13th Annual Outsourcing in Clinical Trials Southern California 2025

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

23 - 24

September

2025
  • Hyatt Regency La Jolla at Aventine, San Diego, USA
  • Complimentary
  • Why attend?
  • Agenda
  • OCT Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Why partner?
  • Resources
  • Contact Us
close

Why attend?

WHAT TO EXPECT FOR 2025?

As this event returns you can expect high level discussion and presentations with industry thought leaders focusing on novel and innovative solutions to some of this years key challenges. Additionally with our technology and innovation stream, learn what is in store for the future of clinical trials.

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, Inspection Readiness presented by the FDA, 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 2 full streams complete with key content.

450+

ATTENDEES

65+

EXHIBITORS

30+

SPEAKERS

50%

ATTENDEES AT DIRECTOR + LEVEL

450+

ATTENDEES

65+

EXHIBITORS

30+

SPEAKERS

50%

ATTENDEES AT DIRECTOR + LEVEL

See What It's All About

Agenda

  • 23 Sep 2025
  • 24 Sep 2025
Expand All

Streams

Stream one

Stream A: Outsourcing & Clinical Operations

Stream two

Stream B: Clinical Trial Technology & Innovation

11 AM

Case study: Integrating vendor data to provide a 360°view of clinical trial progress

  • What are KPIs and how are they used to monitor project progress?
  • What are best practices for selecting KPIs?
  • What are some ways to visually display KPIs for fast understanding and actionable insights?

Speakers

Joe Stalder
VP Program Management, Zentalis

11:30 AM

Reserved for event sponsor

12 PM

PANEL DISCUSSION: Are sponsors ready for AI?

  • How GenAI utilizes existing data and prediction models for clinical trials to reduce the operational burden
  • In a conservative and cautious industry, are sponsors truly ready for AI adoption?
  • Understanding the risks of diving head-first into a technology many still struggle to conceptualize
  • How much risk is too much risk when implementing AI into your trial?
  • Why an over-reliance on AI will ultimately fail: The need for human oversight when the tool is deployed and having enough people reviewing the quality of the data that goes into the final dataset
  • Examples of successful and unsuccessful AI adoption

Speakers

Amy VandenBerg
Vice President of Regulatory Affairs, Biolinq
Michael Murphy
Director, Legal and Associate General Council, Ionis Pharmaceuticals
Joe Stalder
VP Program Management, Zentalis

12:45 PM

Reserved for technology spotlight

1 PM

Lunch and Networking

2 PM

When innovation doesn’t go as expected

  • A case study from WinSanTor
  • How to best implement innovative e-clinical software systems to ensure they work within the service provider universe
  • A harmonious partnership: Balancing innovation and data safety
  • When service providers have too much power, how can we ensure innovation isn’t stifled?

Speakers

Stanley Kim
CEO, WinSanTor

2:30 PM

Reserved for event sponsor

3 PM

Utilizing third party vendors for clinical trial support

  • Determining team bandwidth
  • Assessing clinical trial needs
  • Shopping for the right CRO(s)
  • Lessons learned from outsourcing

Speakers

Bridget Adams
Director, Clinical Operations, Sofie Biosciences

3:30 PM

Afternoon refreshments and networking

4 PM

Studies Beyond Borders: Managing the logistics of conducting worldwide clinical trials

  • Navigating global data restrictions: Lowering concerns and finding solutions regarding the limitations on research imposed by GDPR in the EU
  • Sharing best practice for scaling studies across multiple states and countries despite a lack of consistency with regulations
  • Looking at the intersection of data privacy and sample ownership regulations with the business imperative to address new questions that may arise during study analysis
  • Addressing concerns at the protocol and ICF development phase

Speakers

Michael Murphy
Director, Legal and Associate General Council, Ionis Pharmaceuticals

4:30 PM

Reserved for event sponsor

5 PM

CLOSING PANEL DISCUSSION: Ensuring your FSP model is a success

  • Working closely with FSP vendors: how much oversight do you need?
  • Benefits and challenges of moving to an FSP outsourcing model
  • Comparing vendor management strategies between pharma and biotechs: do you need a different approach?
  • Why is FSP becoming a popular outsourcing model: what benefits can this offer sponsors?

7:30 AM

Registration and Refreshments

8:20 AM

Chair’s Opening Remarks

Speakers

Robert Loll
SVP, Business Development, Praxis Communications

8:30 AM

KEYNOTE: Study start-up challenges in a competitive environment

  • Overcoming financial constraints when budgets are limited and resources tight
  • Fierce competition: How start-ups can compete with established companies for skilled talent
  • Utilizing technology to improve efficiency, reach wider audiences, and differentiate from competitors without compromising patient safety
  • Agile and adaptable: Being prepared to adjust your strategy and approach as needed

Speakers

Janal Urich
Vice President Clinical Development, Atara Biotherapeutics

9 AM

Reserved for event sponsor

9:30 AM

PANEL DISCUSSION: Where is the clinical trial industry headed in 2025?

