Outsourcing in Clinical Trials East Coast 2023

Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget

23 - 24

May

2023
  • King of Prussia, PA, USA
  • Complimentary
  • Why attend?
  • Agenda
  • 2022 Speakers
  • Sponsors
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Why attend?

WHAT TO EXPECT FOR 2023?

200+

Attendees

15+

Exhibitors

15+

Speakers

80%

Attendees at Director+ level

200+

Attendees

15+

Exhibitors

15+

Speakers

80%

Attendees at Director+ level

See What It's All About

Agenda

  • 23 May 2023
  • 24 May 2023
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7:30 AM

Registration & Refreshments

8:20 AM

Chairman’s Opening Remarks

8:30 AM

KEYNOTE Democratizing Decentralised Trials: How Innovative Solutions Can be Accessible for All

9 AM

AI Powered Enrollment Forecasting, Site Selection, and Real Time Study Tracking Against Industry

  • Uncover pathways for all study teams to be able to include decentralization in their next study
  • Discuss strategies for supporting change and adoption at global scale
  • Share forecasts for continued adoption and what lies ahead for decentralized and digital trials

9:30 AM

Acceleration of Clinical Development in the World’s Fastest Growing Region: China

In this keynote discussion you will learn how Medidata Acorn AI’s Intelligent Trials solution leverages performance data from 27,000+ clinical trials and 1M+ study sites to:

  • Keep trials on track with real time monitoring of performance against similar trials and changing industry conditions – looking deeper into the impacts of COVID-19 and the Ukraine crisis
  • Use predictive models to significantly enhance enrollment forecasting and reforecasting, enabling more proactive responses
  • Increase patient diversity by leveraging site level patient demographic data

10 AM

Morning Refreshments & Networking

  • Key drivers of growth in Asia Pacific specifically China
  • Regulatory reform and how this has impacted clinical development
  • Case Study: what can the accelerated pathway look like

10:30 AM

PANEL DISCUSSION Managing Global Trials in a Post-Pandemic World: Top Tips and Key Considerations

  • Debating and defining what it means to apply ethics to technology
  • Discussing the regulations and policies around the latest technologies and how to ensure you are aligned to these regulations
  • How the patient voice should be incorporated
  • Advice on reviewing and monitoring your technology to ensure it is following the right policies and procedures

10:30 AM

PANEL DISCUSSION Merging Data, AI and Technology with the Human: Exploring the Ethics of Advances in Clinical Technology

11 AM

Reducing Noise: Strategies for Ensuring Quality Data in Clinician and Patient-Centric Outcomes

  • Virtual Clinical Supply Model
  • Direct to Patient Capabilities
  • Global Clinical Supply Offering (NEW)
  • Medical Procedures, services, and product reimbursement (NEW)
  • Improve Site Feasibility and Remove Barriers (NEW) 

11 AM

Innovative Solutions for Today’s Clinical Trial Needs

  • Discussing how the COVID-19 pandemic affected global trial management
  • Exploring the tools, technologies and data management techniques to streamline the process of monitoring trials running across different territories
  • Common pitfalls in international trial management and how to avoid them

Panellists:

Ratan Ratnesh, Head of Procurement, Taiho Oncology

&

Jef Benbanaste, VP of Product, Intelligent Trials, Medidata

11:30 AM

Studying the Importance of Getting A Diverse Patient Group Onto Your Study

  • What contributes to noise and variability in data?
  • Inter-rater reliability: what is it and why is it important?
  • Patient-Reported Outcomes: importance of consistency and accuracy. How can we reach the patients?
  • Strategies to minimize noise and strengthen data quality: from training, technology, and surveillance

11:30 AM

FIRESIDE CHAT Clinical Innovation and Technology: Defining Buying Strategy Based on Overcoming Challenges and Pain Points

Getting a varied patient group is getting more and more attention in recent years but can it really help us achieve better results?

  • Exploring why, when the USA has one of the most diverse populations worldwide many of us struggle to recruit a varied patient population and whether improving our recruitment can improve our study results
  • How Social Determinants of Health could be impacting our trials – will taking these into account improve the data we get from our trials?
  • How should we be integrating SDoH’s into our study design to get the most reliable results
  • The implications of not getting a diverse patient group – could this affect the safety of your product?

12 PM

Data-Driven Operations and Oversight with elluminate

Questions include:

 

  • From your experience, what have been the challenging points when buying strategically? Are there any quick solutions to these challenges?
  • How to best engage with internal customers’ and external stakeholders’ through collaborations?
  • Looking at the bigger picture, with virtual trials now playing a pivotal role, what would need to be considered from a buyer perspective (remote monitoring, patient recruitment, CROS etc.)?
  • How do you overcoming the challenges of supplier and vendor risk assessment in virtual world?
  • How do you stay one step ahead – anticipating what your R&D team and portfolio need to find your next long-term partners?

