The Pharma Data

NOVEMBER 30, 2020

About NVX-CoV2373 NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. Novavax was awarded $1.6 billion in funding from the U.S. The award is funding the U.S. and Mexico pivotal Phase 3 trial and manufacturing scale-up. .

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Clinical Development Vaccination Vaccine Development 52

Pharmaceutical Technology

MARCH 2, 2023

QN-023a is under clinical development by Hangzhou Qihan Biotechnology and currently in Phase I for Relapsed Acute Myeloid Leukemia. QN-023a overview QN-023a is under development for the treatment of relapsed or refractory acute myeloid leukemia (AML). The company develops gene-editing organ transplantation technology.

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Gene Editing Genetic Engineering Engineer Clinical Trials 100

Pharmaceutical Technology

APRIL 11, 2023

A study published in Nature Biomedical Engineering validated the ability of CTRL’s cell processing platform to harvest tumour-reactive immune cells from the blood.

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Development Gene Therapy Engineer Clinical Development 130

Outsourcing Pharma

OCTOBER 20, 2023

Dave Hine is the senior director of sales and engineering at Greenphire. He has been reflecting on his time at DPharm and the collaborative approach to life sciences.

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Life Science Engineer Sales Clinical Development 85

ACRP blog

OCTOBER 10, 2024

AI’s margin gains simply aren’t as big an incentive for life sciences businesses to embark on multi-year data engineering projects. Within the clinical trials environment specifically, AI will reduce costs and speed up the trial process, facilitating the development of more drugs and increasing access to them.

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Clinical Trials Clinical Trials Trials Life Science 69

Pharmaceutical Technology

MARCH 23, 2023

Seagen specialises in developing antibody-drug conjugates (ADCs) which will complement Pfizer’s oncology portfolio. Seagen will maintain its operations in the Seattle area and will leverage Pfizer’s protein-engineering capabilities to develop next-generation biologics.

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Licensing Licensing Sales Trials 147

Pharmaceutical Technology

MARCH 2, 2023

Povetacicept is under clinical development by Alpine Immune Sciences and currently in Phase I for Systemic Lupus Erythematosus. The drug candidate is an engineered B-cell modulator. It is administered through intravenous and subcutaneous route. It acts by targeting BAFF and APRIL.

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Protein Engineer Drugs Clinical Trials 100

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Metastatic Adenocarcinoma of The Pancreas. The drug candidate is being developed based on XmAb technology.

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Antibody Engineer Development Drugs 100

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Gastric Cancer. The drug candidate is being developed based on XmAb technology. According to GlobalData, Phase I drugs for Gastric Cancer have a 79% phase transition success rate (PTSR) indication benchmark for progressing into Phase II.

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Antibody Engineer Development Drugs 100

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Adenocarcinoma Of The Gastroesophageal Junction. The drug candidate is being developed based on XmAb technology.

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Antibody Engineer Development Drugs 100

XTalks

JUNE 23, 2022

Utilizing cellular therapies to fight cancer is an area of research and drug development that has been quickly advancing. Bock: Autologous cell therapy clinical development requires tight coordination between a complex manufacturing supply chain and advanced oncology patient treatment.

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Manufacturing Development Engineer Clinical Development 98

Pharmaceutical Technology

APRIL 5, 2023

It’s a multifaceted issue and we perhaps need to go beyond our comfort zone in science and clinical development to understand what barriers patients are really facing. First, by going back to the lab and looking at how we can engineer the process to make these therapies much less expensive.

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Gene Therapy Gene Engineer Production 147

pharmaphorum

APRIL 19, 2022

T pioneer, Adrian Hayday, and together accelerate the development of effective, persistent, globally accessible cell therapy for solid tumors. T therapies. The post 3rd Gamma Delta T Therapies Summit appeared first on.