  • Moving studies forward on unknown territory: Funding clinical trials amidst recent research policy changes and abrupt NIH cuts
  • Shining light on the changing scope of the FDA: Discussion of the latest changes under the new administration including years of critical DEI work
  • Technological developments into 2025 and beyond: what changes can we expect to see in the next 3-5 years?
  • Navigating the constantly evolving vendor and CRO landscape as a small to mid-sized sponsor company

Panelists: Joanna Bolger, VP of Development Operations, MycoMedica

Speakers

Joanna Bolger
VP of Development Operations, MycoMedica

10 AM

Reserved for event sponsor

10:30 AM

Morning Refreshments and Networking

11 AM

Strategies for successful recruitment and retention into clinical trials

  • Discuss methods for identifying and engaging the right patient population
  • Learn strategies for reducing barriers to participation
  • Focus on enhancing site and investigator engagement training, tools, and incentives
  • Building trust - communication and transparency takeaways

Speakers

Sagar Vaidya
Chief Medical Officer, Cerevance

11:30 AM

Reserved for event sponsor

12 PM

PANEL DISCUSSION: Identifying patients as equal partners and including their voice in all stages of drug development

  • Acknowledging the value that patients can bring to every stage of the drug development pathway
  • Engaging patients and advocacy groups early on in the clinical trial design process
  • How minimizing participant burden leads to on-time enrollment and completion
  • Combining patient perspectives with those of healthcare professionals to create a holistic trial model
  • Highlighting financial incentives to amplify the patient voice

Chair: Robert Loll, SVP, Business Development & Strategic Planning, Praxis

Speakers

Robert Loll
SVP, Business Development, Praxis Communications
Anne Severtson
Senior Director, Clinical Operations, AnaptysBio
Michelle Finegan
Senior Director, Patient Advocacy and Strategic Alliances, Neurelis

12:45 PM

Reserved for technology spotlight

1 PM

Lunch and Networking

2 PM

Fine-tuning the site-sponsor partnership by aligning strategies and fostering ongoing communication and flexibility

  • When the demand for research sites is growing and supply is failing to keep up, what can be done for competing trials?
  • Dealing with exorbitant startup fees imposed by sites, with no guarantee of patient enrolment
  • Elevating site support with comprehensive budgets and accelerated site payments
  • Enabling appropriate technology for sponsors to easy access patients’ EMR
  • Working to identify "hidden” costs and trial efforts that sites may not anticipate before negotiations
  • Overcoming outdated paradigms that threaten site-sponsor relationships
  • Carving out a niche to set you apart from the crowd to enable access to sites and patient populations

Speakers

Anne Severtson
Senior Director, Clinical Operations, AnaptysBio

2:30 PM

Reserved for event sponsor

3 PM

Importance of effective vendor management in the clinical trial process through teamwork and clarity

  • Streamlining vendor management to reduce costs and timelines and to improve overall operational efficiency: Clear communication, defined roles and responsibilities and standardized documentation to enhance accessibility and collaboration
  • Mitigating risks associated with compliance, quality, and data integrity and reducing the impact of delays in patient recruitment, data collection, and regulatory submissions on trial budgets and timelines
  • Setting specific, measurable KPIs to evaluate vendor performance throughout the trial, focusing on metrics such as patient enrollment rates, data accuracy, and timeline adherence
  • Leverage technology for real-time monitoring of trial progress and vendor performance, allowing prompt identification of issues
  • Comprehensive evaluation of the closing out the trial process: Aligning goals, timelines and encouraging proactive management of timelines to identify potential bottlenecks early and involve vendors in the resolution process

Speakers

Kim Potter
Director of Clinical Operations, Alume Biosciences

3:30 PM

Afternoon refreshments and networking

4 PM

PATIENT SPOTLIGHT: Effective collaboration in the trial ecosystem: How should pharma work with patient organizations and what are the best ways to engage with them?

  • Highlighting and overcoming the pitfalls of working with patient groups and how to facilitate the outreach to ensure everyone is onboard
  • Tackling lack of patient awareness: Improved methods of connecting community‐based researchers with those in academic centers conducting trials
  • Elevating trial credibility by better working with networks globally to find patients and identify the best centers
  • Why patient advocacy groups becoming gatekeepers for connecting sponsors and vendors
  • Groups becoming gatekeepers for connecting sponsors and vendors
  • A case study presented by Lupus Research Alliance on advancing medical research that will produce promising treatments for patients

Speakers

Amanda Greene
Patient Advocate

4:30 PM

Reserved for event sponsor

5 PM

CLOSING PANEL DISCUSSION Genuine, constructive partnerships: Effective approaches to CRO management without compromising efficiency, quality and patient safety

  • Setting up for success with large CROs in terms of contract structures, financial terms and governance from a small biotech perspective
  • Implementing a gold standard strategic partnership to avoid common pitfalls and improve vendor selection
  • Knowing when to outsource and detailing key activities to be performed for each vendor service to ensure proper oversight
  • Factoring in necessary contracts and approvals for vendor selection in study timelines

Speakers

Robert Loll
SVP, Business Development, Praxis Communications
Chad Orevillo
Executive Vice President, Head of Development Operations, Inhibikase Therapeutics
Delia Alvarez
Executive Director, Clinical Operations, Inhibrx

