12th Annual Outsourcing in Clinical Trials Southern California 2024

Creating a collaborative environment where pharma & biotech leaders can find solutions to current challenges through innovations and partnerships

24 - 25

September

2024
  • Hyatt Regency La Jolla at Aventine, San Diego, USA
  • Complimentary
  • Why attend?
  • Agenda
  • OCT Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
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Featured Speakers

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Eric Pittman​

Director, Bioresearch Monitoring Division (West) and FDA Delegate to the OECD Working Party on GLPs, FDA

Eric Pittman currently serves as the Program Division Director (PDD) for the Bioresearch Monitoring Division II (BIMO-W) staff.  As the PDD, he provides leadership in directing and managing programs and a professional staff in locations from Detroit, MI to Hawaii covering all clinical and non-clinical facilities.  In addition to being the PDD for BIMO-W, Eric is one of the U.S. Representatives to the Organization for Economic Co-Operation and Development (OECD).

Supplement to his work experience with the FDA, Eric has worked in the Medical Device, Food and Drug Industries serving in various capacities such as a Regulatory Affairs Associate and Director of Quality.

Eric attended Purdue University School of Pharmacy and while there also earned a degree in radiation physics. He has an MBA from Youngstown State University along with several certifications for various quality and regulatory activities.

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Brandi Roberts​

Chief Financial Officer, Longboard Pharmaceuticals

Brandi Roberts has more than 25 years of public accounting and finance experience, including 22 years at publicly traded pharmaceutical, medical technology, and life science companies. Ms. Roberts is Executive Vice President and Chief Financial Officer at Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH). Ms. Roberts begun her tenure at Longboard in January 2021 and helped the company go public in March 2021.  Ms. Roberts served as Executive Vice President and Chief Financial Officer of Lineage Cell Therapeutics, Inc. (NYSE: LCTX) from January 2019 to January 2021. Ms. Roberts is a certified public accountant with the State of California and received her B.S. degree in business administration from the University of Arizona and her M.B.A. from the University of San Diego.

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Gurinder S. Sidhu​

MD, MHA, MBA, U.S. Senior Medical Director, Pfizer

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Peter Stiegler​

Vice President Clinical Operations, HuyaBio

PeterStiegler earned his PhD in Molecular Biology at the University of Vienna Biocenter and performed a post doc at Thomas Jefferson University in Philadelphia PA. He since held positions in various operational functions in the Clinical Research arena with a focus in oncology early drug development at companies including EMD, Novartis Oncology Translational Medicine and Novartis Molecular Diagnostics.

After working at the Duke Clinical Research Institute focusing on biomarker development he worked as the Director of Clinical Operations at diagnostic development companies Prometheus Laboratories and Progenit

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Krishna P. Allamneni​

Chief Development Officer, Concarlo Therapeutics, Inc.

Krishna is a seasoned biopharmaceutical executive with a 20+ year track record in translating benefit-risk for regulatory authorities across diverse therapeutic areas. She led the early development of six successful marketed products and managed 25+ IND/IMPD submissions.

Currently, Krishna serves as the Chief Development Officer at Concarlo Therapeutics, Inc., focusing on a p27 inhibitor and overseeing preclinical R&D, CMC, pipeline strategy and portfolio management, clinical strategy, and regulatory affairs. Previously, she was Vice President and Head of Development Sciences at Turning Point Therapeutics, Inc. (now BMS) and served in various leadership roles at Jazz Pharmaceuticals, NGM Biopharmaceuticals, and Genentech. She has also contributed to the American College of Toxicology as a board member. Krishna's leadership ensures expedited and cost-effective global early development regulatory strategies, making her a trusted figure in the clinical and investment communities.

Krishna is a board-certified toxicologist, with a Postdoctoral Training in Pathology and Developmental Lung Biology from Harvard Medical School, an MS/PhD in Pharmacology/Toxicology from University of California, Davis, and a Bachelor of Veterinary Science and Animal Husbandry (Doctor of Veterinary Medicine equivalent).

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Gajanan Bhat, PhD​

Senior Vice President, Global Development Team Lead TORL Biotherapeutics

Gajanan Bhat is a successful clinical research and development executive with a proven record in over 20 years in the development of drugs, biologics, device, radiopharmaceuticals leading to approval and launch.  Gajanan Bhat is currently the Principal and founder of Celyxa, Inc, a digital health company.  Prior to leaving recently, Gajanan was the Senior Vice President of Clinical Science at Spectrum Pharmaceuticals, a clinical stage oncology company for the last 10+ years responsible for a range of clinical development strategy and functions. Gajanan has worked in multiple companies over the last 20+ years with increasing responsibilities including drug, device, diagnostic product development.

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    2023 Sponsors Included:

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    Company Information

    Founded in 1997, Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase.

    Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award 2023, the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2023, the Asia-Pacific Contract Research Organization Company of the Year Award since 2006.

    The Company offers a comprehensive suite of services including laboratories, Phase I facilities, drug development consulting, regulatory expertise, and has experience with over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech is a trusted end-to-end strategic partner of choice.

    For more information or to speak to an expert team member visit www.Novotech-CRO.com

    Company Website

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

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    Company Information

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

    Company Website

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

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    Company Information

    Clario is a leading healthcare research and technology company that generates high quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence generation solutions that combine eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries.  Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2019.

    Company Website

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

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    Company Information

    PCM Trials has been at the forefront of decentralized clinical research since 2008, leading mobile visits and recently introducing community-based research sites. We are driving the shift to patient-centric clinical trials, giving individuals the flexibility to engage in research studies in ways that work best for them. Our approach expands opportunities for participation, resulting in greater patient diversity, reduced patient dropout, and faster study results.

    Company Website

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

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    Company Information

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

    Company Website

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

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    Company Information

    TFS HealthScience is a global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Bringing together nearly 700 professionals, we deliver tailored clinical research services in more than 40 countries. TFS supports customers with comprehensive solutions including full clinical development services, strategic and flexible resourcing. In partnership, we build solution-driven teams of experienced professionals working together for a healthier future. Our mission is to bring treatments to patients faster. For more information, please visit www.tfscro.com.

    Company Website

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

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    Company Information

    At Viedoc, we design engaging software that modernizes clinical research so that necessary treatments can reach the people who need them faster. We believe in life and science, in people, and in our collective power to change the world and build a healthier future. That unmatched driving force is what pushes us to innovate, accelerate and improve every aspect of modern clinical studies.

    Company Website

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

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    Company Information

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

    Company Website

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

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    Company Information

    ACM Global Laboratories is one of the largest global independent central labs in the industry. ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. ACM performs more than 20 million laboratory tests each year—spanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more.

    Company Website

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

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    Company Information

    Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences.  Visit our website to learn more about how we deliver a Better Clinical Experience.

    Company Website

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

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    Company Information

    Advarra is number one in trusted research review services, number one in innovative site and sponsor technology, and the pioneer in clinical research experience software. Our depth of technology and people expertise combine to deliver solutions that enable the collaboration, transparency, and speed required to optimize trial operations and ensure patient safety.

    Company Website

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

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    Company Information

    Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients.

    Company Website

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

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    Company Information

    Established in 1950, Andwin Scientific specializes in outsourced clinical research supply chain and laboratory supplies management to global life science organizations, providing a single source for study supplies & equipment and custom clinical trial & specimen kitting requirements.

