17th Annual Outsourcing in Clinical Trials New England 2025

This year’s Outsourcing in Clinical Trials New England event will boast 4 tracks on Clinical Operations and Outsourcing, Clinical Technology and Innovation, Rare Diseases, and Patient Recruitment and Engagement, meaning for anyone involved in the operational aspects of running a clinical trial, there truly is something for everyone.

15 - 16

October

2025
  • Encore Boston Harbor, Boston, USA
  • Complimentary
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Why attend?

YOUR CHANCE TO MEET AND CATCH UP WITH COLLEAGUES FROM ACROSS THE INDUSTRY

As this event returns to an in-person format, you can look forward to a networking focused event with industry leading presentations, interactive formats and the most innovative solution providers attending. Hear from industry leading speakers, Learn what is round the corner in terms of future trends and get the latest knowledge on new and upcoming disruptors.

  • Keynote presentations on the topics affecting you: from COVID to shipping to disruptive technologies
  • Join in with audience discussions, panel debates and add your voice to the conversation

700+

Attendees

80+

Exhibitors

50+

Speakers

700+

Attendees

80+

Exhibitors

50+

Speakers

See What It's All About

Agenda

  • 15 Oct 2025
  • 16 Oct 2025
Expand All

Streams

Stream one

Stream A: Clinical Outsourcing and Operations

Stream two

Stream B: Clinical Technology and Innovation

Stream three

Stream C: Biotech Strategy

11 AM

PANEL: The New England biotech landscape in 2025: growths, shifts and strategic outlook

  • Analyzing current market dynamics and funding trends shaping biotech growth in 2025
  • Addressing ongoing talent shortages and evolving workforce strategies
  • Funding and investment for biotechs in and around Boston: how has this shifted in 2025?
  • The impact of national political and economic changes on the biotech landscape in Boston and New England

Speakers

Gregg Beloff
Founder, Danforth Health
Harry Barnett
Executive Chairman, Lubris Biopharma
George Tetz
Chief Executive Officer, Second Life Therapeutics
Chris Adams
Chief Executive Officer, Andarix

11:30 AM

Bridging the gaps: Integrating consulting and clinical operations to accelerate biotech development

  • Identify and eliminate “white space”.  Spot gaps between strategic planning and operational execution and apply techniques to streamline transitions across the clinical development lifecycle.
  • Understand how early consulting and clinical pharmacology services work together to enhance strategy and execution. Understand when and how to engage to shape a cohesive development pathway, improve timing, and accelerate decision-making.
  • Align scientific, regulatory, and clinical perspectives from the outset. Explore the benefits of integrated teams in a CRO setting to ensure continuity, reduce delays, and support end-to-end development.
  • Connect strategic and operational elements across development stages. Gain practical insights into bridging planning, execution, and transition phases for smoother progression and better outcomes.

Speakers

Stephanie Bolick
VP Biotech Development Operations, Fortrea

12 PM

CASE STUDY: Securing capital: funding strategies for biotechs and start up companies

  • Navigating the evolving VC landscape and investor expectations
  • Leveraging funding options such as grants, strategic partnerships and government programs
  • Building strong enough data to convince investors while managing with limited capital

Speakers

Dan Housman
Chief Executive Officer, Courage Therapeutics

12:30 PM

Reimagining clinical trials: the role of master protocols in modern research

  • Understand the benefits, optimal use cases and best scenarios for master protocols
  • Maximize trial operations with improved coordination and more sub-study opportunities
  • Enhance data collection and sharing, broadening patient access to new therapies
  • Navigate strategic relationships for safe and successful master protocol research

Speakers

Beth Chamblin
Senior Director, Project Management, Late Phase Oncology, IQVIA Biotech

1 PM

Lunch and networking break

2 PM

PANEL: Staying resilient: leading your biotech through political and economic uncertainty

  • Coping with layoffs and budget cuts
  • Are we expecting droughts for research in the biotech space?
  • Diversifying funding and partnership strategies to reduce financial risk
  • Strengthening operational agility to respond quickly to market and policy disruptions

Speakers

Rich Polgar
Managing Director, Danforth Health
Christopher U Missling
President and Chief Executive Officer, Anavex Life Sciences
Andy Liu
General Manager - China, Novotech

2:30 PM

Reserved for Medidata

3 PM

CASE STUDY: What does it take to start up a biotech company from scratch?

  • An overview of common challenges and how to overcome these
  • Securing initial funding: navigating opportunities available to raise capital
  • Overcoming early stage hurdles
  • Building strategic partnerships to support your biotech

Speakers

Chris Adams
Chief Executive Officer, Andarix

3:30 PM

Afternoon refreshments and networking break

3:50 PM

EXHIBITION APPLE 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!

4 PM

Choosing the right CRO: key considerations for small biotechs

  • Evaluating CRO capabilities and experience relevant to your specific therapeutic area and development stage
  • Balancing cost, quality and timelines within tight budget constraints
  • Negotiating contracts with flexibility to protect your biotech’s goals

Speakers

Dr. Martin Bauer
Chief Medical Officer, Eleva GmbH

4:30 PM

Driving asset value through operational precision

  • Operational inefficiencies quietly erode a drug’s Probability of Technical and Regulatory Success (PTRS) and reduce overall asset value
  • Biotechs must shift from reactive oversight to proactive strategies grounded in near-term visibility and actionable data
  • Same-day insights into trial conduct help de-risk execution, protect endpoints, and accelerate development timelines
  • Faster, cleaner data drives confident decisions and signals operational strength to investors and partners
  • Lessons from 25+ years in drug development offer a practical blueprint for embedding operation excellence into biotech strategy

Speakers

Richard A. Graham
Ph.D., Co Founder and Chairman of the Board, TruTechnologies

5 PM

PANEL: Patient advocacy and incorporating patient perspectives early on in a small biotech

  • Developing relationships with advocacy groups and patient communities from early stages
  • How does patient advocacy differ at biotechs vs large pharma?
  • Integrating patient insights into your study to ensure patients remain the priority throughout your trial

MODERATOR Hollie Schmidt, Vice President, Scientific Operations, Accelerated Cure Project for MS

Speakers

Hollie Schmidt
Vice President, Scientific Operations, Accelerated Cure Project for MS
Rebecca Nordland
Senior Project Manager, Research Services, CISCRP
Katerina Chatzi
Founder and Chief Executive Officer, Promakhos Therapeutics

5:30 PM

Chairperson’s closing remarks

Speakers

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

END OF DAY 1 AND NETWORKING DRINKS

11 AM

The state of the biopharmaceutical industry in 2025: emerging technologies and opportunities

  • Emerging themes and technology advancements in biopharma
  • Leveraging data to predict the outlook for 2025 clinical trials
  • Trends, key players, opportunities, and threats in clinical trial outsourcing
  • Latest biopharma investor activity: venturing financing, IPOs, and grants

Speakers

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

11:30 AM

Reserved for EmVenio

12 PM

Updates and developments on Tufts CSDD: DIA collaborative study results: using AI and ML in clinical development

  • Focus of the innovation and phase of AI implementation (pilot, partial implementation, full implementation) as well as the organizational resources required to deploy the innovation
  • Impact on cycle times and costs
  • Key challenges to implementation and how they have been addressed by organizations
  • Metrics tracked and outcomes that have resulted

Speakers

Mary Jo Lamberti
Research Associate Professor and Director, Sponsored Research, Tufts Center for the Study of Drug Development
Maria Florez
Senior Consultant, Tufts Center for the Study of Drug Development

12:30 PM

Gamification in clinical trials: A proven path to better engagement, retention, and data integrity

Consistent patient engagement is vital to clinical trial success, yet dropout and non-compliance remain persistent challenges. This session introduces gamification as a scientifically grounded strategy to boost retention, enhance adherence, and streamline trial execution.

  • Understand the Science: Explore the behavioral and psychological foundations that make gamification a powerful tool for sustaining patient motivation
  • See Real Results: Review real-world case studies where gamification significantly improved retention, compliance, and trial timelines
  • Apply Proven Methods: Learn practical strategies and best practices for integrating gamified elements into clinical trial protocols

Speakers

Christer Nilsson
Chief Executive Officer, Replior

1 PM

Lunch and networking break

2 PM

Implementing an EDC system: operational and technical considerations

Speakers

Meredith Frank-Molnia
Vice President, Clinical Affairs, Vericel Corporation

2:30 PM

TECHNOLOGY SPOTLIGHT: The impact of Simulation-Based learning on Study Acceleration – Spoken from the Sponsor who converted

  • What forced me to think strategically about clinical research training methodology
  • Gaps & Risks of ‘check-the-box’ training
  • Initial impact of Simulation-Based training on risk mitigation, Site time, Satisfaction, Enrollment and Quality
  • Advances in Simulation-Based training that enhance site and patient engagement as well as optimize protocols

Speakers

Brad Stefanovic
Head of Clinical Innovations, Simulations Plus

3 PM

Harnessing real world experience: driving innovation and decision making

  • Collecting and integrating supportive data sources for complimentary patient insights
  • Understanding the regulatory landscape around RWE and how to navigate this efficiently
  • Ensuring data quality, privacy and regulatory compliance in RWE initiatives

Speakers

Christopher U Missling
President and Chief Executive Officer, Anavex Life Sciences

3:30 PM

Afternoon refreshments and networking break

3:50 PM

EXHIBITION APPLE 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!

