16th Annual Outsourcing in Clinical Trials West Coast 2024

For the 16th Annual event, our flagship show will focus on providing delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials, this is an event not to be missed.

6 - 7

February

2024
  • Hyatt Regency San Francisco Airport, USA
  • Complimentary
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2024 Sponsors Include:

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Company Information

4G Clinical is a leader in randomization and trial supply management (RTSM) for the global life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solution utilizing natural language processing (NLP) and integrated supply forecasting. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia. For more information, please visit www.4gclinical.com

Company Website:http://www.4gclinical.com/

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In 2021, ERT and Bioclinica merged to become Clario creating the broadest endpoint technology platform in the industry and enhancing our scientific expertise. With this expertise, global scale and the broadest endpoint technology platform, Clario will continue to lead the way in clinical trial technology that will transform patients’ lives.

Company Website

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

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Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

Company Website

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

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ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022.

Company Website

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

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Established in 1997, Novotech is a global CRO recognized for its partnership with sponsors in clinical trial development and management. The Company offers a comprehensive suite of services, including laboratories, Phase I facilities, drug development consulting, and regulatory expertise, Novotech has executed over 5,000 clinical projects, spanning Phase I to Phase IV trials and bioequivalence studies.

With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech supports clinical trials across Asia Pacific, the United States, and Europe. Leveraging a vast global footprint, deep relationships, and a robust operational framework, Novotech enables small to medium-sized biotech, biopharma, and pharma sponsors to accelerate the speed and scope of their clinical development endeavours.

Discover more at www.novotech-cro.com

Company Website

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

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Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. We work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference.

Company Website

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

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PCM TRIALS screens, hires, trains and manages all of our own Certified Mobile Research Nurses who conduct clinical trial visits in the subject’s homes. Each nurse is trained, tested, and certified as a Certified Mobile on an annual basis in the principles of clinical trial research, GCP, Nurse Guidelines and IATA.  Services are available in U.S., Canada and ROW.

Company Website

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

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Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease.

Company Website

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

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Saama Technologies is the advanced clinical data and analytics company, unleashing wisdom from data to deliver better actionable business outcomes for the life sciences industry. Saama’s unified, AI-driven clinical data analytics cloud platform seamlessly integrates, curates, and animates unlimited sources of structured, unstructured, and real-world data to deliver actionable insights across all therapeutic areas. The award-winning platform gives unprecedented real-time visibility into clinical data, enabling sponsors to file New Drug Applications (NDAs) more efficiently to bring drugs to market faster and at lower costs. For more information, visit http://www.saama.com.

Company Website

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

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Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

Company Website

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

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

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

Company Website

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

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

Company Website

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

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    Why attend?

    Arena International are delighted to announce Outsourcing in Clinical Trials West Coast will be returning to Burlingame for the annual event on February 6th & 7th 2024!

    The main program of the conference is discussion and debate on the outsourcing of clinical research. This event is a great opportunity to get to know the online casino players who will be performing at this meeting. This is because many conference attendees are likely to be active online casino Poli Pay players in their spare time. During the event, you can explore various advantages and problems of this type of research cooperation, which will be quite interesting for the gambler to learn. Outsourcing can also create difficulties that must be considered when contracting with a third-party supplier.

     

     

    The West Coast Clinical Trials Outsourcing Event 2024 is a highly anticipated event that brings together pharmaceutical industry professionals and experts to discuss the latest trends and developments in clinical trial outsourcing. In fact, it can also be an ideal place to socialize with those who like to play tennis-related online casino games. In addition to opportunities to network with professional online casino players who can uncover insights that can help you win more often at tennis-themed games, the West Coast Clinical Trials Outsourcing Event 2024 will include a series of presentations, seminars and panel discussions on the latest trends and innovations in the industry. clinical trials and outsourcing. This event promises to be exciting and informative for anyone interested in the clinical trials and outsourcing industries, as well as tennis-inspired casino games.

    WHAT TO EXPECT FOR 2024?

    This conference will bring industry professionals together to share knowledge, with a focus on collaboration, advancing clinical development and concentrating on clinical operations, innovation, and technology.

    This is a great opportunity to network and share knowledge with the region’s leading pharmaceutical firms, biotechs and med device companies, discuss operationally efficient, specifically targeted clinical trials. The 2024 program boasts 4 full streams jam packed with content.

     

     

    800+

    Attendees

    		90+

    Exhibitors

    		45+

    Speakers

    		50%

    Attendees at Director + Level
    800+

    Attendees

    		90+

    Exhibitors
    45+

    Speakers

    		50%

    Attendees at Director + Level

    Testimonials

    See What It's All About

    2023 Agenda

    • 1 Mar 2023
    • 2 Mar 2023
    Expand All

    Streams

    Stream one

    Outsourcing & Clinical Operations

    Stream two

    Clinical Innovation & Technology

    10:45 AM

    Keynote Not just ticking a box: Outreach to minority groups is improving but the focus now is on establishing trust and relationships

    • Best practices for engaging the patient community and growing that relationship – using real life case studies
    • Advantages of working alongside grass root organisations and PAGs– what groups are out there?
    • How best to go about educating the patient community?
    • Exploring incentives for the community – if not financial what else can you offer?
    • Making the patient stories the centre of your study with a focus on feedback

    Speakers

    11:30 AM

    Patient Engagement: The Importance of Engaging the Patient in the Clinical Trial Process

    In this presentation we will discuss the following:

    • The value of patient engagement
    • Important topics to address with patients
    • Best timing and approach to successfully engage patients

    Speakers

    12 PM

    INTERACTIVE SESSION Data matters in health outcomes and equity: Collecting and understanding Social Determinants of Health (SDOH) data in clinical trials and beyond

    • Understanding Social Determinants of Health: Identifying the variables that burden trial participants – how can we collect this data?
    • Recognising how Social Determinants of Health contribute to outcomes in disease
    • Assessing which communities you aren’t successfully recruiting from and exploring data to understand why
    • Focussing on education in this space and what we can all do moving forward

    Speakers

    12:30 PM

    How understanding the person behind the patient can improve engagement

    Clinical development has shifted from a scientifically driven journey to a patient-focused one. This presentation will discuss:

    • How applying behavioral science insights can better inform the way we do patient engagement.
    • Why the current state of trials makes it difficult for patients to participate in research
    • How and when to incorporate patient insights into your programs
    • How to create a business case to garner support for investing in solutions
    • The benefit for the study sponsor, and other stakeholders, for investing in solutions to make it easier to be a participant

    Speakers

    1 PM

    Lunch & Networking

    2 PM

    Uncovering how Deconstructed Patient Navigation can enhance patient support

    • Barriers to patient participation with a focus on the barrier that became the impetus of the model
    • Delving into benefits of Patient Navigators and challenges with consistent comprehensive support for patients
    • Exploring the Enhanced Patient Support Services
    • Benefits, challenges & case study review

    Speakers

    2:30 PM

    An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps

    • Cover proactive strategies to address performance risk and protocol deviations
    • How to apply performance data from simulation-based training to manage risk areas
    • Discuss how to interpret and apply learning results to optimize and de-risk your DCT

    Speakers

    3:30 PM

    Afternoon Refreshments, Networking & Prize Drawer in Exhibit Hall

    7:30 AM

    Registration & Refreshments

    8:25 AM

    Chairman’s Opening Remarks

    Speakers

    8:30 AM

    KEYNOTE: Seeing your site as a partner and identifying best practices for reducing site-burden

    With increasing site staff/physician burnout and sites taking on less projects, we are still feeling the ripple effect of this on trials. How do we move forward from here?

    • Rethinking your site management strategy to minimize overburdening sites, dependant on the phase of your study
    • Pinpointing how site turnover impacts the sponsor and how to help reduce it whilst keeping patient care front of mind
    • Advice for the ClinOps team to avoid unnecessary patient visits, how does your protocol affect the site?
    • Working closely with the CRO and giving your site the freedom to breathe
    • Communication is key- how can the sponsor/CRO help and support as a partner

    Speakers

    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?

    Speakers

    9:30 AM

    Phase 1 Trials: How to globalize to accelerate value inflection

    • Review market analysis on location of Phase I studies and discuss why these choices are made.
    • Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry.
    • Review and assess the selection criteria sponsors face when selecting Phase I jurisdiction.
    • What are global biotech executives asking/concerned about when evaluating Phase I study plans?
    • Discuss a pathway to extend biotech cash burn runway while still meeting Phase I objectives… and meeting investor expectations!

    Speakers

    10 AM

    Morning Refreshments & Networking

    10:45 AM

    PANEL DISCUSSION: Optimizing oversight & governance: What does oversight mean to you?

