14th Annual Outsourcing in Clinical Trials Southern California 2026

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

15 - 16

September

2026
  • 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
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Why attend?

WHAT TO EXPECT FOR 2026?

Expect high level discussions and presentations with industry leaders focusing on novel and innovative solutions to some of this years key challenges. Additionally with our Clinical Trial Technology & Innovation track, 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. We’re be showcasing strategies 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, biotechs and CROs to discuss operationally efficient and specifically targeted clinical trials. The 2026 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

  • 15 Sep 2026
  • 16 Sep 2026
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Streams

Stream one

Stream A: Outsourcing & Clinical Operations

Stream two

Stream B: AI, Tech and Innovation in Clinical Trials

11:15 AM

Ensuring AI Usage in Trials is Audit-Ready: Navigating Regulatory Expectations and Compliance in Responsible AI Adoption

  • Understanding the evolving regulatory landscape for AI-enabled trials
  • Preparing for audits and inspections to avoid compliance pitfalls
  • Lessons learned from real-world AI adoption across sponsors and CROs
  • Implementing responsible AI practices to accelerate innovation without regulatory risk

Speakers

Leesa Gentry
Chief Clinical Officer, RenovoRx

11:45 AM

Reserved for event sponsor

12:15 PM

PANEL DISCUSSION: Choosing Tech That Delivers: Evaluating Vendors and Turning Promise into Performance

  • Establishing clear criteria to assess technology vendors beyond marketing claims
  • Measuring the real-world impact of new tools on trial efficiency, patient engagement, and data quality
  • Balancing innovation with risk: how to pilot, scale, and integrate technologies successfully
  • Building a structured framework to ensure vendor commitments translate into measurable trial outcomes

3 seats available for biotech and pharma

1 seat available for event sponsor

12:45 PM

Reserved for technology spotlight

1 PM

Lunch and Networking

2 PM

From Zero To AI: Implementing and Scaling AI on a Budget for Smaller, Leaner Biotechs

  • Strategies for embedding AI tools into everyday workflows and gaining buy-in across cross-functional teams
  • Practical lessons for small biotech companies transitioning from experimentation to enterprise-level AI capabilities
  • Why data quality, governance, and integrated systems must be established before AI can deliver meaningful insights
  • Identifying realistic use cases where AI can support decision-making, forecasting, and operational oversight in drug development

Speakers

Joe Stalder
VP Program Management, Zentalis

2:30 PM

Reserved for event sponsor

3 PM

Session reserved for Danforth Advisors

3:30 PM

Afternoon refreshments, networking and prize draw

3:45 PM

PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

4 PM

Trails Without Borders: Emerging onto the Clinical Trials Landscape in Saudi Arabia, a Case Study Presented by Emmaus Life Sciences

  • Managing regulatory, operational, and cultural considerations for successful site activation: Outsourcing for global submissions
  • Insights into emerging geographies and how to navigate varying cultural landscapes
  • Diving into the practical realities of managing multiple vendors, with strategies for maintaining consistency and compliance across borders
  • Strategies for sponsors to optimize patient recruitment, site engagement, and trial efficiency in evolving clinical landscapes

Presented by Emmaus Life Sciences

4:30 PM

Reserved for event sponsor

7:30 AM

Registration and Refreshments

8:20 AM

Chair’s Opening Remarks

Speakers

Robert Loll
Senior Vice President, Business Development and Strategic Planning, Praxis

8:30 AM

CEO KEYNOTE: Unlocking the Power of Clinical Data in an Impactful Publication Strategy

  • Going beyond initial study objective with post-hoc analyses to assess additional effects of the study drug/treatment
  • Utilizing multiple layers of data to tease out effects of the drug/treatment on subsets of study population
  • Developing a strategy for generating a series of impactful publications with value to clinical, research, and patient communities

Speakers

Craig Chambliss
CEO and Co-Founder, Neurelis

9 AM

Reserved for ICON

9:30 AM

PANEL DISCUSSION: Strengthening Site and Patient Engagement Through Harmonized Sponsor-CRO Coordination

  • Assessing realistic performance expectations for sites and patients, balancing ambition with capacity
  • Tailoring communication to study, site, and indication specifics to avoid overwhelming stakeholders
  • Coordinating sponsors, CROs, and other partners effectively to keep engagement efforts aligned and efficient
  • Preventing operational chaos while driving higher site activation, patient recruitment, and retention

