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Tuesday, January 21
 

8:00am

Seminar Registration and Continental Breakfast
Tuesday January 21, 2020 8:00am - 9:00am

9:00am

Seminar Chairperson's Opening Remarks
Speakers
avatar for Brigid McTague

Brigid McTague

Head, Strategic Partnerships Global Clinical Development Operations (GCDO), Janssen
As Head, GCDO Strategic Partnerships, Brigid McTague is accountable to partner with Janssen R&D Procurement to define and manage the sourcing strategy across all clinical activities for Janssen studies across all markets, phases and all Therapeutic Area. Brigid has over 20 years of... Read More →


Tuesday January 21, 2020 9:00am - 9:15am

9:15am

Seminar Keynote: Create a Blueprint for Effective Full Study Execution
  • Explore effective planning and on-boarding of all key stakeholders during study start-up
  • Review the benefit of shared common goals between Sponsor, CRO, and Study Site
  • Understand and incorporate effective communication strategies and steps to achieve synergy between key stakeholders

Speakers
avatar for Debbie Cote

Debbie Cote

Senior Director Clinical Operations, Coherus BioSciences
Debbie Cote is a Senior Director, Clinical Operations at Coherus BioSciences in Redwood City CA. She recently joined Coherus from Eureka Therapeutics where she was Head of Clinical Operations for T Cell Therapy oncology medicine. Prior to that, she was Director, Clinical Operations... Read More →


Tuesday January 21, 2020 9:15am - 10:00am

10:00am

Case Study: Insights into Successfully Managing a Combination Study
  • Review the evolution of working with combination studies through grassroots efforts
  • Discuss how working with collaborators can optimize trial performance
  • Dive into the advantages, challenges, and lessons learned in working with combination studies, including the key factors of success

Speakers
avatar for Denise Steckel

Denise Steckel

Head, Clinical Collaborations Management, Genentech
Denise Steckel has over 20 years of experience at Genentech in Operations Support, Quality and External Collaborations.  Currently Denise is the Head of the Clinical Collaborations Management group.  In this role Denise and her team ensure alignment of all CMC deliverables, including... Read More →


Tuesday January 21, 2020 10:00am - 10:45am

10:45am

30-Minute Networking Break
Tuesday January 21, 2020 10:45am - 11:15am

11:15am

Panel Discussion: Clearly Define Roles, Responsibilities, and Timelines for Effective Partnership Between Site, Sponsor, and CRO
  • Identify timelines across a multi-stakeholder partnership
  • Review how these partnerships evolve through open communication and shared common goals
  • Remove potential conflict and duplicative efforts by clearly understanding the contract between parties
  • Provide operational oversight of the trial by detailing each role and responsibility in the project

Speakers
avatar for Lauren Murphy

Lauren Murphy

Sr. Clinical Research Consultant, Independent Contractor
Lauren has thirty plus years of Clinical Research and Development experience in both pharmaceutical and CRO industries.  In her current role as a Sr. Clinical Research Associate Consultant, Lauren manages both drug and device trials in the U.S. for a variety of indications.  She... Read More →
avatar for Deborah Collyar

Deborah Collyar

President, Patient Advocates In Research (PAIR)
Deborah Collyar has been a patient engagement leader since her first cancer diagnosis. She founded Patient Advocates in Research (PAIR) international communication network in 1996, "where research meets reality." Deborah infuses hundreds of patient advocates into research programs... Read More →
avatar for Barbara A. Novak

Barbara A. Novak

Senior Manager, Clinical Operations, Kyowa Kirin Pharmaceutical Development
Barbara has more than twenty-five years of Clinical Research and Development experience and has been with Kyowa Kirin for the past ten years. In her role, Barbara is the North America - Europe regional eTMF business administrator and the Global Process and Quality Control Manager... Read More →
avatar for Brigid McTague

Brigid McTague

Head, Strategic Partnerships Global Clinical Development Operations (GCDO), Janssen
As Head, GCDO Strategic Partnerships, Brigid McTague is accountable to partner with Janssen R&D Procurement to define and manage the sourcing strategy across all clinical activities for Janssen studies across all markets, phases and all Therapeutic Area. Brigid has over 20 years of... Read More →
avatar for Aryn Knight, B.S., CCRP

