Upfront

#NoGoingBack

Almost three dozen signatory companies collaborated to form the #NoGoingBack movement, which is committed to continuing the progress made in clinical research during the COVID-19 pandemic.

According to the movement, the industry has learned bold new ways to conduct trials due to COVID-19, and now that we have seen the future so clearly, there is no going back. They are encouraging everyone, whether you work at a sponsor, site, provider, advocacy group, or other healthcare organization, to join in the mission to keep trials moving forward. By making a pledge your name will be posted in support of #NoGoingBack:

I PLEDGE to honor the lessons we’ve learned and progress we’ve made in clinical trials:

We can adapt faster than we thought we could.
Collaboration between “competitors" is needed to accelerate.
Our industry has an unparalleled opportunity. to make huge improvements in drug development.
Patients deserve and want flexible options for trial participation.

I PLEDGE to maintain the momentum we gained from new ideas, partnerships, and technology that help us advance life-changing treatments faster.

I PLEDGE to keep moving forward and that I will never be satisfied with going back to trial conduct of the past.

I PLEDGE to share this charter with my colleagues and peers, and encourage them to pledge to preserve the progress we’ve made in clinical trials.

The chairpersons of #NoGoingBack are: Craig Lipset, advisor and founder of Clinical Innovation Partners; Allyson Small, chief operating officer, SCRS; Scott Connor, chief marketing officer, Signant Health; Maima Karmo, president and CEO, Tigerlily Foundation; and Sung Poblete, CEO, Stand up to Cancer.
For more information, visit https://www.nogoingback.health/

Astellas All in On Gene Therapy

In October, the new Astellas Institute for Regenerative Medicine was opened in Boston; it’s one of the most comprehensive regenerative medicine centers in the industry. The 262,000-square-foot facility will be home to more than 150 researchers and one of the industry’s largest stem-cell libraries and embodies the commitment Astellas has made to developing leading gene therapies. Over the last few years, Astellas made several acquisitions to bolster its capabilities, including Ocata Therapeutics, one of the earliest biotechs developing stem cell therapies under the leadership of stem cell pioneer Dr. Robert Lanza; Universal Cells (Seattle) with a unique technology to produce pluripotent stem cells that have lower immunological rejection to create allogeneic therapies, or off-the-shelf cell therapies, to open the door to treat, and even cure, a wide range of diseases; and Xyphos Biosciences (South San Francisco), with synthetic biology methods to adapt cell therapies with flexibility, increase control, and improve safety, representing techniques for state-of-the-art CAR-T cells as well as stem cell applications.

BioNJ’s company and Pitch Competition

BioNJ announced the winners of its 2020 Company and Pitch Presentation Competition held in conjunction with the organization’s 10th Annual BioPartnering Conference held in October. Presented in concert with J.P. Morgan and Johnson & Johnson Innovation, the conference brought together life-sciences professionals from 11 countries and 24 states as well as the District of Columbia and featured more than 80 company and pitch presentations, including a record number of 21 women leaders who presented on behalf of their companies, hundreds of 1:1 partnering meetings, plenary sessions led by industry leaders, posters, exhibits and presentations by world-renowned research institutions from the region.

The 2020 Company and Pitch Presentation Award Honorees are:

Public Company:
Marco Taglietti, M.D., President & CEO, Scynexis Inc.
Later Stage Investor-Financed Company:
Heather Franklin, President and CEO, Blaze Bioscience Inc.

Private Company:
Raymond Houck, CEO, Aclipse Therapeutics

Institution Spin-Out Pitch:
Robert Scribner, CEO, Respirogen Inc.

Start-Up Pitch:
Irena Volkov, Founder and CEO, Surgicure Technologies Inc.

“We couldn’t be more excited for these entrepreneurs or more pleased with the outcome of the conference", says BioNJ President and CEO Debbie Hart. “In its 10th year, despite being virtual, BioNJ’s BioPartnering Conference once again delivered an energetic atmosphere which fostered collaboration, learning and mentorship."

