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PharmaVOICE Staff

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Interest in Clinical Trials Increases Amid Pandemic

According to a recent PwC US Pharma and Life Science Leader survey, 84% of consumers said they would be at least somewhat willing to share data with their doctors to help discover new treatments or new ways of delivering care. Moreover, 58% said they would be willing to participate in pharma research to develop a treatment or vaccine. Additional highlights of the study include:

Health systems have less patient loyalty: Only 14% of consumers have received health info from their health system, which is true even for certain vulnerable populations (less than 20%).

Longer-term impacts on health: More than half of consumers are opting to delay refills for a few weeks or even until the COVID-19 threat is eliminated, stretching the medication they have by skipping doses or not taking medication to save money.

Social distancing varies across race and age: Persons of color are less likely to say they were social distancing, groups for which chronic disease is more prevalent; 95% of those 65 and older were more able to shelter in place, compared with 58% of 18 to 24 year-olds.

Global Genes Goes Virtual

Global Genes in partnership with the Orphan Disease Center at the Perelman School of Medicine at the University of Pennsylvania, is hosting this year’s RARE Drug Development Symposium in an online setting to continue support for rare disease drug development during the COVID-19 pandemic. This year’s event is happening June 11–12 and will feature Christopher P. Austin, M.D., director, National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) as the keynote speaker. This interactive, personalized experience is dedicated to empowering the rare disease community to continue to push forward on necessary treatments and cures, despite experiencing setbacks as a result of COVID-19.

In Memoriam — Jack Thorne III

Jack Thorne, founder of Alliance Healthcare Information and former Ashfield employee, passed away. Alliance was Ashfield Healthcare’s first U.S. acquisition, and became the foundation on which Ashfield built its North American healthcare call center business. Jack founded Alliance in 1995, and was a pioneer in developing the company as a specialist in tele-detailing for the pharmaceutical sector. Jack’s vision was ahead of its time by using technology to provide innovative solutions to the pharmaceutical industry for communications to healthcare practices and patients. Jack founded Alliance after a long career in advertising, serving in key leadership positions in BBDO, a leading global advertising agency. Following retirement, he remained active as an advisor to Ashfield, as well as serving the industry at large as a member of the Coalition for Healthcare Communications. He also remained active in the arts, serving as a board member of the Young Concert Artists Association, a New York-based organization dedicated to discovering and launching the careers of exceptional, but yet unknown young musicians from all over the world.

ERT COVID-19 Dashboard Highlights Patient Compliance Risks to Protect Study Outcomes

ERT has developed a COVID-19 Dashboard to help sponsors identify areas of imminent risk caused by reduced patient site visits, enabling them to intervene and keep patients engaged throughout clinical trials. The dashboard presents convenient views of COVID-19 cases in relation to study site locations, flags sites and patients with potential device/data risks and enables a targeted intervention approach toward real-time study monitoring to ensure data quality, regardless of patient access to investigative sites.

ERT’s new reporting capabilities help clinical trial sponsors and CROs ensure high-quality data collection during current global stay-home mandates. The COVID-19 Dashboard integrates data on coronavirus infection rates in geographic areas surrounding study investigative sites, so sponsors can identify and proactively intervene where patient and site compliance to study protocols may be at risk.

In response to COVID-19, ERT also launched a cardiac safety solution that helps biopharmaceutical researchers continue important clinical trials during current global stay home mandates. The solution enables clinician-administered ECG readings to evaluate the safety of new vaccines and medical treatments from patients’ homes.

ERT offers additional capabilities that enable remote patient data collection for trial continuity, including respiratory trial support for spirometry and ECG assessments conducted by investigative site personnel in the patient’s home.

COVID-19 Impacting Physician Visits

According to a new survey from Health Perspectives Group among 750 members of its Health Stories Project social sharing community who are living with or caring for those with chronic conditions, half of people with chronic Illness want to see the doctor for new prescriptions, but 26% have been unable.

Pandemic is impacting prescriptions:
48% of respondents want to meet with their healthcare providers for a new prescription
66% have had these meetings
But 26% have not been able to have these meetings

Pandemic is impacting treatment:
21% of respondents report that their treatment plan has changed during the pandemic.
27% have had to cancel or postpone annual/quarterly tests
20% have had to cancel or postpone a specific treatment
11% have had to cancel or postpone a medically necessary surgery
10% have had to cancel or postpone procedure follow-ups
34% of respondents report they are doing more home monitoring

Pandemic is impacting doctor visits:
52% have communicated with their providers via phone
Many respondents are embracing technology for alternatives to connect with their doctors:
35% have used their doctor’s secure patient portal
20% have participated in a video call
18% have used email
18% tried telemedicine appointments through their insurance company for the first time
17% connected via health app messages
14% with previous experience used telemedicine through their insurance company
6% have utilized live chat
4% connected with doctors via social media

Note: Survey participants span 17 chronic disease areas across age groups (18-92), genders, race/ethnicities, education level, location (urban, suburban, rural).


PharmaVOICE 100 News

Justin Freid Named Chief Growth & Innovation Officer
CMI/Compas has promoted Justin Freid to chief growth and innovation officer. Mr. Freid has been instrumental in the growth of the company’s new-media capabilities, and this new position is the next step in a multi-year plan of bringing growth and innovation to the company’s healthcare clients.

His areas of focus is on delivering innovation and growth to clients’ brands and the overall business. He has led the charge in breaking down silos and innovating the way the pharma industry uses search and social channels for better engagement with patients, caregivers, and HCPs. In his previous role as executive VP, he launched the growth and innovation practice, which he will continue to lead.

