16th Annual Outsourcing in Clinical Trials West Coast 2024

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

6 - 7

February

2024
  • Hyatt Regency San Francisco Airport, USA
  • Complimentary
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Featured Speakers

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Dan Solis​

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

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

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Robert J. Boland​

MBA, Global Head of Digital Innovation R&D, Haleon

Currently, Robert is the Global Head of Digital Innovation at Haleon, where he overseas and manages the organization’s Digital Innovation and Technology Portfolio across Research & Development and Laboratory Technologies. Robert formerly was the Global head of Digital Data and Delivery at CSL Behring, and prior, Head Of Digital Health & Clinical Innovation at CGI, and Head of Data Strategy and Digital Connected Solutions at Johnson & Johnson. Robert is an industry thought leaders and lecturer, often speaking on Digital Innovation and Data Strategy, internationally.

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Edward Kuczynski​

Director, Human Research Protection Program, University of California

Edward joined the UCSF Office of Research as its Director of the Human Research Protection Program (HRPP) in May 2020. In this role, he oversees the UCSF HRPP, which is comprised of the Institutional Review Board (IRB) and its committees, the Quality Improvement Unit, and the Human Gamete, Embryo and Stem Cell Research (GESCR) Committee. Edward has a background in strategic planning and business plan implementation for clinical research activities; experience building and directing clinical and research programs at Academic Medical Centers; and familiarity with creating de novo core clinical research support services. He has served as co-investigator on the NIH Clinical Network for Contraceptive Research grant, clinical site investigator for an NIH-funded grant studying Antiphospholipid Pregnancy Loss, and co-investigator on a March of Dimes program grant on risk factors for prematurity. More recently, Edward was a Strategic Advisor for Clinical and Translational Research Programs at the Stanford University Center for Clinical & Translational Research & Education. He has also served as the Director of Clinical Research Operations for the Tufts Clinical and Translational Science Institute, a consult lead for the Johns Hopkins University/Tufts University Trial Innovation Center, as well as an Assistant Professor in the Department of Medicine at Tufts University School of Medicine.

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Abby Kennedy​

Senior Director of Clinical Operations

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Dave Borbas​

Research VP, Head of Data Management, Abcuro

David Borbas is Research VP, Head of Data Management of Abcuro

Prior to Abcuro, David worked for more than 25 years of Data Management and Information Technology experience. He has broad experience starting and developing Data Management groups at SurroMed, Millennium Pharmaceuticals South San Francisco and Jazz Pharmaceuticals. After leaving Jazz Pharmaceuticals he provided Data Management consulting services to small and medium size companies in the Bay Area, throughout the US and Canada. He has been involved in 5 successful NDAs and together with Data Management team members has managed more than 100 studies. His research experience includes Rare Disease, Cardiac, Oncology, Rheumatology, Fibromyalgia, Gene Therapy, Neurology and Psychiatry clinical studies. He has supported clinical studies phase 1 to 4 including Global Phase 3 Studies, IVRS and eDiary applications. In addition, David has clinical experience more than 15 years of clinical and management experience in the areas of Critical Care, Emergency, Hemodialysis and Critical Care Transport. He has a Bachelor of Science in Nursing from the University of Pennsylvania and a Master of Science in Information Systems from Claremont Graduate University. He has given presentations at the CDISC International Interchange and supported the Bay Area CDISC meetings and PhUSE standards work groups.

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Abdel Dridi​

Global Head of Digital Healthcare Technologies (DHT), Personalized Healthcare, Product Development, Roche

Abdel Dridi is the Global Head for Digital Healthcare Technologies at Roche and Genentech. In his role he oversees the global deployment of digital health solutions in late stage, clinical studies and early concepts. He is passionate about creating connected, digital healthcare platforms, and smart medical devices drawing from his deep experience from technology leadership roles at technology companies and in product and service development at technology healthcare organizations.

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    2024 Sponsors Include:

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    Company Information

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

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

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    Company Information

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

    Company Website

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

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    Company Information

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

    Company Website

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

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    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

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

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

    Discover more at www.novotech-cro.com

    Company Website

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

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    Company Information

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

    Company Website

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

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    Company Information

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

    Company Website

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

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    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

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

    Company Website

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

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    Company Information

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

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

    Company Website

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

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    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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      Why attend?

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

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

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

       

      WHAT TO EXPECT FOR 2024?

      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, the review of CTIS 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 4 full streams complete with key content.

      Stream A: Outsourcing & Clinical Operations

      Stream B: Clinical Innovation & Technology

      Stream C Day 1: Patient Engagement with Diversity & Inclusion

      Stream C Day 2: Medical Devices

      800+

      Attendees

      		90+

      Exhibitors

      		45+

      Speakers

      		50%

      Attendees at Director + Level
      800+

      Attendees

      		90+

      Exhibitors
      45+

      Speakers

      		50%

      Attendees at Director + Level

      Testimonials

      See What It's All About

      Agenda

      • 6 Feb 2024
      • 7 Feb 2024
      Expand All

      Streams

      Stream one

      Outsourcing & Clinical Operations

      Stream two

      Clinical Innovation & Technology

      Stream three

      Patient Engagement and Diversity & Inclusion

      10:30 AM

      Diverse and Equitable Participation in Clinical Trials (DEPICT) Act

      Legislation aiming to increase diversity in clinical trials by requiring enhanced data reporting on clinical trial participant demographics.

      • What does a Diversity Plan look like?
      • Determining the dynamic and strategy of such a plan
      • Highlighting a diverse trial that could be emulated
      • Addressing the requirement to include information about the demographic diversity of the clinical trial population and address related issues
      • Practical experience – submitting your diversity plan

      Speakers

      11 AM

      Session Reserved for Paraxel

      11:30 AM

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

      • Discussing the personal experiences of the patient
      • Defining 'patient centricity

      Speakers

      12 PM

      Session Reserved for Medical Research Network (MRN)

      Speakers

      12:30 PM

      Lunch & Networking

      1:30 PM

      PANEL Patient centricity: What does patient centric clinical trial development look like in 2024?

