the date hereof and the Company disclaims any intention or responsibility for updating predictions or expectations in this presentation.
Forward Looking StatementsForward Looking Statements
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The Early History of Regenerative MedicineThe past enables the present and guides the futureThe Early History of Regenerative MedicineThe past enables the present and guides the future
Prometheus Bound
Aeschylus~458 B.C.
The Culture of Organs
Alexis Carrel & Charles Lindbergh1938
FrankensteinModern Prometheus
Mary Shelley1818
1981 Engineered skinE. Bell, et al.
1977 Allogeneic cartilageA.E. Gross, et al.
1966 Small bowel submucosa as vascular graftsT. Matsumoto, et al.
First Kidney Transplant1954
First Bone Marrow Tx1968
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Does Regenerative Medicine Have a Presence in the Present?Does Regenerative Medicine Have a Presence in the Present?
• >35,000 original papers & reviews• >50 companies with products in
clinical development Biomaterials Cells Cells + Biomaterials
• >5,000 FTEs worldwide• > 250 training institutions worldwide• > $1B in total revenue (2008)*• Products are reaching the market
Autologous chondrocytes for articular cartilage repair
Dermal patches / engineered skin for wound healing
Fibrin sealants and patches Collagen matrix for surgical repair
• Trade Organizations are growing
*www.masshightech.com (8/18/2008)
Carticel®
Dermagraft®
OASIS® Wound Matrix
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What Have we Learned?What Have we Learned?
• “The first products…just did not behave as originally intended once they entered the clinic.”
• “…the challenges of commercial-scale manufacture were considerable.”
• “…[the] biotechnology business model centered on out-licensing or partnering through joint ventures…proved wholly inappropriate…”
• “…the capital value of publicly traded tissue engineering corporations dropped by almost 90%, from US$2.5 billion at the end of 2000 to $300 million by the end of 2002.”
Kempo P. History of Regenerative Medicine:Looking backwards to move forwards. Regen Med 1(5): 653-659, 2006
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What else Have we Learned?What else Have we Learned?
“Regenerative Medicine…after a period trapped in the notorious chasm, is now just starting to climb out the other side into mainstream clinical practice…we are probably leaving the chasm by a totally different route to the one we predicted when we tumbled in.”
Mason C. Regenerative medicine 2.0. Regen Med 2(1): 11-18, 2007
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The Future is Challenging…Do we Give Up?Not a Chance!The Future is Challenging…Do we Give Up?Not a Chance!
“Change is the law of life. And those who look only to the past or present are certain to miss the future.” John F. Kennedy
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Applying our Knowledge ForwardTo increase probability of successApplying our Knowledge ForwardTo increase probability of success
• Constrain research with practical clinical and commercial limitations
• Define development pathway in close collaboration with regulatory agencies
• Strategic management of intellectual property Purposeful filing of enabled product-relevant
patents Diligent management of know-how & trade
secrets
• Structure communication for public acceptance, medical understanding, and regulator / payer interactions
• ‘Do not [complicate products] beyond necessity’ (Occam’s Razor)
Successful Clinical & Commercial Translation:
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Peripheral Artery Bypass
Tengion Product PipelineTengion Product Pipeline
Advanced CKD
Cystectomy due to Bladder Cancer
Cystectomy
Spina Bifida
Spinal Cord Injured
Esophagectomy
Short Bowel Syndrome
Coronary Artery Bypass
Vascular Access Graft
Urge Incontinence (laparascopic)
Phase IIIPhase IIPhase IINDPreclinicalOptimization
Neo-Vessel Replacement
Neo-GI Augment
Neo-Kidney Augment
Neo-Urinary Conduit
Neo-Bladder Replacement
Neo-Bladder Augment (1st gen)
Additional Platform Programs (not in active development)
Lead Programs in Development
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Biomaterials
Cel
ls
INPUTSRaw Materials
Iterative Combinatorial Approach to RegenerationDeriving the simplest effective solutionIterative Combinatorial Approach to RegenerationDeriving the simplest effective solution
Bioprocess
Delivery
PRODUCT PROTOTYPECombination ProductsStimulate Regeneration
Integrate into Host
Regenerative Template
REGENERATEDOUTCOME
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Neo-Urinary ConduitJain et al.,
TERMIS 2010
Application-specific Technology Evolutionfor translation of regenerative medicine products Application-specific Technology Evolutionfor translation of regenerative medicine products
• Bladder-derived Urothelial cells Smooth Muscle Cells
• Bladder-derived Smooth Muscle Cells
• Adipose-derived Smooth Muscle Cells
Neo-Bladder Augment Lancet 2006 367:1241
Iteration driven by operational & clinical necessity
SMC-only BladderBertram et al.,
Experimental Biology 2009
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A Future View for Regenerative MedicineSteady progress, product evolution, long-term visionA Future View for Regenerative MedicineSteady progress, product evolution, long-term vision
Targets- Cell Replacement or Structural Repair
- Functional Tissue/Organ Replacement- Total Organ Replacement
Compatibility- One “Size” fits all
- Multiple “Size” options- Personalized Medicine
Availability- Delayed Delivery
- Rapid Delivery- Point-of-Care Delivery
Composition- Assembled combination products
- More defined / integrative products- Inductive biologics
RegeneratedOutcome
2010 2015 2025
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