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WHAT TO EXPECT FOR 2027?

As clinical trials continue to evolve, 2027 brings new challenges and opportunities across clinical operations, technology, regulation and patient engagement. OCT West Coast will bring the industry together to explore what is changing, what is working and what clinical trial teams need to be thinking about next.

Expect practical insights, honest discussions and real-world experiences from leaders across pharma, biotech and the wider clinical trial community. From navigating regulatory change and making the most of new technologies to improving trial efficiency, strengthening partnerships and putting patients at the center, the agenda will focus on the issues shaping clinical development today.

With a strong focus on collaboration and sharing practical experiences, OCT West Coast is an opportunity to connect with the region’s leading pharma and biotech companies, exchange ideas and explore new approaches to delivering smarter, more efficient and patient-focused clinical trials.

800+

Attendees

100+

Exhibitors

70+

Speakers

80%

Attendees at Director + Level

800+

Attendees

100+

Exhibitors

70+

Speakers

80%

Attendees at Director + Level

See What It's All About

2026 Agenda

  • 10 Feb 2027
  • 11 Feb 2027
Expand All

Streams

Stream one

Stream A: Outsourcing & Clinical Operations

Stream two

Stream B: Data, AI & Clinical Innovation

Stream three

Stream C: Biotech Strategy

11:15 AM

Doing More with Less: How Virtual Biotechs Can Successfully Conduct First Clinical Studies on a Budget

  • Stretching limited resources and deciding where a small, underfunded team can prioritize resources and save money without compromising clinical progress
  • Taking advantage of a not-for-profit CRO in Canada to build a lean operating model
  • Generating confidence in first-in-class programmes by building the clinical and safety evidence needed when there is little external validation
  • Breaking the funding catch-22: Turning early data into momentum by delivering meaningful proof points that can unlock further investment and move the programme towards its next stage

Speakers

Michael Weickert
Ph.D, CEO, Pacylex Pharmaceuticals

11:45 AM

Session reserved for event sponsor

12:15 PM

CASE STUDY: When You Stop a Trial Midway, What Changes When You Start Again?

A candid case study on pausing a clinical program, securing new funding and returning to the clinic with a sharper strategy, informed by what went wrong the first time.

  • Building a more decisive development strategy, from rapid dose escalation to a clearer path through the next phase
  • Taking tighter control of translational data and challenging vendors to deliver the evidence needed to make confident development decisions
  • Working closely with the FDA to explore accelerated development pathways and build a more efficient route back to the clinic in a high unmet-need indication
  • Applying the lessons from the first trial to design a more efficient, focused program

Speakers

Pamela Contag
CEO and President, BioEclipse Therapeutics

12:45 PM

Session reserved for event sponsor

1:15 PM

Lunch and networking

Sponsored by Thermo Fisher Scientific

2:30 PM

PANEL DISCUSSION: Why Clinical Trial Start-Up Still Takes So Long

  • Where are the biggest bottlenecks, from regulatory approvals to vendor onboarding, cross-functional alignment, and site activation?
  • Sharing practical approaches to accelerate study start-up while maintaining quality and compliance
  • How can sponsors, CROs, vendors, and sites collaborate earlier to prevent downstream delays before the first patient is enrolled?
  • Understanding why contract negotiations and expectation misalignment continue to delay site activation timelines

Moderator: Available

Seats available for biotech, pharma and event sponsor

Speakers

Yuyi Shen
Vice President, Technical Operations, Abcuro

3 PM

Session reserved for event sponsor

3:30 PM

Afternoon refreshments and networking

3:45 PM

PRIZE DRAW

Sponsored by Dr. Vince Clinical Research

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!

Entries from this prize draw will also be entered into the early birds prize draw at 9.20am on day 2, you must be present to win!