    Company Website

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

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    Company Information

    assisTek has been paving the way for integrating technology and data collection in clinical trials for over 25 years. We have earned a solid reputation around the globe by delivering customized solutions used in over 500 clinical research trials, across 90 different languages in 80 different countries. Based outside Philadelphia, Pennsylvania, we pride ourselves on being boutique by design and always customer focused. eCOA is our core focus but not our only service. Our experienced team has been in this niche of clinical research with deep domain experience for decades and client solutions has been our passion for over two decades.

    Company Website

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

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    Company Website

    To learn more, please visit our website - atreo.io

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    Company Information

    Barrington James are a Global specialist recruitment consul­tancy working across the Healthcare sector.  Our structure, with separate divisions and dedicated consultants for the markets we serve ensures a thorough, professional and intelligent approach in both permanent and interim solutions.  Our tailored methodologies include Contingency database search and executive search.

    Company Website

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

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    Company Information

    IQVIA Technologies help you transform your clinical trials and improve patient safety with SaaS-based applications and tech-enabled services designed to streamline processes, improve workflows, and effectively engage and inform patients. The Orchestrated Clinical Trials (OCT) platform eases the burden on your sites and makes it easier and more appealing for patients to enroll and remain engaged, produces faster trials to database lock, and speeds time to market. For more information visit www.iqvia.com/oct or email us at OrchestrateYourTrials@iqvia.com

     

    Company Website

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

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    Company Information

    CRIO revolutionizes clinical research with cutting-edge cloud technology. CRIO enables remote monitoring and instant data review with CRIO Reviewer, an integrated eSource/EDC solution. Capturing data in real-time and ensuring compliance with various regulations, including 21 CFR 11, ICH-GCP, GDPR, and HIPAA, CRIO eliminates redundant data entry and safeguards data integrity.

    Company Website

    To learn more, please visit our website - https://clinicalresearch.io/

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      Why attend?

      Arena International are delighted to announce Outsourcing in Clinical Trials Southern California 2024 will be returning to San Diego!

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

      Don’t miss out on this years two-streamed agenda; join us in 2024. We can’t wait to see you there!

      Southern California Clinical Trials Outsourcing 2023 is pleased to announce an event for all online casino players. Our flagship clinical show will be held in 2023 with the best online casino https://chiefcasinos.com/low-deposits/1-dollar-deposit/ gamblers. This event cannot be missed, and every online casino player can view the agendas on our website.

      WHAT TO EXPECT FOR 2024?

      As this event returns you can expect high level discussion and presentations with industry thought leaders focusing on novel and innovative solutions to some of this years key challenges. Additionally with our technology and innovation stream, learn what is in store for the future of clinical trials.

      With regulations ever changing and the innovative advancements of technology rapidly growing, this conference will address the everyday and perspective challenges faced when working within the clinical trial space. Legislations such as the DEPICT Act, Inspection Readiness presented by the FDA, to Generative AI and leveraging our global trial footprint to accelerate clinical development, as well as building on our new and existing relationships within our industry.

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

      This is a unique opportunity to network and share knowledge with the region’s leading pharmaceutical firms, biotech’s and medical device companies, to discuss operationally efficient, specifically targeted clinical trials. The 2024 program boasts 2 full streams complete with key content.

      450+

      ATTENDEES

      		65+

      EXHIBITORS

      		30+

      SPEAKERS

      		50%

      ATTENDEES AT DIRECTOR + LEVEL

      450+

      ATTENDEES

      		65+

      EXHIBITORS
      30+

      SPEAKERS

      		50%

      ATTENDEES AT DIRECTOR + LEVEL

      Testimonials

      See What It's All About

      Agenda

      • 24 Sep 2024
      • 25 Sep 2024
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      Streams

      Stream one

      Stream A: Outsourcing & Clinical Operations

      Stream two

      Stream B: Clinical Trial Technology & Innovation

      11 AM

      Generative AI & the future of clinical trials: putting theory into practice.

      • Identify and assess the possibilities for AI in your clinical trial
      • Understanding the technologies behind AI such as machine learning, deep learning, neural networks, and algorithms
      • Social and ethical implications of Artificial Intelligence
      •  A contextual understanding of AI, its history, and evolution, helping you to make relevant predictions for its future trajectory.
      • Looking at how to successfully implement AI into your clinical trial
      • Case Study Overview

      Speakers

      Gajanan Bhat, PhD
      Senior Vice President, Global Development Team Lead TORL Biotherapeutics

      11:30 AM

      Leveraging Generative AI and Data Standards for Efficient Medical Imaging Documentation and data exports in Oncology Clinical Trials

      This presentation explores how AI technology and data standards can elevate the quality of medical imaging document generation and data management.

      This presentation explores how:

      • AI technology and data standards can elevate the quality of medical imaging document generation and data management.
      • Generative AI can produce and verify standardized study documents using a structured questionnaire and quality checks.
      • With expert oversight, Clario is automating the CDM process by mapping, cleaning, reviewing, and exporting medical imaging data through SDTM standards and quality control mechanisms.
      • AI technology can improve workflow and data cleaning processes, detect errors, and ensure high data quality.
      • Technological advancements can offer real-time analytics and insights for the quality of medical imaging data.

      Speakers

      Shyam Banuprakash
      Senior Vice President, Data Science, Clario

      12 PM

      Real World Evidence and Clinical Development

      • How real-world data can inform clinical trial planning
      • Highlights of regulatory guidelines for the use of real-world data in clinical development
      • How can real-world data add value in the clinical development process
      • Case Study

      Speakers

      Gurinder S. Sidhu
      MD, MHA, MBA, U.S. Senior Medical Director, Pfizer

      12:30 PM

      Innovative eCOA strategies that minimize protocol complexities, preserve endpoint integrity, and enhance the end user experience:

      In this presentation we will explore the critical role eCOA  plays in relationship to endpoint strategy and how to proactively anticipate, mitigate and execute eCOA strategies that optimize endpoint data collection while enhancing the site and patient experience. The following topics will be addressed.

      • Navigating common protocol requirements that increase eCOA complexities
      • Balancing the challenges of orchestrated Clinical Technology solutions with the benefits they bring to eCOA data quality and the end user experience (site & patient)
      • How novel and innovative eCOA features  such as photography are shaping clinical work-flow and informing trial results

      Speakers

      Melissa Mooney
      Director, eCOA Solutions Engineering, IQVIA Patient Suite

      1 PM

      Lunch and Networking

      2 PM

      PANEL: Exploring the transition of Innovation & technological advancements in clinical trials

      • Are we making the most of Technology & Innovation in the Clinical Trial space?
      • How are these tools being utilized efficiently?
      • The importance of exploring ethical considerations.
      • Examining the relationship between innovation, creativity, and regulations
      • What’s next?

       

      Speakers

      Amanda Murphy
      Senior Director, Data Intelligence & Solutions, GlobalData
      Joe Shan
      Vice President Clinical Operations, Adcentrx Therapeutics
      Elizabeth Sheehan, PMP
      Sr. Clinical Project Manager, Recor Medical
      Cole Eshbach
      Sr. Clinical Trial Manager, Endo

      2:45 PM

      TECH SPOTLIGHT: Reducing Trial Start-Up Time Through an Innovative Approach to Vendor Qualification

      • Exposing the inefficiencies of current vendor qualification practices and challenging the industry to adopt a proven process innovation that will help Sponsors onboard Providers more quickly leading to a real reduction in clinical trial start-up times.
      • Learn how embracing innovation, and adopting a risk-based data-driven approach to vendor management can help organizations strength their compliance practices in a heavily regulated industry.
      • Uncover the advantages of a centralized approach to vendor qualification that provides unique benefits to both Sponsors and Providers across the globe.

