17th Annual Outsourcing in Clinical Trials West Coast 2025

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

11 - 12

February

2025
  • Hyatt Regency San Francisco Airport, Burlingame, CA, USA
  • Complimentary
  • Why attend?
  • Agenda
  • Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Resources
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Featured Speakers

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Laurin Vincent​

Executive Director, Vendor Quality Management, Gilead

We simply can’t make amazing discoveries and address patient's needs alone. We need to work together: collaborate, being agile, bring in partners, innovate and co-create. Delving in and solving problems, coaching, ensuring quality, optimizing our relationships and bringing the bold and authentic voice to the table is what I do best. I create vibrant and motivated teams enabling meaningful organizational transformation while building strategic relationships.

In my extensive clinical experience, I have built and transformed functions, simplified clinical processes and systems, lead quality programs, managed complex supplier partnerships, negotiated high profile contracts and implemented fit for purpose global governance frameworks. I’ve managed various projects around clinical technologies with an eye to quality, CRO/supplier optimization and supplier oversight. I’ve led global teams that were highly productive, engaged and impactful in achieving the organization’s goals.

I care deeply for making work meaningful and fun for my colleagues, teams, partners and the organization. I do this through collaborating, being agile, simplifying, creating a sense of community and bringing forth bold ideas.

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Leesa Gentry​

Chief Clinical Officer, RenovoRx

Clinical development executive with 29 years of experience of increasing responsibility.
Key achievements include:

  1. Drove development and successful launch of NCE product for the treatment of MDR-TB
    2. Procured over 35 million in non-dilutive funding for development of a suite of products to treat multiple infectious disease indications.
    3. Served as Steering Committee Member and clinical representative for PAN-TB consortium (including Evotec, Janssen, GSK, Otsuka, GMRI, and BMGF)
    4. Drove strategic planning for IND-enabling and clinical-stage programs for small biotech clients and for the development of internal assets.
    5. Expanded company revenue streams to include a clinical services solution and achieved profitability within 12 months.
    6. Collaborated with the C-suite team in developing short-term and long-term goals and strategies to increase clinical revenue.
    7. Drove development of multiple cross-functional strategic development plans and built pathways to licensure.
    8. Increased monthly enrollment rate by 85% from H1 2023 to H2 2023 in a pivotal phase 3 trial for first-line treatment of pancreatic cancer.
    Strengths include communication, analytical thinking, leadership, negotiation, and problem solving.
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Jad Adaimi​

Executive Director - Global Regulatory Affairs, Ultragenyx

Hands on experience in early, mid, and late stage product development and regulatory strategy in small and large pharma.

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Shantheri Pai​

Associate Director - Clinical Operations, Oncology, Gilead

Being able to strategically lead and oversee global complex clinical trials, coach and guide my team, collaborate with external and internal stakeholders, collaborate with the vendors, foresee risks and implement timely mitigation measures, continue to be agile to change management, ability to navigate through fluid/challenging situations, while being inclusive, respectful and empathetic, is what makes me a leader.

Clear decision making, effective communication, tailoring to the audience, funneling the right level of information upwards and cascading the guidance downwards, identifying process gaps and building efficiency where/as needed, keeping my team motivated and fostering a positive/growth mindset and lastly being able to wear multiple hats, with the final goal to make a positive impact to the lives of patient’s globally is what makes me a Clinical Trials Leader.

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Joshua Cox​

Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company

Joshua Cox has been honing his data management expertise in the drug development industry for nearly 20 years.  After breaking into the industry and gaining exposure to diverse therapeutic areas and development approaches with a CRO, Joshua has focused the last 15-years in sponsor driven early phase oncology.  He has enjoyed opportunities with bio-tech start-ups as well as established big pharma companies, each engagement adding valuable knowledge and experience to his skillset.  Joshua has led the development of data management departments by conceiving and implementing fit for purpose and results-driven technologies and processes always with an eye toward innovation and efficiency.  Now pursuing leadership opportunities outside the confines of traditional data management, Joshua is eager and excited to be a part of teams pursuing novel solutions to known challenges as well as employing cutting edge strategies and technologies to elevate the already high standards we expect and ultimately get the best medicines to the patients in need.

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Susan Edelstein, PhD​

SVP, Clinical Research, Ardelyx

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    2025 Sponsors Include:

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    Company Information

    ARENSIA Exploratory Medicine, a German-based company, is a leader in “first-in-patient” Phase IB and II/Proof-of-Concept clinical trials across a wide range of disease areas. With 14 proprietary research clinics and cutting-edge Phase I infrastructure, ARENSIA accelerates the early detection of efficacy signals for new therapies at an unparalleled speed. Its streamlined, highly efficient approach reduces patient recruitment time and costs by over 50% compared to conventional trial sites, which are often overcrowded and understaffed. This exceptional performance has resulted in a 93% repeat business rate and robust growth through collaborations with top pharmaceutical companies, biotechs, and global CROs. Headquartered in Düsseldorf, ARENSIA operates with a team of 600 professionals across 8 countries.

    Company Website

    To learn more, please visit our website - http://www.arensia-em.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 provider of endpoint data solutions that generate high-quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence generation solutions that combine eCOA, cardiac solutions, 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 2012.

    Company Website

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

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    Company Information

    EPS Corporation, an EPS Holdings Group Company, a Japanese headquartered company, is a comprehensive provider of clinical research outsourced services. Since 1991, the EPS Group has grown to over 7,800 staff providing quality R&D support to pharmaceutical, biotech, regenerative medicine, and medical device companies. EPS operates in Japan, China, South Korea, and Taiwan. With a business partner, we also support studies in other Asia-Pacific countries.

    Company Website

    To learn more, please visit our website - https://www.eps-holdings.co.jp/en/

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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

    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

    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

    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 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

    PSI is a privately-owned, full-service contract research organization (CRO), operating globally. PSI’s reputation on the market place is that of a no-nonsense CRO, capable of saving pharmaceutical sponsors millions of development dollars by consistently meeting clinical trial timelines. PSI’s global reach supports the operations of clinical trials across multiple countries.

    Company Website

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

    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

    Advance Research Associates is a premier provider of biostatistical and data management services to the pharmaceutical, biotech, and medical device industries. Since 1996, ARA has supported 700+ clinical trials worldwide across all therapeutic areas. Our collaborative approach helps maximize efficiency and agility by acting as an experienced member of your team.

    Company Website

    To learn more, please visit our website - www.advanceresearch.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 site operations technology, and the pioneer in study collaboration solutions. Our unique portfolio of technology and services reduces friction by decreasing technology burden, improving study visibility, and enabling smarter decisions that advance clinical research.

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

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    Company Website

    To learn more, please visit our website - http://aicure.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

    The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

    Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

    The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

    The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

    To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

    Company Website

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

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    Company Information

    Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, data management and more, all of which can be tailored to specific sponsor requirements. Altasciences… helping sponsors get better drugs to the people who need them, faster.

    Company Website

    To learn more, please visit our website - http://www.altasciences.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 17th annual event on February 11th & 12th 2025!

      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.

      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.

       

       

       

      WHAT TO EXPECT FOR 2025?

      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 2025 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

      400+

      Attendees

      		30+

      Exhibitors

      		30+

      Speakers

      		80%

      Attendees at Director + Level
      400+

      Attendees

      		30+

      Exhibitors
      30+

      Speakers

      		80%

      Attendees at Director + Level

      Testimonials

      See What It's All About

      Agenda

      • 11 Feb 2025
      • 12 Feb 2025
      Expand All

      Streams

      Stream one

      Stream A: Outsourcing & Clinical Operations

      Stream two

      Stream B: Clinical Technology & Innovation

      Stream three

      Stream C: Patient Centricity and DEI

      11 AM

      Ethical requirements and rights for patient disclosure and consent when implementing AI tools

      • How do we look at data transparency issues when scaling AI?
      • Case study on AI rights and a look at recently released survey discussing where things need to change
      • Without GDPR, what can be done to protect patients regarding data sovereignty?
      • Delving into the unique and amplified challenges for AI risk assessment
      • How we can effectively leverage AI in our heavily regulated environment?

      Speakers

      Christine Van Raesfeld
      Patient Advocate

      11:30 AM

      From guidance to action: Diversity insights and industry trends

      • Understand key elements of the FDA’s recent directives and their implications for increasing representation in clinical trials
      • Review data on the growing emphasis on diversity in sponsor submissions and filings, and learn how to align strategies with industry trends
      • Discover practical methods to recruit, engage, and retain underrepresented populations in clinical research
      • Examine how prioritizing diversity improves study validity, compliance, and applicability, supported by real-world data

      Speakers

      Stephanie Hitchcock
      Director, Project Management – Global Clinical Trials, PCM Trials

      12 PM

      PANEL DISCUSSION: Is clinical trial exclusion criteria too stringent?

      • How is the industry approaching diversity and what should the primary focus be?
      • Increasing accessibility to trials whilst simultaneously maintaining an appropriate level of patient safety
      • Assessing the link between restrictive eligibility criteria and rates of serious adverse events to make informed decisions on expanding exclusion conditions
      • Alternative solutions to improve patient numbers amidst pressures to hit recruitment milestones
      • How have increased pressures of patient recruitment lead to the questioning of traditional enrollment methods?

      Chair: Cathy Scharf, Patient Advocate, Patient Advocates of the East Bay

      Speakers

      Jad Adaimi
      Executive Director - Global Regulatory Affairs, Ultragenyx
      Marla Williams
      Associate R&D Strategic Outsourcing Director, Exelixis
      Nisha Trivedi
      Rare Disease Patient Advocate
      Meghan McKenzie
      M.A. Patient Inclusion and Health Equity, Chief Diversity Office, Genentech
      Cathy Scharf
      Patient Advocate, Patient Advocates of the East Bay

      12:45 PM

      The benefits of building trials, focused on patients, delivered in their own community

      • In-home trial delivery makes participation easier, more convenient and more accessible
      • Increasing trial access to more patients by empowering and supporting a variety of community research sites
      • How trial design can deliver increased recruitment and retention in a cost-effective way

      Speakers

      Catherine Jervis
      General Manager Integrated Solutions, MRN

      1:15 PM

      Lunch and networking sponsored by Thermo Fisher Scientific

      2:15 PM

      Patient Engagement starts with the Informed Consent Form

      This session will explore how the ICF can become a patient engagement tool.

      • How do potential participants view consent forms?
      • Changes to make the consent form to be more engaging.
      • Practical tips for changing your consent template.
      • Challenges that exist for implementing a different type of consent form.

