14th Annual Outsourcing in Clinical Trials Southern California 2026

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

15 - 16

September

2026
  • Hyatt Regency La Jolla at Aventine, San Diego, USA
  • Complimentary
  • Why attend?
  • Agenda
  • OCT Advisory Board
  • Speakers
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  • Sponsors
  • Media Centre
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Featured Speakers

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Sagar Vaidya​

Chief Medical Officer, Cerevance

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

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

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

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

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

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Janal Urich​

Vice President Clinical Development, Atara Biotherapeutics

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Stanley Lewis​

Founder, Chief Executive Officer, A28 Therapeutics

Stanley Lewis, MD MPH is a graduate of the University of Texas McGovern Medical School and the University of Texas School of Public Health.  He completed an Internal Medicine residency and fellowship and joined the faculty as Assistant Professor of Medicine.  Dr. Lewis has dedicated his professional career to patient care, teaching, clinical research, and drug development.  His areas of interest are infectious disease, oncology, and metabolic disorders.  He has participated as an Investigator on over 30 clinical trials and authored over 50 scientific abstracts and publications.  Dr. Lewis served as Chief Medical Officer at both public and private biotechnology companies including TaiMed Biologics where he led a small team to develop the first monoclonal antibody for treatment of multi-drug resistant HIV disease.  He later Founded and serves as CEO of A28 Therapeutics where he is developing a targeted lytic peptide for treatment of cancer.

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Stanley Kim​

CEO, WinSanTor

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

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Matthew Spear​

Chief Medical Officer, Chief Development Officer, Denovo Biopharma

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

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Anne Severtson​

Senior Director, Clinical Operations, AnaptysBio

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

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    2025 Sponsors Included:

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    Company Information

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022.

    Company Website

    To learn more, please visit our website - https://www.iconplc.com/sectors/biotech

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    Company Information

    Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development. With deep therapeutic and regulatory expertise and an expansive global footprint across the Asia-Pacific region, North America, and Europe, Novotech offers clients an accelerated path to bring life-changing therapies to market.

    Company Website

    To learn more, please visit our website - www.novotech-cro.com

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    Company Information

    IQVIA Technologies help you transform your clinical trials and improve patient safety with SaaS-based applications and tech-enabled services designed to streamline processes, improve workflows, and effectively engage and inform patients. The Orchestrated Clinical Trials (OCT) platform eases the burden on your sites and makes it easier and more appealing for patients to enroll and remain engaged, produces faster trials to database lock, and speeds time to market. For more information visit www.iqvia.com/oct or email us at OrchestrateYourTrials@iqvia.com

     

    Company Website

    To learn more, please visit our website - www.iqvia.com

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    Company Information

    TFS HealthScience is a global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Bringing together nearly 700 professionals, we deliver tailored clinical research services in more than 40 countries. TFS supports customers with comprehensive solutions including full clinical development services, strategic and flexible resourcing. In partnership, we build solution-driven teams of experienced professionals working together for a healthier future. Our mission is to bring treatments to patients faster. For more information, please visit www.tfscro.com.

    Company Website

    To learn more, please visit our website - www.tfscro.com.

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    Company Information

    KPS is a global, innovative, Clinical Outsourcing Provider delivering clinical trial monitoring, management and quality oversight services to pharmaceutical, biotechnology, medical device, and related industries.   Founded and operated as a more customer centric and nimblealternative to traditional CROs, KPS offers a full range of services leveraging the latest clinical technologies.

    Company Website

    To learn more, please visit our website - http://www.kpslife.com

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    Company Information

    With over 40 years’ experience, 600 beds and locations in NA, EU and Asia, Celerion conducts First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and NDA-enabling clinical pharmacology research. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services.

    Company Website

    To learn more, please visit our website - http://www.celerion.com

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    Company Information

    Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve live. Learn more about and Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp.

    Company Website

    To learn more, please visit our website - medtech.labcorp.com

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    Company Information

    Founded in 2005, Inspire connects life sciences organizations with the voices that matter most—patients and caregivers. With 10 million unique annual visitors across over 3,000 disease states, Inspire leverages its engaged patient communities to accelerate clinical trial recruitment, uncover real-world evidence, deliver actionable market research, and provide targeted advertising solutions for health-focused audiences.  By bridging the gap between patients and life sciences, Inspire enables smarter decision-making and a deeper understanding of the communities it serves.

    Company Website

    To learn more, please visit our website - https://inspireresearch.com/

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    Company Information

    MedNet is a leading eClinical technology company specializing in electronic data capture and clinical study management systems. Since 2001, MedNet’s proven cloud-based solutions have successfully supported research initiatives worldwide. Visit our booth to see iMedNet eClinical…an agile, efficient and, effective solution that allows sponsors and CROs to easily build studies.

    Company Website

    To learn more, please visit our website - http://www.mednetsolutions.com

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    Company Information

    QPS is a global contract research organization (CRO) providing discovery, preclinical and clinical drug development services since 1995. Our mission is to accelerate pharmaceutical breakthroughs across the globe by delivering custom-built research services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. We are passionate about our work, creating value for patients and customers while generating opportunities for employees to thrive.

    Company Website

    To learn more, please visit our website - www.qps.com

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    Company Information

    The aim of MyData-TRUST consists in supporting the Life Sciences Industry in leveraging their compliance related to Data Protection. We are providing a services and solutions aligned with both Health R&D and Data Protection requirements (GDPR, HIPAA, Privacy Shield).

    Company Website

    To learn more, please visit our website - www.mydata-trust.com

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    Company Information

    Syneos Health (Nasdaq:SYNH*) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together, we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to lifeTM visit SyneosHealth.com. 