      Speakers

      Anthea Dransfield
      Head of Quality, Diligent Pharma

      3 PM

      Cardiac Data Matters: Keeping Patients at the Heart of Innovation

      Join an exclusive session with a market leader in continuous cardiac monitoring. Discover how to achieve unparalleled accuracy and patient compliance through cutting-edge, low-touch technology.  Dive into the transformative power of AI and explore real-world applications that are reshaping cardiac care.

       

      ·       Understand how continuous monitoring ensures precise data collection and enhances patient adherence and safety

      ·       Uncover the revolutionary role of artificial intelligence in interpreting cardiac data

      ·       Review practical examples and case studies demonstrating the effectiveness of continuous cardiac monitoring in clinical settings

      Speakers

      Ana Natera
      Director, Clinical Business Strategy, HeartMetrics Cardiac Monitoring, Medtronic

      3:15 PM

      Afternoon Break and Apple Prize Draw

      4 PM

      Streamlining Sensor Study Operations for Better Patient and Site Experiences

      • Addressing the perceived and real life operational challenges of using sensors in clinical trials
      • How to deliver better site and patient experiences with sensors
      • Logistical considerations for those on the ground deploying sensors (including training for site staff and patients, as well as sensor storage and distribution)
      • Strategies to reduce the friction of multi-vendor management

      Speakers

      Marissa M. Ballesteros
      RN, MPH, MBA, Senior Director, Patient Cloud Commercial Strategy, Medidata

      4:30 PM

      MEDICAL DEVICE SPOTLIGHT – EU MDR Impact on Global Clinical Evidence Strategy

      Under EU MDD, class III implants could often be approved for marketing with only post market clinical follow-up requirements. EU MDR has considerably raised the barrier to entry with more refined rules for equivalence and definitions for sufficient clinical evidence to support a medical device’s safety and performance assessment.

      • Prior Go to Market Strategy under EU MDD
      • Farewell CE Mark First Strategy
      • First in Man strategy considerations
      • Global Pivotal Trial Strategy

      Speakers

      Darren LaCour
      Director, Global Clinical Programs, Stryker

      7:45 AM

      Registration and Refreshments

      8:35 AM

      Chair’s Opening Remarks

      Speakers

      Robert Loll
      SVP, Business Development, Praxis Communications

      8:45 AM

      FDA KEYNOTE: How do you prepare for that inevitable knock on the door? Do you worry about FDA’s arrival, or is it an exercise in demonstrating your inspectional readiness?

      During this presentation, you will learn:

      • How to be prepared for an FDA BIMO (or other) inspection.
      • Learn about publicly available resources for use to prepare.
      • Evaluate inspectional metrics and new information provided by FDA.
      • Learn how to respond to an FDA-483 or discussion points.

      Speakers

      Eric Pittman
      Director, Bioresearch Monitoring Division (West) and FDA Delegate to the OECD Working Party on GLPs, FDA

      9:30 AM

      Uncovering the CRDMO Advantage in Drug Development

      • Combining the expertise and technology of a Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO)
      • Navigating the intricacies of bringing new therapies to market without the complications of working with multiple outsourcing partners
      • Delivering speed, simplicity, and scalability to clinical trials, drug development, and manufacturing

      Speakers

      Douglas Ahrens
      Program Transformation Director, Thermo Fisher Scientific

      10 AM

      Do You Have the Right Oncology Sites in a Competitive Market?

      ·       Do you stand out in a competitive market?

      ·       With the recent Project Optimus guidance, are you targeting the right number of sites for your study?

      ·       What non-US countries should you consider for quick activation and strong enrollment?

      Speakers

      Sarah Anderson
      Therapeutic Strategy Lead-Oncology, Novotech

      10:30 AM

      Morning Refreshments and Networking

      11 AM

      The Patient’s Perspective: ‘Why are patient’s voices so important in clinical development?’

      • Discussing the personal experiences of the patient
      • Defining 'patient centricity'
      • Building clinical trials with the perspective of the patients in mind
      • Patient access to the drug post study

      Speakers

      Nisha Trivedi
      Rare Disease Patient Advocate

      11:30 AM

      Maximizing the Consultative Partnership Between CRO and Biotech Sponsors

      • How early engagement will improve outcomes
      • Speaking the same language – one size doesn’t fit all
      • Simplifying the complex, in a world with an awesome amount of outsourcing options

      Speakers

      Betty McGregor
      Executive Director, Project Delivery, ICON Biotech

      12 PM

      Interactive Session: Incorporating Diversity & Inclusion into your Clinical Trials and the necessary steps required to adhere to legislation & perform with best practice.

      • New FDA requirement for the Clinical Diversity Action Plans and why Clinical Trial Diversity is important in evaluating safety and efficacy of drugs
      • CARER Group’s objective grading method for clinical trial diversity (CTD) and reporting of CTD scores of 92 drugs approved by FDA in 2022-2023.
      • Example of best practices for achieving clinical trial diversity in USA

      Speakers

      Kay Olmstead
      Co-Founder, CARER

      12:30 PM

      Accelerating Neurodegenerative Clinical Drug Development with AI

      • The role of AI in dissecting disease pathogenesis
      • Ways AI can improve success rates in neurodegenerative drug discovery and development
      • Methods for accelerating CNS clinical trials with AI, enhancing patient journeys and drug accessibility

      Speakers

      Dr. Sara Doan
      Executive Director, Program Strategy and Delivery for Internal Medicine & Neuroscience, TFS HealthScience

      1 PM

      Lunch and Networking

      2 PM

      PANEL: Considerations for a Patient Centric Trial Design to Increase Trial Success

      • Exploring patient collaboration and the benefits it can bring to the sponsor and the patient.
      • Importance of good communication to the patients and how this can streamline trial timelines
      • Exploring how patients could, and should, be influencing decisions and the R&D process before study start-up.
      • How to optimize collaboration with patient advocacy organizations
      • Patient perspective ‘Pain Points’ throughout various trials

       

      Speakers

      Jessica Hatheway
      MBA, Vice President, Clinical Operations, Daré Bioscience
      Constance Crowley
      Executive Director/Senior Clinical Scientist, Arcturus Therapeutics
      Dr. Paul Grint
      Executive Chairman, Codagenix
      Nick Tresnowski
      Director of Operations, LEAPCURE

      2:45 PM

      Bridging the Gap: Expanding Clinical Trial Accessibility in Healthcare Deserts

      Learning objectives:

      • Understanding the critical role of diversity and accessibility in clinical trials and its influence on research outcomes.
      • Identify barriers to trial participation and analyze the challenges faced by populations in healthcare deserts.
      • Learn how mobile visits and community-based sites can facilitate clinical participation and improve outcomes in hard-to-reach areas, supported by new data demonstrating their effectiveness.
      • Identify strategies for implementing successful mobile visits and community-based sites to expand trial accessibility and inclusivity.

      Speakers

      Katelynn Spingola
      Associate Director, Community Research Sites, EmVenio Research
      Rachael Sawaya
      Associate Director, Project Management – Execution, PCM Trials

      3:15 PM

      Afternoon Break and Apple Prize Draw

      4 PM

      Enhancing Operational Excellence through Digital Solutions

      This presentation will address how to manage, oversee, and improve performance in clinical trials through an integrated technology platform.

