Clinical Quality Oversight Forum, A Virtual Experience: Full Schedule

9:00am EDT

Networking in Virtual Exhibit Hall

Tuesday October 20, 2020 9:00am - 10:00am EDT

Networking Break

10:00am EDT

Welcome to CQOF, A Virtual Experience

Learn the ins and outs of the virtual environment and how you can best take advantage of your time at this event
Meet the conference chair who will be your guide for the next few days

Speakers

Sharon S. Reinhard, M.S.

Vice President, R&D QA, CSL BEHRING

Experienced pharmaceutical executive with 22 years of industry experience, recently taking the position of Vice President of R&D Quality with CSL Behring. Prior to that I spent 3.5 years working for Merck and 4 years running Clinical Compliance Solutions, LLC, offering right sized... Read More →

Tuesday October 20, 2020 10:00am - 10:15am EDT

10:15am EDT

EXPERT PANEL: The Transformation of Clinical Quality

Examine This Pandemic As A Catalyst for Expedited Change and Progress, and Discuss the Current and Lasting Impact on Clinical Quality

Walkthrough the stages of the pandemic from a clinical quality perspective
- What immediate changes had to occur to maintain quality?
- Is paper gone forever?
- Discuss which of these immediate changes have been working well and may be here to stay
Share how quality has had to quickly adapt and accept things that would not have been before COVID-19
Identify innovative tools and process changes that have allowed studies to continue during the pandemic and the impact to clinical quality

Speakers

Grace Crawford

Global Head, Clinical Quality and Compliance, ASTRAZENECA

Kathy Goldstein, PharmD, RPh, CCRA

Senior Director, GCP Quality Management Lead, REGENERON PHARMACEUTICALS, INC.

Kathy Goldstein is currently the Sr. Director, Head, Quality Management Lead at Regeneron Pharmaceuticals. In this position, Dr. Goldstein leads a team of Quality Management Leads who ensure quality and compliance for all global clinical study activities. The quality management lead... Read More →

David Fryrear

Senior Vice President, Head of Clinical and Research Quality Assurance, ASTELLAS

David Fryrear, M.S., is the Medical and Development organization’s senior vice president and head of the Clinical and Research Quality Assurance (CRQA) organization and has responsibility for providing the global vision, leadership and strategic direction of CRQA at Astellas.Fryrear... Read More →

Sheila Gwizdak, M.S.

Vice President, Quality, HALLORAN CONSULTING GROUP

Sheila Gwizdak has over 18 years of experience in the biotechnology and pharmaceutical industry. Her career has focused on quality, process improvement, and training including the execution of corporate and department-level quality assurance initiatives such as SOP development, compliance... Read More →

Tuesday October 20, 2020 10:15am - 11:15am EDT

Panel Discussion

11:15am EDT

Energizer Break

Tuesday October 20, 2020 11:15am - 11:30am EDT

Networking Break

11:30am EDT

PATIENT CENTRICITY AND CLINICAL QUALITY

Discuss the Pandemic-Driven Rapid Advancement of Patient Centric Tools and Operations and the Impact on Clinical Quality and Oversight

Evaluate how continuity of treatment was achieved during the pandemic by implementing more patient-centric tools
Understand the impact of these tools on clinical quality and quality oversight
Discuss the probability of these patient-centric approaches to remain post-pandemic

Speakers

Lynn M. Evans

Head of Quality Planning and Strategy, BioResearch Quality and Compliance, JOHNSON & JOHNSON

Tuesday October 20, 2020 11:30am - 12:00pm EDT

Expert Presentation

12:00pm EDT

Key Take Away Points from The Morning Sessions

Tuesday October 20, 2020 12:00pm - 12:15pm EDT

12:15pm EDT

Networking in the Virtual Exhibit Hall

Tuesday October 20, 2020 12:15pm - 2:00pm EDT

Networking Break

2:00pm EDT

QUALITY SIGNALS FROM CLIN OPS

Leverage Operational Data to Proactively Identify Clinical Quality Signals and Shape the Risk Management Plan

Understand the relationship between operational compliance and regulatory compliance
Discuss how operational compliance data can provide clues into regulatory compliance
Share examples of operational data providing clues to stop issues from happening
Outline how and where this can be built into standard operations

Speakers

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP

Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP is an accomplished clinical quality and regulatory compliance professional with in-depth knowledge of all facets of clinical trial operations and the ability to support management and clinical teams that are conducting compliant clinical... Read More →

