Successfully managed, directed, and coordinated input from several stakeholders including Safety, Medical Affairs, Clinical Development, Epidemiology, Real World Evidence, Health Economics and Value Assessment, Regulatory, and Statistics during EMA’s Article 20 Procedure for Lemtrada, building up responses to PRAC questions and requests throughout the procedure:
Provided leadership and facilitated strategic thinking and alignment among internal stakeholder, supported preparation for KOLs engagement for expert insights and feedback, and developed deliverables (e.g. reports and presentations).
Partnered with multiple stakeholders to ensure best post-hoc analyses of available data to characterize benefit risk profiles and fine-tune target patient population, in order to build up the BR foundation and differentiation of the drug to optimize success in a highly competitive environment.
Supported the preparation and represented Sanofi in meetings with EMA’s PRAC for the Scientific Advisory Group presentation, which resulted in a favorable scientific opinion for the drug.
Supported preparation for Oral Explanation presentation and high-impact labeling discussions with EMA to achieve a favorable outcome.
In addition to Lemtrada, led the benefit risk activities for other high priority products in the Franchise, which included established drugs as well as drugs in various stages of development.
Defined timelines and tactical plans and established a strong network among team members in order to effectively recommend and influence key strategic business decisions through active participation in all pertinent team and governance safety and regulatory meetings and deliberations.
Provided leadership and mentorship for Global Safety Officers in the Franchise regarding handling various aspects of pharmacovigilance-related activities throughout the life cycle of our products, from development to post-market.
Reviewed periodic reports, e.g.: RMPs, Development Safety Update Reports, and Periodic Safety Update Reports/Periodic Benefit Risk Evaluation Reports. Other documents reviewed include regulatory submissions and responses, SERs, CCDS, USPI, SmPC, Investigators Brochures, study protocols, DHCP letters, and Key Results Memos.
Represented Global Pharmacovigilance in the development effort of the first “Digital Therapeutics” product in Sanofi participating in deliberations during due diligence phase and in meetings with both the Global Brand Team and the Development Team.
Represented the Franchise in several internal audits and external regulatory inspections.
Represented Sanofi in internal benefit-risk scientific activities and working groups revolving around updating and fine-tuning the tools, quality documents, business technical documents, and training regarding the BR assessment process for all drugs throughout the company.
Interacted regularly with Therapeutic Area Strategy Leads from other franchises to deliberate on how to enhance the process of BR assessment in Sanofi across the board.
Represented Sanofi in external benefit-risk scientific activities through:
Contributing to international working groups such as the Innovative Medicines Initiatives (IMI 2) sponsored by EMA supporting the effort entitled “Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER)”.
Presenting in the DIA and International Society for Pharmacoepidemiology (ISPE) conferences
Providing training in ISPE’s pre-conference mentoring programs
Actively participating in ISPE’s Special Interest Group in Benefit Risk Assessment, Communication and Evaluation (BRACE).
Provided strategic planning for future projections of resource requirements as well as prioritization and scientific oversight for various drugs in the Franchise.
Merck KGaA (EMD Serono)
Provided leadership for specific products regarding all product-related safety activities through Phase II and III encompassing safety signal detection and management, periodic reports, strategic project related activities, clinical trial related activities, submission related activities, audits and inspections, as well as training as warranted.
Establishment and leadership of a multidisciplinary cross-functional benefit-risk assessment core and strategy teams to provide guidance to early- and late-stage product support teams regarding the selection and deployment of benefit-risk frameworks and methodologies.
Participation in the revision of several Standard Operation Procedures documents and templates related to benefit-risk and safety signal detection/management.
Participation in the Innovative Medicine Initiative (IMI2) supporting the effort entitled “Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER)”.
Participation as an invited speaker in the FDA Public Workshop II: “Benefit-Risk Assessments in Drug Regulatory Decision-Making”. FDA White Oak, Maryland, September 18, 2017.
Participation as an invited discussant in a Duke-FDA Workshop entitled “Advancing Structured Benefit-Risk Assessment in FDA Review”. A high-level closed meeting organized by Duke-Margolis Center for Health Policy, Washington DC, October 4, 2017.
Significant contribution to the science and policy of benefit risk assessment through participation in activities of PhRMA LD KITs (e.g. Patient-Focused Drug Development [PFDD] Working Group), DIA, and ISPE BRACE SIG groups.
During my tenure in Merck, KEYTRUDA® (pembrolizumab) was approved for several indications including melanoma, non-small cell lung cance, head and neck squamous cell carcinoma, and Hodgkin lymphoma.
