ZYUS Life Sciences Strengthens Leadership in Evidence-Based Medicine with Appointment of Clinical Advisory Committee

SASKATOON, Saskatchewan–(BUSINESS WIRE)–ZYUS Life Sciences Inc. (“ZYUS”), a Canadian life sciences company leading scientific research and development in phyto-therapeutics, is pleased to announce the formation of a Clinical Advisory Committee to provide strategic advice and guidance on ZYUS’ clinical trial programs. Five committee members have been appointed to the Clinical Advisory Committee, adding additional medical, scientific, and clinical expertise to its experienced leadership team. This announcement is an important step in ZYUS’ integrated clinical development program and supports the company’s ambitions to pioneer the next generation of life sciences through an evidence-based approach.

Chaired by ZYUS’ Chief Medical Officer, Dr. Lionel Marks de Chabris, a leading expert in chronic pain management and addictions medicine, the ZYUS Clinical Advisory Committee includes four initial committee members including Dr. Mary Lynch, Dr. David J. Shulkin, Dr. Cedric Francois and Dr. Alice Zwerling. As ZYUS scales its clinical trial programs, the Clinical Advisory Committee will work closely with the research team to provide input and guidance on clinical development strategies and evaluate the clinical trial progress.

Each of the named Clinical Advisory Committee members bring remarkable medical leadership and expertise to their advisory roles. Dr. Mary Lynch ranks among North America’s leading experts in pain management. She is a Professor in the Departments of Anesthesiology, Pain Management and Perioperative Medicine, Psychiatry and Pharmacology in the Faculty of Medicine at Dalhousie University. In addition to being the founding director of the Canadian Consortium for the Investigation of Cannabinoids, Dr. Lynch co-chairs the Canadian Pain Strategy and is a member of the Royal College of Physicians and Surgeons Working Group on Pain Management. Her expertise in pain management is directly aligned with ZYUS’ research into the potential of phyto-therapeutics to manage chronic and neuropathic pain, and Dr. Lynch’s scientific research and thought-leadership in this space will provide valuable guidance to ZYUS’ clinical approach.

Providing cross-border expertise and widely respected medical leadership, Dr. David J. Shulkin will bring his decades of experience leading some of North America’s largest and most sophisticated medical networks to the ZYUS Clinical Advisory Committee. Dr. Shulkin previously served as the ninth Secretary of the US Department of Veterans Affairs and prior to holding that role, was appointed Under Secretary for Health by President Obama and confirmed unanimously by the U.S. Senate. In his role as Secretary of the U.S. Department of Veterans Affairs, he represented 21 million American veterans and was responsible for the country’s largest integrated health care system with over 1,200 sites of care. In addition to his roles in the public sector, Dr. Shulkin has served as the chief executive of multiple hospitals and health systems, and has been named as one of the “One Hundred Most Influential People in American Healthcare” by Modern Healthcare. Dr. Shulkin’s experience as a physician, hospital CEO and Secretary of the Department of Veterans Affairs provides unique insights into the medical, societal and political implications of ZYUS’ clinical trial programs.

The co-founder and Chief Executive Officer and President of Apellis Pharmaceuticals,

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US faces major hurdles for COVID-19 vaccine distribution: Vaccine advisory committee

Any coronavirus vaccine that could be authorized for emergency use by the U.S. Food and Drug Administration (FDA) faces several additional hurdles after completing the final stage of clinical trials.

That was the theme of key issues addressed today by the FDA’s vaccine advisory committee — which includes a group of health and science experts who advise the regulatory agency on the best way to approach the path forward for a COVID-19 vaccine.

Among the more immediate hurdles, the path to receive an emergency use authorization remains somewhat murky for the pharmaceutical industry, as the agency has not nailed down specifics for things such as labeling and what qualifies as sufficient monitoring of individuals who have enrolled in clinical trials.

Trial kits for Pfizer coronavirus disease (COVID-19) vaccination study are seen at the Research Centers of America, in Hollywood, Florida, U.S., September 24, 2020. REUTERS/Marco Bello
Trial kits for Pfizer coronavirus disease (COVID-19) vaccination study are seen at the Research Centers of America, in Hollywood, Florida, U.S., September 24, 2020. REUTERS/Marco Bello

In separate letters to the committee, Pfizer (PFE), Johnson & Johnson’s (JNJ) Janssen and trade group BIO all asked for more clarity on the follow-up period for participants following the final dose of the vaccine.

