Robin Huff Email & Phone Number

Raleigh, Nc, Us

Tokyo, Jp

• Collaborate with cross-functional team members on Global Project Team to define a development program that maximizes the probability of regulatory and access success• Lead a global team to develop and implement regulatory submission strategy for late-stage small molecule asset• Influence development of earlier stage assets through oversight of direct reports

Brussels, Be

• Led a global team of US, EU, Japan, China, and ROW regulatory representatives to develop and implement regulatory strategy for 4 – 6 indications for a monoclonal antibody• Indications included neurological and hematological disorders of an autoimmune origin• Led cross-functional team to identify effective means of presenting subgroup data that culminated in approval of a differentiated indication statement• Collaborated with functional group leads and submission project manager to facilitate a detailed submission plan in order to achieve simultaneous global submissions• Led Submission Advisory Forum meetings with senior leadership to keep them apprised of key risks and mitigations and to benefit from their guidance

Brussels, Be

• Led a team of regional regulatory leads (US, EU, Japan and China) to develop global regulatory strategy for company’s lead development asset in neurology• Led meetings with FDA, EMA, PMDA and the Chinese CDE, achieving acceptance of an integrated development plan across the regions that maximized efficiencies for the clinical program• Made key contributions to study designs and accompanying rationale for submissions to regulatory authorities and HTAs to facilitate acceptance of company positions - Advocated proposing a continuous endpoint rather than the traditionally accepted dichotomous endpoint for an actively controlled trial in order to achieve feasible sample size; approach was successful• Led company’s first joint regulator/payer meeting (EMA/EUnetHTA Parallel Consultation)• Led due diligence activities that culminated in the purchase of the subject company and my leading of an EOP2 meeting with FDA within one week of deal closure

• Provided strategic drug development guidance to customers and internal teams, helping to shape clinical development programs that maximize value for both patients and drug manufacturers• Applied experience gained at FDA and in industry to the design of clinical programs, and negotiated with global regulatory authorities to gain acceptance of same• Maintained awareness of and influenced emerging clinical development policy through submission of comments on regulatory guidances and responses to published literature• Prepared and presented educational materials for external and internal audiences

Sant Cugat Del Vallès, Barcelona, Es

• Served as Head of the Regulatory Coordination department, charged with development of strategy to support clinical development projects and major manufacturing changes

Talecris was acquired by Grifols in 2011 (see above).

The assets of Bayer Biologicals were sold in 2005 and became owned by Talecris Biotherapeutics (see above).

Silver Spring, Md, Us

• Led a team of reviewers in the evaluation of INDs and NDAs• Chaired FDA Committee for Advanced Scientific Education, 1999/2000

Silver Spring, Md, Us

Silver Spring, Md, Us

Ph.D., Pharmacology

B.S., Biochemistry