Specialties & Experience of this Expert Witness

Additional Information

Ethical Full Lifecycle Labeling/Prescribing Information That Never Cuts Corners For Pharmaceutical Giants Merck, Shire, and J&J: Labeling strategy and leadership that brings product labeling and products to market supporting vaccines and treatments for infections, internal medicine, oncologic, and rare diseases. These include life-saving, ground breaking, and first-of-its-kind products. Bring decision makers across divisions to the table to negotiate resolution of labeling issues - leading to the creation, revision, and maintenance of clear and compliant product labels that educate health care professionals and patients in the US, EU, Japan, and Rest of World. Gain consensus and champion proactive consensus-building across Research, Statistics, Regulatory, Joint Ventures, Legal, and Marketing on labeling - laser-focused on the bottom line: “What do the doctor and patient need to know?” Provide leadership in support of label development for new applications, supplemental applications, revision filings based on new clinical data, new safety information, local labeling, new guideline compliance, and agency comments. Responsible for labeling for headquarter Company Core Data Sheet (CCDS), US (USPI), EU (SmPC), Rest of World, and Japan. Develop, lead label development, gain consensus, and shepherd labeling through management review as Chair of Worldwide Product Circular Review/Approval Committees. Tackle >25 products concurrently across the full product life cycle from Target Product Labeling through Phase II, Phase III, and Post Marketing, and in Adverse Experience Reports. Products: Gardasil, RotaTeq, ProQuad, M-M-R II, Varivax, Vaqta, Pneumovax, Recombivax, Isentress, Crixivan, Invanz, Stromectol, Emend, Arcoxia, Cozaar, Hyzaar, Vasotec, Vaseretic, Prinivil, Prinzide, Aggrastat. Cosopt, Trusopt, Timoptic, OTCs. Participate in full life cycle labeling discussions and draft labeling text ranging from Target Product Labeling, CCDS, US prescribing information (USPI), EU labeling (SmPC), Rest of World labeling to Japanese labeling. Drive resolution of product labeling inconsistencies between in-country (US, EU, Rest of World, Japan) and Headquarter/company core data sheets (CCDS). Guide Committee that made recommendations and executed corrective plans based on review of databases and literature. Recruit, train and lead 15-member writing team who transformed complex medical information into clear, direct, and life-saving labeling published in Company Data Sheets (CCDS) and Core Patient Information (CPI) for healthcare professionals and patients in the US, EU, and worldwide subsidiaries. Draft rationales and responses to agency comments on proposed labeling worldwide, including the FDA. Support development of labeling for multiple products in Phase II, Phase III, and post-market. Scientifically review clinical documents for accuracy, data support, consistency within and across documents, 100% support of product labeling, and compliance to external and company guidelines. Emerged as a US, EU, and global regulatory labeling landscape (i.e., CCDS, USPI, SmPC) expert well-versed in labeling for diverse therapeutic areas. Remain abreast of global regulatory requirements throughout creation and review of labels for vaccines and products to treat everything from hypertension to infectious diseases. Guide labeling, risk management and product safety for diverse therapeutics that prevent and treat diseases among the leading causes of death worldwide. Performed competitor product reviews and safety surveillance used to review critical adverse experiences, author/co-author and update product safety reports, risk management plans and responses to agency inquiries. Products: M-M-R II, Liquid Pedvax, PedvaxHIb, Haemophilus b Conjugate, Noxafil, Cancidas, Various Investigational Drug Candidates Other: Maintain Medical License and Continuing Medical Education Requirements