Outsourcing in Clinical Trials New England 2023

Our this year's Outsourcing in Clinical Trials New England event will boast 4 tracks, meaning there truly is something for everyone

1 - 2

November

2023
  • John B. Hynes Veterans Memorial Convention Centre
  • Complimentary

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Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

We are a global provider of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

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

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

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

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

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

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    Why attend?

    The 15th Annual Outsourcing in Clinical Trials New England event will bring together clinical trial professionals from big and small biopharma to uncover new technologies and processes, to optimize their clinical and outsourcing operations.

    The two day programme will take a holistic approach to the latest challenges and innovations in clinical operations, such as, the evolvement of DCT and DTP along with regulatory updates in clinical trials. The conference will also be accompanied with case studies in clinical trial supply and medical device innovations, providing attendees the opportunities to enrich their knowledge across the space.

     

     

    Outsourcing clinical trials can be of particular interest to online casino players. Our Outsourcing in Clinical Trials event in 2023 will consist of 4 tracks, each with something for online casino source link players. In addition, this event will bring together many specialists in clinical trials, who also play in online casinos.

    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

    Testimonials

    2022 Agenda

    • 12 Oct 2022
    • 13 Oct 2022
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    7:30 AM

    Registration and refreshments

    8:25 AM

    Chair’s opening remarks

    8:30 AM

    OPENING KEYNOTE: Enabling Innovation in Spite of Barriers

    Join this session hosted by Click Therapeutics to discuss how innovation can still be pushed forward despite barriers and even in disrupted times.

    • A review of 2022 – how did we do in the “new normal”?
    • Rethinking trial design – has the barriers and disruption of the past 2.5 years shown us that different and innovative trial designs are possible?
    • Exploring how to keep pushing the clinical trials industry forward and predictions for the future of trial innovation

    9 AM

    Biotech Market Performance and the Impact on Clinical Trials and Operations

    • Trends in clinical development across the globe over the last 5 years
    • Pre and post covid impact on the clinical trial global economy
    • Patterns in investment and clinical trial equity
    • Where do the opportunities lie for further acceleration in clinical development

    9:30 AM

    Harnessing Data to Improve Study Operations and Outcomes

    Data is the centerpiece of any clinical trial, but how can you harness it’s power to improve the operational performance – and outcomes – for your clinical trial? All too often, analytics are siloed outside of clinical systems. To unlock the next wave of value from data, analytics must be embedded in core user workflows, allowing a seamless transition from insight to action.

    Learn how Medidata is unifying the power of clinical and real-world data to help customers:

    • Identify diverse patient populations to hit their enrollment targets faster
    • Continually monitor their data to identify potential issues, automatically
    • Link real-world data to clinical data to generate better insights and inform trial decisions

    10 AM

    Morning refreshments and networking

    Rare Diseases

    Chair: Robert Loll, SVP, Business Development, Praxis Communications

    Outsourcing & Clinical Operations

    Chair: Bonnie Bain, Global Head and Executive Vice President, GlobalData

    Clinical Trial Technology & Innovation

    Chair: Amanda Murphy, Director of Product Management, GlobalData

    10:45 AM

    The Importance of Patient Advocacy Through a CRO

    Advocacy is the bridge for stakeholder engagement. With intentional, thoughtful communication among all stakeholders, we can improve the lives of patients through CRO work. In this session, you will learn:

    • Best practices for thoughtful and engaged recruitment
    • The importance of providing efficiencies within a clinical study
    • How to increase and maintain better compliance within clinical studies

    10:45 AM

    Inception and Sustainability of a Remote Monitoring Hub

    • Presentation of one solution to the high demand/low capacity US CRA market
    • Outlines timelines, challenges and measurement of success
    • Evaluates future prospects of this model

    10:45 AM

    Decentralized clinical trials and hybrid trials: what you need to understand to run these successfully

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

    11:15 AM

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

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

    11:15 AM

    Mind the Gap: Improving the Diversity and Inclusion of Under-Represented Groups in Clinical Research

    • Exploring why many of us struggle to recruit a varied patient population and whether improving our recruitment can improve our study results
    • Strategies for engaging and recruiting under-represented patients including ethnic minorities, women, LGBTQ+ etc
    • The implications of not getting a diverse patient group – could this affect the safety of your product?

    11:15 AM

    A Deep Dive into Decentralised Trials: Managing the Moving Parts to Result in a Successful Trial

    • How new technologies can be employed to make decentralised trials possible and discussing what tools need to be in place before you launch a remote trial
    • Managing the administrative responsibilities that conducting trials off-site can involve – getting it right so that the trial is run efficiently and saves your staff time
    • The different models that can be utilized – from a completely virtual trial to a hybrid approach – ensuring that you pick the right model for your study in order to effectively streamline your processes

    11:45 AM

    Tackling the Challenges of Operational Delivery in Rare Oncology Studies

    Rare oncology trial pipeline is growing and is largely an unmet service need. Join our Sarah Anderson for a presentation on the challenges associated with rare oncology studies. She’ll tackle topics like:

    • What makes a rare oncology study different?
    • Importance of understanding the patient financial burden
    • Balancing site profile and advocacy awareness

    11:45 AM

    How will the Supply Chain need to adapt to support the growth of Decentralized Clinical Trials?

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

    11:45 AM

    Innovative Processes to Better Address Todays Trial Dynamics

    • Supply Chain Efficiency – Why do extra work and spend more money than necessary?
    • Payment Process Efficiency – Leverage an existing workflow process sites use everyday
    • Understanding the Total Value A Vendor Can Provide – Select a vendor that can demonstrate their total value – (and make you look good in the eyes of your company)

    12:15 PM

    The Future of Rare Disease Trials: How can we Encourage Innovation Whilst Protecting Affordability?

    • As the costs for conducting a rare disease or orphan drug rise, how can we keep costs low while innovating trials
    • Exploring the main barriers and pitfalls that can increase costs and how to tackle these early on
    • The need for innovation and a look into which innovations can have practical impacts to be worth the investment

    12:15 PM

    Facing up to Increased Trial Costs: Top Tips for Staying in Budget

    • Exploring what costs are rising in 2022 and what you need to be keeping an eye on
    • Offering advice on budgeting for large and small clinical trials
    • Top tips on how to get the best deals and keep costs down without compromising on quality

    12:15 PM

    Impact of Dosage Standardization Innovation on Stem Cell Clinical Trials Operations and Support Needs

    • A review of current practices for treatment dosages in stem cell clinical trial development and operations
    • Predictions for the regulatory horizon of dosage standardization for stem cell clinical trial development
    • Emerging technologies for rapid dosing of tissue stem cell treatments that will impact stem cell clinical trial design and operations

    12:45 PM

    Lunch and networking

    12:45 PM

    Lunch and networking

    12:45 PM

    Lunch and networking

    1:45 PM

    Sharing Experiences of Being on Both Sides of a Rare Disease Trial; Focussing on the Move Towards Decentralization and the Patient Journey

    • Addressing the implementation of DCTs with a focus on rare disease
    • Both sides of the coin: Discussing the patient experience in trials and what we can do to improve this
    • Pinpointing how we can allow more people to find out about clinical trials, especially rare disease studies
    • Exploring the importance of collaboration and education on both sides (industry and patient)

    1:45 PM

    Partnering with central lab vendors on continuous improvements

    • Building and maintaining strong partnerships with central lab vendors - how to get there?
    • How partnerships contribute to continuous improvements with central lab vendors
    • Continuous improvements through issue management, standards / workflow efficiencies, and innovation