    Company Website

    To learn more, please visit our website - www.SyneosHealth.com

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    Company Information

    Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. Signant unites eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industry’s most comprehensive patient-centric suite – an evolution built on more than 20 years of proven clinical research technology. Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality – helping them bring life-changing therapies to our families and communities around the world.

    Company Website

    To learn more, please visit our website - www.signanthealth

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    Company Information

    YPrime’s cloud-based technology streamlines clinical trial data collection and management. Electronic clinical outcome assessments (eCOA) and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone.

    We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. We’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster.

    Company Website

    To learn more, please visit our website - http://www.yprime.com/

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    Company Information

    Founded in 1997, Ergomed is a full service, global Phase I-IV clinical development and trial management service partner with leading expertise in developing oncology and rare disease drugs.  Our portfolio includes experience working with novel therapies, early phase development, immunotherapy, and adaptive trial designs. Ergomed embodies a patient-centric approach to recruitment and retention with access to global patients in vital geographical areas.  Ergomed’s proven delivery record, expertise, and true partnership means our sponsors can trust us to deliver their oncology trials whatever the challenge. We also offer an industry-leading suite of specialist pharmacovigilance (PV) solutions under the PrimeVigilance brand.

    Ergomed has supported and managed clinical development, trial management, pharmacovigilance, and medical information services for over 300 clients in more than 100 countries.

    We deliver a complete solution for oncology trials of all sizes and complexity. For more information about Ergomed, please visit: www.ergomedcro.com

    Company Website

    To learn more, please visit our website - www.ergomedcro.com

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    Company Information

    Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes. Our Direct-to-Patient Site and Patient Recruitment solutions enable life sciences companies to reach beyond traditional means of conducting clinical research. To learn more, visit www.science37.com, or email science37@science37.com.

    Company Website

    To learn more, please visit our website - https://www.science37.com/

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    Company Information

    Founded in 2016 and headquartered in Boston, Massachusetts, United States (US), PathAI’s mission is to improve patient outcomes with AI-powered pathology and provide products and services geared towards translational research, clinical trials, diagnostic development, and pathology laboratories globally.

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    Company Information

    Egnyte combines the power of cloud content management, data security, and AI into one intelligent content platform. More than 22,000 customers trust Egnyte to improve employee productivity, automate business processes, and safeguard critical data, in addition to offering specialized content intelligence and automation solutions across industries, including architecture, engineering, and construction (AEC), life sciences, and financial services.

    Company Website

    To learn more, please visit our website - https://www.egnyte.com/solutions/life-sciences

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    Company Information

    Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients.

    Company Website

    To learn more, please visit our website - www.allucent.com

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    Company Information

    Advarra delivers the platform, insights, and expertise that make clinical trials more efficient and connected. We bring over 40 years of trusted IRB oversight, operational intelligence, and collaborative technology to the industry—streamlining study design, startup, and conduct for research sites, sponsors, and CROs worldwide. Learn more at www.advarra.com.

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      Why attend?

      Arena International is pleased to announce the return of the 14th Annual Outsourcing in Clinical Trials Southern California 2026 to San Diego.

      This flagship event brings together senior leaders from sponsors, biotech, and CROs to exchange practical insights and build strategic partnerships across the clinical development landscape. The 2026 program will focus on improving outsourcing models, strengthening sponsor-CRO collaboration, and leveraging innovation and technology to enhance clinical operations.

      Across two dedicated conference streams, attendees will explore case studies, regulatory updates, vendor selection strategies, and operational best practices designed to accelerate trials while maintaining quality and compliance.

      Join us in 2026 to connect with peers, discover new solutions, and leave with actionable strategies you can implement immediately.

      We look forward to welcoming you to San Diego.

       

      Southern California Clinical Trials Outsourcing 2023 is pleased to announce an event for all online casino players. Our flagship clinical show will be held in 2023 with the best online casino https://chiefcasinos.com/low-deposits/1-dollar-deposit/ gamblers. This event cannot be missed, and every online casino player can view the agendas on our website.

      WHAT TO EXPECT FOR 2026?

      Expect high level discussions and presentations with industry leaders focusing on novel and innovative solutions to some of this years key challenges. Additionally with our Clinical Trial Technology & Innovation track, learn what is in store for the future of clinical trials.

      With regulations ever changing and the innovative advancements of technology rapidly growing, this conference will address the everyday and perspective challenges faced when working within the clinical trial space. We’re be showcasing strategies to accelerate clinical development, as well as building on our new and existing relationships within our industry.

      This conference will bring industry professionals together to share knowledge, with a focus on collaboration, advancing clinical development and concentrating on clinical operations, innovation, technology and of course, patient centricity.

      This is a unique opportunity to network and share knowledge with the region’s leading pharmaceutical firms, biotechs and CROs to discuss operationally efficient and specifically targeted clinical trials. The 2026 program boasts 2 full streams complete with key content.

