Biography, Patents & Publications
Joe Sclafani has worked in pharmaceutical R&D for more than 20 years. He formed Joseph Pharmaceutical Consulting in 2009.
As a consultant at Otsuka America Pharmaceutical Inc (OAPI), he oversaw and championed the development and fabrication of an automated process skid to synthesize a new drug candidate for clinical trials and NDA supporting stability studies. Additionally, at OAPI, he oversaw various packaging projects at CMOs and provided support to QC by, for example, having analytical markers synthesized at a CRO.
His efforts at Guilford Pharmaceuticals focused initially on developing injectable or implantable dosage forms for clinical trials. This was followed by various projects that involved working with CMOs to yield drug substance as well as tablets and sterile filled liquid drug product. Joe Sclafani served on multiple product/project teams.
At Ciba-Geigy Corp., Pharmaceuticals Division, Joe Sclafani contributed to R&D efforts of transdermal delivery including iontophoresis.
Prior to these pharmaceutical activities, Joe Sclafani worked in the Industrial Chemicals Division of Procter & Gamble Company on the catalytic oxidation of an alcohol to an acid in a high pressure “Parr” reactor and on the biochemistry of the brain in the Dept. of Neurology Albert Einstein College of Medicine, Bronx, NY.
Joe Sclafani received a MS degree in Chemical Engineering from City University of New York and a Vordiplom in Chemical Engineering from University of Dortmund, Germany. (The Vordiplom is approximately equivalent to the Bachelor degree). Prior to this he earned an undergraduate degree in Biology from State University of New York at Purchase. He is a member of the AIChE.
Patents:
· “Method and Apparatus for Preparing a Solution of a Shear Sensitive Material” U.S. Provisional Application 20090287021 (PCT/US2009/003072)
· “Thermopile Powered Transdermal Drug Delivery Device” (U.S. 5733255)
Publications:
1. E. Hansen, J. Sclafani*, P. Liu and J. Nightingale “ The Effect of Water on a New Binary Transdermal Flux Enhancer (PEG3 Me/IPP): An In Vitro Evaluation using Estradiol” (Drug Dev. and Ind Pharm., 23(1), 9-14,1997, * corresponding author).
2. J. Sclafani, P. Liu, E. Hansen, M. Cettina and J. Nightingale “A protocol for the assessment of receiver solution additive-induced skin permeability changes. An example with γ-cyclodextrin" (Inter. J. Pharm., 124, pp. 213-217, 1995).
3. J. Sclafani, J. Nightingale, P. Liu and T. Kurihara-Bergstrom "Flow-Through System Effects on in Vitro Analysis of Transdermal Systems" (Pharm. Res., Vol 10, No.10, pp. 1521-1526, 1993).
4. H. Yohe, M. Saito, R. Ledeen, T. Kunishita, J. Sclafani, and R. Yu "Further Evidence for an Intrinsic Neuraminidase in CNS Myelin" (Journal of Neurochem., 46, pp 623-629, 1986).
5. M. Byrne, M. Sbashnig-Agler, D. Aquino, J. Sclafani and R. Ledeen "Procedure for Isolation of Gangliosides in High Yield and Purity: Simultaneous Isolation of Neutral Glycosphingolipids" (Analytical Biochem., 148, pp. 163-173, 1985).
6. R.W. Ledeen, T. Kunishita, J. Novak and J. Sclafani "Phospholipid synthesis in myelin: putative role of the axon". In Phospholipids of the Nervous System Physiological Roles, Vol. 2, ED. by L. Horrocks, J. Kanfer and G. Porcellati, Raven Press, New York, pp. 329-340 (1984).
7. R. Ledeen, M. Byrne, F. Roisen, G. Yorke and J. Sclafani "Gangliosides of neuronal membrane and the neuritogenic phenomenon". In Neural Membranes. Ed. by G.Y. Sun, N. Bazan, J.-Y. Wu, G. Portecellati, and A.Y. Sun, Humana Press, New York, pp. 459-477 (1983).
8. M. Byrne, R. Ledeen, F. Roisen, G. Yorke and J. Sclafani " Ganglioside-Induced Neuritogenisis: Verification that Gangliosides are the Active Agents, and Comparison of Molecular Species" (Journal of Neurochem. 41:5, pp. 1214-1222, 1983).
