Conversations in Drug Development Trends

DECEMBER 7, 2023

These survey results also highlight the importance of evaluating a variety of potential CRO partners of different sizes to choose the best match for your clinical development goals and corporate culture. At Worldwide, we understand that every program is different, which means every drug development path forward will be unique.

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Clinical Trials Clinical Development Trials Pharmaceutical Companies 136

Drug Discovery World

NOVEMBER 21, 2023

Fosun Pharma USA and Treehill Partners have formed a jointly operating vehicle for investment in clinical stage assets. The new business will be looking for high-quality, mid- to late-stage assets, clinically focused on the US market.

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Clinical Development Production Marketing Drug Development 130

Drug Discovery World

AUGUST 22, 2024

Prolonging health span with drug development Life Biosciences aims to restore and prolong a patient’s health span by targeting the underlying biology of ageing and increasing the quality of years one spends in good health compared with just increasing the total number of years one lives.

Therapies 147

Therapies DNA Disease RNA 147

Drug Discovery World

JULY 17, 2023

Analysis of 13,490 clinical trials finds almost a third have been cancelled during Phase II amidst an overall decline in clinical development productivity. Data analytics company Phesi has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

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Drug Target Review

SEPTEMBER 5, 2024

However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company. Kristina is a pharmacist and holds a PhD in Medical Science from Linköping University.

Pharma Companies 111

Pharma Companies Licensing Licensing Disease 111

Drug Discovery World

FEBRUARY 12, 2024

“In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. Without fixing the current, broken PV models, the continuous cycle of more complexity in the market, which then pushes organisations to incorporate automation into insufficient processes, will massively hinder PV operations.

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Small Molecule Regulations Clinical Trials Therapies 349

PPD

MARCH 26, 2024

A large majority of drug developers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinical development outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.

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Pharmaceutical Companies Clinical Research Clinical Development Drug Development 98

Drug Discovery World

AUGUST 14, 2023

Research partners in the UK are progressing their orally available small molecule cancer immunotherapy drug into clinical development as a treatment for advanced solid tumours. In cancer, PGE2 acts in the tumour microenvironment to trigger cancer cells to evade the immune system.

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Trials Small Molecule Pharmacokinetics Clinical Trials 130

Cytel

JUNE 20, 2023

How might this affect pediatric drug development? However, two new draft guidelines have now been published, including policy changes that may affect current opportunities for pediatric exclusivity and when data may be extrapolated from adults.

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FDA Marketing Drug Development Drugs 52

Drug Discovery World

AUGUST 30, 2022

The event is tailored to a European audience looking to commercialise ATMPs globally, as well as a global audience looking to understand and expand into the European market. Patient engagement during clinical development: keeping the “customer” in mind. Here are a few of many discussions and events to earmark.

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Therapies Hospitals Clinical Trials Clinical Development 246

Drug Discovery World

MAY 6, 2024

During the period 2016-2021, the Brazilian, Chinese and Indian markets grew by 11.7%, 6.7% respectively compared to an average market growth of 5.8% for the top five European Union markets and 5.6% for the US market 2. Even before this, however, Amsterdam was established as an important centre for drug development.

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Drugs Science Molecular Biology Clinical Trials 147

Drug Discovery World

NOVEMBER 22, 2022

Under the alliance agreement, Astex retains an exclusive worldwide licence to take the most promising projects forward into pre-clinical and clinical drug development.

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Drugs Engineering Clinical Development Research 130

Drug Discovery World

APRIL 13, 2023

In 2018, the US Food and Drug Administration (FDA) introduced a policy for accepting real-world data (RWD) and real-world evidence (RWE) in addition to traditional clinical trial data in new drug applications. With RWD, fewer patients require direct enrolment in randomised clinical trials.

Clinical Trials 130

Clinical Trials Trials FDA Laboratories 130

Drug Discovery World

OCTOBER 4, 2022

Erhardt adds that despite the ever-increasing number of people with AD, there has been an erosion of market value (from $4.2 Oligomerix believes it is focused on the most important segment of the neuroscience market which is the Alzheimer’s/dementia space. is President, Head of Development & Operations of Oligomerix.

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Disease Small Molecule Compound Screening Clinical Development 130

Conversations in Drug Development Trends

APRIL 15, 2024

As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs. Discover how Worldwide is positioned to meet your needs with agility, expertise, and a truly personalized approach.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Pharmaceutical Companies 52

Drug Discovery World

OCTOBER 16, 2023

From the Beatson Institute for Cancer Research in Glasgow, to Edinburgh Drug Discovery in the University of Edinburgh’s Institute for Genetics and Cancer (IGC). At ELRIG’s Scottish Research and Drug Development Forum meeting, DDW’s Diana Spencer provided a snapshot of drug discovery in Scotland.

