3716 transcrip contact sheets final aw

Principal Drug Safety Scientist

Maureen is drug safety scientist with over 19 years of industry experience. She has worked in all phases of drug development and pharmacovigilance from pre-clinical, Phase I/II, Phase III, marketing authorisation submissions, signal detection and evaluation, and post-marketing surveillance. She has broad therapeutic area experience, primarily in oncology but also in cardiovascular, infection, and virology.

Karol Sikora

Senior Academic Partner

Karol is a world respected oncologist and the Dean of the University of Buckingham School of Medicine. He provides support to many of TranScrip’s clients providing strategic input into development programmes of anti-cancer products.

Linda Summerton Head of Oncology

Linda brings a wealth of experience, obtained from over 25 years in the global pharmaceutical industry, to her leadership of oncology programmes within TranScrip.

Prior to joining TranScrip Linda was AstraZeneca’s Project Director for Iressa® and Head of Strategy and Portfolio for Oncology and Infection Therapy Area Management.

James Thorburn

Associate Partner, Hong Kong

James has over 25 years of experience in clinical research and development involving drugs, medical devices, and complementary medicines as well as a successful record of establishing contract research organisations both in the UK and his native Hong Kong.

Glenn Tillotson

Head of TranScrip North America

With 25 years’ experience, Glenn’s positions and roles within the global anti-infective world have enabled him to build a very broad based group of colleagues and connections which assist in the development and running of Advisory Boards. During his time at TranScrip Glenn has been involved with the development of various key documents to support recent antibiotic submissions.

Joanna Tufnell

Deputy Head of Regulatory Affairs and Peri-registration

Joanna has over 30 years’ industry experience in small and large pharmaceutical and biotech companies, as well as the UK Regulatory Agencies. She has worked on numerous applications for drug approvals during her career and is familiar with both technical (CMC, manufacturing) and clinical/nonclinical regulatory requirements applicable in the global regulatory markets.

Gabriel Vital-Durand

Deputy Head of Internal Medicine

Gabriel is an expert in clinical development (Phase I to Phase IV) and international regulatory and medical affairs. He brings broad expertise from his previous roles in industry, at Hoffmann-La Roche and as a reviewer for Swissmedic. Gabriel is based in Basel and is therefore close to many pharmaceutical and scientific centres of excellence.

Gilbert Wagener

Head of Internal Medicine

Gilbert leads the internal medicine team on cardio-metabolic, immune-mediated and non-oncology orphan diseases. He has provided support to proof of concept study designs and discussions with regulatory authorities. He has over 20 years’ industry experience from Phase I to MAA submission and life-cycle management developing stem cell therapies, gene therapies, antisense oligo-nucleotides, monoclonal antibodies, cardio-metabolic and CNS products.

Mark Watling

Head of CNS and Pain

Mark has led the CNS and Pain team in delivering projects for a substantial number of the world’s leading CNS companies. He provides input to strategic and tactical drug development based on 23 years’ experience and first-hand knowledge of the discovery, development and commercialisation of products.

Louise Whitley

Medical Information and PV

Louise is one of TranScrip’s medical affairs and pharmacovigilance scientists with particular experience of label harmonisations and is involved in many of TranScrip’s pre- and post-licensing projects across all therapeutic areas. She has over 20 years’ industry experience, working for companies such as Lederle Laboratories, Wyeth, and Parke Davis.

Contact Us: enquiries@transcrip-partners.com Global & European Regional Head Office TranScrip Partners LLP 400 Thames Valley Park Drive Reading, RG6 1PT, UK Tel: +44 (0)118 963 7846 North America Regional Office TranScrip Partners (USA) LLC 2941 Honeymead Road Downingtown, PA19335 Tel: +1 610 383 5705

Our Team

Pacific Rim Regional Office TranScrip Partners (Australia) Pty Ltd PO Box 475 Brookvale, NSW 2100 Tel: +61 (0)2 8968 9372 Asia Regional Office TranScrip Partners Hong Kong Ltd 20/F., Central Tower, 28 Queen’s Road Central, Hong Kong, SAR Tel: +852 2159 9414 Africa Regional Office TranScrip Partners Ghana Ltd PO Box 6466 Accra-North, Ghana Tel: +233 5534 75240 www.transcrip-partners.com

October 2015

Maureen Rankine

Expertise Oversight Effective Delivery

Paul Branthwaite Marketing

Our talented, insightful teams help our biotech and pharma clients maximise opportunities, reduce risk and create value.

Richard Bax

Deputy Head of Infectious Diseases

Richard is a renowned expert in antibiotics and the development of resistance, with over 30 years of industry experience. In his time at TranScrip Richard has provided extensive support in MAA preparation for submission and clinical development plans, principally for anti-infective agents. He has also supported some of our smaller clients in raising funds for further development, addressing strategic issues.

Andy Blackman

Drug Safety Operation Projects

Whilst at TranScrip Andy has led numerous projects including the safety reporting from early phase clinical trials, medical writing, working with a top 5 pharma company to improve the quality and compliance of the case processing group, and providing EU QPPV and EU Responsible Person services to clients. He brings over 20 years’ experience to this role.

