15th Annual Outsourcing in Clinical Trials East Coast 2024

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

21 - 22

May

2024
  • Valley Forge Casino Resort, King of Prussia, PA, USA
  • Complimentary
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Why attend?

WHAT TO EXPECT FOR 2024?

450+

Attendees

70+

Exhibitors

30+

Speakers

450+

Attendees

70+

Exhibitors

30+

Speakers

See What It's All About

Agenda

  • 21 May 2024
  • 22 May 2024
Expand All

Streams

Stream one

Clinical Operations and Outsourcing

Stream two

Clinical Technology and Innovation

10:30 AM

Morning Refreshments & Networking

11 AM

PANEL DISCUSSION: AI and digitalization in clinical trials

  • How AI can improve and streamline clinical operations: opportunities and real use cases
  • AI as a tool to support thinly stretched clinical operations teams: where can this be utilized to minimize workloads and increase overall output?
  • How are clinical trial sponsors implementing tools such as Generative AI and ChatGPT?
  • FDA perspectives on AI in clinical trials: are there limitations to its use?

Speakers

Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus
Blake Edward Wilson
Partner (FDA Regulatory), Hogan Lovells
Derek Shannon
Director, Statistical Project Management, Madrigal Pharmaceuticals
Jeannette Villabon
Associate Director, Outsourcing Management, Bristol Myers Squibb

11:30 AM

Reserved for Saama Technologies

12 PM

AI 101: the opportunities of AI for clinical trials

  • An overview of different types of AI and machine learning and where there are opportunities to use these in clinical trials
  • Assessing easy ways to incorporate and implement AI into your clinical study
  • Where is AI being utilized in other industries and how can this be applied to clinical trials?

Speakers

Derek Shannon
Director, Statistical Project Management, Madrigal Pharmaceuticals

12:30 PM

Reserved for eClinical Solutions

12:45 PM

Reserved for Acolad

1 PM

Lunch and networking

2 PM

CASE STUDY: Targeting Alzheimer’s Disease and Dementia in Parkinson’s Disease with Blarcamesine (ANAVEX®2-73)

Clinical efficacy is associated with biomarker expression and restoration of neurodegenerative pathways

  • Blarcamesine (ANAVEX®2-73) treatment result in significant improvements in patients with Alzheimer’s Disease and in Parkinson’s Disease Dementia
  • Analysis demonstrates predictive biomarker of efficacy in Alzheimer’s Disease and in Parkinson’s Disease Dementia
  • Whole blood transcriptomics analysis (RNAseq) identifies treatment impact on pathways impaired in neurodegenerative diseases

Speakers

Daniel Klamer
Vice President, Business Development & Scientific Strategy, Anavex Life Sciences

2:30 PM

A holistic approach to Parkinson’s disease endpoint data collection: efficacy, safety and quality of life

  • Wearable digital endpoint solutions and their pivotal role in providing quantitative gait assessment for detection of disease progression
  • eCOA solutions for assessing efficacy and quality of life, leveraging clinical rating scales, symptom diaries, and other patient-reported outcome measures
  • Medical imaging modalities focused on accurately characterizing PD status biologically, paving the way for biomarker-guided drug development
  • Cardiac monitoring in this unique population, collecting high-quality blood pressure and cardiac rhythm data to characterize PD-associated autonomic dysfunction

Speakers

Todd Rudo, MD
EVP & Chief Medical Officer, Clario

3 PM

The impact of high turnover of site staff on data collection and what sponsor companies can do to help

  • How to deal with high turnover of staff as a sponsor company: what issues are caused by this?
  • Assessing available technology and processes to alleviate pressure and workload on site staff
  • The importance of maintaining a strong relationship with sites when it comes to data entry and collection

Speakers

Rosanne Petros
PMP, Associate Director, Clinical Research, Merck Research Laboratories

3:30 PM

Afternoon refreshments, networking

4 PM

Forecasting and budgeting for your clinical trial

  • Ensuring your trial is both cost-conscious and efficient without compromising on quality
  • Techniques, processes and technology to improve forecasting and budgeting
  • Avoiding common mistakes to keep your clinical trial budget on track

Speakers

Subs Tripathy
Head of Global Procurement, Seagen

4:30 PM

Digitalization in clinical trials: a 360 view

  • Presenting on how to digitalize clinical trials in e.g. endpoints, and study designs
  • Highlighting the possibilities that digital trials bring, whilst moving away from the common brick-and-mortar sites
  • Discussing the rigorous standards and scientific integrity required by regulators, whether a regular brick-and-mortar trial or a digital trial
  • How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more
  • Major points to consider in designing digital trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind

Speakers

GREG TULLO
VP Professional Services North America, Viedoc Technologies

5 PM

Critical to quality factors: a simple but powerful framework for risk-based quality management