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Engineer Clinical Development Manufacturing Development 52

pharmaphorum

OCTOBER 5, 2022

.” The partners are still in the discovery stage of the collaboration, and Sanofi will take full responsibility for the programme once a drug candidate to take forward into preclinical and clinical testing has been selected. The aim will be to identify promising candidates in areas of “unmet patient need.”

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RNA Genetics Dermatology Antibody 105

Outsourcing Pharma

NOVEMBER 19, 2020

The control arm, engineered from historical trial data derived from more than 22,000 previous studies, will be used in a Phase III cancer trial.

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FDA Approval Trials Engineer Clinical Development 54

The Pharma Data

DECEMBER 13, 2020

HMBD-001 is a uniquely differentiated anti-HER3 neutralizing antibody that was developed using Hummingbird’s proprietary Rational Antibody Discovery platform. HMBD-001 has been immune-engineered to bind with high affinity to the HER3 dimerization interface and block HER3 growth signals to the cancer. ” About NRG1 fusions.

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Clinical Development Medicine Development Antibody 40

Pharmaceutical Technology

FEBRUARY 18, 2023

The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. Gevokizumab Overview Gevokizumab (XOMA-052) is developing gevokizumab for the treatment of metastatic colorectal cancer gastroesophageal cancer and colon cancer.

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Generic Pharmaceutical Dermatology Antibody Development 100

pharmaphorum

MARCH 8, 2022

Darina Shopova (DS): My first job, in 2005, was as a structural CAD engineer in my home country of Bulgaria. In October 2021, I joined the engineering department at Envair Technology, designing isolators. Darina Shopova is design engineer at Envair Technology, working on the design and development of rigid isolators.

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Life Science Engineer Scientist Doctors 98

The Pharma Data

DECEMBER 31, 2020

where he led global clinical development programs including clinical strategy, clinical development, and regulatory affairs. Prior to Taiho, he held the positions of senior vice president of Clinical Oncology and CMO at Geron Corporation. and CMO for Taiho Oncology, Inc.

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Gene Therapy Engineer Gene Research Analyst 52

The Pharma Data

DECEMBER 22, 2020

Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. The company engineers T cells that target the loss of genetic material in tumors, enabling the selective killing of tumor cells while leaving normal cells unharmed.

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Development Engineer Manufacturing In-Vitro 52

XTalks

JANUARY 29, 2025

Supported by comprehensive cold chain storage solutions, PCI aims to streamline the journey from clinical development to commercialization. Both new Irish facilities will leverage PCIs multidisciplinary expertise in operations, quality assurance, engineering, and project management.

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Drug Delivery Production Packaging Packaging 52

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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Reagent Manufacturing Production Gene Therapy 59

Scienmag

JUNE 22, 2021

Credit: Insilco June 22, 2021, New York / Hong Kong — Insilico Medicine, a global leader in end-to-end artificial intelligence for target discovery, small molecule chemistry, and clinical development, announced that it has closed a $255 million from biotechnology experts to progress Insilico Medicine’s current therapeutic programs into (..)

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Medicine Clinical Trials Clinical Trials Clinical Development 55

pharmaphorum

OCTOBER 13, 2022

Bayer’s quest to revamp its drug discovery engine continues apace, with the company’s recently acquired Vividion subsidiary forging an alliance with Tavros Therapeutics, aimed at finding new drug targets and biomarkers in oncology. million in future payments tied to preclinical, clinical development, and commercial achievements.

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Gene Therapy Genome Genomics Drugs 64

pharmaphorum

OCTOBER 21, 2022

Hookipa’s proprietary arenavirus platform is based on engineering arenaviruses to carry and deliver virus-specific or tumour-specific genes directly in patients in order to evoke an immune response by T cells, also known as CD8+ T cells.

Licensing 52

Licensing Licensing Immune Response Engineer 52

The Pharma Data

AUGUST 24, 2020

This requires an 11-day programme which involves extracting blood from an HIV patient and separating their T cells, which are then engineered in a lab to make them immune to HIV. In a paper published in Molecular Therapy: Methods & Clinical Development , the team discussed why they choose this type of gene therapy to treat HIV.

