EMPLOYMENT AND RESEARCH HISTORY

 

Parexel (Basel – Home-based, Switzerland) Scientific Data Strategy, Director - Dec 2021 – current

- Plan and conduct hybrid (primary and/or secondary data collection) studies at different level of product life cycles, from early engagement (phase II/III), pre-launch (phase III), and on post-marketing (phase IV) post authorization safety studies (PASS) – currently leading 3 large multi-database PASSs - Co-author health authorities responses - Support feasibility, principal investigator/site selection, management, and issue resolution for hybrid clinical trials and real world data (RWD) studies - Protocol and statistical analysis plans (SAP) design, development, and review - Literature review, data landscaping and identification of fit-for-purpose RWD sources to conduct RWE studies globally (US/CAN, EU, APAC) - Management of third parties (data sources and data services providers), including execution of master service agreements, work orders, startup agreements, and contract amendments - Identification of key scientific and safety insights and emerging scientific concepts to solve complex clinical research activities - Develop novel approaches to identify, assess and gain access to RWD - Make recommendations on fit-for-purpose data and analytic solutions - Build partnerships with external KOLs, vendors and data sources to expand access to RWD - Drive decision-making to strategically partner with select data and service providers - Development of proposal and bid defense meeting presentations - Development of integrated evidence generation plans - Contribution to SOP drafting

 

Philip Morris International (Basel, Switzerland) Senior Scientist Real World Evidence - Jul 2020 – Oct 2021

- Development of evidence generation and RWE strategies across different therapeutic areas (e.g., oncology, respiratory, cardiovascular, and gastrointestinal systems) - Providing expertise for developing comprehensive data strategies for both prospective and retrospective studies - Data landscaping and identification of fit-for-purpose RWD sources to conduct RWE studies globally - Design and execute studies to address safety outcomes using large claims databases (e.g., MDV, JMDC, HIRA) - Identification of the evidence needs for research and development, and ideate and make recommendations on fit-for-purpose data and analytics solutions (e.g., composite endpoints, coding algorithms) - Development of strategic plans to access fit-for-purpose data sources to support evidence generation - Cross-functional collaborations with all internal stakeholders to increase the acceptability of RWD and RWE for decision making - Leading and coordinating vendor activities - Comprehensive and systematic literature reviews - Study findings dissemination to different stakeholders - Publication of results.

 

Health & Prevention (Basel, Switzerland) Medical Affairs, Safety, Epidemiology, Public Health, Nutrition, RWE expert (freelance) - Dec 2013 – Jun 2020

- Developed scientific information material, clinical research activity, healthcare landscape and emerging scientific trends within different therapeutic areas - Preparation of scientific information and publications, posters and communications for congress and workshops, including presentation for business-to-business events for customer support - Health services and clinical research, nutrition education, drug safety and epidemiology consulting for pharmaceutical, nutraceuticals, wellness and nutrition companies - Development and implementation of health prevention, educational and corporate wellness programs, and trainings in the area of health risks and prevention for different audiences (e.g. UBS Switzerland; McKinsey, Italy; Bank of International Settlement, Switzerland, International school of Basel, Switzerland) - Clinical trial workflow, including clinical protocol design, development, and review - Primary RWD collection and small database generation - Design of algorithms to determine health outcomes - Design and implementation of structured and semi-structured questionnaires and interviews with patients - Qualitative data analysis - Customized comprehensive literature research, medical writing, scientific communication, and customers support services on scientific topics related to product portfolio - Epidemiology input for regulatory documentations and application submissions

 

Basilea Pharmaceutica (Basel, Switzerland) Drug Safety Officer (contract) --- July 2018 – November 2018

- Case processing: triaging, data entry, coding of adverse event (AE) information, quality control and submission of expediting AE reports to health authorities for investigational and post-marketing products in the safety database - Planning and writing regulatory documents (e.g., study protocols, study reports, SAPs, aggregate safety reports (PSURs), and RMPs, responses to health authority queries and summary submission documents. - Cooperate and manage vendor for ARISg user support and enhancements - Disseminated monthly reporting and case statistics - Developed metrics reports for Drug Safety Operations - Lead monthly signal detection activities - Cross-functional interaction with product-specific drug safety physicians and other department involved in AE collection and processing - Risk minimization activities for serious side effects - Coordinate activities for a health authority inspection.

