Roles at http://pharmaceuticalintelligence.com
Expert, Author, Writer for the following Research Categories:
- Systemic Inflammatory Response Related Disorders
- CANCER BIOLOGY & Innovations in Cancer Therapy
- Human Immune System in Health and in Disease
Raphael Nir, PhD
Personal Bio
Have 22 years of experience in the field of bio-polymers, cell-based assays, protein production and purification, and therapeutic development. Formerly the Associate Principal Scientist at Schering-Plough Research Institute, where I led the development of several novel processes related to protein production. As the Co-Founder and President of SBH Sciences, Inc, I manage all of the research and development activities with a focus on the development and implementation of immunoassays, cell-based assays and efficient manufacturing by cell culture of recombinant cytokines and enzymes.
World leader in these fields with over 70 processes for recombinant proteins in mammalian and insect cell cultures for commercial use in the R&D market and over 280 bioassays which are currently available in SBH Sciences’ two state-of-the-art cell culture facilities. Serve as Director of Process Development at Neumedicines (Pasadena, CA) and led the process development of human IL-12 to mitigate the ionization radiation effects. This project started clinical trials on June 8, 2011.
At present time, at SBH Sciences, Inc., we focused on the anti-cancer and anti-inflammation drug development (see below in the QTDP section).
Dr. Raphael Nir, President & CSO SBH Sciences and President and COO SBH Diagnostics. SBH Sciences partnered with Galectin Therapeutics and we established Galectin Sciences. We have a program to develop small molecules to neutralize Galectin-3 to reduce inflammation and fibrosis.
- SBH Sciences is also Pre-Clinical Contrat Reaserch Organization – we already assisted 37 companies this year. 45 last year.
- One of our clients is targeting CD44 as amarker for cancer.
- We at SBH are producing 40 biologics – 31 recombinant cytokines and 9 enzymes all by mammalian and insect cells. WE already produce over 40 antibodies and develop over 20 ELISA kits.
- We also developed 280 cell based assay to measure biological activity of cytokines. We are the only company in the world that provide those services (in that amount….)
Have work for 7+ years in the Biotechnology Process Development in Schering Plough (1990 – 1997).
Running SBH Sciences for 16+ years (sole owner in the past 8+ years).
SBH Sciences developed the process to make human IL-12 and we license it to Neumedicines (Pasadena, CA). They already “collected” $50M from BARDA. The project is in clinical trials to mitigate atomic radiation…..
SBH Sciences have been as a sub-contractor and have done the following:
A. Develop the cell-culture process (CHO cells).
B. Develop the Protein Purification process.
C. Develop the Analytical HPLC.
D. Develop the Bioassay.
E. Develop the specific ELISA for p70 (vs. p40).
F. Develop the formulation.
G. Perform the stability program.
H. Develop the Anti-Drug Antibodies ELISA.
Co-Founded SBH Diagnostics 2 years ago. We are CLIA certified. We have the 2D automatic Western Blot capability (ProteinSimple). We already assisted in this company – 24 companies. Only 4 are also customers of SBH Sciences.
and
Raphael Nir, President
SBH Sciences
SBH Diagnostics
508-650-6218 Ext. 214
POSITIONS
President and CSO, SBH Sciences, Inc.
1997-Present Co-Founder and President, SBH Sciences, Inc., Natick, MA.
I have been involved in all of the operations, process development, hiring, and business development and licensing since the company’s inception. Currently, SBH Sciences is producing 31 recombinant cytokines and 33 monoclonal anti-cytokines, in addition to offering over 250 cell-based assays for cytokine research and over 200 cell lines for drug optimization. We also have developed over 30 ELISA Development Kits and offering multiplex analysis services.
2008-Present Director of Process Development at Neumedicines, Pasadena, CA
Developed the production method of human IL-12 (p70) including: cell culture, protein purification, analytical HPLC, ELISA, Bioassay, Formulation & Stability studies, as well as Anti-Drug Antibodies screening.