      450+

      ATTENDEES

      		65+

      EXHIBITORS

      		30+

      SPEAKERS

      		50%

      ATTENDEES AT DIRECTOR + LEVEL

      450+

      ATTENDEES

      		65+

      EXHIBITORS
      30+

      SPEAKERS

      		50%

      ATTENDEES AT DIRECTOR + LEVEL

      Testimonials

      See What It's All About

      Agenda

      • 23 Sep 2025
      • 24 Sep 2025
      Expand All

      Streams

      Stream one

      Stream A: Outsourcing & Clinical Operations

      Stream two

      Stream B: Clinical Trial Technology & Innovation

      11 AM

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

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

      Speakers

      Joe Stalder
      VP Program Management, Zentalis

      11:30 AM

      Executing innovative data collection and monitoring strategies to capture high quality patient experience data (PED)

      • What is PED and how is it influencing clinical research today
      • It all begins with smart science – A strong scientific foundation paves the way for creation of fit for purpose PED strategies.
      • Technology is key - Leveraging eCOA and Digital Health Technologies to capture PED
      • Data oversight is essential – Using real-time PED monitoring strategies to protect study endpoints
      • Keeping it real – We will explore real life examples of how robust PED strategies are used in the context of Obesity & Oncology research

      Speakers

      Melissa Mooney
      Director, Patient Solutions Engineering, IQVIA Technologies

      12 PM

      PANEL DISCUSSION: Are sponsors ready for AI?

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

      Moderator: Amanda Murphy, Senior Director, Data Intelligence & Solutions, GlobalData

      Speakers

      Amanda Murphy
      Senior Director, Data Intelligence and Solutions,
      GlobalData Healthcare
      Michael Murphy
      Director, Legal and Associate General Council, Ionis Pharmaceuticals
      Joe Stalder
      VP Program Management, Zentalis
      Angel Cardeno
      Senior Director of Clinical Affairs and Biostatistics, Biolinq
      Madelaine MacKay
      Senior Director, eClinical Development & Delivery, ICON

      12:30 PM

      Fact vs. Fiction: Debunking common misconceptions about mobile visits

      In this session, we’ll address five of the most common myths surrounding mobile visits, replacing assumptions with real-world data and operational insights:

      • Consistent clinician assignments build trust and strengthen patient relationships
      • Mobile visits can offer greater privacy and comfort than traditional sites
      • Decentralized models can accommodate complex protocols without compromising quality
      • Structured planning makes mobile visits logistically viable and scalable
      • Bringing research directly into communities expands access and improves retention and inclusivity

      Speakers

      Alli Applegate
      Director, Global Clinical Trials, Clinical Operations, EmVenio Clinical Research

      1 PM

      Lunch and Networking

      2 PM

      When innovation doesn’t go as expected

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

      Speakers

      Stanley Kim
      CEO, WinSanTor

      2:30 PM

      From sample to strategy: Holistic laboratory partnership to enable delivery of modern trial designs

      • Integrating central lab expertise early in trial design to avoid fragmented workflows and costly delays
      • Enhancing trial efficiency and biomarker strategy through proactive collaboration with laboratory partners
      • Positioning lab providers as co-authors of research success, offering insights on biomarkers, assays, sample logistics, and data flow
      • Ensuring protocols are both scientifically robust and operationally feasible by embedding lab considerations from the outset

      Speakers

      Mark Slette
      Vice President, Global Operations & Strategic Transformation, Labcorp Central Laboratory Services

      3 PM

      Utilizing third party vendors for clinical trial support

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

      Speakers

      Bridget Adams
      Director, Clinical Operations, Sofie Biosciences

      3:30 PM

      Afternoon refreshments, networking and prize draw sponsored by Dr. Vince Clinical Research

      4 PM

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

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

      Speakers

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

      4:30 PM

      Flawed data from inadequate oversight: Everyone’s problem and no one’s problem

      • Protocol deviations – missed or swapped samples, mistimed dosing, skipped assessments – quietly compromise trial integrity
      • Errors are identified too late with current approaches to clinical trial conduct
      • Real-time oversight enables faster, cleaner data through stronger protocol compliance and earlier course correction
      • Proactive and risk-based quality management under ICH E6(R3) provides earlier visibility into site execution
      • Real-world examples of preventable deviations that delayed trials and jeopardized data

      Speakers

      Richard A Graham PhD
      Co-Founder, TruTechnologies

      5 PM

      CLOSING PANEL DISCUSSION: Ensuring your FSP model is a success

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

      Moderator: Amanda Murphy, Senior Director, Data Intelligence & Solutions, GlobalData

      Speakers

      Amanda Murphy
      Senior Director, Data Intelligence and Solutions,
      GlobalData Healthcare
      Shaily Garg
      Head of Clinical and Requlatory Affairs, ReacX Pharmaceuticals
      Bridget Adams
      Director, Clinical Operations, Sofie Biosciences
      Faisal Rahman
      Clinical Trials Expert

      7:30 AM

      Registration and Refreshments

      8:20 AM

      Chair’s Opening Remarks

      Speakers

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

      8:30 AM

      KEYNOTE: Demystifying AI: Practical insights for pharma and biotech professionals

      • Includes clear, relatable examples of how AI is practically applied within healthcare and pharma, empowering executives without deep technical backgrounds

      Speakers

      Dr Elise Victor
      Healthcare Strategist, Author and AI advocate

      9 AM

      Practical ways ICON is using AI to address common delivery pain points

      • Predict high-performing sites and investigators to accelerate enrolment
      • Forecast site activation timelines with greater accuracy
      • Anticipate post-marketing commitments earlier in the process
      • Enhance TMF compliance and quality through intelligent automation
      • Accelerate and streamline site contracting for faster study start-up
      • Drive operational efficiency and cost savings through robotic process automation

      Speakers

      Madelaine MacKay
      Senior Director, eClinical Development & Delivery, ICON

      9:30 AM

      Strategies for successful recruitment and retention into clinical trials

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

      Speakers

      Sagar Vaidya
      Chief Medical Officer, Cerevance

      10 AM

      Biotech Market Outlook 2025: Implications for clinical trials and the CRO landscape

