18th Annual Outsourcing in Clinical Trials West Coast 2026

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

11 - 12

February

2026

Hyatt Regency San Francisco Airport, Burlingame, CA, USA
Complimentary

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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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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 - https://www.iconplc.com/sectors/biotech

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Clario is a leading provider of endpoint data solutions that generate high-quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence generation solutions that combine eCOA, cardiac solutions, medical imaging, precision motion, and respiratory endpoints. Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries. Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2012.

Company Website

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

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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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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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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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Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development. With deep therapeutic and regulatory expertise and an expansive global footprint across the Asia-Pacific region, North America, and Europe, Novotech offers clients an accelerated path to bring life-changing therapies to market.

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 Heart^TM 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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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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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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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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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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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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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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Advarra is number one in trusted research review services, number one in site operations technology, and the pioneer in study collaboration solutions. Our unique portfolio of technology and services reduces friction by decreasing technology burden, improving study visibility, and enabling smarter decisions that advance clinical research.

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

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Company Website

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

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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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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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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 2026
12 Feb 2026

Expand All

Streams

Stream one

Stream A: Outsourcing & Clinical Operations

Stream two

Stream B: Clinical Technology & Innovation

Stream three

Stream C: Patient Centricity and DEI

11 AM

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

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

Speakers

Christine Van Raesfeld

Patient Advocate

11:30 AM

From guidance to action: Diversity insights and industry trends

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

Speakers

Stephanie Hitchcock

Director, Project Management – Global Clinical Trials, PCM Trials

12 PM

PANEL DISCUSSION: Is clinical trial exclusion criteria too stringent?

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

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

Speakers

Jad Adaimi

Executive Director - Global Regulatory Affairs, Ultragenyx

Marla Williams

Associate R&D Strategic Outsourcing Director, Exelixis

Nisha Trivedi

Rare Disease Patient Advocate

Meghan McKenzie

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

Cathy Scharf

Patient Advocate, Patient Advocates of the East Bay

12:45 PM

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

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

Speakers

Catherine Jervis

General Manager Integrated Solutions, MRN

1:15 PM

Lunch and networking sponsored by Thermo Fisher Scientific

2:15 PM

Patient Engagement starts with the Informed Consent Form

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

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

Speakers

Ros Cheetham

Vice President of Clinical Operations, MacroGenics

2:45 PM

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

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

Speakers

Sarah Cross, PhD

Vice President and Global Head of Medical Affairs, Premier Research

3:15 PM

Patient perspective: My clinical trial journey

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

Speakers

Nisha Trivedi

Rare Disease Patient Advocate

3:45 PM

Afternoon refreshments and networking

4:15 PM

From endpoints to impact: Designing trials that resonate with patients

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

Speakers

Dr. Andrew Feigin, MD

Chief Medical Officer, Rho

4:45 PM

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

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

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

Speakers

Ros Cheetham

Vice President of Clinical Operations, MacroGenics

Bruce Morimoto

Vice President, Drug Development, Alto Neuroscience

Susan Edelstein, PhD

SVP, Clinical Research, Ardelyx

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

11 AM

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

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

Speakers

Matthew Albert

Head, Translational Sciences & Early Clinical Development, Octant Biosciences

11:30 AM

End-to-End financial management: Challenges and opportunities

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

Speakers

Zahiah (Zee Zee) Gueddar

Senior Director, Commercial Lead, Financial Strategy & Corporate Development, IQVIA Technologies

