Upfront

GTO and Honeycomb Team Up to Raise Money for Rare Disease

The Greater Than One Group (GTO) and its non-profit subsidiary Honeycomb Health conducted a cross-country road trip to raise money for the rare disease cause. In August, Rebecca Trahan began her trip to raise money for Honeycomb Health, a non-profit designed to help people with rare diseases securely store, manage, and share their health information. Rebecca, a rare disease survivor, has spontaneous coronary artery dissection (SCAD). The goal of the trip is to raise $2.5 million from individual donations from $5 to $500.

Ms. Trahan’s cross-country road trip celebrates her 10th anniversary after her near-death experience with SCAD, along with her birthday. She will initially drive more than 10,000 miles to network with every group of rare and ultra-rare disease patients she can find in however many cities, towns, and neighborhoods she feels is necessary to achieve the goal.
Elizabeth Apelles, founder and CEO of The Greater Than One Group, formed Honeycomb Health, which leverages innovative technologies and inspired market solutions to unite patients, family members and health providers in rare disease management.

“GTO works a great deal in the rare disease space, and rare disease affects a number of people in my family," Ms. Apelles says.

Honeycomb Health also offers free online store fronts to rare disease advocacy groups as a way to contribute to funding new research. The trip is also being funded through a Go Fund Me page which was recently set up where 100% of what is raised will be tax deductible and 100% will go towards the Honeycomb Health platform and the Honeycomb Health stores.
To donate: https://gofund.me/91bfd684

Novartis Pledges Greater Diversity, Equity, and Inclusion Across R&D

Novartis and the Novartis U.S. Foundation have collaborated with Coursera, the National Medical Association, Thurgood Marshall College Fund, Morehouse School of Medicine, and 26 additional historically Black colleges, universities, and medical Schools to co-create programs that address the root causes of systemic disparities in health outcomes and create greater diversity, equity, and inclusion across the research and development ecosystem.

Leaders from these companies, organizations, and learning institutions have signed a pledge to co-develop programs focused on building trust in the healthcare system with communities of color and making measurable progress towards health equity. Working together with the communities they aim to impact, the collaboration will focus on improving access to high-quality education, technology, improved health outcomes, and promising jobs; increasing clinical trial and clinical trial investigator diversity; addressing inherent bias in the data standards used to diagnose and treat disease; and finding actionable solutions to environmental and climate issues that disproportionately affect health among communities of color.

“At Novartis, we envision a world with equity in health for all. Just as there are a multitude of factors and causes behind racial disparities in health and education, there is no single solution to this critical challenge," says Vas Narasimhan, M.D., CEO of Novartis. “It will take the concerted, urgent action of diverse stakeholders across the public and private sectors. We are honored and humbled to work together with these organizations to build enduring solutions to some of the most pressing, deeply rooted, and historic challenges in the United States, and we invite other like-minded companies and organizations to join us in creating this paradigm shift in health equity."

Over an initial period of 10 years, the collaboration will focus on enabling the next generation of Black and African American leaders by creating equitable access to high quality education and professional development for future leaders, in health science, technology and business-related fields, and other key elements.

All parties will spend the next six months co-creating programs with the communities, including establishing the first clinical trial, data standards, and environment, climate and health research centers at Morehouse School of Medicine.

2M Clinical Launches Neighborhoodtrials.com

2M Clinical has launched neighborhoodtrials.com to connect individuals and community-based organizations with customized, interactive, data-driven, AI-powered, and actionable clinical trials information. This new platform continues the 2M Clinical mission: to increase participation and retention in clinical trials across all communities by bringing together study-seeking participants, neighborhood organizations, study sponsors, healthcare organizations, and physicians through the innovative use of technology, digital media, and trained study navigators.

Visitors can use the neighborhoodtrials.com platform to find potential clinical trials by their zip code. In addition, 2M Clinical’s Patient Engagement and Survey Research Center can support a potential patient’s interest in a clinical trial by linking that patient with various clinical trial sites across the U.S. Their goal is to serve as a central source for actionable clinical trials recruitment and participation information for patients, healthcare partners, community and faith-based organizations, and sponsors. Neighborhoodtrials.com combines innovative technology, spatial epidemiology, community outreach through trained study navigators, and social and digital marketing to make clinical trials accessible to everyone. 2M Clinical, Inc. is a technology-driven, full-service African American Owned clinical research firm founded by husband-and-wife team, Dr. Eddilisa Martin and Dr. Marcus Martin.

The Galien Foundation Announces the 2021 Prix Galien USA Award Nominees

The Galien Foundation announced the 2021 Prix Galien USA Award nominees for Best Biotechnology Product, Best Pharmaceutical Agent, Best Medical Technology and Best Digital Health Product. This year’s ceremony is the Prix Galien’s 50th, marking half a century of recognizing excellence in biopharmaceutical and medical technology innovations that improve the human condition. Winners will be announced during the Prix Galien USA Awards Ceremony on October 28, 2021, in New York City. The ceremony will adhere to recommendations from the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO).

