- AI in PV
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- Medical Safety
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- Audits and Due Diligence
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Global Expertise in Medical Safety for Your Most Complex Challenges, Based in Boston, USA.
CMO, iVigee
Accomplished top safety leader in innovative pharmaceutical companies - Vertex, Bristol-Myers Squibb, and Pfizer, Inc.
US educated and trained physician (Tufts, Harvard, Dartmouth), Previously held Board Certification in Internal Medicine, Cardiovascular Disease and Nuclear Cardiology.
Senior physician executive with exceptional medical credentials and expertise in pharmacovigilance, regulatory affairs, clinical development, and medical affairs who has a proven record of leadership and accomplishments. With extensive clinical practice and global senior management experience in small, medium and large sized pharmaceuticals across a spectrum of therapeutic modalities and disease areas including (CV, DM, Hep B&C, HIV, ID, Pul, Neuro, Onc, RA), biologics, stem-cell therapy, CRISPR-Cas9 gene-editing, ASO. and orphan drugs. Dr Seto is uniquely qualified to lead consult with small nimble start-ups to complex global matrix organizations and have consistently demonstrated expertise in strategy, building, rebuilding, change management, operations and innovative problem-solving.
Executive Consultancy 1-1
CMO Services
Support challenging medical safety decisions
Support at US FDA Advisory Committee meetings
Data Safety Monitoring Boards
Challenging label changes
Safety Committees and Advisory Boards
IND Protocol Senior Reviews
Executive Advisory on Drug Development
EMA CHMP and PRAC
Qualified safety physicians - coaching, training, insourcing and outsourcing
Crisis Management
Executive Consultancy 1-1
Our Executive Consultancy 1-1 service offers personalized, one-on-one consultancy sessions with our seasoned executives. This service is designed to provide strategic guidance and tailored insights to address your unique challenges and objectives. Whether you need advice on regulatory strategy, clinical trial design, or risk management, our experts are here to support your success.
CMO Services
Our CMO Services provide comprehensive support to oversee and enhance your medical safety operations. Our Chief Medical Officer will work closely with your team to ensure that all safety protocols are rigorously followed, compliance is maintained, and the overall safety profile of your products is optimized. This service includes ongoing monitoring, safety assessments, and strategic planning to support your organization’s goals.
Support for Challenging Medical Safety Decisions
Navigating complex and high-stakes medical safety decisions can be daunting. Our expert team provides the support you need to make informed and confident decisions. We assist with risk-benefit analysis, crisis management, and the development of robust safety strategies to address any challenges that arise.
Support at US FDA Advisory Committee Meetings
Preparing for and participating in US FDA Advisory Committee meetings requires meticulous planning and expertise. Our team provides professional representation and support to ensure your interests are effectively communicated and defended. We offer comprehensive preparation services, including briefing materials, strategic advice, and expert testimony to support your position.
Safety Committees and Advisory Boards
The formation and leadership of safety committees and advisory boards are critical to robust safety oversight. Our team provides expert guidance in establishing these committees, ensuring they are composed of qualified professionals and operate effectively. We support ongoing management and provide strategic advice to enhance the oversight of product safety.
IND Protocol Senior Reviews
Our IND Protocol Senior Reviews service offers in-depth reviews of Investigational New Drug (IND) protocols by senior experts. We ensure that your protocols meet all regulatory requirements and adhere to best practices in clinical trial design. This service helps to identify and mitigate potential risks, ensuring a smooth and compliant development process.
Data Safety Monitoring Boards
We offer the establishment and management of Data Safety Monitoring Boards (DSMBs) to ensure the highest standards of clinical trial safety. Our DSMBs provide independent oversight of clinical trials, monitoring data for any safety concerns and ensuring the integrity of the study. This service helps to safeguard participant safety and ensure regulatory compliance.
Challenging Label Changes
Managing and negotiating label changes can be complex and challenging. Our expertise in this area ensures that label changes are handled efficiently and in compliance with regulatory requirements. We assist with the preparation of comprehensive documentation, strategic planning, and negotiation with regulatory authorities to achieve the desired outcomes.
Executive Advisory on Drug Development
Our Executive Advisory on Drug Development service provides high-level strategic guidance to support your drug development projects from inception to approval. Our experts offer insights into regulatory strategy, clinical development, and market access, helping you to navigate the complexities of drug development and achieve your objectives.
EMA CHMP and PRAC
With a team of EMA senior ex-regulators and global medical safety leaders, iVigee is the top choice for comprehensive support to pharmaceutical companies facing challenging safety issues during interactions with the EMA's Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance Risk Assessment Committee (PRAC).
Qualified Safety Physicians
Enhance your safety physician team with our senior coaching, training, and peer-to-peer interactions. We offer robust support for peak workloads and provide extra safety physician resources whenever required, both domestically and internationally. Furthermore, our advanced AI technologies can greatly improve the quality and efficiency of your safety physician's work.
Crisis Management
When a drug safety crisis strikes, iVigee is your trusted ally. Our team of top medical safety experts and former EMA regulators will step in to manage the situation with precision. Utilizing our iViReg system, a global regulatory intelligence knowledge management tool, we provide the insights and strategies needed to navigate through the emergency and ensure compliance. Count on iVigee to swiftly resolve your crisis, safeguard your product's reputation, and ensure its benefits outweigh the risks.