4 PM

When is the Right Time to Build Quality Management Systems

  • Determining the right stage of growth to implement formal quality management systems without slowing innovation
  • Building practical frameworks for vendor qualification and oversight selection processes
  • Streamlining essential documentation, including informed consent and SOP development
  • Identifying which quality processes are business-critical versus unnecessarily complex for lean biotechs

Speakers

Charisse Eary
Executive Director, Head of Quality, Aligos Therapeutics

11:15 AM

Don’t Bolt a Jet Engine to the Horse Carriage: Designing AI-Native Workflows for Clinical Development

  • Rethinking clinical workflows from the ground up rather than simply adding AI to existing processes
  • Identifying where AI can genuinely reduce manual effort, improve decision-making and accelerate development
  • Exploring how data, technology and people need to work together to support AI-native operations
  • Sharing practical lessons for moving from isolated AI pilots to scalable, embedded workflows

Speakers

Megan L. Dunham
Associate Director, Clinical Data Innovation, Jazz Pharmaceuticals

11:45 AM

Session reserved for event sponsor

12:15 PM

Beyond the AI Pilot: Scaling AI Across Clinical Development

  • How can biotechs implement AI tools and convince their internal teams to adopt it
  • Access to affordable innovation for companies on a smaller budget and how to best allocate limited resources
  • Sharing practical lessons from implementing Claude AI across a growing organization
  • Maintaining data security and confidentiality for GDPR and HIPAA while using AI tools

Speakers

Dave Borbas
VP Research, Head of Data Management, Abcuro

12:45 PM

Session reserved for event sponsor

1:15 PM

Lunch and networking

Sponsored by Thermo Fisher Scientific

2:30 PM

PANEL DISCUSSION: Future-Proofing Clinical Trials with AI

  • Exploring how AI can support end-to-end clinical trial delivery, from protocol authoring and risk assessment through to data analysis and reporting
  • Examining how regulatory feedback and operational data can be leveraged to improve planning and site strategy
  • Understanding how AI-driven connectivity across departments can break down silos and create a more integrated approach to trial execution
  • Discussing how organizations can operationalize AI strategically to future-proof clinical development processes

Moderator: Available

Seats available for biotech, pharma and event sponsor

Speakers

Dave Borbas
VP Research, Head of Data Management, Abcuro

3 PM

Session reserved for event sponsor

3:30 PM

Afternoon refreshments and networking

3:45 PM

PRIZE DRAW

Sponsored by Dr. Vince Clinical Research

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!

Entries from this prize draw will also be entered into the early birds prize draw at 9.20am on day 2, you must be present to win!

4 PM

PATIENT ORGANIZATION SPOTLIGHT – Placebo-Less Trials for Deadly Diseases: Building Regulatory-Grade Data Sets That Can Be Used for Clinical Trials

  • Accelerating remote monitoring and technology enabled trials through real world case studies
  • Discovering how tech not-for-profit, EverythingALS, is innovating clinical development
  • Identifying trial ready patients and predicting disease progression without traditional biomarkers
  • Integrating patient reported outcomes, speech, wearables and digital measures into clinical development

Speakers

Christian Rubio
Executive Director, EverythingALS

4:30 PM

NEW FOR 2027! INTERACTIVE BEER BOARDROOM

TRACK B: Beyond the Hype: Where Does AI Actually Belong in Clinical Trials?

Participants work together in this collaborative session to separate genuine clinical value from AI hype, exploring where AI can meaningfully improve trial delivery and where human expertise remains essential

  • 5-minute problem statement introducing a sponsor considering AI across multiple areas of clinical trial delivery
  • 20-minute whiteboard exercise mapping where AI can add the most value across trial design, recruitment, operations, data and decision making
  • 5-minute table presentations comparing each group’s learnings and approaches from the session 

Facilitator: Megan L. Dunham, Director, R&D AI Governance & Portfolio Strategy, Jazz Pharmaceuticals 

Co-Facilitator: Available for event sponsor

Speakers

Megan L. Dunham
Associate Director, Clinical Data Innovation, Jazz Pharmaceuticals

