16th Annual Outsourcing in Clinical Trials West Coast 2024

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

6 - 7

February

2024
  • Hyatt Regency San Francisco Airport, USA
  • Complimentary
  • Why attend?
  • Agenda
  • Speakers
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  • 2023 Event Gallery
  • Sponsors
  • Media Centre
  • Resources
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Why attend?

WHAT TO EXPECT FOR 2024?

With regulations ever changing and the innovative advancements of technology rapidly growing, this conference will address the everyday and perspective challenges faced when working within the clinical trial space. Legislations such as the DEPICT Act, the review of CTIS to Generative AI and leveraging our global trial footprint to accelerate clinical development, as well as building on our new and existing relationships within our industry.

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

This is a unique opportunity to network and share knowledge with the region’s leading pharmaceutical firms, biotech’s and medical device companies, to discuss operationally efficient, specifically targeted clinical trials. The 2024 program boasts 4 full streams complete with key content.

Stream A: Outsourcing & Clinical Operations

Stream B: Clinical Innovation & Technology

Stream C Day 1: Patient Engagement with Diversity & Inclusion

Stream C Day 2: Medical Devices

800+

Attendees

90+

Exhibitors

45+

Speakers

50%

Attendees at Director + Level

800+

Attendees

90+

Exhibitors

45+

Speakers

50%

Attendees at Director + Level

See What It's All About

Agenda

  • 6 Feb 2024
  • 7 Feb 2024
Expand All

Streams

Stream one

Outsourcing & Clinical Operations

Stream two

Clinical Innovation & Technology

Stream three

Patient Engagement and Diversity & Inclusion

10:30 AM

Diverse and Equitable Participation in Clinical Trials (DEPICT) Act

Legislation aiming to increase diversity in clinical trials by requiring enhanced data reporting on clinical trial participant demographics.

 

  • What does a Diversity Plan look like?
  • How are companies approaching the DAP process
  • Determining the dynamic and strategy of such a plan
  • Highlighting a diverse trial that could be emulated
  • Addressing the requirement to include information about the demographic diversity of the clinical trial population and address related issues
  • Practical experience – submitting your diversity plan

Speakers

Guinevere (Gwen) Valencia
Associate Director, Global Patient Advocacy, argenx

11 AM

Driving better outcomes with patient informed protocols

Developing effective therapies that deliver meaningful patient benefits begins early in development and includes patient insights at every step. Using a patient-guided approach can help sponsors navigate an increasingly complex reimbursement landscape, mitigate risks, and develop more patient-friendly protocols to deliver new therapies that better meet the needs of patients.

 

This presentation will discuss:

  • The impact on development programs when patient input isn’t incorporated
  • Strategies for when and how to obtain patient input for your protocols
  • Case studies of protocols that were optimized with patient input

Speakers

Kristina Reeder
Director, Patient Engagement, Parexel

11:30 AM

The Patient’s Perspective: ‘Why are patient’s voices so important in drug development?

• Discussing the personal experiences of the patient
• Defining 'patient centricity

Speakers

Christine Von Raesfeld
Founder and CEO, People with Empathy

12 PM

Expanding trial access through patient-centric solutions in the home & at the site

  • What is happening now to support patients through in-home trial delivery & how can we use technology to advance clinical research.
  • The possibilities integration of decentralized elements creates in supporting more diverse patient populations.
  • What can be done to maximize reach through trial sites and what we can do to support our research partners in any community.

Speakers

Edward Triebell
Commercial Executive Director, MRN Technologies
Caroline Potts, MSc
Health Sciences, MSc Healthcare and Design, MRN Site and Patient Services

12:30 PM

Lunch & Networking

1:30 PM

PANEL Patient centricity: What does patient centric clinical trial development look like in 2024?

  • Looking at what is working and what can be done better.
  • Highlighting the patient perspective, providing a platform to share one’s story.
  • Discussing opportunities of further development

Speakers

Christine Von Raesfeld
Founder and CEO, People with Empathy
Archana Sah
Vice President, Head of Clincial Operations
Catherine L. Caserza
RN, MS, MPH Director, Clinical Operations, Daiichi Sankyo
W. G. Paseman
co-founder rarekidneycancer.org
Susanne Schroter
Executive Director, Project Delivery, Biotech, ICON

2:15 PM

A Patient’s Approach to Innovative Clinical Research

  • Room for improvement: Current Critiques of medical innovation
  • Hackathons: Using Gamified Tumor Boards to advance Research on particular patients
  • Research Agents and Digital Twins: Next generation environments for automated data sharing and research

Speakers

W. G. Paseman
co-founder rarekidneycancer.org

2:45 PM

FIRESIDE CHAT Have you developed an understanding of the patient journey as part of your clinical trial design? Bringing the patient’s practical perspective to your trial operations especially for rare disease indications

• Building clinical trials with the perspective of the patient in mind (the patient journey).
• Discussing the collaboration that must exist between patient advocacy groups, study site staff, patients, care givers in order to have a successful trial.
• Highlighting the importance of effective communication to patients and how this can streamline trial timelines.
• Exploring how patients could, and should, be influencing decisions and the R&D process.
• Regulatory situation in support of patient-centred development
• What are the benefits of using multi-stakeholder approaches?

Speakers

Christine Von Raesfeld
Founder and CEO, People with Empathy
Marta Schumacher
Executive Director, Head of Global Clinical Operations, Annexon Biosciences

3:15 PM

Afternoon Refreshments, Networking & Apple Prize Draw in Exhibit Hall

7:30 AM

Registration & Refreshments

8:20 AM

Chairman’s Opening Remarks

Speakers

Abby Kennedy
VP of Clinical Operations, CymaBay Therapeutics, Inc

8:30 AM

Keynote The use of technology to accelerate early drug discovery and reduce the burden for patients

Building personalized digital healthcare solutions to support clinical claims is of great importance to the drug industry. Medical Insights generated from digital healthcare clinical studies emerged as a promising approach to help with:

  • Patient engagement and retention.
  • Collecting richer data to drive insights and accelerate drugs' early research and developments to make better drugs and early medical decisions.
  • Increase efficacy of therapies through continuous monitoring.

This session details a case study on challenges using Digital Healthcare Technologies in the clinical trials ecosystem and use of medical devices to help patients better manage their conditions.

Speakers

Abdel Dridi
Global Head of Digital Healthcare Technologies (DHT), Personalized Healthcare, Product Development, Roche

9 AM

Solving the Clinical Data Challenge

Patient centricity requires data centricity to integrate and manage a growing variety of data sources. The challenge lies in integrating and managing those sources to deliver high-quality data. How do we overcome this?

 

  • Moving from manual, reactive data review and cleaning to proactive, risk-based approaches based on integrated data
  • Providing clinical data management and monitoring teams with workflows and analytics that support their day-to-day functions
  • Leveraging technologies that incorporate AI to automate manual tasks and identify potential issues sooner

 

Speakers

Tim Akers
Managing Partner, Clinical Data Studio, Medidata Solutions

9:30 AM

Cell & Gene Therapy Long Term Follow Up & Future Directions: Leveraging AI, Real-World Evidence and Decentralization

This session will include a brief introduction to cell and gene therapy (CGT) and the importance of long term follow up. We will discuss leveraging artificial intelligence, real-world evidence, and decentralization. We will conclude with some thought-provoking Q&A on the future of CGTs including new therapies and considerations for study designs.

 

 

Speakers

Patricia Anderson, ScM PStat®
Director, Biostatistics, ICON

10 AM

Morning Refreshments & Networking

10:30 AM

State of Affairs on Excellence in Clinical Development

The talk will explore the current state of affairs in Clinical development, the most pressing challenges in 2024 and solutions to address them.

  • Learn about the most pressing challenges and solutions in both early to late stage clinical development- at big pharma as well as small biotechnology companies strategies for increasing representation and diversity,
  • share best practices for patient enrollment and retention, data standards and latest regulatory considerations/guidelines
  • How can technology be leveraged in patient centric drug development

Speakers

Archana Sah
Oncology Board Member, Society for Clinical Research Sites

11 AM

Unlocking the Critical Power of Partnerships and Personalization in Clinical Research: A Cell and Gene Therapy Model

  • Learn how to optimize the partnerships critical to study success for your cell therapy or gene therapy development
  • Discover the top attributes to ensure your CRO provides the true personalization your program requires
  • Framework illuminated by real world examples and case studies

Speakers

Matthew Confeld, PharmD, PhD
Assistant Director, Clinical Research Methodology, Worldwide Clinical Trials

11:30 AM

Smart CRO Contracting: A Start-Up Company Perspective

      • Examining CRO services contract structures
      • Determining best contract structure for the company and trial needs
      • Optimizing contract monitoring, maintenance and service invoice management

Speakers

Gabriel Luciano
Vice President, Clinical Operations, Corvus Pharmaceuticals Inc.

12 PM

Clinical Trial Information System (CTIS) Unveiled: Helping Biotech/Pharma to Streamline Regulatory processes in EU

  • Success Stories and Lessons Learned in CTIS Implementation
  • Real-World Insights: Case Studies that Unravel the CTIS Landscape

Speakers

Diana Filipescu
Business Development Manager, Novotech

12:30 PM

Lunch & Networking

1:30 PM

PANEL Maximising your Sites Productivity & how to lessen the burden

Sites are increasingly challenged with workload and resource constraints. This panel will discuss ways in which to get the best output from sites.
What can we do for them beyond an inflated budget?

• Addressing challenges the sites are currently facing
• An overview of the repercussions of such challenges, and a focus on what we can do to overcome them.
• Forward thinking to strengthen site output.
• Limitations with electronic applications

Speakers

Jasmina Jankicevic
Clinical Development, RAPT Therapeutics, Inc.
Marta Schumacher
Executive Director, Head of Global Clinical Operations, Annexon Biosciences
Harman Hansra
Sr. Director, Global Clinical Ops, Annexon Biosciences
Dan Braga
VP, Healthcare and EHR Solutions, Medidata
Carleen Tabari
Clinical Operations Lead, Gravitas Medical

2:15 PM

Do Mobile Nurse Visits Drive Faster Study Results?

Two important challenges impacting drug development today are patient dropout rates and lengthening trial timelines. New data demonstrates how mobile nurse visits address these two challenges head on, by speeding trial completion and reducing patient dropout.