    • Best practices and tools for managing supplier governance and ascertaining who is accountable
    • Identifying the criteria to determine level of oversight needed for a vendor
    • Local vendor oversight vs global provider oversight – how would you manage this differently?
    • Best practices for managing CRO governance for small/start-up companies with limited resources or large companies with competing priorities

    Speakers

    11:30 AM

    Optimizing cell-based Gene Therapy Programs through the continued evolution

    • Lessons across therapeutic areas
    • Driving success in either unexplored settings or in saturated market settings
    • Context-dependent stakeholder engagement

    Speakers

    12 PM

    GxPs in Cell Therapy and key considerations for Quality and Project Management

    • Raw materials
    • Maintaining Chain of Identity/Chain of Custody
    • QC Testing and Risk Based Batch Release
    • Talent & Training
    • Evolving Technologies & Regulatory Guidance documents
    • Roel of Project Management in helping to drive and streamline cross functional communication
    • Key considerations for communicating timelines and milestones
    • Maintaining focus on Quality centric culture

    Speakers

    12:30 PM

    Practical use cases to improve clinical site efficiency with technology

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

    Speakers

    1 PM

    Lunch & Networking

    2 PM

    GENENTECH CASE STUDY LGTBQ+ Health Inequities & SOGI collection – Why collecting this data is important in your study

    • Understanding LGBTQ+ health inequities
    • Why should we collect Sexual Orientation and Gender Identity in Clinical Research Studies?
    • Genentech pilots for SOGI collection
    • Increasing inclusion in future trials for vulnerable populations with health disparities– some success stories

    Speakers

    2:30 PM

    Going the last millimeter: What you may not know about home visits

    • Home visits have evolved since their inception in 2003
    • Services possible in 2023 – an overview of what is possible today
    • Sourcing the right professionals for visits is essential to success

    Speakers

    3 PM

    FIRESIDE CHAT: Addressing the growing challenge of staff shortages and site delays to develop a seamless contracting and start-up phase

    • Addressing the reduced site pool challenge and focussing on sites you know can deliver
    • Overcoming hurdles with imaging centres with reduced staff when trying to qualify patients in a timely manner
    • Minimize site activity- could decentralization and Direct-to-Patient trials be the answer to staff shortages?
    • Explore online site training as a less time/labour intensive way to educate site
    • Long term solutions: could reducing the site certification process be a realistic solution?

    Speakers

    3:30 PM

    Afternoon Refreshments, Networking & Prize Drawer in Exhibit Hall

    4 PM

    INTERACTIVE SESSION: Establishing and maintaining strong CRO/sponsor relationships and building trust in a more virtual landscape…What have we learned and what should we focus on?

    • Oversight with less presence – how to make this work
    • Effectively building strong working relationships remotely
    • Strategies to deliver training and upskill your team
    • Handling hard discussions with your CRO/partner when you can’t meet in person
    • Optimizing communication channels/effectiveness with your CRO partner and team
    • Maintaining a positive working relationship – prioritizing and building strategies from the outset

    Speakers

    4:30 PM

    Technology as a methodology: Accelerating Clinical Development timelines

    • Clinical trial timelines are lengthy and on average a Phase 3 trial can take between 1-4 years. Trial enrollment accounts for 60% of the total time of the trial and for 80% of trial failures. In addition, 30% of trial participants drop out of the study
    • Innovation should strive to maximize the synergy of all three variables: safety, efficacy, and speed. Per the FDA, “Decentralized Clinical Trials (DCT) hold promise to reduce patient and sponsor burden and increase accrual and retention of a more diverse trial population”
    • Designing clinical trials with technology in mind can empower and power studies. Embedding fit-for-purpose technology solutions enhances access, accelerates enrollment, improves representation, and increases compliance and retention

    Speakers

    5 PM

    CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world

    • Strategies for successfully hiring and growing a ClinOps team in this day and age
    • Discussing how training improvements can increase retention
    • WFH vs in office: Pros and cons of managing a more remote ClinOps team in the US
    • Strategies for avoiding team burn out
    • What can small biotech ClinOps teams learn from large Pharma, and vice versa?

    Speakers

    5:30 PM

    Chairman’s Closing Remarks & Drinks Reception

    10:45 AM

    PANEL DISCUSSION: The concept of DCT, is it the future?

    DCT was previously done out of necessity but are we seeing it as a new world order? Or has the noise around DCT quietened? We are now in the position now to share our practical experiences with Decentralized & Hybrid Clinical Trials;

    • Panellists will address the advantages of DCT; from taking the trial to the patient to boosting recruitment
    • Strategy/Planning: How do you make the decision to run a DCT; what are the considerations?
    • The impact DCT has on diversity, equality and inclusion (DEI) – have we finally managed to tap into under-represented communities?
    • Panellists will discuss the challenges and tech barriers with DCT
    • Are Hybrid trials the more realistic and practical approach compared to full DCT – agree or disagree?

    Speakers

    11:30 AM

    Taking a Data Science approach to gain financial oversight of clinical trials

    In this session, you will learn:

    • How data mining clinical trial costs and benchmarks can lead to operational efficiencies
    • The impact of macroeconomic factors on clinical trials and how to best combat changes
    • How to reimagine financial stability and planning for clinical trials

    Speakers

    12 PM

    Why drugs fail in clinical trials? – Cognizing & mitigating… Does AI-ML offer a solution?

    • Clinical Trials: Success & attritions. Drivers of failures
    • Flawed clinical study design leading to failures
    • Diagnostic indicators and early Go/No-Go decisions in proceeding further during clinical study phases
    • AI-ML, a Hype or Hope. Does it offer a solution?

    Speakers

    12:30 PM

    Improving the patient experience through user-focused design

    • Evolve our technology to improve the study experience for patients, site, and sponsors with the move towards more decentralized trial models
    • Software will be more heavily relied upon to keep patients connected, informed, and engaged
    • Explore the importance of utilizing user-focused research on software design and implementation of eCOA and eConsent in clinical trials

    Speakers

    1 PM

    Lunch & Networking

    2 PM

    Tactical clinical operations in digital health studies

    Speakers

    2:30 PM

    Clinical Outcome Assessments (COAs): Applying scientific rigor and good instrument design

    The bedrock of a successful trial is a well-designed protocol with reliable measurements of biomedical and health-related outcomes to satisfy regulatory standards. This session examines how scientific rigor can be applied to clinical outcome assessments (COAs) even though they are subjective. We will synthesize the scientific practices underpinning good instrument design and COA data collection methods and recommend next steps for addressing data collection challenges.

    Speakers

    3 PM

    Enhancing a responsible quality mindset and culture

    • Define the role of leadership in cultivating a Quality and Compliance culture
    • Establish key considerations for implementation
    • Influence others and empower excellence
    • Explore best practices for ensuring sustainability

    Speakers

    3:30 PM

    Afternoon Refreshments, Networking & Prize Drawer in Exhibit Hall

    4 PM

    FDA’s role in maintaining a secure and resilient supply chain

    • Supply Chain Resiliency
    • Lessons Learned
    • Government to Government Interactions
    • FDA Inspections and pre-arrival data
    • Role of CBP, FDA, and PGAs
    • Communication with Import Divisions
    • Resources

    Speakers

    4:30 PM

    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

    Speakers

    4:45 PM

    Curebase Flexible Virtual Site Demo

    • See how Curebase can design a flexible site model to address specific study concerns
    • Learn about the features Curebase can incorporate based on Sponsor needs
    • Witness how virtual sites can be deployed to collect high-quality patient data in real-world settings

    Speakers

    5 PM

    CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world

    • Strategies for successfully hiring and growing a ClinOps team in this day and age
    • Discussing how training improvements can increase retention
    • WFH vs in office: Pros and cons of managing a more remote ClinOps team in the US
    • Strategies for avoiding team burn out
    • What can small biotech ClinOps teams learn from large Pharma, and vice versa?

    Speakers

    5:30 PM

    Chairman’s Closing Remarks & Drinks Reception

    Streams

    Stream one

    Outsourcing & Clinical Operations

    Stream two

    Clinical Innovation & Technology

    Stream three

    Medical Device

    8:20 AM

    Registration and Refreshments

    8:50 AM

    WORKSHOP: Identifying and overcoming the hurdles associated with global studies including longer timelines, drawn-out budgets and remote teams

    • When to consider global
    • Strategies for global patient recruitment
    • Technology - does it help or hinder?
    • Supplies management and shipping challenges
    • Cultural consideration - translations, typical distance from site, etc.
    • Protocol amendments and managing budgets
    • Monitoring Challenges

    Speakers

    9:30 AM

    European Union Clinical Trial Regulation: Strategic Considerations

    • Key changes for the implementation of the EU CTR
    • Preparation for the EU CTR implementation
    • Submission efficiencies when using a CRO in the EU

    Speakers

    10:30 AM

    Morning Refreshments & Networking

    11 AM

    TECH MEETS QUALITY

    Empowering excellence in supply through digital quality management systems  

    • Exploring how to introduce a new digital quality compliance management system
    • What is critical to get right to make a digital QM System work? 
    • How do you arrange with and clean the large amounts of data generated? 
    • Examining how, even as a small company with limited resources you can successfully introduce time and cost saving QMS measures
    • Can you share some of your workflow procedures? 

    Speakers

    11:30 AM

    Why expert partners and staff matter; what metrics don’t tell

    • Why having IRT experts involved in your study is important
    • Are you choosing best in class or a bundle?
    • Case study on value of expertise in IRT

    Speakers

    12 PM

    Exploring the need for a dedicated regulatory pathway for antibacterial/antimicrobial drugs

    In this session our guest speaker will address the challenges with these drugs in development and looking at parallels in a medical device regulatory strategy

    • Exploring the idea of adopting a medical device-like regulatory philosophy/strategy for bringing drugs forwards, with a focus on antimicrobials
    • Industry is on high alert for bacterial outbreak, with parallels to the covid pandemic
    • What should we be doing now to anticipate, prepare, prevent and respond?
    • Exploring new science and a futuristic perspective on AB/AM drug development

    Speakers

    12:30 PM

    Networking Lunch

    1:30 PM

    Artificial intelligence in medicine & clinical trials

    • Exciting growth of artificial intelligence in medicine
    • A framework on development of artificial intelligence in medicine
    • The power of public attention and funding
    • Market adoption defines the success
    • Business opportunity of artificial intelligence in medicine

    Speakers

    2 PM

    Session Reserved for Event Sponsor

    2:30 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?

    Speakers

    3:15 PM

    Afternoon Refreshments, Networking & Prize Draw in Exhibition Room

    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.

