Robin Huff Email and Phone Number
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Senior regulatory/clinical development professional with extensive experience from both FDA and the pharmaceutical/biologics industry. Develops worldwide strategies for clinical programs that consider commercial implications and minimize timelines, while maintaining a high likelihood of regulatory approval. Has extensive knowledge of the drug development process that derives from her 7 years of reviewer and supervisor experience in two divisions of CDER, her 10 years of leading a regulatory strategy group for a company that had both early and late stage global development programs, 5 years at the world's largest CRO, her role within the Rare Disease Organization of a mid-size biopharmaceutical company and her current position in one of the world's largest pharmaceutical companies.
Eliquent Life Sciences
View- Website:
- eliquent.com
- Employees:
- 369
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Executive Vice President, Drugs And Biologics TeamEliquent Life SciencesRaleigh, Nc, Us
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Executive Director, Global Regulatory Affairs - NeuroscienceTakeda May 2022 - PresentTokyo, 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 -
Global Regulatory Lead, Rare Disease OrganizationUcb Jul 2020 - May 2022Brussels, 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 -
Global Regulatory Lead, NeurologyUcb Jun 2017 - Jun 2020Brussels, 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
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Senior Director, Pediatric And Rare Diseases Centers Of ExcellenceQuintiles Nov 2012 - Jun 2017• 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
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Senior Director, Regulatory CoordinationGrifols Therapeutics Jul 2011 - Nov 2012Sant 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 -
Senior Director, Regulatory AffairsTalecris Biotherapeutics Apr 2007 - Jul 2011Talecris was acquired by Grifols in 2011 (see above).
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Director, Regulatory AffairsTalecris Biotherapeutics Apr 2005 - Apr 2007
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Deputy Director, Regulatory AffairsBayer Biological Products May 2003 - Mar 2005The assets of Bayer Biologicals were sold in 2005 and became owned by Talecris Biotherapeutics (see above).
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Supervisory ReviewerFda, Center For Drug Evaluation And Research, Division Of Pulmonary And Allergy Drug Products Aug 1999 - May 2003Silver Spring, Md, Us• Led a team of reviewers in the evaluation of INDs and NDAs• Chaired FDA Committee for Advanced Scientific Education, 1999/2000 -
Quality Assurance Program Detail, Part TimeFda, Center For Drug Evaluation And Research, Division Of Pulmonary And Allergy Drug Products Jul 2000 - Oct 2000Silver Spring, Md, Us
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Regulatory ReviewerFda, Center For Drug Evaluation And Research, Division Of Pulmonary And Allergy Drug Products Jul 1996 - Aug 1999Silver Spring, Md, Us
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Pharmacology Research Associate (Prat)National Institutes On Drug Abuse Jul 1994 - Jul 1996
Robin Huff Skills
Robin Huff Education Details
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Duke UniversityPharmacology -
Virginia TechBiochemistry
Frequently Asked Questions about Robin Huff
What company does Robin Huff work for?
Robin Huff works for Eliquent Life Sciences
What is Robin Huff's role at the current company?
Robin Huff's current role is Executive Vice President, Drugs and Biologics Team.
What is Robin Huff's email address?
Robin Huff's email address is ro****@****ucb.com
What is Robin Huff's direct phone number?
Robin Huff's direct phone number is +191389*****
What schools did Robin Huff attend?
Robin Huff attended Duke University, Virginia Tech.
What skills is Robin Huff known for?
Robin Huff has skills like Clinical Development, Regulatory Affairs, Drug Development, Clinical Trials, Fda, Biopharmaceuticals, Medical Devices, Biologics, Ema, Pharmaceuticals, Regulatory Strategy, Novel Product Development.
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