12 PM

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

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

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

Speakers

Meir Pinco

Associate Director, IT Data & Analytics, BeiGene

John Rootenberg

Principal Director, Digital Safety and Decision Support, Genentech

Joshua Cox

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

12:45 PM

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

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

Speakers

Kathleen Dowell

VP, Medical Imaging and Specialty Solutions, Clario

1:15 PM

Lunch and networking sponsored by Thermo Fisher Scientific

2:15 PM

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

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

Speakers

Anthony L Colenburg Sr

Senior Director & Site Head of Quality, Sutro Biopharma

2:45 PM

Maximizing asset valuation for biopharma

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

Speakers

Kenneth Park, MD

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

3:15 PM

Session reserved for Sharon Crugnale

Speakers

Sharon Crugnale

Vice President, Clinical Development Operations, Bitterroot Bio

3:45 PM

Afternoon refreshments and networking

4:15 PM

Start expecting more from eCOA/ePRO

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

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

Speakers

Steve Rosenberg

Chief Executive Officer, uMotif

4:45 PM

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

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

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

Speakers

Joshua Cox

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

Yuyi Shen

Vice President, Technical Operations, Abcuro

Sarah Hamirani

Portfolio Director, AbbVie

Jasmina Jankicevic

Clinical Development and Medical Affairs, RAPT Therapeutics

Prasun J Mishra

Founder CEO

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

7:30 AM

Registration & Refreshments

8:20 AM

Chair’s opening remarks

Speakers

Susan Edelstein, PhD

SVP, Clinical Research, Ardelyx

8:30 AM

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

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

Speakers

Leesa Gentry

Chief Clinical Officer, RenovoRx

9 AM

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

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

Speakers

Tatiana Eidus

Director Corporate Development North America, ARENSIA Exploratory Medicine

9:30 AM

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

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

Speakers

Susan Edelstein, PhD

SVP, Clinical Research, Ardelyx

10 AM

Maximizing the consultative partnership between CRO and pharma/biotech partners

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

Speakers

Marija Jovanovic, MD

Director, Project Delivery, ICON Biotech, ICON

10:30 AM

Morning refreshments and networking break sponsored by Ergomed

11 AM

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

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

Speakers

Laurin Vincent

Executive Director, Vendor Quality Management, Gilead

11:30 AM

The 2025 Biotech Landscape: Perspectives and Projections

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

Speakers

Aditya Kotta

Head of Business Development US & EU, Novotech

12 PM

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

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

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

Speakers

Sage Callaway

Associate Director, Clinical Business Operations, Oncology, Ascendis Pharma

Jenni Herber

Associate Director, Clinical Operations, Kamau Therapeutics

Avnika Agarwal

Senior Director, Project Delivery, Biotech, ICON

Susan Edelstein, PhD

SVP, Clinical Research, Ardelyx

Laura O’Donnell

Senior Director, Head, Global Site Engagement, GSK

12:45 PM

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

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

Speakers

Lona Sheeran

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

1:15 PM

Lunch and networking sponsored by Thermo Fisher Scientific

2:15 PM

Session reserved for Jenni Herber

Speakers

Jenni Herber

Associate Director, Clinical Operations, Kamau Therapeutics

2:45 PM

Driving success: Strategies for optimal site support

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

Speakers

Eleanor Miller

Clinical Trial Liaison, PSI CRO

3:15 PM

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

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

Speakers

Bao Dinh

Global Development Business Operation, Takeda

David Larwood

CEO, Valley Fever Solutions

3:45 PM

Afternoon refreshments and networking

4:15 PM

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

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

Speakers

Jon Raven

Chief Commercial Officer, Emsere

Bryan Dunlap

Business Develop Manager, North America, Emsere

4:45 PM

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

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

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

Speakers

Leesa Gentry

Chief Clinical Officer, RenovoRx

Sandra Nino-Siddens

Vice President Global Regulatory Affairs, Ultragenyx Pharmaceutical

Bogdan Sandica

Senior Manager Trial Optimization, ARENSIA Exploratory Medicine

Revati Tatake

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

5:30 PM

Chair’s closing remarks

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

Streams

Stream one

Stream A: Outsourcing & Clinical Operations

Stream two

Stream B: Clinical Data Management

Stream three

Stream C: Medical Devices

8:50 AM

Chair’s opening remarks

Speakers

Chitrang Dave

AI and Advanced Analytics Lead, Avidity Biosciences

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

AI and Advanced Analytics Lead, Avidity Biosciences

9:30 AM

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

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

Speakers

Lian Cunningham

Vice President Of Clinical Affairs, Endogenex

10 AM

Remote study on a shoestring: lessons from an OTC clinical trial

Milli Expanding Vaginal Dilator's Regulatory Arc: Wellness to Rx to OTC
Market told us robust clinical would support adoption—need to do fast and cheap
Developing the study protocol and clinical operations POMPOM - Milli
Recruitment strategies and metrics
Remote data collection and compensation
Baseline Data Abstract accepted by ISSWSH
What we learned
Future studies: lather-rinse-repeat