Learning objectives:

  • Explore current challenges in clinical trials around study timelines and patient dropout rates
  • Analyze the role and impact of mobile nurse visits in shortening clinical trial timelines and reducing patient dropout
  • Understand the importance and value of both experience and expertise in delivering successful mobile nurse visits

Speakers

Stephanie Hitchcock
Associate Director of Project Management, PCM Trials

2:45 PM

Trial Execution Excellence for small & medium biotechnology companies

  • Outlining the outlook for the future on what sponsors & CROs could do to embrace a more strategic and partnership approach to clinical trials for mutual benefits
  • Looking at the use and integration of new tools and technologies to improve our knowledge about the origin of the disease and to identify new therapeutic strategies
  • Approaching product management that emphasizes getting the right products to market faster through deep user insight, a clear product strategy, an

Speakers

Scott McCulloch
Executive Director, Global Clinical Quality & Pharmacovigilance, Recode Therapeutics

3:15 PM

Afternoon Refreshments, Networking & Apple Prize Draw in Exhibit Hall

3:45 PM

Mastering Dose Escalation Studies: Charting the Path from Planning to Execution

This session will highlight key considerations for overcoming obstacles during critical timepoints of early phase clinical research, from initial protocol planning to enrollment. You will learn:

  • Tactics for optimizing Phase 1 studies that span therapeutic areas and treatment modalities
  • Considerations for reducing patient burden and enhancing the patient experience
  • Regulatory strategies to bolster early planning efforts

Speakers

Ashley Herrick, Ph.D.
Executive Director, Oncology Program Strategy, Premier Research

4:15 PM

PANEL DISCUSSION Outsourcing Strategies: how do you approach your outsourcing strategy?

• Determining the best strategy from your service providers
• Uncovering if your offerings are competitive, and if this is indeed value for money.
• Looking into what is driving the increasing costs of running your study, recognising the value associated with costs and their justifications.
• Establishing what can be done to avoid increasing budgets including the evaluation of tools required for the type of study one is conducting.

Speakers

Abby Kennedy
VP of Clinical Operations, CymaBay Therapeutics, Inc
Scott McCulloch
Executive Director, Global Clinical Quality & Pharmacovigilance, Recode Therapeutics
Dave Borbas
Research VP, Head of Data Management, Abcuro
David Kim
Senior Director of Strategic Clinical Outsourcing, Cytokinetics

5 PM

Chairman’s Closing Remarks & Drinks Reception Sponsored by KPS Life

10:30 AM

Expanded Responsibilities for IRBs when Reviewing AI Protocols

  • Protecting Third Parties in Human Subjects Research
  • Ethical, Privacy, and Safety Considerations for:
    • Direct Research Participants
    • Participant Community, Subpopulation, Race, Ethnicity, Gender
    • Society at Large
  • Assessing AI Tool Bias

Speakers

Edward Kuczynski
Director, Human Research Protection Program, UCSF

11 AM

Artificial Intelligence-Enhanced medical imaging and documentation for Clinical Trials

This presentation provides a practical exploration of AI in clinical trials and will focus on Optimizing Processes, Enhancing Quantitative Analysis, and Streamlining Documentation.

 

  • Explore how AI streamlines image labeling for improved clinical trial efficiency
  • Learn about AI's role in advancing quantitative analysis in clinical settings for more nuanced insights
  • Discover how AI may contribute to faster documentation in clinical trials, automating report and summary generation while improving documentation quality

Speakers

Shyam Banuprakash
Senior Vice President, Data Science, Clario
Joonmi Oh
Vice President, Image Analysis and AI Governing, Clario

11:30 AM

Great expectations and how to meet them – connected devices and ePRO in clinical trials

  • Focusing on design considerations
  • Understanding the best framework for your study
  • Considering patient ePRO assessments needed for a specific study
  • Highlighting best practice for data collection
  • Avoiding expensive mistakes that undermine your trial outcome or delay your timeline
  • Outlining Regulatory restrictions around ePro with a focus on EU & UK GDPR concerns, ethical questions in the US
  • Comparison vs Paper Reported Outcomes – why are companies not transitioning fully to ePro?

Speakers

Dave Borbas
Research VP, Head of Data Management, Abcuro

12 PM

Interactive Session Unveiling Polling Data to Drive Clinical Innovation

 

  • Immerse in this interactive session designed to inspire and promote practical application and conversation
  • It’s not just information; we’ll share industry survey data that could improve eClinical solutions
  • Participate in a thought-provoking exchange to address the biggest challenges facing clinical trials today and the future

 

 

Speakers

Tammi Acord
Director, Strategic Solutions, YPrime

12:30 PM

Lunch & Networking

1:30 PM

PANEL FUTURE FORWARD: What’s broken and what’s working when deploying technology in clinical trials

• Current state of affairs in clinical trials technology
• Understanding what is really working
• Deploying technology for informed consent ePro, wearable sensors for remote patient monitoring
• Sharing best practice and case studies from across the sector

Speakers

Allyson Gunsallus
Associate Director, Clinical Outsourcing, BridgeBio
Amy Finnigan
Head of IT R&D, Ultragenyx Pharmaceutical
Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData

2:15 PM

Tech Showcase – Achieve data transparency with elluminate

Learn how the elluminate Clinical Data Cloud provides seamless access to comprehensive trial data across systems and sources with a centralized data workbench. Gain real-time access to data for optimized oversight, and leverage AI/ML capabilities to ensure data quality and improve productivity. See how you can mitigate risk with ease and increase automation with comprehensive analytics and custom visualizations.

Speakers

Dan McGann
Solutions Consultant, eClinical Solutions

2:30 PM

Tech Showcase – Navigating Change: Streamlining Clinical Trials with Smart Vendor Practices

In an era where the clinical trial landscape is rapidly transforming, the critical need for embracing cutting-edge technologies to alleviate the burdens of vendor qualification and oversight cannot be overstated. This session will unravel the benefits of fostering innovation in a heavily regulated industry and show how a data driven approach provides diligence, faster vendor onboarding and better compliance, optimizing drug development, plus enhancing patient access and care.

Speakers

Anthea Dransfield
Head of Quality, Diligent Pharma

2:45 PM

Clinical Trials Budgeting & Forecasting: 7 Key Areas of Focus (that should be “givens”!)

  • Multi-Variables
  • Outsourcing
  • PTS (Probability of Technical Success)
  • FTE (Full-Time Equivalent) Rate
  • Accruals
  • Change
  • Exuberance

Speakers

Chris Chan
Vice President, FP&A, IGM Biosciences

3:15 PM

Afternoon Refreshments, Networking & Apple Prize Draw in Exhibit Hall

3:45 PM

Globalization of Clinical Trials from a Medical Device companies’ perspective

  • Globalization and desire to look to run clinical studies in other countries outside USA
  • How different notified bodies and their regulations presents challenges to our clinical execution strategies

Speakers

Ted Chun
Director, Global Clinical Shared Services at Stryker Neurovascular

4:15 PM

PANEL DISCUSSION – Focusing on today’s Innovation & Technological Advancements

  • Are we making the most of Technology & Innovation in the Clinical Trial space?
  • How are these tools being utilised?
  • What’s next?
  • Considering the use of AI in healthcare & Clinical Trials

Speakers

Priya Ryali
Director, Head of Clinical Operations, ReCode
Rebecca Lin
Chief Strategy Officer, Potrero
Anca Copaescu
Chief Executive Officer, Strategikon Pharma
Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData

Streams

Stream one

Outsourcing & Clinical Operations

Stream two

Clinical Innovation & Technology

Stream three

Medical Device

8:30 AM

Registration and Refreshments

9 AM

Building CRO Relationships. What are the critical factors to consider when procuring from a CRO?

• Establishing common ground with your CRO
• Ascertaining the critical factors to think about when you collaborate with a CRO
• Exploring how the concept of Co-development between Pharma & CRO is working best
• Overcoming the differences between Pharma & CRO business models to work in harmony
• Underlining the factors which could be limiting what choice you make?
Considering the benefit of CRO’s adding a Small biotech division with personalized service to ensure all are valued

Speakers

Jasmina Jankicevic
Clinical Development, RAPT Therapeutics, Inc.

9:30 AM

Clinical Pharmacology at Scale to Reduce Risk and Increase Precision

  • Complexity in early phase clinical drug development has increased massively as more intricate biologic targets and novel therapeutic modalities are pursued, and demand for earlier insights into pharmacodynamics continues to drive more complex trial design
  • The traditional model of fully executing early clinical development within the four walls of a clinical pharmacology unit (CPU) is no longer fit for purpose; rather, an integrated platform is necessary that offers a network of CPUs combined with a site-agnostic project management function, robust medical, scientific and pharmacy capabilities, and a digital data platform that enables precision and speed.
  • Enhanced quality and precision can be ensured by leveraging methodology such as Failure Modes and Effects Analysis, which affords the opportunity to proactively identify and rectify areas of potential ambiguity or uncertainty within a study protocol.

Speakers

Oren Cohen
MD, Chief Medical Officer and President, Clinical Pharmacology Services, Fortrea Inc.

10 AM

Design Concepts in effective product development and clinical outcomes – Expert Lessons

• Concept Target Product Profile (TPP)
• Design of Product and Testing Methodology
• Product Design and Clinical Outcomes

Speakers

Dr. Ramachandran “TR” Thirucote
Chairman & CEO, TesoRx Pharma

10:30 AM

Morning Refreshments & Networking

11:15 AM

Strategies for Efficient Outsourcing of Clinical Trial Applications in Europe

Sponsors applying for CTAs in the EU must select a proficient vendor and optimize their processes, strategies, and workflows to successfully navigate EU CTR 536/2014. Compliance with CTR necessitates integration across teams like Regulatory, Medical Writing, Transparency, and Project Management, and/or engaging a qualified vendor for coordinating with CROs. CTR's emphasis on transparency mandates sponsors to exercise additional care and caution in preparing transparent documents. Establishing a governance strategy and executing this strategy consistently during and after submission is crucial. Our presentation will focus on enhancing processes, fostering cross-collaboration for CTIS, building a dream CTIS team, and sharing lessons learned from supporting CTIS submissions.

Speakers

Swathi Pandhiti
Associate Director, Regulatory Operations, Regulatory Affairs, MMS Holdings

11:45 AM

Ensuring Adequate Sponsor Oversight Of Clinical Trials When Outsourced To Clinical Contract Research Organisations

This presentation will highlight.

  • Ensuring that KPIs are informative and meaningful.
  • Assessing overall project risk and appropriate surveillance tactics
  • Consolidating your overall management strategy that can be coordinated with CRO SOPs
  • Providing documentation of Sponsor oversight activities throughout the study

Speakers

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

12:15 PM

Shining a Light on Imaging Vendor Selection:  What’s Really Important?

  • When should you shop for an imaging vendor?
  • What to include in an RFI for imaging vendors
  • Common clinops/outsourcing errors when selecting an imaging vendor
  • Three vendor processes that directly impact the quality of your imaging results

Speakers

Rick Patt, MD
Co-founder and Director of Medical and Scientific Affairs, RadMD

12:45 PM

Networking Lunch

1:45 PM

Is it me or them? Navigating Professional Relationships in Clinical Trials How do you build strong relationships and navigate difficult ones with critical trial contributors?

  • It starts with internal relationships
  • Don’t forget to think about everyone
  • Maybe they just don’t like you, now what?

