Outsourcing in Clinical Trials UK and Ireland 2023

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Session Details: Best practice for working efficiently and successfully with your CRO 14-06-2022, 12:30 pm View In Agenda

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Session Details: PANEL DISCUSSION: Is decentralisation the future for clinical trials in the UK and Ireland? 14-06-2022, 11:30 am CASE STUDY: Designing a decentralised trial in the UK: learnings and outcomes 14-06-2022, 2:30 pm View In Agenda

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Session Details: PANEL DISCUSSION: Is decentralisation the future for clinical trials in the UK and Ireland? 14-06-2022, 11:30 am Chairperson’s closing remarks 15-06-2022, 5:00 pm View In Agenda

Biography: Barbara is Director, Quality and Risk Management, at GSK. This includes ensuring GSK’s global processes, procedures and training meet current and future regulatory requirements and GCP, and supporting GCP inspection readiness. She has recently taken on responsibility for quality at GSK’s phase 1 unit and for Human Biological Sample Management within clinical trials. Barbara has a PhD in Physiology and Pharmacology from the University of Nottingham. She started in clinical research 25 years ago as a Clinical Research Associate, subsequently working in clinical trial management, training, and various quality roles, for pharmaceutical companies including GSK and Roche. She is a visiting lecturer at Kings College London and an Honorary Fellow of the Institute of Clinical Research.

Session Details: PANEL DISCUSSION: Assessing the impact of the evolving political and economic landscape on running clinical trials in the UK and Ireland 15-06-2022, 10:00 am View In Agenda

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Session Details: Finding CROs and partners as a small to medium sized company: challenges and considerations 15-06-2022, 12:30 pm View In Agenda

Biography: Dr Martin O'Kane MRPharmS is Unit Manager of the Clinical Trials Unit in the Licensing Division of the Medicines and Healthcare products Regulatory Agency (MHRA).  He studied pharmacy at University of Aston and after completing a PhD in pharmacology and post-doctorate neuroscience research project at the University of Glasgow, moved to Japan to work within the pharmaceutical industry. He joined the MHRA in 2005 as a Pharmacopoeial Scientist within the British Pharmacopoeia and moved to the MHRA Clinical Trials Unit as a Pharmaceutical Assessor in 2007.  He became Unit Manager of the Clinical Trials Unit in November 2015 and has been actively involved in development of new clinical trials policy, systems and procedures and well as the UKs exit from the EU. Most recently he has been involved in supporting expedited approval of, and guidance for, clinical trials for COVID-19 vaccines and therapeutics and supporting the recovery and resilience of non-COVID trials.

Session Details: OPENING KEYNOTE FROM THE MHRA: An overview of the MHRA’s consultation on new clinical trial legislation 14-06-2022, 9:00 am View In Agenda

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Session Details: CASE STUDY: Benefits and challenges of remote monitoring in decentralised clinical trials 14-06-2022, 3:30 pm View In Agenda

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Session Details: PANEL DISCUSSION: Assessing the impact of the evolving political and economic landscape on running clinical trials in the UK and Ireland 15-06-2022, 10:00 am View In Agenda

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Session Details: Orphan drug designation in the UK and Europe: understanding regulations for orphan status and accelerated timelines 14-06-2022, 10:00 am PANEL DISCUSSION: Is decentralisation the future for clinical trials in the UK and Ireland? 14-06-2022, 11:30 am View In Agenda

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Eve has a varied background within clinical research, starting her career as a Pharmacy Technician at Guys & St. Thomas’s Hospital London where she developed a passion for clinical research. Whilst working in pharmacy and studying towards a MSc in Clinical Research, Eve started her CRA career in a non-commercial environment. Over the years Eve has moved across to work within a commercial CRO with various clients before specialising in Rare Diseases with Orphan Reach over the last 6 years.