Speakers

Debbie Donovan

Head of Commercial Operations, Materna Medical

10:30 AM

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

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

Speakers

Katie Bessette

Director of Regulatory Affairs, Abbott Laboratories

11 AM

Morning refreshments and networking

11:45 AM

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

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

Speakers

Tania Pearson

Regulatory Systems Director, Medtronic

12:15 PM

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

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

Speakers

Chitrang Dave

AI and Advanced Analytics Lead, Avidity Biosciences

Dorothy H. Kwok

Head of Clinical Operations, Bodyport

Rozanno Gonzales

Clinical Innovation & Technology Leader, Genentech

1 PM

Lunch and networking

2 PM

Strengthening partnerships and processes for clinical trial excellence in medical devices

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

Speakers

Kathryn Wine

Vice President Clinical Affairs, Novocuff

2:30 PM

Chair’s closing remarks and close of stream

8:50 AM

Chair’s opening remarks

Speakers

Joshua Cox

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

9 AM

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

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

Speakers

Meir Pinco

Associate Director, IT Data & Analytics, BeiGene

9:30 AM

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

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

Speakers

Thomas Tremblay

Vice President, Head of Clinical Operations, Trefoil Therapeutics

10 AM

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

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

Speakers

Joshua Cox

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

Hayley Lane

Vice President Clinical Operations, Star Therapeutics

Ros Cheetham

Vice President of Clinical Operations, MacroGenics

Thomas Tremblay

Vice President, Head of Clinical Operations, Trefoil Therapeutics

Jenni Herber

Associate Director, Clinical Operations, Kamau Therapeutics

10:30 AM

Session reserved for Revati Tatake

Speakers

Revati Tatake

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

11 AM

Morning refreshments and networking

11:45 AM

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

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

Speakers

Bruce Morimoto

Vice President, Drug Development, Alto Neuroscience

12:15 PM

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

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

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

Speakers

Joshua Cox

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

Janet Moga

Lead, DCT Operations, Astellas Gene Therapies

Prasun Mishra

Chief Executive Officer, Agility Pharmaceuticals

Peter St. Wecker, Ph.D.

Clinical Development Lead, Neurology, UCB

1 PM

Lunch and networking

2 PM

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

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

Speakers

Chris Chan

Vice President, FP&A, IGM Biosciences

2:30 PM

AI transforming healthcare and life sciences: From discovery to delivery

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

Speakers

Prasun Mishra

Chief Executive Officer, Agility Pharmaceuticals

8:30 AM

Registration and refreshments

8:50 AM

Chair’s opening remarks

Speakers

Revati Tatake

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

9 AM

KEYNOTE: Designing trials to reduce patient and site burden

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

Speakers

Shantheri Pai

Associate Director - Clinical Operations, Oncology, Gilead

9:30 AM

Beyond traditional labels: Customized outsourcing strategies for biotech and pharma

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

Speakers

Neil Berger

Vice President, FSP Commercial and Operational Strategy, Parexel

10 AM

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

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

Speakers

Abby Kennedy

Senior Vice President of Clinical Operations, DermBiont

Vineeta Gulati

Former Director of Clinical Operations, CymaBay Therapeutics

10:30 AM

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

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

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

Speakers

Katsura Kasahara

Executive Professional, EPS Corporation

11 AM

Morning refreshments and networking

11:45 AM

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

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

Speakers

Archana Sah

Vice President, Head of Clincial Operations

12:15 PM

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

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

Speakers

Sandra Shpilberg

Co-Founder & CEO, Adnexi

12:30 PM

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

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

Speakers

Gina Morton

Former Director of Contracts and Outsourcing, Calico and Genentech

1 PM

Lunch and networking

2 PM

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

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

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

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

Speakers

Jenelle Lin

Associate Director, Clinical Operations, Aditum Bio

2:30 PM

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

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

Speakers

Amy Mou

Vendor Strategy Manager – FSP, Pfizer

3 PM

Afternoon refreshments, networking & prize draw in exhibition room

3:30 PM

Speaker Hosted Round Tables

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable lasts for 30 minutes, delegates can select up to 2 roundtables.