     

    RT1 Conducting a study when there is minimal education

    Hang Nguyen, Sr. Director, Clinical Affairs, Materna Medical

     

    RT2 Navigating the complex spiderweb of multiple vendor relationships

    Sarah Mullen, Vice President of Clinical, HeartFlow

     

    RT3 Training Strategies for a Novel Therapeutic Medical Device 

    Ann Louise Armstrong, Senior Manager of Clinical Affairs and Field Operations, Ancora Heart

    Speakers

    4:45 PM

    Close of Conference

    8:15 AM

    Registration and Refreshments

    9 AM

    Current topics in the Medical Device Regulatory Landscape, Presented by the FDA

    • OMDRHO's Key Initiatives, inspectional and compliance activities
    • Update on the 21 CFR Part 820 Transition

    Speakers

    9:30 AM

    The use of Real-World Evidence (RWE) in Neurovascular Medical Device Space

    • Define RWE and real-world data sources/needs
    • Benefits of using RWE
    • Challenges of using RWD to support RWE

    Speakers

    10 AM

    Making progress of a complex Interventional device study during covid

    • Making progress during pandemic for a first-in-human device study
    • Designing a hybrid trial for a novel interventional device
    • Navigating the complexities of multi-specialty study

    Speakers

    10:30 AM

    Morning Refreshments & Networking

    11 AM

    The Digital Transformation of Clinical Trials – the Importance of Data Accuracy

    • Determining the technologies to move studies off site in order to move forward with the ‘new norm’
    • Investigating technology to save costs and improve accuracy of pharmacokinetic and pharmacodynamic data
    • Learning how to improve study drug adherences so only the study participant has access and, can only take the drug as per study protocol
    • Case Study looking at Digitization for objective data and cost saving

    Speakers

    11:30 AM

    Reimbursement for medical devices in trials, and, understanding the process

    • Defining the reimbursement strategy to prove medical benefit and value
    • Understanding codes for medical device technologies
    • Working with the FDA to secure your reimbursement

    Speakers

    12 PM

    Data Management: Programming and metrics in medical device studies

    • Programming for efficient data management
    • Generating metrics for data tracking and study progress
    • Optimizing available technologies
    • Automate the boring stuff

    Speakers

    12:30 PM

    Networking Lunch

    1:30 PM

    Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence.

    • Overview of how we interface with our organization
    • Implementing a cohesive strategy.
    • Discussion of Challenges

    Speakers

    2 PM

    First-hand learnings, breakthrough device system, a case study

    • Brief review of program
    • IceCure's Journey

             - How the process started and steps taken

             - Assessment of eligibility and submission

             - Lessons learnt - how it helped and what we did, what we companies can learn and do better

    • Q&A

    Speakers

    2:30 PM

    Afternoon Refreshments & Networking

    3:15 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.

     

    RT1-

    Discussion focusing on Real World Data; an overview of opportunities and challenges in working with RWD/RWE

    Ted Chun, Director, Global Clinical Shared Services, Stryker Neurovascular

     

    RT2- Navigating the complex spiderweb of multiple vendor relationships

    Sarah Mullen, Vice President of Clinical, HeartFlow

     

    RT3- Training Strategies for a Novel Therapeutic Medical Device

    Ann Louise Armstrong, RN, MSN, CCRC, CCRA, Senior Manager of Clinical Affairs and Field Operations, Ancora Heart

    Speakers

    4:15 PM

    Close of Conference

    8:20 AM

    Registration and Refreshments

    8:50 AM

    FIRESIDE CHAT: 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

    Speakers

    9:30 AM

    A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers

    Digital health technologies and biomarkers in clinical trials requires the highest standards of data collection, transmission, security, quality, and analysis. Scalable clinical analytics platforms built within core engineering frameworks are the only way to ensure the integrity, repeatability, and value of data standards and insights. The groundbreaking WATCH-PD study exemplifies how high-dimensional data sources – allowing more precise, objective, and higher frequency patient monitoring – enable digital biomarker development.

    Speakers

    10 AM

    THE 2023 AI UPDATE AI & disruptive technology: Harnessing the future of Artificial Intelligence to transform clinical trials

    Conduct of clinical trials are increasingly becoming expensive. A significant portion of the cost in a clinical trial can be attributed to operational conduct of the trial such as site monitoring related activities, data management and site oversight. Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible.

    This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations.

    Speakers

    10:30 AM

    Morning Refreshments & Networking

    11 AM

    What can we do to take advantage of high prevalence of disease in populous countries but systems are either rudimentary or non-existent?

    • Key drivers for trial enrolment and in time completion
    • Population and high prevalence of disease in developing countries
    • Barriers and hurdles to access vast pool of patients
    • Strategies/solutions to penetrate through barriers and pass hurdles

    Speakers

    11:30 AM

    Effective management of essential clinical trial documents using eTMF solutions

    • Common operational, security and regulatory issues around the collection, management, and reporting of essential clinical trial documents
    • How eTMF solutions can help to address these issues, and ensure inspection-ready and regulatory compliant storage of trial content
    • How eTMF solutions reduce business risk, improve team collaboration and productivity, reduce auditing and reporting costs, and ensure enhanced artifact quality
    • Major capabilities that current eTMF solutions should provide

    Speakers

    12 PM

    Developing successful communication pathways in a more remote world

    Improving communication, relationships and work-life balance with your internal team as well as partners

    • Should our biggest concern post-covid be remote working?
    • Importance of teams meeting face-to-face so that human touch and team cohesion isn’t lost
    • Setting up rules and expectations – creating space for communication
    • Strategies for prioritising work and tracking milestones with remote teams
    • Assessing the impact on the trial of remote vs in-person working; how to find a happy medium

    Speakers

    12:30 PM

    Networking Lunch

    2 PM

    Session Reserved for Event Sponsor

    3:15 PM

    Afternoon Refreshments, Networking & Prize Draw in Exhibition Room

    4:45 PM

    Close of Conference

    2023 Speakers

    Select a speaker to learn more

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    Dan Solis
    Assistant Commissioner for Import Operations, U.S. Food and Drug Administration

    Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORA’s Office of Import Operations. Prior to this position he was the Division Director for the Division of West Coast Imports since February 9, 2018. He started his career with FDA in 1998. Prior to working in FDA, Mr. Solis worked in the Bioresearch field focusing on Medical Device and Drug Application Products after graduating from the University California of Irvine and the University of La Verne. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch.

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    David Larwood
    CEO, Valley Fever Solutions

    David Larwood is a founder, the CEO, and chief chemist for Valley Fever Solutions, running the manufacturing process for a novel antifungal headed for Phase 2a trials in 2022. In his role as BD lead, he is responsible for many aspects of the company’s planning and operations.

    Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis), for which NikZ will transform the standard of care. NikZ shows promise against other important fungal diseases.

    Mr. Larwood co-invented his first two commercial molecules before age 30. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today. At UCSF he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. Earlier as a bench chemist, he was the first to make Iotrolan, a CT X-ray contrast agent, generic for decades, replaced in about 2005 by newer agents.

    Moving to law, in leading law firms he advised major companies on patent matters. After 3 years as a patent lawyer at Apple Computer, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through successful acquisition in 2005.

    Mr. Larwood is the third of his family to be involved in Valley Fever.  His father was a physician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever.

    Session Details:

    Exploring the need for a dedicated regulatory pathway for antibacterial/antimicrobial drugs

    2023-03-02, 12:00 PM

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    Michael Cox
    Global Outsourcing Director, Development Operations, Ascendis Pharma

    Michael’s background spans contract and proposal development; contract negotiations in multiple languages; set up and management of vendor oversight and governance programs; and related change management. He has worked for CROs as well as small and large biotechnology companies. Over the course of his career, he has worked on clinical development of 23 compounds currently marketed in 1 or more therapeutic indications.

    Session Details:

    PANEL DISCUSSION: Reversing the Conversation What the clinical trial industry really wants from its service providers

    2023-03-02, 2:30 PM

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    Bruce Morimoto
    Vice President, Drug Development, Alto Neuroscience

    Dr Morimoto has over 25 years of industry experience in leading project teams in the development of innovative medicines, providing guidance in the design and execution of preclinical, clinical and regulatory strategies with a therapeutic focus in Parkinson’s, Alzheimer’s and frontotemporal dementias. Previously, Bruce held leadership roles at Alkahest, Celerion and Allon Therapeutics, and works closely with the Michael J Fox Foundation, chairing one of their scientific review panels. He is an advisor to several biotech companies. Bruce started his career on the faculty in the Chemistry Department at Purdue University where his independent research focused on neuronal signal transduction. Bruce earned his doctorate in biochemistry from UCLA and completed a postdoctoral fellowship at the University of California Berkeley.

    Session Details:

    PANEL DISCUSSION: The concept of DCT, is it the future?

    2023-03-01, 10:45 AM

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    Prasun Mishra
    Chief Executive Officer, Agility Pharmaceuticals

    Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American Association for Precision Medicine ( and chair of ACT AAPM’s Coronavirus Taskforce He is leading research efforts focused on preventing curing chronic diseases not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company committed to revolutionizing drug discovery development through technology, big data, robotics, and artificial intelligence He is a serial entrepreneur who founded his first company after graduating high school, and his second company during his Ph D Since then, he has accumulated a wealth of experience by building, investing, and advising numerous other companies He is an investor, co founder/ board member of a few corporations, focused on accelerating drug discovery/ development, data analytics, robotics, mental health, and digital health He is also the founder of AAPM Angels and Investors AAi an investment group focused on investing in drug discovery, diagnostics, precision medicine, technology healthcare companies He is also the founding investor and advisor to Barcelona Ventures and serves as an advisor to a 100 M private equity fund Widely recognized as a thought leader in the field of ‘technology and healthcare’, Dr Mishra has keynoted, chaired, curated, and organized numerous successful international conferences He served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where he participated in several drug discovery project teams Moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic His research work has been recognized globally by over 40 prestigious awards and honors Due to his unique perspective selfless service, he is a highly respected sought after mentor to many The companies that he has advised have raised multimillion dollars Notably, he serves as a mentor and advisor to several VC funds and startup accelerators, including IndieBio HIMSS/Health 2 0 ’s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture, UCSF Invent Fund, and California Life Sciences’s FAST program, to help grow California’s life sciences innovation ecosystem

    Session Details:

    THE 2023 AI UPDATE AI & disruptive technology: Harnessing the future of Artificial Intelligence to transform clinical trials

    2023-03-02, 10:00 AM

    Session Details:

    FIRESIDE CHAT: Overcoming the barriers to trial innovation and technology access from a small company’s point of view

    2023-03-02, 8:50 AM

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    Gabriel Luciano
    Vice President, Clinical Operations, Corvus Pharmaceuticals Inc.

    Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. He was Senior Director of Clinical Operations at Pharmacyclics from 2012 to 2017 where he was responsible for the development, implementation and maintenance of the Clinical Operations infrastructure, as well as the GCP inspection hosting platform and processes, and regulatory authority marketing approval inspection hosting. From 2008 to 2011, he was Senior Clinical Trial Manager at Seattle Genetics where he was responsible for the oversight of multiple oncology clinical trials, as well as support for the development of the Clinical Operations infrastructure and regulatory authority marketing approval inspection hosting. From 1990 to 2008 he held various Clinical Operations positions at Abgenix, Pharmacyclics, Quintiles, Covance and Syntex. Mr. Luciano earned a B.A. in Psychology and Biology from the University of California at Santa Cruz.

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    Estela Mata-Carcamo
    President, Healthcare Advocate, Looms For Lupus

    Estela Mata is the President and co-founder of Looms for Lupus, a non-profit organization that provides Lupus, Fibromyalgia and Mental Health Awareness, advocacy, and support to those living with these conditions, their loved ones, and caregivers. Estela has worked in healthcare for over 30 years, currently supporting private practices with electronic medical records, office workflows to help the practice and patients for a top leading healthcare organization. In 2011 she co-founded Looms for Lupus when her sister almost lost her life to Immune thrombocytopenia and Lupus; she is alive today because she advocated for herself. Estela has supported her sister and her passion to help others has evolved to “iLOOMinating”, Engaging, Empowering and Supporting the community as a whole to take control of their healthcare. For the past 10 years, Estela has co-facilitated support groups, led, and participated in educational symposiums, advocated locally and nationally. As a community leader and healthcare advocate she partners, collaborates with initiatives including the U.S. Department of Health and Human Services’ Office of Minority Health and the U.S. Food and Drug Administration’s Office of Minority Health and Health to increase awareness on the need for diversity in lupus clinical trials, All Of US Research, Scripps Digital Trials Center and Congresswoman Grace Napolitano’s Mental Health Consortium. Estela is an exceptional community engagement liaison for both English and Spanish speakers.

    Session Details:

    Keynote Not just ticking a box: Outreach to minority groups is improving but the focus now is on establishing trust and relationships

    2023-03-01, 10:45 AM

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    Lisa Lea
    Director, Global Patient Engagement and Advocacy, Acceleron Pharma

    Ms. Lea is the Director of Global Patient Engagement and Advocacy for Acceleron, a wholly-owned Subsidiary of Merck. She is a Nurse Practitioner by training and spent over 10 years caring for patients before coming to industry. She has an extensive background including several years of experience in field medical as well as over 6 years in medical affairs. She is driven by listening and incorporating the patient voice and by finding innovative ways to improve the patient experience.

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    Anca Copaescu
    Chief Executive Officer, Strategikon Pharma

    Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side.  She is currently the Founder and CEO of Strategikon Pharma, developer of Clinical MaestroTM, the industry’s only end-to-end cloud-based platform for clinical trial budgeting, sourcing and budget management including strategic alliance/partnership management. Previously she served as Head of Clinical Outsourcing and Analytics for BioMarin Pharmaceuticals, where she was responsible for vendor contractual, relationship and financial management. She also had several leadership positions with PharmaNet Development Group (now Syneos Health), ICON Clinical Research and eMetagen Corporation.

    Session Details:

    Chairman’s Opening Remarks

    2023-03-01, 8:25 AM

    Session Details:

    PANEL DISCUSSION: Reversing the Conversation What the clinical trial industry really wants from its service providers

    2023-03-02, 2:30 PM

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    Meraf Eyassu
    Executive Director, Clinical Operations, Terns Pharmaceuticals

    Meraf Eyassu is a Executive Director of Clinical Operations at Terns Pharmaceuticals. Meraf has over 20 years experience working in biotech, health and the pharmaceutical industry. She has managed and overseen large global clinical trials in various therapeutic areas and multiple phases of development.

    Session Details:

    FIRESIDE CHAT: Addressing the growing challenge of staff shortages and site delays to develop a seamless contracting and start-up phase

    2023-03-01, 3:00 PM

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    Meghan McKenzie
    M.A. Patient Inclusion and Health Equity, Chief Diversity Office, Genentech

    Meghan McKenzie works in Patient Inclusion and Health Equity in Genentech’s Chief Diversity Office. She develops strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical research and to advance health equity Gaining patient, clinician and community insights early in program development is integral to developing what is important to patients and improving access to medicines and treatments for all patients, regardless of race, ethnicity, sexual orientation, gender identity, age, socioeconomic status and ability/disability.
    She has over 25 years of clinical development experience working at sites and in industry, and spanning multiple diseases, including oncology, ophthalmology, immunology, neurology, infectious and rare diseases.
    Meghan received her Master’s Degree in Human Biology at San Francisco State University and her Bachelor’s Degree in Economics at University of North Carolina, Chapel Hill.

    Session Details:

    GENENTECH CASE STUDY LGTBQ+ Health Inequities & SOGI collection – Why collecting this data is important in your study

    2023-03-01, 2:00 PM

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    Esther Marfo
    Project Leader, Health Equity And Population Sciences, Hoffman La Roche

    Esther Marfo, is a Project Leader within the Health Equity and Population Sciences department at Genentech. With over 15 years’ experience in the industry, Esther has predominantly worked in clinical trial management and data management roles across Europe, North America and South Africa. Her passion for ensuring that clinical trials are reflective of our society drove her to her most recent work in Health Equity, where she works with a group of committed and passionate individuals to successfully develop and implement scalable and sustainable strategic interventions for the recruitment of underrepresented patient populations.

    Session Details:

    Uncovering how Deconstructed Patient Navigation can enhance patient support

    2023-03-01, 2:00 PM

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    Abby Kennedy
    VP of Clinical Operations, CymaBay Therapeutics, Inc

    Session Details:

    PANEL DISCUSSION: Optimizing oversight & governance: What does oversight mean to you?

    2023-03-01, 10:45 AM

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    Isabel Brown
    Inclusive Research and Health Equity - gRED ECD Clinical Operations,Genentech

    Isabel Brown (she/her) currently works on the Inclusive Research and Health Equity team for Genentech's Research and Early Development, Clinical Operations group. She serves as an advisor for early phase study teams in developing inclusive clinical trials. Also within Genentech, she is a core member of the Advancing Inclusive Research Site Alliance and leads the company's LGBTQ+ Health equity strategies.

     

    Session Details:

    GENENTECH CASE STUDY LGTBQ+ Health Inequities & SOGI collection – Why collecting this data is important in your study

    2023-03-01, 2:00 PM

    Session Details:

    INTERACTIVE SESSION Data matters in health outcomes and equity: Collecting and understanding Social Determinants of Health (SDOH) data in clinical trials and beyond

    2023-03-01, 12:00 PM

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    Jasmina Jankicevic
    VP Clinical Development, RAPT Therapeutics, Inc.

    Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. She has led clinical development in dermatology and medical aesthetics for pharma/biotech, CROs, medical device and cosmetic companies including RAPT, Innovaderm, Premier Research, Allergan, Leo Pharma, and Murad. She has driven program strategy and planning, including implementation of 300+ clinical study protocols in 25+ indications, by leading global cross-functional teams towards successful regulatory submissions, product launches, and innovative lifecycle management. As an international key opinion leader in dermatology clinical development, Dr. Jankicevic has served as advisor to multiple companies on their path to global regulatory and commercial success. Dr Jankicevic holds Doctor of Medicine degree, Master of Medical Sciences degree, and Board-certification in Dermatology and Venereology from the University of Belgrade, Serbia. She holds medical license issued by Serbian Medical Chamber. She is also a Certified Clinical Research Professional, and a trained journalist. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals.

    Session Details:

    KEYNOTE: Seeing your site as a partner and identifying best practices for reducing site-burden

    2023-03-01, 8:30 AM

    Session Details:

    PANEL DISCUSSION: The concept of DCT, is it the future?

    2023-03-01, 10:45 AM

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    Cecilia Tran-Muchowski
    Sr. Director, Clinical Operations NGM Bio

    Clinical Operations leader with extensive bio-pharmaceutical and CRO industry experiences (20+years) *Develop and implement strategic Clin. Ops components of various FIH studies and global P1-P3 drug development programs and post-marketing studies in Oncology, Hematology-Oncology, Immuno-Oncology, Infectious Diseases, Immunology, Metabolic Diseases, Ophthalmology, and Critical Care conducted in North America, Europe, Africa, Central and South Americas, Asia-Pacific regions including Japan, China, So Korea, and Australia *Lead cross-functional teams and successfully contributed to several INDs, NDAs, FDA, EMEA, TGA, and NMPA regulatory filings and approvals of marketed products within HIV/Virology Therapeutic Area *Mentor, motivate, and develop clinical operations teams and direct reports *Strong, flexible, strategic team leader with extensive change management successes *Track record to develop, problem-solve, and execute creative and innovative process improvements and quality efficiencies within development operations *Motivated and driven to continue contributing to drug development in transformative medicines with a focus on unmet medical needs

    Session Details:

    CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world

    2023-03-01, 5:00 PM

    Session Details:

    CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world

    2023-03-01, 5:00 PM

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    Liza Melchor-Khan
    Sr. Director, Clinical Operations NGM Bio

    Liza Melchor-Khan is a Senior Director of Clinical Operations at NGM Biopharmaceuticals, Inc. with over 25 years of experience in the biotech and pharmaceutical industry. Liza has extensive experience in managing and overseeing phase I-IV clinical trials globally as well as building and growing clinical operations teams in oncology, cardiovascular, metabolic and liver diseases, HIV and trials in gene therapy.