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

1 seat available for event sponsor

Speakers

Robert Loll
Senior Vice President, Business Development and Strategic Planning, Praxis
Michelle Finegan
Senior Director, Patient Advocacy and Strategic Alliances, Neurelis
Julie Nolte
Executive Director,  Clinical Operations, Arcutis Biotherapeutics
Mandy Williams
Director, Clinical Site Liaison, Eledon Pharmaceuticals

10 AM

Reserved for Novotech

10:30 AM

Morning Refreshments and Networking

11:15 AM

KEYNOTE: Strengthening Cross-Functional Collaboration and Governance Models to Keep Complex Trials on Track and Inspection-Ready

  • What clinical trial sponsor companies need from vendors to ensure built in quality culture and inspection readiness
  • Designing and operationalizing increasingly complex protocols while maintaining efficiency, quality, and patient safety
  • Managing the growing matrix of vendors, CROs, and partners to ensure clear accountability, communication, and oversight
  • How do you prepare a clinical site for a regulatory inspection for next generational products in research

Speakers

Ndidi Rickert
Senior Director, GxP Compliance, Kardigan Bio

11:45 AM

Reserved for event sponsor

12:15 PM

PANEL DISCUSSION: Building Smarter Clinical Trial Budgets by Better Aligning Planning to Approval Processes

  • Overcoming inconsistent vendor and CRO budget templates and improving mapping into sponsor financial frameworks
  • Defining what a clinical trial budget truly includes, from core operational costs to patient-enabling services
  • Streamlining internal approval processes and aligning clinical budgets with broader financial planning and company valuations
  • Building stronger financial foundations early to prevent downstream budget misalignment and operational delays

1 seat available for event sponsor

Speakers

David Wattel
Associate Director, Clinical FP&A, Vividion Therapeutics
Mariam Iqbal
Director, Clinical Business Operations, Intercept Pharmaceuticals
Kerry Clancy
Director, Outsourcing and Contract Management, AnaptysBio

12:45 PM

Reserved for technology spotlight

1 PM

Lunch and Networking

2 PM

Driving Efficiency in Clinical Development: A COO’s Playbook for Smarter Clinical Trials

  • Designing efficient start-up strategies that optimize timelines and balance speed, cost, and quality in lean biotech environments
  • Making critical early decisions on study location, site selection, and operational setup to drive timelines and success
  • Strategically aligning clinical plans with financing milestones, ensuring trials generate the right data to support valuation growth
  • Building the right operating model by balancing internal capabilities with CRO and FSP partnerships
  • Aligning clinical operations with key value inflection points to maximize investor confidence and long-term development impact

Speakers

Kamil Sitarz, PhD, EMBA
Chief Operating Officer & Management Board Member, Ryvu Therapeutics

2:30 PM

Reserved for event sponsor

3 PM

Building a Flexible Site Liaison Model to Strengthen Partnerships, Align Stakeholders and Ensure Clinical Trials are Mutually Beneficial for Everyone

  • Bringing the site voice to study design: Partnering with investigators during protocol development to reduce amendments, deviations, and operational friction
  • Preventing problems before they happen: Using real-world site feedback to proactively adjust study design and execution
  • Acting as the connective driver between sponsor, CRO, and sites to ensure alignment, accountability, and continuity across the trial lifecycle
  • Lessons from a lean biotech: Stepping beyond defined roles and filling operational gaps, ensuring data flow and maintaining patient safety
  • Redefining success by measuring the unquantifiable impact of strong site relationships on recruitment, retention, and overall trial performance

Speakers

Mandy Williams
Director, Clinical Site Liaison, Eledon Pharmaceuticals

3:30 PM

Afternoon refreshments, networking and prize draw

3:45 PM

PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

4 PM

PATIENT ADVOCATE SPOTLIGHT Bringing The Lived Patient Experience into How Clinical Trials Are Designed and Navigated

  • Bringing the patient voice into every stage of development and embedding patient advocates from day one, moving from feedback to true co-creation across the trial lifecycle
  • Breaking down barriers in access, diversity, and language to expand participation, build trust, and make trials truly patient-centered
  • Simplifying participation and communication to reduce burden, improve understanding, and generate richer, more meaningful data
  • Leveraging patient experiences to help change the landscape, making clinical trials better for patients worldwide

Speakers

Jacqueline Smith
Patient Advocate, RPh

4:30 PM

Reserved for event sponsor

5 PM

NEW FOR 2026! INDUSTRY HOT TAKES

Closing Plenary Session in Stream A

1 stage, a variety of rapid-fire opinions, bold predictions and myth-busting from experts across the industry. Audience members will vote, agree or disagree, on each hot take! There’ll be a chance for the audience to pose some questions to the panel too.

