David J. Hauss, PhD, RPh Regeneron Pharmaceuticals, Inc. Tarrytown, NY

Staff Qualifications Minimum of a BS degree in a life science Previous experience in scientific/regulatory submission writing and drug development Direct experience in, or thorough understanding of, the drug development process Passion for communications, diligence and high professional standards

Department Purpose Primary Responsibilities Functions supported: Preclinical Development (Toxicology, Pharmacokinetics) Pharmacology (Therapeutic Proteins and Target Discovery), Clinical (Sample Analysis, Pharmacokinetics, Pharmacology) Types of documents created: Sample analysis reports, clinical pharmacokinetic reports, pharmacology reports, briefing books, nonclinical summaries and nonclinical overview (INDs, INDARs, BLAs, IBs), manuscripts, Opt-in documents, response documents, AD COM slides

Customers, Collaborators, and Suppliers From whom do we receive input to our work? Toxicology, Pharmacokinetics, Therapeutic Proteins, TFA groups, Formulations, Sample Analysis, Regulatory Affairs, Regulatory Operations, Program Direction, Program Management, Senior Management, QC, QA, Collaborators, Commercial Who are the internal users of our documents? Regulatory Affairs (for Annual Reports, Submissions), Toxicology, PK, Pharmacology, Scientific Writing (Summaries, IBs, etc), Sample Analysis (for reports), Medical Writing (for sample analysis and clinical PK reports) Medical Affairs (for publications), Commercial (for publications), Program Management (for Opt-in) To whom do we provide output? FDA (Submissions), Collaborators (Opt-in documents) Other sources of information? Publications, IPA slide decks, protocols

REDSTAR PleaseReview SharePoint PubMed, EBSCO Host, Science Direct MS Office Suite (Word,MS Project, MS Excel) eCTD Viewer PES database MAPS database Regeneron WIKI Octagon (templates) Adobe Illustrator GraphPad Prism SigmaPlot EndNote Tools and Technologies

Key Challenges Broad spectrum of responsibilities, encompassing diverse breadth of knowledge, handled by a small staff Late input (source data) Late review comments Insufficient inter-departmental communication Frequent changes to timelines Competing priorities / short timelines Open-ended review comments

2012 Initiatives Continually improve scientific knowledge base of all staff through internal seminars, attendance at scientific conferences and self-study Continue to develop collaboration with Regulatory for tracking and completing INDARs Continue to refine processes for IND and BLA drafting, with a focus on providing high quality documents as efficiently as possible Initiate preclinical gap analyses for all near-term BLA submissions Expand scientific communications (publications) support for TFA groups Develop competency model for preclinical scientific communications professional Establish visible and participative presence at external scientific communications professional organizations Implement Structured Content Management paradigm at Regeneron (ongoing)