About C3 Summit
Join your industry peers for Conversations on Clinical Content, C3 Summit. Panels of pharma, biotech, CRO, and regulatory thought leaders will explore patient diversity, centricity, and outcome assessments, discussing challenges, opportunities, and strategies through the lens of real-world experience. Take away practical insights and participate in a discussion during the Q&A and post-event cocktail hour.
Speakers
Agenda
1:00 – 1:30
Welcome & Check-In
1:30 – 2:00
The Shifting Paradigm: Clinical Insights in Digital Health
Mark Wade
Global Practice Leader
TransPerfect Life Sciences
Mark P. Wade holds the position of Global Practice Leader at TransPerfect Life Sciences the largest Language translation company globally, where he is the resident SME for all clinical trial processes and translation. Mr. Wade’s 20 years in Life Sciences includes International Regional Director for EMEA at Ethicon and Ethicon Endo Surgery, Johnson & Johnson companies (NYSE: JNJ). For almost ten years Mr. Wade was Global Practice Leader at another global language translation company. He is a published expert in Electronic Clinical Outcomes Assessments (eCOA) including two eBooks, Clinical Posters and numerous articles in trade journals. He has significant experience and has published in Clinical Services, Patient Recruitment and Site Selection. Mr. Wade has Chaired, presented and published Posters at DIA Annual Symposia and numerous other internationally recognized conferences. He is an active committee member of ISOQOL Translation & Cultural adaptation (TCA) Special Interest Group (SIG), ISPOR TCA SIG and DIA Endpoint Study Group.
Michelle Bridenbaker
Global Lead Medical Information & Communications
Michelle is an accomplished and success-oriented senior leader with extensive international experience operationalising and digitally transforming many aspects of medical/scientific affairs and customer engagement across pharmaceutical & biotech companies.
Sridevi Nagarajan
Head, Digital Regulatory Strategy
AstraZeneca UK Ltd
Sridevi is the Head of Digital Regulatory Strategy at AstraZeneca. Her background includes a Ph.D. in biochemistry and a master’s in bioinformatics. She is a senior strategic data-driven portfolio management professional with 20 years of experience in leading and delivering successful digital transformation outcomes across pharmaceutical and public health sectors.
Roberta Pandolfi
Head of Digital
Roberta is Head of Digital, Global Strategy & Execution with experience in digital health focused on neuroscience. She has strong interpersonal skills and is oriented to action. She has worked on the most innovative digital solutions for HCPs, patients, R&D and RWE. Roberta is a Management Engineer (Politecnico di Milano and Concordia University Montreal) and has spent a relevant part of her brilliant career working for top technology and innovations consulting firms such as Accenture and tech giants such as Microsoft. She has wide experience in M&A programmes, digital transformation journeys and international projects. Additionally, she has significant interest and expertise in new technologies – cloud, artificial intelligence, IoT, alternative reality and machine learning.
2:00 – 2:30
Patient Recruitment and Inclusivity – Engagement Strategies for Diversity and Accessibility
Leanne Woehlke
Director of Life Sciences Solutions
TransPerfect Life Sciences
Leanne Woehlke is a Director of Life Sciences Solutions at TransPerfect where she helps clients create transformational impact with language, technology and business consulting solutions. She has extensive experience in clinical research, starting her career as a CRA then working her way up to Director before consulting in patient recruitment and process optimization. She has successfully enrolled patients in some of the most difficult studies, including achieving pediatric patent extension. Her knowledge of digital marketing coupled with her extensive coaching background allow her to bring a unique perspective to patient recruitment and engagement. She is passionate about impacting the industry in meaningful ways and bringing life changing treatments to patients who need them.
Dr. Lorna Pender
Global Patient Engagement Lead
Clinigen
Dr. Lorna Pender is the Global Patient Engagement Lead with Clinigen, a pharmaceutical services company with a specialty in offering industry clients expertise and early access to medicines programmes to ensure patients around the world have access to cutting-edge medicines.
Sevtap Rowland
Director of Clinical Operations
4MCS
Director of Clinical Operations at 4MCS, Sevtap’s mission is to accelerate the clinical development process by designing and implementing innovative and adaptive platform trials across all therapeutics areas. Her clinical research career spans more than 13 years and has included programme management, project management and monitoring services (Phases I–IV) for global pharmaceutical companies, biotech companies, CROs and clinical trial units. Sevtap’s experience and skills include forming and maintaining strategic collaborations, leading and developing site operational services, leading transformational change within medium and large organizations to meet strategic goals, global strategic account management and supporting growth and increased operational efficiency. She is passionate about transforming clinical trials for inclusivity. Sevtap is a natural leader who is passionate about giving hope and improving the lives of patients around the world.
Diane Chisholm
Senior Director
Blue Earth Diagnostics Ltd.
