15th Annual Outsourcing in Clinical Trials New England 2023

This year's Outsourcing in Clinical Trials New England event will boast 3 tracks on Clinical Operations and Outsourcing, Clinical Technology and Innovation, and Patient Recruitment and Engagement, meaning for anyone involved in the operational aspects of running a clinical trial, there truly is something for everyone.

1 - 2

November

2023
  • John B. Hynes Veterans Memorial Convention Centre, Boston, USA
  • Complimentary
close

Why attend?

YOUR CHANCE TO MEET AND CATCH UP WITH COLLEAGUES FROM ACROSS THE INDUSTRY

As this event returns to an in-person format, you can look forward to a networking focused event with industry leading presentations, interactive formats and the most innovative solution providers attending. Hear from industry leading speakers, Learn what is round the corner in terms of future trends and get the latest knowledge on new and upcoming disruptors.

  • Keynote presentations on the topics affecting you: from COVID to shipping to disruptive technologies
  • Join in with audience discussions, panel debates and add your voice to the conversation

700+

Attendees

80+

Exhibitors

50+

Speakers

700+

Attendees

80+

Exhibitors

50+

Speakers

Agenda

  • 1 Nov 2023
  • 2 Nov 2023
Expand All

Streams

Stream one

Clinical Outsourcing and Operations

Stream two

Clinical Technology and Innovation

Stream three

Patient Recruitment and Engagement

11 AM

PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

  • The importance of ensuring your patient population is diverse
  • Strategies to improve diversity, equity and inclusion in your trial
  • Building trust and relationships with communities who may not traditionally participate in clinical trials
  • Innovative methods of engaging with the wider patient community
  • Best practice in working closely with patient advocacy groups

MODERATOR:

Behtash Bahador, Director, Health Literacy, CISCRP

Speakers

11:30 AM

Accelerated performance of complex exploratory patient studies: practical insights from investigational site

  • Global challenges and industry trends
  • Research clinics dedicated to early patient trials
  • Key elements to consider when planning a Phase Ib/IIa patient trial
  • Case studies

Speakers

12 PM

Benchmarking patient enrollment and use of recruitment tactics

  • An overview of Tufts CSDD’s study on study and site level metrics on patient enrollment effectiveness and site activation rates
  • Global recruitment and retention tactics
  • Benchmarking results for enrollment and site activation
  • Differences and similarities in cycle times and performance across therapeutic areas

Speakers

12:30 PM

Session reserved for TFS HealthScience

1 PM

Lunch and networking break

2 PM

Working closely with advocacy groups around clinical trial design

  • Key considerations in designing a patient-centric clinical trial
  • How to bring the patient voice into your clinical trial design
  • Engaging patient advocacy groups from the beginning of your design process and benefits of this

Speakers

2:30 PM

How do we make participation in clinical research more patient-friendly

  • Barriers to patient participation in clinical research
  • Pre- and post-pandemic patient expectations
  • Balancing the need for robust data collection and reduced patient burden
  • What does – a potential – future hold?

Speakers

3 PM

Designing patient engagement strategies to inform clinical trial recruitment

  • An overview of frameworks developed around patient recruitment and engagement
  • How to best engage patients, caregivers and advocacy groups in your clinical trial design
  • Key considerations in ensuring your patient recruitment strategy is as patient-centric as possible

Speakers

3:30 PM

Afternoon refreshments and networking break

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

FIRESIDE CHAT: Reducing the burden of clinical trials on patients: what tools are available?

  • Culture shift from the inside out: opportunity to briefly immerse yourself in the clinical trial journey from a patient’s perspective
  • What are the main barriers for patients participating in clinical trials and how can these be minimized?
  • Incorporating technology to support patients and increase engagement and retention

INTERVIEWER: Robert Loll, Senior Vice President, Business Development and Strategic Planning, Praxis

Speakers

4:30 PM

The innovations of decentralized clinical trials

Speakers

5 PM

CASE STUDY: Working with diverse groups in order to meet achieve DEI in clinical trials

  • How to recruit and engage populations who would not typically participate in clinical trials
  • Ensuring your clinical trial participants are representative of the general population
  • Overcoming common challenges around diversity and inclusion

Speakers

5:30 PM

Chairperson’s closing remarks

Speakers

END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY KPS LIFE

11 AM

Reserved for

Speakers

11:30 AM

TECHNOLOGY SPOTLIGHT: Running up that hill: accelerate cycle times and reach patients faster with elluminate

Learn how elluminate and eClinical’s Biometrics Services deliver:

  • Operational insights across numerous data sources that provides definitive answers and analytics on enrollment, protocol compliance and safety
  • Improved study oversight with a holistic view of risk across all data sources
  • 50 out-of-the-box visualizations to support cross-study analysis for deeper insights with self-service access to clinical and operational analytics
  • Increased productivity across data management, medical monitoring, clinical operations, clinical programming and statistical analysis roles

Speakers

12 PM

PANEL DISCUSSION: Is DCT old news?

  • How we should be thinking about decentralization in the long term
  • Hybrid vs decentralized vs traditional clinical trial models: the pros and cons of each
  • Which indications and therapeutic areas does DCT have potential in?
  • FDA regulations and guidance around DCT
  • Incorporating elements of DCT into your clinical trial: is this now commonplace or are we moving away from this?
  • Working with vendors and CROs in order to deliver decentralized and hybrid clinical trials

MODERATOR:

Christine Hurley, Vice President, Clinical Business Operations and Innovation, Relay Therapeutics

PANELLISTS:

Harry Barnett, Executive Chairman, Lubris Biopharma

Mackenzie Johnson, SM, Patient Centricity, Moderna

Senior representative, ICON Plc

Senior representative, Medidata

Speakers

12:30 PM

Hybrid trials using DCT technology and processes: focus on patients and the sites

  • Highlighting the complexity that Hybrid/DCT brings whilst moving away from the common brick-and-mortar sites
  • Discussing the rise in regulator concerns in areas such as investigator oversight, and participant’s safety when face to face contact is limited
  • 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 hybrid/DCT 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

1 PM

Lunch and networking break

2 PM

PANEL DISCUSSION: The impact and potential of new AI tools in clinical trials

  • ChatGPT and its potential in supporting clinical trials
  • What risks and potential pitfalls are there when using AI?
  • Does AI eliminate the need for a human, or is it simply a tool?
  • How FDA guidelines impact the use of AI and machine learning in clinical trials

Speakers

2:30 PM

Session reserved for YPrime

3 PM

Incorporating real world evidence into clinical trials: what new opportunities are created?

