XTalks

APRIL 6, 2023

Modern software development concepts from ecommerce applications are helping eClinical applications meet the precise needs of each clinical trial. Many eClinical products can now integrate data from multiple sources and seamlessly access and share data across applications. And you should expect that from your eClinical vendors.”

Clinical Trials 98

Clinical Trials Clinical Trials Clinical Supply Trials 98

Pharmaceutical Technology

AUGUST 10, 2022

Working with a contract manufacturing organization (CMO) in the pursuit of bringing a new product to market can deliver a range of significant benefits. They are also likely to have already worked with a similar molecule and can even anticipate the hurdles a company may face in production. Proven results??. Process Flow diagram?

Contract Manufacturing 130

Contract Manufacturing Manufacturing Production Packaging 130

Pharmaceutical Technology

JUNE 19, 2023

As the clinical trials industry adapts to the rising demand, it must also tackle important challenges concerning the way advanced medicines like cell and gene therapies are handled. Cell and gene therapies are not your typical clinical supply chain. The risk of mistakes caused by improper planning are enormous.

Gene Therapy 130

Gene Therapy Gene Packaging Packaging 130

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Clinical trial packaging and labelling solutions.

Packaging 100

Packaging Packaging Marketing Clinical Trials 100

Pharmaceutical Technology

JUNE 2, 2023

As we look to find new and better ways to treat ophthalmic diseases, we want to get it right and ensure that our product candidates can be scaled up appropriately for each development stage and, ultimately, for commercialisation. The company is a global contract development and manufacturing organisation (CDMO) for biopharmaceuticals.

Gene Therapy 130

Gene Therapy Gene Clinical Supply Development 130

XTalks

JULY 24, 2023

. “Surgence is not a competitive product but a holistic solution. Many third-party supply chain solutions exist in the market, but none have the full suite offerings available in Surgence,” said Cody Fisher, Concordance EVP and strategic advisor in the company’s news release.

Clinical Supply Chain 97

Clinical Supply Chain Clinical Supply Production Marketing 97

Pharmaceutical Technology

APRIL 28, 2023

Over the past 11 years, Syngene has undertaken development work on several monoclonal antibodies for use in animal health, including developing and manufacturing clinical supplies of a treatment for allergic or atopic dermatitis, now widely used, and Librela®. Syngene’s collaboration with Zoetis started in 2011.

Manufacturing 130

Manufacturing Antibody Clinical Supply Protein 130

The Pharma Data

NOVEMBER 26, 2020

Analyzing the benefits and challenges of implementing direct-to-patient services in the clinical supply chain to help meet patient requirements, improve supply chain efficiency and accelerate speed to market. The benefits of developing a patient-centric clinical supply chain. Add bookmark.

Clinical Trials 52

Clinical Trials Clinical Trials Clinical Supply Chain Trials 52

The Pharma Data

SEPTEMBER 14, 2020

Supply chain uncertainty is a challenge every clinical supply chain manager wrestles with – stemming from increasing product demand and quality, the growing complexity of clinical trial designs and a lack of visibility in the supply chain. Achieving clinical supply chain flexibility now and in the future.

Clinical Supply Chain 52

Clinical Supply Chain Clinical Supply Clinical Trials Clinical Trials 52

Pharmaceutical Technology

OCTOBER 26, 2022

According to Tufts Center for the Study of Drug Development (CSDD), in a typical Phase Ill clinical trial, 119 protocol deviations are implemented on average, involving approximately one-third of all patients participating in that trial. To avoid this, many trial supply managers will overestimate the production of supplies.

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Clinical Trials Clinical Trials Trials Production 130

The Pharma Data

AUGUST 4, 2020

The agreement also puts in place a three year clinical supply agreement for the two companies. Under the terms of the deal, Oxford Biomedica will receive an undisclosed upfront payment, with additional payment related to development and manufacturing of lentiviral vectors for use in clinical trials.

Gene Editing 52

Gene Editing Licensing Licensing Clinical Supply 52

XTalks

JUNE 16, 2023

XTALKS WEBINAR: Fostering Patient-Centricity: Clinical Supply Chain Strategies and Sourcing Solutions Live and On-Demand: Thursday, July 20, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how to review clinical trial trends and supply strategies that impact the patient experience.

Drugs 98

Drugs Manufacturing Clinical Supply Chain Clinical Trials 98

Clinical Trial Podcast

DECEMBER 29, 2022

At NuPulse, Sonna is responsible for developing and executing on strategic initiatives for the company, building a diverse and multidisciplinary team of engineers, regulatory and quality associates, marketing, manufacturing, clinical affairs and education, and trial operations. To learn more, visit slope.io. .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Supply 52

The Pharma Data

SEPTEMBER 18, 2020

BioNTech acquires Novartis GMP manufacturing site to expand Covid-19 vaccine production. BioNTech has agreed to buy a Novartis manufacturing facility in Marbury, Germany, to expand its Covid-19 vaccine production capacity by up to 750 million doses per year, or more than 60 million doses per month, once fully operational.

Vaccine 52

Vaccine Vaccination Manufacturing Clinical Supply Chain 52

Clinical Trial Podcast

JANUARY 17, 2023

The post Clinical Trial Site Networks with Christian Burns appeared first on Clinical Trial Podcast & Blog. To learn more, visit slope.io.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Supply 52

The Pharma Data

DECEMBER 14, 2020

Over the last two years, AlgoTherapeutix took ATX01 from exploratory prototype to final formulation, established its pharmacological profile, conducted a full pre-clinical toxicology package, and scaled-up manufacturing to enable clinical supply production.

