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斯尔伯克朗,梅尔文(Silberklang,Melvin)

核心提示: Highlights of Qualifications Adelphi University: Revised and updated graduate level Biotechnology lecture course (Bio


Adelphi University: Revised and updatedgraduate level Biotechnology lecture course (Bio 645).

York College/CUNY: Educational developmentand new course development, Biotechnology Major revision; teaching intro,advanced & non-major Bio, Molec. Bio, Biotech., Cell Bio. (Bio 120, 202,301, 320; Btec 203, 302, 480); strong experience in development and teaching ofnew lecture & lab courses.

Guest lecturer at Columbia UniversityBiomedical Engineering Seminar course, 2007, 2009

Guest lecturer at Rutgers UniversityBioprocess Engineering Seminar course, 2008

Guest lecturer, University of California,Berkeley, Dept. Bioengineering, 2006

Guest lecturer at Adelphi UniversityBiotechnology Program seminar course, 2002

Board of Advisors, Adelphi UniversityBiotechnology Master’s Degree Program, 2000 - 2005

Designed, oversaw and taught in-house celland molecular biology and wound healing training programs for new technicalhires and product sales and marketing rep’s, Ortec International, Inc.,1996-2003

Organizer and secondary lecturer incondensed Cell Biology course, taught by Prof. Harvey Lodish (MIT) for staff ofDept. of Cell & Molecular Biology, Merck Research Labs, 1992

Proven success in managing and guidingtranslational Biopharmaceutical and Cell Therapy R&D programs throughpre-clinical research, clinical trials and FDA approval (PMA).

Professional Experience

Adelphi University, Dept. Biology

2015 – Present

Professor, Adjunct

Presently teaching introductory graduatelevel course in Biotechnology (Bio 645); greatly revised and uopdated scope ofcourse using new advanced textbook.

York College/CUNY, Dept. Biology

2010

- Present

Professor, Substitute

2011

– 2012

Professor, Adjunct

2010

- Present

Taught biological principles (Bio 202),molecular biology and biotechnology (Btec 203, Bio 301) and human genetics fornon-majors (Bio 120); taught Biotech and Biopharm course of entirely own design(Bio 302) Spring 2014; presently teaching Cell Bilology laboratory course (Bio320) and senior level advanced molecular biology Bio/BTec 480).

Helped develop first syllabus andincorporated new online resources for new Biology Dept. course in MolecularBiology and Biotechnology, Bio 301; course and teaching very highly rated bypeer review and by students.

Developed completely new laboratory modulein protein biochemistry using Baculovirus gene expression

Innovated new online homework module systemthat increased student comprehension and raised grades

Developed innovative newBiotechnology/Biopharmaceuticals course, lecture and lab (Btec 302) andshepherded its approval as a new requirement for the undergraduateBiotechnology major (Biotechnology Major revision)

Well received and very highly rated course– lecture and lab – as well as teaching performance (by students)

Developed preliminary proposals foradditional new lecture course and a new laboratory course in biopharmaceuticals

ForticellBioscience Inc. (formerly Ortec International) N.Y., N.Y.

1995

– Present

Chief Scientific Officer, Inactive

2010

– Present (Consulting)

Chief Scientific Officer

2002- 2010

Vice President, Research and Development(‘95, Acting)

1996- Present (Consulting)

Initiated and guided acquisition of HaptoBiotech (Israel) and melding of Forticell and Hapto research.

Developed (w/Hapto) two new biomaterialmatrices, Haptized Collagen Sponge and Micronized Collagen Sponge, for use ininjectable soft tissue augmentation, cosmetic tissue engineering andmesenchymal stem cell based cartilage tissue engineering (current researchinterest)

Designed and implemented preclinicalresearch program to validate Fibrin Microbead (FMB) Mesenchymal Stem Cellisolation and in vivo delivery technologies in animal models (currentinterest).

Managed technology transfer andrelationship with contract manufacturer for OrCel? manufacturing.

Developed and optimized biomaterials, cellculture, cryopreservation and manufacturing processes, to produce OrCel?Bilayered Cellular Matrix, a tissue-engineered “skin substitute” wound healingdevice. Developed and validated state-of-the-art in-process and Q.C. releasetests. Wrote and edited technical submissions for three IDE’s and two HDE’s,all approved by FDA including complete Manufacturing (CMC) and other technicaldata. Obtained accelerated 6-month FDA approval of PMA (2001) for use of ORCELin treatment of donor site acute wounds in burn victims.

Created, established and managedForticell’s Tissue Bank; obtained and maintained Federal establishment approvaland New York State licensure.

Major Program Achievements

Designed, built and validated efficient,cost-effective R&D and pilot production facility

Recruited, hired, trained and managed staffof over 25 R&D scientists & engineers

Developed cell therapy production and QCfor clinical trials and manufacturing

Set up and managed licensed Tissue Bank

Obtained two FDA marketing approvals, anHDE and a PMA

Molecular Biology, Biomaterials and CellCulture Consulting, General 1995 -Present

Designed and oversaw a variety ofpre-clinical tissue engineering and wound healing studies as well asmanufacturing process development and analytical methods projects, evaluatedcommercial biopharmaceutical research and development programs and recommendedcost effective experimental approaches and scalable process technologies,helped troubleshoot research problems for biotechnology clients in diverse fields,including Tissue Banking, Tissue Engineering, Biomaterials Manufacturing, GeneTherapy, Recombinant Protein Production, Baculovirus Gene Expression Technologyand Antibody Engineering. Set up project planning and tracking, cGMP protocolsand Quality Management documentation, wrote FDA applications and documentation,and participated in FDA meetings in behalf of clients.