J&J wrote that the current guidelines ask for 50% of the trial population to be monitored for two months following the final dosing. With J&J enrolling 60,000 participants, and other competitors only enrolling 30,000, that provides an uneven playing field.

“Specifying a minimum required follow-up in terms of subjects and months … would ensure consistency across all studies,” the company wrote.

Another concern is what happens to trial participants — especially in a placebo group — after an emergency use authorization is awarded. The FDA’s guidelines require that the placebo group is maintained so that collection of data for safety and efficacy continues on through until the vaccine can be fully approved — especially since the vaccine would still be considered “investigational” at the point.

Pfizer had said it anticipates offering the vaccine to the placebo participants once it receives an emergency use authorization (EUA) — which is an ethical obligation, according to BIO.

“Additional discussion is needed to determine how placebo-controlled trials can be maintained after an EUA is granted. As an industry, we have an ethical obligation to make our trial participants aware that a vaccine may be available,” wrote BIO’s senior director of infectious disease policy Gregory Frank.

FDA’s deputy director of vaccines, Doran Fink, said the trial has to remain blinded because that isn’t a step that can be walked back and it could jeopardize the integrity of the massive trials.

When asked what can be done to ensure that participants don’t simply then drop out of the trial or choose to take the vaccine, Fink said the FDA had no idea and is asking the companies to figure it out and describe their plan in any emergency use authorization filings.

Distribution and administration

What happens after an EUA is also of concern, as the distribution process for two frontrunners — Moderna (MRNA) and Pfizer — requires extra cold temperatures. While Moderna has

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The Alliance for Regenerative Medicine Announces Election of 2021 Officers, Executive Committee, and Board of Directors

Washington, DC, Oct. 21, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies, announced today the election of its 2021 Officers, Executive Committee, and Board of Directors.

The Executive Committee and Board of Directors oversee the formation and execution of ARM’s strategic priorities and focus areas over the coming year. The committee and board are subject to an annual re-election or rotation process, with nominations and approval by the ARM membership and current Board.

“We are pleased to welcome such an accomplished group of executives to the 2021 ARM board of directors,” said Janet Lambert, CEO of ARM. “As scientists, commercial leaders, and regulatory experts, the new members of the board will be instrumental in helping ARM and its members deliver transformative and potentially curative regenerative medicines to patients around the world.” 

ARM 2021 Officers:

Emile Nuwaysir, Ph.D. – President and CEO, BlueRock Therapeutics (Chairman)

Usman ‘Oz’ Azam, M.D. – President and CEO, Tmunity Therapeutics (Vice Chairman)

Amy Butler, Ph.D. – President, Biosciences, Thermo Fisher Scientific (Secretary)

Devyn Smith, Ph.D. – COO, Sigilon Therapeutics (Treasurer)

ARM 2021 Executive Committee:
*new to the Executive Committee for 2021

Usman ‘Oz’ Azam, M.D. – President and CEO, Tmunity Therapeutics

Amy Butler, Ph.D. – President, Biosciences, Thermo Fisher Scientific 

* Miguel Forte, M.D., Ph.D. – CEO, Bone Therapeutics

Claudia Mitchell, MBA, Ph.D. – SVP, Product and Portfolio Strategy, Astellas Pharma

Emile Nuwaysir, Ph.D. – President and CEO, BlueRock Therapeutics 

Bob Smith, MBA – SVP, Global Gene Therapy Business, Pfizer Inc.