      Key takeaways:

      • Best practices for addressing risk assessment and central monitoring
      • Tips for improving investigator database and study start-up management
      • Ways to expand global footprint through secure technology sharing with CRO partners
      • Steps to simplify consistent, ongoing data review and optimize data quality
      • How to use technology to improve communications and site relationships

      Speakers

      Nicole Stansbury
      Senior Vice President, Clinical Operations Premier Research

      4:30 PM

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

      • Importance of retention and growth of your team
      • Openness to junior clinical team members
      • Openness to bridge programs with your vendor partner
      • Navigating these challenges in a hybrid environment

      Speakers

      Cole Eshbach
      Sr. Clinical Trial Manager, Endo

      5 PM

      Chairperson’s closing remarks and Networking Drinks

      END OF DAY 1 AND NETWORKING DRINKS RECEPTION SPONSORED BY PCM TRIALS

      Streams

      Stream one

      Stream A: Outsourcing & Clinical Operations

      Stream two

      Stream B: Clinical Trial Technology & Innovation

      8:50 AM

      Chair’s Opening Remarks

      Speakers

      Amanda Murphy
      Senior Director, Data Intelligence & Solutions, GlobalData

      9 AM

      Balancing Hard and Soft Data Endpoints in Clinical Trials

      • Patient-reported outcomes (PRO), are becoming more prevalent in trials, often collected by a phone App
      • While PRO can increase subject engagement, these data are subjective and cannot support regulatory approval alone
      • By understanding the relationships between objective and subjective data endpoints (cortisol level to stress, glucose to Oxygen levels to activity, etc.), trial designers can balance "hard" and "soft" data points.
      • These can be collected, analyzed, and presented to regulatory bodies so that data streams support one another, increasing likelihood of regulatory approval for the product.

      Speakers

      Bruce Lyday
      CEO, Coronavax

      9:30 AM

      Setting up Global Clinical Trials, with a focus on Asia Pacific

      • Strategies for Country and Site Selection
      • Optimizing cost and time
      • Large and small company perspectives
      • Leveraging global trial footprint to accelerate clinical development
      • The evolution of Clinical Development in AsiaPacific
      • How different notified bodies and their regulations present challenges to our clinical execution strategies

      Speakers

      Dr. Mark Glassy
      Clinical Trial Professional

      10 AM

      Morning Refreshments and Networking

      10:45 AM

      Clinical Trials: Usage of CROs

      • Global Activity of Trials Using CROs
      • US Activity of Trials Using CROs
      • Upcoming CRO Invites for 2024
      • Key Takeaways

      Speakers

      Scotty Chung-Siu
      Managing Analyst, Clinical Trials Intelligence, GlobalData

      11:15 AM

      PANEL: AI and digitalization in clinical trials

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

      Speakers

      Amanda Murphy
      Senior Director, Data Intelligence & Solutions, GlobalData
      Tania Azad
      Associate Director, Clinical Project Lead, Alexion
      David Berry
      Principal Data Scientist, PPD clinical research business of Thermo Fisher Scientific
      Renee St.Clair
      Advisor and former Vice President, Ketamine Taskforce, Inc.
      Shyam Banuprakash
      Senior Vice President, Data Science, Clario

      12 PM

      Lunch and networking

      8 AM

      Registration and Refreshments

      8:50 AM

      Chair’s Opening Remarks

      Speakers

      Robert Loll
      SVP, Business Development, Praxis Communications

      9 AM

      Navigating The Complex Vendor Landscape and How to Build Strong Outsourced Relationships

      • Unravelling the ever evolving and persistent challenge of technology adoption
      • Implementing effective vendor management tools to avoid the failure of clinical trials
      • Considering essential factors when procuring from a CRO
      • Underlining the factors which could be limiting what choice you make?
      • Establishing common ground with your CRO

      Speakers

      Tania Azad
      Associate Director, Clinical Project Lead, Alexion

      9:30 AM

      Designing Clinical Trials with Woman in Mind

      Interactive session with audience engagement.

      Focusing on advancing women’s health and meeting unmet needs

      Speakers

      Krishna Allamneni
      Executive Vice President, Chief Development Officer, Concarlo Therapeutics
      Robert Loll
      SVP, Business Development, Praxis Communications

      10 AM

      Morning Refreshments and Networking

      10:45 AM

      Ensuring Adequate Sponsor Oversight of Clinical Trials When Outsourced to Clinical Contract Research Organisations

      This presentation will highlight.

      • Ensuring that KPIs are informative and meaningful.
      • Assessing overall project risk and appropriate surveillance tactics
      • Consolidating your overall management strategy that can be coordinated with CRO SOPs
      • Providing documentation of Sponsor oversight activities throughout the study

      Speakers

      Preeti Baweja
      Director, Clinical Operations, Ventyx Biosciences

      11:15 AM

      PANEL: The Clinical Trial Landscape for Small to Mid-Sized Biopharma in Southern California

      • New regulations and guidance around clinical trials in the US: how will this impact you?
      • Staff turnover and layoffs: handling changes in the industry in order to ensure success
      • Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor company
      • An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?

      Speakers

      Robert Loll
      SVP, Business Development, Praxis Communications
      Sarah Anderson
      Therapeutic Strategy Lead-Oncology, Novotech
      Krishna Allamneni
      Executive Vice President, Chief Development Officer, Concarlo Therapeutics
      Michael Murphy
      Director, Legal & Associate General Counsel, Ionis Pharmaceuticals, Inc.

      12 PM

      Lunch and networking

      1:15 PM

      Psychedelic Compounds in Clinical Trials: The Risks and Benefits of Video Recording Subjects

      • Patient consent
      • Patient safety and clinician accountability
      • Data privacy, HIPAA, 21 CFR Part 11 and related guidelines and regulations
      • Bias
      • Education and research implications

      Speakers

      Dr. Christian Yavorksy
      Chief Scientific Officer, Valis Biosciences Inc.

      1:45 PM

      Top Tips in Effective Budget Management, Forecasting and Contracting: Ensuring Your Resources Are Allocated Correctly

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

      Speakers

      Brandi Roberts
      Chief Financial Officer, Longboard Pharmaceuticals

      2:15 PM

      Afternoon refreshments and networking

      3 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.

      ROUNDTABLE 1: Collaboration On Trial Design to Ensure Study Success

      Steven Chen, Chief Medical Officer, ImpediMed

      ROUNDTABLE 2: An insider’s look into project management from Clinical Trial start-up to closure, and, how to leverage technological tools to your advantage.

