Welcome to the Community College Program DayBIO 2011Washington D.C.<br />
Regenerative Medicine –Today and Tomorrow<br />John W. Ludlow, Ph.D.<br />Senior Director, process Research & Assay Develo...
Forward Looking Statements<br />Certain statements in this presentation may constitute forward looking statements within t...
The Early History of Regenerative MedicineThe past enables the present and guides the future<br />Prometheus Bound<br />Ae...
Does Regenerative Medicine Have a Presence in the Present?<br />Carticel®<br /><ul><li>>35,000 original papers & reviews
>50 companies with products in clinical development</li></ul>Biomaterials<br />Cells<br />Cells + Biomaterials<br /><ul><l...
> 250 training institutions worldwide
> $1B in total revenue (2008)*
Products are reaching the market</li></ul>Autologous chondrocytes for articular cartilage repair<br />Dermal patches / eng...
What Have we Learned?<br /><ul><li>“The first products…just did not behave as originally intended once they entered the cl...
“…the challenges of commercial-scale manufacture were considerable.”
“…[the] biotechnology business model centered on out-licensing or partnering through joint ventures…proved wholly inapprop...
“…the capital value of publicly traded tissue engineering corporations dropped by almost 90%, from US$2.5 billion at the e...
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CCP2011 Ludlow

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CCP2011 Ludlow

  1. 1. Welcome to the Community College Program DayBIO 2011Washington D.C.<br />
  2. 2. Regenerative Medicine –Today and Tomorrow<br />John W. Ludlow, Ph.D.<br />Senior Director, process Research & Assay Development<br />Eighth Annual Community College Program DayBIO International Convention, Washington, DC, June 2011<br />
  3. 3. Forward Looking Statements<br />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. <br />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.<br />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.<br />
  4. 4. The Early History of Regenerative MedicineThe past enables the present and guides the future<br />Prometheus Bound<br />Aeschylus<br />~458 B.C.<br />The Culture of Organs<br />Alexis Carrel & <br />Charles Lindbergh<br />1938<br />1954<br />First Kidney Transplant<br />1966<br />Small bowel submucosa as vascular grafts<br />T. Matsumoto, et al.<br />1968<br />First Bone Marrow Tx<br />1977<br />Allogeneic cartilage<br />A.E. Gross, et al.<br />Frankenstein<br />Modern Prometheus<br />Mary Shelley<br />1818<br />1981<br />Engineered skin<br />E. Bell, et al.<br />
  5. 5. Does Regenerative Medicine Have a Presence in the Present?<br />Carticel®<br /><ul><li>>35,000 original papers & reviews
  6. 6. >50 companies with products in clinical development</li></ul>Biomaterials<br />Cells<br />Cells + Biomaterials<br /><ul><li>>5,000 FTEs worldwide
  7. 7. > 250 training institutions worldwide
  8. 8. > $1B in total revenue (2008)*
  9. 9. Products are reaching the market</li></ul>Autologous chondrocytes for articular cartilage repair<br />Dermal patches / engineered skin for wound healing<br />Fibrin sealants and patches<br />Collagen matrix for surgical repair<br /><ul><li>Trade Organizations are growing</li></ul>OASIS® <br />Wound Matrix<br />Dermagraft®<br />*www.masshightech.com (8/18/2008)<br />
  10. 10. What Have we Learned?<br /><ul><li>“The first products…just did not behave as originally intended once they entered the clinic.”
  11. 11. “…the challenges of commercial-scale manufacture were considerable.”
  12. 12. “…[the] biotechnology business model centered on out-licensing or partnering through joint ventures…proved wholly inappropriate…”
  13. 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.”</li></ul>Kempo P. History of Regenerative Medicine:<br />Looking backwards to move forwards. Regen Med 1(5): 653-659, 2006<br />
  14. 14. What else Have we Learned?<br />“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.”<br />Mason C. Regenerative medicine 2.0. Regen Med 2(1): 11-18, 2007<br />
  15. 15. The Future is Challenging…Do we Give Up?Not a Chance!<br />“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<br />
  16. 16. Applying our Knowledge ForwardTo increase probability of success<br />Commercial<br />Viability<br />Scientific<br />Feasibility<br />Successful Clinical & Commercial Translation:<br /><ul><li>Constrain research with practical clinical and commercial limitations
  17. 17. Define development pathway in close collaboration with regulatory agencies
  18. 18. Strategic management of intellectual property</li></ul>Purposeful filing of enabled product-relevant patents<br />Diligent management of know-how & trade secrets<br /><ul><li>Structure communication for public acceptance, medical understanding, and regulator / payer interactions
  19. 19. ‘Do not [complicate products] beyond necessity’ (Occam’s Razor)</li></li></ul><li>Tengion Product Pipeline<br />Phase III<br />Phase II<br />Phase I<br />IND<br />Preclinical<br />Optimization<br />Lead Programs in Development <br />Neo-Urinary Conduit<br />Cystectomy due to Bladder Cancer<br />Neo-Kidney Augment<br />Advanced CKD<br />Neo-GI Augment<br />Esophagectomy<br />Short Bowel Syndrome<br />Additional Platform Programs (not in active development) <br />Neo-Bladder Replacement<br />Cystectomy<br />Neo-Bladder Augment (1st gen) <br />Spina Bifida<br />Spinal Cord Injured<br />Urge Incontinence (laparascopic)<br />Neo-VesselReplacement<br />Vascular Access Graft<br />Peripheral Artery Bypass<br />Coronary Artery Bypass<br />
  20. 20. Iterative Combinatorial Approach to RegenerationDeriving the simplest effective solution<br />Biomaterials<br />Regenerative Template<br />Delivery<br />Cells<br />Bioprocess<br />INPUTS<br />Raw Materials<br />PRODUCT PROTOTYPE<br />Combination Products<br />Stimulate Regeneration<br />Integrate into Host<br />REGENERATED<br />OUTCOME<br />
  21. 21. Neo-Bladder Augment<br />Lancet 2006 367:1241<br />Application-specific Technology Evolutionfor translation of regenerative medicine products<br /><ul><li>Bladder-derived</li></ul>Urothelial cells<br />Smooth Muscle Cells<br /><ul><li>Bladder-derived</li></ul>Smooth Muscle Cells<br /><ul><li>Adipose-derived</li></ul>Smooth Muscle Cells<br />SMC-only Bladder<br />Bertram et al., <br />Experimental Biology 2009<br />Neo-Urinary Conduit<br />Jain et al.,<br />TERMIS 2010<br />Iteration driven by operational & clinical necessity<br />
  22. 22. A Future View for Regenerative MedicineSteady progress, product evolution, long-term vision<br />2010<br />2015<br />2025<br />Regenerated<br />Outcome<br />Targets<br /> - Cell Replacement or Structural Repair<br /> - Functional Tissue/Organ Replacement<br /> - Total Organ Replacement<br />Compatibility<br /> - One “Size” fits all<br /> - Multiple “Size” options<br /> - Personalized Medicine<br />Availability<br /> - Delayed Delivery<br /> - Rapid Delivery<br /> - Point-of-Care Delivery<br />Composition<br /> - Assembled combination products<br /> - More defined / integrative products<br /> - Inductive biologics<br />
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