    1:45 PM

    Patient Centric SMART Blood Sampling

    • Introducing micro-sampling devices that have shown promise in patient centric studies
    • Sharing results and data from recent Novartis trials that have utilized micro-sampling devices and platforms with success
    • Discussing methods with which micro-sampling can be utilized
    • Examining potential avenues to attain implementation of micro-sampling in decentralized trials

    2:15 PM

    IRT eCOA Orchestration Case Study: Building integrations that reduce site and sponsor burden and improve the patient journey

    • Establishing an architecture that imbeds the right business logic into your API’s and reporting strategies through sponsor/vendor collaboration
    • Looking beyond simple data exchange to opportunities to automate workflows, eliminate redundant tasks, improve study efficiencies and oversight
    • Enabling faster decision making to improves data accuracy and patient compliance by simplifying the site experience

    2:15 PM

    Fast-Track Your Phase 1 Clinical Trial in Australia

    • Understanding the FDA and TGA requirements
    • How these requirements translate into different timelines
    • Key benefits and challenges by jurisdiction
    • Choosing what's right for you

    2:15 PM

    The Importance of the Patient Journey in a Rare Disease Clinical Trial

    • Identifying patients and understanding their disease pathway
    • Designing a study that minimizes the burden on patients
    • How sites can help keep subjects enrolled and engaged

    2:45 PM

    Targeted Personalized Cancer Therapy: The Holy Grail of Cancer Treatment

    • An overview of Andarix’s technology to target lung and pancreatic cancer
    • Emphasising how to incorporate flexibility into rare disease trials from the beginning
    • Developing personalized cancer treatments: challenges and opportunities
    • Shipping products from lab to patient: what is required?
    • Results from Phase 1 studies and plans for Phase 2
    • Identifying national and international partners to make trials a success

    2:45 PM

    Who is Quality and what do they do? How can we invite Quality into the Clinical Operations conversation and into the partnership?

    • Addressing how ClinOps can do more in relation to risk management - looking at it from a GCP perspective and opening up the risk conversation
    • Discussing the recent update with E8 and how it pulls the quality and clinical sides together - what is a risk-based approach?
    • Audit findings: How the clinical side can learn from the GMP side with finding the root of the problem and addressing it
    • Instead of 'inspection readiness' we should be doing 'inspection management' from the get go

    2:45 PM

    PANEL DISCUSSION Overcoming the Barriers to Trial Innovation and Technology Access from a Small Company’s Point of View

    • Discussing the technologies accessible for the smaller biotechs
    • Assessing how to make access to innovations affordable for companies on a smaller budget and how to best allocate limited resources
    • How to work with a vendor partner as a smaller biotech to get access to new technologies
    • Removing the barriers: what still needs to be done to improve access to innovation for all

    3:15 PM

    Afternoon Refreshments and Networking

    3:15 PM

    Afternoon Refreshments and Networking

    3:15 PM

    Afternoon Refreshments and Networking

    3:45 PM

    The Dynamic Duo of Clinical Trial Recruitment

    • AI in endoscopy
    • Full access to EMR data
    • How a combination of the two (AI in endoscopy and having full access to EMR data) can impact clinical trial recruitment

    3:45 PM

    FIRESIDE CHAT: Wearables, ePRO, eConsent, Big Data: Are We Prepared for the Digital Transformation?

    • How do we decide what to invest in?
    • How can we ensure the success of digital transformations?
    • How can we implement new technologies with companies who embody the status quo?
    • Who is responsible for delivering efficiencies? Technology? End User?
    • Are we truly prepared for the digital transformation?

    4:15 PM

    Establishing and Conducting an Oncology Decentralized Clinical Trial (DCT)

    • Understanding the cancer patient journey
    • Considering the stakeholders and their needs
    • Ensuring trial outcomes and data quality

    4:15 PM

    Train the trainer: How to train patients in an era of decentralized clinical trials

    The emergence of DCTs has inspired a new way of thinking about clinical research. As the industry looked to solve the problems created by COVID-19, technologies, protocols, even regulatory standards changed. The needs of patients changed as well.

    This panel discussion will highlight:

    • Realities of patient-focused training and support in the decentralized trial environment
    • Best practices, common errors, and solutions that allow you to consider the support and training of your patients in your trial design
    • Considerations for monitoring the success of your training and support to proactively avoid issues resulting from patients misunderstanding proper trial participation

    4:45 PM

    Discussing the Results of a Tufts Survey on the Impact of Decentralized Clinical Trials on Sponsor-CRO Collaborations

    • Assessing the impact of decentralized and hybrid clinical trials on sponsor-CRO collaborations based on the results of a global survey
    • The results will also benchmark the impact of these trials on sponsor-CRO relationship structure, economics and effectiveness
    • Current and planned usage of specific DCT solutions and technologies by organizations will be discussed
    • Other areas examined include approaches that organizations are taking that disrupt sponsor-CRO relationships, strategies used regarding cost and outsourcing models, as well as oversight and performance
    • Revealing regulatory and global challenges and metrics that assess effectiveness in these relationships

    4:45 PM

    PANEL DISCUSSION Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers

    We’ve all had to sit through several pitches from vendor companies telling us what they can do for us, but now it’s time to reverse the conversation! Hear from the trial industry as they discuss the services they would like to see from their solution providers, including:

    • What they like to see in an outsourced partner organization
    • What they would like a partner to know about them / how they work
    • What things do they need a partner to do and what they don’t need!
    • What things can be best done in house?

    5:15 PM

    Close of Conference & Drinks Reception hosted by KPS Life

    5:15 PM

    Close of Conference & Drinks Reception hosted by KPS Life

    5:15 PM

    Close of Conference & Drinks Reception hosted by KPS Life

    8:15 AM

    Registration and Refreshments

    Technology, Innovation & Devices

    Chair: Robert Loll, SVP, Business Development, Praxis Communications

    Outsourcing & Clinical Operations

    Chair: Judyth Zahora, Sr. Director, Global Quality Systems & Process Improvement, Agenus

    Decentralized, Remote and Virtual Trials

    Chair: Amanda Murphy, Director of Product Management, GlobalData

    9 AM

    OPENING KEYNOTE Doing your first Proof of Concept Study in “Down Under”: Lessons learned from Clinical Trials Outside of the United States

    • Decision criteria to outsource and run trials abroad, and why in “Down Under”?
    • Clinical and regulatory frameworks, workflows and agencies in Australia
    • The “Ethics Committees” – to serve and protect.
    • How to choose your Principle Investigators, trial sites and CROs wisely – without ever meeting them in person.
    • The aspect communications with another part of the world
    • The aspect logistics across borders: data and samples
    • The aspect trial budgets: subsidy, grants, tax incentives
    • What if things go wrong in a place far away? And how to straighten them out

    9 AM

    TOPIC TBC Creating More Patient-Centric Trials, What Role Can Patient Advocates Play?

    • Discussing how working with patient advocates from the pre-clinical stage can help to create more patient focused trials
    • Understanding how better patient engagement can give you an edge over your competitors
    • Exploring how to get patients more involved in the trial design decision-making process
    • How utilizing the passionate patient voice can engage others

    9 AM

    OPENING KEYNOTE Preparedness for FDA Audit for Devices: What Should you be Focusing on Right Now?

    • Back to basics: Addressing the standard aspects you should be considering each time
    • Identifying the parts companies most often get flagged for having deficiencies
    • Which sites do you want to audit and why?
    • Discuss SOPs and other procedures companies typically get in trouble for

    9 AM

    OPENING KEYNOTE Creating More Patient-Centric Trials, What Role Can Patient Advocates Play?

    • Discussing how working with patient advocates from the pre-clinical stage can help to create more patient focused trials
    • Understanding how better patient engagement can give you an edge over your competitors
    • Exploring how to get patients more involved in the trial design decision-making process
    • How utilizing the passionate patient voice can engage others

    9:30 AM

    Operationalizing Long Term Follow-up for Cell and Gene Therapies

    In this session, learn about solutions and approaches for designing long term follow-up studies when monitoring extended exposure and safety to CGT products including:

    • Distilling the regulatory requirements, both in the US and EU
    • Harnessing the benefits of decentralized trial models
    • Identifying the best approach – traditional or hybrid – given your specific study requirements
    • Reducing patient and site burden and ensuring compliance using wearable devices and app technologies
    • Managing data collection securely over the lifecycle of the study

    9:30 AM

    Increasing Patient Choice in Oncology Trials using Remote Consent

    In this session, Camila Matheny will discuss how to make remote electronic consent a standard in your consent management process to greatly ease the burden on trial participants and open up clinical trials as a care option to more cancer patients around the world.

    In this session, attendees will learn:

    • Why eConsent is applicable in every trial, not just decentralized trials
    • How remote eConsent can expand access to more diverse populations
    • The benefits of providing a better alternative to communicate complex trial information to patients
    • FDA and NCI guidance on new standards for remote consent in oncology trials

    9:30 AM

    Three Practical Use Cases to Improve Clinical Trial Efficiency with Technology

    • Using technology to work with sites
    • Using machine learning to increase efficiency
    • Leveraging interoperability to streamline operations

    10 AM

    Setting the CRO up for success – A dual accountability perspective in the launch of a CRO/Sponsor partnership

    How holding the Sponsor accountable is equally critical in the successful outcome of CRO performance.

    • Setting the partnership tone
    • How to build engaging relationships with both internal and external stakeholders that drives performance
    • Laying the foundation of counterpart communication
    • Ensuring the CRO is set up for success
    • How to solicit CRO feedback that is effective
    • Why transparency is the best policy and how to provide it

    10 AM

    Harnessing the Benefits of clinicaltrials.gov to Improve your Access to Clinical Trial Data and Movement Towards DCTs

    • Exploring the various tools at your disposal at clinicaltrials.gov
    • How this data can be of use to you
    • Best techniques and tips in data mining

    10 AM

    Global Women’s Health Innovation and Diversity

    • Exploring Women's Health, globally
    • How to Innovate on a global scale
    • How can we improve engagement by paying more of a focus on race and socioeconomic disparities?
    • Brainstorming solutions: What actions can we take now to get groups interested in participating in innovation and trials?

    10:30 AM

    Morning refreshments and networking

    10:30 AM

    Morning refreshments and networking

    10:30 AM

    Morning refreshments and networking

    11 AM

    Delving into Strategic and Functional Activities to Budget and Execute Clinical Trial Launch

    • Strategic assessment of trial designs and key metrics trial logistics
    • Modelling sponsor and site budget
    • How to best assess vendor capabilities and budgets
    • How trial design affects trial budgets and levers to control budget
    • RFP process to select the ideal vendor team

    11 AM

    A Beginner’s Guide to Decentralizing your Trials from a Small Company’s Point of View

    • An overview of different types of hybrid and DCT models
    • How you can make it work for you and your budget
    • Taking the hybrid approach – what steps towards decentralization can you take now to benefit patients and budgets

    11 AM

    PANEL DISCUSSION Exploring Repurposing Off-Patent Drugs as an Effective Clinical Trial Strategy

    Repurposing off-patent drugs has long been proposed as a cost effective and efficient strategy to develop new treatments, but its potential has not been realized. In this panel discussion, we will explore some of the barriers to adopting a repurposing strategy and gain insights on investing, drug development, and regulatory perspectives on ways to address any obstacles to achieving success.

    11:45 AM

    Internationalize Your Early Phase Clinical Trials

    • The case for international multi-center clinical trials in early phase development
    • What makes an effective international team for early phase trials
    • Operational considerations to internationalize your early phase trials

    11:45 AM

    15min Tech Spotlight: Data-Driven Operations and Oversight with elluminate

    The elluminate Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. Learn how elluminate delivers:

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

    11:45 AM

    Tell Me Why Not: Leveraging Consumer Engagement in an eClinical World

    • Patients are ready, what about sponsors?
    • What does real engagement even look like?
    • Let’s have an open discussion about why consumer engagement will and won’t work in the eClinical space

    12 PM

    15min Tech Spotlight: Herding Cats: Why Can’t Clinical Trial Collaboration Be Easier?

    The initial phase of a clinical trial relies on a constant flow of communication and documentation exchange. Yet, the tools used today haven’t changed in decades. It’s a challenge for site personnel to keep everything straight. In this session, we’ll look at a simplified approach to managing content and communication so everyone stays on the same page.

    12:15 PM

    Accelerating Digital Trials to Improve Outcome Success While Keeping Patient Experience at Heart

    • The importance of putting the human first when digitising your trials and how this is vital to the overall success of your clinical
    • Data confidence and verification: ensuring accuracy and confidence in remotely collected patient data
    • Deploying patient-centric eClinical trial strategies to maximize data efficiencies
    • Strategies for effectively working with patients in a digital trial

    12:15 PM

    The Shifting Paradigm: The Impact of Patient-Centricity Across the Lifecycle of Treatment Development

    • Explore research measuring and evaluating the “Return on Engagement” financial and efficiency value of Patient Centric activities
    • Review key regulatory developments in support of Patient Centered Research
    • Gain insights from the largest global survey on patient and public perceptions and experience in clinical research
    • Examine concrete examples of Patient Centered Research programs and project

    12:15 PM

    State of the Biopharmaceutical Industry – 2022

    We welcome Bonnie Bain from GlobalData to present her research into the state of the Biopharmaceutical Industry in 2022 and moving into 2023. Including:

    • Themes that are shaping the biopharmaceutical industry – both today and into the future
    • Key emerging technologies & disrupters
    • Industry, regulatory and macro-economic factors affecting pharma in 2022

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

    12:45 PM

    Lunch and networking

    12:45 PM

    Lunch and networking

    12:45 PM

    Lunch and networking

    1:45 PM

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

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

    2:15 PM

    Are We There Yet? Gaps in Automation of Clinical Trials

    • Identifying manual tasks and subpar tools
    • Addressing gaps in systems and workflows
    • Applying technology to everyday trial tasks
    • Improving connectivity in training, documents, information, and more

    3:15 PM

    Afternoon Refreshments and Networking

    3:45 PM

    Speaker Hosted Roundtables

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

     

    Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables.

    RT 1     A Group Exercise Focused on Working with Colleagues to Find Solutions to Stumbling Blocks that can Arise During your Trial 

    RT 2      “No Backsliding” – How to Keep Pushing Forward with Pandemic Influenced Innovations in a Normalising World

    RT 3       Promoting Diversity and Inclusion in Clinical Trials: How You Can Help to Include Under-Represented Communities 

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

    4:45 PM

    End of Conference

    2022 Speakers

    Select a speaker to learn more

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    Leigh Dallow
    Advocate For Rare Disease Research And Development, Treatment Access And Patient Support Educator, Rythm Pharmaceuticals
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    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.

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    ROBIN SUTHERLAND
    Vice President, Human Resources And Clinical Operations, Renovia
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    CATHLEEN PLATT
    VP, Clinical Operations, Click Therapeutics

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

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    Hyun Kim
    Head, Clinical Operations, AOBiome

    Hyun has been a part of AOBiome's clinical pipeline leadership since 2016. Hyun brings over 25 years of drug development experience in the pharma and biotech industry.  Prior to this, Hyun has led Clinical and R&D programs and departments at Pfizer, Anika Therapeutics, Transport Pharmaceuticals, and Olympus Biotech.  He started his career at Genetics Institute and Wyeth, advancing R&D programs into the clinic.  He attended Brown University where he studied Biomedical Engineering and completed a PhD in Medical Science.

     

    AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing microbiome-based therapies for local, nasal and systemic inflammatory conditions. Founded in 2012 by PatientsLikeMe founder Jamie Heywood and MIT-trained Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company's portfolio includes multiple clinical-stage programs in atopic dermatitis, rosacea, and acne, as well as additional programs targeting diverse inflammatory indications. 

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    LAURA TARABOANTA
    Sr. Manager, Head Of Clinical Innovations, Click Therapeutics

    Laura Taraboanta, MS is a clinical strategy and development professional with a demonstrated history in health care and clinical trials. She is currently the of Head Clinical Innovation at Click Therapeutics, with a focus on improving speed, efficiency, and cost of prescription digital therapeutics discovery, development and implementation. Prior to Click, Laura was leading clinical operations at Woebot Health, a mental health company focused on delivering evidence-based treatment through an AI chatbot. Laura has been part of two successful FDA Breakthrough Designations for software as medical devices and has overseen numerous research projects in CNS and oncology, tapping into the potential of virtual trials to empower patients. Laura is keen on tackling health disparities by accelerating digital therapeutic development so that clinically-proven, safe and effective solutions can be universally available to patients and their providers.

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    JUDYTH ZAHORA
    Sr. Director, Global Quality Systems & Process Improvement, Agenus

    Ms. Zahora is Sr. Director, Global Quality Systems & Process Improvement with Agenus and is responsible for the Quality Management System (QMS) including document control, vendor management, training, process improvement initiatives, risk/quality issue management, and establishing quality systems analytics. She has a MBA from St. Joseph’s University, a Six Sigma Black Belt, and is PMP certified. Ms. Zahora has developed and implemented an organizational QMS, compliance metrics to assess performance of global quality standards, and has created and implemented: (1) enterprise wide Root Cause Analysis training supporting CAPA effectiveness, (2 ) process review methodology with a Process Scorecard enabling a consistent method for corporate wide process review, (3) Data Trending including visibility of audit findings/quality issues by Key Core Process, SOP, and Corrective/Preventive Actions, and (4) Regulated documentation standards to ensure clear, concise, and compliant process documentation fit for purpose. Ms. Zahora is an instructor for Society of Quality Assurance (SQA) Quality College, Past President of NERCSQA, Past Chair of the Beyond Compliance Specialty Section (BCSS) and is on Nahant’s Advisory & Finance Committee.

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    LEONELLA SEELEY
    Associate Director Of Vendor Management And Operations, Karyopharm Therapeutics
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    RINALDO DORMAN
    MBA, CPSM, Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics
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    Jodi Coughlin
    Director, Vendor Relationship Management, Deciphera Pharmaceuticals
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    Chris Adams
    Chief Executive Officer, Andarix

    Mr. Adams has been a founder or co-founder of life science and technology based companies in Massachusetts for the past several years. Mr. Adams has been instrumental in developing new proprietary therapeutic and medical device technologies and bringing the technologies to commercialization. The companies he has founded include, Compellis Pharmaceuticals, a developer of therapeutics to treat obesity and its co-morbidities, diabetes and hypertension and Mosaic Technologies, a venture backed MIT spin-out genomics company that developed patented technologies for genetic analysis and detection. Chris is the holder of more than 20 issued US and international patents for medical devices and pharmaceuticals.

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    JOSHUA FREEMAN
    VP Of Clinical And Regulatory Affairs, Solace Therapeutics

    Josh has over 20 years of experience working in the as a clinical operations and regulatory affairs professional. Working both as an consultant and leading teams in-house, his career has focused on getting novel medical technology to the market through the design and execution of robust clinical trials, and the preparation of quality regulatory submissions to regulatory authorities in the US and abroad. Through creativity and collaboration, he has helped several medical device start-ups progress towards commercialization across a variety of therapeutic areas, including cardiovascular, diagnostics, orthopedics, and women’s health.

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    FRANCIS KENDALL
    Head Of Oncology Programming, Biometrics, Oncology R&D , AstraZeneca

    A strong proactive leader of groups within the Data Analysis and IT disciplines in the Healthcare industry sector. A managerial style based upon vast global experience, which incorporates a pragmatic approach to issue management together with a progressive attitude to create and successfully implement business driven strategic change initiatives within multicultural environments. Recent key achievements (1) Led a team that developed and implemented a Strategic systems approach to capitalise on the Clinical Data assets own by the Roche Product Development Group (2) Optimising the global sourcing solutions within the group by taking advantage of CRO, Contractors and Offshoring solutions. (3) Transitioned the programming group from being heads down programmers to Analysts who proactively provide and develop solutions for partners and customers

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    LAURA LAROSA
    Director Of Clinical Quality Assurance, Syros Pharmaceuticals

    Laura is the Director of Clinical Quality Assurance at Syros Pharmaceuticals. Strategic clinical research compliance business continuity leadership in COVID-19 environment. Expert knowledge of GCP Quality Operations and Compliance in the Pharmaceutical and Biopharmaceutical industries focusing on risk-based environments.

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    DAVID SHERRIS
    Chief Executive Officer, Penrose TherapeuTx

    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.

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    BEHTASH BAHADOR MS
    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.

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    AMANDA MCEWEN
    Vice President, Clinical Development, Elevian, Inc.

    Amanda McEwen has over 14 years of experience in clinical research that spans work in academia, contract research organizations, and several Boston-area small-to-mid-size biotechnology companies. Throughout her career, Amanda has held roles of increasing responsibility within the Clinical/Regulatory Development space across a range of therapeutic areas including rare, neurodegenerative, respiratory, infectious, and metabolic diseases. Her experience includes a variety of therapeutic product types, including combination products, most notably a novel dry powder inhalation therapy to treat motor issues in Parkinson’s patients, Inbrija™, approved by the FDA and EMA. Amanda has a particular affinity for early phase work and has played pivotal roles in shepherding several programs from the bench to the clinic, most recently in her previous role as Vice President of Clinical Development of Nocion Therapeutics, where she successfully led the efforts to complete Nocion’s first Phase 1 study amidst the backdrop of the emerging SARS-CoV-2 pandemic. In addition to her work in industry, Amanda serves as an adjunct faculty member for Northeastern University’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices, specializing in courses on the strategic and technical considerations for IND and NDA/MAA submissions and Pharmacovigilance regulations and best practices. Amanda holds a BA in Psychology from the College of the Holy Cross and a Master of Research Methods in Psychology degree from the University of York.

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    Kathryn Duschean, Pharm D
    Post-Doctoral Fellow- Biomarker Development, Novartis Pharmaceuticals

    Dr. Kathryn Duschean is a post-Doctoral fellow in Biomarker Development at Novartis Institutes for Biomedical Research in Cambridge, MA. She is currently involved in biomarker operational planning, implementation, and validation of novel patient-centric sampling techniques, in early phase clinical programs 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 toward the ultimate goal of fully decentralized clinical trials in these spaces. Kathryn received both bachelors in English, and in Health Sciences from the University of Iowa, and her Pharm.D from the University of Colorado. She is also currently an adjunct faculty member at the Massachusetts College of Pharmacy and Health Sciences, focusing on teaching various elements associated with the innovation and operational consideration in clinical trials.

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    Hollie Schmidt
    VP Of Scientific Operations, Accelerated Cure Project For Multiple Sclerosis

    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.

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    Michael Breen
    Associate Director, Infectious Disease, GlobalData Healthcare

    Michael Breen, PhD, is the Senior Director of Infectious Diseases and Oncology at GlobalData in Boston. He has over eight years of experience in market analysis, business intelligence, and providing strategic insight for the pharmaceutical industry. Prior to his current role, he was a Senior Analyst for Decision Resources Group, where he gained extensive experience writing in-depth reports and developing forecasts for a variety of indications, including rare and infectious diseases and vaccines. Michael has a BA in biology and biochemistry from Hunter College, and a PhD in biochemistry from Boston University School of Medicine.

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    Michael Patel
    Senior Scientist In Biomarker Development , Novartis Pharmaceuticals

    Michael Patel is a Senior Scientist II at Novartis Institutes of BioMedical Research in Cambridge, MA. There, he is involved in biomarker planning and implementation on early phase clinical programs and studies across a wide range of therapeutic areas. Specifically, he has been heavily involved in identifying and evaluating near patient sample collection and analysis technologies. This includes engaging and collaborating with internal and external partners on progressing to the ultimate goal of applying these to future decentralized and patient-centric clinical studies.

     

    Michael received a bachelor’s degree from Rutgers University and a doctorate in pharmacy from the University of North Carolina.

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    Andrea Bottkova
    Director, Vendor And Contracts Managemen, Karyopharm Therapeutics

    Andrea Bottkova, Director of Vendor Management and Contracts at Karyopharm Therapeutics Inc.  Andrea has been negotiating contracts for little over fifteen years.  In 2019 Andrea has helped established Karyopharm’ s vendor management and procurement department to support vendor oversight, strategic sourcing and maximize financial savings. Andrea is passionate about building partnerships and negotiating business terms of contract resulting in several million dollar saving annually. She believes that she has perfected her negotiations skills while learning from her very curious 5-year-old son Barton.

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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.

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    Oscar Gonzalez
    Former Sr. Project Manager, Research And Development, Lifemine

    Former R&D Sr. Project Manager at LifeMine Therapeutics, Oscar is an innovative Program Manager and Lean 6 Sigma Black Belt, specializing in the strategy, planning, and execution of program and project specific goals across functional departments while utilizing historical data and operational trends to analyze potential risks and create program level efficiencies. His 12 year career began in academic research (oncology, regenerative medicine, and microbiology), before transitioning into the pharma and biotech industry. For the last several years Oscar has worked as a Program, Project, and Alliance manager in R&D and Commercial organizations. He is currently working with pharma and biotech teams to understand and improve their workflows through Lean 6 Sigma practices.

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    Kimberlyn Ford Festi
    Associate Director, Site Contracts & Budgets, Deciphera Pharmaceuticals, LLC
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    Peter Henstock
    Harvard Extension School & Machine Learning & AI Technical Lead, Pfizer

    Strategic & technical leader applying machine learning, data mining, visualization and analytics skills to solve key data science problems. Data science is a hybrid field integrating computer science, visualization, statistics, and business knowledge. The standard skill set emphasizes breadth over depth yet both are critical:
    ● Advise and guide the technical direction of Pfizer's machine learning, deep learning and AI entries into natural language processing, image processing, and predictive modeling
    ● Harvard University lecturer teaching the Master's software engineering capstone and the graduate level, machine learning and data mining courses
    ● Analytics researcher: developed ~30 novel visualization and analytical tools in use at Pfizer
    ● Ph.D. in computer science emphasizing artificial intelligence and machine learning
    ● Master's degrees: software engineering, applied statistics, applied linguistics, image processing and biology
    ● Statistician: primary site statistician for 10 years supporting up to 200 scientific researchers
    ● Broad industry experience including pharmaceuticals, defense, text mining, and education

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    Christopher Missling
    CEO, Anavex Life Sciences

    Dr. Missling, President and CEO of Anavex, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex®, he served as the Chief Financial Officer of Curis and ImmunoGen. In addition, at Aventis (now Sanofi),  Dr. Missling worked as head of financial planning on all aspects of financial strategy and M&A. His career experience also includes working as an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, as well as serving as the head of healthcare investment banking at Brimberg & Co. in New York. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.

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    Adrian Orr
    Director Of Clinical Affairs, MEDIPOST America

    Adrian Orr is the Executive Director of Clinical Affairs at Anika Therapeutics, Inc in Bedford, MA. Adrian has previously worked in a range of small to medium-sized medical device and biologics companies including Gyrus Medical, Serica Technologies, and Haemonetics. He has focused on re-structuring and developing clinical teams to tackle technically challenging surgical and biologics trials. Adrian’s current focus is on joint preservation and tissue regeneration in orthopedics. His talk today will center on the use of eDiaries in clinical research.

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    Arkady Gusev
    Director, Laboratory Excellence And Operations, Novartis Pharmaceuticals
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    Amanda Murphy
    Director of Product Management, GlobalData

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

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    Oliver Steinbach
    Vice President Clinical And Regulatory Affairs, Imagion Biosystems

    Oliver has more than 20 years of experience in pharmaceutical, diagnostics and medical technology solution. He joined in 2022 Roche to lead a regulatory team focusing on especially oncology companion diagnostics. Till end 2011 he was the Vice president Clinical and regulatory affairs in Imagion Biosystems, a FDA-Breakthrough status clinical stage medical device company combining transformative, high-sensitivity imaging and nanomedicine for better, safer diagnosis and therapy delivery in cancer and other diseases. Previously, Oliver served as Vice President R&D at TransCode Therapeutics, dedicated to microRNA-targeted, image-guided, personalized cancer detection and treatment solutions. Before, he held at PHILIPS the positions of Senior Director Clinical Research Board, governing the North America clincial innovation program, moving several products through human trials and approval, further as Senior Director Biomolecular Engineering leading diagnostic/interventional imaging and drug-device combination developments. Oliver started in various R&D positions at ALTANA Pharma AG building the Functional Genomics Group and entrepreneurial ALTANA Research Institute. He received his Ph. D. degree in biochemistry from the University of Tuebingen, Germany

    Session Details:

    Registration and refreshments

    2022-10-13, 7:30 AM

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    BONNIE BAIN
    PHD, Global Head And Executive Vice President Of Healthcare Operations And Strategy, GlobalData Healthcare

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

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    James Sherley
    M.D., PH.D, President & Chief Executive Officer, Asymmetrex

    James L. Sherley, M.D., Ph.D. is the founder, President, and CEO of Massachusetts stem cell biotechnology company Asymmetrex, LLC. Asymmetrex develops and markets technologies for advancing stem cell medicine, including the first method achieving specific and accurate certification of the dosage of therapeutic tissue stem cells, called kinetic stem cell (KSC) counting. Asymmetrex’s kinetic stem cell counting platforms are also used to optimize manufacturing of therapeutic stem cells and for evaluations of drug effects on tissue stem cells. Dr. Sherley is a graduate of Harvard College, with a B.A. degree in biology, and the Johns Hopkins University School of Medicine, earning joint M.D. and Ph.D. degrees. Prior to founding Asymmetrex, he held academic research appointments at the Fox Chase Cancer Center, Massachusetts Institute of Technology, and Boston Biomedical Research Institute. Dr. Sherley’s professional awards include Pew Biomedical Research Scholar, Ellison Medical Foundation Senior Scholar in Aging Research, and NIH Director’s Pioneer Award.

