Cytel

JANUARY 10, 2024

A clinical development strategy is a comprehensive plan designed to establish the safety and efficacy of new therapeutics. Developing an effective plan requires multidisciplinary expertise and adapting to accumulating learning and changes in clinical practice and the market environment.

Clinical Development 52

Clinical Development Production Marketing Disease 52

PPD

JANUARY 15, 2025

Click to enlarge Six AI and machine learning considerations for effective clinical trial management 1. Accelerate customer speed to market With a modern and integrated user experience, AI solutions put the right data and insights into the right hands in real time.

Clinical Trials 95

Clinical Trials Trials Clinical Research Drug Development 95

PPD

NOVEMBER 11, 2024

As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients. According to the United Nation’s 2024 World Population Prospects data, the global population of those 65 years old and over will grow from 0.8

Drug Development 97

Drug Development Clinical Trials Drugs Small Molecule 97

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.

Clinical Trials 136

Clinical Trials Clinical Development Trials Pharmaceutical Companies 136

PPD

NOVEMBER 9, 2023

Decreased timelines A flexible and adaptive protocol provides the potential to expedite drug development timelines by decreasing the overall duration of the early development/Phase I stage. Expediting time to market in this way is extremely valuable for those who ultimately benefit from improved therapeutic care.

Clinical Development 52

Clinical Development Drug Development Clinical Research Treatment 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

The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1.

Biosimilars 52

Biosimilars Clinical Development Production Government 52

PPD

OCTOBER 8, 2024

The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions.

Trials 98

Trials Clinical Trials Clinical Development Clinical Research 98

The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. . ” About Ascletis.

Clinical Development 40

Clinical Development Disease Clinical Trials Therapies 40

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.

Clinical Research 98

Clinical Research Pharmaceutical Companies Clinical Development Drug Development 98

The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

Biosimilars 40

Biosimilars Clinical Development Production Government 40

Drug Target Review

FEBRUARY 10, 2025

My focus has always been on advancing novel medicines from research to clinical development. His experience has played a key role in shaping a more capital-efficient model for bringing cell therapies to market. Over the years, Ive had the privilege of working on more than 25 different products, Bock shared.

Therapies 64

Therapies Treatment Engineering Clinical Trials 64

The Pharma Data

DECEMBER 30, 2020

Ensysce will use the funds to progress the clinical development of PF614, a first in class Trypsin Activated Abuse Protection (TAAP TM ) extended-release opioid prodrug, and its Multi-Pill Abuse Resistance (MPAR TM ) overdose protected counterpart, PF614-MPAR TM. “Our Global Emerging Markets (“GEM”) is a $3.4

Marketing 52

Marketing Production Clinical Development Regulations 52

Cytel

JANUARY 23, 2023

Ever since the first immune checkpoint inhibitor was approved for market nearly twelve years ago, the industry has witnessed a steady rise in the search for new immunotherapies. This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinical development in oncology.

Clinical Development 52

Clinical Development Trials Clinical Research Treatment 52

The Pharma Data

JANUARY 24, 2021

. (“Citius” or the “Company”) (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has entered into securities purchase agreements with certain institutional and accredited investors to raise approximately $20.0

Marketing 40

Marketing Pharmaceuticals Pharmaceutical Companies Production 40

Drug Target Review

SEPTEMBER 5, 2024

This was very challenging for me and at that moment I decided to get experience from later stage products and therefore took on the role as Global Product Director for late-stage marketed cardiovascular products. Already, three candidates are in clinical development and the lead candidate is ready to enter Phase III.

Pharma Companies 111

Pharma Companies Licensing Licensing Disease 111

PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. Growth of the FSP market is steadily increasing.

Drug Development 98

Drug Development Clinical Trials Drugs Clinical Research 98

Drug Target Review

JULY 18, 2023

AI is being used to find the targets themselves, design the drugs to manipulate that biology, and thirdly, AI is being used to support validation of those targets and drugs as part of pre-clinical development. Cavlan explains that “they are brilliant at developing and bringing new drugs to market.”

Drug Development 98

Drug Development Drugs Clinical Development Pharmaceutical Companies 98

Cytel

JUNE 20, 2023

How might this affect pediatric drug development? Legislation on pediatric studies has existed for more than 20 years in the US, yet additional guidance from the FDA has been relatively scarce.