1995-1997 Associate Principal Scientist, Dept. of Biotechnology Process Development, Schering-Plough Research Inst. Union, NJ.
Engaged in p53 gene therapy project; developed improved protein-free and serum-free media for NSO cell culture and engaged in the scale-up of the fermentation; developed an approach for minimizing oxidation during recovery of genetically engineered proteins.
1992-1995 Senior Scientist, Dept. of Biotechnology Process Development, Schering-Plough Research Inst., Union, NJ. Supervised engineers and technicians engaged in recovery/purification of proteins and antibiotics; developed an assay for evaluating E. coli inclusion bodies and optimized the unfolding/refolding steps of cytokines; developed improved processes for the purification of multi-gram quantities of pharmaceutical grade cytokines and monoclonal antibodies; developed and scaled-up a new process for purifying Everninomicin from whole broth using crossflow ultra-filtration; and implemented an “In Process” analysis of Everninomicin. purification of multi-gram quantities of pharmaceutical grade cytokines and monoclonal antibodies; developed and scaled-up a new process for purifying Everninomicin from whole broth using crossflow ultra-filtration; and implemented an “In Process” analysis of Everninomicin.
1992 Post-Doctoral Fellow, Dept. of Biotechnology Process Development, Schering-Plough Research Inst., Union, NJ. Developed a novel cell screening method based on immobilization of mammalian cells and sorted by flow cytometry.
EDUCATION |
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INSTITUTION AND LOCATION |
DEGREE |
Year |
FIELD OF STUDY |
Tel-Aviv University, Israel |
BS |
1982 |
Chemistry |
Tel-Aviv University, Israel |
MS |
1984 |
Biochemistry |
Tel-Aviv University, Israel |
PhD |
1990 |
Biotechnology |
New Jersey Institute of Technology, USA |
MSM |
1997 |
Management |
HONORS:
- 1994 & 1995 Schering-Plough’s Excellence Award
- 1997 Schering-Plough’s Impact Award
SELECTED PEER-REVIEWED PUBLICATIONS:
1. R. Nir, A. Gasith and A.S. Perry. 1989 “ Influence of pH, salinity and a complexing agent on growth and Cadmium removal from solution by Water Hyacinths”, In: Environmental quality and ecosystem stability Vol 4-B P. 543-552, ISEEQS Pub. Eds,: E. Spanier, Y. Steinberger and M. Luria, Jerusalem, Israel.
2. A. Rosenbluh, R. Nir, E. Sahar and E. Rosenberg. 1989 “Cell-Density-Dependent lysis and sporulation of Myxococcus Xanthus in Agarose Microbeads”.J, Bacteriology 171: 4923-4929.
3. R. Nir, A. Gasith and A.S. Perry. 1990 “Cadmium uptake and toxicity to Water Hyacinths: Effect of repeated exposure under controlled conditions”. Bull. Environ. Contam. Toxicol. 44: 149-157.
4. R. Nir, R. Lamed, L.Gueta and E. Sahar. 1990. “Single-Cell entrapment and microcolony development within uniform microspheres amenable to Flow Cytometry”.Apl. Environ. Microbiol. 56: 2870-2875.
7. E. Sahar, R. Nir, T. Molcho and R. Lamed . 1993. “Flow Cytometry of Microcolonies as an approach for mutant selection and industrial strain improvement”. Progress in Biotechnology 9, p. 571 – 575. Ed. L. Alberghina, L. Frotali and P. Sensi.
8. E. Sahar, R. Nir and R. Lamed . 1994.”Flow Cytometric analysis of entire microbial colonies”. Cytometry 15: 213 – 221.