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Gene Therapy Gene FDA Approval Trials 52

Delveinsight

JULY 22, 2021

Joachim Fruebis, chief development officer of BlueRock, said that receiving fast track designation from the FDA is a crucial step, which will help them further progress clinical development of their DA01 cell therapy approach for Parkinson’s disease.

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Cardiology Development Engineer Clinical Trials 98

The Pharma Data

DECEMBER 13, 2020

Nasdaq: SYBX ), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced SYNB1891 has advanced into the combination therapy stage of the ongoing Phase 1 trial. CAMBRIDGE, Mass. , 14, 2020 /PRNewswire/ — Synlogic, Inc. Sokolovska, A., Nature Communications 11, 2739 (2020)).

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Immune Response Engineer Medicine Clinical Trials 40

The Pharma Data

OCTOBER 21, 2020

(Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced that it will present a poster on SYNB8802, an investigational Synthetic Biotic medicine for the treatment of Enteric Hyperoxaluria (HOX), during the American Society of Nephrology (ASN) Kidney Week, Oct.

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Engineer Containment Medicine Clinical Trials 40

Delveinsight

SEPTEMBER 14, 2021

Vor Biopharma has declared that the FDA has awarded their acute myeloid leukemia (AML) engineered hematopoietic stem cell therapy (eHSC), VOR33, a Fast Track Designation. VOR33 comprises CRISPR genome-edited hematopoietic stem and progenitor cells , which have been engineered to exclude CD33.

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RNA Clinical Trials Clinical Trials Drugs 67

The Pharma Data

DECEMBER 10, 2020

Spending several years with Sanofi in Paris, France as a Global safety officer, he then relocated to New Jersey, USA to work in Early and Late Stage Clinical Development in Immunology, when he became the Global Project Head of Dupixent, a medicine that has revolutionized the field of allergic and atopic diseases. Source link.

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Research Doctors Doctor Medicine 52

The Pharma Data

OCTOBER 26, 2020

With a premiere synthetic biology platform that leverages a reproducible, modular approach to microbial engineering, Synlogic designs Synthetic Biotic therapeutics that target validated underlying biology to treat disease in new ways. About Synlogic Synlogic is bringing the transformative potential of synthetic biology to medicine.

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Clinical Trials Clinical Trials Containment Clinical Development 52

XTalks

SEPTEMBER 21, 2023

XTALKS WEBINAR: Clinical Trial Risk Identification, Management and Reporting from Clinical Development to Marketing Live and On-Demand: Friday, October 27, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how to successfully develop and maintain the safety profile of medicinal products.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

pharmaphorum

JANUARY 4, 2023

The University of Michigan spinoff’s NanoDisc technology relies on the use of synthetic, high-density lipoproteins that can be engineered to carry a payload of antigens, presenting them for recognition by the immune system – specifically, dendritic cells within lymph nodes.

Immune Response 52

Immune Response Engineer Licensing Licensing 52

The Pharma Data

DECEMBER 17, 2020

Kurtz brings more than 26 years of experience in global manufacturing, engineering, supply chain, CMC development and program management for drugs and devices at various stages of development. Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs.

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Development Gene Therapy Engineer Life Science 52

The Pharma Data

NOVEMBER 18, 2020

SEFA’ stands for Structurally Engineered Fatty Acid, i.e. chemically engineered fatty acids, to generate compounds with differentiated physiochemical properties. The Company’s third SEFA, 6179, is expected to enter the clinic in the first half of 2021, targeting IFALD, for which no treatment is currently available.

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Trials Engineer Development Licensing 40

XTalks

OCTOBER 20, 2023

Clinical-stage genome editing company Intellia Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to start a pivotal phase III trial of NTLA-2001 for the treatment of transthyretin (ATTR) amyloidosis with cardiomyopathy.

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In-Vivo Gene Editing Trials Gene 52