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Vice President
Extensive expertise related to commercialization, global market access, product development, and evidence generation.
View BiographyVice President, Health Advances
Arushi Agarwal joined the Health Advances team in 2011 and spends the majority of her time working in the Diagnostics and…
View BiographyVice President, Health Advances
Kristen Garner Amanti joined the Health Advances team in 2010 and is a leader in the Reproductive and Genomic Health practice…
View BiographyVice President, Technical, Regulatory Consulting Services
Former regulator with MHRA. Experience includes Head of Inspectorate, GMP and GDP inspections, Qualified Person, IRCA…
View BiographySenior Vice President, Worldwide Head of Regulatory & Access
Experience in CMC, European licensing procedures
View BiographyDirector
Experienced with Medical Devices, Biologics, Data Integrity auditing within GMP quality, Quality Systems Regulation (QSR) and…
View BiographyVice President, Technical
Former regulatory with FDA. Experience in CBER and CDER in CMC review, facility assessment & compliance (including…
View BiographyGlobal HTA Strategy Lead & Vice President, Pricing and Market Access
Experience in early evidence generations strategies, engaging early with European HTA bodies via the early scientific advice…
View BiographyTechnical Vice President, Clinical
Jorge Camarero, a former EMA professional as an alternate member of the Committee for Medicinal Products for Human Use (CHMP)…
View BiographyVice President, Health Advances
Gary leads Health Advances’ Hong Kong office and is focused on growing the firm’s practice in the Asia Pacific with pharma,…
View BiographyPartner, Health Advances
Greg co-leads Health Advances’ Health IT and Digital Health practice, building upon fifteen years of experience in strategy,…
View BiographyVice President, Technical
International experience in pharmaceuticals, biologics and medical device industries. Provides risk-based GMP consulting…
View BiographyPrincipal Consultant
Experience in pharmaceutical, biologics and medical device industries. Provides GMP consulting services in Quality Systems,…
View BiographyHeath has over 25 years of industry and consulting experience in parenterals and biologics
View BiographyVice President, Strategic Resourcing & Operations
Responsible for project management, change management and resourcing for all consulting engagements. 20 years of experience…
View BiographyPrincipal Consultant
A qualified pharmacist. Previously worked with MHRA as a Pharmaceutical Assessor/ CMC Reviewer.
View BiographyScientific Data Solutions Architect and Project Director
Managing real-world data (RWD) activities and working closely with data scientists, data stewards, biostatisticians, and…
View BiographyVice President - Technical
An engineer with wide-ranging experience including medical devices. Held position within Center for Devices and Radiological…
View BiographyConsultant- Advanced Analytics, HEOR
Responsible for all aspects of statistical analysis, providing technical statistical programming expertise and supporting the…
View BiographyPrincipal Consultant
Former Pharmacologist at FDA. Experience in nonclinical development programs in acute and chronic pain syndromes, medical…
View BiographyDirector, Modelling and Advanced Analytics
An experienced statistician working in the advanced analytics area within HEOR
View BiographyVice President, RCS Head of Global Compliance
FDA/CDER experience in CMC review (CDER Master Reviewer for INDs, NDAs, BLAs, ANDAs and DMFs), policy development, and…
View BiographyPrincipal Consultant
Former FDA lead reviewer, policy analyst, and researcher. Ph.D.-level biomedical engineer and medical device/combination…
View BiographyVice President, Health Advances
Balazs has over 15 years of healthcare experience in corporate development, strategy, finance and operational positions.
View BiographySenior Director
25 years of R&D, Regulatory Affairs and Quality Assurance expertise. Experience with quality systems designed to Good…
View BiographyPrincipal Consultant
China Drug Administration drug review (NMPA) experience with a particular focus on CMC/Bioequivalence and regulatory strategy…
View BiographySenior Director, Customer Strategy, Medical Communications
Over 13 years’ experience, Nichola provides clients with strategic approaches to patient, physician, and site communication…
View BiographyVice President, Clinical Trial Regulatory Services
A pharmacist and now heads Clinical Trial Regulatory Services (CTRS) worldwide and is based in Berlin, Germany.
View BiographyVP, Real-World Evidence Strategy
20 years’ experience designing global real-world evidence (RWE) solutions to support the development and commercialization of…
View BiographyPartner
Wyatt brings 20 years of life sciences experience to Health Advances, and joined the firm after a successful career leading…
View BiographyCorporate Vice President
36+ years of experience as a regulatory and drug development professional, advising biotech and biotechnology companies.
View BiographyPrincipal Consultant
10 years of FDA experience as a CMC reviewer and Quality Assessment Lead for the Office of New Drug Products in the Office of…
View BiographyPartner and Managing Director, Health Advances
Gary joined Health Advances in 2005 and leads the firm’s Precision Medicine Practice.