5:45 PM

Chair’s closing remarks

END OF DAY 1 AND NETWORKING DRINKS

Streams

Stream one

Stream A: Outsourcing & Clinical Operations

Stream two

Stream B: Clinical Trial Technology & Innovation

9 AM

KEYNOTE: Leveraging data-driven insights and cross-functional collaboration to drive patient-centric innovation in clinical trials

  • Placing data-driven insights at the core: Need for integrating real-world data (RWD) and real-world evidence (RWE) into clinical trial design
  • How data-driven insights enhance patient engagement and improve trial outcomes, addressing unmet patient needs?
  • Driving patient-centric innovation with AI: Role of AI in personalizing patient selection, optimizing recruitment, and predicting treatment responses
  • Bridging silos: medical, commercial, and clinical teams: Impact of collaboration between commercial, medical, and clinical teams to ensure a holistic patient journey
  • Harnessing technology for improved trial efficiency: Examples of successful deployments of AI and analytics in clinical trials, showing measurable impacts on trial success rates

Speakers

Murali Pinnaka
Senior Director, Analytics and Insights for Commercialization, Arcutis Biotherapeutics

9:30 AM

Reserved for event sponsor

10 AM

How clinical data consolidation can bring precision to patient care

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

Speakers

Preeti Baweja
Director, Clinical Operations, Ventyx Biosciences

10:30 AM

Morning refreshments and networking

11 AM

PANEL DISCUSSION: Selecting the right partners to leverage new technologies in clinical research

  • Understanding the risks and opportunities in collaborating with technology providers to drive innovation in pharma
  • Key criteria in vendor selection: How important is therapeutic area knowledge when choosing CROs and partners?
  • Balancing patient, site, CRO and investor priorities in your trial design
  • Navigating the outsourcing landscape: An overview of new tools and solutions available on the market

Speakers

Ines Hoffmann
Strategic Director of Clinical Operations, Verge Genomics
Vara Wuyyuru
Global Principle Clinical Lead, Alcon
Bridget Adams
Director, Clinical Operations, Sofie Biosciences

11:45 AM

Reserved for event sponsor

12:15 PM

How to align financial incentives between CROs and biotechs so that both sides win

  • Fine-tuning the partnership and incentivizing CROs to be more thoughtful in proposals
  • Reconsidering PM involvement and responsibilities
  • Encouraging data system investment
  • Building better budgets on the known

Speakers

AJ Bergmann
Chief Financial Officer, Capricor Therapeutics

12:45 PM

Lunch and networking

8 AM

Registration

8:15 AM

Interactive Breakfast Speaker-Hosted Roundtable Discussions

With drinks and refreshments, 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. Each discussion will be led by a table moderator and will focus on a different challenge within clinical trials. Roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

  1. Roundtable 1- Emerging startup company trends and challenges
    Hosted by Peter Heifetz, CEO, OrPro Therapeutics
  2. Roundtable 2- Navigating the latest release of ICH E6 (R3): How are you carrying out gap assessments of processes and what changes are you making?
    Hosted by Christina Sanchez, Director, Clinical Quality Assurance, Neurocrine Biosciences
  3. Roundtable 3- Postproduction handling and administration of biologics drugs
    Hosted by Kevin Zen, Director, Opthea
  4. Roundtable 4- Implications of the latest administration on clinical trial progress
  5. Roundtable 5- Successfully navigating the study startup phase

8:50 AM

Chair’s Opening Remarks

9 AM

KEYNOTE: (Clinical) Trials and Tribulations – Our biotech’s out of US Phase 1 experience

  • Voyage of Discovery: Why we crossed the ocean for our FIH Trial
  • Speed Dating: Choosing partners for the clinical research dance
  • Do You Feel a Draft?: Endless iterations of study-specific documents
  • H-Wrecked: navigating unexpected reefs in the journey to study start-up
  • Out of Site, Out of Mind

Speakers

Roger Schechter
Director, Clinical Research, SMSbiotech

9:30 AM

Reserved for event sponsor

10 AM

FIRESIDE CHAT: Reinforcing the sponsor’s pivotal role in ensuring trial integrity with the latest ICH E6 (R3) updates on sponsor oversight

  • What are the guidelines suggesting sponsors to do internally, from the perspective of QA, governance and metrics?
  • Recommended vendor management reporting: the oversight, the eTMF and data quality/ validation oversight
  • How are sponsors going to address these suggested new guidelines from ICH and what are the timelines to react and the most immediate need?
  • Understanding updated requirements to document oversight of who is contracted with any sub-contractors
  • Focusing on a proportionate risk-based approach to vendor oversight and encompassing a broad range of information
  • Addressing the robustness of the Quality Management System or oversight of vendors and highlighting the data types that the ICH suggests
  • Processes and practices currently being implemented that are responding well to the ICH guidelines

Chair: Robert Loll, SVP, Business Development & Strategic Planning, Praxis

Speakers

Robert Loll
SVP, Business Development, Praxis Communications
Kerry Clancy
Director, Outsourcing and Contract Management, AnaptysBio
Barbara Birch
Associate Director, Clinical Vendor Management, Ultragenyx

10:30 AM

Morning refreshments and networking

11 AM

PANEL DISCUSSION: How can smaller biotechs achieve scalability when resources are tight

