Exploring Recent Developments and Trends in the CRO & CDMO Industries: A Comprehensive Update
The Contract Research Organization (CRO) & Contract Development and Manufacturing Organization (CDMO) industries have recently experienced some interesting developments and trends shaping its future. To help our readers stay up to date with the latest industry news, we have put together & summarized some updates on a selection of the recent happenings in the CRO & CDMO industries!
Source credit: contractpharma.com
AmplifyBio Expands Cell Therapy Characterization, Fills Gap in Preclinical Development
AmplifyBio, a preclinical contract research organization, has acquired assets from PACT Pharma, including a site and a team of TCR-based drug development experts to enhance its discovery and characterization capabilities. The company has also partnered with several clients to improve single-cell genotype and phenotype assessment of CAR-Ts and other cell-based therapies, with a focus on tumor microenvironments. AmplifyBio plans to onboard platforms in the near future to refine the study of drug products in these environments. The company’s South San Francisco site is collaborating with clients to provide various services in cell therapy development. AmplifyBio also plans to add a third site in Ohio to expand its advanced therapy services and become a commercial accelerator for delivering safe and effective advanced therapies to patients. J. Kelly Ganjei Ganjei, CEO of AmplifyBio, stated that many cell and gene therapy developers are choosing AmplifyBio to mitigate financial and product development risks, and the company aims to become the leader in the field.
LEO Pharma and ICON Partner to Advance Clinical Trials in Dermatology
LEO Pharma, a global leader in medical dermatology, has formed a strategic partnership with ICON plc, a clinical research organization, to scale clinical trial execution that is patient-centric and cost-effective to support LEO Pharma’s clinical portfolio. The partnership, called PACE, reflects the shared values of Passion, Agility, Communication, and Excellence in delivery. The partnership will leverage both fully outsourced and functional outsourcing models in a tailored and flexible hybrid approach. LEO Pharma plans to drive efficiencies in clinical trials, significant and lean scalability in all areas of clinical development, co-investment within the area of decentralized clinical trials, access to ICON in-house ancillary services, economies of scope and scale, and access to external data, knowledge, expertise, and technologies.
In supporting LEO Pharma through the partnership, ICON will draw upon a team of over 500 professionals from across its business to provide tailored services and capabilities including its laboratories, Accellacare site-network, FIRECREST site management, and decentralized clinical trial capabilities, to create strategic advantage in how the trials are delivered. Joerg Moeller, MD, executive vice president and head of Global R&D at LEO Pharma, stated, “Partnering with ICON supports our 2030 strategy as it will help us to bring innovative treatments to patients faster while also supporting a more sustainable business through scalability and flexibility.” Steve Cutler, CEO of ICON, commented, “We take a flexible and integrated approach when working with our partners, utilising fully outsourced, hybrid and FSP models that complement our partner’s internal capabilities and enable them to achieve their strategic goals. It is also motivating for our employees to be working with a partner that shares our values and has a commitment to improving the lives of patients.”
Novotech to Share Advantages of Expanded Global Operations
Novotech, a biotech contract research organization (CRO) with a focus on the Asia Pacific region, will attend BIO Europe to meet with clinical stage biotechs and share the benefits of its recently expanded operations in Europe. At JPMorgan, Novotech announced its acquisition of EastHORN – A Novotech Company, a European CRO with clinical, medical, and regulatory expertise in multiple strategically important locations across the continent. EastHORN, which is retaining its brand, is now integrated into Novotech’s systems and processes, allowing biotech clients to access Novotech’s suite of CRO services globally with a specialist focus on the Asia Pacific region.
The acquisition is part of Novotech’s global expansion program to provide in-country expertise across Asia-Pacific, North America, and Europe to deliver global drug development programs. John Moller, CEO of Novotech, stated, “This acquisition is a strategic move to further expand our CRO operations and provide biotech clients with in-country expertise across Asia-Pacific, North America, and Europe to deliver their global drug development programs.” Novotech has more than 50 Site Partnership agreements with major medical research institutions in the Asia Pacific region to deliver exclusive benefits for sponsors.
Center for Breakthrough Medicines Offers Preclinical Package for IND-enabling Activities
Center for Breakthrough Medicines (CBM), a contract development, manufacturing, and testing organization (CDMO), is offering an IND-enabling package to innovator companies to manufacture high-quality drug substance and product for preclinical studies required for IND-enabling activities. The package includes off-the-shelf AAV rep-cap and helper plasmids, custom plasmid manufacturing, access to a proprietary cell line, streamlined process development services, scalable preclinical vector manufacturing services, and regulatory support for INTERACT and Pre-IND meetings.
Avi Nandi, CBM’s chief technical officer, stated that the past year has been a catalyst moment for gene therapies with approvals for AAV- and LV-based gene therapies driving renewed momentum in the pre-clinical pipeline. The package enables developers to generate high-quality material and data in under five months and positions them to move rapidly towards IND approval and GMP clinical manufacturing. Additionally, the preclinical offerings will supply drug substance and product for proof-of-concept, toxicology, safety, biodistribution studies, method development, interim reference standard, development stability, and drug product development critical for IND packages. Upon preclinical manufacturing completion, clients have full transparency to the data from execution, production, and purification, a critical data set for the sponsor of any clinical program.
These recent developments across the industry demonstrate the sector’s ongoing growth and commitment to improving clinical research. By expanding services, forming strategic partnerships, and investing in new technologies, CROs & CDMOs are driving innovation and accelerating the development of novel therapies. As the industry continues to evolve, we can expect to see even more exciting advancements that will ultimately benefit patients and transform healthcare worldwide.
