Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. How does “potency” apply to cell and gene therapy (CGT) products?

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PPD

JULY 6, 2023

As a result, sponsors must decide whether to leverage a CRO partner even earlier in their drug development timelines to ensure proper planning for these constraints. How a CRO Accelerates Clinical Development Clinical trials are becoming increasingly complex as the industry evolves.

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The Premier Consulting Blog

AUGUST 21, 2024

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. P) is per the specific IMPD guidance.

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The Premier Consulting Blog

JULY 9, 2023

During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. These evaluations include the active pharmaceutical ingredient (API), also known as the drug substance, and the drug product (formulated product).

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Cytel

DECEMBER 6, 2023

Chemistry, Manufacturing, and Controls (CMC) is a critical component of drug product development. As a Senior Consultant in Drug Development, I serve as a representative for sponsors with the Contract Development and Manufacturing Organization (CDMO). This is a long-term relationship.

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Conversations in Drug Development Trends

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. The post Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

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FDA Law Blog: Drug Discovery

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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Drug Target Review

JANUARY 8, 2024

We are at the forefront of drug development in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. About the author Jerry McLaughlin CEO, Life Biosciences, Inc.

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

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The Pharma Data

JANUARY 13, 2021

This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients.”. We also market or plan to market in China additional oncology products licensed from Amgen Inc.,

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Alta Sciences

OCTOBER 30, 2023

TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. Catch up on what you may have missed below! Watch the video. Listen here. The Altascientist : Issue No. Read or listen now. Want to see more?

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LifeSciVC

OCTOBER 18, 2023

However, the challenge here lies in the finite number of experienced leaders/drug development teams that can operate these companies and are also willing to bet on the future upside. In a market like today, later stage, clinically validated targets are a potentially ‘safer’ place to balance portfolios.

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Vial

MARCH 1, 2024

billion in 2023 attributable to its laboratory products and biopharma services segment (53.8% Recent and significant activities among these top CROs based in the US include the acquisition of Pharmaceutical Product Development (PPD), a global industry leader in clinical development and analytical services, by Thermo Fisher Scientific Inc.

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The Pharma Data

DECEMBER 28, 2020

Dr Reimer will replace Dr Charlotte Russel and be overall medically responsible for Alligator’s drug development candidates, with an emphasis on bringing mitazalimab and ATOR-1017 into Phase II efficacy studies. Furthermore, there are two partnered assets: ALG.APV-527 in co-development with Aptevo Therapeutics Inc.

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The Pharma Data

JANUARY 13, 2021

14, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced the addition of Robert Barrow , an accomplished pharmaceutical executive, as Chief Development Officer. We are excited to attract such top tier talent from the psychedelic drug development community.

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PPD

NOVEMBER 14, 2023

In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development. This comes as the demand for qualified clinical research associates (CRAs) is expected to increase by more than 36% in the next decade.

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The Pharma Data

DECEMBER 15, 2020

The project also seeks to engage the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to identify opportunities for regulatory endorsement of such drug development tools. The Diamyd Medical data includes relevant information about disease progression, drug effects and clinical trial design.

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Cytel

MARCH 13, 2023

We are already seeing incredible gains in productivity, efficiency, and in our ability to ask and answer increasingly more complex and novel questions.

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PPD

SEPTEMBER 6, 2023

Under the stresses of the COVID-19 pandemic, drug development organizations faced difficult decisions about keeping staff employed and productive. It’s an effective way to manage capacity and labor uncertainty and provides drug developers the option to retain knowledgeable, proven personnel.

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Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? IRL1117 is expected to be ready to move into clinical development at the end of 2024/first half 2025. At the biopharmaceutical company Albireo AB/Pharma Inc, she worked as VP Clinical & Regulatory Affairs and VP Global Project Head.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

The hope with this new program is that it can similarly benefit the development and review of regenerative medicine therapies. It is not especially novel even within CBER, as previous publications had encouraged the use of standards in product development.

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The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations.

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PPD

MARCH 13, 2024

This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

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The Pharma Data

FEBRUARY 21, 2022

At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients. “We In particular, AI bears vast potential for advancing radiology.

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Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. Understanding the Numbers: How Many Clinical Trials Utilize CROs?

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PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

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The Pharma Data

APRIL 6, 2022

Novartis announced the introduction of a new organizational structure and operating model designed to support the company’s innovation, growth, and productivity ambitions as a focused medicines company in the coming decade. Change in Global Drug Development (GDD) Leadership. Novartis has appointed Shreeram Aradhye, M.D.,

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The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”.

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The Pharma Data

DECEMBER 13, 2020

Our company and R&D portfolio are entering into an exciting phase, as evidenced by the recent close of Series B financing and submission of the first gene editing product IND in China,” said Dong Wei, Ph.D.?CEO Dr. Zhang has around 20 years of experience in research and drug development in both industry and academia in the US.

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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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The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

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PPD

JUNE 22, 2023

Sponsors and clinical research organizations (CROs) alike are facing competitive recruiting from limited talent pools. These challenges were echoed in a 2022 industry survey conducted by the PPD clinical research business of Thermo Fisher Scientific. We are committed to operational excellence across drug development.

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The Pharma Data

JANUARY 20, 2021

” “Dynacure is a leader in rare disease drug development, as evidenced by its lead product candidate DYN101, which is in clinical development for the treatment of Myotubular and Centronuclear Myopathies for which there are no FDA or EMA approved therapeutics,” said Ms.

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Conversations in Drug Development Trends

MAY 14, 2024

As the strategists for Worldwide Clinical Trials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. Our approach is informed by our combined 30+ years in rare disease clinical development and our time in various stakeholder roles, such as scientists, CRAs, and project managers.

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Agency IQ

FEBRUARY 12, 2024

The pilot focused on identifying commonalities across products using Adeno-Associated Virus (AAV) vectors to reduce duplication of efforts across individual therapeutic programs and to encourage the field to move away from the current “one-disease-at-a-time approach.”

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The Pharma Data

JULY 29, 2021

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval. About Eisai Co.,

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Conversations in Drug Development Trends

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study.

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