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Thursday, September 26
 

7:45am EDT

Registration and Networking Breakfast
Thursday September 26, 2024 7:45am - 8:30am EDT
Thursday September 26, 2024 7:45am - 8:30am EDT
  Networking

8:30am EDT

Conference Welcome
Thursday September 26, 2024 8:30am - 8:45am EDT
Thursday September 26, 2024 8:30am - 8:45am EDT
  General Session

8:45am EDT

Opening Keynote: Modernize Clinical Trials
Thursday September 26, 2024 8:45am - 9:15am EDT
Celebrate Recent Advancements and Recognize the Importance of Embracing Change to Optimize Clinical Research 
  • Examine the impact of adapting and modernizing trial design and protocols to drive efficiencies
    • Evaluate the utilization of technology and AI to enhance clinical trials
    • Highlight how the needs of patients have evolved clinical trials
    • Discuss the promise of genetic medicines and what it means for the future of clinical trials
  • Outline strategies for combatting the industry's reluctance to change and need for transparency with regulators
Speakers
avatar for Bari Kowal

Bari Kowal

Senior Vice President, Head Development Operations & Portfolio Management, Regeneron
Bari Kowal joined Regeneron in 2015 and became head of global clinical operations in 2017. She currently serves as senior vice president, development operations, portfolio management and biostatistics data management, and is responsible for clinical trial strategy and execution, along... Read More →
Thursday September 26, 2024 8:45am - 9:15am EDT
  General Session
  • Qtag clinicaloperationsfeaturedsession

9:15am EDT

Risk-Based Clinical Development
Thursday September 26, 2024 9:15am - 9:45am EDT
Understand and Address the Barriers Preventing the Industry from Realizing the Promises of Risk-Based Approaches 
  • Understand the evolution of the regulators' expectations when it comes to risk-based approaches 
  • Examine why the industry has struggled to benefit from the promises of risk-based approaches  
  • Discuss industry data detailing what is holding trial sponsors back  
  • Outline ideal approaches for realizing the efficiency and resource benefits 
Speakers
avatar for Jonathan Rowe

Jonathan Rowe

Principal, Head of R&D Quality, Operations, and Risk Management, ZS
Jonathan Rowe has more than 25 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Principal, Head of R&D Quality, Operations and Risk Management... Read More →
Thursday September 26, 2024 9:15am - 9:45am EDT
  General Session

9:45am EDT

Keynote Panel: DEI In Clinical Research
Thursday September 26, 2024 9:45am - 10:30am EDT
Optimize Patient Outcomes and Promote Health Equity by Ensuring Clinical Data Accurately Reflects the Patient Population 
  • Why are we still talking about this?  Have we made progress as an industry?
  • Examine the power and importance of defining a DEI goal and align partners behind it
  • Identify actions the industry can take to make studies more approachable to ALL communities
Speakers
avatar for Tyrone Quarterman, MPH

Tyrone Quarterman, MPH

Senior Manager, Health Equity, Diversity, Equity, and Inclusion, and University Programs, Myriad Genetics
I am a dedicated Diversity, Equity, Inclusion, and Belonging (DEIB) professional with nearly a decade of experience navigating the intersections of for-profit, non-profit, and government healthcare settings. My career has been marked by a commitment to driving systematic change and... Read More →
avatar for Jatin Shah, M.D.

Jatin Shah, M.D.

Chief Medical Officer, Sumitomo Pharma America
Dr. Jatin Shah has served as Chief Medical Officer – Oncology of Sumitomo Pharma America since April 1, 2024. Prior to this role, he served as the Chief Oncology Development Officer since the Company’s formation in 2023, and as Executive Vice President, Chief Medical Officer and... Read More →
avatar for Jennifer Sheller

Jennifer Sheller

Vice President, Head of Clinical Sites, Data Management & Quality, Merck
Jennifer Sheller joined Merck in 2017 as an Associate Vice President, Clinical Operations. She is currently the Global Head of Monitoring Excellence, Site Partnerships / Engagement and Clinical Trial Diversity. Jennifer’s background includes a bachelor’s degree in Molecular Biology... Read More →
avatar for Keith Ho