Aryn Knight, B.S., CCRP

Administrative Director, Center for Clinical Research, TEXAS HEART INSTITUTE
Aryn is a Certified Clinical Research Professional (CCRP) with more than 16 years of direct experience in clinical research in academia and hospital environments. Since 2013, Ms. Knight has also served as the active Chapter Chair for Houston/Galveston Society of Clinical Research... Read More →
avatar for Matt Lowery, ACRP-CP, CCRC

Matt Lowery, ACRP-CP, CCRC

Director of Clinical Research, Suncoast Neuroscience Associates
Matt has over 12 years of experience in clinical research on both the site and sponsor level. On the site side, Matt has worked as a study coordinator, site manager, director of clinical research, and assists other sites with general consulting, business development, and budget/contract... Read More →
avatar for Casey E. Orvin

Casey E. Orvin

President, Society for Clinical Research Sites (SCRS)
Casey Orvin is President of the Society for Clinical Research Sites (SCRS), a global organization representing over 9500 clinical sites in 47 countries.  Prior to joining SCRS, Orvin successfully led a network of research sites conducting clinical trials for pharmaceuticals, vaccines... Read More →


Tuesday January 21, 2020 11:15am - 12:15pm

12:15pm

Luncheon for Seminar Participants
Tuesday January 21, 2020 12:15pm - 1:15pm

1:15pm

Implement The Risk-Based Approach And How It Is Changing The Way You Engage With Partners
  • Address trends instead of data points being led by stats and data management
  • Understand how the approach increases operational efficiency, and reduce costs
  • Ensure monitoring obligations are fulfilled, and protocol is deployed correctly and reported appropriately

Speakers
avatar for Patrick Zbyszewski

Patrick Zbyszewski

Vice President, Data Management, Onconova
Patrick Zbyszewski has more than 20 years of clinical/pharmaceutical experience in the areas of clinical operations, data management and marketing. He has been employed at small biotechnology firms including Corixa Corporation, clinical research organizations such as Quintiles and... Read More →


Tuesday January 21, 2020 1:15pm - 1:45pm

1:45pm

Centralized Monitoring: The Core of RBM – Case Studies and Value Proposition
  • Understand centralized monitoring techniques
  • Identify opportunities to help monitors make more informed decisions
  • Technology and Analytical enablers for efficient and effective monitoring

Speakers
avatar for Zabir Macci

Zabir Macci

Associate Director, Process/Technology/Analytics, Centralized Monitoring Services, IQVIA
Zabir Macci represents Centralized Monitoring for IQVIA, focused on optimizing the approach to risk-based monitoring (RBM). He brings expertise spanning risk-based monitoring, business analysis, continuous process improvement, and analytics for clinical trials. He currently leads... Read More →


Tuesday January 21, 2020 1:45pm - 2:30pm

2:30pm

Q&A on RBM
Speakers
avatar for Zabir Macci

Zabir Macci

Associate Director, Process/Technology/Analytics, Centralized Monitoring Services, IQVIA
Zabir Macci represents Centralized Monitoring for IQVIA, focused on optimizing the approach to risk-based monitoring (RBM). He brings expertise spanning risk-based monitoring, business analysis, continuous process improvement, and analytics for clinical trials. He currently leads... Read More →
avatar for Patrick Zbyszewski

Patrick Zbyszewski

Vice President, Data Management, Onconova
Patrick Zbyszewski has more than 20 years of clinical/pharmaceutical experience in the areas of clinical operations, data management and marketing. He has been employed at small biotechnology firms including Corixa Corporation, clinical research organizations such as Quintiles and... Read More →


Tuesday January 21, 2020 2:30pm - 3:00pm

3:00pm

30-Minute Networking Break
Tuesday January 21, 2020 3:00pm - 3:30pm

3:30pm

Deep Dive Into Outsourcing and Innovation In 2020 And Beyond
  • Create a strategy model for partnering with CROs or new types of partners out there
  • Organize companies and partnerships across the industry to get their attention and keep their attention
  • Collaborate with CROs earlier to increase innovation and decrease disruptive quality trials

Speakers
avatar for Colleen Graham

Colleen Graham

Director, Clinical Development Operations, Momenta Pharmaceuticals, Inc.
Colleen Graham has over 20 years of extensive Clinical Research experience. She began her research career at a Clinical Site, and has held a variety of operational positions from an Ethical Review Board to CROs and Pharmaceutical companies, both large and small. Her experience includes... Read More →