    Session Details:

    CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world

    2023-03-01, 5:00 PM

    Session Details:

    CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world

    2023-03-01, 5:00 PM

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    Vineeta Gulati
    Director, Clinical Operations GSID

    Session Details:

    WORKSHOP: Identifying and overcoming the hurdles associated with global studies including longer timelines, drawn-out budgets and remote teams

    2023-03-02, 8:50 AM

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    Kimberlyn Ford Festi
    Associate Director, Site Contracts & Budgets Deciphera Pharmaceuticals, LLC

    Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. Solution-oriented professional, with strong problem solving capabilities.

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    Sandy Mohan
    Vice President, Quality Iovance Biotherapeutics

    Sandy Mohan is the VP of Quality at Iovance Biotherapeutics. Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck. She has worked at several companies in positions of increasing responsibility including VP of Quality at InterMune (acquired by Roche) and Director of Quality at CV Therapeutics (acquired by Gilead). She has over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules. She has extensive experience in building quality organizations, overseeing Phase 3 global clinical trials, supporting marketing authorization applications in the US and EU, and managing pre-approval inspections leading to multiple product approvals and launches. She received her MS and PhD in Microbiology from New York University and did a postdoctoral research at Merck Research Laboratories.

    Session Details:

    GxPs in Cell Therapy and key considerations for Quality and Project Management

    2023-03-01, 12:00 PM

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    Peter B. Heifetz
    President and CEO OrPro Therapeutics

    I am the CEO at OrPro Therapeutics, a biotechnology company in San Diego, CA developing biologic drug solutions to unmet needs in serious epithelial diseases including cystic fibrosis. My training is in genetics (Ph.D.) and mechanical/biochemical engineering (M.S.), both from Duke University where I was also an undergraduate. I went into industry for post-doctoral studies at the biotechnology research center at Ciba-Geigy Corp. (Novartis) and have over three decades of academic and industrial research and senior management experience in protein and metabolic engineering, bio-based manufacturing, and drug discovery / development. I am passionate about the life sciences and the clinical and commercial potential of novel therapeutics and applications of synthetic biology.

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    Hang Nguyen
    Senior Director Of Clinical Affairs , Materna Medical

    Hang Nguyen brings over 20 years of medical device clinical research and is currently the Sr. Director of Clinical Affairs at Materna Medical, a novel OBGYN platform company defining a $6B market in the most common pelvic conditions women face. She has executed a variety of clinical trials involving therapeutic areas including autologous breast reconstruction, heart failure, hypertension, arrhythmia management and erectile dysfunction. She also has worked within the clinical department at several reputable companies like Axogen, Medtronic, Coloplast and CR Bard.

    Session Details:

    Speaker Hosted Roundtables

    2023-03-02, 3:45 PM

    Session Details:

    Speaker Hosted Roundtables

    2023-03-02, 3:15 PM

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    Umar Hayat
    Vice President, CMC and Supply Chain, Union Therapeutics

    Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. He held senior level positions with Relypsa (acquired by Galenica for 1.52B US$), Anacor (acquired by Pfizer for 5.2B US$) and Transcept Pharmaceuticals (revers merger with Paratek). He played a pivotal role in the development and commercialization of Veltassa® (USA and EU), a treatment for hyperkalemia, Intermezzo® for MOTN insomnia, Kerydin® for onychomycosis, and Eucrisa® for atopic dermatitis. Dr. Hayat is managing partner of Revive Pharm USA. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. He received M.Sc. Chemistry degree from Punjab University, Institute of Chemistry

    Session Details:

    PANEL DISCUSSION: The concept of DCT, is it the future?

    2023-03-01, 10:45 AM

    Session Details:

    What can we do to take advantage of high prevalence of disease in populous countries but systems are either rudimentary or non-existent?

    2023-03-02, 11:00 AM

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    Kumar Gadamasetti
    Chief Executive Officer Certum Bio

    Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. Currently he is the CEO of Certum Bio in San Francisco Bay area and honors the co-appointment as the Member of the Board of Advisors, UC Berkeley Postdoc Entrepreneurs Program (BPEP). Over the past 30 years his focus has been in the areas of drug substance as well as drug product R&D, manufacturing and outsourcing the small molecules as well as biologics. The therapeutic areas include: Cancer, CV, CNS and infectious diseases. He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. CA; X-Mine, CA; Delphian Pharma, CA and Certum LLC, CA). He has been actively involved on both sides of the business in managing CDMOs and CROs. Of the several programs he worked at Pharma and Biotech companies, three culminated in making to the market [PaclitaxelTM – Bristol-Myers Squibb; SensiparTM – Amgen and DuexisTM - Horizon Therapeutics). As the Founder and Chairman, he spearheaded the ACS ProSpectives international conferences on, ‘Process Chemistry in the Pharmaceutical Industry’, and as the chair, speaker and the moderator at numerous national and international conferences on API Process Chemistry, ADCs and Drug Discovery & Development. He has been a visiting professor at Catholic U., Louvain, Belgium and U. Pittsburgh, Pittsburgh, PA and visiting speaker at Humboldt U. in Berlin, Germany. In addition to several peer reviewed publications and patents he published two volumes on, ‘Process Chemistry in the Pharmaceutical Industry’ and currently is working on the third volume entitled, ‘Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry’ jointly with the bio-process leaders at Pfizer. Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia.

    Session Details:

    Why drugs fail in clinical trials? – Cognizing & mitigating… Does AI-ML offer a solution?

    2023-03-01, 12:00 PM

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    Irene Szeto
    Executive Director, Global Digital Quality Management Systems and Business Intelligence BeiGene

    Session Details:

    TECH MEETS QUALITY

    2023-03-02, 11:00 AM

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    Wendi Carroll
    President, Carroll & Morrisette Consulting, LLC

    Wendi Carroll received her Pharm D from the University of the Pacific. She has 20+ years of diverse global experience in the biotechnology industry including roles within Clinical Development, Medical Affairs, and Risk Management. During her career she has advocated for critical partnerships with vendors supporting integration with internal stakeholders. Wendi is currently the Executive Director, Global Medical Affairs Evidence Generation COE at BioMarin Inc. where she oversees global operational strategy and execution for programs in the post-approval setting.

    Session Details:

    Developing successful communication pathways in a more remote world

    2023-03-02, 12:00 PM

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    Ann Louise Armstrong
    RN, MSN, CCRC, CCRA, Senior Manager of Clinical Affairs and Field Operations Ancora Heart

    Session Details:

    Speaker Hosted Roundtables

    2023-03-02, 3:45 PM

    Session Details:

    Speaker Hosted Roundtables

    2023-03-02, 3:15 PM

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    Audrey Funwie
    Genentech Chief Diversity Office, Patient Inclusion And Health Equity,

    Currently, Audrey Funwie works in the Patient Inclusion and Health Equity team of Genentech’s Chief Diversity Office. In this position, she focuses on initiatives for employee development or training and topics to advance health literacy for underserved communities as it relates to clinical trial access. Additionally, Funwie collaborates with colleagues to co-create educational resources as a part of the core team of the Advancing Inclusive Research Site Alliance, which focuses on addressing disparities in clinical research. Prior to working at Genentech, she graduated from the Johns Hopkins Bloomberg School of Public Health with a Master of Bioethics. Funwie strives to do meaningful work that combines and applies her bioethics background while prioritizing and addressing health equity in the context of clinical studies, patient experience, and policy.

    Session Details:

    INTERACTIVE SESSION Data matters in health outcomes and equity: Collecting and understanding Social Determinants of Health (SDOH) data in clinical trials and beyond

    2023-03-01, 12:00 PM

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    Kristina Reeder
    Director Patient Innovation Center, Patient Insights, Parexel

    Kristina leads the Patient Insights team at Parexel and is dedicated to bringing a thorough understanding of the patient journey, and the patient voice to the entire spectrum of research services. Over 20 years in clinical research, including patient innovation, feasibility, strategy, patient recruitment, retention, site engagement. 12 years at Parexel. Lead on the diversity and inclusion team, and member of DTRA, CISCRP and other industry consortiums aimed at improving access to clinical research and providing clinical research as a care option. Post doctoral research studies in Human Behavior. BS in Human and Organizational Behavior, and Communication Studies and authored numerous trade articles and frequently present on behalf of Parexel at trade conferences. Experienced in research methodologies and conducting qualitative and quantitative research in a variety of therapy areas including respiratory, cardiology, oncology, immunology rare diseases and emerging therapy areas.

    Session Details:

    How understanding the person behind the patient can improve engagement

    2023-03-01, 12:30 PM

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    Dr Chris Apfel
    CEO, SageMedic Corp

    Dr. Chris Apfel is the founder and CEO of SageMedic Corp., an early-stage clinical diagnostics company to assist oncologists in selecting the most effective treatment for their patients. Dr. Apfel is also the Chair of Life Sciences at the Keiretsu Angel Investment Forum, where he invests in life-science companies that have the potential to positively impact patients with serious conditions. Prior to starting SageMedic, he was an Associate Professor at UCSF. Dr. Apfel is an internationally known authority on designing, conducting, and publishing highest quality clinical trials with thousands of patients that have changed medical practice with over 100 peer-reviewed publications. Dr. Apfel is a California licensed physician with 20+ years of clinical experience in anesthesiology, critical care medicine, and emergency medicine. He received his medical degree (MD) and his doctoral degree (PhD equivalent) from Justus-Liebig-Universität Giessen, Germany, and his Master of Business Administration (MBA) from the Wharton School of Business, University of Pennsylvania, PA

    Session Details:

    FIRESIDE CHAT: Overcoming the barriers to trial innovation and technology access from a small company’s point of view

    2023-03-02, 8:50 AM

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    Kunal Sampat
    Host, Clinical Trial Podcast

    Kunal Sampat is the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. His goal is to help you accelerate your clinical research career and be a more effective leader. Kunal has over 18 years of experience managing and conducting clinical trials. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning.

    Session Details:

    PANEL DISCUSSION: Optimizing oversight & governance: What does oversight mean to you?

    2023-03-01, 10:45 AM

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    Sarah Mullen
    Vice President Of Clinical, HeartFlow

    Session Details:

    Speaker Hosted Roundtables

    2023-03-02, 3:45 PM

    Session Details:

    Speaker Hosted Roundtables

    2023-03-02, 3:15 PM

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    Arun Sivanandam
    Associate Director, Clinical Operations, Santen

    Arun Sivanandam has more than 12 years of experience in clinical research at site and sponsor side. He investigated mechanisms by which active ingredients in cumin seeds halt Prostate Cancer progression and metastasis at the Vattikutti Urology Institute, Henry Ford Hospital. With a dual clinical appointment in Robotic-Surgery at the Institute, Arun focused on post-surgical outcomes of Da-Vinci Robotic Prostatectomy for Hormone Refractory Patients. He worked as a Research Associate to improve recruitment metrics in the Million Veterans Program genomic biobanking initiative for Loma Linda VA Medical Center where he developed a novel Point of Care recruitment solution in outpatient clinics. To understand site-side difficulties in trial recruitment and conduct, Arun served as a Senior Clinical Research Coordinator for Cardiology Phase 4 trials at the Loma Linda VA Medical Center, and as a Lead Clinical Research Specialist for Investigator-Initiated and Phase 0 – 3 Gastric Neuroendocrine Rare Disease trials at Stanford Cancer Center. Subsequently, Arun lead the Gastric-Immuno-Oncology Rare Disease Bispecific-T cell-Engager portfolio at Amgen on various aspects of clinical research operations. More recently, Arun headed to Santen, with a focus on driving operational excellence in Ophthalmology clinical research as Associate Director Global Clinical Development and Operations, where he oversees Phase 1 – 4 clinical trial conduct. Arun received a Bachelor’s degree in Biological Sciences from University of California-Riverside, a Master’s degree in Biomedical Sciences from Wayne State University and completed Doctoral degree coursework from Michigan State University College of Human Medicine. His thesis was on the role of the Androgen Receptor in Hormone Refractory Prostate Cancer. He received a Certificate for Graduate Biostatistics at Harvard University Extension. He also conducted undergraduate research on osteoporosis progression and has authored several papers, abstracts and a book chapter on protein signal transduction.

    Session Details:

    PANEL DISCUSSION: Optimizing oversight & governance: What does oversight mean to you?

    2023-03-01, 10:45 AM

    Session Details:

    FIRESIDE CHAT: Addressing the growing challenge of staff shortages and site delays to develop a seamless contracting and start-up phase

    2023-03-01, 3:00 PM

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    Sharon Horton
    Vice President, Program Management, Iovance Biotherapeutics

    Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. Proven ability to organize and manage late-stage development cross-functional teams completing projects on time with meticulous attention to detail.

    Session Details:

    GxPs in Cell Therapy and key considerations for Quality and Project Management

    2023-03-01, 12:00 PM

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    Amy Que-Xu
    Health Technology - Clinical Research, Meta

    Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. Passionate about novel tech-enabled medical devices that advance the understanding and treatment of diseases.

    Session Details:

    Tactical clinical operations in digital health studies

    2023-03-01, 2:00 PM

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    Frances Rubenstein
    Director, Database Management, Nevro Corporation

    Dr Frances Rubenstein has worked in clinical data management for more than 20 years in both medical device and pharmaceutical companies. She has extensive experience in leading data management activities for multiregional clinical trials in all phases and several therapeutic areas. Frances has an undergraduate degree in Physiology and a PhD in medical science from the University of Sydney. Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. In her role at Nevro, Frances is responsible for leading the data management team, driving the adoption of new technologies and innovative data management processes to bring new treatments to patients.

     

    Session Details:

    Data Management: Programming and metrics in medical device studies

    2023-03-02, 12:00 PM

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    Shay Levav
    VP Quality Assurance, Regulatory Affairs And Clinical, IceCure Medical

    Vast experience of over 20 years in Quality, Regulatory, Processes Improvements and leading cross organization projects

    VP Quality Assurance, Regulatory Affairs and Clinical at IceCure Medical, since September 2020, leading the company compliance and clinical affairs

    Prior to joining IceCure Medical, held a position of Director of Quality, Regulatory and Customer Support at Applied Spectral Imaging (ASI) and Several positions at Carestream Health (formerly Orex Computed Radiography)

    Session Details:

    First-hand learnings, breakthrough device system, a case study

    2023-03-02, 2:00 PM

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    John Hsu
    CEO, IPill dispenser

    Dr. Hsu is anesthesiologist and pain management physician, but also a serial entrepreneur. His most recent activity is as CEO and Founder of QuiVivePharma, a company he took from inception to a FDA face-to-face PreIND meeting in just 1 year.

    He is also President of SBS Medical Management, a healthcare economic consulting firm for investment banks and Expert Medical Reviews, including the California Medical Board.

    Other companies he has founded or co-founded include: 1) IMTH, a real estate investment trust with properties through the state of California; 2) iPill Dispenser, a medical device that uses a mobile app to control a secure, stand-alone pill dispenser to prevent opioid sharing, diversion, and drug overdoses; and 3) NAOMI systems, a practice management software company that integrates digital X-rays devices in PACS, EMR and RCM billing modules.

    After years of watching the opioid crisis develop, John has developed an innovative drug and dispenser to safely treat pain and deter abuse.  His drive to improve healthcare is based on passion, compassion and hope.

    Session Details:

    The Digital Transformation of Clinical Trials – the Importance of Data Accuracy

    2023-03-02, 11:00 AM

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    Dr Lian Cunningham
    Vice President Of Clinical Affairs, Endogenex

    Dr. Cunningham has over 15 years’ experience in clinical leadership position in medical device industry, overseeing a full spectrum of clinical development programs ranging from FIM to pivotal to post-market phases. She has a unique perspective in leading clinical programs in a dynamic startup environment. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. She currently serves as Vice President of Clinical Affairs at Endogenex, a medical device company developing innovative solutions for the treatment of Type 2 diabetes. Dr. Cunningham came from academic background. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China.

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    Anne Reid
    Program Director, Office Of Medical Device And Radiological Health Operations, FDA

    Anne Reid is the Program Director of the Office of Medical Device and Radiological Health Operations (OMDRHO).  OMDRHO is one of five programs in the Office of Medical Products Operations within FDA’s Office of Regulatory Affairs. She is a career FDA federal service veteran with vast experience in technical and managerial positions across multiple commodities.  Anne came to FDA in 1990 with an undergraduate degree in Biochemistry and a master’s degree in Food Science and segued into FDA’s laboratory science regulatory operations.  Since 2000, Anne has held supervisory and branch director positions.  In 2010 she became the Deputy Director of ORA’s Southeast Region, and in 2012 she assumed the responsibilities of Acting Director for the Southeast Region.  Collaterally with her Regional Food and Drug Director duties, Anne served as the acting program director for both the Biologics and Tobacco programs during significant planning phases for program alignment.  She became the Deputy Program Director for OMDRHO in 2017 and ultimately became OMDRHO Program Director in February 2022.

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    Lea Doyle
    Director, Clinical Programs, Clinical Affairs, ReCor Medical

    Clinical research professional with 25 years of experience in clinical and medical affairs, most recently as Director of Clinical Affairs and Associate Director of Medical Affairs for a global medical device manufacturer focusing on endovascular and surgical repair of aortic disease.

    Session Details:

    Reimbursement for medical devices in trials, and, understanding the process

    2023-03-02, 11:30 AM

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    Brandi Coffin
    Director Global Patient Safety- Device And Digital Health, AstraZeneca

    Brandi Coffin has been in the medical device industry for over 15 years with various roles in post market surveillance, quality, compliance and patient safety.  She is a Registered Respiratory Therapist, holds the CPPS (Certified Professional in Patient Safety) credential from IHI and has a Master’s degree from Johns Hopkins in Patient Safety and Healthcare Quality.  She is currently Director of Patient Safety Medical Device for AstraZeneca and supports products across the enterprise.  During her career she has supported Class 1-3 devices through the entire product lifecycle.  Brandi has participated in numerous regulatory inspections as the Management representative, authored HHEs for all levels of products and issues and prides herself on being a patient advocate.  She is definitely not afraid of being the least popular girl in the room in order to support patient safety!

     

    Session Details:

    Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence.

    2023-03-02, 1:30 PM

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    Emmett ‘Alton’ Sartor
    Medical Director, Patient Safety Physician Digital & Devices, AstraZeneca

    Alton Sartor completed a combined MD/MBA from Tulane University. Subsequently completed a Neurology Residency at Columbia University with additional Fellowship training in Neuro-Oncology at the Mass General Brigham program. Practiced Neuro-Oncology and General Neurology at the VA and Boston Medical Center. Joined industry with a goal of developing digital and devices to improve patient care. Currently a Medical Director/Patient Safety Physician Digital & Devices at Astrazeneca.

    Session Details:

    Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence.