 

The University of Queensland (Basel, Switzerland) Adjunct Associate, Level B, School of Pharmacy

Oct 2012 – Oct 2021 - Clinical research, pharmacoepidemiology and international drug utilization analysis

 

Novartis Pharma (Basel, Switzerland) Epidemiologist (contract) --- Oct 2014 – Dec 2015

- Developed, implemented, and monitored global epidemiology research projects and RMPs for new product development and post-marketing surveillance - Supported Brand Safety Leaders and Pharmacovigilance Leaders with Drug Safety and Epidemiology department contributing to regulatory submissions - Ad hoc literature reviews related to safety outcomes - Clinical Expert Statements, epidemiology input to PSUR for known, and potential risks defined in RMP - Epidemiological input into regulatory responses and risk management reports, safety update reports and profiling plans, labeling, expert statements, and health authority requests - Disseminated study findings to clinical, regulatory, outcomes, and modeling functions to internal and external stakeholders.

 

DePuy Synthes, a Johnson & Johnson Company (Waldenburg, Switzerland) Project Manager, Orthopedic Medical Devices (contract) - Sept 2013 – Dec 2013

- Reviewed and redesigned the orthopedic medical device reporting systems - Global Remediation Quality Plan (GRQP) facilitation - Built learning plan requirements and ensure consistency and training dissemination - Quality systems based training initiatives leadership and execution, including logistical support, data management, scheduling, in classroom assistance

 

Novartis Pharma (Basel, Switzerland) Quality Assurance Operational Manager (contract) - May 2012 – Sep 2012

- Guided development teams in quality and compliance decision making to drive sustainable quality and compliance excellence - Guidance and leadership for the development and implementation of corrective and preventive actions (CAPA), and their review to identify root causes and implement solutions - Identified ways to continuously improve quality and compliance with regulations and company standards, policies, and procedures - Represented Franchise QA in interactions with internal and external contacts, ensure inspection readiness, and sponsor-monitor inspections; provide inspection management support and follow-up post inspection - Provided Good Clinical Practice (GCP) regulations, company standards, guidelines, policies and procedures expertise to internal stakeholders

 

Sinotradeservices (Shanghai, China) Project Manager - Jul 2011 – Feb 2012

- Assessed business feasibility, created business plan for submission to local food regulatory authorities - Developed marketing campaigns, marketing plans, and promotional items - Hired, trained, and supervised local employees - Initiated and maintained strong working relationships with vendors (both in China, and Europe) - Negotiation for pricing and deliveries with customers and suppliers - Submissions to Chinese regulatory agencies

 

Novartis Pharma (Basel, Switzerland) Global Epidemiologist --- Jan 2009 – Jul 2011

- Developed, implemented, and monitored global epidemiology research projects and RMPs for new product development and post-marketing surveillance - Designed and reviewed epidemiology studies aimed at investigating natural history of disease, treatment patterns, or potential safety signals, including automated databases (e.g. GPRD, PharMetrics, MarketScan) - Clinical trial workflow, including clinical protocol design, development, and review - Assessment and analyses of safety signals in large adverse events reporting system databases (e.g. AERS, WHO), and interpretation and reporting on data analysis results to other line functions - Support to PV and Brand Safety Leaders for regulatory submissions - Ad hoc literature reviews - Clinical Expert Statements, epidemiology input to PSUR for known, and potential risks defined in RMPs - Epidemiological input into regulatory responses and risk management reports, safety update reports and profiling plans, labeling, expert statements and health authority requests - Disseminate study findings to other functions within the organization, and external organizations (including regulatory bodies)

 

EXPERIENCES OLDER THAN TEN YEARS (between 1998 and 2008)