Tuesday January 21, 2020 3:30pm - 4:15pm

4:15pm

Seminar Concludes
Tuesday January 21, 2020 4:15pm - 4:15pm
 
Wednesday, January 22
 

7:00am

8:00am

Congress Chairperson's Opening Remarks
Speakers
avatar for Pablo Graiver

Pablo Graiver

Vice President, Site & Patient Network, IQVIA
Pablo is the founder and CEO of Antidote. Since 2009, under his leadership, the company (formerly known as TrialReach) has raised almost $20m in venture capital and grown to become a leading player within the digital health sector, empowering thousands of patients worldwide to discover... Read More →


Wednesday January 22, 2020 8:00am - 8:30am

8:30am

Anticipating the Impact Of The Patient Engagement Movement On Clinical Operations
  • Overview of the current clinical landscape and primary drug development operating conditions
  • Review of market forces necessitating the adoption of patient-centric activity
  • Assessment of critical areas most impacted and the implications for new operating models
  • Analysis of data quantifying the return on patient engagement initiatives

Speakers
avatar for Kenneth Getz

Kenneth Getz

Deputy Director, Research Professor, Tufts Center For the Study of Drug Development
Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center... Read More →


Wednesday January 22, 2020 8:30am - 9:15am

9:15am

Enhance Populations for Clinical Trial Diversity
  • Discuss FDA Guidance on enhancing the diversity of clinical trial populations — including eligibility criteria, enrollment practices, and trial designs as guidance for industry
  • Deep dive into recommendations such as enrichment, inclusive trial practices, and design, and methodological ways to bring in a wider range of patient populations
  • How to ensure the inclusion of diverse patients in clinical trial design

Speakers
avatar for Jovonni  R. Spinner, MPH, CHES

Jovonni R. Spinner, MPH, CHES

Senior Public Health Advisor, U.S. Food and Drug Administration, Office of Minority Health and Health Equity (OMHHE)
Ms. Jovonni Spinner is a public health strategist and thought leader with a deep passion for improving health equity across the lifespan through research, communication, multi-sector partnerships, and leadership coaching. She is known as a public health programming guru using her... Read More →


Wednesday January 22, 2020 9:15am - 10:00am

10:00am

Keynote Presentation Presented By: IQVIA
Speakers
avatar for Pablo Graiver

Pablo Graiver

Vice President, Site & Patient Network, IQVIA
Pablo is the founder and CEO of Antidote. Since 2009, under his leadership, the company (formerly known as TrialReach) has raised almost $20m in venture capital and grown to become a leading player within the digital health sector, empowering thousands of patients worldwide to discover... Read More →


Wednesday January 22, 2020 10:00am - 10:45am

10:45am

30-Minute Networking Break
Wednesday January 22, 2020 10:45am - 11:15am

11:15am

Advantages Of - And Practical Ways To - Involve Patients In Clinical Research
  • Enhance how disease and stage appropriate patients can help you refine your research questions
  • Understand how patients can help with accrual
  • Best practices on how to find relevant patient advocates

Speakers
avatar for Dr. Kelly Shanahan

Dr. Kelly Shanahan

Patient Advocate
In 2008, Kelly Shanahan had everything going for her: a busy and successful ob-gyn practice; a precocious 9 year old daughter; and a well used passport from traveling all over the world with her family to attend conferences, with a liberal dose of vacation on the side. When she was... Read More →


Wednesday January 22, 2020 11:15am - 12:00pm

12:00pm

Look To How The Clinical Industry Will Be Impacted By Change In The Future
  • Discuss how to facilitate clinical development and clinical trials through process improvement tips
  • Review efforts around new technology systems and the tools needed to make the clinical research process more effective
  • Dive into the main themes needed for successful change management: People, Process, and Tools

Moderators
avatar for Craig Lipset

Craig Lipset

Former Head, Clinical Innovation, Pfizer

Speakers
avatar for Mitchell Katz

Mitchell Katz

Vice President, Development Operations, Ferring Pharmaceuticals
Dr. Mitchell Katz recently joined Ferring Pharmaceuticals, Inc. as Vice President, Development Operations. In this position, he is responsible for providing strategic direction and operational excellence in running Ferring’s clinical stage programs. Dr. Katz has over 25 years... Read More →
avatar for Caryn Barnett