This is a brief presentation on cultivating meaningful relationships with your team, your vendors, and your sites, followed by time for open discussion. If you had, or are having, difficulty communicating with a specific trial contributor (internal, site, patient - anyone!), let’s talk about it together. Feel free to bring an example from your professional experience.

Speakers

Carleen Tabari
Clinical Operations Lead, Gravitas Medical

2:15 PM

PANEL DISCUSSION Diversity & Inclusion in Clinical Trials

  • Diversity in clinical trials; Definitions and The Why
  • Critical barriers in recruiting and retention
  • Action for increasing diversity
  • Regulatory Updates

Speakers

Kim Erby
Director Clinical Operations, Cytokinetics
Shalini Mohan
Executive Director, Head of Health Equity and Inclusive Research (HEIR), US Medical Affairs, Genentech
Edward Kuczynski
Director, Human Research Protection Program, UCSF
Guinevere (Gwen) Valencia
Associate Director, Global Patient Advocacy, argenx

3 PM

Afternoon Refreshments, Networking & Prize Draw in Exhibition Room

3:30 PM

Speaker Hosted Roundtables

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. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.
Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables.

RT 1
Managing the workload of a small biotech with limited resources
Ghesal Razag, Sr. Director, GI Clinical Operations, Biora Therapeutics
RT 2
Leveraging global trial footprint to accelerate clinical development
Priya Ryali, Director, Head of Clinical Operations, ReCode
RT 3
Deciding between outsourcing clinical studies versus managing them in house
Anitha Achyutha, Director, Clinical Research (Farapulse PFA), Electrophysiology, Boston Scientific

RT 4
Finding the right time to seek strategic investments for medical device startups
Melanie Crystal, Clinical Director, Medtronic Endoscopy, Medtronic

Speakers

Ghesal Razag
Sr. Director, GI Clinical Operations, Biora Therapeutics
Priya Ryali
Director, Head of Clinical Operations, ReCode
Anitha Achyutha
Director, Clinical Research (Farapulse PFA), Electrophysiology, Boston Scientific
Melanie Crystal
Clinical Director, Medtronic

4:30 PM

Close of Conference

8:30 AM

Registration and Refreshments

Chair : Rebecca Lin, Chief Strategy Officer, Potrero Medical

Speakers

Rebecca Lin
Chief Strategy Officer, Potrero

9 AM

Opening keynote: Navigating the importation landscape for medical devices to gain and maintain competitiveness in a global market

  • What industry should provide to a vendor to be able to import medical device
  • Understanding and avoiding medical device importation errors
  • Detained medical devices: How to overcome the violation to get product into commerce

Speakers

Gordon Chu
Director of Investigations Branch, FDA
Sylvia Thomas
Supervisor Consumer Safety Officer, FDA

9:30 AM

Improving Interactions with Regulatory Agencies: The Importance of Pre-Submission Meetings

• Why collaboration with regulatories must remain paramount in the approval process for medical devices
• Practical look at pre-submission meeting requirements with regulatory agencies
• Knowing the expectations and aligning with the FDA for successful IDE approval

Speakers

Laura Moffett
Director of Clinical & Regulatory Affairs, VDyne, Inc.

10 AM

Designing trials to demonstrate clinical efficacies while preparing for commercialization

• How to interpret preliminary data in order to choose an appropriate trial design
• Effectively assessing trial design to minimize risks and maximize benefits
• Incorporating best practice in trial design to increase chances of success

Speakers

Laura Yecies
CEO and Board Member, Bone Health Technologies

10:30 AM

Morning Refreshments & Networking

11:15 AM

Implementing a Recruitment Lead to Address Patient Recruitment Struggles in Medical Device Studies

  • Discuss the current landscape and need for inventive patient recruitment strategies for clinical studies
  • The role, responsibilities, and impact of implementing a Recruitment Lead
  • Case studies: How a Recruitment Lead helped meet enrollment goals on a neuro device study / neuro therapeutic study

Speakers

Heidi Boehm
RN, BSN, Senior Director, Program Delivery, MedTech Premier Research

11:45 AM

Collaborating With Digital Innovation: Data Security And Governance Under A New Age Of AI

  • Trends, opportunities, and challenges from AI
  • Finding the right balance between protecting data and enabling innovation
  • Preparing medical device applications amidst geopolitical changes and managing evolving cyber and privacy laws
  • Establishing long term foundations under cost control

Speakers

Dr Bill Chen
CISO, Natera

12:15 PM

Levelling up CRO partnerships for medical device companies so that both sides win

  • Being more strategic with CRO partnerships and knowing what it means to be a true partner
  • Case study: What it looks like to not be strategic
  • Why CRO flexibility and ability to customize is mission critical for sponsors
  • Ensuring alignment of incentives to avoid delays in trial execution

Speakers

Melanie Crystal
Clinical Director, Medtronic

12:45 PM

Networking Lunch

1:45 PM

Non-significant risk device studies: Designing pivotal studies for medical device approval in the US

  • Understand how to identify and categorize the type of medical device you are evaluating
  • Collaborate with different stakeholders for alignment
  • Design a clinical study that fits the needs for the medical device regulatory approval

Speakers

Dorothy H. Kwok
Head of Clinical Operations, Bodyport

2:15 PM

PANEL DISCUSSION Sharing best practice for improving patient enrolment and engagement for successful medical device clinical trials

• How to expedite enrolment through interface with the sites in medical device studies
• Collaborating with patients to ensure patient-centric clinical trials and improved engagement
• Getting enrolment interest back to where it was before the pandemic
• Incorporating hybrid decentralized trials as a potential solution to decreased patient enrolment
• Understanding how much patients value the human touch to tend to their needs better
• Improving site engagement techniques

 

Moderator: Rebecca Lin, Chief Strategy Officer, Potrero Medical

Panelists:

  • Dr. Sanjay Shrivastava, CEO, Innova Vascular, Inc.
  • Anitha Achyutha, Director, Clinical Research (Farapulse PFA), Electrophysiology, Boston Scientific
  • Dr Bill Chen, CISO, Natera

 

Speakers

Dr. Sanjay Shrivastava
CEO, Innova Vascular, Inc
Anitha Achyutha
Director, Clinical Research (Farapulse PFA), Electrophysiology, Boston Scientific
Dr Bill Chen
CISO, Natera
Rebecca Lin
Chief Strategy Officer, Potrero

3 PM

Afternoon Refreshments, Networking & Prize Draw in Exhibition Room

8:30 AM

Registration and Refreshments

9 AM

Fireside Chat: How to establish a fit for growth model for young biotech company

Partnering with patients/caregivers, sites, and CROs/vendors to reduce site and patient burden through strong partnerships.

  • Prioritizing the patient voice when designing the clinical trial
  • Supporting sites with white glove service through a FSP model
  • Defining gaps within the young biotech company and identifying CROs/vendors that fill those gaps
  • Throughout the trial’s lifecycle examining what is going well & what could be improved

Speakers

Susan Owen
Vice President, Clinical Operations, Pliant Therapeutics
Vinita Bhatt
Associate Director, Clinical Operations Maze Therapeutics, Inc.

9:30 AM

Charting a Course through Complexity: Leveraging Experience in Approaching Complex Clinical Trial Protocols

The landscape of clinical trials has undergone a remarkable transformation with the introduction of eClinical solutions, fundamentally reshaping day-to-day processes from traditional approaches. Automation and the integration of cutting-edge technologies are now the standard for clinical trial teams. However, amidst these advancements, the core requirements and understanding essential for running successful clinical trials remain steadfast. Experience emerges as the primary predictor of success – experience with protocol designs, study team and site expectations, and best standard practices.

Join Kathleen Greenough, an industry veteran with over 20 years of experience, as she delves into the intricate distinctions involved in delivering these sophisticated solutions and why experience is critical. Discover how mastery of these crucial elements can be the key to achieving the successful implementation of technology solutions supporting modern clinical trials. Don't miss this opportunity to explore the perfect blend of cutting-edge technology and invaluable experience that can revolutionize the future of clinical trials.

 

Speakers

Kathleen Greenough
VP, Marketing & Commercial Operations , 4G Clinical

10 AM

FIRESIDE CHAT Decentralised Clinical Trials; a discussion on modernising clinical trials whilst minimising site burden

Perspectives from Sponsors & Sites; How to implement DCT’s, addressing the challenges and lessons learnt, sharing best practice.

Moderator: Jane Myles, Program Director, Decentralized Trials & Research Alliance (DTRA)
Panellists: Shalini Mohan, Head, Health Equity and Inclusive Research, Genentech
Kimberly Barnholt, Executive Director, Evidence Generation, Genentech

Speakers

Jane Myles
Program Director, Decentralized Trials & Research Alliance (DTRA)
Shalini Mohan
Executive Director, Head of Health Equity and Inclusive Research (HEIR), US Medical Affairs, Genentech
Kimberly Barnholt
Executive Director, Evidence Generation, Genentech, Roche Group

10:30 AM

Morning Refreshments & Networking

11:15 AM

The Importance of Real-Time Forecasting in Clinical Trials

  • Review the challenges of forecasting clinical trial costs and the impact on cash flow.
  • Understand how a data-driven and automated approach can produce more accurate forecasts quickly.
  • Learn how you can apply these methodologies.

Speakers

Jim DiCesare
Senior Director, Study Operations, Clinical Trial Payments IQVIA Technologies

11:45 AM

Assessing The Clinical Trial Landscape of Precision and Personalized Medicine, Twenty-Five Years On

This presentation will highlight:

  • How the clinical trial landscape of precision and personalized medicine (PPM) has evolved twenty-five years since the public was introduced to the term ‘personalized medicine’.
  • The competitive landscape of precision and personalized medicine in the West Coast and globally. Highlighting the top industry sponsors, prominent CROS, non-industry sponsors, regions and countries leading the way.
  • The research landscape of PMM included the top therapy areas, indications, and notable characteristics of clinical trials for marketed PPM drugs.
  • Discussing the use of virtual components within PPM studies.
  • Feasibility analysis comparing project timelines for a PPM study compared to a small molecule study.

 

Speakers

12:15 PM

Digitalization in clinical trials, a 360 view

• Presenting on how to digitalize clinical trials in e.g. endpoints, and study designs
• Highlighting the possibilities that digital trials bring, whilst moving away from the common brick-and-mortar sites
• Discussing the rigorous standards and scientific integrity required by regulators, whether a regular brick-and-mortar trial or a digital trial
• How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more
• Major points to consider in designing digital trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind

Speakers

Sverre Bengtsson
Co-Founder, Viedoc

12:45 PM

Networking Lunch

1:45 PM

Which Approach to Invest in? With numerous emerging innovative solutions on the market, how are organisations assessing the right approach for the right trials?