      Speakers

      Ros Cheetham
      Vice President of Clinical Operations, MacroGenics

      2:45 PM

      Patient advocacy groups: Bridging clinical trials and patient communities for meaningful DEI impact

      • Understand the need for collaborative partnerships with patient advocacy groups
      • Discuss valuable insights these groups provide into the patient journey, clinical trial design, and study participation to reduce barriers faced by diverse patient populations
      • Share best practices for leveraging advocacy groups to enhance patient recruitment and retention
      • Explore how patient advocacy groups help align the objectives of clinical trials with broader

      Speakers

      Sarah Cross, PhD
      Vice President and Global Head of Medical Affairs, Premier Research

      3:15 PM

      Patient perspective: My clinical trial journey

      • Details of my two hybrid clinical trial participations
      • What worked well during the trials
      • Areas of improvement observed during/after the trials
      • Recommendations for ensuring patient-centric trial design

      Speakers

      Nisha Trivedi
      Rare Disease Patient Advocate

      3:45 PM

      Afternoon refreshments and networking

      4:15 PM

      From endpoints to impact: Designing trials that resonate with patients

      • Redefining hope: navigating tough conversations about disease-modifying treatments.
      • Genetic testing’s unexpected role in driving patient enthusiasm for trials.
      • When science outpaces understanding: bridging the gap with patients and clinicians.
      • Lessons from case studies

      Speakers

      Dr. Peter Schmidt, PhD
      Chief Scientific Officer, Rho
      Dr. Andrew Feigin, MD
      Chief Medical Officer, Rho

      4:45 PM

      CLOSING PANEL DISCUSSION: Innovative approaches to engage and retain patients in an era of recruitment struggles

      • DEI considerations: How can we establish trust within less-represented groups?
      • How can patient advocacy groups remain at the forefront of the discussion on study design and tailored communication programs
      • Overcoming obstacles in recruiting pediatric patients and how to make it easier for them and their parents to participate
      • Ensuring optimal communication with sites to support their efforts
      • The need for clinical trials to be accessible to patients

      Chair: Ros Cheetham, Vice President, Clinical Operations, MacroGenics

      Speakers

      Ros Cheetham
      Vice President of Clinical Operations, MacroGenics
      Bruce Morimoto
      Vice President, Drug Development, Alto Neuroscience
      Susan Edelstein, PhD
      SVP, Clinical Research, Ardelyx

      END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY Dr. Vince Clinical Research

      11 AM

      How Machine Learning (ML) and human genetics are accelerating drug discovery: Foreseeing the impact on clinical trials

      • In such sensitive environments, can you really trust AI to ensure the
      • total compliance of your clinical trial?
      • How can we overcome data shortages in smaller trials for the necessary algorithms
      • Tangible use cases for successful implementation of AI in clinical trial data management
      • Ascertaining an attractive ROI with AI investment
      • Redefining biostatistics reporting as we traditionally know it with AI tools
      • Unlocking new endpoints

      Speakers

      Matthew Albert
      Head, Translational Sciences & Early Clinical Development, Octant Biosciences

      11:30 AM

      End-to-End financial management: Challenges and opportunities

      • Gain insights into the complete process of end-to-end financial management.
      • Identify the inefficiencies caused by manual steps and siloed technologies.
      • Explore how combining services and software can optimize the financial management process.
      • Learn how IQVIA Technologies' expertise and global reach can support your financial management needs, whether insourced or outsourced.

      Speakers

      Zahiah (Zee Zee) Gueddar
      Senior Director, Commercial Lead, Financial Strategy & Corporate Development, IQVIA Technologies

      12 PM

      PANEL DISCUSSION: Translating technology into tangible outcomes and what are the latest ways in which it’s disrupting the clinical trial industry

      • Are we playing technology catch-up: What can we learn and adapt from other industries, and how can we implement this on scale despite increased regulation?
      • Lots of clinical management systems are generic but do we have ones that are clinically focused: Are you reaching the right audience in the right way and how can CROs get recognized by biotechs?
      • Recognizing the impact of technology solutions on the patients journey and ways to progress this even further
      • How do smaller biotechs prepare their supply chains for IRT adoption and compliance?

      Chair: Joshua Cox, Vice President of Clinical Data & Analytics Capabilities, Eli Lilly and Company

      Speakers

      Meir Pinco
      Associate Director, IT Data & Analytics, BeiGene
      John Rootenberg
      Principal Director, Digital Safety and Decision Support, Genentech
      Joshua Cox
      Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company

      12:45 PM

      Unlocking trial success: How clinical adjudication drives sponsor and regulatory confidence in study results

      • How independent adjudication improves endpoint accuracy and consistency in trials.
      • Ways adjudication improves data accuracy and regulatory compliance.
      • Strategies to reduce risk and streamline trial timelines.
      • How to reduce variability and disputes in clinical endpoint assessments.

      Speakers

      Kathleen Dowell
      VP, Medical Imaging and Specialty Solutions, Clario

      1:15 PM

      Lunch and networking sponsored by Thermo Fisher Scientific

      2:15 PM

      Cross-functional team collaboration and alignment in meeting ‘on time’ clinical supply needs

      • Aligning the clinical trial ecosystem to be operationally efficient and reduce delays in supply deliverables
      • Fine-tuning the clinical supply vendor partnership: How can sponsors and service providers start using guidance in totality instead of in silos?
      • Maintaining open communication with manufacturers to address precise trial needs and perfect demand planning
      • Working in tandem across the trial ecosystem to better manage demands for increasingly complex clinical supply needs

      Speakers

      Anthony L Colenburg Sr
      Senior Director & Site Head of Quality, Sutro Biopharma

      2:45 PM

      Maximizing asset valuation for biopharma

      • Biopharma has historically focused on achieving regulatory approval for value creation
      • Asset valuations at the time of licensing or sale can be increased by expanding research plans to address non-regulatory stakeholders
      • At the same time, new innovations in R&D productivity can lower the cost of trials while better managing risks of trial success

      Speakers

      Kenneth Park, MD
      Kenneth Park, MD, VP, R&D Strategy and Productivity, Consulting, Fortrea

      3:15 PM

      Session reserved for Sharon Crugnale

      Speakers

      Sharon Crugnale
      Vice President, Clinical Development Operations, Bitterroot Bio

      3:45 PM

      Afternoon refreshments and networking

      4:15 PM

      Start expecting more from eCOA/ePRO

      Patient data is the lifeblood of a clinical trial, but the eCOA/ePRO market has yet to live up to the promise of engaging more patients. Sponsors and CROs should expect more. We need an objective look at where the market is lagging, and concrete steps we can take to improve.

      • Describe why a legacy eCOA/ePRO system will not deliver the same results as a system developed with modern, digital technology
      • Examine how eCOA/ePRO technologies should promote compliance by giving patients apps that are akin to apps they use in daily life, on their own devices
      • Discuss how eCOA/ePRO will not become a strategic component of sponsor and CROs technology portfolios unless vendors embrace continuous innovation

      Speakers

      Steve Rosenberg
      Chief Executive Officer, uMotif

      4:45 PM

      CLOSING PANEL DISCUSSION: How sustainable drug development will empower and optimize the way clinical trials are planned to improve productivity and minimize costs

      • Future-proofing supply chains to endure greater long-term sustainability responsibilities
      • Adhering to sustainable practices without adding cost and risk to already tight budgets
      • Operational implications of striving for more sustainable trial design
      • Collaborating with supplier ecosystems to drive sustainability goals
      • Sharing best practice for circular supply chain strategies and creating win-win business opportunities

      Chair: Joshua Cox, Vice President of Clinical Data & Analytics Capabilities, Eli Lilly and Company

      Speakers

      Joshua Cox
      Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company
      Yuyi Shen
      Vice President, Technical Operations, Abcuro
      Sarah Hamirani
      Portfolio Director, AbbVie
      Jasmina Jankicevic
      Clinical Development and Medical Affairs, RAPT Therapeutics
      Prasun J Mishra
      Founder CEO

      END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY Dr. Vince Clinical Research

      7:30 AM

      Registration & Refreshments

      8:20 AM

      Chair’s opening remarks

      Speakers

      Susan Edelstein, PhD
      SVP, Clinical Research, Ardelyx

      8:30 AM

      KEYNOTE: How to optimize efficiencies at clinical trial sites when they’re underperforming

      • Building a partnership reciprocity between sites and sponsors to reduce discord and ensure sites are confident enough to succeed
      • Is it fair to place the shortcomings of trial success on site performance?
      • Developing an integrated strategic global site engagement model to transform site experience
      • Enabling innovative approaches to drug development and delivering new treatments to patients faster
      • Equipping sites with a clear and well-defined protocols to be able to best respond to sponsor needs

      Speakers

      Leesa Gentry
      Chief Clinical Officer, RenovoRx

      9 AM

      Why so slow? Insider insights from the clinic floor to speed up the conduct of proof-of-concept patient trials

      • Feasibility figures true to delivery
      • Regulatory dynamics for strategic advantages
      • Collaborate with patients and physicians to enhance access to innovative therapies
      • New study designs that accelerate development programs

      Speakers

      Tatiana Eidus
      Director Corporate Development North America, ARENSIA Exploratory Medicine

      9:30 AM

      Optimizing clinical trials: Sponsor/CRO cooperation; working together to enroll appropriate patients

      • Choosing the “right” CRO for your study and ensuring you get the “A” team or the team you were promised: and building a positive relationship with them
      • Clearly identifying who is responsible for each action item; especially items that are part of study start up (site ID, feasibility, site qualification) and how to proceed efficiently
      • Establishing realistic timelines and practicing constant communication to avoid timelines slipping
      • Keeping patients in mind when designing the protocol
      • Utilizing updated technology: A look at a recently adopted eISF system and potentially adopting a RBQM system
      • Using sites with a diverse population and promising constant communication with them
      • Sending an initial budget template early on to help streamline the budget process and identify sites that may not fit within the study budget early on.

      Speakers

      Susan Edelstein, PhD
      SVP, Clinical Research, Ardelyx

      10 AM

      Maximizing the consultative partnership between CRO and pharma/biotech partners

      • How early engagement can improve outcomes
      • How do we speak the same language, no one size fits all approach
      • Simplifying the complex, in a world of overwhelming outsourcing options and models

      Speakers

      Marija Jovanovic, MD
      Director, Project Delivery, ICON Biotech, ICON

      10:30 AM

      Morning refreshments and networking break sponsored by Ergomed

      11 AM

      Ensuring that vendor oversight is embedded from end-to-end

      • Effectively implementing a risk-based approach to vendor oversight
      • How to right-size vendor oversight for our high-risk activities being outsourced
      • Why is vendor oversight important and what regulations drive this
      • Recognizing the importance of cross-functional collaboration to best manage vendor activity

      Speakers

      Laurin Vincent
      Executive Director, Vendor Quality Management, Gilead

      11:30 AM

      The 2025 Biotech Landscape: Perspectives and Projections

      • Trends observed during the JP Morgan Healthcare conference
      • The impact of the new administration on clinical trials

      Speakers

      Aditya Kotta
      Head of Business Development US & EU, Novotech

      12 PM

      PANEL DISCUSSION: Battling insufficient resources to allow your trial to succeed in an increasingly competitive landscape

      • Battling site competitiveness to reduce delays on study start-up: what can you do differently to tackle these operational challenges?
      • When there are immense pressures on the trial ecosystem, how can we build quality and ensure quantity in an innovative way
      • Developing an optimized strategy as a small to medium-sized biotech with limited resources to stay afloat
      • Discussing the importance of protocol optimization and specialized statistical support to reduce the pressure on sites and relieve bottlenecks

      Chair: Susan Edelstein, PhD, SVP, Clinical Research, Ardelyx

      Speakers

      Sage Callaway
      Associate Director, Clinical Business Operations, Oncology, Ascendis Pharma
      Jenni Herber
      Associate Director, Clinical Operations, Kamau Therapeutics
      Avnika Agarwal
      Senior Director, Project Delivery, Biotech, ICON
      Susan Edelstein, PhD
      SVP, Clinical Research, Ardelyx
      Laura O’Donnell
      Senior Director, Head, Global Site Engagement, GSK

      12:45 PM

      Breaking through: Success in streamlining SAD/MAD and NDA-Enabling studies

      • Breaking through the complexity of phase 1 studies
      • Prioritizing Phase 1 schedule
      • Optimizing efficiencies for NDA-Enabling studies

      Speakers

      Lona Sheeran
      Senior Vice President, Clinical Operations Early Phase, Worldwide Clinical Trials

      1:15 PM

      Lunch and networking sponsored by Thermo Fisher Scientific

      2:15 PM

      Session reserved for Jenni Herber

      Speakers

      Jenni Herber
      Associate Director, Clinical Operations, Kamau Therapeutics

      2:45 PM

      Driving success: Strategies for optimal site support

      • The evolving landscape of clinical trials and the need for more engaged sites: trial complexity, competition, and site staff turnover
      • How the CRO fits into addressing site support as a focal point
      • The sponsor’s role in site support
      • The road forward: methods of addressing site support

      Speakers

      Eleanor Miller
      Clinical Trial Liaison, PSI CRO

      3:15 PM

      FIRESIDE CHAT: Successful strategies on CRO FSP management, scaling teams, and bridging low-cost offshore footprint while maintaining quality and efficiency

      • Evolution of CRO FSP models
      • Balancing growth and quality in a hybrid model
      • The future of scaling and offshore integration

      Speakers

      Bao Dinh
      Global Development Business Operation, Takeda
      David Larwood
      CEO, Valley Fever Solutions

      3:45 PM

      Afternoon refreshments and networking

      4:15 PM

      What do you mean you need equipment? Demystifying the complexities of the equipment supply chain

      • Explore the critical role of equipment in enabling clinical trial success, from ensuring compliance to supporting protocol-specific needs.
      • Understand key challenges in the equipment supply chain, including global logistics, maintenance, and vendor management.
      • Discover practical solutions, such as centralized planning, global harmonization, and leveraging technology for supply chain optimization.
      • Learn from real-world examples illustrating how proactive equipment management saves time, reduces costs, and ensures trial continuity.

