Outsourcing in Clinical Trials West Coast (OCT West)

Break · Outsourcing & Clinical Operations

Registration & Refreshments

Other · Outsourcing & Clinical Operations

Chair’s opening remarks

Susan Edelstein, Ardelyx

Keynote · Outsourcing & Clinical Operations

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

Leesa Gentry, RenovoRx

Talk · Outsourcing & Clinical Operations

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

Tatiana Eidus, ARENSIA Exploratory Medicine

Talk · Outsourcing & Clinical Operations

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

Susan Edelstein, Ardelyx

Talk · Outsourcing & Clinical Operations

Maximizing the consultative partnership between CRO and pharma/biotech partners

Marija Jovanovic, ICON

Break · Outsourcing & Clinical Operations

Morning refreshments and networking break sponsored by Ergomed

Talk · Patient Centricity and DEI

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

Christine Van Raesfeld

Talk · Clinical Technology & Innovation

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

Matthew Albert, Octant Biosciences

Talk · Outsourcing & Clinical Operations

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

Laurin Vincent, Gilead

Talk · Patient Centricity and DEI

From guidance to action: Diversity insights and industry trends

Stephanie Hitchcock, PCM Trials

Talk · Clinical Technology & Innovation

End-to-End financial management: Challenges and opportunities

Zahiah Gueddar, IQVIA Technologies

Talk · Outsourcing & Clinical Operations

The 2025 Biotech Landscape: Perspectives and Projections

Aditya Kotta, Novotech

Panel · Patient Centricity and DEI

Panel discussion: Is clinical trial exclusion criteria too stringent?

Jad Adaimi, Ultragenyx · Marla Williams, Exelixis · Nisha Trivedi · Meghan McKenzie, Genentech · Cathy Scharf, Patient Advocates of the East Bay

Panel · Clinical Technology & Innovation

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

Meir Pinco, BeiGene · John Rootenberg, Genentech · Joshua Cox, Eli Lilly and Company

Panel · Outsourcing & Clinical Operations

Panel discussion: Battling insufficient resources to allow your trial to succeed in an increasingly competitive landscape

Sage Callaway, Ascendis Pharma · Jenni Herber, Kamau Therapeutics · Avnika Agarwal, ICON · Susan Edelstein, Ardelyx · Laura O’Donnell, GSK

Talk · Patient Centricity and DEI

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

Catherine Jervis, MRN

Talk · Clinical Technology & Innovation

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

Kathleen Dowell, Clario

Talk · Outsourcing & Clinical Operations

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

Lona Sheeran, Worldwide Clinical Trials

Break · Patient Centricity and DEI · Clinical Technology & Innovation · Outsourcing & Clinical Operations

Lunch and networking sponsored by Thermo Fisher Scientific

Talk · Patient Centricity and DEI

Patient Engagement starts with the Informed Consent Form

Ros Cheetham, MacroGenics

Talk · Clinical Technology & Innovation

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

Anthony L Colenburg Sr, Sutro Biopharma

Talk · Outsourcing & Clinical Operations

Session reserved for Jenni Herber

Jenni Herber, Kamau Therapeutics

Talk · Patient Centricity and DEI

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

Sarah Cross, Premier Research

Talk · Clinical Technology & Innovation

Maximizing asset valuation for biopharma

Kenneth Park, Fortrea

Talk · Outsourcing & Clinical Operations

Driving success: Strategies for optimal site support

Eleanor Miller, PSI CRO

Talk · Patient Centricity and DEI

Patient perspective: My clinical trial journey

Nisha Trivedi

Talk · Clinical Technology & Innovation

Session reserved for Sharon Crugnale

Sharon Crugnale, Bitterroot Bio

Fireside chat · Outsourcing & Clinical Operations

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

Bao Dinh, Takeda · David Larwood, Valley Fever Solutions

Break · Patient Centricity and DEI · Clinical Technology & Innovation · Outsourcing & Clinical Operations

Afternoon refreshments and networking

Talk · Patient Centricity and DEI

From endpoints to impact: Designing trials that resonate with patients

Andrew Feigin, Rho

Talk · Clinical Technology & Innovation

Start expecting more from eCOA/ePRO

Steve Rosenberg, uMotif

Talk · Outsourcing & Clinical Operations

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

Jonathan Raven, Emsere · Bryan Dunlap, Emsere

Panel · Patient Centricity and DEI

Closing panel discussion: Innovative approaches to engage and retain patients in an era of recruitment struggles

Ros Cheetham, MacroGenics · Bruce Morimoto, Alto Neuroscience · Susan Edelstein, Ardelyx

Panel · Clinical Technology & Innovation

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

Joshua Cox, Eli Lilly and Company · Yuyi Shen, Abcuro · Sarah Hamirani, AbbVie · Jasmina Jankicevic, RAPT Therapeutics · Prasun Mishra, Precision BioPharma

