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?
  • 2025 Agenda
  • Advisory Board
  • 2025 Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Resources
  • Why partner?
  • Contact Us
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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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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.

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Sage Callaway​

Associate Director, 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.

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

    Company Website

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

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    Company Information

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

    Company Website

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

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    Company 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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    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

      2025 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

      Reserved for event sponsor

      12 PM

      PANEL DISCUSSION: Is clinical trial exclusion criteria too stringent?

      • 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 decision 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

      12:30 PM

      Reserved for MRN

      1 PM

      Lunch and networking

      2 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

      Reserved for 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

      Reserved for event sponsor

      4:45 PM

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

      • 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
      • Mission critical: Ensuring frequent communication with sites to support their efforts
      • The need for clinical trials to be more accessible to patients, have we
      • regressed from COVID and remote health?

      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
      SVP, Clinical Research, Ardelyx

      END OF DAY 1 AND NETWORKING DRINKS

      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

      Reserved for IQVIA

      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?

      Speakers

      Meir Pinco
      Associate Director, IT Data & Analytics, BeiGene
      John Rootenberg
      Principal Director, Digital Safety and Decision Support, Genentech

      12:30 PM

      Reserved for Clario

      1 PM

      Lunch and networking

      2 PM

      Maximizing profitability: Alternative solutions to longstanding trial inefficiencies from a non-traditional clinical research company perspective

      • Delivering customized solutions for conducting research
      • Examining how small, nimble and adaptive companies ensure their trials progress faster
      • Leveraging such a billable industry when there are no financial benefits to accelerating drug development
      • Why the CRO and lab models are up for disruption: Adopting AI to download similar trial data to assess risk factors and failure points to educate protocol development

      2:45 PM

      Reserved for Fortrea

      3:15 PM

      Why patient-centric data management matters and how can we prioritize this patient focus?

      • Demystifying individual participant data return to modernize and personalize clinical trials
      • An end-to-end data-driven patient journey: from patient-friendly DCT conduct to individualized patient data return
      • Use-cases: What measures will enable its adoption?
      • What can we do to ensure the safe handling of vast amounts of sensitive patient data?

      Speakers

      Jenni Herber
      Associate Director, Clinical Operations, Kamau Therapeutics

      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: Building transparency to foster trust: Balancing the need for centralized and secondary data usage with the respect for patients’ ownership of their data

      • Addressing data privacy concerns by using synthetic healthcare data that complies with regulations
      • What can we do to ensure the safe handling of vast amounts of sensitive data?
      • Leveraging AI tools to adhere to data privacy regulations
      • Is the data ever fully protected and how can we measure this?

      Speakers

      Prasun Mishra
      Founding Partner, World Investors and Entrepreneurs Society

      END OF DAY 1 AND NETWORKING DRINKS

      7:30 AM

      Registration & Refreshments

      8:20 AM

      Chair’s opening remarks

      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

      Dr. Claudia Hesselmann
      Founder & CEO, ARENSIA Exploratory Medicine

      9:30 AM

      Plan for success and prepare for adversity: How can we transform contingency planning to help anticipate unforeseen circumstances

      • A macroeconomic perspective on clinical supplies – Managing supply distribution, resource shortages and transportation constraints to and in areas of conflict
      • Forecasting to optimize clinical trial supply management and better-informed decision making in dynamic trials
      • Key considerations for minimizing impact on patients during unprecedented situations
      • Collaborating cross-functionality to respond to trial disruptors to allow the trial to progress

      Speakers

      Susan Edelstein
      SVP, Clinical Research, Ardelyx

      10 AM

      Reserved for ICON

      10:30 AM

      Morning refreshments and networking

      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

      Reserved for 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

      Speakers

      Sage Callaway
      Associate Director, Ascendis Pharma
      Susan Griffing
      Vice President, Global Monitoring and Site Engagement, GSK
      Jenni Herber
      Associate Director, Clinical Operations, Kamau Therapeutics

      12:30 PM

      Reserved for Worldwide Clinical Trials

      1 PM

      Lunch and networking

      2 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

      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

      Speakers

      Bao Dinh
      Associate Director, Vendor Engagement & Business Operations, CDM, Takeda