Diane Chisholm is a Senior Director at Blue Earth Diagnostics Ltd, a radiopharmaceutical company. She is passionately interested in improving the relevance of clinical trials for patients whilst providing much-needed data for registration purposes.
Naomi Litchfield
Director, Patient Advocacy
Bionical Emas
Naomi has extensive experience working in clinical research and with patient advocacy communities. As Director of Patient Advocacy at Bionical Emas, Naomi’s role is fundamental to the company’s mission of bringing life-changing medicines to patients around the world. Naomi and her team focus on ensuring the patient voice is always represented, creating a positive patient journey and reducing burden where possible when designing Bionical Emas’ clinical trials (CTs) or early access programmes (EAPs). Naomi is accountable for all internal and external advocacy activities and fosters the company’s thought leadership in patient centricity by partnering with global patient organisations.
2:30 – 2:40
Break
2:40 – 3:10
Patient Recruitment and Inclusivity – The Patient Perspective
Leanne Woehlke
Director of Life Sciences Solutions
TransPerfect Life Sciences
Leanne Woehlke is a Director of Life Sciences Solutions at TransPerfect where she helps clients create transformational impact with language, technology and business consulting solutions. She has extensive experience in clinical research, starting her career as a CRA then working her way up to Director before consulting in patient recruitment and process optimization. She has successfully enrolled patients in some of the most difficult studies, including achieving pediatric patent extension. Her knowledge of digital marketing coupled with her extensive coaching background allow her to bring a unique perspective to patient recruitment and engagement. She is passionate about impacting the industry in meaningful ways and bringing life changing treatments to patients who need them.
Carole Scrafton
Patient Advocate and Director, Co-founder of a Non-Profit Patient Organisation
Flutters and Strutters Patient Advocacy Organisation
Carole established the FibroFlutters Patient Advocacy Organisation for chronic/rare illnesses, a patient-driven and focused patient-advocacy organisation that is for everyone, #notjustpatients. FibroFlutters connects different stakeholders from across the industry and helps to develop, nurture and advocate for multidisciplinary/multi-stakeholder approaches to all aspects of medical healthcare so that chronic illness & rare disease patients can receive the type of care and treatments they need. FibroFlutters also supports disease education and awareness through better medical and health communications. Carole is a patient with a chronic illness and genetic disorder, rare gene mutations and rare bone anomalies. She campaigns and advocates at many levels, including patient forums, and takes part in many global conferences, both in person and remotely. She encourages more efficient patient engagement practises with a view to the better development of therapies and treatments within the pharma, medical and clinical environments.
3:10 – 3:40
Beyond Data Points: Harnessing the Potential of eCOA Technology to Empower the Patient Voice
Mark Wade
Global Practice Leader
TransPerfect Life Sciences
Mark P. Wade holds the position of Global Practice Leader at TransPerfect Life Sciences the largest Language translation company globally, where he is the resident SME for all clinical trial processes and translation. Mr. Wade’s 20 years in Life Sciences includes International Regional Director for EMEA at Ethicon and Ethicon Endo Surgery, Johnson & Johnson companies (NYSE: JNJ). For almost ten years Mr. Wade was Global Practice Leader at another global language translation company. He is a published expert in Electronic Clinical Outcomes Assessments (eCOA) including two eBooks, Clinical Posters and numerous articles in trade journals. He has significant experience and has published in Clinical Services, Patient Recruitment and Site Selection. Mr. Wade has Chaired, presented and published Posters at DIA Annual Symposia and numerous other internationally recognized conferences. He is an active committee member of ISOQOL Translation & Cultural adaptation (TCA) Special Interest Group (SIG), ISPOR TCA SIG and DIA Endpoint Study Group.
Bill Byrom
Principal, eCOA Science
Signant Health
Bill serves as Vice President at Signant Health, a global eClinical solution and eCOA provider. He has worked in the pharmaceutical industry for 30 years and is a recognised leader in eClinical product strategy, eCOA and decentralised trials. Bill is the author of more than 70 publications and two industry textbooks on ePRO. He is an active member of the eCOA Consortium and two ISPOR task forces and is a visiting professor within Nottingham Trent University’s Medical Engineering Design Research Group.
Andrew Lloyd
Company Director
Acaster Lloyd Consulting Ltd
Andrew Lloyd is co-founder and Director of Acaster Lloyd Consulting Ltd (ALC). His background is in patient-reported outcomes research with a focus on HTA. ALC provide COA/PRO consulting services to the industry with a group based in London. Andrew is also an Honorary Professor at the London School of Hygiene and Tropical Medicine. He is a former co-editor of Value in Health. He is also active in the EuroQol Group, where he sits on the Board.