The panel will answer the following:

  • Biggest mistake in clinical trials today
  • One thing pharma should stop doing
  • One prediction for 2030
  • What’s overhyped and what’s worth the hype
  • What vendors misunderstand
  • Where trials fail most often
  • Biggest recruitment mistake
  • Hot takes from the audience

1 seat available for event sponsor

Speakers

Puiwah Braswell
Vice President, Clinical Operations, Eyexora
Mariam Iqbal
Director, Clinical Business Operations, Intercept Pharmaceuticals
Richard Firth
Associate Director, Development Business Operations, Arcturus Therapeutics

5:30 PM

Chair’s closing remarks

END OF DAY 1 AND NETWORKING DRINKS

Best 3 LinkedIn posts from day 1 with hashtag #OCT and @Outsourcing in Clinical Trials Event Series tagged will win a prize in day 2 morning’s prize draw during chair’s opening remarks. Deadline end of drinks reception day 1. You must be present to win!

Streams

Stream one

Stream A: Outsourcing & Clinical Operations

Stream two

Stream B: AI, Tech and Innovation in Clinical Trials

11:15 AM

PANEL DISCUSSION: Reimagining Clinical Data Flow: Smarter, Faster Paths to High-Quality Trial Data

  • Rethinking data capture in clinical trials: Moving beyond traditional workflows to streamline how clinical data is collected, integrated, and validated
  • Reducing data friction across the trial lifecycle: Innovative approaches to minimize manual processes, site burden, and downstream data cleaning
  • Accelerating decision-ready data: Enabling faster monitoring, analysis, and database lock through more efficient data pipelines
  • Connecting operational efficiency to ROI: How modern data strategies translate into reduced trial timelines, lower costs, and greater scalability for sponsors

3 seats available for biotech and pharma

1 seat available for event sponsor

12 PM

Reserved for event sponsor

12:30 PM

Session reserved for

Speakers

Adeleke Badejo
Managing Analyst, GlobalData

1 PM

Lunch and networking

8 AM

Registration and refreshments

8:20 AM

Chair’s opening remarks and early birds prize draw

Best 3 LinkedIn posts from day 1 with hashtag #OCT and @Outsourcing in Clinical Trials Event Series tagged will win a prize in day 2 morning’s prize draw. Deadline end of drinks reception day 1. You must be present to win!

8:30 AM

Interactive Speaker-Hosted Breakfast Breakout Discussions

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

Discussion 1 Turning inspection fears into operational readiness in an uncertain regulatory environment

Hosted by Regina Griffin, Associate Director, Clinical Operations, Autobahn Therapeutics

Discussion 2 Strategic partnerships in clinical development: Driving portfolio value through external innovation

Hosted by Denise Deegan, Associate Director, Clinical Operations, Pionyr Immunotherapeutics

Discussion 3 Conducting clinical trials in a greener, sustainable way
Discussion 4 How to strategically plan and curb risk as a small biotech
Discussion 5 Finding the right balance with digital health tools in clinical trials

9:30 AM

KEYNOTE: The Value of Culture: A Strategic Asset

  • Embedding a strong internal culture to drive consistent execution, accountability, and scientific rigor across cross-functional clinical teams
  • Extending cultural alignment beyond the organization to CROs, labs, and technology partners to enable more effective collaboration and shared ownership
  • Improving communication, escalation pathways, and transparency to identify and manage risks earlier in complex, outsourced trial environments
  • Accelerating decision-making by aligning expectations, behaviors, and governance across global clinical programs
  • Reducing operational friction and delays by proactively addressing cultural misalignment and reinforcing shared ways of working