Keith Ho

Director of Clinical Innovation and Optimization, Jazz Pharmaceuticals
Keith Ho is the Director of Clinical Innovation and Optimization within the clinical operations organization and the co-lead for the Trial Inclusiveness and Diversity Initiative at Jazz Pharmaceuticals. In his role, his objective is to develop an enterprise-level trial inclusiveness... Read More →
Thursday September 26, 2024 9:45am - 10:30am EDT
  General Session
  • Qtag clinicaloperationsfeaturedsession

10:30am EDT

Networking Break
Thursday September 26, 2024 10:30am - 11:00am EDT
Thursday September 26, 2024 10:30am - 11:00am EDT
  Networking

11:00am EDT

Charting the Future: Technology's Impact on Productivity
Thursday September 26, 2024 11:00am - 11:45am EDT
Evaluating Present Realities and Future Possibilities in Clinical Development 
  • Discuss the current state of industry-level productivity based on IQVIA Institute’s Global Trends in R&D 2024 report
  • Explore how shifts in the funding, emerging biopharma, product portfolio, regulatory, and policy environments are changing the clinical development landscape
  • Understand where productivity enablers appear to be having an impact and where there is additional opportunity
  • Assess the potential implications of upcoming elections on innovation in life sciences
Speakers
avatar for Anthony Mikulaschek

Anthony Mikulaschek

VP, Commercial Strategy, IQVIA Technologies
As Vice President of Commercial Strategy at IQVIA, Anthony Mikulaschek manages all operations, data management, quality management, training and eCOA project work associated with IQVIA eCOA. Anthony has extensive experience in validated system implementation, systems integration... Read More →
avatar for Murray Aitken

Murray Aitken

SVP & Executive Director, IQVIA Institute for Human Data Science, IQVIA
As head of the IQVIA Institute for Human Data Science, Murray Aitken provides policy setters and decision-makers in the global health sector with evidence, analysis, and insights that contribute to the advancement of Human Data Science to improve human health outcomes. Aitken is... Read More →
Thursday September 26, 2024 11:00am - 11:45am EDT
  General Session

11:45am EDT

Keynote Panel: A Future Without Pharma
Thursday September 26, 2024 11:45am - 12:30pm EDT
Can Non-Profit and Patient Organizations Own the Future of Next Generation Clinical Trial Innovation?   
Moderators
avatar for Craig Lipset

Craig Lipset

Advisor & Founder, Clinical Innovation Partners
Craig Lipset operates at the forefront of innovation in clinical research and medicine development. He brings unique perspective as a pharmaceutical executive and technologist, as well as a patient advocate. For over 20 years Craig has been leading the transformation of clinical trials... Read More →
Speakers
avatar for Len Rosenberg, PhD, RPh

Len Rosenberg, PhD, RPh

Head, Clinical Operations, Beat AML, a division of The Leukemia & Lymphoma Society
Executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, CRO and eClinical sectors - diverse background includes executive management, clinical and regulatory operations, business development and new product/licensing... Read More →
avatar for Craig Martin

Craig Martin

Founder & CEO, Orphan Therapeutics Accelerator
My experience includes more than two decades in biotech, health tech, digital health and healthcare markets -- providing executive leadership, business strategy, business development, corporate, product and pipeline communications, stakeholder engagement, policy and advocacy, as a... Read More →
avatar for Tracey Sikora

Tracey Sikora

Co-Founder, Every Cure
Tracey Sikora is the Co-Founder of Every Cure, a nonprofit organization dedicated to finding additional uses for existing drugs. She has a 15 year career conducting pre-clinical and clinical research in multiple rare diseases, including MPS I, Niemann-Pick Type C, Familial Hypercholesterolemia... Read More →
Thursday September 26, 2024 11:45am - 12:30pm EDT
  General Session
  • Qtag clinicaloperationsfeaturedsession

12:30pm EDT

Networking Lunch
Thursday September 26, 2024 12:30pm - 1:30pm EDT
Thursday September 26, 2024 12:30pm - 1:30pm EDT
  Networking