END OF DAY 1 AND NETWORKING DRINKS

7:30 AM

Registration & Refreshments

8:15 AM

Chairperson’s opening remarks

Speakers

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

8:30 AM

KEYNOTE: Accelerating Drug Development with the 505(b)(2) Pathway: Smarter Clinical Strategies by Leveraging Existing Evidence

  • Exploring the growing reliance on the 505(b)(2) route and what it signals about evolving regulatory and development strategies
  • Practical insights on what works, common pitfalls, and how to successfully execute within a 505(b)(2) strategy
  • Identifying when 505(b)(2) is the right route and how it shapes clinical trial design, timelines, and investment strategy
  • Designing efficient trials within the 505(b)(2) framework and leveraging existing data while ensuring robust, targeted clinical evidence to support approval

FDA invited

9 AM

Session reserved for featured sponsor

9:30 AM

PANEL DISCUSSION: Where Should You Run Your Next Clinical Trial? Opportunities And Challenges in USA, APAC And Beyond

  • Why are some countries moving faster than the US? Comparing regulatory and operational timelines across emerging trial destinations
  • Understanding where international technology and infrastructure are creating advantages
  • Deciding which countries to prioritize and which to avoid
  • Diving into the practical realities of managing multiple vendors, with strategies for maintaining consistency and compliance across borders

Moderator: Meghal Vakil, Director, Regulatory Affairs, BeOne Medicines USA

Seats available for biotech, pharma and event sponsor

Speakers

Meghal Vakil
Director, Regulatory Affairs, BeOne Medicines USA
Sarah Hamirani
Portfolio Director, AbbVie
Malinda Longphre
Head of Clinical Operations, Attovia Therapeutics

10 AM

Session reserved for featured sponsor

10:30 AM

Morning refreshments and networking break

11:15 AM

Navigating Complexity: Reimagining Study Management in High-Stake Clinical Trials

  • Building agile and scalable study management strategies that can adapt as trials evolve
  • Managing shifting priorities, unexpected challenges and increasing operational complexity without losing momentum
  • Enabling clinical leaders to make more effective decisions in rapidly changing trial environments
  • Managing complex protocols, multiple vendors and global stakeholders while maintaining control of timelines, quality and execution

Speakers

Catherine Caserza
Director, Clinical Operations, Daiichi Sankyo

11:45 AM

Session reserved for event sponsor

12:15 PM

FIRESIDE CHAT: What Sponsors Still Get Wrong About Patient-Centered Clinical Research

  • Moving beyond tokenistic engagement to meaningfully involve patients in trial design and decision-making
  • Understanding what creates real patient burden and designing studies around the realities of patients’ lives
  • Using patient insights and data to improve recruitment, retention and the overall trial experience
  • Challenging internal assumptions about what patients actually want, need and value from clinical research

Moderator: Available

Speakers

Sarah Hamirani
Portfolio Director, AbbVie
Guinevere Valencia
Associate Director, Global Patient Advocacy, Argenx

12:45 PM

Session reserved for technology spotlight

1 PM

Session reserved for technology spotlight

1:15 PM

Lunch and networking

Sponsored by Thermo Fisher Scientific

2:30 PM

ASK THE EXPERTS: The Regulatory Questions You Should Have Asked Six Months Ago

This is an audience-led panel where regulatory experts respond in real time to the most pressing submission challenges attendees are dealing with today. The conversation is driven by live Q&A with questions that have been submitted in person/via Slido during the session.

Some questions the panel will cover:

  • What information regulators actually need at different stages of development
  • What sponsors can learn from countries achieving dramatically faster development timelines
  • Understanding new approaches to expedited IND and early development pathways
  • Building regulatory strategy into the trial before problems emerge

Moderator: Shilpen Patel, Senior Vice President, Perspective Therapeutics

Seats available for biotech, pharma and event sponsor

Speakers

Shilpen Patel
Senior Vice President, Perspective Therapeutics
Meghal Vakil
Director, Regulatory Affairs, BeOne Medicines USA
Chitra Sharma
Senior Vice President, Development, Scribe Therapeutics

3 PM

Session reserved for event sponsor

3:30 PM

Afternoon refreshments and networking

3:45 PM

PRIZE DRAW

Sponsored by Dr. Vince Clinical Research

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!

