Frank Petrillo, Pharmd, Jd, Chc Email & Phone Number

United States

Plantation, Florida, Us

Senior attorney within the Legal, Risk, and Corporate Responsibility team, addressing all aspects of pharmacy and healthcare compliance, risk analysis, and rule applications to support the growing healthcare arm of the business.► Support healthcare compliance team with compliance initiatives and identify and interpret relevant laws► Review and manage general research work product on state and federal law, including 50-state surveys► Review pharmacy and healthcare-related marketing, promotional, and advertising materials► Review and assist resolution of consumer complaints► Lead a team to support regulatory and compliance issues related to healthcare issues► Provide timely and actionable counsel to all areas and levels within Chewy Healthcare► Collaborate with and manage external legal counsel► Review legislation having a possible impact on operations and develop advice on that potential business impact.

San Francisco, California, Us

► Launched the Alto enterprise risk assessment to guide all business units in identifying, mitigating, and eliminating risk associated with Alto’s unique operational business model.► Highlighted and prioritized a major patient safety gap related to ineffective drug utilization review for all patients.► Responded to audits and inspections conducted by state and federal agencies.► Strengthened the national licensing matrix to provide redundant coverage to all US patients.► Educated leadership on the importance of a robust and successful compliance program as defined by the OIG/HHS.

Seattle, Wa, Us

► Prevented operational disruption, secured compliance, and enabled several locations to obtain a CA license by identifying and rectifying a non-compliant California prescription label. Teamed with various internal groups and external vendors to draft, test, and implement a label meeting strict and unique compliance requirements.► Continually strengthened compliance across the pharmacy practice, handling ongoing compliance matters. Critical part of a team creating a network-wide controlled substance policy, monitoring adherence to Drug Supply Chain Security Act (DSCSA), and handling HIN/340B certification program management.► Reduced a critical compliance risk by interviewing and selecting license tracking software. Engaged multiple stakeholders in the selection of software designed to proactively track expiring facility and professional licenses, greatly reducing the risk of regulatory discipline and busniness interruption to customers. ► Generated significant savings by transitioning nationwide regulatory licensing function from outside counsel to in-house. Designed phased implementation strategy, developed policies, assembled team, and equipped team through training.► Increased employee training and education by selecting, revising robust and specialized pharmacy compliance training courses. These courses not only serve critical compliance training and education requirements as set forth by the OIG, but provide our licensed learners with a minimum of 10 ACPE CE credits yearly.► Led the compliance initiative to develop a compliant labeling process in states requiring a multi-language prescription label.► Analyzed compliance issues surrounding a promotions project designed to increase customer participation.► Compliance lead for our unique Business-to-Business (B2B) vendor and partner management programs.► Reduced significant regulatory risk related to patient-ordered OTC products commingled with Rx products in compliance packaging.

Bad Homburg, Frankfurt, De

I led U.S. pharmacy operations, a regulatory team covering 500+ licenses, and 2 cost centers ($8M). I guided pharmacists in clinical practice, state dispensing guidelines, resident state pharmacy law, and regulatory compliance. I also advised on state pharmacy and wholesale drug distribution law and liaised with State Boards of Pharmacy.COMPLIANCE► I closed compliance gaps, achieving perfect NABP VPP® inspections.► Gaining wholesale distribution certification in many states, I facilitated multiple NABP VAWD® inspections.► I maintained full compliance, facilitating state Board of Pharmacy Inspections.► I acquired a critical pharmacy license for our only remote order entry facility, secured several non-resident pharmacy licenses for a central facility, and headed the build of a compliant pharmacy in Puerto Rico.► Cutting risks nationally, I deployed compliant pharmacy software and led design of patient-centered labels.PATIENT SERVICE & COST CONTROL► I initiated pharmacy tech training to reduce next-day deliveries, saving $1M.► By minimizing patient product returns through tailored patient therapy, I saved millions.► Substituting product in stock locally for back-ordered items, I lowered shipping costs.► I facilitated the introduction of a patient refill portal and electronic prescribing modules.OPERATIONS► I prevented a major operational disruption, negotiating with the TX Board of Pharmacy to modify audit findings.► Securing 15 waivers, I avoided interruption of MA operations.► Ensuring compliance without compromising patient service, I relocated 2 pharmacies.► I mitigated a potential service gap for when a pharmacist with 18 state licenses resigns/retires.► I designed a novel wholesale to pharmacy inventory model that eliminates all waste and overage.TEAMS► I cut employee turnover 75% and filled 90% of open positions internally.► I coached an associate into a manager role and mentored a 6th-year pharmacy student who was hired by the FDA.

Boston, Ma, Us

I wrote and negotiated all oncology clinical trial agreements between Dana-Farber’s 3 partner institutions and global pharmaceutical and biotech companies, as well as negotiating subcontracts with leading U.S. cancer centers and executing contracts for principal investigator-initiated clinical trials. An articulate liaison, I communicated with sponsor-hired Contract Research Organizations and worked with Beth Israel Deaconess & Children’s Hospitals on multi-institution trials.► By drafting and revising master contracts for clinical trials with leading pharmaceutical and biotechnology companies, I accelerated the start of clinical trials for ground-breaking cancer therapies.

Cambridge, Ma, Us

I evaluated adverse event information in patients using marketed products or undergoing clinical trials and reported serious adverse events to the FDA and other global authorities. I also trained external partners to report events.

Boston, Massachusetts, Us

While coordinating a civil litigation caseload, I conducted legal research and applied my medical and pharmaceutical expertise to identify potential malpractice suits.

New York, New York, Us

As a member of the clinical development team, I oversaw the entire clinical trial process and coordinated the manufacture of phase 1, 2, and 3 clinical supply materials for global clinical trials.► I initiated multi-language labeling and the randomization of clinical material.

Cambridge, Cambridgeshire, Gb

I formulated the development of new sterile liquid dosage forms, nasal sprays, semi-solids, and dry powder inhalers for development in the U.S. market and introduced and transferred EU drugs to a U.S. manufacturing facility. I also shaped processes for the scale-up of experimental products for large-scale manufacture.► I contributed to the formulation of a Xylocaine line, Rhinocort Aqua, Pulmicort Respules & Turbuhaler, and EMLA cream.

Deerfield, Il, Us

Staff pharmacist

Bs, Pharmacy

Pharmd, Pharmacy

Pharmacy Regulatory Specialist

Jd Cum Laude, Law