  • Accomplishing the right vendor selection to ensure better equipped budget and overhead wise for smaller companies
  • Optimizing boutique service providers to guarantee the flexibility and attention you need for study start up
  • Building the appropriate infrastructure needed to scale up clinical research and knowing when to invest in outsourcing services
  • Looking at the latest technologies which are demonstrating that scalability is a solvable problem
  • Having a comprehensive understanding of global requirements and timelines

Chair: Robert Loll, SVP, Business Development & Strategic Planning, Praxis

Speakers

Robert Loll
SVP, Business Development, Praxis Communications
Shaily Garg
Head of Clinical and Requlatory Affairs, ReacX Pharmaceuticals
Diane Ichinaga
Associate Director, Outsourcing and Budget Management, ImmunityBio
Matthew Spear
Chief Medical Officer, Chief Development Officer, Denovo Biopharma
Kim Potter
Director of Clinical Operations, Alume Biosciences

11:45 AM

Reserved for event sponsor

12:15 PM

Engaging in successful partnerships with the U.S. NIH

  • Growing in a thoughtful manner to ensure FDA inspection readiness
  • Allowing future studies to benefit from standards established and remained consistent right from the start
  • Engaging in respectful partnerships and supporting a demand-driven basis, aligning with country-driven strategies and procedures

Speakers

Allan Camaisa
CEO & Chair of The Board of Directors, Calidi Biotherapeutics

12:45 PM

Lunch and networking

1:45 PM

Session reserved for GlobalData

2:15 PM

Reserved for event sponsor

2:45 PM

Afternoon networking, prize draw and closing remarks

3:30 PM

END OF CONFERENCE

Speakers

Select a speaker to learn more

Back
Vara Wuyyuru
Global Principle Clinical Lead, Alcon
  • 20+ years’ experience in clinical development, and operations in class II and III implantable medical device industry.
  • Known for outstanding work ethic and delivering the clinical projects on time and budget.
  • Adept and pragmatic in using project management tools with a focus on cross-functional collaboration and achieving goals by deadlines.
  • Steered the team in accordance with company strategic vision and business expectations sticking to commitments with clinical development & medical affairs partners.
  • Lead clinical support for commercial products globally (US, EU, Canada, Paris, Swiss, Germany, Turkey, Russia, Singapore, Taiwan and Korea).
  • Expert in clinical data analysis, patient reported outcome (PRO) design and assessment, and data analytics. Comprehensive knowledge about clinical database systems design and development.
  • Highly passionate, technology driven, big picture oriented team player.

Session Details:

PANEL DISCUSSION: Selecting the right partners to leverage new technologies in clinical research

2025-09-24, 11:00 AM

View In Agenda
Next speaker
Back
Kim Potter
Director of Clinical Operations, Alume Biosciences

I contribute to protocol development, protocol medical writing, conceptual development per FDA guidance, background research, QC/QA, compilation of TMF, and briefing and supporting documents. I am experienced in writing/reviewing ICFs, CSRs, NTF/MTF, IRB material, data tables, data spreadsheets, and briefing documents. I am responsible for the development and execution of clinical study plans and budget analysis. I am skilled in MS Office, SAS and SPSS, EDC, public speaking, and team building.

Session Details:

PANEL DISCUSSION: How can smaller biotechs achieve scalability when resources are tight

2025-09-24, 11:00 AM

Session Details:

Importance of effective vendor management in the clinical trial process through teamwork and clarity

2025-09-23, 3:00 PM

View In Agenda
Next speaker
Back
Anne Severtson
Senior Director, Clinical Operations, AnaptysBio

I am a clinical research operations specialist with two decades of experience with CRO's, startups, research sites, and small consulting firms. I am creative, efficient, effective, and a problem solver. I am able to identify with the challenges of research from many different perspectives.

Session Details:

Fine-tuning the site-sponsor partnership by aligning strategies and fostering ongoing communication and flexibility

2025-09-23, 2:00 PM

Session Details:

PANEL DISCUSSION: Identifying patients as equal partners and including their voice in all stages of drug development

2025-09-23, 12:00 PM

View In Agenda
Next speaker
Back
Kerry Clancy
Director, Outsourcing and Contract Management, AnaptysBio

Result-driven professional in the life sciences industry with 25 years of combined vendor outsourcing/selection, proposal/RFI development, contract management, process improvement, and team leadership expertise. Resourceful and proficient in problem solving and risk mitigation, negotiating cost savings, vendor relationship management, contract and change order negotiations, and streamlining processes to support clinical outsourced services.

Session Details:

FIRESIDE CHAT: Reinforcing the sponsor’s pivotal role in ensuring trial integrity with the latest ICH E6 (R3) updates on sponsor oversight

2025-09-24, 10:00 AM

View In Agenda
Next speaker
Back
Murali Pinnaka
Senior Director, Analytics and Insights for Commercialization, Arcutis Biotherapeutics

As a Practice Leader in Advanced Analytics and Data Science for Life Sciences Commercialization, I specialize in navigating the complexities of data and technology strategy to drive impactful business outcomes. My expertise spans Life Sciences Commercialization from pre to post-launch, crafting robust Data Strategies, defining KPIs and BI Strategies, and leveraging Advanced Analytics for a comprehensive understanding of the Patient Journey. I also bring a rich and diverse experience of guiding 20+ large bio-tech, emerging pharma, and med-tech companies involved with their product launches, growth trajectory, and M&A scenarios

With a deep focus on Customer Strategy and Segmentation, Opinion Leader Intelligence, Omni Channel, and CRM Experience, I deliver actionable insights that drive organizations towards success. I bring deep expertise around diverse commercial and market access data, to help deliver insights for key account planning, payer targeting and various other operational and analytics use cases

Leveraging a diverse skill set, I excel in Cross-Functional Partnerships, Team Building, and Coaching, driving data science, engineering, and architecture initiatives. Proficient in Cloud Architecture and tools for CRM/CDP/MDM, I bring an Agile mindset to strategy and execution.