Entries from this prize draw will also be entered into the early birds prize draw at 9.20am on day 2, you must be present to win!

4 PM

Designing for Delivery: Building Operationally Feasible Clinical Trials

  • Mapping patient populations, site realities and regulatory requirements early to inform delivery
  • Building patient and site feasibility into protocol design to reduce complexity and burden
  • Stress testing recruitment, eligibility, visits, procedures, endpoints and timelines before finalization
  • Aligning data, technology, vendors and operational KPIs to identify risks and support scalable delivery

Speakers

Nicholas D’Amato
Director of Clinical Operations, Vaxart

4:30 PM

NEW FOR 2027! INTERACTIVE BEER BOARDROOM

TRACK A: How Can We Make Patient Participation Easier?

Participants work together to rethink the patient enrolment journey for an early phase trial, identifying practical ways sponsors, sites and trial teams can improve recruitment and remove barriers to participation.

  • 5-minute problem statement introducing a realistic Phase I trial scenario where identifying and recruiting the right patient population is proving challenging
  • 20-minute whiteboard exercise where each table maps the patient journey from finding a trial through to screening and consent, identifying the biggest barriers and points of drop-off
  • 5-minute table presentations comparing each group’s learnings and approaches from the session

Facilitator: Mamatha Reddy, Executive Director and Head of Clinical Operations, Infinimmune

Co-Facilitator: Available for event sponsor

Speakers

Mamatha Reddy
Executive Director and Head of Clinical Operations, Infinimmune

5:30 PM

Chairperson’s closing remarks

END OF DAY 1 AND NETWORKING DRINKS

Streams

Stream one

Stream A: Outsourcing & Clinical Operations

Stream two

Stream B: Data, AI & Clinical Innovation

Stream three

Stream C: Biotech Strategy

9:30 AM

Session reserved for

Speakers

Suyash Prasad
President, Research and Development, Stealth Mode Biotech

10 AM

Session reserved for event sponsor

10:30 AM

Morning refreshments and networking break

11:15 AM

When Trials Go Off Track: How Clinical Operations Leaders Recover Timelines, Sites and Study Performance

  • Identifying early warning signs that timelines, recruitment or site performance are starting to slip
  • Deciding when to intervene, escalate or adapt the trial operating model
  • Recovering underperforming sites, recruitment plans and vendor delivery without compromising quality
  • Balancing speed, resources and risk when making critical decisions to get a trial back on track

Speakers

Sanjay Mourya
Senior Director, Clinical Operations, Unicycive Therapeutics

11:45 AM

Session reserved for event sponsor

12:15 PM

VC SPOTLIGHT Standing Out in a Competitive and Crowded Clinical Trial Landscape

  • Optimizing clinical trial resources in a complex landscape
  • Your pipeline looks great. But can you actually execute it?
  • What does an optimal development strategy look like for biotechs today?
  • Understanding what investors want to see at different stages of development

Speakers

Omer Siddiqui
Venture Partner and Senior Development Advisor, NeuroVC

12:45 PM

Lunch and networking

9:30 AM

LIVE DEBATE: Are Too Many AI Tools Holding Back Clinical Development?