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    John Seman
    CEO , REVITALE Pharma

    John Seman is a Pharmaceutical Executive with a consistent track record of building teams, solving problems, adapting to changing markets, and establishing long term growth strategies.

     

     

    Mr. Seman began his career in global life science corporations working for E. R. Squibb & Sons and multiple divisions of Johnson & Johnson, holding various management positions in sales, marketing and business development.  During his tenure at Squibb, he was a team member responsible for the introduction a new cardiovascular drug that achieved highest first year sales in company history.  At Johnson & Johnson, he managed a portfolio of eight biotech products in various stages of pre-clinical and clinical development, and actively participated in the licensing and acquisition of anti-infective pharmaceutical products.  He served as Vice President of Marketing at the central laboratory division of Corning Pharmaceutical Services where he was responsible for expansion of services into the European market, and for developing an innovative marketing strategy to increase profitability with a growing base of top tier pharma customers.

     

     

    For the past 20 years, Mr. Seman has been a serial entrepreneur involved in multiple startups including:  A Founder of AVANTEC, an innovative technology based company focused on accelerating the receipt of clinical trial data from investigator sites, where he secured over $10M from multiple rounds of financing; CEO at HealthBridge, a reimbursement services company, where he tripled revenue and successfully positioned the company for a sale; CEO at PhysioGenix, a preclinical research company, where he secured seed funding from angel investors; and most recently licensed technology from universities for commercialization with ZOETIC Pharmaceuticals and REVITALE Pharma focused on expanded use of anti-virals.

     

     

    Mr. Seman’s non-profit experience includes executive leadership of the Alosa Foundation, an independent medical education organization, where he secured multi-year contracts from the Commonwealth of Pennsylvania, the Commonwealth of Massachusetts and the District of Columbia public health departments for the dissemination of evidence based treatment strategies to primary care physicians.  He also served as the Founding CEO of Launch NY, an economic development organization serving the 27 counties of upstate New York, raising $7 million from the federal government and regional foundations.

     

     

    Mr. Seman holds a Bachelor of Science degree in Pharmacy, and received a Master of Science degree with honors in Pharmaceutical Economics and Business Administration, from the Massachusetts College of Pharmacy. He is an active participant in industry associations, and continues to be sought after to present at national and regional life science conferences.  Mr. Seman also volunteers as a coach and mentor to aspiring life science entrepreneurs from the University at Buffalo, McMaster University, and Syracuse University to support their efforts to build companies, win business plan competitions, and secure financing.

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    MARISSA FAYER
    CEO, DeepLook Medical

    Marissa Fayer is a 22-year medtech executive, innovator, entrepreneur, investor, and philanthropist. She is the CEO and founder of social enterprise / non-profit HERhealthEQ, President of DeepLook Medical, VP of Operations at Ultrasound AI, and US Partner at Goddess Gaia Ventures. Her mission is to move innovation and the health of women forward throughout the world. Marissa has previously served as an executive at Hologic, Olympus (formerly ACMI), Maquet-Getting (formerly Atrium Medical), Providien Medical, and Accumed Innovative Technologies. Her consulting clients include many of the Top 500 healthcare companies and innovative start-ups including Pfizer, Boehringer Ingelheim, Nuvasive, the National Institute of Health (NIH), Oerlikon Medical, Lonza Precision Medical, Emit Imaging, and others. Marissa sits on the board of medtech companies Welwaze Medical and DeepLook both focused on improving the diagnosis of breast cancer; Ultrasound AI focused on predicting Preterm birth, and PMD Medical focused on urinary incontinence; Marissa graduated from Boston University with a BS in Manufacturing Engineering and from University of Connecticut with an MBA. Marissa is a TEDx Speaker (2019 at TEDxLugano), a UCSC Miller Center Social Entrepreneur Fellow, and has been listed as one of the Top 100 Women in Medtech in 2018, a Top Woman Activist to Watch, awarded the 2018/9 Africa Development Award, a Wonder Women in Medtech, and has delivered keynote discussions at the World Alliance Forum, MedExec Women, Lithuanian Biotechnology Association, Leading Entrepreneurs of the World, Women’s Health Innovation Summit, DeviceTalks, HER.Talks, and others. Marissa has appeared in several online and print publications such as Medical Design & Outsourcing, BloombergLaw, FemTech Analytics, the Maven Collective, Med Device Online, and TheStreet.com. Marissa leads the #wealththroughhealth and #healthequityforwomen movements and is dedicated to innovative solutions for global operations and improving women’s health throughout the world. Marissa lives in New York City and can be found at www.marissafayer.com

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    Shaheen Lakhan
    CMO, Click Therapeutics
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    CRAIG LIPSET
    Co-Chair, Decentralised Trials And Research Alliance
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    Mac Winslow
    Senior Director, Global Customer Development, Clinical Services, Avantor

    Mac Winslow is the Senior Director of Global Customer Development for Clinical Services at Avantor, which maximizes clinical trial efficiencies across the globe, providing scalable, end-to-end service capabilities including biorepository and sample management, custom kitting, and clinical trial equipment and ancillary solutions. Mac has more than 20 years of sales experience, including a decade of specialization in biorepository services and sample management sales. Prior to joining Avantor, Mac spent eight years at BioStorage Technologies, Inc., where he oversaw North American and European sales teams. Mac earned a BS in Agricultural Business Management from North Carolina State University.

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    Holly John
    Senior Director, Patient Advocacy , Agios Pharmaceuticals

    Holly John, Senior Director, Patient Advocacy at Agios is an innovative and strategic leader with a passion for elevating the patient voice and ensuring patient insights are woven into all activities across the lifecycle. With experience spanning multiple disease areas within the biotech and pharmaceutical industries, Holly has led and built advocacy functions and teams organized around the patient, bringing value to activities across the business while delivering better outcomes for patients.  Holly has a strong record in achieving exceptional results, through cross-functional collaboration on complex initiatives and through creating and fostering strong partnerships with patients, patient advocates and clinicians. Since joining Agios in 2020, Holly has spearheaded a project to define an ambition for patient-centricity that goes beyond words, driving meaningful action & change.  Ultimately, the goal is to raise the bar and set a new standard for patient engagement across the pharmaceutical industry

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    Chris Fourment
    SVP Clinical Strategy , Iterative Scopes
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    Tim Curry
    Senior Vice President Of Account Development, MedPoint Digital

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

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    Akiko Shimamura
    VP, Medidata Link, Medidata Solutions

    Akiko has over 10 years of experience in the life sciences industry, previously at McKinsey & Company advising pharmaceutical clients in strategy, digital and advanced analytics.  She holds an MBA from London Business School and a BA in Law from the University of Tokyo.

    Session Details:

    Registration and Refreshments

    2022-10-12, 8:15 AM

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    Jay Smith
    Head of Product, Trial Interactive, TransPerfect

    Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. He brings over 25 years of product management, consulting, and engineering experience across verticals such as life sciences, enterprise software, healthcare, government, entertainment and manufacturing. Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. He has supervised the management of a clinical portal, eTMF, CTMS, RTSM, EDC, Coding and Grants solutions. Jay has also created and managed products for eCTD submission publishing and review, enterprise quality management, document management, computer validation, as well as mobile apps for physicians, sales reps, and music and sports fans.

    Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College.

