Vice President, Health Advances
Extensive expertise related to commercialization, global market access, product development, and evidence generation.
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Vice President, Health Advances
Arushi Agarwal joined the Health Advances team in 2011 and spends the majority of her time working in the Diagnostics and…
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Vice President, Health Advances
Kristen Garner Amanti joined the Health Advances team in 2010 and is a leader in the Reproductive and Genomic Health practice…
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Vice President, WW Head HEOR
Head of HEOR services with experience in RWE, Network Meta-Analysis, Rare Diseases, biologics and gene therapies.
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Vice President, Technical, Regulatory Consulting Services
Former regulator with MHRA. Experience includes Head of Inspectorate, GMP and GDP inspections, Qualified Person, IRCA…
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Senior Vice President, Worldwide Head of Regulatory & Access
Experience in CMC, European licensing procedures
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Senior Director
Experienced with Medical Devices, Biologics, Data Integrity auditing within GMP quality, Quality Systems Regulation (QSR) and…
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Vice President, Technical
Former regulatory with FDA. Experience in CBER and CDER in CMC review, facility assessment & compliance (including…
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VP and Global Head, Pricing and Market Access
Experience in early evidence generations strategies, engaging early with European HTA bodies via the early scientific advice…
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Technical Vice President, Clinical
Jorge Camarero, a former EMA professional as an alternate member of the Committee for Medicinal Products for Human Use (CHMP)…
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Vice 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,…
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Partner, Health Advances
Greg co-leads Health Advances’ Health IT and Digital Health practice, building upon fifteen years of experience in strategy,…
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Vice President, Technical
International experience in pharmaceuticals, biologics and medical device industries. Provides risk-based GMP consulting…
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Principal Consultant
Experience in pharmaceutical, biologics and medical device industries. Provides GMP consulting services in Quality Systems,…
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Heath has over 25 years of industry and consulting experience in parenterals and biologics
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Vice President, Strategic Resourcing & Operations
Responsible for project management, change management and resourcing for all consulting engagements. 20 years of experience…
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Principal Consultant
A qualified pharmacist. Previously worked with MHRA as a Pharmaceutical Assessor/ CMC Reviewer.
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Scientific Data Solutions Architect and Project Director
Managing real-world data (RWD) activities and working closely with data scientists, data stewards, biostatisticians, and…
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Vice President - Technical
An engineer with wide-ranging experience including medical devices. Held position within Center for Devices and Radiological…
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Consultant- Advanced Analytics, HEOR
Responsible for all aspects of statistical analysis, providing technical statistical programming expertise and supporting the…
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Vice President, Integrated Strategic Solutions, Parexel
Recently designated the honor of being named to the list of the 100 Most Inspiring People by PharmaVoice, her breadth of…
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Director, Modelling and Advanced Analytics
An experienced statistician working in the advanced analytics area within HEOR
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Vice 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…
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Principal Consultant
Former FDA lead reviewer, policy analyst, and researcher. Ph.D.-level biomedical engineer and medical device/combination…
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Vice President, Health Advances
Balazs has over 15 years of healthcare experience in corporate development, strategy, finance and operational positions.
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Senior Director
25 years of R&D, Regulatory Affairs and Quality Assurance expertise. Experience with quality systems designed to Good…
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Senior Director, Customer Strategy, Medical Communications
Over 13 years’ experience, Nichola provides clients with strategic approaches to patient, physician, and site communication…
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Vice President, Clinical Trial Regulatory Services
A pharmacist and now heads Clinical Trial Regulatory Services (CTRS) worldwide and is based in Berlin, Germany.
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VP, Real-World Evidence Strategy
20 years’ experience designing global real-world evidence (RWE) solutions to support the development and commercialization of…
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Partner
Wyatt brings 20 years of life sciences experience to Health Advances, and joined the firm after a successful career leading…
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Corporate Vice President
36+ years of experience as a regulatory and drug development professional, advising biotech and biotechnology companies.
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Partner and Managing Director, Health Advances
Gary joined Health Advances in 2005 and leads the firm’s Precision Medicine Practice.