      • Current biotech funding and pipeline trends shaping early and late phase development
      • How market dynamics are influencing trial initiation and program design in 2025
      • Shifts in CRO selection and strategic approaches among emerging biotechs

      Speakers

      Aditya Kotta
      VP Business Development, Novotech

      10:30 AM

      Morning Refreshments and Networking

      11 AM

      Study start-up challenges in a competitive environment

      • Overcoming financial constraints when budgets are limited and resources tight
      • Fierce site competition: How start-ups can compete with established companies for sites
      • Utilizing effective planning to improve study and program efficiency without compromising patient safety
      • Agile and adaptable: Being prepared to adjust your strategy and approach as needed

      Speakers

      Janal Urich
      Vice President Clinical Development, Atara Biotherapeutics

      11:30 AM

      Not all site networks are created equal: A Sponsor’s guide to smarter site partnerships

      • Understand what often goes unseen in site networks, including turnover, burnout, and uneven site support, and how these issues impact delivery
      • Learn how to evaluate CRO and network partners beyond surface-level metrics like site count and start-up timelines
      • Explore why sustainable site relationships depend on consistency, communication, and shared goals rather than financial incentives alone
      • Hear real-world insights into the operational strain sites face and how sponsors can better align with what sites truly need to succeed
      • Gain a more realistic, strategic framework for assessing site networks before outsourcing decisions are made

      Speakers

      Bhakti Patel
      Senior Director, Project Delivery, TFS Health Science

      12 PM

      PANEL DISCUSSION: Where is the clinical trial industry headed?

      • Moving studies forward on unknown territory: Funding clinical trials amidst recent research policy changes and abrupt NIH cuts
      • Shining light on the changing scope of the FDA: Discussion of the latest changes under the new administration including years of critical DEI work
      • Technological developments into 2026 and beyond: what changes can we expect to see in the next 3-5 years?
      • Navigating the constantly evolving vendor and CRO landscape as a small to mid-sized sponsor company

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

       

      Speakers

      Robert Loll
      Senior Vice President, Business Development and Strategic Planning, Praxis
      Faisal Rahman
      Clinical Trials Expert
      Aditya Kotta
      VP Business Development, Novotech
      Michelle Finegan
      Senior Director, Patient Advocacy and Strategic Alliances, Neurelis
      Rich Polgar
      Managing Director, Danforth Health

      12:30 PM

      A comprehensive site support model for complex trials

      • Today’s clinical trials are becoming more complex, trending towards patient-centric approaches and biomarker-driven designs
      • Higher burdens are put on sites and patients to adhere to the protocols
      • We present a comprehensive site support model that reduces burdens on investigators, site clinical research staff and patients, increasing protocol compliance and data quality.

      Speakers

      Vinnette Sallo
      Senior Director, Project Management, Ergomed

      1 PM

      Lunch and Networking

      2 PM

      FDA’s Office of Import Operations (OIO): Updates and tips for supporting importation of safe and quality FDA-regulated products

      • Organizational Updates
      • Nationalized Entry Review
      • Pharmaceuticals import and entry transmission compliance requirements
      • Biologics import and entry transmission compliance requirements

      Speakers

      Alyson Nicks
      Supervisory Consumer Safety Officer Investigations Branch, FDA

      2:30 PM

      Navigating the complexities of site relationships: defining roles for sponsors and CROs

      • How sponsor and CRO priorities differ, and the importance of clearly defined roles in fostering effective site partnerships
      • Key distinctions between site engagement and site management, and how responsibilities should be strategically allocated
      • Opportunities for sponsors to strengthen site relationships through proactive engagement and thoughtful collaboration
      • Best practices for leveraging CRO networks and KOL partnerships to support site success, particularly in later-phase trials

      Speakers

      Nicole Stansbury
      Senior Vice President, Clinical Operations Premier Research

      3 PM

      Best practices for clinical trial execution from a financial perspective

      • Tips and tricks to negotiate better contracts with sites and vendors
      • Clinical trial budgeting and operational oversight from the financial perspective

      Speakers

      AJ Bergmann
      Chief Financial Officer, Capricor Therapeutics

      3:30 PM

      Afternoon refreshments, networking and prize draw sponsored by Dr. Vince Clinical Research

      4 PM

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

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

      Speakers

      Kim Potter
      Director of Clinical Operations, Alume Biosciences

      4:30 PM

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

      • How do we look at data transparency issues when scaling AI?
      • Case study on AI rights and a look at recently released survey discussing where things need to change
      • Without GDPR, what can be done to protect patients regarding data sovereignty?
      • Delving into the unique and amplified challenges for AI risk assessment
      • How can we effectively leverage AI in our heavily regulated environment?

      Speakers

      Christine von Raesfeld
      Patient Advocate, The Light Collective

      5 PM

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

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

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

      Speakers

      Robert Loll
      Senior Vice President, Business Development and Strategic Planning, Praxis
      Joanna Bolger
      SVP Clinical Development, Lighthouse Pharma
      Constance Crowley
      Executive Director, Clinical Development, Arcturus Therapeutics
      Zhiyun Zhang
      Vice President, Symray Biopharma

      5:30 PM

      Chair’s closing remarks

      END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY KPS LIFE

      Streams

      Stream one

      Stream A: Outsourcing & Clinical Operations

      Stream two

      Stream B: Clinical Trial Technology & Innovation

      9 AM

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

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

      Speakers

      Murali Pinnaka
      Senior Director, Analytics and Insights for Commercialization, Arcutis Biotherapeutics
      Julie Nolte
      Executive Director,  Clinical Operations, Arcutis Biotherapeutics