      Elizabeth Sheehan, Sr. Clinical Project Manager, Recor Medical

      ROUNDTABLE 3: Redefining Dose Selection in Oncology: Navigating the Impact of Project Optimus Through Collaborative Insights

      Krishna Allamneni, Executive Vice President, Chief Development Officer, Concarlo Therapeutics

      Speakers

      Steven Chen
      Chief Medical Officer, ImpediMed
      Elizabeth Sheehan, PMP
      Sr. Clinical Project Manager, Recor Medical
      Krishna Allamneni
      Executive Vice President, Chief Development Officer, Concarlo Therapeutics

      4 PM

      Chairperson’s closing remarks

      END OF CONFERENCE

      Speakers

      Select a speaker to learn more

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      Robert Loll
      SVP, Business Development, Praxis Communications

      Robert Loll is the SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies with award-winning creative and superior execution.  Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 16+ years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.  Robert is an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

      Session Details:

      Chair’s Opening Remarks

      2024-09-24, 8:35 AM

      Session Details:

      Chair’s Opening Remarks

      2024-09-25, 8:50 AM

      Session Details:

      Designing Clinical Trials with Woman in Mind

      2024-09-25, 9:30 AM

      Session Details:

      PANEL: The Clinical Trial Landscape for Small to Mid-Sized Biopharma in Southern California

      2024-09-25, 11:15 AM

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      Amanda Murphy
      Senior Director, Data Intelligence & Solutions, GlobalData

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

      Session Details:

      PANEL: Exploring the transition of Innovation & technological advancements in clinical trials

      2024-09-24, 2:00 PM

      Session Details:

      Chair’s Opening Remarks

      2024-09-25, 8:50 AM

      Session Details:

      PANEL: AI and digitalization in clinical trials

      2024-09-25, 11:15 AM

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      Eric Pittman
      Director, Bioresearch Monitoring Division (West) and FDA Delegate to the OECD Working Party on GLPs, FDA

      Eric Pittman currently serves as the Program Division Director (PDD) for the Bioresearch Monitoring Division II (BIMO-W) staff.  As the PDD, he provides leadership in directing and managing programs and a professional staff in locations from Detroit, MI to Hawaii covering all clinical and non-clinical facilities.  In addition to being the PDD for BIMO-W, Eric is one of the U.S. Representatives to the Organization for Economic Co-Operation and Development (OECD).

      Supplement to his work experience with the FDA, Eric has worked in the Medical Device, Food and Drug Industries serving in various capacities such as a Regulatory Affairs Associate and Director of Quality.

      Eric attended Purdue University School of Pharmacy and while there also earned a degree in radiation physics. He has an MBA from Youngstown State University along with several certifications for various quality and regulatory activities.

      Session Details:

      FDA KEYNOTE: How do you prepare for that inevitable knock on the door? Do you worry about FDA’s arrival, or is it an exercise in demonstrating your inspectional readiness?

      2024-09-24, 8:45 AM

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      Nisha Trivedi
      Rare Disease Patient Advocate

      Nisha is a patient advocate for the rare genetic skin disorder Epidermolysis Bullosa. She also has participated in two clinical trials. Through The EveryLife Foundation’s Rare Disease Week and Rare Across America events, along with other organizations' advocacy events, she has shared her story with members of Congress to encourage them to support policies that benefit rare disease patients. She represents EB Research Partnership on ELF’s Community Congress and sits on ELF’s Rare Disease Legislative Advocates Advisory committee. Previously, she served on the board of directors of The Shanti Project, a San Francisco–based nonprofit that enhances the well-being and quality of life of people facing serious illnesses or isolation.

      Nisha lives in South San Francisco and works at mbaMission, a leading MBA admissions consulting firm, guiding applicants to top business schools in the U.S. and abroad in building their personal brands by identifying and showcasing the strongest aspects of their candidacy in their applications. She is also a certified business etiquette trainer who coaches organizations on positive professional behaviors, and authored the LinkedIn Learning course “Business Etiquette for the Modern Workplace”. Nisha holds an MBA from the University of Michigan and BA in Communication from the University of Pennsylvania.

      Session Details:

      The Patient’s Perspective: ‘Why are patient’s voices so important in clinical development?’

      2024-09-24, 11:00 AM

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      Gajanan Bhat, PhD
      Senior Vice President, Global Development Team Lead TORL Biotherapeutics

      Gajanan Bhat is a successful clinical research and development executive with a proven record in over 20 years in the development of drugs, biologics, device, radiopharmaceuticals leading to approval and launch.  Gajanan Bhat is currently the Principal and founder of Celyxa, Inc, a digital health company.  Prior to leaving recently, Gajanan was the Senior Vice President of Clinical Science at Spectrum Pharmaceuticals, a clinical stage oncology company for the last 10+ years responsible for a range of clinical development strategy and functions. Gajanan has worked in multiple companies over the last 20+ years with increasing responsibilities including drug, device, diagnostic product development.

      Session Details:

      Generative AI & the future of clinical trials: putting theory into practice.

      2024-09-24, 11:00 AM

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      Gurinder S. Sidhu
      MD, MHA, MBA, U.S. Senior Medical Director, Pfizer

      Session Details:

      Real World Evidence and Clinical Development

      2024-09-24, 12:00 PM

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      Joe Shan
      Vice President Clinical Operations, Adcentrx Therapeutics

      Collaborative and outcome-based biopharmaceutical servant-leader providing 20+ years of clinical operations experience. Passionately advancing the mission of improving patients’ lives through timely and efficient execution of clinical trials. Adept at building and managing cross-functional teams comprising internal and/or external partners and CROs to meet the dynamic business needs of virtual start-ups to leading life science companies.

      Session Details:

      PANEL: Exploring the transition of Innovation & technological advancements in clinical trials

      2024-09-24, 2:00 PM

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      Elizabeth Sheehan, PMP
      Sr. Clinical Project Manager, Recor Medical

      Experienced project management professional with a strong background in medical device clinical trials. Elizabeth is currently a Sr. Clinical Project Manager at Recor Medical, a medical device company located in Palo Alto, California. Previous work experience includes knowledge manager at a big three strategy consulting firm, and archivist at UCLA organizing, preserving, and providing access to collection materials.

      Session Details:

      Speaker Hosted Roundtables

      2024-09-25, 3:00 PM

      Session Details:

      PANEL: Exploring the transition of Innovation & technological advancements in clinical trials

      2024-09-24, 2:00 PM

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      Constance Crowley
      Executive Director/Senior Clinical Scientist, Arcturus Therapeutics

      Thirty-five years experience in clinical research and development (oncology, cardiovascular, dermatology, immunology, antiinfective/antiviral, central nervous system, inflammatory diseases). Ability to build and manage highly-functioning clinical operations teams.

      Session Details:

      PANEL: Considerations for a Patient Centric Trial Design to Increase Trial Success

      2024-09-24, 2:00 PM

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      Darren LaCour
      Director, Global Clinical Programs, Stryker

      A biomedical product development professional experienced with GMP, GLP, and GCP requirements for products seeking U.S. regulatory approval. My primary experience encompasses the design and execution of clinical trials with oversight of clinical data input through the phases of Endovascular products development life cycle. I transitioned to the clinical research industry after being a Pharmaceutical Chemist for several years.

      Session Details:

      MEDICAL DEVICE SPOTLIGHT – EU MDR Impact on Global Clinical Evidence Strategy

      2024-09-24, 4:30 PM

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      Bruce Lyday
      CEO, Coronavax

      Bruce Lyday is CEO and co-founder of Coronavax, Inc., a Biotechnology Company located in Orange, CA. Coronavax is developing CVAX-001, a new immunotherapeutic for Long COVID. Mr. Lyday has been a researcher in the fields of immunology, virology, oncology, and cell biology. Mr. Lyday has multiple patents and one Investigational New Drug (IND), approval for a novel cancer therapy. Mr. Lyday has successfully negotiated agreements with the U.S. Army at USAMMDA-Ft. Detrick, MD, and the Centers for Disease Control for use of their virus strains to treat cancer.