  • Managing multiple AI tools that cannot communicate with one another
  • Understanding whether fragmented technology is limiting AI's potential
  • Building a complementary technology ecosystem
  • Asking whether sponsors, CROs and vendors need to rethink how technology is selected

Moderator: Margot L. Goodkin, Vice President, Ophthalmology Clinical Development, Annexon

Debater 1: Available for biotech/ pharma

Debater 2: Available for event sponsor

Speakers

Margot L. Goodkin
Vice President, Ophthalmology Clinical Development, Annexon

10 AM

Session reserved for event sponsor

10:30 AM

Morning refreshments and networking break

11:15 AM

Optimizing Remote Data Capture: New Trends and Technology in Data Acquisition

  • Incorporating innovative products and tools into your clinical trial for remote data capture
  • FDA regulatory guidance around data acquisition and collecting data in remote settings
  • Easing burden on patients through remote data collection: how to utilize these tools effectively
  • How new tools such as eCOA solve patient issues

Session available

11:45 AM

Session reserved for event sponsor

12:15 PM

PANEL DISCUSSION: Why Innovation Fails to Scale at the Pilot Stage

  • Defining clear ownership, success metrics, and decision points at every stage of implementation
  • Exploring how sponsors, CROs, and technology partners can better align expectations and timelines
  • Is the industry too risk-averse to innovate properly?
  • Identifying when to pivot, pause, or scale innovations based on measurable impact and long-term feasibility

Moderator: Available

1 seat available for biotech, pharma and event sponsor

Speakers

Jenny Holt
Chief Development Officer, Ray Therapeutics
Megan L. Dunham
Associate Director, Clinical Data Innovation, Jazz Pharmaceuticals

12:45 PM

Lunch and networking

2 PM

Session reserved for GlobalData

2:30 PM

Session reserved for event sponsor

3 PM

Afternoon refreshments, networking and prize draw

3:30 PM

Chair’s closing remarks and end of conference

8 AM

Registration and Refreshments

8:30 AM

Interactive 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

Figuring Out the Right Complimentary Mix of Vendors for Your Study

Moderator available

Discussion 2

Understanding New Regulatory Approaches to Expedited IND And Early Development Pathways

Moderator available

Discussion 3

How Can Biotechs Run Lean Without Compromising Trial Delivery?

Moderator available

Discussion 4

Revolutionizing HealthTech: Confidently Leveraging the Latest Technologies to Accelerate Clinical Trials

Moderator available

9:20 AM

Chair’s opening remarks and early birds prize draw

The prize draw will take place in TRACK A: Outsourcing and Clinical Operations

Entries from the day 1 prize draw will be entered into the draw. You must be present to win!

9:30 AM

The Cost of Delay: How Contracts and Budgets Can Make or Break Trial Timelines

  • Identifying contract and budget bottlenecks that can delay study start-up and execution
  • Exploring how slow negotiations, unclear scopes and change orders impact trial timelines
  • Aligning sponsors, CROs and sites on budgets, responsibilities and expectations from the outset
  • Sharing practical strategies to resolve financial and contractual roadblocks before they become costly delays

Speakers

Axel Van Chee
Associate Director, Investigator Budgets & Payments – Clinical Operations, Exelixis
Christopher Shinn
Senior Director and Counsel, Contracts, Exelixis

10 AM

Session reserved for event sponsor

10:30 AM

Morning refreshments and networking break

11:15 AM

Session reserved

Speakers

Meghan McKenzie
Director, AIR Portfolio Alliance Lead, Population Science, Genentech

11:45 AM

Session reserved for event sponsor

12:15 PM

PANEL DISCUSSION: Taking Control of Your CRO Strategy

  • Navigating CRO selection and choosing partners that fit your stage, study needs and growth plans
  • Deciding what to outsource, what to retain in-house and when an FSP model makes sense
  • Managing multiple CROs, systems, data standards and SOPs without creating unnecessary complexity
  • Protecting timelines and continuity through CRO consolidation and vendor transitions

Moderator: Margot L. Goodkin, Vice President, Ophthalmology Clinical Development, Annexon

1 seat available event sponsor

Speakers

Margot L. Goodkin
Vice President, Ophthalmology Clinical Development, Annexon
Abhijit Ramachandran
Director, Clinical Development Operations – Oncology, Corcept Therapeutics
Sue Naim
Senior Vice President, Clinical Operations, Mirum Pharmaceuticals
Anirban Mukherjee
Vice President, Strategic Sourcing, Vera Therapeutics