Tuesday October 20, 2020 2:00pm - 2:30pm EDT

Expert Presentation

2:30pm EDT

TMF AS A QUALITY TOOL

Leverage the Trial Master File (TMF) to Improve Overall Quality of The Trial

Recognize the TMF as a tool to ensure trial integrity
Understand how the TMF can impact quality in the clinical trial
Evaluate how to leverage the TMF to drive those quality improvements

Speakers

Donna Dorozinsky

President and CEO, JUST IN TIME GCP

As the President & CEO of Just inTime GCP, Donna is responsible for running all facets of the business. She is a business consultant who has over 30 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply... Read More →

Tuesday October 20, 2020 2:30pm - 3:00pm EDT

Expert Presentation

3:00pm EDT

Energizer Break

Tuesday October 20, 2020 3:00pm - 3:15pm EDT

Networking Break

3:15pm EDT

PANEL: Critical to Quality Factors

Reevaluate Risks During A Pandemic to Ensure The Focus is Only On The Quality Issues That Matter

Discuss how risk management practices were impacted by the pandemic initially and now
Examine risk indicators before COVID and if they were impacted by the pandemic-drive adoption of remote tools and technologies
Outline actions for ongoing risk assessment and the impact on the risk management plan and event management when conditions change

Speakers

Jill Heinz, MHS, CCRC, CRCP

President, FAMILY CARE RESEARCH and INJURY CARE RESEARCH

Jill has worked in the research industry for over 19 years and has been involved with clinical research studies ranging from those funded by the National Cancer Institute, Investigator Initiated and Private Industry. She has experience in studies that include oncology, family practice... Read More →

Michael Torok, Ph.D.

Clinical Quality Assurance Head, ASTELLAS

Michael Torok has over 20 years of experience in pharmaceutical development and has held leadership roles in Clinical Operations, Project and Portfolio Management, and Contracts and Outsourcing. After completing coursework in data analytics and machine learning, Michael transitioned... Read More →

Margaret McShane

Managing Expert, YOUR ENCORE CLINICAL CENTER OF EXCELLENCE

Margaret McShane is a Clinical Operations professional with more than 30 years of experience across multiple therapeutic areas, including numerous rare diseases. Margaret began her career in big pharma (initially The Upjohn Company; ultimately Pfizer) supporting the execution of clinical... Read More →

Arti Bajpai

Managing Expert, YOUR ENCORE QUALITY CENTER OF EXCELLENCE

Arti Bajpai is a visionary Quality and Compliance expert driving continuous process improvements. She consistently works to gain trust, achieve results and build efficiencies.As a seasoned expert in Compliance and Quality, Arti’s experience provides the foundation from which she... Read More →

Cheryl McCarthy, CQA, CBA, RQAP-GCP

Director, Research Quality, IRONWOOD PHARMACEUTICALS

Cheryl McCarthy has over 20 years in industry working for CROs and Sponsors supporting compliance and quality efforts. She is currently at Ironwood Pharmaceuticals in the role of Director, Research Quality Assurance managing their GCP, GLP and GVP compliance programs. Her experience... Read More →

Tuesday October 20, 2020 3:15pm - 4:15pm EDT

Panel Discussion

4:30pm EDT

Key Take Away Points from the Afternoon Sessions

Tuesday October 20, 2020 4:30pm - 4:30pm EDT

4:30pm EDT

Interactive Zoom Roundtable Discussions

Tuesday October 20, 2020 4:30pm - 5:30pm EDT

Interactive

9:00am EDT

Networking in Virtual Exhibit Hall

Wednesday October 21, 2020 9:00am - 10:00am EDT

Networking Break

10:00am EDT

Welcome to Day Two of CQOF, A Virtual Experience

Speakers

Sharon S. Reinhard, M.S.