12 PM

Supporting technology deployment in a global decentralised clinical trial

Operational oversight within outsourced models has become increasingly complex for teams who are tasked with managing trials amid a rapidly changing landscape of partners, technologies, and global regulations. The elluminate® Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. 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

12:15 PM

Discover the Power of the TMF Reference Model Exchange Mechanism Standard Between Clinical Systems

  • DCT system components & considerations
  • Tips on choosing the right DCT system for your global study
  • Product and the Patient
  • Connected Device Considerations
  • Global study deployment

12:30 PM

Networking Lunch

12:30 PM

Networking Lunch

ArisGlobal has been serving life sciences for 35 years, and LifeSphere eTMF was the first system to support TMF Reference Model document types and the TMF Exchange Mechanism Standard. Join our tech showcase to see how our eTMF and CTMS leverage the eTMF Exchange Mechanism Standard to provide the following benefits to our customers across the globe:

 

  • Sponsors will discover how utilizing clinical systems that support the TMF Exchange Mechanism Standard can supply CRO trial oversight
  • Learn how CROs can offer a way to supply visibility and transparency to sponsors in a real-time manner
  • By leveraging solutions that support the TMF Exchange Mechanism Standard, Sponsors and CROs have the opportunity to lower costs between Sponsor and CRO systems, increase efficiency and improve the overall Sponsor/CRO relationship

1:30 PM

LEADERS PANEL DISCUSSION Framing Pandemic-Based Disruption as an Opportunity for Technological Advancement: What Have we Learnt?

  • Understanding the reasons why ethnic minority participation in clinical trials is still low
  • Exploring how to work with specific groups on health matters and the impacts this can have
  • How telemedicine and decentralized trials can be put at the forefront of diverse patient engagement, breaking down the barriers to minority recruitment
  • Strategies for reaching other marginalized communities, e.g. LGBTQ+, differently abled, rural?

 

1:30 PM

PANEL DISCUSSION Diversity, Equality, & Inclusion: Strategies for Engaging and Recruiting Under-Represented Patients

2:15 PM

Think Sync/aSync

  • Key learnings from running DCT/hybrid trials so far
  • Points to consider designing your coming clinical trials using DCT processes and technologies
  • The building blocks in your DCT/Hybrid trials

2:15 PM

Decentralized Clinical Trials/Hybrid Trials: What You Need to Understand to Run Them Successfully

  • Debating the opinion that the pandemic has allowed out of the box thinking to find new solutions to old problems
  • The rise of new technologies as solutions: what new techs have our panel been able to experiment with over the pandemic?
  • Which new technologies are a useful investment and which aren’t worth the hype?
  • Keeping the innovation going – how to ensure new ideas and ways of doing things continue to be nurtured in a “normal” world

Shaheen Lakhan, CMO, Click Therapeutics

&

Todd M Solomon, Director of Clinical Development & Head of Digital Psychiatry, MindMed

Further panellists welcome, please apply

2:45 PM

Ensuring Top Quality Project Teams from Vendors from a Small Biotech’s Point of View

Great things happen when you combine the power of synchronous (live) virtual meetings with asynchronous (24/7) web platforms. Done correctly, Sync/aSync strategies can boost productivity and engagement among Sponsors, Investigators, Patients, CRAs and others. Effectively meshing live and 24/7 digital technologies can also yield tremendous value in data capture, quality, cost savings and carbon footprint. This presentation will review use cases and approaches that leverage Sync/aSync methodologies.

2:45 PM

CASE STUDY: Moving Forward for Clinical Trials on Alzheimer’s Disease: How Technology is Enabling Progress in Drug Development

With an ever-more competitive market, how do we ensure the best teams?

  • Exploring the strategies we can employ to ensure that we receive the best possible proposal from our preferred vendor even when having a smaller portfolio means that we don’t have the most leverage
  • “Sharpen your pencil” – Exploring negotiation techniques so that we can ensure the best possible team and get the attention of our preferred vendor in a crowded marketplace
  • Retention of your project manager and your team – are there strategies we can employ to ensure our ideal team isn’t pulled off our project?

 

3:15 PM

Afternoon Refreshments & Networking

  • A review of the challenges faced by trials in the Alzheimer’s space
  • Exploring how technology can be harnessed to streamline trial operations
  • Lessons learnt: what advice can be taken forward for other trial managers

3:15 PM

Afternoon Refreshments & Networking

3:30 PM

Prize Draw in the Exhibit Hall

3:30 PM

Prize Draw in the Exhibit Hall

3:45 PM

Blockchain – Exploring the Implications for the Future

3:45 PM

Taking a patient centric approach in developing a virtual trial for your study

In this session Frank Leu, CEO at Novapeutics explores where he sees Blockchain going in the future, its implications and whether we should all be investing in it. Our expert will be answering such questions as:

 

  • How can it be best adapted into a clinical trial?
  • Which system should you use? It seems every vendor has the own system but how are we supposed to know which is the best?
  • Is the FDA likely to pick it up?
  • Will it actually save us money and time in the long run? Exploring examples of when Blockchain has been effectively implemented and the benefits it has had

4:15 PM

Keeping Patients Engaged: Digital Innovation & Patient Retention

In this key note presentation Viroclinics Xellerate, a global logistics specialty services provider and Medicago, a pioneer in plant-based therapeutics, will share their best practices on:

How outsourced global specialty logistics can enable vaccine development in light of pandemic related challenges.