  • What types of innovative approaches are trending?
  • How are organisations evaluating different approaches?
  • Establishing the best fit for your trial - how to optimize fit-for-purpose and fit-for-patient?
  • Underlining the risk between huge benefits and wasted time
  • Uncovering longevity: here one-minute and gone the next

Speakers

Kimberly Barnholt
Executive Director, Evidence Generation, Genentech, Roche Group

2:15 PM

INTERACTIVE SESSION WITH Q&A : How are today’s patients coping with modernized trials?

• A firsthand insight onto what it is like participating in a trial
• Which key things helped make my time simpler on a trial
• How even minor things from the protocol can have a huge impact on patients

Speakers

Catherine L. Caserza
RN, MS, MPH Director, Clinical Operations, Daiichi Sankyo

3 PM

Afternoon Refreshments, Networking & Prize Draw in Exhibition Room

Speakers

Select a speaker to learn more

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Robert J. Boland
MBA, Global Head of Digital Innovation R&D, Haleon

Currently, Robert is the Global Head of Digital Innovation at Haleon, where he overseas and manages the organization’s Digital Innovation and Technology Portfolio across Research & Development and Laboratory Technologies. Robert formerly was the Global head of Digital Data and Delivery at CSL Behring, and prior, Head Of Digital Health & Clinical Innovation at CGI, and Head of Data Strategy and Digital Connected Solutions at Johnson & Johnson. Robert is an industry thought leaders and lecturer, often speaking on Digital Innovation and Data Strategy, internationally.

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Christine Von Raesfeld
Founder and CEO, People with Empathy

Christine Von Raesfeld (she/her), founder and CEO of People with Empathy (PwE), is a pillar of patient advocacy and allyship in the rare and chronic disease community. Through the lens of her lived experiences in health care, she has become a champion for patient voices, diversity and inclusion in clinical research, and equitable patient–sponsor partnerships.

Christine has brought her unique perspective and honed expertise as a featured speaker for numerous conferences on topics ranging from clinical trial recruitment to data and digital rights, from a true patient perspective. She serves as an e-patient scholar with Stanford Medicine X and a Technical Expert Panelist with the Centers for Medicare & Medicaid Services (CMS), among other roles. Wherever possible, Christine generates momentum toward progress around her patient advocacy interests, and she has become a thought leader worldwide, stimulating dialog on a range of topics relevant to patients, clinicians, and industry as moderator and host of People with Empathy: The Inside Track on Clubhouse.

Session Details:

PANEL Patient centricity: What does patient centric clinical trial development look like in 2024?

2024-02-06, 1:30 PM

Session Details:

The Patient’s Perspective: ‘Why are patient’s voices so important in drug development?

2024-02-06, 11:30 AM

Session Details:

FIRESIDE CHAT Have you developed an understanding of the patient journey as part of your clinical trial design? Bringing the patient’s practical perspective to your trial operations especially for rare disease indications

2024-02-06, 2:45 PM

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Archana Sah
Oncology Board Member, Society for Clinical Research Sites

Archan Sah is a clinical development thought leader with extensive (30 years) experience and passion for developing medicines for patients having led and contributed to 15 FDA/EMEA drug approvals in Oncology, Immuno-Oncology, Precision Therapeutics, Rare Diseases, Metabolic Diseases and Women's Health. She has held various global positions at Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON Clinical Research, two Oncology biotech start up companies and Medable- a leading technology platform provider. She is now an independent strategy consultant and Board Advisor provides strategic advisory services in clinical development and operations as well as on leveraging innovative patient centered digital health technologies in a fit for purpose approach to improve diversity, access and efficiencies within the healthcare ecosystem. She has been honored as Top20 women in immuno oncology drug development (2020) and featured in PharmaFEATURES (May 2022) on Oncology drug development and Digital Health technology.

She is a recognized leader/change agent leading industry collaborations and has been the co-founding chair and currently a member of Society for Clinical Research Sites Oncology Board and chaired the annual Oncology Summits. She is a past member of the Leadership Council for Decentralized Trials and Research Alliance and Digital Innovation in Oncology Roundtable with DiMe. She serves as an Advisor to American Cancer Society Cancer Action Network and has contributed to the clinical trial sites Standardization and Harmonization with the Forum on Drug Discovery and Development, National Academy of Sciences.

Session Details:

State of Affairs on Excellence in Clinical Development

2024-02-06, 10:30 AM

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Gabriel Luciano
Vice President, Clinical Operations, Corvus Pharmaceuticals Inc.

Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. He was Senior Director of Clinical Operations at Pharmacyclics from 2012 to 2017 where he was responsible for the development, implementation and maintenance of the Clinical Operations infrastructure, as well as the GCP inspection hosting platform and processes, and regulatory authority marketing approval inspection hosting. From 2008 to 2011, he was Senior Clinical Trial Manager at Seattle Genetics where he was responsible for the oversight of multiple oncology clinical trials, as well as support for the development of the Clinical Operations infrastructure and regulatory authority marketing approval inspection hosting. From 1990 to 2008 he held various Clinical Operations positions at Abgenix, Pharmacyclics, Quintiles, Covance and Syntex. Mr. Luciano earned a B.A. in Psychology and Biology from the University of California at Santa Cruz.

Session Details:

Smart CRO Contracting: A Start-Up Company Perspective

2024-02-06, 11:30 AM

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Jasmina Jankicevic
Clinical Development, RAPT Therapeutics, Inc.

Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. She has led clinical development in dermatology and medical aesthetics for pharma/biotech, CROs, medical device and cosmetic companies including RAPT, Innovaderm, Premier Research, Allergan, Leo Pharma, and Murad. She has driven program strategy and planning, including implementation of 300+ clinical study protocols in 25+ indications, by leading global cross-functional teams towards successful regulatory submissions, product launches, and innovative lifecycle management. As an international key opinion leader in dermatology clinical development, Dr. Jankicevic has served as advisor to multiple companies on their path to global regulatory and commercial success. Dr Jankicevic holds Doctor of Medicine degree, Master of Medical Sciences degree, and Board-certification in Dermatology and Venereology from the University of Belgrade, Serbia. She holds medical license issued by Serbian Medical Chamber. She is also a Certified Clinical Research Professional, and a trained journalist. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals.

Session Details:

PANEL Maximising your Sites Productivity & how to lessen the burden

2024-02-06, 1:30 PM

Session Details:

Building CRO Relationships. What are the critical factors to consider when procuring from a CRO?

2024-02-07, 9:00 AM

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Harman Hansra
Sr. Director, Global Clinical Ops, Annexon Biosciences

Session Details:

PANEL Maximising your Sites Productivity & how to lessen the burden

2024-02-06, 1:30 PM

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Amy Finnigan
Head of IT R&D, Ultragenyx Pharmaceutical

Amy Finnigan is a seasoned Business Relationship Manager in the pharmaceutical industry with a passion for leveraging technology to drive innovation and growth. With a solid foundation in life sciences technology consulting, she specializes in crafting and executing large-scale technology strategies, implementations, and services for organizations in the pharmaceutical sector. She holds a degree in International Health from Georgetown University, and began her career journey in clinical research at the University of Chicago Department of Endocrinology. Over the past decade, Mrs. Finnigan has had the privilege of consulting with diverse organizations before taking on her current role at Ultragenyx. At Ultragenyx Pharmaceutical, Mrs. Finnigan is dedicated to driving innovation and transformation, ensuring that technology aligns seamlessly with the company's mission to improve the lives of patients with rare and ultra-rare diseases.

Session Details:

PANEL FUTURE FORWARD: What’s broken and what’s working when deploying technology in clinical trials

2024-02-06, 1:30 PM

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Scott McCulloch
Executive Director, Global Clinical Quality & Pharmacovigilance, Recode Therapeutics

Session Details:

Trial Execution Excellence for small & medium biotechnology companies

2024-02-06, 2:45 PM

Session Details:

PANEL DISCUSSION Outsourcing Strategies: how do you approach your outsourcing strategy?

2024-02-06, 4:15 PM

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Edward Kuczynski
Director, Human Research Protection Program, UCSF

Edward joined the UCSF Office of Research as its Director of the Human Research Protection Program (HRPP) in May 2020. In this role, he oversees the UCSF HRPP, which is comprised of the Institutional Review Board (IRB) and its committees, the Quality Improvement Unit, and the Human Gamete, Embryo and Stem Cell Research (GESCR) Committee. Edward has a background in strategic planning and business plan implementation for clinical research activities; experience building and directing clinical and research programs at Academic Medical Centers; and familiarity with creating de novo core clinical research support services. He has served as co-investigator on the NIH Clinical Network for Contraceptive Research grant, clinical site investigator for an NIH-funded grant studying Antiphospholipid Pregnancy Loss, and co-investigator on a March of Dimes program grant on risk factors for prematurity. More recently, Edward was a Strategic Advisor for Clinical and Translational Research Programs at the Stanford University Center for Clinical & Translational Research & Education. He has also served as the Director of Clinical Research Operations for the Tufts Clinical and Translational Science Institute, a consult lead for the Johns Hopkins University/Tufts University Trial Innovation Center, as well as an Assistant Professor in the Department of Medicine at Tufts University School of Medicine.

Session Details:

PANEL DISCUSSION Diversity & Inclusion in Clinical Trials

2024-02-07, 2:15 PM

Session Details:

Expanded Responsibilities for IRBs when Reviewing AI Protocols

2024-02-06, 10:30 AM

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Allyson Gunsallus
Associate Director, BridgeBio
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Dr. Ramachandran “TR” Thirucote
Chairman & CEO, TesoRx Pharma

Dr. Ramachandran “TR” Thirucote is a founding Chair and CEO of TesoRx Pharma, LLC and its affiliate, LIPAC Oncology, Inc., clinical stage companies that are focused on delivering innovative, optimized therapies in areas of unmet medical needs.  Each of the companies leverage a novel drug delivery platform technology to target a range of treatments including  urology and oncology.  TR has several decades of experience in the design, development and launch of innovative therapeutics and dosage forms covering all dosage forms such as solid orals, parenteral and topicals.  At Roxro Pharma, LLC, a leading edge virtual pharma company model, TR was instrumental is design development and NBA launch of SprixTM, a novel nasal spray drug-device combination for a non-opioid for post-operative surgical pain.  At SRI International (formerly Stanford Research Institute), TR pioneered a contract pharma model (CRO), that encompassed government contracts with commercial pharma product development, setting the table for the successful establishment of several start up biotech and pharma companies across the country. He was also very successful as a PI and helped establish ongoing contracts with NIH affiliated institutes such as NIAID and NCI. At Agouron Pharma (now Pfizer), TR led the oncology portfolio development, moving the company’s first lead molecule in to clinical trials. As a scientist at Thermedics (now a division of Thermo Fischer Scientific), TR was responsible for the development of a novel polymeric wound dressing under a DOD contract, advised by Dr. R. Langer (MIT).

