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16: Content Hubs [clear filter]
Monday, June 24
 

10:10am

#101 CH: Modernizing Data Review in Drug Development with R Shiny
Component Type: Workshop
Level: Intermediate

ASA Biopharm/DIA Safety Working Group, safety clinicians, statisticians and data scientists, developed an R Shiny tool available for all, initially for detection and review of hepatotoxicity. Discuss this new tool and seek input on next steps and support.

Learning Objectives

Describe an R Shiny safety tool developed by the Interactive Safety Graphics taskforce of the ASA Biopharm/DIA Safety Working Group, for review of liver function and Hy’s Law for use during drug development and submission review; Discuss audience feedback on path forward for this new model of agile software development and support, with consideration of compliance.

Chair

Susan Duke, MSc


Speakers
avatar for Susan Duke

Susan Duke

Mathematical Statistician, OB, OTS, CDER, FDA
Susan became involved in safety related industry-wide graphics in 2009 when she joined the FDA/Industry/Academia Safety Graphics WG. She is currently a Mathematical Statistician reviewer in CDER and member of a cross-functional safety monitoring WG co-sponsored by DIA and ASA Biopharm... Read More →


Monday June 24, 2019 10:10am - 10:40am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:15pm

#122 CH: Leveraging Extra Value from an Intern Program: Non- Traditional Majors Add Unexpected Value
Component Type: Workshop
Level: Basic

This workshop will assist attendees in conducting a needs assessment for an effective intern program, identify potential areas of opportunity and discuss the process for implementing/improving an intern program.

Learning Objectives

Define and create an intern program. Design an infrastructure to leverage new skills and ways of working; Identify and create an opportunity map with cross mapping of potential majors.

Chair

Diane Schommer, MBA


Speakers
avatar for Diane Schommer

Diane Schommer

Associate Director, Project Management, Global PV Strategy Management Office, AbbVie
Diane Schommer is an Associate Director, Project Management, Global Pharmacovigilance Strategy Management Office at AbbVie. She has over 25 years of project management experience and has had her PMP since 2000. She has her BBA from Baylor University and her MBA from the University... Read More →


Monday June 24, 2019 12:15pm - 12:45pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:00pm

#126 CH: Separating the Hype from Reality in Pharmacovigilance Automation
Component Type: Workshop
Level: Intermediate

This interactive session will synthesize the PV automation journey and share lessons learned through case studies of solutions implemented at pharma companies. It will cover the technical, process, governance, and compliance challenges encountered.

Learning Objectives

Develop an end-to-end perspective on implementing pharmacovigilance (PV) process automation and the benefits being achieved in operation; Describe preparing the business case and roadmap and how to manage expectations; Identify technology choices, compliance issues, and change management considerations.

Chair

Jill Notte

Speaker

Facilitator
Harpreet Singh Kanwar



Speakers
avatar for Jill Notte

Jill Notte

Associate Director - Marketing, Cognizant
Jill Notte is a communications professional who has focused on drug safety for nearly 20 years. In 2001, she joined one of the first firms to offer adverse event case processing services and safety system hosting to pharmaceutical companies. She helped establish pharmacovigilance... Read More →
avatar for Harpreet Kanwar

Harpreet Kanwar

CTO Life Sciences, Cognizant
Harpreet Kanwar has more than 25 years’ experience in information technology and leads digital transformation programs for global pharma companies. As Chief Technology Officer, he is responsible for driving emerging technology adoption, delivery transformation, technology and architecture... Read More →


Monday June 24, 2019 1:00pm - 1:30pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:45pm

#132 CH: Advancing Trailblazing Research and Development: When to Speed Up, When to Slow Down
Component Type: Workshop
Level: Intermediate

Using a case study, participants will discuss a real-life example of a manufacturing roadblock and discuss problem-solving strategies, the importance of taking prudent risk, and building the right team for success.

Learning Objectives

Analyze risks and recognize trade-offs in preclinical development planning; Identify problem-solving strategies and formulate a plan to proceed accordingly in development planning; Apply case study-specific steps and learnings to any potential scenario; Apply best practices in participants’ own work.

