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Center for Breakthrough Medicines Adds Two Senior Vice Presidents to Leadership Team

Mandy Conver, SVP Business Development for Testing & Analytics, and Jennifer Manning, SVP Global Strategic Partnerships, Each Bring Twenty-Plus Years of Expertise

King of Prussia, PA, July 27, 2022 – The Center for Breakthrough Medicines (CBM) announced today the appointment of Mandy Conver as Senior Vice President (SVP) of Business Development for Testing & Analytics, and Jennifer Manning as (SVP) of Global Strategic Partnerships.

“Both Mandy and Jennifer are accomplished and recognized leaders in the biotechnology industry and we are thrilled to have them join our team,” said Joerg Ahlgrimm, Chief Executive Officer of CBM. “Each brings extensive expertise in strategy formulation, team development, process management and commercial leadership, and are expected to have a significant impact on the continued growth of CBM.”

Mandy Conver, SVP Business Development for Testing & Analytics
Conver will tap into her 20-plus years of diverse experience in the biotechnology and BioPharma industries to strategically lead all organic and new business development opportunities for CBM’s Testing & Analytics division. She will be responsible for leading and directing a team of highly technical Business Development professionals to repeated success while driving revenue growth.

Most recently, Conver led the successful launch of QIAGEN’s QIAcuity Digital PCR portfolio in North America, where she oversaw market strategy and commercial activities, including creation of a specialized commercial team and customized training for a large-matrix sales organization. Additionally, she also negotiated strategic alliances and heavily influenced portfolio evolution that led to QIAGEN achieving widespread adoption of the platform throughout the cell and gene therapy field.

“I’m honored to join CBM and lead the continued, rapid expansion of the testing and analytical services business,” said Conver. “CBM’s comprehensive, end-to-end capabilities are transforming the client experience through their commitment to partnership, innovation and building process efficiency. I’m excited to partner with their team of industry experts to help accelerate life-saving therapies to patients.”

A resident of Vienna, VA, Conver earned her bachelor’s in chemistry from The George Washington University. In her spare time, she enjoys traveling, gardening and spending time outdoors with her three children, Reese, Ryan and Cooper.

Jennifer Manning, SVP of Global Strategic Partnerships
With more than 25 years of bioprocessing and cell and gene therapy experience, Manning will negotiate, develop and lead strategic partnerships with academic institutions, private equity and venture capital firms, and large pharma at CBM. Additionally, she will help set the strategy for growing CBM revenue, establish senior-level relationships with partners, and build a team of Strategic Account Directors ensuring CBM partners have access to its technologies and services, while focusing on establishing and nurturing thoughtful, long-term collaborations.

Most recently, Manning built and led the North American Advanced Therapy Commercial Development Team at Fujifilm Diosynth Biotechnologies, where she was responsible for the growth of the viral vector, recombinant vaccine, and oncolytic virus businesses. Previous roles and responsibilities include advancing global capabilities for industry leading CDMOs such as Lonza, DSM Biologics, Alcami Corporation, and Patheon and helping to build and lead the sales training department at Human Genome Sciences for the successful launch of BENLYSTA.

“I am incredibly motivated knowing the work CBM and its partners are doing can save lives,” said Manning. “The cell and gene therapy industry has matured to an inflection point where we will be doing just that, but for many more patients and at breakthrough access and speed. I am proud and excited to be a part of the CBM team.”

Manning earned her bachelor’s degree in biological sciences from Clemson University and a Master of Public Administration, Health Policy and Management from New York University. A resident of Gaithersburg, MD with her husband Steve and their children Hunter, Jackson, and Sawyer, Manning loves the Clemson Tigers, practices yoga and enjoys reading, traveling and journaling.

“Mandy and Jennifer are leaders who have made significant contributions throughout their careers and each will continue to excel here at CBM,” said Audrey Greenberg, CBM co-founder and Chief Business Officer. “Women are making meaningful impacts in the cell processing and biopharma industries, and CBM is proud to have several leadership and executive roles occupied by extremely well-qualified females.”

About The Center for Breakthrough Medicines
CBM is a cell and gene therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia’s Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector manufacturing, cell banking, cell processing, and a full suite of complementary testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.