      Session Details:

      Balancing Hard and Soft Data Endpoints in Clinical Trials

      2024-09-25, 9:00 AM

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      Brandi Roberts
      Chief Financial Officer, Longboard Pharmaceuticals

      Brandi Roberts has more than 25 years of public accounting and finance experience, including 22 years at publicly traded pharmaceutical, medical technology, and life science companies. Ms. Roberts is Executive Vice President and Chief Financial Officer at Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH). Ms. Roberts begun her tenure at Longboard in January 2021 and helped the company go public in March 2021.  Ms. Roberts served as Executive Vice President and Chief Financial Officer of Lineage Cell Therapeutics, Inc. (NYSE: LCTX) from January 2019 to January 2021. Ms. Roberts is a certified public accountant with the State of California and received her B.S. degree in business administration from the University of Arizona and her M.B.A. from the University of San Diego.

      Session Details:

      Top Tips in Effective Budget Management, Forecasting and Contracting: Ensuring Your Resources Are Allocated Correctly

      2024-09-25, 1:45 PM

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      Preeti Baweja
      Director, Clinical Operations, Ventyx Biosciences

      Experienced clinical research, project management professional with more than 17years of experience in the industry. In-depth knowledge of drug development process (with immunology, inflammatory & oncology focus) and industry practices.

      Leading multiple project teams with broad background in overseeing the conduct of the clinical trial (Phase I-IV) globally following elements of the ICH/GCP or GPP in observational and non-interventional studies. Experienced indication lead overseeing study start up, maintenance and termination activities (database lock, CSR), including but not limited to, site identification, feasibilities, ICF negotiations, IRB/EC and global Regulatory Authority submissions, review and approval of essential documents, remote Site initiation visits (SIV), Monitoring Visit (MV), Source data verification (SDV)/ Source Data Review (SDR), drug accountability, site payments, and close out visits. Extensive study and site management experience. Experienced in RBQM, and systems like cluepoints for data analytics. Experienced in leading cross-sectional study team responsible for clinical study delivery as the primary point for contact for leadership. Experienced with vendor management of multiple complex vendors (EDC build and maintenance, IRT/IWRS, central lab, histopath lab, large global CROs as well as drug packaging and distribution vendors). Knowledge of project management processes and tools with multiple direct reports.

      Session Details:

      Ensuring Adequate Sponsor Oversight of Clinical Trials When Outsourced to Clinical Contract Research Organisations

      2024-09-25, 10:45 AM

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      Steven Chen
      Chief Medical Officer, ImpediMed

      Session Details:

      Speaker Hosted Roundtables

      2024-09-25, 3:00 PM

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      Dr. Mark Glassy
      Clinical Trial Professional

      Dr. Glassy graduated from the University of San Francisco in 1974 with a B.S. in Biology and Chemistry.  He then attended University of California, Riverside and received his Ph.D. in biochemistry in 1978.  He did his post-doctoral studies in molecular immunology at the Scripps Research Institute in La Jolla.  Dr. Glassy joined the faculty of the Department of Medicine and Cancer Center at UCSD in 1980 and is currently in the Translational Neuro-Oncology Laboratory at the UCSD Moores Cancer Center.  In addition to UCSD, Dr. Glassy has held several upper management positions in commercial biotechnology.  He has prepared and directed several FDA approved clinical trials involving human monoclonal antibodies to cancer.  Dr. Glassy has over 175 publications in the scientific and medical literature, is the inventor of several issued patents in the human antibody field, is the Editor-in-Chief of the journal, HUMAN ANTIBODIES, and the Program Chairman of the meeting series, "The International Conference on Human Antibodies and Hybridomas".  Glassy is the inventor of pritumumab, the first human antibody used to treat a cancer patient and is the recipient of the 2003 Arthur Furst Award (citation: “Outstanding research advancing science for the betterment of humanity”).  He is also the author of the books, "The Biology of Science Fiction Cinema", “Movie Monsters in Scale”, and "Biology Run Amok!".

      Session Details:

      Setting up Global Clinical Trials, with a focus on Asia Pacific

      2024-09-25, 9:30 AM

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      Scotty Chung-Siu
      Managing Analyst, Clinical Trials Intelligence, GlobalData

      Session Details:

      Clinical Trials: Usage of CROs

      2024-09-25, 10:45 AM

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      Tania Azad
      Associate Director, Clinical Project Lead, Alexion

      Tania Azad is an experienced Global Clinical Project Manager with over 20 years of experience in Oncology, Diabetes and Orthopedics within various organizations, including Clinical Research Organization, Biotech and large pharmaceutical companies. Tania started her career at the Toronto Western Hospital and has since led different phases of clinical research projects including Bioequivalence and Phase I through Phase IV. Tania has been instrumental in leading site feasibility, selection and patient retention and successfully bringing projects to completion and regulatory submission. Currently Tania is the Associate Director, Clinical Project Lead at Alexion – AstraZeneca Rare Disease Unit leading Late Phase Global Registry in Neuromyelitis Optica Spectrum Disorder (NMOSD) and Natural History Study in gene therapy as well as creating an operational framework to optimize ways of working with CRO partners.

      Session Details:

      Navigating The Complex Vendor Landscape and How to Build Strong Outsourced Relationships

      2024-09-25, 9:00 AM

      Session Details:

      PANEL: AI and digitalization in clinical trials

      2024-09-25, 11:15 AM

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      Stanley Lewis
      Founder, Chief Executive Officer, A28 Therapeutics

      Stanley Lewis, MD MPH is a graduate of the University of Texas McGovern Medical School and the University of Texas School of Public Health.  He completed an Internal Medicine residency and fellowship and joined the faculty as Assistant Professor of Medicine.  Dr. Lewis has dedicated his professional career to patient care, teaching, clinical research, and drug development.  His areas of interest are infectious disease, oncology, and metabolic disorders.  He has participated as an Investigator on over 30 clinical trials and authored over 50 scientific abstracts and publications.  Dr. Lewis served as Chief Medical Officer at both public and private biotechnology companies including TaiMed Biologics where he led a small team to develop the first monoclonal antibody for treatment of multi-drug resistant HIV disease.  He later Founded and serves as CEO of A28 Therapeutics where he is developing a targeted lytic peptide for treatment of cancer.

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      Dr. Paul Grint
      Executive Chairman, Codagenix

      Dr. Paul Grint is the Executive Chairman of Codagenix. He was most recently CEO and a member of the board of directors of AmpliPhi Biosciences, which merged with C3J Therapeutics to form Armata Pharmaceuticals. Dr. Grint has more than two decades of experience in biologics and small-molecule research and development, including the successful approval and commercialization of products in the infectious diseases, immunology, and oncology therapeutic areas. Dr. Grint has also served in senior management roles at Cerexa, Forest Laboratories, Pfizer, IDEC Pharmaceuticals, and Schering-Plough Corporation. He is currently a board member at Codagenix, Inhibikase Therapeutics, Persephone Biosciences, CRISP QC and Synedgen.  He is a Fellow of the Royal College of Pathologists, a member of numerous professional and medical societies, and holds a bachelor’s degree from St. Mary’s Hospital College, University of London and a medical degree from St. Bartholomew’s Hospital College, University of London.