Vice President, R&D QA, CSL BEHRING

Wednesday October 21, 2020 10:00am - 10:15am EDT

10:15am EDT

SITE OVERSIGHT

Empower Sites and Enable Monitors Remotely to Optimize Oversight and Ensure A Continual State of Site-Audit Readiness

Discuss the challenges of conducting site oversight remotely
Evaluate what monitors and sites need to be able to do their jobs
Understand how standardization, consistency and automation empowers the sites
Outline what is needed from the trial sponsor to optimize site oversight

Speakers

Dylan Loch

Director, Industry Business Development, COMPLION

With 8 years of experience in business development for technology companies, Dylan understands how to achieve organizational outcomes through innovation. Dylan served as the director of site business development prior to overseeing industry business development, therefore brings together... Read More →

Wednesday October 21, 2020 10:15am - 10:45am EDT

Expert Presentation

10:45am EDT

Study Oversight In The Pandemic Era and Beyond

Achieve Effective Oversight for Hybrid and Remote Models with a Cloud-based CTMS

Understand how to ensure quality for virtual and hybrid trials
Discuss the most challenging aspects of oversight when transitioning to remote monitoring
Discover how cloud-based CTMS helps ensure compliance across studies, sites, CROs, and sponsors
Share how oversight will change post-pandemic and the impact on clinical operations

Speakers

Henry Galio

Senior Director, Vault CTMS, VEEVA SYSTEMS

Henry Galio is responsible for the overall market strategy and direction of the Veeva Vault CTMS application. With over 30 years of experience in life sciences and 18 years in developing and implementing clinical trial systems and clinical data analytics, Henry is an expert in clinical... Read More →

Chris McSpiritt

Senior Director, Vault Clinical, VEEVA SYSTEMS

Chris is part of Veeva's R&D Strategy group where he focuses on the Clinical Operations Suite. He works with clients and prospects to understand their pain points and to align software solutions with their desired future state. In addition to helping clients understand the capabilities... Read More →

Wednesday October 21, 2020 10:45am - 11:15am EDT

Expert Presentation

11:15am EDT

Energizer Break

Wednesday October 21, 2020 11:15am - 11:30am EDT

Networking Break

11:30am EDT

PANEL: Inspection Experience During The Pandemic

Share Experiences with Remote Inspections and Other Engagement with Regulatory Authorities During the Pandemic

Discuss inspection experiences during the pandemic
- Share communication with regulatory agencies during the pandemic
- Were you part of a hybrid or remote inspection? What did that look like?
Understand experiences with direct access to systems and the associated challenges
- How were inspectors trained on the system?

Speakers

Nancy Bitters

GCP/GVP Inspection Lead, EMD SERONO

Nancy Bitters has more than 20 years of experience in the pharmaceutical industry. Nancy is currently employed by EMD Serono Inc. She is an Inspection Management Lead for EMD Serono.In her role within the Research & Development Quality Assurance Department, Nancy oversees and/or facilitates... Read More →

Priya Annamalai

Director, Inspection Program, ASTELLAS

With over 15 years of experience, Priya has a strong background in CAPA/Quality Systems, various GxP functional areas, and extensive experience leading global regulatory inspections. Her experience includes managing and leading large scale sponsor GCP, PV, GLP and Bioanalysis lab... Read More →

Barbara A. Novak, BS, MT(ASCP)

Systems and Process Management Lead/Clinical Operations – NA/EU, KYOWA KIRIN PHARMACEUTICAL DEVELOPMENT, INC.

Education: BS MT (ASCP)Douglass College, Rutgers University;St Peter’s School of Medical Technology, St Peter’s MedCTR Internship:Clinical Laboratory background, specialty – HemOncCareer20++yrs Clinical Development / Clinical Research: eTMF Business Administrator and Trainer... Read More →

Stacey Pipala

Head, Regulatory Compliance and Risk Management, NOVARTIS

Stacey Pipala has more than 15 years of experience in the pharmaceutical industry. Stacey is the Global Head of Regulatory Compliance and Risk Management at Novartis Pharmaceuticals. In this role, her responsibilities include aspects of inspection management and the development... Read More →

Wednesday October 21, 2020 11:30am - 12:30pm EDT

Panel Discussion

12:30pm EDT

Networking in the Virtual Exhibit Hall

Wednesday October 21, 2020 12:30pm - 2:00pm EDT

Networking Break

2:00pm EDT

CRO PERSPECTIVE

Preserving Data Quality in Phase I Studies During COVID-19

Identify new complexities that are being experienced when running Phase I clinical trials during the pandemic
Discuss new practices clinical operations professionals across the industry are adopting to maintain data quality, compliance, and preserve the overall integrity of clinical trials
Share how the COVID-19 pandemic may permanently impact some aspects of clinical trials

Speakers

Oren Cohen, M.D.

