Site Best Practice & Innovations
Industry Leaders Think Tank
29th June 2022, Windsor UK
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Introducing the Co-Founder of GCSA and IAOCR, along with our guest speakers
Jacqueline Johnson North - Co-Founder of IAOCR and GCSA | CEO (IAOCR) Chair (GCSA)
Jacqueline co-founded IAOCR in 2011 with a focus on addressing workforce challenges that effect capacity, quality and risk in clinical trials. Following the joint IAOCR/NIHR industry meeting in 2018 Jacqueline co-founded IAOCR’s sister company, GCSA to deliver a global best practice model for clinical trial site processes.
Jacqueline has extensive experience in fast-moving, innovative companies and start-ups and has also worked for large corporations such as PWC, Wyeth, and Dun & Bradstreet. Prior to IAOCR, Jacqueline worked in leadership and consultancy roles across a variety of sectors including pharmaceuticals, technology, sponsorship, and mining. She has more than twenty years’ experience working in business-focused positions within the clinical research industry and her international experience spans countries as diverse as Argentina, DRC, India, Europe and the USA.
Jacqueline has completed executive education programs “Gateway to Global Growth” at Cass Business School, London and a scholarship program (supported by the Ellis Goodman Foundation) at Kellogg School of Management, Chicago. She is passionate about bringing experts and influencers together to drive positive change locally and globally.
In her spare time, Jacqueline runs a smallholding in Herefordshire with her husband, Simon and twins.
Our guest speakers:
Dr Agnieszka Gackowska* - Senior Director and Global Head, Site Solutions
Dr Agnieszka Gackowska graduated from the Medical University of Warsaw with a diploma of Doctor of Medicine and has over 25 years of experience in the pharmaceutical industry.
Since 2016 she has been associated with the CRO Parexel where she is responsible for leading the Global Site Solutions Team with the mission of partnering with research institutions at a strategic level to make clinical trials accessible to every patient and easier to manage for investigative teams. In addition to this role, she also led Parexel Clinical Feasibility and Site Intelligence Teams. Before joining Parexel, Dr Gackowska served as the Head of the Patient & Site Networks Department in CEE & ME for IQVIA and worked in big pharmaceutical companies, such as GSK and Novo Nordisk in various managing positions in the Marketing and Sales departments.
In addition to her regular job, Dr Gackowska collected her expertise as a non-profit Managing Director of the Haemophilia Foundation in Poland. Throughout her career, she has been involved in the development of educational programs in the field of preventive medicine, vaccines, modern treatments and clinical trials, both for the medical community (doctors and nurses) and patients. She was also the creator of the program and a lecturer at postgraduate studies in the field of clinical trials conducted by the Medical University of Gdańsk, the Medical University of Lublin and the John Paul II Catholic University in Lublin. Currently, she actively cooperates as a member with the following societies: SCRS, GCSA IAOCR and GCP.pl
*Sadly Aga unavoidably had to cancel her attendance at today's event but her colleague, Andrew Boden - Associate Director, Site Alliances, had kindly stepped in and will co-present with Dace Dimza-Jones
Alan Warnes - Independent Clinical Research Consultant and GCSA Global Advisory Board Member
Alan has gained considerable experience working in Academia at Porton Down on gene expression, in Industry as an R&D Manager for a British Diagnostics company generating a positive return after 5 years and for the NHS as an R&D Director supporting clinical trials at a large London NHS Trust.
He has been involved in a number of key initiatives in the clinical studies arena including; developing a patient referral model; a contract and process to transfer NHS patients into Phase 1 Units; development of a Pharmacy training programme (Q3P) with the School of Pharmacy to support pharmacists in obtaining their QP status.
In the clinical trials arena Alan has also been involved in successfully managing a large number of studies including one which had a serious impact at a national level and changed the way drug delivery is implemented in Phase 1 units. Alan is now supporting further developments in clinical studies with the IAOCR by enhancing through accreditation; the workforce, training and processes staff are involved in supporting clinical trials in an NHS environment.