Chris Frost
Chief Operations Officer
Aparito
Aparito digitises clinical trials and unlocks real-world data through mobile apps, video assessments and wearable devices. Chris is responsible for delivering Aparito’s objectives and the continuous evolution of our flagship product, Atom5TM. Chris has a passion for developing innovative digital outcome measures and, as such, has been responsible for the delivery of more than 1,000 eCOA tools and co-authored several papers during his time at Aparito.
Monica Hadi
Senior Director
Evidera
Monica Hadi, Ph.D., is a Senior Director and Research Scientist with the Patient-Centered Research group at Evidera, based in London. Dr. Hadi is a scientist with more than 15 years of experience in the patient-centered outcomes field. She has extensive experience in the development and validation of clinical outcome assessments (COAs) and the design and implementation of COA endpoint strategies in clinical development programmes. She also has specific expertise in real-world data studies and registry study design. Monica holds a Ph.D. in evidence-based medicine and health outcomes from The University of Oxford and an MSc in health psychology from University College London.
3:40 – 4:25
EU Clinical Trial Regulation: Operational Considerations and Impacts
Pierre-Frédéric Omnes
Executive Director at TransPerfect Life Sciences
TransPerfect
Pierre-Frédéric Omnes, Executive Director at TransPerfect Life Sciences, has over 20 years of experience in global CROs and pharma companies as a regulatory affairs consultant overseeing numerous multinational clinical trial applications globally. Pierre is a subject-matter expert on site startup and regulatory operations in global clinical trials as well as on the EU Clinical Trial Regulation 536/2014 (EU CTR) for corporate readiness, implementation and Clinical Trial Information System. Pierre is part of the EMA-led initiative developing the EU Clinical Trial Information System (CTIS) as Lead Product Owner representing the Industry & Academia since 2019, continuing an engagement of several years in user acceptance testings, workshops and analysis & design sessions related to CTIS development and optimization.
Mircea Ciuca
Therapeutic Area Head, Clinical Safety and Pharmacovigilance
Mircea Ciuca, MD, is currently Global Therapeutic Area Head (Respiratory & Transplant) in Clinical Safety and Pharmacovigilance. He has led a team of safety physicians involved in all aspects of pharmacovigilance, in both development and post-marketing settings.
Gabriella Di Matteo
Director, Clinical Trial Regulatory Operations Team Manager
Pfizer, Global Regulatory Sciences
Gabriella Di Matteo has been working in early clinical research and regulatory submissions for more than 25 years and has participated in the evolution from pre-CTD to CTR implementation. She also manages clinical trial submissions managers who submit trials in Europe and in CTIS. She is a member of Pfizer workstreams implementing EU CTR and a tester of the portal since UAT 1 in early 2016. She has also been a member of Sponsor PO group since 2019.
Ana-Zeralda Canals Hamann
Senior Clinical Trial Supplies Manager
Debiopharm International S.A.
Ana has been in the pharmaceutical industry for the past 15 years working for small-to-medium biotech and pharmaceutical companies. She is currently in clinical trial supplies but has experience in CMC, clinical operations, project management, regulatory and preclinical. She has been at Debiopharm for the past 3.5 years, where drug development is mainly in oncology and bacterial infections.
Flavia Pirovano
Clinical Research Associate
Fern Valley
As a philosophy and biomedical ethics graduate, Flavia realised that she really liked the world of clinical trials, so she started to work at the European Society of Anaesthesiology. Flavia then moved to Pauwels Consulting as a consultant for Johnson & Johnson in a clinical study administrator role, and is now working at Fern Valley as a consultant for Johnson & Johnson as a Clinical Research Associate. She loves the diversity of the work and the support provided by Fern Valley for every new challenge she wants to take on. She is currently also completing a master’s in clinical research and medical affairs at Università Guglielmo Marconi.
4:25 – 4:30
Closing Remarks
4:30 – 6:00
Cocktail Reception
FAQs
Is this event free?
Yes, there is no registration fee associated with this event. However, spots are limited and you will receive a confirmation email once your seat is confirmed.
Will travel and hotel be provided?
No, TransPerfect will not be covering any travel or hotel costs incurred to attend the event.
Who is the event for?
C3 Summit is geared toward executives, directors, and senior managers within Pharma, Medical Device, Biotech, and Contract Research Organizations. Spaces are limited and will be prioritized accordingly, therefore eligibility is subject to approval by the TransPerfect Life Sciences team.
Will I receive a Certificate of Attendance?
All attendees joining the TMF track of the London C3 Summit may request a training certificate. This certificate verifies your attendance and participation in intensive TMF workshops, trainings, and educational discussions that both reinforce and expand on your knowledge of TMF management and successful TMF health and inspection readiness strategies. While not an accredited certification, you can share your certification with relevant parties in your organization as proof of your commitment to ongoing education and excellence. You will be better positioned to support your organization’s efforts towards creating a culture of inspection readiness that can improve quality, reduce risks, and expedite timelines.