Panel · Outsourcing & Clinical Operations

Closing panel discussion: Macro perspective: Facilitating the harmonization and equivalence of working across regions

Leesa Gentry, RenovoRx · Sandra Nino-Siddens, Ultragenyx Pharmaceutical · Bogdan Sandica, ARENSIA Exploratory Medicine · Revati Tatake, GlobalData Plc

Other · Outsourcing & Clinical Operations

Chair’s closing remarks

Break · Outsourcing & Clinical Operations

Registration and refreshments

Other · Medical Devices

Chair’s opening remarks

Chitrang Dave, Avidity Biosciences

Other · Clinical Data Management

Chair’s opening remarks

Joshua Cox, Eli Lilly and Company

Other · Outsourcing & Clinical Operations

Chair’s opening remarks

Revati Tatake, GlobalData Plc

Talk · Medical Devices

Innovating with data in life sciences

Chitrang Dave, Avidity Biosciences

Keynote · Clinical Data Management

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

Meir Pinco, BeiGene

Keynote · Outsourcing & Clinical Operations

Keynote: Designing trials to reduce patient and site burden

Shantheri Pai, Gilead

Talk · Medical Devices

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

Lian Cunningham, Endogenex

Talk · Clinical Data Management

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

Thomas Tremblay, Trefoil Therapeutics

Talk · Outsourcing & Clinical Operations

Beyond traditional labels: Customized outsourcing strategies for biotech and pharma

Neil Berger, Parexel

Talk · Medical Devices

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

Debbie Donovan, Materna Medical

Panel · Clinical Data Management

Panel discussion: Choosing an outsourcing model: FSO vs FSP vs inhouse

Joshua Cox, Eli Lilly and Company · Hayley Lane, Star Therapeutics · Ros Cheetham, MacroGenics · Thomas Tremblay, Trefoil Therapeutics · Jenni Herber, Kamau Therapeutics

Talk · Outsourcing & Clinical Operations

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

Abby Kennedy, DermBiont · Vineeta Gulati, CymaBay Therapeutics

Talk · Medical Devices

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

Katie Bessette, Abbott Laboratories

Talk · Clinical Data Management

Session reserved for Revati Tatake

Revati Tatake, GlobalData Plc

Talk · Outsourcing & Clinical Operations

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

Katsura Kasahara, EPS Corporation

Break · Outsourcing & Clinical Operations · Medical Devices · Clinical Data Management

Morning refreshments and networking

Talk · Medical Devices

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

Tania Pearson, Medtronic

Talk · Clinical Data Management

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

Bruce Morimoto, Alto Neuroscience

Talk · Outsourcing & Clinical Operations

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

Archana Sah, Society for Clinical Research Sites

Panel · Medical Devices

Panel discussion: Key considerations for evaluating clinical vendors in effective study execution

Chitrang Dave, Avidity Biosciences · Dorothy H. Kwok, Bodyport · Rozanno Gonzales, Genentech

Panel · Clinical Data Management

Panel discussion: Embracing innovative technologies in clinical data management: Opportunities and challenges

Joshua Cox, Eli Lilly and Company · Janet Moga, Astellas Gene Therapies · Prasun Mishra, Precision BioPharma · Peter St. Wecker, UCB

Talk · Outsourcing & Clinical Operations

Technology spotlight: Innovative Digital Opinion Leader Identification with Adnexi to Improve Trial Awareness

Sandra Shpilberg, Adnexi

Talk · Outsourcing & Clinical Operations

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

Gina Morton, Calico and Genentech

Break · Outsourcing & Clinical Operations · Medical Devices · Clinical Data Management

Lunch and networking

Talk · Medical Devices

Strengthening partnerships and processes for clinical trial excellence in medical devices

Kathryn Wine, Novocuff

Talk · Clinical Data Management

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

Chris Chan, IGM Biosciences

Talk · Outsourcing & Clinical Operations

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

Jenelle Lin, Aditum Bio

Other · Medical Devices

Chair’s closing remarks and close of stream

Talk · Clinical Data Management

AI transforming healthcare and life sciences: From discovery to delivery

Prasun Mishra, Precision BioPharma

Talk · Outsourcing & Clinical Operations

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

Amy Mou, Pfizer

Break · Outsourcing & Clinical Operations

Afternoon refreshments, networking & prize draw in exhibition room

Roundtable · Outsourcing & Clinical Operations

Speaker Hosted Round Tables

Bruce Morimoto, Alto Neuroscience · Meghan McKenzie, Genentech · Kade Shippy, Genentech · Audrey Funwie, Genentech · Gina Morton, Calico and Genentech

Other · Outsourcing & Clinical Operations

Chair’s closing remarks and end of conference

Networking · Patient Centricity and DEI · Clinical Technology & Innovation · Outsourcing & Clinical Operations

End of day 1 and networking drinks sponsored by Dr. Vince Clinical Research