      9:30 AM

      CEO PANEL DISCUSSION: Fundraising in the real world — Lessons, pivots and pitfalls

      Moderator: Jeff Trickett, Business Advisor, Archetype Therapeutics

      Speakers

      Jeff Trickett
      Business Advisor, Archetype Therapeutics
      James Mackay
      President and CEO, Crystalys Therapeutics
      Stanley Lewis
      Founder, Chief Executive Officer, A28 Therapeutics

      10:15 AM

      Morning refreshments and networking

      11 AM

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

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

      Moderator: Amanda Murphy, Senior Director, Data Intelligence & Solutions, GlobalData

      Speakers

      Amanda Murphy
      Senior Director, Data Intelligence and Solutions,
      GlobalData Healthcare
      Vara Wuyyuru
      Global Principle Clinical Lead, Alcon
      Bridget Adams
      Director, Clinical Operations, Sofie Biosciences

      12:15 PM

      Lunch and networking

      1:45 PM

      Engaging in successful partnerships with the U.S. NIH

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

      Speakers

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

      7:30 AM

      Registration

      7:50 AM

      Chair’s Opening Remarks

      8 AM

      Interactive Breakfast Speaker-Hosted Roundtable Discussions

      With drinks and refreshments, interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Each discussion will run twice and be led by a table moderator and will focus on a different challenge within clinical trials. Roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

      Roundtable 1 Navigating the latest release of ICH E6 (R3): How are you carrying out gap assessments of processes and what changes are you making?

      Hosted by Christina Sanchez, Director, Clinical Quality Assurance, Neurocrine Biosciences
      Roundtable 2 Postproduction handling and administration of biologics drugs 

      Hosted by Kevin Zen, Director, Opthea
      Roundtable 3 Collaborative solutions between Sponsors and CROs for accurate site budgeting and forecasting

      Hosted by Richard Firth, Associate Director, Development Business Operations, Arcturus Therapeutics
      Roundtable 4 Emerging startup company trends and challenges
      Roundtable 5 Implications of the latest administration on clinical trial progress

      Speakers

      Christina Sanchez
      Director, Clinical Quality Assurance, Neurocrine Biosciences
      Kevin Zen
      Director, Opthea
      Richard Firth
      Associate Director, Development Business Operations, Arcturus Therapeutics

      9 AM

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

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

      Speakers

      Roger Schechter
      Director, Clinical Research, SMSbiotech

      9:30 AM

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

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

      Moderator: Melody Puckett, Director, GXP Quality, Janux Therapeutics

       

       

      Speakers

      Melody Puckett
      Director, GXP Quality, Janux Therapeutics
      Kerry Clancy
      Director, Outsourcing and Contract Management, AnaptysBio
      Barbara Birch
      Associate Director, Clinical Vendor Management, Ultragenyx

      10:15 AM

      Morning refreshments and networking

      11 AM

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

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

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

      Speakers

      Robert Loll
      Senior Vice President, Business Development and Strategic Planning, Praxis
      Shaily Garg
      Head of Clinical and Requlatory Affairs, ReacX Pharmaceuticals
      Matthew Spear
      Chief Medical Officer, Chief Development Officer, Denovo Biopharma
      Kim Potter
      Director of Clinical Operations, Alume Biosciences
      Roger Schechter
      Director, Clinical Research, SMSbiotech

      11:45 AM

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

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

      Speakers

      Anne Severtson
      Senior Director, Clinical Operations, AnaptysBio

      11:45 AM

      Trial Master File (TMF): Expectations from Sponsors, CROs and Sites

      • FDA’s expectations from site and sponsor’s documents
      • Required components of TMF
      • Best practices for the set-up and maintenance of TMF
      • Tools and SMEs

      Speakers

      Preeti Baweja
      Director, Clinical Operations, Ventyx Biosciences

      12:15 PM

      Lunch and networking

      1:15 PM

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

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

      Moderator: Amanda Murphy, Senior Director, Data Intelligence & Solutions, GlobalData

      Speakers

      Amanda Murphy
      Senior Director, Data Intelligence and Solutions,
      GlobalData Healthcare
      Anne Severtson
      Senior Director, Clinical Operations, AnaptysBio
      Michelle Finegan
      Senior Director, Patient Advocacy and Strategic Alliances, Neurelis

      2:15 PM

      Clinical trials surged in H1 2025! What happened and what you must know to stay ahead

      GlobalData’s clinical trials data indicates that new trials initiated in H1 2025 has increased significantly over previous years. In addition to surprising Wall Street, this has shaken up the biopharma competitive landscape and created major opportunities for CROs, CDMOs, Pharma Tech, and consultancies. Behind the headlines, clinical trial reporting lags, shifting start dates, and withdrawals make it easy to miss where the real growth is happening.

      This session breaks down what drove the surge, where the next wave is coming from, and how early signals can give you the edge on predicting future market shifts. Whether you run trials, manufacture at scale, or advise life sciences companies, this is about being prepared, before your competitors are.

      Speakers

      Amanda Murphy
      Senior Director, Data Intelligence and Solutions,
      GlobalData Healthcare

      2:45 PM

      Afternoon networking, prize draw and closing remarks

      3:15 PM

      END OF CONFERENCE

      Speakers

      Select a speaker to learn more

      Back
      Stanley Lewis
      Founder, Chief Executive Officer, A28 Therapeutics

      Stanley Lewis, MD MPH is a graduate of the University of Texas McGovern Medical School and the University of Texas School of Public Health.  He completed an Internal Medicine residency and fellowship and joined the faculty as Assistant Professor of Medicine.  Dr. Lewis has dedicated his professional career to patient care, teaching, clinical research, and drug development.  His areas of interest are infectious disease, oncology, and metabolic disorders.  He has participated as an Investigator on over 30 clinical trials and authored over 50 scientific abstracts and publications.  Dr. Lewis served as Chief Medical Officer at both public and private biotechnology companies including TaiMed Biologics where he led a small team to develop the first monoclonal antibody for treatment of multi-drug resistant HIV disease.  He later Founded and serves as CEO of A28 Therapeutics where he is developing a targeted lytic peptide for treatment of cancer.