 

  • Flexibility in scaling up and down
  • Importance of solution-thinking
  • Ability to respond to fluctuations in needs and demands

 

4:15 PM

Agility and Accessibility in the Development of a Vaccine in a Pandemic

  • Explore some of the barriers and motivators for patients to participate in decentralized trials
  • Understand the places you should consider getting patient input into the development process

4:45 PM

Pfizer & Decentralized Clinical Trials

  • YPrime will discuss the role of the patient in clinical trials and how technology has impacted its evolution
  • The importance of patient retention will be highlighted, as well as how technology plays a critical role in patient engagement by providing a customizable, user-focused experience throughout a clinical trial

5:15 PM

Chairman’s Closing Remarks

  • Defining Decentralized Clinical Trials
  • DCT Modalities at Pfizer
  • Value Drivers

5:20 PM

Close of Day One & Drinks Reception Sponsored by KPS Life

8:15 AM

Registration and Refreshments

8:50 AM

Chairman’s Opening Remarks

8:50 AM

Chairman’s Opening Remarks

9 AM

OVERVIEW: The state of the biopharmaceutical industry in 2022

We welcome Bonnie Bain from GlobalData to present her research into the state of the Biopharmaceutical industry in 2022. Including:

 

 

  • Identification of key themes that were triggered by COVID-19 and how they are shaping the biopharmaceutical industry, both today and into the future
  • Key emerging technologies and disrupters
  • Industry, regulatory and macro-economic factors affecting pharma in 2022

 

Don’t miss this talk; it is crucial for the biopharmaceutical industry to recognize the factors shaping the clinical trial landscape in order to maximize their future success.

9 AM

OPENING KEYNOTE Decentralised Trials: Practical Today, Predicting Tomorrow

Unpacking the hype: are decentralised trials a realistic solution?

 

  • Exploring whether decentralised trials can increase patient satisfaction in clinical trials and the potential benefits increased satisfaction and recruitment can bring
  • Overcoming the challenges in remote data management and collection
  • The regulators’ response – a realistic look on how likely a decentralised trial is to be passed by the regulators using case study examples

9:30 AM

Innovation: Good or Evil?

Whether clinical trial innovation is a benefit or a burden is in the eye of the beholder. Join industry veterans Malia Lewin and Tom Julian for a discussion about innovation that considers the implications from different stakeholder perspectives. Audience interaction is encouraged as we explore what drives, scares, and inspires us along the innovation journey.

9:30 AM

Optimize Your Study Through Technology-driven Patient Co-Creation

  • Enhance your knowledge of patient co-creation processes to ensure appropriate input is taken into consideration during all phases of the clinical research life cycle and allow for patient-centric trial design.
  • Understand FDA guidance on incorporating patient feedback, as well as recommended best practices and current challenges with traditional methodologies.
  • Explore how you can utilize a novel technology-enabled approach to optimize your research study to be more patient-centric and alleviate the current burden associated with the collection of on-going feedback from key stakeholders.

10 AM

Top Tips in Effective Budget Management, Forecasting and Contracting: Ensuring Your Resources Are Allocated Correctly

  • Best practices for CRO contract costing to reduce common pitfalls and avoid stretching your budget during the trial
  • Identifying and implementing the most effective budgets ensuring it fits with your trial priorities
  • Debating the role training and knowledge plays within your clinical team to avoid errors and misallocation of funds
  • Highlighting tips on accurate forecasting to ensure reliable cost models

10 AM

Developing a Platform for Conducting Decentralized Studies in Precision Psychiatry: The Mind Med ADDAPT Program

  • Understand the intersection of Psychedelic Drug Development, Digital Medicine & DCT
  • Examine the advantages of using a DCT platform to collect Precision Psychiatry Data
  • Discuss challenges and benefits associated with developing and deploying a custom-built platform ‘in-house’

10:30 AM

Morning Refreshments & Networking

10:30 AM

Morning Refreshments & Networking

11 AM

WORKSHOP SESSION Solving the Feasibility Questionnaire Dilemma During Site Selection to Ensure a Timely Trial Start and Reduced Recruitment/Logistical Obstacles

Tired of dealing with data silos, low response rates, tedious results analysis of site feasibility surveys?

 

The first portion of this interactive session will focus on your pain points with site selection as it pertains to site identification and feasibility questionnaires. We will poll the audience on the issues their teams face (including any complications around managing recipients in rolling feasibility, CDA statuses, exclusive site networks, etc.) and any solutions they have implemented to resolve those obstacles. The audience will have the opportunity to discuss their thoughts with colleagues and hopefully with some site representatives as well!

 

We will then review how GlobalData has experienced some of the audience’s main pain points issues being resolved through sophisticated electronic feasibility questionnaires with various case studies.

