Benchling | January 27, 2023
On January 27, 2023, Benchling, the R&D cloud that powers the biotechnology sector, announced that it has passed the System and Organization Controls (SOC) 2 certification. Schellman, an independent Certified Public Accounting (CPA) firm, conducted the Type 2 SOC 2 test according to the AICPA's SOC 2 standards.
Type 2 SOC 2 evaluates the design and operational performance of an organization's security processes and controls to meet its security goals and customer commitments during a predetermined evaluation period. Constant monitoring, evaluation, and modification of the requirements and security measures guarantee a secure environment for doing business.
The CISO at Benchling, Zach Powers, said, "Biotechs are managing an evolving landscape of security and compliance risks, and they require trusted software partners to help them meet these demands." He added, "At Benchling, we make the security, privacy, and compliance of our customers' sensitive data a company-wide, critical investment, not only through Type 2 SOC 2, but also through our best-in-class security team, our trust-but-verify processes, and our adherence to global compliance standards."
(Source – PR Newswire)
Benchling's R&D Cloud is the biotech R&D platform of choice, trusted by over 1,000 organizations worldwide in highly regulated areas such as biopharmaceuticals, agribusiness, industrials, and consumer packaged goods. Benchling is used by customers to securely store, standardize, and analyze crucial data related to the design and development of innovative biotech products. Benchling's objective is to protect client data; hence, the firm utilizes sophisticated data security and privacy protections and complies with tight regulatory regulations such as the NIST Cybersecurity Framework. The organization is also ISO 27001 certified.
The successful completion of Benchling's Type 2 SOC 2 inspection assures that its biotech clients can conduct crucial R&D work in the Benchling R&D Cloud while following the highest security requirements.
Benchling is a San Francisco-based firm that focuses on private and public life science cooperation by developing cloud-based software tools for digital DNA sequence editing, planning and performing experiments, evaluating data, and sharing research. More than 200,000 scientists from over 1,000 firms and 7,500 university and research institutions worldwide have used the Benchling R&D Cloud to create breakthrough discoveries and deliver the next generation of medicines, foods, and materials to market more quickly. In addition, the R&D cloud assists these companies in modernizing their scientific processes and accelerating their cooperation to transform the complexity of biology into world-changing outcomes.
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.
MEDTECH, INDUSTRIAL IMPACT
INOVIO Pharmaceuticals, Inc. | February 01, 2023
On January 31, 2023, INOVIO, a leading biotechnology firm focused on the development and commercialization of DNA medicines to protect and treat people from cancer, HPV-associated diseases, and infectious diseases, announced a strategic reorganization to meet operational efficiency commitments and better position the company to deliver DNA medicines to patients.
Following the previously announced end of clinical development projects in late 2022, the restructuring is estimated to result in yearly savings of roughly $4.3 million and an 11% reduction in full-time personnel. These and other strategic initiatives divert resources needed to progress critical programs, such as INOVIO's product candidate INO-3107 for the treatment of Recurrent Respiratory Papillomatosis (RRP).
INOVIO anticipates a $1.1 million one-time restructuring charge in the first quarter of 2023. Its 2022 fourth-quarter and year-end financial results announcement, scheduled for March 2023, will provide more precise financial guidance.
INOVIO's lead initiatives include therapies for HPV-related disorders, such as INO-3107 for RRP and VGX-3100 for cervical high-grade squamous intraepithelial lesions (HSIL). In the first quarter of 2023, INOVIO is anticipated to release the results of its Phase 3 REVEAL2 study for VGX-3100 and the second cohort of its Phase 1/2 trial for INO-3107.
About INOVIO Pharmaceuticals, Inc.
Headquartered in Plymouth Meeting, PA, INOVIO Pharmaceuticals, Inc. is a biotechnology firm dedicated to bringing precisely designed DNA therapeutics to market in order to treat, cure, and protect individuals from infectious diseases, cancer, and HPV-related diseases. INOVIO's in-development DNA medications are delivered utilizing its investigational proprietary smart device, CELLECTRA®, to elicit immune responses against targeted pathogens and malignancies. Its DNA medicines platform and the proprietary smart device can target almost any DNA sequence. With 15 clinical studies in development, the company has the potential to save and protect lives throughout the world and fuel a new decade of DNA medicines.