Speakers

Jeff Douglas
Vice President, Development Operations, Alumis

10 AM

Reserved for event sponsor

10:30 AM

Morning refreshments and networking

11:15 AM

PANEL DISCUSSION: Responsible CRO Governance by Ensuring Transparent Decisions and Responsible, Effective Oversight

  • Planning transitions between trial phases while maintaining clear governance and operational continuity for small biotechs as well as large pharma
  • Creating transparency around planning assumptions and defining decision-making authority within governance boards
  • Tailoring oversight strategies to the biotech environment, where agility and limited resources are critical
  • Strengthening responsible vendor oversight with up-to-date documentation and compliance aligned with evolving ICH guidance and regulatory expectations

1 seat available for biotech and pharma

1 seat available for event sponsor

Speakers

Kerry Clancy
Director, Outsourcing and Contract Management, AnaptysBio
Regina Griffin
Associate Director, Clinical Operations, Autobahn Therapeutics

12 PM

Reserved for event sponsor

12:30 PM

Money, Money, Money: Driving Optimized Cost Predictability in Clinical Trials

  • From estimates to accuracy: Strengthening cost transparency and alignment of financial priorities between sponsors and CRO partners
  • Identifying hidden cost drivers and financial assumptions that are often missed during initial contracting
  • Ensuring critical trial activities are properly funded—even when they are not primary profitability drivers
  • Creating accountability and incentives for more accurate forecasting to reduce budget surprises and protect trial timelines

Speakers

AJ Bergmann
Chief Financial Officer, Capricor Therapeutics

1 PM

Lunch and networking

2:15 PM

PANEL DISCUSSION: Accelerating Study Start-Up: Driving Operational Readiness and Trial Momentum for Faster Trial Launches

  • Effectively championing adaptive trial designs to stay nimble as the clinical research landscape continues to evolve
  • Streamlining protocol finalization, regulatory submissions, and feasibility assessments to shorten start-up timelines
  • Identifying and engaging the right sites as part of a broader operational readiness strategy
  • Coordinating cross-functional teams, vendor partnerships, and internal stakeholders to ensure smooth study initiation
  • Implementing robust onboarding, training, and communication plans to set the trial up for success from day one
  • Reducing contract cycle times to accelerate study start-up

 

2 seats available for biotech and pharma

1 seat available for event sponsor

Speakers

Puiwah Braswell
Vice President, Clinical Operations, Eyexora

3 PM

Reserved for event sponsor

3:30 PM

Afternoon networking, prize draw and closing remarks

3:45 PM

PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

4 PM

END OF CONFERENCE

Speakers

Select a speaker to learn more

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Jeff Douglas
Vice President, Development Operations, Alumis

Session Details:

KEYNOTE: The Value of Culture: A Strategic Asset

2026-09-16, 9:30 AM

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Julie Nolte
Executive Director,  Clinical Operations, Arcutis Biotherapeutics

Session Details:

PANEL DISCUSSION: Strengthening Site and Patient Engagement Through Harmonized Sponsor-CRO Coordination

2026-09-15, 9:30 AM

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Richard Firth
Associate Director, Development Business Operations, Arcturus Therapeutics

Associate Director, Development Business Operations with over 15 years of experience in drafting, reviewing, and negotiating contractual and legal documents within the CRO/Pharmaceutical/Clinical Site environment, for both CROs and for sponsors. I am highly competent and knowledgeable at managing internal and external budgets, including site budgets, cash flow analysis, and revenue recognition through developing a range of cash positive payment schedules. My knowledge in proposal, contract, and budget development has been invaluable in the critical assessment of the multiple aspects of vendor proposals and contracts and in the selection of US and Ex-US vendors including in the evaluation of bid defences.

My experience in tracking and analysing internal and external metrics have helped ensure contractual timelines are met and critical study related milestones are achieved. My proven leadership qualities comprise global line management and project management which are evident through development, advancement and implementation of global contracting processes, template management, and document review processes designed to create efficiencies and ensure client and sponsor satisfaction.

My clinical research experience is supported through my degree in pharmacology which provides essential theoretical knowledge in a number of scientific research fields actively involved in clinical research trials.