  • Tapping into the full potential of real world evidence and incorporating this into your trial
  • Barriers to adopting real world evidence: how to address and overcome these
  • Navigating regulations in the USA in relation to the use of real world evidence in clinical trials

Speakers

3:30 PM

Afternoon refreshments and networking break

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: Implementing eClinical technology in a medical device setting

  • Implementing EDC, CTMS and eTMF for a medical device trial and what benefits these can bring
  • Choosing between technology providers: what are the main factors in decision-making?
  • Common challenges and hurdles when introducing new systems to your medical device clinical trial
  • Considerations for medical device trials compared to drug trials in EDC, CTMS and eTMF

Speakers

4:30 PM

Session reserved for

Speakers

5 PM

Key considerations when choosing vendors and partners as a small biotech

  • How specialized should your CRO be in your therapeutic area: is this the most important factor?
  • As a small biotech, what are the benefits of working with a large global CRO vs a small specialized organization?
  • Working with and collaborating with multiple vendors: considerations and best practice

Speakers

5:30 PM

Chairperson’s closing remarks

Speakers

END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY KPS LIFE

7:30 AM

Registration and refreshments

8:20 AM

Chair’s opening remarks

Speakers

8:30 AM

OPENING KEYNOTE: Innovation in the US pharma industry: uncovering challenges and opportunities

  • Harnessing the power of language models such as GPT to revolutionize pharma innovation
  • The potential of advanced technology to drive advancements in drug discovery, optimize clinical trials and enable personalized medicine
  • Practical takeaways: how you can leverage AI and Generative AI to achieve transformative innovation in your clinical trial

Speakers

9 AM

Solving the clinical data challenge

Patient centricity requires data centricity to integrate and manage a growing variety of data sources. The challenge lies in integrating and managing those sources to deliver high-quality data. How do we overcome this?

  • Moving from manual, reactive data review and cleaning to proactive, risk-based approaches based on integrated data
  • Providing clinical data management and monitoring teams with workflows and analytics that support their day-to-day functions
  • Leveraging technologies that incorporate AI to automate manual tasks and identify potential issues sooner

Speakers

9:30 AM

PATIENT ADVOCACY KEYNOTE: Patient experience in oncology trials: lessons learned from a patient advocacy-driven, decentralized clinical trial

  • How easy and accessible are oncology trials to patients, and where are the main hurdles?
  • What do pharma and biotech sponsors need to be doing in order to ensure a reduced burden on patients participating in clinical trials?
  • Decentralized clinical trials: and what are the benefits and challenges of incorporating elements of decentralization into your clinical trial from a patient perspective?

Speakers

10 AM

Session reserved for Novotech

10:30 AM

Morning refreshments and networking break

11 AM

Choosing a vendor as a small biotech: creating a hierarchy of considerations

  • What are the most important factors when selecting vendors and CROs for your clinical trial?
  • Is it always crucial to have trial partners with expertise in your therapeutic area?
  • Should cost be the primary factor in vendor selection?

Speakers

11:30 AM

Simplifying protocols to enable home-base trial activities

  • How simplification of a protocol for Parkinson’s disease enabled a home-based trial
  • Lean Design approach to radical simplification: results for Merck protocols
  • Overcoming resistance to simplification: common issues

Speakers

12 PM

Choosing the right site for your study: key factors

  • Selection criteria when identifying sites: what should you measure?
  • Transparency around site costs: ensuring you are budgeting and forecasting efficiently
  • Building a strong relationship with your site in order to maximize study success

Speakers

12:30 PM

Assessing risk in your clinical trial using the Pediatric Risk Assessment Map (PRAM):

  • An interactive, reusable, and shareable tool that helps to identify common risks that may exist in a pediatric clinical trial
  • Populates with risk category and mitigation strategies for consideration when risk is identified
  • Tallies and populates key risks and categories identified

Speakers

1 PM

Lunch and networking break

2 PM

CASE STUDY: Best practice in managing ongoing relationships with CROs, vendors and other partners

  • Communicating and liaising effectively with CROs: overcoming common challenges
  • Creating and fostering a long term relationship with vendors
  • Balancing levels of vendor oversight in your clinical trial

Speakers

2:30 PM

Continued evolution of cell and gene therapy development programs

  • Technology-based development trends
  • Driving success in either unexplored settings or in saturated market settings
  • Context-dependent stakeholder engagement

Speakers

3 PM

Biomarker opportunities in FiH and clinical pharmacology studies run in an outsourcing model

  • Introduction: history of “fully outsourced” studies at Novartis
  • Personalized medicine and the shift in clinical trial goals
  • CRO relationships with biomarkers
  • Lessons learned from biomarkers
  • Balancing risks vs benefits

Speakers

3:30 PM

Afternoon refreshments and networking break

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 and you will need to be physically present to be eligible for a prize. Make sure you don’t miss out!

4 PM

PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

  • Establishing upfront communication on responsibilities and escalation processes
  • What do vendors expect from sponsors in terms of oversight?
  • Best practice in building a strong relationship with vendors
  • Regulatory guidance for sponsors around vendor communications and oversight: what do you need to be doing as a sponsor?

MODERATOR: John J Seman, CEO, Revitale Pharma

Speakers

4:30 PM

Innovative processes to better address today’s trial dynamics

  • Supply chain efficiency: why do extra work and spend more money than necessary?
  • Payment process efficient: leverage an existing workflow process that sites use everyday
  • Understanding the total value a vendor can provide
  • Select a vendor that can demonstrate its total value (and make you look good in the eyes of your company)

Speakers

5 PM

Designing a vendor strategy that works for your clinical trial

  • Choosing between one full service CRO and working with multiple vendors: what are the main advantages and disadvantages?
  • Ensuring sponsors, vendors and sites are aligned under one shared goal
  • Overcoming challenges around communication with vendors in order to create strong relationships

Speakers

5:30 PM

Chairperson’s closing remarks

Speakers

END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY KPS LIFE

Streams

Stream one

Clinical Outsourcing and Operations

Stream two

Clinical Technology and Innovation

Stream three

Patient Recruitment and Engagement

9 AM

Patient centricity through health literacy

  • Sponsor funded initiatives that incorporate Health Literacy into the clinical trial lifecycle
  • Beginning patient involvement before the study: building awareness of clinical research
  • The importance of partnership and co-development throughout the research lifecycle
  • Tools and resources available to assist research organizations in effective patient centricity planning

Speakers

9:30 AM

The importance of scientific validation and data integrity when using accessibility features

  • FDA recommendation for accessible features and designs to increase clinical trial inclusivity eg zoom in/zoom out functionality
  • Importance for patients who may have visual impairments, hearing, motor and dexterity, or cognitive difficulties that may impact inclusivity into clinical trials
  • Significance of deploying these functionalities where the drug under study may cause visual impairment such as certain oncology treatments or population under study, eg older adults, may have one or more impairments
  • Results of an industry-first clinical study on the ePRO instrument equivalence across accessibility features and patient communication modality preferences