9. R. Ledeen and J. Sclafani "New Strategies for Detection and Resolution of Minor Gangliosides as Applied to Brain Fucogangliosides" in New Vistas in Glycolipid Research, (Maketa, Handa, Taketomi and Nagai, eds.) Plenum Publishing Co. 1982, pp. 47-53.
10. R. Ledeen, J. Skrivanek, J. Nuñez, J. Sclafani, W. Norton, and M. Farooq "Implications of the Distribution and Transport of Gangliosides in the Nervous System" (in Gangliosides in Neurological and Neuromuscular Function, Development and Repair, (Maurice M. Rapport and Alfredo Gorio, eds) Raven Press, New York, 1981 pp. 211-223.
Presentations* and posters:
1. W. Dang, E. Aaron, S. Dordunoo, J. Sclafani, F. Foster, E. Bortey. 2001. "Polymeric paclitaxel depot formulation (PACLIMER TM Microspheres) is more efficacious than TaxolÒ in a murine lung metastasis model". Proceed. Of the American Cancer Association for Cancer Research. 42, 2014.
2. G. Troiano, H. Howland, A. Kader, J. Sclafani, S. Dordunoo, Z. Zhao, W. Dang. 2000. “Sustained release of a model protein from polilactofate Microspheres.” Proceed. int'l. symp. control. rel. bioact. mater. 27: 1008-1009.
3. *J. Sclafani, D. Cline, W. Dang. “In Vitro – In Vivo Correlation of BCNU release using Gliadel Wafers with Three Drug Loadings and Two Different Thinknesses.” Proceed. int'l. symp. control. rel. bioact. mater. 27: 151-152.
4. P. DePalma, S. Dhanesar, S. Dordunoo, Z. Zhao W. G. Troiano, H. Howland, H. Wang, A. Kader, J. Sclafani, Dang. 2000. “Polyphosphoester paclitaxel Microspheres (PACLIMERTM Microspheres): in vitro characterization using hplc and lc/ms.” Proceed. int'l. symp. control. rel. bioact. mater. 27: 532-533.
5. Kader, D. Cline, J. Sclafani, G. Su, Z. Zhao, and W. Dang. “Effect of gamma irradiation on the stability and release of paclitaxel from novel poly(phosphoester) Microspheres”. AAPS, San Francisco, 1998.
6. *Polyanhydride Drug Delivery System for Intracranial Brain Tumor Therapy, D. Nowotnik, W. Dang, P. Nanjappan, J. Sclafani and D. Barnette, 1996 Conference on Pharmaceutical Science and Technology, August, 1996, Chicago, Il).
7. Polymerization Endpoint Determination for Polyanhydride Based Drug Delivery System, J. Sclafani, D. Barnette, P.G. Nanjappan, W. Dang and D. Nowotnik, Controlled Release Society, Baltimore, MD, August 1996.
8. *Applying Chemical Engineering in Industry, (Sclafani, J. Chemical Engineering Dept, Johns Hopkins University, October 1996).
9. In Vitro Permselectivity of Human Skin, J. Sclafani, J. Nightingale and T. Kurihara-Bergstrom, Proceed. Intern: Symp. Control. Rel. Bioact. Mater., 20(1993), Controlled Release Society, Washington DC.
10. * An Overview of Transdermal Drug Delivery. (Sclafani, J., Chemistry Dept., State University of NewYork at Purchase, April 1992).
11. * Application of Finite-Dose Mathematical Modelling to Flow-Through In Vitro Analysis of Transdermal Systems. (J. Nightingale, J. Sclafani, P. Liu, T. Kurihara-Bergstrom. Proceed. Intern. Symp. Control Rel. Bioact. Mater., 18:181-182, July, 1991, Controlled Release Society Amsterdam, The Netherlands).
12. A Fillable Transdermal Therapeutic System (FTTS) for In Vitro and Clinical Evaluation of Finite Dose (J. Nightingale, F. Hischak, J. Sclafani, T. Kurihara-Bergstrom, 7(9):S-194, Amer. Assoc. Pharmaceutical Sci., 5th Annual Meeting, Nov. 1990).
13. Effect of pH on the Iontophoretic Delivery of Ionic Compounds (Nightingale. J., Sclafani, J., Kurihara-Bergstrom, T., Proceed. Intern. Symp. Control. Rel. Bioact. Mater., 17 July, 1990 Controlled Release Society, Reno, NV).
14. Effect of pH on the Iontophoretic Delivery of Ionic Compounds (Sclafani, J., Nightingale. J., Kurihara-Bergstrom, T., June, 1990 Eastern Reg. Meeting, Amer. Assoc. Pharmaceutical Sci.).