4 PM

Opportunities in building AI models for efficiency in outsourcing

  • Identifying outsourcing opportunities and pitfalls to avoid that can be addressed through AI driven solutions: timeline standards, document prep and system utilization
  • Developing operationally, process and system driven AI models to support clinical operations and outsourcing: what can be streamlined?
  • Integrating AI insights into outsourcing strategy to drive speed, quality and cost effectiveness: timelines, project management and reconciliation

Speakers

Jeannette Villabon
Associate Director, Clinical Operations and Vendor Management, Alkermes

4:30 PM

PSI’s VISIONAL: enhancing feasibility and enrollment predictions with GenAI

  • Explore how PSI integrates GenAI for protocol similarity searches and enrollment rate predictions, improving accuracy and efficiency in clinical trial planning
  • Learn how VISIONAL™ incorporates three new data sources to enhance site performance analysis and offer insights across 56 countries, supporting better decision-making
  • Discover how VISIONAL™ enables sponsors to quickly generate multi-country feasibility scenarios and budgets in under 30 minutes, streamlining the planning process

Speakers

Emily McInturf
Director, Feasibility, PSI CRO

5 PM

Direct to patient study results

Speakers

Maria Florez
Senior Consultant, Tufts Center for the Study of Drug Development

5:30 PM

Chairperson’s closing remarks

Speakers

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

END OF DAY 1 AND NETWORKING DRINKS

7:30 AM

Registration and refreshments

8:15 AM

GlobalData opening remarks

Speakers

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

8:25 AM

Chairperson’s opening remarks

8:30 AM

PANEL: Assessing the impact of the political and economic landscape in the US on outsourcing decisions in pharma

  • 10 months in: how has the new administration affected the pharma and biotech industry in New England?
  • Dealing with change and uncertainty: ensuring your clinical trial timelines stay on track
  • Discussing pros and cons of running trials in the US vs overseas considering recent changes
  • How have funding and resources been affected in 2025 and how has this impacted outsourcing and clinical operations?

MODERATOR Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

Speakers

Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare
Harry Barnett
Executive Chairman, Lubris Biopharma

9 AM

Clinical trials in Japan: a new era of opportunity for global sponsors

  • Japan as one of the largest pharmaceutical markets presents unique challenges and opportunities
  • Overview of the current clinical trial environment, government support and major regulatory reforms
  • What’s the reward of running clinical trials in Japan and Japan market entry?

Speakers

Kento Nakamura
Strategy and Corporate Development, CMIC

9:30 AM

PANEL: Strengthening supplier relationships: strategies for positive collaboration and communication

  • Fostering transparent and constant communication with CROs and other suppliers to minimize delays and ensure timelines stay on track
  • Ensuring your suppliers’ goals align with your study goals
  • Monitoring CRO and supplier performance with clearly defined KPIs
  • Aligning on project timelines, milestones and quality expectations from the beginning

MODERATOR
Rich Polgar, Managing Director, Danforth Advisors

Speakers

Rich Polgar
Managing Director, Danforth Health
Rinaldo Dorman
Associate Director, R&D Global Procurement and Strategic Sourcing, Sarepta Therapeutics
Stacey Oppenheimer
Director, Third Parth Quality Lead, Pfizer
Nicole McElroy
Director, Strategic Partnerships and Outsourcing, Takeda
Kathleen Martyn
Manager, Vendor and Clinical Operations, Karyopharm Therapeutics

10 AM

China as an Early Phase Solution: Opportunities for US Sponsors

  • Why plan your trials in China?
  • Key considerations in evaluating China
  • Key success factors
  • Case studies

Speakers

Andy Liu
General Manager - China, Novotech

10:30 AM

Morning refreshments and networking break

11 AM

Leveraging untapped resources: capitalizing on expertise from non-industry professionals

  • The importance of transferrable skills and assessing potential hires based on more than direct industry experience
  • Challenging your mindset to expand your talent pipeline
  • Integrating fresh perspectives and how this can drive innovation and broaden your knowledge
  • Onboarding and supporting cross-sector hires for long term impact and retention

Speakers

Nick Pelletier
Head of Clinical Operations and Program Management, Delix Therapeutics
Sydney DeCaro
Clinical Trial Associate, MapLight Therapeutics

11:30 AM

Reserved for ICON Plc

12 PM

FIRESIDE CHAT: Keeping patients and caregivers at the center of rare disease clinical trials: collaborating with patients, caregivers, and nonprofits for better outcomes

  • Understanding the provider-patient conversations: point-of-patient and provider discussions to shape trial design that is patient centric
  • Survey design: creating questions focused on patient and caregiver needs during the trial and post-trial to keep patients engaged and enrolled leading to better outcomes
  • Share your Rare Action: mention your post-session action to improve your process that includes rare patients, caregivers, and non-profits

Speakers

Sarah Woods
Founder, Serenely Guided Foundation

12:30 PM

Beyond the Buzzword: Practical AI strategies for accelerating clinical research

  • Define AI use across the biotech industry
  • Provide a framework for when and how to incorporate AI into clinical trials
  • Uncover areas where AI is relatively easy to use within your current corporate environment
  • Share real-world examples of how rare disease focused companies are leveraging AI to expedite drug development

Speakers

Derek Ansel
Vice President, Therapeutic Strategy Lead, Rare Disease, Worldwide Clinical Trials

1 PM

Lunch and networking break

2 PM

Partnering with patient advocacy groups in order to align clinical trials with patient priorities

  • Engaging with patient advocacy groups to uncover true patient needs
  • Incorporating patient insights early on in design and launch plans
  • Identifying clinical trial design elements that may hinder recruitment and retention
  • De-risking development programs by aligning with patient priorities
  • Real world case studies on how advocacy input shaped treatment selection, clinical trial design, and trial results dessemination

Speakers

Hollie Schmidt
Vice President, Scientific Operations, Accelerated Cure Project for MS

2:30 PM

From first step to final outcome: Reframing feasibility as an operational strategy

  • ow integrating cross-functional risk assessment of the feasibility process can enhance site strategy, clinical oversight, system selection(s) product solutions, and long-term trial delivery
  • How to identify feasibility approaches that align with execution, not just enrollment, and how a more connected model helped de-risk a complex study
  • Practical strategies to elevate feasibility from a planning task to a foundational element of trial success
  • Understand the difference between traditional feasibility and true operational feasibility, and why that distinction matters
  • Learn how early cross-functional risk assessments can expose delivery risks before they surface mid-study
  • Discover how to align feasibility insights with cross-functional oversight, site strategy, and fit-for-purpose systems with customized solutions from the outset
  • Explore how an integrated feasibility-to-delivery model can improve performance in high-complexity, high-variability trials

Speakers

Jessica Wessel
Senior Director, Project Delivery, TFS HealthScience

3 PM

PANEL: Making a success of FSP models for your clinical trial

  • Weighing up pros and cons of FSP vs other outsourcing models: is FSP right for your clinical trial?
  • Defining the FSP model and understanding when it is the right fit for your organization
  • Selecting the right FSP partners to complement internal capabilities
  • Optimizing cost efficiency and scalability through flexible FSP partnerships

Speakers

John Seman
Chief Executive Officer, Revitale Pharma
Leonella Seeley
Director, Vendor Management and Operations, Karyopharm Therapeutics
Carrie Lewis
Executive Director, Clinical Program Optimization, Endo
Leticia Tarilonte
Vice President, Head of Global Clinical Operations, Pyxis Oncology
Beth Davis
Senior Manager, Development Services and Operational Excellence, Vendor and Relationship Management Lead, Regeneron

3:30 PM

Afternoon refreshments and networking break

3:50 PM

EXHIBITION APPLE 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!

4 PM

PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

  • Reviewing last year’s FDA feedback on audits: what were the main reasons for failure?
  • Tips and tricks to ensure you are ready for inspection
  • Simplifying processes in order to prepare for an FDA inspection

Speakers

Leticia Tarilonte
Vice President, Head of Global Clinical Operations, Pyxis Oncology
Kelsey Miller-Torchia
Senior Vice President, Clinical and Business Development, Intrinsic Therapeutics

4:30 PM

Strategic site selection in early development: Meeting the demands of complex therapies

  • Examining common pitfalls in site selection for complex therapies and how data informed approaches can help sponsors overcome them
  • Exploring strategies to balance sponsor preferred sites, CRO recommendations, KOL influence, and community investigators for stronger performance
  • Understanding how to connect internal knowledge with external databases to drive greater accuracy and efficiency in early development
  • Reviewing real world case studies that highlight innovative solutions to early phase challenges in complex therapies, from timeline management to site readiness

Speakers

Amanda Fierro
Project Manager, Oncology, Premier Research
Marilyn Kludt
Senior Project Director, Oncology, Premier Research

5 PM

CASE STUDY: Getting a new site up and running: challenges, opportunities and lessons learned

  • Top tips for working with and supporting naïve physicians in order to ensure their success
  • The importance of maintaining and growing the pool of investigator sites
  • Lessons learned for the future: what should you consider when working with naïve doctors?

