Narrativa | May 19, 2021
Narrativa, which has developed an artificial intelligence (AI) medical writing platform to assist pharmaceutical firms in speeding up drug approval and lowering overall compliance costs, recently completed a $1.3 million funding round.
The Los Angeles-based firm currently uses its SaaS platform to automate the production of Clinical Study Reports (CSRs) and other regulatory reports for several pharmaceutical firms and other clinical research organizations (CROs).
The AI-writing assistant platform utilizes advanced Natural Language Generation (NLG) to process millions of data points from clinical trials and generate readable and understandable written medical narratives, improving accuracy and minimizing the time and expense of producing critical (and time-consuming) regulatory documents.
"The pharma industry has evolved as a result of the availability and quality of data from clinical trials, with the most significant impact on drug discovery. To detect trends, test hypotheses, and understand the effectiveness of treatments, pharmaceutical firms have often focused on empirical data. It's time to put artificial intelligence to work assisting medical authors in the development of regulatory documents "Narrativa's founder and CEO, David Llorente, says.
Pharmaceutical firms spend more than $1.5 billion on regulatory documentation, and it may take up to a year to complete the paperwork for FDA approval of a new drug. The amount of time taken on regulatory documentation significantly lengthens the time it takes for new drugs to reach the market.
Narrativa was established in 2015 with the idea that technology should be used to positively transform the world. Narrativa, named one of the most important companies in the field of NLG by Samsung, helps companies expand by anticipating trends and converting data into the human language in real-time. Narrativa creates automated content in a variety of areas, including finance, pharmaceuticals, insurance, media, and gaming, using its artificial intelligence system and machine learning experience.
CureVac, EMA | February 18, 2021
The European Medicines Agency (EMA's) Committee for Human Medicinal Products (CHMP) has begun a moving audit of CureVac AG's COVID-19 antibodies, CVnCoV.
The survey was started on the grounds that starter research facility contemplates and early clinical preliminary outcomes recommend the immunization triggers the creation of antibodies and insusceptible cells that target SARS-CoV-2, the infection that causes COVID‑19.
The survey will successively audit information as it opens up, beginning with the preclinical and beginning stage proof presently submitted. As opposed to a customary advertising authorisation application, in which all information on a medication's or immunization's viability, security and quality and all necessary archives should be prepared toward the beginning of the assessment.
Continuous preliminaries are proceeding to assess the immunization's wellbeing, immunogenicity and viability against COVID-19. EMA will assess information from these and other clinical preliminaries as they become accessible.
The moving audit will proceed until the CHMP concludes that adequate information is accessible for a conventional showcasing authorisation application. Because of the work attempted in the moving audit, it should take less time than typical to assess such an application.
EMA will survey the immunization's consistence with the typical norms for adequacy, wellbeing and drug quality inside the moving audit measure.
CVnCoV is an mRNA vaccine which encodes the SARS-CoV-2 Spike (S) protein. The mRNA sequence is formulated in minute lipid particles to prevent it from being broken down too quickly.
When a person receives the vaccine, some of their cells will use the mRNA molecules to temporarily produce the S protein. This activates the person’s immune system, priming it to respond more quickly to a subsequent SARS-CoV-2 infection.
McKesson Corporation, Vanderbilt Health Rx Solutions | March 18, 2021
McKesson Corporation, a worldwide healthcare organization, reports another cooperation with Vanderbilt Health Rx Solutions (VHRxS), a public chief in specialty pharmacy technique and execution, to offer VHRxS's full suite of specialty pharmacy consulting services to McKesson's health system clients. This new, specialized offering from VHRxS will supplement the experience of McKesson, which has offered industry-driving pharmacy services for over 40 years, by bringing the skill of VHRxS, which was established by Vanderbilt University Medical Center to propel the mission of health systems specialty drug stores cross country.
The new help will offer altered specialty pharmacy services and development procedures to emergency clinics and health systems in each period of their development. VHRxS's portfolio of strong specialty pharmacy consulting services will help health systems improve patient and supplier fulfillment while making new income transfers by fully coordinating pharmacy services into specialty centers.
Scott Miller, president of McKesson Health Systems, shares, “Our teams work closely with customers to understand their challenges and this was a clear need for health systems addressing their specialty pharmacy capabilities. Along with our existing portfolio of services and solutions, this is one more way customers can achieve more for their hospitals and patients by creating new or strengthening existing revenue streams.”
McKesson's pharmacy chiefs and the VHRxS group of experienced, involved counsels comprehend the requirements and difficulties of health system specialty drug stores. The groups have profound experience working with health systems altogether phases of development, from creating and carrying out starting specialty pharmacy development methodologies to improving existing activities to arrive at the following level.
Jim Hayman, president of VHRxS and Chief Pharmacy Officer at Vanderbilt Health, states, “By collaborating with McKesson, we can better extend our expertise as a leading health system-based specialty pharmacy provider to help our peers. We know from experience that investing in your specialty pharmacy operations boosts patient and provider satisfaction, which reaps seen and unseen benefits many times over.”
About McKesson Corporation
McKesson Corporation is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information solutions. McKesson partners with pharmaceutical manufacturers, providers, pharmacies, governments and other organizations in healthcare to help provide the right medicines, medical products and healthcare services to the right patients at the right time, safely and cost-effectively. United by our ICARE shared principles, our employees work every day to innovate and deliver opportunities that make our customers and partners more successful all for the better health of patients.
About Vanderbilt Health Rx Solutions
Vanderbilt Health Rx Solutions (VHRxS) is a national specialty pharmacy strategy and management company founded and operated by Vanderbilt University Medical Center (VUMC), Middle Tennessee’s largest private employer and the largest academic medical center in the Mid-South with over 2.5 million patient encounters annually. VHRxS uniquely and effectively addresses the specialty pharmacy needs of companies, hospitals and health systems through building patient-centered, clinically integrated specialty pharmacy programs in collaboration with health system clients and leading employers. Founded on VUMC’s historic global leadership in clinical pharmacology, best-in-class specialty pharmacy operations and employee health plan performance, VHRxS draws on years of hands-on experience creating and executing specialty pharmacy strategies to help clients build successful programs of their own.