Session Details:

NEW FOR 2026! INDUSTRY HOT TAKES

2026-09-15, 5:00 PM

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Regina Griffin
Associate Director, Clinical Operations, Autobahn Therapeutics

Experienced Clinical Study Manager with a demonstrated history of working in the pharmaceuticals industry. Skilled in Project Management, People Management, Clinical Monitoring, and Good Clinical Practice (GCP). Strong research professional with a B.A. focused in Psychology from University of California, San Diego.

Session Details:

PANEL DISCUSSION: Responsible CRO Governance by Ensuring Transparent Decisions and Responsible, Effective Oversight

2026-09-16, 11:15 AM

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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:

PANEL DISCUSSION: Building Smarter Clinical Trial Budgets by Better Aligning Planning to Approval Processes

2026-09-15, 12:15 PM

Session Details:

PANEL DISCUSSION: Responsible CRO Governance by Ensuring Transparent Decisions and Responsible, Effective Oversight

2026-09-16, 11:15 AM

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Mike Guerra
President & CEO, California Life Sciences
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AJ Bergmann
Chief Financial Officer, Capricor Therapeutics

Session Details:

Money, Money, Money: Driving Optimized Cost Predictability in Clinical Trials

2026-09-16, 12:30 PM

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Mandy Williams
Director, Clinical Site Liaison, Eledon Pharmaceuticals

I am an experienced clinical research professional with experience in multiple indications and trial phases (I-IV) at the site, clinical research organization (CRO) and sponsor areas of clinical trials. My experience as a clinical research coordinator as well as a clinical research associate provide me with a unique ability to oversee and troubleshoot obstacles and issues from an operational standpoint. My skills allow me to better identify potential risks as well as foster relationships across functional roles, help review and revise SOPs to better support operational aspects of trials, oversee documents (consent forms) and ethics submissions to ensure compliance with human subject protections. My experience gleaned from my career allows me to better advocate for sites as well as sponsors in the development, implementation and oversight of clinical trials. I enjoy sharing my passion for clinical research with others, and collaborate with others to mentor and foster growth in knowledge for the process. I've done this with peers, colleagues and at the school level. I endeavor for opportunities to share my experience and learn new skills to grow within this field.

Session Details:

PANEL DISCUSSION: Strengthening Site and Patient Engagement Through Harmonized Sponsor-CRO Coordination

2026-09-15, 9:30 AM

Session Details:

Building a Flexible Site Liaison Model to Strengthen Partnerships, Align Stakeholders and Ensure Clinical Trials are Mutually Beneficial for Everyone

2026-09-15, 3:00 PM

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Puiwah Braswell
Vice President, Clinical Operations, Eyexora

Accomplished project management professional in Phase I-III global clinical research specializing in aligning clinical development strategies with regulatory and business objectives to advance innovative therapies from concept to approval. Competent in team development / cross-functional team leadership, project implementation and management and CRO/vendor oversight. Strengths include solid communication and interpersonal / customer service skills, self-starter / works independently, excellent organizational and problem-solving skills, detailed-oriented with focus on quality and efficiency, budget planning / forecasting / milestone tracking, highly motivated and strong leadership that results in successful execution and deliverance of quality outcomes within project goals / timelines.

Session Details:

NEW FOR 2026! INDUSTRY HOT TAKES

2026-09-15, 5:00 PM

Session Details:

PANEL DISCUSSION: Accelerating Study Start-Up: Driving Operational Readiness and Trial Momentum for Faster Trial Launches

2026-09-16, 2:15 PM

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Adeleke Badejo
Managing Analyst, GlobalData

As a Managing Analyst at GlobalData Plc, I provide data-driven insights and analysis on the immunology market and competitive landscape. I have completed multiple projects on drug discovery, clinical trials, patent intelligence, and market forecasting, using various tools and platforms such as Python, R, Tableau, and Power BI. I have a strong background in pharmacology, with a PhD from Tulane University and over ten years of experience in biomedical research, publishing several papers in peer-reviewed journals. I also have a MS in Data Science and Analytics from Georgia State University, where I learned and applied various techniques and methods such as machine learning, deep learning, text mining, sentiment analysis, and topic modeling. I am passionate about applying data science and NLP to solve real-world problems and challenges in the pharmaceutical industry.