Paul is responsible for marketing and recruitment at TranScrip. He has over 30 years’ experience in the pharmaceutical industry, including clinical R&D, business development, and marketing.

Chris Brearley

Sarah Daniels

Head of Drug Safety and Pharmacovigilance

During her time at TranScrip Sarah has overseen several successful projects ranging from signal detection and Summary of Product Characteristics label harmonisation to drug safety narrative reviews. Sarah is also the Clinical Safety Lead for a successful oncology indication expansion programme, involving many interactions with regulatory agencies. Previous roles included EU QPPV and Head of Drug Safety (UK Affiliate) for Roche Products Ltd.

Anne Hancock

Chief Operating Officer

As COO for TranScrip, Anne is responsible for the management and direction of TranScrip’s global operational teams, supporting the organisation in delivery of client assignments and assisting in leading the business through the next planned phase of growth.

Flic Gabbay

Laura Hiles

Flic co-founded TranScrip in 2008 and is the Managing Partner. As one of TranScrip’s specialists in pre- and peri-registration drug safety she has worked in many therapeutic areas including, antifungals, respiratory, renal disease and oncology. Flic has played a pivotal role in many successful license applications, including five which were developed and defended during her time at TranScrip.

Laura is one of TranScrip’s drug safety scientists and specialises in pharmacovigilance and medical writing.

She has over 14 years of industry experience working on peri- and post-licensing projects and has worked for companies such as Genentech, Roche, and Merck (UK). Her experience includes the therapeutic areas of transplant and breast cancer.

Carol Burley

Dave Griffin

Tim Joslin

With over 30 years’ experience in the industry, the last 6 years with TranScrip, Carol’s expertise is in the management of clinical development projects, including regulatory submissions. Having previously worked for both major pharmaceutical companies and within the service sector, she has a holistic view of clinical development and operations from both the customer and the service provider’s perspective.

As a microbiology expert, Dave has been involved in many of TranScrip’s antibacterial, antifungal and antiviral drug development and medical affairs projects. He has 37 years’ industry experience at GSK and Chiron.

Head of Translational Medicine

Chris brings over 20 years’ experience in both small molecules and biologicals across several therapeutic areas, including cardiovascular, metabolic, CNS and inflammation. He has been responsible for integrating pre-clinical safety and toxicology findings into first in human studies, and creating strategies for Proof of Concept and PK/PD modelling to support efficacy studies.

Deputy Head of Clinical Development and Operations

Deputy Head of Drug Safety and Pharmacovigilance

Microbiology Specialist

Principal Drug Safety Scientist

Head of Respiratory

Tim leads TranScrip’s clients’ programmes in respiratory product development, registration, and post-licensing and is also Head of Portfolio Management and Commercial Strategy. He has over 30 years of industry experience covering the complete commercial product life-cycle from “Target Product Profile” and national/ global launches to post-patent strategies for respiratory, infectious diseases, as well as cardio-metabolic, CNS, and orphan spaces.

Lars Larsson

Deputy Head of Respiratory

Lars has led many of TranScrip’s respiratory development, registration and post-licensing programs involving small molecules as well as biologics. He has 30 years’ experience across all phases of respiratory drug development, including regulatory agency interactions and marketing support. He is a board certified Physician and Associate Professor of Pulmonary Medicine at the University of Umeå, Sweden.

Ennis Lee

Deputy Head of Translational Medicine

Ennis specialises in pharmacovigilance and translational medicine. She is a drug development and drug safety expert in several therapeutic areas including immunology, virology and oncology. She was formerly the EU QPPV for Johnson & Johnson Pharma and has over 30 years of industry experience in various pharmaceutical companies and in the UK Competent Authority, MHRA.

Julia Lloyd-Parks

Head of Clinical Development and Operations

Julia provides clinical development support and project management to many of TranScrip’s larger projects. This includes development and management of clinical plans and documents, clinical programmes and regulatory submissions. She has worked across a number of therapeutic areas and has over 30 years of industry experience gained from large pharma companies, biotechs and service providers.

Marcin Mankowski

Head of Infectious Diseases

Marcin co-founded TranScrip in 2008 and is the Deputy Managing Partner. With 20 years’ industry experience he has been involved in the launch and development of many anti-infective products. Marcin has led TranScrip’s Infectious Diseases Team in the preparation of six successful MAAs/NDAs for antibiotics and antifungals and provides extensive support for launch and medical affairs activities for anti-infective products.

Bob Milsted

Head of Regulatory Affairs and Peri-registration

Bob’s industry experience spans over 30 years and includes leadership of numerous meetings with the FDA, EMA and PDMA as well as membership of the board of the ICH Clinical Trial Report working party. Bob has also been responsible for the clinical programmes for world leading medicines in breast and prostate cancer (Arimidex®, Casodex®, Zoladex®).

Judi Proctor

Head of Medical Writing

Judi has nearly 20 years’ experience in medical writing and document auditing. She has a broad range of expertise in medical writing for both drugs and devices, across a wide range of therapeutic and development functional areas, particularly oncology, CNS and orthopaedic and orthodontic devices.