European Medicines Agency (EMA) (London, United Kingdom) Occupational Trainee, EudraVigilance of Human – Post Authorization Evaluation Unit

The University of Queensland (Brisbane, Australia) Research Assistant, School of Pharmacy and School of Molecular and Microbial Sciences

Merck KgaA (Darmstadt, Germany) Occupational Trainee, Department of Spectroscopy and Optics - Feb

University Frederich Alexander (Erlangen, Germany) Occupational trainee, Department of Pharmaceutical Technologies

Dreger-werk (Lubeck, Germany) Occupational Trainee, Department for Basic Development and Chemical Sensors Development

University Frederich Alexander (Erlangen, Germany) Occupational Trainee, Department of Pharmaceutical Technologies, with European Socrates/Erasmus program

 

EDUCATION

 

Eidgenössische Technische Hochschule (ETH) (Zurich, Switzerland) --- Sep 2012 – Jan 2014

- Master of Advance studies in Nutrition and Health, Thesis title: “Clinical evidence of herbal-nutrient interaction in chemotherapy” - Advanced education on aspects of nutritional epidemiology, influence of nutrition on health, public health nutritional issues, and the potential for prevention of diseases.

 

The University of Queensland (Brisbane, Australia) - Jan 2005 – May 2008

- PhD in Pharmacoepidemiology and Health Services Research - Thesis title: “Use of prescription medicines in different countries; comparisons and contrasts between Australia, Nova Scotia (Canada) and parts of Europe” - Managed data collection and analysis, abstracted from large, administrative databases - Drug utilization time-series analysis and comparison of drug utilization in different countries - Interacted with local health authorities for accessing to customized datasets - Negotiation of human ethics committee requirements - Designed and administered questionnaires and structured interviews with patients and healthcare workforce - Organized focus groups (participant recruitment, design and evaluation of questionnaire) - Designed, implemented and evaluated a health educational intervention - Qualitative data analysis - International comparison of health policies and healthcare systems - Literature review, meta-analysis and academic writing

 

Università degli Studi di Milano, Faculty of Pharmacy (Milan, Italy) - Sep 1998 – Jul 2002

- Master’s Degree in Pharmaceutical Chemistry and Technology (Industrial Pharmacy)

Sportsoracle for the International Olympic Committee (IOC) --- Feb 2018 – Nov 2019 uInternational Olympic Committee Diploma in Sport Nutrition

 

GRANTS AND SCHOLARSHIPS AWARDED

- International Postgraduate Research Scholarship (IPRS), 2005-2008 - University of Queensland International Living Allowance Scholarship (UQILAS), 2005 – 2008 - Graduate School Research Travel Grant (GSRTG), 2007 uInternational Society for Pharmacoepidemiology (ISPE) Student Travel Scholarship, 2007 - Canadian Association of Population and Therapeutics Student Travel Scholarship, 2007 - Socrates/Erasmus scholarship, 1998

 

COURSES ATTENDED

- Jun 2015, Mental Coaching for High Performance - Nov 2014, Public Speaking Certificate - Oct 2014, Neuro-Linguistic Programming (NLP) Licensed Master Practitioner - May 2014, Neuro-Linguistic Programming (NLP) Licensed Practitioner - Jun 2008 - Jul 2008, European Educational Program in Epidemiology 21st Summer course in Epidemiology

 

WORKSHOPS and FURTHER EDUCATION

- Fundamentals of project management - Advanced qualitative data analysis course - GCP - Introduction to Markov modeling - Research animal workshop - Dissolution workshop

 

TEACHING EXPERIENCE

- Designed and presented several courses, seminars and workshops for corporate programs, private schools and private groups for public health, nutrition, motivation, sport nutrition, weight management and lifestyle changes - Lectures, laboratory classes and tutorials to Pharmacy undergraduate students (University of Queensland, Australia)

 

LANGUAGES

- Italian: mother tongue - English: fluent working proficiency - Spanish: intermediate - German: B1-B2