Speakers

10 AM

CASE STUDY: Recruiting for a rare disease trial

  • Identifying eligible patients for an orphan drug trial: designing your recruitment campaign
  • Best practice in collaborating with patient advocacy groups for rare diseases
  • The role of social media and other online tools to drive patient recruitment for a rare disease trial

Speakers

10:30 AM

Morning refreshments and networking break

11 AM

Engaging patients in a rare disease clinical trial

  • How rare disease trials are unique when it comes to building and fostering relationships with patients
  • Reasons and tactics to engage longitudinally with rare disease patients
  • Working with patients, carers and advocacy groups for a successful patient engagement strategy

Speakers

11:30 AM

Improving randomization rates with Machine Learning and AI

  • Learn the key differences between Machine Learning and Artificial Intelligence for patient recruiting
  • Find out why study data is more impactful than patient data on predicting recruitment success
  • Discover how to combine your model's results with your business strategy to create reliable recruitment

Speakers

12 PM

Using data intelligence during to optimize geographic feasibility, site selection and patient recruitment

  • Join this session to hear Amanda Murphy speak about GlobalData’s clinical trial data, software solutions and common obstacles our clients face when trying to leverage data in planning clinical trials. She will focus on current needs to plan for very specific patient populations (race/ethnicity, biomarkers, severity, histology, etc.).

Speakers

12:30 PM

Lunch and networking break

9 AM

PANEL DISCUSSION: How to choose technology vendors for your study

  • Key questions to ask when selecting clinical trial technology
  • Building relationships with vendors in order to deliver a seamless and efficient clinical trial
  • Working with patients and advocacy groups to ensure all new technology is for the ultimate benefit of the patient
  • Making technology and systems easy for sites to adopt
  • Balancing cost and opportunity when weighing up benefits of new technology

Speakers

9:30 AM

Session reserved for Emmes

Speakers

10 AM

CASE STUDY: Revolutionizing drug delivery devices: paving the way for clinical success

  • Overview: the potential from using nose-to-brain technology to treat complex CNS disorders
  • Learnings and outcomes from running a clinical trial on a drug delivery device
  • Advancing treatment for neurogenerative diseases: how Kurve is reshaping this

Speakers

10:30 AM

Morning refreshments and networking break

11 AM

CASE STUDY: Introducing and implementing new technologies

  • Understanding and overcoming common challenges around new technology and systems
  • Compliance and support: what do you need to consider?
  • How to introduce and implement new technology smoothly, efficiently and effectively

Speakers

11:30 AM

Session reserved for IQVIA Technologies

12 PM

Innovating your data management strategy: how to stay ahead of the curve

  • Developing efficient infrastructures and processes for clinical data management
  • Navigating changing regulatory requirements around data in clinical trials
  • Key drivers for innovation: considerations for 2024

Speakers

12:30 PM

Lunch and networking break

8 AM

Registration and Refreshments

9 AM

Finances and managing your clinical trial budget as a small or medium sized biotech company

  • Cutting down your expenses without compromising on the quality of your trial
  • Forecasting and budgeting costs for your clinical trial
  • Solutions in order to ensure your trial budget stays on track

Speakers

9:30 AM

Modernizing site management and monitoring roles to meet the dynamic needs of clinical research

  • The purpose of a Site Manager and how they interact with other monitors on the study to avoid duplicate efforts and contain costs
  • When to use a Site Manager for optimal study conduct
  • The benefits a Site Manager can bring to studies with highly complex logistics, such as cell and gene therapies or rare disease trials
  • How technology drives efficiencies and streamlines communications across the various resources on a study

Speakers

10 AM

PANEL DISCUSSION: Assessing the potential of different geographical regions for running a clinical trial

  • Benefits and opportunities of running clinical trials outside of the US including Latin America, Europe, Asia and Australia
  • Do the challenges and risks outweigh the benefits of running trials internationally?
  • Understanding and navigating clinical trial regulations in different geographical regions
  • What factors are most important when choosing a location for your clinical trial?

Speakers

10:30 AM

Morning refreshments and networking break

11 AM

Leveraging CRO partnerships in effective biomarker development

  • Maintaining and tracking the CRO/sponsor partnership
  • Exploring tools and metrics that can be put in place
  • How best to utilize these in order to strengthen partnerships with CROs to ensure trial success

Speakers

11:30 AM

Session reserved for Cerba Research

12 PM

CASE STUDY: Running a clinical trial when repurposing an existing drug

  • An overview of benefits, challenges and key considerations in drug repurposing clinical trials
  • FDA regulations and guidance when it comes to drug repurposing
  • Utilizing existing safety studies to speed up your trial timeline

Speakers

12:30 PM

Lunch and networking break

1:30 PM

Operating conditions and trends impacting global clinical trial performance

  • Review macro-level drug development trends
  • Characterize the current operating environment for planning and executing clinical trials
  • Discuss underlying drivers of inefficiency and poor performance
  • Explore new strategies to address and counter the effect of underlying drivers

Speakers

2:15 PM

Forging the future with CTMS

Clinical trials play a crucial role in medical advancements. With increasing challenges, it is essential for our tools to adapt. CTMS represents a significant step forward in how we manage these trials, and by utilizing it effectively, we can improve the healthcare landscape for everyone.

Speakers

2:45 PM

KEYNOTE PANEL DISCUSSION: Where can we expect clinical trials to be in 2024?

  • How will new and upcoming regulations affect clinical trials, and how can sponsor companies best navigate these?
  • The impact of emerging AI tools such as ChatGPT on clinical trials: are these a challenge or an opportunity?
  • Should we still be discussing decentralization as a long term clinical trial model?
  • Where are the primary opportunities to make clinical trial participation easier on patients and thus improve recruitment, engagement and retention?

MODERATOR:

Amanda Murphy, Senior Director, Data Intelligence and Solutions, GlobalData

PANELLISTS:

Hollie Schmidt, Vice President, Scientific Operations, Accelerated Cure Project for MS

Prasanna Rao, Senior Director, Global Head of AI and ML, Pfizer

Rinaldo Dorman, MBA, CPSM, Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics

Jasmine Benger, Senior Director, Research Services, CISCRP

Speakers

3 PM

Afternoon refreshments and networking break

3:35 PM

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the conference 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 and you will need to be physically present to be eligible for a prize. Make sure you don’t miss out!

3:45 PM

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

During the roundtable discussion session, the conference hall will be divided into three ‘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. Roundtables will take place in the Stream B conference room.