11 AM

Strategies and Tips for Building a Robust Mobile Data Suite

  • How do you identify what you need
  • Where do you find what you need?
  • How do you build a Mobile Data Suite?
  • How to put what you’ve found into practical operation

11:30 AM

How will the Supply Chain Need to Adapt to Support the Growth of Decentralized Clinical Trials?

  • Decentralized Clinical Trials are becoming the new norm – but let’s consider the impact on every step of the Clinical Workflow.
  • Digitization and decentralization go hand in hand – but does this approach lead to the “consumerization” of clinical trials and redefine how patients engage with providers?
  • The characteristics of Decentralized Clinical Trials present multiple Supply Chain challenges – is collaboration the solution to these challenges and importantly, are they worth rising to?

11:30 AM

Optimizing ePRO Data in Decentralized Trials

For clinical trials to detect a true treatment effect, the measurement approach must be reliable and valid. With current regulatory guidance to incorporate Patient Reported Outcomes (PROs) as critical endpoints, it is crucial that studies utilize evidence-based decisions in the design, deployment, and management of PRO data. PROs inherently rely on participant buy-in, comprehension, and motivation to contribute to the advancement of medical and scientific knowledge. In this presentation, we will look at:

 

  • Strengths and limitations of PROs, with specific attention to optimizing these endpoints in decentralized trials that deploy ePRO data capture technology
  • Reducing the time to unlock more accurate clinical evidence needed to bring new treatments to market by incorporating these methods

12 PM

LEADERS PANEL DISCUSSION: “The New Constant is Uncertainty”: A Debate of the Future of the Clinical Trial Industry

Our panel will reflect on the future of the industry and what we think the “new normal” of a world post-COVID will look like.

 

We will attempt to answer such questions as:

 

  • What do we think the next 5 years will hold for us?
  • Are we going back to normal or will events of last year change us?
  • What are the most important lessons from the pandemic that we need to take forwards?
  • What are the technologies and innovations that our panel thinks will have the biggest impact on the industry in the future
  • What will be the biggest challenges our panel sees ahead and how can they best be tackled

12:30 PM

Networking Lunch

12:30 PM

Networking Lunch

1:30 PM

Combatting Public Mistrust: How Better Community Engagement Can Lead to Better Trial Outcomes

Misinformation surrounding clinical trials are more prevalent than ever in our society. But how can this be improved through better community engagement and communication?

 

  • Exploring why communities can become mistrustful of clinical trials
  • Who is the demographic of people more likely to be swayed by misinformation and mistrust? What can the industry do to engage and educate these groups of people?
  • What can be done better? Taking an honest look at areas the clinical trials industry may be failing in to effectively represent the communities they are trying to help
  • Exploring how can these issues be faced through better community engagement and communication

2 PM

Q&A SESSION Moving Vendors: Exploring What We Need to Know When Choosing the Right Partner for your Trial

  • Questions to ask your provider so that you can ensure they have understood your needs
  • Identifying exactly what you need from a vendor and what aspects can be better managed in house
  • Combatting “status quo” bias – identifying when it is best to move despite being comfortable with the vendor you know
  • How do you know when you have hit on the right partner? Our panel share their thoughts on what makes them know they have found the right vendor

2:30 PM

Steps to Streamline Information Flow and Futureproof Data for a Modern Trial

  • Reviewing and defining effective data policy and how to ensure this is communicated effectively across all teams
  • Tips on putting clear objectives, policies and processes in place to streamline and futureproof data
  • How a robust database can improve data quality and remove issues around data integrity
  • Applying and integrating these processes with outsourced partners, ensuring all parties are on the same page

3 PM

Afternoon Refreshments & Prize Draw

3 PM

Afternoon Refreshments & Prize Draw

3:30 PM

Speaker Hosted Roundtables

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

 

Each roundtable session lasts for 45 minutes, and delegates may attend up to 2 roundtables.

 

RT 1

 

Remote Working & Return to the Office – How we made it work for us

 

This discussion will look at the transition to working from home that many of us had to adjust to during the pandemic. Share your thoughts on how you made it work for your employees, the benefits and negatives you saw and of course whether you think the trial manager of the future will be a remote worker or office-based.

 

Alice Drumheller, Vice President of Clinical Operations, Sensei Bio

 

RT 2

 

Advancing Data Analytics to New Frontiers During the COVID-19 Pandemic Restart

 

Paresh Patel, Director Data Science & Technologies, Otsuka

 

RT 3

 

Promoting Diversity and Inclusion in Clinical Trials: How You Can Help to Include Under-Represented Communities

 

This group will be discussing practical steps you can take to promote diversity and inclusion in clinical trials.

 

RT 4

 

Opening up: A Discussion on Returning Supply Chains to “Normal” in a Post-Pandemic World

 

We will discuss adaptations made to supply chains since the pandemic began – and are these adaptations planned to be continued? How can we ensure robost supply chains moving forwards?

4 PM

Close Of Conference

OTHER POTENTIAL SESSIONS:

Blockchain – Is the Biggest Buzzword in Technology the Best Weapon Against Counterfeit Drugs?