The Quality by Design (QbD) and Critical to Quality (CTQ) Factor concepts were introduced by the Clinical Trials Transformation Initiative (CTTI) in 2015 and included in ICH E8(R1) (General Considerations for Clinical Trials) in 2021.  The current draft of ICH E6(R3) integrates the QbD and CTQ Factor concepts with RBQM.  Despite Health Authority and Industry endorsement and support, Sponsors and CROs aren’t taking full advantage of CTQ Factors in the clinical trial process. This presentation will explain how a CTQ Framework can be implemented simply and flexibly – to align RBQM activities from the protocol to the risk assessment to the operationalization of mitigation activities in the functional plans and more. 

Speakers

Jehan Poco
Associate Director, BDM Planning and Functional Excellence, Biostatistics & Data Management, Daiichi Sankyo, Inc
Kevin Douglass
Associate Director, RBQM Center of Excellence, Global Clinical Operations, Daiichi Sankyo, Inc

5:30 PM

Chairperson’s closing remarks

Speakers

Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc

7:30 AM

Registration & Refreshments

8:20 AM

Chairperson’s opening remarks

Speakers

Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

8:30 AM

PATIENT ADVOCACY KEYNOTE: A caregiver’s story: supporting children participating in a clinical trial

  • What do patients and caregivers experience when participating in a clinical trial, from start to finish?
  • Understanding patients’ motivations for choosing and staying in a clinical trial
  • Hurdles and barriers to patients’ participation in pediatric clinical trials: what can pharma companies do to improve this and relieve burden on patients and caregivers?

Speakers

Kelly Franchetti
Patient Advocate

9 AM

Reserved for Medidata Solutions

9:30 AM

PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

  • Weighing up pros and cons of different outsourcing models: which is best for your trial?
  • When is mixing and matching better than fully outsourcing or keeping trials fully in house?
  • Developing an outsourcing strategy as a small to medium sized biotech with limited resources
  • Why is FSP becoming a popular choice among sponsor companies and how can this support meeting trial timelines?

 

MODERATOR:

John J. Seman, Chief Executive Officer, REVITALE Pharma

 

PANELLISTS:

Terry Katz, Senior Director, Biostatistics and Data Management Planning and Functional Excellence, Daiichi Sankyo

Jessica King, Head of Clinical Operations, Sonnest

Maria Metzger, Executive Director, Supplier Relationship Management and Performance, Clinical Development Operations, Eikon Therapeutics

Priya Marreddy, Vice President, Clinical Operations, Context Therapeutics

Speakers

John J. Seman
Chief Executive Officer, REVITALE Pharma
Terry Katz
Sr. Director, Biostatistics and Data Management Planning and Functional Excellence, Daiichi Sankyo, Inc.
Jessica King
Head of Clinical Operations, Sonnest
Maria Metzger
, Executive Director, Supplier Relationship Management and Performance, Clinical Development Operations, Eikon Therapeutics
Priya Marreddy
Vice President, Clinical Operations, OnCusp Therapeutics

10 AM

Reserved for ICON

10:30 AM

Morning refreshments and networking break

11 AM

Site management: building a strong partnership with sites to ensure you are a sponsor of choice

  • Creating a partnership that is built on reciprocity and providing a voice for site feedback
  • Collaboration and training to ensure sites are confident and equipped to successfully complete trial
  • Reducing the burden on sites financially and operationally
  • Supporting sites individual needs from established clinics to naïve sites

Speakers

Suzy Montanye
Site Relationship Manager, Endo Pharmaceuticals

11:30 AM

Reserved for Worldwide Clinical Trials

Speakers

MarieElena Cordisco
MA, NP-C, Senior Director, Therapeutic Strategy Lead, Metabolic, Worldwide Clinical Trials

12 PM

Insights into barriers to care in the rare disease community

  • Challenges and nuances of rare disease patients’ journey to receive a diagnosis
  • Recognizing the pivotal role insurance plays in accessing healthcare services
  • Assessing adequacy of healthcare coverage, affordability of services, and the extent to which patients utilize available healthcare resources
  • Exploring overall experiences individuals have had within the healthcare system: strengths and areas for improvement
  • Mental health and well-being: the emotional toll rare diseases take on patients and caregivers

Speakers

Jenifer Waldrop
Executive Director, Rare Disease Diversity Coalition

12:30 PM

Access for all: how mobile visits help sponsors meet new diversity goals

Speakers

Tajuana Barron
Vice President, Project Management, PCM Trials

1 PM

Lunch and networking

2 PM

Effective patient education to increase enrolment and retention

  • Making trial participation easy for patients: what is effective and what isn’t?
  • Ensuring communications with patients are pitched at the right level in order to maximize understanding and thus increase retention
  • Innovative ways to create resources for patients using new technology and digital content