Chair

Sandy Macrae, PhD


Speakers
avatar for Sandy Macrae

Sandy Macrae

Chief Executive Officer, Sangamo Therapeutics
Sandy Macrae serves as a member of the Company’s Board of Directors. He has twenty years of experience in the pharmaceutical industry most recently serving as the Global Medical Officer of Takeda Pharmaceuticals, where he established and led the Global Medical Office, which encompasses... Read More →


Monday June 24, 2019 1:45pm - 2:15pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#172 CH: Paving the Path for Family-Centered Design: Caregiver Roles in Medical Product Development
Component Type: Workshop
Level: Basic

Family caregivers are increasingly important to health care systems. Findings from a national multi-stakeholder summit on the caregiver’s role in medical product development offers new insight for engaging caregivers.

Learning Objectives

Discuss how informal caregivers, such as friends and relatives, support patients with activities of daily living and medical/nursing tasks; Describe existing regulatory pathways for family engagement in clinical trials; Discuss potential frameworks to engage caregivers in medical product development.

Chair

Grace Whiting, JD


Speakers
avatar for Grace Whiting

Grace Whiting

President and Chief Executive Officer, National Alliance for Caregiving
C. Grace Whiting, J.D., is the President and CEO of the National Alliance for Caregiving, a non-profit committed to advancing family caregiving through research, innovation, and advocacy. Ms. Whiting has led national and global research including Caregiving in the U.S. 2015 with AARP... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

9:15am

#221 CH: Getting the Question Right (GTQR) with Interdisciplinary Collaboration
Component Type: Workshop
Level: Intermediate

Inspired by the E9 R1 estimand framework, the DIA Getting the Question Right (GTQR) webinar series was organized in 2018 via intercommunity collaboration. This hub will provide a synthetic overview of the 6 popular webinars, followed by open Q&As.

Learning Objectives

Discuss the estimand framework described in the draft ICH E9 addendum; Recognize how the estimand framework may help get the question right and can be applied in various therapeutic and safety/benefit-risk contexts; Define how the estimand framework may advance the interpretation of study results.

Chair

William Wang, PhD


Speakers
avatar for William Wang

William Wang

Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader... Read More →


Tuesday June 25, 2019 9:15am - 9:45am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:00am

#227 CH: GCP for Contributing Investigator Versus Conducting Investigator-Initiated Trials in Emerging Regions
Component Type: Workshop
Level: Intermediate

Emerging regions are participating in clinical trials, but that only provides drug benefits to a small number of patients. Shifting to Investigator-initiated trials maximizes patient access, but requires more activities to be GCP compliant.

Learning Objectives

Define GCP for Investigator-Initiated trials; Discuss strategies for GCP compliance in emerging regions.

Chair

Terry Katz, MS


Speakers
avatar for Terry Katz

Terry Katz

Director, Head of Global Data Management and Statistics, Merck Animal Health
Terry Katz is Head of Data Management and Statistics at Merck Animal Health. Previously he was Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician, and Certifications... Read More →


Tuesday June 25, 2019 10:00am - 10:30am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11:45am

#250 CH: How to Efficiently Implement a Healthcare Compliance Program in Preparation for Your First Product Launch
Component Type: Workshop
Level: Basic

This interactive workshop will address important government requirements impacting life sciences companies pre- and post-commercialization, as well as discuss approaches to implementing strong healthcare compliance programs with limited resources.

Learning Objectives

Discuss the importance of ethical conduct, and how compliance generates future success (before and after commercialization); Describe the relevant healthcare compliance-related laws, regulations and guidances; Identify methods to implement efficiently implement a healthcare compliance program despite limited resources.

Chair

Marc Adler, JD


Speakers
MA

Marc Adler

President, Global Compliance Strategies


Tuesday June 25, 2019 11:45am - 12:15pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#278 CH: How to Write a Compelling Poster Abstract
Component Type: Workshop
Level: Basic

The workshop will discuss helpful hints in writing a complete and compelling abstract for poster submission at DIA.

Learning Objectives

Discuss how to tell a complete and compelling story with my poster abstract; Describe what to include, what to leave out, and how an abstract is scored for inclusion; Identify examples (blinded or fictitious) of strong and not-so-strong abstracts.