      • • Looking at what is working and what can be done better.
        • Highlighting the patient perspective, providing a platform to share one’s story.
        • Discussing opportunities of further development

      Speakers

      2:15 PM

      The use of technology to accelerate early drug discovery and reduce the burden for patients

      Building personalized digital healthcare solutions to support clinical claims is of great importance to the drug industry. Medical Insights generated from digital healthcare clinical studies emerged as a promising approach to help with:

       

      • Patient engagement and retention.
      • Collecting richer data to drive insights and accelerate drugs' early research and developments to make better drugs and early medical decisions.
      • Increase efficacy of therapies through continuous monitoring.

       

      This session details a case study on challenges using Digital Healthcare Technologies in the clinical trials ecosystem and use of medical devices to help patients better manage their conditions.

      Speakers

      2:45 PM

      FIRESIDE CHAT Have you developed an understanding of the patient journey as part of your clinical trial design? Bringing the patient’s practical perspective to your trial operations especially for rare disease indications

      • Building clinical trials with the perspective of the patient in mind (the patient journey).
      • Discussing the collaboration that must exist between patient advocacy groups, study site staff, patients, care givers in order to have a successful trial.
      • Highlighting the importance of effective communication to patients and how this can streamline trial timelines.
      • Exploring how patients could, and should, be influencing decisions and the R&D process.
      • Regulatory situation in support of patient-centred development
      • What are the benefits of using multi-stakeholder approaches?

      Speakers

      3:15 PM

      Afternoon Refreshments, Networking & Apple Prize Draw in Exhibit Hall

      7:30 AM

      Registration & Refreshments

      8:20 AM

      Chairman’s Opening Remarks

      Speakers

      8:30 AM

      Session Reserved for Session Sponsor

      9 AM

      Session Reserved for Medidata

      9:30 AM

      Session Reserved for Event Sponsor

      10 AM

      Morning Refreshments & Networking

      10:30 AM

      State of Affairs on Excellence in Clinical Development

      The talk will explore the current state of affairs in Clinical development, the most pressing challenges in 2024 and solutions to address them.

      • Learn about the most pressing challenges and solutions in both early to late stage clinical development- at big pharma as well as small biotechnology companies strategies for increasing representation and diversity,
      • share best practices for patient enrollment and retention, data standards and latest regulatory considerations/guidelines
      • How can technology be leveraged in patient centric drug development

      Speakers

      11 AM

      Session Reserved for Worldwide Clinical Trials

      11:30 AM

      CRO Cost Control and Smart Contracting

      • Examining how CRO contracts are structured.
      • Handling CRO advantage and focusing on the components Sponsors can control.

      Speakers

      12 PM

      Session Reserved for Novotech

      12:30 PM

      Lunch & Networking

      1:30 PM

      PANEL Maximising your Sites Productivity & how to lessen the burden

      Sites are increasingly challenged with workload and resource constraints. This panel will discuss ways in which to get the best output from sites.
      What can we do for them beyond an inflated budget?

      • Addressing challenges the sites are currently facing
      • An overview of the repercussions of such challenges, and a focus on what we can do to overcome them.
      • Forward thinking to strengthen site output.
      • Limitations with electronic applications

      Speakers

      2:15 PM

      Session Reserved for PCM Trials

      Speakers

      2:45 PM

      Trial Execution Excellence for small & medium biotechnology companies

      • Outlining the outlook for the future on what sponsors & CROs could do to embrace a more strategic and partnership approach to clinical trials for mutual benefits
      • Looking at the use and integration of new tools and technologies to improve our knowledge about the origin of the disease and to identify new therapeutic strategies
      • Approaching product management that emphasizes getting the right products to market faster through deep user insight, a clear product strategy, an

      Speakers

      3:15 PM

      Afternoon Refreshments, Networking & Apple Prize Draw in Exhibit Hall

      3:45 PM

      Mastering Dose Escalation Studies: Charting the Path from Planning to Execution

      This session will highlight key considerations for overcoming obstacles during critical timepoints of early phase clinical research, from initial protocol planning to enrollment. You will learn:

      • Tactics for optimizing Phase 1 studies that span therapeutic areas and treatment modalities
      • Considerations for reducing patient burden and enhancing the patient experience
      • Regulatory strategies to bolster early planning efforts

      Speakers

      4:15 PM

      PANEL DISCUSSION Outsourcing Strategies: how do you approach your outsourcing strategy?

      • • Determining the best strategy from your service providers
        • Uncovering if your offerings are competitive, and if this is indeed value for money.
        • Looking into what is driving the increasing costs of running your study, recognising the value associated with costs and their justifications.
        • Establishing what can be done to avoid increasing budgets including the evaluation of tools required for the type of study one is conducting.

      Speakers

      5 PM

      Chairman’s Closing Remarks & Drinks Reception

      10:30 AM

      How are we digitally moving us into the next generation of laboratories for clinical trials

      • NextGen Labs
      • Digital transformation

      Speakers

      11 AM

      Session Reserved for Clario

      11:30 AM

      Great expectations and how to meet them – connected devices and ePRO in clinical trials

      • Focusing on design considerations
      • Understanding the best framework for your study
      • Considering patient ePRO assessments needed for a specific study
      • Highlighting best practice for data collection
      • Avoiding expensive mistakes that undermine your trial outcome or delay your timeline
      • Outlining Regulatory restrictions around ePro with a focus on EU & UK GDPR concerns, ethical questions in the US
      • Comparison vs Paper Reported Outcomes – why are companies not transitioning fully to ePro?

      Speakers

      12 PM

      Session Reserved for ICON

      12:30 PM

      Lunch & Networking

      1:30 PM

      PANEL FUTURE FORWARD: What’s broken and what’s working when deploying technology in clinical trials

      • Current state of affairs in clinical trials technology
      • Understanding what is really working
      • Deploying technology for informed consent ePro, wearable sensors for remote patient monitoring
      • Sharing best practice and case studies from across the sector

      Speakers

      2:15 PM

      Session Reserved for YPrime

      2:45 PM

      Expanded Responsibilities for IRBs when Reviewing AI Protocols

      • • Protecting Third Parties in Human Subjects Research
        • Ethical, Privacy, and Safety Considerations for:
      • o Direct Research Participants
        o Participant Community, Subpopulation, Race, Ethnicity, Gender
        o Society at Large
      • Assessing AI Tool Bias

      Speakers

      3:15 PM

      Afternoon Refreshments, Networking & Apple Prize Draw in Exhibit Hall

      3:45 PM

      Session Reserved for eClinical Solutions – 15 min tech showcase

      4:00 Diligent Pharma - 15 min tech showcase Session Reserved for Event Sponsor

      4:15 PM

      PANEL DISCUSSION Focusing on today’s Innovation & Technological Advancements

      • Are we making the most of Technology & Innovation in the Clinical Trial space?
      • How are these tools being utilised?
      • What’s next?
      • Considering the use of AI in healthcare & Clinical Trials

       

      Moderator: GlobalData
      Panellists:

      Speakers

      Streams

      Stream one

      Outsourcing & Clinical Operations

      Stream two

      Clinical Innovation & Technology

      Stream three

      Medical Device

      8:30 AM

      Registration and Refreshments

      9 AM

      Building CRO Relationships. What are the critical factors to consider when procuring from a CRO?

