Pfizer lays out gene therapy aspirations

BioPharma Dive | January 28, 2020

Pfizer aims to be the third big pharma with a significant presence in gene therapy. Its plans to initiate this year three Phase 3 trials targeting mutation-driven blood and muscular diseases would make it a large player in this cutting-edge area of medicine. The difference between Pfizer and its Swiss rivals Novartis and Roche is that its treatments for muscular dystrophy and hemophilia do not look like they will be the first to market. With hopes that gene therapy could be a one-and-done treatment, arriving second could put Pfizer at a disadvantage if eager patients rush for curative therapies. Having spun of its off-patent drugs business, the pharma is now trying to talk up the "new Pfizer." Its gene therapies are among seven pipeline projects that it cited Tuesday during its year-end earnings call as critical to its strategy of becoming a more innovation-focused company.

Spotlight

Fewer than one in eight chronic-disease sufferers say they watch when a drug commercial comes on TV, according to one recent study of community users. And for the millennials among them, the percentage is even less so. That’s despite the $5.1 billion spent by biopharma on the medium in 2018. We take a look at these data points and many others from two recent studies on the media habits of patients and doctors.


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Verizon Business Selected to Transform Astellas Pharma’s Global Network Infrastructure

Verizon Sourcing LLC | August 10, 2022

Verizon Business has been selected to manage Astellas Pharma Inc’s global network infrastructure. The network transformation will enable Astellas to harness advanced technologies to help reduce drug development timelines, healthcare costs and drive new revenue opportunities for the Japanese pharmaceutical multinational. Headquartered in Tokyo, Japan, Astellas is a global pharmaceutical company involved in the research, development, manufacture, and marketing of innovative new drugs under the vision of “Stand on the forefront of healthcare change to turn innovative science into VALUE for patients”. The company employs 14,000 employees worldwide. The company has identified digital transformation as a key driver of its business growth and began the search for a global partner to transform all aspects of its global technology infrastructure including building, designing and executing a next-generation secure network. In particular, Astellas was looking for a scalable and predictable platform that could seamlessly manage tens of thousands of devices and endpoints across Astellas’ 70+ global locations across a virtualized multi-sourced environment. Verizon’s relationship with Astellas stretches back more than a decade. In 2016, Astellas successfully deployed Verizon’s Secure Cloud Interconnect solution to provide a high-bandwidth secure connection to its Amazon Web Services and Microsoft Azure cloud services. Verizon’s current remit includes the build and deployment of Astellas’ global integrated network with a full suite of managed services, including Managed Wide Area Network, Local Area Network, Managed Security Services Secure Gateway, Zero Trust Network Access and Unified Communications and Collaboration as a Service. “From R&D to sales, we are seeing enormous amounts of data and intelligence flow through our business, across our 70 locations around the world. We want to ensure that we have a future-proof network in order to utilize cutting-edge technologies such as Artificial Intelligence, machine learning and robotics to make data-driven decisions to deliver better value for our patients. Our network transformation will underpin the next phase of our growth.” Shinya Suda, Senior Vice President, Information Systems, Astellas “The network is transformative in its ability to enable innovation and growth and Astellas is changing the way they are using the tools at their disposal to completely revolutionize their business. This is truly a watershed moment for the pharmaceutical industry as companies grapple with the pressures of reducing time and costs for the development of drugs while improving patient care and value. We’re proud to have been a part of Astellas’ growth journey for more than a decade,” said Robert Le Busque, Regional Vice-President, Verizon Business Group, Asia Pacific. Today’s announcement builds on the company’s network-as-a-service foundation and supports its private networks, mobile edge compute and business solutions vectors of growth. Verizon Communications Inc. was formed on June 30, 2000 and is one of the world’s leading providers of technology and communications services. Headquartered in New York City and with a presence around the world, Verizon generated revenues of $133.6 billion in 2021. The company offers data, video and voice services and solutions on its award-winning networks and platforms, delivering on customers’ demand for mobility, reliable network connectivity, security and control. VERIZON’S ONLINE MEDIA CENTER News releases, stories, media contacts and other resources are available at verizon.com/news. News releases are also available through an RSS feed.

