Clinical Development and Development - Clinical Research Informer

9 Ways Worldwide Optimizes Clinical Development for Your Biotech Growth Journey

Worldwide Clinical Trials

AUGUST 15, 2023

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations. You have the oversight you need.

Clinical Development

Clinical Development Development Compliance Trials

Triventi secures $92m to advance clinical development of antibody therapy

Pharmaceutical Technology

OCTOBER 26, 2023

The Series A funds will go towards the clinical development of TRIV-509, with plans for a proof-of-concept atopic dermatitis study.

Clinical Development

Clinical Development Development Antibody

Adcentrx raises funds to advance ADCs into clinical development

Pharmaceutical Technology

APRIL 26, 2023

Biotechnology company Adcentrx Therapeutics has raised $38m in Series A+ financing to advance its pipeline of new antibody-drug conjugate (ADC) therapeutics into clinical development. Adcentrx Therapeutics is focused on developing protein conjugate therapeutics to treat cancer and other life-threatening diseases.

Clinical Development

Clinical Development Development Clinical Trials Clinical Trials

Clinical development rates are falling - but it’s not all bad news

pharmaphorum

JULY 18, 2024

While clinical development rates are falling, there is still hope in the Phase I bio sector. Learn more about the potential opportunities and positives in this challenging trend.

Clinical Development

Clinical Development Development

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies.

Clinical Trials

Rivus raises $132m to advance clinical development of obesity treatment

Pharmaceutical Technology

SEPTEMBER 23, 2022

“Following encouraging data from our Phase IIa clinical trial in patients with obesity, this financing enables us to advance development of HU6 and a pipeline of controlled metabolic accelerators to address a range of cardio-metabolic conditions.”.

Clinical Development

Clinical Development Development Life Science Trials

Navigating the challenges of proper fill and finish in clinical development

Bio Pharma Dive

FEBRUARY 1, 2021

Given all the uncertainties of fill and finish in clinical development, one thing is certain – there is little room for failure, and rarely a second chance.

Clinical Development

Clinical Development Development

How Can You Manage the Complexity of Early Phase Clinical Development?

XTalks

JUNE 4, 2024

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. And that has a lot of downstream consequences.” This trend, which Dr.

Clinical Development

Clinical Development Development Clinical Trials Clinical Trials

Myricx Bio gains $114m in Series A round to develop NMTi-ADCs

Pharmaceutical Technology

JULY 8, 2024

Myricx Bio has secured £90m ($114m) in its Series A financing round to propel its NMTi-ADC therapeutics into the clinical development stage.

Development

Development Clinical Development

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinical development? Explore the limitations of what we know about prescription drug dosing The future of Clinical Research April 12, 2023 at 11:00 am PDT, 2:00 pm EDT, 7:00 pm GMT

Clinical Research

Ensuring R&D investments deliver maximum potential: Notable ways to enhance clinical development strategy and design

pharmaphorum

JANUARY 10, 2024

Ensuring R&D investments deliver maximum potential: Notable ways to enhance clinical development strategy and design Mike.Hammerton Wed, 10/01/2024 - 11:23 Bookmark this

Clinical Development

Clinical Development Development

Digital tools must be used in pharma manufacturing to keep pace with drug discovery and clinical development

pharmaphorum

MARCH 7, 2024

Digital tools must be used in pharma manufacturing to keep pace with drug discovery and clinical development Mike.Hammerton Thu, 07/03/2024 - 09:43 Bookmark this

Clinical Development

Clinical Development Manufacturing Development Drugs

Why Should Companies Use Digital Endpoints Across Clinical Development?

XTalks

MAY 28, 2024

Our discussion delved into the potential of DHTs to reshape how clinical trials are conducted, making them not only faster and less costly but also more patient-centric and reflective of real-world outcomes. This approach can speed up development and improve data quality, potentially leading to more effective and personalized therapies.

Clinical Development

Clinical Development Development Clinical Trials Clinical Trials

Acute lymphocytic leukaemia leads in cell therapy clinical development

Pharmaceutical Technology

JULY 12, 2022

The post Acute lymphocytic leukaemia leads in cell therapy clinical development appeared first on Pharmaceutical Technology. Despite the market size for B-cell non-Hodgkin’s lymphoma (NHL) being at least five times that of ALL, NHL has a smaller pipeline of cell therapies.

