BUSINESS INSIGHTS

Ginkgo Bioworks and Novo Nordisk to Collaborate on Expression Systems for Pharmaceutical Products

Ginkgo Bioworks and Novo Nordisk, | June 08, 2022

Ginkgo Bioworks
Ginkgo Bioworks the leading horizontal platform for cell programming, announced a collaboration with Novo Nordisk, a leading global healthcare company, to create novel expression hosts for pharmaceutical products.

hundreds of millions of people are living with diabetes, obesity, and other serious chronic diseases, putting a strain on individuals, families, and healthcare systems. More effective medicines could improve treatment options for these people. Using synthetic biology, Ginkgo and Novo Nordisk will collaborate to unlock the potential of expression systems, which may accelerate and enhance the discovery and development of Novo Nordisk's biological medicines.

"Novo Nordisk is constantly pushing the boundaries for innovative tools to bring new treatments to people living with diabetes and other serious chronic diseases. Using synthetic biology and the reprogramming of expression system genomes, we have the potential to engineer biological systems that will expand the chemical space of biological medicines."

Brian Vandahl, Senior Vice President, Global Research Technologies, Novo Nordisk

"It's an honor to work with partners like Novo Nordisk that not only have an incredible range of critically important products, but that also provide us with the opportunity to do meaningful work that could help so many patients," said Jason Kelly, CEO and cofounder of Ginkgo Bioworks. "At Ginkgo, we are always on the lookout for projects that will have an outsized impact on people's lives and well-being. We're excited to be working with Novo Nordisk in our efforts to use biology to create better medicines for patients with chronic diseases."

Under the terms of the partnership, Ginkgo and Novo Nordisk will launch a multi-year collaboration. Ginkgo will receive an upfront R&D fee and is eligible to receive milestone payments as the parties advance in the collaboration.

About Ginkgo Bioworks
Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. 

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DiMe Releases Toolkits to Improve Sensor Data Integration and Power Better, Faster Global Healthcare and Research

Digital Medicine Society | July 18, 2022

Today, the Digital Medicine Society released the Sensor Data Integrations Toolkits, four comprehensive toolkits to guide data producers, processors, and consumers to use the influx of data from the increased use of wearables and digital sensing products at scale. These resources are based on the Sensor Data Integrations project, comprised of healthcare leaders from Amazon Web Services Oracle, the Moffitt Cancer Center, Takeda, the US Department of Veterans Affairs and more. These toolkits will help realize the promise of sensor generated data to drive better decisions, faster, to improve healthcare delivery and research. The project team will conduct a demo of the toolkits during a live launch event on July 18 at 10:30 am ET, featuring Micky Tripathi, the National Coordinator for Health Information Technology at the US Department of Health and Human Services. The surge of data from sensor technologies is far outpacing the industry's ability to collect, store, analyze, protect, and use this data effectively for patient care and research. The number of US patients using remote patient monitoring devices is expected to surpass 70 million by 2025. Between 2022 and 2028, the global market for wearable technology is expected to grow around 18.5 percent, reaching $380.5 billion. The number of unique digital endpoints being used in industry sponsored trials of new medical products increased by over 950% between October 2019 and May 2022. The number of sponsors using these products in medical product development increased from 12 to 96 in the same timespan. And while the ability to discern high-quality sensor data suitable for clinical decision making is increasing rapidly, the ability to access these data is constrained by a current dependence on individual point solutions. "Sensor generated data, captured during people's daily lives, offer the opportunity to redefine how we measure health and disease. This opportunity powers the possibility of using high quality, high resolution flows of data to reimagine our approach to healthcare and research, leveraging more complete information to improve individual clinical decisions, decisions about the effectiveness of new medical products, and broader policy and public health decisions. DiMe's new Sensor Data Integrations Toolkits provide action-oriented resources to help data producers, processors, and consumers come together to create a sensor data ecosystem suitable for scale." DiMe CEO Jennifer Goldsack AWS has contributed customer feedback and technical expertise to ensure the toolkit meets the needs of today's modern healthcare system. "Across every industry, we see companies trying to accelerate their path to the cloud," said Lita Sands, Head of Solutions Life Sciences at AWS. "Timelines are getting quicker while the data collected is increasing exponentially – there is a clear and significant need for how to effectively and securely collect and use this information at scale. DiMe's new toolkits are a lifeline to organizations working with sensor data. They offer a comprehensive starting point for data producers, processors, and consumers to help build an integrated pipeline to support better and faster decision making." The development of these toolkits builds on DiMe's previous pre-competitive initiatives, such as The Playbook, the essential guide for developing and deploying digital clinical measures to advance patient care, clinical research, and public health. The Sensor Data Integrations Toolkits go further to ensure that high quality sensor data can be used at scale to improve patient care and speed efficient medical product development. The DiMe community is currently working on additional projects related to taking digitally generated data to scale and will be releasing additional resources over the coming months. DiMe is not only committed to creating and disseminating new digital health approaches and tools, but also sharing user experiences with the broader community. We encourage Sensor Data Integrations Toolkits users to contribute to Dime's "Resources in Action" case study hub by sharing how you are using resources to further the safe, effective, equitable, and ethical use of digital medicine to redefine healthcare and improve human health. The leading organizations from across the global healthcare, research, and digital health innovation sectors that collaborated with DiMe to create these open-access resources are AWS, Elevance Health, Evidation, US Food and Drug Administration (FDA), Human First, Institute of Electrical and Electronics Engineers, Medable, Moffitt Cancer Center, Open mHealth, Oracle, Savvy, Takeda, and US Department of Veterans Affairs (VA). About the Digital Medicine Society DiMe is a global non-profit and the professional home for all members of the digital medicine community. Together, we tackle the toughest digital medicine challenges, develop clinical-quality resources on a technology timeline, and deliver these actionable resources to the field via open-source channels and educational programs. Join us to advance the ethical, effective, equitable, and safe use of digital medicine to redefine healthcare and improve lives.