As a consultant at Otsuka America Pharmaceutical Inc (OAPI), he oversaw and championed the development and fabrication of an automated process skid to synthesize a new drug candidate for clinical trials and NDA supporting stability studies. Additionally, at OAPI, he oversaw various packaging projects at CMOs and provided support to QC by, for example, having analytical markers synthesized at a CRO.
His efforts at Guilford Pharmaceuticals focused initially on developing injectable or implantable dosage forms for clinical trials. This was followed by various projects that involved working with CMOs to yield drug substance as well as tablets and sterile filled liquid drug product. Joe Sclafani served on multiple product/project teams.
At Ciba-Geigy Corp., Pharmaceuticals Division, Joe Sclafani contributed to R&D efforts of transdermal delivery including iontophoresis.
Prior to these pharmaceutical activities, Joe Sclafani worked in the Industrial Chemicals Division of Procter & Gamble Company on the catalytic oxidation of an alcohol to an acid in a high pressure “Parr” reactor and on the biochemistry of the brain in the Dept. of Neurology Albert Einstein College of Medicine, Bronx, NY.
Joe Sclafani received a MS degree in Chemical Engineering from City University of New York and a Vordiplom in Chemical Engineering from University of Dortmund, Germany. (The Vordiplom is approximately equivalent to the Bachelor degree). Prior to this he earned an undergraduate degree in Biology from State University of New York at Purchase. He is a member of the AIChE.
Patents:
· “Method and Apparatus for Preparing a Solution of a Shear Sensitive Material” U.S. Provisional Application 20090287021 (PCT/US2009/003072)
· “Thermopile Powered Transdermal Drug Delivery Device” (U.S. 5733255)
Publications:
1. E. Hansen, J. Sclafani*, P. Liu and J. Nightingale “ The Effect of Water on a New Binary Transdermal Flux Enhancer (PEG3 Me/IPP): An In Vitro Evaluation using Estradiol” (Drug Dev. and Ind Pharm., 23(1), 9-14,1997, * corresponding author).
2. J. Sclafani, P. Liu, E. Hansen, M. Cettina and J. Nightingale “A protocol for the assessment of receiver solution additive-induced skin permeability changes. An example with γ-cyclodextrin" (Inter. J. Pharm., 124, pp. 213-217, 1995).
3. J. Sclafani, J. Nightingale, P. Liu and T. Kurihara-Bergstrom "Flow-Through System Effects on in Vitro Analysis of Transdermal Systems" (Pharm. Res., Vol 10, No.10, pp. 1521-1526, 1993).
4. H. Yohe, M. Saito, R. Ledeen, T. Kunishita, J. Sclafani, and R. Yu "Further Evidence for an Intrinsic Neuraminidase in CNS Myelin" (Journal of Neurochem., 46, pp 623-629, 1986).
5. M. Byrne, M. Sbashnig-Agler, D. Aquino, J. Sclafani and R. Ledeen "Procedure for Isolation of Gangliosides in High Yield and Purity: Simultaneous Isolation of Neutral Glycosphingolipids" (Analytical Biochem., 148, pp. 163-173, 1985).
6. R.W. Ledeen, T. Kunishita, J. Novak and J. Sclafani "Phospholipid synthesis in myelin: putative role of the axon". In Phospholipids of the Nervous System Physiological Roles, Vol. 2, ED. by L. Horrocks, J. Kanfer and G. Porcellati, Raven Press, New York, pp. 329-340 (1984).
7. R. Ledeen, M. Byrne, F. Roisen, G. Yorke and J. Sclafani "Gangliosides of neuronal membrane and the neuritogenic phenomenon". In Neural Membranes. Ed. by G.Y. Sun, N. Bazan, J.-Y. Wu, G. Portecellati, and A.Y. Sun, Humana Press, New York, pp. 459-477 (1983).
8. M. Byrne, R. Ledeen, F. Roisen, G. Yorke and J. Sclafani " Ganglioside-Induced Neuritogenisis: Verification that Gangliosides are the Active Agents, and Comparison of Molecular Species" (Journal of Neurochem. 41:5, pp. 1214-1222, 1983).
9. R. Ledeen and J. Sclafani "New Strategies for Detection and Resolution of Minor Gangliosides as Applied to Brain Fucogangliosides" in New Vistas in Glycolipid Research, (Maketa, Handa, Taketomi and Nagai, eds.) Plenum Publishing Co. 1982, pp. 47-53.