Speakers

Susan Neal
Director, Clinical Operations, Novavax

2:30 PM

Reserved for session sponsor

3 PM

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

  • How can expanding into diverse geographies support meeting DEI regulations for trials?
  • DEI in rare diseases: how to ensure your trial participants represent the overall population in trials with limited patient numbers
  • Navigating FDA regulations and devising a strategy for diversity and inclusion
  • Building trust and relationships with communities who may not traditionally participate in clinical trials
  • Working with advocacy groups to increase trial diversity and patient numbers

MODERATOR:

Rosalie Filling, Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

PANELLISTS:

Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health

Dija Atta, Senior Director, Clinical Operations, Incyte

Jenifer Waldrop, Executive Director, Rare Disease Diversity Coalition

Mohammed Ali, M&D Head of Reporting, Analytics and Insights, Astellas Pharma

Speakers

Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals
Ram Raju
Senior Vice President and Community Health Investment Officer, Northwell Health
Dija Atta
Senior Director, Clinical Operations, Incyte
Jenifer Waldrop
Executive Director, Rare Disease Diversity Coalition
Mohammed Ali
M&D Head of Reporting, Analytics and Insights, Astellas Pharma

3:30 PM

Afternoon refreshments, networking

3:50 PM

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

4 PM

CASE STUDY: Practical challenges when running a rare disease trial in the US

  • The regulatory landscape for rare disease trials in the US: what do you need to be aware of?
  • Learnings and outcomes from running a rare disease trial: where were the main hurdles
  • Working with CROs and vendors in order to deliver a successful orphan drug clinical trial

4:30 PM

Reserved for session sponsor

5 PM

CASE STUDY: Targeting Alzheimers: rationale and clinical trial plans at Neurotez

Speakers

Dr Nikolaos Tezapsidis
President and Chief Executive Officer, Neurotez

5:30 PM

Chairperson’s closing remarks

Speakers

Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

5:50 PM

NETWORKING DRINKS RECEPTION AND END OF DAY 1

Streams

Stream one

Clinical Operations and Outsourcing

Stream two

Clinical Technology and Innovation

9 AM

Site selection for increased patient recruitment and retention

  • Highlighting discrepancies in the distance between clinical trial sites and the disease prevalent populations using case studies
  • Exploring the impact of appropriate and inappropriate site selection on a trial’s success through case studies
  • Showcasing how patient accrual has been affected in clinical trials utilizing virtual components

Speakers

Sonnika Lamont
Analyst, Clinical Trials Intelligence, GlobalData Plc

9:30 AM

Technology spotlight reserved for Diligent Pharma

9:45 AM

Technology spotlight reserved for Egnyte

10 AM

Topic TBC

Speakers

Blake Edward Wilson
Partner (FDA Regulatory), Hogan Lovells

10:30 AM

Morning Refreshments & Networking

11 AM

PANEL DISCUSSION: Has DCT passed its peak in popularity?

  • Was DCT just a COVID buzzword or does it still have practical applications?
  • How can elements of decentralization be applied to clinical trials in order to maximize patient engagement?
  • Does DCT still have a future in a post-COVID world or has the clinical trial industry returned to ‘normal’?
  • Are there therapeutic areas where elements of decentralization or hybridization are essential to success?
  • Where are the main technological and practical hurdles to DCT taking off?

MODERATOR:

Judyth Zahora, Senior Director, GCP Quality Risk Management and Process Improvement, Agenus

 

PANELLISTS:

Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health

Rosanne Petros, PMP, Associate Director, Clinical Research, Merck Research Laboratories

Kristen Olszyk, Senior Director, Clinical Scientist, Neuraptive Therapeutics

Speakers

Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus
RAM RAJU
Former CEO, NYC Health & Hosptials Corporation
Rosanne Petros
PMP, Associate Director, Clinical Research, Merck Research Laboratories
Kristen Olszyk
Senior Director, Clinical Scientist, Neuraptive Therapeutics

11:30 AM

Reserved for uMotif

12 PM

FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

  • Training and inducting staff with technology and systems in order to ensure a smooth transition
  • The importance of your staff when it comes to clinical trial efficiency: why you need to avoid overlooking this
  • Ensuring your new staff training programs are as effective as possible: what should you consider?