Caryn Barnett

Vice President, Clinical Operations, Advanced Accelerator Applications
Caryn Barnett has 24 years in the pharmaceutical industry both in large pharma and the biotech sectors.  Caryn spent over 22 years with Eli Lilly and Company and supported numerous disease areas and has extensive clinical project management, quality, and overall drug delivery experience... Read More →
avatar for Camisha Harge

Camisha Harge

Vice President, Clinical Operations, Coherus BioSciences
avatar for Panna Sharma

Panna Sharma

Chief Executive Officer & President, Lantern Pharma
Panna Sharma is the President, Chief Executive Officer and Board member of Lantern Pharma, a clinical stage oncology biotech using artificial intelligence (AI) and genomics to innovate the rescue, revitalization, and development of precision cancer therapeutics. Lantern is focused... Read More →
avatar for Jim Kremidas

Jim Kremidas

Executive Director, Association of Clinical Research Professionals (ACRP)


Wednesday January 22, 2020 12:00pm - 1:00pm

1:00pm

Luncheon for Conference Participants
Wednesday January 22, 2020 1:00pm - 2:00pm

2:00pm

Track A: Novel Approaches In Data and Technology
Speakers
avatar for Kerensa Saljooqi

Kerensa Saljooqi

Sr. Director, Clinical Operations, Emalex Biosciences Inc.
Data science and AI are being incorporated early in drug development to help detect subject phenotypes and allow us to enrich the patient population with subjects who are likely to respond to treatment. Digital tech is being trialed to detect trends compared to standard primary endpoint... Read More →


Wednesday January 22, 2020 2:00pm - 2:00pm

2:00pm

Track B: Trial Innovations
Speakers
avatar for Craig Lipset

Craig Lipset

Former Head, Clinical Innovation, Pfizer


Wednesday January 22, 2020 2:00pm - 2:00pm

2:00pm

Track A: Utilize Novel Imaging Data As Part Of Your Real-World Evidence
  • Look at accessing, aggregating and normalizing at scale with heterogenous imaging data, and link to other longitudinal data sets
  • How to operate and mine valuable information from imaging to access more clinically instructive pieces of data
  • Deep dive into the growing pressure to deidentify and share clinical data post-trial, and how data derived from imaging can assist

Speakers
avatar for Matthew Michela

Matthew Michela

President and CEO, Life Image
Matthew A. Michela has been a healthcare industry executive for 30 years. He joined Life Image as CEO in 2015 with the mission of democratizing data to create an interoperable healthcare ecosystem that creates a connected view of a patient’s journey. Throughout his career, Matthew... Read More →


Wednesday January 22, 2020 2:00pm - 2:35pm

2:00pm

Track B: Discuss Innovative Digital Solutions In Clinical Research
  • Leverage new technology platforms and new tools to support all stakeholders involved in clinical research
  • Create a seamless approach to maximize and optimize tools for higher qualities and shorter timelines
  • Fundamentally change the way you are and the way you implement the organization

Speakers
avatar for Craig Lipset

Craig Lipset

Former Head, Clinical Innovation, Pfizer


Wednesday January 22, 2020 2:00pm - 2:35pm

2:35pm

Transition Time
Wednesday January 22, 2020 2:35pm - 2:40pm

2:40pm

Track A: Patient Perspectives on Real World Data (RWD) & Evidence (RWE)
  • This session provides a brief background on RWD and RWE as patients see them. 
  • Points include the way RWD/RWE impacts patients in ways that are not normally discussed with the intent to explain why key variables, such as adaptive design, health literacy principles, and data sharing and privacy are important factors for sponsors and vendors to incorporate into their trials. 
  • We will also describe what patients want and need from research, and how the approval process is only the beginning.