Speakers

Carrie Lewis
Executive Director, Clinical Program Optimization, Endo

5:30 PM

Chairperson’s closing remarks

Speakers

John Seman
Chief Executive Officer, Revitale Pharma

END OF DAY 1 AND NETWORKING DRINKS

Streams

Stream one

Stream A: Clinical Outsourcing and Operations

Stream two

Stream B: Clinical Technology and Innovation

Stream three

Stream C: Biotech Strategy

8:50 AM

Chairperson’s opening remarks

Speakers

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

9 AM

PANEL: Handling finances for your biotech: tips for managing funding, investment and budgets

  • Ensuring your trial is cost-conscious and efficient without compromising on quality or on patient care
  • Forecasting and budgeting in order to accurately predict costs and minimize unforeseen expenses
  • Keeping your clinical budget on track
  • Negotiating prices and contracts in order to ensure maximum benefit without going over budget

MODERATOR
Rene Stephens, Managing Director, Clinical Business Operations, Danforth Advisors

Speakers

Rene Stephens
Managing Director, Clinical Business Operations, Danforth Health
Veronica Ludensky
Director of Procurement, Clinical, Flagship Pioneering
Molly James
Associate Director, Strategic Sourcing, Beam Therapeutics
Dan Housman
Chief Executive Officer, Courage Therapeutics

9:30 AM

Reserved for TransPerfect

10 AM

INTERACTIVE SESSION: What are investors looking for in a biotech or start up?

Speakers

Shailesh Chavan
Managing Partner, Ingenious Global Venture Partners

10:30 AM

Morning refreshments and networking break

11 AM

CASE STUDY: Making a strategic success of public-private partnerships

  • Exploring different funding avenues: how to structure fundraising initiatives
  • Working in collaboration with academia: benefits and opportunities
  • The importance of building networks and insights from investors in addition to capital
  • Lessons learned: analyzing both successes and learnings for future biotech initiatives

Speakers

Steffen-Sebastian Bolz
Co-Founder and Chief Scientific Officer, Aphaia Pharma and Executive Board Member and Chief Scientific and Medical Officer, Qanatpharma

11:30 AM

Available for event sponsor

12 PM

PANEL: Driving technology and innovation in a small biotec

  • What is realistic, what isn’t, and how can you stay ahead of the curve?
  • How biotech and pharma differ when it comes to technology and innovation: as a biotech, where should your priorities lie?
  • Staying ahead of competitors when funding and resources are limited for technology investment
  • Leveraging agility and flexibility to adopt technology quickly
  • Balancing innovation with risk management and scalable development

Speakers

Harry Barnett
Executive Chairman, Lubris Biopharma
Veronica Ludensky
Director of Procurement, Clinical, Flagship Pioneering

12:30 PM

Lunch and networking break

8:50 AM

Chairperson’s opening remarks

Speakers

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

9 AM

Successfully planning a clinical supply chain for new drug modalities

  • Overviewing trends and developments in drug modalities to evaluate differences in supply management
  • Strategizing an effective trial supply plan to minimize setbacks
  • Implementing changes in supply chain management across teams to best facilitate a new modality

Speakers

Matthew Birmingham
Head, Supply Chain and External Manufacturing, Prime Medicine

9:30 AM

Beyond integration: How AI creates a clinical trial platform

  • The challenge: Disconnected systems creating blind spots in trial management
  • The opportunity: AI as the connective tissue between documentation and execution
  • The Intelligent Trial Assistant: Natural Language Queries Across ETMF and CTMS
  • AI-Driven Inspection Readiness: Connecting Document Quality to Trial Execution
  • Predictive Trial Health: Using AI to Connect the Dots Between Documents and Operations
  • Smart Document Classification Meets Smart Workflow: End-to-End Trial Automation

Speakers

April Mattison-Wolfe
Senior Manager Technical Services, TransPerfect
Katherine Cianciarelli
Senior Product Manager, eTMF and AI, TransPerfect

10 AM

PANEL: AI and machine learning in clinical trials: where are we in 2025?

  • Opportunities for incorporating AI into clinical research: where should the industry be focusing?
  • Why has pharma been relatively slow to utilize AI in clinical research?
  • Understanding limitations of GenAI: what do you need to be wary of?
  • Real case studies on AI in the clinical trial industry: where has there been progress and success?
  • What does the future hold for AI in clinical trials?

MODERATOR Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

Speakers

Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare
Jeannette Villabon
Associate Director, Clinical Operations and Vendor Management, Alkermes

10:30 AM

Morning refreshments and networking break

11 AM

Digital health innovations in cardiovascular clinical trials: assessing Apple Watch as a sensor-based digital health technology for atrial fibrillation

  • Harnessing Apple Watch technology: key features for detecting heart arrhythmias
  • What the evidence says: insights from published cardiovascular studies
  • From wrist to research: smart distribution models for clinical trial success
  • Making it work: tackling operational and data management hurdles for clinical trial success

Speakers

Amir M. Behdani
PharmD, Biomarker Development Postdoctoral Fellow, Novartis

11:30 AM

3 technology use cases shaping the future of trial design and implementation

  • Optimizing and de-risking trial design and feasibility: how data-driven modeling and simulation tools are helping sponsors design smarter, more efficient trials from the outset
  • Enabling in-stream decision-making during execution: using real-time insights to adapt trial operations dynamically, improving quality, timelines, and decision confidence
  • AI's transformative impact on trial delivery: from reshaping how we plan and run trials to redefining roles and workflows, AI is set to re-engineer every stage of clinical development

Speakers

Christopher Schoonmaker
Chief Operating Officer, MMS Holdings

12 PM

The Early Feasibility Study: getting it right for a medical device

  • Designing the study and getting IRB permission to run it
  • Site selection
  • The importance of electronic data capture
  • Why a sponsor's representative must be there
  • The physician's or surgeon's muscle memory

Speakers

Jerrold M. Shapiro
President, Floelle

12:30 PM

Lunch and networking break

8 AM

Registration and Refreshments

8:50 AM

Chairperson’s opening remarks

Speakers

T.J. Sharpe
Patient Advocate

9 AM

From insight to impact: translating patient voices into study materials that matter

  • Maximize the value of existing patient involvement efforts by “translating” patient advisory board insights into participant-facing materials
  • Meet growing regulatory expectations for patient involvement in participant materials development
  • Implement a co-development approach with patients and advisors review
  • Internal planning tips for timelines, stakeholder engagement, and IRB submission strategies
  • Best practices in health literacy to ensure clarity, trust, and accessibility

Speakers

Behtash Bahador
Senior Director, Community Engagement & Partnerships, CISCRP
Ellyn Getz
Director, R&D Patient Partnerships, R&D Strategic Operations, CSL Behring

9:30 AM

Beyond the Middleman: Strategic Outsourcing of IOR/EOR for Global Clinical Trials

  • Demystifying the Importer of Record (IOR) and Exporter of Record (EOR) functions and reframing it as a strategic enabler of cost efficiency, regulatory compliance, and accelerated timelines in global clinical trial logistics
  • What IOR/EOR really means in a clinical context: Role in customs declarations, tax responsibility, and compliance.
  • IOR providers' responsibilities through HS classification, valuation review, and pre-clearance planning.
  • Best-fit model: When and where to outsource vs. manage in-house.
  • Tax pitfalls in outsourced IOR: Misclassification of goods (e.g., placebo vs. commercial drug), overpaying duties or VAT due to poor documentation control, and ignoring the available tax saving opportunities.
  • Tax planning by design: The importance of implementing a sound IOR strategy to avoid the highlighted tax pitfalls.
  • Walk away with a deeper understanding of IOR/EOR as a strategic lever for improved global clinical execution, guidance on how to incorporate an outsourced IOR for global clinical trials and a “Red Flag Checklist” with critical questions to vet vendors for outsourcing IOR/EOR

Speakers

Louisa Carlse
Director of Partnerships, TecEx Medical

10 AM

Reimagining the clinical trials infrastructure for Inclusive and accessible rare diseases and orphan therapies

  • Uncovering the invisible: a 20-year analysis of medically underrepresented populations in clinical trials
  • Benchmarking against the US census reveals structural gaps and needs
  • Adopt a six-pillar architecture to embed equity from the ground up

Speakers

Harsha K. Rajasimha
MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
Jenifer Waldrop
Executive Director, Rare Disease Diversity Coalition

10:30 AM

Morning refreshments and networking break

11 AM

CASE STUDY: Management of tumor biomarker testing to boost study enrolment

Speakers

Helen Chalk
Vice President, Clinical Operations, Mythic Therapeutics
Malina Traianova
Director, Lab and Vendor Management, Mythic Therapeutics

11:30 AM

Strength meets agility: Co-developing a framework for seamless FSO to FSP transition

  • Big pharma is a battleship in a speedboat world. FSP outsourcing offers the agility to cut through traditional development timelines and chart a faster course to patients.
  • In this presentation, Parexel will share how they partnered with Bristol Myers Squibb (BMS) to make a strategic shift, transitioning from a predominantly full-service outsourcing model to a functional service provider model. This involved redefining traditional roles, innovating tasks and responsibilities, and talent redeployment in support of pipeline priorities.
  • The presenters will discuss the strategic considerations and benefits of this transition, demonstrating how through a collaborative partnership, they worked to enhance BMS’ clinical trial operations, creating resource efficiencies, increasing agility, and optimizing clinical operations across their global portfolio. This presentation will offer valuable insights for companies seeking to adapt their outsourcing strategies to meet the demands of today's complex and rapidly changing drug development environment.

