Overview
Amiel Gross has taken on the role of Head of Legal for the Center for Breakthrough Medicines. He has been in this position since 2020 and has many responsibilities. One of these is making sure the business strategies and policies are aligned with all legal implications, obligations, and risks.
Gross dedicates on a multi-disciplinary life science practice, providing counsel to executives and senior management as well as negotiating complex commercial transactions and facilitating strategic alliances.
Gross has a hands-on experience across a wide array of subject matters, such as licensing deals, master service agreements, procurement contracts, intellectual property, corporate affairs, sponsored R&D collaborations and FDA regulatory and compliance.
Amiel Gross is a professional who has studied International Law at the Queen Mary University of London. Amiel holds a Bachelor of Arts Degree from the Southwestern University and a Doctor of Law Degree from The University of Texas School of Law.
Services
Non-Fiction
Work experience
Center for Breakthrough Medicines
Multi-disciplinary life science practice focused on counseling executives and senior management, negotiating complex commercial transactions, facilitating strategic alliances and supporting a range of legal issues arising in the course of highly-regulated biotechnology business operations. Oversight responsibility and hands-on experience across array of subject matters including master services agreements, licensing deals, procurement contracts, corporate affairs, intellectual property, sponsored R&D collaborations, FDA regulatory and compliance, labor and employment, litigation, cybersecurity and privacy.
Projects
Osmolality: A Powerful Tool in Bioprocessing
Amiel Gross Head of Legal at Center for Breakthrough Medicines shares that 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,” says Amiel Gross Head of Legal at Center for Breakthrough Medicines.
Amiel Gross indicates that 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.”
SK Inc. Enters into Exclusive Financing Deal with the Center for Breakthrough Medicines
Amiel Gross Head of Legal at 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 Amiel Gross, Head of Legal at 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 Amiel Gross Head of Legal at 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 Amiel Gross Head of Legal at 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.”
The Center for Breakthrough Medicines Adopts Veeva Vault Quality Suite to Help Advance Cell and Gene Therapy Contract Services
Amiel Gross, Head of Legal of the Center for Breakthrough Medicinesshares that 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 Amiel Gross Head of Legal 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.
According to Amiel Gross, 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.”
Amiel Gross Head of Legal at Center for Breakthrough Medicines shares that 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.