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

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

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

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

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

Speakers

Bruce Morimoto

Vice President, Drug Development, Alto Neuroscience

Meghan McKenzie

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

Kade Shippy

Chief Diversity Office, Patient Inclusion and Health Equity, Genentech

Audrey Funwie

Chief Diversity Office, Patient Inclusion and Health Equity, Genentech

Gina Morton

Former Director of Contracts and Outsourcing, Calico and Genentech

4:30 PM

Chair’s closing remarks and end of conference

2025 Speakers

Select a speaker to learn more

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Laurin Vincent

Executive Director, Vendor Quality Management, Gilead

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

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

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

Session Details:

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

2025-02-11, 11:00 AM

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Susan Edelstein, PhD

SVP, Clinical Research, Ardelyx

Session Details:

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

2025-02-11, 9:30 AM

Session Details:

Chair’s opening remarks

2025-02-11, 8:20 AM

Session Details:

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

2025-02-11, 12:00 PM

Session Details:

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

2025-02-11, 4:45 PM

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Jon Raven

Chief Commercial Officer, Emsere

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

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

Session Details:

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

2025-02-11, 4:15 PM

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Bryan Dunlap

Business Develop Manager, North America, Emsere

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

Session Details:

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

2025-02-11, 4:15 PM

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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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Sarah Cross, PhD

Vice President and Global Head of Medical Affairs, Premier Research

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

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

Session Details:

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

2025-02-11, 2:45 PM

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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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Marija Jovanovic, MD

Director, Project Delivery, ICON Biotech, ICON

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

Session Details:

Maximizing the consultative partnership between CRO and pharma/biotech partners

2025-02-11, 10:00 AM

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Tatiana Eidus

Director Corporate Development North America, ARENSIA Exploratory Medicine

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

Session Details:

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

2025-02-11, 9:00 AM

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Leesa Gentry

Chief Clinical Officer, RenovoRx

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

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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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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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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Bogdan Sandica

Senior Manager Trial Optimization, ARENSIA Exploratory Medicine

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

Session Details:

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

2025-02-11, 4:45 PM

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Revati Tatake

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

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

Session Details:

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

2025-02-11, 4:45 PM

Session Details:

Session reserved for Revati Tatake

2025-02-12, 10:30 AM

Session Details:

Chair’s opening remarks

2025-02-12, 8:50 AM

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Joshua Cox

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

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

Session Details:

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

2025-02-11, 4:45 PM

Session Details:

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

2025-02-11, 12:00 PM

Session Details:

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

2025-02-12, 12:15 PM

Session Details:

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

2025-02-12, 10:00 AM

Session Details:

Chair’s opening remarks

2025-02-12, 8:50 AM

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Yuyi Shen

Vice President, Technical Operations, Abcuro

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

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

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

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

Session Details:

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

2025-02-11, 4:45 PM

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Sarah Hamirani

Portfolio Director, AbbVie

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

Session Details:

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

2025-02-11, 4:45 PM

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Jasmina Jankicevic

Clinical Development and Medical Affairs, RAPT Therapeutics

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

Session Details:

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

2025-02-11, 4:45 PM

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Prasun J Mishra

Founder CEO

Dr. Mishra (Ex-Genentech, Ex-NCI, Ex-NIH) is the Founder and CEO of Agility Pharmaceuticals. He is a serial entrepreneur who founded his first company after graduating high school, and second company during his PhD. Since then, he has accumulated a wealth of experienced by building, investing and advising numerous other companies. He is an investor/ co-founder/ board member of a few US based corporations focused on accelerating drug discovery & development, blockchain & digital health. Dr. Mishra is also founding president & CEO of American Association for Precision Medicine (AAPM) and is leading research efforts focused on preventing & curing chronic diseases; not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives.