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Asahi Kasei Bioprocess to Showcase Award-winning MOTIV™ Buffer Management Technology for Pharmaceutical Manufacturing at ACHEMA 2022

Asahi Kasei Bioprocess | August 01, 2022

Asahi Kasei Bioprocess America, subsidiary of diversified Japanese multinational company Asahi Kasei, will be featuring their MOTIV™ Buffer Management Technology at ACHEMA 2022 in Frankfurt this August. Winner of “Best in Show” at Interphex in 2017, “Technology of the Decade” from Bioprocess international in 2012 and originator of the concept for inline buffer formulation (IBF™), Asahi Kasei Bioprocess is a market leader that keeps pharmaceutical production moving efficiently and precisely through solutions like MOTIV with built-in automation software so that medicine can get to patients sooner and safer. Buffers are used for the vast majority of processes in pharmaceutical development, which has traditionally required storage in extremely large tank farms to be utilized as necessary. MOTIV can blend buffers from concentrates in small, single-use bags and is controlled with sensors to maintain and assure precision. It is also able to blend buffers to exact specifications as needed during a downstream development process and can handle a wide variety of buffer formulations. In addition, it is automated by the integrated OCELOT™1 System Control software to be repeatable and also helps to reduce waste created in the development process, so it is a more sustainable means of pharmaceutical manufacturing. “We have been working to ‘standardize’ system designs as much as we can, to make them more readily available with shorter lead times; but are also very capable at building custom systems to meet the specific needs of customers,” says Chris Rombach, Vice President of Sales and Marketing at Asahi Kasei Bioprocess America. “One of our strengths is not only having an innovative product, but also an extensive family of MOTIV systems to choose from. Buffer is the lifeblood of pharma manufacturing and with the R&D opportunities of being a part of the Asahi Kasei Group we have been able to develop MOTIV to be the most reliable and efficient IBF technology in the market today. Not to mention, Operation Warp Speed helped push capacity to expand globally and billions of dollars are being invested by manufacturers to ramp up production as quickly as possible. This drives a new sense of value for systems like our MOTIV family that can streamline processes.” 1 The OCELOT System Control is an Asahi Kasei Bioprocess proprietary technology that integrates and/or interfaces with plant-wide control systems in a universally compatible format, allowing for far-reaching data collection and analysis. About Asahi Kasei Bioprocess The Fluid Management Business Unit of Asahi Kasei Bioprocess is devoted to solving therapeutic product safety, efficiency and purity challenges within the pharmaceutical and bioprocessing industries. With technology platforms for virus filtration, chromatography, inline buffer formulation and oligonucleotide synthesis, our bioprocessing systems, columns, and automation solutions advance GMP manufacturing of critical drug substances around the world. Built with pride, built with quality, built to exceed your high expectations. “Built for You.” About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents.

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Prime Medicine Expands Leadership Team with Key Appointments to Support Continued Growth and Advancement of Prime Editing Technology and Portfolio

Prime Medicine | July 29, 2022

Prime Medicine, Inc. a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, Prime Editors, to address the widest spectrum of diseases by deploying Prime Editing technology “Prime Medicine is advancing a first-of-its-kind technology intended to expand the number of patients who may benefit from genetic medicines. We are thrilled to welcome Richard, Niamh and Fubao to the team. Together, they bring strong business acumen, extensive clinical and regulatory experience and leadership of successful teams that position us well to achieve our mission. These esteemed leaders have deep expertise across their respective focus areas, each of which is key to the advancement of our novel Prime Editing technology.” Keith Gottesdiener, M.D., Chief Executive Officer of Prime Medicine Richard Brudnick, Chief Business Officer, brings extensive industry experience, including leading successful business development transactions, across multiple stages of development and an array of therapeutic areas. Mr. Brudnick was previously Chief Business Officer and Head of Strategy at Codiak BioSciences and, before that, was Executive Vice President of Business Development and Alliance Management at Bioverativ, Inc., a company he helped found in 2016. Mr. Brudnick joined Bioverativ at the time of its spinoff from Biogen where, over the course of nearly 15 years, he initiated, led and completed numerous transactions, including for several of the company's marketed products and late-stage pipeline, including Tecfidera, Spinraza and its biosimilars joint venture with Samsung. Previously, Mr. Brudnick was the Chief Executive Officer of a regional pharmaceutical distribution business that he sold to a strategic buyer, co-founded two companies, and was a strategy consultant at Bain & Company. Mr. Brudnick earned his undergraduate degree in management science from MIT and his M.S. in management from the Sloan School of Management at MIT. Niamh Alix, Chief Human Resources (HR) Officer, is a human resources leader who brings nearly 20 years of experience helping to grow teams from small, early-stage organizations to global enterprises. She joins Prime from Orchard Therapeutics, where she was Vice President, Global Talent and HR Business Partner. Prior to that, Ms. Alix held multiple global and regional roles at Lonza, including HR Business Partner for Americas, Mexico, and Canada where she led the HR team and people strategy for a 5,000+ employee population across corporate and manufacturing clients, and across multiple scientific platforms including cell and gene therapy. Prior to that, she held senior HR roles of increasing responsibility at Novartis and Bristol Myers Squibb. She holds a master’s degree in HR strategies from Dublin City University and a B.Sc. in management from the Technological University of Dublin. Fubao Wang, Ph.D., SVP, Head of Regulatory, has substantial experience leading product development of genomic medicine products, as well as regulatory strategies and execution for both clinical and commercial-stage products. Before Prime, Dr. Wang served as Senior Vice President, Head of Regulatory Affairs at Asklepios BioPharmaceutical where he built and led the regulatory team to support the development of clinical-stage AAV-based gene therapy products. Earlier, he was Vice President, Head of Regulatory CMC at Sarepta Therapeutics, where he supported the development of AAV gene therapy and RNA products, including the FDA approvals of Vyondys and Amondys. He also served as Associate Vice President, U.S. Site Head, CMC Dossiers at Sanofi to support the BLA approval of Dupixent, a monoclonal antibody product. Prior to that, he held a 16-year tenure at Merck serving in research, development and regulatory roles of increasing responsibility, most recently as director, global and emerging markets regulatory affairs, led and contributed to the discovery and development of a variety of vaccine and biologics products. Dr. Wang holds a Ph.D. in molecular biology from Heidelberg University and completed his postdoctoral work in molecular biology at Stanford University. About Prime Medicine Prime Medicine, Inc. is a biotechnology company committed to delivering a new class of differentiated, one-time, curative genetic therapies to address the widest spectrum of diseases. The company is deploying Prime Editing technology, a versatile, precise, efficient and broad gene editing technology, which is designed to make only the right edit at the right position within a gene. With the theoretical potential to repair approximately 90 percent of known disease-causing genetic mutations across many organs and cell types, medicines based on Prime Editing, if approved, could offer a one-time curative genetic therapeutic option to a broad set of patients.