FDA 52

FDA Marketing Drug Development Drugs 52

Conversations in Drug Development Trends

AUGUST 23, 2023

How the Patient’s Role in FDA Engagement Benefits Sponsors When the FDA, patient community, and sponsors can successfully collaborate, an investigational product’s chances of receiving regulatory approval and gaining market acceptance may improve. “We

FDA 96

FDA Trials Clinical Trials Disease 96

Conversations in Drug Development Trends

APRIL 15, 2024

The Advantages of Midsize CROs In contrast to large CROs, midsize CROs like Worldwide Clinical Trials offer a unique value proposition to the market. To gain deeper insights into this pivotal shift and how it can benefit your clinical development strategy, we invite you to download our full industry survey report.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Pharmaceutical Companies 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.

Clinical Development 61

Clinical Development Clinical Trials Marketing Production 61

LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. Figure 2 shows pipelines across modalities for some of the competitive targets today.

Small Molecule 138

Small Molecule Trials Therapies Disease 138

Drug Target Review

APRIL 3, 2024

I had to learn to actively make noise, advertise my work, engage in discussions, network with peers, and become active in self-marketing. She joined the company in November 2018 with more than 10 years of experience in drug discovery and non-clinical development of immunomodulatory drugs in the immuno-oncology space.

Science 105

Science Clinical Development Treatment DNA 105

Alta Sciences

NOVEMBER 15, 2024

As the CRO, our role is to provide a broader perspective and identify additional areas where our expertise can support their development program,” explains Lisa. For example, at Altasciences, we can discuss clinical development strategies that include adding study arms such as ethnobridging , or early precision QT analysis assessments.

Drug Development 52

Drug Development Clinical Trials Trials Drugs 52

Conversations in Drug Development Trends

DECEMBER 20, 2023

In some cases, the FDA has had to remove approvals of oncology drugs based on single-arm trials after they came to market because confirmatory studies had found that the safety/tolerability profile was less acceptable in the wider population.

Clinical Trials 83

Clinical Trials Trials Pharmacokinetics FDA 83

PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. To find success among the competition, sponsors must have access to the necessary expertise and resources to approach this burgeoning market.

Therapies 97

Therapies Clinical Trials Clinical Research Trials 97

Fierce BioTech

SEPTEMBER 10, 2024

Further, women’s health issues tend to be deprioritized in clinical development, medical treatment, and online health information. Marketers can use a better understanding of access and payer dynamics to improve pull-through. Women’s Health marketers are addressing formerly taboo topics in their education and promotion.

Clinical Development 52

Clinical Development Treatment Marketing Production 52

The Pharma Data

OCTOBER 31, 2020

.” According to Global Data, the global market for influenza antivirals reached 2.34 Currently the market is comprised primarily of the neuraminidase inhibitor oseltamivir and the newly developed endonuclease inhibitor baloxavir. TaiGen’s TG-1000 is poised to take full advantage of this development.

FDA Approval 52

FDA Approval FDA Clinical Development Virus 52

Cytel

APRIL 5, 2024

Written by Sydney Ringold, Customer Success Manager, and Kevin Trimm, Chief Product Officer In an ever-changing clinical development environment, sponsors face many challenges when designing clinical trials.

Clinical Trials 45

Clinical Trials Trials Clinical Development Regulations 45

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 Pharma Data

AUGUST 10, 2020

Novavax is partnering up with the Serum Institute of India Private Limited (SIIPL) in a licensing deal to development and marketing of up to one billion doses of its potential recombinant COVID-19 vaccine candidate, NVX?CoV2373.

Vaccine 52

Vaccine Licensing Licensing Clinical Development 52

PPD

JUNE 13, 2023

It is imperative that the right vaccine development partner demonstrates expertise from early clinical development to study design, execution, regulatory submission and commercialization. Working with a vertically integrated organization can further accelerate market entry.

Vaccine 52

Vaccine Clinical Trials Clinical Research Trials 52

The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion each year.

Laboratories 52

Laboratories FDA Clinical Development Regulations 52

The Pharma Data

MAY 30, 2023

The development of this unique digital asset underscores Syneos Health’s continued focus on Medical Affairs, an increasingly critical component of successful clinical development. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Clinical Development 52

Clinical Development Therapies Marketing 52

The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan.

Clinical Trials 52

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies 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.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Supply Trials 52