www.greyscaling.comRegulatory Consulting for Drug Development

LedgerDomain is an enterprise blockchain company working to bring fast, personalized, and secure transactions to the pharmaceutical supply chain. Their technology drives powerful mobile applications and executive dashboards that help deliver the right medications to the patients who need them.

Unlearn.AI leverages AI-generated prognostic digital twins to enable smaller, more efficient pivotal clinical trials.

Global Regulatory Lead Lyrica. Responsible for developing and executing regulatory strategies for Lyrica, Pfizer’s top selling medicine. Leads regulatory subteam covering US, EU, Emerging Markets, Japan and Canada. Successes include:-Developed and executed creative regulatory strategy for pediatric epilepsy program valued over $1B. -Multiple 1st cycle Approvals for new indications (spinal cord injury, pediatric epilepsy) and controlled release formulation. -Gained agreement with ex-US health authority on a regulatory path forward to submit an application with a study that failed its primary endpoint.

Global Regulatory Lead for Detrol LA, Toviaz, Viagra, Neurontin-Managed all regulatory aspects including lifecycle strategy, global advertising & promotion review, and compliance. Successes include overcoming multiple regulatory hurdles that led to industry's first virtual clinical trialUS Regulatory Lead for Cox-2s-Responsibilities included product defense and evaluating licensing opportunities

Served on cross-divisional informatics board that oversaw a $200M budget and retired/consolidated 54 IT systems as part of the Pfizer/Pharmacia Integration.Led Clinical Supply Chain Integration leading to a Service Level Agreement resulting in improved planning and on-time performance for both the supply chain and clinical operations.

Managed Clinical Data Operations process re-engineering projects through the deployment of new technology and related procedures. Successes include -Clearing backlog of closing out over 2500 studies utilizing CROs. Closed out more studies in 3 years than in the previous 10. -Established quality standards and processes that reduced Quality Assurance observations for clinical study reports by 60%.

Oversaw development of Standard Operating Procedures (SOPs). Created more than 30 SOPs covering monitoring, data management, safety reporting and regulatory submission

Developed and maintained clinical project plans. Responsibilities included negotiating timelines and resources.

OTC projects