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LTS takes next step in its Growth Journey with the acquisition of Tapemark Inc.

LTS Lohmann Therapie-Systeme AG | August 23, 2022

LTS LOHMANN Therapie-Systeme AG announces the closing of the acquisition of Tapemark Inc. located in St. Paul, MN, USA. This acquisition combines Tapemark, a world-class CDMO specialized in transdermal drug delivery systems and oral thin films as well as unit dose semi-solid drug and iontophoresis products with LTS, a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches Oral Thin Films and Micro Array Patches (MAP) for major Bio- /Pharmaceutical, Generic, and Consumer Health companies. With the acquisition, Tapemark´s St. Paul facility will become part of the worldwide operations network of LTS, along with LTS' existing facilities in Andernach, Germany and West Caldwell, NJ in the US. Bas van Buijtenen, CEO of LTS, commented, "We are very pleased to welcome the Tapemark team to the LTS family. This strategic acquisition demonstrates our commitment to continue to set the standard as the best CDMO in TTS and OTF and to strengthen our footprint in the US, the world's most important pharma market. We will offer an even more complete portfolio of drug delivery expertise and expanded manufacturing capabilities to our customers and their patients, and we are excited to welcome Tapemark's customers to LTS' global network. The acquisition strengthens our R&D capabilities in North America, allowing us to bring ever more innovation and development support to players developing innovative therapies and new drug delivery systems. With that, we're even better positioned to address our customers' desire for a single partner to support them from feasibility through commercialization. We are particularly pleased that such a talented team is joining our organization. I am delighted that Beau Garrett will be strengthening our Global Leadership Team in the role of SVP Strategy and Corporate Development. His track record as a leader successfully driving growth will bolster our LTS Growth Journey." "Joining LTS strengthens our ability to craft the best product development and manufacturing strategy to deliver complex drugs for our customers who ultimately bring these to market and help patients around the world. Having spoken to our customers, I know they are excited to benefit from the breadth of LTS's global technology portfolio, its product development capabilities, and the vast global network. Together, we will reach more pharmaceutical partners and ultimately help more patients. Personally, I am pleased our executive team is joining such a strong team at LTS. From the day I met Bas and several of the senior leaders at LTS, I knew this was the right fit for both companies, our employees, and our customers." Beau Garrett, CEO of Tapemark The transaction has obtained the necessary regulatory approvals and has closed as of August 19, 2022. Financial details of the transaction are not disclosed. Bourne Partners served as the exclusive financial advisor to Tapemark. About LTS LTS LOHMANN Therapie-Systeme AG is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches and Oral Thin Films for the pharmaceutical industry. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Micro Array Patches for the transdermal delivery of large molecule, biological actives and vaccines. Founded in 1984, LTS operates today from three sites: in Andernach, Germany, West Caldwell, NJ, USA and St. Paul, MN, USA. LTS has also a representative office in Shanghai, China.

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Societal CDMO Selected To Provide Tech Transfer And Manufacturing Services To Support Clinical Development Of An Oral Solid Dose Product In Europe

Societal CDMO, Inc. | July 21, 2022

Societal CDMO, Inc. a contract development and manufacturing organization dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has been selected to provide CDMO services to support the ongoing clinical development of a novel drug candidate in Europe. The compound is an oral solid dose anti-viral therapy product approved for the prevention and treatment of human immunodeficiency virus in select countries in Europe and Societal’s work is focused on supporting the expansion of the product’s indications. Under terms of the new agreement, Societal CDMO will execute appropriate technology transfer activities, followed by cGMP manufacture of clinical trial material to support the initiation and execution of Phase 2 studies of the drug candidate. This work will include production, packaging and labeling of both the active compound and matching placebo for the study. “This is a key new agreement for Societal CDMO as it is a clear demonstration of the company’s ability to capitalize on the increasing interest of drug developers in the onshoring and reshoring of contract manufacturing activities to the U.S. from other regions around the globe. We are proud to be trusted by our partner to execute the tech transfer, manufacturing and packaging services that will be necessary for the initiation of its planned Phase 2 study in Europe. We continue to be pleased with our progress in leveraging our end-to-end CDMO service offerings to grow our business and expand our client base.” David Enloe, chief executive officer of Societal CDMO About Societal CDMO Societal CDMO is a bi-coastal contract development and manufacturing organization with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.

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