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CCP2011 Ludlow
- 1. Welcome to the Community College Program DayBIO 2011Washington D.C.
- 2. Regenerative Medicine –Today and TomorrowJohn W. Ludlow, Ph.D.Senior Director, process Research & Assay DevelopmentEighth Annual Community College Program DayBIO International Convention, Washington, DC, June 2011
- 3. Forward Looking StatementsCertain 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.
- 4. The Early History of Regenerative MedicineThe past enables the present and guides the futurePrometheus BoundAeschylus~458 B.C.The Culture of OrgansAlexis Carrel & Charles Lindbergh19381954First Kidney Transplant1966Small bowel submucosa as vascular graftsT. Matsumoto, et al.1968First Bone Marrow Tx1977Allogeneic cartilageA.E. Gross, et al.FrankensteinModern PrometheusMary Shelley18181981Engineered skinE. Bell, et al.
- 5. Does Regenerative Medicine Have a Presence in the Present?Carticel®>35,000 original papers & reviews
- 6. >50 companies with products in clinical developmentBiomaterialsCellsCells + Biomaterials>5,000 FTEs worldwide
- 7. > 250 training institutions worldwide
- 8. > $1B in total revenue (2008)*
- 9. Products are reaching the marketAutologous chondrocytes for articular cartilage repairDermal patches / engineered skin for wound healingFibrin sealants and patchesCollagen matrix for surgical repairTrade Organizations are growingOASIS® Wound MatrixDermagraft®*www.masshightech.com (8/18/2008)
- 10. What Have we Learned?“The first products…just did not behave as originally intended once they entered the clinic.”
- 11. “…the challenges of commercial-scale manufacture were considerable.”
- 12. “…[the] biotechnology business model centered on out-licensing or partnering through joint ventures…proved wholly inappropriate…”
- 13. “…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
- 14. 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
- 15. 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
- 16. Applying our Knowledge ForwardTo increase probability of successCommercialViabilityScientificFeasibilitySuccessful Clinical & Commercial Translation:Constrain research with practical clinical and commercial limitations
- 17. Define development pathway in close collaboration with regulatory agencies
- 18. Strategic management of intellectual propertyPurposeful filing of enabled product-relevant patentsDiligent management of know-how & trade secretsStructure communication for public acceptance, medical understanding, and regulator / payer interactions
- 19. ‘Do not [complicate products] beyond necessity’ (Occam’s Razor)Tengion Product PipelinePhase IIIPhase IIPhase IINDPreclinicalOptimizationLead Programs in Development Neo-Urinary ConduitCystectomy due to Bladder CancerNeo-Kidney AugmentAdvanced CKDNeo-GI AugmentEsophagectomyShort Bowel SyndromeAdditional Platform Programs (not in active development) Neo-Bladder ReplacementCystectomyNeo-Bladder Augment (1st gen) Spina BifidaSpinal Cord InjuredUrge Incontinence (laparascopic)Neo-VesselReplacementVascular Access GraftPeripheral Artery BypassCoronary Artery Bypass
- 20. Iterative Combinatorial Approach to RegenerationDeriving the simplest effective solutionBiomaterialsRegenerative TemplateDeliveryCellsBioprocessINPUTSRaw MaterialsPRODUCT PROTOTYPECombination ProductsStimulate RegenerationIntegrate into HostREGENERATEDOUTCOME
- 21. Neo-Bladder AugmentLancet 2006 367:1241Application-specific Technology Evolutionfor translation of regenerative medicine productsBladder-derivedUrothelial cellsSmooth Muscle CellsBladder-derivedSmooth Muscle CellsAdipose-derivedSmooth Muscle CellsSMC-only BladderBertram et al., Experimental Biology 2009Neo-Urinary ConduitJain et al.,TERMIS 2010Iteration driven by operational & clinical necessity
- 22. A Future View for Regenerative MedicineSteady progress, product evolution, long-term vision201020152025RegeneratedOutcomeTargets - Cell Replacement or Structural Repair - Functional Tissue/Organ Replacement - Total Organ ReplacementCompatibility - One “Size” fits all - Multiple “Size” options - Personalized MedicineAvailability - Delayed Delivery - Rapid Delivery - Point-of-Care DeliveryComposition - Assembled combination products - More defined / integrative products - Inductive biologics