View BiographyVice President, Pricing & Market Access
Provides leadership to Parexel’s Pricing & Market Access consultants and offers strategic guidance and oversight in the…
View BiographyVice President, Technical
Former FDA at CDER. Expertise includes clinical safety and efficacy, preclinical development, and biomarker/surrogate…
View BiographyVice President, Technical, Regulatory Consulting Services
Advisers on clinical development plans, gap analyses, MAA, NDA and variation applications, ODD applications and responses to…
View BiographyPartner and Managing Director, Health Advances
Sheela is a leader in Health Advances’ biopharma practice, helping companies maximize the value of their assets and build…
View BiographyVice President, Technical
Former FDA regulator, Branch Chief (Acting) in Division of Cellular and Gene Therapy (DCGT) in the Office of Tissues and…
View BiographyPartner, Health Advances
Donna joined Health Advances in 2005 and leads the firm’s Diagnostics and Life Science Tools Practice, a global practice…
View BiographySenior Director, Regulatory & Access
Experienced in clinical and non-clinical programs, proof of concept studies for neuroscience and served as a in-vitro…
View BiographyDirector, Patient Communications
15 years’ experience managing global patient and site communication delivery within Parexel's Medical Communications team
View BiographyVice President, Health Advances
At Health Advances, Carrie works towards the advancement of novel therapeutics, drawing from experience across…
View BiographySenior Consultant
Experience in strategic areas of value proposition, payer evidence generation planning, pricing, market access, and value…
View BiographyVice President, Technical
Former FDA, with expertise in development of analgesic and addiction (alcohol and opioid) therapies, as well as in…
View BiographyVice President, Technical
Lucas has 8 years of experience in drug review, development, and regulatory experience at the U.S. Food and Drug…
View BiographySenior Director
Dina is a senior professional with over 20 years of experience in providing solid leadership in managing critical global…
View BiographyDirector, Customer Strategy
Provides strategic direction and clinical insights that inform Medical Affairs communication planning across a broad array of…
View BiographyPrincipal Consultant
Experience in nonclinical drug development strategies including new molecular entities as well as creating unique strategies…
View BiographyPrincipal Consultant, Clinical Pharmacology
Over 20 years of medical & scientific expertise in early drug development, from translational science to Phase I – II.
View BiographyVice President, Health Advances
Darcy has 20 years of strategic healthcare consulting experience, having advised medical device, biopharma, and diagnostic…
View BiographyPrincipal Consultant
Andrew is a prior member of numerous Agency, Center and Office-level FDA Technical Committees and Working Groups. His…
View BiographyVice President, APAC
China national with experience as FDA medical reviewer, CMO/CRO and pharmaceutical industries for overall regulatory and…
View BiographyVice President, Technical
Yuexia has the in-depth knowledge in cGMP compliance and the FDA inspection findings. She is also very familiar with the FDA…
View BiographyVice President, Technical
20+ years of clinical and drug development experience that includes hospital clinical practice, R&D experience in big and…
View BiographySenior Consultant, Health Economics
Leads varied market access related activities, typically reimbursement applications in the Nordic countries with a special…
View BiographyCMC Subject Matter Expert
Brings CMC expertise for biologic products and expertise in CDE/NMPA ’s regulatory and technical guidance on CMC for…
View BiographyPrincipal Consultant, Modelling and Advanced Analytics
10 years of experience providing advice on health economic modelling and pharmaceutical market access to clients in the life…
View BiographyConsultant – Machine Learning & Data Analytics
A machine learning specialist who also has a background in health economic modelling.
View BiographyPartner, Health Advances
Andrew joined Health Advances in 2009. He co-leads the firm’s Digital Health and Health IT Practice.
View BiographySenior Director
As a Senior Director, Catherine advises and consults with clients on all aspects of CMC drug development and regulatory…
View BiographyVice President, Regulatory Consulting Services
Amy, former FDA regulator, including Deputy Center Director, Oncology Center of Excellence (OCE) and Supervisory Associate…
View BiographyVice President, Health Advances
Kristine has over 15 years of Life Science industry experience that spans diagnostics, medical devices, and therapeutics.