Session Details:

Session reserved for

2026-09-16, 12:30 PM

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Ndidi Rickert
Senior Director, GxP Compliance, Kardigan Bio

A Kaizen-certified cross-functional leader with operations experience, I specialize in Global GxP Compliance, Audit Strategy and Execution and FDA BIMO, PAI, MHRA, EMA and Health Canada Inspections. I’ve helped bring life-saving therapies to market while fostering cultures of quality. A trusted change agent and co-creator of quality transformation initiatives, critical thinker, collaborator, embedding a culture of continuous improvement and regulatory excellence across complex, matrixed organizations. My work centers on aligning operational excellence with human impact because behind every system is a story, and behind every story is a life worth protecting. Passionate about Quality allyship, mentorship, learning and reinvesting in community.

I lead with purpose and heart, anchored in authenticity, I cultivate humane spaces where identity is honored and excellence, equity, and empathy co-exist.

My leadership is shaped by resilience, legacy, and the belief that stories bridge connection. Born in Sierra Leone, schooled in the UK, I now live in the US. As a perpetual incomer, I lead with commitment to equity, turning lived experience into systems that uplift.

Fun Facts: I grew up on the beaches of Sierra Leone | Myers-Briggs: INFJ | Sickle-Cell and Newborn Screening Advocate | STEM Mentor | Believer in Kindness

LinkedIn Bio: https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/

Session Details:

KEYNOTE: Strengthening Cross-Functional Collaboration and Governance Models to Keep Complex Trials on Track and Inspection-Ready

2026-09-15, 11:15 AM

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Emily Johnson
Director, Clinical Operations, MapLight Therapeutics
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Craig Chambliss
CEO and Co-Founder, Neurelis

Session Details:

CEO KEYNOTE: Unlocking the Power of Clinical Data in an Impactful Publication Strategy

2026-09-15, 8:30 AM

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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: Strengthening Site and Patient Engagement Through Harmonized Sponsor-CRO Coordination

2026-09-15, 9:30 AM

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Jacqueline Smith
Patient Advocate, RPh

Jacqueline Smith, RPh, is a pharmacist and endometrial and ovarian cancer survivor committed to improving patient outcomes. Drawing on her pharmacy background, she champions federal research funding, treatment innovation, early detection, and public awareness for ovarian cancer. Jackie holds leadership roles with national and state ovarian cancer organizations, presents at major gynecologic oncology conferences, and serves as a research reviewer for the Congressionally Directed Medical Research Programs (CDMRP). Jackie is also a coauthor of a Gynecologic Oncology publication on patient-researcher collaboration and a member of the AACR Scientist↔Survivor Program®.

Session Details:

PATIENT ADVOCATE SPOTLIGHT Bringing The Lived Patient Experience into How Clinical Trials Are Designed and Navigated

2026-09-15, 4:00 PM

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Denise Deegan
Associate Director, Clinical Operations, Pionyr Immunotherapeutics

With over 15 years of progressive experience in the field, I have successfully led global clinical studies across various phases and therapeutic areas, including complex protocols and accelerated development programs. My core competencies include clinical strategy, study management, vendor oversight, budget control, regulatory compliance, and cross-functional collaboration. I am passionate about advancing innovative immunotherapies for cancer patients and delivering high-quality clinical data and outcomes.

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Robert Loll
Senior Vice President, Business Development and Strategic Planning, Praxis

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

2026-09-15, 8:20 AM

Session Details:

PANEL DISCUSSION: Strengthening Site and Patient Engagement Through Harmonized Sponsor-CRO Coordination

2026-09-15, 9:30 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:

  1. Drove development and successful launch of NCE product for the treatment of MDR-TB
    2. Procured over 35 million in non-dilutive funding for development of a suite of products to treat multiple infectious disease indications.
    3. Served as Steering Committee Member and clinical representative for PAN-TB consortium (including Evotec, Janssen, GSK, Otsuka, GMRI, and BMGF)
    4. Drove strategic planning for IND-enabling and clinical-stage programs for small biotech clients and for the development of internal assets.
    5. Expanded company revenue streams to include a clinical services solution and achieved profitability within 12 months.
    6. Collaborated with the C-suite team in developing short-term and long-term goals and strategies to increase clinical revenue.
    7. Drove development of multiple cross-functional strategic development plans and built pathways to licensure.
    8. Increased monthly enrollment rate by 85% from H1 2023 to H2 2023 in a pivotal phase 3 trial for first-line treatment of pancreatic cancer.
    Strengths include communication, analytical thinking, leadership, negotiation, and problem solving.