      Session Details:

      CEO PANEL DISCUSSION: Fundraising in the real world — Lessons, pivots and pitfalls

      2025-09-24, 9:30 AM

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

      Session Details:

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

      2025-09-24, 11:00 AM

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

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

      Session Details:

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

      2025-09-23, 4:00 PM

      Session Details:

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

      2025-09-24, 11:00 AM

      View In Agenda
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      Anne Severtson
      Senior Director, Clinical Operations, AnaptysBio

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

      Session Details:

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

      2025-09-24, 1:15 PM

      Session Details:

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

      2025-09-24, 11:45 AM

      View In Agenda
      Next speaker
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      Dr Elise Victor
      Healthcare Strategist, Author and AI advocate

      I believe sustainable success is about developing emotionally intelligent resilient leaders who combine a growth mindset with an unwavering commitment to human-centered technology.

      Here is what I am doing with my time now:
      ✍️ Finishing my book, "AI Uncomplicated,"
      🎤 Speaking: Responsible AI and Future of Work
      👩🏻‍🏫 Teaching, guest lecturing,
      🏛️ Developing Higher Ed. courses & curriculum

      Experience:
      25+ years in healthcare, business, and consulting + PhD in health informatics from UNT.

      Session Details:

      KEYNOTE: Demystifying AI: Practical insights for pharma and biotech professionals

      2025-09-23, 8:30 AM

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      Kerry Clancy
      Director, Outsourcing and Contract Management, AnaptysBio

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

      Session Details:

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

      2025-09-24, 9:30 AM

      View In Agenda
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      Jeff Trickett
      Business Advisor, Archetype Therapeutics

      Session Details:

      CEO PANEL DISCUSSION: Fundraising in the real world — Lessons, pivots and pitfalls

      2025-09-24, 9:30 AM

      View In Agenda
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      Richard Firth
      Associate Director, Development Business Operations, Arcturus Therapeutics

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

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

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

      Session Details:

      Interactive Breakfast Speaker-Hosted Roundtable Discussions

      2025-09-24, 8:00 AM

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

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

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

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

      Session Details:

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

      2025-09-24, 9:00 AM

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      Julie Nolte
      Executive Director,  Clinical Operations, Arcutis Biotherapeutics

      Session Details:

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

      2025-09-24, 9:00 AM

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

      Session Details:

      Study start-up challenges in a competitive environment

      2025-09-23, 11:00 AM

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      Angel Cardeno
      Senior Director of Clinical Affairs and Biostatistics, Biolinq

      Session Details:

      PANEL DISCUSSION: Are sponsors ready for AI?

      2025-09-23, 12:00 PM

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

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

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

      Session Details:

      Engaging in successful partnerships with the U.S. NIH

      2025-09-24, 1:45 PM

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      AJ Bergmann
      Chief Financial Officer, Capricor Therapeutics

      Session Details:

      Best practices for clinical trial execution from a financial perspective

      2025-09-23, 3:00 PM

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      Sagar Vaidya
      Chief Medical Officer, Cerevance

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

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

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

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

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

      Session Details:

      Strategies for successful recruitment and retention into clinical trials

      2025-09-23, 9:30 AM

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      James Mackay
      President and CEO, Crystalys Therapeutics

      Distinguished scientist and global life sciences business leader with strong record of bringing multiple drugs to market and patients

      • Led successful $1.2B acquisition and transition of Ardea Biosciences into AstraZeneca

      • Achieved FDA and EMA approval of Zurampic, the first novel MOA for the treatment of gout
      in over 50 years

      • Led successful commercial licensing of Zurampic and Duzallo to Ironwood Pharmaceuticals and
      Grunenthal

      • Transformed the AstraZeneca/BMS Diabetes global development and commercial collaboration, and
      established Onglyza, Kombiglyze XR and Komboglyze as key growth drivers in the AZ portfolio

      • Designed and implemented multiple innovative delivery and partnership models including an
      industry leading approach to delivery of outsourced clinical work through development of strategic
      partnerships with CROs

      • Designed and implemented multiple strategic re-organizations, led major global change
      management, whilst delivering improved efficiencies and productivity

      Session Details:

      CEO PANEL DISCUSSION: Fundraising in the real world — Lessons, pivots and pitfalls

      2025-09-24, 9:30 AM

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      Faisal Rahman
      Clinical Trials Expert

      Session Details:

      PANEL DISCUSSION: Where is the clinical trial industry headed?

      2025-09-23, 12:00 PM

      Session Details:

      CLOSING PANEL DISCUSSION: Ensuring your FSP model is a success

      2025-09-23, 5:00 PM

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

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

      Session Details:

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

      2025-09-24, 11:00 AM

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      Bin Pan
      Executive Director, Operational Strategy, Ergomed

      Bin Pan brings over 25 years of clinical research experience with a strong focus on oncology clinical development. Throughout her career, she has advanced through roles in clinical operations, trial management, and oversight across pharma, biotech, and CRO companies. Bin’s scientific expertise is anchored by her PhD in Molecular Biology, equipping her with deep insights into innovative treatment strategies. Passionate about precision medicine and immuno-oncology, she is also committed to addressing the unmet needs of patients—especially those battling rare cancers.