Session Details:

KEYNOTE: Leveraging data-driven insights and cross-functional collaboration to drive patient-centric innovation in clinical trials

2025-09-24, 9:00 AM

View In Agenda
Next speaker
Back
Janal Urich
Vice President Clinical Development, Atara Biotherapeutics

Session Details:

KEYNOTE: Study start-up challenges in a competitive environment

2025-09-23, 8:30 AM

View In Agenda
Next speaker
Back
Amy VandenBerg
Vice President of Regulatory Affairs, Biolinq

Session Details:

PANEL DISCUSSION: Are sponsors ready for AI?

2025-09-23, 12:00 PM

View In Agenda
Next speaker
Back
Allan Camaisa
CEO & Chair of The Board of Directors, Calidi Biotherapeutics

Allan Camaisa is a serial entrepreneur, investor, and technologist, with proven leadership skills in bootstrapping startups. He has had four successful exits, which were sold to publicly traded Fortune 1000 companies. Mr. Camaisa has always created a tremendous return for his shareholders. He has proven operational experience in recruiting the right team as well as creating a culture of trust, and collaboration. Since taking over as Chairman and CEO of Calidi Biotherapeutics, he signed an agreement with National Institute of Health (NIH), recruited top immunologists to the Scientific Advisory Board, and entered license negotiations with large pharmaceutical organizations.

Before entering business, Mr. Camaisa served eight years as a surface warfare officer in the United States Navy. He currently owns seven U.S. patents and has received many personal awards including the Deloitte FAST 50, the Governor’s Small Business of the Year Award and the Ernst and Young Regional Entrepreneur of the Year. He also received awards from the San Diego Asian Business Association and many other awards.

Session Details:

Engaging in successful partnerships with the U.S. NIH

2025-09-24, 12:15 PM

View In Agenda
Next speaker
Back
AJ Bergmann
Chief Financial Officer, Capricor Therapeutics

Session Details:

How to align financial incentives between CROs and biotechs so that both sides win

2025-09-24, 12:15 PM

View In Agenda
Next speaker
Back
Sagar Vaidya
Chief Medical Officer, Cerevance

Biotech executive driving progress to urgently create new medicines for people suffering from neurological diseases with significant unmet medical need.

Proven organizational leadership and management of cross-functional teams in a rapidly-growing matrix environment. Track record of delivering robust development plans tailored to each CNS disease indication. Experience across preclinical development, IND-filing, Phase I-IV studies, clinical trial design and operations, biomarker strategy, PK/PD, and regulatory submissions. Previous roles at Travere Therapeutics, BioMarin, Sangamo Therapeutics, and Harvard Medical School.

- Clinical development leader with a passion for science and broad range of experience across modalities and therapeutic areas, including small molecules, biologics, AAV-based gene therapy and engineered cell therapy.

- Board-certified physician with expertise across CNS diseases, rare diseases, internal medicine, pediatrics, immunology, and infectious diseases.

- Believer in the innovation economy and disruptive potential of big data/AI to radically improve drug development.

Session Details:

Strategies for successful recruitment and retention into clinical trials

2025-09-23, 11:00 AM

View In Agenda
Next speaker
Back
Matthew Spear
Chief Medical Officer, Chief Development Officer, Denovo Biopharma

Dr. Spear has been working in oncology and gene therapy research and development for over 30 years. He received a B.A. degree from the Johns Hopkins University and an M.D. degree from Stanford University. Post-graduate training was in the Massachusetts General Hospital / Harvard University program. He has served as an Associate Professor on the faculty of the USC Keck School of Medicine, and the UCSD Medical School / UCSD Cancer Center where he managed a clinical practice, drug discovery/gene therapy research, and clinical trial programs for cancer. Dr. Spear led multiple oncology clinical development programs at Pfizer. He subsequently served as Chief Medical Officer and Senior Vice-President at Nereus Pharmaceuticals, followed by Head of Oncology and Head of Biotherapeutics at Sunovion Pharmaceuticals, then as a Vice-President at Incyte and Sangamo Therapeutics, and Chief Medical Officer at Poseida Therapeutics developing multiple CAR-T cell and gene therapy products. He is currently Chief Development Officer / Chief Medical Officer at Denovo Biopharma. He has also served as a CIRM CAR-T cell principal investigator, NIH / NCI study section, CPRIT grant review panel, biotechnology and pharmaceutical advisory boards, IRB/SRC, and scientific journal editorial review committees related to cancer and gene therapy, as well as authoring numerous scientific papers and patent applications.