1:30pm EDT

OPERATIONS TRACK: Chair Opening
Thursday September 26, 2024 1:30pm - 1:45pm EDT
Speakers
avatar for Brendan Doran, PharmD

Brendan Doran, PharmD

Executive Director, Clinical Operations, CinRx Pharma
 Brendan Doran, PharmD serves as the Executive Director of Clinical Operations for CinRx Pharma and brings more than 15 years of experience in the pharmaceutical industry and clinical pharmacy practice. Dr. Doran oversees clinical operations for CinRx’s 6 therapeutically focused... Read More →
Thursday September 26, 2024 1:30pm - 1:45pm EDT
  Clinical Operations Track

1:30pm EDT

QUALITY TRACK: Chair Opening
Thursday September 26, 2024 1:30pm - 1:45pm EDT
Speakers
avatar for Grace Crawford

Grace Crawford

Head, Clinical Operations Quality & Learning, AstraZeneca
Grace is accountable for the development, implementation, maintenance and adoption of business quality management practices and GxP learning services for BioPharma Clinical Operations, and relevant areas within R&D BioPharmaceuticals and R&D Oncology. Grace has extensive experience... Read More →
Thursday September 26, 2024 1:30pm - 1:45pm EDT
  Clinical Quality Track

1:30pm EDT

TECH & DCT TRACK - Chair Opening
Thursday September 26, 2024 1:30pm - 1:45pm EDT
Speakers
avatar for Craig Lipset

Craig Lipset

Advisor & Founder, Clinical Innovation Partners
Craig Lipset operates at the forefront of innovation in clinical research and medicine development. He brings unique perspective as a pharmaceutical executive and technologist, as well as a patient advocate. For over 20 years Craig has been leading the transformation of clinical trials... Read More →
Thursday September 26, 2024 1:30pm - 1:45pm EDT
  DCT & Technology Track

1:45pm EDT

OPERATIONS TRACK: Participant Payments
Thursday September 26, 2024 1:45pm - 2:15pm EDT
Navigating Global Challenges with Innovative Approaches

Join IQVIA Technologies to explore the intricacies of participant payments in global studies. As trials continue to grow in complexity and scale, understanding these global intricacies – including country-specific regulatory nuances – is crucial. Together, we’ll dig into the details of paying participants in several notoriously challenging countries, discuss best practices to navigate these country- specific challenges and introduce a new approach to managing participant payments.
  • Discuss the complexities of managing participant payments and in global studies.
  • Review country-specific challenges and gain insights into effective methods to manage participant payments around the world.
  • Explore a new approach to providing participant payments that addresses global complexities.
Speakers
avatar for Shaun Williams

Shaun Williams

Senior Director, Participant Payment Solutions, IQVIA Technologies
Shaun Williams leads the Clinical Trial Participant Payment Solutions business as Senior Director at IQVIA Technologies. Prior to joining IQVIA, Shaun held senior leadership positions at several life sciences companies including Syneos Health, Sitero, Premier Research, Grifols, and... Read More →
Thursday September 26, 2024 1:45pm - 2:15pm EDT
  Clinical Operations Track
  • Qtag clinicaloperationsfeaturedsession

1:45pm EDT

QUALITY TRACK: Quality at the Site Level
Thursday September 26, 2024 1:45pm - 2:15pm EDT
Sponsor Review of Monitoring Visits and TMF Oversight for FDA Inspections 
  • Learn successful site-specific strategies for a proactive approach to FDA inspections
  • Get an in-depth understanding of an FDA inspection and post-inspection activities for sites and sponsors
  • Gain valuable insight from a sponsor Standard Operating Procedural perspective while examining the TMF/site information to stay “inspection ready
  • Understand best practices to assure study integrity and GCP compliance
Speakers
avatar for Lella Baker

Lella Baker

Senior Consultant, GxP, Advarra
Lella Baker is a quality-minded professional with over 15 years of pharmaceutical and medical device experience. Lella has expertise in conducting vendor qualification and requalification audits, internal audits and ISA audits. She has completed regulatory filings for ADE drug safety... Read More →
Thursday September 26, 2024 1:45pm - 2:15pm EDT
  Clinical Quality Track
  • Qtag clinicalqualityfeaturedsession