      3:45 PM

      Afternoon refreshments and networking

      4:15 PM

      Reserved for event sponsor

      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

      Speakers

      Leesa Gentry
      Chief Clinical Officer, RenovoRx
      Sandra Nino-Siddens
      Vice President Global Regulatory Affairs, Ultragenyx Pharmaceutical

      5:15 PM

      Session reserved for Sharon Crugnale, Vice President, Clinical Development Operations, Bitterroot Bio

      Speakers

      Sharon Crugnale
      Vice President, Clinical Development Operations, Bitterroot Bio

      5:45 PM

      Chair’s closing remarks

      END OF DAY 1 AND NETWORKING DRINKS

      Streams

      Stream one

      Stream A: Outsourcing & Clinical Operations

      Stream two

      Stream B: Clinical Data Management

      Stream three

      Stream C: Medical Devices

      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

      Reserved for event sponsor

      10 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

      10:30 AM

      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

      Moderator

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

       

      Panelists

      Dorothy H. Kwok, Head of Clinical Operations, Bodyport

      Speakers

      Chitrang Dave
      Global Head of Enterprise Data & Analytics, Edwards Lifesciences
      Dorothy H. Kwok
      Head of Clinical Operations, Bodyport

      11 AM

      Morning refreshments and networking

      11:30 AM

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

      Speakers

      Charles Aunger
      Managing Director, Health2047

      12 PM

      Reserved for event sponsor

      12:30 PM

      Navigating complexity: best practices in program management for medical device success

      • Emphasize the importance of collaboration among diverse teams, including engineering, regulatory, and clinical experts
      • Implement agile project management techniques to enhance flexibility and responsiveness
      • Prioritize early and ongoing engagement with key stakeholders, including healthcare professionals and end-users

      Speakers

      Rajni Subramanian
      Associate Director, Becton Dickinson

      1 PM

      Lunch and networking

      2 PM

      Optimizing subject recruitment in medical device trials: challenges and lessons

      • Exploring connected and integrated technologies, such as electronic health records (EHRs) and telemedicine, enabling seamless communication among healthcare providers
      • Technology-driven approaches, including remote monitoring and mobile health apps, empower patients to actively engage in their own care
      • Leveraging data analytics and AI so healthcare providers can make informed, real-time decisions based on comprehensive patient data

      Speakers

      Kathryn Wine
      Vice President Clinical Affairs, Novocuff

      2:30 PM

      Exploring data requirements for regulatory approval and reimbursement of medical devices

      • Understanding the essential preclinical and clinical data needed for regulatory approval, including safety, efficacy, and performance metrics
      • Learning how to collect and present health economic data, clinical effectiveness evidence, and real-world data to build a compelling case for reimbursement
      • Identifying common pitfalls in data collection and submission processes

      Speakers

      Tania Pearson
      Regulatory Systems Director, Medtronic

      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

      Reserved for event sponsor

      10 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

      10:30 AM

      Reserved for event sponsor

      11 AM

      Morning refreshments and networking

      11:30 AM

      How clinical data consolidation can bring precision to patient care

      • Moving away from fragmented data and towards simplified pathways and what are the tools needed to facilitate data alignment
      • Providing comprehensive research participant information in a cohesive manner and improve overall data efficiency
      • Adapting to increased data sources and understanding the roadblocks to consolidating disparate data
      • How can biotechs reliably minimize data risk and maximize data quality when combining different data sources?

      Speakers

      Carrie Lewis
      Executive Director, Clinical Program Optimization, Endo Pharmaceuticals

      12 PM

      Reserved for event sponsor

      12:30 PM

      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

      1 PM

      Lunch and networking

      2 PM

      A unique insight into the common areas of negotiation between CROs and pharma

      • What are the business needs and why does internal legal make teams do things in a certain way?
      • A look at governance: How to predetermine escalation prior to something going amiss
      • Do you have a clear pathway when things go wrong

      Speakers

      Gina Morton
      Director Development Contracts, Calico Life Sciences LLC

      2:30 PM

      Session reserved for GlobalData

      8:30 AM

      Registration and refreshments

      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

      Reserved for 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
      Director of Clinical Operations, CymaBay Therapeutics

      10:30 AM

      Reserved for EPS Corporation

      11 AM

      Morning refreshments and networking

      11:30 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 PM

      Innovative trial site intelligence with Adnexi to improve site selection

      • Learn about a new technology solution to search for trial sites with the exact prior experience needed for your trial
      • Discover how to find sites that are most likely to accelerate your clinical trial
      • Understand the types of prior experience criteria that Adnexi can help you find
      • Learn about two case studies for sponsors with specific site criteria