Alistair MacDonald - Advisor to CEO
20+ years experience in the biopharmaceutical industry
Prior to Syneos Health, Alistair served as CEO of INC Research since 2016, leading global operations, driving the company’s global expansion, overall project delivery and implementation of new technologies, processes and solutions
Joined INC Research in 2002 and served in multiple roles including INC’s Head of Global Business Development and Marketing, Head of Alliances Development and Delivery teams, head of Global Oncology, and President of Clinical Development Services
Has held management positions in the pharmaceutical industry across manufacturing, consultancy, business and corporate development, data management, and clinical operations
Master of Science in Environmental Diagnostics, Cranfield University; Bachelor of Science (Honors) in Applied Geology, Plymouth Polytechnic; Diploma Qualification, UK Institute of Directors
Angela O'Connell - Board Member
GCSA and IAOCR
Angela is a co-founder and Executive of GCSA and heads up Innovation and Strategic Partnerships for both IAOCR and GCSA.
Prior to joining the team Angela had operated at board level within Barclays Bank PLC leading transformation of Barclays Financial Services and Barclays Property Business prior to setting up her own international consultancy practice, Michelangelo Partnership in 1996.
Angela has extensive consultancy and international experience in the area of business strategy & organizational design and development. She has worked internationally across a wide variety of sectors including, financial services, property, facilities management, leisure, chemical engineering, retail and education. Examples of clients include PWC, Virgin Media, Unilever, UK Depatment of Education, Royal Institute of British Architects (RIBA), Australian Institute of Architects (AIA), University of Newcastle (NSW), Carillion, Jarvis, Britvic, Bass and Holiday Inn Group.
Angela is passionate about ensuring best practice standards in the industries she has worked and uses her breadth of experience to influence and make a difference, to the Clinical Research Sector. She facilitated and mobilised the development of an the Apprenticeship Program for Clinical Research working with a cross section of Industry Stakeholders. Her knowledge and expertise have been underpinned through education and development at Ashridge Business School and London Business School.
Angela enjoys a full and active life with her husband and twin boys. She enjoys tennis, skiing and sailing, is Governor of a Primary and Secondary schools and stages many local events in her local community.
Colette Donaghy - Accreditation Quality Manager
Colette Donaghy was educated at Queen’s University Belfast where she achieved an Honours degree in Psychology. Colette went on to study Nursing at the Royal Group of Hospitals in Belfast and then returned to Queen’s to complete a Master of Science in Nursing in 1994.
Colette has over thirty years’ experience working in the clinical research industry having started with Upjohn Limited in 1992 as a Clinical Research Associate and progressed through a number of roles in Clinical Research to become a Clinical Programme Lead with Pfizer Inc. until 2009.
In 2009 an opportunity arose for Colette to join Belfast’s local CRO Medevol Limited as their Chief Operating Officer where she was responsible for a diverse portfolio of clinical studies in both primary and secondary care until the group were acquired in December 2013 by the Irish CRO Venn Life Sciences. Colette remained with Venn until 2020 where she led their European Project management group in her role as Clinical Operations Manager.
In 2021 Colette joined IAOCR in the role of Quality Accreditation Manager and is passionate in her role working with Clinical Research professionals to help them attain their international accreditation award.
Dace Dimza-Jones - Industry Facilitator
NIHR Clinical Research Network Greater Manchester
Dace has a public health background and also works as a guest lecturer at Riga Stradins University, Latvia. She is also a board member of the Association of Latvian Diaspora Nurses and Midwifes.
As Industry Facilitator, Dace works in close collaboration with sponsors, CROs, clinicians and academics, as well as other life sciences researchers to support and facilitate opportunities for innovative and ground-breaking research across Greater Manchester. Part of her role requires her to support the delivery of high-quality research studies across 30 clinical areas (e.g. cardiovascular, oncology, diabetes, surgery, emergency, renal, respiratory, public health, primary care) to ensure the people across Greater Manchester have the opportunity to take part in innovative, ground-breaking and life-changing research to improve health and wealth.