Session Details:

Ensuring AI Usage in Trials is Audit-Ready: Navigating Regulatory Expectations and Compliance in Responsible AI Adoption

2026-09-15, 11:15 AM

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Kamil Sitarz, PhD, EMBA
Chief Operating Officer & Management Board Member, Ryvu Therapeutics

Kamil Sitarz is Chief Operating Officer and Management Board Member at Ryvu Therapeutics, a European clinical-stage oncology company advancing a diversified pipeline of innovative therapies. He leads corporate strategy, enterprise governance, capital planning, and cross-functional clinical development execution across a diversified oncology portfolio.

He has been instrumental in transforming Ryvu into a multi-program clinical-stage organization, embedding disciplined portfolio governance and architecting development pathways designed to enhance execution predictability in complex, high-risk oncology settings. His leadership integrates clinical strategy with capital allocation discipline, ensuring alignment across scientific ambition, regulatory positioning, operational design, and financial planning to drive sustainable enterprise value.

 

Under his direction, Ryvu has built and scaled a robust clinical development organization capable of delivering international Phase I/II programs across challenging hematologic indications and multi-country site networks. He has also played a key role in establishing and governing strategic clinical collaborations with leading global oncology partners, strengthening Ryvu’s development footprint and reinforcing its credibility within the international biotech ecosystem.

 

With a PhD in Medical Genetics and an Executive MBA, Kamil combines scientific depth with enterprise-level strategic and operational leadership to advance innovation with rigor, accountability, and long-term growth orientation.

Session Details:

Driving Efficiency in Clinical Development: A COO’s Playbook for Smarter Clinical Trials

2026-09-15, 2:00 PM

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David Wattel
Associate Director, Clinical FP&A, Vividion Therapeutics

20+ years of biotech finance experience working in FP&A, and clinical finance roles. His career started in Big-Pharma and has shifted to small and mid-sized Pharma companies the past several years. Expertise: R&D (Pre-clinical/Clinical/CMO) FP&A. clinical trial finance modeling & accounting, budgeting & forecasting, long range planning , revenue forecasting, financial systems (Hyperion, Oracle, SAP, Netsuite, MS D365, Anaplan, Adaptive Planning, R&D Logic, Great Plains), finance process improvement, business partnering.

Session Details:

PANEL DISCUSSION: Building Smarter Clinical Trial Budgets by Better Aligning Planning to Approval Processes

2026-09-15, 12:15 PM

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Joe Stalder
VP Program Management, Zentalis

Joe Stalder, PharmD, PMP, is the Vice President of Project Management at Zentalis in San Diego, CA, co-founder of Groundswell Pharma Consulting, and editor of the book "Project Management for Drug Developers". Joe has over 15 years of project management experience in pharmaceutical development in large and small companies. His experience includes Project Management department head, PMO head, and Lead Project Manager on several early- and late-stage development assets in oncology, infectious disease, cardiology, metabolism, and pulmonology. Joe is also a regular speaker at conferences and is involved in community organizations including PIPMG and BiopharmaPM.

Session Details:

From Zero To AI: Implementing and Scaling AI on a Budget for Smaller, Leaner Biotechs

2026-09-15, 2:00 PM

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OCT Advisory Board

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Dr Alison McMorn
Head of Clinical Strategy and Development, LifeArc

Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

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Behtash Bahador
Senior Director, Community Engagement & Partnerships, CISCRP

Behtash Bahador is the Senior Director of Community Engagement & Partnerships 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.

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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.

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Aditya Kotta
VP Business Development, Novotech

Aditya Kotta is the VP of Business Development for Novotech. He has been with the company since 2018. He has 14 years of experience in the clinical trial industry, working in both Clinical Operations and Business Development. He holds degrees in Biomedical Engineering from Johns Hopkins University and Medical Science from Boston University.

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Martin Rodriguez
Consumer Safety & Evidence Global Quality & Excellence Head, Opella

Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

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Rosalie Filling
Vice President, Senior Global Head R&D Operations, Keenova

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.

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Edwin van Vulpen
Executive Director and Head of Clinical Business Development Euro-Asia
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