      Speakers

      Jon Raven
      Chief Commercial Officer, Emsere
      Bryan Dunlap
      Business Develop Manager, North America, Emsere

      4:45 PM

      CLOSING PANEL DISCUSSION: Macro perspective: Facilitating the harmonization and equivalence of working across regions

      • How can sponsors and service providers start using guidance in totality instead of in silos?
      • Overcoming the lack in consistency of regulations between regions and countries
      • Collaborative ways to render it easier for regulators to accept multiregional trial data
      • Developing shared expectations for trial conduct, acceptability of endpoints and data transparency

      Chair: Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData

      Speakers

      Leesa Gentry
      Chief Clinical Officer, RenovoRx
      Sandra Nino-Siddens
      Vice President Global Regulatory Affairs, Ultragenyx Pharmaceutical
      Bogdan Sandica
      Senior Manager Trial Optimization, ARENSIA Exploratory Medicine
      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc

      5:30 PM

      Chair’s closing remarks

      END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY Dr. Vince Clinical Research

      Streams

      Stream one

      Stream A: Outsourcing & Clinical Operations

      Stream two

      Stream B: Clinical Data Management

      Stream three

      Stream C: Medical Devices

      8:50 AM

      Chair’s opening remarks

      Speakers

      Chitrang Dave
      Global Head of Enterprise Data & Analytics, Edwards Lifesciences

      9 AM

      Innovating with data in life sciences

      Data plays an increasingly critical role in the age of AI in life sciences. Using data and AI effectively can help:

      • accelerate research & development by making new and larger data points easily accessible
      • optimize trial design and enrolment by analyzing population and patient characteristics
      • improve manufacturing efficiency and commercialization

      Speakers

      Chitrang Dave
      Global Head of Enterprise Data & Analytics, Edwards Lifesciences

      9:30 AM

      Building a robust medical device clinical development program: best practices and insights

      • Key considerations for medical device clinical development program at different stages
      • Optimize protocol design using data-driven approaches
      • Leveraging policy advantages of Asia-Pacific to accelerate the program timeline
      • Important factors when selecting a contract research organization (CRO) or other partners to manage a successful medical device study

      Speakers

      Lian Cunningham
      Vice President Of Clinical Affairs, Endogenex

      10 AM

      Q&A SESSION: What do venture capitalists look for in startups? Unveiling the main criteria for investment

      Speakers

      Charles Aunger
      Managing Director, Health2047

      10:30 AM

      Recent FDA guidance on clinical research topics and what it means to you

      • Find out when you can waive the need for Consent Forms
      • When needed, ensure that Informed Consent Forms include key information
      • Implement decentralized clinical trial elements to improve trial participant engagement, recruitment, enrollment, and retention

      Speakers

      Katie Bessette
      Director of Regulatory Affairs, Abbott Laboratories

      11 AM

      Morning refreshments and networking

      11:45 AM

      Global UDI Compliance: strategies for navigating unique device identification standards worldwide

      • Understanding UDI requirements across regions
      • Implementing UDI systems for traceability and safety
      • Leveraging UDI data for operational efficiency

      Speakers

      Tania Pearson
      Regulatory Systems Director, Medtronic

      12:15 PM

      PANEL DISCUSSION Key considerations for evaluating clinical vendors in effective study execution

      • Aligning vendor expertise with study needs
      • Assessing operational transparency and communication
      • Balancing innovation with compliance

      Speakers

      Chitrang Dave
      Global Head of Enterprise Data & Analytics, Edwards Lifesciences
      Dorothy H. Kwok
      Head of Clinical Operations, Bodyport
      Rozanno Gonzales
      Clinical Innovation & Technology Leader, Genentech

      1 PM

      Lunch and networking

      2 PM

      Strengthening partnerships and processes for clinical trial excellence in medical devices

      • Learning criteria for identifying investigator aligned with study goals, device expertise and regulatory expectations
      • Building relationships at clinical sites
      • Effective training for investigators and site staff
      • Optimizing the informed consent process

      Speakers

      Kathryn Wine
      Vice President Clinical Affairs, Novocuff

      2:30 PM

      Chair’s closing remarks and close of stream

      8:50 AM

      Chair’s opening remarks

      Speakers

      Joshua Cox
      Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company

      9 AM

      KEYNOTE: Automating manual processes to improve decision-making and patient care

      • Automating Adverse Event Evaluations: Enhancing speed and accuracy using AI.
      • Streamlining Clinical Protocol Training: Efficiently generating consistent training materials with AI.
      • Improving Medical Coding: Utilizing AI for accurate adverse event classification and regulatory compliance.
      • Reducing cycle times and operational costs and enhancing data accuracy to
        better clinical trial results

      Speakers

      Meir Pinco
      Associate Director, IT Data & Analytics, BeiGene

      9:30 AM

      Integrating Risk-Based Quality Monitoring (RBQM) into each phase of the trial to ensure maximum efficiency and robust data validation processes

      • Designing and executing a successful RBQM framework to meet your specialized trial goals
      • Sharing best practice on implementing new modern EDC systems to provide built-in validation checks and automated information checks when some CROs are lacking
      • Focusing on critical data and processes by documenting risks, roles, and mitigation strategies
      • Meaningful key performance indicators for RSQM

      Speakers

      Thomas Tremblay
      Vice President, Head of Clinical Operations, Trefoil Therapeutics

      10 AM

      PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

      • Weighing up pros and cons of different outsourcing models: which is best for your trial?
      • When is mixing and matching better than fully outsourcing or keeping trials fully in house?
      • Developing an outsourcing strategy as a small to medium sized biotech with limited resources
      • Why is FSP becoming a popular choice among sponsor companies and how can this support meeting trial timelines?
      • How do strategic alliances impact this decision?

      Speakers

      Joshua Cox
      Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company
      Hayley Lane
      Vice President Clinical Operations, Star Therapeutics
      Ros Cheetham
      Vice President of Clinical Operations, MacroGenics
      Thomas Tremblay
      Vice President, Head of Clinical Operations, Trefoil Therapeutics
      Jenni Herber
      Associate Director, Clinical Operations, Kamau Therapeutics

      10:30 AM

      Session reserved for Revati Tatake

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc

      11 AM

      Morning refreshments and networking

      11:45 AM

      Realizing the value of data sharing and outlining the supported initiatives to enhance data transparency

      • Recognizing and preserving patient trust: how and why should their data be shared?
      • How data sharing platforms can work for you and what are the pragmatic ways to achieving the benefits?
      • Ensuring an ROI on your data: Key financial considerations of data curation
      • Logistical and regulatory challenges hindering the progress of data sharing

      Speakers

      Bruce Morimoto
      Vice President, Drug Development, Alto Neuroscience

      12:15 PM

      PANEL DISCUSSION: Embracing innovative technologies in clinical data management: Opportunities and challenges

      • Overcoming regulatory hurdles: How are agencies responding to new technologies?
      • Ethical considerations: Ensuring patient data privacy and compliance.
      • Operational barriers: Integration with existing trial frameworks (or do we need to adapt?)
      • Future Outlook: What technologies will dominate in the next 5–10 years?

      Chair: Joshua Cox, Vice President of Clinical Data & Analytics Capabilities, Eli Lilly and Company

      Speakers

      Joshua Cox
      Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company
      Janet Moga
      Lead, DCT Operations, Astellas Gene Therapies
      Prasun Mishra
      Chief Executive Officer, Agility Pharmaceuticals
      Peter St. Wecker, Ph.D.
      Clinical Development Lead, Neurology, UCB

      1 PM

      Lunch and networking

      2 PM

      The 7 wondrous ways to immediately improve your R&D Financial Accruals process

      • Discuss why financial accruals for clinical and R&D activities are still so challenging after all these years
      • Using real-life case studies, discuss common pain-points experienced by biopharma companies when it comes to financial accruals
      • Ponder easy implementations you can consider for your accruals processes that can significantly improve efficiency and decrease pain

      Speakers

      Chris Chan
      Vice President, FP&A, IGM Biosciences

      2:30 PM

      AI transforming healthcare and life sciences: From discovery to delivery

      • Delving into the transformative impact of AI across the healthcare and life sciences ecosystem
      • Exploring how AI technologies are revolutionizing drug discovery, enhancing clinical trial efficiency, and enabling more personalized patient care.
      • Streamlining early-stage research and optimizing real-world applications in patient monitoring and therapeutic delivery
      • How AI is paving the way for faster, more precise, and impactful healthcare solutions
      • Insights into the latest AI-driven innovations and how these advancements are shaping the future of healthcare from concept to patient outcomes

      Speakers

      Prasun Mishra
      Chief Executive Officer, Agility Pharmaceuticals

      8:30 AM

      Registration and refreshments

      8:50 AM

      Chair’s opening remarks

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc

      9 AM

      KEYNOTE: Designing trials to reduce patient and site burden

      • How to create a patient-centric clinical protocol to obtain the necessary data and validate your primary objective
      • How biotechs are using tools internally and managing different stakeholders to pressure test themselves to have less complicated protocols
      • Looking at ways to ensure patients don’t go through a burdensome process
      • Championing collaborative sites for a streamlined trial

      Speakers

      Shantheri Pai
      Associate Director - Clinical Operations, Oncology, Gilead

      9:30 AM

      Beyond traditional labels: Customized outsourcing strategies for biotech and pharma

      • Prioritizing your organizational structure and goals
      • Key considerations for developing a bespoke outsourcing framework
      • Building resilient outsourcing strategies that align with future clinical development needs

      Speakers

      Neil Berger
      Vice President, FSP Commercial and Operational Strategy, Parexel

      10 AM

      Winning the “Clinical Operations Super Bowl”: Regulatory inspections from a Clinical Operations perspective

      • Showcasing and defending the clinical operations strategy and outcome for pivotal studies during Sponsor regulatory inspections as the culmination of years of intense and important work; or the “Super Bowl” of Clinical Operations
      • Sharing best practices based on real-life examples, for surviving and thriving during FDA and EMA Sponsor regulatory inspections from the Clinical Operations viewpoint
      • Collaborating with QA and other cross-functional partners for success
      • Best practices in logistics and Clin Ops teamwork in advance of, during and after the inspections
      • Common, recent findings related to Clinical Operations during inspections

      Speakers

      Abby Kennedy
      Senior Vice President of Clinical Operations, DermBiont
      Vineeta Gulati
      Former Director of Clinical Operations, CymaBay Therapeutics

      10:30 AM

      Breaking Borders: Mastering the art of global business expansion to Japan

      Japan, as do other countries, has unique characteristics that are often difficult to understand from an outsider’s perspective. These differences include not only pharmaceutical regulations and medical systems but also customs, culture, and language. Despite efforts toward global harmonization, the distinctiveness of each country, shaped over many years, still persists. This guide serves as your ultimate resource for navigating the complexities of conducting clinical trials on a global scale, including Japan.