Dace is very passionate about inclusive research and, it is important for her to integrate the ethos of inclusiveness across all aspects of my professional and personal life. She is honoured to have the opportunity to play a role in shaping, improving, and fostering a dialogue on fantastic research opportunities across our local underserved participant groups.
Her vision is, that in the future everyone across Greater Manchester, no matter of age, ethnicity, gender and beliefs, will be enabled and keen to participate in our research studies, and will see the value research brings to the local community and beyond.
Dr Emer MacSweeney - CEO & Medical Director
With a determination and passion to provide a solution for the unacceptable problem of dementia, Emer co-founded Re:Cognition Health in 2011.
Emer’s medical knowledge and training in neurosciences, corporate experience, personal credibility and contacts, enabled her to assemble a team of Brain and Mind Experts to create Re:Cognition Health; an internationally recognized expert provider of the best diagnosis, treatment and hope for people with memory loss and other cognitive symptoms.
Focusing, initially on the Global Pandemic, Alzheimer’s Disease (AD) and working closely with providers of sophisticated biomarkers and pharmaceutical sponsor’s R&D to provide new medications; Emer’s team have enabled thousands of individuals to gain early access to novel diagnostic tests and new medications, designed to halt or slow progression of AD, through international clinical trials. This work, for which Emer was awarded an UK “EY Entrepreneur of the Year” award for Societal Impact in 2019 and multiple other awards, continues to grow.
Emer graduated at the University of London and underwent postgraduate training in medicine at the London postgraduate hospitals. Dr MacSweeney trained in radiology at Hammersmith Hospital and neuroradiology at the National Hospital Queen Square. She was appointed as a Consultant Neuroradiologist and later Director of Neuroradiology at Atkinson Morley’s Hospital, St George’s Healthcare Trust, specialising in diagnostic and interventional neuroradiology.
The Re:Cognition Health’s clinics in London, Birmingham, Guildford, Plymouth, Winchester, Bristol and Washington DC USA, are major centres for diagnosis and treatment of brain and mind disorders for patients of all ages; in addition to globally recognized centres for international trials of disease-modifying and new symptomatic drugs, for Alzheimer’s disease and other neurological conditions.
Gary Bradder - Managing Consultant
Gary is a highly experienced consultant and Manager. He has gained extensive knowledge through a mix of learning with a world class market leading lean exponent, then leading and implementing numerous transformation projects through manufacturing, marine, food and Healthcare.
His early experience was with Toyota. With over 25 years in change and process management to draw on, Gary has been involved with and managed projects in numerous sectors and across most aspects of the Healthcare system.
He has been a key member of the GCSA product development team and is now involved in GCSA projects across NHS and commercial sites.
Janelle Bowden - Managing Director & Consultant
Janelle Bowden, PhD, is a scientist by training and a passionate advocate for clinical trials and the patient voice in research and industry. Janelle has worked in and around clinical trial operations since 2000 in both sponsor and site roles, as a consultant, and more recently engaging with patients, carers and advocates. Through her business AccessCR and in her own time, Janelle aims to improve consumer awareness, participation, involvement and experience in clinical research. She recently launched of the concept of CCReW, the Community and Consumer Research Workforce, to recognise and formalise the important stakeholder group that takes part in and is involved in research, and help support, connect and advocate for their needs.
Jayne Goodwin - National Head of Research Delivery for Health & Care Research Wales
NHS R&D Forum
Jayne Goodwin is National Head of Research Delivery for Health and care Research Wales, providing nationwide, operational oversight of research delivery and ensuring a rapid and responsive service for high quality research activities. Jayne is responsible for strategic leadership and development of the research delivery workforce across a range of primary and community, secondary and social care settings.