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Media Contact:
Keith Bowermaster, APR, CCMP
Coyne Public Relations
973-588-2000
kbowermaster@coynepr.com

July 27, 2022

Center for Breakthrough Medicines Accelerates Plans to Build the Largest Cell Therapy Manufacturing Operation in the World

CBM Responds to Critical Lack of Cell Therapy Manufacturing Supply by Adding Capacity for More than 10,000 Patients

King of Prussia, PA, June 14, 2022 – The Center for Breakthrough Medicines (CBM) in partnership with the Discovery Labs announced today the acceleration of plans to build capacity to manufacture more than 10,000 patient therapies in direct response to the critical shortage of cell therapy supply, which will help patients win their courageous battles against cancer.

“We are acutely aware of the importance of getting these lifesaving therapies to patients immediately,” said Joerg Ahlgrimm, Chief Executive Officer of Center for Breakthrough Medicines. “We share their race against time and apply extreme urgency to everything we do. There is a critical shortage of cell therapy manufacturing in the world forcing doctors to make heartbreaking decisions resulting in patient deaths that could be avoided. We focus every day on our patients and their families, so the intense urgency of our mission is never compromised.”

Planning has begun on a massive expansion of CBM’s cell therapy manufacturing suites and supporting infrastructure which when completed will have the ability to produce treatments for more than 10,000 patients per year, the largest in the world. While a final cost has yet to be determined, the expansion is expected to cost hundreds of millions of dollars over the coming years.

CBM is currently providing process development, analytical development and testing capabilities with extensive viral vector, cell therapy and plasmid DNA manufacturing coming online monthly.  

“Everyone at CBM works to save lives. This decision not only provides critically needed manufacturing capacity but also emphasizes CBM’s unwavering commitment to deliver advanced therapies for patients in need,” said John Lee, Vice President and Head of Cell Therapy at CBM. “CBM’s steadfast commitment to the patient is underscored by this decision.”

CBM’s facility will manufacture cell therapies across indications including oncology immunotherapies and regenerative medicine applications. The state-of-the-art facilities will be forward engineered with modular designs to adapt an array of cell types, manufacturing processes, and capacity demands to maximize efficiency while minimizing costs. To further enable next-generation cell therapies, the CBM team will implement rapid autologous manufacturing, high-fidelity gene-editing capabilities, and fully automated processes prior to the facility coming online.

CBM is working with multiple academic institutions and innovator companies to advance these critical modalities, lower cost, shorten timelines and scale manufacturing of approved therapies so that all patients can receive treatment.

About The Center for Breakthrough Medicines
CBM is a cell and gene therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia’s Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector manufacturing, cell banking, cell processing, and a full suite of complimentary testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.

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Media Contact:
Keith Bowermaster, APR, CCMP
Coyne Public Relations
973-588-2000
kbowermaster@coynepr.com

June 13, 2022

iECURE Enters Agreement with Center for Breakthrough Medicines (CBM) to Supply Materials for Future Clinical Programs

Partnership to focus on manufacturing clinical materials for future clinical studies

PHILADELPHIA–(BUSINESS WIRE)–iECURE, a gene editing company focused on mutation-agnostic in vivo gene insertion, or knock-in, editing for the treatment of liver disorders with significant unmet need, and Center for Breakthrough Medicines (CBM) today announced the companies have entered into a strategic collaboration wherein CBM will produce and supply Good Manufacturing Practices (GMP)-grade adeno-associated virus (AAV) for use in iECURE’s future clinical studies to enable development of iECURE’s programs with the shared mission of accelerating the availability of these potential treatments to the patients.

“Our approach to gene editing relies on highly complex manufacturing processes, and we are eager to establish partnerships to ensure a reliable supply of GMP materials for future clinical development,” said Paul Firuta, Chief Operating Officer of iECURE. “CBM was able to offer us significant amount of guaranteed capacity with scheduling flexibility and we are confident that they will be a strong partner with their state-of-the-art facilities and end-to end capabilities.”

“iECURE’s approach to gene editing is quite innovative and has the potential to bring significant hope to patients and families facing devastating diagnoses,” said Audrey Greenberg, Chief Business Officer and Co-Founder of CBM. “Our ability to provide customizable clinical and commercial GMP manufacturing solutions integrated with industry-leading comprehensive in-process testing, quality control, and lot release programs allows us to support our partners like iECURE through the entirety of their product lifecycle and is aligned with our mission to bring life changing medicines to patients in need.”

