Recent Project Experience

Pharmacovigilance

  • Global PV Lead at a mid-size biotech for the oversight of patient interactions from PSP activities and ensured appropriate PV provisions in all third-party agreements via SDEAs/PVAs.
  • Head of a Worldwide Drug Safety Office with oversight responsibilities for 65 DSOs and staff. Increased the overall quality of PV operations, morale, and competence of staff and vendors. Reduced global ICSR submission errors by more than 60% while improving on-time reporting to 98% on heavy PSP caseloads. Drove a 60% reduction in major and critical DSO/LSO CAPAs hitting the PSMF.
  • Led the turnaround and recovery of an underperforming PV & PQC/PTC operation at a blue chip pharmaceutical company. Directed staff of 35 to improve accuracy of case investigations and reporting. Reduced case aging from 7 days to 1; improvement in compliance went to 100% from 55%.
  • Designed and delivered a comprehensive pharmacovigilance resource decision support tool to drug safety executives of a top 3 global pharma company to aid in determining and justifying appropriate staffing for EMEA, APAC, NA and LATAM Regions.
  • Chaired joint QA/GPV leadership and integral participant on an Executive Steering Committee to address and remediate to multiple FDA 483 findings.
  • Assumed responsibility for Worldwide Inspection Readiness efforts. Initiated global training programs and assembled proof books in advance of HA inspections resulting in significantly reduced findings.
  • Accountable for the setup, oversight, timely updates and delivery of the Pharmacovigilance System Master File (PSMF) to the EUQPPV.

Medical Affairs

  • Team leader with budget responsibility for a mid-size organization’s Global Medical Affairs transformation which successfully re-engineered key roles and responsibilities and redesigned several functions including Medical Education, Internal Training and a central information compendium.
  • Drove strategic planning for a multimillion-member online nutritional database at UCLA targeting US and Chinese populations and in conjunction with the “Biggest Loser” TV series. Organized team of executive sponsors, high-level physicians and technical experts toward successful completion within established resources and timelines.
  • Directed Key Opinion Leader (KOL) identification and development. Managed contracts, honoraria and global speaker bureau utilization activity.
  • Successfully orchestrated MA activities including scientific symposia, advisory boards, roundtables and publications. Mediated round table discussions.
  • Directed the establishment of bi-coastal speaker-training programs for a 1,000-member bureau with extraordinary efficiency thus maintaining budget control. MA liaison to Commercial Ops, New Product Development and Brand Management for the purposes of data mining.
  • Led phase IV post-marketing trial design and execution.
  • Formulated clinical development plan and presentation for initial investor funding.
  • Deployed Alliance Management systems for MA and R&D operations.

Business Transformation

M2D has engineered countless business successes and turnarounds within the following disciplines and areas of expertise:

  • Strategic Business Process and Resource Optimization
  • Organizational infrastructure design, optimization and transformation
  • Resource planning including business process off-shoring/outsourcing (BPO)
  • Performance management
  • Development of decision support tools, dashboards and scorecard KPIs and metrics

Drug Safety Mind Set

Most development stage organizations do not yet possess a safety governance model, infrastructure to handle signal detection or worldwide reporting.  We can reduce this risk and help you setup a PV system quickly and without sacrificing quality.

Medical Affairs Food For Thought...

During successful global medical affairs transformations, several factors must be considered and analyzed including:

  • Local Cultures
  • Local Regulations
  • Competition and Utilization
  • Economic Conditions