Our Experts

Jeffrey Abraham

Vice President

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

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…

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…

Mark Birse

Vice President, Technical, Regulatory Consulting Services

Former regulator with MHRA. Experience includes Head of Inspectorate, GMP and GDP inspections, Qualified Person, IRCA…

Paul Bridges, Ph.D.

Senior Vice President, Worldwide Head of Regulatory & Access

Experience in CMC, European licensing procedures

Paula Brockmeyer

Director

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

Kurt Brorson, Ph.D.

Vice President, Technical

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

Irena Budaite

Principal Consultant

Sangeeta Budhia

Global 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…

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)…

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,…

Greg Chittim

Partner, Health Advances

Greg co-leads Health Advances’ Health IT and Digital Health practice, building upon fifteen years of experience in strategy,…

Shamim Chowdhury

Vice President, Technical

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

Eileen Clancy

Principal Consultant

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

Heath Coats

Heath has over 25 years of industry and consulting experience in parenterals and biologics

Katie Connelly

Vice President, Strategic Resourcing & Operations

Responsible for project management, change management and resourcing for all consulting engagements. 20 years of experience…

Michael Craig

Principal Consultant

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

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…

Sugato De, M.S.

Vice President - Technical

An engineer with wide-ranging experience including medical devices. Held position within Center for Devices and Radiological…

Tuli De, PhD

Consultant- Advanced Analytics, HEOR

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

Marcus S. Delatte, Ph.D.

Principal Consultant

Former Pharmacologist at FDA. Experience in nonclinical development programs in acute and chronic pain syndromes, medical…

Mark Edmondson-Jones

Director, Modelling and Advanced Analytics

An experienced statistician working in the advanced analytics area within HEOR

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…

Trisha Eustaquio, Ph.D.

Principal Consultant

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

Balazs Felcsuti

Vice President, Health Advances

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

Felicia Ford-Rice

Senior Director

25 years of R&D, Regulatory Affairs and Quality Assurance expertise. Experience with quality systems designed to Good…

Yang (Frank) Gao, M.S.

Principal Consultant

China Drug Administration drug review (NMPA) experience with a particular focus on CMC/Bioequivalence and regulatory strategy…

Nichola Gokool

Senior Director, Customer Strategy, Medical Communications

Over 13 years’ experience, Nichola provides clients with strategic approaches to patient, physician, and site communication…

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.

Matthew Gordon

VP, Real-World Evidence Strategy

20 years’ experience designing global real-world evidence (RWE) solutions to support the development and commercialization of…

Wyatt Gotbetter

Partner

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

Alberto Grignolo, Ph.D

Corporate Vice President

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

Danuta Gromek-Woods, Ph.D.

Principal 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…

Gary Gustavsen

Partner and Managing Director, Health Advances

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

Janice Haigh

Vice President, Pricing & Market Access

Provides leadership to Parexel’s Pricing & Market Access consultants and offers strategic guidance and oversight in the…

Changting Haudenschild, M.D.

Vice President, Technical

Former FDA at CDER. Expertise includes clinical safety and efficacy, preclinical development, and biomarker/surrogate…

Bridget Heelan, M.B., D.Phil.

Vice President, Technical, Regulatory Consulting Services

Advisers on clinical development plans, gap analyses, MAA, NDA and variation applications, ODD applications and responses to…

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…

Mohammad Heidaran, Ph.D.

Vice President, Technical

Former FDA regulator, Branch Chief (Acting) in Division of Cellular and Gene Therapy (DCGT) in the Office of Tissues and…

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…

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…

Jakki James

Director, Patient Communications

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

Carrie Jones

Vice President, Health Advances

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

Jamie Jordan

Senior Consultant

Experience in strategic areas of value proposition, payer evidence generation planning, pricing, market access, and value…

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…

Lucas Kempf, M.D.

Vice President, Technical

Lucas has 8 years of experience in drug review, development, and regulatory experience at the U.S. Food and Drug…

Dina Khairo, B.Sc., MBA

Senior Director

Dina is a senior professional with over 20 years of experience in providing solid leadership in managing critical global…

Jamie L. Kistler, PhD

Director, Customer Strategy

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

Gopala Krishna, PhD, MBA, DABT, FATS

Principal Consultant

Experience in nonclinical drug development strategies including new molecular entities as well as creating unique strategies…

Matthias Kruse, MD, PhD

Principal Consultant, Clinical Pharmacology

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

Darcy Krzynowek

Vice President, Health Advances

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

Andrew Langowski

Principal Consultant

Andrew is a prior member of numerous Agency, Center and Office-level FDA Technical Committees and Working Groups. His…

Chang Q. Lee, M.D., MSHA, Dr.PH, FCAP

Vice President, APAC

China national with experience as FDA medical reviewer, CMO/CRO and pharmaceutical industries for overall regulatory and…

Yuexia Li

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…

Yajie Li

Vice President, Technical

20+ years of clinical and drug development experience that includes hospital clinical practice, R&D experience in big and…

Jonas Lindblom, MSc, PhD

Senior Consultant, Health Economics

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

Jianhui Luo, M.D.