      • Establishing common ground with your CRO
      • Ascertaining the critical factors to think about when you collaborate with a CRO
      • Exploring how the concept of Co-development between Pharma & CRO is working best
      • Overcoming the differences between Pharma & CRO business models to work in harmony
      • Underlining the factors which could be limiting what choice you make?
      Considering the benefit of CRO’s adding a Small biotech division with personalized service to ensure all are valued

      Speakers

      9:30 AM

      Clinical Pharmacology at Scale to Reduce Risk and Increase Precision

      Speakers

      10 AM

      Design Concepts in effective product development and clinical outcomes – Expert Lessons

      • Concept Target Product Profile (TPP)
      • Design of Product and Testing Methodology
      • Product Design and Clinical Outcomes

      Speakers

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      CASE STUDY ALL OF US Research programme

      The All of Us Research Program is an historic effort to collect and study data from one million or more people living in the United States. The goal of the program is better health for all.

      Speakers

      11:30 AM

      Session Reserved for MMS Holdings

      12 PM

      The Elephant in the Room:

      What is holding you back from developing key relationships when managing your trials and Vendor Relationships? Are you in your own way?
      How do you relate and interact with:
      • Your Study Team
      • Your Vendors
      • Your Manager
      • Yourself
      • Are you willing to face others’ perceptions of you?
      This will be a brief presentation followed by an Open discussion on some barriers to communication that Clinical Operations professional experience.

      Speakers

      12:30 PM

      Session reserved for RadMD

      1 PM

      Networking Lunch

      2 PM

      A look at the CTR – European Submission

      • Understanding the process from start to finish to minimise delays in your study start-up.
      • Uncovering the European Union Clinical Trials Directive. As of Jan 31st, 2022-23, sponsors may submit trials under EUCTR
      • Outlining the Clinical Trial Information System (CTIS) and looking into the EU’s expeditious plan to role this out

      Speakers

      2:30 PM

      PANEL DISCUSSION Diversity & Inclusion in Clinical Trials

      • Diversity in clinical trials; Definitions and The Why
      • Critical barriers in recruiting and retention
      • Action for increasing diversity
      • Regulatory Updates

      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.

      RT 1
      Managing the workload of a small biotech with limited resources
      Ghesal Razag, Sr. Director, GI Clinical Operations, Biora Therapeutics
      RT 2
      Leveraging global trial footprint to accelerate clinical development
      Priya Ryali, Director, Head of Clinical Operations, ReCode
      RT 3
      Deciding between outsourcing clinical studies versus managing them in house
      Anitha Achyutha, Director, Clinical Research (Farapulse PFA), Electrophysiology, Boston Scientific

      RT 4

      Finding the right time to seek strategic investments for medical device startups

      Melanie Crystal, Clinical Director, Medtronic Endoscopy, Medtronic

      Speakers

      4:45 PM

      Close of Conference

      8:30 AM

      Registration and Refreshments

      Chair : Rebecca Lin, Chief Strategy Officer, Potrero Medical

      Speakers

      9 AM

      Navigating the importation landscape for medical devices to gain and maintain competitiveness in a global market

      • What industry should provide to a vendor to be able to import medical device
      • Understanding and avoiding medical device importation errors
      • Detained medical devices: How to overcome the violation to get product into commerce
      • Ensuring good manufacturing practice and compliance to domestic regulation

      Speakers

      9:30 AM

      Improving interactions with regulatory agencies on submission requirements and study results from a startup perspective

      • Why collaboration with regulatories must remain paramount in the approval process for medical devices
      • Practical look at pre-submission meeting requirements with regulatory agencies
      • Knowing the expectations and aligning with the FDA for successful IDE approval

      Speakers

      10 AM

      Designing trials to demonstrate clinical efficacies while preparing for commercialization

      • How to interpret preliminary data in order to choose an appropriate trial design
      • Effectively assessing trial design to minimize risks and maximize benefits
      • Incorporating best practice in trial design to increase chances of success

      Speakers

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      Collaborating with digital innovation: Data security and governance under a new age of AI

      • Trends, opportunities, and challenges from AI
      • Finding the right balance between protecting data and enabling innovation
      • Preparing medical device applications amidst geopolitical changes and managing evolving cyber and privacy laws
      • Establishing long term foundations under cost control

      Speakers

      11:30 AM

      Session reserved for Premier Research

      12 PM

      Non-significant risk device studies: Designing pivotal studies for medical device approval in the US

      • Understand how to identify and categorize the type of medical device you are evaluating
      • Collaborate with different stakeholders for alignment
      • Design a clinical study that fits the needs for the medical device regulatory approval

      Speakers

      12:30 PM

      Levelling up CRO partnerships for medical device companies so that both sides win

      • How to effectively request a bid from a CRO and how to streamline this process
      • Why CRO flexibility and ability to customize is mission critical for sponsors
      • Optimizing regional partnerships with CROs to best support clients and avoid dissatisfaction
      • Ensuring alignment of incentives to avoid delays in trial execution

      Speakers

      1 PM

      Networking Lunch

      2 PM

      Presentation of paper on data integrity: Reducing the impact of increased data privacy requirements under GDPR on medical device companies

      • Managing all considerable factors when it comes to data handling
      • Ensuring an additional language is included in contracts
      • Do the sites or vendors have a Data Privacy Officer or SOPs around data handling?
      • How to review data in an efficient way

      Speakers

      2:30 PM

      PANEL DISCUSSION Sharing best practice for improving patient enrolment and engagement for successful medical device clinical trials