Speakers

Kerri McCaul-Claus
Vice President, Head of FSP Biometrics, Parexel
Allison Covucci
Senior Director, Statistical Programming, Bristol Myers Squibb

12 PM

The importance of accurate and consistent sample collection and management in clinical trials

Speakers

John Smutko
Head of Oncology Scientific Operations, GSK
Ben Laiviere
Associate Director, Scientific Operations, GSK

12:30 PM

Lunch and networking break

1:30 PM

KEYNOTE PRESENTATION AND WORKSHOP: Applying AI to our clinical operations challenges

  • What’s stopping us from using AI?
  • How to overcome barriers to AI: creative starter ideas
  • AI case studies, stories and key takeaways

Speakers

Dan Seewald
Co-Founder and COO, LiviWell and Founder and Chief Executive Officer, Deliberate Innovation

2:20 PM

I’ve chosen my CRO – Now what? Preparing for success in the first 90 days of your strategic partnership

  • How to build a strong CRO onboarding plan that sets your study up for success
  • Making your kickoff meeting count: aligning teams, timelines, and expectations
  • Fast-tracking your study start-up — from project plan to site activation
  • Anticipating and mitigating early risks to protect your study timelines

Speakers

Vinnette Sallo
Senior Director, Project Management, Ergomed

2:50 PM

PANEL: Running clinical trials in different geographical regions: benefits of running trials inside vs outside the US

  • With uncertainty and constant change in the US, is the solution to look overseas for clinical trial sites?
  • Working with CROs and partners overseas: assessing benefits as well as potential challenges
  • Positive and negative impacts of trials abroad on clinical trial finances and budgeting
  • What advantages are there of keeping trials inside the US?

MODERATOR Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

Speakers

Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare
Hyun Kim
Senior Vice President, Clinical Development, AOBiome Therapeutics
Yolanda Wan
Head of Clinical Operations, Orna Therapeutics

3:20 PM

Afternoon refreshments and networking break

3:40 PM

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the conference and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

3:50 PM

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations. Roundtables will take place in the Stream A conference room.

ROUNDTABLE 1: Navigating biological material regulations

Sean D. Smith, Biological Threat Exclusion Coordinator (BTEC), US Customs and Border Protection

ROUNDTABLE 2: Keeping patients at the heart of your clinical trial

Behtash Bahador, Senior Director, Community Engagement & Partnerships, CISCRP

ROUNDTABLE 3: Fostering a positive relationship with your CRO and vendor partners

Liza Micioni, Director, Clinical Operations, Tris Pharma

ROUNDTABLE 4: Negotiation tips for emerging startups

Speakers

Liza Micioni
Director, Clinical Operations, Tris Pharma
Behtash Bahador
Senior Director, Community Engagement & Partnerships, CISCRP
Sean Smith
Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, Office of Field Operations,
U.S. Customs and Border Protection

End of Conference

Speakers

Select a speaker to learn more

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Hollie Schmidt
Vice President, Scientific Operations, Accelerated Cure Project for MS

Hollie Schmidt is the VP of Scientific Operations at Accelerated Cure Project for Multiple Sclerosis. She co-chairs the Research Committee of iConquerMS™, a research cohort established to perform and support patient-centered research in MS. She also founded and leads the MS Minority Research Engagement Partnership Network, a multi-stakeholder initiative aimed at increasing racial and ethnic diversity in MS research studies.

Session Details:

Partnering with patient advocacy groups in order to align clinical trials with patient priorities

2025-10-15, 2:00 PM

Session Details:

PANEL: Patient advocacy and incorporating patient perspectives early on in a small biotech

2025-10-15, 5:00 PM

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Jeannette Villabon
Associate Director, Clinical Operations and Vendor Management, Alkermes

Session Details:

Opportunities in building AI models for efficiency in outsourcing

2025-10-15, 4:00 PM

Session Details:

PANEL: AI and machine learning in clinical trials: where are we in 2025?

2025-10-16, 10:00 AM

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Christopher U Missling
President and Chief Executive Officer, Anavex Life Sciences

Dr. Missling, President and CEO of Anavex, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex®, he served as the Chief Financial Officer of Curis and ImmunoGen. In addition, at Aventis (now Sanofi),  Dr. Missling worked as head of financial planning on all aspects of financial strategy and M&A. His career experience also includes working as an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, as well as serving as the head of healthcare investment banking at Brimberg & Co. in New York. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.

Session Details:

Harnessing real world experience: driving innovation and decision making

2025-10-15, 3:00 PM

Session Details:

PANEL: Staying resilient: leading your biotech through political and economic uncertainty

2025-10-15, 2:00 PM

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Chris Adams
Chief Executive Officer, Andarix

Mr. Adams has been a founder or co-founder of life science and technology based companies in Massachusetts for the past several years. Mr. Adams has been instrumental in developing new proprietary therapeutic and medical device technologies and bringing the technologies to commercialization. The companies he has founded include, Compellis Pharmaceuticals, a developer of therapeutics to treat obesity and its co-morbidities, diabetes and hypertension and Mosaic Technologies, a venture backed MIT spin-out genomics company that developed patented technologies for genetic analysis and detection.

Chris is the holder of more than 20 issued US and international patents for medical devices and pharmaceuticals.

Session Details:

CASE STUDY: What does it take to start up a biotech company from scratch?

2025-10-15, 3:00 PM

Session Details:

PANEL: The New England biotech landscape in 2025: growths, shifts and strategic outlook

2025-10-15, 11:00 AM

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Hyun Kim
Senior Vice President, Clinical Development, AOBiome Therapeutics

Hyun has been a part of AOBiome's clinical pipeline leadership since 2016. Hyun brings over 25 years of drug development experience in the pharma and biotech industry.  Prior to this, Hyun has led Clinical and R&D programs and departments at Pfizer, Anika Therapeutics, Transport Pharmaceuticals, and Olympus Biotech.  He started his career at Genetics Institute and Wyeth, advancing R&D programs into the clinic.  He attended Brown University where he studied Biomedical Engineering and completed a PhD in Medical Science.

AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing microbiome-based therapies for local, nasal and systemic inflammatory conditions. Founded in 2012 by PatientsLikeMe founder Jamie Heywood and MIT-trained Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company's portfolio includes multiple clinical-stage programs in atopic dermatitis, rosacea, and acne, as well as additional programs targeting diverse inflammatory indications.

Session Details:

PANEL: Running clinical trials in different geographical regions: benefits of running trials inside vs outside the US

2025-10-16, 2:50 PM

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Steffen-Sebastian Bolz
Co-Founder and Chief Scientific Officer, Aphaia Pharma and Executive Board Member and Chief Scientific and Medical Officer, Qanatpharma

Session Details:

CASE STUDY: Making a strategic success of public-private partnerships

2025-10-16, 11:00 AM

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Jennifer Sydney Goldman
Clinical Finance and Business Operation Consultant, ARTBIO

I’m a clinical finance and operations leader with 20+ years of experience driving global strategies for clinical trial financial planning, strategic outsourcing, vendor management, site contracts and budgets, and investigator grant payments.

I specialize in optimizing systems and workflows to ensure accuracy, compliance, and audit readiness, while building strong cross-functional partnerships across Clinical Operations, Finance, Legal, and Outsourcing.

My experience is predominantly with early-stage biotech, preparing for Phase 1 trials and IPO in 1-3 years. While hands on, as the portfolio grows, I’ve built and led Clinical Business Operations teams.

I enjoy solving complex problems, mentoring teams, implementing automation tools, and working at the intersection of data, people, and purpose-ultimately enabling faster, more transparent trials that serve patients and sites alike, while ensuring financial control and compliance with regulatory requirements.

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Molly James
Associate Director, Strategic Sourcing, Beam Therapeutics

Molly James is the Associate Director of Strategic Sourcing at Beam Therapeutics. In this role she manages all vendors and leads strategic partnerships for the development organization within Beam. She has over 10 years of experience in strategic sourcing and vendor management within the pharmaceutical industry.

Session Details:

PANEL: Handling finances for your biotech: tips for managing funding, investment and budgets

2025-10-16, 9:00 AM

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Dan Housman
Chief Executive Officer, Courage Therapeutics

I am interested in acting as an entrepreneur to create companies that can build cultures and products that change the world. I am a versatile player willing to take on many different positions because of my background in both technology (chemistry, biology, software) and business. I prefer the role of visionary and to work to build a team, culture, product, and partnerships. I like the challenge of creating innovative solutions to hard underserved problems.

I am currently focused on my start-up ventures including Graticule (Digital accelerators for Advanced real world data), Courage Therapeutics (medical discovery for eating disorders), and advocacy work towards improving research, treatment, and payment for Anorexia Nervosa.