EnzonInc., Piscataway, NJ

1993-1995

Senior Director, Process Research andDevelopment

Prepared all production (CMC), technicaland product description documentation for successful FDA IND submissionregarding the use of recombinant PEGylated GlucoCerebrosidase (GC) as an enzymereplacement therapy to treat the genetic deficiency syndrome, Gaucher Disease.

Led development, documentation andimplementation of unique, economical cGMP Baculovirus-based production processfor production of GC. Completed cGMP production campaign, one of the first inthe world using Baculovirus technology. Phase I clinical trial was launchedwith this material.

Developed novel recombinant gene expressionand metabolic engineering strategies for second generation GC expression in theBaculovirus system, which tripled yield.

Developed high-level GC expression in theyeast host organism, Pichia pastoris.

Achievements

Secured two IND approvals within 20 months.

Developed one of the firstBaculovirus-based biopharmaceutical production systems to enter clinicaltrials.

Instituted low-cost modular bioreactor,recovery and purification systems suitable for stepwise scale-up of productionto meet future market needs.

Designed and built cost-effective soft-wallclean room production facility

Merck Research Laboratories, Rahway, NJ

1981 - 1993

Associate Director, Cellular &Molecular Biology

1988 - 1993

Recruited, hired and managedmultidisciplinary group of PhD’s, MS’s and BS’s, including molecularbiologists, biochemists, cell biologists and biochemical engineers.

Conducted cell and molecular biologytraining for new hires from varied disciplines

Directed protein engineering and geneexpression as well as all preclinical Process R&D for 5

major protein biopharmaceutical productcandidates, including 3 recombinant antibodies.

Humanized and expressed multiplerecombinant antibody proteins in CHO and NS0 cells. Developed serum-free mediaand fed-batch and perfusion culture processes that improved CHO and NS0productivity up to tenfold.

Developed novel scalable viral vaccineprocess for Varicella Zoster Virus (Chicken Pox and Shingles), and consulted onscale-up of two other vaccines. Participated in GMP cell and viral seedpreparation.

Developed and headed the original R&Dprogram (1992-3) that eventually led to the recently FDA approvedanti-human-Papillomavirus, female cervical cancer-preventing vaccine, Gardasil.

Achievements

Developed pragmatic product and processdevelopment strategies that fostered seamless process transfers to large-scalepilot production.

Optimized recombinant expression andfed-batch cell culture production processes to achieve, in its time, thehighest antibody product yield ever reported (1.8 g/L).

Developed new cell and viral seedproduction strategies for viral vaccine candidate.

Research Fellow

1981 - 1988

Established cell culture scale-up group anddesigned and oversaw construction and equipping of state-of-the-art cGMP animalcell bioreactor clean-room suite, the first of its kind at Merck. Establishedcentral animal cell gene expression group and expressed over 15 recombinantproteins at high levels, ranging from viral antigens to hormones to receptors.

Developed and executed $2,200,000 capitalexpenditure plan to design, build and fully equip both molecular biology andscale-up laboratories; supervised move to new facilities and planned futureexpansion; set up departmental Apple computer network with help of corporate ITprofessionals.

Expressed Herpes and Epstein-Barr Viralantigens in mammalian cells as vaccine candidates. Epstein-Barr gp350 vaccineshown to protect marmoset monkeys against viral challengeDeveloped novelmammalian cell gene expression vectors based on autonomous plasmids and viralpromoters.

Dept. Biochem. and Biophys., U.C.S.F., SanFrancisco, CA

1977 - 1981

Assistant Research Biochemist

1980 - 1981

Studied Drosophila molecular genetics,development and cell biology, including tRNA and structural RNA genes andcellular lipid metabolism as Principal Investigator under own N.S.F. researchgrant support: Structure and Expression of Drosophila tRNA Genes.

Postdoctoral Fellow

1977-1980

Studied Drosophila molecular genetics anddevelopment under Prof. Brian McCarthy.

Analyzed DNA sequences and chromosomalstructures and evolution of tRNA gene clusters and identified developmentalinfluences on gene expression.

Dept. Biology, M.I.T., Cambridge, MA

1971-1976

Ph.D. Candidate and Postdoctoral Fellow(Sept-Dec 1976)

Developed novel RNA sequencing andnucleotide analytical methods and appliedthese to elucidating tRNA, 5S RNA andRNA viral genome structures, under Prof. U.L. RajBhandary (H.G. Khorana group);several of these methods have remained standards in the field.

Education

School

Year

Course

Degree

Mass. Inst. Tech.

1977

Biochemistry

Ph.D.

Columbia College

1971

Biology

B.A.

Continuing:

Merck

1992

Molecular Cell Biology

Merck

1991

Statistical Experimental Design

Univ. Minnesota

1986

Animal Cell Reactor Engineering

Management Training:

Merck

1990

Management for Middle Managers

Merck

1989

Stress and Time Management

Merck

1989

Leader Effectiveness Training

Professional Society Memberships

American Association for the Advancement ofScience

Wound Healing Society

International Society for Stem CellResearch

Other Professional Interests (MeetingOrganization)

1. Cell Culture Engineering I, EngineeringFoundation Conference, Workshop Session Co–chairman, Insect Cell Culture.February 1988.

2. Cell Culture Engineering III,Engineering Foundation Conference, Organizing Committee and Session Co-Chair,Regulation of Secretory Protein Synthesis, Post-Translational Processing andSecretion, February 1992.

3. Biochemical Engineering VIII,Engineering Foundation Conference, Session Co-Chair, Eukaryotic CellularProcesses, July 1993.

4. Cell Culture Engineering IV, EngineeringFoundation Conference, Organizing Committee and Session Co-Chair, Regulation ofPost-Translational Processing, March 1994.

5. Cell Culture Engineering V, EngineeringFoundation Conference, Session Chair, Genetic Engineering of Host Cells,January 28 - February 2, 1996, San Diego California.