    2023-03-02, 1:30 PM

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    Lisa Sergas
    Executive Director, Clinical Outsourcing and Alliance Management, BridgeBio Pharma, Inc.

    Extensive Outsourcing and Contracts experience in the area of Clinical Development primarily at small to mid-size biotech organizations. Includes management of the RFP process for outsourced services as well as contract/proposal and budget negotiations, vendor selection, and vendor oversight/relationship management. Previous roles within both CRO and Sponsor organizations which provide valuable perspective from both sides of the industry.

    Session Details:

    INTERACTIVE SESSION: Establishing and maintaining strong CRO/sponsor relationships and building trust in a more virtual landscape…What have we learned and what should we focus on?

    2023-03-01, 4:00 PM

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    Aditya Kotta
    Regional Director, Business Development, Novotech

    Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv.

     

    Session Details:

    Biotech Market Performance and the impact on Clinical Trials and Operations

    2023-03-01, 9:00 AM

    Session Details:

    PANEL DISCUSSION: Reversing the Conversation What the clinical trial industry really wants from its service providers

    2023-03-02, 2:30 PM

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    David Hadden
    President, Founder and Chief Game Changer, Pro-ficiency

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

    Session Details:

    An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps

    2023-03-01, 2:30 PM

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    Chris Hickey
    Executive Vice President Business Development, Nucleus Network

    Chris has dedicated his 16-year career to the services side of the Phase I clinical drug development industry, including both operational and business development roles. Having worked within all major biopharma markets including USA, Japan, China, EU and Australia has enabled him to become a trusted advisor to many customers and help them achieve their clinical drug development objectives. Chris’ deep knowledge of the global early phase drug development industry strengthens the tradition of success of Nucleus Network, our customers and partners in “Advancing Medicines, Improving Lives”.

    Session Details:

    Phase 1 Trials: How to globalize to accelerate value inflection

    2023-03-01, 9:30 AM

    Session Details:

    PANEL DISCUSSION: The concept of DCT, is it the future?

    2023-03-01, 10:45 AM

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    Wayne Bowden
    Head of Business Development, Curebase

    As Vice President, Business Development at Curebase, Wayne leverages more than a decade of experience in clinical research across both clinical operations and strategic sales to identify new areas for growth within the company. He is a key member of the leadership team responsible for defining the company's go to market strategy and value proposition across the many segments of the pharmaceuticals and device research industry. Before joining Curebase, Wayne served as Vice President at mid-sized Florida based CRO Biorasi, where he helped to lead that company to a successful acquisition by a private equity partner in 2018. Wayne holds an MBA and B.S. degree in Neurobiology and is the author of several peer-reviewed papers in prostate cancer and premature ovarian failure. Wayne resides in Miami, Florida.

    Session Details:

    Curebase Flexible Virtual Site Demo

    2023-03-01, 4:45 PM

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    Dan McGann
    Solutions Consultant, eClinical Solutions

    As a Solutions Consultant with eClinical Solutions, Dan serves as a subject matter expert for the elluminate Clinical Data Cloud, the foundation of digital trials. Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs.

    Session Details:

    Data-driven operations and oversight with elluminate

    2023-03-01, 4:30 PM

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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.

    Session Details:

    Practical use cases to improve clinical site efficiency with technology

    2023-03-01, 12:30 PM

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    Lindsay Hughes
    Director, eCOA Science & Consulting, Clario

    Dr. Lindsay Hughes, Director of eCOA Clinical Science and Consulting at Clario, is a scientist and leader with over 15 years of experience in behavioral and life sciences. She has held key national leadership roles including advisor within the Obama/Biden administration’s global HIV response team, advisor to United Nations leadership and instructor at the CDC and USAID. An international speaker, Dr. Hughes is responsible for a team of scientific experts who provide guidance and analysis services related to the creation of electronic data collection systems for clinical trials.

    Session Details:

    Clinical Outcome Assessments (COAs): Applying scientific rigor and good instrument design

    2023-03-01, 2:30 PM

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    Jowita Marszewska
    Scientific Advisor, Clario

    Jowita Marszewska, Ph.D. is a Scientific Advisor at Clario, a global data and technology company that helps minimize risk in clinical trials. Dr. Marszewska has experience with electronic data capture and data management in clinical research. She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. Dr. Marszewska earned her MSc and PhD degrees in the field of chemistry. She has authored or co-authored 10 publications and has been an advocate for STEM education throughout her career.

    Session Details:

    Clinical Outcome Assessments (COAs): Applying scientific rigor and good instrument design

    2023-03-01, 2:30 PM

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    Ellen Weiss
    Vice President, In-Home Solutions, Decentralized Clinical Trials, PCM Trials

    Ellen Weiss is the Vice President, In-Home Solutions, Decentralized Clinical Trials at PCM Trials. Ellen brings decentralized clinical trial visits to patients with PCM Trials experienced Certified Mobile Research Nurses. She is mastering the logistics of dosing and testing clinical trial participants where they live, work, and study. With nearly a decade of home visits learnings, Ellen has a unique perspective on how decentralized clinical trials have changed over the years and what the future looks like.

    Session Details:

    Going the last millimeter: What you may not know about home visits

    2023-03-01, 2:30 PM

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    Alexis Garelli
    Technical Solutions Director, Calyx

    Alexis Garelli has over 15 years of diverse healthcare information and pharmaceutical software technology experience. She has worked with Calyx for over 7 years as a key strategic leader and director in IRT solutions and services.

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    Amy Raymond
    Therapeutic Strategy Lead, Gene Therapy Think Tank, Worldwide Clinical Trials

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

    Session Details:

    Optimizing cell-based Gene Therapy Programs through the continued evolution

    2023-03-01, 11:30 AM

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    Debashish Niyogi
    Vice President, Product Management, Anju Software

    Dr. Debashish Niyogi is currently Vice President, Product Management at Anju Software, where he is responsible for the vision, strategy, and roadmap for the company’s eTMF and CTMS solutions. Debashish has over 18 years of experience in the life sciences / clinical trials industry, including several leadership roles in Product Management. His expertise is in regulated content management, and he is a member of the TMF Reference Model Project Team. Debashish has previously managed successful eTMF products at Veeva and Medidata, as well as clinical trial imaging tools at Synarc (now part of Clario). Debashish earned a PhD in Computer Science from the State University of New York at Buffalo, specializing in the application of AI techniques in document analysis.

    Session Details:

    Effective management of essential clinical trial documents using eTMF solutions

    2023-03-02, 11:30 AM

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    Caroline Cooper
    Associate Director of Clinical Operations, CymaBay Therapeutics

    Caroline Cooper is the Director of Clinical Operations at CymaBay Therapeutics, Inc. with over 10 years of experience in clinical research. Caroline is experienced in the planning and execution of global clinical drug trials in the European, North American, Latin American, and Asia Pacific regions. She is currently managing a Ph3 program in rare liver disease.

    Session Details:

    WORKSHOP: Identifying and overcoming the hurdles associated with global studies including longer timelines, drawn-out budgets and remote teams

    2023-03-02, 8:50 AM

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    Joe Coffie
    Sr. Clinical Operations Professional, Imago BioSciences

    Session Details:

    PANEL DISCUSSION: Reversing the Conversation What the clinical trial industry really wants from its service providers

    2023-03-02, 2:30 PM

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    Rebecca Lin
    Chief Strategy Officer, Potrero

    With her unique blend of business acumen and technical expertise, Rebecca Lin is a dynamic leader with many years of success in the healthcare industry. Today she serves as the Chief Strategic Officer for Potrero Medical, a Hayward, California-based predictive health company developing the next generation of medical devices with smart sensors and artificial intelligence. Lin, who has been with the company since October 2016, previously served as the Senior Vice President of Sales and Marketing. In that role, she built and led the commercial organization that developed go-to-market strategies for Potrero's Accuryn Monitoring System.

    Over the years, Lin has achieved success at both large corporations and startups. Prior to her work at Potrero, she was the VP of Business Development at Theranova and led marketing initiatives for C. R. Bard (now owned by Becton Dickinson), in both Shanghai and the U.S. She has also worked as a Board Fellow at the American Red Cross Bay Area, currently serves as a guest lecturer at the University of California, San Francisco and Berkeley, and spent several years in sales and training at Johnson & Johnson. Lin holds a Master of Science in management from the Stanford University Graduate School of Business and a master's in marine biology from Sun Yat-sen University in Guangdong, China.

     

    Session Details:

    Artificial intelligence in medicine & clinical trials

    2023-03-02, 1:30 PM

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    Lian Cunningham
    Vice President Of Clinical Affairs, Endogenex

    Dr. Cunningham has over 15 years’ experience in clinical leadership position in medical device industry, overseeing a full spectrum of clinical development programs ranging from FIM to pivotal to post-market phases. She has a unique perspective in leading clinical programs in a dynamic startup environment. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. She currently serves as Vice President of Clinical Affairs at Endogenex, a medical device company developing innovative solutions for the treatment of Type 2 diabetes.   Dr. Cunningham came from academic background. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. 

    Session Details:

    Making progress of a complex Interventional device study during covid

    2023-03-02, 10:00 AM

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    Nina Samra
    Executive Director, Project Delivery, ICON

    Nina is an experienced executive director of clinical services with over 25 years in the pharmaceutical/biotechnology and clinical research organization industry. She oversees US and EU Project Services teams including project management, client partnerships, team and portfolio management. She has demonstrated success in managing first-in-human through large, international clinical programs with multiple protocols in Phase I-III drug development resulting in several NDAs/BLAs. Before joining ICON, Nina served as Project Director focusing on Neuroscience, Immunology & Infectious Disease at Covance and held several PM roles at Takeda, TAP Pharmaceuticals, Gilead and Genentech. Nina holds a BS in Cellular Molecular Biology and a Masters in Biomedical Laboratory Science.