Session Details:

Design Concepts in effective product development and clinical outcomes – Expert Lessons

2024-02-07, 10:00 AM

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Marta Schumacher
Executive Director, Head of Global Clinical Operations, Annexon Biosciences

Marta Schumacher joined Annexon,Inc. in 2019 and currently serves as Head of Clinical Operations (Executive Director) with a team dedicated to executing global clinical trials. She was VP of Clinical Operations at BioPharmX from 2017 to 2019 where she was responsible for building and leading the clinical operations department. From  1999 to 2017 she held various Clinical Operations positions at Roche, Corgentech, BN Immunotherapeutic, Inclin and Genentech. Marta earned a B.A. in Genetics from the University of California at Berkeley and an M.B.A at Golden Gate University.

Session Details:

PANEL Maximising your Sites Productivity & how to lessen the burden

2024-02-06, 1:30 PM

Session Details:

FIRESIDE CHAT Have you developed an understanding of the patient journey as part of your clinical trial design? Bringing the patient’s practical perspective to your trial operations especially for rare disease indications

2024-02-06, 2:45 PM

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Ghesal Razag
Sr. Director, GI Clinical Operations, Biora Therapeutics

Ghesal Razag is currently Sr. Director of Clinical Operations at Biora Therapeutics, Inc. focused on drug/device combination product development in gastrointestinal diseases. She has over 20 years of experience in the pharmaceutical industry and has worked in different therapeutic areas, including gastrointestinal, rare disease, ophthalmology, and oncology. Ghesal earned a B.A. from the University of California Los Angeles.

Session Details:

Speaker Hosted Roundtables

2024-02-07, 3:30 PM

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Dave Borbas
Research VP, Head of Data Management, Abcuro

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

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

Session Details:

Great expectations and how to meet them – connected devices and ePRO in clinical trials

2024-02-06, 11:30 AM

Session Details:

PANEL DISCUSSION Outsourcing Strategies: how do you approach your outsourcing strategy?

2024-02-06, 4:15 PM

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Bruce Morimoto
Vice President, Drug Development, Alto Neuroscience

Dr Morimoto has over 25 years of industry experience in leading project teams in the development of innovative medicines, providing guidance in the design and execution of preclinical, clinical and regulatory strategies with a therapeutic focus in Parkinson’s, Alzheimer’s and frontotemporal dementias.  Previously, Bruce held leadership roles at Alkahest, Celerion and Allon Therapeutics, and works closely with the Michael J Fox Foundation, chairing one of their scientific review panels.  He is an advisor to several biotech companies.

Bruce started his career on the faculty in the Chemistry Department at Purdue University where his independent research focused on neuronal signal transduction.  Bruce earned his doctorate in biochemistry from UCLA and completed a postdoctoral fellowship at the University of California Berkeley.

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Shalini Mohan
Executive Director, Head of Health Equity and Inclusive Research (HEIR), US Medical Affairs, Genentech

Dr. Shalini Mohan joined Genentech in 2015 in Global Safety Science in which she was responsible for the pharmacovigilance for multiple molecules and supported late stage clinical trials, one of which led to the filing and approval of tocilizumab for giant cell arteritis. Shalini currently leads a team focused on advancing health equity through inclusive research and supporting access to trials and healthcare for underserved populations in the US. She conducted the largest randomized placebo-controlled trial for COVID-19 pneumonia and was successful in enrolling 85% historically underrepresented patients. This trial has become foundational for Genentech’s mission to be a leader in health equity research. Prior to Genentech Shalini was a Clinical Research Fellow in Oncology and Dermatology and a Postdoctoral Fellow at Stanford University. She has authored more than 25 peer-review publications and received multiple awards including the 2023 Genentech Professional BusinessWomen of California (PBWC) Industry Leader Award.

Session Details:

PANEL DISCUSSION Diversity & Inclusion in Clinical Trials

2024-02-07, 2:15 PM

Session Details:

FIRESIDE CHAT Decentralised Clinical Trials; a discussion on modernising clinical trials whilst minimising site burden

2024-02-07, 10:00 AM

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Melanie Crystal
Clinical Director, Medtronic

Experienced Clinical Director with a demonstrated history of working in the medtech and pharmaceuticals industry. Strong program and project management professional skilled in Clinical Research, Drug Development, Medical Devices, and Oncology.

Session Details:

Speaker Hosted Roundtables

2024-02-07, 3:30 PM

Session Details:

Levelling up CRO partnerships for medical device companies so that both sides win

2024-02-07, 12:15 PM

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Kimberly Barnholt
Executive Director, Evidence Generation, Genentech, Roche Group

Kimberly Barnholt has been a healthcare leader in various roles spanning from academic research, to disruptive start-up, to global pharmaceutical company. In all roles, she has focused on bridging science, data, and operational disciplines to challenge the status quo and transform how we can deliver more impact for our patients. At Genentech, she has served as a Program Leader for cross-industry collaborations and cross-R&D data ecosystem transformation. Currently, Dr. Barnholt is leading an Evidence Generation team of data strategists and clinical innovation and technology leaders to integrate new approaches to clinical trials.

Session Details:

Which Approach to Invest in? With numerous emerging innovative solutions on the market, how are organisations assessing the right approach for the right trials?

2024-02-07, 1:45 PM

Session Details:

FIRESIDE CHAT Decentralised Clinical Trials; a discussion on modernising clinical trials whilst minimising site burden

2024-02-07, 10:00 AM

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Kim Erby
Director Clinical Operations, Cytokinetics

Kim Erby is Director of Clinical Operations at Cytokinetics, Inc. where she oversees the Cardiovascular program for obstructive hypertrophic cardiomyopathy (oHCM) and other CV pipeline products.  Kim has been in the research industry for 25+ years and has worked in the areas of heart failure, hepatitis B and vaccine development, ophthalmology, and oncology.  She is passionate about conducting quality research while making a difference for patients and has been fortunate to see several products come to market from Phase 1 to FDA approval.  She grew up in Cincinnati, OH and has been living in the San Francisco Bay Area since graduating from Stanford University. 

Session Details:

PANEL DISCUSSION Diversity & Inclusion in Clinical Trials

2024-02-07, 2:15 PM

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Jane Myles
Program Director, Decentralized Trials & Research Alliance (DTRA)

Jane is a clinical research change agent with molecule development success in both global and start up biotechnology/ pharmaceutical companies. She have extensive experience leading global teams through changing business, technical, regulatory and competitive needs. Clinical Operations and DCT design /. execution is her expertise, from due diligence and protocol design through study conduct, regulatory submission and approval. In recent roles, she has lead teams to solve how technology can support clinical trial objectives and patient access. Technology, data assets and patient behaviors have evolved, and so has my focus. A passion for driving patient and site-friendly approaches to clinical trials, creating efficiency and speed along with a great customer experience. A unique strength in finding the fit between innovative solutions and development team needs.
My core competencies include:
• Innovation • Leadership • Patient-Centricity • Technology Scale and Deployment
• Project Management •Strategic Planning •Data-driven Execution
• Process Improvement • People Development •Building and Leading Teams

Session Details:

FIRESIDE CHAT Decentralised Clinical Trials; a discussion on modernising clinical trials whilst minimising site burden

2024-02-07, 10:00 AM

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Priya Ryali
Director, Head of Clinical Operations, ReCode

Priya Ryali, MBA, brings over 18+ years of experience in biopharmaceutical research and development. She is currently Head of Clinical Operations at ReCode Therapeutics focused on rare disease drug development in Primary Ciliary Dyskinesia and Cystic Fibrosis.

Previously she was Director of Clinical Operations at Alector, where she focused on leading the company's marquee program in Alzheimer's Disease. Before joining Alector, Priya worked on rare disease programs at Denali, in an early-phase neuro pediatric program for MPS II (Hunter Syndrome), at Ultragenyx, leading the company's Disease Monitoring Program for one of its first marketed products, and at Crysvita for treatment of XLH, a rare bone disease in pediatrics and adults. Priya began her work in clinical operations in Janssen Alzheimer's Immunotherapy and at Gilead, where she worked on late-phase HIV programs, including Biktarvy and Genvoya. She started in the industry doing bench research in early lead discovery at Amgen. Priya holds a BS in biotechnology from the University of California, Davis, and an MBA from Santa Clara University.

Session Details:

Speaker Hosted Roundtables

2024-02-07, 3:30 PM

Session Details:

PANEL DISCUSSION – Focusing on today’s Innovation & Technological Advancements

2024-02-06, 4:15 PM

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Rebecca Lin
Chief Strategy Officer, Potrero

Healthcare Leader | Global Growth Strategist | Educator | Keynote Speaker on AI and Innovation |
Top 25 Women Leaders in Medical Devices 2023

Rebecca Lin is a distinguished healthcare leader with a proven track record in formulating growth strategies for emerging businesses to achieve global success. Her exceptional expertise has earned her recognition as one of The Top 25 Women Leaders in Medical Devices of 2023.

Currently serving as the Chief Strategy Officer at Potrero, a cutting-edge MedTech AI innovation company based in the Bay Area, Rebecca's visionary leadership drives the company's growth and market expansion. Her strategic guidance has been instrumental in positioning Potrero as a trailblazer in the industry.

Rebecca's career encompasses leadership roles in both large corporations and startups, providing her with a dynamic perspective that empowers her to guide teams at different stages of growth and maturity. Her winning strategies have left a lasting impact on esteemed companies such as Johnson & Johnson, CR Bard (acquired by Becton Dickinson), and TheraNova, spanning across business development, marketing, sales, training, and clinical management.
Having operated in both US and international markets, Rebecca has cultivated a unique blend of business acumen and technical expertise. This combination enables her to effectively communicate with diverse audiences and establish key partnerships that scale businesses globally.

Beyond her corporate roles, Rebecca actively contributes to the healthcare community. She serves as an editorial board member at the Chinese Journal of Medical Instrumentation, where she helps shape the discourse in the medical device industry. Furthermore, Rebecca shares her vast knowledge and insights as a lecturer in the Master of Translational Medicine programs at UCSF and UC Berkeley, nurturing the next generation of healthcare innovators. As a keynote speaker on AI and Innovation, Rebecca inspires audiences with her commitment to advancing healthcare through innovation and strategic expertise. She continues to be a driving force in the industry, shaping the future of healthcare.

Rebecca is an alumna of Stanford Business School and holds a Masters in Marine Biology from Sun Yat-Sen University. Her publications include a chapter titled “Industry Perspectives and Commercial Opportunities of Artificial Intelligence in Medicine” in the book ARTIFICIAL INTELLIGENCE IN MEDICINE.