6. New York/New Jersey Molecular BiologyClub, Coordinating Committee for annual seminar series, 1988-2006, andTreasurer 1991-1993, Secretary 2000-2001.

References

Available upon request.

Bibliography Melvin Silberklang, Ph.D.

1. *Silberklang, M. (1976). The 3'-end ofTurnip Yellow Mosaic Virus RNA; Application of Novel Sequencing Techniques.Thesis, MIT.

2. *Silberklang, M., Prochiantz, A.,Haenni, A.L., and RajBhandary, U.L. (1976). Novel Sequencing Techniques Appliedto the 'tRNA-like' 3'-Terminus of Turnip Yellow Mosaic Virus RNA. AnimalVirology, Vol. IV, ICN/UCLA Symp. Mol. Cell. Biol., ed. Baltimore, D. andHuang, A.S. (Academic Press, NY), pp. 583-595.

3. Chang, S.H., Brum, C.K., Silberklang,M., RajBhandary, U.L., Hecker, L.I. and Barnett, W.E. (1976). The FirstNucleotide Sequence of an Organelle Transfer RNA: Chloroplastic tRNA-Phe. Cell,9: 717-723.

4. *Silberklang, M., Prochiantz, A.,Haenni, A.L. and RajBhandary, U.L. (1977). Studies on the Sequence of the3'-Terminal Region of Turnip Yellow Mosaic Virus RNA. Eur. J. Biochem., 72:465-478.

5. *Silberklang, M., Gillum, A.M., andRajBhandary, U.L. (1977). Use of Nuclease P1 in Sequence Analysis of End GroupLabeled RNA. Nucl. Acids Res., 4: 4091-4108.

6. Gillum, A.M., Hecker, L.I., Silberklang,M., Schwartzbach, S.D., RajBhandary, U.L., and Barnett, W.E.

(1977). Nucleotide Sequence of Neurosporacrassa Cytoplasmic Initiator tRNA. Nucl. Acids Res., 4:

4109-4132.

7. *Silberklang M., Gillum, A.M., andRajBhandary, U.L. (1979). Use of In vitro 32P-Labelling in the SequenceAnalysis of Non-Radioactive tRNAs. Methods in Enzymol, LIX, 58-109.

8. Kunkel, L.M., Silberklang, M., andMcCarthy, B. J. (1979). A Third Restriction Endonuclease from Xanthomonasmalvacearum. J. Mol. Biol., 132: 133-139.

9. Hosbach, H., Silberklang, M., andMcCarthy, B.J. (1980). Evolution of a Drosophila melanogaster Glutamate tRNAGene Cluster. Cell, 21: 169-178.

10. Chang, S.H., Hecker, L.I., Brum, C.K.,Schnabel, J.J., Heckman, J.E., Silberklang, M., RajBhandary, U.L., and Barnett,W.E. (1981). The Nucleotide Sequence of Euglena Cytoplasmic PhenylalanineTransfer RNA; Evidence for Possible Classification of Euglena Within the AnimalRather than the Plant Kingdom. Nucl. Acids. Res., 10: 3199-3204.

11. Sharp, S., DeFranco, D., Silberklang,M., Hosbach, H., Schmidt, T., Kubli, E., Gergen, P., Wensink, P., and Soll, D.(1981). The Initiator tRNA Genes of Drosophila melanogaster: Evidence for atRNA Pseudogene. Nucl. Acids. Res., 9: 5867-5882.

12. *Silberklang, M., RajBhandary, U.L.,Luck, A., and Erdmann, V.A. (1983). Chemical Reactivity of E. coli 5S RNA InSitu in the 50S Ribosomal Subunit. Nucl. Acids. Res., 11: 605-617.

13. *Silberklang, M., Havel, C.M., Friend,D.S., McCarthy, B.J., and Watson, J.A. (1983). Isoprene Synthesis in IsolatedEmbryonic Drosophila Cells: I, Sterol-Deficient Eukaryotic Cells. J. Biol.Chem., 258: 8503-8511.

14. Scolnick, E.M., Silberklang, M., andHirschmann, R.F. (1985). Applications of Oncogenes to the Diagnosis, Therapyand Prevention of Human Cancer, in Opportunities in Chemistry, Section IV-B,Report of the National Research Council, National Academy Press, Washington,D.C., pp. 175-177.

15. Whang, Y., Silberklang, M., Morgan, A.,Munshi, S., Lenny, A.B., Ellis, R.W. and Kieff, E. (1987). Expression of theEpstein-Barr Virus gp350/220 Gene in Rodent and Primate Cells. J. Virol., 61:1796-1807.

16. *Silberklang, M., Kopchick, J., Munshi,S. Lenny, A., Livelli, T. and Ellis, R.W. (1987). Foreign Gene Expression inRat Pituitary GH3 Cells, in Modern Approaches to Animal Cell Technology, ed.Spier, R.E. and Griffiths, J.B., Butterworth, U.K., pp. 199-214.

17. Emini, E.A., Silberklang, M., Schultz,L.D., Ellis, R.W., Qualtiere, L.F., Pearson, G.R., and Kieff, E. (1987).Antigenic Analysis of Epstein-Barr Virus Major Membrane Protein (gp350/220)Expressed in Yeast and Mammalian Cells, in Vaccines ‘87: Modern Approaches toNew Vaccines, R.M. Chanock, R.A. Lerner, F. Brown, and H. Ginsberg (eds.), ColdSpring Harbor Laboratory, New York, pp. 412-418.

18. Emini, E.A., Schleif, W.A., Armstrong,M.E., Silberklang, M., Schultz, L.D., Lehman, D., Maigetter, R.Z., Qualtiere,L.F., Pearson, G.R., and Ellis, R.W. (1988). Antigenic Analysis of theEpstein-Barr Virus Major Membrane Antigen (gp350/220) Expressed in Yeast andMammalian Cells; Implications for the Development of a Subunit Vaccine.Virology, 166: 387-393.