1:45pm EDT

TECH & DCT TRACK: Technology Standardization
Thursday September 26, 2024 1:45pm - 2:15pm EDT
Redefining Modern Trials with Technology Standards 
  • Delve into critical areas of technical standards and regulatory work in clinical research and why these matters  
  • Discuss how standards relate to risk-based assessments, AI/ML applications, telehealth approaches, and cybersecurity in clinical research  
  • Learn about the latest regulations, guidelines, and FDA guidance shaping the field 
  • Gain knowledge from ongoing efforts in developing technical standards across crucial domains 


Speakers
avatar for Isaac Rodriguez-Chavez, PhD, MHS, MS

Isaac Rodriguez-Chavez, PhD, MHS, MS

Co-Chair, IEEE-SA-DCT/DHT Program & CEO/Principal Consultant, 4Biosolutions Consulting, IEEE
Dr. Isaac R Rodriguez-Chavez is a scientific and regulatory leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, Microbiology, Vaccinology and rare diseases. His experience covers the entire life cycle of medical products from basic, preclinical, interventional... Read More →
avatar for Mathew E. Rose, MD MS

Mathew E. Rose, MD MS

Co-Chair, IEEE
Dr. Mathew Rose is an Investor, Physician, Entrepreneur, and Blockchain Specialist focused on innovations that improve health and quality of life. He founded SAAVHA, a social impact startup that personalizes patient experiences to reduce inequity and administrative friction around... Read More →
Thursday September 26, 2024 1:45pm - 2:15pm EDT
  DCT & Technology Track
  • Qtag dct&techfeaturedsessions

2:15pm EDT

OPERATIONS TRACK: Panel - Trial Design Innovation
Thursday September 26, 2024 2:15pm - 3:00pm EDT
Optimize Clinical Trials Post-Pandemic Through Efficient Trial Design 
  • Explore the evolving dynamics between clinical trial sponsors and research sites, focusing on remote operations and site access challenges post-COVID-19
  • Quantify the impact of protocol complexity on patient burden and site operations
  • Leverage data-driven approaches to streamline start-up activities, lower costs, and enhance enrollment efficiencies.
  • Discuss strategies for effective collaboration and relationship building, with an emphasis on integrating site and patient perspectives in protocol design
Speakers
avatar for Brendan Doran, PharmD

Brendan Doran, PharmD

Executive Director, Clinical Operations, CinRx Pharma
 Brendan Doran, PharmD serves as the Executive Director of Clinical Operations for CinRx Pharma and brings more than 15 years of experience in the pharmaceutical industry and clinical pharmacy practice. Dr. Doran oversees clinical operations for CinRx’s 6 therapeutically focused... Read More →
avatar for Leila Cupersmith

Leila Cupersmith

Founder, CEO, and Principal Consultant, Choice ClinOps, LLC
As the owner of ChoiceClinOps, my focus is on providing expert consultation for phase 1-3 global oncology clinical trials, ensuring they are conducted with the utmost precision, from start-up to close-out. Our team excels in managing intricate operations, evaluating suppliers, and... Read More →
avatar for Victor Lucariello

Victor Lucariello

Associate Director, Study Optimization, Bristol Myers Squibb
Pharmaceutical industry professional with 20+ years’ experience in drug research, specializing in CR&D with an expertise in hematology & oncology trials for Phase I (patients) through Phase IIIb. In the past 10 years skillsets for Project Management and Process Development have... Read More →
avatar for Suzanne Parker

Suzanne Parker

Executive Director, Clinical Operations, MacroGenics
Suzanne Parker is a pharmaceutical industry professional with over 25 years of experience leading teams through the various stages of the clinical development process from study concept, enrollment, reporting and health authority submissions in major global and emerging markets. Suzanne... Read More →
Thursday September 26, 2024 2:15pm - 3:00pm EDT
  Clinical Operations Track
  • Qtag clinicaloperationsfeaturedsession

