MEDICAL, DIAGNOSTICS
Premier Research | March 14, 2023
Premier Research has partnered with InSilicoTrials, a leader in using artificial intelligence (AI) and computational modeling and simulation (CM&S) to speed up the development of new therapies and medical devices. Premier Research helps biotech and device companies take their ideas from the idea stage to the commercialization stage. The aim of the partnership is to make it easier, faster, and safer for treatments for rare diseases to get approval from the government.
CM&S and AI have made it possible to use virtual patients in clinical trials in whole or in part, which the FDA approves of in some cases. In silico trials make it possible to create fake control or treatment arms, help figure out how to sign up patients, and predict the safety and effectiveness of new drugs and medical devices more accurately.
The use of synthetic control arms generated using in silico CM&S techniques represents a powerful tool for enabling non-feasible rare disease research, both preclinical and clinical research. In the last five years, Premier Research has been in charge of more than 240 rare disease studies for a wide range of indications. This shows that the company is committed to orphan drug development for a long time. Premier Research is continuing to put money into trials for rare diseases by partnering with InSilicoTrials.
One major advantage of in silico simulation is the ability to investigate 'what if' scenarios, particularly in rare diseases where a larger patient population does not exist. By using biological, molecular, or genetic data to describe rare diseases, in silico models can make synthetic control arms. This, along with Premier Research's expertise in clinical and preclinical development, execution, and regulatory aspects of small population trials, can shorten the time it takes to make effective treatments for rare diseases.
The partnership between Premier Research and InSilicoTrials will focus on smarter in silico study design, leading to a more effective pre-clinical review of trial design parameters and faster submission-ready studies. CEO of InSilicoTrials Luca Emili says that combining modeling and simulation with AI is the best way to improve the R&D process in drug development. This is because it allows sponsors to speed up the development of new treatments, make medical products safer, and lower R&D costs.
About Premier Research
Premier Research is a global company that does clinical research, product development, and consulting. It focuses on using new technologies to design and run smart studies and trials. With more than 2,500 employees in 75 countries, it has a lot of experience in certain therapeutic areas and uses. The company is committed to empowering its customers to meet the unmet needs of patients and offers great benefits and flexible working conditions.
Read More
INDUSTRIAL IMPACT
Resilience | February 20, 2023
National Resilience, Inc. (Resilience), a manufacturing company with a technology-focused mission to improve access to complex medications, recently announced a 10-year biomanufacturing partnership with a top pharmaceutical company for its portfolio of services in process and analytical development, drug substance manufacturing, and drug product manufacturing. The extensive agreement covers prospective biologic, vaccine, nucleic acid, cell, and gene therapy manufacturing.
Resilience’s recently acquired facility in Cincinnati, Ohio, is its worldwide center of excellence to produce commercial medicinal products, and will deliver the first product as stipulated under the agreement. The development of complicated pharmaceuticals, such as cell and gene therapies, has not kept up with the rate of scientific advancements that are supporting them. Resilience brings together exceptional minds in science and engineering to bridge this gap with access to state-of-the-art technology.
Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience, said, “The partnership announced today is a major milestone for Resilience.” He further added, “We are grateful to have this opportunity to work with our partner to deliver important, life-saving medicines to patients. We understand the trust placed with us to manufacture the medicine with the highest quality, regulatory compliance, and reliability. We are committed to maintaining a responsible manufacturing operation that exceeds the expectations of our partners and enables us to make a meaningful impact on global healthcare.”
(Source – Business Wire)
With the addition of this alliance to its expanding commercial portfolio, the company anticipates generating record revenues in 2023.
About Resilience
Resilience is a technology-focused biomanufacturing startup. The company intends to increase access to sophisticated medications. The firm is establishing a long-term network of cutting-edge, all-inclusive manufacturing solutions to guarantee that the therapies of today and the future may be produced efficiently, securely, and at scale. Resilience aims to continuously develop the science of biopharmaceutical manufacture and development, so their partners concentrate on the discoveries that enhance patients' lives and safeguard biopharmaceutical supply chains from future disruptions.
Read More
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
The Center for Breakthrough Medicines | March 13, 2023
Nucleus Biologics and Stoic Bio have teamed up to form a supply agreement with the Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization that aims to accelerate the development and manufacture of advanced therapies. Under the agreement, Nucleus Biologics will become CBM's selected supplier of cell culture media and other biological solutions, ensuring a consistent supply of this critical material with tighter quality control measures.
Nucleus Biologics' approach to cell culture media, which sees it as a critical raw material that can drive desired attributes of cells crucial to the success of cell and gene therapy research, is complementary to CBM's focus on transparency, technology, and end-to-end solutions. By working together, they hope to expedite cell and gene therapy breakthroughs.
In addition, CBM will be an early adopter of Stoic Bio's innovative family of point-of-use media makers, Krakatoa™, which allows scientists to manufacture their own media with 65% fewer CO2 emissions than conventional media. By demonstrating that developing and manufacturing lifesaving therapies doesn't have to come with a high environmental cost, CBM hopes to set an example for the industry.
With over 2,200 cell and gene therapies in development, collaborations like this one are needed to speed up the process of getting these therapies to the clinic and ultimately approved. The CBM, Stoic Bio and Nucleus Biologics collaboration aim to create a unique service offering that introduces a paradigm shift in development and manufacturing, showing how technology and sustainability can converge to make better therapies sustainably.
About The Center for Breakthrough Medicines
The Center for Breakthrough Medicines (CBM) is a CDMO focused on accelerating the development and manufacture of advanced therapies to save lives. It offers end-to-end solutions such as process development, manufacturing, and quality control for cell and gene therapies, gene editing, and immunotherapies. In addition, CBM collaborates with pharmaceutical companies, academic institutions, and healthcare providers to make advanced therapies more accessible while ensuring compliance with regulatory standards. The company also prioritizes sustainability by implementing green initiatives and sustainable technology and strives to positively impact the communities it operates in.
Read More