ROUNDTABLE 1: US vs international CROs: which is best for your trial?
Vikas Agarwal, Vice President, Head of Program Development, Greenfire Bio

ROUNDTABLE 2: Managing clinical trial budgets effectively
Marilyn Fontaine, Director, Clinical Operations, AnHeart Therapeutics

ROUNDTABLE 3: Delivering large and complex clinical trials with cross functional teams
Jenny Bentsen Gordon, Vice President, Head of Clinical Operations, Editas Medicine

Speakers

End of Conference

5 PM

Chairperson’s closing remarks

Speakers

Select a speaker to learn more

Back
Hollie Schmidt
Vice President, Scientific Operations, Accelerated Cure Project for MS

Hollie Schmidt is the VP of Scientific Operations at Accelerated Cure Project for Multiple Sclerosis. She co-chairs the Research Committee of iConquerMS™, a research cohort established to perform and support patient-centered research in MS. She also founded and leads the MS Minority Research Engagement Partnership Network, a multi-stakeholder initiative aimed at increasing racial and ethnic diversity in MS research studies.

Session Details:

KEYNOTE PANEL DISCUSSION: Where can we expect clinical trials to be in 2024?

2023-11-02, 2:45 PM

View In Agenda
Next speaker
Back
Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus

Session Details:

Chair’s opening remarks

2023-11-01, 8:20 AM

Session Details:

Chairperson’s closing remarks

2023-11-01, 5:30 PM

Session Details:

Chairperson’s closing remarks

2023-11-01, 5:30 PM

Session Details:

Chairperson’s closing remarks

2023-11-01, 5:30 PM

View In Agenda
Next speaker
Back
Adrienne Gaggi
Associate Director, Clinical Development, Aldeyra Therapeutics

Session Details:

Working closely with advocacy groups around clinical trial design

2023-11-01, 2:00 PM

View In Agenda
Next speaker
Back
Deborah Howe
Global Patient Recruitment and Engagement, Alexion Pharmaceuticals

Session Details:

FIRESIDE CHAT: Reducing the burden of clinical trials on patients: what tools are available?

2023-11-01, 4:00 PM

Session Details:

Designing patient engagement strategies to inform clinical trial recruitment

2023-11-01, 3:00 PM

View In Agenda
Next speaker
Back
Rohita Sharma
PhD, Global Senior Director, LEAP Lead, Patient Insights and Solutions, Medical Affairs, Alexion Pharmaceuticals

Session Details:

FIRESIDE CHAT: Reducing the burden of clinical trials on patients: what tools are available?

2023-11-01, 4:00 PM

View In Agenda
Next speaker
Back
Shelby Abel-Kilmartin
Director, Data Management Strategic Outsourcing and Vendor Management, Alexion, AstraZeneca Rare Disease

Session Details:

PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

2023-11-01, 4:00 PM

View In Agenda
Next speaker
Back
Dr. Claudia Hesselmann
Founder and CEO, Arensia

Dr. Claudia Hesselmann, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.

Session Details:

Accelerated performance of complex exploratory patient studies: practical insights from investigational site

2023-11-01, 11:30 AM

View In Agenda
Next speaker
Back
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.

Session Details:

The innovations of decentralized clinical trials

2023-11-01, 4:30 PM

View In Agenda
Next speaker
Back
Siddharth Parulkar
Associate Director, Clinical Operations, Blueprint Medicines

Session Details:

Designing a vendor strategy that works for your clinical trial

2023-11-01, 5:00 PM

View In Agenda
Next speaker
Back
Behtash Bahador
Director, Health Literacy, CISCRP

Behtash Bahador is the Director of Health Literacy at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

Session Details:

PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

2023-11-01, 11:00 AM

Session Details:

Patient centricity through health literacy

2023-11-02, 9:00 AM

View In Agenda
Next speaker
Back
Sarah Tressel Gary
Ph.D., Senior Scientific Advisor, eCOA Clinical Science and Consulting, Clario

Session Details:

The importance of scientific validation and data integrity when using accessibility features

2023-11-02, 9:30 AM

View In Agenda
Next speaker
Back
Cathleen Platt
Vice President, 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

Session Details:

PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

2023-11-01, 11:00 AM

View In Agenda
Next speaker
Back
Marilyn Fontaine
Director, Clinical Operations, AnHeart Therapeutics

Marilyn joins us with over 12 years of pharmaceutical development experience focusing small oncology company settings.  Her career started as a Clinical Trial Associate at Sumitomo Pharma Oncology (formerly Boston Biomedical). In her time there, she led a global phase 3 study, managed the TMF department, and supported multiple studies at the program level.  She spent some time at Black Diamond Therapeutics developing process and training for the Clinical Operations department. She is currently Director of Clinical Operations at Compass Therapeutics, where she leads a program with an ongoing phase 2 and phase 2/3 study. Marilyn holds a BS in Anatomy and Cell Biology from McGill University.

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2023-11-02, 3:45 PM

Session Details:

PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

2023-11-01, 11:00 AM

Session Details:

Finances and managing your clinical trial budget as a small or medium sized biotech company

2023-11-02, 9:00 AM

View In Agenda
Next speaker
Back
Jodi Coughlin
Director, Vendor Relationship Management, Deciphera Pharmaceuticals

Jodi Coughlin, Director of Vendor Relationship Management at Deciphera Pharmaceuticals has over 15 years of industry experience spanning across small to large CRO and Sponsor organizations.  She attributes developing budgets and proposals in her early CRO days to deepening her understanding of the critical relationship between CROs and Sponsors. As she progressed in her career, Jodi transitioned to supporting Sponsor organizations in Outsourcing Management, developing processes and negotiating CRO budgets and contracts for Phase I-IV clinical trials.  Her passion for developing effective communication and governance structures expanded as she discovered a gap in “true strategic partnerships” between cross-functional trial teams.  With the addition of ICH E6 R2, Jodi found her niche as she began to lead and develop strategic and innovative vendor management and performance management oversight solutions between Sponsor and CRO matrix organizations.  She is highly passionate about establishing internal and external cross-functional communication processes and finds joy in building positive strategic partnerships that drive quality performance in support of clinical trial development.