12:45 PM

Lunch and networking

2 PM

One Trial, Many Partners: Building a Governance Model That Strengthens Vendor Partnerships

  • Clarifying accountability, decision-making and escalation across partners
  • Aligning vendors around shared goals, timelines and quality expectations
  • Using real-time data to identify risks and intervene earlier
  • Adapting governance as trial complexity and vendor needs evolve
  • Creating greater transparency across the vendor ecosystem

Speakers

Anirban Mukherjee
Vice President, Strategic Sourcing, Vera Therapeutics

2:30 PM

Session reserved for event sponsor

3 PM

Afternoon refreshments, networking and prize draw

3:15 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 devices or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

2026 Speakers

Select a speaker to learn more

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Kiran Palukuri
Director, Clinical Development Operations, 92Bio
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Sarah Hamirani
Portfolio Director, AbbVie

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

Session Details:

PANEL DISCUSSION: Where Should You Run Your Next Clinical Trial? Opportunities And Challenges in USA, APAC And Beyond

2027-02-10, 9:30 AM

Session Details:

FIRESIDE CHAT: What Sponsors Still Get Wrong About Patient-Centered Clinical Research

2027-02-10, 12:15 PM

View In Agenda
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Dave Borbas
VP Research, Head of Data Management, Abcuro

David Borbas is Research VP, Head of Data Management of Abcuro

Prior to Abcuro, David worked for more than 25 years of Data Management and Information Technology experience. He has broad experience starting and developing Data Management groups at SurroMed, Millennium Pharmaceuticals South San Francisco and Jazz Pharmaceuticals. After leaving Jazz Pharmaceuticals he provided Data Management consulting services to small and medium size companies in the Bay Area, throughout the US and Canada. He has been involved in 5 successful NDAs and together with Data Management team members has managed more than 100 studies. His research experience includes Rare Disease, Cardiac, Oncology, Rheumatology, Fibromyalgia, Gene Therapy, Neurology and Psychiatry clinical studies. He has supported clinical studies phase 1 to 4 including Global Phase 3 Studies, IVRS and eDiary applications. In addition, David has clinical experience more than 15 years of clinical and management experience in the areas of Critical Care, Emergency, Hemodialysis and Critical Care Transport. He has a Bachelor of Science in Nursing from the University of Pennsylvania and a Master of Science in Information Systems from Claremont Graduate University. He has given presentations at the CDISC International Interchange and supported the Bay Area CDISC meetings and PhUSE standards work groups.

Session Details:

Beyond the AI Pilot: Scaling AI Across Clinical Development

2027-02-10, 12:15 PM

Session Details:

PANEL DISCUSSION: Future-Proofing Clinical Trials with AI

2027-02-10, 2:30 PM

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Yuyi Shen
Vice President, Technical Operations, Abcuro

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

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

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

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

Session Details:

PANEL DISCUSSION: Why Clinical Trial Start-Up Still Takes So Long

2027-02-10, 2:30 PM

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Charisse Eary
Executive Director, Head of Quality, Aligos Therapeutics

Session Details:

When is the Right Time to Build Quality Management Systems

2027-02-10, 4:00 PM

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Margot L. Goodkin
Vice President, Ophthalmology Clinical Development, Annexon

Session Details:

LIVE DEBATE: Are Too Many AI Tools Holding Back Clinical Development?