CMC Subject Matter Expert

Brings CMC expertise for biologic products and expertise in CDE/NMPA ’s regulatory and technical guidance on CMC for…

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…

Maciej Maruszczak, MSc

Consultant – Machine Learning & Data Analytics

A machine learning specialist who also has a background in health economic modelling.

Andrew Matzkin

Partner, Health Advances

Andrew joined Health Advances in 2009. He co-leads the firm’s Digital Health and Health IT Practice.

Catherine McHugh

Senior Director

As a Senior Director, Catherine advises and consults with clients on all aspects of CMC drug development and regulatory…

Amy McKee, M.D.

Vice President, Regulatory Consulting Services

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

Kristine Mechem, PhD

Vice President, Health Advances

Kristine has over 15 years of Life Science industry experience that spans diagnostics, medical devices, and therapeutics.

Emma Medin, MD, MSc

Vice 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…

Anita R. Michael

Principal Consultant

Anita has more than 20 years direct experience in GMP requirements, quality systems, commercial manufacturing, pharmaceutical…

Kelly M. Miller, MSc.

Director

Kelly has over 23 years of experience within the regulated industry to help US and international clients prepare and manage…

Vivek Mittal

Partner, Health Advances LLC

Vivek leads Health Advances’ San Francisco office and is focused on building Health Advances’ expertise in translational…

Rakhee Modha, PhD

Senior Director, Pricing & Market Access

Specializes in planning and implementation of evidence generation plans to support and optimize market access and…

Dr. Holger Müller

Vice President, Health Advances

Holger applies his deep expertise in commercializing scientific innovations in product development strategy, product…

Cecil Nick

Vice President, Biotechnology

Cecil has been working in regulatory affairs and clinical development for over 30 years with particular expertise in…

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…

Antonina Nikolova, Ph.D.

Principal Consultant

Antonina is a Regulatory Affairs professional with over 15 years of experience in the reviewing and preparation/coordination…

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

Peter Origenes

Vice President, Health Advances

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

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…

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…

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,…

Jahanara Rahuldev

Senior Director, Regulatory Outsourcing Services/Global Delivery

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

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…

Ruggero Rossi

Vice President, Health Advances

Ruggero brings 15 years of life science experience to Health Advances’ biopharma practice. He focuses on corporate strategy,…

Katja Rudell, PhD

Director Clinical Outcomes Assessments (COA)

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

Ewelina Rzepa, PhD

Clinical Outcomes Assessment (COA) Consultant

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

Amanda Sani

Engagement Manager, Health Advances

Expertise in portfolio strategy and opportunity assessments for novel platforms. Amanda co-leads the Market Insights Group at…

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…

Jason She

Principal Consultant

10 years’ experience in IND and NDA submissions of different types of products to FDA and NMPA, including Novel Biologics,…

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…

Gregg Sherman

Director

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

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...

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…

James P. Stumpff, RPh

Principal Consultant

James draws on 23 years of FDA experience to improve clients’ regulatory compliance. James assists biopharmaceutical and…

Rieko Tanegashima, Ph.D.

Consultant

Rieko joined Parexel in October 2015 and is a consultant with significant regulatory expertise in medical devices.

Ivan Tommasini, Ph.D.

Director, Regulatory Consulting Services

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

Catrin Treharne, MSc

Principal Consultant, Modelling and Advanced Analytics

Focused on the design and development of economic models. Experience of designing and constructing cohort-based Markov models…

Erika Turkstra, MSc, PhD

Senior Consultant, Parexel Access Consulting

Experience in HTA submissions, global evidence and value dossiers, value-based solutions of high-priced products, HEOR…

Mirko von Hein, MSc

Consultant, HEOR

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

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…

Luman Wing, PhD

Principal Consultant

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

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…

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…

Ned Wydysh, Ph.D

Vice President, Health Advances