Chief Medical Officer and Global Head, Clinical Pharmacology, COVANCE

Oren Cohen, M.D. joined Covance in December 2017 to serve as Chief Medical Officer and Head of Clinical Pharmacology Services.Oren has extensive clinical development experience, most recently from Viamet Pharmaceuticals where he was CMO. He brings more than 30 years of healthcare... Read More →

Wednesday October 21, 2020 2:00pm - 2:30pm EDT

Expert Presentation

2:30pm EDT

The Path To Successful Remote Monitoring

Common Barriers to Successful Adoption of Remote Monitoring and Proactive Strategies to Overcome Them

Understand the burden on sites when transitioning formerly onsite tasks to virtual
Discuss technology options and challenges
Identify organizational barriers and tactics to overcome them
Evaluate potential studies and sites for initial projects and identify success factors

Speakers

Ken Lownie

Head of Operations: Americas, AGATHA INC.

Ken Lownie is the head of North American Operations for Agatha Life Sciences, a provider of SaaS-based business applications for managing SOP, regulatory documents, and clinical trial master file records. His goal is to help organizations implement easy to deploy solutions that empower... Read More →

Wednesday October 21, 2020 2:30pm - 3:00pm EDT

Expert Presentation

3:00pm EDT

PANEL: Remote Technology Successes and Challenges

Varying Stakeholders Weigh-In on The Good, Bad and Ugly Experiences of Remote Technology Adoption

Examine the motivations and challenges of remote monitoring from the site, CRO and trial sponsor perspectives
Identify the profiles of successful remote monitoring initiatives
Review the technology selected and used in successful projects
Discuss direct experiences of remote technology achievements and nightmares
Leave with takeaways to overcome technology and behavior implementation obstacles

Speakers

Joel Kordyak

Executive Director, Product Delivery, PRA HEALTH SCIENCES

Highly effective, results driven clinical trials executive serving sponsors and patients via digital innovation and technology platforms. Joel builds bridges between technology and clinical trials operations to deliver best-in-class patient centric solutions to effectively modernize... Read More →

Michael Wieczerzak

Associate Director, Clinical Quality Management, EMD SERONO

Michael Wieczerzak is an Associate Director, Clinical Quality Management at EMD Serono. His main responsibilities are within inspection readiness and quality risk management. Prior to joining the Clinical Quality Management department, he was a Clinical Trial Lead running immunology... Read More →

Sheri Kuss

Director, Clinical Quality Lead, PFIZER

Sheri Kuss has more than 25 years of clinical research experience, with 17 of them being in a quality role. She is currently a Director, Clinical Quality Lead at Pfizer supporting the Covid Vaccine study.

Ken Lownie

Head of Operations: Americas, AGATHA INC.

Jill Heinz, MHS, CCRC, CRCP

President, FAMILY CARE RESEARCH and INJURY CARE RESEARCH

Wednesday October 21, 2020 3:00pm - 4:00pm EDT

Panel Discussion

4:00pm EDT

Key Take Away Points from The Day

Wednesday October 21, 2020 4:00pm - 4:15pm EDT

4:30pm EDT

Interactive Virtual Zoom Roundtable Discussions

Wednesday October 21, 2020 4:30pm - 5:30pm EDT

Interactive

9:00am EDT

Networking in the Virtual Exhibit Hall

Thursday October 22, 2020 9:00am - 10:00am EDT

Networking Break

10:00am EDT

MERCK CASE STUDIES: Remote QA Best Practices

Proven Methodologies and Important Considerations from Case Studies of Remote Audits and Remote Inspections

Learn from Merck’s recent experiences with remote site audits and remote study-level audits
- Discuss the challenges identified and how they were overcome
- Share best practices and process improvements going forward
Walk through Merck’s remote inspection experience
- Retrospectively view what could have been smoother, from a process and technology perspective
- Outline the communication with the regulatory authorities before and during the remote inspections

Speakers

Jolie Weintraub

Associate Vice President, Clinical Quality Assurance, MERCK

Jolie Weintraub is the Associate Vice President in MRL Quality Assurance (QA) at Merck, Clinical Head responsible for oversight of QA activities across the Oncology, Vaccine/Infectious Disease and Primary Care portfolios. She works closely with Global Clinical Development and Clinical... Read More →

