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Outsourcing in Clinical Trials UK and Ireland 2023

We are delighted to welcome you again to Outsourcing in Clinical Trials UK and Ireland.

5 - 6

September

2023

Hilton Park Lane, London
Complimentary

Why attend?
2022 Agenda
2022 Speakers
Plan Your Visit
Event Gallery
Sponsors
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Register

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REYNALD CASTAÑEDA

Clinical Trials Editor, Clinical Trials Arena, GlobalData

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Medidata is leading the digital transformation of life science, with the world’s most used platform for clinical development, commercial, and real-world data. Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/

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To learn more , please visit our website - https://www.medidata.com/

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Novotech is an Australia based clinical CRO operating across Asia and South Africa. Headquartered in Sydney since 1996, Novotech has come to be recognised as the CRO of choice for many US and European biotechnology firms in the Asia Pacific. Our full service offering includes clinical program management, biometrics services and regulatory affairs.

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To learn more , please visit our website - http://www.novotech-cro.com/

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Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and more than 25 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.

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To learn more , please visit our website - https://www.calyx.ai

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At Merative, we’re building a more connected future in health. One where organizations can see the whole picture – and its pieces – at the highest levels of privacy and security.  We’ve been at the forefront of health innovation for nearly 50 years, pioneering the use of cloud, real-world data and industry-leading AI. Our name is new – but our trailblazing spirit isn’t. Our team spans the entire health industry and has decades of experience. We get the importance of knowing what it’s like to walk in your shoes – and having a partner who’s with you every step of the way.

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To learn more , please visit our website - merative.com

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To learn more , please visit our website - www.tcr-solutions.com

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Founded in 2015 Teckro provides solutions to simplify and modernize clinical research for leading pharmaceutical and emerging biotech companies. To date, Teckro manages more than 100 clinical trials and is used by more than 11,800 active study sites around the world. Teckro employs more than 100 staff across its global headquarters in Limerick, Ireland, engineering excellence hub in Dublin, Ireland and its US-based office in Nashville, Tennessee. Visit www.teckro.com for more information.

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To learn more , please visit our website - http://www.teckro.com/

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Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. We are known for our superior statistical leadership and data management expertise and proud to have supported thousands of studies across a diverse range of diseases. For more than 40 years, Emmes has been dedicated to research for a healthier world.

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To learn more , please visit our website - www.emmes.com

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THREAD is a leading provider of a proprietary, decentralized research platform and suite of supporting services used by biopharma, CROs and life science organizations to remotely capture data from participants and sites during, in-between and in lieu of in-clinic visits. THREAD’s platform and supporting services are helping customers to shorten study launch timelines, reduce study budgets with Virtual Visits, and bring studies from the clinic to patients’ homes. THREAD provides key platform features such as eConsent, eCOA/ePRO, sensors, reminders, and telehealth Virtual Visits to support remote data capture, hybrid virtual studies, and fully decentralized studies in key therapeutic areas. In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners.

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To learn more , please visit our website - https://www.threadresearch.com/

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Viedoc designs engaging software for the life science industry. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. www.viedoc.com

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To learn more , please visit our website - www.viedoc.com

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YPrime’s cloud-based technology streamlines clinical trial data collection and management. Electronic clinical outcome assessments (eCOA) and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone.

We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. We’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster.

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To learn more , please visit our website - http://www.yprime.com/

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eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. The elluminate® Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. elluminate software and data driven services have been used by more than 100 life sciences companies on over 500 clinical trials to reduce cycle time and improve data quality. For more information, visit www.eclinicalsol.com, or contact us at info@clinicalsol.com.

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To learn more , please visit our website - www.eclinicalsol.com

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4MCS is an independent SMO (clinical research study site) with its Headquarters based in Greater Manchester. 4MCS has access to over 20,000 patients based on prescription data. Our strong links with General Practitioners, Pharmacists and Dentists in Greater Manchester allows us to identify and approach an additional 40,000 potential study participants in a shorter timeframe than under normal circumstances.