2027-02-11, 9:30 AM

Session Details:

PANEL DISCUSSION: Taking Control of Your CRO Strategy

2027-02-11, 12:15 PM

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Guinevere Valencia
Associate Director, Global Patient Advocacy, Argenx

Session Details:

FIRESIDE CHAT: What Sponsors Still Get Wrong About Patient-Centered Clinical Research

2027-02-10, 12:15 PM

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Malinda Longphre
Head of Clinical Operations, Attovia Therapeutics

Malinda Longphre is Head of Clinical Operations at Attovia Therapeutics, where she oversees the execution of early-phase clinical programs. With over 25+ years' experience in biotech and pharma (BMS, Bayer, Aerovance, Oriel, Novartis, Connect), she has led complex global studies and driven cross-functional collaboration between Clinical Operations, CMC, and supply chain teams to ensure efficient and high-quality trial execution. She is a strong advocate for streamlined processes and strategic planning to accelerate development opportunities. Malinda holds a PhD from Johns Hopkins University and trained at UCSF prior to entering industry.

Session Details:

PANEL DISCUSSION: Where Should You Run Your Next Clinical Trial? Opportunities And Challenges in USA, APAC And Beyond

2027-02-10, 9:30 AM

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Meghal Vakil
Director, Regulatory Affairs, BeOne Medicines USA

Session Details:

PANEL DISCUSSION: Where Should You Run Your Next Clinical Trial? Opportunities And Challenges in USA, APAC And Beyond

2027-02-10, 9:30 AM

Session Details:

ASK THE EXPERTS: The Regulatory Questions You Should Have Asked Six Months Ago

2027-02-10, 2:30 PM

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Pamela Contag
CEO and President, BioEclipse Therapeutics

Session Details:

CASE STUDY: When You Stop a Trial Midway, What Changes When You Start Again?

2027-02-10, 12:15 PM

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Abhijit Ramachandran
Director, Clinical Development Operations – Oncology, Corcept Therapeutics

Abhijit Ramachandran, Director of Clinical Operations at Corcept Therapeutics Inc. is an established versatile leader with deep experience in clinical trial operations management. Expertise in conducting and coordinating multi-center international clinical trials and managing cross-functional project teams. Highly skilled in liaising with Contract Research Organizations (CROs) and other suppliers to achieve program and company goals. Adept at managing the progress of clinical studies and ensuring adherence to study protocols, regulatory/internal SOPs, intended timelines, and budget. Solid experience with early and late-phase clinical studies, including orphan disease indications.

Session Details:

PANEL DISCUSSION: Taking Control of Your CRO Strategy

2027-02-11, 12:15 PM

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Catherine Caserza
Director, Clinical Operations, Daiichi Sankyo

Session Details:

Navigating Complexity: Reimagining Study Management in High-Stake Clinical Trials

2027-02-10, 11:15 AM

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Christian Rubio
Executive Director, EverythingALS

Session Details:

PATIENT ORGANIZATION SPOTLIGHT – Placebo-Less Trials for Deadly Diseases: Building Regulatory-Grade Data Sets That Can Be Used for Clinical Trials

2027-02-10, 4:00 PM

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Next speaker
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Axel Van Chee
Associate Director, Investigator Budgets & Payments – Clinical Operations, Exelixis

Session Details:

The Cost of Delay: How Contracts and Budgets Can Make or Break Trial Timelines

2027-02-11, 9:30 AM

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Christopher Shinn
Senior Director and Counsel, Contracts, Exelixis

Session Details:

The Cost of Delay: How Contracts and Budgets Can Make or Break Trial Timelines

2027-02-11, 9:30 AM

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Meghan McKenzie
Director, AIR Portfolio Alliance Lead, Population Science, Genentech

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

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

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

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

Session Details:

Session reserved

2027-02-11, 11:15 AM

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Justin Chickles
CEO, Glycyx
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Mamatha Reddy
Executive Director and Head of Clinical Operations, Infinimmune

Session Details:

TRACK A: How Can We Make Patient Participation Easier?

2027-02-10, 4:40 PM

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Megan L. Dunham
Associate Director, Clinical Data Innovation, Jazz Pharmaceuticals

Session Details:

Don’t Bolt a Jet Engine to the Horse Carriage: Designing AI-Native Workflows for Clinical Development

2027-02-10, 11:15 AM

Session Details:

PANEL DISCUSSION: Why Innovation Fails to Scale at the Pilot Stage

2027-02-11, 12:15 PM

Session Details:

TRACK B: Beyond the Hype: Where Does AI Actually Belong in Clinical Trials?