Thursday October 22, 2020 10:00am - 10:30am EDT

Expert Presentation

10:30am EDT

PANEL: A New Way To Audit

Discuss Best Practices and Adaptation Challenges to The New World of Remote and Hybrid Audits

Discuss panelists experience with remote and hybrid auditing before the pandemic
Share auditing practices throughout the pandemic and how they have changed
Strategize on how to overcome the common challenges associated with remote and hybrid audits
Predict what audits will look like post-pandemic and beyond

Speakers

Jolie Weintraub

Associate Vice President, Clinical Quality Assurance, MERCK

Cheryl McCarthy, CQA, CBA, RQAP-GCP

Director, Research Quality, IRONWOOD PHARMACEUTICALS

Maryann Livolsi, MSN, RN

GCP Compliance Leader, BILL AND MELINDA GATES MEDICAL RESEARCH INSTITUTE

Accomplished leader in R&D Quality Assurance with effective management experience worked in small, mid-sized, large pharmaceutical/bio-pharmaceutical and a non-profit bio-pharmaceutical company, in depth knowledge in clinical trial management, GXP auditing, process gap analysis, SOP... Read More →

Thursday October 22, 2020 10:30am - 11:15am EDT

Panel Discussion

11:15am EDT

Energizer Break

Thursday October 22, 2020 11:15am - 11:30am EDT

Networking Break

11:30am EDT

Virtual Vendor Qualification Audits

Outline the Critical Aspects of a Vendor Qualification Audit and How to Execute Remotely

Identify the high-level topics that should be covered in any vendor audit
Evaluate methods for assessing critical content remotely
Discuss best practices for conducting remote interviews with key personnel
Execute virtual tours when facilities and equipment need to be evaluated
Understand how company SOPs need to change to accommodate virtual vendor qualifications

Speakers

Sean Storms

Senior Director, Trial and Quality Systems, CSL BEHRING

Senior Director of Trials and Systems at CSL Behring. Clinical Quality Assurance and Business and Technology Systems senior profession with over 21 years in the life sciences industry. Sean has worked as a consultant for 8 of the top pharmaceutical companies, over 25 midrange, and... Read More →

Thursday October 22, 2020 11:30am - 12:00pm EDT

Expert Presentation

12:00pm EDT

Key Take Away Points from The Morning Sessions

Thursday October 22, 2020 12:00pm - 12:15pm EDT

12:15pm EDT

Networking in the Virtual Exhibit Hall

Thursday October 22, 2020 12:15pm - 2:00pm EDT

Networking Break

2:00pm EDT

Data Integrity

Identify the Top Data Integrity Challenges Resulting from the Pandemic and Oversight Strategies to Mitigate Them

Discuss the different ways the pandemic has impacted the integrity of clinical data
Identify clinical data integrity areas of concern and risks that should be monitored
Share oversight best practices to mitigate these risks?

Speakers

Devry Spreitzer

Senior Director, Data Integrity Quality Assurance, ASTELLAS

Devry Spreitzer is the Senior Director, Data Integrity Quality Assurance at Astellas Pharmaceutical Global Development, Inc. He has 24 years of experience working in the Pharma industry in the areas of Data Integrity, Electronic Records / Electronic Signatures regulations, computer... Read More →

Thursday October 22, 2020 2:00pm - 2:30pm EDT

Expert Presentation

2:30pm EDT

Quality By Design

Understand How the Pandemic Has Reinforced Quality By Design Principles

Understand the definition and purpose of quality by design
Examine how applied QbD principles mitigated risk during the pandemic
Discuss how the pandemic has demonstrated the value of QbD

Speakers

Sharon S. Reinhard, M.S.

Vice President, R&D QA, CSL BEHRING

Thursday October 22, 2020 2:30pm - 3:00pm EDT

Expert Presentation

3:00pm EDT

Energizer Break

Thursday October 22, 2020 3:00pm - 3:15pm EDT

Networking Break

3:15pm EDT

INTERACTIVE DISCUSSION: Clinical Quality Post-Pandemic

Examine Process and Technology Adaptations Forced by the Pandemic That Have Had A Positive Impact on Clinical Quality

Discuss which processes and operations have been positively impacted by the pandemic
Have any questions that haven’t been answered during the conference? Bring them to this session and we’ll discuss.

Speakers

Interactive

4:15pm EDT

Top Takeaway Points From This Year's CQOF

Thursday October 22, 2020 4:15pm - 4:30pm EDT