Session Details:

Choosing a vendor as a small biotech: creating a hierarchy of considerations

2023-11-01, 11:00 AM

View In Agenda
Next speaker
Back
Stacey Limauro
Executive Director, Clinical Operations, Deciphera Pharmaceuticals

Session Details:

Choosing a vendor as a small biotech: creating a hierarchy of considerations

2023-11-01, 11:00 AM

View In Agenda
Next speaker
Back
Kim Ford Festi
Associate Director, Site Contracts and Budgets, Deciphera Pharmaceuticals

Session Details:

Choosing the right site for your study: key factors

2023-11-01, 12:00 PM

View In Agenda
Next speaker
Back
Holly Huang
Vice President, Head of Biometrics, Denovo Biopharma

Session Details:

Innovating your data management strategy: how to stay ahead of the curve

2023-11-02, 12:00 PM

View In Agenda
Next speaker
Back
Jenny Bentsen Gordon
Vice President, Head of Clinical Operations, Editas Medicine

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2023-11-02, 3:45 PM

Session Details:

CASE STUDY: Recruiting for a rare disease trial

2023-11-02, 10:00 AM

View In Agenda
Next speaker
Back
Colleen Graham
Director, Clinical Development Operations

Colleen Graham has over 20 years of extensive Clinical Research experience. She began her research career at a Clinical Site, and has held a variety of operational positions from an Ethical Review Board to CROs and Pharmaceutical companies, both large and small. Her experience includes Phases I-IV drugs, biologics and device studies across a variety of therapeutic areas working with companies such as Biogen, Pfizer, and Takeda Pharmaceuticals. Her operational experience includes resource management, process development and she has managed large-scale global studies. Colleen is currently Director of Clinical Development Operations at Momenta Pharmaceuticals, where she responsible for clinical development of M281 in rare immune-mediated diseases.

Session Details:

PANEL DISCUSSION: How to choose technology vendors for your study

2023-11-02, 9:00 AM

View In Agenda
Next speaker
Back
Neha Ghosh
Associate Director, Clinical Research, Fresenius Medical Care

Session Details:

CASE STUDY: Working with diverse groups in order to meet achieve DEI in clinical trials

2023-11-01, 5:00 PM

View In Agenda
Next speaker
Back
Amanda Murphy
Senior Director of Data Intelligence & Solutions, 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.

Session Details:

KEYNOTE PANEL DISCUSSION: Where can we expect clinical trials to be in 2024?

2023-11-02, 2:45 PM

Session Details:

Using data intelligence during to optimize geographic feasibility, site selection and patient recruitment

2023-11-02, 12:00 PM

View In Agenda
Next speaker
Back
Vikas Agarwal
Vice President, Head of Program Development, Greenfire Bio

Session Details:

PANEL DISCUSSION: The impact and potential of new AI tools in clinical trials

2023-11-01, 2:00 PM

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2023-11-02, 3:45 PM

View In Agenda
Next speaker
Back
Blake E Wilson
Partner, Hogan Lovells LLP

Session Details:

PANEL DISCUSSION: The impact and potential of new AI tools in clinical trials

2023-11-01, 2:00 PM

Session Details:

PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

2023-11-01, 11:00 AM

View In Agenda
Next speaker
Back
Chris Cain
Vice President, Clinical and Regulatory Affairs, Hyalex Orthopaedics

Session Details:

PANEL DISCUSSION: Assessing the potential of different geographical regions for running a clinical trial

2023-11-02, 10:00 AM

View In Agenda
Next speaker
Back
Missy Hansen
Paediatric Strategy Liaison, ICON Plc

Session Details:

Assessing risk in your clinical trial using the Pediatric Risk Assessment Map (PRAM):

2023-11-01, 12:30 PM

View In Agenda
Next speaker
Back
Jenny Wakefield
Senior Director- Quality Development Operations, Incyte

Jenny Wakefield is an Adult and Pediatric Oncology and Critical Care Registered Nurse, ACRP-CP and CCRA Certified. Jenny graduated with her BSN from Florida International University in Miami, Florida, and has worked in Clinical Research since 1997 in a variety of roles, at the Site, CRO and Sponsor levels in all Phases of Global Clinical Trials and multiple disease indications. With her diverse experience, Ms. Wakefield brings a unique level of insight to the challenges faced in the management of Clinical Trials. Jenny currently is the Senior Director of Quality and Clinical Operations at Incyte. Ms. Wakefield’s specific focus is delivering Quality Programs with a humanistic approach, blending what’s expected from Clinical Research Professionals with what the real world presents.

Next speaker
Back
Kelsey Miller
Director, Clinical Development, Intrinsic Therapeutics

Kelsey started her career in academics with The Boston Spine Group at the renowned New England Baptist Hospital. There she developed and managed their patient registries as well as their investigator and IDE clinical trials.  After 7 years at the Baptist she joined Impliant (a start-up medical device company), where she served as their Clinical Marketing Manager overseeing their US IDE, as well as post-market clinical trials in Brazil, Israel and Belgium. Since 2011 Kelsey has been with Intrinsic Therapeutics in their Clinical department successfully guiding the company’s flagship product through PMA approval.

Session Details:

PANEL DISCUSSION: Assessing the potential of different geographical regions for running a clinical trial

2023-11-02, 10:00 AM

View In Agenda
Next speaker
Back
Lori Clark
Senior Director, IT Portfolio and Project Management, Karyopharm Therapeutics

Session Details:

CASE STUDY: Introducing and implementing new technologies

2023-11-02, 11:00 AM

View In Agenda
Next speaker
Back
Leonella Seeley
Associate Director Of Vendor Management And Operations, Karyopharm Therapeutics

Session Details:

Key considerations when choosing vendors and partners as a small biotech

2023-11-01, 5:00 PM

View In Agenda
Next speaker
Back
Judith Murphy
Executive Director, Centralized Contracting and Outsourcing, Kura Oncology

Session Details:

PANEL DISCUSSION: Assessing the potential of different geographical regions for running a clinical trial

2023-11-02, 10:00 AM

View In Agenda
Next speaker
Back
David Sherris
Chief Executive Officer, GenAdam Therapeutics

Dr. Sherris has over 30 years’ experience in translational medicine involving basic research, pharmaceutics and diagnostics. Dr. Sherris has been a successful serial entrepreneur developing biotechnology companies from the ground up, devising corporate strategy, enacting programs and carrying companies through funding and acquisition. Dr. Sherris prides himself as a “roll up your sleeves” CEO, entrepreneur, business development officer, drug developer and scientist, not simply a delegator. Dr. Sherris has worked with venture capital companies, investment banks and angel investors where he has advised and raised well over $100 million for biotech companies. Dr. Sherris has been employed by pharmaceutical and biotechnology companies to manage external (academic groups and contract research organizations) and internal (directly manage, augment and expand internal scientific programs) research and development. Dr. Sherris has been a frequently invited guest speaker at biopharmaceutical business and scientific conferences, a published author and holder of patents in a wide range of therapeutic areas including oncology, ophthalmology, dermatology, neurology, gene therapy and infectious disease. Dr. Sherris has held positions of increasing responsibility in public and private companies. Dr. Sherris has developed drugs from the bench to the clinic, partnered technologies to pharmaceutical companies and raised capital for companies at the triple digit million dollar levels.