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Vice President, Technical, Regulatory Consulting Services
Advisers on clinical development plans, gap analyses, MAA, NDA and variation applications, ODD applications and responses to…
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Partner and Managing Director, Health Advances
Sheela is a leader in Health Advances’ biopharma practice, helping companies maximize the value of their assets and build…
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Vice President, Technical
Former FDA regulator, Branch Chief (Acting) in Division of Cellular and Gene Therapy (DCGT) in the Office of Tissues and…
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Partner, Health Advances
Donna joined Health Advances in 2005 and leads the firm’s Diagnostics and Life Science Tools Practice, a global practice…
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Senior Director, Regulatory & Access
Experienced in clinical and non-clinical programs, proof of concept studies for neuroscience and served as a in-vitro…
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Director, Patient Communications
15 years’ experience managing global patient and site communication delivery within Parexel's Medical Communications team
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Vice President, Health Advances
At Health Advances, Carrie works towards the advancement of novel therapeutics, drawing from experience across…
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Senior Consultant
Experience in strategic areas of value proposition, payer evidence generation planning, pricing, market access, and value…
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Vice President, Technical
Former FDA, with expertise in development of analgesic and addiction (alcohol and opioid) therapies, as well as in…
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Vice President, Technical
Lucas has over 15 years of pharmaceutical R&D in academia and government from basic research, translational sciences, design…
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Director, Customer Strategy
Provides strategic direction and clinical insights that inform Medical Affairs communication planning across a broad array of…
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Vice President, HEOR Services
Katarzyna heads up Parexel's HEOR division with 20 years' experience in healthcare and health economics. She is a Professor…
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Principal Consultant, Clinical Pharmacology
Over 20 years of medical & scientific expertise in early drug development, from translational science to Phase I – II.
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Vice President, Health Advances
Darcy has 20 years of strategic healthcare consulting experience, having advised medical device, biopharma, and diagnostic…
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Principal Consultant
Andrew is a prior member of numerous Agency, Center and Office-level FDA Technical Committees and Working Groups. His…
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Senior Vice President, Real-World Evidence and Access
Leanne brings over 25 years’ experience in healthcare, featuring extensive work in pharmaceutical product development and…
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Vice President, Technical
Yuexia has the in-depth knowledge in cGMP compliance and the FDA inspection findings. She is also very familiar with the FDA…
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Vice President, Technical
20+ years of clinical and drug development experience that includes hospital clinical practice, R&D experience in big and…
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Senior Consultant, Health Economics
Leads varied market access related activities, typically reimbursement applications in the Nordic countries with a special…
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CMC Subject Matter Expert
Brings CMC expertise for biologic products and expertise in CDE/NMPA ’s regulatory and technical guidance on CMC for…
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Principal Consultant, Regulatory Affairs
Former senior clinical reviewer at China CDE/NMPA, responsible for different therapeutic areas and indications (e.g.,…
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Principal Consultant, Modelling and Advanced Analytics
10 years of experience providing advice on health economic modelling and pharmaceutical market access to clients in the life…
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Partner, Health Advances
Andrew joined Health Advances in 2009. He co-leads the firm’s Digital Health and Health IT Practice.
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Vice President, Regulatory Consulting Services
Amy, former FDA regulator, including Deputy Center Director, Oncology Center of Excellence (OCE) and Supervisory Associate…
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Senior Director, Global Head Integrated Solutions, Clinical Trial Supplies & Logistics
Laurie McRae joined Parexel’s Clinical Trial Supply and Logistics (CTS&L) team in 2012 and leads the CTS&L consulting…
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Vice President, Health Advances
Kristine has over 15 years of Life Science industry experience that spans diagnostics, medical devices, and therapeutics.
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VP, Operations and Development, RWE & Access
Emma is MD with experience in HTA submissions, value-based solutions of orphan drugs and ATMPs, HEOR and how RWE can be…
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Director
Kelly has over 23 years of experience within the regulated industry to help US and international clients prepare and manage…
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Partner, Health Advances LLC
Vivek leads Health Advances’ San Francisco office and is focused on building Health Advances’ expertise in translational…
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Senior Director, Pricing & Market Access
Specializes in planning and implementation of evidence generation plans to support and optimize market access and…
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Vice President, Health Advances
Holger applies his deep expertise in commercializing scientific innovations in product development strategy, product…
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Senior Regulatory Affairs Consultant
Expert in CMC of Biological Medicinal Products and Regulatory Affairs. A former CMC assessor for Ireland's regulator, HPRA.