      Speakers

      Sandra Shpilberg
      Co-Founder & CEO, Adnexi

      12:15 PM

      Reserved for event sponsor

      12:30 PM

      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

      Speakers

      Yuyi Shen
      Vice President, Technical Operations, Abcuro
      Prasun Mishra
      Founding Partner, World Investors and Entrepreneurs Society

      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, Vir Biotechnology

      2:30 PM

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

      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
      Digital health for patients in and after trials
      Hosted by Meghan McKenzie, Patient Inclusion and Health Equity in Chief Diversity Office, Genentech
      Kade Shippy, Patient Inclusion and Health Equity, Genentech
      Audrey Funwie, Health Equity and Data Associate, Genentech

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

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

      Speakers

      Kade Shippy
      Chief Diversity Office, Patient Inclusion and Health Equity, Genentech
      Audrey Funwie
      Chief Diversity Office, Patient Inclusion and Health Equity, Genentech
      Meghan McKenzie
      M.A. Patient Inclusion and Health Equity, Chief Diversity Office, Genentech
      Bruce H. Morimoto
      PhD Vice President, Drug Development Alto Neuroscience, Inc

      4:30 PM

      Chair’s closing remarks and end of conference

      2025 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, 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:

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

      2025-02-12, 12:30 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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      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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      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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      Sharon Crugnale
      Vice President, Clinical Development Operations, Bitterroot Bio

      Session Details:

      Session reserved for Sharon Crugnale, Vice President, Clinical Development Operations, Bitterroot Bio

      2025-02-11, 5:15 PM

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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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      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
      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, 2:00 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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      Sage Callaway
      Associate Director, 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
      Director Development Contracts, Calico Life Sciences LLC

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

      Session Details:

      A unique insight into the common areas of negotiation between CROs and pharma

      2025-02-12, 2:00 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:

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

      2025-02-12, 12:30 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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      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.

      Next speaker
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      Jenelle Lin
      Associate Director, Clinical Operations, Vir Biotechnology

      Jenelle Lin is the Associate Director of Clinical Operations at Vir Biotechnology, Inc., where she leads clinical programs focused on developing transformative medicines for infectious diseases, including chronic hepatitis delta, an underdiagnosed and severe form of hepatitis. 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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      Prasun Mishra
      Co-Founder, Precision BioPharma
      Next speaker
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      Meghan McKenzie
      M.A. Patient Inclusion and Health Equity, Chief Diversity Office, Genentech

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

      Session Details:

      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
      SVP, Clinical Research, Ardelyx

      Session Details:

      Plan for success and prepare for adversity: How can we transform contingency planning to help anticipate unforeseen circumstances

      2025-02-11, 9:30 AM

      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:

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

      2025-02-11, 12:00 PM

      Session Details:

      Why patient-centric data management matters and how can we prioritize this patient focus?

      2025-02-11, 3:15 PM

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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, 2:00 PM

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      Susan Griffing
      Vice President, Global Monitoring and Site Engagement, GSK

      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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      Rajni Subramanian
      Associate Director, Becton Dickinson

      Session Details:

      Navigating complexity: best practices in program management for medical device success

      2025-02-12, 12:30 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, 10:30 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, 10:00 AM

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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, 11:30 AM

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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:

      Optimizing subject recruitment in medical device trials: challenges and lessons

      2025-02-12, 2:00 PM

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      Tania Pearson
      Regulatory Systems Director, Medtronic

      Session Details:

      Exploring data requirements for regulatory approval and reimbursement of medical devices

      2025-02-12, 2:30 PM

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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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      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
      Associate Director, Vendor Engagement & Business Operations, CDM, 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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      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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      Dr. Claudia Hesselmann
      Founder & CEO, ARENSIA Exploratory Medicine

      Dr. Claudia Hesselmann, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.

       

      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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      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:

      Innovative trial site intelligence with Adnexi to improve site selection

      2025-02-12, 12:00 PM

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      Advisory Board

      Select a member to learn more

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      Bao
      Vendor Engagement and Business Operations Leader | Strategic Advisor | Clinical Data Management Expert

      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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