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Mark LaneVice President, Principal Consultant Development Consulting & Scientific Affair |
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Adair TurnerHead of US Regulatory Affairs, PharmaLex |
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Dr. Patrick LarcierSenior Director of Development Consulting and Scientific Affairs, PharmaLex |
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Pain points
• Program delays or additional overruns when clients don’t engage or don’t engage early enough with Regulatory Agencies to gain alignment on their programs
• Failure to recognize the benefits that special regulatory designations may bring such as rolling review, more frequent Agency input on the development program and possible financial incentives, among others.