Eve’s current role as a Project Director allows her to provide guidance and support for clients with programs of studies, mentoring junior staff and managing her own studies

Session Details: Feasibility and site selection for rare disease studies in the UK 15-06-2022, 9:30 am View In Agenda

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Session Details: CASE STUDY: Setting up a clinical trial from the perspective of a small biotech: challenges and lessons learned 14-06-2022, 2:30 pm View In Agenda

Biography: Dalila has been in the pharma industry for over 20 years. During the last 13 years, she’s been working mainly with biotech companies where projects were outsourced to vendors. She grew and developed over the years, and she learned fundamental skills in managing projects and more importantly people, without whom there would be no projects. Dalila believes that being a great Manager, whether managing projects or being the CEO of a company, stems from 1) leading people to grow and develop their strengths, recognise their weaknesses and strive to improve them and show up in their best version every single day, 2) empowering those around them so they feel responsible, driven and motivated to contribute in their project and/ or company’s mission 3) offering a safe and understanding environment supported by a coaching culture where people matter more than metrics. Therefore, Dalila has focused on teams’ dynamic which led her to coaching. She understood the importance of executive and corporate coaching and how companies could benefit from it, be it within a project team, a department or across the board. Today, Dalila works part-time in the pharma industry and part-time in the coaching industry. The combination of these two roles gives her a tremendous drive to bring or increase awareness around the importance of people in projects or companies. Her mission is to help companies transform their managers into leaders, their management into a coaching and supportive culture whilst delivering successful projects and reaching their highest growth.

Session Details: How can leadership contribute to outsourcing clinical trials? 15-06-2022, 11:30 am View In Agenda

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Session Details: Working with vendors and CROs: tips on fostering a strong relationship in the wake of the pandemic 14-06-2022, 3:30 pm View In Agenda

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Session Details: All about them: how we manage our suppliers 15-06-2022, 9:00 am View In Agenda

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Session Details: Innovating your recruitment campaign to ensure diversity in your trial participants 14-06-2022, 11:30 am View In Agenda

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Session Details: CASE STUDY: Innovation in clinical trials and leveraging technology to improve patient involvement and engagement 14-06-2022, 12:30 pm View In Agenda

Biography: have over 30 years of experience in the global pharmaceutical and biological industry and in healthcare IT, both at the helm of operations (from business unit head to general manager and CEO) and in marketing and commercial positions (from product marketing at country level to global marketing strategy). Through these local and global positions, I have acquired direct experience with blockbuster products in diverse markets (primary care, specialty care, hospital, vaccines, and biotechnology), geographies (US, Europe, Japan, China, India, Emerging Markets) and organizations.

Session Details: Commercialising your product: what do you need to know now to be ready 14-06-2022, 4:30 pm View In Agenda

Biography: More than 25 years of clinical research experience at biopharmaceutical companies and contract research, software, and service organizations leading technical teams following comprehensive regulatory requirements. Leadership and strategic planning of YPrime's Customer Experience and Data Science global teams including leadership of YPrime's Global Information Technology organization. With the goal of continuous improvement, Customer Experience includes our Customer Care, Customer Success, and Logistics functions. YPrime's Data Science organization brings together our Data Management, Data Science, and Technical Delivery functions to create greater synergies for our customers

Session Details: Begin with the end in mind: best practices for high-quality eCOA data when collaborating with CROs and vendors 15-06-2022, 2:30 pm View In Agenda

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Session Details: Trends in new drug approvals and clinical trials 15-06-2022, 3:00 pm View In Agenda

Biography: Experienced clinical operations professional with proven successful delivery of complex local and global studies as well as accountability for an extensive portfolio of studies (phase I-IV) in the Pharmaceutical industry. Experience in heading up large departments (over 100 staff). Is recognised for being an insightful, reliable, trusted and resilient leader. Has held a number of roles with increasing seniority within three different pharma companies. Extensive vendor selection and top ten CRO oversight experience. Trusted team leader on cross functional matrix teams and multiple governance committees. Sound financial acumen, with accountability for budgets at study and portfolio level. Thirteen yrs experience in coaching and line management (including second line management). Recent therapeutic area focus has been in Rare Diseases, particularly gMG. Previous experience in the areas of cardiology, diabetes, RA and Neuroscience as well as infectious diseases, ophthalmology and breast cancer.

Session Details: PANEL DISCUSSION: Assessing the impact of the evolving political and economic landscape on running clinical trials in the UK and Ireland 15-06-2022, 10:00 am View In Agenda

Biography: Chris has over 27 years experience in product and service development within regulated industries across multiple markets. The last 13+ years have focused on Clinical technologies; including tools and platforms to, engage, educate and retain participants (and their families) in clinical studies. Chris is a recognised subject matter expert in eCOA and patient engagement, with a proven ability in the technical domain. Chris believes in the utilisation of technology for the benefit of all and is a proponent of change, so that our industry is able to support the globalisation of clinical research, which supports diverse participant populations.