      • How to expedite enrolment through interface with the sites in medical device studies
      • Collaborating with patients to ensure patient-centric clinical trials and improved engagement
      • Getting enrolment interest back to where it was before the pandemic
      • Incorporating hybrid decentralized trials as a potential solution to decreased patient enrolment
      • Understanding how much patients value the human touch to tend to their needs better
      • Being aware of the implications of cultural differences on how medical device instructions are understood globally during decentralized clinical trials

       

      Moderator: Rebecca Lin, Chief Strategy Officer, Potrero Medical

      Panelists:

      • Dr. Sanjay Shrivastava, CEO, Innova Vascular, Inc.
      • Anitha Achyutha, Director, Clinical Research (Farapulse PFA), Electrophysiology, Boston Scientific
      • Dr Bill Chen, CISO, Natera

       

      Speakers

      3:15 PM

      Afternoon Refreshments, Networking & Prize Draw in Exhibition Room

      8:30 AM

      Registration and Refreshments

      9 AM

      Tactical clinical operations in digital health studies

      • • Designing clinical operation workflows for studies with complex hardware and software components
        • Structuring real-time data insights into protocol focus and adherence
        • Focusing on improving data quality and data curation for product development

      Speakers

      9:30 AM

      Session Reserved for 4G Clinical

      10 AM

      FIRESIDE CHAT Decentralised Clinical Trials; a discussion on modernising clinical trials whilst minimising site burden

      Perspectives from Sponsors & Sites; How to implement DCT’s, addressing the challenges and lessons learnt, sharing best practice.

      Moderator: Jane Myles, Program Director, Decentralized Trials & Research Alliance (DTRA)
      Panellists: Shalini Mohan, Head, Health Equity and Inclusive Research, Genentech
      Kimberly Barnholt, Executive Director, Evidence Generation, Genentech

      Speakers

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      Session Reserved for Priya Nair,

      Session Reserved for Priya Nair, Senior Analyst, Clinical Trials Intelligence, GlobalData

      Speakers

      11:30 AM

      The Importance of Real-Time Forecasting in Clinical Trials

       

      • Review the challenges of forecasting clinical trial costs and the impact on cash flow.
      • Understand how a data-driven and automated approach can produce more accurate forecasts quickly.
      • Learn how you can apply these methodologies.

      Speakers

      12 PM

      Which Approach to Invest in? With numerous emerging innovative solutions on the market, how are organizations assessing the right approach for the right trials?

      • What types of innovative approaches are trending?
      • How are organisations evaluating different approaches?
      • Establishing the best fit for your trial - how to optimize fit-for-purpose and fit-for-patient?
      • Underlining the risk between huge benefits and wasted time
      • Uncovering longevity: here one-minute and gone the next

      Speakers

      12:30 PM

      Session reserved for Viedoc

      1 PM

      Networking Lunch

      2 PM

      Clinical Trials Budgeting & Forecasting: 7 Key Areas of Focus (that should be “givens”!)

      • Multi-Variables
      • Outsourcing
      • PTS (Probability of Technical Success)
      • FTE (Full-Time Equivalent) Rate
      • Accruals
      • Change
      • Exuberance

      Speakers

      2:30 PM

      INTERACTIVE SESSION WITH Q&A : How are today’s patients coping with modernized trials?

      • A firsthand insight onto what it is like participating in a trial
      • Which key things helped make my time simpler on a trial
      • How even minor things from the protocol can have a huge impact on patients

      Speakers

      3:15 PM

      Afternoon Refreshments, Networking & Prize Draw in Exhibition Room

      Speakers

      Select a speaker to learn more

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      Robert J. Boland
      MBA, Global Head of Digital Innovation R&D, Haleon

      Currently, Robert is the Global Head of Digital Innovation at Haleon, where he overseas and manages the organization’s Digital Innovation and Technology Portfolio across Research & Development and Laboratory Technologies. Robert formerly was the Global head of Digital Data and Delivery at CSL Behring, and prior, Head Of Digital Health & Clinical Innovation at CGI, and Head of Data Strategy and Digital Connected Solutions at Johnson & Johnson. Robert is an industry thought leaders and lecturer, often speaking on Digital Innovation and Data Strategy, internationally.

      Session Details:

      How are we digitally moving us into the next generation of laboratories for clinical trials

      2024-02-06, 10:30 AM

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      Christine Von Raesfeld
      Independent Patient Advocate

      Few people with a cause walk the talk as boldly and graciously as Christine Von Raesfeld, founder and CEO of People with Empathy. Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. Through the lens of her lived experiences in healthcare, she has become a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. Christine has brought her unique perspective and honed expertise to countless roles as a featured speaker for numerous conferences dedicated to the rare disease community and disease awareness initiatives. Wherever possible, Christine generates momentum toward progress along her patient advocacy interests and stimulates dialog on a range of topics relevant to patients, clinicians, and industry. As a patient advisor, Christine has assisted several initiatives including the Stanford "Humanwide" Precision Medicine Program, All of Us Research, and the 23andMe Lupus initiative. For her many contributions to her field, she has been named one of the top 100 Women of Influence by Silicon Valley Business Journal, a member of the 2021 HIMSS Future 50, and one of Medika Life's medikal life 50 most influential voices in healthcare 2022 among other distinctions. With her guidance and support, we will continue to optimize the patient journey for people worldwide.

      Session Details:

      PANEL Patient centricity: What does patient centric clinical trial development look like in 2024?

      2024-02-06, 1:30 PM

      Session Details:

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

      2024-02-06, 11:30 AM

      Session Details:

      FIRESIDE CHAT Have you developed an understanding of the patient journey as part of your clinical trial design? Bringing the patient’s practical perspective to your trial operations especially for rare disease indications

      2024-02-06, 2:45 PM

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      Archana Sah
      Oncology Board Member, Society for Clinical Research Sites

      Archan Sah is a clinical development thought leader with extensive (30 years) experience and passion for developing medicines for patients having led and contributed to 15 FDA/EMEA drug approvals in Oncology, Immuno-Oncology, Precision Therapeutics, Rare Diseases, Metabolic Diseases and Women's Health. She has held various global positions at Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON Clinical Research, two Oncology biotech start up companies and Medable- a leading technology platform provider. She is now an independent strategy consultant and Board Advisor provides strategic advisory services in clinical development and operations as well as on leveraging innovative patient centered digital health technologies in a fit for purpose approach to improve diversity, access and efficiencies within the healthcare ecosystem. She has been honored as Top20 women in immuno oncology drug development (2020) and featured in PharmaFEATURES (May 2022) on Oncology drug development and Digital Health technology.

