KR Brain - CV - April 2016
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`CURRICULUM VITAE
`Name:
`Date of birth:
`Nationality:
`Qualifications:
`
`Employment:
`
`KEITH ROGER BRAIN
`250545
`British
`BPharm (Nottingham) 1966 PhD (Bath) 1969
`
`CEO
`An-eX analytical services ltd
`Cardiff, UK
`(1988-date)
`and
`Honorary Senior Research Fellow
`School of Pharmacy and Pharmaceutical Sciences
`Cardiff University, UK
`(2011-date)
`Reader in Dermatopharmaceutics
`School of Pharmacy and Pharmaceutical Sciences
`Cardiff University, UK
`(1969-2011)
`
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`
`For past 28 years CEO of An-eX analytical Services ltd, an independent contract R&D
`company based in Cardiff that is globally recognised for expertise in development and
`evaluation, particularly in the dermal field.
`
`Also member of the academic
`staff of the School of Pharmacy and Pharmaceutical
`Sciences, Cardiff University for 42 years.
`
`Expert Witness in Patent Litigation:
`I have acted as an Expert Witness in the following three patent litigation cases in the dermal
`area in the past four years.
`
`1) FOUGERA v TOLMAR Civil Action No 10-2635 (KSH) (PS) - Declaration
`
`(settled)
`
`2) NOVEN V WATSON Civil Action No 2: 11-cv-5997 (DMC) (MF) - Expert Reports,
`Deposition, Trial Preparation (settled)
`
`3) EN DO v MYLAN Civil Action No 1:11-cv-00220-GMS - Expert Reports
`
`(settled)
`
`I have also provided expert advice on other matters.
`
`MYLAN - EXHIBIT 1003
`
`

`

`KR Brain - CV - April 2016
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`2 of 17
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`Selected external participation/esteem measures
`Expert Panel Member, Workshop on Dermal Absorption for Pesticide Risk Assessment:
`Harmonization of an In Vitro Protocol for Regulatory Use, MVS, Gaithersburg, MD, May 1-2,
`2012
`Member of HIPODERM consortium (An-eX, Cardiff University, Eirgen Pharma and Waterford
`Institute) awarded 836,000 euros through EU Marie Curie IAPP scheme (2011-2015)
`Member of the Planning Committee for the FDA/DIA meeting on Improved Development and
`Regulation of Transdermal Systems, Arlington VA, Sep 15-16, 2011
`Invited Speaker on TDDS: Past, Present and Future, at the FDA/DIA meeting on Improved
`Development and Regulation of Transdermal Systems, Arlington VA, Sep 15-16, 2011
`Invited Speaker on An Integrated Data-Driven Approach to Development and Evaluation of
`Improved Formulations for Dermal Protection, DTRA Dermal Toxicity Workshop, St
`Petersburg, FL, Jan 11-14, 2010
`One of two academic members on the ECETOC Selection Team - HETRA A2.3 International
`workshop on dermal exposure modelling meeting (part of the CEFIC Long-range Research
`initiative) in Brussels, Belgium, August 2003
`Invited participant in CEFIC expert workshop on methods to determine dermal permeation for
`human risk assessment, Utrecht, Netherlands, July 2004
`Invited member of Expert Workshop on Percutaneous Absorption, Institute for In Vitro
`Sciences, Gaithersburg, Md, USA, July 2005
`Frequent presentations at major national/international meetings
`Invited participant in Gordon Research Conference on Barrier Function of Mammalian Skin in
`Pisa, Italy, 1999, Bristol, Rl, USA, 2001 and Mount Holyoake, MA, USA, 2005 and 2007.
`Member of the Debating Team on each occasion. Invited Debate Moderator in 2009.
`Invited to join the Scientific Board, Society for Molecular Imprinting, September, 2006
`Invited Speaker, American Association of Pharmaceutical Scientists Annual Meeting, Salt
`Lake City, USA, November, 2003
`Invited Speaker, American Association of Pharmaceutical Scientists, Pharmaceutics and
`Drug Delivery Meeting, Philadelphia, USA, July, 2004
`Invited Speaker, Perspectives in Percutaneous Conference, La Grande Motte, France, April,
`2004
`Invited Speaker, AgChemForum Meeting, Amsterdam, Netherlands, September, 2004
`Invited Speaker, MIP2004 Workshop, Cardiff, September, 2004
`Invited Speaker, Perspectives in Percutaneous Conference, La Grande Motte, France, April,
`2006
`Invited Speaker, Perspectives in Percutaneous Conference, Southampton, April, 1999
`
`
`  
`