Chair

Margaret Richards, PhD


Speakers
avatar for Margaret Richards

Margaret Richards

Executive Director, Scientific Affairs, Real-World Solutions, PRA Health Sciences
Dr. Meg Richards has over 25 years' experience as an epidemiologist in the public health, biopharmaceutical, and contract research sectors. Prior to joining PRA as Executive Director of Scientific Affairs, Dr. Richards worked for 8 years at Mapi (ICON plc) and PPD-Evidera. Dr. Richards... Read More →


Tuesday June 25, 2019 3:30pm - 4:00pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Featured Topics Student Programming
  • Tags Workshop

4:15pm

#299.1 CH: Challenge of Regulatory Starting Material Designation and Its Implication on the Global Markets for the Post Approval Process
Component Type: Workshop
Level: Intermediate

Definition of the Regulatory Starting Material and its Impact on the Drug Substance manufacturing

Learning Objectives

Interpret the key elements for the designation of the regulatory starting material under ICH Q11 and describe its regulatory impact on the post approval changes in the global markets.

Chair

Xuhong Cheng, DrSc, PhD


Speakers
avatar for Xuhong Cheng

Xuhong Cheng

Associate Director, GRS - RA, Janssen, Pharmaceutical Companies of Johnson and Johnson
Xuhong holds a PhD degree in Organic Chemistry. She has eighteen years of pharmaceutical industrial experience including fourteen years of regulatory CMC for small molecule and biologic-pen injector combination products.


Tuesday June 25, 2019 4:15pm - 4:45pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

9:15am

#320 CH: Considering Consulting? The Good, the Bad, the Ugly, and the Profitable!
Component Type: Workshop
Level: Basic

Considering becoming a consultant, but not sure how to get started? This session explores the steps to becoming an independent consultant, common challenges and strategies to deal with them, and ways to make it rewarding and profitable.

Learning Objectives

Define what's really involved in being an independent consultant; Identify steps to becoming independent consultant; Discuss the pros of being an independent consultant, cons and how to deal with them.

Chair

Sheila Mahoney Jewels, MBA


Speakers
avatar for Sheila Mahoney Jewels

Sheila Mahoney Jewels

CEO, Reg/Clin Ops SME Independent Consultant, LifeSciHub
Sheila has over 25 years of experience in reg/clin ops, having operated as an SME on both the sponsor and vendor sides. Her current focus as an independent consultant (IC) is advocating for the independent workforce, and helping sponsors engage with them. Sheila has spent the last... Read More →


Wednesday June 26, 2019 9:15am - 9:45am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:00am

#326 CH: 2020 and Beyond, Data Capture Across Systems, Functions, and Modalities
Component Type: Workshop
Level: Advanced

This workshop will lead an interactive discussion related to clinical trials of the future. How will pharmaceutical companies interact with sites and patients? How do we better connect trial conduct and outcomes to our data consumers?

Learning Objectives

Discuss organization strategy; Recognize data modalities and their impact on the clinical trial space; Describe clinical trials of the future with an emphasis on data and site management.

Chair

Muzafar Mirza

Speaker

Facilitator
John Manlay, MS



Speakers
MM

Muzafar Mirza

Director, Program Lead, Pfizer Inc
Muzafar (Muz) Mirza is currently a Program Lead for the Hematology Portfolio in the Oncology Therapeutic Area that is part of the Data Monitoring &Management (DMM) group at Pfizer. As well as managing aspects of the Oncology portfolio, Muz is working on addressing challenges related... Read More →
JM

John Manlay

Director Clinical Data Management, Pfizer Inc


Wednesday June 26, 2019 10:00am - 10:30am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:30pm

#348 CH: Project Managing Your Own Leadership Journey
Component Type: Workshop
Level: Intermediate

The majority of us are somewhere in the middle of our leadership journeys. This discussion will bring together people who can share the successes they've had while helping each other to identify ways to continue our collective growth as leaders

Learning Objectives

Discuss how to develop a leadership development plan for their growth; Identify gaps and opportunities for growth; Recognize different ways to contribute and be seen as a leader.

