Gilead, working on its own remdesivir ramp-up, scouts licensing partners for global production

Fiercepharma | May 06, 2020

Gilead Sciences can only produce so much of its newly authorized COVID-19 drug remdesivir, so it’s scouting other companies to bolster global supply. Even as it presses ahead with its own remdesivir ramp-up, Gilead says it’s in licensing talks with the “world’s leading chemical and pharmaceutical manufacturing companies” about their ability to produce remdesivir for countries in Europe, Asia and beyond until at least 2022. Remdesivir manufacturing relies on “scarce” raw materials that command their own “lengthy” production timelines, Gilead has said. Moving forward, coordination on producing the drug will be “critical,” the drugmaker says. Disruptions could reduce output or increase manufacturing time.

Spotlight

Your localization partner is going to do a deep-dive into your business—so start by diving deep into theirs. Are they an industry-leader with 20 years of experience or a relative newcomer? Will they speak Samoan, Uzbek, or Swahili (and all your customers’ languages)? Can they deliver on-time and on-budget—every time? Ask how many languages they support. Find out whether their translator team comprises just linguists, or linguists and subject matter experts. Explore the backgrounds of their senior management team. Be nosey. Ask questions. Cyberstalk.

Spotlight

Your localization partner is going to do a deep-dive into your business—so start by diving deep into theirs. Are they an industry-leader with 20 years of experience or a relative newcomer? Will they speak Samoan, Uzbek, or Swahili (and all your customers’ languages)? Can they deliver on-time and on-budget—every time? Ask how many languages they support. Find out whether their translator team comprises just linguists, or linguists and subject matter experts. Explore the backgrounds of their senior management team. Be nosey. Ask questions. Cyberstalk.

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BUSINESS INSIGHTS

CEM Corporation and AmbioPharm enter into US partnership for GMP peptide production

CEM Corporation | September 16, 2021

CEM Corporation and AmbioPharm, Inc. are pleased to announce the formation of a partnership to produce GMP peptides for the global market. The partnership includes the exclusive 1Use of CEM's microwave peptide synthesis technology on a large scale for the production of GMP peptides up to several kilograms using its own scalable reactors. The main advantages of this new relationship are the extremely short production times, the ability to efficiently produce more difficult peptide sequences, and the ability to incorporate green chemistry protocols. This partnership will enable the rapid and efficient production of new chemical peptide entities (NCEs) using the latest available technologies. With this agreement, AmbioPharm has started peptide synthesis at its North Augusta facility to better serve customers with fast microwave synthesis processes. CEM's peptide production technology utilizes automated, large-scale microwave solid phase peptide synthesis systems (SPPS) that have been proven to improve peptide purity and minimize excess reagents. In addition, the CEM has developed proprietary coupling methods optimized for reactions at elevated temperatures 2 , a unique way to combine the coupling and deprotection reactions in a single step 3 , and established the use of more environmentally friendly solvents that are more accessible at elevated temperatures 4 . These unique technological advantages are licensed to AmbioPharm for GMP production. AmbioPharm is a recognized leader in cGMP peptide production. The company employs more than 675 people and recently completed a major expansion of its headquarters in South Carolina, USA, adding nearly 56,000 square feet of additional peptide manufacturing capacity. The production plant has a cleaning capacity of up to 30 kg / batch and a freeze-drying capacity of up to 1,000 liters. The CEM Liberty Pro Synthesizer offers different reactor sizes (3, 8 and 15 liters) that allow the synthesis of batches from 5 g to 500 g of the final peptide. Peptide-based drugs have enormous potential for the future and we are pleased to be able to help improve their production process. AmbioPharm is an ideal partner and we believe this relationship will enhance the opportunities for the manufacturing of peptide therapeutics. - Michael J. Collins, Ph.D., President and CEO of CEM Corporation. With the addition of CEM's microwave technology to our GMP peptide manufacturing options, we can offer even better service in terms of faster delivery for our partners' products and unique opportunities to make longer and more complex peptides accessible using microwave methods. - Chris Bai, Ph.D., CEO of AmbioPharm Inc. About CEM CEM Corporation, a privately held company based in Matthews, North Carolina, is a leading provider of laboratory instruments. The company has subsidiaries in the UK, Germany, Italy, France, Japan and Singapore and a worldwide network of distributors. CEM designs and manufactures systems for life sciences, analytical laboratories and processing plants worldwide. The company's products are used in many industries, including the pharmaceutical, biotech, chemical and food industries, as well as academic research. About AmbioPharm, Inc . AmbioPharm, part of the Ambio Pharmaceuticals Group, is a leading, innovation-driven company that specializes in the development and manufacture of peptides and peptide-like products. AmbioPharm offers a comprehensive range of services and produces customized products for research, clinical development and commercial use for pharmaceutical and biotechnology companies worldwide. AmbioPharm operates internationally, has its headquarters in the USA, locations in Europe, the USA and Asia and has more than 14 years of experience and expertise.