10. R. Ledeen, J. Skrivanek, J. Nuñez, J. Sclafani, W. Norton, and M. Farooq "Implications of the Distribution and Transport of Gangliosides in the Nervous System" (in Gangliosides in Neurological and Neuromuscular Function, Development and Repair, (Maurice M. Rapport and Alfredo Gorio, eds) Raven Press, New York, 1981 pp. 211-223.
Presentations* and posters:
1. W. Dang, E. Aaron, S. Dordunoo, J. Sclafani, F. Foster, E. Bortey. 2001. "Polymeric paclitaxel depot formulation (PACLIMER TM Microspheres) is more efficacious than TaxolÒ in a murine lung metastasis model". Proceed. Of the American Cancer Association for Cancer Research. 42, 2014.
2. G. Troiano, H. Howland, A. Kader, J. Sclafani, S. Dordunoo, Z. Zhao, W. Dang. 2000. “Sustained release of a model protein from polilactofate Microspheres.” Proceed. int'l. symp. control. rel. bioact. mater. 27: 1008-1009.
3. *J. Sclafani, D. Cline, W. Dang. “In Vitro – In Vivo Correlation of BCNU release using Gliadel Wafers with Three Drug Loadings and Two Different Thinknesses.” Proceed. int'l. symp. control. rel. bioact. mater. 27: 151-152.
4. P. DePalma, S. Dhanesar, S. Dordunoo, Z. Zhao W. G. Troiano, H. Howland, H. Wang, A. Kader, J. Sclafani, Dang. 2000. “Polyphosphoester paclitaxel Microspheres (PACLIMERTM Microspheres): in vitro characterization using hplc and lc/ms.” Proceed. int'l. symp. control. rel. bioact. mater. 27: 532-533.
5. Kader, D. Cline, J. Sclafani, G. Su, Z. Zhao, and W. Dang. “Effect of gamma irradiation on the stability and release of paclitaxel from novel poly(phosphoester) Microspheres”. AAPS, San Francisco, 1998.
6. *Polyanhydride Drug Delivery System for Intracranial Brain Tumor Therapy, D. Nowotnik, W. Dang, P. Nanjappan, J. Sclafani and D. Barnette, 1996 Conference on Pharmaceutical Science and Technology, August, 1996, Chicago, Il).
7. Polymerization Endpoint Determination for Polyanhydride Based Drug Delivery System, J. Sclafani, D. Barnette, P.G. Nanjappan, W. Dang and D. Nowotnik, Controlled Release Society, Baltimore, MD, August 1996.
8. *Applying Chemical Engineering in Industry, (Sclafani, J. Chemical Engineering Dept, Johns Hopkins University, October 1996).
9. In Vitro Permselectivity of Human Skin, J. Sclafani, J. Nightingale and T. Kurihara-Bergstrom, Proceed. Intern: Symp. Control. Rel. Bioact. Mater., 20(1993), Controlled Release Society, Washington DC.
10. * An Overview of Transdermal Drug Delivery. (Sclafani, J., Chemistry Dept., State University of NewYork at Purchase, April 1992).
11. * Application of Finite-Dose Mathematical Modelling to Flow-Through In Vitro Analysis of Transdermal Systems. (J. Nightingale, J. Sclafani, P. Liu, T. Kurihara-Bergstrom. Proceed. Intern. Symp. Control Rel. Bioact. Mater., 18:181-182, July, 1991, Controlled Release Society Amsterdam, The Netherlands).
12. A Fillable Transdermal Therapeutic System (FTTS) for In Vitro and Clinical Evaluation of Finite Dose (J. Nightingale, F. Hischak, J. Sclafani, T. Kurihara-Bergstrom, 7(9):S-194, Amer. Assoc. Pharmaceutical Sci., 5th Annual Meeting, Nov. 1990).
13. Effect of pH on the Iontophoretic Delivery of Ionic Compounds (Nightingale. J., Sclafani, J., Kurihara-Bergstrom, T., Proceed. Intern. Symp. Control. Rel. Bioact. Mater., 17 July, 1990 Controlled Release Society, Reno, NV).
14. Effect of pH on the Iontophoretic Delivery of Ionic Compounds (Sclafani, J., Nightingale. J., Kurihara-Bergstrom, T., June, 1990 Eastern Reg. Meeting, Amer. Assoc. Pharmaceutical Sci.).