      • Understanding key factors for conducting drug development in Japan
      • Analyzing the challenges of drug development in regions with less visible dynamics, using Japan as a case study.
      • Exploring solutions to maximize the probability of success in drug development.

      Speakers

      Katsura Kasahara
      Executive Professional, EPS Corporation

      11 AM

      Morning refreshments and networking

      11:45 AM

      Examination of the World Health Organization’s (WHO) recently released guidance on best practices for clinical trials to enhance the efficiency and credibility of clinical research

      • Looking at gathered contributions from clinical trial regulators, researchers, civic society and patient groups, pharmaceutical industry, ethicists, funders and many more
      • Exploring the key contributors to a successful clinical trial ecosystem to achieve clinical development operational excellence
      • Reinforcing global standards in the design, conduct and reporting of clinical trials

      Speakers

      Archana Sah
      Vice President, Head of Clincial Operations

      12:15 PM

      TECHNOLOGY SPOTLIGHT: Innovative Digital Opinion Leader Identification with Adnexi to Improve Trial Awareness

      • Understand the reliance of both patients and doctors alike on online resources for trial and disease awareness.
      • Learn about a new technology solution to search for digital opinion leaders sharing content online about the therapeutic area
      • Discover how to identify and track Digital Opinion Leaders across all social and online platforms
      • Plan how to engage Digital Opinion Leaders in trial awareness

      Speakers

      Sandra Shpilberg
      Co-Founder & CEO, Adnexi

      12:30 PM

      Put on your “risk management goggles” when evaluating common areas of negotiations

      • Uncover and understand stakeholder and vendor business requirements
        • Who’s bringing what to the party?
        • Quality/Speed/Price
      • Various development phases and vendor types
        • Business risks
        • Legal considerations
        • Vendor types
          • Early research/ development
          • CROs
          • Clinical sites and collaborations/HCPs
          • CMO/CDMOs
      • Escalations and governance as a safety net

      Speakers

      Gina Morton
      Former Director of Contracts and Outsourcing, Calico and Genentech

      1 PM

      Lunch and networking

      2 PM

      Clinical trials in rare disease populations: challenges and opportunities, a case study

      Clinical operations in rare disease trials have unique challenges due to small patient populations, limited understanding of the disease, and lack of established clinical endpoints. In this case study, we will explore:

      • Adaptive trials designs to adjust clinical protocols based on interim results
      • Specialized approaches to managing sponsor and site relationship
      • Decentralized trials and leveraging technology to perform remote assessments
      • Collaboration with patient communities and others

      We may also discuss approaches that we previously employed but concluded as not suitable or too premature for rare disease trials.

      Speakers

      Jenelle Lin
      Associate Director, Clinical Operations, Aditum Bio

      2:30 PM

      Closeout process of vendor strategy management beginning with a finish in mind

      • Begin with the end in mind: Termination Clause
      • Identify and access file repositories
      • Understand PII and security requirements
      • Close out projects in the storage phase
      • Secure vendor-backed documents and files
      • Reconcile finances and finalize invoices
      • Issue termination letters
      • Complete contract close-out

      Speakers

      Amy Mou
      Vendor Strategy Manager – FSP, Pfizer

      3 PM

      Afternoon refreshments, networking & prize draw in exhibition room

      3:30 PM

      Speaker Hosted Round Tables

      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 lasts for 30 minutes, delegates can select up to 2 roundtables.

      RT 1
      Careful planning and effective communication to implement tailored patient recruitment strategies
      Hosted by Bruce Morimoto, Vice President, Drug Development, Alto Neuroscience

      RT 2
      Opportunities for AI and Digital Health to improve clinical research
      Hosted by:
      Meghan McKenzie, Director of Health Equity and Clinical Research, Chief Diversity Office, Genentech Kade Shippy, Chief Diversity Office, PKade Shippyatient Inclusion and Health Equity, Genentech Audrey Funwie, Chief Diversity Office, Patient Inclusion and Health Equity, Genentech

      RT 3
      Navigating the regulation landscape and the different approaches trial stakeholders are taking to be compliant

      Hosted by Gina Morton, Former Director of Contracts and Outsourcing, Calico and Genentech

      RT4
      MEDICAL DEVICE ROUNDTABLE: Overcoming barriers to scaling: funding, regulatory hurdles, and market entry strategies for startups

      Speakers

      Bruce Morimoto
      Vice President, Drug Development, Alto Neuroscience
      Meghan McKenzie
      M.A. Patient Inclusion and Health Equity, Chief Diversity Office, Genentech
      Kade Shippy
      Chief Diversity Office, Patient Inclusion and Health Equity, Genentech
      Audrey Funwie
      Chief Diversity Office, Patient Inclusion and Health Equity, Genentech
      Gina Morton
      Former Director of Contracts and Outsourcing, Calico and Genentech

      4:30 PM

      Chair’s closing remarks and end of conference

      Speakers

      Select a speaker to learn more

      Back
      John Rootenberg
      Principal Director, Digital Safety and Decision Support, Genentech

      Session Details:

      PANEL DISCUSSION: Translating technology into tangible outcomes and what are the latest ways in which it’s disrupting the clinical trial industry

      2025-02-11, 12:00 PM

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      Thomas Tremblay
      Vice President, Head of Clinical Operations, Trefoil Therapeutics

      Session Details:

      Integrating Risk-Based Quality Monitoring (RBQM) into each phase of the trial to ensure maximum efficiency and robust data validation processes

      2025-02-12, 9:30 AM

      Session Details:

      PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

      2025-02-12, 10:00 AM

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      Bruce Morimoto
      Vice President, Drug Development, Alto Neuroscience

      Dr Morimoto has over 25 years of industry experience in leading project teams in the development of innovative medicines, providing guidance in the design and execution of preclinical, clinical and regulatory strategies with a therapeutic focus in Parkinson’s, Alzheimer’s and frontotemporal dementias.  Previously, Bruce held leadership roles at Alkahest, Celerion and Allon Therapeutics, and works closely with the Michael J Fox Foundation, chairing one of their scientific review panels.  He is an advisor to several biotech companies.

      Bruce started his career on the faculty in the Chemistry Department at Purdue University where his independent research focused on neuronal signal transduction.  Bruce earned his doctorate in biochemistry from UCLA and completed a postdoctoral fellowship at the University of California Berkeley.

      Session Details:

      CLOSING PANEL DISCUSSION: Innovative approaches to engage and retain patients in an era of recruitment struggles

      2025-02-11, 4:45 PM

      Session Details:

      Speaker Hosted Round Tables

      2025-02-12, 3:30 PM

      Session Details:

      Realizing the value of data sharing and outlining the supported initiatives to enhance data transparency

      2025-02-12, 11:45 AM

      View In Agenda
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      Shantheri Pai
      Associate Director - Clinical Operations, Oncology, Gilead

      Being able to strategically lead and oversee global complex clinical trials, coach and guide my team, collaborate with external and internal stakeholders, collaborate with the vendors, foresee risks and implement timely mitigation measures, continue to be agile to change management, ability to navigate through fluid/challenging situations, while being inclusive, respectful and empathetic, is what makes me a leader.

      Clear decision making, effective communication, tailoring to the audience, funneling the right level of information upwards and cascading the guidance downwards, identifying process gaps and building efficiency where/as needed, keeping my team motivated and fostering a positive/growth mindset and lastly being able to wear multiple hats, with the final goal to make a positive impact to the lives of patient’s globally is what makes me a Clinical Trials Leader.

      Session Details:

      KEYNOTE: Designing trials to reduce patient and site burden

      2025-02-12, 9:00 AM

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      Matthew Albert
      Head, Translational Sciences & Early Clinical Development, Octant Biosciences

      Matthew Albert is Head of Translational Sciences and Early Clinical Development at Octant Biosciences, using cellular intelligence and high throughput approaches to develop corrector therapeutics. Prior roles include: Chief Translational Officer at Human Immunology Biosciences (HI-Bio 2018-2019); and Sr Vice President of Biology and Translational Genetics at insitro, a biotechnology company committed to leveraging biomolecular data at scale for purposes of drug development (2019-2021). He was a Principal Scientist at Genentech, working in the Department of Cancer Immunology where he led a team of immunologists, geneticists, microbiome scientists and mathematicians with the aim to derive new insight from human subject studies and real world data (2015-2019). His prior academic career included INSERM director of research and full professor working at Institut Pasteur, where he headed the Director of the Department of Immunology (2010 - 2015); and was the Founding Director of The Center for Human Immunology at Institut Pasteur (2007 - 2015).

      Matthew received his M.D. at Cornell University Medical College and his Ph.D. in Immunology at The Rockefeller University. He trained in Clinical Pathology at The New York Presbyterian Hospital and was a Clinical Scholar at The Rockefeller University Hospital. His basic science and clinical research achievements include the characterization of the cellular and molecular mechanisms underlying the cross-priming of tumor and viral-specific cytolytic T lymphocytes (CTLs). He has also made impactful contributions in the fields of tumor immunity in patients with bladder cancer; and helped to define the complex role of type I IFNs in HCV disease pathogenesis.

      He has successfully launched a commercialized biomarker assay for agonist and antagonist forms of CXC10, in partnership with Myriad-RBM; and established point-of-care tests for managing patients with Hepatitis C with Epistem, Inc. Other notable achievements include coordination of multiple international projects, including the The Milieu Intérieur Project: Defining the genetic and environmental determinants of immune phenotype variance – establishing a path towards personalized medicine.

      Session Details:

      How Machine Learning (ML) and human genetics are accelerating drug discovery: Foreseeing the impact on clinical trials

      2025-02-11, 11:00 AM

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      Laura O’Donnell
      Senior Director, Head, Global Site Engagement, GSK

      Laura is a perceptive, versatile, results-oriented and proven clinical operations leader with a passion for patient and site experience, access to healthcare, and co-creating the future of clinical research. Leveraging deep experience in study delivery, people leadership and development, and data-driven insights, she believes that the cores of leadership are curiosity and service.

      Session Details:

      PANEL DISCUSSION: Battling insufficient resources to allow your trial to succeed in an increasingly competitive landscape

      2025-02-11, 12:00 PM

      View In Agenda
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      Abby Kennedy
      Senior Vice President of Clinical Operations, DermBiont

      Session Details:

      Winning the “Clinical Operations Super Bowl”: Regulatory inspections from a Clinical Operations perspective

      2025-02-12, 10:00 AM

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      Vineeta Gulati
      Former Director of Clinical Operations, CymaBay Therapeutics

      Experienced Clinical Operations and Clinical Data Management professional with over 20 yrs of Biotech/ Pharma industry, and Study Site experience. Phase I through Phase IV clinical studies experience in various therapeutic areas, e.g. infectious disease, oncology, GI, and HIV AIDS.