Chair

Matthew J Meitzner, MS


Speakers
avatar for Matthew Meitzner

Matthew Meitzner

Associate Director, Project Management, Merck & Co., Inc.
Matt Meitzner is an experienced project manager in the pharmaceutical and medical device industries.


Wednesday June 26, 2019 12:30pm - 1:00pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:15pm

#353 CH: The Current and Future State of RIM
Component Type: Workshop
Level: Basic

An open discussion about the current and future state of RIM within different sized organizations with emphasis on the pros/cons of having a cloud based solution, the benefit of crafting a RIM ecosystem and approaching change management.

Learning Objectives

Describe the current and future state of RIM; Discuss the value added of crafting a complete RIM eco system; Identify and anticipate the impact of these systems on the end users.

Chair

Richard F Fredericks


Speakers
avatar for Richard Fredericks

Richard Fredericks

Director, Regulatory Systems and Information Management, Tesaro
I have been in the life sciences industry for 10+ years operating entirely within the Regulatory Operations space. My career began as a publisher and over the past decade has been gravitating towards the technology and process side of the business. Currently I lead the Regulatory... Read More →


Wednesday June 26, 2019 1:15pm - 1:45pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#373 CH: Success in the Workplace: What Does That Mean and How Can You Achieve it?
Component Type: Workshop
Level: Basic

Join this session to learn what differentiates successful people in the workplace and what you can do to emulate them. We'll learn the timeless principles that lead to success with an aim to help you create an immediate impact.

Learning Objectives

Discuss different aspects of a workplace environment; Recognize areas where we can make a positive impact; Define practices and tips for handling difficult situations.

Chair

Vidhi Vashisht, MS

Speaker

Timeless Principles of Personal Success
Vidhi Vashisht, MS



Speakers
avatar for Vidhi Vashisht

Vidhi Vashisht

Associate Director, Kinapse Ltd
Vidhi believes that success and wisdom doesn't always come with age and experience, but with an open mind and willingness to take action. While working as a medical writer, she developed passion for understanding and applying the timeless principles of success and saw the positive... Read More →


Wednesday June 26, 2019 2:00pm - 2:30pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#378 CH: Measuring “Value” in Value-Based Healthcare: A Health Economics Perspective
Component Type: Workshop
Level: Basic

Value-based healthcare (VBHC) is enabled by evidence-based approaches, such as health economics and outcomes research (HEOR). This workshop will engage with peers to explore the opportunities and challenges at the intersection of HEOR and VBHC.

Learning Objectives

Discuss the elements of value from a health economics and outcomes research (HEOR) perspective; Identify the strengths and limitations of HEOR applications in value-based healthcare.

Chair

Fabian D'Souza, MD, MBA


Speakers
avatar for Fabian D'Souza

Fabian D'Souza

Founder and President, Boston Strategic Partners, Inc.
Dr. D’Souza is the Founder and President of Boston Strategic Partners, Inc. a consultancy dedicated to serving pharma-biotech, devices/ diagnostics, and Health-IT through different practices: business and clinical strategy, HEOR, and medical communications. He has also led projects... Read More →


Wednesday June 26, 2019 3:30pm - 4:00pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Thursday, June 27
 

8:30am

#402 CH: Manage Risks and Enhance Engagement Through Digital Approaches
Component Type: Workshop
Level: Intermediate

Even now, most risk minimization programs are paper based, though digital communication is used in all aspects of our lives. Digital channels provide a more engaging and effective educational experience through dynamic presentation and interactivity

Learning Objectives

Describe where digital approaches can be used to achieve better engagement in risk management outreach; Discuss what lessons can be learned from current projects through case studies; Determine top priority changes in people, process or tech to enable a move to digital in their own organizations.

Chair

Mark Perrott, PhD


Speakers
avatar for Mark Perrott

Mark Perrott

Head of Development Consulting, Huron Life Sciences
Mark is Head of Development Consulting at PopeWoodhead where he leads a team of Benefit-Risk and Risk Minimisation professionals. He joined PW in November 2016 and his >20 year pharma career has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI and Foresight... Read More →


Thursday June 27, 2019 8:30am - 9:00am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA