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Jeffrey Abraham

Jeffrey Abraham

Vice President, Health Advances

Extensive expertise related to commercialization, global market access, product development, and evidence generation.

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Arushi Agarwal

Arushi Agarwal

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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Kristen Garner Amanti, PhD

Kristen Garner Amanti, PhD

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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Farhad Amiri, PhD, FAHA

Farhad Amiri, PhD, FAHA

Principal Regulatory Affairs Consultant

Over 15 years’ experience working for the pharmaceutical business in roles involving nonclinical to early clinical studies…

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Rito Bergemann, MD, PhD, MBA

Rito Bergemann, MD, PhD, MBA

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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Mark Birse

Mark Birse

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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Paul Bridges, Ph.D.

Paul Bridges, Ph.D.

Head of Consulting

Experience in CMC, European licensing procedures

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Paula Brockmeyer

Paula Brockmeyer

Senior Director

Experienced with Medical Devices, Biologics, Data Integrity auditing within GMP quality, Quality Systems Regulation (QSR) and…

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Kurt Brorson, Ph.D.

Kurt Brorson, Ph.D.

Vice President, Technical

Former regulatory with FDA. Experience in CBER and CDER in CMC review, facility assessment & compliance (including…

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Irena Budaite

Irena Budaite

Principal Consultant

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Sangeeta Budhia

Sangeeta Budhia

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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Jorge Camarero

Jorge Camarero

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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Amar Chawla, PhD

Amar Chawla, PhD

Principal Consultant

Over 8 years of market access experience, including IQVIA and J&J with over 50 publications in leading medical and industry…

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Gary Cheng

Gary Cheng

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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Greg Chittim

Greg Chittim

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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Shamim Chowdhury

Shamim Chowdhury

Vice President, Technical

International experience in pharmaceuticals, biologics and medical device industries. Provides risk-based GMP consulting…

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Eileen Clancy

Eileen Clancy

Principal Consultant

Experience in pharmaceutical, biologics and medical device industries. Provides GMP consulting services in Quality Systems,…

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Katie Connelly

Katie Connelly

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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Michael Craig

Michael Craig

Vice President - Technical

A qualified pharmacist. Previously worked with MHRA as a Pharmaceutical Assessor/ CMC Reviewer.

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Evelyn P. Davila, PhD, MPH

Evelyn P. Davila, PhD, MPH

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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Tuli De, PhD

Tuli De, PhD

Consultant- Advanced Analytics, HEOR

Responsible for all aspects of statistical analysis, providing technical statistical programming expertise and supporting the…

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Brett Doble, PhD

Brett Doble, PhD

Principal Consultant, Health Economics Modelling

A health economist and former a Technical Adviser in Economics and Data Analytics at the National Institute for Health and…

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Lynne A. Ensor, Ph.D.

Lynne A. Ensor, Ph.D.

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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Trisha Eustaquio, Ph.D.

Trisha Eustaquio, Ph.D.

Vice President – Technical

Former FDA lead reviewer, policy analyst, and researcher. Ph.D.-level biomedical engineer and medical device/combination…

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Balazs Felcsuti

Balazs Felcsuti

Vice President, Health Advances

Balazs has over 15 years of healthcare experience in corporate development, strategy, finance and operational positions.

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Mohamed Ghorab, PhD

Mohamed Ghorab, PhD

Principal Consultant

Former Director for FDA's Division of Regulations, Guidance and Standards in CDER/OPQ/Office of Policy for Pharmaceutical…

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Nichola Gokool

Nichola Gokool

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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Bettina Goldberg

Bettina Goldberg

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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Celina González-Colaço

Celina González-Colaço

Principal Consultant, Clinical Trial Regulatory Services

Former Clinical Trial Assessor, AEMPS and previously National Expert Clinical & Non-Clinical Compliance Service, EMA,…

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Matthew Gordon

Matthew Gordon

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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Wyatt Gotbetter

Wyatt Gotbetter

SVP & WW Head of Access Consulting

Wyatt brings 20 years of life sciences experience to Health Advances, and joined the firm after a successful career leading…

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Alberto Grignolo, Ph.D

Alberto Grignolo, Ph.D

Corporate Vice President

36+ years of experience as a regulatory and drug development professional, advising biotech and biotechnology companies.

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Gary Gustavsen

Gary Gustavsen

Partner and Managing Director, Health Advances

Gary joined Health Advances in 2005 and leads the firm’s Precision Medicine Practice.

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Sheela Hegde

Sheela Hegde

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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Donna Hochberg, PhD

Donna Hochberg, PhD

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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Rathna Iyer, M.S., PMP

Rathna Iyer, M.S., PMP

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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Jakki James

Jakki James

Director, Patient Communications

15 years’ experience managing global patient and site communication delivery within Parexel's Medical Communications team

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Carrie Jones

Carrie Jones

Vice President, Health Advances

At Health Advances, Carrie works towards the advancement of novel therapeutics, drawing from experience across…

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Mwango A. Kashoki, M.D., MPH

Mwango A. Kashoki, M.D., MPH

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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Jamie L. Kistler, PhD

Jamie L. Kistler, PhD

Director, Customer Strategy

Provides strategic direction and clinical insights that inform Medical Affairs communication planning across a broad array of…

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Katarzyna Kolasa, PhD

Katarzyna Kolasa, PhD

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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Matthias Kruse, MD, PhD

Matthias Kruse, MD, PhD

Vice President, Technical, Clinical Pharmacology

Over 20 years of medical & scientific expertise in early drug development, from translational science to Phase I – II.

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Darcy Krzynowek

Darcy Krzynowek

Vice President, Health Advances

Darcy has 20 years of strategic healthcare consulting experience, having advised medical device, biopharma, and diagnostic…

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Andrew Langowski

Andrew Langowski

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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Chris Learn, Ph.D., PMP

Chris Learn, Ph.D., PMP

Vice President, Head of the Cell and Gene Center of Excellence

As a caregiver to his parents with incurable genetic illnesses, Vice President, Head of Cell and Gene Therapy Center of…

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Yajie Li

Yajie Li

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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Jonas Lindblom, MSc, PhD

Jonas Lindblom, MSc, PhD

Senior Consultant, Health Economics

Leads varied market access related activities, typically reimbursement applications in the Nordic countries with a special…

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Ricken (Liquan) Ma

Ricken (Liquan) Ma

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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Johan Maervoet, PhD, MBA

Johan Maervoet, PhD, MBA

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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Andrew Matzkin

Andrew Matzkin

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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Amy McKee, M.D.

Amy McKee, M.D.

Chief Medical Officer and Global Head, Oncology Center of Excellence

Amy, former FDA regulator, including Deputy Center Director, Oncology Center of Excellence (OCE) and Supervisory Associate…

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Laurie McRae

Laurie McRae

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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Kristine Mechem, PhD

Kristine Mechem, PhD

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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Chris Middendorf, M.S.

Chris Middendorf, M.S.

VP Technical, Strategic Compliance Consulting

Chris has over two decades of experience at the FDA. A former Drug Specialist in ORA Chris was assigned the most difficult…

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Vivek Mittal

Vivek Mittal

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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Rakhee Modha, PhD

Rakhee Modha, PhD

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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David Murray, PhD

David Murray, PhD

Principal Consultant

Expert in CMC of Biological Medicinal Products and Regulatory Affairs. A former CMC assessor for Ireland's regulator, HPRA.

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Cecil Nick

Cecil Nick

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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Christiane Niederlaender, Ph.D.

Christiane Niederlaender, Ph.D.

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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Kevin Nolan

Kevin Nolan

Principal Consultant

Quality Control and Regulatory Affairs leadership experience, has successfully launched and licensed recombinant biologics,…

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Natalie Ong, MSc, BSc

Natalie Ong, MSc, BSc

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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Peter Origenes

Peter Origenes

Vice President, Health Advances

Peter has over 30 years of healthcare experience including corporate executive, principal investor and strategy consulting…

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Roopal Patel

Roopal Patel

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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David Pérez, PhD

David Pérez, PhD

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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Susan A. Posner

Susan A. Posner

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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Diane Raccasi, B.S

Diane Raccasi, B.S

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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Boris Rachev

Boris Rachev

Senior Director, Advanced Analytics

20+ years specializing in healthcare policy and systems, including economics, government, health technology assessment,…

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Jahanara Rahuldev

Jahanara Rahuldev

Vice President, FSP Biometrics, India

Jahanara is a Senior Director for Regulatory Outsourcing Services and Global Delivery. She develops high growth and…

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Beate Roder

Beate Roder

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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Rosamund Round

Rosamund Round

Vice President, Patient Engagement

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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Katja Rudell, PhD, MSc, CPsychol

Katja Rudell, PhD, MSc, CPsychol

Director Clinical Outcomes Assessments (COA)

Experience in strategic and scientific guidance on robust design, implementation and dissemination of patient-centric…

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Ewelina Rzepa, PhD

Ewelina Rzepa, PhD

Clinical Outcomes Assessment (COA) Consultant

COA Consultant with experience in qualitative interviews, focus groups, feasibility and scoping activities, quantitative…

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Vincent Santa Maria

Vincent Santa Maria

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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Dr. Sinan B. Sarac, MD, MSc, PhD

Dr. Sinan B. Sarac, MD, MSc, PhD

Vice President, Technical

Oncology specialist and former regulator with the Danish Medicines Agency and the Committee for Medicinal Products for Human…

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Siegfried Schmitt, Ph.D

Siegfried Schmitt, Ph.D

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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Jason She

Jason She

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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Stephanie Sheesley, RAC

Stephanie Sheesley, RAC

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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Gregg Sherman

Gregg Sherman

Director

Gregg has over 20 years of experience developing and implementing quality processes to achieve organizational quality,…

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Julie Shutt

Julie Shutt

Patient Advocacy Manager

Julie engages with Patient Advocacy Groups (PAGs) to improve the clinical trial experience for both patient, sponsor and CRO.

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Phil Smith, PhD

Phil Smith, PhD

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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Mark Speers

Mark Speers

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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Paula Ness Speers

Paula Ness Speers

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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Kumar Sripathirathan, Ph.D.

Kumar Sripathirathan, Ph.D.

Senior Regulatory Consultant

25 years of experience in Toxicology and Pharmacology studies and working with candidate drugs (small molecules, biologics)…

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Simona Stankeviciute, MD, MSc

Simona Stankeviciute, MD, MSc

Principal Consultant

Former clinical pharmacology and clinical assessor,for European Medicines Agency (EMA). Served as an alternate member of the…

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Ivan Tommasini, Ph.D.

Ivan Tommasini, Ph.D.

Director, Regulatory Consulting Services

Ivan has extensive Research and Development experience gained within the EU Regulatory Affairs functions of top…

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Erika Turkstra, MSc, PhD

Erika Turkstra, MSc, PhD

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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Jackie Vanderpuye-Orgle, PhD

Jackie Vanderpuye-Orgle, PhD

Vice President and Global Head of Advanced Analytics

A health economist with over 20 years of experience, with expertise in network meta-analysis, parametric modelling,…

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Mirko von Hein, MSc

Mirko von Hein, MSc

Principal Consultant, HEOR

Experience includes health technology assessment (HTA) submissions as well as the development and adaptation of…

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Sanjay Vyas

Sanjay Vyas

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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Tracy Walters

Tracy Walters

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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Chiaochun Joanne “Jo” Wang

Chiaochun Joanne “Jo” Wang

Vice President - Technical

Former CMC reviewer and inspector of the FDA with experience in drug delivery, drug-device combination product, cell/tissue…

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Philipp Warnebier

Philipp Warnebier

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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Luman Wing, PhD

Luman Wing, PhD

Vice President - Technical

Luman is a regulatory lead for cell, tissue, and gene therapy programs and specializes in antibody-drug conjugates, CAR-T…

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Steve Winitsky, M.D.

Steve Winitsky, M.D.

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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Richard E. Wright

Richard E. Wright

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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Ned Wydysh, Ph.D

Ned Wydysh, Ph.D

Vice President, Health Advances

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John Zhang, Ph.D.

John Zhang, Ph.D.

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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