Session Details:

PANEL DISCUSSION – Focusing on today’s Innovation & Technological Advancements

2024-02-06, 4:15 PM

Session Details:

Registration and Refreshments

2024-02-07, 8:30 AM

Session Details:

PANEL DISCUSSION Sharing best practice for improving patient enrolment and engagement for successful medical device clinical trials

2024-02-07, 2:15 PM

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Dr Bill Chen
CISO, Natera

As the Chief Information Security Officer (CISO) at Natera, Dr. Bill Chen is responsible for managing an enterprise-wide cybersecurity program that encompasses strategic, governance, risk and compliance (GRC), data protection, product security, and privacy engineering. Prior to joining Natera, he held different executive and technical positions at VISA, Palo Alto Networks, Cisco, Microsoft, and Coupang. With over two decades of experience in cybersecurity, he is also a successful start-ups advisor, a public speaker, and an author with multiple publications and patents. In his spare time, he plays guitar and enjoys the outdoors.

Session Details:

PANEL DISCUSSION Sharing best practice for improving patient enrolment and engagement for successful medical device clinical trials

2024-02-07, 2:15 PM

Session Details:

Collaborating With Digital Innovation: Data Security And Governance Under A New Age Of AI

2024-02-07, 11:45 AM

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Laura Yecies
CEO and Board Member, Bone Health Technologies

Session Details:

Designing trials to demonstrate clinical efficacies while preparing for commercialization

2024-02-07, 10:00 AM

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Dr. Sanjay Shrivastava
CEO, Innova Vascular, Inc

Session Details:

PANEL DISCUSSION Sharing best practice for improving patient enrolment and engagement for successful medical device clinical trials

2024-02-07, 2:15 PM

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Anitha Achyutha
Director, Clinical Research (Farapulse PFA), Electrophysiology, Boston Scientific

Session Details:

Speaker Hosted Roundtables

2024-02-07, 3:30 PM

Session Details:

PANEL DISCUSSION Sharing best practice for improving patient enrolment and engagement for successful medical device clinical trials

2024-02-07, 2:15 PM

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Laura Moffett
Director of Clinical & Regulatory Affairs, VDyne, Inc.

Session Details:

Improving Interactions with Regulatory Agencies: The Importance of Pre-Submission Meetings

2024-02-07, 9:30 AM

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Dorothy H. Kwok
Head of Clinical Operations, Bodyport

Session Details:

Non-significant risk device studies: Designing pivotal studies for medical device approval in the US

2024-02-07, 1:45 PM

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Dr. Bryan Cornwall
Chief Scientist / FEED-Research

Bryan Cornwall, PhD, MBA, PEng is an Academic Scientist with 25+ years experience in the Medical Device Industry. Dr. Cornwall is adjunct faculty at the Surgical Orthopedic Research Laboratory (SORL) at the University of New South Wales (UNSW) and the Shiley-Marcos School of Engineering (SMSE) at the University of San Diego (USD); he is also principle of FEED-Research, a medical device consulting firm.

Bryan Cornwall’s most recent industry role was as Executive Vice President, Research and Clinical Affairs at Surgalign. The company had a global spine implant business and had the first US 510k cleared spine navigation system combining Augmented Reality for enhanced visualization and Artificial Intelligence (AI) for intraoperative spine anatomy recognition and autonomous pedicle screw planning. Dr. Cornwall has numerous publications including 25 peer-reviewed journal articles, 26 U.S. patents and eight book chapters.

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Chandramohan Thiruvamkulam
Director Quality Systems, Endologix
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Abby Kennedy
VP of Clinical Operations, CymaBay Therapeutics, Inc

Session Details:

Chairman’s Opening Remarks

2024-02-06, 8:20 AM

Session Details:

PANEL DISCUSSION Outsourcing Strategies: how do you approach your outsourcing strategy?

2024-02-06, 4:15 PM

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Chris Chan
Vice President, FP&A, IGM Biosciences

Session Details:

Clinical Trials Budgeting & Forecasting: 7 Key Areas of Focus (that should be “givens”!)

2024-02-06, 2:45 PM

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Shoaib Khan
Medical Director, Pfizer
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Catherine Caserza
Director, Clinical Operations, Daichii Sankyo
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Abdel Dridi
Global Head of Digital Healthcare Technologies (DHT), Personalized Healthcare, Product Development, Roche

Abdel Dridi is the Global Head for Digital Healthcare Technologies at Roche and Genentech. In his role he oversees the global deployment of digital health solutions in late stage, clinical studies and early concepts. He is passionate about creating connected, digital healthcare platforms, and smart medical devices drawing from his deep experience from technology leadership roles at technology companies and in product and service development at technology healthcare organizations.

Session Details:

Keynote The use of technology to accelerate early drug discovery and reduce the burden for patients

2024-02-06, 8:30 AM

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Oren Cohen
MD, Chief Medical Officer and President, Clinical Pharmacology Services, Fortrea Inc.

Oren Cohen, MD, is President of Clinical Pharmacology and Chief Medical Officer, partnering with biopharmaceutical companies to optimize early clinical development through excellence in study design and execution. He has served in this position since Fortrea’s launch as an independent company in July 2023 following its spinoff from Labcorp.

Following a decade of translational research at the U.S. National Institute of Allergy and Infectious Diseases under the mentorship of Anthony Fauci, MD, Oren has more than 20 years of experience in various medical and scientific executive leadership roles in the pharmaceutical industry. Most recently, Oren served as Chief Medical Officer and head of Clinical Pharmacology Services at Labcorp Drug Development since 2017. Prior to Labcorp, he was Chief Medical Officer at Viamet Pharmaceuticals, where he worked closely with clinical investigators and key opinion leaders to formulate and execute clinical development programs across a portfolio, developing and executing strategy and protocol designs. Previously, he held several senior medical and operational leadership positions at Quintiles, now part of IQVIA.

Oren received his MD from Duke University and served his internship and residency at The New York Hospital, Cornell Medical Center in New York City. He completed his infectious diseases fellowship at the National Institute of Allergy and Infectious Diseases (NIAID) and stayed on to become an investigator in the Laboratory of Immunoregulation. Oren is also Consulting Professor of Medicine at Duke University Medical Center, a member of the Board of Visitors for Duke University School of Medicine and a Fellow of the Infectious Diseases Society of America. His research has been published in journals including The New England Journal of Medicine, Science, Proceedings of the National Academy of SciencesNature Medicine and the Journal of Clinical Investigation.

Session Details:

Clinical Pharmacology at Scale to Reduce Risk and Increase Precision

2024-02-07, 9:30 AM

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Ashley Herrick, Ph.D.
Executive Director, Oncology Program Strategy, Premier Research

Dr. Ashley Herrick provides strategic planning, coordination, knowledge, and expertise for oncology projects. She has more than 14 years of experience in oncology clinical trial oversight and drug development. She has experience with all phases of clinical trials but has a keen interest and deep knowledge of early phase and first-in-man studies. She has led numerous global clinical trials and has experience with strategic management, study oversight, study start-up, efficient enrollment, and study close-out/CSR development.

Prior to joining Premier Research, Dr. Herrick was Director of Operational Strategy Management for a mid-sized CRO overseeing the strategic planning for studies. She also supported their Oncology Site Network and was responsible for oversight of a biomarker driven patient matching group. She has also served as Project Director, Project Manager, and CRA throughout her years working in the CRO industry and has devoted her entire career to Oncology research. Prior to joining the CRO industry, she worked as a Program Manager for largest Phase I clinical trial unit in the country at MD Anderson Cancer Center, where she was responsible for oversight of more than 50 industry sponsored and investigator led Phase I clinical trials.

Dr. Herrick holds a doctorate degree in molecular and cellular biology with a focus on hematologic malignancies from Baylor College of Medicine. She is CCRP certified and is a member of the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO). She is an active volunteer with the Leukemia and Lymphoma Society (LLS).

Session Details:

Mastering Dose Escalation Studies: Charting the Path from Planning to Execution

2024-02-06, 3:45 PM

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Swathi Pandhiti
Associate Director, Regulatory Operations, Regulatory Affairs, MMS Holdings

Swathi is an experienced and successful leader with over 12 years of Pharmaceutical, Biologics, and Medical Device experience specializing in submissions to global health authorities.   She has led large diverse teams to ensure regulatory submission success from investigational, marketing, and post-marketing submissions.   Swathi holds a Master of Science degree in Regulatory Affairs, as well as RA Certifications from RAPS in both the US and EU.  With a unique combination of Regulatory Affairs and submissions experience, she drives the teams with best practices for methodical planning, efficient development, and management of multi-country dossiers.

Session Details:

Strategies for Efficient Outsourcing of Clinical Trial Applications in Europe

2024-02-07, 11:15 AM

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Joonmi Oh
Vice President, Image Analysis and AI Governing, Clario

Joonmi has 15+ years of experience in medical imaging and its application to clinical research and clinical trials. She is leading quantitative analysis and QC department and governing AI on delivery and R&D at Clario. Her experience includes product development, imaging protocol design, image processing algorithm and operational imaging service development. Joonmi has a Ph.D. degree in Electronical Engineering from University of Birmingham, UK.

Session Details:

Artificial Intelligence-Enhanced medical imaging and documentation for Clinical Trials

2024-02-06, 11:00 AM

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Shyam Banuprakash
Senior Vice President, Data Science, Clario

Shyam has 15+ years of experience in data management and life sciences industry and has a strong expertise in data science and analysis. Shyam heads up the data science department for the Medical Imaging business segment of Clario. The department oversees design, collection, cleaning and standardization of medical imaging data; and creating analysis and AI models on clinical, operational, and financial data. His experience includes working for Janssen Alzheimer’s Immunotherapy and Medtronic. Shyam has a master’s in data science and engineering from UCSD. 

Session Details:

Artificial Intelligence-Enhanced medical imaging and documentation for Clinical Trials

2024-02-06, 11:00 AM

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Kristina Reeder
Director, Patient Engagement, Parexel

Kristina leads the Patient Insights team at Parexel and is dedicated to bringing a thorough understanding of the patient journey, and the patient voice to the entire spectrum of research services.  With over 20 years in  clinical research, including  patient  innovation, feasibility, strategy, patient recruitment, retention, site engagement 12 of those years have been at Parexel.  She is the lead on the diversity and inclusion team, and member of DTRA, CISCRP and other industry consortiums aimed at improving access to clinical research and providing clinical research as a care option.  With post doctoral research studies in Human Behavior she has a BS in Human and Organizational Behavior, and Communication Studies and authored numerous trade articles and frequently present on behalf of Parexel at trade conferences.  She is experienced in research methodologies and conducting qualitative and quantitative research in a variety of therapy areas including respiratory, cardiology, oncology, immunology rare diseases and emerging therapy areas.