Widely recognized as a thought leader in the field of Technology and Healthcare, Dr. Mishra has keynoted, chaired, curated and organized numerous successful international conferences. Prior to Agility Pharma, Dr. Mishra served as a scientist and Principal Investigator at Genentech, Roche. Moreover, his passion for drug development and precision medicine has led to identification of new drug targets, biomarkers, companion diagnostics and several drugs/ combinations in the clinic.

His research work has been recognized globally by over 40 prestigious awards and honors. Due to his unique perspective & selfless service, he is highly respected & sought-after mentor to many. The companies that he has advised have raised multimillion dollars. Notably, he serves as a mentor and advisor to startup accelerators such as IndieBio, Health2.0’s Project Zygote and CLSI FAST program, to help grow California’s life sciences innovation ecosystem.

Session Details:

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

2025-02-11, 4:45 PM

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Kenneth Park, MD

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

Session Details:

Maximizing asset valuation for biopharma

2025-02-11, 2:45 PM

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Ros Cheetham

Vice President of Clinical Operations, MacroGenics

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

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

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

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

Session Details:

Patient Engagement starts with the Informed Consent Form

2025-02-11, 2:15 PM

Session Details:

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

2025-02-11, 4:45 PM

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

2025-02-12, 10:00 AM

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Lian Cunningham

Vice President Of Clinical Affairs, Endogenex

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

Session Details:

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

2025-02-12, 9:30 AM

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Lona Sheeran

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

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

Session Details:

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

2025-02-11, 12:45 PM

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Sandra Shpilberg

Co-Founder & CEO, Adnexi

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

Session Details:

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

2025-02-12, 12:15 PM

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Chris Chan

Vice President, FP&A, IGM Biosciences

Session Details:

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

2025-02-12, 2:00 PM

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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

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

2025-02-12, 9:00 AM

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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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Eleanor Miller

Clinical Trial Liaison, PSI CRO

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

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

Session Details:

Driving success: Strategies for optimal site support

2025-02-11, 2:45 PM

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Zahiah (Zee Zee) Gueddar

Senior Director, Commercial Lead, Financial Strategy & Corporate Development, IQVIA Technologies

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

Session Details:

End-to-End financial management: Challenges and opportunities

2025-02-11, 11:30 AM

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Stephanie Hitchcock

Director, Project Management – Global Clinical Trials, PCM Trials

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

Session Details:

From guidance to action: Diversity insights and industry trends

2025-02-11, 11:30 AM

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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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Katsura Kasahara

Executive Professional, EPS Corporation

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

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

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

Session Details:

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

2025-02-12, 10:30 AM

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Tania Pearson

Regulatory Systems Director, Medtronic

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

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

Session Details:

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

2025-02-12, 11:45 AM

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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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Neil Berger

Vice President, FSP Commercial and Operational Strategy, Parexel

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

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

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

Session Details:

Beyond traditional labels: Customized outsourcing strategies for biotech and pharma

2025-02-12, 9:30 AM

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Bao Dinh

Global Development Business Operation, Takeda

Session Details:

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

2025-02-11, 3:15 PM

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David Larwood

CEO, Valley Fever Solutions

Dr. David Larwood brings a rare combination of scientific innovation and business acumen to the fight against Valley Fever, a serious and often overlooked fungal disease. While pursuing his PhD in chemistry and chemical biology at UCSF, Dr. David Larwood explored the therapeutic potential of brilacidin, an antimicrobial compound with promising activity against fungal pathogens such as coccidioides, the organism responsible for Valley Fever, which disproportionately affects immunocompromised individuals. At UCSF, he invented PEGylated lipids and with his advisor made the first ever PEGylated liposomes, which lets the “payload” content circulate much longer in the bloodstream, making new forms of delivery possible. The delivery system is integral to Doxil, a drug that treats various cancers. It also is critical to the mRNA COVID vaccines. He was also the first to synthesize Iotrolan, a widely used contrast agent in medical imaging such as X-rays and CT scans, producing more effective clinical diagnostics. His doctoral work was the foundation of a robust career at the convergence of pharmaceutical chemistry and biotech innovation.