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Spotlight Therapeutics Appoints Visionary Global Pharma Drug Developer Antoine Yver, M.D., M.Sc. as First Independent Board Member

Spotlight Therapeutics | July 18, 2022

Spotlight Therapeutics, Inc. a biotechnology company applying new insights to develop cell-targeted in vivo CRISPR gene editing biologics, announced the appointment of Antoine Yver, M.D., M.Sc. to the Spotlight Board of Directors. Trained as an oncologist and immunologist, Dr. Yver’s extensive industry experience and perceptive acumen will be extremely valuable as Spotlight continues to strengthen its highly differentiated TAGE platform and advance lead therapeutic candidates towards the clinic. “We are thrilled to welcome Antoine to Spotlight’s Board of Directors. Few people in our industry enjoy such a remarkable track record of successful drug development, exercising extreme rigor in following the science to deliver practice-changing medicines that serve patients with significant unmet medical needs.” Mary Haak-Frendscho, Ph.D., President and Chief Executive Officer of Spotlight As Executive Vice President and Global Head of Oncology R&D at Daiichi Sankyo, Dr. Yver played a key role in the development of the new breakthrough cancer biologic, Enhertu®, that is redefining breast cancer treatment and promises to set a new standard of care, as well as other Daiichi Sankyo DXd ADCs. From 2009 to 2016, Dr. Yver held executive leadership positions at AstraZeneca, including SVP & Global Head of Oncology Development. Under his leadership, Tagrisso® and Lynparza® were successfully developed and commercialized for patients. Prior to joining AstraZeneca, Dr. Yver held roles at Merck, Johnson & Johnson, Aventis and Rhone-Poulenc Rorer. Dr. Yver is Executive Vice President and Chairman of Development at Centessa Pharmaceuticals plc and currently serves as an Independent Director of the Board of Directors at Sanofi. “I am delighted to join the Spotlight Board and support the mission to unlock the full potential of gene editing and enable effective single administration therapeutics for patients,” said Dr. Yver. “Spotlight’s biologics-based delivery approach has the potential to forge a new generation of cell-targeted in vivo CRISPR gene editing medicines across multiple therapeutic areas.” “Antoine’s deep insights and vast global pharma experience will help propel Spotlight to becoming a clinical stage company,” said Craig Gordon, M.D., Spotlight board member, Founder, CEO, and CIO of GordonMD™ Global Investments. “We look forward to working together to impact the strategic decisions of the company that will ultimately provide benefit to patients.” About Spotlight Therapeutics Established in mid-2018, Spotlight Therapeutics is a privately held biotechnology company advancing a pipeline of cell-targeted in vivo CRISPR gene editing therapies. Spotlight's proprietary technology platform TAGE is a new class of biologics, CRISPR effectors engineered for direct delivery in vivo, to achieve cell-selective therapeutic genome editing. Spotlight's pipeline is advancing its modular programmable CRISPR effectors towards clinical studies in immuno-oncology, ophthalmic diseases and hemoglobinopathies.

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Spotlight

Fewer than one in eight chronic-disease sufferers say they watch when a drug commercial comes on TV, according to one recent study of community users. And for the millennials among them, the percentage is even less so. That’s despite the $5.1 billion spent by biopharma on the medium in 2018. We take a look at these data points and many others from two recent studies on the media habits of patients and doctors.

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