About iECURE

iECURE is a gene editing company focused on developing therapies that utilize mutation-agnostic in vivo gene insertion, or knock-in, editing for the treatment of monogenic liver disorders with significant unmet need. We believe our approach has the potential to replace and restore the function of a dysfunctional gene by knocking-in a healthy copy, regardless of mutation, to offer durable gene expression and long-term, potentially curative, therapeutic benefit. Our management team has extensive experience in executing global orphan drug and gene therapy clinical trials and successfully commercializing multiple products. We intend to leverage our team’s core strength in research and development strategy to identify what we believe to be the most suitable target and modality for our product candidates to address particular liver diseases. We are collaborating with the University of Pennsylvania’s Gene Therapy Program, or GTP, led by James M. Wilson, M.D., Ph.D., to utilize GTP’s world-class translational expertise and infrastructure, which has helped generate our initial pipeline of potential product candidates. For more information, visit www.iecure.com and follow on LinkedIn.

About Center for Breakthrough Medicines (CBM)

CBM is a cell and gene therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia’s Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector, cell therapy and a full suite of testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.

Contacts
Investors:
David Garrett
dgarrett@iecure.com

Media:
Danielle Cantey
Canale Communications
danielle.cantey@canalecomm.com

May 25, 2022

The Center for Breakthrough Medicines (CBM) Strikes Multi-Year Deal with UK Cell Therapy Powerhouse

Strategic Partnership to Deliver US Based Manufacturing Capacity for Novel Cell Therapy

King of Prussia, PA — April 12, 2022The Center for Breakthrough Medicines (CBM) announced today a partnership with London-based Achilles Therapeutics plc (NASDAQ: ACHL). The deal provides expanded cell therapy manufacturing capabilities required to supply products for Achilles’ ongoing Phase I/IIa clinical trials in advanced non-small cell lung cancer and metastatic or recurrent melanoma patients. CBM is a contract development and manufacturing organization (CDMO) dedicated to addressing the challenges associated with developing and manufacturing advanced therapies. Achilles is a clinical-stage biopharmaceutical company developing precision T-cell therapies to treat solid tumors.

“We are bringing together two powerful, experienced cell therapy organizations for the benefit of cancer patients,” said John Lee, Ph.D., Vice President, Head of Cell Therapy, CBM. “We look forward to mobilizing our world-class cell therapy capabilities, with our first wave of cell therapy suites to enable Achilles to accelerate the development of their flagship precision T cell product candidate.”

“Achilles is thrilled to partner with CBM given their experience, capabilities, available cell therapy capacity and strategic location. After opening our US headquarters in Philadelphia, CBM’s King of Prussia location was perfect for our needs,” said Edward Samuel, Executive Vice President of Technical Operations at Achilles Therapeutics. “The expertise of the CBM team, along with their ability to provide on-demand, flexible access to autologous cell therapy manufacturing GMP space was vital in our decision.”

CBM will manufacture Achilles’ precision T cell therapy for the company’s ongoing Phase I/IIa clinical trials in non-small cell lung cancer and melanoma patients.

“Our ability to deliver customizable manufacturing solutions for partners seeking autologous cell therapy production positions us well with Achilles, and we are excited to support them on their journey to bring desperately needed treatment options to cancer patients,” said Audrey Greenberg, co-founder, CBM. “We employ the most sophisticated scheduling, supply chain and inventory control systems integrated with industry-leading comprehensive in-process testing, quality control, and lot release programs in the industry. Achilles’ goal to deliver improved therapies to cancer patients also aligns with CBM’s mission and culture.”

About The Center for Breakthrough Medicines (CBM)
CBM is a purposefully built advanced therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia’s Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector, cell therapy and a full suite of testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.

About Achilles Therapeutics
Achilles is a clinical-stage biopharmaceutical company developing precision T cell therapies targeting clonal neoantigens: protein markers unique to the individual that are expressed on the surface of every cancer cell. The Company has two ongoing Phase I/IIa trials, the CHIRON trial in patients with advanced non-small cell lung cancer (NSCLC) and the THETIS trial in patients with recurrent or metastatic melanoma. Achilles uses DNA sequencing data from each patient, together with its proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient, and then develop precision T cell-based product candidates specifically targeting those clonal neoantigens.