Aditum Bio Launches Tempero Bio

Aditum Bio has launched Tempero Bio, a spin-out that focuses on developing an advanced neuroscience drug, TMP-301, to treat addiction and anxiety as part of Aditum Bio’s mission to bring medical innovation to highly prevalent diseases. The urgent need to treat addiction and anxiety has increased due to the pandemic, with Americans three times more likely to report anxiety symptoms than in 2019, according to the CDC, and 13% of Americans reporting increased drinking or drug use — the ripple effect of these increases could impact public health for years to come.

Aditum Bio is the biotech investment firm co-founded in 2019 by former Novartis CEO Joe Jimenez and former President of the Novartis Institutes for BioMedical Research (NIBR) Dr. Mark Fishman. Tempero Bio is the second independent company launched by Aditum Bio, whose mission is to give large patient populations access to medicines which otherwise may not be developed.

BioCentriq Opens in New Jersey

The New Jersey Innovation Institute (NJII) and Choose New Jersey hosted a virtual ribbon cutting, facility tour, and panel discussions to mark the opening of BioCentriq, NJII’s cutting-edge cell and gene therapy development and clinical manufacturing center located on the campus of the New Jersey Institute of Technology (NJIT) in Newark, N.J.

“BioCentriq’s mission is to bring together industry, technology developers, academia, and regulatory agencies to help advance the development and manufacturing of cell and gene therapies," says Haro Hartounian, Ph.D., senior VP and GM of the biopharma division, and senior VP and general manager of BioCentriq. “We are thrilled to open the doors to our center at a time when demand for process development and clinical manufacturing of cell and gene therapies exceeds capacity available from existing contract development and manufacturing organizations. Our goal is to provide a collaborative space where innovative approaches and technologies can be utilized to help make emerging therapeutics available to the patients that so desperately need them."

Eversana Named Great Place to Work

Building on its momentum as a pioneer of next-generation commercialization services to the life sciences industry, Eversana has again been certified as a Great Place to Work, for the second consecutive year, by the global authority in workplace culture.

Eversana was named to the prestigious list, based on feedback from an anonymous survey by the company’s more than 3,000 employees.

“To receive this recognition during a year like 2020 speaks to the culture we work so hard to create every day," says Jim Lang, CEO, Eversana. “We will always invest the time and resources to create a best-in-class workplace that creates best-in-class support for our employees, clients and patients."

The Great Place to Work recognition, which measures companies against organizations of similar size and industry, provides a valuable benchmark for employees and reinforces the company’s commitment to retaining and attracting the best talent to serve its clients worldwide.(PV)

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2021 Therapeutic Digests

January: Diabetes
February: Digital Therapeutics
March: Endocrinology
April: Immunization and Vaccines
May: Cardiology
June: Oncology
July: Dermatology
August: Arthritis and Other Inflammatory Diseases
September: Gene Therapy for Rare Disorders
October: Neurology
November: Infectious Disease — update on COVID-19
December: Pulmonology & Respiratory Medicine

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Contributed Articles:
Modern Medical Affairs: Embracing Digital Agility and Customer Centricity
Provided By: Indegene

Indegene Digital Summit 2020 Set to be the North Star for Dialogues on Digital Acceleration in Life Sciences
Provided By: Indegene

Changing Landscape of Clinical Trials Data Capture and Reporting during COVID-19 Pandemic
Provided By: Indegene

eBook:
Innovating for the Future of Drug Development
Sponsored by: Parexel

Podcasts:
How Do You Launch a Therapy for an Ultra-Rare Disease?
Sponsored by: Fishawack Health
https://www.pharmavoice.com/podcasts/launch-ultra-rare-disease/

Unmet Needs with Traditional Patient Support Programs
Sponsored by: Mango Health, a TrialCard company
https://www.pharmavoice.com/podcasts/unmet-needs-patient-support-programs/

The Pandemic’s Impact on Patient Assistance Programs: TrialCard’s TC Script Leads the Way
Sponsored by: TrialCard

Using Virtual Engagement to Improve HCP Access and Drive Brand Performance
Sponsored by: TrialCard

Therapeutic Digests:
CNS
Provided by: ThinkGen and PharmaVOICE

Digital Therapeutics
Provided by: ThinkGen and PharmaVOICE

Women’s Health
Provided by: ThinkGen and PharmaVOICE