Biopharma Consulting

Publications

Brief CV – David John Snodin

Qualifications

Academic:

BSc, ARCS:  Honours Chemistry, Imperial College, London University, 1966

PhD:  Organic Chemistry, University of Bristol, 1970

MChemA:  Mastership in Chemical Analysis, Royal Society of Chemistry, 1976

MSc:  Toxicology, University of Surrey, 1980

MSc:  Applied Statistics, Sheffield Hallam University, 1996

Professional:

FTOPRA:  Fellow of The Organisation for Professionals in Regulatory Affairs

FRSC:  Fellow of Royal Society of Chemistry

Present and Past Posts

  • February 2010              Principal, Xiphora Biopharma Consulting.
  • 2002-2010                   VP Nonclinical at PAREXEL Drug Development Consulting.
  • 1991-2002                   Expert Preclinical Assessor at UK Medicines Control Agency; UK representative on CPMP Safety Working Party.
  • 1988-1990                   Independent Scientific Consultant specialising in providing advice in toxicology, environmental and regulatory affairs on food and pharmaceutical ingredients.
  • 1977-1988                   Safety & Regulatory Affairs Manager, Tate & Lyle Group Research and Development.  Safety assessment and registration of new food and pharmaceutical ingredients.

Recent publications

  • – Snodin DJ (2017) The Cancer Threshold of Toxicological Concern (TTC) in relation to Foodstuffs and Pharmaceuticals: A Potentially Useful Concept Compromised by a Dubious Derivation. Hum Exp Toxicol. Submitted for publication
  • Snodin DJ (2017) Regulatory Risk Assessments: Is there a Need to Reduce Uncertainty and Enhance Robustness? Update on Parabens. Hum Exp Toxicol. doi 10. 1177/0960327117718042. [Epub ahead of print.]
  • – Snodin DJ (2017)   ICH M7 guideline on mutagenic impurities in pharmaceuticals. Regulatory Rapporteur. 14(3). 5-9.
  • – Snodin DJ (2015) Regulatory risk assessments: is there a need to reduce uncertainty and increase robustness. Hum Exp Toxicol. 34: 1258-1271.
  • – Snodin DJ (2015) Pharmaceutical Impurities: Surveying the regulatory landscape from a toxicological perspective. Regulatory Rapporteur. 12 (9). 17-21.
  • – Snodin DJ, Teasdale A. (2015) Mutagenic alkyl sulfonate impurities in sulfonic-acid salts: reviewing the evidence and challenging regulatory perceptions. Org. Process Res. Dev. 19 (11), 1465-1485.
  • – Snodin D (2014) Potentially Mutagenic Impurities (PMIs): Optimizing Toxicological and Analytical Assessments. Org. Process Res. Dev. July 1. 18 (7), 836-839
  • – Snodin D. (2014) Unnecessary Development of Highly Sensitive Assays for Potentially Mutagenic Impurities (PMIs). Org. Process Res. Dev.18 (3), 360–361.
  • – Snodin DJ, McCrossen S (2013) Mutagenic impurities in pharmaceuticals: a critique of the derivation of the cancer TTC (Threshold of Toxicological Concern) and recommendations for structural-class-based limits. Regul Toxicol Pharmacol, 67, 299–316
  • . – Elder DP, Snodin DJ. (2013) Genotoxic/Mutagenic Impurities Part 3: CMC (Chemistry, Manufacturing and Controls) Overview. Pharmaceutical Outsourcing, May Edition
  • – Snodin DJ, Elder DP. (2012) Genotoxic Impurities Part 2: Toxicological Aspects. Pharmaceutical Outsourcing, September Edition
  • Snodin D, Cartwright A, Matthews B. (2012) Alkyl mesilate impurities: a case study in regulation, GMP Review, 11 (3), October, 9-11.
  • – Elder DP, Snodin DJ. (2012) Genotoxic Impurities Part 1: General Overview. Pharmaceutical Outsourcing, May/June Edition
  • Snodin DJ, Cartwright AC, Matthews BR. (2012) Production statement for mesilate-salt drug substances is no longer justified. Pharmeuropa Readers’ Tribune, April, pp 1-10.
  • Snodin DJ, McCrossen S (2012) Guidelines and pharmacopoeial standards for pharmaceutical impurities: overview and critical assessment. Regul Toxicol Pharmacol, 63, 298-312.
  • Snodin DJ (2011) EMA reflection paper on generic nanoparticle iron products: a case of bias by omission? Scrip Regulatory Affairs, August 2011, 10-11
  • – Snodin DJ (2011) Genotoxic Impurities: a regulatory toxicology commentary on recent articles in Organic Process Research & Development, Org. Process Res. Dev., 2011, 15 (6), 1243–1246.
  • – Snodin DJ, Suitters A. (2012) Toxicology and Adverse Drug Reactions, in Stephens’ Detection of New Adverse Drug Reactions, Sixth Edition, pp 157-214.
  • – Snodin DJ (2010) Genotoxic Impurities: from structural alerts to qualification, Org Proc Res Dev, 14 (4), 960-976
  • – Elder DP, Snodin DJ, Teasdale A (2010) Review: Analytical approaches for the detection of epoxides and hydroperoxides in active pharmaceutical ingredients, drug products and herbals, J. Pharm. Biomed. Anal. 51, 1015-1023.
  • – Snodin, DJ (2009) Environmental Risk Assessment. .In: International Pharmaceutical Product Registration (2nd Edn) Informa Press.
  • – Cartwright, AC, Snodin, DJ (2009) Drug Substance Characterisation. In: International Pharmaceutical Product Registration (2nd Edn) Informa Press.
  • – Snodin, DJ, Vudathala, GK (2009) Genotoxic impurities: time for a regulatory rethink? AAPS Journal. February 2009
  • – Elder, D, Snodin, DJ (2009) Drug substances presented as sulfonic acid salts: overview of utility, safety and regulation. J Pharm Pharmacol. 61, 269-278
  • – Snodin, DJ (2008) EU guideline on genotoxic impurities needs updating. RAJ Pharma. Part I September (593-598); Part II October (663-670).
  • – Ryle, PR, Snodin, DJ (2008) Implementation of ICH S6: EU Perspective. In Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to facilitating Clinical Trials, Ed Joy A Cavagnaro
  • – Snodin DJ (2007) Scientific and regulatory aspects of nonclinical drug development to meet European requirements, p 11-39. In Nonclinical Drug Safety Assessment, Eds Sietsema & Schwen, FDAnews
  • – Snodin, DJ (2006) Residues of genotoxic alkyl mesylates in mesylate salt drug substances:  real or imaginary problems?  Regul Toxicol Pharmacol, 45, 79-90.
  • – Snodin, DJ, Ryle, PR (2006)  Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals, BioDrugs, 20, 25-52.
  • – Snodin, D (2005), Biogenerics – Nonclinical Aspects, Regulatory Rapporteur, February edition
  • – Snodin, D (2004), Regulatory immunotoxicology:  does the published evidence support mandatory nonclinical immune function screening in drug development? Regul Toxicol Pharmacol, 40, 336-355.
  • – Kirkland, D and Snodin, D (2004), Setting limits for genotoxic impurities:  threshold-based and pragmatic approaches, Int J Pharm Med, 18, 197-207.
  • – Snodin, D and Parsley, J (2004), Overview of nonclinical guidelines and CTD in relation to drug development, Regulatory Rapporteur, October edition
  • – Snodin, DJ (2004), Toxicology and Adverse Drug Reactions, in Stephens’ Detection of New Adverse Drug Reactions, Fifth Edition, Edited by Talbot, J and Waller, P, (Wiley)
  •  – Van der Laan, JW, Silva Lima, B and Snodin, DJ (2002), Alternative models in carcinogenicity testing – a European perspective, Toxicol Pathol, 30, 157-159.