Session Details:

PANEL DISCUSSION: How can smaller biotechs achieve scalability when resources are tight

2025-09-24, 11:00 AM

View In Agenda
Next speaker
Back
Diane Ichinaga
Associate Director, Outsourcing and Budget Management, ImmunityBio

Session Details:

PANEL DISCUSSION: How can smaller biotechs achieve scalability when resources are tight

2025-09-24, 11:00 AM

View In Agenda
Next speaker
Back
Chad Orevillo
Executive Vice President, Head of Development Operations, Inhibikase Therapeutics

Experienced pharmaceutical professional with proven leadership of clinical development and operations teams

Session Details:

CLOSING PANEL DISCUSSION Genuine, constructive partnerships: Effective approaches to CRO management without compromising efficiency, quality and patient safety

2025-09-23, 5:00 PM

View In Agenda
Next speaker
Back
Delia Alvarez
Executive Director, Clinical Operations, Inhibrx

Session Details:

CLOSING PANEL DISCUSSION Genuine, constructive partnerships: Effective approaches to CRO management without compromising efficiency, quality and patient safety

2025-09-23, 5:00 PM

View In Agenda
Next speaker
Back
Michael Murphy
Director, Legal and Associate General Council, Ionis Pharmaceuticals

Session Details:

PANEL DISCUSSION: Are sponsors ready for AI?

2025-09-23, 12:00 PM

Session Details:

Studies Beyond Borders: Managing the logistics of conducting worldwide clinical trials

2025-09-23, 4:00 PM

View In Agenda
Next speaker
Back
Amanda Greene
Patient Advocate

I believe that storytelling is an invaluable way to create awareness and build community. Within the healthcare, entertainment and media sectors, I work with businesses, individuals and non-profit organizations to create, consult and build community. I facilitate clients, potential customers and vendors using the real-time web, helping companies build communities.

My professional experience include speaking from the perspective of a person living with chronic diseases at leading healthcare conferences from keynoting conferences, speaking and serving as a panelist. The patient perspective is vital in the healthcare conversation whether I am leading workshop and conference sessions for your company in a conference room or in front of over a thousand people in a ballroom. Including patients as advisers and consultants is a valuable way to gain insights and perspective. Using social media to create and build brand, product or event awareness my services provide engagement that works on across internet platforms in a variety of industry sectors. Understanding the power in "humanizing the connection" to work for you and your bottom line.

During the pandemic I became a certified Health and Life Coach, and I utilize my personal experience and training enable me to support and empower those living with a chronic illness. Whether newly diagnosed or struggling to manage the complexities of managing health and life. I strive to help everyone thrive with simple tools and easy shifts to create meaningful impact in their lives.

Session Details:

PATIENT SPOTLIGHT: Effective collaboration in the trial ecosystem: How should pharma work with patient organizations and what are the best ways to engage with them?

2025-09-23, 4:00 PM

View In Agenda
Next speaker
Back
Joanna Bolger
VP of Development Operations, MycoMedica

Clinical Development Operations Leader with over 20 years of drug development and clinical project management experience.

I am very passionate about drug development process and bringing new therapies to patients in need. My expertise benefits small and large biotech and pharmaceutical companies with all stages of drug and medical device development programs. I have worked in the following therapeutic areas: Alzheimer’s disease, oncology (hematologic malignancy T- cell therapy, and solid tumors), cardiology (stem cell therapy), infectious diseases, endocrinology and rare diseases.

Specialties: Clinical Operations department head (team structure and assignments), Clinical Study strategy and management (CRO/vendor selection, management and oversight) cross-functional team leader, global phase 3 studies, study sites selection, management and monitoring, study Protocol and other document writing, GCP and FDA regulations, budget management, risk management

Session Details:

PANEL DISCUSSION: Where is the clinical trial industry headed in 2025?

2025-09-23, 9:30 AM

View In Agenda
Next speaker
Back
Michelle Finegan
Senior Director, Patient Advocacy and Strategic Alliances, Neurelis

I have diverse experience in the pharmaceutical and medical device fields in patient advocacy as well as coaching pharma and STEM clients in communication and leadership skills.

I am passionate about patient advocacy and being the voice of the patient. I have held active and influential roles in advocacy, Key Opinion Leaders (KOL) relationships, marketing and senior management. My experience in both the commercial and patient advocacy side of business makes me:

  • Nimble in fast-paced, dynamic, regulated environments
  • Strong leadership skills with the ability to build high performance teams
  • Identify synergies and collaborations that support opportunities for the company with various stakeholders
  • Teamwork with the ability to work cross-functionally and communicate with a myriad of internal and external stakeholders

Session Details:

PANEL DISCUSSION: Identifying patients as equal partners and including their voice in all stages of drug development