 

Blockchain is often pointed to as one of the new technologies most likely to revolutionize clinical trials supply – but how useful could it be in tackling counterfeit drugs:

 

  • With the counterfeit drugs market being worth an estimated $200 billion, what is the role Blockchain can play in combatting counterfeit drugs and tracking product authenticity?
  • How likely is it that governments will introduce new regulations in regards to labelling and tracking products throughout the supply chain – and what role can Blockchain play in this
  • Is the cost of setting up Blockchain worth it in your company? What are the alternatives?
  • A quick review of real world evidence in regards to Blockchain – how it has been successfully used in supply chain management and the lessons learnt from this

How We Did It: Getting Device Approval Through the FDA’s Breakthrough Devices Program 

 

  • A review of what the FDA Breakthrough Devices Program is
  • How we got approval and a walkthrough of the approval process
  • Lessons learnt and the benefits of this program
  • What companies need to know when seeking approval in the US through this route – could this be the right program for your device?

CASE STUDY: Company Expansion: Handling the Growing Pains 

 

We welcome X from X to discuss how they expanded their company and overcame the associated challenges.

 

  • Translating your company into a larger business when you only have a small workforce – do you outsource to cover processes that can no longer be dealt with in house?
  • Discussing and debating at what stage you should look to step up your workforce and invest in expansion
  • Surprises and challenges that arose when expanding the company – and how these were overcome
  • Discussing the solution providers that helped with the expansion process – how to make the decision on what help to bring in

Working with a Smaller, Niche Supplier: Can this be the right option for your trial?  

 

  • Benefits and opportunities that can come with working with a smaller niche supplier on your trial – and how this compares to working with a large CRO
  • Identifying the pitfalls and challenges that come with working with a smaller supplier – what questions do you need to ask to ensure they can adequately cover your needs?
  • How can we mitigate and minimise the risk that something could go wrong when relying on one small supplier – tips and tricks
  • Exploring ways to look into the backgrounds of your small supplier – how to best get reliable information on the reputation of a small supplier. Where is the best place to go to for recommendations on a supplier whose advice can we most trust?

ROUNDTABLE: Starting Over: How to Recognise When Trial Protocols Need to be Redone

 

Recognising that your trial protocols aren’t working is a difficult thing to do. Join this group to discuss red flags and key signs that could indicate that a trial needs to be abandoned and restarted with new protocols. 

 

Moving Forward for Rare Disease Studies: Are Decentralized and Virtual Trials a Permanent Solution?

 

  • Getting your trial back on track post- COVID-19: are remote solutions the way forward?
  • Weighing up the pros and cons of virtual and decentralized trials for rare disease studies
  • Considerations needed for a rare-disease specific remote trial
  • How a virtual trial can benefit the rare disease patient

A Fresh Look at Patient Recruitment Focusing on the Top of the Funnel – Is Our Image the Problem? 

 

This talk will focus on why we should be looking at the top of the patient recruitment funnel – why we should be targeting patients before they have even thought about joining our study – in order to more successfully recruit for trials. This new approach is vital as studies show we are failing at efficiently engaging patients – some experts claim we are still only reaching 10% of our potential pool of patients. 

 

  • Strategies for changing the public’s perception of clinical trials and how this can benefit all of us
  • How we should be using social media and other tools to engage with your potential audience and encourage them to see you in a positive light
  • What we can learn from the oil and gas industries – why are we seen as ‘greedier’ than them?!

Electronic Informed Consent: The First Thing to Introduce for a Modern, Streamlined Study   

 

While they may be flashy, technologies such as DCTs, wearables, Machine Learning and blockchain can be expensive, hard to learn and difficult to immediately integrate into most studies. However there are other technologies you can invest in such as Electronic Informed Consent that can position you as a modern, future-ready institution.    

 

  • An overview of Electronic Informed Consent and how it can be quicker and easier in the long run to implement an electronic system
  • Facing up to the challenges in implementation such as adhering to regulations over different regions and developing a platform
  • Exploring the impact on patient engagement – will it really lead to easier recruitment and fewer patient dropouts?
  • How the pandemic has streamlined the adoption of virtual solutions for patient consent and the benefits this has had

Conducting Trials in North Africa and The Middle East: Key Considerations and Best Practices

 

In this session, we welcome X to break down the various challenges and benefits that come with expanding into emerging markets in North Africa and the Middle East.

 

This session will cover:

 

  • Regulatory considerations – exploring what US companies need to be aware of before submitting a trial in these territories
  • Unpacking the cultural differences and taking a realistic look into how this could impact your trial protocol and design
  • Exploring the benefits such as large, treatment naïve populations, lower costs etc.
  • The other side of the coin: downsides that need to be taken into consideration such as a lack of infrastructure, slower regulatory processes etc.