      Evaluated and managed CROs for both Clinical and CDM activities. Monitored and co-monitored national and international study sites (India and Thailand). Led implementation of, and worked with various software systems like DataFax, Oracle Clinical, ClinTrial, Clinical Trial Management system, and Document Management. Experienced in managing clinical trial process from inception to reporting and submission.

      Specialties: Management of CROs, study sites (US, Asia), and Clinical Data Management. Establishing Data Management Dept and implementing software systems and processes that are well integrated with Clinical, Biostat/Programming, QA/QC, and Research.

      Session Details:

      Winning the “Clinical Operations Super Bowl”: Regulatory inspections from a Clinical Operations perspective

      2025-02-12, 10:00 AM

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      Sandra Nino-Siddens
      Vice President Global Regulatory Affairs, Ultragenyx Pharmaceutical

      Global Regulatory Affairs executive with 20+ years of drug development and management experience with expertise in all stages of drug development and successful filing and registration experience.
      Therapeutic areas include oncology (hematology and solid tumors) gastroenterology, ophthalmology, HIV as well as combination products and medical devices.

      Session Details:

      CLOSING PANEL DISCUSSION: Macro perspective: Facilitating the harmonization and equivalence of working across regions

      2025-02-11, 4:45 PM

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      Jad Adaimi
      Executive Director - Global Regulatory Affairs, Ultragenyx

      Hands on experience in early, mid, and late stage product development and regulatory strategy in small and large pharma.

      Session Details:

      PANEL DISCUSSION: Is clinical trial exclusion criteria too stringent?

      2025-02-11, 12:00 PM

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      Marla Williams
      Associate R&D Strategic Outsourcing Director, Exelixis

      20 years of Clinical Development experience with an expertise in Outsourcing best practices for all study phases with an understanding of the drug development process and the cross-functional responsibilities including trial design, start-up, maintenance, and close-out
      •In-depth experience soliciting and evaluating CRO and service provider proposals, with highly successful SOW negotiations, along with growing long-term, strategic relationships with various clinical operations vendors
      •Global therapeutic experience in Neurology, Oncology, Diabetes, Cardiology, Asthma, Sleep and Pain
      •FDA and EMA inspection experience
      •Strong data analysis and clinical financial reporting capabilities including post RFP analysis, accruals, and forecasting
      •Successful management of a team
      •Clinical trial monitoring, regulatory and legal experience
      •Investigator, Advisory Board and Ad Comm Meeting coordinating experience

      Session Details:

      PANEL DISCUSSION: Is clinical trial exclusion criteria too stringent?

      2025-02-11, 12:00 PM

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      Ros Cheetham
      Vice President of Clinical Operations, MacroGenics

      Ros Cheetham is Vice President, Clinical Operations, at MacroGenics. Immediately prior to joining MacroGenics, Ms Cheetham was Senior Vice President, Clinical Solutions and Strategic Partnerships at the WIRB Copernicus Group.

      Prior to these roles, Ms Cheetham spent several years as a consultant to the Biotech industry following a varied career within the pharmaceutical industry. Those industry roles included Vice President of Global Clinical Operations at Allergan; several leadership positions at GSK, including Vice President and Medicines Development Leader in both Neurosciences and Rare Diseases, as well as other leadership positions within global clinical operations. Earlier in her career she worked for Janssen Pharmaceutica in the US, Belgium and South Africa and had a pivotal role in the global development and registration of the novel antipsychotic, risperidone (Risperdal®).

      Throughout her career, Ms Cheetham has taken a keen interest in how to improve trial outcomes and success including enhancing diversity in clinical trials. She has advised Biotech companies on their DEI strategies and has successfully led the creation of FDA Diversity plans.

      Ms Cheetham obtained her undergraduate degree at Imperial College, London and her Master’s degree at the University of the Witwatersrand, Johannesburg.

      Session Details:

      Patient Engagement starts with the Informed Consent Form

      2025-02-11, 2:15 PM

      Session Details:

      CLOSING PANEL DISCUSSION: Innovative approaches to engage and retain patients in an era of recruitment struggles

      2025-02-11, 4:45 PM

      Session Details:

      PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

      2025-02-12, 10:00 AM

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      Sage Callaway
      Associate Director, Clinical Business Operations, Oncology, Ascendis Pharma

      Experienced Professional with a demonstrated history of working in the biotechnology industry. Skilled in Medical Devices, Biotechnology, Management, Cell Culture, and U.S. Food and Drug Administration (FDA). Strong healthcare services professional with a Masters of Science focused in Biological Science with an emphasis in Therapeutic Science and Pharmaceutical Business from Dominican University of California.

      Session Details:

      PANEL DISCUSSION: Battling insufficient resources to allow your trial to succeed in an increasingly competitive landscape

      2025-02-11, 12:00 PM

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      Gina Morton
      Former Director of Contracts and Outsourcing, Calico and Genentech

      Passionate about leadership and talent development, optimization and innovation in healthcare.

      Session Details:

      Put on your “risk management goggles” when evaluating common areas of negotiations

      2025-02-12, 12:30 PM

      Session Details:

      Speaker Hosted Round Tables

      2025-02-12, 3:30 PM

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      Yuyi Shen
      Vice President, Technical Operations, Abcuro

      Experienced and self-motivated process development scientist and team leader with specialty in process improvement, scale up, technical transfer to bioprocess manufacturing in cGMP environment. Strong subject matter experts in design robust processes for protein purification with monoclonal antibody, antigen and VLP etc, ensuring Critical Quality Attributes are achieved.

      Solid trouble shooting and problem solving skills and encouraging innovation technology to achieve high efficiency and avoid repetitive work.

      Strong proven track of define, design, manage and deliver projects upon all milestones, goals and cost target.

      Build, develop, train and supervise team members and engage and motivate members to ensure the overall success and growth.

      Session Details:

      CLOSING PANEL DISCUSSION: How sustainable drug development will empower and optimize the way clinical trials are planned to improve productivity and minimize costs

      2025-02-11, 4:45 PM

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      Christine Van Raesfeld
      Patient Advocate

      Session Details:

      Ethical requirements and rights for patient disclosure and consent when implementing AI tools

      2025-02-11, 11:00 AM

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      Jenelle Lin
      Associate Director, Clinical Operations, Aditum Bio

      Jenelle Lin is the Associate Director, Clinical Operations at Aditum Bio. Jenelle has extensive experience in operations oversight and program management, having previously led the first pivotal program in rare disease Transthyretin Cardiomyopathy at Eidos Therapeutics, a BridgeBio company, from early stage to NDA filing. Jenelle contributed to global programs in hematology and oncology at FibroGen and supervised multiple trials at the University of California San Francisco. Jenelle has academic research experience in oncology, ophthalmology, morbidity and human papillomavirus (HPV). Additionally, Jenelle currently advises biotechnology startups through California Life Sciences. Jenelle holds a MSc in Epidemiology and Public Health from the University of Miami School of Medicine and is currently pursuing an executive program at Stanford University Graduate School of Business.

      Session Details:

      Clinical trials in rare disease populations: challenges and opportunities, a case study

      2025-02-12, 2:00 PM

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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:

      Patient perspective: My clinical trial journey

      2025-02-11, 3:15 PM

      Session Details:

      PANEL DISCUSSION: Is clinical trial exclusion criteria too stringent?

      2025-02-11, 12:00 PM

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      Leesa Gentry
      Chief Clinical Officer, RenovoRx

      Clinical development executive with 29 years of experience of increasing responsibility.
      Key achievements include:

      1. Drove development and successful launch of NCE product for the treatment of MDR-TB
        2. Procured over 35 million in non-dilutive funding for development of a suite of products to treat multiple infectious disease indications.
        3. Served as Steering Committee Member and clinical representative for PAN-TB consortium (including Evotec, Janssen, GSK, Otsuka, GMRI, and BMGF)
        4. Drove strategic planning for IND-enabling and clinical-stage programs for small biotech clients and for the development of internal assets.
        5. Expanded company revenue streams to include a clinical services solution and achieved profitability within 12 months.
        6. Collaborated with the C-suite team in developing short-term and long-term goals and strategies to increase clinical revenue.
        7. Drove development of multiple cross-functional strategic development plans and built pathways to licensure.
        8. Increased monthly enrollment rate by 85% from H1 2023 to H2 2023 in a pivotal phase 3 trial for first-line treatment of pancreatic cancer.
        Strengths include communication, analytical thinking, leadership, negotiation, and problem solving.

      Session Details:

      KEYNOTE: How to optimize efficiencies at clinical trial sites when they’re underperforming

      2025-02-11, 8:30 AM

      Session Details:

      CLOSING PANEL DISCUSSION: Macro perspective: Facilitating the harmonization and equivalence of working across regions

      2025-02-11, 4:45 PM

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

      Meghan McKenzie is a Director of Health Equity and Clinical Research in Genentech’s Chief Diversity Office. She develops strategies to drive greater inclusion of underrepresented patient populations in clinical research and to advance health equity by working directly with sites in our Advancing Inclusive Research (AIR) Site Alliance and by gaining patient insights to change behavior and protocols.

      Gaining patient, clinician and community insights early in program development is integral to developing what is important to patients and improving access to medicines and treatments for all patients, regardless of race, ethnicity, sexual orientation, gender identity, age, disability and socioeconomic status.

      She has over 25 years of clinical development research experience working at the site, CRO and biotech level, and spanning multiple diseases, including oncology, ophthalmology, immunology, neurology, infectious and rare diseases.   

      Meghan received her Master’s Degree in Human Biology at San Francisco State University and her Bachelor’s Degree in Economics at University of North Carolina, Chapel Hill and has earned the Cornell University ‘Advanced D&I Certificate’ and the Columbia Business School ‘Certificate in Business Excellence.’ 

      Session Details:

      PANEL DISCUSSION: Is clinical trial exclusion criteria too stringent?

      2025-02-11, 12:00 PM

      Session Details:

      Speaker Hosted Round Tables

      2025-02-12, 3:30 PM

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      Meir Pinco
      Associate Director, IT Data & Analytics, BeiGene

      Driven by a passion for transformative innovation, I leverage my deep expertise in data science, informatics, and data management to pioneer solutions in the biotechnology and pharmaceutical sectors. With a robust background in system and data analytics, I excel in orchestrating change to address complex scientific and clinical challenges.

      Holding a Ph.D. in neuroscience complemented by extensive training in clinical research, epidemiology, and data science, I am at the forefront of integrating cutting-edge technologies into practical applications. My journey has led me to spearhead projects harnessing the power of Large Language Models and AI agents, specifically tailored to enhance clinical outcomes and drug safety.

      As a seasoned data technologist and research scientist, my proficiency encompasses the full software development lifecycle, project management, and the creation of dynamic databases and informatics systems. I thrive on cultivating internal and external partnerships, leading multidisciplinary teams distributed across geographies.

      My current endeavors focus on deploying AI-driven platforms that refine clinical systems and data management projects. I am committed to advancing the capabilities of AI to improve decision-making processes, reduce risks, and ultimately elevate patient care and safety in the medical field.