19. Han, J., Law, S., Keller, P.M.,Kniskern, P.J., Silberklang, M., Tung, J.-S., Gasic, G., Gasic, T. , Friedman,P.A., and Ellis, R.W. (1989). Cloning and Expression in Insect Cells of cDNAEncoding Antistasin, a Leech-Derived Factor Xa Inhibitor. Gene,75: 47-57.

20. Emini, E.A., Schleif, W.A.,Silberklang, M., Lehman, D., and Ellis, R.W. (1989). Vero-ExpressedEpstein-Barr Virus (EBV) gp350/220 Protects Marmosets from EBV Challenge, J.Med. Virol. 27: 120-123.

21. Jain, D., Ramasubramanyan, K., Gould,S., Lenny, A., Candelore, M., Tota, M., Strader, C., Alves, K., Cuca, C., Tung,J.-S., Hunt, G., Junker, B., Buckland, B.C. and Silberklang, M. (1991)Large-Scale Recombinant Protein Production Using the Insect Cell-BaculovirusExpression Vector System: Antistasin and ?-Adrenergic Receptor, Proceedings ofthe 10th Meeting of the European Society for Animal Cell Technology (ESACT):Production of Biologicals from Animal Cells in Culture, Butterworth, U.K..

22. Jain, D., Ramasubramanyan, K., Gould,S., Seamans, C., Wang, S., Lenny, A. and Silberklang, M. Production ofAntistasin using the Baculovirus Expression System (1991) in Expression Systemsand Processes for rDNA Products, American Chemical Society Symposium Series#477, ed. Hatch, R.T., Goochee, C., Moreira, A., Alroy, Y., American ChemicalSociety, Washington, D.C. pp. 97-110.

23. Palladino, L.O., Tung, J.-S.,Dunwiddie, C., Alves, K., Lenny, A.B., Przysiecki, C., Lehman, D., Nutt, E.,Cuca, G.C., Law, S.W., Silberklang, M., Ellis, R.W. and Mark, G.E. Expressionand Characterization of the N-Terminal Half of Antistasin, an AnticoagulantProtein Derived from the Leech Haementeria officinalis, Protein Expression andPurification 2: 37-42.

24. DeMartino, J.A., Daugherty, B.L., Law,M.-F., Cuca, G.C., Alves, K., Silberklang, M. and Mark, G.E.: Rapidhumanization and expression of murine monoclonal antibodies. AntibodyImmunoconjugates and Radiopharmaceuticals, 4: 829-835.

25. Talento, A., Nguyen, M., Law, S., Wu,J.K., Poe, M., Blake, J.T., Patel, M., Wu, T.-J., Manyak, C., Silberklang, M.,Mark, G., Springer, M., Sigal, N.H., Weissman, I.L., Bleackley, R.C., Podack,E.R., Tykocinski, M.L. and Koo, G.C. (1992) Transfection of Mouse CTL with anAntisense Granzyme A Vector Reduces Lytic Activity. J. Immunology, 149:4009-4015.

26. Junker, B.H., Wu, F., Wang, S.,Waterbury, J., Hunt, G., Hennesey, J., Aunins, J., Lewis, J., Silberklang, M.and Buckland, B. (1992) Evaluation of a microcarrier process for large-scalecultivation of Hepatitis A Virus. Cytotechnology , 9:173-187.

27. Mark, G.E., Cuca, G., Daugherty, B.L.,DeMartino, J.A., Elliston, K.O., Forrest, M.J., Kawka, D.W., Kazazis, D.M.,Law, M.-F., MacIntyre, D.E., Meurer, R., Padlan, E.A., Pandya, S., Schmidt,J.A., Scott, S., Silberklang, M., Williamson, A.R., Singer, I.I. (1994) OptimalHumanization of 1B4, an Anti-CD18 Murine Monoclonal Antibody, is Achieved byCorrect Choice of Human V-Region Framework Sequences, J. Immunology , 150:2844-2857.

28. *Silberklang, M., Ramasubramanyan, K.,Gould, S.L., Lenny, A.B., Seamans, T.C., Wang, S., Hunt, G.R., Junker, B.,Mazina, K.E., Tota, M.R., Palyha, O. and Jain, D. (1995) Baculovirus-MediatedProduction of Proteins in Insect Cells: Examples of Scale-Up and ProductRecovery, in Baculovirus Expression Systems and Biopesticides, eds. Shuler,M.L., Granados, R.R., Wood, H.A. and Hammer, D.A., Wiley-Liss, N.Y, pp.205-231.

29. Yu-Ip, C.C., Miller, W.J., Silberklang,M., Mark, G. E. and Ellis, R.W. (1994) Structural Characterization of theN-Glycans of Humanized Anti-CD18 Murine Monoclonal Antibody 1B4, Arch BiochemBiophys, 308: 387-399.

30. Robinson, D.K., Chan, C.P., Yu Ip, C.,Tsai, P.-K., Tung, J., Seamans, T.C., Lenny, A.B., Lee, D.K., Irwin, J., andSilberklang, M. (1994) Characterization of a Recombinant Antibody Produced inthe Course of a High Yield Fed-Batch Process, Biotechnology and Bioengineering,44: 727-735.

31. Seamans, T.C., Gould, S.L., DiStefano,D.J., Silberklang, M. and Robinson, D.K. (1994) Use of Lipid Emulsions asNutritional Supplements in Mammalian Cell Culture, in Biochemical EngineeringVIII, Annals of the New York Academy of Sciences, v. 745, pp. 240- 243.