Speakers
avatar for Catina O'Leary

Catina O'Leary

President & CEO, Health Literacy Media (HLM)
As President and CEO, Catina O’Leary oversees Health Literacy Media’s core activities, including the Clearly Communicating Clinical Trials program (C3T), and works to set and maintain the strategic vision for the organization. Catina has steered the organization onto the course... Read More →
avatar for Deborah Collyar

Deborah Collyar

President, Patient Advocates In Research (PAIR)
Deborah Collyar has been a patient engagement leader since her first cancer diagnosis. She founded Patient Advocates in Research (PAIR) international communication network in 1996, "where research meets reality." Deborah infuses hundreds of patient advocates into research programs... Read More →


Wednesday January 22, 2020 2:40pm - 3:15pm

2:40pm

Track B: Implement Strategic Innovations in Clinical Trials
  • Review of implementation of past and current innovations – what went well, what could have been done better. Deep dive into the most impactful innovation of the past 40 years and why it was successful.
  • Discuss the necessity of having a foundation and what goes into the foundation.
  • Review the necessity of having aligned stakeholders – the ‘what’s in it for me’ question. What is the common problem?
  • Have the right team in place, led by the business. Do not rush implementation; first impressions are everything. Start with small successes – don’t try for the home run at the beginning

Speakers
avatar for Hugh Donovan

Hugh Donovan

Managing Expert, Clinical Center of Excellence, YourEncore
Hugh Donovan has had over 40 years of drug development experience. He has managed Biostatistics, Data Management and Programming groups of ever-increasing size in medium-sized pharma, large-sized pharma, small biotech, large biotech companies and large CROs, in both Europe and the... Read More →


Wednesday January 22, 2020 2:40pm - 3:15pm

3:15pm

30-Minute Networking Break
Wednesday January 22, 2020 3:15pm - 3:45pm

3:45pm

Track A: Develop Endpoints And Reported Outcomes To Enhance Patient-Centric Strategy And Models
  • Develop and execute digital strategy for engagement, enrollment, and retention
  • Integrate patient-centric initiatives throughout the strategy and planning from participating in patient advisory boards to protocol review committees
  • Create communication resources such as apps, texts, and real-time reminders/notifications

Speakers
avatar for Christine Sawicki

Christine Sawicki

Director Specialty Clinical Innovation, CVS Health
Christine leads innovation for CVS Health’s Specialty division. Her team identifies and introduces solutions that improve patient experience, enhance clinical care, and provide cost-effective solutions to deliver the highest level of clinical care.Ms. Sawicki has more than 25 years... Read More →


Wednesday January 22, 2020 3:45pm - 4:20pm

3:45pm

Track B: How A Mid-Sized Organization Performs Risk Evaluation, Identification, Monitoring, And Risk Reviews
  • CRO partnership during risk evaluation, identification, and escalation processes
  • Organizing teams to perform the risk evaluation and review processes Risk identification and root cause analysis tips
  • Documentation of actions and audit-readiness

Speakers
avatar for Amy Neubauer

Amy Neubauer

Director, Data Quality Oversight, Alkermes
Amy Neubauer serves as Director, Data Quality Oversight at Alkermes, a company developing innovative medicines that address the unmet needs and challenges of people living with debilitating diseases, such as schizophrenia, depression, addiction, multiple sclerosis, and cancer.  She... Read More →


Wednesday January 22, 2020 3:45pm - 4:20pm

4:20pm

Transition Time
Wednesday January 22, 2020 4:20pm - 4:25pm

4:25pm

Track A: Enable Patient-Centric Clinical Studies: TransCelerate's Patient Engagement Tools
  • Describe TransCelerate’s Patient Experience Initiative and the toolkits
  • Recognize the value of patient engagement in the development of clinical study protocols
  • Identify the clinical study participant experience as a valuable outcome measure
  • Appreciate the opportunity for embedding these practices into the development process

Speakers
avatar for Mary Elmer

Mary Elmer

Executive Director, Patient Experience Organization, Merck & Co., Inc.
Mary Elmer is the Executive Director of Patient Experience and Insights at Merck. This group seeks to create an experience that engages patients and caregivers in optimizing their health, wellbeing, and healthcare outcomes. She leads a patient engagement team that brings the voice... Read More →


Wednesday January 22, 2020 4:25pm - 5:00pm

4:25pm

Track B: Dive Into Risk-Based Monitoring (RBM) As A Business Intelligence Of The Clinical Trials. Are We Realizing The Full Potential?
  • Elevate monitoring to the next level through continuous improvement, organizational silos, reduction, and increased efficiency
  • Understand key risk indicators, thresholds, algorithms, and issue management
  • Envision RBM as a business intelligence function in the clinical trials oversight to expand its benefits