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PHARMA TECH

Quantum Leap and SignalPath to Integrate Clinical Trial Software Infrastructure Across I-SPY Platform Trials

Quantum Leap, SignalPath | February 24, 2021

Quantum Leap Healthcare Cooperative (Quantum Leap) and SignalPath reported a partnership today that will further enable the I-SPY platform trials with vigorous, streamlined technology infrastructure to drive the straightforwardness and efficiency of trial execution. SignalPath will integrate existing work process instruments being utilized to control the I-SPY trials into SignalPath's research operations and financial platform. In view of the public health emergency surrounding the COVID-19 pandemic, this advanced technology infrastructure will initially be conveyed for I-SPY COVID-19 with subsequent expansion to I-SPY2. “As we continue to grow our platform trials with a focus on I-SPY COVID-19, and the growing complexity of processing drug candidates through our platform trials, we need sophisticated infrastructure to ensure we can maintain our efficiency and agility. SignalPath provides the missing link for a comprehensive, tech-enabled trial technology platform to unlock the full potential of adaptive trial designs. This further empowers us to address urgent health needs that can only be solved through exceptional, technology-enabled clinical research,” observed James Palazzolo, CEO of Quantum Health. The I-SPY platform has had incredible accomplishment in working with leading academic medical centers around the United States. SignalPath is helping to extend that footprint across the a-list community health systems on the SignalPath platform. The objective is to continue to draw in community health systems with hearty research programs in cutting edge research to help their patients. “We founded SignalPath to re-imagine clinical trial execution through technology,” stated Brad Hirsch, MD, CEO and Co-Founder, SignalPath. “The Quantum Leap team has already accomplished an amazing amount in the fight against breast cancer and is now applying their full force to drive insights into COVID-19. It is an incredible opportunity for us to collaboratively support trial execution through our powerful technology infrastructure to meaningfully reduce the complexity for both the Quantum Leap team and the sites involved in the I-SPY trials. Everyone’s goal is the same - to bring life-saving medicines to patients that need them most.” About SignalPath SignalPath is the premier clinical trial technology partner for research sites and sponsors, focused on improving the ease and efficiency of trial execution and management. Supporting over 5,000 trials across more than 300 sites and thousands of active users, SignalPath is the industry standard that addresses key pain points in the conduct of trials. About Quantum Leap Healthcare Collaborative Quantum Leap Healthcare Collaborative is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate care and research, and to foster high-impact trials with embedded clinical processes and systems technology and improved data management, greater access to clinical trial matching, and greater benefit to patients, providers, and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. About the I-SPY TRIALs The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations.

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PHARMACY MARKET

NRx Pharmaceuticals to Work with Cardinal Health to Ensure Efficient Distribution of Potential Therapies

NRx Pharmaceuticals | August 26, 2021

NRx Pharmaceuticals announced today it has signed an agreement with Cardinal Health to provide third party logistics and distribution of ZYESAMI™ upon the potential Emergency Use Authorization (EUA) approval by the US Food and Drug Administration (FDA). In May, NRx submitted an application for EUA to the FDA for ZYESAMI™ (aviptadil) for patients suffering from Critical COVID-19 with respiratory failure. "This partnership creates an efficient and highly flexible logistics and distribution model for NRx. Cardinal Health's expertise will enable ZYESAMI to quickly reach patients in the intensive care units, as limiting the time to treatment is crucial," said Robert Besthof, Head of Operations and Chief Commercial Officer of NRx. "This also allows NRx to continue focusing on answering requests from the FDA in support of our application for Emergency Use Authorization for ZYESAMI." Cardinal Health Specialty Pharmaceutical Distribution will serve as the exclusive distributor for ZYESAMI, providing broad access to hospitals for this needed medicine upon FDA authorization. With one of the largest healthcare supply chains, Cardinal Health services more than 90% of hospitals in the U.S., and has more than 20 years of experience supporting rapid delivery of lifesaving medicines. Additionally, Cardinal Health's Third-Party Logistics Services (3PL) will support the warehousing and distribution, full order to cash, and necessary title model services. "As the COVID-19 pandemic continues, so does the need for more innovative, effective and FDA-approved therapies for critically-ill patients with respiratory failure," said Marc DeLorenzo, Senior Vice President of Strategic Sourcing at Cardinal Health. "Cardinal Health is pleased to ensure that COVID-19 patients get access to treatment in a timely and efficient manner." About NRx Pharmaceuticals NRx Pharmaceuticals draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, NRx was awarded an exclusive worldwide license to develop and commercialize the BriLife (VSV-ΔG) COVID-19 vaccine developed by the Israel Institute of Biological Research. About Cardinal Health Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities. With 50 years in business, operations in more than 35 countries and approximately 44,000 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at cardinalhealth.com.

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