The Center for Breakthrough Medicines Adopts Veeva Vault Quality Suite to Help Advance Cell and Gene Therapy Contract Services
PLEASANTON, CA — Nov. 16, 2021 — Veeva Systems (NYSE: VEEV) today announced that the Center for Breakthrough Medicines (CBM) adopted Veeva Vault Quality Suite to modernize development and manufacturing services for sponsors. With a flexible and scalable quality system, the company is advancing its vision to build the world’s largest cell and gene therapy manufacturing and testing facility and enable the rapid development and delivery of groundbreaking treatments for patients.
“Using modern quality systems and industry best practices right from the start is a priority to provide high-quality services to our customers,” said Audrey Greenberg, co-founder and executive director at Center for Breakthrough Medicines. “With Veeva Vault Quality Suite, we can more efficiently and effectively meet GxP requirements, accelerate manufacturing and delivery, and improve affordability for lifesaving and life-changing therapies from the bench to the patient.”
CBM is a contract development and manufacturing organization (CDMO) dedicated to alleviating the lack of capacity that is preventing patients from accessing critically needed cell and gene therapies. The company is focused on accelerating the delivery and affordability of therapies by offering a complete solution for discovery, development, and commercialization.
Vault Quality Suite enables CBM to harmonize quality processes, content, and training for greater visibility and control across their manufacturing and testing network. By adopting a unified quality solution, CBM can drive manufacturing efficiency and increase collaboration across departments, suppliers, and customers.
“We’re excited to partner with the Center for Breakthrough Medicines to advance their vision of building a leading cell and gene manufacturing and testing facility,” said Ashley Wentworth, director, Vault Quality at Veeva Systems. “With Veeva’s modern quality solutions, the company has the systems in place to drive quality, transparency, and growth for years to come.”
The Vault Quality Suite includes Veeva Vault QMS, Veeva Vault Product Surveillance, Veeva Vault QualityDocs, Veeva Vault Validation Management, Veeva Vault Station Manager, Veeva Vault Training, Veeva LearnGxP, and Veeva Vault LIMS to automate and harmonize quality processes globally.
Watch on-demand Veeva R&D and Quality Summit Connect sessions to learn how leading companies partner with Veeva to modernize quality manufacturing for improved collaboration and speed.
For more on Veeva Vault Quality Suite, visit: veeva.com/QualityManufacturing
Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems
Follow @veevasystems on Twitter: twitter.com/veevasystems
About The Center for Breakthrough Medicines
The Center for Breakthrough Medicines (CBM) is a horizontally integrated cell and gene therapy contract development and manufacturing organization (CDMO) enabling advanced therapy development and commercialization. CBM seeks to accelerate the time to market and affordability of advanced therapies from discovery to commercialization with single source, end-to-end solutions. The ability to host pre-clinical translational research and process development and scale from bench to bedside in one place offers the opportunity for incubators, academics, researchers, and companies small to large to align with the most comprehensive manufacturing partner in the industry.
About Veeva Systems
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit veeva.com.
This release contains forward-looking statements, including the market demand for and acceptance of Veeva’s products and services, the results from use of Veeva’s products and services, and general business conditions, particularly within the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva’s expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva’s financial results are included under the captions, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in the company’s filing on Form 10-Q for the period ended July 31, 2021. This is available on the company’s website at veeva.com under the Investors section and on the SEC’s website at sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.
SK Inc. Enters into Exclusive Financing Deal with the Center for Breakthrough Medicines
KING OF PRUSSIA, Pa., Nov. 16, 2021 /PRNewswire/ — The Center for Breakthrough Medicines (CBM) announced today that it has entered into exclusive negotiations with SK Inc., significantly accelerating CBM’s mission to create the world’s largest end-to-end cell and gene therapy contract development and manufacturing organization (CDMO). Established in 2019, CBM offers fully integrated pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, and viral vector manufacturing, cell banking, cell processing, and a full suite of testing and analytic capabilities.
The financing is expected close in December 2021.
“We are thrilled by the opportunity to join forces with SK Inc., the perfect strategic partner to enable CBM’s core mission of expediting the path to approval for cell and gene therapies for patients in need,” said Audrey Greenberg, Co-Founder, Center for Breakthrough Medicines.
SK Inc. is a publicly-traded (KRX: 034730) holding company based in Seoul, South Korea and primarily invests in energy, chemicals, semiconductors, logistics, services and biopharma sectors, with significant investments in cell and gene therapy.
“We are thrilled by the opportunity to join forces with SK Inc., the perfect strategic partner to enable CBM’s core mission of expediting the path to approval for cell and gene therapies for patients in need,” said Audrey Greenberg, Co-Founder, Center for Breakthrough Medicines. “SK’s mission of delivering value and happiness for all, culture of safety and quality, emphasis on ESG values, and global reach creates an ideal match for CBM. SK has a strong biopharma portfolio, including considerable investments in cell & gene therapy companies creating enormous strategic value for CBM. The SK CBM partnership will bring capacity to a starved CGT marketplace and expedite the delivery of new therapies to patients who need them now.”