Clinical Development

Clinical Development Development Production Sales

The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making

CTTI (Clinical Trials Transformation Initiative)

OCTOBER 15, 2024

The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making The post The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making appeared first on CTTI.

Clinical Development

Clinical Development Development Trials

ArsenalBio secures $325m to develop cell therapy programmes

Pharmaceutical Technology

SEPTEMBER 5, 2024

ArsenalBio has secured $325m in a Series C financing round to propel its programmable cell therapy programmes through clinical development.

Development

Development Clinical Development

Upstream Bio raises funds to advance clinical development of UPB-101

Pharmaceutical Technology

JUNE 9, 2023

It is also preparing for a swift transition to Phase III development. Upstream Bio will use the funds to advance its UPB-101 into Phase II trials to treat asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). It targets the human thymic stromal lymphopoietin receptor to inhibit signalling.

Clinical Development

Clinical Development Development Life Science Clinical Trials

Interview: The evolution of data management in clinical development

Outsourcing Pharma

JANUARY 9, 2024

Equally, OSP was delighted to speak to him to discuss the evolution of data management in clinical development and how intelligent data use can reduce clinical trial cancellations, minimise protocol amendments, and accelerate patient recruitment. Gen Li is president and founder of Phesi.

Clinical Development

Clinical Development Development Clinical Trials Clinical Trials

Future of clinical development highlighted in online event

Outsourcing Pharma

APRIL 7, 2022

Experts from the Decentralized Trials and Research Alliance and Rafael Pharmaceuticals discuss progress and possibilities during Clinical Development Advances.

Clinical Development

Clinical Development Development Trials Research

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Production

Production Clinical Development Development Regulation

Precision eye therapy for dogs ready for human clinical development

Medical Xpress

APRIL 26, 2023

A successful gene therapy trialed at Michigan State University in dogs with an inherited eye disease is ready to be developed for clinical use in human patients with a rare condition called retinitis pigmentosa.

Clinical Development

Clinical Development Gene Therapy Development Gene

Vectura Signs Pre-Clinical Development Agreement with Incannex to Advance IHL-216A for the Treatment of Traumatic Brain Injury

Pharma Mirror

JUNE 23, 2021

Vectura Group plc, an industry leading inhalation CDMO, today announced it has signed an agreement with Incannex Healthcare Limited, an Australian cannabinoid medicines development company, to provide pre-clinical development services for IHL-216A, Incannex’s proprietary inhaled drug product for the treatment of traumatic brain injury (TBI).

Clinical Development

Clinical Development Development Manufacturing Medicine

AltruBio secures $225m for immune checkpoint programme development

Pharmaceutical Technology

MAY 22, 2024

AltruBio has secured $225m in an oversubscribed Series B financing round to propel the clinical development of its ICE programme.

Development

Development Clinical Development

Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

Compliance

Compliance Clinical Development Development Clinical Trials

Adverum Down After Clinical Development Shift for Gene Therapy Program

BioSpace

JULY 22, 2021

Shares of Adverum Biotechnologies plunged more than 20% in premarket trading after the company announced it was revising its clinical development plan for investigational gene therapy candidate ADVM-022 based on safety concerns in patients with diabetic macular edema (DME).

Gene Therapy

Gene Therapy Clinical Development Gene Development

Generative AI and how we can harness its power in clinical development

Fierce Pharma

OCTOBER 26, 2023

By Thomas Pietsch, Global Head of Scientific Data Technology and AI, Parexel International | AI holds unlimited potential to change today’s clinical development paradigm. Explore three broad areas where it could be especially useful today.

Clinical Development

Clinical Development Development

Abzena, Alira Health and Oncodesign launch DRIVE Biologics to support access to specialist services from discovery to clinical development for oncology and inflammation

Pharma Mirror

FEBRUARY 25, 2022

This joint service offering, DRIVE™-Biologics, will leverage Abzena’s strength in design and developability, and cell line development through to commercial manufacturing.

Clinical Development

Clinical Development Development Manufacturing Medicine

Insilico Medicine appoints Sujata Rao, M.D., as Senior Vice President to oversee clinical development

Scienmag

JULY 19, 2022

July 19, 2022, New York—Insilico Medicine, a clinical-stage end-to-end artificial intelligence (AI) driven drug discovery company, has appointed Dr. Sujata Rao as Senior Vice President (SVP) with responsibility for the global clinical development strategy of Insilico Medicine’s therapeutic programs.