Clinical Development 52

Clinical Development Development Clinical Supply Packaging 52

The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In July 2020, the U.S. subsidiary MorphoSys US Inc., has more than 600 employees.

Containment 52

Containment Clinical Development Antibody Development 52

Cloudbyz

AUGUST 15, 2024

As the complexity of clinical trials continues to increase, especially with the rise of multi-center, adaptive, and decentralized trials, the need for robust RTSM systems has become more critical than ever. What is Trial Supply Management (TSM) in Clinical Trials? What are the benefits of using an RTSM system in clinical trials?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

XTalks

JUNE 27, 2023

Xtalks spoke with Aaron Severs, DocGo’s chief product officer, to learn how DocGo provides on-demand urgent care, at scale, while offering cost efficiencies over traditional ER visits. They bring over a hundred different supplies into the home.” What is DocGo? Our clinicians actually bring two bags,” explains Severs.

Doctors 98

Doctors Doctor Licensing Licensing 98

The Pharma Data

DECEMBER 4, 2021

The companies are exploring these advances through their newly created Pfizer Amazon Collaboration Team (PACT) initiative, which applies AWS capabilities in analytics, machine learning, compute, storage, security, and cloud data warehousing to Pfizer laboratory, clinical manufacturing and clinical supply chain efforts.

Manufacturing 52

Manufacturing Development Drugs Clinical Supply Chain 52

Cloudbyz

MAY 13, 2023

Investigational Product Management: This tracks how well each site manages the investigational product, including storage, dispensing, and return or disposal. Clinical Supply Management: This assesses the site’s management of clinical supplies, such as tracking inventory levels, re-order timelines, and wastage.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

The Pharma Data

AUGUST 15, 2021

VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinical trial to determine the safety, tolerability, and pharmacological activity of a single intravenous infusion in adult patients with Wilson Disease. Pfizer is collaborating with Vivet on the clinical supply of VTX-801 for the Phase 1/2 clinical trial.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

VirTrial

APRIL 18, 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, the European Medicines Agency (EMA) in the EU, and the Food and Drug Administration (FDA) in the US all have regulations that require a documented audit trail review.

Regulation 59

Regulation Clinical Trials Clinical Trials Trials 59

The Pharma Data

NOVEMBER 18, 2020

These restrictions and uncertainty around the duration, severity and geographic scope of the COVID-19 outbreak are projected to slow down the enrolment of patients due to re-prioritisation of hospital activities towards COVID-19 patients and away from clinical studies such as PARADIGME.

Trials 40

Trials Production Development Marketing 40

VirTrial

APRIL 18, 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, the European Medicines Agency (EMA) in the EU, and the Food and Drug Administration (FDA) in the US all have regulations that require a documented audit trail review.

Regulation 52

Regulation Clinical Trials Clinical Trials Trials 52

VirTrial

APRIL 18, 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, the European Medicines Agency (EMA) in the EU, and the Food and Drug Administration (FDA) in the US all have regulations that require a documented audit trail review.

Regulation 52

Regulation Clinical Trials Clinical Trials Trials 52

The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to treat a variety of acute and chronic diseases.

Drugs 52

Drugs Containment Development Clinical Development 52

XTalks

APRIL 11, 2024

J&J has ambitious plans for Carvykti as it is looking to target peak product sales of over $5 billion for the therapy. The companies have also expanded a contract manufacturing agreement with Novartis that will help produce Carvykti for both commercial and clinical supply at the New Jersey plant through the end of 2029.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

The Pharma Data

NOVEMBER 22, 2020

Molecular Partners is also collaborating with AGC Biologics, Baccinex, and Ivers-Lee Clinical Supply Management (IL-CSM) to support development of its anti-COVID-19 program, and has reached an agreement with the Swiss Government regarding rights to purchase up to 3.2 million doses of MP0420, if it is approved in Switzerland.

Trials 40

Trials Protein Clinical Trials Clinical Trials 40

VirTrial

APRIL 18, 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, the European Medicines Agency (EMA) in the EU, and the Food and Drug Administration (FDA) in the US all have regulations that require a documented audit trail review.

Regulation 40

Regulation Clinical Trials Clinical Trials Trials 40

The Pharma Data

OCTOBER 27, 2020

During the clinical development stage, Molecular Partners will provide clinical supply. The companies will work together to scale-up manufacturing capacity, in collaboration with Sandoz, the generics and biosimilar Novartis division, to provide worldwide supply. About Molecular Partners AG.

Development 40

Development Protein Manufacturing Medicine 40

Pharmaceutical Technology

MARCH 20, 2023

Africa has considerable advantages and opportunities for trialling investigational medicinal products that, if pharma companies can correctly harness, will turn the continent into a superpower for clinical trials. In addition, the time-savings offered by this facility in the clinical supply chain are considerable.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Supply Chain 130

Pharmaceutical Technology

MAY 23, 2023

When war broke out in Ukraine in early 2022, many clinical trial patients had to flee the country or relocate, presenting considerable disruption to existing clinical trials and risking data collection on medical products. The situation has tested business continuity plans to their limits. But it doesn’t end there. “We’re

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Supply Chain 130