Exhibit Hall Opens

AQC Pre-Conference Workshop

Hear what the Avoca Quality Consortium (AQC) has been up to this year and the progress we have made on the 2020 AQC Workstreams:

• Inspection Readiness
• Provider Qualification
• Site Centricity
• Risk Based Quality Management
• Change Control

Presenters:

• Janis Hall, Senior Consultant, The Avoca Group
• Irene Michas, Senior Consultant, The Avoca Group

Welcome and Opening Remarks

For years, we have waited for a technology company or some other disrupter to enter pharmaceutical drug development, and now COVID has officially disrupted our industry.  Historically, inefficient and siloed approaches lead to long lag times for drug development which is a disservice to the patients whom we serve. We must keep momentum created by the fast adaptation to COVID to continue to improve our processes through innovative solutions. Our focus over the next two days will be on what we can do, now, today to improve our processes and how we need to drastically change our mindset to open clinical development to new technologies and a new way of thinking about the drug development process.

• Patricia Leuchten, Founder and CEO, The Avoca Group

Speaker: Jim Lawless, Motivational Speaker, Bestselling Author, “Taming Tigers”

Hear from award-winning speaker and author, Jim Lawless, about empowerment and the need for change during this unprecedented time in the clinical trials industry.

Brief Intermission

Interview with Brian Burk, Global Healthcare, Health Insurance and Life Sciences Vertical Leader, Verizon

An enlightening interview to discuss Verizon’s involvement and partnerships utilizing technology to evolve clinical trial patient engagement.

Workshop: ICH E6 (R3)

Brief overview of the proposed ICH E6 (R3) business plan and a workshop to discuss what guidance the industry needs from the regulators to adequately implement these technologies while ensuring patient safety and data integrity. A thoughtful guide through exercises that attendees will work through in considering their company’s needs.

Facilitator:

• Steve Whittaker, Senior Consultant, The Avoca Group

Interview with Mark Matousek, President, Mark Matousek Media

The Avoca Group CEO interviews Mark who provides an illuminating description of his experience as a clinical trial patient and the key factors that impacted his interest in joining and participating in a clinical trial.

Executive Panel and Q&A: The Current State of the Industry as it Pertains to Patient Centered Approaches

Join The Avoca Group’s Senior Consultant, Denise Calaprice, who developed Avoca’s Patient Engagement Materials, and a panel of senior leaders as well as patients to discuss the path to a clinical trial – who winds up in them and who does not? And why is diversity in clinical trial participants a continuous challenge?

Moderator:

• Denise Calaprice, PhD, Senior Consultant, The Avoca Group

Panelists:

• Leslie R. Boone, Research Services Consultant, Vanderbilt Institute for Clinical and Translational Research
• Rose Kidd, Senior Vice President, Clinical Operations, ICON
• Gaurang Majmudar, Senior Director, Patient Centric Services, Marken
• Paulo Moreira, Global Head of Clinical Operations, Agenus
• Meghan Swardstrom, Vice President, Clinical Development & Operations, Impel NeuroPharma
• Owen Swardstrom, Patient in Clinical Trial

Final Comments

Sessions End for Day 1
Exhibit Hall remains open until 5:00pm

Exhibit Hall Opens

Welcome and Opening Remarks

Keynote Speaker: Majid Iqbal, Strategic Design Lead of Janssen’s DEEP Initiative and Principal of Designcoders.org

Get motivated by keynote speaker, Majid Iqbal, as he describes how Janssen is advancing innovation and harnessing the power of collaboration with their Digital Endpoints Ecosystem and Protocols (DEEP) project. Majid, strategic design lead of the DEEP initiative, will share his views on how quality and innovation go “hand-in-hand” and how his model for Thinking in Services can be used to expedite the adoption of innovation.

Executive Panel and Q&A: Innovation

A panel of senior leaders discuss the impacts of innovation within our industry and how each player in the ecosystem will impact the adoption of these new ways of working.

Moderator:

• Steve Whittaker, Senior Consultant, The Avoca Group

Panelists:

• Gregg Fromell, MD, Vice President & Clinical Director, HCA Research Institute
• Bert Hartog, PhD, R&D Operations – Senior Director Janssen Clinical Innovation, Johnson & Johnson
• Hassan Kadhim, Global Head of Clinical Trial Business Capabilities, Clinical Innovation & Industry Collaborations Global Development Operations, Bristol Myers Squibb
• Dineo Lioma, Founder, Deep Medical Therapeutics
• Robert Metcalf, PhD, Vice President, Clinical Design Delivery & Analytics, Eli Lilly and Company

Interview with Dineo Lioma, Founder, Deep Medical Therapeutics

An Interview with Dineo Lioma, biotech innovator and businessperson on her plans to use artificial intelligence in the world of medicine to help combat viruses throughout the globe.

Brief Intermission

Workshop: Risk Management

University of Utah’s Maryse Brulotte will provide a case study on how they’ve implemented an organizational right-sized risk management framework. The workshop will then discuss how to ensure that your risk management approaches are aligned with the size and capabilities of your organization and what these risk management frameworks look like when operationalized across different sized organizations.

Facilitator:

• Jay Turpen, Senior Consultant, The Avoca Group

Interview with Coleen Glessner, Senior Vice President, Chief Quality Officer, Alexion Pharmaceuticals

Coleen will share her reflections about quality and risk management in clinical trials, from a past, present, and future perspective, post-COVID-19.

Executive Panel and Q&A: Quality and Risk

How does the increasing complexity in study design and disruptive innovations in clinical trials affect quality and risk management frameworks in clinical trial delivery?

Moderator:

• Cheryl Murphy, Senior Vice President, Client Development and Engagement, The Avoca Group

Panelists:

• Priya Chaturvedi, PhD, Vice President, Global Clinical Quality Assurance, Eisai
• James Dixon, Senior Vice President, Quality and Enterprise Learning, PPD
• David Fryrear, Global Head of Clinical and Research Quality Assurance, Astellas Pharma
• Diane Puglia Ryan, Head of Process Quality & Operations, Quality Center of Excellence, Pfizer
• Christine R. Sahagian, MS, Vice President, Quality Assurance and Compliance (GCP/GLP/GPvP), Apellis Pharmaceuticals

Closing Remarks

Sessions End for Day 2
Exhibit Hall remains open until 5:00pm