Outsourcing in Clinical Trials West Coast 2023

For the 15th 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.

  • Hyatt San Francisco Airport, Burlingame, San Francisco
  • Complimentary
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Featured Speakers

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Umar Hayat​

VP, 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

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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

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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.

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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.

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Wendi Carroll​

Executive Director, Global Medical Affairs Study Management, BioMarin Pharmaceuticals, Inc

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.

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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.

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Sarah Mullen​

Vice President Of Clinical, HeartFlow

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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.

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Irene Szeto ​

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

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    Featured Sponsors

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    Company Website

    To learn more , please visit our website - theactigraph.com

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    Company Information

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

    Company Website

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

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    Company Information

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

    Company Website

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

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    Company Information

    Nucleus Network is Australia’s largest Phase 1 clinical research organisation and the only Phase 1 specialist globally with phase I facilities in the US and Australia. 

    Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. Combined, our clinics offer over 200 beds. All three clinics are strategically co-located within leading medical, research and biotech precincts offering unique access to ancillary services including bioanalytical laboratories, MRI, lumbar punctures, chest X-rays, ophthalmology assessments and others. 

    Since our establishment in 2004, we have conducted over 700 phase I clinical trials, with 80% of our clients consisting of US based biotech and pharmaceutical companies. 

    We have access to a population of over 10.5 million people across all 3 sites, and the ability to offer a multi-site solution in recruiting participants and patients to our clients. 

    Together with our client partners, we are fulfilling our purpose of ‘Advancing medicine, improving lives.’

    Company Website

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

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    Company Information

    At Strategikon Pharma, we bring a high level of precision and speed to outsourced clinical trial operations through our flagship SaaS platform, Clinical Maestro. Our Sponsor Edition includes dedicated applications for clinical study planning and budgeting, outsourcing and forecasting. Our Provider Edition offers a CRO costing module and bid benchmarking.

    Company Website

    To learn more , please visit our website - http://strategikonpharma.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 March 1st & 2nd 2023!

      Day 1 will kick off with a talk on designing a playbook for how to handle an undesirable CRO-Sponsor partnership, followed by a Keynote Panel allowing attendees to debate how to optimize their oversight & governance, led by Abby Kennedy (VP of Clinical Operations, CymaBay Therapeutics). Dan Solis from The FDA will give the closing keynote.

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      Genentech will give a case study session on piloting health inequities and gender identity data – why collecting this data now will aide you with your clinical trial.

      The Patient Engagement track will be chaired by Estela Mata-Carcamo (Healthcare Advocate) and will delve into topics such as, outreach to minority groups, social determinants of health, and best practices for engaging the patient community. 

      Don’t miss out; join us in Burlingame on March 1st & 2nd 2023!

      WHAT TO EXPECT FOR 2023?

      This is a great opportunity to network and share knowledge with region’s leading pharmaceutical firms, biotechs and med device companies, discuss operationally efficient, specifically targeted clinical trials. The 2023 program boasts 4 full streams jam packed with content:

      1

      Clinical Operations & Outsourcing

      		2

      Technology & Innovation

      		3

      Patient Engagement

      		4

      Medical Device Trials
      1

      Clinical Operations & Outsourcing

      		2

      Technology & Innovation
      3

      Patient Engagement

      		4

      Medical Device Trials

      Testimonials

      See What It's All About

      Agenda

      • 1 Mar 2023
      • 2 Mar 2023
      Expand All

      Streams

      Stream one

      Outsourcing & Clinical Operations

      Stream two

      Clinical Innovation & Technology

      Stream three

      Patient Engagement

      7:30 AM

      Registration & Refreshments

      8:25 AM

      Chairman’s Opening Remarks

      Speakers

      8:30 AM

      KEYNOTE: A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around

      Is it worth tweaking the relationship? How do you know when/how to severe ties?

      • Utilizing milestone data to identify if the CRO-Sponsor partnership is efficient and successful
      • Renegotiate – pros/cons of tweaking the CRO relationship compared to cutting ties, particularly in niche areas
      • Don’t burn bridges – identifying when to bail and how to go about it with grace
      • Exploring why the CRO isn’t hitting those milestones and what can be changed
      • Practical solutions and case study to conclude

      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

      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

      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 strong CRO/sponsor relationships and building trust in a more virtual landscape- What 5 things should we focus on right now?

