Expert Profile
Dr. Ralph ***** is an independent external consultant at JANSSEN ***** . He specializes in drug product formulations and primary packaging for injectable dosage forms with a special focus on biotechnology and peptidide formulation and delivery. He started his post doctoral employment at HOFFMANN-LA ROCHE (US subsidiary of ROCHE Holdings Inc in 1989) and was promoted to Research Director, Pharmaceutical and Analytical R&D in 1995, heading up the Sterile Formulation Development Group.
During his tenure at ROCHE, he served as Head Sterile Formulations, Package Research and Clinical Manufacturing .. His primary areas of research have been drug delivery systems (device and formulation approaches) formulation of peptides, solubilization and formulation of insoluble oncology small molecules. During this time period served also as a CMC Leader and Formulations Expert for four successfully launched ***** . He has published in the area of drug delivery and formulation research and was the primary inventor for a patented subcutaneous sustained release formulations
Dr. ***** ’s scope was global.
Dr. ***** played a key role in the global harmonization of pharmaceutical formulations and processes at Roche over the last 20 years which improved development times and streamlined regulatory submissions. He was a member of Roche’s Global Formulation Research Management Team, and the Chair of the International Technology Working Group as well as the Global Peptide Delivery Champion. In this role, he was responsible for identifying, obtaining funding for and carrying out feasibility studies with novel formulation and device opportunities outside ***** Approximately 10 collaborations were conducted and several technologies advanced to the clinical evaluation stage,
In addition, was the Subject Matter Expert for Sterile Products and served as instructor to FDA investigators for biotechnology formulation development. He managed both GLP and GMP sterile facilities and successfully produced over 500 toxicology and clinical batches during his tenure at *****
Dr. ***** is a registered pharmacist, received his PhD from Saint John’s University and attended New York University for his pre-professional studies. He is a member of AAPS, the Controlled Release Society. He is an Adjunct Assistant Professor in Pharmaceutical Sciences, Long Island University (inactive) and has served as the Chair, Basic Pharmaceutical Sciences, Academy of Research and Science
American Pharmaceutical Association.
Janssen *****
Roche *****
Research Director, Formulation Research
-Subject Matter Expert, Sterile Products
-Led US Sterile Product Formulation Development
-Peptide Drug Delivery Champion
-Chair International Pharmaceutical Working Group
PhD - Saint John's University
BS - Pharmacy, LIU
AAPS
Controlled Release Society
American Pharmaceutical Association
Consulting - Biotechnology products/primary packaging
- Medical Communications
PUBLICATIONS/PRESENTATIONS
1. R.Chari, F. Qureshi ,J. Moschera , R.***** , D. Kalonia Development of Improved Empirical Models for Estimating the Binding Constant of a β-Cyclodextrin Inclusion Complex. Pharmaceutical Research. 26, 151 (2009)
2. R Payne, R. Nayar, R.*****, S. Del Terzo J. Moschera, J. Die, . D. Heilman, B.Bray, M. Manning, C. Henry. 28. Second virial coefficient determination of a therapeutic peptide by self-interaction chromatography. Peptide Science, 84, 527 (2006).
3. C. Bailey, R. Margolis, A. Railkar, H.K. Sandhu, E. Spence, R. *****, the Discovery -Development Interface: Early Formulation Strategies for Poorly Soluble Small Molecule Therapeutics. Podium Presentation at AAPS National Meeting. Seattle Washington, October 1996. Published Abstract
4. C. Bailey, A. Railkar, R. *****. Along the Development Superhighway: At the Interface Between Discovery and Development of Orally Active Small Molecules. Podium Presentation. American Chemical Society Meeting. New Orleans, Louisiana, March, 1996. Published Abstract
5. J. Lepore, H.K. Sandhu and R. *****. The Thermal Isomerization of the Vitamin D Analogue Ro ***** and Comparison to Calcitriol and Cholecalciferol. Podium Presentation at AAPS Meeting, Orlando Florida, November 1995 .Published Abstract
6. S. Del Terzo, A. Divincenzo, s. Kumar, J. Lepore, R. Margolis, H.K. Sandhu, and R.*****. Effect of Storage and Handling on the Stability of Benzyl Alcohol. Poster Presentation at AAPS Meeting, Orlando Florida, November 1995 .Published Abstract
7. R. *****, E. Bishop, F. C. Chen, K. Iqbal and A. W. Malick. 8-Methyl-2-Pyrrolidone as a Cosolvent: Relationship of Cosolvent Effect with Solute Polarity and the Presence of Protein Donating Groups on Model Drug Compounds. J. Pharm. Sci., 83, 1213 (1995).
