LifeSciVC

FEBRUARY 27, 2024

By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC Patients and their care partners are at the center of our work in the life sciences industry – but at what point during the drug development process should companies start to engage these key stakeholders?

Drug Development 63

Drug Development Disease Drugs Treatment 63

Drug Discovery World

APRIL 6, 2023

Programme highlights The topic tracks include everything from clinical trials, drug development, immunology and bioinformatics, to global health, survivorship, prevention and tumour biology, to name just a few.

Small Molecule 130

Small Molecule Targeted Protein Degradation Clinical Trials Engineering 130

Perficient: Drug Development

JUNE 21, 2024

It’s like having a special workshop just for building and trying out different parts of your website or app. Storybook is like a workshop where you can make each piece of furniture (like a chair or a table) separately from the house. These stories help developers visually test the Button component in different scenarios.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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FDA Science Regulations Clinical Trials 40

Drug Discovery World

AUGUST 4, 2022

The development of easy to use, intuitive home administration devices, including wearable devices, that can deliver medicines to patients on demand is expanding. The increasing complexity of drug products has raised concern among pharmaceutical developers. Testing compatibility.

Drugs 130

Drugs Clinical Trials FDA Pharmaceuticals 130

Perficient: Drug Development

OCTOBER 2, 2023

Breakout Sessions and Workshops Attendees will have access to more than 35 breakout sessions featuring exclusive guest speakers, practical tutorials, innovative strategies, and everything in between.

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Science Production 59

Drug Discovery World

NOVEMBER 29, 2022

The new Clinical Pharmacology degree was launched in 2019 by Professors Emma Baker and Iain Greenwood and aims to take a holistic view of the development of drugs and create graduates that will stand out in the job market. Pharmacokinetics: How the body handles drugs. Pharmacodynamics: How drugs exert their effects on the body.

Clinical Pharmacology 130

Clinical Pharmacology Clinical Trials Drugs Drug Development 130

Perficient: Drug Development

JULY 28, 2023

The accelerator is available at three different intervention levels: a workshop, technical enablement, or full team consulting. In 6-12 weeks, we architect a proof of concept that delivers a more secure, compliant, reliable, and automated solution for you and your business.

Engineering 52

Engineering Compliance 52

Perficient: Drug Development

JULY 3, 2024

We summarized why D2C is important to many companies during our workshop and discussed the latest trends. We use this framework to talk about a company’s maturity and develop a roadmap to help them with many transformational business needs. Let’s discuss what was so exciting about these insights.

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J.

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Therapies FDA Trials Clinical Trials 98

Drug Discovery World

AUGUST 22, 2023

These factors alone pose a significant threat to a Gx company’s ability to successfully develop, scale up and launch a complex product. Regulatory & Policy: As mentioned earlier, regulatory uncertainty for generic drug developers rises from various factors including the lack of standard regulatory guidelines for complex Gx.

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Production Pharma Companies Clinical Trials FDA 130

FDA Law Blog: Biosimilars

AUGUST 23, 2023

By the end of Q2 FY 2023, FDA will convene the first of a series of 5 public meetings or workshops with key stakeholders including patients, biopharmaceutical companies, DHT companies, and academia to gather input into issues related to the use of DHTs in regulatory decision-making.

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Production Clinical Trials FDA Drugs 52

Perficient: Drug Development

AUGUST 1, 2023

Through a series of workshops and activities designed to capture and refine success metrics, deployment requirements, and training topics, a pilot process allows an organization to tailor its approach to its people and build requirements from hard data, not guesses.

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Production 98

Perficient: Drug Development

MARCH 14, 2024

There were over 300 sessions to attend, from technical talks to hands-on workshops where attendees could learn how to build copilots and how to use the latest Salesforce platform features directly from product managers , architects, and fellow developers.

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Production Science Marketing 111

Drug Discovery World

NOVEMBER 15, 2022

Synthetic libraries for antibody drug discovery . Developing therapeutic antibodies, one of the most successful approaches in drug development, involves identifying and characterising antibodies to be used as treatment against different types of cancers as well as autoimmune and cardiovascular diseases.

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DNA Engineering Drugs Vaccine 246

FDA Law Blog: Drug Discovery

JANUARY 23, 2023

Public Workshop and Congressional Reports FDORA requires FDA to convene public workshops and solicit comments on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study diversity, and publish a report on the recommendations raised in the workshop.

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FDA Trials Clinical Trials Drugs 59

The Premier Consulting Blog

NOVEMBER 12, 2023

The FDA is actively supporting this increased AI/ML integration in a variety of ways, including: Establishing the CDER AI Steering Committee (AISC) to provide guidance and oversight on AI/ML in drug development. Developing a framework for AI/ML-based devices to ensure that these devices are safe and effective.

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FDA Drug Development Regulations FDA Approval 52

Perficient: Drug Development

JANUARY 18, 2024

As parents started their daily tasks, kids were having a gala at Puppet making workshop. The Chennai and Bangalore teams took a great initiative in organizing a Yoga workshop for their colleagues. The Yoga workshop ended with everyone agreeing on the importance of doing yoga and promising to practice the learned ‘Aasanas’ daily.