Session Details: Building a patient-focused eCOA strategy: insights and best practices 14-06-2022, 1:00 pm View In Agenda

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Cameron has a diverse background in Software as a Service, and specifically in creating and championing solutions that engage a wide range of participants, such as clinicians, patients, data managers and sponsors. Cameron’s experience includes SaaS / Cloud, Imaging, Simulations, Analytics, Data Integration, Risk and  Compliance Management, Training, and Patient Advocacy.

Session Details: Now is the time to embrace the future of hybrid trials 14-06-2022, 12:00 pm View In Agenda

Biography: Peter MacLennan, TCRS CEO, is an experienced professional with a track record of success in academia, pharma, biotech and CROs. He has in-depth knowledge of clinical development with an emphasis on risk management, project governance, metrics, and budgeting. With his TCRS colleagues, his task is to ensure that our clients’ objectives are delivered on time, on budget and to the highest standards of quality.

Session Details: Pre and post-COVID: what has changed in the clinical research landscape? 14-06-2022, 10:30 am View In Agenda

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Session Details: Pre and post-COVID: what has changed in the clinical research landscape? 14-06-2022, 10:30 am View In Agenda

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Neta Bendelac, 4G Clinical Senior Director of Strategy, has over 10 years of experience in Clinical Supply Chain Management. She headed the Clinical Supply Chain department at Teva Pharmaceuticals, where she established new and innovative approaches to managing IMPs in clinical trials, designing them with a highly acclaimed and unique patient perspective. Prior to Teva, Neta worked as an international Supply Chain consultant, providing simulations and optimization tools to clients worldwide. Neta holds a BS in Industrial Engineering  and a Master of Business Administration (MBA) from Tel Aviv University, Israel. Neta is always focused on execution, finding joy in creative solutions to help patients around the world.

Session Details: Modern track and trace strategies: decreasing burden and improving supply chain oversight 14-06-2022, 3:00 pm View In Agenda

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Session Details: Innovative technologies for forecasting patient recruitment and event counts 15-06-2022, 2:00 pm View In Agenda

Biography: Farooq Hussain is the Regional Director Europe for Avantor Clinical Services.  Working with customers across the region to improve their clinical trial effectiveness and efficiencies, through providing scalable, end-to-end service capabilities, including biorepository and sample management, custom kitting, and clinical trial equipment & ancillary solutions.  Farooq has over two decades of experience in the pharmaceutical sector, both for pharma companies in a variety of commercial roles as well as working for service providers to the industry. He earned his BSc in Biological Sciences from Nottingham Trent University.

Session Details: How will the supply chain need to adapt to support the growth of decentralised clinical trials? 14-06-2022, 3:00 pm View In Agenda

Biography: Joan is a transformation and service excellence oriented executive with 19+ years’ experience in delivering technology innovation and leading tech-enabled services teams across healthcare and clinical sectors. During his 16 years at Calyx, he has had several roles across eClinical Technology R&D and Professional Services. He is currently leading the global IRT and EDC solutions and services teams. Joan’s experience and background have driven his pursuit to find innovative ways to maximize the value Calyx’s products and services delivered to help bring new medical treatments to market faster.

Session Details: Meeting regulatory expectations on IRT data ownership 15-06-2022, 10:30 am View In Agenda

Biography: Achilleas Zaras heads the Solutions Consulting team at eClinical solutions; he has over 15 years of experience in the software industry in various capacities including software demonstrations, managing a team of 15+ developers, hands-on coding on Microsoft’s .NET platform and QlikSense. Achilleas has enjoyed a progressive career in diverse roles such as Solutions Consultant, Team Manager, Software Engineer and Business Intelligence Analyst across various industries including Banking, Retail and now the Pharmaceutical industry.

Session Details: Data-driven operations and oversight with elluminate 14-06-2022, 1:00 pm View In Agenda

Biography: Heike is the Shareholder and Co-Founder of Lumis International, Lumis Life Science Consulting and the newly founded UK branch Lumis International Limited. She has more than 25 years of experience in leadership positions in international clinical research and drug development. She has profound knowledge of the clinical drug development processes and regulatory requirements from first in human to market access. She is experienced in developing strategies and concepts for biopharmaceutical and medical device companies covering clinical operations, clinical research, outsourcing, vendor management and oversight management.