The 2021 Prix Galien USA nominees, totaling a record-breaking 83 product nominations, include products evaluated in the following categories: Best Biotechnology Product — 21 nominees; Best Pharmaceutical Agent – 34 nominees; Best Medical Technology — 18 nominees; and Best Digital Health Solution — 10 nominees.

To qualify, each candidate must be U.S. Food and Drug Administration (FDA) approved for marketing within the last five years and demonstrate tremendous potential to improve human health. Sales data are not considered by the nominating committee in their award nominee selection, only science and health impact.

“These nominees reflect our celebration of 50 years of the Prix Galien Awards and the progress made in working to improve the state of human health," says Bruno Cohen, Chairman of The Galien Foundation.

The Prix Galien USA Awards Committee, composed of 12 renowned leaders from the biomedical industry and academia, including five Nobel Laureates, is responsible for evaluating nominees. The Prix Galien USA Digital Health Awards Committee is composed of nine distinguished leaders from the biomedical industry and academia.

In addition, the Galien Foundation announced that six world-leading biopharma companies responsible for development of COVID-19 vaccines and therapeutics will jointly receive the 2021 Roy Vagelos Pro Bono Humanum Award for Global Health Equity.

The award recognizes innovative individual and group efforts to improve the human condition through the application of biomedical science to health problems in developing or underserved populations worldwide.

This year’s award recipients will consist of senior leaders from COVID-19 vaccine makers Pfizer/BioNTech SE, Moderna Inc., AstraZeneca PLC, and Johnson & Johnson. The Prix Galien committee will also recognize top executives representing Regeneron Pharmaceuticals, which received Emergency Use Authorization (EUA) for the investigational COVID-19 antibody cocktail REGEN-COV (casirivimab and imdevimab), and Eli Lilly & Company, which received EUA for bamlanivimab.

AbbVie, Roche Top Data Transparency List

A group of Yale bioethicists have found that larger pharmaceutical companies are better at clinical trial transparency and sharing data among their peers than smaller companies. AbbVie, Amgen, Bayer, Merck KGaA, Roche, Takeda, and Novartis all got perfect scores on the ranking of overall transparency. Following close behind were Merck & Co., Novo Nordisk, and Sanofi.

Using Good Pharma Scorecard (GPS) measures, companies and products were evaluated on their clinical trial registration, results dissemination, and FDA Amendments Act (FDAAA) implementation; companies were ranked using these measures and a multicomponent data sharing measure. Associations between company transparency scores with company size (large vs non-large), location (US vs non-US) and sponsored product type (drug vs biologic) also were examined.

Only 26% of products examined had results for all trials supporting their approval made available to the public. On the flip side, 11% of trials had no results reported at the time of approval. Of those seven products, two were approved based on ongoing trials manufactured by U.S.-based companies, meaning they did not yet have to report results. The report also noted that 42% of FDA-approved drugs failed to meet the regulator’s own data transparency requirements and yet the agency has only once warned a company for failing to provide information.

The study concluded that it was feasible to apply the GPS transparency measures and ranking tool to non-large companies and biologics. Greater research transparency is needed, particularly among non-large companies, to maximize the benefits of research for patient care and scientific innovation.

Transparency studies typically examine information available on the U.S. government’s clinicaltrials.gov database, but the Yale study went further to include data from trial registrations, results reporting, FDA compliance, and patient-level data sharing practices among pharma companies. The study looked at novel drugs and biologics.

The Yale report covers information released for drugs approved in 2016 and 2017 — long before COVID-19 was even a distant risk. But its findings are important in the context of the pandemic, the authors argue. If all pharmaceutical companies laid bare all the data supporting their clinical trials, maybe the public would be more trusting of medical science — and a few more people could be convinced to sign up for their COVID shots.

DTx Predicted to Grow

Frost & Sullivan’s recent analysis finds that digital therapeutics (DTx) in the United States are considered legitimate alternatives to traditional pharmacotherapy. These solutions are comprehensively regulated and granted prescription status by various national- or state-level regulatory agencies based on reported evidence of improved clinical outcomes for a defined patient population.

As life-sciences companies aim to enhance patients’ treatment experiences and find new biomarkers that aid drug discovery, DTx companies diversify their pipelines by adding new indications, addressing unmet needs. Consequently, this market is estimated to witness more than three-and-a-half-fold growth, reaching $4.54 billion by 2025 from $1.23 billion in 2020, expanding exponentially at a compound annual growth rate of 29.8%.

“In the next three to five years, multiple technology vendors will offer digital treatments that will be regarded as safe and effective as subscriptions to personalized medication," says Koustav Chatterjee, healthcare & life sciences principal at Frost & Sullivan. “Additionally, patients would be allowed or advised to modify dosages and reduce consumption of nonemergency medications based on their daily vitals that DTx solutions will capture and contextualize."

Mr. Chatterjee adds patient-centric digital health vendors have strived for a business model that allows physicians to recommend their products, patients to use them for a defined period (without fail), caregivers to monitor outcomes 24/7, and payers to reimburse the cost of usage. “Further, DTx companies partnering with payers, providers, and life-sciences companies provide the best way of getting access to patients for scalability, apart from risk-sharing agreements," he says.