      She is a recognized leader/change agent leading industry collaborations and has been the co-founding chair and currently a member of Society for Clinical Research Sites Oncology Board and chaired the annual Oncology Summits. She is a past member of the Leadership Council for Decentralized Trials and Research Alliance and Digital Innovation in Oncology Roundtable with DiMe. She serves as an Advisor to American Cancer Society Cancer Action Network and has contributed to the clinical trial sites Standardization and Harmonization with the Forum on Drug Discovery and Development, National Academy of Sciences.

      Session Details:

      State of Affairs on Excellence in Clinical Development

      2024-02-06, 10:30 AM

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

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

      Session Details:

      CRO Cost Control and Smart Contracting

      2024-02-06, 11:30 AM

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      Jasmina Jankicevic
      Clinical Development, RAPT Therapeutics, Inc.

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

      Session Details:

      PANEL Maximising your Sites Productivity & how to lessen the burden

      2024-02-06, 1:30 PM

      Session Details:

      Building CRO Relationships. What are the critical factors to consider when procuring from a CRO?

      2024-02-07, 9:00 AM

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      Harman Hansra
      Sr. Director, Global Clinical Ops, Annexon Biosciences

      Session Details:

      PANEL Maximising your Sites Productivity & how to lessen the burden

      2024-02-06, 1:30 PM

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      Amy Finnigan
      Head of IT R&D, Ultragenyx Pharmaceutical

      Amy Finnigan is a seasoned Business Relationship Manager in the pharmaceutical industry with a passion for leveraging technology to drive innovation and growth. With a solid foundation in life sciences technology consulting, she specializes in crafting and executing large-scale technology strategies, implementations, and services for organizations in the pharmaceutical sector. She holds a degree in International Health from Georgetown University, and began her career journey in clinical research at the University of Chicago Department of Endocrinology. Over the past decade, Mrs. Finnigan has had the privilege of consulting with diverse organizations before taking on her current role at Ultragenyx. At Ultragenyx Pharmaceutical, Mrs. Finnigan is dedicated to driving innovation and transformation, ensuring that technology aligns seamlessly with the company's mission to improve the lives of patients with rare and ultra-rare diseases.

      Session Details:

      PANEL FUTURE FORWARD: What’s broken and what’s working when deploying technology in clinical trials

      2024-02-06, 1:30 PM

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      Scott McCulloch
      Executive Director, Global Clinical Quality & Pharmacovigilance, Recode Therapeutics

      Session Details:

      Trial Execution Excellence for small & medium biotechnology companies

      2024-02-06, 2:45 PM

      Session Details:

      PANEL DISCUSSION Outsourcing Strategies: how do you approach your outsourcing strategy?

      2024-02-06, 4:15 PM

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      Edward Kuczynski
      Director, Human Research Protection Program, University of California

      Edward joined the UCSF Office of Research as its Director of the Human Research Protection Program (HRPP) in May 2020. In this role, he oversees the UCSF HRPP, which is comprised of the Institutional Review Board (IRB) and its committees, the Quality Improvement Unit, and the Human Gamete, Embryo and Stem Cell Research (GESCR) Committee. Edward has a background in strategic planning and business plan implementation for clinical research activities; experience building and directing clinical and research programs at Academic Medical Centers; and familiarity with creating de novo core clinical research support services. He has served as co-investigator on the NIH Clinical Network for Contraceptive Research grant, clinical site investigator for an NIH-funded grant studying Antiphospholipid Pregnancy Loss, and co-investigator on a March of Dimes program grant on risk factors for prematurity. More recently, Edward was a Strategic Advisor for Clinical and Translational Research Programs at the Stanford University Center for Clinical & Translational Research & Education. He has also served as the Director of Clinical Research Operations for the Tufts Clinical and Translational Science Institute, a consult lead for the Johns Hopkins University/Tufts University Trial Innovation Center, as well as an Assistant Professor in the Department of Medicine at Tufts University School of Medicine.

      Session Details:

      Expanded Responsibilities for IRBs when Reviewing AI Protocols

      2024-02-06, 2:45 PM

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      Jenny Wakefield
      Senior Director- Quality Development Operations, Incyte

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

      Session Details:

      PANEL Patient centricity: What does patient centric clinical trial development look like in 2024?

      2024-02-06, 1:30 PM

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      Allyson Gunsallus
      Associate Director, BridgeBio
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      Dr. Ramachandran “TR” Thirucote
      Chairman & CEO, TesoRx Pharma

      Dr. Ramachandran “TR” Thirucote is a founding Chair and CEO of TesoRx Pharma, LLC and its affiliate, LIPAC Oncology, Inc., clinical stage companies that are focused on delivering innovative, optimized therapies in areas of unmet medical needs.  Each of the companies leverage a novel drug delivery platform technology to target a range of treatments including  urology and oncology.  TR has several decades of experience in the design, development and launch of innovative therapeutics and dosage forms covering all dosage forms such as solid orals, parenteral and topicals.  At Roxro Pharma, LLC, a leading edge virtual pharma company model, TR was instrumental is design development and NBA launch of SprixTM, a novel nasal spray drug-device combination for a non-opioid for post-operative surgical pain.  At SRI International (formerly Stanford Research Institute), TR pioneered a contract pharma model (CRO), that encompassed government contracts with commercial pharma product development, setting the table for the successful establishment of several start up biotech and pharma companies across the country. He was also very successful as a PI and helped establish ongoing contracts with NIH affiliated institutes such as NIAID and NCI. At Agouron Pharma (now Pfizer), TR led the oncology portfolio development, moving the company’s first lead molecule in to clinical trials. As a scientist at Thermedics (now a division of Thermo Fischer Scientific), TR was responsible for the development of a novel polymeric wound dressing under a DOD contract, advised by Dr. R. Langer (MIT).