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Agency IQ

JANUARY 19, 2024

As the FDA has previously acknowledged : “Many complex drug products did not exist” when the Hatch-Waxman Amendments was first passed into law. “As As drugs have increased in complexity in recent years, the scientific and regulatory roadmaps for drug development and approval may not be as well-established for more complex generics.”

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FDA Research Production Regulations 40

Perficient: Drug Development

MAY 2, 2024

In fact , Perficient recently partnered with Parentaly for a workshop on successfully preparing for parental leave as well as returning to work. Furthermore, Perficient boasts a comprehensive parental leave policy that provides ample time off for bonding with newborns and adjusting to the demands of motherhood.

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Nurses 98

Perficient: Drug Development

APRIL 25, 2024

I had the opportunity to spend time with Mark at one of his dealerships holding a digital marketing workshop with his team. Mark was the leader of the Smail Automotive Group, and he was loved by his fellow dealers.

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Marketing 52

Perficient: Drug Development

DECEMBER 28, 2023

Our team is currently scheduling Trusted AI Workshops and Einstein Readiness Assessments with our client as we head into 2024. Organizations can work with their trusted consulting partner and their Salesforce Account Executives to understand what capability or set of tools to use in order to address their use cases.

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International Marketing 59

Perficient: Drug Development

APRIL 8, 2024

OneStream is expecting 2,300+ attendees to converge on Las Vegas for four days of best practices, product updates, networking and hands-on workshops with finance and industry experts from around the globe. Splash, OneStream’s annual Global User Conference and Partner Summit , takes place May 20-23 in Las Vegas!

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Production Marketing 52

The Pharma Data

JANUARY 7, 2021

Notable’s functional precision medicine platform will advance drug development and enable pharmaceutical companies to get new therapies to patients faster. Learn more at notablelabs.com and follow us @notablelabs. Biotech Showcase is produced by Demy-Colton and EBD Group. .

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Pharmaceutical Companies Therapies Science Pharmaceuticals 52

Perficient: Drug Development

MARCH 27, 2024

Throughout the month, the company continued to host discussions, workshops, and mentorship programs aimed at empowering women and fostering a supportive and inclusive work environment. As part of Perficient’s commitment to gender equality, the celebration of International Women’s Day extended beyond a single day.

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Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. FDORA also directed the FDA to convene a meeting.

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FDA Research Clinical Trials Regulations 40

Perficient: Drug Development

DECEMBER 28, 2023

Our team is currently scheduling Trusted AI Workshops and Einstein Readiness Assessments with our client as we head into 2024. Organizations can work with their trusted consulting partner and their Salesforce Account Executives to understand what capability or set of tools to use in order to address their use cases.

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International Marketing 52

Perficient: Drug Development

JUNE 13, 2024

Education and Training: Integrating accessibility and inclusive design into educational curricula for designers, developers, and engineers can build a foundation for future professionals. Offering workshops, certifications, and continuous learning opportunities can keep professionals updated on best practices and emerging trends.

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Engineering Compliance Government Regulations 52

Perficient: Drug Development

OCTOBER 9, 2023

Our work involves strategic and digital transformation topics ranging from technology innovation, data monetization, capabilities assessments, platform selections, AI, and analytical workshops. We focus on pragmatic strategy that allows our clients to get things done and achieve excellent ROI.

Research 52

Research Marketing 52

Perficient: Drug Development

OCTOBER 11, 2023

It often featured sessions, workshops, and presentations on various Sitecore-related topics. Collaboration : It provided a platform for MVPs to collaborate with Sitecore employees, including developers, product managers, and executives. Correct, complimentary for anyone who purchased a SUGCON NA ticket!

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Production Marketing Hospitals International 59

Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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FDA Science Regulations Production 40

Drug Discovery World

JULY 11, 2023

How AI and ML are influencing drug development Biopharma has experienced significant growth in using these technologies for the past 10 years. However, other areas of the drug development pathway, such as target discovery, biomarker discovery, and product manufacturing, are increasingly looking to AI and ML to improve outcomes.

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Science Drugs FDA Engineering 100

FDA Law Blog: Drug Discovery

MAY 4, 2023

For example, in March 2023, FDA issued a Framework for the Use of Digital Health Technologies in Drug and Biological Product Development , which noted that FDA would publish guidance on the use of DHTs in both traditional and decentralized clinical trials.

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Clinical Trials Trials FDA Production 59

Sygnature Discovery

DECEMBER 17, 2021

In June, we established an Early Candidate Developability Screening Group in Nottingham – backed by £1.5m of capital investment – to help our customers formulate drug candidates for regulatory drug development and overcome even the most complex of bioavailability challenges.

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Small Molecule Laboratories Drugs Pharmaceuticals 52

Agency IQ

JUNE 2, 2023

Title Type Comments Close Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act Guidance June 5 Patient Preference Information—Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in (..)

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FDA Science Regulations Compliance 40

Drug Discovery World

FEBRUARY 27, 2023

For founders planning to launch their start-ups, specifically drug developers, there needs to be sound, foundational science with promising data that will enable you to push further down the drug discovery pipeline.

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RNA Science Small Molecule Engineering 130

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The workshop is also discussed in Cell & Gene here and here.

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