Devyn Smith, Ph.D. – COO, Sigilon Therapeutics

* Arthur Tzianabos, Ph.D. – President and CEO, Homology Medicines

* Christopher Vann – COO, Autolus Therapeutics 

ARM 2021 Board of Directors:
*new to the Board for 2021

Usman ‘Oz’ Azam, M.D. – President and CEO, Tmunity Therapeutics

Ronald Bartek – Co-Founder and President, Friedreich’s Ataxia Research Alliance

Amy Butler, Ph.D. – President, Biosciences, Thermo Fisher Scientific

Bradley Campbell, MBA – President and COO, Amicus Therapeutics

Cindy Collins, MBA – President and CEO, Editas Medicine

* Maria Fardis, Ph.D., MBA – President and CEO, Iovance Biotherapeutics

Miguel Forte, M.D., Ph.D. – CEO, Bone Therapeutics

Jonathan Garen, M.S. – CBO, uniQure

* Bobby Gaspar, M.D., Ph.D. – CEO, Orchard Therapeutics

Michael Hunt, ACA – CFO, ReNeuron

Jerry Keybl, Ph.D. – Senior Director, Cell & Gene Therapy, MilliporeSigma

* Louise Rodino-Klapac, Ph.D. – SVP, Gene Therapy, Sarepta Therapeutics

Ann Lee, Ph.D. – SVP and Head of Cell Therapy Development & Operations, Bristol Myers Squibb

* Dave Lennon, Ph.D. – President, Novartis Gene Therapies

Bruce Levine, Ph.D. – Barbara and Edward Netter Professor in Cancer Gene Therapy, and Founding Director, Clinical Cell and Vaccine Production Facility, Department of Pathology and Laboratory Medicine, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania

John Maslowski, M.S. – President and CEO, Castle Creek Pharmaceuticals

Claudia Mitchell, MBA, Ph.D. – SVP, Product and Portfolio Strategy, Astellas Pharma

* Adora Ndu, PharmD,

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Karmanos Cancer Institute Launches Diversity and Inclusion Committee

Karmanos Cancer Institute Launches Diversity and Inclusion Committee

PR Newswire

DETROIT, Oct. 19, 2020

DETROIT, Oct. 19, 2020 /PRNewswire/ — The Barbara Ann Karmanos Cancer Institute is pleased to announce the launch of a Diversity and Inclusion Committee. Led by this committee, Karmanos will integrate best practices in diversity, inclusion and cultural competence to deliver outstanding and equitable medical care to the patients we serve and provide a welcoming and supportive environment for staff members.

“Diversity at Karmanos has always been an organizational strength,” says Justin Klamerus, M.D., MMM, president, Karmanos Cancer Hospital & Network.
“Diversity at Karmanos has always been an organizational strength,” says Justin Klamerus, M.D., MMM, president, Karmanos Cancer Hospital & Network.

Justin Klamerus, M.D., MMM, president, Karmanos Cancer Hospital & Network will serve as executive sponsor of the local committee with Kay Carolin, chief nursing officer, as the chair.

“Diversity at Karmanos has always been an organizational strength,” said Dr. Klamerus. “To enhance its power, we must continue to educate and embrace culture shifts, seek ways to improve, stay present and bridge gaps in care for our patient population. This cannot be done by the local committee alone. We will align with the McLaren Health Care corporate council and seek engagement from staff to empower the community we serve.”

The Diversity and Inclusion Committee is comprised of members from many different areas of the organization from leadership and administration to clinical staff and researchers. They will hold their first meeting on October 19, 2020. In addition to core members, the committee will work with department leaders in identifying staff members to participate in initiatives to broaden the scope of voices and ideas.

Karmanos’ Health Equity Book Club
In alignment with the organization’s increased focus on diversity and inclusion and to encourage open conversation about inequity, Karmanos has launched a Health Equity Book Club. The purpose of this quarterly program is to educate health care providers on the history of systemic racism in medicine and to set the stage for developing strategies and interventions to eliminate the impact of racial inequities in medical practice and society. This will be done through the reading and discussion of texts that explore a range of topics related to equity in health care.

“Karmanos encourages everyone to learn more and support our community. Doing so makes us better caregivers, colleagues and individuals,” said Michael Simon, M.D., MPH, co-leader of the Breast Cancer Multidisciplinary Team and creator of Karmanos’ Health Equity Book Club.

For more information and to register for the first virtual dialogue session on Thursday, October 22, 2020, from 4 – 5:30 p.m., visit www.karmanos.org/bookclub.

“No time is soon enough for us to heighten our long-standing commitment to diversity and inclusion. Through open conversation, vulnerability and education, we can take steps that will allow us to better understand our patients, our colleagues and ourselves,” said Dr. Simon.

A history of diversity and inclusion
While the formalization of a Diversity and Inclusion committee and the Health Equity Book Club are new additions, Karmanos has long been committed to serving diverse populations. Through

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