Professional recognition and credibility of ERT across Europe. How to leverage? Professor Ruth Roberts, PhD ATS, FBTS, ERT Senior Director Toxicology, AstraZeneca Louise Cornes, Capability Development Director AstraZeneca & SafeSciMET, Executive Committee Member EUROTOX August 29 th 2011

2 “Safety issues are major reasons for discontinuing otherwise promising drug candidates from pharmaceutical development of new medicines” The Challenge……… “The potential for a significant miss judgment to cause harm worldwide will be minimized if all practicing toxicologists involved in the evaluation of regulatory safety studies are well documented to have acquired a standard set of critical skills, knowledge, and experience” Global Recognition of qualified Toxicologic Pathologists. Toxicol Pathol June 2009 vol. 37 no

Drug Discovery & Development: Reasons for Attrition (IMI-2007) IMI Strategic Research Agenda (NPEV)

Employee Career Development Regulatory Agencies Professional recognition and credibility of ERT across Europe. Who do we need to influence to gain maximum leverage? Employers Why should employers ask for ERT certification in job advertisements? Why should Regulatory Authorities & Health Authorities request evidence of ERT certification? How will ERT certification help Employee Career Development?

Employee Regulators What is the benefit to them? Employers Provides objective demonstration of breadth and current knowledge Supports scientific credibility Gain a competitive advantage by recruiting/retaining employees with more advanced skills Certification by ERT provides access to other certified colleagues who can provide expertise in diverse areas to other certified colleagues who can provide expertise in diverse areas.

Employees What is the benefit to them? Employers Provides objective demonstration of breadth and current knowledge Supports scientific credibility Regulatory agencies can more easily compare educational backgrounds of regulatory-type Toxicologists to other certified colleagues who can provide expertise in diverse areas. Regulators

What is the benefit to them? Employers ERT certification provides personal satisfaction and intellectual stimulation ERT certification recognises broad expertise in general toxicology for those with formal toxicology training, as well as those trained in other related disciplines ERT often offers advantages in the job market and career development, and has been associated with higher levels of compensation** ERT enhances credibility in consultancy and legal testimony Regulators Employees **(Gad Fifth triennial toxicology salary survey. Int. J. Toxicol, 21: ).

“Anyone who stops learning is old, whether at 20 or 80. Anyone who keeps learning stays young. The greatest thing in life is to keep your mind young." Henry Ford

9 Potential resistance from Key Stakeholders: Employers, Regulators, Employees………. Cost, effort and time to sell the benefits to key stakeholders No return on investment Regulators don’t request it Employers don’t stipulate it in job adverts as an essential employment criteria Employees see no tangible salary or career enhancement benefits

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11 To successfully leverage professional recognition and credibility of ERT across Europe, we would need to:……….. Add substantial value for individual practitioners and ensure this is communicated Inspire confidence in ERTs by employers, Health Authorities, Regulatory agencies and the general public How do we do this?

Learning from others 12  MRC Path & DABT  Today board certification of Pathologists is expected or at least favoured by employers and by the recipients of regulatory dossiers  Schemes were created by those who wished to set standards for their profession  Employer expectation and regulatory requirement came later ERT created ERT members use designation Employers ask for it Regulatory Authorities require it

13 What course should the European community of Toxicologists pursue now? A proposal………. To host a European summit of elected representatives of Employers, Employees, Regulatory Agencies and Health Authorities to initiate a formal dialogue to consider how to optimally sell the benefits to all stakeholders?

Louise Cornes, Capability Development Director AstraZeneca, UK SafeSciMET, Executive Committee Member "Great works are performed not by strength, but by perseverance." Dr Samuel Johnson Acknowledgements