      Session Details:

      PANEL DISCUSSION: Translating technology into tangible outcomes and what are the latest ways in which it’s disrupting the clinical trial industry

      2025-02-11, 12:00 PM

      Session Details:

      KEYNOTE: Automating manual processes to improve decision-making and patient care

      2025-02-12, 9:00 AM

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      Susan Edelstein, PhD
      SVP, Clinical Research, Ardelyx

      Session Details:

      Optimizing clinical trials: Sponsor/CRO cooperation; working together to enroll appropriate patients

      2025-02-11, 9:30 AM

      Session Details:

      Chair’s opening remarks

      2025-02-11, 8:20 AM

      Session Details:

      PANEL DISCUSSION: Battling insufficient resources to allow your trial to succeed in an increasingly competitive landscape

      2025-02-11, 12:00 PM

      Session Details:

      CLOSING PANEL DISCUSSION: Innovative approaches to engage and retain patients in an era of recruitment struggles

      2025-02-11, 4:45 PM

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      Jenni Herber
      Associate Director, Clinical Operations, Kamau Therapeutics

      Session Details:

      Session reserved for Jenni Herber

      2025-02-11, 2:15 PM

      Session Details:

      PANEL DISCUSSION: Battling insufficient resources to allow your trial to succeed in an increasingly competitive landscape

      2025-02-11, 12:00 PM

      Session Details:

      PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

      2025-02-12, 10:00 AM

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      Anthony L Colenburg Sr
      Senior Director & Site Head of Quality, Sutro Biopharma

      Dedicated Quality Assurance Leader who excels at phase-appropriate development/redevelopment, management and strengthening of an organization's Quality Culture to ensure a constant state of Inspection Preparedness & Readiness by:

      - establishing/re-aligning a current state feedback loop which utilizes close to real-time data, Quality metrics & Key Performance Indicators (KPI's);

      - creating robust assessment and evaluation programs that builds sensitivity, accountability, transparency and awareness collaboratively to constantly reduce Cost of Quality;

      - developing a strategic approach of continuous improvement to a Company's Quality Management System Elements which remain in a state of control.

      Session Details:

      Cross-functional team collaboration and alignment in meeting ‘on time’ clinical supply needs

      2025-02-11, 2:15 PM

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      Chitrang Dave
      Global Head of Enterprise Data & Analytics, Edwards Lifesciences

      Session Details:

      Innovating with data in life sciences

      2025-02-12, 9:00 AM

      Session Details:

      PANEL DISCUSSION Key considerations for evaluating clinical vendors in effective study execution

      2025-02-12, 12:15 PM

      Session Details:

      Chair’s opening remarks

      2025-02-12, 8:50 AM

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      Lian Cunningham
      Vice President Of Clinical Affairs, Endogenex

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

      Session Details:

      Building a robust medical device clinical development program: best practices and insights

      2025-02-12, 9:30 AM

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      Amy Mou
      Vendor Strategy Manager – FSP, Pfizer

      Session Details:

      Closeout process of vendor strategy management beginning with a finish in mind

      2025-02-12, 2:30 PM

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      Kathryn Wine
      Vice President Clinical Affairs, Novocuff

      Vice President of Clinical Operations: Reporting to the COO and 4th employee of the company, built a clinical operations team and led re-design, enrollment and completion of the pivotal (IDE) trial of the Jada System for abnormal postpartum uterine bleeding and hemorrhage. Strategic leadership for all U.S. and O.U.S. clinical operations. In this role Kathryn has;
      • Led 15-center US pre-market pivotal IDE study, enrolling the maximum of 107 subjects in a challenging recruitment setting. Developed site relationships, negotiated favorable study contracts and budgets with each site, led training program that certified over 700 site team members as investigators and research staff, drove enrollment programs that approached >16,000 patients and secured informed consent from >7,000 in under 15 months.
      • Built clinical study team from 0 to maximum of 6 team members including the roles of Director, Prof Ed Manager, In-house, Field-based and Contract CRAs and Clinical Coordinator. Recruited key talent to executive and adjacent teams.
      • Designed and executed “Continued Access” program to ensure extended data collection after close of pivotal study, including successful FDA approval of IDE.
      • Presented Clinical Operations updates to quarterly BOD Meetings and investor presentations.
      • Developed relationships and key interactions with OB/GYN and Maternal Fetal Medicine specialist KOLs for understanding and advancement of the Jada System.

      Session Details:

      Strengthening partnerships and processes for clinical trial excellence in medical devices

      2025-02-12, 2:00 PM

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      Tania Pearson
      Regulatory Systems Director, Medtronic

      Tania Pearson is a Regulatory Systems Director for Medtronic responsible for the global UDI strategy and implementation and Lifecycle Management and Distribution solutions for Medtronic, Inc. She has been working in the medical device sector for 13 years. Prior to joining Medtronic, she worked in R&D for Pfizer for 12 years. She has a BS in Chemistry from the University of Illinois at Urbana-Champaign and a MS in Regulatory Affairs from San Diego State University.

      Tania is currently serving a two-year term with the GS1 Healthcare Executive Leadership Committee and is the MedTech Europe UDI Working Group Chair and DITTA UDI WG Chair. She is engaged in many other external industry groups including the GS1 Healthcare Global Public Policy group, Global Harmonization Working Party (GHWP) WG9, Australian UDI Technical Working Group and the MedTech EUDAMED Working Group.

      Session Details:

      Global UDI Compliance: strategies for navigating unique device identification standards worldwide

      2025-02-12, 11:45 AM

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      Kade Shippy
      Chief Diversity Office, Patient Inclusion and Health Equity, Genentech

      Kade Shippy works within Genentech's Chief Diversity Office on the Patient Inclusion and Health Team as part of a year-long internship. Prior to joining Genentech, Kade received a Bachelor of Science in Healthcare Economics from the Wharton School of the University of Pennsylvania. In Kade’s current role, she partners on advancing inclusive research and health equity projects. This includes evaluating educational materials for potential use in patient and HCP audiences based on metrics of cultural representation and reading levels. Kade aims to harness her background in healthcare economics and outcomes research to promote value-based care, equitable access to clinical studies, and innovative outreach in areas of high unmet need.

      Session Details:

      Speaker Hosted Round Tables

      2025-02-12, 3:30 PM

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

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

      Session Details:

      Speaker Hosted Round Tables

      2025-02-12, 3:30 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.

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      Steve Rosenberg
      Chief Executive Officer, uMotif

      Steve’s career in life science and healthcare spans more than 40 years. He has led the development and deployment of cloud-based solutions with a focus on driving more integrated approaches to patient-centric trial management. Today, he continues to leverage this deep experience to drive uMotif’s hypergrowth.

      Steve was most recently Senior Vice President and General Manager of Oracle Health Sciences. Before that, Steve was at the forefront of advancing the adoption of electronic data capture and was the visionary behind the integrated clinical technology suite introduced by Phase Forward which was acquired by Oracle in 2010.

      Steve has been named twice to the prestigious PharmaVoice 100 list. He recently served on the Board of Anju Software and currently sits on Prix Galien’s Digital Media and USA Digital Health Advisory boards. He also served a six-year term on CDISC’s Board.

      Session Details:

      Start expecting more from eCOA/ePRO

      2025-02-11, 4:15 PM

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      Bao Dinh
      Global Development Business Operation, Takeda

      Session Details:

      FIRESIDE CHAT: Successful strategies on CRO FSP management, scaling teams, and bridging low-cost offshore footprint while maintaining quality and efficiency

      2025-02-11, 3:15 PM

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      Janet Moga
      Lead, DCT Operations, Astellas Gene Therapies

      With over 25 years of experience in the healthcare industry, I am a passionate and driven digital health leader who strives to improve the patient experience, access and outcomes through innovative and collaborative technical solutions.

      My core competencies include digital health, innovation, cross-functional collaboration, clinical development, remote patient monitoring, data collection, RWE studies, strategic partnerships, DCT platforms, product management, and agile methodology. In my previous roles, I have successfully co-created and launched digital health initiatives with key stakeholders, led teams through medical activity and launch planning, and acted as a product manager and business lead for a decentralized clinical trial platform with a wearable for remote patient monitoring. I am motivated by the opportunity to leverage digital health technology to enhance patient care and outcomes.

      Session Details:

      PANEL DISCUSSION: Embracing innovative technologies in clinical data management: Opportunities and challenges

      2025-02-12, 12:15 PM

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      Cathy Scharf
      Patient Advocate, Patient Advocates of the East Bay

      Session Details:

      PANEL DISCUSSION: Is clinical trial exclusion criteria too stringent?

      2025-02-11, 12:00 PM

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      Sandra Shpilberg
      Co-Founder & CEO, Adnexi

      Sandra Shpilberg is the CEO & Co-founder of Adnexi, a software platform that helps biopharma identify the best trial sites (Site Intelligence), Key Opinion Leaders (KOL) and Digital Opinion Leaders (DOL) who can accelerate treatment development. Adnexi provides rapid, accurate, tech-enabled, customized, complete and continuously updating identification of trial sites, searching for prior experience that's relevant to your trials. Prior to Adnexi, Sandra was the CEO & Founder of Seeker Health, a successful patient finding platform that was acquired by Eversana. Prior to being an entrepreneur, Sandra held executive roles at biopharma companies including BioMarin and Johnson & Johnson.

      Session Details:

      TECHNOLOGY SPOTLIGHT: Innovative Digital Opinion Leader Identification with Adnexi to Improve Trial Awareness

      2025-02-12, 12:15 PM

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      Avnika Agarwal
      Senior Director, Project Delivery, Biotech, ICON

      Avnika Agarwal has 20+ years of experience in clinical research with proven track record of success in project management deliverables. She has demonstrated strong program leadership through all phases of drug development in a global context. Avnika focuses on problem solving and planning skills related to study design and cross-functional interactions in development areas.

      Session Details:

      PANEL DISCUSSION: Battling insufficient resources to allow your trial to succeed in an increasingly competitive landscape

      2025-02-11, 12:00 PM

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      Marija Jovanovic, MD
      Director, Project Delivery, ICON Biotech, ICON
      • Marija Jovanovic, Director of Project Delivery for ICON Biotech
      • Medical Doctor degree and 16 years of progressive experience in global Phase I-4 clinical trials. Comprehensive experience in designing and executing clinical trials in neuroscience,  immunology, dermatology, rare diseases and gene therapy. Particularly skilled in managing complex CNS trials and navigating the unique challenges of rare disease and gene therapy studies.
      • Strategic and pragmatic leader, skilled at identifying client needs, crafting tailored solutions, leverages comprehensive understanding of ICH-GCP standards and regulations to deliver high-value solutions across the full spectrum of clinical development.
      • Combines deep therapeutic knowledge to drive successful trial outcomes and client satisfaction. Proven track record of building and nurturing client relationships and vendor partnerships, resulting in increased operational efficiency and repeat business.

      Session Details:

      Maximizing the consultative partnership between CRO and pharma/biotech partners

      2025-02-11, 10:00 AM

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      Kenneth Park, MD
      Kenneth Park, MD, VP, R&D Strategy and Productivity, Consulting, Fortrea

      Session Details:

      Maximizing asset valuation for biopharma

      2025-02-11, 2:45 PM

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      Zahiah (Zee Zee) Gueddar
      Senior Director, Commercial Lead, Financial Strategy & Corporate Development, IQVIA Technologies

      Zahiah (Zee Zee) Gueddar leverages over 17 years of diverse industry expertise encompassing delivery, finance, operational effectiveness, and the commercial sector. Zee Zee offers invaluable insight into the challenges encountered by sponsors, CRO’s, sites and patients. In her role leading IQVIA’s Financial Technology offerings, she serves as an innovative partner for clients seeking transformative outcomes and growth opportunities. Known as a strategic thinker and problem solver, Zee Zee is responsible for driving growth and differentiation, product go-to market & ensuring innovative and competitive offerings. Zee Zee is based in Southern California and is a graduate of San Diego State University.