View BiographyVice President, Pricing and Market Access
Emma is MD with experience in HTA submissions, value-based solutions of orphan drugs and ATMPs, HEOR and how RWE can be…
View BiographyPrincipal Consultant
Anita has more than 20 years direct experience in GMP requirements, quality systems, commercial manufacturing, pharmaceutical…
View BiographyDirector
Kelly has over 23 years of experience within the regulated industry to help US and international clients prepare and manage…
View BiographyPartner, Health Advances LLC
Vivek leads Health Advances’ San Francisco office and is focused on building Health Advances’ expertise in translational…
View BiographySenior Director, Pricing & Market Access
Specializes in planning and implementation of evidence generation plans to support and optimize market access and…
View BiographyVice President, Health Advances
Holger applies his deep expertise in commercializing scientific innovations in product development strategy, product…
View BiographyVice President, Biotechnology
Cecil has been working in regulatory affairs and clinical development for over 30 years with particular expertise in…
View BiographyVice President - Technical
Former UK medicines regulator at the MHRA, most recently as the Unit Manager of the Biologicals Unit. With significant…
View BiographyPrincipal Consultant
Antonina is a Regulatory Affairs professional with over 15 years of experience in the reviewing and preparation/coordination…
View BiographySenior Consultant, Pricing & Market Access
Experience in market access strategy and value communication, such as on AMCP, GVD, manuscript, and HTA submission projects
View BiographyVice President, Health Advances
Peter has over 30 years of healthcare experience including corporate executive, principal investor and strategy consulting…
View BiographyPrincipal Consultant
David was a CMC/Quality assessor at the Spanish Medicines Agency (AEMPS) for 4 years. He was involved in the assessment of…
View BiographyPartner, Health Advances
Susan co-leads the Medtech Practice Group at Health Advances, where she has worked on over 200 project engagements, with a…
View BiographyPrincipal Consultant
Former Senior Microbiology BLA Reviewer for CDER/OPQ/OPF/Division of Microbiology Assessment at the FDA. Experience of USP,…
View BiographySenior Director, Regulatory Outsourcing Services/Global Delivery
Jahanara is a Senior Director for Regulatory Outsourcing Services and Global Delivery. She develops high growth and…
View BiographySenior Director, Clinical Trial Regulatory Services
Beate, a Senior Director of Clinical Trial Regulatory Services, manages a team of more than 100 staff members in Central and…
View BiographyVice President, Health Advances
Ruggero brings 15 years of life science experience to Health Advances’ biopharma practice. He focuses on corporate strategy,…
View BiographyDirector Clinical Outcomes Assessments (COA)
Experience in strategic and scientific guidance on robust design, implementation and dissemination of patient-centric…
View BiographyClinical Outcomes Assessment (COA) Consultant
COA Consultant with experience in qualitative interviews, focus groups, feasibility and scoping activities, quantitative…
View BiographyEngagement Manager, Health Advances
Expertise in portfolio strategy and opportunity assessments for novel platforms. Amanda co-leads the Market Insights Group at…
View BiographyVice President, Technical
Siegfried joined Parexel Consulting in 2007, He provides consulting services to the healthcare industry on all aspects of…
View BiographyPrincipal Consultant
10 years’ experience in IND and NDA submissions of different types of products to FDA and NMPA, including Novel Biologics,…
View BiographyAssociate Director
Stephanie has over 15 years global regulated industry experience in R&D and QA/RA compliance with a majority of her…
View BiographyDirector
Gregg has over 20 years of experience developing and implementing quality processes to achieve organizational quality,…
View BiographyPartner and Managing Director, Health Advances
Mark has been advising senior medtech executives for nearly 40 years. He co-founded Health Advances in 1992...
View BiographyPartner and Managing Director, Health Advances
Paula co-founded Health Advances over 25 years ago, and continues to lead senior level client engagements focused on…
View BiographyPrincipal Consultant
James draws on 23 years of FDA experience to improve clients’ regulatory compliance. James assists biopharmaceutical and…
View BiographyConsultant
Rieko joined Parexel in October 2015 and is a consultant with significant regulatory expertise in medical devices.
View BiographyDirector, Regulatory Consulting Services
Ivan has extensive Research and Development experience gained within the EU Regulatory Affairs functions of top…
View BiographyPrincipal Consultant, Modelling and Advanced Analytics
Focused on the design and development of economic models. Experience of designing and constructing cohort-based Markov models…
View BiographySenior Consultant, Parexel Access Consulting
Experience in HTA submissions, global evidence and value dossiers, value-based solutions of high-priced products, HEOR…
View BiographyConsultant, HEOR
Experience includes health technology assessment (HTA) submissions as well as the development and adaptation of…
View BiographyPartner and Managing Director, Health Advances
Tracy works with a wide variety of medical device clients ranging from small start-ups to some of the largest public…
View BiographyPrincipal Consultant
Luman is a regulatory lead for cell, tissue, and gene therapy programs and specializes in antibody-drug conjugates, CAR-T…
View BiographyVice President – Technical
Steve brings over 11 years of former FDA experience as a Medical Officer, Team Leader, and Acting Branch Chief in the Office…
View BiographyVice President, Technical
Richard manages a team of Parexel consultants and serves as a member of the management team responsible for the Strategic…
View Biography