2:15pm EDT

QUALITY TRACK: Panel - Drive a Quality Culture
Thursday September 26, 2024 2:15pm - 3:00pm EDT
Relate Risk-Based Quality Management (RBQM) Operational Improvements to Cultural Change and Fuel a Quality-First Organization  
  • Consider how using quality by design as a broader business objective and partnering across R&D demonstrates value of Quality to the organization 
  • Explore the shift in the RBQM era that affects the ways of working and innovating from analytics and AI to vendor oversight and management 
  • Manage the operational complexity of acquisitions happening across the industry impacting the processes, people, technologies, and external stakeholders 
  • Discuss the change management approaches used to navigate the emotional engagement and upskilling needed to bring people to the next level 

Moderators
avatar for Paul Houri

Paul Houri

Senior Vice President, Chief Quality Officer, Bristol Myers Squibb
Speakers
avatar for Sheri Kuss

Sheri Kuss

Sr. Director, GCP Quality Vaccines Category Head, Pfizer
A clinical research professional with over 20 years of GCP experience including FDA inspection preparation and facilitation, FDA Warning Letter remediation plan development, quality and compliance assessment, project management, auditing, process and SOP development, monitoring, training... Read More →
avatar for Jennifer Krohn, MS, CCRP

Jennifer Krohn, MS, CCRP

Associate Director, RBQM, Clinical Operations, Gilead Sciences
I have over 10 years of experience in leading and overseeing the centralized statistical monitoring and risk-based quality management (RBQM) of clinical trials. My mission is to ensure the quality, safety, and efficiency of clinical data and operations, and to support the delivery... Read More →
avatar for Grace Crawford

Grace Crawford

Head, Clinical Operations Quality & Learning, AstraZeneca
Grace is accountable for the development, implementation, maintenance and adoption of business quality management practices and GxP learning services for BioPharma Clinical Operations, and relevant areas within R&D BioPharmaceuticals and R&D Oncology. Grace has extensive experience... Read More →
Thursday September 26, 2024 2:15pm - 3:00pm EDT
  Clinical Quality Track
  • Qtag clinicalqualityfeaturedsession

2:15pm EDT

TECH & DCT: Panel - The Role of AI
Thursday September 26, 2024 2:15pm - 3:00pm EDT
Understand how Artificial Intelligence (AI) is THE Game Changer Clinical Research So Desperately Needs
    • Understand how AI is being implemented and envisioned across clinical operations functions and the impact on resource needs 
    • Share how different organizations are piloting and evaluating AI solutions to enhance clinical operations  
    • Outline how AI has the potential to be a game changer for clinical research and what actions should be taken now to prepare  


Speakers
avatar for Dawn Lundin

Dawn Lundin

Quality Leader, Lykos Therapeutics
Recognized expert in risk based quality management and compliance from 28 years in drug/vaccine development, quality oversight, and compliance roles. Current Vice President of Global Quality for Lykos Therapeutics, and faculty member of the Institute for Translational Medicine and... Read More →
avatar for Lorraine Fay

Lorraine Fay

Executive Director, Head Clinical Development and Quality Operations, Bristol Myers Squibb
Lorraine has over 25 years in the pharmaceutical industry, starting her career as a medicinal chemist with Pfizer and moved into Clinical Quality Assurance 16 years ago. Lorraine is currently Head of Clinical Development and Operations Quality, at BMS where her and her team are responsible... Read More →
avatar for Ronojit Adyanthaya

Ronojit Adyanthaya

Senior Director, MRL QA Analytics & Insights, Merck
19 years of professional experience in Data Analytics, Data Science, Quality Assurance, Risk Management, and Design Controls in the pharmaceutical and medical device industry.Accomplished leader with progressive technical, operational, and leadership experience specializing in analytics... Read More →
Thursday September 26, 2024 2:15pm - 3:00pm EDT
  DCT & Technology Track

3:00pm EDT

Networking Break
Thursday September 26, 2024 3:00pm - 3:30pm EDT
Thursday September 26, 2024 3:00pm - 3:30pm EDT
  Networking

3:30pm EDT

OPERATIONS TRACK: The Quality and Compliance Compass
Thursday September 26, 2024 3:30pm - 4:00pm EDT
Leverage the Trial Master File (TMF) to Gain Valuable Insight into the Clinical Quality Compliance of Your Study 
  • Understand how missing protocol training documentation can indicate greater quality compliance issues in the study
  • Examine critical documents like site monitoring reports and oversight documentation to evaluate possible risks and compliance concerns
  • Discuss how TMF content gaps may signify data integrity issues within the study
  • Use the TMF as a strategic study asset to ensure the study’s success by proactively identifying risks

Speakers
avatar for Donna Dorozinsky

Donna Dorozinsky

Founder & CEO, Just in Time GCP
As the Founder and CEO of Just in Time GCP, my mission is to elevate clinical compliance and inspection readiness through strategic leadership and the adept use of clinical technologies. With a robust background in the field, our team excels in executing eClinical technology and GCP... Read More →
Thursday September 26, 2024 3:30pm - 4:00pm EDT
  Clinical Operations Track
  • Qtag clinicalqualityfeaturedsession

3:30pm EDT

QUALITY TRACK: QA Competency
Thursday September 26, 2024 3:30pm - 4:00pm EDT
The Astellas-CSU PharmD Industry Rotation Partnership
  • Learn about Astellas’ recent experience welcoming Chicago State University PharmD candidates for rotations in Quality Assurance
  • Understand the benefits for both students and Astellas of this collaboration, and what other biopharma companies can take away from these learnings to initiate their own partnerships

Speakers
avatar for John Bolling

John Bolling

Director, Clinical Quality Assurance, Astellas Pharma US
John leads a team of global Asset Quality Leads in GCP with Astellas. He started his career 'on the bench', then managed laboratories before shifting to Quality Assurance for the lab/preclinical space (GLP). He has 20 years of QA experience and has been with Astellas for 11 years... Read More →
Thursday September 26, 2024 3:30pm - 4:00pm EDT
  Clinical Quality Track
  • Qtag clinicalqualityfeaturedsession

3:30pm EDT

TECH & DCT TRACK: AI & CSRs
Thursday September 26, 2024 3:30pm - 4:00pm EDT
Leverage Artificial Intelligence (AI) to Expedite and Increase the Accuracy of Writing Clinical Study Reports (CSRs) 

Speakers
avatar for Madhavi Gidh-Jain, PhD

Madhavi Gidh-Jain, PhD

Global Head of Medical Writing and Document Management, Clinical Documentation, Sanofi US
Strategic-thinking, solution-oriented, pharmaceutical leader fostering a culture of innovation in healthcare while nurturing a culture of excellence centered around patients and medical writers across global locations. Driving the transformation of the medical writing landscape through... Read More →
Thursday September 26, 2024 3:30pm - 4:00pm EDT
  DCT & Technology Track

4:00pm EDT

OPERATIONS TRACK: Panel - Site Engagement
Thursday September 26, 2024 4:00pm - 4:45pm EDT
Build Deep-Rooted Relationships with Investigators and Site Teams to Increase the Innovation and Optimization of Clinical Operations 

  • Evaluate the efficiency and quality benefits from investing in effective site engagement
  • Discuss strategies for prioritizing the need for site engagement internally
  • Leverage different functional models to share resources across studies for most cost effective development
  • Identify easy action items to operationalize better site engagement

Speakers
avatar for Brendan Doran, PharmD

Brendan Doran, PharmD

Executive Director, Clinical Operations, CinRx Pharma
 Brendan Doran, PharmD serves as the Executive Director of Clinical Operations for CinRx Pharma and brings more than 15 years of experience in the pharmaceutical industry and clinical pharmacy practice. Dr. Doran oversees clinical operations for CinRx’s 6 therapeutically focused... Read More →
avatar for Shafaat Ali Khan, M.B., B.S.

Shafaat Ali Khan, M.B., B.S.

Associate Director – Investigator Engagement Clinical Research Lead (CRL), Eli Lilly
Ali is a seasoned clinical research professional with a passion for revolutionizing the way clinical trials are conducted. As the leader of Lilly's Site and Investigator Engagement organization, Ali spearheads efforts to operationalize and execute highly decentralized clinical trials... Read More →
avatar for Solomon Yakubov

Solomon Yakubov

Associate Director, Site Engagement – Global Clinical Operations, GSK
Results-driven clinical operations leader with a 10+ year career in successfully delivering clinical trials across immuno-oncology, oncology, vaccines, infectious disease, cardiovascular, respiratory, and renal + metabolic therapeutic areas. Currently serving as Associate Director... Read More →
Thursday September 26, 2024 4:00pm - 4:45pm EDT
  Clinical Operations Track
  • Qtag clinicaloperationsfeaturedsession

4:00pm EDT

QUALITY TRACK: Panel - GCP Inspection Readiness
Thursday September 26, 2024 4:00pm - 4:45pm EDT
Navigate the New Normal of Inspection Readiness and Create a Roadmap for Compliance  
    • Review how GCP inspections have changed post-COVID 
    • Share best practices for working with partners to ensure inspection readiness  
    • Understand the practical insights and tools to conduct thorough clinical quality due diligence during and after M&A transactions 
    • Evaluate needed resources and strategies for best leveraging them to ensure your study is inspection- prepared  
Moderators
avatar for Priya Annamalai

Priya Annamalai

Director, Inspection Program – Quality Operations, Quality Assurance, Astellas
My professional career spans across various QA and compliance roles within the pharmaceutical industry with responsibilities in the areas of Quality Systems/CAPA management, regulatory intelligence, product complaints, pharmacovigilance and most recently, leading global regulatory... Read More →
Speakers
avatar for Matthew Burtt

Matthew Burtt

Senior Director, Internal Audits & Inspections, AbbVie
Matt leads a diverse, cross-disciplinary team of Quality Professionals, delivering strong internal Quality Oversight via risk-based audit programs, and developing key insights that enable real-time inspection preparation by Inspection Management team members also under his stewardship... Read More →
avatar for Priya Chaturvedi, Ph.D.

Priya Chaturvedi, Ph.D.

Vice President, Head of Global Clinical Quality, Eisai
Priya Chaturvedi is Vice President, Head of Global Clinical Quality at Eisai Inc. She has responsibility for Global Clinical Quality Assurance, Clinical Quality Management and Global Process and Standards. She joined Eisai in 2019. Prior to that, she was Executive Director, CQA at... Read More →
avatar for Mary MacDonald, MS, RQAP-GCP

Mary MacDonald, MS, RQAP-GCP

Head of Clinical Quality Assurance, Neuroscience, Takeda
Mary MacDonald is the Head of Clinical Quality Assurance, Neuroscience. In this role she partners with the Neuroscience Therapeutic Area Unit and additional quality and research and development business partners to ensure compliance and inspection readiness for all Takeda clinical... Read More →
Thursday September 26, 2024 4:00pm - 4:45pm EDT
  Clinical Quality Track
  • Qtag clinicalqualityfeaturedsession

4:00pm EDT

TECH & DCT TRACK: Panel - Accelerate DCT Adoption
Thursday September 26, 2024 4:00pm - 4:45pm EDT
Discuss the Decrease in Decentralized Trials (DCT) Post-Pandemic and How to Overcome Barriers to Adoption  
  • Learn about the Decentralized Trials Research Alliance (DTRA) initiative to identify gaps and issues preventing DCT adoption 
    • Global Conduct Map 
    • Collaborate on Regulatory Gaps  
    • Data Connectivity  
  • Evaluate the impact of the pandemic on DCT adoption  



Speakers
avatar for Craig Lipset

Craig Lipset

Advisor & Founder, Clinical Innovation Partners
Craig Lipset operates at the forefront of innovation in clinical research and medicine development. He brings unique perspective as a pharmaceutical executive and technologist, as well as a patient advocate. For over 20 years Craig has been leading the transformation of clinical trials... Read More →
avatar for Caroline Redeker

Caroline Redeker

Clinical Research Innovator
Clinical Research Innovator, Leader and Mentor with 30 years of experience in creating new solutions and adding value to clinical programs. Current member of Chief, Healthcare Businesswomen's Association (HBA), and Decentralized Trials Research Alliance (DTRA). Deputy Director of... Read More →
avatar for Michelle Shogren