Jayne leads national Support and Delivery programmes of work on behalf of Health and Care Research Wales and supports Specialty Leads to increase capacity and capability within their therapeutic area nationwide.
Jayne is a Registered General Nurse with a wealth of clinical experience and knowledge having working in the NHS since 1987 and completed MSc studies in Professional Practice and Health and Social Care Leadership and is a PhD student and honorary lecturer at Bangor University, North Wales. Jayne has worked within the NHS clinical research delivery setting since 2000 in various roles supporting the continuous development and improvement of research capability and capacity building in Wales.
Jayne was fortunate to work at the front line of research delivery during the Covid-19 pandemic, for example, embedding Urgent Public Health research in the Wales surge hospitals and the Covid-19 vaccine research delivery programme in Wales. Jayne remains committed to and continues to play a key leadership role in the development of One Wales approaches to ensure the future research delivery capacity and capability in Wales.
Karen Cloete - Quality and Regulatory Head (TASK); Director (TASK Academy)
Karen Cloete obtained her BSC degree in Occupational Therapy at the University of Stellenbosch in 1997 where after she opened her private practice, Boland Therapy and Learning Centre, in Paarl and Malmesbury. South Africa. Karen has worked in clinical research since 2008 and joined TASK Applied Science in 2010, where she instituted the Quality division.
Karen holds the position of Quality and Regulatory Head at TASK Applied Sciences. Leading the two teams, she coordinates and oversees study start-up to site initiation; drafts, evaluates and implements risk analysis and quality management systems, guidelines and company policies; and works closely with all sponsors and various TASK teams to ensure integrity and validity of data across all sites and protocols. She is also the founder / director of TASK Academy which is driven by the mission and vision to “develop tomorrow’s clinical research professional’s today”.
Karen is also currently involved in a joint programme in the Netherlands, Spain, and Portugal to implement training programs and mentoring to support capacity building in clinical trials in Paraguay, South America.
Kristin Croucher - Vice President & Head of Clinical Operations (Europe)
Kristin Croucher is a clinical operations and project management specialist whose experience includes two decades of leading teams and implementing multi-national trial operations. Currently, Kristin is Vice President, Clinical Operations & Delivery at Lightship, a virtual-first and hybrid clinical research organization.
Mohammed Islam - Deputy Head of Healthcare, Healthcare UK
Department of International Trade
Mo currently leads engagement with NHS organisations supporting them to promote their services, skills, and knowledge internationally. Together the team has helped NHS organisations successfully win contracts across the globe - from UAE to Thailand, from educating clinical service staff to providing bespoke consultancy support.
Mo's skills have also seen him work in key Policy, Delivery and Project Management roles across Eu Exit, Defence and Benefit reform.
Sarah Everitt is the Vice President of Operations at IAOCR.
She is passionate about the competence of Clinical Research employees, ensuring skills and knowledge are correctly aligned from a high-quality performance and delivery success perspective to drive and maintain professional standards.
Sarah is an experienced senior leader within the pharmaceutical industry with over 30 years’ working in the Clinical Trials sector for both large pharma and clinical research organisations. She has held varied Global, operational and strategic positions across Clinical Operations, Project Management and Recruitment
As a former nurse, prior to her roles in the pharma industry, Sarah firmly believes that quality and patient safety sits at the heart of Clinical Research.
Soraya Mitchard - Head of Life Sciences, Portfolio Delivery & Strategy Team
Department of International Trade
Soraya leads the Life Sciences Portfolio Delivery and Strategy team, focusing on strategy and programmes to support the Life Sciences sector team’s inward investment and export promotion priorities. The sector team works closely with life sciences trade associations, medtech and biopharma companies and sector stakeholders across government. Our focus is to deliver a portfolio of investment and export offers in biotechnology and pharmaceuticals, communicating international value propositions, and managing top projects/opportunities.