32. Robinson, D.K., Seamans, T.C., Gould,S.L., DiStefano, D.J., Chan, C.P., Lee, D.K., Bibila, T., Glazomitsky, K.,Munshi, S., Daugherty, B., O’Neill-Palladino, L., Stafford-Hollis, J., Hollis,G.F. and Silberklang, M. (1994) Optimization of a Fed-batch Process for Productionof a Recombinant Antibody, in Biochemical Engineering VIII, Annals of the NewYork Academy of Sciences, v. 745, pp. 285-96.

33. Robinson, D.K., DiStefano, D., Gould,S.L., Cuca, G., Seamans, T.C., Benincasa, D., Munshi,

S., Chan, C.P., Strafford-Hollis, J.,Hollis, G.F., Mark, G.E. and M Silberklang (1995). Production of EngineeredAntibodies in Myeloma and Hybridoma Cells: Enhancements in Gene Expression andProcess Design, in Antibody Engineering, American Chemical Society SymposiumSeries, ed. Wang, H. and Imanaki, T., pp. 1 - 14.

34. Benincasa, D., Silberklang, M., Mark,G.E.III and Ludmerer, S.W. (1996) Rapid, High-Level Transient Expression ofPapillomavirus-Like Particles in Insect Cells, BioTechniques , 20: 890-895.

35. Yang, J.-D., Gecik, P., Collins, A.,Czarnecki, S., Hsu, H.-H., Lasdun, A., Sundaram, R., Muthukumar, G. andSilberklang, M. (1996) Rational Scale-Up of a Baculovirus-Insect Cell BatchProcess Based on Medium Nutritional Depth, Biotechnology and Bioengineering,52: 696-706.

36. Eisenbud, D., Huang, NF, Luke, S andSilberklang, M. (2004) Skin Substitutes and Wound Healing: Current Status andChallenges Wounds 16:2-17.

37. Marx, G, Hotovely-Salomon, A,Levdansky, L, Gaberman, E, Adler, L, Snir, G, Sievner, Z, Klauzner, Y, Silberklang,M, Thomas, D, Hoffman, N, Luke, S, Lesnoy, D, Gorodetsky, R (2008)Haptide-coated collagen sponge as a bioactive matrix for tissue regeneration JBiomed Mater Res B Appl Biomater., 84(2):571-83.

PATENTS and APPLICATIONS

1. Palladino Linda O, Silberklang Melvin,Tung Jwu-Sheng, Law Simon W, Mark George E: Antistasin

derived anticoagulant protein. MerckFebruary 1993: US 5189019 (10 worldwide citation)

2. Palladino Linda O'Neill, Tung Jwu-Shang,Silberklang Melvin, Law Simon W, Mark George

E: Anticoagulant protein and method ofproduction. Merck October 1991 US5189019: EP0454372 (8 worldwide citation)

3. Jenh Chung-Her, Law Ming-Fan,Silberklang Melvin, Mark Iii George E: Mammalian inducible promoter

cascade system. Merck November 1991:EP0455424 (5 worldwide citation)

4. Vlasuk George P, Polokoff Mark A, DixonRichard A F, Schultz Loren D, Hofmann Kathryn J, Silberklang Melvin, EllisRonald W, Emini Emilio A, Gerety Robert J: Recombinant gag precursor of hiv,product, process, and use as aids vaccine. Merck November 1989: EP0340837 (2worldwide citation).

5. Jenh Chung-Her, Law Ming-Fan,Silberklang Melvin, Mark George E Iii: Mammalian inducible promoter

cascade system. / Systeme en cascade, promoteurinductible de mammifere. Jenh Chung-Her 0: CA 2041619

6. Palladino Linda O, Tung Jwu-Sheng,Silberklang Melvin, Law Simon W, Mark George E: Anticoagulant protein andmethod of production. / Proteine ayant des proprietes anticoagulantes et procedede fabrication. Merck 0: CA 2040960

7. Palladino Linda O, Tung Jwu-Sheng,Silberklang Melvin, Law Simon W, Mark George E: Anticoagulant

protein and its preparation. Merck February1994: JP 1994-041198

8. Jenh Chung-Her, Law Ming-Fan,Silberklang Melvin, Mark George E Iii: Mammalian inducible promoter

cascade system. Merck March 1996: JP1996-066190

9. *Silberklang, M. And Kronenthal, R.L.Endothelial-Cell-Derived Extracellular Matrix for Tissue Engineering ofVascular Tissue filed January, 2001 (eventually abandoned due to loss ofcorporate sponsor support).

ABSTRACTS and LECTURES

1. *Silberklang, M., Prochiantz, A.,Haenni, A.L., and RajBhandary, U.L. (UCLA) (1976). Novel Sequencing TechniquesApplied to the 'tRNA-like' 3'-Terminus of Turnip Yellow Mosaic Virus RNA. J.Supramolecular Structure and Cellular Biochemistry. Supplement.

2. Hosbach, H.A., Silberklang, M. andMcCarthy, B.J. (1979). Structure of Drosophila Melanogaster tRNA Genes. ColdSpring Harbor tRNA Meeting.

3. *Silberklang, M., Hosbach, H. andMcCarthy, B.J. (1980). Structure and Organization of Drosophila tRNA Genes.Annual Drosophila Meeting, Indiana University.

4. *Silberklang, M., Hosbach, H. and McCarthy,B.J. (1980). Organization and Structure of Drosophila tRNA Genes. InternationalTransfer RNA Meeting, Strasbourg, France.

5. Havel, C.M., Silberklang, M., Friend,D.S., McCarthy, B.J. & Watson, J.A. (1980). Sterol-Free Cultured EukaryoticCells. Fed. Proc., 39, 2602.

6. Friend, D.S., Havel, C.M., Silberklang,M., and Watson, J.A. (1980). Distribution and Effects of Cholesterol on3-B-Hydroxysterol-Free Eukaryotic Cells. J. Cell Biol. 87. ME 1520.