Speakers

Carrie Lewis
Executive Director, Clinical Program Optimization, Endo Pharmaceuticals
Deanna Lutte
Senior Clinical Trial Manager, Clinical Operations, Endo Pharmaceuticals

8 AM

Registration and Refreshments

8:50 AM

Chairperson’s opening remarks

Speakers

Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

9 AM

PANEL DISCUSSION: Fostering a strong relationship with your CRO

  • Technology and new developments when it comes to managing CRO relationships
  • How to ensure your study is prioritized
  • Maintaining a strong relationship with vendors in remote and hybrid work settings
  • How to blend a CRO team with your internal team in order to foster communication and overall success of your trial

MODERATOR:

John J. Seman, Chief Executive Officer, REVITALE Pharma

 

PANELLISTS:

Hal J. Mann, Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions

Kathleen Cohen, Vice President, Clinical Development, Marinus Pharmaceuticals

Douglas Kling, Chief Operating Officer, NewAmsterdam Pharma

Patti O’Malley, Associate Director, Strategic Relationship Management, Incyte

Speakers

John J. Seman
Chief Executive Officer, REVITALE Pharma
Hal J. Mann
Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions
Kathleen Cohen
Head of Clinical Operations, Marinus Pharma
Douglas Kling
Chief Operating Officer, NewAmsterdam Pharma
Patti O’Malley
Associate Director, Strategic Relationship Management, Incyte

9:30 AM

Reserved for TRI

Speakers

Todd Rudo, MD
EVP & Chief Medical Officer, Clario

10 AM

Selecting vendors and CRO partners: what are the most important considerations?

  • Balancing cost alongside other considerations when selecting a CRO
  • Should trial partners always need expertise in your therapeutic area or are there other factors to consider?
  • Advantages and disadvantages of choosing a small CRO vs a global CRO for your trial

Speakers

Laurie Taraborrelli
Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

10:30 AM

Morning refreshments and networking

11 AM

CASE STUDY: Designing and running a trial for pediatric diseases: overcoming challenges when working with younger patients

  • Working with and supporting caregivers throughout the clinical trial process, and where sponsors can relieve burden
  • Additional considerations when designing a pediatric study: best practice when working with children and teenagers
  • Regulatory guidance in the USA around enrolling under 18s in a clinical trial and how to navigate this

Speakers

Gurdyal Kalsi
Chief Medical Officer, Asklepion Pharmaceuticals

11:30 AM

Reserved for session sponsor

12 PM

PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

  • Advantages and disadvantages of regions including APAC, Latin America and Asia for running clinical trials
  • Regulatory hurdles to overcome when running trials outside of the USA
  • Key factors to consider in selection of sites and geographies for your clinical trials
  • Sourcing CROs, vendors and partners overseas
  • Analyzing cost and benefit of keeping your trial in the US vs taking it overseas

MODERATOR:

Judyth Zahora, Senior Director, GCP Quality Risk Management and Process Improvement, Agenus

 

PANELLISTS:

Susan Neal, Director, Clinical Operations, Novavax

Akihiro Ko, Chief Executive Officer, Co-Founder and Board Chairman, Elixirgen Therapeutics

Speakers

Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus
Susan Neal
Director, Clinical Operations, Novavax
Akihiro Ko
Chief Executive Officer, Co-Founder and Board Chairman, Elixirgen Therapeutics

12:30 PM

Lunch and Networking

1:30 PM

KEYNOTE PRESENTATION: Can patients out innovate pharma?

While pharma struggles to adopt clinical trial innovations at scale, another stakeholder has demonstrated the urgency, will and creativity to disrupt clinical research: patients. 

This keynote will explore ways in which patients have already "out-innovated" pharma and will provide clues to a power shift that may be in our future.

Speakers

Craig Lipset
Advisor and Founder, Clinical Innovation Partners

2 PM

Developing a cell therapy for patients with telomere biology disorders: challenges and lessons learned

  • An overview of Elixirgen’s lead EXG-34217 program from a clinical operations perspective
  • Running a clinical trial with patients with a rare disease: what do you need to consider?
  • Key challenges faced during Phase I/II trials on EXG-34217 and future opportunities uncovered

Speakers

Akihiro Ko
Chief Executive Officer, Co-Founder and Board Chairman, Elixirgen Therapeutics

2:30 PM

CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

  • What more should sponsors, sites and CROs be doing in order to ensure clinical trials are as patient centric as possible?
  • Innovative strategies for working with patients and advocacy groups from early on in your trial design
  • Engaging groups and communities who would not typically participate in trials in order to achieve targets around diversity and inclusion
  • Reducing the burden on patients participating in clinical trials

MODERATOR:

Judyth Zahora, Senior Director, GCP Quality Risk Management and Process Improvement, Agenus

 

PANELLISTS:

Rosanne Petros, PMP, Associate Director, Clinical Research, Merck Research Laboratories

Harsha K. Rajasimha, MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

Laurie Taraborrelli, Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

Kelly Franchetti, Patient Advocate

Speakers

Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus
Rosanne Petros
PMP, Associate Director, Clinical Research, Merck Research Laboratories
Harsha K. Rajasimha
MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
Laurie Taraborrelli
Clinical Programs and Compliance Specialist, Fujirebio Diagnostics
Kelly Franchetti
Patient Advocate

3 PM

Afternoon refreshments and networking

3:20 PM

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

3:30 PM

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

During the roundtable discussion session, the conference hall will be divided into four ‘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.