Michelle Shogren

CEO, Innovate in What You Do! LLC; Former Senior Director, Business Excellence & Innovation Pharma R&D at BAyer
At the helm of Innovate In What You Do! LLC for over two years, my mission has been to infuse over two decades of clinical trials expertise into every aspect of business innovation. The company thrives on transforming creative concepts into tangible results, tailoring innovation workshops... Read More →
avatar for Brandon Maggio

Brandon Maggio

Head of Digital Operations & Process Optimization, GSK
Brandon Maggio is a Director of Digital, Analytics & Performance, within Global Clinical Operations at GSK. Mr Maggio holds degrees in Biotechnology and Biochemical Pharmacology from the University at Buffalo and has dedicated 20 years to the pharmaceutical industry. He leads a diverse... Read More →
Thursday September 26, 2024 4:00pm - 4:45pm EDT
  DCT & Technology Track

4:45pm EDT

Roundtable Discussions
Thursday September 26, 2024 4:45pm - 5:30pm EDT
Choose one topic from the list below to informally discuss at a table with your peers.   You’ll have a chance to choose your preferred topic before the conference and onsite, unpopular topics will be eliminated.   Interested in leading a roundtable discussion and/or suggesting a topic?  Contact Kristen Hunter at khunter@questex.com.  

  1. SMALL COMPANY PERSPECTIVE: Discuss Effective Strategies for Optimizing Clinical Operations with Limited Resources
  2. SITE SELECTION STRATEGY: Evaluate Different Criteria for Selecting Sites for Your Study
  3. VENDOR SELECTION STRATEGY: Outline Different Criteria for Choosing the Right Vendor for Your Company Culture
  4. CRITICAL TO QUALITY FACTORS: Understand How to Identify CTQs and How to Develop the Study Around Them
  5. INTRO TO CLINICAL DATA ANALYTICS: Overview of the Basics and How Data Analytics are Revolutionizing Clinical Research  
  6. CULTURAL CHANGE MANAGEMENT: Be the Spearhead for Cultural Change at Your Company and Drive Clinical Process Optimization
  7. TRIAL MASTER FILE: Share Strategies for Using the TMF to Assess the Overall Quality of the Study
  8. STUDY SALVAGE: Understand When It's Time to Fire Your Clinical Partners and What Trial Rescue and Recovery Looks Like
  9. CLINICAL PROCESS ASSESSMENT: Learn How to Determine if Your Clinical Processes and Operations can Support the Scope of Your Trial
Speakers
avatar for Marek Wasiluk

Marek Wasiluk

Visionary Entrepreneur and Founder, Clinmark
Dr. Marek Wasiluk is the driving force behind Clinmark, a globally recognized Contract Research Organization (CRO) known for its excellence in clinical research. With a unique blend of medical expertise and business acumen, Marek has positioned Clinmark as a leader in the industry.Marek's... Read More →
avatar for Jaroslaw Kasprowicz, PhD, MBA

Jaroslaw Kasprowicz, PhD, MBA

Head of Clinical Operations, Clinmark
Jarosław Kasprowicz is a seasoned clinical research professional with over 12 years of experience in organizing, conducting, and managing both local and international clinical trials across phases I, II, III, and observational studies in various therapeutic areas. He has previously... Read More →
Thursday September 26, 2024 4:45pm - 5:30pm EDT
  Networking

5:30pm EDT

Networking Reception
Thursday September 26, 2024 5:30pm - 6:30pm EDT
Thursday September 26, 2024 5:30pm - 6:30pm EDT
  Networking

6:30pm EDT

Day Concludes
Thursday September 26, 2024 6:30pm - 6:30pm EDT
Thursday September 26, 2024 6:30pm - 6:30pm EDT
 
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Wednesday, September 25
Thursday, September 26
Friday, September 27
  • Clinical Operations Track
  • Clinical Quality Track
  • DCT & Technology Track
  • General Session
  • Networking
  • Operations & Quality Track
  • Workshop