2027-02-10, 4:40 PM

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Sue Naim
Senior Vice President, Clinical Operations, Mirum Pharmaceuticals

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PANEL DISCUSSION: Taking Control of Your CRO Strategy

2027-02-11, 12:15 PM

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Omer Siddiqui
Venture Partner and Senior Development Advisor, NeuroVC

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VC SPOTLIGHT Standing Out in a Competitive and Crowded Clinical Trial Landscape

2027-02-11, 12:15 PM

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Michael Weickert
Ph.D, CEO, Pacylex Pharmaceuticals

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Doing More with Less: How Virtual Biotechs Can Successfully Conduct First Clinical Studies on a Budget

2027-02-10, 11:15 AM

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Shilpen Patel
Senior Vice President, Perspective Therapeutics

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ASK THE EXPERTS: The Regulatory Questions You Should Have Asked Six Months Ago

2027-02-10, 2:30 PM

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Jenny Holt
Chief Development Officer, Ray Therapeutics

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PANEL DISCUSSION: Why Innovation Fails to Scale at the Pilot Stage

2027-02-11, 12:15 PM

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Chitra Sharma
Senior Vice President, Development, Scribe Therapeutics

Chitra Sharma is a high-impact biotechnology executive with over 25 years of experience architecting product lifecycles from early-stage development through successful NDA/BLA approvals. A specialist in CMC and global Quality operations, she has pioneered regulatory and development strategies, working for industry titans including Genentech, Roche Bioscience, Cor Therapeutics and Vivus.
Currently, as SVP of Development at Scribe Therapeutics, she integrates breakthrough innovation with operational excellence.

Chitra’s expertise spans a sophisticated portfolio of CRISPR, Cell and Gene Therapy, Biologics and small molecules. Over 13 years as a founder and consultant, she served as a premier bridge between scientific discovery and commercial viability for both Fortune 500 firms and agile startups.
A pragmatic leader with deep technical mastery, Chitra is defined by her ability to scale global operations and build high-performing, compliant organizations that navigate the complexities of international drug development.

Session Details:

ASK THE EXPERTS: The Regulatory Questions You Should Have Asked Six Months Ago

2027-02-10, 2:30 PM

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Suyash Prasad
President, Research and Development, Stealth Mode Biotech

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Session reserved for

2027-02-11, 9:30 AM

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Sanjay Mourya
Senior Director, Clinical Operations, Unicycive Therapeutics

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When Trials Go Off Track: How Clinical Operations Leaders Recover Timelines, Sites and Study Performance

2027-02-11, 11:15 AM

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Nicholas D’Amato
Director of Clinical Operations, Vaxart

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Designing for Delivery: Building Operationally Feasible Clinical Trials

2027-02-10, 4:00 PM

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Anirban Mukherjee
Vice President, Strategic Sourcing, Vera Therapeutics

Session Details:

PANEL DISCUSSION: Taking Control of Your CRO Strategy

2027-02-11, 12:15 PM

Session Details:

One Trial, Many Partners: Building a Governance Model That Strengthens Vendor Partnerships

2027-02-11, 2:00 PM

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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:

Chairperson’s opening remarks

2027-02-10, 8:15 AM

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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, Center for Information & Study on Clinical Research Participation (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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Nick McCudden

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+61 280 978 126

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Niki Khoshkbary

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+44 204540 7545

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Karina Gomez

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Sunny Saikia

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SPONSORSHIP ENQUIRIES


Head of OCT Sponsorship

Nick McCudden


+61 280 978 126

SPEAKER ENQUIRIES


Program Director

Niki Khoshkbary


+44 204540 7545

MARKETING ENQUIRIES


Head of Marketing

Karina Gomez


 

DELEGATE ENQUIRIES


Delegate Manager

Sunny Saikia