PharmaVOICE - 
March 2021
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In Every Issue
Letter from the Editor
Thank you… Our special Patient Voice issue is one of [...]
By

Taren Grom, Editor

Upfront
Lilly and Life for a Child Expand Partnership Lilly, Life [...]
By

PharmaVOICE Staff

HealthTech
Biogen to Launch Pioneering Study to Develop Digital Biomarkers of [...]
By

PharmaVOICE Staff

Artificial Intelligence
90% of Large Pharma Initiated AI/ML Projects In 2020 Trend [...]
By

PharmaVOICE Staff

On The Cover

Patient Power: Personal Journeys of Courage
The power of patients is palpable, powerful, and pervasive. Patient-centricty has evolved into patient engagement. The distinction, while subtle, is also palpable, powerful, and pervasive. Engagement requires active participation. Rather than being passively placed in the center of vague initiatives, patients are actively engaging in strategic decisions that affect their health and that of others. [...]
By

PharmaVOICE Staff

Features

Unflagging Courage — Dana Deighton
As both a caregiver and a patient, I’ve had lots of on-the-job training. It started when I was 32, with young kids, my mom (who was an RN) was diagnosed at age 61 with stage four colon cancer. She only lived for another six weeks and those six weeks were fraught with gut-wrenching pain, smells [...]
By

Dana Deighton, Executive Board Member of ECAN; Patient Representative, Locally Advanced Esophageal Cancer Guideline Panel for the American Society of Clinical Oncology (ASCO); member of NCI Patient Advocate Steering Committee and NCI Esophago-Gastric Task Force; Esophageal and Stomach Cancer Project Patient Advisory Committee, a project led by the Broad Institute of MIT and Harvard; Senior Project Manager, Inspire.

Bringing Health Equity to All Patients
Health equity has long been an issue for communities of color. This past year, the Black Lives Matter movement and recognition of the impact of COVID-19 on many communities has shed new light on the problem of health inequity. Social determinants of health (SDH) remain a huge barrier to health equity. The World Health Organization [...]
By

Kim Ribbink

Advocacy Cheerleader — Barby Ingle
I have been battling chronic pain since 1997. First with endometriosis, which resulted in a full hysterectomy and left oophorectomy. Then in 2002, I developed Reflex Sympathetic Dystrophy (RSD), which is also known as Central Pain Syndrome. This is a progressive neuro-autoimmune condition that affects multiple systems in the body and needs to be treated [...]
By

Barby Ingle, International Pain Foundation Advocate, Author

The Patient Knows Best
The patient voice is crucial throughout the entire healthcare process, but especially relevant in creating spot-on patient education. Shantana Hazel, Wayne Eskridge, and Lisa Lurie are just three of thousands of patient activists who have used their own patient journey and experiences to create informational and support tools for others. Through their own experience, they [...]
By

Robin Robinson

Education is Key — Daniel Garza
I remember being at Ben Taub Hospital in Houston. Texas. September 2000, I think it was Tuesday the 26th. I had been in the hospital over the weekend, weighed about 110 lbs. with a T-cell count of 108, and the diagnosis was AIDS. I had been in an isolated room, with only my mother, father, [...]
By

Daniel Garza, HIV Educator; Chair, Client Advisory Committee, Radiant Health Centers; Actor, Speaker, Podcast host

Virtual Patient Care: Starting to Shine
Virtual patient care has moved from healthcare’s bit player to co-star, and it won’t be giving up that role anytime soon. As the COVID-19 pandemic swept across the United States last year, healthcare organizations that had been slow to embrace a virtual health model suddenly began implementing virtual care solutions at a breakneck pace. And [...]
By

Carolyn Gretton

A Family Affair — Estela Lugo
I wish I could say there was a time in my life when I felt “normal,” but there really isn’t. Some of my first memories include sitting on the number rug in kindergarten and showing off my new plastic leg braces to friends. It was 1984 when doctors at Nassau County Medical Center in New [...]
By

Estela Lugo, Hereditary Neuropathy Foundation

Decentralized Clinical Trials: The Way Forward
COVID-19 prompted the need for the industry to address patient needs in the clinical trial space, and companies along the drug development paradigm pivoted successfully to the benefit of patients. Necessity is the mother of invention, and over the past 12 to 18 months because of the limitations necessitated by COVID-19, clinical trials have undergone [...]
By

Taren Grom, Editor

Becoming a Patient Partner — Claire Snyman
May 14, 2010. I woke up to the room spinning. That day is forever etched in my mind. Firstly, because of the unfamiliar, sickening vertigo that rippled through my body, rendering me helpless. Secondly, because this symptom led to a cascade of events that four days later landed me in the ER diagnosed with a [...]
By

Calire Snyman, Advocate, Patient Activation/Experience, Author, Speaker TEDx2018; Synapse Consulting President and CEO

Patient Heroes
Patient heroes have the power to positively change the status quo because of their influence, knowledge, passion, and commitment to improving the patient journey. The global patient engagement solutions market size is expected to reach .5 billion by 2028, according to a new report by Grand View Research. The market is expected to expand at [...]
By

PharmaVOICE Staff

Advocate For Changes That Protect Patients — Molly Stallings
My mission is to create the best patient experience possible — from product development through program execution, each department plays a unique role in contributing to a patient’s overall experience. The consumerization of healthcare combined with the disruptive power of mobile technology presents new opportunities for pharmaceutical manufacturers to deliver services and support more effectively [...]
By

Molly Stallings, VP, Product Management, TrialCard

Mission: Disrupt Health Disparities — Dr. Altovise Ewing
I envision a future of healthcare where genetics is used to advance health equity. I deem this a critical and possible mission, and believe our work at Genentech is a step in the right direction to getting us there. Dr. Altovise Ewing’s passion for health equity is personal. As a Black woman raised in the [...]
By

