Pharmaceutical Regulation Expert Witnesses in Pennsylvania

Blue Bell, Pennsylvania

Pharmaceutical Regulation, Warnings & Labels - Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Compliance, Safety, FDA, Off-label Use

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 appl...

Pennsylvania

Marketing, Pharmaceutical Regulation - Bio-similar drugs, Biotech & Pharma Marketing, Operations, Promotion, CNS Products, Medicare, Launch delay, Pharma Commercialization, Pharmaceutical Contracting & Pricing, Pharmaceutical Launch, Pharma Marketing, Pharma Sales, Specialty Pharma, DTC, Commercially Reasonable Efforts, CRE, Pharmaceuticals , Promotional compliance

Mr. Hosier is a strategic advisor to the life sciences industry drawing on 30 years of sales, marketing and managed markets experience in commercial healthcare organizations. He has provided insights to small molecule & biotechnology companies across multiple therapeutic areas but has maintained a heavy concentration in oncology and specialty pharmaceuticals. He has led brand launch; corporate, franchise, and strategic brand planning; commercial integration; organizational design; and operational effectiveness from multiple perspectives (as the client, as the independent consultant, and as an agency lead). Mr. Hosier’s firm has architected the launch of rare disease and oncology business units for multiple pharmaceutical clients (large and small); led development of the managed markets, trade, and distribution strategy for the launch of new chemical entities (NCEs) and 505(b)2 assets for various organizations; advised on commercially reasonable effort (CRE); and provided commerci...