2025-09-23, 12:00 PM

View In Agenda
Next speaker
Back
Christina Sanchez
Director, Clinical Quality Assurance, Neurocrine Biosciences
Next speaker
Back
Kevin Zen
Director, Opthea
  • Over 20 years of experience in Biologics CMC, both in large biopharma and startup biotech companies, providing operational and strategic leadership for process development, analytical development, manufacturing, and supply chain for clinical and commercial
  • Broad experience in selecting, partnering and managing the external service providers (CDMO and CRO) for tech transfer, process characterization, scale up/out, cGMP manufacturing, process validation (DS/DP PPQ), as well as analytical transfer, method validation, QC for release and stability, extended characterization (PTM, MAM, HCP by Proteomic MS, HOS, PS20/80 Degradation, Charge Variant Characterization, Cell-Based Assay), and comparability study
  • Deep understanding of regulatory requirements: FDA guidance, USP Pharmacopeia, Ph Eur, EMA, and ICH guidelines
  • Experience in co-authoring and reviewing CMC sections (Quality Module 3 DS and DP) for IND/IMPD
  • Strong expertise in GMP best practices (used to practice GMP at Catalent Biopharma Solutions for 5 years), applying “GMP principle” to non-GMP data integrity (good documentation practice and data verification) for global regulatory filings
  • Chairing specification committee on patient-centric specification setting and justification for in-process and final product QC release/stability
  • Experience in responding to the regulatory queries from health authorities worldwide
Next speaker
Back
Dr. Peter Heifetz
CEO, OrPro Therapeutics

Dr. Peter Heifetz is President and CEO of OrPro Therapeutics Inc., a Johnson & Johnson San Diego JLABS alumni company developing a novel biologic drug platform based on human thioredoxin for the treatment of multiple indications associated with inflammatory and oxidative stress. Dr. Heifetz has over 30 years of academic and industry experience in drug discovery and development with a primary focus on gene, protein and metabolic engineering technologies. Prior to founding OrPro, Dr. Heifetz held positions as a senior scientist and group leader at Novartis (NYSE: NVS), research director at the Novartis Research Foundation, head of biopharma and consumer health R&D at Syngenta (NYSE:SYT), fellow at Diversa Corporation (NASDAQ:DVSA), and was chief scientific officer at private biotechnology companies ERA Biotechnology (Barcelona) and Rincon Pharmaceuticals (San Diego). Dr. Heifetz studied at Duke University with degrees in genetics (PhD), mechanical/biochemical engineering (MS) and biology (BS) and was a National Institutes of Health graduate research trainee with interdisciplinary research support from the Department of Energy. Dr. Heifetz also earned an executive certificate in innovation management from the Kenan-Flagler School of Business at the University of North Carolina at Chapel Hill.

Next speaker
Back
Robert Loll
SVP, Business Development, Praxis Communications

Robert Loll is the SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies with award-winning creative and superior execution.  Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 16+ years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.  Robert is an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

Session Details:

Chair’s Opening Remarks

2025-09-23, 8:20 AM

Session Details:

PANEL DISCUSSION: Identifying patients as equal partners and including their voice in all stages of drug development

2025-09-23, 12:00 PM

Session Details:

FIRESIDE CHAT: Reinforcing the sponsor’s pivotal role in ensuring trial integrity with the latest ICH E6 (R3) updates on sponsor oversight

2025-09-24, 10:00 AM

Session Details:

PANEL DISCUSSION: How can smaller biotechs achieve scalability when resources are tight

2025-09-24, 11:00 AM

Session Details:

CLOSING PANEL DISCUSSION Genuine, constructive partnerships: Effective approaches to CRO management without compromising efficiency, quality and patient safety

2025-09-23, 5:00 PM

View In Agenda
Next speaker
Back
Shaily Garg
Head of Clinical and Requlatory Affairs, ReacX Pharmaceuticals

Session Details:

PANEL DISCUSSION: How can smaller biotechs achieve scalability when resources are tight

2025-09-24, 11:00 AM

View In Agenda
Next speaker
Back
Roger Schechter
Director, Clinical Research, SMSbiotech

Session Details:

KEYNOTE: (Clinical) Trials and Tribulations – Our biotech’s out of US Phase 1 experience

2025-09-24, 9:00 AM

View In Agenda
Next speaker
Back
Bridget Adams
Director, Clinical Operations, Sofie Biosciences

Session Details:

PANEL DISCUSSION: Selecting the right partners to leverage new technologies in clinical research

2025-09-24, 11:00 AM

Session Details:

Utilizing third party vendors for clinical trial support

2025-09-23, 3:00 PM

View In Agenda
Next speaker
Back
Barbara Birch
Associate Director, Clinical Vendor Management, Ultragenyx

Senior manager with over 25 years experience in clinical research and the CRO industry and proven abilities in clinical project management, strategic business development, and FSP alliance leadership.

Specialties: Strategic CRO Business Development, Alliance/FSP Leadership, Clinical Project Management & Planning, Budget & Expense Control,Team Leadership & Consensus-Building, Contract & Price Negotiation,Project Resourcing, Financial & Resource Forecasting, 
Staff Development & Motivation, Line Management, Operations Process Improvement

Session Details:

FIRESIDE CHAT: Reinforcing the sponsor’s pivotal role in ensuring trial integrity with the latest ICH E6 (R3) updates on sponsor oversight

2025-09-24, 10:00 AM

View In Agenda
Next speaker
Back
Preeti Baweja
Director, Clinical Operations, Ventyx Biosciences

Experienced clinical research, project management professional with more than 17years of experience in the industry. In-depth knowledge of drug development process (with immunology, inflammatory & oncology focus) and industry practices.