      Session Details:

      PANEL: Considerations for a Patient Centric Trial Design to Increase Trial Success

      2024-09-24, 2:00 PM

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      Carrie Lewis
      Executive Director, Clinical Program Optimization, Endo Pharmaceuticals

      Carrie Lewis has over 20 years of varied Clinical Research experience.  Carrie is currently an Executive Director, Clinical Program Optimization at Endo USA, Inc. where she oversees Clinical as well Business Operations, eTMF/inspectional readiness, and Training/Oversight.  Prior to Endo, Carrie garnered extensive knowledge in many roles while in academia, at large sponsors, generic sponsor, as well as a global CRO.  She has a Master’s Degree in Clinical Research Administration and has experience in multiple therapeutic areas.

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      Krishna Allamneni
      Executive Vice President, Chief Development Officer, Concarlo Therapeutics

      Session Details:

      Speaker Hosted Roundtables

      2024-09-25, 3:00 PM

      Session Details:

      Designing Clinical Trials with Woman in Mind

      2024-09-25, 9:30 AM

      Session Details:

      PANEL: The Clinical Trial Landscape for Small to Mid-Sized Biopharma in Southern California

      2024-09-25, 11:15 AM

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      Douglas Ahrens
      Program Transformation Director, Thermo Fisher Scientific

      Session Details:

      Uncovering the CRDMO Advantage in Drug Development

      2024-09-24, 9:30 AM

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      Nicole Stansbury
      Senior Vice President, Clinical Operations Premier Research

      Nicole Stansbury, Senior Vice President, Global Clinical Operations, is responsible for oversight of clinical operations which includes clinical strategy and delivery, study start up, central monitoring, and site management and risk-based monitoring at Premier Research. She leverages an innovative, data-driven approach and more than 25 years of industry experience to help sponsors address the rapidly evolving demands of the clinical development industry. In her role, Stansbury is focused on finding ways to simplify process and improve technology adoption to decrease the time, cost, complexity, and risk of delivering clinical research.

      Prior to joining Premier Research, Stansbury held various CRO leadership positions where she was instrumental in the strategic implementation of risk-based monitoring, central monitoring and continuous improvement of clinical operations processes. Stansbury has been co-lead for the Association of Clinical Research Organizations Risk-Based Monitoring (ACRO RBM) Working Group working with TransCelerate and the FDA since 2014.

      She holds a Bachelor of Science from Texas A&M and a Lean Six Sigma – Yellow Belt certification.

      Session Details:

      Enhancing Operational Excellence through Digital Solutions

      2024-09-24, 4:00 PM

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      Melissa Mooney
      Director, eCOA Solutions Engineering, IQVIA Patient Suite

      Melissa Mooney has over 19  years of  experience in the development of eCOA solutions for use in clinical trials. Melissa’s area of expertise is eCOA solution design where she has supported clients and eCOA vendors in developing robust and usable eCOA software solutions that meet eCOA protocol requirements. She also brings a plethora of experience in eCOA requirement gathering, leading  eCOA User Acceptance testing, eCOA data management, and BD support.

       

      Session Details:

      Innovative eCOA strategies that minimize protocol complexities, preserve endpoint integrity, and enhance the end user experience:

      2024-09-24, 12:30 PM

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      Betty McGregor
      Executive Director, Project Delivery, ICON Biotech

      Betty has 20+ years of clinical research experience in various roles at the site and CRO, and has been with ICON for over 5 years now.  Her experience traverses varying therapeutic areas and phases, but falls mostly in oncology/hematology early phase trials.

      Session Details:

      Maximizing the Consultative Partnership Between CRO and Biotech Sponsors

      2024-09-24, 11:30 AM

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      Katelynn Spingola
      Associate Director, Community Research Sites, EmVenio Research

      Katelynn Spingola brings nearly a decade of invaluable experience in healthcare and research to her role as Associate Director of Clinical Site Operations at EmVenio Research. Leading teams across multiple locations in the East and Central time zones, Katelynn is dedicated to making a tangible impact within their respective communities. Under her adept guidance, these teams function as vital advocates, diligently working to raise awareness, educate the public, and establish a strong local presence. Katelynn's primary objective is optimizing site operations to ensure each location meets enrollment goals across a diverse array of study indications. Her extensive expertise in clinical research ensures that these endeavors lead to successful outcomes and good clinical data. Katelynn's leadership style is marked by a commitment to community engagement and operational excellence, positioning her as a pivotal figure in advancing the mission of EmVenio Research.

      Session Details:

      Bridging the Gap: Expanding Clinical Trial Accessibility in Healthcare Deserts

      2024-09-24, 2:45 PM

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      Rachael Sawaya
      Associate Director, Project Management – Execution, PCM Trials

      Rachael Sawaya is an Associate Director of Project Management at PCM Trials with over seven years of experience in the clinical research field. Prior to PCM Trials, she worked as a clinical research coordinator where she gained extensive knowledge of working at the site and has taken that experience to reduce the burden and better support sites to implement mobile visits. At PCM Trials, Rachael oversees the execution of mobile visits across a wide variety of therapeutic areas and on a global scale. She supports clients throughout the implementation of mobile visits to maintain customer satisfaction and implement efficiencies across therapeutic areas and geographies. Rachael is passionate about implementing solutions for participants that increase participant engagement to ensure clinical trials can obtain critical long-term data, especially in rare disease and vulnerable patient populations.

      Session Details:

      Bridging the Gap: Expanding Clinical Trial Accessibility in Healthcare Deserts

      2024-09-24, 2:45 PM

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      Dr. Sara Doan
      Executive Director, Program Strategy and Delivery for Internal Medicine & Neuroscience, TFS HealthScience

      Dr. Sara Doan is the Executive Director, Program Strategy and Delivery for Internal Medicine & Neuroscience at TFS HealthScience. She brings a robust 27-year background in global clinical research to her role, with a particular emphasis on psychiatry over the past 12 years. Her expertise spans a broad range of disorders including Alzheimer’s, Parkinson’s, Narcissistic Personality Disorder, Borderline Personality Disorder, Major Depressive Disorder, Post Traumatic Stress Disorder, Bipolar Disorder, Migraine, and Anxiety. Dr. Doan is a Doctor of Chiropractic with a specialization in the Central Nervous System, having earned her degree from Parker University in Dallas, Texas. She is proficient in both English and Farsi.

      Session Details:

      Accelerating Neurodegenerative Clinical Drug Development with AI

      2024-09-24, 12:30 PM

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      Marissa M. Ballesteros
      RN, MPH, MBA, Senior Director, Patient Cloud Commercial Strategy, Medidata

      Marissa M. Ballesteros, RN, MPH, MBA, serves as the Senior Director of Clinical Data & Sensor Strategy at Medidata, where she specializes in commercial strategy development and establishing partnerships with sensor technology companies. With a career spanning over two decades, Marissa has honed her expertise in leading clinical trial operations, having held pivotal roles at industry giants such as Pfizer, Roche, Scripps Translational Science Institute and Qualcomm. Marissa's professional background uniquely blends clinical acumen gained from her experience as a wellness and cardiology nurse with a keen business insight cultivated through involvement in diverse areas such as due diligence for in-licensing and mergers & acquisitions, key opinion leader (KOL) management, budgeting/contracting, and pharmaceutical sales.

      Session Details:

      Streamlining Sensor Study Operations for Better Patient and Site Experiences

      2024-09-24, 4:00 PM

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      Jessica Hatheway
      MBA, Vice President, Clinical Operations, Daré Bioscience

      Session Details:

      PANEL: Considerations for a Patient Centric Trial Design to Increase Trial Success

      2024-09-24, 2:00 PM

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      Renee St.Clair
      Advisor and former Vice President, Ketamine Taskforce, Inc.