Next speaker
Back
Harry Barnett
Executive Chairman And Founder, Lubris BioPharma

Harry Barnett Harry is the co-founder and Executive Chairman of Lubris BioPharma, a clinical-stage biotech company developing a proprietary version of the novel, ubiquitous human protein, PRG4, for use in multiple indications.  Novartis owns rights to Lubris’ technology for ophthalmology. Harry’s two-decade life science career includes: (i) co-founding and executive management roles at three life science companies and two CROs; (ii) incubating, partnering and licensing successfully a wide array of pharmaceutical products and technologies including Pepcid Complete®, the OTC hearburn remedy sold by J&J, and; (iii) innovating multi-center, clinical trial processes using techniques that have been adopted as industry standard.  Prior to his transition to life science and biotech, Harry was a transactional business lawyer in private practice at DLA Piper in San Diego, and later at Faneuil Advisors, Inc., an investment advisory firm based in Boston where he served as General Counsel and Executive Vice President.

Session Details:

PANEL DISCUSSION: Is DCT old news?

2023-11-01, 12:00 PM

Session Details:

PANEL DISCUSSION: Assessing the potential of different geographical regions for running a clinical trial

2023-11-02, 10:00 AM

View In Agenda
Next speaker
Back
Mackenzie Johnson
Senior Manager, Patient Centricity, Moderna

Session Details:

PANEL DISCUSSION: Is DCT old news?

2023-11-01, 12:00 PM

View In Agenda
Next speaker
Back
Rana Said
Biomarker Study Coordinator, Novartis

Rana Said is a second year Biomarker Development fellow at Novartis in conjunction with MCPHS. She graduated from Rutgers with her PharmD in May 2022. At Novartis her primary focus is operational support for biomarker sampling on early clinical trials including setting up CRO support for studies. In addition, she works closely on the team that manages the CRO relationship for the Translational Medicine group, with a focus on managing issues.

Session Details:

Leveraging CRO partnerships in effective biomarker development

2023-11-02, 11:00 AM

View In Agenda
Next speaker
Back
Kathryn Duschean
Senior Scientist, Laboratory Excellence and Operations, Novartis

Dr. Kathryn Duschean is a Senior Scientist in Biomarker Development at Novartis Institutes for Biomedical Research in Cambridge, MA, following a 2-year post-doctoral fellowship. She is currently involved in biomarker operational planning, focusing on streamlining fully outsourced studies containing biomarkers. She is also involved in the implementation, and validation of novel patient-centric sampling techniques across a variety of therapeutic areas. Her deep personal passions and former research in autoimmune and related conditions heavily influence and progress her interests and projects in this area. She believes that engaging with internal and external partners is critical to advancing the capabilities of clinical trials, including recruitment and decentralization. Kathryn received both bachelors in English, and in Health Sciences from the University of Iowa, and her PharmD from the University of Colorado.

Session Details:

Biomarker opportunities in FiH and clinical pharmacology studies run in an outsourcing model

2023-11-01, 3:00 PM

View In Agenda
Next speaker
Back
Nan Doyle
Patient Advocate

Session Details:

Engaging patients in a rare disease clinical trial

2023-11-02, 11:00 AM

View In Agenda
Next speaker
Back
Prasanna Rao
Senior Director, Global Head of AI and ML, Pfizer

Prasanna Rao is an AI practitioner and Industry Thought Leader whose current role is Head of Artificial Intelligence and Data Science for Data Management at Pfizer. He has 30 years of experience in Information technology and Analytics, with 10+ years in Healthcare and Life Sciences. In his previous role as a Watson Solution Architect at IBM, he was instrumental in implementing many different AI systems from idea to implementation with various clients. In his current role, he works with various stakeholders, vendors, business SMEs, Machine Learning developers, and Data Scientists to deliver innovation and drive adoption of AI. He has presented at several industry conferences including SCDM, DIA and SCOPE.

Session Details:

OPENING KEYNOTE: Innovation in the US pharma industry: uncovering challenges and opportunities

2023-11-01, 8:30 AM

Session Details:

KEYNOTE PANEL DISCUSSION: Where can we expect clinical trials to be in 2024?

2023-11-02, 2:45 PM

View In Agenda
Next speaker
Back
Stacey Oppenheimer
Imaging Vendor Oversight and Sourcing Strategy Lead, Pfizer

Session Details:

PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

2023-11-01, 4:00 PM

View In Agenda
Next speaker
Back
Robert Loll
Senior Vice President, Business Development and Strategic Planning, Praxis

Robert Loll is the SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies with award-winning creative and superior execution.

Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 15 years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.

Robert received a BA from the University of Iowa and completed the Athletic Training Curriculum Program within the Department of Exercise Science and Physical Education. Post-graduate courses include exercise science and Clinical Pharmacology, Drug Development, and Regulation with the Center for the Study of Drug Development at Tufts University.

Robert is an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP) an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

Session Details:

FIRESIDE CHAT: Reducing the burden of clinical trials on patients: what tools are available?

2023-11-01, 4:00 PM

View In Agenda
Next speaker
Back
Nicole Stansbury
Senior Vice President and Head of Global Clinical Operations, Premier Research

Nicole Stansbury joined Premier Research in May 2023 as the Senior Vice President and Head of Global Clinical Operations. Prior to joining Premier, Nicole spent 25 years in the CRO industry where she served in leadership roles including Global Head of Clinical Trial Management, Global Head of Central Monitoring, and Head of Global Clinical Performance, a team responsible for SOPs, metrics, training, clinical systems, and clinical quality. Nicole’s 30 years of industry experience has included positions at the site level and other CRO roles such as CRA and Project Manager.

Nicole’s therapeutic experience has primarily been in Dermatology, Gastroenterology, Urology and Women’s Health; however, Nicole has leadership experience overseeing trials in Oncology, Neuroscience and General Medicine.

Nicole has a Bachelor’s in Animal Science from Texas A&M University and has a Lean Six Sigma Yellow Belt. Nicole has served as Co-Lead for the Association of Clinical Research Organization’s (ACRO) Risk-Based Monitoring (RBM) Working Group since 2014 where she works with TransCelerate and global regulatory authorities on driving RBM adoption in the industry.

Nicole is a member of PhUSE, collaborates regularly in industry publications, and is a frequent presenter and panelist at SCOPE, DIA, and other industry conferences.

Session Details:

Modernizing site management and monitoring roles to meet the dynamic needs of clinical research

2023-11-02, 9:30 AM

View In Agenda
Next speaker
Back
Christine Hurley
Vice President, Clinical Business Operations and Innovation, Relay Therapeutics

Session Details:

CASE STUDY: Best practice in managing ongoing relationships with CROs, vendors and other partners

2023-11-01, 2:00 PM

Session Details:

PANEL DISCUSSION: Is DCT old news?