7. *Silberklang, M., Hosbach, H. andMcCarthy, B.J. (1981). Structure and Regulation of Drosophila tRNA Genes. J.Supramolecular Structure and Cellular Biochemistry, Supplement 58.

8. *Silberklang, M., Kopchick, J.,Malavarca, R., Munshi, S., Lenny, A., Pasleau, F., Livelli, T. and Leung, F.(1986). Transient and Stable Transfection of Rat Pituitary GH3 Cells. J.Cellular Biochemistry, Supplement 10D, 0228.

9. Whang, Y., Silberklang, M., Kieff, E.,and Ellis, R.W. (1986). Expression and Analysis of Epstein-Barr MembraneAntigen in Several Mammalian Continuous Cell Lines. Eleventh InternationalHerpesvirus Workshop. Leeds, U.K.

10. Morgan, Z.J., Kieff, E., Silberklang,M., Whang, Y., Keller, P.M., and Ellis, R.W. (1986). VZV gpI is a Promoter forthe Expression of Recombinant-Derived Proteins in Mammalian Cells. EleventhInternational Herpesvirus Workshop. Leeds, U.K.

11. Emini, E.A., Qualtiere, L.F., Pearson,G.R., Kieff, E., Silberklang, M., Schultz, L.D., and Ellis, R.W. (1986).Antigenic Analysis of the Epstein-Barr Virus Major Membrane Protein(gp350/gp220) Expressed in Yeast and Mammalian Cells.

Modern Approaches to New Vaccines. ColdSpring Harbor, NY.

12. *Silberklang, M., Kopchick, J., Munshi,S., Lenny, A.B., Livelli, T., and Ellis, R.W. (1987). Foreign Gene Expressionin Rat Pituitary GH3 Cells. European Society for Animal Cell Technology, 8thMeeting: Modern Approaches to Animal Cell Technology. Tiberias, Israel.

13. Emini, E.A., Silberklang, M., Kieff,E., Lehman, D. and Ellis, R.W. (1987). Protection of Susceptible Callithrixjacchus Marmosets from Epstein-Barr virus (EBV) Infection; Positive Efficacy ofa Vero Cell-Expressed EBV gp350/gp220 Vaccine. Modern Approaches to NewVaccines. Cold Spring Harbor, NY.

14. Emini, E.A., Silberklang, M., Schultz,L.D., and Ellis, R.W. (1988). The Effects of Post-Translational Modificationson the Antigenic Presentation of Expressed Proteins. J. Cellular Biochemistry,Suppl. #12, part B

15. *Silberklang, M., Lenny, A., Gould, S.,Diehl, R., Candelore, M., Dixon, R.A.F. and Strader, C.D. (1988). High-LevelExpression of Mammalian Beta-Adrenergic Receptor with the Insect BaculovirusVector System. International Symposium on Baculoviruses and BaculovirusExpression Vectors, Oxford, U.K.

16. Jenh, C.-H., Law, M.-F., Ellis, R.W.and Silberklang, M. (1988). Enhanced Translational Efficiency of a Natural EucaryoticmRNA In Vivo Obtained by Substituting Plant Viral for Endogenous 5'Nontranslated Leader Sequences. J. Cell Biol., 107, #6 part 3, 1723.

17. *Silberklang, M., Lenny, A., Munshi,S., Daugherty, B., Zavodny, S., Law, S., Kniskern, P., Petroski, C., DiRenzo,J., Han, J., Mark, G. and Ellis, R.W. (1988). Expression in Insect andMammalian Cells of cDNA Encoding the Potent Leech-Derived Anticoagulant,Antistasin. J. Cell Biol., 107, #6 part 3, 1724.

18. Strader, C.D., Cheung, A.-H., Tsai,A.-M., Gould, S.L., Lenny, A.B. and Silberklang, M. (1988). Purification ofLarge Quantities of beta-Adrenergic Receptor Using the Baculovirus ExpressionVector System. J. Cell Biol., 107, #6 part 3, 343.

19. Han, J.H., Law, S.W., Keller, P.M.,Kniskern, P.J., Silberklang, M., Tung, J.-S., Gasic, T.B., Gasic, G.J.,Friedman, P.A. and Ellis, R.W. Cloning and Expression of cDNA EncodingAntistasin, a Leech-Derived Protein Having Anti-Coagulant and Anti-MetastaticProperties. (1989) J. Cellular Biochemistry, Suppl.

20. Daugherty, B., Zavodny, S., Lenny, A.,Silberklang, M., Tung, J.S., Law, S.W., Mark, G.E. and Ellis, R.W. (1989) TheUse of Polymerase Chain Reaction to Identify Recombinant Baculovirus and toMonitor its Purification. UCLA Symposia, The Polymerase Chain Reaction:Methodology and Application, Keystone, CO.

21. *Silberklang, M., Tung, J.S., Law,S.W., Mark, G.E. and Ellis, R.W. (1989) The Use of Polymerase Chain Reaction toIdentify Recombinant Baculovirus and to Monitor its Purification. UCLASymposia, The Polymerase Chain Reaction:

Methodology and Application, Keystone, CO.

22. Gould, S., Wang, S., Seamans, C.,Lenny, A., Jain, D., and Silberklang, M. (1989) Protein production with theBaculovirus Expression System: Multiparametric Monitoring of SuspensionCultures. In Vitro Cellular and Developmental Biology, 25(II), 146, 1989.

23. Jain, D., Gould, S., Seamans, C., Wang,S., Lenny, A.B. and Silberklang, M. (1989) Production of Antistasin Using theBaculovirus Expression Vector System. American Chemical Society 198th NationalMeeting, Miami Beach, FL.

24. *Silberklang, M., Gould, S., Lenny, A.,Ramasubramanyan, K., Seamans, C., Wang, S., Tung, J.-S., Palladino, L., Jain,D. (1990) Application of the Baculovirus Expression Vector System to Productionof the Anticoagulant Antistasin. American Chemical Society 199th NationalMeeting, Boston, MA.