Today, Dr. Larwood is founder, president, and CEO of Valley Fever Solutions, where he leads a team working to advance Nikkomycin Z (NikZ), a targeted antifungal therapy. With $7 million in NIH support and a collaborative research team, Dr. Larwood is driving efforts to improve treatments in the regions most affected by Valley Fever, including the Southwestern U.S., Mexico, and Central and South America. Dr. Larwood's 2020 review of NikZ therapy has been cited more than 37 times and continues to inform the field.

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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Kathleen Dowell

VP, Medical Imaging and Specialty Solutions, Clario

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

Session Details:

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

2025-02-11, 12:45 PM

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Aditya Kotta

Head of Business Development US & EU, Novotech

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

Session Details:

The 2025 Biotech Landscape: Perspectives and Projections

2025-02-11, 11:30 AM

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Jenni Herber

Associate Director, Clinical Operations, Kamau Therapeutics

Session Details:

Session reserved for Jenni Herber

2025-02-11, 2:15 PM

Session Details:

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

2025-02-11, 12:00 PM

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

2025-02-12, 10:00 AM

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Catherine Jervis

General Manager Integrated Solutions, MRN

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

Session Details:

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

2025-02-11, 12:45 PM

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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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Meghan McKenzie

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

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

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

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

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

Session Details:

PANEL DISCUSSION: Is clinical trial exclusion criteria too stringent?

2025-02-11, 12:00 PM

Session Details:

Speaker Hosted Round Tables

2025-02-12, 3:30 PM

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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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Janet Moga

Lead, DCT Operations, Astellas Gene Therapies

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

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

Session Details:

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

2025-02-12, 12:15 PM

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Prasun Mishra

Chief Executive Officer, Agility Pharmaceuticals

Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American Association for Precision Medicine ( and chair of ACT AAPM’s Coronavirus Taskforce He is leading research efforts focused on preventing curing chronic diseases not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company committed to revolutionizing drug discovery development through technology, big data, robotics, and artificial intelligence He is a serial entrepreneur who founded his first company after graduating high school, and his second company during his Ph D Since then, he has accumulated a wealth of experience by building, investing, and advising numerous other companies He is an investor, co founder/ board member of a few corporations, focused on accelerating drug discovery/ development, data analytics, robotics, mental health, and digital health He is also the founder of AAPM Angels and Investors AAi an investment group focused on investing in drug discovery, diagnostics, precision medicine, technology healthcare companies He is also the founding investor and advisor to Barcelona Ventures and serves as an advisor to a 100 M private equity fund Widely recognized as a thought leader in the field of ‘technology and healthcare’, Dr Mishra has keynoted, chaired, curated, and organized numerous successful international conferences He served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where he participated in several drug discovery project teams Moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic His research work has been recognized globally by over 40 prestigious awards and honors Due to his unique perspective selfless service, he is a highly respected sought after mentor to many The companies that he has advised have raised multimillion dollars Notably, he serves as a mentor and advisor to several VC funds and startup accelerators, including IndieBio HIMSS/Health 2 0 ’s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture, UCSF Invent Fund, and California Life Sciences’s FAST program, to help grow California’s life sciences innovation ecosystem

Session Details:

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

2025-02-12, 12:15 PM

Session Details:

AI transforming healthcare and life sciences: From discovery to delivery

2025-02-12, 2:30 PM

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Peter St. Wecker, Ph.D.