      Session Details:

      Design Concepts in effective product development and clinical outcomes – Expert Lessons

      2024-02-07, 10:00 AM

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      Marta Schumacher
      Executive Director, Head of Global Clinical Operations, Annexon Biosciences

      Marta Schumacher joined Annexon,Inc. in 2019 and currently serves as Head of Clinical Operations (Executive Director) with a team dedicated to executing global clinical trials. She was VP of Clinical Operations at BioPharmX from 2017 to 2019 where she was responsible for building and leading the clinical operations department. From  1999 to 2017 she held various Clinical Operations positions at Roche, Corgentech, BN Immunotherapeutic, Inclin and Genentech. Marta earned a B.A. in Genetics from the University of California at Berkeley and an M.B.A at Golden Gate University.

      Session Details:

      PANEL Maximising your Sites Productivity & how to lessen the burden

      2024-02-06, 1:30 PM

      Session Details:

      FIRESIDE CHAT Have you developed an understanding of the patient journey as part of your clinical trial design? Bringing the patient’s practical perspective to your trial operations especially for rare disease indications

      2024-02-06, 2:45 PM

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      Ghesal Razag
      Sr. Director, GI Clinical Operations, Biora Therapeutics

      Session Details:

      Speaker Hosted Roundtables

      2024-02-07, 3:45 PM

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      Dave Borbas
      Research VP, Head of Data Management, Abcuro

      David Borbas is Research VP, Head of Data Management of Abcuro

      Prior to Abcuro, David worked for more than 25 years of Data Management and Information Technology experience. He has broad experience starting and developing Data Management groups at SurroMed, Millennium Pharmaceuticals South San Francisco and Jazz Pharmaceuticals. After leaving Jazz Pharmaceuticals he provided Data Management consulting services to small and medium size companies in the Bay Area, throughout the US and Canada. He has been involved in 5 successful NDAs and together with Data Management team members has managed more than 100 studies. His research experience includes Rare Disease, Cardiac, Oncology, Rheumatology, Fibromyalgia, Gene Therapy, Neurology and Psychiatry clinical studies. He has supported clinical studies phase 1 to 4 including Global Phase 3 Studies, IVRS and eDiary applications. In addition, David has clinical experience more than 15 years of clinical and management experience in the areas of Critical Care, Emergency, Hemodialysis and Critical Care Transport. He has a Bachelor of Science in Nursing from the University of Pennsylvania and a Master of Science in Information Systems from Claremont Graduate University. He has given presentations at the CDISC International Interchange and supported the Bay Area CDISC meetings and PhUSE standards work groups.

      Session Details:

      Great expectations and how to meet them – connected devices and ePRO in clinical trials

      2024-02-06, 11:30 AM

      Session Details:

      PANEL DISCUSSION Outsourcing Strategies: how do you approach your outsourcing strategy?

      2024-02-06, 4:15 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.

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      Shalini Mohan
      Head, Health Equity and Inclusive Research, Genentech

      Developing models for advancing health equity by increasing access to care for underserved populations.

      Over 7 years of pharma industry experience in product development and medical affairs. Experience spanning direct patient care in both academic and institutional healthcare systems as well as basic and translational clinical research with demonstrated competence in design, execution, statistical analysis and reporting of research. Working knowledge of the regulations, laws, policies and procedures related to clinical and human subjects research, including ICH, GCP, HIPAA, CITI certification and IRB practices.

      Session Details:

      FIRESIDE CHAT Decentralised Clinical Trials; a discussion on modernising clinical trials whilst minimising site burden

      2024-02-07, 10:00 AM

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      Kolbi Brown
      Director of Engagement, National Institute of Health (NIH) partner with Pyxis Partners

      Session Details:

      CASE STUDY ALL OF US Research programme

      2024-02-07, 11:00 AM

      Session Details:

      PANEL DISCUSSION Diversity & Inclusion in Clinical Trials

      2024-02-07, 2:30 PM

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      Melanie Crystal
      Clinical Director, Medtronic

      Experienced Clinical Director with a demonstrated history of working in the medtech and pharmaceuticals industry. Strong program and project management professional skilled in Clinical Research, Drug Development, Medical Devices, and Oncology.

      Session Details:

      Speaker Hosted Roundtables

      2024-02-07, 3:45 PM

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      Kimberly Barnholt
      Executive Director, Evidence Generation, Genentech

      Kimberly Barnholt has been a healthcare leader in various roles spanning from academic research, to disruptive start-up, to global pharmaceutical company. In all roles, she has focused on bridging science, data, and operational disciplines to challenge the status quo and transform how we can deliver more impact for our patients. At Genentech, she has served as a Program Leader for cross-industry collaborations and cross-R&D data ecosystem transformation. Currently, Dr. Barnholt is leading an Evidence Generation team of data strategists and clinical innovation and technology leaders to integrate new approaches to clinical trials.

      Session Details:

      Which Approach to Invest in? With numerous emerging innovative solutions on the market, how are organizations assessing the right approach for the right trials?

      2024-02-07, 12:00 PM

      Session Details:

      FIRESIDE CHAT Decentralised Clinical Trials; a discussion on modernising clinical trials whilst minimising site burden

      2024-02-07, 10:00 AM

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      Kim Erby
      Director Clinical Operations, Cytokinetics

      Co-Head of the Clinical Operations Department at Cytokinetics. Responsible for the Cardiovascular portfolio Phases 1 - 4, and developing quality standards across the organization. Provide management, leadership, and operational strategy for the Clin Ops teams responsible for trial management.

      Session Details:

      PANEL DISCUSSION Diversity & Inclusion in Clinical Trials

      2024-02-07, 2:30 PM

      Session Details:

      PANEL DISCUSSION Outsourcing Strategies: how do you approach your outsourcing strategy?