Drugs 189

Drugs Science Therapies Targeted Protein Degradation 189

Drug Discovery World

JUNE 29, 2023

It’s been another busy month for senior appointments in the drug discovery sector. David Favre, Chief Development Officer, SpliceBio Dr Favre brings more than 25 years of experience in gene therapy, immunology and drug development throughout academia and the biopharma industry.

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Drugs Laboratories Research Laboratories Clinical Trials 130

Drug Discovery World

FEBRUARY 10, 2023

The top stories: Study shines a light on representation in clinical research A diversity study has shown that clinical trials should use real world diseases epidemiology data, rather than US Census Bureau race and ethnicity data, to ensure enrolment reflects the populations affected by different diseases.

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Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Clinical Development 52

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. QOS – optional Module 3.2.S QOS – optional Module 3.2.S

Clinical Development 52

Clinical Development Pharmaceuticals Clinical Trials Trials 52

Cytel

FEBRUARY 14, 2024

During drug development, a comprehensive regulatory strategy is key for saving time and money. There are many common mistakes drug developers make that can be avoided if they consider their regulatory strategy and adapt it over time.

Drug Development 59

Drug Development Marketing Drugs Clinical Development 59

Alta Sciences

MARCH 21, 2024

Watch Now The Altascientist: Central Nervous System Early-phase development of CNS-acting drugs is a complex, challenging undertaking. Watch Now The Altascientist: Central Nervous System Early-phase development of CNS-acting drugs is a complex, challenging undertaking.

Clinical Trials 40

Clinical Trials Trials FDA Drug Development 40

Drug Discovery World

FEBRUARY 12, 2024

Dr Pandora Pound , Fellow Oxford Centre for Animal Ethics explores the hinderances of animal testing in pharma and why new technologies such AI, genomics and synthetic biology c an further drug development. Drug discovery and development tomorrow – Changing the mindset. Clinical Development Success Rates 2006-2015.;

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Animal Testing Disease Trials Research 147

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?

Clinical Trials 52

Clinical Trials Trials FDA Drug Development 52

LifeSciVC

OCTOBER 18, 2023

By Bob Clarke, CEO of Kinaset Therapeutics, as part of the From The Trenches feature of LifeSciVC As we enter the final leg of 2023, navigating the investment market in biotech continues to be fraught with twists and turns. Where are investments going in the current market? This type of approach can certainly yield winners.

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Clinical Development Marketing Clinical Trials Production 63

Drug Discovery World

AUGUST 12, 2022

VLA15 is the only Lyme disease vaccine candidate currently in clinical development. If the Phase III trial is successful, Pfizer aims to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025. .

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Vaccine Disease Trials Pharmaceutical Companies 130

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? between 2023 and 2032.

Clinical Trials 52

Clinical Trials Trials Clinical Research Marketing 52

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2.

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Clinical Trials Biosimilars Pharma Companies Production 130

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. Agility and scalability.

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Clinical Trials Trials Testimonials Drug Development 98

Drug Discovery World

SEPTEMBER 6, 2022

As public markets adjust and the economy recovers in early 2022, investments in the cell and gene therapy space may plateau. . As a relatively new industry, working knowledge of bringing advanced therapies to market is limited. Record breaking investments in 2021 fuel an industry on fire . billion raised.

Therapies 130

Therapies Clinical Trials Production Disease 130

Vial

MARCH 1, 2024

By geographical region, the global CRO services market in 2023 was dominated by North America. Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market.

Clinical Trials 52

Clinical Trials Clinical Research Laboratories Trials 52

PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. References Hingorani, A.D., Sci Rep 9, 18911 (2019).

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Drugs Pharmacokinetics FDA Approval Drug Development 52

The Premier Consulting Blog

JULY 9, 2023

(Degradants are impurities arising from the degradation of the drug substance or a reaction with an excipient and/or the immediate container.) What sets this guidance apart from ICH Q3A and ICH Q3B is that it applies to all stages of clinical development, not just to approval.

Small Molecule 52

Small Molecule DNA Drugs Clinical Development 52

PPD

NOVEMBER 21, 2023

The drug development industry is constantly adapting and evolving to bring novel therapeutics to market to improve the lives of patients across the globe. While the drug development industry experienced setbacks during the COVID-19 pandemic, the field  is again gaining momentum reminiscent of its pre-pandemic pace.

Clinical Development 52

Clinical Development Clinical Trials Trials Clinical Research 52

Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video. TOP MANUFACTURING AND ANALYTICAL RESOURCES The Altascientist : Issue No. Listen here.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

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.

Drug Development 40

Drug Development Clinical Trials Vaccine Trials 40

PPD

OCTOBER 31, 2023

FSOs offer the complete outsourcing of most — if not all — tasks for a clinical development project, reducing the client’s management burden. FSP models enable clients to tune talent levels up and down based on research needs and market conditions.

International 52

International Clinical Research Clinical Development Research 52