 

Presentations/Workshops/Panels

2017

  • Annual Genotoxic Impurities Summit, Vienna, June 2017
  • Presentation: ICH M7: Pitfalls and Pragmatic Solutions

 

2016

  • Medicines for Malaria Venture (MMV): one-day DART toxicology expert meeting. London, 22nd July 2016
  • Genotoxic Impurities, Berlin, September 2016
    • Presentation: Alkyl-sulfonate impurities in sulfonic-acid salts: fact or fiction?
    • Workshop leader on mutagenic degradation products in pharmaceuticals

 

2014

  • Genotoxic Impurities. Problem-solving workshop leader. Berlin , 25th June, 2014,

2013

  • Genotoxic Impurities. Pre-conference workshop leader. Berlin, 18th June, 2013
  • Scientific Update, Leeds, December 2013. Winter Process Chemistry Conference: A Toxicological Perspective on Dealing with Pharmaceutical Impurities: Key Principles and Pragmatic Solutions

 

2006-2011

  • Regular speaker on PTI course on introduction to pharmaceutical regulatory affairs (covering nonclinical/clinical aspects)

 

1995-2012

  • Speaker at numerous conferences/courses on nonclinical studies in general, as applied to biopharmaceuticals and impurity qualification.
  • Various expert panels and due diligence evaluations in relation to acquisitions

 

Referee for Peer Review

  • Reviewer for journals such as: Regul Tox Pharmacol, Hum Exp Toxicol, Crit Rev Toxicol, Drug Chem Toxicol, Org Proc Res Dev, J Pharm Anal.