      2024-02-06, 4:15 PM

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      Danielle McMullin
      Director Clinical Operations, BridgeBio

      Session Details:

      A look at the CTR – European Submission

      2024-02-07, 2:00 PM

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      Jane Myles
      Program Director, Decentralized Trials & Research Alliance (DTRA)

      Jane is a clinical research change agent with molecule development success in both global and start up biotechnology/ pharmaceutical companies. She have extensive experience leading global teams through changing business, technical, regulatory and competitive needs. Clinical Operations and DCT design /. execution is her expertise, from due diligence and protocol design through study conduct, regulatory submission and approval. In recent roles, she has lead teams to solve how technology can support clinical trial objectives and patient access. Technology, data assets and patient behaviors have evolved, and so has my focus. A passion for driving patient and site-friendly approaches to clinical trials, creating efficiency and speed along with a great customer experience. A unique strength in finding the fit between innovative solutions and development team needs.
      My core competencies include:
      • Innovation • Leadership • Patient-Centricity • Technology Scale and Deployment
      • Project Management •Strategic Planning •Data-driven Execution
      • Process Improvement • People Development •Building and Leading Teams

      Session Details:

      FIRESIDE CHAT Decentralised Clinical Trials; a discussion on modernising clinical trials whilst minimising site burden

      2024-02-07, 10:00 AM

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      Priya Ryali
      Director, Head of Clinical Operations, ReCode

      Session Details:

      Speaker Hosted Roundtables

      2024-02-07, 3:45 PM

      Session Details:

      PANEL DISCUSSION Focusing on today’s Innovation & Technological Advancements

      2024-02-06, 4:15 PM

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      Rebecca Lin
      Chief Strategy Officer, Potrero

      Healthcare Leader | Global Growth Strategist | Educator | Keynote Speaker on AI and Innovation |
      Top 25 Women Leaders in Medical Devices 2023

      Rebecca Lin is a distinguished healthcare leader with a proven track record in formulating growth strategies for emerging businesses to achieve global success. Her exceptional expertise has earned her recognition as one of The Top 25 Women Leaders in Medical Devices of 2023.

      Currently serving as the Chief Strategy Officer at Potrero, a cutting-edge MedTech AI innovation company based in the Bay Area, Rebecca's visionary leadership drives the company's growth and market expansion. Her strategic guidance has been instrumental in positioning Potrero as a trailblazer in the industry.

      Rebecca's career encompasses leadership roles in both large corporations and startups, providing her with a dynamic perspective that empowers her to guide teams at different stages of growth and maturity. Her winning strategies have left a lasting impact on esteemed companies such as Johnson & Johnson, CR Bard (acquired by Becton Dickinson), and TheraNova, spanning across business development, marketing, sales, training, and clinical management.
      Having operated in both US and international markets, Rebecca has cultivated a unique blend of business acumen and technical expertise. This combination enables her to effectively communicate with diverse audiences and establish key partnerships that scale businesses globally.

      Beyond her corporate roles, Rebecca actively contributes to the healthcare community. She serves as an editorial board member at the Chinese Journal of Medical Instrumentation, where she helps shape the discourse in the medical device industry. Furthermore, Rebecca shares her vast knowledge and insights as a lecturer in the Master of Translational Medicine programs at UCSF and UC Berkeley, nurturing the next generation of healthcare innovators. As a keynote speaker on AI and Innovation, Rebecca inspires audiences with her commitment to advancing healthcare through innovation and strategic expertise. She continues to be a driving force in the industry, shaping the future of healthcare.

      Rebecca is an alumna of Stanford Business School and holds a Masters in Marine Biology from Sun Yat-Sen University. Her publications include a chapter titled “Industry Perspectives and Commercial Opportunities of Artificial Intelligence in Medicine” in the book ARTIFICIAL INTELLIGENCE IN MEDICINE.

      Session Details:

      PANEL DISCUSSION Focusing on today’s Innovation & Technological Advancements

      2024-02-06, 4:15 PM

      Session Details:

      Registration and Refreshments

      2024-02-07, 8:30 AM

      Session Details:

      PANEL DISCUSSION Sharing best practice for improving patient enrolment and engagement for successful medical device clinical trials

      2024-02-07, 2:30 PM

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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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      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:

      Navigating the importation landscape for medical devices to gain and maintain competitiveness in a global market

      2024-02-07, 9:00 AM

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      Dr Bill Chen
      CISO, Natera

      As the Chief Information Security Officer (CISO) at Natera, Dr. Bill Chen is responsible for managing an enterprise-wide cybersecurity program that encompasses strategic, governance, risk and compliance (GRC), data protection, product security, and privacy engineering. Prior to joining Natera, he held different executive and technical positions at VISA, Palo Alto Networks, Cisco, Microsoft, and Coupang. With over two decades of experience in cybersecurity, he is also a successful start-ups advisor, a public speaker, and an author with multiple publications and patents. In his spare time, he plays guitar and enjoys the outdoors.

      Session Details:

      Collaborating with digital innovation: Data security and governance under a new age of AI

      2024-02-07, 11:00 AM

      Session Details:

      PANEL DISCUSSION Sharing best practice for improving patient enrolment and engagement for successful medical device clinical trials

      2024-02-07, 2:30 PM

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      Laura Yecies
      CEO and Board Member, Bone Health Technologies

      Session Details:

      Designing trials to demonstrate clinical efficacies while preparing for commercialization

      2024-02-07, 10:00 AM

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      Dr. Sanjay Shrivastava
      CEO, Innova Vascular, Inc

      Session Details:

      PANEL DISCUSSION Sharing best practice for improving patient enrolment and engagement for successful medical device clinical trials

      2024-02-07, 2:30 PM

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      Anitha Achyutha
      Director, Clinical Research (Farapulse PFA), Electrophysiology, Boston Scientific

      Session Details:

      Speaker Hosted Roundtables

      2024-02-07, 3:45 PM

      Session Details:

      PANEL DISCUSSION Sharing best practice for improving patient enrolment and engagement for successful medical device clinical trials

      2024-02-07, 2:30 PM

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      Laura Moffett
      Director of Clinical & Regulatory Affairs, VDyne, Inc.

      Session Details:

      Improving interactions with regulatory agencies on submission requirements and study results from a startup perspective

      2024-02-07, 9:30 AM

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      Dorothy H. Kwok
      Head of Clinical Operations, Bodyport

      Session Details:

      Non-significant risk device studies: Designing pivotal studies for medical device approval in the US

      2024-02-07, 12:00 PM

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      Dr. Bryan Cornwall
      Chief Scientist / FEED-Research

      Bryan Cornwall, PhD, MBA, PEng is an Academic Scientist with 25+ years experience in the Medical Device Industry. Dr. Cornwall is adjunct faculty at the Surgical Orthopedic Research Laboratory (SORL) at the University of New South Wales (UNSW) and the Shiley-Marcos School of Engineering (SMSE) at the University of San Diego (USD); he is also principle of FEED-Research, a medical device consulting firm.

      Bryan Cornwall’s most recent industry role was as Executive Vice President, Research and Clinical Affairs at Surgalign. The company had a global spine implant business and had the first US 510k cleared spine navigation system combining Augmented Reality for enhanced visualization and Artificial Intelligence (AI) for intraoperative spine anatomy recognition and autonomous pedicle screw planning. Dr. Cornwall has numerous publications including 25 peer-reviewed journal articles, 26 U.S. patents and eight book chapters.