8. C. Bailey, P. Bryla, A. W. Malick, E. Spence and R. *****. The Use of In-Vitro Release Profiles from Disposable Transport Units for Rapid Screening of Semi-Solid Sustained Release Dosage Forms. Podium Presentation at AAPS Meeting, San Diego, California, November, 1994. Published Abstract.
9. M. T. Carvajal, P. Gasior, E. M. Phillips, A. Weinrib, R. ***** and A. W. Malick. Spray Drying Optimization to Produce Powder for Inhalation. Podium Presentation at AAPS Meeting, San Diego, California, November, 1994. Published Abstract.
RALPH *****, Ph.D. Page Two
Residence: ***** ralph.**********
10. N. H. Shah, A. S. Railkar, F. C. Chen, R. *****, S. Kumar, M. Murjani, D. Palmer, M. H. Infeld and A. W. Malick. A Biodegradable Injectable Implant for Delivering Micro and Macromolecules Using (lactic-co-glycolic) Acid (PLGA) Copolymers. Journ. Cont. Rel. Soc., 27, 139 (1993).
11. R. *****, R. Vladyka, A. Cutie, E. Bishop, M. Infeld and A. W. Malick. Evaluation of a Solvent Precipitation Method for Fabricating Poly(lactide-co-glycolide) Biodegradable Implants. Poster Presentation at AAPS Meeting, San Antonio, Texas, November, 1992. Published Abstract.
12. N. H. Shah, A. S. Railkar, F. C. Chen, R. *****, S. Kumar, M. H. Infeld and A. W. Malick. A Novel Formulation for a Biodegradable Injectable Implant Using PLGA. Poster Presentation at AAPS Meeting, San Antonio, Texas, November, 1992. Published Abstract.
13. R. *****, A. Pagan, K. Iqbal and A. W. Malick. Critical Factors for Maintaining Low Oxygen Levels in Sterile Solutions. Poster Presentation at AAPS Eastern Regional Meeting, New Brunswick, New Jersey, June, 1992.
14. E. Bishop, R. *****, T. Vangieri and K. Iqbal. Stability of Roferon-A in Dextrose 5% Injection, USP During Preparation and Simulated Administration Using an Ambulatory Infusion Apparatus. Poster at AAPS Eastern Regional Meeting, New Brunswick, New Jersey, June, 1992.
15. R. *****, E. Bishop, F. C. Chen, K. Iqbal and A. W. Malick. N-Methyl-2-Pyrrolidone as a Cosolvent: Correlation of Cosolvency Properties with Estimated Partition Coefficients and Deviation from Log-Linear Solubilization. Podium Presentation, AAPS Meeting, Washington, DC, November, 1991. Published Abstract.
16. R. *****, S. Negit, K. Iqbal and A. W. Malick. A Rapid Screen for Selecting Chelating Agents for Solution Dosage Forms. Poster Presentation, AAPS Meeting, Las Vegas, Nevada, November, 1990. Published Abstract.
17. R. *****, D. W. Adair, S. Bolton. In-Vitro and In-Vivo Release of Salicylic Acid from Povidone/Polydimethylsiloxace Matrices. Drug Dev. Ind. Pharm., 16, 1217 (1990).
18. R. *****, D. W. Adair, S. Bolton. Enhanced drug release from povidone/polydimethyolsiloxane matrices presented at AAPS meeting, Orlando, Florida, October, 1988. Published Abstract.
19. R. *****, D W. Adair, Enhancement of Bioavailability with Sub-Micron Suspensions. Presented at AAPS Meeting, Washington, DC, November, 1986. Published Abstract.