ROUNDTABLE 1: Topic TBC
Laurie Taraborrelli, Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

ROUNDTABLE 2: Working with patient advocacy groups to design a patient centric clinical trial 
Speaker TBC

ROUNDTABLE 3: Using an FSP model for your clinical outsourcing strategy
Hal J. Mann, Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions

ROUNDTABLE 4: Operational challenges when running a rare disease clinical trial
Harsha K. Rajasimha, MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

ROUNDTABLE 5: Lessons from the pandemic: are there any DCT technologies which are here to stay?
Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health

Speakers

Laurie Taraborrelli
Clinical Programs and Compliance Specialist, Fujirebio Diagnostics
Hal J. Mann
Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions
Harsha K. Rajasimha
MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
Ram Raju
Senior Vice President and Community Health Investment Officer, Northwell Health

End of conference

END OF CONFERENCE – SEE YOU NEXT YEAR!

Additional topic suggestions:

Adaptive study design: creating a trial that is flexible and responsive to change

  • Assessing the advantages of adaptive design over traditional fixed designs and how this can improve your clinical trial efficiency
  • Key considerations for adaptive design
  • What additional flexibility is available when using adaptive design?

CASE STUDY: Overcoming operational challenges for a CAR-T trial: learnings and best practice

  • How are CAR-T trials unique from an operational standpoint: what do you need to consider?
  • Designing KPIs and other metrics to measure the efficiency of your CAR-T trial
  • Best practice in collaboration with CROs, vendors and other partners to make your CAR-T trial a success

Creating a budget that works for hybrid trials

  • Introducing elements of decentralization into your trial while remaining cost-conscious
  • Maximizing ROI on investment in new technology to support hybrid trials
  • Where can hybridization of trials help to minimize costs and reduce timelines?

Leveraging AI to design a cutting-edge patient recruitment strategy

  • Utilizing AI to minimize patient recruitment costs and maximize speed of enrolment
  • An overview of how data driven technology is able to enhance patient recruitment in trials
  • Leveraging AI and ML to reach a wider population when recruiting for a clinical study 

CASE STUDY: eConsent and the benefits for patients, sites, investigators and sponsors

  • Using eConsent as a tool to speed up recruitment and thus overall trial timelines
  • The regulatory landscape surrounding eConsent: what challenges are there to this?
  • Maintaining a relationship with patients in order to ensure consent is informed in remote settings

Using data and information from electronic medical records in order to shorten patient recruitment timelines

  • What are the benefits of electronic medical records and how can they enhance patient recruitment processes?
  • Navigating challenges and overcoming hurdles when using electronic medical records
  • Using electronic medical records in conjunction with other methods of identifying and screening patients in order to shorten timelines and reduce overall costs 

Risk based quality management systems: an overview of solutions available in the market

  • Best practice in processes for risk based management
  • Tools available to streamline risk based management and how to best leverage these
  • How can risk based quality management be used effectively in order to maximize trial success

Utilizing technology to maximize patient engagement and retention

  • Increasing patient touchpoints without increasing burden through the use of technology
  • The importance of having lighter, more frequent touchpoints in order to increase communications and improve relationships with patients
  • Assessing technologies available for supporting patient engagement and retention

Real world data in clinical trials: how can you utilize this effectively?

  • Navigating FDA and international regulations around the use of RWE in clinical trials
  • Understanding the full potential of RWE and how this can benefit your trial
  • Collecting and analyzing RWE effectively: how to address and overcome challenges

Speakers

Select a speaker to learn more

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Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus

Session Details:

PANEL DISCUSSION: AI and digitalization in clinical trials

2024-05-21, 11:00 AM

Session Details:

PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

2024-05-22, 12:00 PM

Session Details:

PANEL DISCUSSION: Has DCT passed its peak in popularity?

2024-05-22, 11:00 AM

Session Details:

CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

2024-05-22, 2:30 PM

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Daniel Klamer
Vice President, Business Development & Scientific Strategy, Anavex Life Sciences

Dr Daniel Klamer, Vice President of Business Development and Scientific Strategy of Anavex, has more than 15 years of experience in neuroscience and the orphan disease space, with acquisition, partnering and R&D experience in Europe and the USA. Prior to Anavex he worked at Retrophin and Neurosearch Sweden. At Neurosearch Sweden, Dr Klamer led and evaluated multiple discovery-phase neuropharmacological research products with an emphasis on strategic evaluation of preclinical and clinical development.