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Biography: Dr Florence Mowlem is Medable’s Subject Matter Expert on digitising the capture of Clinical Outcome Assessments (COAs) in clinical trials, ensuring optimal solutions for clients that meet the scientific needs of their studies. She contributes expertise on solution design for all eCOA types (ePROs, eClinROs, eObsROs, ePerfOs, eDiaries) and advises around project complexities, to ensure adherence with the protocol requirements, that industry best practices are followed, and regulatory considerations accounted for. Flo is an active member of industry consortium (C-PATH eCOA, DIA), has presented at international conferences, and has numerous peer-reviewed publications. Flo has an MSc and PhD in Social, Genetic, & Developmental Psychiatry from the Institute of Psychiatry, Psychology, & Neuroscience (King’s College London), where her research focused on sex differences in the diagnosis and treatment of Attention Deficit Hyperactivity Disorder (ADHD), and the psychometric evaluation and validation of a new patient-reported measure for use in adult ADHD.

Session Details: Increasing adoption of Bring-Your-Own-Device (BYOD) 14-06-2022, 12:00 pm View In Agenda

Biography: Paul O’Donohoe is Scientific Lead, eCOA and Mobile Health at Medidata Solutions, a clinical software platform provider. He is responsible for developing the company’s scientific expertise for electronic clinical outcome assessments and mobile health, and is responsible for ensuring internal teams, partners and Sponsors are following industry, regulatory and scientific best practices when it comes to integrating technology into clinical trials. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and is currently the Industry Vice-Director of the C-Path ePRO Consortium. Previously, Paul worked as a research psychologist at a child and adolescent mental health clinic based in Dublin, Ireland. He moved into the health consulting field with United BioSource Corporation where he worked across the health outcomes, health economics and health data capture groups. Prior to Medidata, Paul was Director of Health Outcomes at CRF Health, an eCOA provider, where he led their health outcomes team. He has a MSc in Cognitive and Clinical Neuroscience.

Session Details: Empowering patients through next generation eCOA technology 14-06-2022, 9:30 am View In Agenda

Biography: Senior Business Development from Novotech with over 16 years of experience in the service provider industry. He is passionate about driving collaborative efforts to improve patient accessibility and diversity in clinical trials. He believes this can be achieved by the convergence of science and technology.

Session Details: The diversity of Asia: what makes this region, particularly China, a preferred destination for clinical trials 14-06-2022, 5:00 pm View In Agenda

Biography: Daniela Duffett is the European Solutions Consultant at Suvoda, based out of our Barcelona office. She consults with clients and prospects, delivering presentations and demonstrations, while acting as a Subject Matter Expert on Suvoda’s solutions. She started at Suvoda three years ago on the Project Management side of our Services Delivery organisation, so can impart her hands-on delivery experience & knowledge.  

Session Details: Leveraging the power of supply chain technology 15-06-2022, 12:00 pm View In Agenda

Biography: Sean Smith is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Agro/Bio-Terrorism Countermeasures. As a BTEC, Mr. Smith is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S. Mr. Smith joined CBP in 2005 as an Agriculture Specialist (CBPAS) and was promoted to Supervisory CBPAS in 2008. He has served CBP in the following ports of entry: San Diego, San Ysidro, Otay Mesa and Boston Logan Airport. From 2011- 2018, Mr. Smith served as the primary Public Affairs Liaison and Border Community Liaison, respectively, for CBP in New England. He has also volunteered to assist in past domestic and international CBP disaster recovery operations, including: Hurricane Ike (2008), 'Operation Safe Return' (Haitian Relief Effort- 2010), and Hurricane Harvey, DHS Surge Capacity Force (2017). Prior to CBP, Mr. Smith contributed to wildlife conservation for nearly a decade, completing field work on rare endemic Hawaiian birds on the Big Island of Hawaii, and raising rare and endangered birds (in some cases, extinct in the wild) at the San Diego Zoo's Avian Propagation Center. Also, Mr. Smith is a former reserve firefighter and EMT for the City of Borrego Springs in California. He holds a Bachelor of Science degree in Ecology and Systematic Biology from Cal Poly San Luis Obispo, California. Mr. Smith, his wife, two children, one dog, and one chicken live in an old farmhouse in Massachusetts.

Session Details: Getting your pharmaceutical products seamlessly into the US: what you need to know 14-06-2022, 4:30 pm View In Agenda