      Next speaker
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      Amanda Murphy
      Senior Director, Data Intelligence and Solutions,
      GlobalData Healthcare

      Session Details:

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

      2025-09-24, 1:15 PM

      Session Details:

      PANEL DISCUSSION: Are sponsors ready for AI?

      2025-09-23, 12:00 PM

      Session Details:

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

      2025-09-24, 11:00 AM

      Session Details:

      CLOSING PANEL DISCUSSION: Ensuring your FSP model is a success

      2025-09-23, 5:00 PM

      Session Details:

      Clinical trials surged in H1 2025! What happened and what you must know to stay ahead

      2025-09-24, 2:15 PM

      View In Agenda
      Next speaker
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      Melissa Mooney
      Director, Patient Solutions Engineering, IQVIA Technologies

      Melissa Mooney has over 20  years of  experience in the development of eCOA solutions for use in clinical trials. Melissa’s area of expertise is eCOA solution design where she has supported clients and eCOA vendors in developing robust and usable eCOA software solutions that meet eCOA protocol requirements. She also brings a plethora of experience in eCOA requirement gathering, leading  eCOA User Acceptance testing, eCOA data management, and BD support.

      Session Details:

      Executing innovative data collection and monitoring strategies to capture high quality patient experience data (PED)

      2025-09-23, 11:30 AM

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      Mark Slette
      Vice President, Global Operations & Strategic Transformation, Labcorp Central Laboratory Services

      Session Details:

      From sample to strategy: Holistic laboratory partnership to enable delivery of modern trial designs

      2025-09-23, 2:30 PM

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      Joanna Bolger
      SVP Clinical Development, Lighthouse Pharma

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

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

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

      Session Details:

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

      2025-09-23, 5:00 PM

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      Michelle Finegan
      Senior Director, Patient Advocacy and Strategic Alliances, Neurelis

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

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

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

      Session Details:

      PANEL DISCUSSION: Where is the clinical trial industry headed?

      2025-09-23, 12:00 PM

      Session Details:

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

      2025-09-24, 1:15 PM

      View In Agenda
      Next speaker
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      Christina Sanchez
      Director, Clinical Quality Assurance, Neurocrine Biosciences

      Session Details:

      Interactive Breakfast Speaker-Hosted Roundtable Discussions

      2025-09-24, 8:00 AM

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

      Session Details:

      Interactive Breakfast Speaker-Hosted Roundtable Discussions

      2025-09-24, 8:00 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:

      Chair’s Opening Remarks

      2025-09-23, 8:20 AM

      Session Details:

      PANEL DISCUSSION: Where is the clinical trial industry headed?

      2025-09-23, 12:00 PM

      Session Details:

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

      2025-09-24, 11:00 AM

      Session Details:

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

      2025-09-23, 5:00 PM

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      Nicole Stansbury
      Senior Vice President, Clinical Operations Premier Research

      Nicole Stansbury, Senior Vice President, Global Clinical Operations, is responsible for oversight of clinical operations which includes clinical strategy and delivery, study start up, central monitoring, and site management and risk-based monitoring at Premier Research. She leverages an innovative, data-driven approach and more than 25 years of industry experience to help sponsors address the rapidly evolving demands of the clinical development industry. In her role, Stansbury is focused on finding ways to simplify process and improve technology adoption to decrease the time, cost, complexity, and risk of delivering clinical research.

      Prior to joining Premier Research, Stansbury held various CRO leadership positions where she was instrumental in the strategic implementation of risk-based monitoring, central monitoring and continuous improvement of clinical operations processes. Stansbury has been co-lead for the Association of Clinical Research Organizations Risk-Based Monitoring (ACRO RBM) Working Group working with TransCelerate and the FDA since 2014.

      She holds a Bachelor of Science from Texas A&M and a Lean Six Sigma – Yellow Belt certification.

      Session Details:

      Navigating the complexities of site relationships: defining roles for sponsors and CROs

      2025-09-23, 2:30 PM

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      Shaily Garg
      Head of Clinical and Requlatory Affairs, ReacX Pharmaceuticals

      Session Details:

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

      2025-09-24, 11:00 AM

      Session Details:

      CLOSING PANEL DISCUSSION: Ensuring your FSP model is a success

      2025-09-23, 5:00 PM

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      Roger Schechter
      Director, Clinical Research, SMSbiotech

      Session Details:

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

      2025-09-24, 9:00 AM

      Session Details:

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

      2025-09-24, 11:00 AM

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      Bridget Adams
      Director, Clinical Operations, Sofie Biosciences

      Session Details:

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

      2025-09-24, 11:00 AM

      Session Details:

      Utilizing third party vendors for clinical trial support

      2025-09-23, 3:00 PM

      Session Details:

      CLOSING PANEL DISCUSSION: Ensuring your FSP model is a success

      2025-09-23, 5:00 PM

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      Bhakti Patel
      Senior Director, Project Delivery, TFS Health Science

      Bhakti Patel is a strategic clinical operations leader specializing in ophthalmology, medical devices, and drug/device combination trials. As Senior Director of Project Delivery within the Ophthalmology business unit, Bhakti leads global clinical delivery efforts with a focus on cross-functional collaboration, regulatory compliance, and operational efficiency.