Leading multiple project teams with broad background in overseeing the conduct of the clinical trial (Phase I-IV) globally following elements of the ICH/GCP or GPP in observational and non-interventional studies. Experienced indication lead overseeing study start up, maintenance and termination activities (database lock, CSR), including but not limited to, site identification, feasibilities, ICF negotiations, IRB/EC and global Regulatory Authority submissions, review and approval of essential documents, remote Site initiation visits (SIV), Monitoring Visit (MV), Source data verification (SDV)/ Source Data Review (SDR), drug accountability, site payments, and close out visits. Extensive study and site management experience. Experienced in RBQM, and systems like cluepoints for data analytics. Experienced in leading cross-sectional study team responsible for clinical study delivery as the primary point for contact for leadership. Experienced with vendor management of multiple complex vendors (EDC build and maintenance, IRT/IWRS, central lab, histopath lab, large global CROs as well as drug packaging and distribution vendors). Knowledge of project management processes and tools with multiple direct reports.

Session Details:

How clinical data consolidation can bring precision to patient care

2025-09-24, 10:00 AM

View In Agenda
Next speaker
Back
Ines Hoffmann
Strategic Director of Clinical Operations, Verge Genomics

Session Details:

PANEL DISCUSSION: Selecting the right partners to leverage new technologies in clinical research

2025-09-24, 11:00 AM

View In Agenda
Next speaker
Back
Stanley Kim
CEO, WinSanTor

Stanley Kim is an entrepreneur with a passion for innovation. His colleagues warmly refer him as an eclectic or parallel entrepreneur having founded several technology (healthcare and software) companies that develop products which enhance or better people’s lives. Stanley has been fortunate enough to work with leading technologists and research institutes in the world which act as the foundation for his companies.

Session Details:

When innovation doesn’t go as expected

2025-09-23, 2:00 PM

View In Agenda
Next speaker
Back
Joe Stalder
VP Program Management, Zentalis

Effective project manager with broad experience in pharmaceutical development, including preclinical research, clinical development, and commercialization. I specialize particularly in late-stage clinical development (Ph2 to NDA). Demonstrated flexibility in a variety of corporate cultures from small biotech to big pharma, startup to mature, and in several therapeutic areas. Strong working knowledge of many project management tools, techniques, and methodologies. Demonstrated ability to align team to project goals and objectives and work with stakeholders and team members to achieve success.

Session Details:

PANEL DISCUSSION: Are sponsors ready for AI?

2025-09-23, 12:00 PM

Session Details:

Case study: Integrating vendor data to provide a 360°view of clinical trial progress

2025-09-23, 11:00 AM

View In Agenda
Next speaker

OCT Advisory Board

Select a member to learn more

Back
Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

 

Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

 

Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

 

Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

 

Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

Next
Back
Kathleen Cohen
Vice President, Clinical Development, Marinus Pharmaceuticals

Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

Next
Back
Thomas M. Tremblay RN, BSN
Vice President of Clinical Development, Hallux Inc.

Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience.  His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality.  He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

Next
Back
Behtash Bahador
Director, Health Literacy, CISCRP

Behtash Bahador is the Director of Health Literacy at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

Next
Back
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.’

Next

Plan Your Visit

Venue

Hyatt Regency La Jolla at Aventine, 3777 La Jolla Village Drive San Diego, California 92122 United States

Arena International Events Group “(Arena”) is aware of numerous third-party agencies which are contacting Arena’s customers and purporting to have access to hotel room bookings, events attendee lists and selling unsolicited services. It is unclear whether the agencies in question are in possession of such information, or whether they intend to scam unsuspecting customers. Whilst Arena International Events Group pursues such third-party companies for their potentially illicit activity, Arena encourages you to be cautious in engaging with such third-party agencies and Arena shall not accept any responsibility for any losses incurred by you should you choose to engage with third parties that have no affiliation to Arena International Events Group..

Sponsors

Select a sponsor to learn more

Featured Sponsors

Session Sponsors

Associate Sponsor

Drinks Reception

Prize Draw Sponsor

Exhibitor

Co-Sponsor

Why partner?

 

Contact us to become a partner

Partnership Opportunities

We work with you to design a bespoke package to meet your business needs, where you could:

  • 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
  • Showcase your business and its services at an exhibition booth, which provides a perfect meeting place for prospective new clients
    Present the value proposition of your offering over your competitors, in front of an audience of active, engaged potential customers
  • Speak with key decision makers as part of our intimate, interactive roundtable style workshop sessions with over 8 hours allowed for networking

Event reach

  • 450+ attendees each year
  • 80% attendees C-suite level

 

Take a look at our current sponsors

Resources

       
       
     

Media Centre

Become A Media Partner

Enquiry

Contact Us

SPONSORSHIP ENQUIRIES

Nick McCudden

Head of OCT Events

+61 280 978 126

SPEAKER AND MARKETING ENQUIRIES

Niki Khoshkbary

Senior Conference Producer

+44 (0)20 4540 7545

DELEGATE ENQUIRIES

Sunny Saikia

VIP Delegate Manager

SPONSORSHIP ENQUIRIES

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

Nick McCudden

Head of OCT Events


+61 468 609 047

SPEAKER ENQUIRIES

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

Niki Khoshkbary

Senior Conference Producer


+44 20 4540 7545