Conan Young, Ph.D.
Founder/Principal of CY Preclinical Consulting LLC
I bring over 20 years of commercially-focused expertise in the development and manufacturing of biologic/device combination products for regenerative medicine that include recombinant proteins, living cell therapies, human tissue allograft, and/or bioresorbable devices. I have a Ph.D. with a scientific background in cell biology, protein biochemistry, molecular biology and microbiology. I have held R&D leadership roles at several pharmaceutical and medical device companies including Stryker, Wright Medical, Shire Pharmaceuticals, Advanced BioHealing and BioMimetic Therapeutics, and academically with the Harvard/Forsyth Institute developing combination products that provide solutions for unmet regenerative medicine applications.
Detailed Bio
Recombinant protein/device experience My track record of success includes contributing to the preclinical development of two commercially-successful recombinant PDGF-BB protein growth factor/device combination products, AUGMENT® Bone Graft and AUGMENT® Injectable, only the second and third combination products of this type approved by FDA and internationally for orthopaedic bone repair. Leading a team of cross-functional technical experts, I oversaw the successful technical transfer of the biologic PDGF drug substance manufacturing process to a new CMO.
Cell therapy/device experience I led the nonclinical R&D effort characterizing the safety and efficacy of a living human neonatal dermal fibroblast cell/device combination product, known as DERMAGRAFT®, for treatment of diabetic foot ulcers (DFUs), and to explore new uses in venous leg ulcer (VLU) and dystrophic epidermolysis bullosa (DEB) treatment. My experience extends to cell therapy manufacturing where I led a cross-functional team of experts in the successful technical transfer of a human endothelial cell therapy clinical manufacturing process to a new CMO.
Human tissue allograft experience I led preclinical R&D product characterization and a team developing analytical methods supporting human amniotic tissue allograft products, EPIFIX® and AMNIOFIX®, and their development for new uses and indications. I provided expert support for product commercialization in the field, and contributed to the advancement of clinical testing of amniotic tissue products to Phase 2 clinical trials.
Regulatory experience I have directly interfaced as a preclinical/nonclinical SME with regulatory agency experts at FDA, Health Canada, and notified bodies in the EU (EMEA) to partner with and defend development strategies for biologic/device combination products. I have authored nonclinical dossiers/summaries in support of IND, IDE, PMA and BLA regulatory submissions that went on to receive regulatory approvals. I am an author on over 25 peer-reviewed scientific publications and inventor on 4 U.S. patents.
Scientific Publications
Massee, M., Chinn, K., Lim, J.J., Godwin, L., Young, C.S., and T.J. Koob. 2016. Type I and II diabetic adipose-derived stem cells respond in vitro to dehydrated human amnion/chorion membrane allograft treatment by increasing proliferation, migration, and altering cytokine secretion. Adv. Wound Care (New Rochelle) 5(2): 43-54.
https://pubmed.ncbi.nlm.nih.gov/26862462
Massee, M., Chinn, K., Lei, J., Lim, J.J., Young, C.S., and T.J. Koob. 2015. Dehydrated human amnion/chorion membrane regulates stem cell activity in vitro. J. Biomed. Mater. Res. B Appl. Biomater. Doi: 10.1002/jbm.b.33478.
https://pubmed.ncbi.nlm.nih.gov/26175122
Koob, T.J., Young, C.S., Lim, J.J., Chinn, K., Massee, M., Carter, M., Spencer, R., Mason, D., and Fetterolf, D.. 2015. “A Primer on Amniotic Membrane Regenerative Healing”. Reviewed by Li, W.W. and Moyer, M.P.. MiMedx/Color House Graphics, Grand Rapids, MI.
Perrien D.S., Young C.S., Alvarez-Urena P.P., Dean D.D., Lynch S.E., and Hollinger J.O. 2013. Percutaneous injection of augment injectable bone graft (rhPDGF-BB and β-tricalcium phosphate [β-TCP]/bovine type I collagen matrix) increases vertebral bone mineral density in geriatric female baboons. Spine J. 13(5): 580-586.
https://pubmed.ncbi.nlm.nih.gov/23541446
Young, C.S., Bradica, G., Hart, C.E., Karunanidhi, A., Street, R.M., Schutte, L., and J.O. Hollinger. 2011. Preclinical toxicology studies of recombinant human platelet-derived growth factor-BB either alone or in combination with beta-tricalcium phosphate and type I collagen. J. Tissue. Eng. 2010: 1-8.
https://pubmed.ncbi.nlm.nih.gov/21350649
Young, C.S., Ladd, P.A., Browning, C.F., Thompson, A., Bonomo, J., Shockley, K. and C.E. Hart. 2009. Release, biological potency, and biochemical integrity of recombinant human platelet-derived growth factor-BB (rhPDGF-BB) combined with AugmentTM Bone Graft or GEM 21S beta-tricalcium phosphate (b-TCP). J. Control. Release 140(3): 250-255.
https://pubmed.ncbi.nlm.nih.gov/19577598
Abukawa H., Zhang W., Young C.S., Asrican R., Vacanti J.P., Kaban L.B., Troulis M.J., and P.C. Yelick. 2009. Reconstructing mandibular defects using autologous tissue-engineered tooth and bone constructs. J. Oral Maxillofac. Surg. 67(2): 335-347.
https://pubmed.ncbi.nlm.nih.gov/19138608
Sharpe, P.T. and C. S. Young. 2005. Test-Tube Teeth. Scientific American 293(2): 34-42.
https://pubmed.ncbi.nlm.nih.gov/16053135
Young, C.S., Abukawa, H., Asrican, R., Ravens, M., Troulis, M.J., Kaban, L.B., Vacanti, J.P., Bartlett, J.D. and P.C. Yelick. 2005. Tissue-engineered hybrid tooth and bone. Tissue Engineering 11(9/10): 1599-1610.
https://pubmed.ncbi.nlm.nih.gov/16259613
Kubota, K., Lee, D.H., Tsuchiya, M., Young, C.S., Everett, E.T., Martinez-Mier, E.A., Snead, M.L., Nguyen, L., Urano, F., and J.D. Bartlett. 2005. Fluoride induces ER stress in ameloblasts responsible for dental enamel formation. J. Biol. Chem. 280(24): 23194-23202.
https://pubmed.ncbi.nlm.nih.gov/15849362
Young, C.S., Kim, S.W., Qin, C., Baba, O., Butler, W.T., Taylor, R.R., Vacanti, J.P., Bartlett, J.D., and P.C. Yelick. 2005. Developmental analysis and computer modeling of bioengineered teeth. Arch. Oral Biol. 50: 259-265.
https://pubmed.ncbi.nlm.nih.gov/15721159
Duailibi, M., Duailibi, S., Young, C. S., Bartlett, J. D., Vacanti, J. P., and P. C. Yelick. 2004. Bioengineered teeth from cultured rat tooth bud cells. J. Dent. Res. 83(7):523-8.
https://pubmed.ncbi.nlm.nih.gov/15218040
Young, C. S., Terada, S., Vacanti, J.P., Honda, M., Bartlett, J.D., and P.C. Yelick. 2002. Tissue engineering of complex tooth structures on biodegradable polymer scaffolds. J. Dent. Res. 81: 695-700. (received William J. Geis award for best paper in JDR for 2002)
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