Participation as PhRMA representative (subject matter expert) in the ICH Expert Working Group (EWG) M4E (R2): ”Enhancing the Format and Structure of Benefit-Risk Information”. The EWG is tasked to revise the current ICH Guideline in the Section 2.5.6 (Benefit-Risk Conclusions) of the Common Technical Document (CTD).
Establishment and leadership of a multidisciplinary cross-functional (benefit-risk) BR strategy team to provide guidance to early- and late-stage product support teams regarding the selection and deployment of benefit-risk frameworks and methodologies. The goal is to enhance Merck’s capacity in BR assessment leading to increased competitive edge and market access by distinguishing its products’ BR profile as part of the strategic planning of product development in an end-to-end fashion.
Participation in the Innovative Medicine Initiative (IMI2) supporting the effort entitled “Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER)”
Participation, as a planning committee member, as an invited speaker, and as an invited discussant in Institute of Medicine (IOM) workshop on addressing uncertainties in the assessment of benefits and risks of pharmaceuticals.
Represented Merck for three years in the Council for International Organizations of Medical Sciences (CIOMS) X Expert Working Group. This is a working group of internationally diverse senior scientists from drug regulatory agencies, biopharmaceutical industry, and academia charged to develop a consensus on scientific and methodological criteria that represent good practices when applied to meta-analyses of clinical trials drug safety information within the regulatory process.
Participation, as Session Chair, Program Committee member, and/or invited speaker in several IOM, FDA, DIA, and other local, national, and international scientific meetings discussing advances in regulatory science.
Participation in scientific activities related to observational research through engaging groups like the Observational Health Data Sciences and Informatics (OHDSI, http://ohqdsi.org) program. OHDSI is a multi-stakeholder, interdisciplinary collaborative to create open-source solutions that bring out the value of observational health data through large-scale analytics.
Delivered a series of lectures entitled “Pearls and Perils in Clinical Research and Real World Evidence”. The goal is to strengthen professional awareness and quantitative expertise of colleagues and enhance their ability to anticipate and handle regulatory requests.
Significant contribution to the science and policy of benefit risk assessment through participation in activities of ICH, PhRMA LD KITs, DIA, ISPE BRACE SIG, and BIO groups.
Establishment of the intra-mural drug safety research program and the Data Management and Analysis team in DEPI/OSE. This entailed establishing the team, acquiring the electronic medical records databases, building the computational infrastructure, identifying capable talents, collaborating with computational resources in other agencies, establishing Operations Research Analyst (ORA) position in OSE, and mentoring of several pre-and post-doctoral fellows and summer interns over several years.
Played instrumental role in building up the Epidemiology Division in CDER, focusing on population-based drug safety. The Division was established in 2008 for the first time in the history of the Center.
Represented the FDA for two years in the Council for International Organizations of Medical Sciences (CIOMS) X Expert Working Group. This is a working group of internationally diverse senior scientists from drug regulatory agencies, biopharmaceutical industry, and academia charged to develop a consensus on scientific and methodological criteria that represent good practices when applied to meta-analyses of clinical trials drug safety information within the regulatory process.
Publication of several drug safety studies conducted in collaboration with FDA colleagues including landmark papers discussing the association between antidepressant drug exposure and the risk of suicidality among adolescents and adults.
Development of Regulatory Science Handbook establishing a system that governs various aspects conducting intramural and extramural drug safety research in OSE
Development, as the Course Director, of the Epidemiology in Drug Safety (formerly known as Epidemiology For Non-Epidemiologist) course, which is a two-month CDER-level course accredited by the Accreditation Council for Continuing Education
Leadership of the strategic planning effort in DEPI/OSE
Leadership and participation in the development of the Standards for Data Management and Analytic Processes (MaPP 6700.2) and Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets Guidance
Leadership and participation in several PAGs (Project Advisory Groups) leading to the procurement of the several of the data resources used for regulatory investigations
Participation, as Session Chair, Program Committee member, and/or speaker in several FDA/DIA and other local, national, and international scientific meetings discussing advances in regulatory science
Nutramax Laboratory Inc.
Establishment of the scientific research program, which entailed building the infrastructure and interacting with pertinent academic and regulatory entities.
Leadership and participation in several clinical trials and experimental animal studies related to the safety and efficacy of several products in the company’s pipeline.
Listed as inventor of several patents and continuations-in-part for several novel products.