2023-11-01, 12:00 PM

Session Details:

PANEL DISCUSSION: How to choose technology vendors for your study

2023-11-02, 9:00 AM

View In Agenda
Next speaker
Back
Emily Matthews
Senior Manager, Clinical Business Operations, Relay Therapeutics

Session Details:

CASE STUDY: Best practice in managing ongoing relationships with CROs, vendors and other partners

2023-11-01, 2:00 PM

View In Agenda
Next speaker
Back
John J Seman
Chief Executive Officer, Revitale Pharma

Session Details:

PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

2023-11-01, 4:00 PM

Session Details:

CASE STUDY: Running a clinical trial when repurposing an existing drug

2023-11-02, 12:00 PM

View In Agenda
Next speaker
Back
Shari Coslett
Vice President, Clinical Operations, Rhythm Pharmaceuticals

Session Details:

PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

2023-11-01, 4:00 PM

View In Agenda
Next speaker
Back
Kara Titus
Head, Clinical Vendor Management, Sage Therapeutics
Next speaker
Back
RINALDO DORMAN
MBA, CPSM, Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics

Session Details:

KEYNOTE PANEL DISCUSSION: Where can we expect clinical trials to be in 2024?

2023-11-02, 2:45 PM

View In Agenda
Next speaker
Back
Nancy Goodman
Associate Director, Clinical Operations Program Leader, Takeda

Nancy Goodman is a Registered Nurse, RN, BSN Nancy has 24 years in Clinical Operations, Ph. 1-4, with a focus in Early Phase, working in multiple therapeutic areas in small, medium and large biotech/pharmaceutical companies in the Boston area.  She has worked on a successful sNDA in Oncology.  Currently, Nancy is at Takeda Pharmaceuticals as an Associate Director, Clinical Operations Program Leader, COPL, Early Clinical Development.  Prior to this remit, she assumed COPL responsibilities in the Neuroscience Therapeutic area working on Neurodegenerative diseases.

Outside of work, Nancy enjoys spending time with her husband, being outdoors, cycling, hiking, kayaking and playing tennis and travel.  She is located in the Boston area.

Next speaker
Back
Jim Palma
Executive Director, TargetCancer Foundation

Jim Palma is the Executive Director of TargetCancer Foundation. Since joining TargetCancer Foundation in 2010, Jim has overseen its growth from a small start-up to a nationally recognized foundation supporting comprehensive rare cancer research programs and patient support services. Prior to joining TargetCancer Foundation, he spent eleven years at Fidelity Investments in Boston, MA. Jim is a member of the Board of Directors of the National Organization for Rare Disorders (NORD), and is a founding Co-Chair of the NORD Rare Cancers Coalition. In addition, Jim is a Steering Committee member at the GI Cancers Alliance and the Global Cholangiocarcinoma Alliance. Jim completed studies at the Institute for Nonprofit Management and Leadership at the Questrom School of Business at Boston University, and received his B.A. from Loyola University Maryland.

Session Details:

PATIENT ADVOCACY KEYNOTE: Patient experience in oncology trials: lessons learned from a patient advocacy-driven, decentralized clinical trial

2023-11-01, 9:30 AM

View In Agenda
Next speaker
Back
Meredith Frank-Molnia
Senior Director, Clinical Operations, Third Pole Therapeutics

Meredith Frank-Molnia is currently employed at Third Pole Therapeutics as Senior Director of Clinical Operations. Third Pole is a medical device company producing electrically generated nitric oxide for treatment of hypoxic respiratory failure and lung disease.  Previously, Meredith held the position of Senior Director Clinical Management, while working at Axiom Real-Time Metrics Inc., where she established and expanded their Clinical Management department. Meredith has been in Clinical Project Management/Operations for 26 years in numerous roles of increasing responsibilities. Meredith has worked managing device/biologic and drug studies.

Session Details:

CASE STUDY: Implementing eClinical technology in a medical device setting

2023-11-01, 4:00 PM

View In Agenda
Next speaker
Back
Tom Gottschalk
Senior Director, Business Development, TrialCard

Tom Gottschalk has worked in the life sciences industry for over 25 years.  His first 10 years were spent as a Pharmaceutical Representative and Product Manager for Bertek Pharmaceuticals, Merck, and GSK.  He then joined RxSolutions as a commercial services account representative before transitioning into a focused clinical role after creating the RxStudy Card offering.  He joined TrialCard in 2019 via its acquisition of RxSolutions.  For over 12 years, Tom has been committed to changing the paradigm of the traditional clinical trial supply process through the RxStudy Card.

Session Details:

Innovative processes to better address today’s trial dynamics

2023-11-01, 4:30 PM

View In Agenda
Next speaker
Back
Ken Getz
Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

Ken is the Director of Sponsored Research and Associate Professor at the Tufts Center for the Study of Drug Development, and Chairman of the Center for Information and Study on Clinical Research Participation, a non-profit organization that he founded to raise public and patient awareness of the clinical research enterprise. He is founder and owner of CenterWatch, and an owner and board member of the Metrics Champion Consortium. A well-known speaker at symposia, universities, and corporations, Ken has published extensively in peer-reviewed journals, books and in the trade press.  He has been an active DIA member for 25 years and has held board appointments in the private and public sectors.  Ken earned his MBA from Northwestern University.

Session Details:

Operating conditions and trends impacting global clinical trial performance

2023-11-02, 1:30 PM

View In Agenda
Next speaker
Back
Mary Jo Lamberti
Research Associate Professor and Director, Sponsored Research, Tufts Center for the Study of Drug Development

Mary Jo Lamberti is a Research Associate Professor at Tufts University Medical School and Director of Sponsored Research at the Tufts Center for the Study of Drug Development. She has extensive experience on benchmarking drug development operating practices. Her research focuses on a variety of areas including outsourcing and partnerships, clinical research workforce issues, investigative site initiation and management, patient recruitment and retention, and the use of technologies and digital solutions in clinical trials. She has been a frequent speaker at global industry conferences and has published extensively. She holds a B.A. from Wellesley College and a Ph.D. from Boston University.

Session Details:

Benchmarking patient enrollment and use of recruitment tactics

2023-11-01, 12:00 PM

View In Agenda
Next speaker
Back
Amy Raymond
Therapeutic Strategy Lead, Gene Therapy Think Tank, Worldwide Clinical Trials

Amy has been a drug discovery and development professional for 25+ years, including progressive roles in clinical operations and clinical strategy. Her clinical development experience spans all therapeutic areas and all stages of the clinical development lifecycle, from natural history studies through registrational global trials, and Long-Term Follow Up and Post Marketing surveillances. In addition to her deep understanding of the unique dynamics of developing novel treatments for rare and complex diseases, Dr. Raymond also leverages her combination of training and experience leading the Gene Therapy Think Tank at Worldwide Clinical Trials. This experience includes in vivo viral- vectored gene therapies, ex-vivo viral vectored and gene edited treatments for oncology and non-oncology patient communities, and RNA medicine modalities. Her experiences in academia, biotech, and CROs confirm that meeting the needs of all stakeholders – payers, regulators, patients, families, and sites – is a critical success factor for efficient development programs. Dr. Raymond completed her doctoral training in molecular biology at University of California San Diego and post-doctoral training in molecular biology at Memorial Sloan-Kettering in New York City, New York, USA.