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    Bin Pan
    Executive Director & Head Of Hematology/Oncology , TFS HealthScience

    Bin Pan - Bin is an Executive Director of Program Strategy at TFS HealthScience where she interfaces with global, multifunctional teams from business development to project delivery. Bin has over 20 years of clinical research experience in Asia and North America. Bin was educated in Beijing, China and the United States. She is based in Colorado, US.

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    Edyta Korzuch
    Senior Director Hematology/Oncology Unit, TFS HealthScience

    Edyta Korzuch - Edyta is a Sr. Director of Project Management at TFS HealthScience. She has over 20 years of experience in clinical research industry within global and cross-cultural environment where she successfully managed studies from Phase 1 first in human to Phase 3 registrational trials. Her current focus is on innovative solutions for early phase oncology and hematology clinical development. Edyta was educated at Silesian Medical University in Katowice, Poland and Oxford Brookes University, UK. She is based in Paris, France.

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    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:

    Registration and Refreshments

    2022-10-12, 8:15 AM

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    Ian Greenfield
    Data Innovation, YPrime

    Ian Greenfield helped transform Oregon’s healthcare delivery system while serving in Governor John A. Kitzhaber, MD’s administration. He has held leadership positions in numerous companies and non-profit organizations, including the world’s leading death with dignity advocacy group, Compassion & Choices. His marketing work has earned both an International Association of Business Communicators’ Bronze Beacon Award and a Public Relations Society of America Award of Excellence.

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    Sarah R. Anderson
    Executive Director, Oncology Strategy Lead , Worldwide Clinical Trials

    Sarah R. Anderson is an Executive Director, Oncology Strategy Lead at Worldwide Clinical Trials.  Ms. Anderson has dedicated the past 17 years to building and advancing innovative oncology clinical trial concepts through development execution. Her passion is leading therapeutic strategy development along with a strategic thoughtfulness on advancing clinical trial options to patients in a local community setting.

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    Christine McSherry
    Co-Founder Of Casimir, An Emmes Company

    Christine McSherry founded Jett Foundation in 2001, when her son now 24-year-old Jett was diagnosed with Duchenne Muscular Dystrophy. As head of the Jett Foundation, Christine co-founded the International Duchenne Alliance, a partnership of over 40 independent organizations that has funded nearly $15 million dollars in research to date.

    Christine has advocated for the patient perspective to be considered by the FDA when reviewing safe and potentially effective treatments for Duchenne. In April of 2016, Christine presented the Jett Foundation's Patient Centered Outcomes report at the FDA's meeting of the Peripheral and Central Nervous System Drugs Advisory Committee.

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    Kris O’Brien
    Executive Director, Program Strategy, Rare Disease And Pediatrics, Premier Research

    Kris O’Brien is an Executive Director in Program Strategy specializing in Rare Disease and Pediatrics at Premier Research. Kris has been conducting clinical research for more than 35 years and has covered multiple functions during that time. Her experience in a multitude of therapeutic indications has led to an acute knowledge of study conduct and execution with a keen focus on protocol dynamics. This experience has allowed her to understand the nuances that set rare and pediatric studies apart from routine clinical studies and develop proper strategies for clients to execute their studies in real world settings.

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    Daniel Behr
    EVP External Innovations & Academic Partnering, OCEAN BIOMEDICAL

    I'm an innovation catalyst and entrepreneurial leader skilled at commercializing inventions and ideas to address customers’ unmet needs and to generate enterprise growth. I bring a unique combination of experiences in business & innovation strategy, startups, venture capital, business development, and university technology transfer.

    Using innovation as a lever for growth and value creation is a common thread in my career. In some cases this involves finding or building pathways to enable the translation of new technologies and ideas into viable products and solutions; in other cases it involves the discovery of customers' unmet needs that can be addressed with innovations such as new products and services or even simply with more finely-tuned messaging.

    My innovation expertise is industry and product agnostic - for example, most recently I've applied it in early-stage biotech, performance fabrics, and specialty plastic films. In prior years I helped bring products to markets in materials science and industrial instrumentation.

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    Michael King
    Managing Director, EF Hutton

    Michael G. King, Jr. is Managing Director, Equity Research at HC Wainwright & Co., LLC. Prior to joining H.C. Wainwright, Mr. King was Entrepreneur in Residence at Fortress Biotech, Inc., where he worked for approximately three years. Before joining Fortress, Mr. King had a distinguished 25 year career as a senior biotechnology research analyst, most recently as a Managing Director at JMP Securities. Earlier in his career Mr. King held senior positions at a number of investment banks including Rodman & Renshaw, where has was Director of Research and led the Healthcare team, Banc of America Securities, Dillon, Read & Co., Vector Securities and Robertson Stephens. Mr. King has been recognized by The Wall Street Journal (Best on the Street 2014) and Institutional Investor (Home Run Hitter 2000) during his career for his research in the sector. He holds a BA in finance from The Bernard M. Baruch College of the City University of New York.

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    Anne F. Lewis
    Director, Strategic Initiatives , CorEvitas

    Ms. Lewis is an experienced and versatile professional with over 25 years in the clinical research industry across a variety of therapeutic areas using a range of methodologies and strategies. Her experience includes the design and implementation of phase 3 and 4 studies as well as large-scale global safety and effectiveness registries, clinical trial simulations and digital app experience workshops. She has led numerous qualitative research projects involving patients, caregivers and healthcare professionals.  In addition, Ms. Lewis has spearheaded the development of educational materials and communications for patients and physicians, as well as oversight of several large-scale longitudinal survey-based projects. In addition, she has created content for and scripted multiple Investigator Meetings as well as Study Team launch meetings.  She has held positions within the healthcare sector, CROs and pharmaceutical industry, as Project Director, Director of Late Phase Research, Director of Health Economics and Outcomes Research, Senior Project Manager, and Senior Clinical Administrator for a research foundation.

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    Maria Milas
    Senior Manager, Site Engagement , Teckro

    Maria joined the clinical trials field as a Clinical Trial Assistant for one of the top 10 CROs supporting Clinical Research Associates (CRA) with the management of the trial documentation, focusing on Oncology phases II and III trials. After a Master in Clinical Trial Monitoring and some experience, Maria changed to a CRA role monitoring trials phases I-IV in different therapeutical areas: oncology, respiratory, rare diseases, hematology, etc. Five years later, Maria joined Teckro to help bring technological innovation to clinical sites.

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    Helen Greta
    Director, Project Management, , Cenduit IRT, An IQVIA Business

    Helen brings over 17 years of deep expertise from the clinical research industry and significant global experience working with various CROs, supporting clinical operations teams across, Asia, Middle East, Europe and US.  Her expertise includes Clinical monitoring, Project management, Regulatory affairs, and Clinical technologies such as IRT and eCOA. Helen has been a part of IQVIA /Cenduit leadership team since 2015, She has recently taken on responsibility as IRT eCOA customer success lead and supporting North America Project Management team at Cenduit. Prior to her stint at IQVIA, Helen held several positions across various global CROs. Helen is based out of IQVIA headquarters in Durham, North Carolina.

     

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    Esther Howard
    Advisor , THREAD

    THREAD Research is a leading provider of Decentralized Clinical Trial (DCT) technologies for life sciences. In her role, Esther oversees THREAD’s oncology strategy and collaborates directly with clients to help them build the best oncology solution in a DCT design that integrate with THREAD’s platform.

    Esther is committed to the mission of improving the lives of cancer patients, globally. She has twenty years of experience in the healthcare and clinical research industry, primarily in oncology drug development at PRA Health Sciences (now ICON) and Labcorp Oncology. For the past 5 years Esther has been working hard to find a path to bring clinical research as a care option to cancer patients and is now working with THREAD and THREAD’s customers to design and innovate to achieve this mission.