Speakers
avatar for Vera Pomerantseva

Vera Pomerantseva

Senior Central Monitoring Lead, Bristol-Myers Squibb
Over 18 years of pharmaceutical industry experience in various functions, such as analytics, clinical operations, project management, trainings and risk-based monitoring. Published author of multiple articles in international magazines, such as Pharmaceutical Medicine Journal of New... Read More →


Wednesday January 22, 2020 4:25pm - 5:00pm

5:00pm

Networking Reception
Wednesday January 22, 2020 5:00pm - 6:00pm

6:00pm

Main Conference Day One Concludes
Wednesday January 22, 2020 6:00pm - 6:00pm
 
Thursday, January 23
 

8:00am

Registration and Continental Breakfast
Thursday January 23, 2020 8:00am - 9:00am

9:00am

Chairperson's Opening Remarks
Speakers
avatar for Pablo Graiver

Pablo Graiver

Vice President, Site & Patient Network, IQVIA
Pablo is the founder and CEO of Antidote. Since 2009, under his leadership, the company (formerly known as TrialReach) has raised almost $20m in venture capital and grown to become a leading player within the digital health sector, empowering thousands of patients worldwide to discover... Read More →


Thursday January 23, 2020 9:00am - 9:15am

9:15am

Unified Clinical Operations: What Does It Really Mean?
  • Explore the real meaning of “Unified Clinical Operations” from both technology and process perspectives
  • Touchpoints between eClinical systems
  • Processes experiencing the most value from a unified approach and expected benefits
  • Adapting processes to take advantage of technology and automation
  • Practical implications and cost impact if complete unification is not desired, or not practical

Speakers
avatar for Kathie Clark

Kathie Clark

Product Director, CTMS, Ennov
Kathie is Director, CTMS for Ennov. She provides thought leadership for the industry and is the author of many white papers, journal articles and blog posts on eTMF and regulatory topics. She is a member of the TMF Reference Model steering committee and has chaired or participated... Read More →


Thursday January 23, 2020 9:15am - 10:00am

10:05am

Discuss The People, Process, and Technology Needed For A Successful Clinical Trial
  • Explore new practices leveraging cutting-edge tools to collect data in real-time and apply data-driven decision-making
  • Review an example of using advanced technologies by trial subjects, that is driving operational insights and improvements
  • Learn how to incorporate digital strategies for patient engagement throughout the trial process

Speakers
avatar for Debbie Profit

Debbie Profit

Associate Director, Alliance Management, Business Operations, Otsuka Pharmaceutical Development & Commercialization, Inc.
Debbie Profit is the Associate Director, Alliance Management - Global Clinical Development for Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC). Ms. Profit has also served in the role of Associate Director of Clinical Operations for over 9 years at OPDC.


Thursday January 23, 2020 10:05am - 11:00am

11:00am

30-Minute Networking Break
Thursday January 23, 2020 11:00am - 11:30am

11:30am

Panel Discussion: Deep Dive Into Diversity and Inclusion in Clinical Trials From a Patient and Industry Perspective
  • Look beyond race and ethnicity and focus on age and gender
  • Understand what this means and how it is used as a strategic approach for the future of clinical trials
  • Gain insights into inclusive research that can help ensure positive health outcomes

Moderators
avatar for Mary Elmer

Mary Elmer

Executive Director, Patient Experience Organization, Merck & Co., Inc.
Mary Elmer is the Executive Director of Patient Experience and Insights at Merck. This group seeks to create an experience that engages patients and caregivers in optimizing their health, wellbeing, and healthcare outcomes. She leads a patient engagement team that brings the voice... Read More →

Speakers
avatar for Dr. Kelly Shanahan

Dr. Kelly Shanahan

Patient Advocate
In 2008, Kelly Shanahan had everything going for her: a busy and successful ob-gyn practice; a precocious 9 year old daughter; and a well used passport from traveling all over the world with her family to attend conferences, with a liberal dose of vacation on the side. When she was... Read More →
avatar for Cassandra R. Smith

Cassandra R. Smith

Diversity and Inclusion in Clinical Trials Lead, Janssen Research & Development
Cassandra Smith currently serves as the Diversity & Inclusion in Clinical Trials Lead, at Janssen Research & Development, LLC, part of the Pharmaceutical Companies of Johnson & Johnson.  In this role, she leads efforts to advance Janssen’s diversity and inclusion in clinical trial... Read More →
avatar for Jovonni  R. Spinner, MPH, CHES