Session Details:

Continued evolution of cell and gene therapy development programs

2023-11-01, 2:30 PM

View In Agenda
Next speaker
Back
Lisa Kang
Head, Clinical Development Operation, Yoda Pharmaceuticals

Session Details:

PANEL DISCUSSION: The impact and potential of new AI tools in clinical trials

2023-11-01, 2:00 PM

View In Agenda
Next speaker
Back
Sverre Bengtsson
Co-Founder, Senior Vice President Strategic Relations, Viedoc

Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used. Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

Session Details:

Hybrid trials using DCT technology and processes: focus on patients and the sites

2023-11-01, 12:30 PM

View In Agenda
Next speaker
Back
Evan Hahn
Senior Vice President, IRT Solutions, YPrime
Next speaker
Back
April Mattison-Wolfe
Senior Solutions Architect, TransPerfect

Session Details:

Forging the future with CTMS

2023-11-02, 2:15 PM

View In Agenda
Next speaker
Back
Hope Weisser
Senior Product Manager, TransPerfect

Session Details:

Forging the future with CTMS

2023-11-02, 2:15 PM

View In Agenda
Next speaker
Back
Ivor Clarke
Chief Innovation Officer, SubjectWell

Session Details:

Improving randomization rates with Machine Learning and AI

2023-11-02, 11:30 AM

View In Agenda
Next speaker
Back
Steven Cummings
Executive Director, San Francisco Coordinating Center at California Pacific Medical Center Research Institute

Session Details:

Simplifying protocols to enable home-base trial activities

2023-11-01, 11:30 AM

View In Agenda
Next speaker
Back
David Hadden
President, Founder and Chief Game Changer, Pro-ficiency

David Hadden is the pioneer of AI-driven Virtual Patient Simulation technology. His last company, TheraSim, trained over 1 million physicians worldwide and was sold to WebMD in 2013. At Pro-ficiency, Dave has transformed clinical research training into a powerful study resource and analytics tool, and Pro-ficiency has become the leader in the proactive, metric-driven approach to training that contradicts the traditional, check-it-off-the-list approach.

Session Details:

Session reserved for

2023-11-01, 4:30 PM

View In Agenda
Next speaker
Back
Ken Hamill
Senior Director, Clinical Operations Portfolio, Medidata Solutions

Ken Hamill is the Senior Director, Clinical Operations Portfolio, at Medidata, a Dassault Systèmes company. Ken works across the organization and with customers in their adoption of clinical operations technologies that help automate trial quality workflows. Ken also leads the development and execution of strategic marketing programs for Clinical Operations at Medidata. Prior to Medidata, Ken had over 15 years of experience in life science product management, most recently at PerkinElmer where he led the strategy team for drug discovery assay development. Ken holds an MBA in Health Sector Management from Boston University, and an BS in Chemistry from Tufts University.

Session Details:

Solving the clinical data challenge

2023-11-01, 9:00 AM

Session Details:

Registration and Refreshments

2022-10-12, 8:15 AM

View In Agenda
Next speaker
Back
Ching Tian
Chief Innovation Officer, Emmes

Session Details:

Session reserved for Emmes

2023-11-02, 9:30 AM

View In Agenda
Next speaker
Back
Jason Konn
Solution Consultant, eClinical Solutions

As a Solution Consultant, Jason works with Sponsor organizations to understand their challenges and come up with creative solutions leveraging the elluminate platform. Jason has lead design & development for several products ranging from a Data Management Workbench, Data Integrations, Clinical Operations Platform, Clinical Analytics, and Risk Based Quality Management.  Jason has been in the clinical trials industry for over 15 years and his prior experience includes, global central laboratory, eCOA design, process improvement, and building an automated workforce.

Session Details:

TECHNOLOGY SPOTLIGHT: Running up that hill: accelerate cycle times and reach patients faster with elluminate

2023-11-01, 11:30 AM

View In Agenda
Next speaker
Back
Jasmine Benger
Senior Director, Research Services, CISCRP

Session Details:

KEYNOTE PANEL DISCUSSION: Where can we expect clinical trials to be in 2024?

2023-11-02, 2:45 PM

View In Agenda
Next speaker
Back
Alex Bai
Head of Clinical Contracts, Biogen

Session Details:

Reserved for

2023-11-01, 11:00 AM

View In Agenda
Next speaker
Back
Joyce Moore
Global Head of Patient Engagement, Allucent

Session Details:

How do we make participation in clinical research more patient-friendly

2023-11-01, 2:30 PM

View In Agenda
Next speaker

Plan Your Visit

Conference Venue

John B. Hynes Veterans Memorial Convention Centre, Boston, USA

Please be aware the conference takes place in John B. Hynes Veterans Memorial Convention Centre, Boston, USA and you can book your accommodation at the Sheraton Boston Hotel, which is only 3 minutes walk from the conference venue.

Accommodation: 

Please be aware that should you be contacted by any 3rd party housing companies that they are not affiliated with us or the hotel

Sponsors

Select a sponsor to learn more

FEATURED SPONSOR

Drinks Sponsor

SESSION SPONSOR

Technology Showcase Sponsor

Associate Sponsor

Exhibitors

Co-Sponsor

Media Centre

MEDIA PARTNERS

Become A Media Partner

Your chance to meet and catch up with colleagues from across the industry

As this event hear from industry leading speakers, learn what is round the corner in terms of future trends and get the latest knowledge on new and upcoming disruptors.

▶️ Keynote presentations on the topics affecting you

▶️ Join in with audience discussions, panel debates and add your voice to the conversation

 

 

Enquiry

Contact Us

SPONSORSHIP ENQUIRIES

Nicholas McCudden

Head of OCT events

+61 280 978 126

SPEAKER ENQUIRIES

Louisa Manning

Programme Director

MARKETING ENQUIRIES

Moona Popal

Marketing Manager

SPONSORSHIP ENQUIRIES

To enquire about sponsorship opportunities for the conference, please contact:

Nicholas McCudden

Head of OCT events


+61 280 978 126

SPEAKER ENQUIRES

To enquire about speaking opportunities for the conference, please contact:

Louisa Manning

Programme Director


+44 (0)20 766 10552