      • Oversight with less presence– designing an oversight plan based on KPIs, fewer monitoring visits and more virtual meetings, how to make this work
      • Lessons learned on how to effectively build working relationships remotely
      • Strategies to deliver training and upskill your clinical trial team
      • Handling hard discussions with the site remotely if can’t get there in person
      • Guidance on improving CRO communication channels– how to keep CROs in the loop and draw on their extensive experience
      • We are all human, we all fail: Ensuring positivity in initial stages and taking responsibility

      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

      Keynote: Deep dive into Wearables Three thoughts and a question

      • User acceptance: The first step toward change is awareness. The second step is acceptance
      • Security: The good we secure for ourselves is precarious and uncertain until it is secured for all of us and incorporated into our common life
      • Ethics: Sharing is caring and is it good or important to share things?
      • Big Data: Without big data, you are blind and deaf and in the middle of a freeway

      Speakers

      12:30 PM

      Session Reserved for Yprime

      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 for digital therapeutics (DTx) study in pharmaceuticals

      • 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

      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

      A strategic approach to engaging patients in Rare Disease Clinical Trials

      In this presentation we will discuss the following:

      • The value of patient engagement and recruitment
      • 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

      Streams

      Stream one

      Outsourcing & Clinical Operations

      Stream two

      Clinical Innovation & Technology

      Stream three

      Medical Device

      8:15 AM

      Registration and Refreshments

      9 AM

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

      • Update on the 21 CFR Part 820 Transition
      • OMDRHO’s key initiatives, inspectional and compliance activities

      Speakers

      9:30 AM

      Session Reserved for Event Sponsor

      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- ‘Conducting a study when there is minimal education – Denovo Devices’

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

      Speakers

      4:15 PM

      Close of Conference

      Patient engagement and relationship building                                                               

      • Overcoming the impact of covid to ensure clinical trial enrolment
      • Focusing on a relationship-based approach to clinical research and how this encourages education and good working habits
      • Overcoming the barriers of onsite trials to get your device to market

      Extra sessions

      Outsourcing your medical device clinical trial to save on expenditure

      • Streamlining the many moving parts involved in taking your device from the idea stage, to trial, through regulatory, to patient.
      • Establishing transparency with your chosen CRO to ensure stable working relationship
      • Harnessing the relationship to ensure clear communication

      Case Study on a medical device which has recently had ‘PMA’ Pre-market approval

      • Exploring the opportunities with PMA
      • Analysing the challenges with securing PMA
      • Considering the implications if PMA is not accepted
      • Highlighting the solutions to get your device PMA
      • Evaluating the result

      What is driving the need for medical device regulatory advancements?

      • Reviewing historical steps in order to understand the current demands
      • Analysing the obstacles to smaller companies getting their product on the market
      • Adhering to the ever-changing regulations to ensure time & money is not wasted
      • Regulatory timelines, how quick can I get my product to market?

       

      Exploiting the advancement in AI & Robotics in Healthcare 

      • Exploring how AI & Robotics can assist in removing gender challenges
      • Ensuring the longevity of physician’s careers using robotic assistant surgery
      • PANEL/FIRESIDE

       

      Analysing the differences between pharma and medical device studies

       

      Technology

      • Use of technology to ease the cost and reduce the workload of doing studies.

       

      Artificial Intelligence in the Healthcare Field; looking into innovating our current procedures 

      • Discussing what the future can bring for the medical device industry; in terms of direction, what do we expect in the next several years, how can science be advanced in the medical device space?
      • Focusing on advancements and innovation to progress into the future of clinical trials
      • Harnessing the longevity of physician’s careers using robotic assistant surgery and in turn, removing gender challenges

      Lakshmi Raghavan, Founder & President, Solaris Pharma Corporation  

       

      IVDR and how our diagnostic companies are addressing the increased regulatory & ethics committee requirements?

      • Addressing the new requirements for getting diagnostics approved in the EU, how are we going to adapt?

              - New products to the market 

              - Existing products: how can we continue to market existing products on the market

      • Existing products to the market – Using Real World Data vs Running clinical trials to generate the data
      • Companion diagnostics; collaborations between the pharma partner vs the diagnostic partner

      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 registration: 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 AM

      Executing clinical trials on a shoestring: Optimizing the CRO Functional Service Provider model

      • What study management services are best managed by the sponsor vs. CRO
      • Which study conduct systems to utilize – sponsor vs. CRO
      • How to best co-manage the trial
      • How to best manage service/SOW changes throughout the course of the trial
      • How to maintain a win-win outcome

      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

      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

      Networking Lunch

      1:30 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

      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

      8:20 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

      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

      3:15 PM

      Afternoon Refreshments, Networking & Prize Draw in Exhibition Room

      4:45 PM

      Close of Conference

      Speakers

      Select a speaker to learn more

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      Brandi Coffin
      Associate 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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      Meghan McKenzie
      Genentech Chief Diversity Office, Patient Inclusion and Health Equity

      Meghan has over 20 years of clinical research experience in Phase 1 to 3 Clinical trials in oncology, ophthalmology, immunology, neurology, and infectious disease. Her vision includes developing strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical research and to support the optimal use of Genentech medicines. Gaining patient insights early in program development is integral to developing what is important to patients but just as important is getting access to medicines and treatments for all patients, regardless of race/ancestry, sexual orientation, gender identity, socioeconomic status and ability/disability. Her prior positions include Clinical Program Director. Clinical Program Leader, Trial monitor, Data manager, Research Coordinator and NASA Research associate. She has a Bachelor's degree in Behavioral Economics from UNC-Chapel Hill and a Master's degree from San Francisco State University in Human Biology.