25. Jain, D., Ramasubramanyan, K., Gould,S., Lenny, A., Candelore, M., Tota, M., Strader, C., Alves, K., Cuca, C., Tung,J.-S., Hunt, G., Junker, B., Buckland, B.C. and Silberklang, M. (1990)Large-Scale Recombinant Protein Production Using the Insect Cell-BaculovirusExpression Vector System: Antistasin and ?– Adrenergic Receptor. EuropeanSociety for Animal Cell Technology 10th Meeting: Production of Biologicals fromAnimal Cells in Culture, Avignon, France.

26. Talento, A., Patel, M., Law, S.,Nguyen, M., Zavodny, S., Wu, T.-J., Wu, J., Poe, M., Manyak, C., Weissman, I.,Tykocinski, M., Silberklang, M., Mark, G., Springer, M., Sigal, N.H. and Koo,G.C. (1990) Transfection of Mouse CTL with an Anti-Sense Granzyme A Vector,American Society for Biochemistry and Molecular Biology.

27. Jain, D., Gould, S., DiStefano, D.,Cuca, G., Benincasa, D., Ramasubramanyan, K., Lenny, A., Mark, G.E. andSilberklang, M. Application of nutrient utilization analysis to obtain improvedproduction of a recombinant antibody. For presentation at: European Society forAnimal Cell Technology, 11th Annual Meeting, University of Sussex, Brighton,U.K.

28. *Silberklang, M., Gould, S., DiStefano,D., Cuca, G., Benincasa, D., Ramasubramanyan, K., Jain, D., Lenny, A. and Mark,G.E. (1992) A Nutrient Homeostasis Fed-Batch Process Design for RecombinantAntibody Production, Cell Culture Engineering III, Engineering FoundationConference, Palm Coast, FL.

29. Junker, B., Wu, F., Wang, S.,Waterbury, J., Hunt, G., Aunins, J., Jain, D., Lewis, J., Silberklang, M. andBuckland, B. (1992) Evaluation of microcarriers for large-scale cultivation ofa viral vaccine, Cell Culture Engineering III, Engineering Foundation Conference,Palm Coast, FL.

30. Yu Ip, C.C., Miller, W.J., Oliver,C.N., Krips, D.M., Aunins, J.G., Cuca, G., DiStefano, D.J., Gould, S., Seamans,C., Silberklang, M., Mark, G.E. and Ellis, R.W. (1992) Glycosylation ofrecombinant monoclonal antibody expressed in several cell lines. AmericanChemical Society 203rd National (Spring) Meeting, San Francisco, CA.

31. Gould, S., DiStefano, D., Cuca, G.,Robinson, D. and Silberklang, M. (1992) Major Metabolic Changes AccompanyTransfection and Selection for High Level Expression of Recombinant Genes. InVitro 28, part II, 162A..

32. *Silberklang, M.(1992) Very High LevelExpression of Recombinant Antibody Genes in Murine Myeloma Cells. Presented atthe Ninth International Biotechnology Symposium, Crystal City, VA.

33. Ramasubramanyan, K., Jain, D. andSilberklang, M. (1992) A Scaleable Process for the Microcarrier Culture andHarvest of a Human Endothelial Cell Line, American Institute of ChemicalEngineers, 1992 Annual Meeting.

34. Howard, A.D., Palyha, O.C., Ding,G.J>-F., Peterson, E.P., Calaycay, J.C., Griffin, P.R., Mumford, R.A.,Lenny, A.B., Robinson, D.K., Wang, S., Silberklang, M., Lee, C., Sun, W.,Ayala, J.M., Egger, L.A., Miller, D.K., Raju, S.M., Yamin, T.T., Jackson, J.,Chapman, K.T., Schmidt, J.A., Tocci, M.J. and Thornberry, N. (1993) High LevelProduction and Characterization of a Functional Human Interleukin-1? ConvertingEnzyme in Baculovirus and E. coli Expression Systems. Keystone Symposium onMolecular Mechanisms in Rheumatoid Arthritis and Related Diseases, Keystone CO.

35. Robinson, D.K., Chan, C.P., Lee, D.K.,Lenny, A.B., Seamans, T.C., Tung, J.-S., Tsai, P.K., Irwin, J., Yu Ip, C.C.,Mark, G.E. and Silberklang, M. (1993) Product Consistency During Long-Term Fed-BatchCulture, European Society for Animal Cell Technology, Wurzburg, Germany.

36. Gould, S.L., DiStefano, D.,Silberklang, M. and Robinson, D.K. (1993) Cell Culture Medium Development Usingan Automated Multiwell Cell Growth Monitoring Device. International Congress onCell and Tissue Culture.

37. Robinson, D.K., Seamans, T.C., Gould,S.L., DiStefano, D.J., Chan, C.P., Lee, D.K., Bibila, T., Glazomitsky, K.,Munshi, S., Daugherty, B., O’Neill-Palladino, L., Stafford-Hollis, J., Hollis,G.F

and Silberklang, M. (1993) Optimization ofa Fed-Batch Process for Production of a Recombinant Antibody, BiochemicalEngineering VIII, Engineering Foundation Conference, Princeton, NJ.

38. Seamans, T.C.,, Gould, S.L., DiStefano,D.J., Silberklang, M. and Robinson, D.K.

(1993) Use of Lipid Emulsions asNutritional Supplements in Mammalian Cell Culture. Biochemical EngineeringVIII, Engineering Foundation Conference, Princeton, NJ.

39. Yang, J-D., Robinson, E., Gecik, P.,Czarnecki, S.,, Collins, A., Oloruntoba, D., Arunakumari, A., Hsu, H.-H., andSilberklang, M. (1994) Design of a Serum-Free Fed-Batch Process forBaculovirus-Based Production of a Human Lysosomal Enzyme, Cell CultureEngineering IV, Engineering Foundation Conference, San Diego, CA.