Companies are expected to invest in DTx solutions, enabling the subsidized cost to patients in exchange for marketing and access to patient data.

In Memorium Lisa Stockman

Lisa Stockman Mauriello, who was most recently Syneos Health’s president of diversified communications services, passed away from ALS August 4 in her home with family and loved ones.

Lisa’s very public and brave fight was chronicled on social media and Twitter at #tofersen4lisa. Lisa’s considerable efforts to gain access to Biogen’s experimental treatment Tofersen led the company to reverse its stance and made the medicine for Lou Gehrig’s disease available to some people who have no other treatment options and who are dying of the incurable illness, starting in July. The drug is now being offered to the most rapidly progressing patients after researchers completed a key study this summer, the company said in a statement posted on its website. Tofersen hasn’t been approved by regulators in any country. It will be given on a compassionate-use basis after everyone who was given a placebo during the clinical trial has been offered the medicine, Biogen said.

The move comes after Lisa, who was diagnosed with the disease in January, launched an aggressive campaign to get access to the medicine under the Right To Try law or through a conventional compassionate use program backed by the FDA.

A wife and mother of three beautiful sons, Lisa spent her 30-year career in the field of pharmaceutical healthcare communications, where she made a significant difference for patients around the world.

In 2016, Lisa was recognized as a PharmaVOICE 100 for these efforts as well as her ability to inspire hundreds of communications experts to make magic happen on. The industry has lost a true luminary.

BioNJ BioPartnering Conference

BioNJ announced the winners of its 2021 Company and Pitch Presentation Competition held in conjunction with the organization’s 11th Annual BioPartnering Conference.

Presented in concert with J.P. Morgan and Johnson & Johnson Innovation on May 18 and 19, the Conference brought together life-sciences professionals from nine countries and 20 states as well as the District of Columbia and featured almost 70 company and pitch presentations, hundreds of one-on-one partnering meetings and plenary sessions led by industry leaders and world-renowned research institutions from the region.

The 2021 Company and Pitch Presentation Award Honorees are:

Diagnostics & Enabling Technologies:
Elizabeth Holmberg, Chief Financial Officer, Third Pole Therapeutics
Devices:
Joe Muldoon, CEO, FAST BioMedical
Oncology Therapeutics:
Michael Ferraresso, Chief Commercial Officer, AVEO Oncology
Pitch Presentations:
Alexander Ploss, Ph.D., President, Acurasset Therapeutics
Therapeutics & Enabling Technologies:
Ira Spector, Ph.D., MBA CEO, SFA Therapeutics, Inc.
Therapeutics:
Susanne Wilke, Ph.D., MBA, President & CEO, Cognoptix

“We couldn’t be more excited for these entrepreneurs or more pleased with the outcome of this year’s Conference," says BioNJ President and CEO Debbie Hart. “I’d like to thank both J.P. Morgan and Johnson & Johnson Innovation for their continued support and commitment. The energy, expertise and thought leadership they bring to the development of the Conference year after year is impactful and instrumental to it success. In its 11th year, BioNJ’s BioPartnering Conference once again, despite being virtual, delivered an energetic atmosphere which fostered collaboration, learning and mentorship."

Women of the Week Podcast Series

JUNE

Sharon Cunningham, CEO and Cofounder, Shorla Pharma
Diane Bryant, CEO, NovaSignal
Erica Cohen, Senior VP, Operations
Greenphire
Jill Quigley, Chief Operating Officer
Passage Bio
Jennifer Aquino, VP, Digital Patient Suite
IQVIA

JULY
Christi Shaw, CEO, Kite, a Gilead company
Nancy Lurker, President and CEO, EyePoint
Therapeutics
Retsina Meyer, Ph.D., Head of Strategic
Projects and Alliances, Delix Therapeutics
Kim Mehle, VP, Oncology Commercial
Services, IQVIA

Contributed Articles:
Accelerate Clinical Trials Enrollment with Digital Precision
Sponsored by: Firstsource

Selecting a Strategic Artificial Intelligence and Pharmacovigilance Focused Technology Partner
Sponsored by: Tata Consultancy Services

eBooks and Whitepapers:
Transitioning from Quantitative PCR to Droplet Digital PCR for Mycoplasma Detection
Sponsored by: Bio-Rad

Opportunities to Accelerate Decentralized and Digital Trials
Sponsored by: eClinical Solutions

Japan and China are Outpacing Europe as Leading Biopharmaceutical Innovation Hubs
Sponsored by: Health Advances

Envisioning a bold, new future of clinical development
Sponsored by: IQVIA

Digital health solutions and SaMD: Pharma’s five steps for success
Sponsored by: S3 Connected Health

Don’t Do It Alone: To De-Risk Your Next Trial, Seek Outside Expertise
Sponsored by: WCG

Podcasts:
Mycoplasma Detection for Cell and Gene Therapy
Sponsored by: Bio-Rad

Opportunities to Accelerate Decentralized and Digital Trials
Sponsored by: eClinical Solutions

Therapeutic Digests:
July: Dermatology
Provided by: PharmaVOICE and ThinkGen

August: Arthritis and Other Inflammatory Diseases
Provided by: PharmaVOICE and ThinkGen