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

      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

      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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      Francis Sibilla
      Senior Lead, Vertical Integration and Quality Processes, GCS | GCS Vertical Integration and Quality Processes, Medidata

      Session Details:

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

      2023-03-01, 10:45 AM

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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

      2023-03-02, 12:00 PM

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

      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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      David Hadden
      President/Founder, 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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      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.

      Session Details:

      Executing clinical trials on a shoestring: Optimizing the CRO Functional Service Provider model

      2023-03-02, 10:00 AM

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      Wayne Bowden
      Head of Business Development, Curebase

      As Head of 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 for digital therapeutics (DTx) study in pharmaceuticals

      2023-03-01, 4:45 PM

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      Henry Lin
      VP, Data Science & Algorithms, Medidata

      Session Details:

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

      2023-03-01, 11:30 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.

      Next speaker
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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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      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. 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 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:

      Keynote: Deep dive into Wearables Three thoughts and a question

      2023-03-01, 12:00 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 12 years as Director, Database Management. In her role at Nevro, Frances is responsible for selecting and managing vendors and technology to deliver quality clinical trial data to support decisions that bring new treatment to patients.

      Session Details:

      Data Management: Programming and metrics in medical device studies

      2023-03-02, 12:00 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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      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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      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:

      Session Reserved for Yprime

      2023-03-01, 12:30 PM

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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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      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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      Aditya Kotta
      Regional Director Business Development, Westcoast- USA, 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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      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:

      KEYNOTE: A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around

      2023-03-01, 8:30 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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      Rebecca Lin
      Chief Strategy Officer, Potrero

      Session Details:

      Artificial intelligence in medicine & clinical trials

      2023-03-02, 1:30 PM

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      John Hsu
      CEO And Co-Founder, IPill Smart Dispenser

      Dr. John Hsu worked 29 years as an anesthesiologist and pain management physician. In his practice he often found it difficult to monitor medication adherence and was always concerned about misuse and diversion. To solve this problem in his practice, he founded iPill Dispenser for medication adherence monitoring, secure storage, active control dispensing, and destruction of unused pills. In his past, Dr. Hsu founded QuivivePharma, a drug development company that combined an opioid with a respiratory stimulant. After receiving a NIDA NIH grant, he is working with the Cleveland Clinic on a clinical study. QuivivePharma has gone from an FDA 505(b)2 PreIND meeting to an FDA drug filing. He also founded Fentavive, an abuse deterrent Fentanyl patch that has will have a commerical product in about a years time. He co-founded NAOMI systems, a digital software platform integrating digital X-rays devices, practice management, EMR and RCM billing systems. He currently holds 8 granted patents in digital medicine, medical devices and drug development.

      Session Details:

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

      2023-03-02, 11:00 AM

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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 passion in nurturing a quality mindset across the organization and has been recognized as a thought leader in driving strategic and continuous improvement. After completing her education in the United Kingdom, Ndidi began her career working for Parexel followed by Merck Sharp & Dohme. She then ventured across the pond to the United States is now settled in the San Francisco Bay Area. Presently, Ndidi currently leads Quality Culture at Ultragenyx where she has worked for over 7 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 is the former leader and steering committee member of the X2 Women in Biotech and was 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, as well as issues impacting women and children.

       

      Fun fact: Ndidi is a descendant of the Creole people who were freed slaves that resettled in Freetown, Sierra Leone.

      Session Details:

      Enhancing a responsible quality mindset and culture

      2023-03-01, 3:00 PM

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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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      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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      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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      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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      Dan Solis
      Assistant Commissioner for Import Operations, FDA

      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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      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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      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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      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:

      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

      Session Details:

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

      2023-03-01, 10:45 AM

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      Jasmina Jankicevic
      Consulting Dermatologist, Clinical Development & Medical Affairs 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:

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

      2023-03-01, 10:45 AM

      Session Details:

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

      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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      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

      2023-03-02, 12:00 PM

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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.

      Session Details:

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

      2023-03-02, 9:00 AM

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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, 1:30 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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      Umar Hayat
      VP, 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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      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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      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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      Lea Doyle
      Director, Clinical Programs, Clinical Affairs, ReCor Medical

      Session Details:

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

      2023-03-02, 11:30 AM

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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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      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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      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 10 years as a key strategic leader and director in IRT solutions and services.

      Session Details:

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

      2023-03-02, 11:30 AM

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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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      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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      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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      Wendi Carroll
      Executive Director, Global Medical Affairs Study Management, BioMarin Pharmaceuticals, Inc

      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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      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 strong CRO/sponsor relationships and building trust in a more virtual landscape- What 5 things should we focus on right now?

      2023-03-01, 4:00 PM

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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 registration: Strategic considerations

      2023-03-02, 9:30 AM

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

      o 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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      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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      Kris O’Brien
      Executive Director, Program Delivery, Rare Disease, Premier Research

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

      Session Details:

      A strategic approach to engaging patients in Rare Disease Clinical Trials

      2023-03-01, 11:30 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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      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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      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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      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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      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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      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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      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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