      With nearly two decades of experience across CRO, pharma, and site networks, she brings deep expertise in clinical trial management across all phases, including vendor oversight, risk mitigation, audit readiness, and data-driven process improvement. Her leadership has supported successful trials in a broad range of therapeutic areas, with particular depth in ophthalmology indications such as geographic atrophy, glaucoma, diabetic macular edema (DME), and gene therapy.

      Prior to joining TFS, Bhakti held senior leadership roles at Velocity Clinical Research, Glaukos Corporation, and ORA, where she implemented scalable systems, enhanced site performance, and led inspection readiness across global studies. She is also known for building and mentoring high-performing teams that consistently deliver on time and with quality.

      Bhakti holds a bachelor's degree in Microbiology, Immunology, and Biochemistry and is a certified Lead Auditor. She is deeply committed to patient-centered research, continuous improvement, and empowering teams to drive lasting impact.

       

      Session Details:

      Not all site networks are created equal: A Sponsor’s guide to smarter site partnerships

      2025-09-23, 11:30 AM

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      Barbara Birch
      Associate Director, Clinical Vendor Management, Ultragenyx

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

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

      Session Details:

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

      2025-09-24, 9:30 AM

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      Preeti Baweja
      Director, Clinical Operations, Ventyx Biosciences

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

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

      Session Details:

      Trial Master File (TMF): Expectations from Sponsors, CROs and Sites

      2025-09-24, 11:45 AM

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      Stanley Kim
      CEO, WinSanTor

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

      Session Details:

      When innovation doesn’t go as expected

      2025-09-23, 2:00 PM

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      Joe Stalder
      VP Program Management, Zentalis

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

      Session Details:

      PANEL DISCUSSION: Are sponsors ready for AI?

      2025-09-23, 12:00 PM

      Session Details:

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

      2025-09-23, 11:00 AM

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

      Session Details:

      PANEL DISCUSSION: Are sponsors ready for AI?

      2025-09-23, 12:00 PM

      Session Details:

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

      2025-09-23, 4:00 PM

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      Alli Applegate
      Director, Global Clinical Trials, Clinical Operations, EmVenio Clinical Research

      Session Details:

      Fact vs. Fiction: Debunking common misconceptions about mobile visits

      2025-09-23, 12:30 PM

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      Richard A Graham PhD
      Co-Founder, 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:

      Flawed data from inadequate oversight: Everyone’s problem and no one’s problem

      2025-09-23, 4:30 PM

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      Vinnette Sallo
      Senior Director, Project Management, Ergomed

      Vinnette Sallo is a pharmaceutical professional with over 25 years of experience, currently serving as the Head of Project Management for North America at Ergomed CRO. A strategic, problem-solving leader committed to successful project delivery, fostering employee development, and ensuring customer satisfaction. She started her career in large pharma, progressing from development labs to managing clinical research studies from Phase I-IV. Her clinical research experience includes multiple therapeutic areas working in Clinical Development, Early Phase Oncology, Oncology Global Medical Affairs, and with Investigator Initiated Programs. Vinnette has also successfully supported FDA inspections throughout the development process leading to FDA approvals and has contributed to publications presented at international oncology symposiums.

      Session Details:

      A comprehensive site support model for complex trials

      2025-09-23, 12:30 PM

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      Zhiyun Zhang
      Vice President, Symray Biopharma

      Session Details:

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

      2025-09-23, 5:00 PM

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      Melody Puckett
      Director, GXP Quality, Janux Therapeutics

      Session Details:

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

      2025-09-24, 9:30 AM

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      Aditya Kotta
      VP Business Development, Novotech

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

      Session Details:

      Biotech Market Outlook 2025: Implications for clinical trials and the CRO landscape

      2025-09-23, 10:00 AM

      Session Details:

      PANEL DISCUSSION: Where is the clinical trial industry headed?

      2025-09-23, 12:00 PM

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      Constance Crowley
      Executive Director, Clinical Development, Arcturus Therapeutics

      Session Details:

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

      2025-09-23, 5:00 PM

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      Dominic Jackson
      Head of Data Management, Eclevar

      Dominic Jackson is a forward-thinking clinical data professional with deep experience across Central Lab, CRO, and Sponsor environments. He brings a unique, end-to-end perspective on how data can be used more intelligently and creatively in clinical research.

      Dominic is particularly interested in how emerging technologies, cross-functional collaboration, and smarter data strategies can unlock new efficiencies and insights. He’s a strong advocate for rethinking traditional approaches and embracing innovation to improve outcomes for both sponsors and patients.

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      Krissy Meckel Parker
      Associate Director, Clinical QA, Neurocrine Biosciences
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      Nadine Knowles
      Vice President, Clinical Operations, Longboard Pharmaceuticals
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      Madelaine MacKay
      Senior Director, eClinical Development & Delivery, ICON

      Session Details:

      PANEL DISCUSSION: Are sponsors ready for AI?

      2025-09-23, 12:00 PM

      Session Details:

      Practical ways ICON is using AI to address common delivery pain points

      2025-09-23, 9:00 AM

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      OCT Advisory Board

      Select a member to learn more

      Back
      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.

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      Kathleen Cohen
      Vice President, Clinical Development, Marinus Pharmaceuticals

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

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      Aditya Kotta
      VP Business Development, Novotech

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

      Session Details:

      Biotech Market Outlook 2025: Implications for clinical trials and the CRO landscape

      2025-09-23, 10:00 AM

      Session Details:

      PANEL DISCUSSION: Where is the clinical trial industry headed?

      2025-09-23, 12:00 PM

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

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

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

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      Rosalie Filling
      Vice President, Senior Global Head R&D Operations, 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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      Edwin van Vulpen
      Executive Director and Head of Clinical Business Development Euro-Asia
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