Session Details:

Driving better outcomes with patient informed protocols

2024-02-06, 11:00 AM

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Patricia Anderson, ScM PStat®
Director, Biostatistics, ICON

Session Details:

Cell & Gene Therapy Long Term Follow Up & Future Directions: Leveraging AI, Real-World Evidence and Decentralization

2024-02-06, 9:30 AM

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Tammi Acord
Director, Strategic Solutions, YPrime

Tammi Acord serves as the Director of Strategic Solutions at YPrime, leveraging over two decades of expertise within the Life Sciences sector with roles in commercial (pharmaceutical & medical device), sponsor (pediatric ultra-rare), and vendor (technology) companies. With a proven track record, she excels in developing, leading, executing, and overseeing clinical development programs from inception to commercialization and drug launch. Tammi brings a unique perspective, having navigated the industry's intricacies across the entire lifecycle, offering valuable insights into the present and future landscape. Based in the vibrant SF/Bay Area, she holds a B.S. from the University of California, Davis.

Session Details:

Interactive Session Unveiling Polling Data to Drive Clinical Innovation

2024-02-06, 12:00 PM

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Dan McGann
Solutions Consultant, eClinical Solutions

As a Solutions Consultant with eClinical Solutions, Dan serves as a subject matter expert for the elluminate Clinical Data Cloud, the foundation of digital trials. Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs.

Session Details:

Tech Showcase – Achieve data transparency with elluminate

2024-02-06, 2:15 PM

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Anca Copaescu
Chief Executive Officer, Strategikon Pharma

Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. She is currently the Founder and CEO of Strategikon Pharma, developer of Clinical MaestroTM, the industry’s only end-to-end cloud-based platform for clinical trial budgeting, sourcing and budget management including strategic alliance/partnership management. Previously she served as Head of Clinical Outsourcing and Analytics for BioMarin Pharmaceuticals, where she was responsible for vendor contractual, relationship and financial management. She also had several leadership positions with PharmaNet Development Group (now Syneos Health), ICON Clinical Research and eMetagen Corporation.

Session Details:

PANEL DISCUSSION – Focusing on today’s Innovation & Technological Advancements

2024-02-06, 4:15 PM

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Stephanie Hitchcock
Associate Director of Project Management, PCM Trials

Stephanie Hitchcock is an Associate Director of Project Management at PCM Trials. Stephanie specializes in adapting trial designs for mobile visit services. She is passionate about expanding the use of high quality, patient-centric models to drive clinical development. Stephanie is an expert in establishing logistics and procedures on a global scale for complex visit schedules and expanding the scope of what mobile visits can support globally.

Session Details:

Do Mobile Nurse Visits Drive Faster Study Results?

2024-02-06, 2:15 PM

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Anthea Dransfield
Head of Quality, Diligent Pharma

Anthea has over 30 years of experience within operational and recruitment leadership for clinical sites, technical validation, analytical and manufacturing aspects of cGMP, and quality oversight spanning GxPs.  She advocates for risk-based, phase-appropriate approaches designed to enable compliance, and has a drive for process and attention to detail with a focus on using technology to ease the quality burden.

Session Details:

Tech Showcase – Navigating Change: Streamlining Clinical Trials with Smart Vendor Practices

2024-02-06, 2:30 PM

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Diana Filipescu
Business Development Manager, Novotech

Diana Filipescu is from Bucharest, România. Diana has a regulatory background, with 11 years of experience in clinical trials. She worked in Regulatory for almost 8 years and then transitioned from Regulatory Line Manager to Business Development Manager. She has earned two BSc., one in Management and the other one in Law. In addition, she also has a MSc. in Health Management. She is very passionate about finding new ways to improve the healthcare industry by ensuring compliance with all applicable laws and regulations. Her goal is to make sure that all medical products are safe for consumers.

Session Details:

Clinical Trial Information System (CTIS) Unveiled: Helping Biotech/Pharma to Streamline Regulatory processes in EU

2024-02-06, 12:00 PM

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Rick Patt, MD
Co-founder and Director of Medical and Scientific Affairs, RadMD

Dr. Patt is co-founder and principal of RadMD, and is an acknowledged expert in the field of applying medical imaging to new drug development.

He has numerous publications, has served on an NCI Advisory Panel, is a reviewer for major radiology journals, and has been an invited lecturer across the US and Europe on the use of medical imaging in clinical trials.

Dr Patt’s experience includes design and management of site and central reviews for over 500 oncology trials with a focus on early-phase efficiency for better decision-making.

Session Details:

Shining a Light on Imaging Vendor Selection:  What’s Really Important?

2024-02-07, 12:15 PM

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Carleen Tabari
Clinical Operations Lead, Gravitas Medical

Carleen joined Gravitas Medical as the Clinical Operations Lead in March 2023 after three years at Verily Life Sciences, where she quickly advanced from coordinator to Clinical Trial Manager for medical devices. She currently oversees all aspects of Clin Ops at Gravitas, including the conduct of multiple NIH-funded multisite studies.  Carleen also spearheaded Gravitas' receipt of two FDA Breakthrough Device Designations in 2023 for the Gravitas Feeding Tube System. Carleen regularly draws from her clinical and patient care experience as an EMT and Clinical Research Coordinator at Stanford to develop and operate efficient in-hospital studies. Carleen attended University of Washington, where she studied Medical Anthropology & Global Health and Spanish, and continues to be passionate about improving public health and addressing health disparities. In her freetime, Carleen is a Pure Barre instructor and enjoys traveling.

Session Details:

PANEL Maximising your Sites Productivity & how to lessen the burden

2024-02-06, 1:30 PM

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Is it me or them? Navigating Professional Relationships in Clinical Trials How do you build strong relationships and navigate difficult ones with critical trial contributors?

2024-02-07, 1:45 PM

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Session Details:

Assessing The Clinical Trial Landscape of Precision and Personalized Medicine, Twenty-Five Years On

2024-02-07, 11:45 AM

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Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData

Amanda Murphy is the Director of Product Management at GlobalData, a company that focuses on research, data analytics and consulting that provide actionable insight into the pharmaceutical and medical device sectors.  She has 10+ years of experience working in pharmaceutical data science and web platform development (including BioPharm Insight, Lead Sheet, and the Pharma Intelligence Center).  She has developed models and solutions to support Clinical Operations & Feasibility teams plan and optimize trials, including an e-feasibility questionnaire tool resulting in 4x faster response rates from sites.  Amanda also has many years of experience supporting business development at CROs through data-driven lead delivery and CRM integration solutions.

Session Details:

PANEL FUTURE FORWARD: What’s broken and what’s working when deploying technology in clinical trials

2024-02-06, 1:30 PM

Session Details:

PANEL DISCUSSION – Focusing on today’s Innovation & Technological Advancements

2024-02-06, 4:15 PM

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

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

Session Details:

Ensuring Adequate Sponsor Oversight Of Clinical Trials When Outsourced To Clinical Contract Research Organisations

2024-02-07, 11:45 AM

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Kathleen Greenough
VP, Marketing & Commercial Operations , 4G Clinical

Kathleen Greenough, Vice President of Marketing & Commercial Operations at 4G Clinical, has decades of experience in life sciences spanning Clinical Operations, Finance, and IT. Her wide range of solutions implementation expertise includes RTSM, CTMS, trial costing tools, OLAP financial suites and patient enrollment planning. Kathleen has also spent many years as a Clinical Financial Planner and Analyst at a major biotech in Cambridge, MA, gaining a broad and deep understanding of the challenges inherent in Clinical Development. Specializing in software adoption and a frequent speaker at industry conferences, Kathleen is most in her element when working within a user community to facilitate solutions that are insightful and truly helpful.

Session Details:

Charting a Course through Complexity: Leveraging Experience in Approaching Complex Clinical Trial Protocols

2024-02-07, 9:30 AM

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Gordon Chu
Director of Investigations Branch, FDA

Gordon Chu is the Director of Investigations Branch at the Food and Drug Administration (FDA) Division of West Coast Imports (DWCI) within the Office of Enforcement and Import Operations (OEIO).

In this role, Mr. Chu develops, manages, and evaluates inspectional matters for DWCI covering all FDA import activities associated with air and sea port operations in the States of Hawaii, California, Nevada, Oregon, and Washington. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. He works cooperatively and collaborates with Federal, State, and local agencies to ensure appropriate consumer protection.

Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. In 2010, he became a Supervisor Consumer Safety Officer (SCSO). As a supervisor, he had the opportunity to manage an Import Field Operation Team, an FDA team in the Centralized Examination Stations (CES), and the Los Angeles International Mail Facility. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018.

Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. He also served on multiple FDA Headquarter working group and committee related to Food Safety Modernization Act (FSMA), import process improvement, strategic framework, rapid screening technology, and partnership agreements. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine.

Session Details:

Opening keynote: Navigating the importation landscape for medical devices to gain and maintain competitiveness in a global market

2024-02-07, 9:00 AM

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Tim Akers
Managing Partner, Clinical Data Studio, Medidata Solutions

Tim Akers is a Subject Matter Expert at Medidata, focusing in Clinical Trial Innovation. His background surrounds various roles within the lifecycle of clinical research. He has vast experience as a monitor on multiple late stage trials primarily in Oncology. He also has experience as a Project manager in Early Clinical Development. During his time at a large CRO, he helped develop strategic Vendor Management initiatives focusing on controlling and improving how business is conducted with 3rd party vendors in an outsourced clinical trial.  Tim has unique experience as he transitioned to a commercially focused role, focused on helping biotech and mid-market customers graduate through IND enabling and into First in Human trials. During his time at Medidata, Tim has played a leadership role in the development of Medidata's vision for CTMS, eTMF,  and RBQM by helping clients redesign their Platform model and innovative approaches to Study team workflows. He now leads a team of SME's focused on Central Data aggregation, standardization, and analytics.

Session Details:

Solving the Clinical Data Challenge

2024-02-06, 9:00 AM

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Dan Braga
VP, Healthcare and EHR Solutions, Medidata

Dan Braga is the VP for medical imaging solutions at Medidata. Dan works with sponsors, CROs, core labs, and sites to adopt medical image technologies to help automate image acquisition, distribution, assessment, and data collection. Prior to Medidata, Dan was one of the co-founders of Intelemage, a medical image management and workflow company later acquired by Medidata. Prior to Intelemage, Dan worked in various product management, operational and sales roles with healthcare technology companies such as GE Healthcare, PocketScript, and WebMD.

Session Details:

PANEL Maximising your Sites Productivity & how to lessen the burden

2024-02-06, 1:30 PM

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Edward Triebell
Commercial Executive Director, MRN Technologies

Edward is the Executive Director of Digital Health at Medical Research Network (MRN) and leads their strategy on empowering the use of digital technology in MRN’s Decentralized Clinical Trials services.

Mr. Triebell has been on the forefront of disruptive innovations in the development and application of digital technology for companies in the telecommunications, software, and healthcare industries.  He started his career in design engineering and then transitioned into project engineering, program management, and sales eventually running global sales and marketing teams for technology focused enterprises, providing a wide lens on the requirements, development and launch of successful digital products and services.

For the past several years, Mr. Triebell has been involved in equity funded strategic roles.  His most recent role pivoted an Internet of Things (IoT) software platform into an eCOA solution for successful acquisition by a CRO.

Within the healthcare industry, Mr. Triebell has been involved with programs including a telemedicine network for the Mayo Clinic network of hospitals to accomplish remote diagnosis and surgical treatments with high resolution imaging/videos, RFID solutions for patient tracking within Emergency Departments as well as audited tracking of patient biological samples and outsourcing radiological contouring for cancer treatments using a joint venture with China’s leading Cancer hospital.

Mr. Triebell earned his bachelor’s degree in electrical engineering and completed graduate coursework for his dual master’s degree in electrical engineering/engineering management from Florida Institute of Technology.  He also completed an Executive Management program at the Wharton School of Business.

Session Details:

Expanding trial access through patient-centric solutions in the home & at the site

2024-02-06, 12:00 PM

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Caroline Potts, MSc
Health Sciences, MSc Healthcare and Design, MRN Site and Patient Services

General Manager – MRN Site and Patient Services, Medical Research Network

Caroline has worked for the MRN since 2018, her current role being General Manager for MRN Site and Patient Services.

Before joining MRN, Caroline worked in the public sector for 15 years supporting research in hospitals and the primary care setting as well as providing support to research academics by writing funding applications, making submissions to regulatory authorities and running a large portfolio of studies to ICH-GCP requirements in clinical specialties such as stroke medicine, Parkinson’s disease, orthopaedics, gastrointestinal medicine and respiratory medicine. During this time, Caroline was one of the founding members of the UKRD group as well as an Executive member of the RD Forum providing R&D Directors and research staff working in the public sector with strategic guidance in supporting high quality research in the NHS.

Session Details:

Expanding trial access through patient-centric solutions in the home & at the site

2024-02-06, 12:00 PM

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Jim DiCesare
Senior Director, Study Operations, Clinical Trial Payments IQVIA Technologies

Jim DiCesare is passionate about delivering innovative Cost Benchmarking, CTA Negotiation and Site Payment services that support clinical research conducted by sponsors and CROs. With over 25 years of industry experience leading clinical operations teams at Merck, DrugDev, and now IQVIA Technologies, Jim has expertise across the contracting, budgeting, and investigator grant payment management continuum. He is a frequent speaker at industry conferences and has written for a variety of publications. He has a B.S. in Accounting from Kutztown University.

Session Details:

The Importance of Real-Time Forecasting in Clinical Trials

2024-02-07, 11:15 AM

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Ted Chun
Director, Global Clinical Shared Services at Stryker Neurovascular

Session Details:

Globalization of Clinical Trials from a Medical Device companies’ perspective

2024-02-06, 3:45 PM

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Susan Owen
Vice President, Clinical Operations, Pliant Therapeutics

Susan Owen joined Pliant in June 2022 and brings over 20 years of clinical operations expertise across the areas of respiratory, oncology, cardiology and infectious diseases. Prior to Pliant, she most recently held the role of Executive Director and Head of Clinical Operations at Apexigen where she oversaw the company’s immuno-oncology portfolio. Prior to this, she held clinical operations roles at Cytokinetics, Genentech and InterMune where she managed the conduct of trials including Phase 2/ 3 clinical development respiratory program.

Ms. Owen received a B.A. in biological sciences from Smith College and a M.S. in epidemiology from the University of Massachusetts at Amherst’s School of Public Health and Health Sciences.

Session Details:

Fireside Chat: How to establish a fit for growth model for young biotech company

2024-02-07, 9:00 AM

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Guinevere (Gwen) Valencia
Associate Director, Global Patient Advocacy, argenx

Guinevere (Gwen) Valencia began her career in healthcare while completing her graduate degree in Global Health Sciences at the University of California, San Francisco (UCSF). While at UCSF, she worked on numerous maternal health research projects within the Bay Area and Guatemala, partnering with the Bill and Melinda Gates Foundation.

From there, she started her journey within the pharmaceutical industry, where her previous roles centered around community engagement, advocacy, clinical education, and clinical operations. Her focus has always been to highlight the patient experience to reach the true needs of the patients we serve through drug development. In her most recent role, she helped lead Takeda's strategic vision for increasing the diversity of the company's clinical trial programs by fostering partnerships & implementing strategies focused on education, awareness, and access.

Gwen is an alumna of Johns Hopkins University, where she graduated with a double major in Political Science and Latin American Studies. Her passion in this field revolves around her belief that pharmaceutical companies are well-positioned to advance health equity and realize better patient outcomes.

A native of Phoenix, Arizona, but with family roots in Ecuador, she enjoys outdoor activities, yoga, mindfulness, dancing, traveling to new places, and spending time with her loved ones. She currently resides in San Francisco with her family.

Session Details:

Diverse and Equitable Participation in Clinical Trials (DEPICT) Act

2024-02-06, 10:30 AM

Session Details:

PANEL DISCUSSION Diversity & Inclusion in Clinical Trials

2024-02-07, 2:15 PM

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Mario Esquivel
Director of Clinical Affairs, RefleXion Medical
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Heidi Boehm
RN, BSN, Senior Director, Program Delivery, MedTech Premier Research

Heidi Boehm, RN, BSN Senior Director, Program Delivery, MedTech – Based in the US, Heidi Boehm joined Premier Research in 2021 and currently functions as operational support for therapeutically aligned programs including client engagement and cross functional management. Prior to joining Premier Research, Heidi worked under two large CROs, where she gained extensive knowledge in global study delivery with an emphasis on medical device and diagnostics. Heidi offers more than 25 years of CRO, academic, site management, and nursing experience with extensive experience in cardiology, medical device, and diagnostics. Heidi is proficient in oncology, acute care, pulmonology, dermatology, women’s health, infectious disease, renal disorders, neuroscience, and surgical therapeutic areas. Heidi began her career as a registered nurse in 1998, working in acute care medical, oncology, and surgical units. Two years later, Heidi joined the cardiovascular acute and critical care unit. This experience led her to begin a new chapter in clinical research as a coordinator, working alongside physicians conducting research for eleven years. In 2013, Heidi joined the research team as project Manager at the University of Montana to study patient centered outcomes research in rural populations. Heidi then joined the CRO industry and has been actively working in a variety of roles with medium to large size CROs, gaining knowledge in diverse medical device and diagnostic fields of research.

Session Details:

Implementing a Recruitment Lead to Address Patient Recruitment Struggles in Medical Device Studies

2024-02-07, 11:15 AM

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David Kim
Senior Director of Strategic Clinical Outsourcing, Cytokinetics

David is the Sr. Director of Clinical Outsourcing and Contract Management at Cytokinetics.

He is responsible for developing transformational outsourcing solutions that fosters strong collaborative partnerships, mitigates operating risks and maximizes efficiencies via time and money. With over 22 years in the Pharma industry, David is an expert in clinical outsourcing strategy development through implementation, alliance management and clinical finance operations.

Session Details:

PANEL DISCUSSION Outsourcing Strategies: how do you approach your outsourcing strategy?

2024-02-06, 4:15 PM

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Susanne Schroter
Executive Director, Project Delivery, Biotech, ICON

Session Details:

PANEL Patient centricity: What does patient centric clinical trial development look like in 2024?

2024-02-06, 1:30 PM

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Vinita Bhatt
Associate Director, Clinical Operations Maze Therapeutics, Inc.

Vinita Bhatt joined Maze Therapeutics in 2023 and currently serves as the Associate Director of Clinical Operations where she leads Maze’s first renal program in APOL1 mediated chronic kidney disease. Vinita started her career as a scientist and then later began working on the CRO side. Prior to Maze, Vinita held various clinical operations positions at sponsor companies, such as BridgeBio and BioMarin, where she focused on bringing rare disease/orphan treatments to patients.

Vinita earned a BA in Biochemistry and Molecular Biology and MA in Biotechnology from Boston University and an MS in Biomedical Sciences at Rutgers University.

 

Session Details:

Fireside Chat: How to establish a fit for growth model for young biotech company

2024-02-07, 9:00 AM

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Sylvia Thomas
Supervisor Consumer Safety Officer, FDA

Session Details:

Opening keynote: Navigating the importation landscape for medical devices to gain and maintain competitiveness in a global market

2024-02-07, 9:00 AM

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Matthew Confeld, PharmD, PhD
Assistant Director, Clinical Research Methodology, Worldwide Clinical Trials

Matthew has 10+ years of experience in pharmaceutical science. His experience spans preclinical drug development of environment responsive nanoparticles for various solid tumor indications, serves as a translational advisor to a National Institute of Health center of biologic research in pancreatic cancer, and has extensive experience in pharmacy including clinical pharmacogenomics for a large healthcare system and specialty pharmacy management. He provides consulting-like services to sponsors across phases of development from preclinical through NDA.

Session Details:

Unlocking the Critical Power of Partnerships and Personalization in Clinical Research: A Cell and Gene Therapy Model

2024-02-06, 11:00 AM

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Sverre Bengtsson
Co-Founder, Viedoc

Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used. Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

Session Details:

Digitalization in clinical trials, a 360 view

2024-02-07, 12:15 PM

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Bill Paseman
Co-Founder and Patient Advocate, Rare Kidney Cancer

After being diagnosed with a meningioma and p1RCC (a rare kidney cancer) in 2014, Bill co-founded rarekidneycancer.org with Dr. James Hsieh in 2016.  In 2018 and 2020, with Pete Kane, he brought together 17 teams of more than 100 researchers who used his medical data to determine “genes of interest” related to his disease.  He applied ensemble reasoning to evaluate the results of these hackathons (which Bill calls “gamified tumor boards” ) to discover better ways to do cancer research.  Bill is currently automating these “gamified tumor boards” using Large Language Models (LLMs).  Bill is also involved in several patient organizations and is a CDMRP reviewer.

Prior to rarekidneycancer.orgBill worked with Sabrina Paseman to use non-invasive Blood fluorescence to detect iron deficiency anemia (Patent 8,306,594) and with Katherine Paseman to expand Pulse oximetry technology to do non-invasive measurement of Hemoglobin and Hematocrit 

Bill’s 50 year career in AI started at age 18, when he worked with Howie Johnson at Rice University using n-grams (like chatGPT) to do classical music composition.  He continued his music work at MIT in Steve Ward’s lab exploring generative grammars and constraints.  He then applied his Symbolic AI knowledge to Electrical Design Automation as the 16th employee at Daisy Systems. Bill next founded Atherton Technology (which failed) and then Calico Commerce (which IPOed), where he repurposed his music composition system to do sales configuration over the internet (Patent 5,745,765).  After Bill took Calico public, he retired and, as discussed above, has dedicated his time to rarekidneycancer.org, patient advocacy and working with his daughters on non-invasive blood analysis.

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Kincaid's Fish, Chop & Steakhouse

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New England Lobster Market & Eatery

Click here for more information: https://newenglandlobster.net/

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