Clinical Development Lead, Neurology, UCB

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

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

Some specifics about me:

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

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

Session Details:

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

2025-02-12, 12:15 PM

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Thomas Tremblay

Vice President, Head of Clinical Operations, Trefoil Therapeutics

Session Details:

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

2025-02-12, 9:30 AM

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

2025-02-12, 10:00 AM

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Dr. Andrew Feigin, MD

Chief Medical Officer, Rho

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

Session Details:

From endpoints to impact: Designing trials that resonate with patients

2025-02-11, 4:15 PM

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Sage Callaway

Associate Director, Clinical Business Operations, Oncology, Ascendis Pharma

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

Session Details:

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

2025-02-11, 12:00 PM

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Avnika Agarwal

Senior Director, Project Delivery, Biotech, ICON

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

Session Details:

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

2025-02-11, 12:00 PM

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Laura O’Donnell

Senior Director, Head, Global Site Engagement, GSK

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

Session Details:

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

2025-02-11, 12:00 PM

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Chitrang Dave

AI and Advanced Analytics Lead, Avidity Biosciences

Session Details:

Innovating with data in life sciences

2025-02-12, 9:00 AM

Session Details:

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

2025-02-12, 12:15 PM

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Chair’s opening remarks

2025-02-12, 8:50 AM

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Bruce Morimoto

Vice President, Drug Development, Alto Neuroscience

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

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

Session Details:

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

2025-02-11, 4:45 PM

Session Details:

Speaker Hosted Round Tables

2025-02-12, 3:30 PM

Session Details:

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

2025-02-12, 11:45 AM

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Kathryn Wine

Vice President Clinical Affairs, Novocuff

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

Session Details:

Strengthening partnerships and processes for clinical trial excellence in medical devices

2025-02-12, 2:00 PM

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Gina Morton

Former Director of Contracts and Outsourcing, Calico and Genentech

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

Session Details:

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

2025-02-12, 12:30 PM

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Speaker Hosted Round Tables

2025-02-12, 3:30 PM

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Dorothy H. Kwok

Head of Clinical Operations, Bodyport

Session Details:

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

2025-02-12, 12:15 PM

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Rozanno Gonzales

Clinical Innovation & Technology Leader, Genentech

Session Details:

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

2025-02-12, 12:15 PM

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Abby Kennedy

Senior Vice President of Clinical Operations, DermBiont

Session Details:

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

2025-02-12, 10:00 AM

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Vineeta Gulati

Former Director of Clinical Operations, CymaBay Therapeutics

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

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

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

Session Details:

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

2025-02-12, 10:00 AM

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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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Anthony L Colenburg Sr

Senior Director & Site Head of Quality, Sutro Biopharma

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

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

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

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

Session Details:

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

2025-02-11, 2:15 PM

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Katie Bessette

Director of Regulatory Affairs, Abbott Laboratories

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

Session Details:

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

2025-02-12, 10:30 AM

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Jenelle Lin

Associate Director, Clinical Operations, Aditum Bio

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

Session Details:

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

2025-02-12, 2:00 PM

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Archana Sah

Vice President, Head of Clincial Operations

Archana Sah, MS Pharm, PMP

Vice President, Head of Clincial Operations, Tizona Therapeutics

Chair, Society of Clinical Research Sites Oncology Board

Archana Sah is a clinical development thought leader with 22+ 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 within Biotech, Big pharma and Oncology startup companies and in the last five years she has led/contributed to 10 drugs from research to approvals in the Oncology and Immuno-oncology space at Genentech/Roche. She is currently Vice President, Head of Clinical Operations with Tizona Therapeutics, a company focused on improving outcomes for cancer patients by translating novel scientific insights into developing first-in-class immunotherapies.

She has led highly matrixed, cross-functional teams to create value and deliver strategy and execution with several molecules in Phase I-III development through approvals. Archana is recognized as a strategic expert on emerging topics ranging from therapeutic landscape/treatment trends expertise to thought leader relationship management. Her passion is to develop high-performing teams and create inclusive, empowering and diverse cultures focused on accountability and customer-centric mindset.

Ms. Sah also chairs the Society for Clinical Research Sites Oncology Board with a vision to cure cancer through efficiency in process and strength in the relationships between clinical research sites, pharmaceutical companies, oncology vendors and patients. She provides direction and guidance for the vision, mission and three strategic workstreams for the Board. Ms. Sah also serves as a member of American Cancer Society Cancer Action Network workstreams on Barriers to Clinical Trial Enrollment Implementation, Clinical Trial Matching and ClinicaTrials.gov

She holds patents, publications, performance awards, and is often an invited speaker at several industry conferences. Ms. Sah received her Master’s in Pharmaceutical Sciences from University of Cincinnati, College of Pharmacy and a Bachelors in Pharmacy from M. S. University in India.