Dr. Klamer earned his PhD in Pharmacology at The Sahlgrenska Academy at University of Gothenburg, Sweden, his MBA at Fordham Gabelli School of Business, and his Post-Doctoral training at the Department of Psychiatry, Yale University School of Medicine. In addition, Dr. Klamer holds a position as an Associate Professor at the Department of Pharmacology at The Sahlgrenska Academy at the University of Gothenburg.

Session Details:

CASE STUDY: Targeting Alzheimer’s Disease and Dementia in Parkinson’s Disease with Blarcamesine (ANAVEX®2-73)

2024-05-21, 2:00 PM

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Gurdyal Kalsi
Chief Medical Officer, Asklepion Pharmaceuticals

Session Details:

CASE STUDY: Designing and running a trial for pediatric diseases: overcoming challenges when working with younger patients

2024-05-22, 11:00 AM

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Mohammed Ali
M&D Head of Reporting, Analytics and Insights, Astellas Pharma

Session Details:

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

2024-05-21, 3:00 PM

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Jeannette Villabon
Associate Director, Outsourcing Management, Bristol Myers Squibb

Session Details:

PANEL DISCUSSION: AI and digitalization in clinical trials

2024-05-21, 11:00 AM

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Todd Rudo, MD
EVP & Chief Medical Officer, Clario

As Clario’s Chief Medical Officer, Dr. Todd Rudo provides medical and scientific leadership across the organization. Passionate about leveraging our scientific expertise to support our customers’ success, Dr. Rudo has focused efforts on optimizing our solutions across the therapeutic areas. His team supports Clario’s clients by providing expert consulting services on scientific and regulatory strategy, and ensures our product portfolio is scientifically robust, generating high quality data to support clinical trial endpoints. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden. With nearly 20 years of clinical cardiology and pharmaceutical research experience, Dr. Rudo has focused his career predominantly on drug safety. He has worked within therapeutic areas including oncology, immuno-inflammatory diseases, urology, and cardiometabolic diseases, and has achieved board certifications in internal medicine, cardiology, cardiac electrophysiology, nuclear cardiology, and adult echocardiography.

Session Details:

A holistic approach to Parkinson’s disease endpoint data collection: efficacy, safety and quality of life

2024-05-21, 2:30 PM

Session Details:

Reserved for TRI

2024-05-22, 9:30 AM

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Craig Lipset
Advisor and Founder, Clinical Innovation Partners

Session Details:

KEYNOTE PRESENTATION: Can patients out innovate pharma?

2024-05-22, 1:30 PM

View In Agenda
Next speaker
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Terry Katz
Senior Director, Biostatistics, Data Management Planning, Functional Excellence, Daiichi Sankyo
Next speaker
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Jehan Poco
Associate Director, BDM Planning and Functional Excellence, Biostatistics & Data Management, Daiichi Sankyo, Inc

Jehan, Associate Director, Functional Excellence, Biostatistics & Data Management (BDM), Daiichi Sankyo, Inc.

 

Jehan is an Associate Director in the Biostatistics & Data Management Functional Excellence at Daiichi-Sankyo.  In this role, Jehan partners with BDM and R&D teams on functional initiatives, system roll outs, and committee as well as supporting key partners like the RBQM COE as a member.

 

Jehan has 18+ years of industry experience working for numerous companies in various positions (TMF, Clinical Monitoring, Quality & Compliance, Operational Excellence/Change Management, Metrics/Benchmarking and RBQM).  He received a BA in Cell Biology & Neuroscience from Rutgers College, an MBS in Biomedical Science from the University of Medicine and Dentistry NJ (UMDNJ), and is certified Auditing and Change Management methodologies.

 

Jehan can be contacted at jpoco@dsi.com

Session Details:

Critical to quality factors: a simple but powerful framework for risk-based quality management

2024-05-21, 5:00 PM

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Next speaker
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Kevin Douglass
Associate Director, RBQM Center of Excellence, Global Clinical Operations, Daiichi Sankyo, Inc

Kevin Douglass, Associate Director, RBQM Center of Excellence, Biostatistics & Data Management (BDM), Daiichi Sankyo, Inc.

 

Kevin is an Associate Director in the Risk-Based Quality Management Center of Excellence (RBQM COE) at Daiichi-Sankyo.  The RBQM COE partners within BDM, with cross-functional stakeholders, and CRO partners to optimize RBQM processes and tools.  The RBQM COE has central (e.g., as process owners developing and delivering tools and training) and Program/Study-level responsibilities (providing guidance to study teams).

 

Kevin has 40+ years of industry experience working for numerous companies in various positions (Data Management, Quality & Compliance, Operational Excellence/Change Management, and RBQM).  He received a BS in Biology from Ursinus College, an MS in Biology from Villanova University, and is certified in Lean Six Sigma and multiple Change Management methodologies.