 
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`
`Conference Organisation
`Organiser of biennial international Perspectives in Percutaneous Penetration conference and
`Introductory Course on Percutaneous Penetration from 1993-date ((93, 95, 97, 98, 00, 02,
`04, 06, 08, 10, 12, 14, 16)).
`Organiser of biennial international Molecularly Imprinted Polymers Workshop from 2000-date
`(00, 02, 04, 06, 08, 10).
`
`

`

`KR Brain - CV - April 2016
`
`Both of these meetings are recognised as major global events.
`
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`u
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`3 of 17
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`Reviewing
`Regular reviewer for:
`Analytical and Bioanalytical Chemistry
`Analytica Chimica Acta
`Bioorganic and Medicinal Chemistry
`Drug Metabolism and Disposition
`International Journal of Pharmaceutics
`Journal of Controlled Release
`Journal of Drug Targeting
`Journal of Investigative Dermatology
`Journal of Pharmacy and Pharmacology
`Nature Biotechnology
`Pharmaceutical Research
`
`Publications
`The data contained in the publication list below is divided into peer-reviewed publications,
`invited book chapters, authored books, edited books, peer reviewed papers in conference
`proceedings and conference abstracts.
`
`5.
`
`  
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`=3c2<g23c<4QK=3c2@QQKbQ5LŽjE2iAr<2AQ43@AL,..-LuL/-P/,
`
`
`Publications in peer reviewed journals
`Martin CJ, Allender CJ, Brain KR, Morrissey, A, Birchaii, JC, Low temperature fabrication of
`biodegradable sugar glass microneedles for transdermal drug delivery applications, J Contr Rel, 2012,
`158, 93-101
`Green DM, Jones AC, Brain KR, Content variability of active drug substance in compounded oral 3,4-
`diaminopyridine products. J Clin Pharm Ther. 2012, 37, 53-57
`Hillberg AL, Brain KR, Allender CJ, Design and evaluation of thin and flexible theophylline imprinted
`polymer membrane materials, J Mol Recognit. 2009, 22, 223-31
`Morris AP, Brain KR, Heard CM, Skin permeation and ex vivo skin metabolism ofO-acyl haloperidol ester
`prodrugs. Int J Pharm. 2009, 367, 44-50
`Morris AP, Brain KR, Heard CM, Synthesis of haloperidol prodrugs and their hydrolysis by porcine liver
`esterase, Drug Metab Lett. 2008, 2, 275-9
`Pearton M, Allender C, Brain K, Anstey A, Gateley C, Wilke N, Morrissey A, Birchaii J, Gene delivery to
`the epidermal cells of human skin explants using microfabricated microneedles and hydrogel formulations,
`Pharm Res. 2008, 25, 407-16
`Brain KR, Green DM, Api AM and Lalko J, In-vitro human skin penetration of the fragrance material
`geranyl nitrile, Toxicol. In Vitro, 2007, 2, 133-138
`Turner NW, Jeans CW, Brain KR, Allender CJ, Hlady V, and Britt DW, From 3D to 2D: A Review of the
`Molecular Imprinting of Proteins, Biotechnol. Prog., 22, 1474-1489
`Lavignac N, Brain KR, Allender CJ, Concentration dependent atrazine-atrazine complex formation
`promotes selectivity in atrazine imprinted polymers, Biosens Bioelectron, 2006, 22, 138-44
`10. Coulman SA, Barrow D, Anstey A, Gateley C, Morrissey A, Wilke N, Allender C, Brain K, Birchaii JC,
`Minimally invasive cutaneous delivery of macromolecules and plasmid DNA via microneedles, Curr Drug
`Deliv, 2006, 3, 65-75
`11. Brain KR, Green DM, Dykes PJ, Marks R, Bola TS, The role of menthol in skin penetration from topical
`formulations of ibuprofen 5% in vivo, Skin Pharmacol. Physiol., 2006, 19,17-21
`12. Hillberg AL, Brain KR, Allender CJ, Molecular imprinted polymer sensors: Implications for therapeutics,
`Adv. Drug Del. Rev., 2005, 57, 1875-1889
`13. Birchaii J, Coulman S, Pearton M, Allender C, Brain K, Anstey A, Gateley C, N Wilke, A Morrissey,
`Cutaneous DNA delivery and gene expression in ex vivo human skin explants via wet-etch
`microfabricated microneedles, J. Drug Targeting, 2005,13, 415-421
`
`g
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`

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`KR Brain - CV - April 2016
`
`  
`