Session Details:

CASE STUDY: Securing capital: funding strategies for biotechs and start up companies

2025-10-15, 12:00 PM

Session Details:

PANEL: Handling finances for your biotech: tips for managing funding, investment and budgets

2025-10-16, 9:00 AM

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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.

Session Details:

From insight to impact: translating patient voices into study materials that matter

2025-10-16, 9:00 AM

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2025-10-16, 3:50 PM

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Rebecca Nordland
Senior Project Manager, Research Services, CISCRP

Session Details:

PANEL: Patient advocacy and incorporating patient perspectives early on in a small biotech

2025-10-15, 5:00 PM

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Bailey Willis
Associate Director, Medical Operations and Sourcing, Click Therapeutics
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Kento Nakamura
Strategy and Corporate Development, CMIC

Kento Nakamura is a global professional having worked both in the Western and Eastern healthcare landscapes. He has been in various roles, contributing significantly to drug development, market access, and pharmaceutical marketing.

At CMIC, Japan and South Korea’s first CRO, Kento wears multiple hats including helping formulate corporate strategy, creating mutually beneficial partnerships with other companies, and taking initiative to create business development opportunities.

During his tenure at KM Pharmaceutical Consulting, a boutique drug development consulting firm, Kento co-pioneered the market access perspective on drug development, resulting in key additional endpoints in an ongoing phase 2 study. He also played a crucial role in developing the global drug safety plan, ensuring compliance with reporting requirements across multiple continents.

Kento holds an MPH in Health Management from Harvard University and a BS in Biology from Tufts University. He is fluent in English and Japanese. In his free time, Kento enjoys playing tennis, watching football, visiting contemporary art museums, and traveling around the world.

Session Details:

Clinical trials in Japan: a new era of opportunity for global sponsors

2025-10-15, 9:00 AM

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Ellyn Getz
Director, R&D Patient Partnerships, R&D Strategic Operations, CSL Behring

Session Details:

From insight to impact: translating patient voices into study materials that matter

2025-10-16, 9:00 AM

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Gregg Beloff
Founder, Danforth Health

A business professional who has served as an executive officer in both privately held and publicly traded companies, an investment banker and a corporate attorney. Demonstrated experience in all aspects of financial and business management, strategy and operations including operations management, strategic planning, technology outlicensing, legal, mergers and acquisitions, IPO’s, private placements, finance and accounting, facilities, human resources, IT systems and corporate communications.

Specialties: As CFO raised over $2 billion in equity and debt financings for emerging public and private companies
Designed and executed financial and corporate development strategies
Built and managed operational departments including finance and accounting, human resources, facilities, corporate communications and information systems
Worked as both an investment banker and corporate attorney

Session Details:

PANEL: The New England biotech landscape in 2025: growths, shifts and strategic outlook

2025-10-15, 11:00 AM

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Rene Stephens
Managing Director, Clinical Business Operations, Danforth Health

Réne Stephens is a biopharmaceutical research and development industry consultant with over 25 years of business operations and outsourcing experience. He has worked within pharmaceutical, CRO, SMO, medical imaging, academic CRO, and EDC companies, and private consultation. Réne understands the critical path of development and has a wealth of experience in outsourcing/procurement strategies, practices and negotiations, vendor relationship management, oversight and governance, clinical operations, finance, contracting, process development and improvement, and technology solutions. He holds a BA in Corporate & Organizational Communications (WKU), and an MSHS in Clinical Research Administration (GWU). While at Astellas Pharma Global Development as Executive Director and global head of Contracts & Outsourcing, Réne also served as the Global Procurement Lead for TransCelerate Biopharma, Inc., acting on behalf of and supporting the 20 biopharmaceutical company consortium for vendor selection, negotiation, and governance. He is the former moderator for the quarterly Linking Leaders Outsourcing Roundtable meeting, where current issues are discussed among development outsourcing heads; and, he is a regular speaker at conferences and symposia on business operations topics as related to drug development, outsourcing, vendor and site contracting, and oversight/governance. Since 2017, he has been supporting biopharmaceutical companies in this function as the Managing Member and founder of Renatus Consulting, LLC.

Session Details:

PANEL: Handling finances for your biotech: tips for managing funding, investment and budgets

2025-10-16, 9:00 AM

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Rich Polgar
Managing Director, Danforth Health

Steering the helm for biotechs at Danforth Advisors, my strategic procurement proficiency shapes the landscape of clinical development. With a laser focus on sourcing strategy and risk mitigation, my contribution has been pivotal in advising organizations through critical transitions, including mergers and acquisitions. The expertise I honed while advising on operational growth strategies and variabilizing workforces underscores my current mission to optimize our clients' partnerships and exit strategies.

My tenure as a Senior Director at Danforth Advisors cultivated a deep understanding of clinical sourcing, from preclinical and translational stages to real-world evidence and late-phase data analysis. This comprehensive background facilitates my current role, where I'm committed to advancing sourcing of trials & digital health through robust supplier and stakeholder engagement, thereby empowering the acceleration of our clients' portfolio growth and fostering strategic partnerships.

Session Details:

PANEL: Strengthening supplier relationships: strategies for positive collaboration and communication

2025-10-15, 9:30 AM

Session Details:

PANEL: Staying resilient: leading your biotech through political and economic uncertainty

2025-10-15, 2:00 PM

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Nick Pelletier
Head of Clinical Operations and Program Management, Delix Therapeutics

Session Details:

Leveraging untapped resources: capitalizing on expertise from non-industry professionals

2025-10-15, 11:00 AM

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Sydney DeCaro
Clinical Trial Associate, MapLight Therapeutics

Clinical Operations and research professional with 5 years of clinical research experience, including greater than one year of experience in the biotechnology sector and multiple years leading trials and teams at academic medical research centers. I leverage my deep understanding of the patient journey and site-level operations to bring a site- and patient-centeric perspective to sponsor-side clinical trial execution, driving high-quality studies delivered on time, on budget, and with meaningful impact.

Session Details:

Leveraging untapped resources: capitalizing on expertise from non-industry professionals

2025-10-15, 11:00 AM

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Dr. Martin Bauer
Chief Medical Officer, Eleva GmbH

Session Details:

Choosing the right CRO: key considerations for small biotechs

2025-10-15, 4:00 PM

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Carrie Lewis
Executive Director, Clinical Program Optimization, Endo

Carrie Lewis has over 20 years of varied Clinical Research experience.  Carrie is currently an Executive Director, Clinical Program Optimization at Endo USA, Inc. where she oversees Clinical as well Business Operations, eTMF/inspectional readiness, and Training/Oversight.  Prior to Endo, Carrie garnered extensive knowledge in many roles while in academia, at large sponsors, generic sponsor, as well as a global CRO.  She has a Master’s Degree in Clinical Research Administration and has experience in multiple therapeutic areas.

Session Details:

CASE STUDY: Getting a new site up and running: challenges, opportunities and lessons learned

2025-10-15, 5:00 PM

Session Details:

PANEL: Making a success of FSP models for your clinical trial

2025-10-15, 3:00 PM

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Veronica Ludensky
Director of Procurement, Clinical, Flagship Pioneering

Veronica Ludensky is the Director of Procurement, Clinical. She is responsible for establishing and growing the procurement function for clinical services to leverage the Flagship ecosystem to advance companies’ clinical development goals.

Veronica has almost two decades of experience in clinical sourcing functions for multiple compounds from Phase 1 through 4, in small biotech, large pharma and CROs. During her career, Veronica was responsible for supporting project teams across multiple therapeutic areas in selecting, negotiating costs, contracting and business oversight of CROs, laboratories and all other vendor types in support of clinical programs at AstraZeneca, Alexion Pharmaceuticals, Millenium Pharmaceuticals and Takeda.

Session Details:

PANEL: Handling finances for your biotech: tips for managing funding, investment and budgets

2025-10-16, 9:00 AM

Session Details:

PANEL: Driving technology and innovation in a small biotec

2025-10-16, 12:00 PM

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Jerrold M. Shapiro
President, Floelle

An effective team-building leader who takes new medical devices from concept through design, pilot & production manufacturing, clinical trial, FDA regulatory approval, production and service. As an associate professor of medicine, surgery and ophthalmology at the Boston University School of Medicine, led interdisciplinary teams in creating, designing, developing, implementing and testing innovative biomedical instrumentation. Wrote proposals which secured over $1 million in federal research grants. Commercialized one of four patented inventions, designed and ran clinical trial and secured FDA 510(k) clearance. Used over 30 years of laser experience to develop diagnostic and therapeutic instrumentation.

Current goals are to take Floelle Inc.'s patented small medical device through its Early Feasibility Study, pivotal clinical trial and FDA de novo 510(k) process (and the equivalent in Europe) into the market to restore the quality of life to one billion incontinent women worldwide, and to bring high value to physicians, third party payers, investors and governments, and well as removing trillions of absorbent products from landfills.

Specialties: Development of new product concepts, taking concepts all the way to servicing the finished product in the field, regulatory affairs, all aspects of medical device manufacturing, purchasing, program management, engineering management, operations management, ophthalmology, dermatology, gynecology, urology, laser surgery, 3-D imaging, image processing, pharmacodynamics, among many others.

