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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Why attend?

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

See What It's All About

2025 Agenda

  • 11 Feb 2025
  • 12 Feb 2025
Expand All

Streams

Stream one

Outsourcing & Clinical Operations

Stream two

Clinical Innovation & Technology

Stream three

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?

11:30 AM

Reserved for event sponsor

Speakers

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

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?

Speakers

Jad Adaimi

12:30 PM

Reserved for event sponsor

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 event sponsor

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?

Speakers

Ros Cheetham
Vice President of Clinical Operations, MacroGenics
Bruce Morimoto
Vice President, Drug Development, Alto Neuroscience

7:30 AM

Registration & Refreshments

8:20 AM

Chairman’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

9 AM

Reserved for ARENSIA

9:30 AM

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

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
Head, Supplier Performance Management

11:30 AM

Reserved for Novotech

12 PM

PANEL DISCUSSION: Battling insufficient resources to allow your trial to succeed in an increasingl

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

12:30 PM

Reserved for event sponsor

Speakers

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

1 PM

Lunch and networking

2 PM

Reviewing remote patient monitoring in DCTs for stronger clinical trial evidence and meaningful outcomes

  • Moving away from traditional methods to improve patient compliance, data quality and reduce costs
  • Proactively engaging with emerging, unexplored technologies
  • In an inherently risk-adverse environment, can we keep up with the speed technology is advancing at?
  • Evaluating the impacts of RPM interventions on patient safety, adherence and quality-of-life

Speakers

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

2:45 PM

Reserved for event sponsor

3:15 PM

Why effective communication is the cornerstone of successful clinical trial drug management

  • Frank and transparent conversations with your team to ensure deadlines are met and milestones achieved
  • Truly understanding what motivates sponsors and CROs: Timely communication with the right people to avoid major delays and de-motivated vendors and employees
  • Implementing communication best practices to enhance coordination, efficiency, and successful outcomes in your trials
  • Robust communication strategies to identify and mitigate risks early in the trial

Speakers

Karen Sayka Coyle
Associate Director, Clinical Operations, Corcept Therapeutics

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
Sandra Nino-Siddens

5:30 PM

Chair’s closing remarks

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

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

Speakers

Amy Que-Xu

2:45 PM

Reserved for event sponsor

3:45 PM

Afternoon refreshments and networking

4:15 PM

Reserved for event sponsor

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

Streams

Stream one

Outsourcing & Clinical Operations

Stream two

Medical Device

Stream three

Clinical Data Management

8:30 AM

Registration and refreshments

Speakers

Esther Marfo
Project Leader, Health Equity And Population Sciences, Hoffman La Roche

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 event sponsor

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 Director of Clinical Operations
Vineeta Gulati
Director, Clinical Operations

10:30 AM

Reserved for event sponsor

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

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
VP Technical Operations, Abcuro
Prasun Mishra
Founding Partner, World Investors and Entrepreneurs Society

1 PM

Lunch and networking

2 PM

Case Study: ClinOps in rare disease trials

Speakers

Jenelle Lin

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

4:30 PM

Chair’s closing remarks and end of conference

Speakers

Esther Marfo
Project Leader, Health Equity And Population Sciences, Hoffman La Roche

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

10:30 AM

Reserved for event sponsor

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

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 Subramaniannj
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 Operations

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

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

Sharon Crugnale
Vice President, Clinical Development Operations, Bitterroot Bio

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

2025 Speakers

Select a speaker to learn more

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

Session Details:

Reviewing remote patient monitoring in DCTs for stronger clinical trial evidence and meaningful outcomes

2025-02-11, 2:00 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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Karen Sayka Coyle
Associate Director, Clinical Operations, Corcept Therapeutics

Session Details:

Why effective communication is the cornerstone of successful clinical trial drug management

2025-02-11, 3:15 PM

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Laurin Vincent
Executive Director, Vendor Quality Management, Gilead
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Sharon Crugnale
Vice President, Clinical Development Operations, Bitterroot Bio

Session Details:

How clinical data consolidation can bring precision to patient care

2025-02-12, 11:30 AM

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Amy Que-Xu
Health Technology - Clinical Research, Meta

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

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

Matthew brings over two decades of experience in discovery research, pharma and biotechnology to Octant. His expertise includes immuno-oncology, autoimmunity, metabolic diseases and neuro-degeneration. Prior to joining Octant, he was Chief Translational Officer at Human Immunology Biosciences, served as SVP at insitro where he directed the Department of Translational Genetics and Biology, and was founder and Head of the Reverse Translation Organization at Genentech in the Cancer Immunology Department. His academic positions included Director of the Immunology Department at Institut Pasteur, Paris and co-founder of the Milieu Interieur Consortium, a global real-world data effort that has identified actionable insights into the genetic, microbiome and environmental determinants of health and disease.

Matthew's contributions have led to the discovery of new drug targets and he has helped to advance multiple drug candidates in first-in-human Ph1 studies and through post-marketing / indication expansion trials. His seminal work offered definitive evidence that naturally occurring tumor immunity in humans is established by the cross-priming of antigen-specific cytotoxic (CD8+) T cells, establishing the foundation for current approaches in immuno-oncology. He holds a Ph.D. in Immunology, an M.D. and residency training in Clinical Pathology, from Rockefeller University, Weill Cornell Medical School and New York Presbyterian Hospital, respectively.

Matthew enjoys spending quality time with his wife and daughter, as well as cycling, backcountry skiing and cooking.

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 Director of Clinical Operations

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, Clinical Operations

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

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

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 Director, Clinical Outsourcing and Vendor Relations
  • 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
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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 enhancing diversity in clinical trials and she has worked closely with Advocacy groups in both Rare Diseases and Oncology. 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

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 increasingl

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
VP 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
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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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Jenelle Lin

Dedicated to advancing treatment options for patients with rare diseases and unmet need | Supporting early-stage innovators and startups in biotechnology

Session Details:

Case Study: ClinOps in rare disease trials

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

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Leesa Gentry

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
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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.

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Meir Pinco

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
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Jenni Herber
Associate Director, Clinical Operations, Kamau Therapeutics
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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, 9:30 AM

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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 increasingl

2025-02-11, 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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+61 280 978 126

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+61 280 978 126

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+44 204540 7545