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Contact:
Keith Bowermaster
Coyne PR
(o) 973-588-2168 (c) 770-891-9247
kbowermaster@coynepr.com

April 12, 2022

Center for Breakthrough Medicines Launches Analytical Testing Services for Advanced Therapies, Bringing Solutions to a Supply-Constrained Industry

Testing Business Unit Will Grow to More Than 400 Employees, Eliminate Wait Times, and Enable Faster Release Times for The Pharma Industry

KING OF PRUSSIA, Pa., January 16, 2022 — The Center for Breakthrough Medicines (CBM) announced the opening of their analytical testing services laboratories that will deliver the most comprehensive testing capabilities in the industry. These vital service offerings address growing capacity needs in the severely supply-constrained cell & gene therapy market.

More than 2,500 submissions are currently under review in the Food and Drug Administration’s (FDA) cell and gene therapy pipeline. This volume, combined with FDA’s increased scrutiny, has caused bottlenecks for product release results, with testing queues of up to 8 months. By 2025, the FDA expects to receive upwards of 200 investigational new drug (IND) applications for cell and gene therapies annually, with an estimated approval of 10 to 20 cell and gene therapies each year. This unprecedented growth comes with challenges, particularly in testing. Tremendous backlogs in critical long-lead assays across the industry are leading to 6–12-week delays for cell-based methods, safety assays, and advanced analytics.

CBM’s Testing and Analytical Services provides an integrated and comprehensive portfolio of services to its clients all on one campus located in the heart of Philadelphia’s Cellicon Valley, with a goal to dramatically shorten development timelines, greatly reduce regulatory risks and accelerate cures for patients. CBM’s testing services will support custom assay development, characterization, and release for cell and gene therapy products, as well as for biologics, vaccines and plasmids. Regardless of a company’s development stage, CBM offers tailored solutions from IND through commercialization and lot release.

“Our laboratories support R&D and GMP testing services, enabling the continued expansion of the on-site capabilities that can be scaled up at our expansive King of Prussia facility,” said Dana Cipriano, Senior Vice President of Testing and Analytical Services, Center for Breakthrough Medicines. “Our testing service is backed by strong scientific expertise and advanced analytical equipment and is located across the hall from our Process Development and Manufacturing Operations, allowing us to offer a complete on-site end to end service for our manufacturing clients as well as the option for standalone external testing for our clients.

CBM’s Comprehensive Testing Capabilities & Massive Expansion Plan

CBM’s Testing and Analytical Services business occupies approximately 200,000 sq ft across four buildings along with a stand-alone safety testing laboratory segregated from GMP operations on one campus. In addition to massive analytical development capabilities, the campus has advanced analytics at the forefront of the operation, including the following components:

  • CBM dedicated Bioassay lab that supports potency assay development with a “partner-in-plant” philosophy welcoming CBM’s clients to promote early development of these methods and provide a progressive approach to development throughout a product’s life cycle.
  • CBM dedicated analytical lab to support assay development, full product and process characterization, as well as release testing.
  • CBM next-generation sequencing (NGS) and molecular biology laboratories for full product characterization early in product development through commercial approval.
  • CBM validated testing platforms to support gene therapies, cell therapies, biologics, vaccines and plasmids.
  • CBM dedicated stability labs to support International Council for Harmonization (ICH) Q2 Stability programs.

CGT Industry’s Most Comprehensive Analytical Testing Capability on One Campus

“CBM’s Testing and Analytical Services business has a concentrated focus on meeting the unprecedented market demand where testing queues are at all-time highs,” said Joerg Ahlgrimm, President and CEO, Center for Breakthrough Medicines. “Clients and patients need in-process and product release testing, and CBM can meet this need. We provide speed to market by expediting the path to approval by utilizing advanced analytical methods and platform assays to demonstrate potency, purity, identity, and safety for FDA approval.”

CBM’s Testing and Analytical Services strengthen the company as a leading contract testing business, making testing a key strategic asset supporting the contract development and manufacturing organization (CDMO), and helps fill an extensive and growing analytical testing shortage in the CGT industry.