      Most recently Renee C. St.Clair, Esq. was In-House Counsel for Valis Biosciences Inc, where she also served at the Regulatory Affairs, Operations, and Compliance Lead.  Ms. St.Clair has over 25 years of legal and regulatory experience advising California employers, is the co-founder of a woman owned law firm based in San Diego, California, and is a specialist in appellate research and writing, including a successful appeal to the U.S. Supreme Court.

      Ms. St.Clair pivoted to the life sciences industry hoping to apply her legal skillset to advance science, medicine, and patient outcomes; particularly for patients and veterans struggling with mental health issues.  She has a unique perspective, having been on various sides of the clinical trial process.  Ms. St.Clair provided regulatory guidance at one of the first clinical trial sites in the world to administer psilocybin to participants with depression, has worked with R&D scientists as they developed clinical trial protocols for ketamine, co-drafted IND applications, transitioned a biopharma lab from R&D to GMP-readiness, positioned a biopharma company to obtain state authorization to conduct nonhuman research of Schedule I compounds (DMT, LSD, psilocin, THC, MDMA, 5-MEO-DMT), and currently applies her regulatory background to facilitate Valis Biosciences Inc.’s science based and technology driven clinical trial tools and solutions—often in challenging populations (children) or difficult to measure conditions (mental health and CNS).

      Session Details:

      PANEL: AI and digitalization in clinical trials

      2024-09-25, 11:15 AM

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      Nick Tresnowski
      Director of Operations, LEAPCURE

      Nick is the Director of Operations at Leapcure. Leapcure's mission is to enable equitable clinical trials, aligning the needs of sponsors, sites, and patients. Nick oversees dozens of patient-centric study projects and partnerships, leading the Leapcure team to thousands of impactful, live patient conversations every month, keeping study enrollments on or ahead of schedule. Nick has particular experience synchronizing the interests of patients, sites, and sponsors with rare diseases.

      Session Details:

      PANEL: Considerations for a Patient Centric Trial Design to Increase Trial Success

      2024-09-24, 2:00 PM

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      Ana Natera
      Director, Clinical Business Strategy, HeartMetrics Cardiac Monitoring, Medtronic

      Ana Natera is a highly accomplished Clinical Director with extensive experience in clinical research and cardiac monitoring. She has been instrumental in driving innovative solutions and expanding the integration of technology in clinical trials. Her dedication to patient-centered care is evident in her commitment to improving cardiac monitoring through technological advancements. In addition to her professional achievements, she is an advocate for fostering connection within the industry and contributes to advancing technology in clinical trials. She is also passionate about increasing diversity, equity, and inclusion in the clinical space.

      Ana holds a Bachelor’s in Biomedical Electrical Engineering, a Master of Science in Forensic Science, and an MBA, bringing a unique blend of technical expertise and business acumen to her role.

      Session Details:

      Cardiac Data Matters: Keeping Patients at the Heart of Innovation

      2024-09-24, 3:00 PM

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      David Berry
      Principal Data Scientist, PPD clinical research business of Thermo Fisher Scientific

      Dave Berry is a Principal Data Scientist at PPD/Thermo Fisher Scientific, where he leads the development of advanced machine learning models to optimize clinical trial operations. With a diverse background in data science, computational biology, and bioinformatics, Dave has a proven track record of innovating at the intersection of life science and artificial intelligence. His work focuses on leveraging generative AI, large language models, and machine learning to drive operational efficiency and transformative solutions in clinical research.

      Session Details:

      PANEL: AI and digitalization in clinical trials

      2024-09-25, 11:15 AM

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      Dr. Christian Yavorksy
      Chief Scientific Officer, Valis Biosciences Inc.

      Dr. Yavorsky has been involved in over 80 Phase II-IV trials in clinical trials, schizophrenia, bipolar disorder, depression, Alzheimer’s disease, anxiety, and Parkinson’s disease. Dr. Yavorsky is part of several working groups of the International Society for Clinical Trials Methodology (ISCTM) and co-chairs the Rapid-Acting Antidepressants (RAAD) working group. This group is tasked with developing novel psychometric instruments to measure change in clinical trials with psychedelic and other rapid-acting compounds. Findings from the working group were recently published in a special issue of Frontiers in Psychiatry focusing on ketamine treatment (Yavorsky et al., 2023). He regularly lectures on the topic of psychedelic research and is currently involved in clinical trials using DMT, MDMA, ketamine, and other compounds for the treatment of indications such as Alcohol Use Disorder, PTSD, treatment resistant depression, and bipolar disorder. Dr. Yavorsky is the Chief Scientific Officer of Valis Bioscience, a company focused on measurement and safety in clinical trials with psychedelic and other compounds. When not engaged in clinical trials Christian, who fancies himself a garagiste of sorts, can be found attempting to synchronize finicky carburetors on vintage cars, sometimes watching rocket launches from his back yard in Cape Canaveral, or enjoying time spent with his daughters and family.

       

      Session Details:

      Psychedelic Compounds in Clinical Trials: The Risks and Benefits of Video Recording Subjects

      2024-09-25, 1:15 PM

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      Shyam Banuprakash
      Senior Vice President, Data Science, Clario

      Shyam has 15+ years of experience in data management and life sciences industry and has a strong expertise in data science and analysis. Shyam heads up the data science department for the Medical Imaging business segment of Clario. The department oversees design, collection, cleaning and standardization of medical imaging data; and creating analysis and AI models on clinical, operational, and financial data. His experience includes working for Janssen Alzheimer’s Immunotherapy and Medtronic. Shyam has a master’s in data science and engineering from UCSD. 

      Session Details:

      Leveraging Generative AI and Data Standards for Efficient Medical Imaging Documentation and data exports in Oncology Clinical Trials

      2024-09-24, 11:30 AM

      Session Details:

      PANEL: AI and digitalization in clinical trials

      2024-09-25, 11:15 AM

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      Cole Eshbach
      Sr. Clinical Trial Manager, Endo

      Cole Eshbach is a clinical research professional with experience managing Phase 1-4 trials, driving innovation, and fostering collaboration.  With over six years dedicated to Endo projects, along with previous roles at Global CROs, have further enriched his skill set.  Before entering the clinical research industry, Cole conducted assessments for Autism (ADOS-II) in the greater Philadelphia area and completed behavioral consulting.

      Session Details:

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

      2024-09-24, 4:30 PM

      Session Details:

      PANEL: Exploring the transition of Innovation & technological advancements in clinical trials

      2024-09-24, 2:00 PM

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      Michael Murphy
      Director, Legal & Associate General Counsel, Ionis Pharmaceuticals, Inc.

      Session Details:

      PANEL: The Clinical Trial Landscape for Small to Mid-Sized Biopharma in Southern California

      2024-09-25, 11:15 AM

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      OCT Advisory Board

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

      In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

       

      Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

       

      Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

       

      Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

       

      Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

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      Kathleen Cohen
      Vice President, Clinical Development, Marinus Pharmaceuticals

      Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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      Thomas M. Tremblay RN, BSN
      Vice President of Clinical Development, Hallux Inc.

      Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience.  His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality.  He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

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      Behtash Bahador
      Director, Health Literacy, CISCRP

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

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