      Session Details:

      Levelling up CRO partnerships for medical device companies so that both sides win

      2024-02-07, 12:30 PM

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      Chandramohan Thiruvamkulam
      Director Quality Systems, Endologix

      Session Details:

      Data integrity simplified

      2024-02-07, 4:45 PM

      Session Details:

      Presentation of paper on data integrity: Reducing the impact of increased data privacy requirements under GDPR on medical device companies

      2024-02-07, 2:00 PM

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      Abby Kennedy
      VP of Clinical Operations, CymaBay Therapeutics, Inc

      Session Details:

      Chairman’s Opening Remarks

      2024-02-06, 8:20 AM

      Session Details:

      PANEL DISCUSSION Outsourcing Strategies: how do you approach your outsourcing strategy?

      2024-02-06, 4:15 PM

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      Chris Chan
      Vice President, FP&A, IGM Biosciences

      Session Details:

      Clinical Trials Budgeting & Forecasting: 7 Key Areas of Focus (that should be “givens”!)

      2024-02-07, 2:00 PM

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      Shoaib Khan
      Medical Director, Pfizer
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      Priya Nair
      Senior Analyst, GlobalData

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      Session Reserved for Priya Nair,

      2024-02-07, 11:00 AM

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      Catherine Caserza
      Director, Clinical Operations, Daichii Sankyo
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      Abdel Dridi
      Global Head of Digital Healthcare Technologies (DHT), Personalized Healthcare, Product Development, Roche

      Abdel Dridi is the Global Head for Digital Healthcare Technologies at Roche and Genentech. In his role he oversees the global deployment of digital health solutions in late stage, clinical studies and early concepts. He is passionate about creating connected, digital healthcare platforms, and smart medical devices drawing from his deep experience from technology leadership roles at technology companies and in product and service development at technology healthcare organizations.

      Session Details:

      The use of technology to accelerate early drug discovery and reduce the burden for patients

      2024-02-06, 2:15 PM

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      Oren Cohen
      MD, Chief Medical Officer and President, Clinical Pharmacology Services, Fortrea Inc.

      Oren Cohen, MD, is President of Clinical Pharmacology and Chief Medical Officer, partnering with biopharmaceutical companies to optimize early clinical development through excellence in study design and execution. He has served in this position since Fortrea’s launch as an independent company in July 2023 following its spinoff from Labcorp.

      Following a decade of translational research at the U.S. National Institute of Allergy and Infectious Diseases under the mentorship of Anthony Fauci, MD, Oren has more than 20 years of experience in various medical and scientific executive leadership roles in the pharmaceutical industry. Most recently, Oren served as Chief Medical Officer and head of Clinical Pharmacology Services at Labcorp Drug Development since 2017. Prior to Labcorp, he was Chief Medical Officer at Viamet Pharmaceuticals, where he worked closely with clinical investigators and key opinion leaders to formulate and execute clinical development programs across a portfolio, developing and executing strategy and protocol designs. Previously, he held several senior medical and operational leadership positions at Quintiles, now part of IQVIA.

      Oren received his MD from Duke University and served his internship and residency at The New York Hospital, Cornell Medical Center in New York City. He completed his infectious diseases fellowship at the National Institute of Allergy and Infectious Diseases (NIAID) and stayed on to become an investigator in the Laboratory of Immunoregulation. Oren is also Consulting Professor of Medicine at Duke University Medical Center, a member of the Board of Visitors for Duke University School of Medicine and a Fellow of the Infectious Diseases Society of America. His research has been published in journals including The New England Journal of Medicine, Science, Proceedings of the National Academy of Sciences, Nature Medicine and the Journal of Clinical Investigation.

      Session Details:

      Clinical Pharmacology at Scale to Reduce Risk and Increase Precision

      2024-02-07, 9:30 AM

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      Stuart Thiede
      VP & Global Head Financial Lifecycle, IQVIA

      Stuart is responsible for leading the international team of professionals that delivers investigator grant payment solutions to clinical trial sponsors and CROs. He was Senior VP of Global Payment Services at CFS Clinical when it was acquired by DrugDev in 2014, and continued to lead and grow the Clinical Trial Payments offering after DrugDev was acquired by IQVIA in 2017. Stuart’s diverse background includes executive roles in finance, operations, service delivery, and account management in enterprises ranging from Fortune 500 technology companies to start-ups. He has significant international experience, including an expatriate assignment in Europe and a finance director role for a Latin American division of Unisys Corporation. Stuart has a B.S. in Accounting and an M.B.A. from Bowling Green State University.

      Session Details:

      The Importance of Real-Time Forecasting in Clinical Trials

      2024-02-07, 11:30 AM

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      Ashley Herrick, Ph.D.
      Executive Director, Oncology Program Strategy, Premier Research

      Dr. Ashley Herrick provides strategic planning, coordination, knowledge, and expertise for oncology projects. She has more than 14 years of experience in oncology clinical trial oversight and drug development. She has experience with all phases of clinical trials but has a keen interest and deep knowledge of early phase and first-in-man studies. She has led numerous global clinical trials and has experience with strategic management, study oversight, study start-up, efficient enrollment, and study close-out/CSR development.

      Prior to joining Premier Research, Dr. Herrick was Director of Operational Strategy Management for a mid-sized CRO overseeing the strategic planning for studies. She also supported their Oncology Site Network and was responsible for oversight of a biomarker driven patient matching group. She has also served as Project Director, Project Manager, and CRA throughout her years working in the CRO industry and has devoted her entire career to Oncology research. Prior to joining the CRO industry, she worked as a Program Manager for largest Phase I clinical trial unit in the country at MD Anderson Cancer Center, where she was responsible for oversight of more than 50 industry sponsored and investigator led Phase I clinical trials.

      Dr. Herrick holds a doctorate degree in molecular and cellular biology with a focus on hematologic malignancies from Baylor College of Medicine. She is CCRP certified and is a member of the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO). She is an active volunteer with the Leukemia and Lymphoma Society (LLS).

      Session Details:

      Mastering Dose Escalation Studies: Charting the Path from Planning to Execution

      2024-02-06, 3:45 PM

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