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To learn more , please visit our website - http://4mcs.co.uk/

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ACM Global Laboratories is one of the largest global independent central labs in the industry. ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. ACM performs more than 20 million laboratory tests each year—spanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more.

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To learn more , please visit our website - www.ACMGlobalLab.com

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The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

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To learn more , please visit our website - https://www.almacgroup.com

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Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, data management and more, all of which can be tailored to specific sponsor requirements. Altasciences… helping sponsors get better drugs to the people who need them, faster.

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To learn more , please visit our website - http://www.altasciences.com/

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B. Braun specialises in manufacturing market leading infusion therapy products, many of which are supplied into clinical trials. With presence in over 64 countries around the world, we work closely with our partners to select solutions that fit with the individual clinical trial requirements.

For more information, please visit:

Company Website

To learn more , please visit our website - bbraun.co.uk/en/products-and-therapies/bbraun-industrial-business.html

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To learn more , please visit our website - https://www.boostcode.eu

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To learn more , please visit our website - www.bsi-lifesciences.com

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BTH Recruitment are a boutique headhunting firm specialising in the Pharmaceutical and Clinical industry. Our core business focuses on small-medium sized life sciences businesses, sourcing and securing the highest calibre individuals in the market (i.e. you!). We pride ourselves on the consultative approach we take, supporting you to find the best next step for your career. Our friendly and professional approach is complimented by our in-depth industry knowledge and experience.

Company Website

To learn more , please visit our website - www.bthrecruitment.com

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Choice Health are a UK Imaging Diagnostics company specialising in Research and Clinical Trials. We connect medical imaging and consultants to Pharma, CRO and research clients globally. We work closely with the NHS, biotech vendors, and our network of 80+ highly specialised medical consultants to specifically focus on your clinical trials and medical research workload. Boost capacity, avoid delays, and ensure accuracy with our Imaging experts at Choice Health

Company Website

To learn more , please visit our website - www.choice.health

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Why attend?

We are delighted to welcome you again to Outsourcing in Clinical Trials UK and Ireland.

This is a great opportunity to get back together and network face to face, hear from our expert speaker line-up and discuss the latest innovations in the industry.

It is becoming clear that the only options are to disrupt or be disrupted: and so, this event is focused on examining real world evidence into innovations and industry trends that you cannot afford to miss.

We look forward to you joining us!

This, exclusive event brings together attendees from established pharma, large and small, alongside with biopharmaceutical companies and gives opportunity to dive into the operational challenges and innovations in clinical development found within the UK & Ireland region.

WHAT TO EXPECT FOR 2023?

200+ Attendees	30+ Exhibitors	35+ Speakers
200+ Attendees	30+ Exhibitors
35+ Speakers

Testimonials

See What It's All About

2022 Agenda

15 Jun 2022
16 Jun 2022

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8 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

9 AM

OPENING KEYNOTE FROM THE MHRA: An overview of the MHRA’s consultation on new clinical trial legislation

An overview of proposals for the UKâ€™s clinical trial legislation designed to make the UK the best place to research and develop safe and innovative medicines
Results from the MHRAâ€™s consultation: feedback on proposals
What the new clinical trial legislation will mean for the future of clinical trials in the UK

9:30 AM

Empowering patients through next generation eCOA technology

The new myMedidata app launches with further integrations of key Medidata technologies in pursuit of a better and more flexible patient experience. Join this session to learn more about the latest developments in eCOA to strengthen decentralized clinical trials with features such as image capture. This provides patients with the ability to capture photos from any device in any location from any location on a secure and compliant platform. See how these updates can be leveraged to improve patient experiences while also streamlining data capture for your trials.

10 AM

Orphan drug designation in the UK and Europe: understanding regulations for orphan status and accelerated timelines

Understanding MHRA orphan designation and how this differs from EMA regulations
How can orphan drug status from the MHRA support clinical development for rare diseases?
Navigating hurdles around data and evidence for studies with smaller numbers of patients
Ensuring early access to drugs and how to make sure drugs are both safe and quickly available to the British market

10:30 AM

Pre and post-COVID: what has changed in the clinical research landscape?

Regulatory and ethics strategy and tactics
Hospital site set-up
Onsite monitoring

11 AM

Morning refreshments and networking

STREAM A: Clinical Operations and Outsourcing

Chair: Reynald CastaÃ±eda, Clinical Trials Editor, Clinical Trials Arena, GlobalData

STREAM B: Clinical Technology and Innovation

Chair: James Rudge, Technical Director, Neoteryx

11:30 AM

PANEL DISCUSSION: Is decentralisation the future for clinical trials in the UK and Ireland?

How easy is it to incorporate remote monitoring and wearables into your clinical trial?
Working constructively with patients and advocacy groups to ensure your trial is accessible and patient focused
Is decentralisation always best for patients? Considering hybrid trials as a means to cater to all patient needs
Beyond just pandemic crisis management: what is next for virtual, remote and decentralised clinical trials in the UK and Ireland?

MODERATOR:

Reynald Castañeda, Clinical Trials Editor, Clinical Trials Arena, GlobalData

PANELLISTS:

Krzysztof Potempa, Founder and Chief Executive Officer, Braincures

Suki Malhi, Senior Director, Clinical Affairs, Oakhill Bio

11:30 AM

Innovating your recruitment campaign to ensure diversity in your trial participants

Why are racial and ethnic minorities often underrepresented in clinical trials?
Methods to engage minority communities and demographics who might not usually participate in clinical trials
Utilising social media as part of patient recruitment

12 PM

Increasing adoption of Bring-Your-Own-Device (BYOD)

Why is there still hesitancy in the adoption of Bring-Your-Own-Device (BYOD) to capture electronic Patient-reported outcomes (ePROs) in clinical trials?
Have PRO endpoints captured using BYOD been successfully submitted to regulatory bodies and used for labeling?
A call to action: pledge your intention to contribute to a database of PRO endpoints captured via BYOD used in medical product labeling
Are the concerns around BYOD as compared to provisioned devices and paper justified?
The importance of a considered approach to BYOD in your clinical trials; ensuring controlled flexibility to foster patient centricity
What is the role of BYOD in traditional, hybrid, and decentralised clinical trials?

12 PM

Now is the time to embrace the future of hybrid trials

How are hybrid trials defined
What are hybrid technologies
How hybrid benefits your trials
Disruptive technologies

12:30 PM

Best practice for working efficiently and successfully with your CRO

Balancing degree of oversight over your CRO: how involved should you be?
Looking at how trial sponsors can maintain good outsourcing partnerships
Aligning vendor and sponsor teams under one shared goal to deliver your trial smoothly and efficiently

12:30 PM

CASE STUDY: Innovation in clinical trials and leveraging technology to improve patient involvement and engagement

1 PM

Building a patient-focused eCOA strategy: insights and best practices

Why eCOA is an important part of your trial design
Why patient insights are key to both trial design and your eCOA strategy
Why it is important to ensure that the right eCOA are selected for your study population by identifying the unique challenges of rare disease and oncology patient populations
Highlight the lessons learned from COVID and how we can define a new norm for research which puts the participants at the center
How your eCOA strategy needs to focus on the global perspective and to ensure inclusivity
Why it is important to monitor your eCOA compliance and identify triggers early so that sites can be active partners in the study

1 PM

Data-driven operations and oversight with elluminate

Learn how elluminate delivers:
Operational analytics including enrollment, protocol compliance and safety
Risk-based analyses and insights with elluminate RBQM
Operational knowledge for data-driven development with elluminate CTMS
Centralized issue management across roles in operations, data and medical review
Sample tracking, data forecasting and financial performance indicators

1:15 PM

Lunch and networking

1:30 PM

Lunch and networking

2:30 PM

CASE STUDY: Designing a decentralised trial in the UK: learnings and outcomes

An overview of the process of designing a decentralised trial for the first time
Regulatory challenges in the UK when it comes to decentralised trials and what to consider during planning and design stages
Assessing the benefits of decentralised vs traditional vs hybrid

2:30 PM

CASE STUDY: Setting up a clinical trial from the perspective of a small biotech: challenges and lessons learned

End to end trial coverage without an exorbitant price tag: how to budget and keep costs minimal
Creating and building a network of external support to run your clinical trial
Key lessons learned: what would we have done differently?

3 PM

How will the supply chain need to adapt to support the growth of decentralised clinical trials?

Decentralised clinical trials are becoming the new norm, but letâ€™s consider the impact on every step of the clinical workflow
Digitisation and decentralisation go hand in hand, but does this approach lead to the â€œconsumerisationâ€ of clinical trials and redefine how patients engage with providers?
The characteristics of decentralised clinical trials present multiple supply chain challenges: is collaboration the solution to these challenges and importantly, are they worth rising to?

3 PM

Modern track and trace strategies: decreasing burden and improving supply chain oversight

Challenges today: the track and trace landscape, site burden, and trends
Deep dive into shipment and site storage tracking
Data silos across the supply chain and how technology can be leveraged to a centralized model
Use case: the drug journey taking into account regulation requirements
Tips for implementation and key takeaways

3:30 PM

Working with vendors and CROs: tips on fostering a strong relationship in the wake of the pandemic

What constitutes a good sponsor-CRO relationship?
Handling communications with CROs in situations where you have never met face to face: what can you do to make the relationship easier?
Considerations when choosing a CRO in order to facilitate a strong partnership
Remote communications: best practice for selecting and working with a CRO when working remotely

3:30 PM

CASE STUDY: Benefits and challenges of remote monitoring in decentralised clinical trials

What are the benefits of remote monitoring patients in clinical trial design?
What are the concerns about remote sampling in clinical trials?
What can be reliably measured from dried blood microsamples and how does that effect clinical trial design and deployment
Pharmaceutical approach to offering remote sampling in clinical trials

4 PM

Afternoon refreshments and networking

4 PM

Afternoon refreshments and networking

4:30 PM

Commercialising your product: what do you need to know now to be ready

We welcome Pierre Morgan to present this case study style discussion focussing on the commercialisation of a vaccine. The aim of this talk will be to take a realistic look at what is needed for commercialisation so you can plan accordingly.
Technology impact on scalability and manufacturing lead times
Evaluating technical feasibility and regulatory acceptability of technology transfers to localize production
Assessing demand to right-size supply and adjust delivery schedule
Managing affordability for buyers and corporate profitability objectives through pricing and advanced commitments

4:30 PM

Getting your pharmaceutical products seamlessly into the US: what you need to know

Breaking down all that you need to know about CBP and other agency importation requirements to facilitate clinical supply shipments
Receive detailed information on how to correctly declare biological products at the US border (Ports of Entry)
Discover which biological products may have transportation restrictions that must be factored into your clinical supply chain strategy
Covering the importance of permit requirements, including looking at whether a biological material may be hand-carried in the air environment, and what the proper labelling and packaging criteria are

5 PM

The diversity of Asia: what makes this region, particularly China, a preferred destination for clinical trials

Key factors driving the growth in the worldâ€™s fastest growing region for clinical development
Decentralised clinical trials in APAC current landscape and future expectations
Cutting edge technologies and considerations when planning for success

5:30 PM

Chairperson’s Closing Remarks & Canapes and Cocktails

8 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

9 AM

All about them: how we manage our suppliers

End to end supplier processes from selection to retirement: what is needed
Is the supplier review process a one size fits all or should you be looking at this on a case by case basis?
Supplier documentation: what should we have? Is there a minimum or a defined set?
Keeping on top of records and the importance of this: managing records internally
When an inspector calls: what does the inspector want to see?

9:30 AM

Feasibility and site selection for rare disease studies in the UK

NIHR feasibility service in the UK, a short overview of the current process, the advantages for common disease areas and why a slightly different approach is needed for rare disease
How to identify potential sites to approach for initial discussions and feasibility information
How can patient advocacy groups support the site or investigator identification process?
OR feasibility process and site selection, an overview of our process including developing a robust study specific FQ, building relationships with site staff and presenting results to the sponsor

10 AM

PANEL DISCUSSION: Assessing the impact of the evolving political and economic landscape on running clinical trials in the UK and Ireland

Impacts of Brexit and the future of British clinical trials within the European landscape
COVID-19 recovery and lessons learned from the pandemic
Why have clinical trials in the UK recovered more slowly post COVID?
Working in conjunction with the NHS to run clinical trials during and after the pandemic
Has the anti-vax movement in the UK had an impact on a declining trust in the clinical trial industry?

PANELLISTS:

Jeff Pilot, Senior Clinical Project Manager, Norgine

Barbara Hepworth-Jones, Director Capability Building, Global Clinical Operations, GSK

Simon Guiver, Head, Programme Delivery, Rare Diseases, UCB

Note: given the political nature of this panel discussion, panellists’ views are their own and not necessarily their employers’ official stance.

10:30 AM

Meeting regulatory expectations on IRT data ownership

Understanding the emerging expectations on what IRT data ownership really is
Discuss how regulatory expectations impact sponsors, sites and vendors
Explore the cultural changes required to enable the new evolving solutions

11 AM

Morning refreshments and networking

11:30 AM

How can leadership contribute to outsourcing clinical trials?

The crucial role of management styles (internally and externally)
The power of the mindset and its impact on your work relationships and projects
How soft skills training could improve your teams and companyâ€™s results?

12 PM

Leveraging the power of supply chain technology

IRT as a tool to manage your trial supply chain with flexibility, visibility, and control. uncover how clinical trials can leverage a flexible IRT to improve supply chain efficiency and help you control unforeseen circumstances. In this presentation, we will discuss:
Challenges to optimizing clinical supply chains
Leveraging technology to create real-time visibility and streamline drug supply management
How trials are using flexible IRT to gain control over their supply chains

12:30 PM

Finding CROs and partners as a small to medium sized company: challenges and considerations

What criteria is most important when selecting a CRO as a biotech or SME?
Is therapeutic expertise the most important factor in vendor selection?
Weighing up the pros and cons of choosing a small CRO vs a large global CRO as a biotech or SME

1 PM

Lunch and networking

2 PM

Innovative technologies for forecasting patient recruitment and event counts

Advanced technologies to maximize patient recruitment predictability at different
stages
Forecasting recruitment under different restrictions
Optimal cost-efficient recruitment design, sites/countries selection
Centralized statistical monitoring and detecting unusual data patterns
Forecasting future recruitment performance
Forecasting event counts in event driven trials (oncology, CRV)

2:30 PM

Begin with the end in mind: best practices for high-quality eCOA data when collaborating with CROs and vendors

Recommendations on how to smooth the Data Transfer Agreement process with multiple stakeholders
How a simple annotated Screen Report (aSR) can improve communication to remove surprises at database lock
Why and how an eCOA data management kick-off meeting can surface inconsistencies early
Call-to-action: pledge your intention to implement industry-recognized data standards for eCOA data collection
The benefits of Questionnaire Libraries to improve timelines and quality
Reduce end-game headaches: does your eCOA vendor have SMEs that understand FDA/PMDA data submission standards?

3 PM

Trends in new drug approvals and clinical trials

How past FDA and EMA approvals can inform future trends and tell us where the future focus of the industry and clinical trials will be
Why review designations are growing and their increasing benefits
How COVID-19 impacted clinical trials and their future trends
The rise ofbBiologics within the market and industry pivot to more complex molecules
How clinical trials over the last ten years help inform us on the state of the market

3:30 PM

Afternoon refreshments and networking

4 PM

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

During the roundtable discussion session, the conference hall will be divided into two ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations in oncology trials. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

How do our believes shape the way we work in the industry today?

Dalila Karbiche, Independent Clinical Trials Expert

How to make clinical trials successful and reduce risk of failure through using best practices in vendor and oversight management

Heike Schön, Managing Director, Lumis International

Outsourcing challenges: finding a CRO best suited for your study

Milena Kanova, Vice President Clinical Operations, Palladio Biosciences, Inc., a Centessa company

5 PM

Chairperson’s closing remarks

2022 Speakers

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Diane Chisholm

Head Of Clinical Operations, Blue Earth Diagnostics Ltd

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Krzysztof Potempa

Founder And Chief Executive Officer, Braincures

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REYNALD CASTAÑEDA

Clinical Trials Editor, Clinical Trials Arena, GlobalData

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Barbara Hepworth-Jones

Director Of Clinical Development Regulations And Advocacy, GSK

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.

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Will Moore

Director, Clinical Operations, Mereo BioPharma Group Plc

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MARTIN O’KANE

Head Of Clinical Trials Unit At Medicines And Healthcare Products Regulatory Agency, MHRA

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.

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James Rudge

Technical Director, Neoteryx

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Jeff Pilot

Senior Clinical Project Manager, Norgine

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Suki Malhi

Senior Director, Clinical Affairs, Zogenix, Inc.

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Eve Wallace

Project Director, Orphan Reach

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

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Valentino Parravicini

Chief Scientific Officer, Oxford Cannabinoid Technologies

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Dalila Karbiche

Senior Clinical Project/Programme Manager – Freelance,

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.

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Milena Kanova

Vice President Clinical Operations, Palladio Biosciences, Inc., A Centessa Company

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Karen Hue

Head Of Quality And GxP Compliance, 30 Technology

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Diane Driver

Head Program Delivery, PV Development Solutions, UCB BioPharma UK

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David Collier

Clinical Director, William Harvey Clinical Research Centre

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Pierre Morgon

Non-Executive Director, SVP , Chairman, NED, Vacitech, CanSino Bio, Eurocine Vaccines, Univercells

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.

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Terek Peterson

Senior Vice President, Customer Experience And Data Science, YPrime

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

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Quentin Horgan

Managing Analyst, Pharmaceutical Data And Analytics, GlobalData Plc

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Simon Guiver

Head, Programme Delivery, Rare Diseases, UCB Pharma

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.

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Chris Watson

Director, Consulting, THREAD Research

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.

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Cameron Kinnear

Senior Sales Consultant, Medrio

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.

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Peter MacLennan

CEO, Tailored Clinical Research Solutions

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.

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Davy Yeung

Managing Director, Tailored Clinical Research Solutions

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Neta Bendelac

Senior Director, Strategy, 4G Clinical

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.

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Vladimir Anisimov

Principal Data Scientist | Data Science | Center For Design & Analysis, Amgen

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Farooq Hussain

Regional Director, Clinical Services, Avantor

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.

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Joan Munoz-Pujol

Vice President, IRT, CALYX

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.

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Achilleas Zaras

Solutions Consultant, EClinical Solutions

Achilleas has 12+ years of experience in software industry involving software demonstrations, managing a team of 15+ developers, hands-on coding in Microsoft .Net platform and Business Intelligence Suites like QlikSense. He has enjoyed a progressive career in diverse roles including responsibilities of a Sales Engineer, Team Manager, Software Engineer and Business Intelligence Analyst in various industries like Banking, Retail and now the Pharmaceutical industry with eClinical Solutions.

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HEIKE SCHÖN

Managing Director, Lumis International GmbH

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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Florence Mowlem

Director, ECoa, Medable

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.

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PAUL O’DONOHOE

Senior Director, ECOA Product And Science, Medidata Solutions

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.

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David Chia

Senior Business Development Manager In Business Development United Kingdom, Novotech

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.

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Daniela Duffett

Solutions Consultant, Suvoda

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.

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Sean Smith

Biological Threat Exclusion Coordinator, US Customs And Border Protection

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.

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