Session Details:

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

2025-02-12, 11:45 AM

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Kade Shippy

Chief Diversity Office, Patient Inclusion and Health Equity, Genentech

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

Session Details:

Speaker Hosted Round Tables

2025-02-12, 3:30 PM

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Audrey Funwie

Chief Diversity Office, Patient Inclusion and Health Equity, Genentech

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

Session Details:

Speaker Hosted Round Tables

2025-02-12, 3:30 PM

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Hayley Lane

Vice President Clinical Operations, Star Therapeutics

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

Session Details:

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

2025-02-12, 10:00 AM

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Debbie Donovan

Head of Commercial Operations, Materna Medical

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

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

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

Session Details:

Remote study on a shoestring: lessons from an OTC clinical trial

2025-02-12, 10:00 AM

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Sharon Crugnale

Vice President, Clinical Development Operations, Bitterroot Bio

Session Details:

Session reserved for Sharon Crugnale

2025-02-11, 3:15 PM

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Advisory Board

Select a member to learn more

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Bao Dinh

Global Development Business Operation, Takeda

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

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

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Demonstrate your expertise on the agenda – have the attention of the entire audience. For greatest impact, why not position your talk before a networking break and immediately conduct follow up conversations with highly engaged attendees
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Present the value proposition of your offering over your competitors, in front of an audience of active, engaged potential customers
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800+ attendees each year
80% attendees C-suite level

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Nick McCudden

Head of OCT Events

NicholasMcCudden@arena-international.com +61 280 978 126

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Niki.Khoshkbary@arena-international.com +44 204540 7545

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moona.popal@arena-international.com

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VIP Delegate Manager

sunny.saikia@arena-international.com

Sponsorship Enquiries

To enquire about sponsorship opportunities for the conference, please contact:

Nick McCudden

Head of OCT Events

NicholasMcCudden@arena-international.com

+61 280 978 126

Speaker Enquiries

To enquire about speaking opportunities for the conference, please contact:

Niki Khoshkbary

Senior Conference Producer

niki.khoshkbary@arena-international.com

+44 204540 7545

18th Annual Outsourcing in Clinical Trials West Coast 2026

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

2025 Sponsors Include:

WHAT TO EXPECT FOR 2025?

Testimonials

See What It's All About

2025 Agenda

Streams

11 AM

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

Speakers

11:30 AM

From guidance to action: Diversity insights and industry trends

Speakers

12 PM

PANEL DISCUSSION: Is clinical trial exclusion criteria too stringent?

Speakers

12:45 PM

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

Speakers

1:15 PM

Lunch and networking sponsored by Thermo Fisher Scientific

2:15 PM

Patient Engagement starts with the Informed Consent Form

Speakers

2:45 PM

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

Speakers

3:15 PM

Patient perspective: My clinical trial journey

Speakers

3:45 PM

Afternoon refreshments and networking

4:15 PM

From endpoints to impact: Designing trials that resonate with patients

Speakers

4:45 PM

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

Speakers

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

11 AM

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

Speakers

11:30 AM

End-to-End financial management: Challenges and opportunities

Speakers

12 PM

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

Speakers

12:45 PM

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

Speakers

1:15 PM

Lunch and networking sponsored by Thermo Fisher Scientific

2:15 PM

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

Speakers

2:45 PM

Maximizing asset valuation for biopharma

Speakers

3:15 PM

Session reserved for Sharon Crugnale

Speakers

3:45 PM

Afternoon refreshments and networking

4:15 PM

Start expecting more from eCOA/ePRO

Speakers

4:45 PM

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

Speakers

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

7:30 AM

Registration & Refreshments

8:20 AM

Chair’s opening remarks

Speakers

8:30 AM

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

Speakers