“We are aggressively attacking the testing market through our massive execution and delivery of the most comprehensive analytical testing capability in the CGT industry located on one campus,” said Audrey Greenberg, Co-founder and Chief Business Officer of Center for Breakthrough Medicines. “Our integrated manufacturing and testing services provide quality and speed – robust and unique advantages for our clients.”

About The Center for Breakthrough Medicines
CBM is a cell and gene therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia’s Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector manufacturing, cell banking, cell processing, and a full suite of complimentary testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.

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Media Contact:
John F. Kouten, DeFazio Communications
(o) 609-241-7352 (c) 908-227-4714
John@defaziocommunications.com

 

February 16, 2022

The Center for Breakthrough Medicines and the University of Pennsylvania Partner in the Manufacturing of Gene Therapies

CBM has large-scale Gene Therapy Manufacturing Capacity, Testing, and Analytics

— Penn’s Innovation in Process Science Combines with CBM Manufacturing Capability to Develop Large-Scale Gene Therapy Manufacturing Capacity, Testing, and Analytics —

KING OF PRUSSIA, Pa., Jan. 18, 2022 – The Center for Breakthrough Medicines (CBM) and the University of Pennsylvania’s Gene Therapy Program (GTP) have signed a landmark collaboration agreement, to combine Penn’s knowledge and expertise in the development of gene therapies with CBM’s manufacturing capacity and singular focus on advanced therapies.

This partnership is focused on moving therapeutics safely and rapidly from concept to clinic by connecting certain of Penn’s established gene therapy platforms with CBM’s manufacturing and analytical capacity. This combination will allow small biotech firms, universities, and large pharmaceutical companies to advance gene therapies from discovery to First-In-Human (FIH) studies with the potential for less risk and expense. By utilizing Penn’s gene therapy expertise, which has already been applied to numerous commercially sponsored clinical programs and avoiding the typical capital-intensive infrastructure builds associated with gene therapy manufacturing, gene therapy developers will be able to enter the field sooner and with less risk with confidence that this platform is scalable for later clinical stages and commercialization.

Under the renewable five-year deal, CBM will be the only for-profit contract development and manufacturing organization (CDMO) with commercial rights to certain of GTP’s gene therapy manufacturing platform, advanced analytics, and any future process or analytical improvements achieved through its collaboration with GTP.

“This agreement represents a giant leap forward for the Center for Breakthrough Medicines and its mission to accelerate the development and manufacturing of life-saving gene therapies,” said Audrey Greenberg, Co-founder, Center for Breakthrough Medicines. “This partnership with the GTP at Penn enables our clients the potential to advance to Investigational New Drugs with a high-quality process, materials and analytical methods.”

Gene therapies hold promise to treat and cure both rare and non-rare hematological, ophthalmic, musculoskeletal and neurologic diseases such as hemophilia, choroideremia, Duchenne muscular dystrophy, and Huntington’s disease, as well as oncology solid and non-solid tumor diseases. CBM is committed to successfully scaling up viral vectors to commercial scale and producing consistent personalized products for any patient population.

“Our mission at the Penn Gene Therapy Program is to discover, translate and greatly accelerate the development of next-generation gene transfer vectors and their application in the treatment of a variety of acquired and inherited diseases,” said James M. Wilson, MD, PhD, Director, Gene Therapy Program; Rose H. Weiss Professor and Director, Orphan Disease Center; and Professor of Medicine and Pediatrics, Perelman School of Medicine at the University of Pennsylvania. “This partnership is ideal in furthering that mission.”

As part of the partnership Penn will receive access to a best-in-class, state-of-the art GMP manufacturing partner with 700,000 planned square footage capacity plus a Sponsored Research Agreement to continue advancing the field of gene therapies. A primary goal of the partnership is to decrease the development costs, timelines and manufacturing Costs of Goods Sold (COGS), thus increasing the accessibility of life-changing treatments to patients.

“Our collaboration with the GTP at Penn will allow CBM the ability to offer accelerated gene therapy manufacturing services under one roof regardless of where a program is in its development timeline,” said Joerg Ahlgrimm, President and CEO, Center for Breakthrough Medicines. “With this access to GTP’s gene therapy production expertise, CBM becomes an appealing manufacturing partner with a differentiated offering. We will offer the best of an academic vector core (speed to clinic) and commercial CDMO (commercially viable process) combined.”