Clinical Development

Clinical Development Medicine Development Drugs

FogPharma secures $145m to develop cancer therapy

Pharmaceutical Technology

MARCH 4, 2024

FogPharma has secured $145m in a Series E financing round to support the clinical development of its cancer therapy, FOG-001.

Development

Development Clinical Development

Innovations and Clinical Trial Diversity in Medical Aesthetics: Insights from Dr. Stephanie Manson Brown, VP & Head of Clinical Development at Allergan Aesthetics – Xtalks Life Science Podcast Ep. 134

XTalks

NOVEMBER 1, 2023

Stephanie Manson Brown, VP & Head of Clinical Development & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. She also spoke about clinical trials in the space, including Allergan Aesthetics’ commitment to increasing diversity in trials and developing products that do not cater to any one beauty standard.

Life Science

Life Science Clinical Trials Clinical Trials Clinical Development

How early utilisation of AI can de-risk and accelerate clinical development

Outsourcing Pharma

SEPTEMBER 12, 2024

Recent investments by major pharmaceutical companies signal a growing confidence in artificial intelligenceâs (AI's) potential to transform drug development.

Clinical Development

Clinical Development Development Drugs

Francis Crick and ICL spinout raises £90m to clinically develop cancer treatments

Pharma Times

JULY 9, 2024

Myricx Bio’s therapies include treatments for breast, lung and colorectal cancer

Clinical Development

Clinical Development Development

Ablaze Pharmaceuticals to develop drug candidate for liver cancer

Pharmaceutical Technology

APRIL 3, 2023

Ablaze Pharmaceuticals is set to develop a new GPC3-targeted peptide drug candidate for the treatment of liver cancer in China. The agreement allows Ablaze to clinically develop and commercialise the drug in Greater China. The company is licensing the first-in-class drug candidate under an existing deal with RayzeBio.

Development

Development Drugs Clinical Development Licensing

Xequel Bio selects Societal CDMO to support clinical development of iNexin

Outsourcing Pharma

MAY 9, 2023

Xequel Bio has selected Societal CDMO to support the ongoing clinical development of a patented new chemical entity based on its aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) platform.

Clinical Development

Clinical Development Development Contract Manufacturing Manufacturing

LoQus23 secures $43m to advance Huntington’s Disease therapy

Pharmaceutical Technology

OCTOBER 2, 2024

The funds will support the development of LoQus23’s lead candidate, its MutSβ inhibitor, as it enters clinical development.

Clinical Development

Clinical Development Development

MBrace secures $85m to develop ADCs for oncology targets

Pharmaceutical Technology

NOVEMBER 14, 2023

MBrace Therapeutics has secured $85m in a Series B funding round to advance clinical development of ADCs for oncology targets.

Development

Development Clinical Development

FORE Biotherapeutics raises funding to expedite plixorafenib development

Pharmaceutical Technology

AUGUST 24, 2023

FORE Biotherapeutics has raised $75m in its Series D investment round led by SR One to expedite the clinical development of plixorafenib.

Development

Development Clinical Development

ESCAPE Bio Snags $73 Million to Advance Neurodegenerative Clinical Development Programs

BioSpace

SEPTEMBER 15, 2020

Clinical-stage biopharmaceutical firm ESCAPE Bio has snagged a $73 million crossover financing deal, led by Wellington Management Company, which will help advance the company’s two clinical development programs of precision neurology medicines for patients with genetic neurodegeneration.

Clinical Development

Clinical Development Development Genetics Medicine

Chinook and Ionis partner to develop ASO therapy for kidney disease

Pharmaceutical Technology

MAY 17, 2023

Chinook Therapeutics and Ionis Pharmaceuticals have entered a partnership to develop an antisense oligonucleotide (ASO) therapy to treat a rare, severe chronic kidney disease. The collaboration aims to discover, develop and commercialise an ASO therapy.

Development

Development Protein RNA Genetics

Hookipa partners with Roche for cancer immunotherapy development

Pharmaceutical Technology

OCTOBER 21, 2022

Hookipa Pharma and Roche have signed a strategic partnership and licence agreement for developing HB-700 and another undisclosed arenaviral immunotherapy. Under the deal, Hookipa will carry out research and initial clinical development through Phase Ib for HB-700 to treat KRAS-mutated cancers.

