Our Experts

Allyn Becker, Ph.D.

Principal Consultant

Broad responsibility for preformulation, formulation, analytical chemistry, and other aspects of product development in the…

Ulrike Behr

Senior Director, Clinical Trial Regulatory Services

Responsibility includes the implementation and management of Clinical Trial Applications to regulatory authorities worldwide,…

Andrea Berardi, MSc

Principal Consultant, Modelling and Advanced Analytics

Experience in statistical and health economic modelling across a range of disease areas including oncology, auto-immune and…

David J. Bergeson

Principal Consultant

Former Investigator with the FDA. Medical Device expertise. Experience in identifying and remediating GMP and QSR issues,…

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.

Corporate 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…

Sangeeta Budhia

Global HTA Strategy Lead & Senior Director, Pricing and Market Access

Experience in early evidence generations strategies, engaging early with European HTA bodies via the early scientific advice…

Felicia A. Bullock, MBA

Director

25 years of CMC and Quality Systems experience, including development activities for US INDs, NDAs and ANDAs through the…

Judy Bunch

Senior Consultant

Previously held roles at the FDA including a field investigator and a medical device reviewer. Provides QSR and GMP auditing…

Kimberley Buytaert-Hoefen, Ph.D.

Principal Consultant

19+ years industry experience. Former Consumer Safety Officer at the FDA. Expertise in medical devices, biotechnology,…

Jacqueline Carranza Rosenzweig

Principal Consultant

General engagement management, HEOR and pricing and reimbursement responsibilities supporting both global and US groups.

Keith Chidwick, Ph.D

Vice President, Technical

Background in biochemistry research and the regulation of biotech medicines. Previously served at the MHRA.

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,…

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.

Philip E.M. Crooker, J.D.

Vice President - Technical

Former attorney and FDA regulator. 21 years in applying laws, regulations, and policy for biotechnology and pharmaceutical…

Sugato De, M.S.

Principal Consultant

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

Marcus S. Delatte, Ph.D.

Principal Consultant

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

Bhardwaj Desai, M.D.

Vice President, Technical

Global Oncology Clinical Development experience. Previous Principle Investigator.

Leslie Devos, R.N., M.S.

Vice President, Regulatory Consulting Services

Head of Parexel’s Global Regulatory Consulting Services. Experience in orphan indications, sepsis, oncology and inflammatory…

Vincent Duan, Ph.D.

Principal Consultant

China national with FDA drug review experience. Expertise in gastroenterology & inborn errors, reproductive & urology,…

Lynne A. Ensor, Ph.D.

Vice President, Technical

FDA/CDER experience in CMC review (CDER Master Reviewer for INDs, NDAs, BLAs, ANDAs and DMFs), policy development, and…

Felicia Ford-Rice

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…

Manuel M. Garza

Principal Consultant

Former FDA investigator, including foreign PAI and GMP inspections of sterile and not sterile pharma manufacturers, both API…

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.

Wyatt Gotbetter

Vice President, Health Advances LLC

Experience led teams in growth and product launch strategies, M&A integration, organizational optimization and new product…

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…

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…

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…

Vaughn Hunsicker

Senior Consultant, Pricing & Market Access

Robert L. Iser, M.S.

Vice President, Regulatory Consulting Services

Former FDA as the Director of the Office of Process and Facilities in CDER, with experience in CMC review, pre-approval…

Rathna Iyer, M.S., PMP

Director, Integrated Product Development

Experienced in clinical and non-clinical programs, proof of concept studies for neuroscience and served as a in-vitro…

Jamie Jordan

Senior Consultant

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

Parastoo Karoon

Principal Consultant

Former MHRA with experience in pediatrics, small molecule clinical and scientific experience

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…

Dina Khairo, B.Sc., MBA

Director, Integrated Product Development

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

Ifty Khan, BSc, MSc, PhD

Director, Modelling and Analytics

15 years of experience in clinical trials and economic evaluation across industry, academia and the regulatory setting. Dr…

Gopala Krishna, PhD, MBA, DABT, FATS

Principal Consultant

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

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…

David LeProhon

Principal Consultant

David draws on 27 years of diverse experience in the Biopharmaceutical, Pharmaceutical, and Medical Device industries to…

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…

Jonas Lindblom, MSc, PhD

Senior Consultant, Health Economics

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

Mark Lookabaugh

Principal Consultant

Mark provides GMP and QSR auditing and consulting services to Parexel clients worldwide.

Richard Macaulay, PhD

Senior Director, Pricing & Market Access

Expertise in value message development, quantitative and qualitative pricing research, payer evidence planning, primary and…

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…

Silvy Mardiguian, DPhil

Principal Consultant, Pricing & Market Access

experience in strategic communications, market access strategy, and evidence generation activities, developing global and…

Mark Matis

Principal Consultant

Mark draws on 23 years of diverse experience in project management, Information Technology Quality Systems, Consent Decree,…

Catherine McHugh

Principal Consultant

As a Principal Consultant for Parexel, Catherine advises and consults with clients on all aspects of CMC drug development and…

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…

Susan Metz

Principal Consultant, IDMP

Sue is a subject matter expert in xEVMPD, IDMP and regulatory information management with Parexel.

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

Cecil Nick

Vice President, Biotechnology

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

Antonina Nikolova, Ph.D.

Principal Consultant

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

Rebecca Olin

Principal Consultant

Rebecca has over 26 years of FDA experience both as a Field Investigator and Reviewer/Inspector for the Center for Biologics…

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

Daniela Palazzolo

Principal Consultant

Provides strategic guidance on commercial opportunity/landscape assessments, market entry and pricing strategies, HEOR…

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…

Cornelia Roibu, MBiochem

Consultant, Pricing and Market Access

Managed a variety of market access projects such as value message development and testing, landscape assessments, primary…

Partha Roy, Ph.D.

Vice President, Technical

Partha draws on over 19 years of drug development experience that includes core training in translational sciences in…

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…

Ebony Samuals, BSc, PhD

Vice President, Pricing & Market Access

Experience in value communications designed to support a product’s market access strategy, including value story and…

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…

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,…

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.

Michael Tang, BSc

Senior Principal Consultant, Pricing & Market Access

Works across value communications, market access and health economics specialising in value dossiers, evidence generation…

Ron Tetzlaff, Ph.D.

Corporate Vice President

Ron has more than 50 years of experience performing FDA inspections, conducting GMP audits, and evaluating compliance with…

Ivan Tommasini, Ph.D.

Principal Consultant

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…

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…

Jenny Xiradakis

Principal Consultant

Jenny has more than 16 years FDA experience and is specialized in conducting routine GMP and Pre-Approval inspections and…

MingPing Zhang

Vice President, Technical

Mingping is responsible for providing clients with regulatory and Chemistry, Manufacturing, and Controls (CMC) consulting for…