      Session Details:

      End-to-End financial management: Challenges and opportunities

      2025-02-11, 11:30 AM

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      Joshua Cox
      Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company

      Joshua Cox has been honing his data management expertise in the drug development industry for nearly 20 years.  After breaking into the industry and gaining exposure to diverse therapeutic areas and development approaches with a CRO, Joshua has focused the last 15-years in sponsor driven early phase oncology.  He has enjoyed opportunities with bio-tech start-ups as well as established big pharma companies, each engagement adding valuable knowledge and experience to his skillset.  Joshua has led the development of data management departments by conceiving and implementing fit for purpose and results-driven technologies and processes always with an eye toward innovation and efficiency.  Now pursuing leadership opportunities outside the confines of traditional data management, Joshua is eager and excited to be a part of teams pursuing novel solutions to known challenges as well as employing cutting edge strategies and technologies to elevate the already high standards we expect and ultimately get the best medicines to the patients in need.

      Session Details:

      CLOSING PANEL DISCUSSION: How sustainable drug development will empower and optimize the way clinical trials are planned to improve productivity and minimize costs

      2025-02-11, 4:45 PM

      Session Details:

      PANEL DISCUSSION: Translating technology into tangible outcomes and what are the latest ways in which it’s disrupting the clinical trial industry

      2025-02-11, 12:00 PM

      Session Details:

      PANEL DISCUSSION: Embracing innovative technologies in clinical data management: Opportunities and challenges

      2025-02-12, 12:15 PM

      Session Details:

      PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

      2025-02-12, 10:00 AM

      Session Details:

      Chair’s opening remarks

      2025-02-12, 8:50 AM

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      Catherine Jervis
      General Manager Integrated Solutions, MRN

      Catherine has 27 years’ experience of working in a global environment across the pharmaceutical and CRO industry. Through her experience she's gained deep knowledge and expertise across research, clinical development, decentralized and community-based trial operations as well as outsourcing and external alliance management. Catherine is an accomplished leader, passionate about leveraging new ways to bring trials and medicines to patients.

      Session Details:

      The benefits of building trials, focused on patients, delivered in their own community

      2025-02-11, 12:45 PM

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      Neil Berger
      Vice President, FSP Commercial and Operational Strategy, Parexel

      As Vice President, FSP Commercial and Operational Strategy, Neil Berger is an operational and commercial strategist for clinical development outsourcing solutions at Parexel. Bringing 20 years of commercial and research operations experience, he is a recognized expert in holistic and cross-functional approaches to talent development – integrating acquisition, development and retention to meet long-term portfolio needs for biopharmaceutical sponsors.

      Prior to joining Parexel in 2015 as a commercial account leader, Neil held a range of positions of increasing responsibility in project management and client services for Pharma Medica Research, a contract research organization based in Canada.

      Neil earned a master of business administration degree from Schulich School of Business, and holds a master’s and bachelor’s degree in science from McGill University.

      Session Details:

      Beyond traditional labels: Customized outsourcing strategies for biotech and pharma

      2025-02-12, 9:30 AM

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      Sarah Cross, PhD
      Vice President and Global Head of Medical Affairs, Premier Research

      Dr. Sarah Cross is the Vice President and Global Head of Medical Affairs at Premier Research. Dr. Cross received her PhD from UCLA and has previously served in leadership roles in medical affairs and clinical development at CRO, biotech/medtech, and pharmaceutical organizations.

      She is responsible for oversight of medical strategy and execution for all phase of clinical trials, and is the external engagement lead responsible for partnerships with patient advocacy groups and professional societies implementing initiatives designed to remove patient barriers, improve diversity and inclusion in medical research, and elevate awareness of clinical trials.

      Session Details:

      Patient advocacy groups: Bridging clinical trials and patient communities for meaningful DEI impact

      2025-02-11, 2:45 PM

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      Tatiana Eidus
      Director Corporate Development North America, ARENSIA Exploratory Medicine

      Tatiana Eidus received her Master’s Degree in Biophysics from Moscow State University. Entering the industry more than a decade ago, Tatiana has accumulated wide expertise in all the operational aspects of initiating and managing Phase I-III trials across Europe and US. Prior to joining ARENSIA Exploratory Medicine, Tatiana worked for GSK and Merck. Primarily focused on early-stage exploratory programs, she conducted trials in various disease areas. In her current role as Director Corporate Development, Tatiana supports ARENSIA’s partners in the US, supervising cross-functional coordination throughout study planning, start-up and execution.

      Session Details:

      Why so slow? Insider insights from the clinic floor to speed up the conduct of proof-of-concept patient trials

      2025-02-11, 9:00 AM

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      Bogdan Sandica
      Senior Manager Trial Optimization, ARENSIA Exploratory Medicine

      Bogdan Sandica, a seasoned professional with over 10 years of experience in clinical research, specializing in early-phase studies. As a Senior Trial Optimization Manager at ARENSIA Exploratory Medicine, Bogdan collaborates closely with Sponsors, CROs, and multidisciplinary teams to ensure regulatory compliance and the delivery of high-quality data outcomes.

      Session Details:

      CLOSING PANEL DISCUSSION: Macro perspective: Facilitating the harmonization and equivalence of working across regions

      2025-02-11, 4:45 PM

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      Dr. Peter Schmidt, PhD
      Chief Scientific Officer, Rho

      Dr. Peter Schmidt is a neuroscientist with a wealth of experience in biomedical research. He's been an inventor, principal investigator, and mathematician with experience in neurology, psychiatry, and immunology. Before joining Rho, he was the Vice Dean at East Carolina University’s Brody School of Medicine, where he oversaw research and clinical care. During his time at the Parkinson’s Foundation, Dr. Schmidt designed and led the largest clinical study of Parkinson’s disease, enrolling 12,000 patients across 30 academic medical centers in five countries. He has served in advisory and board roles for national and international organizations in clinical care, research, and patient advocacy including the National Quality Forum, the Cystic Fibrosis Foundation, and the Huntington’s Study Group. He holds two patents and has authored many peer-reviewed journal articles.

      Session Details:

      From endpoints to impact: Designing trials that resonate with patients

      2025-02-11, 4:15 PM

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      Dr. Andrew Feigin, MD
      Chief Medical Officer, Rho

      Dr. Andrew Feigin is a neurologist with over 30 years of experience. Throughout his career, he's made groundbreaking contributions to neurology and clinical research. After a fellowship in experimental therapeutics, Dr. Feigin joined North Shore University Hospital as an assistant professor of neurology. There, he set up a clinical trial program for Parkinson’s, Huntington’s, Tourette syndrome, dystonia and other movement disorders. Subsequently, Dr. Feigin joined the NYU Grossman School of Medicine as Professor of Neurology where he directed the Fresco Institute for Parkinson’s and Movement Disorders. He's been the site principal investigator for over 30 clinical trials, and a global PI for several multicenter clinical trials including the first phase 1 gene therapy trial for Parkinson's and several large multicenter trials for Huntington’s disease. Dr. Feigin has pursued independent research developing imaging biomarkers for neurodegenerative disorders, and he has published over 150 peer-reviewed articles. He's a member of prestigious organizations including the American Academy of Neurology, the American Neurological Association, and the Movement Disorder Society, and he has served on numerous advisory boards, steering committees, DSMB’s, and NIH and foundation review committees.

      Session Details:

      From endpoints to impact: Designing trials that resonate with patients

      2025-02-11, 4:15 PM

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      Chris Chan
      Vice President, FP&A, IGM Biosciences

      Session Details:

      The 7 wondrous ways to immediately improve your R&D Financial Accruals process

      2025-02-12, 2:00 PM

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      Jon Raven
      Chief Commercial Officer, Emsere

      Jon is a seasoned professional with over 20 years of experience and has demonstrated expertise in helping Pharma, Biotech and CROs solve complex and challenging development issues; ensuring clinical studies remain on their critical path to success.

      Throughout his tenured career, Jon has held pivotal roles at Pfizer and Avantor where he has made significant contributions to the development and launch of life saving and life changing medicines and he now brings that expertise to Emsere. As a speaker, Jon engages audiences with insightful discussions, drawing from his extensive experience and unique perspectives.

      Session Details:

      What do you mean you need equipment? Demystifying the complexities of the equipment supply chain

      2025-02-11, 4:15 PM

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      Bryan Dunlap
      Business Develop Manager, North America, Emsere

      Bryan brings over nine years of experience in clinical trial support, having held diverse roles at Emsere in logistics, equipment preparation and testing, project management, and business development. His multifaceted career has provided him with a comprehensive understanding of the clinical trial landscape, including the numerous factors and touchpoints that can influence trial success. Bryan’s cross-departmental expertise enables him to identify potential challenges, anticipate real-world implications of decisions, and provide actionable insights to ensure smoother trial operations.

      Session Details:

      What do you mean you need equipment? Demystifying the complexities of the equipment supply chain

      2025-02-11, 4:15 PM

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      Katsura Kasahara
      Executive Professional, EPS Corporation

      Katsura Kasahara is currently serving as an Executive Professional in the Global Business Development Division at EPS Corporation since 2021. In this role, Katsu strengthens the bridge between Japan and  international pharmaceutical development projects. This role leverages over 30 years of experience in pharmaceutical development and licensing within the industry.

      Katsu's extensive career spans numerous countries and regions, working with both Japanese pharmaceutical companies, Ono Pharmaceutical and Shionogi, as well as global mega-pharma, Eli Lilly. From the Japan base, Katsu managed pharmaceutical development not only in Japan but also in East Asia and Singapore. Additionally, Katsu has spent approximately 15 years stationed in the UK and the US, leading European expansion from the UK and overseeing US operations, including successful FDA approvals.

      Katsu's knowledge and experience in pharmaceutical development and business are underpinned by a strong foundation in medicinal chemistry. Katsu holds a Master's degree in Pharmacy and is a licensed pharmacist.

      Session Details:

      Breaking Borders: Mastering the art of global business expansion to Japan

      2025-02-12, 10:30 AM

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      Rozanno Gonzales
      Clinical Innovation & Technology Leader, Genentech

      Session Details:

      PANEL DISCUSSION Key considerations for evaluating clinical vendors in effective study execution

      2025-02-12, 12:15 PM

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      Prasun Mishra
      Co-Founder, Precision BioPharma
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      Katie Bessette
      Director of Regulatory Affairs, Abbott Laboratories

      Dr. Katie Bessette has 22 years of medical device research and development experience leading global regulatory strategies and submissions.  Dr. Bessette received her PhD from UCLA and has previously served in leadership roles in Regulatory Affairs at both Fortune 500 and Start-Up Companies.  She is responsible for oversight of regulatory strategies, regulatory operations, and compliance for new product and on market product development, including the regulation of clinical research studies.

      Session Details:

      Recent FDA guidance on clinical research topics and what it means to you

      2025-02-12, 10:30 AM

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      Hayley Lane
      Vice President Clinical Operations, Star Therapeutics

      Ms. Lane has over 25 years of experience in the Pharma/Biotech industry in clinical operations and project management. She is currently the VP of Clinical Operations at Star Therapeutics and has held leadership positions at Genentech, Avalanche, Geron, Pfizer and Sanofi. Her extensive experience in Clinical Operations includes operational execution of phase II-IV trials across multiple therapeutic areas, as well as IND,BLA, CTA filings. She has vast experience in CRO/vendor management, program and clinical site management and monitoring as well as patient recruitment.