 
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`3@c@42bbQK2QbQ<5Q5[54Q=5LŽj;6<2=j;6<2=<cbL/C>CCBdC
`
`
`14. Pearton M, Barrow D, Anstey A, Gateley C, Morrissey A, Wilke N, Allender C, Brain K, Birchall JC,
`Disruption of stratum corneum by microfabricated microneedles for gene delivery from hydrogels,
`Br.J.Dermatol., 2005, 152, 842-842
`15. Brain KR, Walters KA, Green DM, Brain S, Loretz LJ, Sharma RK, Dressier WE, Percutaneous
`penetration of diethanolamine through human skin in vitro: Application from cosmetic vehicles,
`Fd.Chem.Toxicol., 2005, 43, 681-690
`16. Chabri F, Bouris K, Jones T, Barrow D, Hann A, Allender C, Brain K, Birchall J, Microfabricated silicon
`microneedles for nonviral cutaneous gene delivery, Br.J.Dermatol., 2004, 150, 869-877
`17. Lavignac N, Allender CJ, Brain KR, 4-(3-aminopropylene)-7-nitrobenzofurazan: a new polymerisable
`monomer for use in homogeneous molecularly imprinted sorbent fluoroassays, Tet.Lett, 2004, 45, 3625-
`3627
`18. Lavignac N, Allender CJ, Brain KR, Current status of molecularly imprinted polymers as alternatives to
`antibodies in sorbent assays, Anal.Chim.Acta, 2004, 510, 139-145
`19. Watkinson AC, Brain KR, Basic mathematical principles in skin permeation, J.Tox.Cutan.Ocular Tox.,
`2002, 21, 371-402
`20. Allender CJ, Brain KR, Ballatore C, Cahard D, Siddiqui A, McGuigan C, Separation of individual antiviral
`nucleotide prodrugs from synthetic mixtures using cross-reactivity of a molecularly imprinted stationary
`phase, Anal.Chim.Acta, 435, 2001, 107-113
`21. CJ Allender, C Richardson, B Woodhouse, CM Heard and KR Brain, Pharmaceutical applications for
`molecularly imprinted polymers, Int.J.Pharm., 195, 2000, 39-43
`22. R Suedee, KR Brain and CM Heard, Differential permeation of propranolol enantiomers across human
`skin in vitro from formulations containing an enantioselective excipient, Chinality, 11, 680-683
`23. KA Walters, AC Watkinson and KR Brain, In vitro skin permeation evaluation: the only realistic option,
`Int.J.Cosm.Sci. 20,1998, 307-316
`24. KA Walters, KR Brain, DM Green, VJ James, AC Watkinson and RH Sands, Comparison of the
`transdermal delivery of estradiol from two gel formulations, Maturitas, 29, 1998,189-195
`25. AC Watkinson and KR Brain, Ceramides and fatty acids; Boosting the skin's barrier function, Soap,
`Perfumery and Cosmetics, 6, 1998, 49-54
`26. KA Walters, KR Brain, WE Dressier, DM Green, D Howes, VJ James, CK Kelling, AC Watkinson, SD
`Gettings, Percutaneous penetration of N-nitroso-N-methyldodecylamine through human skin in vitro:
`Application from cosmetic vehicles, Fd Chem.Toxicol. 35 (1997) 705-712
`27. MA Pellett, AC Watkinson, J Hadgraft and KR Brain, Comparison of permeability data from traditional
`diffusion cells and ATR-FTIR spectroscopy Part II. Determination of diffusional pathlengths in synthetic
`membranes and human stratum corneum, Int.J.Pharm. 154 (1997) 217-227
`28. MA Pellett, AC Watkinson, J Hadgraft and KR Brain, Comparison of permeability data from traditional
`diffusion cells and ATR-FTIR spectroscopy Part I. Synthetic membranes, Int.J.Pharm. 154 (1997) 205-215
`29. MA Pellett, AC Watkinson, KR Brain and J Hadgraft, Evaluation of diffusion coefficients in silicone
`membranes using ATR-FTIR spectroscopy and concentration-depth profiles, Pharm.Res., 14 (1997) S36
`30. KA Walters, KR Brain, D Howes, VJ James, AL Kraus, NM Teetsel, M Toulon, AC Watkinson and SD
`Gettings Percutaneous penetration of octyl salicylate from representative sunscreen formulations through
`human skin in vitro, Fd.Chem. Toxicol., 35 (1997) 1219-1225
`31. R Suedee, KR Brain and CM Heard, Stereoselective release of propranolol enantiomers from matrices
`containing cellulose derivatives. Chirality 9 (1997) 307-312
`32. CJ Allender, CM Heard and KR Brain, Mobile phase effects on enantiomer resolution using molecularly
`imprinted polymers, Chirality 9 (1997) 238-242
`33. CJ Allender, KR Brain and CM Heard, Binding cross-reactivity of boc-phenylalanine enantiomers on
`molecularly imprinted polymers, Chirality 9 (1997) 233-237
`34. CM Heard, KR Brain and R Suedee, Differential penetration of propranolol across human skin in vitro
`caused by stereoselective sorption in vehicle, J.Pharm.Pharmacol, 49 (1997) S41
`35. WJ Kee, KR Brain and CM Heard, Towards malaria prophylaxis by transdermal delivery of some anti­
`malarial drugs, J.Pharm.Pharmacol, 49 (1997)3142
`36. CJ Allender, MAE Bowman, KR Brain and CM Heard, Evaluation of molecularly imprinted polymers as
`selective sorbents for the preliminary screening of combinatorial libraries, J.Pharm.Pharmacol, 49 (1997)
`S173
`37. CJ Allender, MAE Bowman, KR Brain and CM Heard, Molecularly imprinted polymers as novel excipients
`in controlled release systems, J.Pharm.Pharmacol, 49 (1997) S119
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`KR Brain - CV - April 2016
`
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`