Session Details:

The Early Feasibility Study: getting it right for a medical device

2025-10-16, 12:00 PM

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Ingrid Abrahamsen
Executive Director, Clinical Operations, Fulcrum Therapeutics

Ingrid Abrahamsen is an experienced clinical research leader with a focus on clinical trial management and clinical operations. Her 15 years of experience have been concentrated in early and late phase rare disease and oncology clinical research. Her experience in the span of  the last 5 years has been focused in the cell and gene therapy (CGT) industry, contributing to the clinical development of multiple autologous cell and gene therapies. Most recently, Ingrid was leading clinical operations at Editas Medicine in the development of reni-cel, an AsCas12a gene-edited cell therapy in severe sickle cell disease (SCD).

In her Clinical Operations leadership roles, Ingrid has formed and led teams to optimize clinical trial execution and build cross-functional relationships. Ingrid is currently the Head of Clinical Operations at Fulcrum Therapeutics, leading the advancement of their small molecule pipeline with their lead clinical program in SCD. Ingrid holds an MS and BS from Penn State University and is a Certified Clinical Research Professional (CCRP) via the Society of Clinical Research Associates (SOCRA).

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

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

Session Details:

Chairperson’s closing remarks

2025-10-15, 5:30 PM

Session Details:

GlobalData opening remarks

2025-10-15, 8:15 AM

Session Details:

PANEL: AI and machine learning in clinical trials: where are we in 2025?

2025-10-16, 10:00 AM

Session Details:

PANEL: Running clinical trials in different geographical regions: benefits of running trials inside vs outside the US

2025-10-16, 2:50 PM

Session Details:

PANEL: Assessing the impact of the political and economic landscape in the US on outsourcing decisions in pharma

2025-10-15, 8:30 AM

Session Details:

The state of the biopharmaceutical industry in 2025: emerging technologies and opportunities

2025-10-15, 11:00 AM

Session Details:

Chairperson’s opening remarks

2025-10-16, 8:50 AM

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Amanda Murphy
Senior Director, Data Intelligence and Solutions,
GlobalData Healthcare
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John Smutko
Head of Oncology Scientific Operations, GSK

Experienced BioPharma professional with a strong background in Genomics, Technical Support, Training, and Clinical Biomarker Operations.

Session Details:

The importance of accurate and consistent sample collection and management in clinical trials

2025-10-16, 12:00 PM

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Ben Laiviere
Associate Director, Scientific Operations, GSK

Session Details:

The importance of accurate and consistent sample collection and management in clinical trials

2025-10-16, 12:00 PM

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Shailesh Chavan
Managing Partner, Ingenious Global Venture Partners

Physician-scientist executive with experience in the industry (pharma, biotech & CRO). Leadership role with focus on patient centric innovation, building and leading high performing teams in Early to Late Phase Product development, launch and life-cycle management, business development, due diligence and integration. Ability to integrate development and operations experience in various TA's including Immunology, Oncology, Neurology and Transplantation.
All opinions and views are my own.

Session Details:

INTERACTIVE SESSION: What are investors looking for in a biotech or start up?

2025-10-16, 10:00 AM

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Kelsey Miller-Torchia
Senior Vice President, Clinical and Business Development, Intrinsic Therapeutics

Session Details:

PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

2025-10-15, 4:00 PM

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Beth Chamblin
Senior Director, Project Management, Late Phase Oncology, IQVIA Biotech

Beth Chamblin has 25 years of experience in Pharmaceutical/BioPharmaceutical development, including over 15 years in global clinical project management and 4 years in oncology project management. At IQVIA Biotech, she specializes in strategic oversight of late-phase global clinical programs, supporting emerging biotech companies. Beth has managed global Phase I-III studies across multiple regions and has expertise in novel trial designs. She also leads a team of 10 project managers/directors, providing mentoring and support. Her broad experience allows her to align each study with a company's long-term goals, ensuring project success.

Session Details:

Reimagining clinical trials: the role of master protocols in modern research

2025-10-15, 12:30 PM

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Leonella Seeley
Director, Vendor Management and Operations, Karyopharm Therapeutics

Session Details:

PANEL: Making a success of FSP models for your clinical trial

2025-10-15, 3:00 PM

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Kathleen Martyn
Manager, Vendor and Clinical Operations, Karyopharm Therapeutics

Session Details:

PANEL: Strengthening supplier relationships: strategies for positive collaboration and communication

2025-10-15, 9:30 AM

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Helen Chalk
Vice President, Clinical Operations, Mythic Therapeutics

Helen Chalk is a Clinical Development leader who has worked in Clinical and Program Management roles across the pharmaceutical, biotechnology and CRO sectors for over 25 years.  She has a breadth of global industry experience including oversight of Phase 1-4 clinical trials, medical affairs and global managed access programs in indications including oncology, autoimmune disorders, respiratory disorders, cardiovascular and infectious diseases.  Fueled by opportunities to build effective, cohesive teams and processes, Helen enjoys the challenges and daily risk management required to develop drugs and bring them to market.

Beyond work, Helen loves to travel with her family and spend time with her two dogs.  Helen relishes any opportunity to ride horses and to volunteer in a therapeutic riding program in Norfolk, MA.

Session Details:

CASE STUDY: Management of tumor biomarker testing to boost study enrolment

2025-10-16, 11:00 AM

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Malina Traianova
Director, Lab and Vendor Management, Mythic Therapeutics

Session Details:

CASE STUDY: Management of tumor biomarker testing to boost study enrolment

2025-10-16, 11:00 AM

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Amir M. Behdani
PharmD, Biomarker Development Postdoctoral Fellow, Novartis

Session Details:

Digital health innovations in cardiovascular clinical trials: assessing Apple Watch as a sensor-based digital health technology for atrial fibrillation

2025-10-16, 11:00 AM

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Yolanda Wan
Head of Clinical Operations, Orna Therapeutics

Yolanda is the Vice-President of Clinical Operations at Accutar Biotechnology. She brings along 17 years of experience in Clinical Development, with focus on both Clinical Operations and Clinical Project Management. Her areas of expertise include strategic operations planning at the compound-level; first-in-human study planning & adaptive execution in therapeutic areas of oncology and ophthalmology. Leadership with cross-functional teams has included the development and implementation of governance and operational strategy, optimizing processes and building dynamic teams to exceed business objectives. Prior to joining Accutar, she held various positions at Bayer in the US and a number of countries within Asia. This attributes to her extensive knowledge of bridging-strategy between the two continents.

Session Details:

PANEL: Running clinical trials in different geographical regions: benefits of running trials inside vs outside the US

2025-10-16, 2:50 PM

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T.J. Sharpe
Patient Advocate

T.J. Sharpe is a Stage IV melanoma survivor who began sharing his journey through cancer as a blogger and later a keynote speaker. Diagnosed in August 2012 and given two years to live, he has undergone six surgeries and four immunotherapy treatments over two different clinical trials. His story of overcoming numerous issues to find, select, enroll, and complete two trials illustrates the hurdles many patients encounter when faced with a difficult diagnosis.
Taking his personal journey and the insights gleaned from a decade+ of listening to and working with leaders in healthcare, clinical research, digital medicine technologies, and patient advocacy, he speaks frankly about and works tirelessly towards creating advanced patient engagement to benefit all.
Now a speaker, writer, and patient expert consultant, he has worked with top pharmaceutical companies and clinical research stakeholders to address the power imbalance in patient care through sustained, ingrained, and consistent patient engagement. A South Jersey native, T.J. lives in Fort Lauderdale with his wife Jennifer and two children, Josie and Tommy. He is active on Twitter at @TeamTJSharpe and LinkedIn at https://www.linkedin.com/in/tjsharpe/.

Session Details:

Chairperson’s opening remarks

2025-10-16, 8:50 AM

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Stacey Oppenheimer
Director, Third Parth Quality Lead, Pfizer

Stacey Oppenheimer is in the Clinical Imaging group at Pfizer in Cambridge, MA, where she is the Head of Vendor Oversight and Sourcing for Pfizer’s clinical trials with imaging.  In this role, she specializes in alliance management, issue resolution, auditing and providing scientific guidance for clinical study teams.  Prior to this role, she was an imaging lab head at Pfizer in the Drug Metabolism and Medicinal Chemistry Departments. She has a PhD in Chemistry from Vanderbilt University and an MBA from Northeastern University.

Session Details:

PANEL: Strengthening supplier relationships: strategies for positive collaboration and communication

2025-10-15, 9:30 AM

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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 closing remarks

2025-10-15, 5:30 PM

Session Details:

Chairperson’s opening remarks

2025-10-16, 8:50 AM

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Matthew Birmingham
Head, Supply Chain and External Manufacturing, Prime Medicine

Matt Birmingham is a seasoned operations leader with over 24 years of experience managing clinical and commercial operations in the biologics and cell and gene therapy (CGT) industries. His career includes extensive experience leading teams and operations at Genentech where he oversaw quality engineering and validation of computerized systems and laboratory equipment, clinical and commercial production planning and commercial product distribution and logistics for high-value biologics and small-molecule products.  Matt has spent the last 10 years playing pivotal roles in building and strengthening supply chains for leading CGT companies, contributing to the successful launch of four commercial CGT products. As Senior Director of Supply Chain and External Manufacturing at Prime Medicine, Matt leads all clinical manufacturing and supply chain operations for autologous cell and in vivo gene therapies.

Matt holds an MBA from the University of Maryland, a Bachelor of Science in Business Administration from the University of Vermont, and is APICS Certified in Production and Inventory Management.

Session Details:

Successfully planning a clinical supply chain for new drug modalities

2025-10-16, 9:00 AM

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Katerina Chatzi
Founder and Chief Executive Officer, Promakhos Therapeutics

Session Details:

PANEL: Patient advocacy and incorporating patient perspectives early on in a small biotech

2025-10-15, 5:00 PM

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Emily McInturf
Director, Feasibility, PSI CRO

Emily McInturf, Director of Feasibility, has worked in the clinical research industry for the past 15 years. As a leader within PSI’s global feasibility team, Emily specializes in strategy development across multiple therapeutic areas – focusing on aligning a study’s design with top enrolling investigators in the right countries.

Using PSI’s INTELIA platform, a machine-learning-powered system for data-driven feasibility and enrollment forecast, Emily models and compares hundreds of country and site combinations, their budgets and probability of success, ultimately recommending the most optimal enrollment scenario in line with each sponsor’s key objectives. As a director, Emily provides oversight for global feasibility and site identification activities for both pre- and post-award opportunities and projects.

Session Details:

PSI’s VISIONAL: enhancing feasibility and enrollment predictions with GenAI

2025-10-15, 4:30 PM

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Leticia Tarilonte
Vice President, Head of Global Clinical Operations, Pyxis Oncology

Leticia has over 23 years of industry experience managing several research projects and clinical studies in various roles. She started her career in Pharma at Biogen, working collaboratively in an integrated monoclonal antibody research team and then moving to development in clinical operations, where she managed numerous phase I-III clinical trials in diverse therapeutic areas including, gastroenterology, immunology, neurology, and neuropathic pain.

She continued her career at Merck/EMD Serono where she provided strategic and operational expertise in the planning and conduct of several Phase I-III clinical studies in oncology and immuno-oncology, which led to the FDA accelerated approval of BAVENCIO® in merkel cell carcinoma and in urothelial carcinoma. Later she served as a Chief of Staff to the Sr. VP and Head of Development in Oncology, where she partnered with executive sponsors to identify and promote projects that are of strategic importance to the company and translating the function strategy into operational plans.
After many years in big Pharma, Leticia continued her career at various biotech companies: first at Kiniksa Pharmaceuticals, where she was responsible for various programs with high complexity in rare diseases, consisting of numerous global clinical trials in 10 different indications. Followed by Black Diamond Therapeutics, a biotech company addressing the significant unmet need for novel precision oncology therapies for patients with genetically defined cancers. In her last role, Leticia served as the Clinical Operations Lead at Nimbus Therapeutics, a biotech company working on the development of a HPK1 inhibitor in solid tumors.

Leticia also serves as an IRB Member at Yale University and is the Chair and President of the Association of Clinical Research Professionals (ACRP) - New England Chapter.
Leticia earned her Bachelor’s Degree in Biomedical Laboratory and Clinical Sciences from the School of Medicine at Boston University, followed by a Master’s Degree in Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and Health Sciences in Boston.

Session Details:

PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

2025-10-15, 4:00 PM

Session Details:

PANEL: Making a success of FSP models for your clinical trial

2025-10-15, 3:00 PM

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Jenifer Waldrop
Executive Director, Rare Disease Diversity Coalition

Session Details:

Reimagining the clinical trials infrastructure for Inclusive and accessible rare diseases and orphan therapies

2025-10-16, 10:00 AM

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Beth Davis
Senior Manager, Development Services and Operational Excellence, Vendor and Relationship Management Lead, Regeneron

Session Details:

PANEL: Making a success of FSP models for your clinical trial

2025-10-15, 3:00 PM

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John Seman
Chief Executive Officer, Revitale Pharma

John Seman is the CEO and Founder of REVITALE Pharma.  He began his career working in Big Pharma - Johnson & Johnson and Bristol Myers Squibb - in sales, marketing and business development.  The second half of his career was spent as a serial entrepreneur having Founded a half dozen companies that provided either products or services for the pharmaceutical industry.  John earned his bachelor's and master's degrees from the Massachusetts College of Pharmacy.

Session Details:

PANEL: Making a success of FSP models for your clinical trial

2025-10-15, 3:00 PM

Session Details:

Chairperson’s closing remarks

2025-10-15, 5:30 PM

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Rinaldo Dorman
Associate Director, R&D Global Procurement and Strategic Sourcing, Sarepta Therapeutics

Rinaldo leads the Clinical Procurement team at Sarepta Therapeutics; which focuses on the clinical trial outsourcing for phases 1 through 3. His tenure as a Procurement professional includes roles at large and small organizations across both pharmaceuticals as well as biotech organizations. He has an MBA from Northeastern University and is a Certified Professional of Supply Management.

Session Details:

PANEL: Strengthening supplier relationships: strategies for positive collaboration and communication

2025-10-15, 9:30 AM

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George Tetz
Chief Executive Officer, Second Life Therapeutics

George Tetz, MD, PhD, and CEO/Cofounder of Second Life Group, has dedicated his life’s work to addressing some of medicine’s most unmet needs.

Second Life Group includes three different clinical-stage entities, including Second Life Therapeutics, Second Life Diagnostics, and Second Life Vaccines. Together, these companies address some of the most critical, unmet needs in medicine, including advanced solid tumors, antibiotic resistance and longevity with first-in-class personalized medicines and medical devices.

Throughout his career as both a medical practitioner and researcher, Dr. Tetz has focused on applying cutting-edge multifactorial approaches to a variety of medical problems. One of his most groundbreaking findings is the existence of the previously unknown Universal Receptive System and Teazeled receptors. With this discovery, Dr. Tetz is modulating cellular memory for the first time, bringing cell control to a new and unprecedented level.

Dr. Tetz began his career as a medical practitioner, then earned his PhD in molecular microbiology. He serves as Director of the Department of Systems Biology at the Human Microbiology Institute, where he played an integral role in groundbreaking studies. Dr. Tetz is also a member of the American Society for Microbiology, Society for Neurosciences, and New York Academy of Sciences.

 

Session Details:

PANEL: The New England biotech landscape in 2025: growths, shifts and strategic outlook

2025-10-15, 11:00 AM

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Sarah Woods
Founder, Serenely Guided Foundation

Session Details:

FIRESIDE CHAT: Keeping patients and caregivers at the center of rare disease clinical trials: collaborating with patients, caregivers, and nonprofits for better outcomes

2025-10-15, 12:00 PM

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Colleen Smith
Director, Clinical Affairs Operations, Siemens Healthineers Endovascular Robotics
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Brad Stefanovic
Head of Clinical Innovations, Simulations Plus

Clinical Research, Bio-Tech, expert with over 18 years of experience working in the Life Sciences Industry. Brings a unique blend of clinical trial expertise, safety management, scientific and technology consulting. Possesses strong team-working, leadership, communication skills and attention to detail. Enthusiastic and excited about furthering the cause of clinical research.

I was born in Australia and reside in New York City, NY and I am fortunate to be in an extremely active family. Being from this environment with active siblings had thrust me into a leadership position early in my life and I have embraced that leadership mentality ever since. I wake every morning thankful for the great family and friends I now call family.

Session Details:

TECHNOLOGY SPOTLIGHT: The impact of Simulation-Based learning on Study Acceleration – Spoken from the Sponsor who converted

2025-10-15, 2:30 PM

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Nicole McElroy
Director, Strategic Partnerships and Outsourcing, Takeda

Customer-focused healthcare manager with 20+ years of experience (11 years at Takeda/Shire, 7 years at Pfizer/Wyeth) in Clinical Research and Pharmaceutical industries. Expertise managing teams (up to 6 employees); overseeing complex vendor relationships; and negotiating clinical vendor and investigator contracts, and phase I–IV master service agreements. Proven record implementing innovative tools, processes, metrics, strategic practices, and global trainings to improve supplier and site management, outsourcing management, vendor qualification, vendor accountability, contract negotiations, compliance, and profitability. Earned numerous awards for exceeding goals and work excellence.

Session Details:

PANEL: Strengthening supplier relationships: strategies for positive collaboration and communication

2025-10-15, 9:30 AM

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Louisa Carlse
Director of Partnerships, TecEx Medical

Proven success in supporting the Health and Lifesciences industry as Partnership Director.   Fostering B2B partnerships, and driving customer success initiatives for overall efficiency across clinical trials in support of timely delivery of supplies to sites and patients. Recognized for implementing key projects, reducing compliance risks, and leading Importer of Record initiatives. Leader with a visionary and strategic mindset, fostering innovation, inclusivity, and continuous improvement.

Session Details:

Beyond the Middleman: Strategic Outsourcing of IOR/EOR for Global Clinical Trials

2025-10-16, 9:30 AM

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Richard A. Graham
Ph.D., Co Founder and Chairman of the Board, TruTechnologies

Richard Graham, founder of Mirador Therapeutics and TruTechnologies, is a seasoned leader with extensive experience in business operations, corporate strategy, fundraising, scientific research, and therapeutics development. He excels at aligning corporate strategy with scientific expertise and building partnerships with executives, board members, and investors.

A proven leader in global team management, Rick has successfully driven large-scale R&D programs from concept to completion, consistently achieving ambitious milestones. His work has advanced therapeutics through late-stage development, contributing to the approvals of Erivedge™, Kadcyla™, Kyprolis™, Perjeta™, and Yupelri™.

Session Details:

Driving asset value through operational precision

2025-10-15, 4:30 PM

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Mary Jo Lamberti
Research Associate Professor and Director, Sponsored Research, Tufts Center for the Study of Drug Development

Research Assistant Professor at Tufts University School of Medicine and Director of Sponsored Projects at Tufts CSDD.
Expertise in benchmarking drug development operating practices.
Research focus includes outsourcing and partnerships; clinical supplies; investigative site initiation and management; patient recruitment and retention; and the use of technologies and digital solutions in clinical trials.
Published extensively and is a frequent speaker at global conferences.
Current Initiatives Include:
• Study volunteer diversity in clinical trials
• Benchmarking patient recruitment and retention practices
• Industry use of automation, IT technologies and applications

Session Details:

Updates and developments on Tufts CSDD: DIA collaborative study results: using AI and ML in clinical development

2025-10-15, 12:00 PM

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Maria Florez
Senior Consultant, Tufts Center for the Study of Drug Development

Maria Florez is involved in research looking at the impact of digital transformation in clinical research and organizational strategies and practices driving improvement in development operations and economics. Maria has been a researcher and strategist in the healthcare sector for 15 years. She has held positions at Cleveland Clinic and at New York-Presbyterian Hospital of Columbia and Cornell Universities and has published articles in trade and peer-reviewed journals. She holds a B.S. in economics and an M.A. in international economics from The Fletcher School of Law and Diplomacy at Tufts University.

Session Details:

Updates and developments on Tufts CSDD: DIA collaborative study results: using AI and ML in clinical development

2025-10-15, 12:00 PM

Session Details:

Direct to patient study results

2025-10-15, 5:00 PM

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Sean D. Smith
Biological Threat Exclusion Coordinator (BTEC), US Customs and Border Protection
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Meredith Frank-Molnia
Vice President, Clinical Affairs, Vericel Corporation

Meredith Frank-Molnia is currently employed as Vice President of Clinical Affairs at Vericel Corporation. Previously, Meredith held the position of Senior Director Clinical Management, while working at Axiom Real-Time Metrics Inc., where she established and expanded their Clinical Management department. Meredith has been in Clinical Project Management/Operations for 26 years in numerous roles of increasing responsibilities. Meredith has worked managing device/biologic and drug studies.

Session Details:

Implementing an EDC system: operational and technical considerations

2025-10-15, 2:00 PM

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Jessica Wessel
Senior Director, Project Delivery, TFS HealthScience

Session Details:

From first step to final outcome: Reframing feasibility as an operational strategy

2025-10-15, 2:30 PM

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Allison Covucci
Senior Director, Statistical Programming, Bristol Myers Squibb

Session Details:

Strength meets agility: Co-developing a framework for seamless FSO to FSP transition

2025-10-16, 11:30 AM

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Kerri McCaul-Claus
Vice President, Head of FSP Biometrics, Parexel

Kerri oversees the global Functional Service Provider (FSP) biometrics team at Parexel, spanning North America, South America, EMEA, and APAC.

With tenure at Parexel of more than 28 years, Kerri has also overseen Parexel’s team of FSP solution consultants, and served in a commercial and sales support role and as a solution consultant herself. Kerri’s career at Parexel spans more than 19 years in operational management in statistical programming. She brings a wealth of expertise, a deep understanding of client needs, and a passion for operational excellence. Kerri holds a master’s degree in health studies from Brock University.

Session Details:

Strength meets agility: Co-developing a framework for seamless FSO to FSP transition

2025-10-16, 11:30 AM

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Andy Liu
General Manager - China, Novotech

Mr. Andy Liu has strong operational experience in the CRO industry and a deep understanding of the regional market. Andy worked at Covance, Inc., a global CRO, for more than 10 years in a number of executive positions. Before joining PPC group, he was General Manager of Covance’s Central Laboratory Service, Asia Pacific, where he led a large multi-functional team of around 500 employees across multiple sites in APAC. Andy holds an MBA from the Booth School of Business at the University of Chicago, an MS in Electrical Engineering from the Rose-Hulman Institute of Technology, and a BS in Electrical Engineering from Tsinghua University.

Session Details:

PANEL: Staying resilient: leading your biotech through political and economic uncertainty

2025-10-15, 2:00 PM

Session Details:

China as an Early Phase Solution: Opportunities for US Sponsors

2025-10-15, 10:00 AM

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Jennifer Holloway
Nurse Practitioner/ Sub-Investigator, EmVenio Clinical Research

Jennifer Holloway is a board-certified Nurse Practitioner with a Doctor of Nursing Practice and over 10 years of experience in critical care and clinical research. Her career has focused on delivering high-acuity care while advancing evidence-based practices through research and quality improvement initiatives. Mrs. Holloway is passionate about bridging the gap between bedside care and clinical inquiry, and she continues to advocate for innovative, patient-centered approaches within interdisciplinary teams. Her work reflects a deep commitment to clinical excellence, research integration, and the ongoing advancement of nursing practice.

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Christopher Schoonmaker
Chief Operating Officer, MMS Holdings

A biostatistician by training, Chris is an executive leader with the technical and business experience required to lead in the clinical research industry. He held executive and senior leadership roles before MMS, including management of biometrics operations as well as oversight of key customer accounts. His key strengths include his statistical and data expertise, building and maintaining required operational delivery models to ensure quality delivery, implementing effective governance to ensure successful client collaborations and relationships, and providing statistical consultation.  Throughout his career, Chris has been a statistical lead for hundreds of clinical studies, served as a voting member on data monitoring committees, and guided the statistical strategy for regulatory submissions.

As Chief Operating Officer, Chris has global responsibility for operations across all MMS service lines globally as well as business strategies for growth. Chris is responsible for driving corporate operational excellence, including talent planning, productivity improvements and cost management across the organization.

Chris received his Master of Public Health in Epidemiology and Biostatistics from Boston University.

Session Details:

3 technology use cases shaping the future of trial design and implementation

2025-10-16, 11:30 AM

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Stephanie Bolick
VP Biotech Development Operations, Fortrea

Stephanie has nearly 3 decades of experience in the global biopharmaceutical industry specializing in end-to-end clinical development operations and delivery, strategic planning, and client management.  She leads the team of biotech portfolio leaders focused on delivery excellence, functional connectivity, and customer partnership – ensuring programs move with the speed, flexibility and expertise biotech clients require.  Stephanie’s core focus is to strengthen and evolve Fortrea’s biotech delivery strategy to stay ahead of industry needs, deliver with optimal agility and operational excellence, and consistently enhance the experience for our customers and their programs. She is passionate about cultivating strong, collaborative relationships – both within teams and with customers – and about equipping organizations to think entrepreneurially, move decisively, and deliver with accountability.  As a biotech-focused leader within Global Project Delivery, Stephanie offers executive-level engagement for biotech customers to support success and achieve business objectives.

Session Details:

Bridging the gaps: Integrating consulting and clinical operations to accelerate biotech development

2025-10-15, 11:30 AM

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April Mattison-Wolfe
Senior Manager Technical Services, TransPerfect

April Mattison-Wolfe brings 24 years of Clinical Operations experience to TransPerfect’s Trial Interactive (TI) Technical Services, including 7+ years as a Clinical Operations Trainer and Clinical Business Systems Analyst. With expertise from both sponsors and CROs, she helps TI clients identify CTMS needs and configure tailored solutions. April’s deep understanding of clinical systems requirements and pharmaceutical business practices ensures clients optimize their clinical trial management systems for efficiency and compliance.

Session Details:

Beyond integration: How AI creates a clinical trial platform

2025-10-16, 9:30 AM

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Katherine Cianciarelli
Senior Product Manager, eTMF and AI, TransPerfect

Katherine Cianciarelli is a senior product manager with almost a decade of experience in eClinical technology. An engineer by trade, she focuses on building practical AI tools that improve clinical research workflows. Her work centers on finding smart ways to optimize processes while ensuring responsible and compliant technology use, always seeking to bridge the gap between technical innovation and real-world research needs.

Session Details:

Beyond integration: How AI creates a clinical trial platform

2025-10-16, 9:30 AM

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Katie Norton
Trial Optimization SME

Katie Norton is a transformational leader with over 20 years of experience building and scaling patient recruitment, feasibility, and engagement functions for global clinical trials. She has led high-impact organizational change at companies including Moderna, EMD Serono, and Takeda, creating innovative, patient-centered strategies that accelerate development and deliver meaningful results.

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OCT Advisory Board

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Dr Alison McMorn
PH.D – VP, CLINICAL DEVELOPMENT, AMO PHARMA LTD

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.

Session Details:

From insight to impact: translating patient voices into study materials that matter

2025-10-16, 9:00 AM

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2025-10-16, 3:50 PM

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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
Head of Business Development, Novotech

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

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

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, 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.

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