Jovonni R. Spinner, MPH, CHES

Senior Public Health Advisor, U.S. Food and Drug Administration, Office of Minority Health and Health Equity (OMHHE)
Ms. Jovonni Spinner is a public health strategist and thought leader with a deep passion for improving health equity across the lifespan through research, communication, multi-sector partnerships, and leadership coaching. She is known as a public health programming guru using her... Read More →
avatar for Christina Brennan, MD, MBA

Christina Brennan, MD, MBA

VP, Clinical Research, Northwell Health
Christina Brennan, MD has devoted her career to clinical research and currently serves as Northwell Health’s vice president of clinical research. Committed to the advancement of science and medicine, Dr. Brennan has more than 20 years of extensive clinical research experience, including... Read More →


Thursday January 23, 2020 11:30am - 12:30pm

12:30pm

Luncheon For Conference Participants
Thursday January 23, 2020 12:30pm - 1:30pm

1:30pm

Practical Approaches to Risk Management: Partnering with Clinical QA
  • Describe changes to Risk Management based on Regulatory Requirements
  • Examine how Clinical Operations and Clinical Quality Assurance can collaborating develop plans and manage risk
  • Discuss some real-world examples in partnering with Clinical QA

Speakers
avatar for Dawn M. Niccum

Dawn M. Niccum

Senior Director of QA and Compliance, inSeption Group
Dawn Niccum is the Sr. Director of QA and Compliance at the inSeption Group, where she is responsible for all quality and compliance areas for the company including SOP development, deviation & CAPA management, oversight of computer system validation, audit conduct and support, and... Read More →


Thursday January 23, 2020 1:30pm - 2:15pm

2:30pm

Quality Trends That Impact Clinical Development
  • Include the advancements in technology with inspections
  • Address how to analyze metrics to identify trends and recent findings
  • Learn how to adapt to new quality trends that are impacting clinical development
  • Observe how to improve clinical operations in your clinical trial

Speakers
avatar for Linda Vineski

Linda Vineski

Associate Director, Clinical Quality Operations Manager, Merck
Linda Vineski has over 18 years of clinical trial experience in Quality, Risk Management, Operations Support, External Collaborations, Clinical Trial Conduct and Global Inspections. Currently, at Merck, Linda is responsible for end to end Quality Management Support of clinical trials... Read More →


Thursday January 23, 2020 2:30pm - 3:15pm

3:15pm

Review Draft ICH E8 Considerations For Clinical Studies
  • Describe the proposed stakeholder role (including patients and treating physicians) proposed in designing clinical trials
  • Explore what the proposed ICH guideline means for subjects in clinical trials
  • Understand how designing quality into a study can increase the trust in the results

Speakers
avatar for Matt Lowery, ACRP-CP, CCRC

Matt Lowery, ACRP-CP, CCRC

Director of Clinical Research, Suncoast Neuroscience Associates
Matt has over 12 years of experience in clinical research on both the site and sponsor level. On the site side, Matt has worked as a study coordinator, site manager, director of clinical research, and assists other sites with general consulting, business development, and budget/contract... Read More →
avatar for Betsy Fallen

Betsy Fallen

Consultant, BAFallen Consulting LLC
Ms. Fallen is an authority on the business processes and associated use of information technology in drug development with a focus on regulatory and clinical. A passionate advocate for moving life sciences business on-line, Betsy is an expert on regulatory and clinical operations... Read More →


Thursday January 23, 2020 3:15pm - 4:00pm

4:00pm

Improve The Patient Experience Through Health Literacy
  • Why health literacy is important in improving the Patient Experience
  • How can we incorporate health literacy into daily activities?

Speakers
avatar for Catina O'Leary

Catina O'Leary

President & CEO, Health Literacy Media (HLM)
As President and CEO, Catina O’Leary oversees Health Literacy Media’s core activities, including the Clearly Communicating Clinical Trials program (C3T), and works to set and maintain the strategic vision for the organization. Catina has steered the organization onto the course... Read More →


Thursday January 23, 2020 4:00pm - 4:45pm

4:45pm

Conference Concludes
Thursday January 23, 2020 4:45pm - 4:45pm