This deal comes on the heels of Penn GTP’s expansion to the Discovery Labs’ campus, located in the same facility as CBM, which creates a further synergized collaboration between the two organizations.

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.

Financial disclosure: Dr. Wilson is a scientific collaborator and the Chief Scientific Advisor to The Center for Breakthrough Medicines (CBM). Under this agreement, his laboratory at Penn will receive sponsored research funding from CBM and, as an inventor of certain technologies to be licensed to CBM, he may receive additional future financial benefits under licenses granted by Penn to CBM. The University of Pennsylvania also holds equity and licensing interests in CBM and may receive additional future financial benefits as a result of such interests.

Media Contact:
John F. Kouten, DeFazio Communications
(o) 609-241-7352 (c) 908-227-4714
John@defaziocommunications.com

January 18, 2022

SK Inc., the Second Largest Conglomerate in South Korea, has invested $350 million in the Center for Breakthrough Medicines

“We chose to partner with SK based on our shared deep desire to cure cancer and eradicate genetic disease”
-Brian O’Neill, Chairman, Center for Breakthrough Medicines

For Immediate Release

The Center for Breakthrough Medicines and SK Inc. are partnering to Hire 2,000 Advanced Therapy Experts and build the largest manufacturer of cell and gene therapies in the world

King of Prussia, PA, (January 10, 2022) – The Center for Breakthrough Medicines (CBM) announced today that it has received $350 million in equity financing from SK Inc. (KRX: 034730) (SK). CBM is partnering with SK to create the world’s largest end-to-end cell and gene therapy contract development and manufacturing organization (CDMO).

CBM will leverage this investment to enhance its fully integrated pre-clinical through commercial manufacturing capabilities with world class automation and infrastructure. Existing and future capabilities include process development, viral vector manufacturing, cell processing, plasmid DNA, cell banking, and a full suite of complimentary analytical development and testing capabilities.

“We chose to partner with SK based on our shared deep desire to cure cancer and eradicate genetic disease,” said Brian O’Neill, Chairman, Center for Breakthrough Medicines. “Thousands of people are dying every day, and we have the ability to cure patients by manufacturing these new technologies. This unprecedented collaboration will allow us to bring over 700,000 square feet of capacity online, and hire 2,000 of the world’s most brilliant, advanced therapy experts, all at the Discovery Labs site in King of Prussia, Pennsylvania.”

“SK is the perfect strategic partner to enable CBM’s core mission of expediting approval for cell and gene therapies,” said Audrey Greenberg, Co-Founder, Center for Breakthrough Medicines. “SK’s mission of delivering value and happiness for all, their emphasis on a culture of safety and quality, and their global reach creates an ideal match for CBM allowing us to scale and deliver in an unprecedented manner.”

In addition to supporting lab and GMP suite build-out, this investment will also enable strategic joint ventures, sponsored research agreements, and development of proprietary technology platforms.

“People of all ages are suffering from cancer and genetic diseases around the world. Our partnership with SK accelerates our ability to bring together the world’s most brilliant minds to develop and manufacture cures,” said Joerg Ahlgrimm, President and CEO, Center for Breakthrough Medicines. “The partnership with SK, Inc. allows us to more fully realize our mission to save lives by accelerating the development and manufacturing of advanced therapies. This mission is the foundation of our company culture – we always put our partners and patients first, it is the premise of CBM and why we come to work every day.”

“CBM’s strong management team and geographic location in Philadelphia, the birthplace of the cell & gene therapy industry, were core elements in our desire to invest in the company,” said Mr. Dong Hoon Lee, Executive Vice President of SK Inc., “Through our investment in CBM, which was made through SK Pharmteco, an SK holding company, we have secured a crucial foundation for realizing SK pharmteco’s vison in 2025 to become a global top-tier CDMO.”

Incentrum Group acted as exclusive financial advisor on the transaction.

About The Center for Breakthrough Medicines
CBM is a horizontally integrated cell and gene therapy contract development and manufacturing organization (CDMO). CBM offers fully integrated, bench to bedside, pre-clinical through commercial manufacturing capabilities including, process development, plasmid DNA, viral vector manufacturing, cell banking, cell processing, and a full suite of complimentary testing and analytic capabilities. CBM’s innovative horizontal integration enables the utmost quality and accelerates time to market and affordability of advanced therapies from discovery to commercialization without compromising quality through a single-source, end-to-end solution, providing the opportunity for incubators, academics, researchers, and companies small to large to align with the most comprehensive manufacturing partner in the industry.

