Track Record

EMD Serono (Merck KGaA)

  1. Establishment and leadership of a multidisciplinary cross-functional BR core strategy team to provide guidance to early- and late-stage product support teams regarding the selection and deployment of benefit-risk frameworks and methodologies. 
  2. Participation in the revision of several Standard Operation Procedures documents and templates related to benefit-risk and safety signal detection/management. 
  3. Establishment of a training series for clinical reviewers entitled “Population Evidence Based Medicine in Drug Safety”. The goal is to strengthen professional awareness and quantitative expertise of staff and enhance their ability to anticipate and handle regulatory requests. 
  4. Participation in the Innovative Medicine Initiative (IMI2) supporting the effort entitled “Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER)”. 
  5. Participation, as Session Chair, Program Committee member, and/or invited speaker in several FDA, DIA, ISPE, and other local, national, and international scientific meetings discussing advances in regulatory and drug safety science. 
  6. 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.

Merck
  1. 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.
  2. 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).
  3. Establishment and leadership of a multidisciplinary cross-functional 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.
  4. Participation in the Innovative Medicine Initiative (IMI2) supporting the effort entitled “Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER)”
  5. 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.
  6. 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 data within the regulatory process.
  7. 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.
  8. 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.
  9. Establishment of two training series entitled “Epidemiology in Drug Safety” and “Pearls and Perils in Clinical Research and Real World Evidence”. The goal is to strengthen professional awareness and quantitative expertise of staff and enhance their ability to anticipate and handle regulatory requests.
  10. 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.
 
FDA
  1. Establishment of the intra-mural 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
  2. Played instrumental role in building up the Epidemiology Division in CDER. The Division was established in 2008 for the first time in the history of the Center.
  3. 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 data within the regulatory process.
  4. Publication of several studies conducted in collaboration with FDA colleagues including landmark papers discussing the association between antidepressant drug exposure and the risk of suicidality among adolescents
  5. Development of Regulatory Science Handbook establishing a system that governs various aspects conducting intramural and extramural research in OSE
  6. 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
  7.  Leadership of the strategic planning effort in DEPI/OSE
  8.  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
  9.  Leadership and participation in several PAGs (Project Advisory Groups) leading to the procurement of the several of the data resources used for regulatory investigations
  10.  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.
  1. Establishment of the scientific research program, which entailed building the infrastructure and interacting with pertinent academic and regulatory entities
  2. 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
  3. Listed as inventor of several patents and continuations in part for several novel products
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