Soraya previously set up the UK Investment Council and led the Board of Trade Secretariat, prior to which as a communications and engagement specialist she has worked with a range of government and public sector clients, including the Department of Health and King’s College Hospital NHS Foundation Trust.
Steve Boam - CEO
Steve is a seasoned Director, Advisor, Lecturer and Author in the field of improvement and transformation.
Steve has worked with some of the biggest household names in industry and over 50 NHS Trusts and Sites in England, as well as within Healthcare systems in Australia, New Zealand, Canada and Singapore, where he has supported the implementation of new process, pathway redesign, service redesign and transformation to improve quality, access and capacity for the patient and cost for the tax payer.
Steve supported the creation and development of the ‘Productive Series’ which was a National programme created to help hospitals and Primary care organisations to improve operations, processes and management and is still used today across the NHS and other countries internationally.
Steve is passionate about helping Healthcare leadership to learn from industry and re-design healthcare provision to be patient focussed and centric.
Dr Suki Balendra - Life Sciences Lead, Imperial College Healthcare NHS Trust; LCRN London North West Core Team
Suki Balendra a senior leader in the NHS with a 20-year background in facilitating, growing, and promoting health research in the U.K. She has substantial, in-depth experience across sectors including industry, academia, NHS, and central government.
She is currently the Life Sciences Lead for the clinical research network in Northwest London. She leads the strategic work with the Life sciences industry in the region. She started her career in the Biotechnology Industry at Abbott Diagnostics Ltd. Within a Good manufacturing practice (GMP) environment she worked on several operational projects to improve efficiency, cost, and reproducibility.
She focused her clinical research career within the Diabetes Research Network (DRN) at Imperial College in a national role. The DRN was in the early stages of development when she joined. She was integral to the setup of the network, from creating and establishing new governance structures to working with the charity sector in creating a patient registry to support recruitment of diabetes studies. As the Industry and portfolio lead at the DRN she had direct responsibility for building and maintaining strategic partnerships with life science companies with exceptional success in bringing more research opportunities in diabetes into the U.K.
In 2018 she was seconded to the Office of Life Sciences within the Department of Business and Industrial Strategy. where she attracted and negotiated new business to increase the UK’s market share of health and care research activity. During the pandemic she provided operational leadership to the NHS covid vaccine research response in Northwest London.
Suki has PhD from the University of Warwick, and she is accredited to black belt in Lean Six Sigma. She is a passionate advocate for UK PLC as the number one destination to conduct clinical trials.
Sunder Chita - Health Service Research Manager
London North West University Healthcare NHS Trust
Sunder works as the Health Service and PPI Manager at London North West University Healthcare Trust and oversees the Quality Assurance, Trust sponsored and academic studies and grant applications. She is passionate about service improvement and delivering the best possible patient experience through research. She is an ardent supporter of turning individual success into team success through inclusivity, collaboration and co-operation with other colleagues, healthcare professionals, community and patients together. She represents North West London as a research champion and chairs a research ethics committee supporting the Health Research Authority. Sunder is a member of the Independent Staff Insight Group and a speak up champion representing the interests of the employees.
Trish Winn - Associate Director Transformation and Research
London North West University Healthcare NHS Trust
An experienced Senior Manager working across transformation and research with extensive knowledge of transformation and research from a whole system perspective. Trish works to develop the strategic, operational and clinical patient pathway programmes within the Trust and across the North West London Sector.
Passionate about the care delivered to patients she has worked with her multidisciplinary team to engage staff in meeting the best of their abilities leading on the Research Departments Staff Engagement programme and Peoples Promise initiative.
She has achieved key clinical operational and strategic priorities in recovering from COVID 19 pandemic including the development of the Clinical Trials Facility at Northwick Park Hospital leading to fast turn over of vaccine trails, and paediatric commercial trials. She has worked innovatively with commercial research teams to understand real world research and the impact on transforming patient care.
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