Mr. Freid is a 2016 PharmaVOICE 100.


Woman of the Week Podcast Series


Kellie Malloy Foerter, Chief Clinical Development Officer, OncoSec Medical
Sharon Callahan, Chairman, TBWA\WorldHealth Group; CEO, CDM Group; Chief Client Officer, Omnicom Health Group, TBWA\WorldHealth
Dr. Jessica Grossman, CEO, Medicines360
Dr. Margaret Yu, VP, Disease Area Leader, Prostate Cancer, Janssen Research and Development
Cinda Orr, CEO, SCORR Marketing


COVID-19 Update

The rapid progression of the COVID-19 pandemic has greatly impacted the way the industry is doing business. Here are some ways companies are solving for COVID-19.

Alveo Technologies and Janssen Pharmaceuticals to Advance At-Home Testing Platform for Viral Infectious Diseases
Alveo Technologies, a developer of novel technologies that enable real-time, low-cost, at-home molecular detection of infectious disease, has entered into a research collaboration with Janssen Pharmaceuticals to advance its be.well platform of analyzers, nasal swabs and cartridges for the detection of viral infectious diseases, including respiratory syncytial virus (RSV) and potentially SARS-CoV-2. Janssen will work with and fund Alveo to accelerate research and development of be.well. While it is not yet approved for use, Alveo has been working to get the testing platform approved and ready for market and expects this deal to significantly accelerate that process. Alveo will use a phased approach and first seek emergency use authorization (EUA) for a SARS-CoV-2 assay, followed by a multiplex version for home use.

Novartis Technical Operations Copes With COVID-19 Hurdles
Novartis has implemented a number of guiding principles to support Novartis Technical Operations (NTO)’s navigation through the COVID-19 crisis. A taskforce was created to map and mitigate the issues the pandemic might create. One of its crucial functions is to track real-time information from a number of sources and quickly take action to ensure supply to patients. NTO is responsible for ensuring essential medicines reach the patients and for maintaining its supply chain.

At NTO Stein, Switzerland, its Cell and Gene Therapy team has redeployed associates to fill 40,000 testing vials for use in desperately needed COVID-19 testing kits.

At ChemOps Mengeš, Slovenia, the team has prepared and bottled 2,000 liters of 70% isopropanol for disinfection purposes to support not only all of Novartis’ Slovenian sites but also the local community.

Novartis has also started to ship hydroxychloroquine to countries around the world as its donated doses start to be put to use in clinical trials. Furthermore, the business is preparing to manage an increased demand for Jakavi, should the Phase III clinical trial indicate that it has a role to play in treating cytokine storm.

NTO has reduced the number of people at its facilities through remote working and establishing additional safety measures for those who need to be on site. These protections include adapted working patterns to avoid interaction between shifts, virtual shift handovers, using the telephone or Skype, and having defined exit paths in case of any symptoms. In addition, surgical masks are being distributed to offer protection to people working in areas in which social distancing is not entirely possible.

Employees from other parts of NTO have been stepping forward to help on the shop floor of production operations. This commitment has helped safeguard the continuity of manufacturing and supply.

Saama and iNDX.Ai Create COVID-19 Command Center Analytics Platform
Clinical analytics platform company Saama Technologies has partnered with iNDX.Ai, a multi-omics data analytics and translational research platform company, to launch a COVID-19 Command Center. The center is a purpose-built, therapeutic area-specific data analytics platform that will accelerate the ability of life-sciences companies to expedite internal research and development programs for therapies to prevent and treat COVID-19.

Earlier this year, Saama contributed its AI-powered Life Science Analytics Cloud technology platform to establish the EndPandemic National Data Consortium with the goal to integrate data from all ongoing and future clinical studies to accelerate analysis on COVID-19 and SARS-CoV-2 research. The platform allows researchers to visualize, analyze, and interrogate data across all available programs.

The COVID-19 Command Center was created to provide sponsors that are pursuing in-house COVID-19 clinical development efforts only with the same powerful, state-of-the-art, AI-powered data analytics platform being used by the EndPandemic National Data Consortium. The COVID-19 Command Center includes patient data from ongoing COVID-19 clinical trials in China, South Korea, and the United States with almost 8,500 patients, including more than 3,000 positive cases.

UK Biotech Company Announces Discovery of Novel Potential COVID-19 Treatments
ILC Therapeutics has patented a new interferon-alpha subtype, called Interferon Alpha 14, which can be administered to patients through injection or inhalation. This natural human molecule treatment could prevent COVID-19 induced acute respiratory distress syndrome (ARDS), which would mean that a considerable number of patients may no longer need to be on a ventilator.

Interferon Alpha 14 is the most potent antiviral interferon that exists and requires very small doses for treatment. It could also treat COVID-19 by boosting the body’s natural killer cells that fight the virus and prevent an immune overreaction that can cause fatal damage to the lungs. This would prevent the onset of ARDS, which remains the leading cause of COVID-19 fatalities, and also drastically reduce the need for ventilators.

Funding for safety studies and the first clinical trials, projected for early 2021, will be led by CEO Dr. Alan Walker and Chief Scientific Officer Professor Bill Stimson.


Successful BYOD with Rapid Build Timelines
Provided by: Clinical Ink

Therapeutic Digests:
Diabetes Care


Failure to Start: Filling the Cracks COVID Exposed in Patient Onboarding Support to Enable Successful New Therapy Initiations in an Uncertain World
Sponsored by: Noble, an Aptar company

Business Intelligence & Analytics for the New Age
Sponsored by: Qlik

White Paper:
Successful BYOD in Any Phase
Provided by: Clinical Ink

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