 

Kevin can be contacted at kdouglass@dsi.com.

Session Details:

Critical to quality factors: a simple but powerful framework for risk-based quality management

2024-05-21, 5:00 PM

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Maria Metzger
, Executive Director, Supplier Relationship Management and Performance, Clinical Development Operations, Eikon Therapeutics

Session Details:

PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

2024-05-21, 9:30 AM

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Aki Ko
Chief Executive Officer, Co-Founder and Board Chairman, Elixirgen Therapeutics
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Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

Session Details:

Chairperson’s closing remarks

2024-05-21, 5:30 PM

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Carrie Lewis
Executive Director, Clinical Program Optimization, Endo Pharmaceuticals

Session Details:

FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

2024-05-22, 12:00 PM

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Suzy Montanye
Site Relationship Manager, Endo Pharmaceuticals

Session Details:

Site management: building a strong partnership with sites to ensure you are a sponsor of choice

2024-05-21, 11:00 AM

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Deanna Lutte
Senior Clinical Trial Manager, Clinical Operations, Endo Pharmaceuticals

Session Details:

FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

2024-05-22, 12:00 PM

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Laurie Taraborrelli
Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-05-22, 3:30 PM

Session Details:

Selecting vendors and CRO partners: what are the most important considerations?

2024-05-22, 10:00 AM

Session Details:

CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

2024-05-22, 2:30 PM

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Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc

Session Details:

Chairperson’s closing remarks

2024-05-21, 5:30 PM

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Sonnika Lamont
Analyst, Clinical Trials Intelligence, GlobalData Plc

Session Details:

Site selection for increased patient recruitment and retention

2024-05-22, 9:00 AM

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Blake Edward Wilson
Partner (FDA Regulatory), Hogan Lovells

Blake Wilson is a Partner in Hogan Lovells’ FDA Regulatory group.  He holds a juris doctorate from the University of Pennsylvania and a master’s degree in biostatistics from Columbia University.  Prior to becoming an attorney he managed Phase I and II pharmaceutical trials at Brown University.  His legal practice focuses on FDA’s premarket approval process for drugs/biologics/devices, oversight of clinical trials including BIMO audits, as well as navigating changes in laws or regulations that govern the life sciences industry.  He also guides sponsors through the special designation programs available at the premarket stage, like RMAT, accelerated approval, and breakthrough.  In this capacity, Blake advises extensively on novel products, study design considerations, and the use of clinical data in FDA-related matters.  By stress testing clinical materials through the lens of an FDA reviewer, Blake helps sponsors avoid pitfalls that can delay or derail a project.

Session Details:

PANEL DISCUSSION: AI and digitalization in clinical trials

2024-05-21, 11:00 AM

Session Details:

Topic TBC

2024-05-22, 10:00 AM

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Dija Atta
Senior Director, Clinical Operations, Incyte

Session Details:

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

2024-05-21, 3:00 PM

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Patti O’Malley
Associate Director, Strategic Relationship Management, Incyte

Session Details:

PANEL DISCUSSION: Fostering a strong relationship with your CRO

2024-05-22, 9:00 AM

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Harsha K. Rajasimha
MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-05-22, 3:30 PM

Session Details:

CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

2024-05-22, 2:30 PM

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Derek Shannon
Director, Statistical Project Management, Madrigal Pharmaceuticals

Session Details:

PANEL DISCUSSION: AI and digitalization in clinical trials

2024-05-21, 11:00 AM

Session Details:

AI 101: the opportunities of AI for clinical trials

2024-05-21, 12:00 PM

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Kathleen Cohen
Vice President, Clinical Development, Marinus Pharmaceuticals
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Rosanne Petros
PMP, Associate Director, Clinical Research, Merck Research Laboratories

Session Details:

The impact of high turnover of site staff on data collection and what sponsor companies can do to help

2024-05-21, 3:00 PM

Session Details:

PANEL DISCUSSION: Has DCT passed its peak in popularity?

2024-05-22, 11:00 AM

Session Details:

CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

2024-05-22, 2:30 PM

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Kristen Olszyk
Senior Director, Clinical Scientist, Neuraptive Therapeutics

Kristen Olszyk joined Neuraptive in March 2020 and is the Acting Head of Clinical Operations.  She brings with her 20 years in the pharmaceutical industry.  Kristen’s areas of expertise include data science, clinical development, clinical operations and regulatory affairs, and she has been involved with several successful regulatory submissions in multiple therapeutic areas.  Prior to joining Neuraptive, Kristen held positions at Wyeth Pharmaceuticals/Pfizer, Endo Pharmaceuticals and Paratek Pharmaceuticals.