QUALIFYING THERAPEUTIC DISCOVERY PROJECT (QTDP) GRANTS
Leading the two therapeutics development projects at SBH Sciences. During 2010, SBH Sciences have been awarded with two QTDP grants related to these projects:
- Developing Therapy for Pancreatic Cancer Targeting Nuclear Export by CRM-1
- Development of a Therapy for Liver Fibrosis by Specific Targeting of Galectin-3
LATEST ABSTRACTS IN LEAD DRUG DEVELOPMENT RESEARCH (2012 – 2012)
Sharon Shacham, Raphael Nir, Dirk Daelemans, Sharon Shechter, Ivana Vancurova, Ashish Juvekar, Winnie Lau, Guy Higgins, Giulio Draetta and Michael Kauffman (2010). KPT0127, A Novel, Potent, and Selective Inhibitor of CRM1-Mediated Nuclear Export Shows Selective Cytotoxicity for Neoplastic over Normal Cells and is Well-Tolerated in Animals. AACR Translational Cancer Medicine; San Francisco, July 2010.
Vincent Sandanayaka, Raphael Nir, Sharon Shechter, Michael Kauffman and Sharon Shacham (2010). Discovery of CRM1-Mediated Nuclear Transport Inhibitors as Novel Modulators of Epigenetic Enzymes. American Chemical Society Meeting; Boston, August 2010.
S. Shacham, R. Nir, D. Daelemans, S. Shechter, I. Vancurova, A. Juvekar, J. Turner, W. Lau, G. Higgins, G. Draetta and M. Kauffman (2010). KPT0127, A Novel, Potent, and Selective Inhibitor of CRM1-Mediated Nuclear Export Shows Selective Cytotoxicity for the Treatment of Hematological Cancers. XXXIII World Congress of the International Society of Hematology; Jerusalem, Israel, October 2010.
S. Shacham, J.G. Turner, R. Nir, G. Draetta, V. Sandanayaka, S. Shechter, M. Kauffmanand D. Sullivan (2010). Preclinical Development of Small-Molecule CRM1 Inhibitors as Novel Therapy for the Treatment of Myeloma and Other Hematological Malignancies. 52nd ASH Annual Meeting and Exposition; Orlando, December 2010.
S. Shacham, M. Kauffman, V. Sandanayaka, G. Draetta, S. Shechter, J. Williams and R. Nir (2011). Preclinical Development of Small-Molecule CRM1 Inhibitors as Novel Therapy for the Treatment of Colorectal Cancer. 2011 Gastrointestinal Cancers; San Francisco, January 2011.
S. Shacham, M. Kauffman, V. Sandanayaka, G. Draetta, S. Shechter, J. Williams and R. Nir (2011). Discovery of SINE: Selective Inhibitors of Nuclear Export Increase Levels of Regulatory Proteins p53, p21, FOXO and IkB Leading to Apoptosis of Malignant Cells. American Association for Cancer Research (AACR) Meeting; Orlando, April 2011.
Dilara McCauley, Tami Rashal, Sharon Shacham, Michael Kauffman, Yossi Landesman, Jean St-Martin, Trinayan Kashyap, William Senapedis, Jennifer L. Williams, Raphael Nir, Maya Illuz, Nir Peled (2012). Selective inhibitors of nuclear export (SINE) induce multiple tumor suppressor proteins (TSP) activity and show single agent antitumor effect and synergy with Bcl-2 antagonist in non-small cell lung cancer. American Association for Cancer Research (AACR) Meeting. Chicago, USA, April 2, 2012
Dilara McCauley, Yosef Landesman, William Senapedis, Trinayan Kashyap, Jean-Richard Saint-Martin, Louis Plamondon, Vincent Sandanayaka, Sharon Shechter, Doriana Froim, Raphael Nir, Jennifer Williams, Lynda Chin, Cyril Benes, Mansoor Raza Mirza, Michael Kauffman, Sharon Shacham (2012); Preclinical evaluation of selective inhibitors of nuclear export (SINE) in basal-like breast cancer (BLBC). American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, USA, June, 2012
Raphael Nir and Eliezer Zomer (2012); Monocyte activation model to study cytokine involvement in angiogenesis and inflammation promoting metastasis ; The40th ISOBM Anniversary Congress – Innovations in Oncological Treatments and Tumor Markers ; Jerusalem, Israel, October, 2012.
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