Altovise T. Ewing, Ph.D., LCGC, Senior Science Leader — Global Health Equity and Population Science, Genentech

SHOWCASE: Real-World Evidence: Realizing the Benefits of RWE
The real-world evidence (RWE) market has grown significantly in recent years, supported by a favorable regulatory environment. Increasingly, companies recognize that real-world evidence (RWE) presents an opportunity to improve efficiency and innovation. One of the biggest challenges for pharma companies is the time it takes to bring products to market. To shorten these timelines, companies [...]
By

PharmaVOICE Staff

Four Key Considerations When Using Real-World Data in Drug Development and Regulatory Submissions
Interest in using real-world data (RWD) in drug development and regulatory submissions has grown substantially over the past several years. This development can largely be attributed to passage of the 21st Century Cures Act, which mandated that FDA establish a program to evaluate the use of real-world evidence (RWE) to support approval of new indications [...]
By

Scott Swain, Ph.D., MPH, Director of Regulatory Sciences and Real-World Evidence, Cardinal Health

Leveraging RWE to Enhance Experiences Across the Patient Journey
In a tech-driven healthcare ecosystem in which patients are engaged consumers, product value is contingent on treatment outcomes and patient success. With digital tools and resources at their fingertips, today’s patient is empowered to make informed treatment decisions; and physicians need enhanced support to ensure they’re meeting patient needs. Providing physicians with the tools to [...]
By

Melissa Thompson, BSc., MBA, Senior VP, Value & Evidence, EVERSANA; Chris Cameron, Senior VP, Value & Evidence, EVERSANA; Justin Forrester, GM, HERO Analytics Data & Data Integration, EVERSANA; Katya Svoboda, Senior Principal, EVERSANA Management Consulting; and Maneesh Gupta, Managing Director, EVERSANA Management Consulting

Modernizing Oncology Approvals
Using real world evidence to bolster oncology accelerated approvals and label extensions Regulators are increasingly leveraging real world evidence (RWE) to inform their understanding of the benefits and risks of using targeted therapies in patients who are treated as part of routine clinical care, including patients who are very ill, who suffer from co-morbidities, or [...]
By

Jennifer Christian, Pharm.D., Ph.D., FISPE, VP, Clinical Evidence & Epidemiology, IQVIA

Shot in the Arm: COVID-19 Boost to RWD
Times Have Changed It’s early 2021 in the Northeast and a major snowstorm has just been announced. Schools will be closed for the next two days. Kids will be home and likely, quite happy to be off from school. Under normal circumstances, parents would be home too, trying to work and probably attempting to create [...]
By

Iyiola Obayomi, Practice Lead, Marketing Analytics, Ogilvy Health

The RWE Evolution
With so much attention being focused on real-world evidence (RWE) and real-world data (RWD), it would be easy to assume that this critical area of drug development is revolutionary. But, in fact, RWE has been around for decades and what the industry is currently experiencing is an evolution of processes founded in solid science and [...]
By

David Brown, Ph.D., VP, Epidemiology, Matthew Gordon, VP, Real-World Evidence Strategy, Kim Maguire-Wright, VP, Real-World Evidence, Parexel

Best Practices in Long-Term Safety Follow-Up Studies in Oncology
As the quest to develop more effective treatments for cancer continues, a growing number of therapies are receiving accelerated approval from the U.S. Food and Drug Administration (FDA).1 The percentage of new oncology drugs that have gone through the Accelerated Approval Program increased approximately 30% between 2012 and 2020.2 Accelerated approval often comes with a [...]
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Jane Bentley, VP, Business Strategy, Mike D’Ambrosio, VP, Late Phase Operations, Noolie Gregory, VP Operations Management, Decentralized Solutions, Melanie Scheckle, Manager Business Strategy, Oncology & Hematology Business Unit, Syneos Health

20 Years in the Making: Special Section
From day one our goal has been to convene a community of experts who would be committed to our mission of: read, think, and participate. And you have. PharmaVOICE is proud to celebrate the contributions of thousands of thought leaders and subject matter experts who have lent their insights on a wide range of topics [...]
By

Taren Grom, Editor

Commanders & Chiefs: Chief Patient Officers
More and more companies are elevating patient-facing roles to the C-Suite, as a result, these key roles continue to expand and evolve to address the goals of patient-centricity and patient engagement. Dr. Julie Gerberding Merck Respecting Voices Across the Spectrum of Advocacy The concept of patient-centricity became visible in the 1980s and early 1990s, driven [...]
By

PharmaVOICE Staff

Executive Perspective: A Learning Model: A Deployment Strategy for the Future
Throughout her 20-year-plus career, Jaime Thompson has become an expert in driving client launches and brand success through commercial and medical channels. Her deep analytical expertise provides customers with innovative ways to execute on their brand strategies — from the first launch of an oral oncolytic, to the design and build out of outcomes-based patient [...]
By

Jaime Thompson, Senior VP and General Manager of the Contract Sales and Medical Solutions, IQVIA

Speak Out: Making Your Trial Break Through: How Imaging Can Make — or Break — Your Accelerated Trial
Breakthrough Therapy studies evaluate the effects of therapies on the most severe diseases, where patients have irreversible morbidity or mortality [IMM] or symptoms that represent serious outcomes of their sickness. The pressure to deliver quality data is immense because the cost of not delivering can result in patient deaths that may have been prevented. The [...]
By

Peter Steiger, PhD, Chief Scientific Officer, Calyx, and Elizabeth Dalton, Vice President, Technical Solutions, Calyx

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