 Launching Your First Clinical Trial: Top Tips and Lessons Learnt

 

  • Advice on vendor negotiation and management – how to ensure you are working with a partner who can cater to your specific trial needs
  • Staying on budget and sticking to timelines: advice on how this can be done
  • Exploring governance and risk control – ensuring you remain in control of all aspects of your trial
  • Lessons learnt: what advice should be passed on to a first time trial manager

Top Tips for Starting up Trials in the Rare Disease Space: Best Practices and Considerations

 

  • Starting off strong: What you need to know before launching your rare disease trial
  • Change your mindset: how rare diseases require a much more individual approach to patient recruitment
  • Preparing for your study: ensuring you have understood the impact on patients and their caregivers
  • Finding the right vendor partner: how to ensure your CRO can handle a rare disease trial

The Single Most Important Technology You Can Have: Cybersecurity

 

With many of us turning to remote monitoring and virtual at home data tracking solutions – how can we ensure this data is accurate and secure?

 

  • The argument that cybersecurity is the single most important investment your company can make – and why it is that so many companies are ignoring the issue and failing to adequately protect their data
  • Data breaches and cyberattacks – how to remain vigilant at all stages
  • Exploring how you cannot innovate other areas of your supply chain with wearables, AI, virtual site visits etc if your data protection and cybersecurity is not adequate

2022 Speakers

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STEVE BRANDAO
Regional Director Business Development, East Coast, US, Novotech
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TOLA OLORUNNISOLA
VP, Strategy, Innovation, Marketing And Digital, Avantor

Ms. Olorunnisola is currently VP – Innovation, Marketing & Digital in the Avantor Services business unit. She leads Innovation, Marketing and Digital Solutions for the Supply Chain (Lab) Services and Clinical Services. She has over 15 years of experience in the Medical Device and Life Science industry developing and executing digital and go-to-market strategies. Additionally, she has led the development and deployment of large-scale enterprise solutions. Ms. Olorunnisola received her BA in Electrical Engineering from the University of Illinois at Chicago.

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MARC VAN PRUIJSSEN
General Manager, Viroclinics Xellerate
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AUBREY VERNA
Product Director, ECOA, YPrime

Aubrey Verna guides eCOA product development using evolving industry needs and stakeholder-informed insights across sponsors, sites, and patients. Her experience includes building and executing product strategies starting with the creation of roadmaps all the way to product releases. Additionally, Aubrey has experience in the management of global eCOA programs and has oversight of the teams responsible for implementation.

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PATRICK FLOODY
Executive Director, Global Clinical Trial Services, Regeneron Pharmaceuticals

Patrick has over 27 years’ experience in new drug development. He joined Regeneron in March 2020. His current role is the Head of the Global Clinical Trial Services group, responsible for global site management, central monitoring, study feasibility and site selection, study/site start up and eCOA and patient technology initiatives. Prior to this, Patrick spent 25 years at Pfizer, with most of his time spent in clinical program operations but also includes GCP Quality (level 1) and Analytics. Patrick has extensive international experience in drug development. He helped establish the Pfizer country office development teams in Latin America, India and other parts of Asia. Subsequently, Patrick spent 10 years in Pfizer’s Development Japan organization as Head of Japan Development Operations and Development Japan Portfolio & Project Management Groups. He was the recipient of the PGRD Achievement Award in 2007. Patrick is a former officer in the U.S. Army and is a veteran of the first Gulf War. He holds a bachelor’s degree in Biology from the University of Rhode Island and a Master of Business Administration from Temple University.

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AMANDA STELLMAN
Senior Clinical Trial Manager, Click Therapeutics
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KATIE RODAMMER
Associate Director, Clinical Operations, Click Therapeutics
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GENE FILIPP
Senior Solutions Consultant Lead, Global Commercial Operations, ArisGlobal

Gene Filipp currently leads the ArisGlobal Clinical and Regulatory Solutions Consulting team. Gene brings over two decades of experience that begin in the classroom teaching 7th grade science in Texas. Very quickly he completed his masters focusing on instructional technology and transitioned into a technology administrator role. After 10 years working in the Texas education system, Gene left education for clinical research by joining the CRO Chiltern International. Starting as a Trainer in the eClinical Solutions team, Gene ended his time managing the Americas for the team. Gene often speaks of his time at Chiltern as basis of his deep knowledge and understanding of the clinical research process. With his education and experience, Gene has been a solutions consultant for 11+years with several life science technology companies which include Medidata, ERT and presently ArisGlobal.

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CHRISTOPHER FARINA
Associate Director, Listening & Linguistics, InVibe, A Division Of THREAD

As an Associate Director on the Listening Team, Christopher Farina collaborates with clients to develop and implement research programs that provide rich insight into stakeholder perspectives. Along with a team of linguists, he employs qualitative methods to illuminate meaningful patterns in complex language data which he distills into practical solutions for specific business needs. Christopher holds a doctorate in linguistics from the University of South Carolina. He has over 10 years of experience across a wide range of functions in qualitative and quantitative research in applied linguistics and in the social sciences more broadly.

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OLIVIA GIORDANO
Senior Associate Solution Specialist Strategic Partnerships, Pfizer
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GREG TULLO
VP Professional Services North America, Viedoc Technologies

Greg is an expert at designing innovative data collection plans, managing quality control of collected data, and creating custom tools and databases for end users, leveraging expertise in clinical software applications including SAS, DataFax, OpenClinica, Excel, and Access.

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ALEX CRAWFORD
Product Director - Decentralised Clinical Trials, ICON
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MALIA LEWIN
Global Head Of Strategy, Teckro

Malia Lewin is global head of strategy, ensuring both clinical and market fit for Teckro products. An attorney by training, Malia Lewin has over 20 years of experience in the life sciences industry. Passionate about getting life-changing healthcare innovations to patients, Malia has worked on behalf of non-profit organizations, pharmaceutical and biotechnology companies, hospital systems, and technology companies to expedite the path of scientific discoveries from bench to clinic. Most recently, Malia served as chief business officer of CherryCircle Software, where she led the global go-to-market strategy for QbDVision, a SaaS platform to optimize the development and manufacturing of drug products. Prior to that, she served as director of global oncology strategy at Veeva Systems, where she worked closely with clients in the oncology space to harness the power of technology to develop and commercialize oncology innovations. During her seven-year tenure as VP of client services and head of strategic operations at Rivermark, LLC (an IQVIA company), Malia led strategic consulting teams advising on the development, launch, and adoption of diagnostics and treatments, across therapeutic areas. This included the development of novel digital products for stakeholder mapping and engagement, network visualization and activation, and reporting and analytics. Earlier in her career, Malia had the opportunity to serve non-profit organizations as the founding CEO and executive director of the International Psoriasis Council and as lead partner of Networking and Affiliations at Ascension Health. Malia holds Bachelor of Arts Degrees in English and in Women’s Studies from the University of Richmond and a Juris Doctor from The George Washington University Law School.

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TOM JULIAN
Clinical Trial Innovation,

Tom Julian started his career in various dot coms and moved into digital health, working in managed care and then pharma. He was most recently at Bristol Myers Squibb where he led clinical trial innovation initiatives and built out the R&D group’s digital recruitment strategy. Tom is passionate about helping patients and puts them at the center of his work.

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NIK TEZAPSIDIS
President & CEO, Neurotez Inc
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TODD M SOLOMON
Director Of Clinical Development & Head Of Digital Psychiatry, MindMed

Dr. Solomon is a Clinician / Scientist with over 15 years of experience in clinical research and development in neuropsychiatry and neurodegenerative diseases. Previously to his role at Mind Med, Todd was a Director of Global Clinical Development at Avanir Pharmaceuticals leading development programs in neurologic and psychiatric disorders such as Schizophrenia and Traumatic Brain Injury. Prior to that, Todd served as the Associate Director of Clinical Programs and Data Science for CNS programs at Signant Health. He holds degrees in psychology and neuroscience (BA) from St. Lawrence University and Clinical Neuropsychology (PhD) from New York University. Todd completed his fellowship in neurodegenerative disease at Boston University School of Medicine where he served as an associate faculty member, clinician, and investigator for several years.

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JEN HORONJEFF
Founder And CEO, Savvy Cooperative
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INEZ RUIZ-WHITE
R&D Lead Of Diversity, Equity, & Inclusion (DE&I),, Otsuka Pharmaceutical Companies (U.S.)
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BARI KOWAL
Vice President & Head, Global Clinical Operations, Regeneron Pharmaceuticals
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JEREMY R. PRICE
Director, Clinical Innovation & Strategic Partnerships, Pfizer
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Jef Benbanaste
VP Of Product, Medidata Acorn AI Intelligent Trials

Jef Benbanaste has led the launch and commercialization of multiple analytical SaaS solutions at Medidata and currently leads Intelligent Trials. Jef has over 16 years of experience improving business processes and decision-making through the use of technology and analytics.

Prior to joining Medidata, Jef led projects at the global insurance company AIG which applied predictive modeling and machine learning techniques to improve risk segmentation and shape business unit strategies. Before that, he was in technology consulting at Deloitte. Jef has a MBA from MIT and a BS from the University of Virginia.

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RICK O’HARA
Associate Director, Clinical Operations Outsourcing, Endo Pharmaceuticals
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KATHLEEN COHEN
Director, Program Management R&D, Marinus Pharma
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Tim Curry
Senior Vice President Of Account Development, MedPoint Digital

Tim Curry joined MedPoint Digital in 2006 and in his current role leads an elite team focused on strategic global program development. Tim has extensive experience consulting with biopharma clients on effective applications across a broad suite of digital platforms and services. Tim holds an MBA from the University of Chicago.

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LAUREN SUNSHINE
Global Alliances - Clinical Technology, Bristol Myers Squibb
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Paresh Patel
Head Of Global Clinical Intelligence, Otsuka
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DAVE POTTER
Director, Data Management, Daiichi Sankyo, Inc.
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Terry Katz
Sr. Director, Biostatistics and Data Management Planning and Functional Excellence, Daiichi Sankyo
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KATHY MACHUZAK
Director, Patient Advocacy, Travere Therapeutics
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Janine Penman
Head, Clinical Strategy, Rare Disease, reVision Therapeutics
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JULIA FARIDES-MITCHELL
Associate Director, Health Communication Services, CISCRP
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CATHLEEN PLATT
VP, Clinical Operations, Click Therapeutics

Former Associate Vice President, Global Clinical Trial Management at Allergan Former Executive Director, Global Clinical Trial Management at Actavis plc Former Executive Director, Clinical Operations at Warner Chilcott Former Senior Director, Technical Services at Consumer Product Testing Company Former Section Head, Toxicology at Leberco Testing A., Biology, Rutgers University

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Amanda Murphy
Director of Product Management, GlobalData

Amanda Murphy is the Director of Product Management at GlobalData, a company that focuses on research, data analytics and consulting that provide actionable insight into the pharmaceutical and medical device sectors.  She has 10+ years of experience working in pharmaceutical data science and web platform development (including BioPharm Insight, Lead Sheet, and the Pharma Intelligence Center).  She has developed models and solutions to support Clinical Operations & Feasibility teams plan and optimize trials, including an e-feasibility questionnaire tool resulting in 4x faster response rates from sites.  Amanda also has many years of experience supporting business development at CROs through data-driven lead delivery and CRM integration solutions.

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Dawn Kaminski
Vice President, Business Development Operations, EClinical Solutions

Dawn has over 20 years of experience in the pharmaceutical industry. She have worked within every level of clinical data management, from Data Coordinator to Senior Director where she participated in or had oversight for more than 250 clinical trials.

During her time in the industry, she has provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter as well as Co-Chair of the annual conference (2018-2021) and serves on the SCDM Board of Trustees. Dawn is involved as a member of the CDISC-CDASH core team, Diabetes sub-team, CDASH CFAST Expanded Leadership Team and former Co-Chair of the CRF Library project.

Dawn currently holds the position of Vice President, BD Operations, where she supports business development as a Clinical Subject Matter Expert for both software and data services as well as overseeing the Proposals and Solution Consulting departments.

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Stefanie Kuhner
Global Head Of Clinical Technology, Innovation & Patient Recruitment – Strategic Sourcing & Procurement, Bristol Myers Squibb
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ROLANA AVRUMSON
Vice President Of Clinical Projects, Clinical Assessment Technologies, Worldwide Clinical Trials
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Bonnie Bain, PhD
Global Head And Executive Vice President Of Healthcare Operations And Strategy, GlobalData Healthcare

Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.

Session Details:

Chairman’s Opening Remarks

2023-05-23, 8:20 AM

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ALICE DRUMHELLER
Vice President Of Clinical Operations, Sensei Bio

Alice Drumheller has over twenty years’ experience in the clinical operations area with the focus on executing clinical trials. Prior to joining the Sensei Bio, Alice was Senior Director of Clinical Operations at MacroGenics where she executed the company’s clinical strategy. Previous to MacroGenics, Alice was part of the team at Amgen/Micomet where she contributed to the approval of BLINCYTO®. Alice has held positions of increasing responsibility at large pharmaceutical companies, start-up companies and clinical research organizations, including Nabi Biopharmaceuticals, Bristol-Myers Squibb, Kendle (now Syneos), British Biotech and Henri Beaufour Institute (a subsidiary of Ipsen). Alice holds a BS in Public and Community Health from Southern Connecticut State University in New Haven, CT.

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RAM RAJU
Former CEO, NYC Health & Hosptials Corporation

Dr. Ram Raju has a distinguished career over 40 years as a healthcare provider, teacher, researcher and community organizer. In his role at Northwell Health, Dr. Raju set the strategic vision to improve population health by finding ways to meet the needs of its most vulnerable communities, by examining the existing programs aimed at improving the health system's response to the community's needs and working with local organizations to address them. Northwell Health is the largest healthcare provider in the state of New York, is a system with 23 hospitals and 830 outpatient facilities that sees 2 million people every year in the New York metro area and beyond.

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Frank Leu
CEO, Novapeutics,

Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman, speaker, moderator, and facilitator for many life-sciences and drug development events.

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RATAN RATNESH
Director Of Clinical Outsourcing, Otsuka

Ratan Ratnesh is a Director and Head of Clinical Outsourcing at Otsuka Pharmaceutical. He received his Bachelors in Mechanical Engineering from National Institute of Technology, India and an MBA from University of Louisiana. Ratan has broad experience in strategic sourcing, clinical outsourcing, operations and supply chain improvements in Fortune 500 and growth companies. He started his career in management consulting specializing in supply-chain across different industries and moved to clinical outsourcing in early 2000. In Pharmaceutical industry he worked at Wyeth and Novartis prior to joining Otsuka and he has managed different categories related to clinical outsourcing.

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CRAIG LIPSET
Co-Chair, Decentralised Trials And Research Alliance

Session Details:

KEYNOTE Democratizing Decentralised Trials: How Innovative Solutions Can be Accessible for All

2023-05-23, 8:30 AM

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Jorge Franceschi
Director, Business Development TrialCard
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Shaheen Lakhan
CMO, Click Therapeutics
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Jessica Emerson
PhD, MS, Scientific Advisor Clario
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