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Vice President, Biotechnology
Cecil has been working in regulatory affairs and clinical development for over 30 years with particular expertise in…
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Vice President - Technical
Former UK medicines regulator at the MHRA, most recently as the Unit Manager of the Biologicals Unit. With significant…
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Principal Consultant
Quality Control and Regulatory Affairs leadership experience, has successfully launched and licensed recombinant biologics,…
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Senior Consultant, Pricing & Market Access
Experience in market access strategy and value communication, such as on AMCP, GVD, manuscript, and HTA submission projects
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Vice President, Health Advances
Peter has over 30 years of healthcare experience including corporate executive, principal investor and strategy consulting…
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Vice President, Global Head, Project Management & Delivery
Roopal Patel joined Parexel’s Clinical Trial Supply and Logistics (CTS&L) team in 2014 and serves as the global head of…
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Principal Consultant
David was a CMC/Quality assessor at the Spanish Medicines Agency (AEMPS) for 4 years. He was involved in the assessment of…
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Partner, Health Advances
Susan co-leads the Medtech Practice Group at Health Advances, where she has worked on over 200 project engagements, with a…
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Principal Consultant
Former Senior Microbiology BLA Reviewer for CDER/OPQ/OPF/Division of Microbiology Assessment at the FDA. Experience of USP,…
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Senior Director, Advanced Analytics
20+ years specializing in healthcare policy and systems, including economics, government, health technology assessment,…
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Senior Director, Regulatory Outsourcing Services/Global Delivery
Jahanara is a Senior Director for Regulatory Outsourcing Services and Global Delivery. She develops high growth and…
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Senior 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…
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Vice President, Patient Innovation Center
Rosamund has spent more than 15 years devoted to simplifying the patient journey in clinical trials, with a focus on reducing…
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Director Clinical Outcomes Assessments (COA)
Experience in strategic and scientific guidance on robust design, implementation and dissemination of patient-centric…
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Clinical Outcomes Assessment (COA) Consultant
COA Consultant with experience in qualitative interviews, focus groups, feasibility and scoping activities, quantitative…
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Vice President, Worldwide Clinical Trial Materials & Depot Operations
Vincent Santa Maria joined Parexel’s Clinical Trial Supply and Logistics (CTS&L) team in 2012 and leads the global…
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Vice President, Technical
Siegfried joined Parexel Consulting in 2007, He provides consulting services to the healthcare industry on all aspects of…
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Principal Consultant
10 years’ experience in IND and NDA submissions of different types of products to FDA and NMPA, including Novel Biologics,…
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Associate Director
Stephanie has over 15 years global regulated industry experience in R&D and QA/RA compliance with a majority of her…
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Director
Gregg has over 20 years of experience developing and implementing quality processes to achieve organizational quality,…
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Vice President, Parexel Regulatory Outsourcing Services
Leader of Parexel's Regulatory Outsourcing services, with many years’ experience in the design, implementation and delivery…
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Partner and Managing Director, Health Advances
Mark has been advising senior medtech executives for nearly 40 years. He co-founded Health Advances in 1992...
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Partner and Managing Director, Health Advances
Paula co-founded Health Advances over 25 years ago, and continues to lead senior level client engagements focused on…
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Principal Consultant
Former clinical pharmacology and clinical assessor,for European Medicines Agency (EMA). Served as an alternate member of the…
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Principal Consultant
James draws on 23 years of FDA experience to improve clients’ regulatory compliance. James assists biopharmaceutical and…
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Consultant
Rieko joined Parexel in October 2015 and is a consultant with significant regulatory expertise in medical devices.
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Director, Regulatory Consulting Services
Ivan has extensive Research and Development experience gained within the EU Regulatory Affairs functions of top…
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Principal Consultant, Pricing & Marketing Access
Experience in HTA submissions, global evidence and value dossiers, value-based solutions of high-priced products, HEOR…
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Consultant, HEOR
Experience includes health technology assessment (HTA) submissions as well as the development and adaptation of…
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Executive Vice President, India Country Head & Managing Director, SBU-Head Clinical Trial Supplies & Logistics
Sanjay Vyas joined Parexel’s Clinical Trial Supplies and Logistics (CTS&L) team in 2016 and leads the operational management…
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Partner 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…
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Principal Consultant
Former CMC reviewer and inspector of the FDA with experience in drug delivery, drug-device combination product, cell/tissue…
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Senior Director, Strategy Development & Project Management Office, Clinical Trial Supplies & Logistics, Senior Director Project Management Office Parexel India
Philipp Warnebier joined Parexel’s Clinical Trial Supplies and Logistics (CTS&L) team in 2016. Philipp is responsible for…
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Principal Consultant
Luman is a regulatory lead for cell, tissue, and gene therapy programs and specializes in antibody-drug conjugates, CAR-T…
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Vice President – Technical
Steve brings over 11 years of former FDA experience as a Medical Officer, Team Leader, and Acting Branch Chief in the Office…
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Vice President, Technical
Richard manages a team of Parexel consultants and serves as a member of the management team responsible for the Strategic…
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Vice President - Technical, Regulatory Consulting
Former Chief Review in CMC technical evaluation at the NMPA/CDE. Expertise in APIs, small molecules and OTC medicines in…
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