    Session Details:

    European Union Clinical Trial Regulation: Strategic Considerations

    2023-03-02, 9:30 AM

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    Richard Abelson
    CEO and Founder, SDC

     

    Dr. Richard Abelson, President & CEO of Statistics & Data Corporation (SDC), founded the company in November of 2005. Prior to SDC’s inception, Richard served on the Board of Directors of Ora, Inc. (www.oraclinical.com) for over 10 years. Richard holds a Ph.D. in Industrial Engineering with a focus on applied statistics, quality, and reliability engineering from Arizona State University (ASU), a Master of Science in Industrial Engineering focused in Operations Research and Production Systems (ASU) and a Bachelor of Science in Engineering in Industrial Engineering (ASU), and is certified as a Six Sigma Black Belt. He is a member of DIA, ARVO and CDISC.

     

    Session Details:

    PANEL DISCUSSION: The concept of DCT, is it the future?

    2023-03-01, 10:45 AM

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    David Anderson
    Principal Scientist, Clinical ink

    Dr. David Anderson is a Senior Scientist at Clinical Ink, where he focuses on the development of digital biomarkers in decentralized and remotely-monitored clinical research. His current work focuses on deep collaboration with an interdisciplinary team of engineers and scientists to successfully integrate data from multiple assessments and sensors, implement high-dimensional feature engineering, and both evaluate as well as apply scalable machine learning algorithms. A visual cognitive neuroscientist by training, Dr. Anderson has over a decade of experience developing both hardware and software to evaluate behavioral and neural mechanisms of attention, working memory, and visual perception. Before joining Clinical Ink in 2021, he was an Assistant Professor in the Department of Ophthalmology & Visual Sciences at the University of Nebraska Medical Center. There, he employed a broad range of methodologies, including: visual psychophysics, neuropsychological and computer-based cognitive assessments, eye tracking, electrophysiology, and structural imaging.

    Session Details:

    A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers

    2023-03-02, 9:30 AM

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    Reem Yunis
    VP Digital Transformation Strategy, Medable

    Dr. Yunis is a scientist with multidisciplinary training and experience in the mechanism of diseases. Reem enjoys working in startups bringing forward long-term vision and strategies. At Medable, she works cross-functionally with engineering, product development, regulatory, AI/ML, and data science to develop first-in-class DCT solutions. She leads the scientific development of digital clinical measures and the modernization of clinical development models under the banner ‘Technology As Methodology’. Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. Reem holds a PhD in genetics from the Hebrew University of Jerusalem.

    Session Details:

    Technology as a methodology: Accelerating Clinical Development timelines

    2023-03-01, 4:30 PM

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    Karl McEvoy
    Product Director, Decentralised Trial Technology at YPrime

    Dr. Karl McEvoy has over a decade of industry experience in both the vendor and sponsor sides. His clinical trial experience spans from set-up to delivery across all phases in a wide variety of disease and therapeutic areas. Karl has collaborated with the world's top 20 pharmaceutical companies and has extensive experience in patient-centered outcomes research, eCOA strategy, and drug development.

    Session Details:

    Improving the patient experience through user-focused design

    2023-03-01, 12:30 PM

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    Francis Sibilla
    Senior Lead, Global Compliance and Strategy, Medidata

    Francis is an expert in clinical system regulatory compliance with over 20 years pharma experience spanning R&D, manufacturing and clinical research.  Francis has lead supplier oversight responsibilities for sponsors, CROs and clinical system vendors.

     

    Session Details:

    PANEL DISCUSSION: Optimizing oversight & governance: What does oversight mean to you?

    2023-03-01, 10:45 AM

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    Henry Lin
    VP, Data Science & Algorithms, Medidata

    Henry is a Vice President of Data Sciences at Medidata. His team’s mission is to build scalable data science and engineering software services that are integrated into Medidata platform to accelerate the generation of actionable insights across the clinical development lifecycle. Previously, he has led and worked on data science teams across different functions at Janssen Pharmaceuticals, Johnson & Johnson Medical Device Companies and Roche Pharmaceuticals. Henry earned his B.S. in Electrical Engineering & Computer Science from UC Berkeley and Ph.D. in Biological & Medical Informatics from UCSF.

    Session Details:

    Taking a Data Science approach to gain financial oversight of clinical trials

    2023-03-01, 11:30 AM

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    Meghan Harrington
    VP Clinical Trial Financial Management, Medidata

    Meghan serves as the VP, Clinical Trial Financial Management at Medidata driving roadmap and strategy across our Grants Manager and Site Payments products. Meghan started her career as a Masters level psychologist working within a medical care team treating patients with ALS and traumatic brain injury. It was through this privileged relationship with patients facing devastating diagnoses that Meghan witnessed first hand the life-saving and life-enhancing effects of medical and therapeutic intervention thus piquing her interest in the drug development process. Meghan joined a CNS-focused start up in RTP and has spent the last 15+ years working in the life science technology industry. The last decade of this time has been solely focused on the investigator grant administration domain driving strategy and leading teams implementing payment technology in both BPO and enablement models.

    Session Details:

    Taking a Data Science approach to gain financial oversight of clinical trials

    2023-03-01, 11:30 AM

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    Arvinder Dhalla
    VP of Clinical Development, Rani Therapeutics

    Dr. Arvinder Dhalla has more than twenty years of experience in pharmaceutical R&D, project management, regulatory affairs and clinical development across several therapeutic areas. Currently, Arvinder is VP of Clinical Development at Rani Therapeutics, where she is responsible for Clinical and Regulatory functions for all programs. Previously, Arvinder has worked at CV Therapeutics and Gilead Sciences where she led various projects from early discovery to clinical development. Arvinder received her undergrad in Biophysics and doctorate in Cardiovascular Physiology from University of Manitoba, Canada

    Session Details:

    Phase 1 Trials: How to globalize to accelerate value inflection

    2023-03-01, 9:30 AM

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    Gordon Chu
    Director of Investigations Branch, FDA

    Gordon Chu is the Director of Investigations Branch at the Food and Drug Administration (FDA) Division of West Coast Imports (DWCI) within the Office of Enforcement and Import Operations (OEIO).

    In this role, Mr. Chu develops, manages, and evaluates inspectional matters for DWCI covering all FDA import activities associated with air and sea port operations in the States of Hawaii, California, Nevada, Oregon, and Washington. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. He works cooperatively and collaborates with Federal, State, and local agencies to ensure appropriate consumer protection.

    Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. In 2010, he became a Supervisor Consumer Safety Officer (SCSO). As a supervisor, he had the opportunity to manage an Import Field Operation Team, an FDA team in the Centralized Examination Stations (CES), and the Los Angeles International Mail Facility. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018.

    Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. He also served on multiple FDA Headquarter working group and committee related to Food Safety Modernization Act (FSMA), import process improvement, strategic framework, rapid screening technology, and partnership agreements. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine.

    Session Details:

    FDA’s role in maintaining a secure and resilient supply chain

    2023-03-01, 4:00 PM

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    Scotty Chung-Siu
    Senior Analyst, GlobalData Healthcare
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    Ndidi Rickert
    Associate Director, Quality Culture Excellence, Ultragenyx Pharmaceutical

    Ndidi Rickert is an experienced Quality Assurance leader with over 20 years of experience in the Pharmaceutical/Biotechnology industry. She is acknowledged for her expertise and passion in Data Integrity and Vendor Oversight, and has been recognized as a thought leader in process optimization and standardization as they relate to Inspection Readiness. After completing her education in England, Ndidi began her career working for Parexel followed by Merck Sharp & Dohme. She then ventured across the pond to the United States where she worked for Novartis, Pfizer, Johnson & Johnson and Aeras (one of the Bill Gates Foundation companies specializing in TB and Malaria). An opportunity at Gilead Sciences sparked her move to the West Coast, and she is now settled in the San Francisco Bay Area. Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. Her background in Biotechnology and proficiency in Data Management solidified her proven ability to identify data integrity risks, and problem solve the most complaint path to drug submissions and approvals. Ndidi also leads the X2 Women in Biotech Group speaker series and is one of the founding members of the UltraMosaic Employee Resource Group. In her spare time, Ndidi enjoys creative writing and interior decorating. She intentionally injects laughter and authenticity into everything she does, and is an advocate for kindness, diversity and inclusion, as well as issues impacting women and children.

    Fun fact: Ndidi was born and raised in Sierra Leone, and is a descendant of the Krio people who were freed slaves that returned to Freetown from Africa, America and The West Indies.

    #DareGreatly – T. Roosevelt

    LinkedIn Bio: https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/

    Session Details:

    Enhancing a responsible quality mindset and culture

    2023-03-01, 3:00 PM

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    Erin Tibo
    Associate Director, CALYX

    Erin has over 20 years of clinical trial and pharmaceutical software technology experience . She has been with Calyx for 17 years as a key strategic leader, with a specific focus on IRT solutions.

    Session Details:

    Why expert partners and staff matter; what metrics don’t tell

    2023-03-02, 11:30 AM

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    Rhonda Mecl
    Deputy Program Director, Office of Medical Devices and Radiological Health Operations (OMDRHO), ORA, FDA

    Rhonda Mecl recently became the Deputy Program Director after serving as the Program's Operations Staff Director for the previous five years.   She has a wealth of knowledge and experience having served more than 24 years in ORA managing staff and operations focused on medical devices, radiological health, and MQSA.  She facilitates policy and procedure development within OMDRHO and collaborates with medical product partners in the Office of Medical Product and Tobacco Operations, and with peers throughout CDRH during daily operations and on special projects.  Rhonda has more than 30 years of experience in FDA, starting as an ORA Investigator in Portland, OR before becoming a manager located in FDA's Minneapolis office. 

    Session Details:

    Current topics in the Medical Device Regulatory Landscape, Presented by the FDA

    2023-03-02, 9:00 AM

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