      Session Details:

      PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

      2025-02-12, 10:00 AM

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      Debbie Donovan
      Head of Commercial Operations, Materna Medical

      Debbie Donovan is a seasoned commercial leader in the medical device industry. She is known for developing revenue-generating programs and operationalizing effective strategies. She excels in leading teams in market access, clinical marketing, communications, and sales to clinicians, consumers, and payers.

      Currently, Debbie is the Head of Commercial Operations at Materna Medical, overseeing marketing, sales, business development, and reimbursement. Previously, she was the Director of Marketing Operations at Cala Health, where she launched a bioelectrical wearable therapy for chronic conditions. At EndoGastric Solutions, she established a robust digital marketing foundation for the TIF procedure for reflux. Her experience also includes roles at Intuitive Surgical, Avantis, Conceptus, Kyphon, and Somnus, serving various medical specialties.

      Debbie holds a BA in public relations journalism from the University of Southern California. She co-chairs the Boardroom Journey Committee for MedtechWOMEN and is the VP of Administration and Finance for the San Francisco Bay Area Chapter of the International Association of Business Communicators. Additionally, she presents and co-chairs medical device marketing conferences and has been a guest lecturer at UC Extension courses.

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      Laurin Vincent
      Executive Director, Vendor Quality Management, Gilead

      We simply can’t make amazing discoveries and address patient's needs alone. We need to work together: collaborate, being agile, bring in partners, innovate and co-create. Delving in and solving problems, coaching, ensuring quality, optimizing our relationships and bringing the bold and authentic voice to the table is what I do best. I create vibrant and motivated teams enabling meaningful organizational transformation while building strategic relationships.

      In my extensive clinical experience, I have built and transformed functions, simplified clinical processes and systems, lead quality programs, managed complex supplier partnerships, negotiated high profile contracts and implemented fit for purpose global governance frameworks. I’ve managed various projects around clinical technologies with an eye to quality, CRO/supplier optimization and supplier oversight. I’ve led global teams that were highly productive, engaged and impactful in achieving the organization’s goals.

      I care deeply for making work meaningful and fun for my colleagues, teams, partners and the organization. I do this through collaborating, being agile, simplifying, creating a sense of community and bringing forth bold ideas.

      Session Details:

      Ensuring that vendor oversight is embedded from end-to-end

      2025-02-11, 11:00 AM

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      Sarah Hamirani
      Portfolio Director, AbbVie

      Accomplished leader with 20+ yrs. of clinical trial experience in oncology, respiratory, and metabolic diseases. Industry expert, consistently delivering programs with high integrity. Adept at influencing stakeholders. Spearheads innovation. Passionate about transforming patient and caregiver experience in clinical trials.A Diversity, Equity and Belonging champion- founder of inclusive research group in Phase I oncology trials at AbbVie and creator of affinity groups within the community.
      A suitcase-loathing adventurer. A Tiny Human’s Personal Assistant.

      Session Details:

      CLOSING PANEL DISCUSSION: How sustainable drug development will empower and optimize the way clinical trials are planned to improve productivity and minimize costs

      2025-02-11, 4:45 PM

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      Jasmina Jankicevic
      Clinical Development and Medical Affairs, RAPT Therapeutics

      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:

      CLOSING PANEL DISCUSSION: How sustainable drug development will empower and optimize the way clinical trials are planned to improve productivity and minimize costs

      2025-02-11, 4:45 PM

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      Amy Que-Xu
      Health Technology - Clinical Research, Meta

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

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      David Larwood
      CEO, Valley Fever Solutions

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

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

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

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

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

      Session Details:

      FIRESIDE CHAT: Successful strategies on CRO FSP management, scaling teams, and bridging low-cost offshore footprint while maintaining quality and efficiency

      2025-02-11, 3:15 PM

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      Charles Aunger
      Managing Director, Health2047

      Session Details:

      Q&A SESSION: What do venture capitalists look for in startups? Unveiling the main criteria for investment

      2025-02-12, 10:00 AM

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      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc

      Revati Tatake, PhD, is the Global Head of Pharma Research, Analysis and Competitive Intelligence at GlobalData Healthcare.  Revati has over 25 years of multidisciplinary experience in academic research and the healthcare industry, both on the client and agency sides of the business. Previously she worked as a VP of Databases and Analytics at GlobalData, where she made significant contributions to Pharma Intelligence Center. Before joining GlobalData, Revati worked at Citeline/Informa, where she was involved in competitive intelligence and analytics of clinical trials and drugs in the areas of Autoimmune/Inflammation, Central Nervous System, and Ophthalmology.  Earlier, Revati worked at Boehringer Ingelheim Pharmaceuticals for over 12 years as Senior Scientist to Senior Principal Scientist, where she led drug discovery projects involving traditional high-throughput screening, as well as innovative approaches for gene and cell therapies. She also worked at Boehringer Ingelheim as a Director of Competitive Intelligence for projects in cardiometabolic space and research beyond borders. She is a co-inventor on many issued US patents related cell and gene therapies and has several publications in peer reviewed scientific journals. Revati holds a PhD in Tumor Immunology from the Tata Cancer Research Institute in Mumbai, India. She did her postdoctoral fellowship at the University of Connecticut Health Center and Boehringer Ingelheim.

       

      Session Details:

      CLOSING PANEL DISCUSSION: Macro perspective: Facilitating the harmonization and equivalence of working across regions

      2025-02-11, 4:45 PM

      Session Details:

      Session reserved for Revati Tatake

      2025-02-12, 10:30 AM

      Session Details:

      Chair’s opening remarks

      2025-02-12, 8:50 AM

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      Eleanor Miller
      Clinical Trial Liaison, PSI CRO

      Eleanor Miller, Clinical Trial Liaison, is an oncology certified nurse with 17 years of oncology nursing experience at academic medical centers, including both inpatient and outpatient care, most recently leading an oncology nurse navigation program. Much of her career has been in direct collaboration with investigators and research teams to improve patient access to trials through increased awareness, patient education, and coordination of care.

       

      At PSI, she uses this operational and clinical expertise to develop site specific recruitment strategies, tailored study tools and training. She can anticipate barriers to enrollment and resolve site needs with the project team. Eleanor is a strong collaborator and strategic thinker by identifying patterns, and bridging gaps between sites, clinical operations, project management, and sponsors.

      Session Details:

      Driving success: Strategies for optimal site support

      2025-02-11, 2:45 PM

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      Lona Sheeran
      Senior Vice President, Clinical Operations Early Phase, Worldwide Clinical Trials

      Lona Sheeran brings more than two decades of operational and financial excellence to her role as Senior Vice President, Clinical Operations Early Phase, at Worldwide Clinical Trials. Lona applies her deep analytical skills honed through years of risk and benefit oversight and experience with Lean Six Sigma techniques to ensure the company’s clinical pharmacology unit in San Antonio, Texas, continues to exceed customer expectations.

      Session Details:

      Breaking through: Success in streamlining SAD/MAD and NDA-Enabling studies

      2025-02-11, 12:45 PM

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      Kathleen Dowell
      VP, Medical Imaging and Specialty Solutions, Clario

      Kathleen Dowell is a Vice President leading Clario’s Specialty Solutions group which includes a suite of services including clinical event adjudication. Before this position, she was a Managing Director and Sr. Project Manager at Bioclinica within the Medical Imaging and Cardiac Safety business. She has over 25 years in clinical research and medical device experience in a variety of therapeutic areas such as MSK, Neurology, Dermatology, Ophthalmology and Oncology and has held positions as a clinical research associate, study coordinator and trial manager, private practice administrator, optician and medical photographer.   She’s been a lecturer on variety of topics at regional and national meetings including common adverse events from emerging treatments for retinal disease and clinical trials best practices.

      Session Details:

      Unlocking trial success: How clinical adjudication drives sponsor and regulatory confidence in study results

      2025-02-11, 12:45 PM

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      Aditya Kotta
      Head of Business Development US & EU, Novotech

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

      Session Details:

      The 2025 Biotech Landscape: Perspectives and Projections

      2025-02-11, 11:30 AM

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      Stephanie Hitchcock
      Director, Project Management – Global Clinical Trials, PCM Trials

      Stephanie Hitchcock is a Director of Project Management at PCM Trials. Stephanie specializes in adapting trial designs for mobile visit services. She is passionate about expanding the use of high-quality, patient-centric models to drive clinical development. Stephanie is an expert in establishing logistics and procedures on a global scale for complex visit schedules and expanding the scope of what mobile visits can support globally.

      Session Details:

      From guidance to action: Diversity insights and industry trends

      2025-02-11, 11:30 AM

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      Peter St. Wecker, Ph.D.
      Clinical Development Lead, Neurology, UCB

      I thrive on communication. This theme runs through everything I do, including running multi-national clinical program teams, maximizing the use of information technology in both my business and personal life, and passionately seeking out new ideas and information to share with others. My background in medical research has given me the tools necessary to succeed in the field of clinical operations, while my skills and interest in technology continue to drive me towards new ways to connect and interact with others.

      As we move into a new era of drug development, I am increasingly interested in leveraging technology to streamline and decentralizalize clinical trials. This includes wearable devices, remote monitoring, EMR access, and solutions in digital health.

      Some specifics about me:

      • Over 20 years expertise in Clinical Program Management and Operations at Pharma, Biotech, CRO, and Service Providers.
      • Demonstrated success in hands-on problem solving and decision-making.
      • Successful management of complex national and international Phase I through IV clinical trials and registries.
      • Experienced in managing NDA and BLA preparation.
      • Proven analytical skills in process development, technology integration, and training.
      • Experienced in protocol development and review, budgeting, and time management.
      • In-depth knowledge of Internet research resources and web interfaces.
      • Highly proficient at Microsoft Office Suite, including Outlook, Excel, Word, and PowerPoint.
      • Strong leadership, interpersonal, communication, and presentation skills, with supportive attitude.
      • Bilingual in English and French.

      Specialties: Phase I to IV clinical trials in multiple therapeutic areas, Patient Registries, Study Protocol Development, EDC (Electronic Data Capture), IVR (Interactive Voice Response), IST (Investigator Sponsored Trials), TMF (Trial Master Files), SOP development and process improvement, Budget Management, Software Training, Web Research, Broad Technical Knowledge.

      Session Details:

      PANEL DISCUSSION: Embracing innovative technologies in clinical data management: Opportunities and challenges

      2025-02-12, 12:15 PM

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      Advisory Board

      Select a member to learn more

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      Bao Dinh
      Global Development Business Operation, Takeda

      With over 15 years of experience in Clinical Data Management, Bao leads business strategy and vendor operations for Takeda’s Clinical Data Management, Clinical Data Engineering, and Clinical Data Standards groups, driving organizational growth, managing global FSP partnerships, and enhancing cross-functional collaboration. As a member of the 2024–2025 OCT Advisory Board, Bao brings expertise in clinical outsourcing, strategic vendor partnerships, and RFP process optimization, providing a fresh vision for the organization.

      Beyond professional achievements, Bao is dedicated to fostering collaboration and investing in the local community. As a partner of The Town FC and a Silicon Valley angel investor, Bao champions ventures that advance sustainable growth, youth enrichment, and innovation in technology.’

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