 

Kristen earned her Bachelor of Science degree in Biochemistry from The Pennsylvania State University and her Master of Science degree in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy.

Session Details:

PANEL DISCUSSION: Has DCT passed its peak in popularity?

2024-05-22, 11:00 AM

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Dr Nikolaos Tezapsidis
President and Chief Executive Officer, Neurotez

Session Details:

CASE STUDY: Targeting Alzheimers: rationale and clinical trial plans at Neurotez

2024-05-21, 5:00 PM

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Douglas Kling
Chief Operating Officer, NewAmsterdam Pharma

Session Details:

PANEL DISCUSSION: Fostering a strong relationship with your CRO

2024-05-22, 9:00 AM

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Ram Raju
Senior Vice President and Community Health Investment Officer, Northwell Health

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.

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-05-22, 3:30 PM

Session Details:

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

2024-05-21, 3:00 PM

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Susan Neal
Director, Clinical Operations, Novavax

Session Details:

Effective patient education to increase enrolment and retention

2024-05-21, 2:00 PM

Session Details:

PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

2024-05-22, 12:00 PM

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Priya Marreddy
Vice President, Clinical Operations, OnCusp Therapeutics

Session Details:

PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

2024-05-21, 9:30 AM

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Kelly Franchetti
Patient Advocate
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Tajuana Barron
Vice President, Project Management, PCM Trials

Session Details:

Access for all: how mobile visits help sponsors meet new diversity goals

2024-05-21, 12:30 PM

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Jenifer Waldrop
Executive Director, Rare Disease Diversity Coalition

Jenifer Ngo Waldrop joined the Black Women’s Health Imperative (BWHI) as Executive Director of the Rare Disease Diversity Coalition (RDDC) in October 2022. Before joining the leadership team of RDDC, she developed models and programs for diversity, equity, and inclusion initiatives to support multiple business units with Fortune 500 companies and organizations in Asia, Canada, and the US.

Jenifer has led initiatives at non-profit organizations where she recruited local community members to participate in numerous health-related fundraising events and developed programs to target disparities and underrepresented groups. In addition to facilitating development and fundraising, Jenifer developed a reputation for successful coalition building.

Jenifer received her undergraduate degree from Colby College and her Master of Human Resources Development from Villanova. As the Professional Development Director of the National Association of Asian-American Professionals (NAAAP) of Colorado, Jenifer continues her outreach in society. Through this organization, she mentors formally and informally.

Session Details:

Insights into barriers to care in the rare disease community

2024-05-21, 12:00 PM

Session Details:

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

2024-05-21, 3:00 PM

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John J. Seman
Chief Executive Officer, REVITALE Pharma

Session Details:

PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

2024-05-21, 9:30 AM

Session Details:

PANEL DISCUSSION: Fostering a strong relationship with your CRO

2024-05-22, 9:00 AM

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Hal J. Mann
Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions

I am a Clinical Research Professional with more than 30 years of experience ranging in perspective from the Study Site, small and large CRO’s, large Pharma, and large Diagnostics companies.  During my 15 years with GlaxoSmithKline, I spent my early years designing and conducting Clinical Trials before focusing on supplier management and strategic outsourcing.  In 2013, I joined Roche Molecular in Pleasanton, CA, where I currently lead a chapter in Clinical Development and Medical Affairs delivering Clinical Contracts & Outsourcing, Clinical Supplies Management, Functional Excellence / Clinical Quality, Clinical IT Solutions and Analytics, and sample management and testing from our internal Clinical Trial Support Lab.

Session Details:

PANEL DISCUSSION: Fostering a strong relationship with your CRO

2024-05-22, 9:00 AM

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-05-22, 3:30 PM

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Subs Tripathy
Head of Global Procurement, Seagen

Session Details:

Forecasting and budgeting for your clinical trial

2024-05-21, 4:00 PM

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Jessica King
Head of Clinical Operations, Sonnest

Session Details:

PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

2024-05-21, 9:30 AM

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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.

Session Details:

Digitalization in clinical trials: a 360 view

2024-05-21, 4:30 PM

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MarieElena Cordisco
MA, NP-C, Senior Director, Therapeutic Strategy Lead, Metabolic, Worldwide Clinical Trials

MarieElena has been active in both research and clinical care through her career.  She brings more than ten years of leadership experience in clinical research sites management to the Worldwide team. She is also a clinically active nurse practitioner with more than 17 years of experience and a specialty in endocrinology. She has served as principal and sub-investigator for cardiometabolic trials and holds publications in peer-reviewed and high-impact journals. She is passionate about bringing her understanding of the patient journey to the Worldwide team.

Session Details:

Reserved for Worldwide Clinical Trials

2024-05-21, 11:30 AM

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