About SK Inc. & SK Pharmteco
SK Inc. is a diversified, publicly-traded (KRX: 034730), investment holding company for SK Group, a leading conglomerate in Seoul, South Korea with major operating companies in energy, semiconductors, telecommunications and life sciences, with significant investments in BioPharma cell and gene therapies. SK pharmteco, a holding company of SK CDMO business based in California, consolidates the operations of AMPAC Fine Chemicals, SK biotek, SK bioteck Ireland, and Yposkesi. The company has global manufacturing facilities with demonstrated capabilities in process development, scale-up, and cGMP-compliant commercial production of active pharmaceutical ingredients and registered intermediates for pharmaceutical and biotechnology customers worldwide.

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Media Contact:
John F. Kouten, DeFazio Communications
(o) 609-241-7352 (c) 908-227-4714
John@defaziocommunications.com

January 10, 2022

The Center for Breakthrough Medicines Implements GMP Validated System Delivered by Navigator Business Solutions

LEHI, Utah, Dec. 20, 2021 /PRNewswire/ — Navigator Business Solutions today congratulates the Center for Breakthrough Medicines (CBM) on the completion of SAP Business ByDesign, as a GMP validated system. 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 and development.

Navigator was instrumental in the implementation of the Enterprise Resource Planning (ERP) system covering, Finance, Client Project Management, Procurement, Supply Chain Planning, Warehousing & Logistics, Manufacturing and Quality. This implementation is part of a multitiered strategy CBM is deploying to set up a strong foundation to execute its growth plans. Automation, digitalization, business process excellence and technology innovation are key success factors CBM is using to build the largest end to end CDM for Advanced Therapies.

“With a validated and scalable ERP 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,” said Peter Carbone, Chief Operating Officer, Center for Breakthrough Medicines. “Navigator executed the work on time and on budget and has proven to be an invaluable partner in our corporate development.”

CBM’s journey began in 2020 searching for ERP vendors and an implementation partner. CBM finalized on SAP Business ByDesign as the ERP software with Navigator Business Solutions as our implementation partner and the project was kicked off in February 2021 culminating with GMP validation system in December 2021.

“We’re excited to support the Center for Breakthrough Medicines in their progress to build a leading cell and gene manufacturing and testing facility,” said Russell DeLapp, EVP Services, at Navigator Business Solutions. “With Navigator’s expertise delivering ERP systems for Life Sciences organizations, our clients have the systems in place to drive quality, transparency, and growth for years to come.”

Additional Information
For more on Navigator Business Solutions, visit: nbs-us.com/sap-erp-for-life-sciences
Connect with Navigator on LinkedIn: linkedin.com/company/navigator-business-solutions

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 Navigator Business Solutions
Life Sciences/Biotechnology, Distribution, and Consumer Products Organizations come to Navigator Business Solutions when they find their ability to grow and or adapt is being limited by their current business processes and systems. Navigator has built its extensive expertise working on more than 500 ERP implementations and ERP system optimization projects.

Navigator configures and implements ERP solutions built on SAP Business One and SAP Business ByDesign, so clients can break free of the limiting and disconnected business systems that hold them back from achieving their true growth potential.

Contact:

Sean Barbera
Navigator Business Solutions
801-642-0123
326219@email4pr.com

John F. Kouten
DeFazio Communications
(o) 609-241-7352 (c) 908-227-4714
326219@email4pr.com

SOURCE Navigator Business Solutions

December 20, 2021

The Center for Breakthrough Medicines Adopts Veeva Vault Quality Suite to Help Advance Cell and Gene Therapy Contract Services

PLEASANTON, CA — Nov. 16, 2021Veeva 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.

Additional Information
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.

Forward-looking Statements
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.

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Contact:

Deivis Mercado
Veeva Systems
925-226-8821
deivis.mercado@veeva.com

November 16, 2021

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.”

Focused Investment

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.”

Unsurpassed Leadership

“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.

Media Contact:
John F. Kouten, DeFazio Communications
(o) 609-241-7352 (c) 908-227-4714
John@defaziocommunications.com