     

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    Kathlyn Tilley
    Director Of Business Development, Nucleus Network

    Kathlyn Tilley is Director of Business Development for Nucleus Network, Australia’s largest Phase 1 clinical research organization and the only Phase 1 specialist globally with facilities in the USA and Australia.  She has over 15 years of experience working in the CRO industry, supporting clinical development efforts in the US, China, and Australia.  Kathlyn has successfully served clients in biotech, pharma, and academic institutions to discover the strategy and tools they need to reach their clinical development milestones.  Kathlyn holds a BS in Biology from the State University of New York at Geneseo and MS in Clinical Research Management from Drexel University.

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    CAMILA MATHENY
    Senior Director, Solution Consulting, Medable

    An expert in clinical trial operations, Camila Matheny works closely with Pharma, Biotech and CRO customers to clearly articulate the value of adopting digital technologies to deliver decentralized and hybrid clinical trials. A member of the SCDM eSource Consortium and DTRA, Camila leads with data - the driving force behind bringing new therapies to market. With over 15 years of clinical trials experience, a background in data management and a passion for the latest cutting-edge technologies, Camila provides a unique combination of expertise to help guide the industry towards the future state of patient-first clinical trials.

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    Helen Yeardley
    Senior Vice President, Global Clinical Operations, Pharma Solutions, ICON Plc, ICON Plc

    Helen Yeardley is Global Clinical Operations Head at ICON. In this role, she oversees the timely and quality delivery of a team of approximately 4,000 staff in areas including clinical and hub monitoring, clinical risk management and trial master file services. With over 25 years’ experience in monitoring and managing clinical trials, in both CROs and large pharma companies, Helen has held numerous senior positions in the areas of feasibility, site identification and start-up, clinical trial management and project management. She started her career as a CRA, and her therapeutic background is oncology as well as internal medicine.

    Helen is also actively involved in ICON’s Diversity, Inclusion and Belonging operations, with a particular focus on the company’s Disability Awareness Network, DAWN. DAWN is one of ICON’s community groups and is focused on developing and fostering a mind-set towards creating an inclusive workplace and working environment where everyone is treated equally with respect and dignity, irrespective of any visible or hidden disabilities.

    Session Details:

    OPENING KEYNOTE Doing your first Proof of Concept Study in “Down Under”: Lessons learned from Clinical Trials Outside of the United States

    2023-11-01, 9:00 AM

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    Stephen M. Brandao
    US East Coast Regional Director, Business Development, Novotech

    Steve Brandao has spent more than 30 years in research and development.  His experience includes time with a major pharmaceutical company, work with two leading SMO’s, and business development positions with large global CRO’s, a medical device CRO, and an EDC technology company.  He is currently the US Regional Director of Business Development for Novotech, an Asia-Pacific centered CRO with global capabilities.  Steve has a graduate degree in psychology and worked as a psychotherapist before starting his career in biopharma research and development.

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    Dr. Ahmar Zaidi
    Medical Director, Clinical Development, Agios Pharmaceuticals

    Dr. Ahmar U. Zaidi is a pediatric hematologist who spent the last several years at the Children’s Hospital of Michigan, where he helped care for over 800 patients with sickle cell disease. He currently serves as Medical Director, Clinical Development for Agios Pharmaceuticals. Along with numerous publications and clinical trial experience, he has worked tirelessly as an advocate for sickle cell disease patients, fueled by a belief that medical misinformation and disinformation steadily contribute to poor outcomes in sickle cell disease patients.  He co-founded and hosts the sickle cell educational podcast, Cheat Codes; and has been an advocate for social media as a tool for patient and physician education.  He currently serves as the Chair of the Hematology Anti-Racism Task Force for the American Society of Hematology and the Chair of the Board for The Sickle Cell Reproductive Health Directive.

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    Desmond Cabrera
    Global Therapeutic Operational Lead, Cell And Gene Therapy, Allucent

    Desmond Cabrera serves as Executive Director, Cell & Gene Therapies and brings over 15 years of experience in the CRO industry. In his current position, Desmond is the Global Therapeutic Operations Lead for Allucent’s Cell and Gene Portfolio in which he leads the strategy and team executing trials for sponsors who are developing CAG Therapies.

    Desmond has gained extensive experience in the execution and management of clinical trials in all phases throughout his career and has worked at large CROs including ICON, IQVIA, Labcorp, and Parexel. He has led multinational teams and projects overseeing trials for oncology, pediatric, CNS and large-scale cardiovascular studies that involved 1,000+ sites and 25,000 patients. Desmond has overseen several early phase cell and gene therapy (CGT) projects involving feasibility and safety assessments, first-in-human studies, and dose escalation and expansion for oncology indications including breast and lung cancer, acute myeloid leukemia, and myelodysplastic syndrome.

    Session Details:

    Operationalizing Long Term Follow-up for Cell and Gene Therapies

    2023-11-02, 9:30 AM

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    Tom Gottschalk
    Director Business Development, Trialcard

    Tom has worked in the life sciences industry for over 20 years, initially as a pharmaceutical representative and then as a pharmaceutical product manager. Over the past 10 years Tom has become an expert in providing sponsors and CRO’s with an innovative clinical supply process that is patient centric, saves clinical operations and supply management teams time and saves sponsors money.

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    Dawn Kaminski
    Vice President, Business Development Operations, EClinical Solutions

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

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

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

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    Robert Loll
    SVP, Business Development , Praxis Communications

    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.

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    Sverre Bengtsson
    Co-Founder, Viedoc Technologies

    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.

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    Tim Kulbago
    Senior Vice President Of Integrated Customer Solutions And Trial Oversight, Clario

    Senior Vice President of Integrated Customer Solutions and Trial Oversight

    As Senior Vice President of Integrated Platforms and Trial Oversight at Clario, Tim is responsible for delivering solutions that bring together the Clario portfolio of products to provide exceptional experiences for patients, sites, and sponsors.  His team focuses on minimizing the burden for patients and sites through the delivery of intuitive streamlined applications by uniquely combining traditional eCOA, Respiratory, Cardiac Safety and Imaging interactions in a harmonized ecosystem. Tim has 25 years’ experience of working in healthcare, with a focus on the medical imaging industry. He has held many executive positions, including Product Line Executive, CTO, CSO, and also as President and CEO at ImageIQ, where he led the company’s deployment of software engineering, high-resolution imaging and custom-tailored image analysis, to support the delivery of high-quality imaging data for clinical research

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    Michael Patel
    Senior Scientist in Biomarker Development Novartis Pharmaceuticals
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    Ahmar Zaidi
    Medical Director, Clinical Development, Agios Pharmaceuticals

    Dr. Ahmar U. Zaidi is a pediatric hematologist who spent the last several years at the Children’s Hospital of Michigan, where he helped care for over 800 patients with sickle cell disease. He currently serves as Medical Director, Clinical Development for Agios Pharmaceuticals. Along with numerous publications and clinical trial experience, he has worked tirelessly as an advocate for sickle cell disease patients, fueled by a belief that medical misinformation and disinformation steadily contribute to poor outcomes in sickle cell disease patients. He co-founded and hosts the sickle cell educational podcast, Cheat Codes; and has been an advocate for social media as a tool for patient and physician education. He currently serves as the Chair of the Hematology Anti-Racism Task Force for the American Society of Hematology and the Chair of the Board for The Sickle Cell Reproductive Health Directive.

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    Mary Jo Lamberti
    Professor, Director, Tufts
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