 
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`
`38. JE Harrison, PW Groundwater, KR Brain and J Hadgraft, Azone® induced fiudity in human stratum
`corneum. A fourier transform infrared spectroscopy investigation using the perdeuterated analogue.
`J.Contr.Rei. 41 (1996) 283-290
`39. C M Heard, K R Brain and K A Walters, Chiral Delivery, Brit Pat Appl 9526478.4 (1996)
`40. GC Ebi,, KR Brain and OK Udeala, Mannich reaction of 1-n-butyl-3-p-tosylurea .1. syntheses of3-n-
`butyl-2-oxo-1,5-di-p-tosyl-perhydro-1,3,5-triazine and 3,5-di-n-butyl-2-oxo-1 -p-tosyl-perhydro-1,3,5-
`triazine, Chem.Pharm. Bull. 44 (1996) 639-641
`41. K R Brain, M A Shatalebi, A Abdel-Aziz and A Carabot Cuervo, Relacion estructura-actividad de
`saponinas con efecto molusquicida, Revista Latinoamericana de Quimica, 24 (1996) 25-32
`42. A C Watkinson, J Harrison, DM Green, K R Brain and J Hadgraft, The relative effect of Azone® and
`Transcutol® on diffusivity and solubility in human stratum corneum. Pharm. Res. (1996)13, 542-546
`43. A C Watkinson, H Joubin, D M Green, K R Brain and J Hadgraft, The influence of vehicle on permeation
`from saturated solutions, Int.J.Pharm., 121 (1995) 27-37
`44. C M Heard and K R Brain, Does solute stereo-chemistry influence percutaneous penetration? Chirality 7
`(1995) 305-309
`45. A M L Tralhao, A C Watkinson, K R Brain, J Hadgraft and N A Armstrong, Use of ATR-FTIR spectroscopy
`to study the diffusion of ethanol through glycerogelatin films, Pharm. Res. 12 (1995) 572-575
`46. A M Tralhao, A C Watkinson, K R Brain, J Hadgraft and N A Armstrong, Measurement of diffusion of
`ethanol through glycerogelatin films by ATR-FTIR spectroscopy, Eur J Pharm Sci 2 (1994) 155
`47. K R Brain, K A Walters, V J James, W E Dressier, D Howes, C K Kelling, S J Moloney and S D Gettings,
`Percutaneous Penetration of dimethylnitrosamine through human skin in vitro : Application from cosmetic
`vehicles, Fd Chem Toxic 33 (1995) 315-322
`48. A C Watkinson, J Hadgraft, K A Walters and K R Brain, Measurement of diffusional parameters in
`membranes using ATR-FTIR spectroscopy, Int J Cosmet Sci 16 (1994) 199-210
`49. C M Heard, K R Brain and J Hadgraft, Enantiomer enrichment and differential facilitated transport of
`propranolol and bupranolol enantiomers across a solid-supported liquid membrane, Bioseparation, 4
`(1994) 111-116
`50. K R Brain and A. Abdel-Aziz, Cromatografia de gases-espectrometria de masas de captura de iones de
`espirostenos y sapogeninas 22,25-epoxifurostenos hidroxilados en el anillo F, Rev Fac Farm 29 (1994)
`31-38
`51. J Hadgraft and K.R. Brain, Comments on 'A new approach towards the development of a transdermal
`terbutaline releasing system', J ContrRel 27 (1993) 175-176
`52. AC. Watkinson , K. R. Brain, K. A. Walters and J. Hadgraft, Investigation of relative rates of solvent and
`solute penetration through protective glove materials. Pesticide Sci, 39, 251-256 (1993)
`53. CM Heard, A.C. Watkinson, K.R. Brain and J. Hadgraft, In vitro skin penetration of propranolol
`enantiomers, Int.J.Pharm, 90 (1993) R5-R8
`54. KR Brain, The implications of developments in pharmaceutical analysis and new medicines on
`pharmaceutical education, J.Pharm.Pharmacol. 45S (1993) 381-383
`55. AC Watkinson, K.R. Brain, K.A Walters and J. Hadgraft, Prediction of the percutan