Education

Biography

Rafiqul Islam is the Senior Director of Bioanalytical Services at Celerion Inc. In his current role he is responsible for the scientific and operational leadership for both small and large molecule bioanalysis. He is also responsible for developing and executing a strategic plan to deliver scientific, operational and service excellence to Celerion clients to support drug discovery, drug development and tobacco research. Previously, Rafiq held positions at EMD Millipore where he was the Scientific Director for Biopharma Services. He held similar positions at Covance and Huntingdon Life Sciences. He also had several positions of increasing responsibility with Curagen Corporation. He has held various positions within drug discovery, target optimization, drug metabolism, pharmacokinetics and biomarker development and validation. He played a key role in developing and industrializing the Predictive Toxicology System (PTS) at Curagen. His experience includes global product research and development, bioanalytical and in-vitro toxicology analysis in an FDA regulated environment, and streamlining workflows for laboratories with diverse operations in multiple sites. He successfully led bioanalytical businesses utilizing a blend of scientific knowledge and managerial expertise in major CROs. He has 15 years of industry experience including more than ten years of experience in regulated bioanalysis. He is an active member of the American Association of Pharmaceutical Scientists (AAPS) and the Global CRO Council (GCC). He is actively involved in industry and regulatory discussions regarding the development of standard practices and guidances for bioanalytical analysis.

Research Interest

1. Novel bioanalytical techniques and technologies for the measurement biotherapeutics
2. Using hybrid LC-MS/MS and LBA methods for the bioanalysis of large molecules including antibody drug conjugates (ADCs)
3. Regulatory science involving bioanalysis
4. Automation of bioanalytical processes and techniques
5. Application of Design of Experiments (DOE) in bioanalysis
6. Bioanalytical challenges involving biosimilars
7. Generation of novel antibodies and binding reagents such as aptamer to improve bioanalytical techniques

Professional Activities:

1. Senior Director (2012- present) Global Bioanalytical Services ,Celerion Inc. Lincoln, NE
2. Chairman, Scientific Advisory Board (2011- present) ,Somru BioScience Inc. PE, CANADA
3. Scientific Director (2010- 2012) Biopharma Services ,EMD Millipore St, Charles MO
4. Associate Director (2007- 2010) Immunochemistry Services, Covance Chandler, AZ
5. Associate Director (2005- 2007) Ligand Binding Assay group,Huntingdon Life Sciences East Millstone, NJ
6. Various Positions of Increasing Responsibilities (1998- 2004) ,Curagen Corporation New Haven, CT

Publications

1. Islam R. Chapter 16: Bioanalytical Development. Book Title: Biosimilars of Monoclonal Antibodies, a Practical Guide to Manufacturing and Preclinical and Clinical Development Edited by Cheng & Morrow. Under publication by John Wiley.
2. Islam R. Bioanalytical challenges of biosimilars. Bioanalysis (2014) 6(3), 349–356
3. Lapko V., Miller P., Brown G., Islam R., Peters S., Sukovaty R., Rhun P., Kafonek C. Sensitive Glucagon Quantification: Comparison of Immunochemical and LC-MS/MS Methods Bioanalysis (2013) 5(23), 2957–2972.
4. Islam R. Improving productivity and profitability of a bioanalytical business through sales and operation planning. Bioanalysis (2013) 5(14),
5. Islam R, and Islam C. Bioanalytical challenges in the development of biosimilars. Bioanalysis of Biotherapeutics. (2013) doi: 10.4155/9781909453739
6. Islam R, O’Dell M, Snow M, and Bowsher RR. Peptide therapeutics: emerging drugs with unique bioanalytical challenges. AAPS Newsmagazine 14(5): 15-20 (2011)
7. 2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies & Biomarkers (Part 3 – LBA, Biomarkers and Immunogenicity). Bioanlaysis. To be published.
8. 8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation. Bioanalysis (2014) 6(22), 2957–2963 RAFIQUL ISLAM Page 5 of 5
9. 2013 White Paper on recent issues in bioanalysis: ‘hybrid’ – the best of LBA and LCMS. Bioanalysis (2013) 5(23), 2903–2918
10. 4th Global CRO Council for Bioanalysis:coadministered drugs stability, EMA/US FDA Guidelines, 483s and Carryover. Bioanalysis (2012) 4(7), 763–768
11. 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars. Bioanalysis (2012) 4(19), 2335–2342
12. Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC). Bioanalysis (2012) 4(17), 2117–2126
13. Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC). Bioanalysis (2012) 4(6), 651–660
14. Recommendations on biomarker bioanalytical method validation by GCC. Bioanalysis (2012) 4(20), 2439–2446
15. Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC). Bioanalysis (2012) 4(6), 651–660