In addition to CDMO services, CBM has been investing significantly in proprietary cell and gene manufacturing technology which allows clients to leverage the Company’s cutting-edge platforms to accelerate speed to market and lower cost. This, combined with the scale of capacity and integrated single-site supply chain, and the deep expertise of the team, positions CBM as the ideal CDMO partner for company’s looking for a strategic development and manufacturing partner.
CBM will use the net proceeds of this financing to support operations, research, lab and GMP suite build out, strategic joint ventures, sponsored research agreements, technology platforms, automation and infrastructure.
CBM will occupy nearly 700,000 square feet at The Discovery Labs — located in the heart of Philadelphia’s Cellicon Valley in King of Prussia, Pennsylvania.
“The capital provided by SK will enable us to fully execute on our mission of saving lives by accelerating the development and manufacturing of advanced therapies.” said Joerg Ahlgrimm, President and CEO, Center for Breakthrough Medicines. “We are building an unprecedented amount of desperately needed capacity. CBM will be hiring 2,000 new team members in the next 4 years, providing extraordinary growth opportunities for the industry’s talented scientists who share our mission to save lives.”
“CBM’s has assembled a world class team of leaders which was a core element in our desire to invest in the company,” said Mr. Dong Hoon Lee, Executive Vice President of SK Inc., “In addition to their industry-leading management team, CBM is an ideal investment because of its geographic location in Philadelphia – the birthplace of the cell & gene therapy industry, established cell and gene therapy manufacturing capabilities and the Company’s opportunity to address significant capacity constraints in the cell and gene therapy manufacturing space.” He also adds “With the successful investment in CBM, SK have secured a crucial foundation for realizing the ‘SK CMO Financial Story’ which envisions completing the chemical·biologic drug value chain across the U.S., Europe and Asia by 2025.”The CBM team is led by Joerg Ahlgrimm, President & CEO, who held positions of senior leadership at Lonza AG, where he was responsible for 37 sites on four continents and over 8,000 employees, and at Baxter Healthcare, BioScience Division/Baxalta Inc. CBM’s C-suite is rounded out with a diverse group of leaders with substantial experience in global pharma, biotech and the CDMO industry.
About The Center for Breakthrough Medicines
The Center for Breakthrough Medicines (CBM) is a fully integrated, end-to-end advanced therapy CDMO partner providing a full spectrum of services, all in one location, to companies working on pre-clinical to commercial phase therapies. This horizontal integration enables the utmost quality and accelerates speed to market with one single-source, end-to-end solution.
About SK Inc.
SK Inc. is an investment holding company for SK group, a leading conglomerate in Seoul, South Korea with major operating companies in energy, semiconductors, telecommunications and life sciences. SK Inc. enhances its portfolio values by developing long-term strategies with globally competitive affiliates in energy and chemicals, ICT, semiconductor and materials, logistics and services, and bio and pharmaceuticals.
John F. Kouten, DeFazio Communications
(o) 609-241-7352 (c) 908-227-4714
Osmolality: a powerful tool in bioprocessing
Over the past decade, biotech research has greatly focused on cell and gene therapies, which have shown great promise in the treatment of a broad variety of indications, including rare and orphan diseases with high unmet need. In this era of precision medicine, cell and gene therapies move us closer to true personalized medicine: This means patients’ experience and quality of life during treatment are crucial considerations during the development of these advanced therapies.
The Center for Breakthrough Medicines is a contract development and manufacturing organization working on innovative cell and gene therapies. Their services are aimed at accelerating speed to market for advanced therapies. “We are able to apply our knowledge of microbiology and expertise to help propel cell and gene therapy research forward,“ explains Kayla Pasake, Research Associate for Analytical Development at The Center for Breakthrough Medicines. “We are helping companies accelerate the delivery of safe and effective therapies to patients.”
Navigating CDMO Capacities & Capabilities
“Audrey Greenberg says that among those cell and gene therapy companies choosing to outsource, about half of them do so in hybrid fashion, often through a co-location arrangement with organizations like the center For Breakthrough Medicines. “The R& D and tech transfer processes are quite cumbersome, so co-location has many advantages to streamline that path to commercialization,” she says. “With cell and gene therapy, it’s all about speed to market. Co-location typically eliminates a lot of the speed bumps that would take place along the way in a purely outsourced or do-it-yourself environment.”
Those speedbumps, says Greenberg, include a shortage in bioreactors, consumables, analytical methods, and the talent required to handle it all. She says a good CDMO partner will have access to not just material supply and manufacturing capacity, but also process and manufacturing expertise.
They hybrid model is one that Verma has embraced for Iovance. “We’ve partnered with various CDMOs over the past couple of years to support our clinical programs and products and our supply chain network, and that’s blossomed into a diverse and talented group of partners in the U.S. and Europe that’s helped us to make ground in advancing our company’s growth trajectory,” he says. “We’ve benefitted from access to the technologies and sciences needed for TIL therapies. While we have brilliant individuals in our Tampa facility performing the benchtop and lab work associated with our proprietary TILs, we weren’t sure that we could do this on our own.””