Development

Development Production Licensing Licensing

Cloud robotics labs are accelerating drug discovery and development

Pharmaceutical Technology

OCTOBER 28, 2022

Drug discovery and development is an incredibly expensive and time-consuming process, taking between 12 and 18 years, and costing on average between $2 billion and $3 billion. Robots can improve drug discovery and development. Lab-specific industrial co-bots can carry out both complex and repetitive tasks such as liquid handling.

Development

Development Drugs Pharma Companies Life Science

Amygdala scores $2m NIAAA grant to develop alcohol use disorder therapy

Pharmaceutical Technology

AUGUST 2, 2023

The grant will support the early development of Amygdala’s ALDH2 Inhibitor currently in pre-clinical development.

Development

Development Clinical Development

Astellas to support development of Taysha’s gene therapy programmes

Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

Gene Therapy

Gene Therapy Gene Development Genetics

Merck and Moderna partner to develop and sell cancer vaccine

Pharmaceutical Technology

OCTOBER 14, 2022

German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). In 2016, the companies entered a strategic partnership to develop novel messenger RNA (mRNA) based PCVs.

Vaccination

Vaccination Vaccine Development Immune Response

9 Ways Worldwide Optimizes Clinical Development for Your Biotech Growth Journey

Triventi secures $92m to advance clinical development of antibody therapy

Trending Sources

Adcentrx raises funds to advance ADCs into clinical development

Clinical development rates are falling - but it’s not all bad news

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Rivus raises $132m to advance clinical development of obesity treatment

Navigating the challenges of proper fill and finish in clinical development

How Can You Manage the Complexity of Early Phase Clinical Development?

Myricx Bio gains $114m in Series A round to develop NMTi-ADCs

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Ensuring R&D investments deliver maximum potential: Notable ways to enhance clinical development strategy and design

Digital tools must be used in pharma manufacturing to keep pace with drug discovery and clinical development

Why Should Companies Use Digital Endpoints Across Clinical Development?

Acute lymphocytic leukaemia leads in cell therapy clinical development

The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making

ArsenalBio secures $325m to develop cell therapy programmes

Upstream Bio raises funds to advance clinical development of UPB-101

Interview: The evolution of data management in clinical development

Future of clinical development highlighted in online event

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

Precision eye therapy for dogs ready for human clinical development

Vectura Signs Pre-Clinical Development Agreement with Incannex to Advance IHL-216A for the Treatment of Traumatic Brain Injury

AltruBio secures $225m for immune checkpoint programme development

Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance

Adverum Down After Clinical Development Shift for Gene Therapy Program

Generative AI and how we can harness its power in clinical development

Abzena, Alira Health and Oncodesign launch DRIVE Biologics to support access to specialist services from discovery to clinical development for oncology and inflammation

Insilico Medicine appoints Sujata Rao, M.D., as Senior Vice President to oversee clinical development

FogPharma secures $145m to develop cancer therapy

Innovations and Clinical Trial Diversity in Medical Aesthetics: Insights from Dr. Stephanie Manson Brown, VP & Head of Clinical Development at Allergan Aesthetics – Xtalks Life Science Podcast Ep. 134

How early utilisation of AI can de-risk and accelerate clinical development

Francis Crick and ICL spinout raises £90m to clinically develop cancer treatments

Ablaze Pharmaceuticals to develop drug candidate for liver cancer

Xequel Bio selects Societal CDMO to support clinical development of iNexin

LoQus23 secures $43m to advance Huntington’s Disease therapy

MBrace secures $85m to develop ADCs for oncology targets

FORE Biotherapeutics raises funding to expedite plixorafenib development

ESCAPE Bio Snags $73 Million to Advance Neurodegenerative Clinical Development Programs

Chinook and Ionis partner to develop ASO therapy for kidney disease

Hookipa partners with Roche for cancer immunotherapy development

Cloud robotics labs are accelerating drug discovery and development

Amygdala scores $2m NIAAA grant to develop alcohol use disorder therapy

Astellas to support development of Taysha’s gene therapy programmes

Merck and Moderna partner to develop and sell cancer vaccine

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