40. *Silberklang, M. (1994) Toward aFed-Batch Process for Scaleable Baculovirus-based Production in Insect Cells,The Williamsburg Bioprocessing Conference, Williamsburg, VA.

41. *Silberklang, M. (1995) From ShakerFlask to cGMP Bioreactor: the Baculovirus Bioprocess Odyssey, presented at theBaculovirus and Insect cell Gene Expression Conference, Pinehurst, NorthCarolina, March 26-30, 1995.

42. *Silberklang, M. (1996) A New CompositeCultured Skin Product - From Orphan Medical Device to Broader-Indication WoundHealing Dressing, presented at Cell & Tissue BioProcessing, Kansas City MO,September 9-12, 1996.

43. *Silberklang, M. (1997) Reliability andConsistency in Complex Cell Culture Processes, presented at BioProcessing ‘97,San Diego CA, September 8-9, 1997.

44. *Silberklang, M. (2002) Mechanisms ofWound Healing: Studies with the Bilayered Cellular Matrix, OrCel, presented atSymposium on Advanced Wound Care, Baltimore MD April 27-30, 02.45.

45. Windsor, ML, Wilson, CA, Tewari, R,Chimanji, N, *Luke, S, Eisenberg, M, Moore, GPM and Silberklang, M. (2003) Anovel wound healing model in the SCID mouse applied to the therapeutic culturedcell device, OrCel? Bilayered Cellular Matrix, presented at the annual meetingof the Tissue Engineering Society International, Orlando FL, December 10– 13, 2003.

46. Prajapati, RT, Choi, C, McDonald, LJ,Windsor, ML, Xu, B, Eisenberg, M, Moore, GPM, Silberklang, M. (2003) Cytokineproduction in vitro and in vivo by OrCel? Bilayered Cellular Matrix, atherapeutic cultured cell device, presented at the annual meeting of the TissueEngineering Society International, Orlando FL, December 10 – 13, 2003.

47. *Chimanji, N, Tewari, R, Luke, S,Silberklang, M. (2004) In Vitro Evidence for the Histocompatibility of theAllogeneic Cells in the Cultured Skin Substitute, OrCel? Bilayered CellularMatrix, presented at the

14th Annual Meeting of the Wound HealingSociety, Orlando, FL, May 18 – 21, 2004.

48. *Tewari, R, Luke, S, Lesnoy, D, Burke,E, and Silberklang, M. (2004) Histological Analysis

of the Collagen Sponge Component of aTissue Engineered Skin Substitute, presented at the Biomedical EngineeringSociety annual meeting, Philadelphia, PA October 13 – 16, 2004.

49. *Silberklang, M. and *Papastephanou, C(2005) Tissue-Engineered Skin Substitutes: Toward an Understanding of TheirMechanism of Action and Therapeutic Efficacy, presented at the Symposium onAdvanced Wound Care, San Diego CA, April 21 – 24, 2005.

50. *Silberklang, M. and Papastephanou, C(2005) Anatomy of a Biotech Company (Structure, Challenges), presented at the15th Annual Meeting of the Wound Healing Society, Chicago IL, May 18 – 21,2005.

51. *Silberklang, M. (2006) The SkinSubstitute as a Paradigm for Regenerative Medicine, Guest Lecture in the Dept.of Bioengineering, U. California, Berkeley, June, 2006.

52. *Silberklang, M. (2007) OrCel?Bilayered Cellular matrix, An Industry Perspective,

Presented at the Society for Advanced WoundCare/Wound Healing Society Joint meeting, Tampa Fl, April 28 – May 1, 2007.

53. *Silberklang, M. (2008) OrCel?Challenges and Strategies in Cell Therapy and Tissue Engineering ProcessDevelopment, presented at Rutgers U. Bioprocess Engineering Seminar course,April, 2008.

54. *Silberklang, M. (2009) Pitfalls on theBiotech Road to Success, Guest Lecture in BioEngineering Seminar course,Columbia U. Dept. Bioengineering, March 19, 2009.

55. *Silberklang, M. (2011) Managingbiomedical technology development and commercialization: some lessons and somepitfalls from the experience of Forticell Bioscience, Presented to the fellowsof the New York City chapter of the Startup Leadership Program (SLP), New York,November 15, 2011.

56. *Silberklang, M. (2006) Sourcing andQuality Control of Cells and Biological Scaffolds for Cell, Stem Cell andTissue Engineering Therapies, presented at the 2nd Annual Tissue Engineeringand Regenerative Medicine Conference, Brussels, Belgium, November 7-8, 2006.

57. *Silberklang, M. (2007) The SkinSubstitute as a Paradigm for Stimulated Tissue Regeneration, Guest Lecture inBioengineering Seminar course, Columbia U. Dept. Bioengineering, February,2007.

58. *Silberklang, M. (2007) OrCel?Bilayered Cellular matrix, An Industry Perspective,

Presented at the Society for Advanced WoundCare/Wound Healing Society Joint meeting, Tampa Fl, April 28 – May 1, 2007.

59. *Silberklang, M. (2008) OrCel?Challenges and Strategies in Cell Therapy and Tissue Engineering Process Development,presented at Rutgers U. Bioprocess Engineering Seminar course, April, 2008.

60. *Silberklang, M. (2009) Pitfalls on theBiotech Road to Success, Guest Lecture in BioEngineering Seminar course,Columbia U. Dept. Bioengineering, March 19, 2009.

61. *Silberklang, M. (2011) Managingbiomedical technology development and commercialization: some lessons and somepitfalls from the experience of Forticell Bioscience, Presented to the fellowsof the New York City chapter of the Startup Leadership Program (SLP), New York,November 15, 2011.









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