Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Download your copy today. In this complimentary webinar , Mel B. Watch the webinar.

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Our rare disease team at Worldwide will be hosting a panel discussion webinar with patient advocates active in Rare Disease Day events to synthesize the most salient conversations taking place. See their conversation below and register for the webinar to hear more from these advocates!

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Conversations in Drug Development Trends

JUNE 13, 2024

At Worldwide, Matt Cooper and Jim Eamma , our Executive Directors, Therapeutic Strategy Leads in Oncology, shed light on the intricacies of modern oncology trials in their recent webinar, “ Navigating the Landscape of Complex & Adaptive Oncology Trials.” How Does Project Optimus Impact Your Study’s Operations?

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Fierce BioTech

OCTOBER 26, 2023

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval? pesurya Thu, 10/26/2023 - 14:05 Tue, 12/05/2023 - 11:00 Resource Type Webinar Julie Bullock, PharmD Krithika Shetty, PhD Blaire Osborn, Ph.D. png Listing Introduction Clinical pharmacology information comprises more than 50% of a drug label.

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Fierce BioTech

JANUARY 12, 2024

Developing and Manufacturing Minitablets to Extend Drug Lifecycle pesurya Fri, 01/12/2024 - 12:38 Wed, 02/28/2024 - 11:00 Resource Type Webinar Robert Strickley, PhD Valjon Demiri, MSc Duration 60 Minutes Oral minitablets can offer several advantages in pharmaceutical applications, making them a valuable option in drug delivery.

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Conversations in Drug Development Trends

FEBRUARY 26, 2024

However, incorporating the patient experience into your design is one of the best ways to ensure your drug development program is a commercial success. It plays a significant role in patient recruitment and retention, both of which are vital to maintaining timelines, decreasing program costs, and gaining market approval.

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Fierce BioTech

APRIL 4, 2024

Discover how leading organizations leverage AI to revolutionize operations and expedite drug development, ensuring faster access to life-saving treatments. Key Takeaways: Accelerate time-to-market by integrating AI-driven real-time visibility, streamlined workflows, and intelligent decision support. Click here to login.

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The Pharma Data

SEPTEMBER 9, 2020

We respect your privacy, by clicking “Download Your Copy” you will receive our e-newsletter, including information on Podcasts, Webinars, event discounts, online learning opportunities and agree to our User Agreement. Transition to advanced analytics platforms to accelerate a product’s time-to-market.

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Alta Sciences

MARCH 21, 2024

Watch Now The Altascientist: Central Nervous System Early-phase development of CNS-acting drugs is a complex, challenging undertaking. In this article, we provide a detailed overview of the multiple facets you need to consider during the planning and conduct of your CNS-active drug development.

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Agency IQ

JULY 8, 2024

Several webinars and training sessions are geared towards ISO identification of medicinal products (IDMP) standards which is referred to as Substance, Product, Organization, Referentials (SPOR) data management services. Some “add-on” regulatory data protection may also be converted to market exclusivity.

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Fierce BioTech

OCTOBER 26, 2023

Separating the Science from the Fiction: Bringing the Lab of the Future to In Vivo Studies swheeler Thu, 10/26/2023 - 12:09 Thu, 12/07/2023 - 14:00 Resource Type Webinar Julie Morrison Ian Levine Jason M.

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Conversations in Drug Development Trends

MAY 1, 2024

This is a mechanism for experts to concurrently engage in scientific discourse with sponsors on key issues during the development phase of new medicinal products. Check out our recent webinar for a more comprehensive dive into early and ongoing regulatory engagement and how it drives program and commercial success. Japan, and China.

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Perficient: Drug Development

OCTOBER 4, 2023

Tailor offers according to emerging trends and customer pain points through market research. Limited Marketing Resources: Leverage digital marketing and social media to cost-effectively reach a broader audience. Collaborate with complementary businesses for co-marketing opportunities.

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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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Drug Target Review

DECEMBER 5, 2024

6 (CC BY 4) Overcoming traditional analytical barriers in capsid ratio determination While there are numerous analytical technologies available on the market for testing rAAV capsid ratios, none of the current methods are endorsed by regulatory agencies for large-scale product manufacturing. Bio-Rad, Bulletin 3725 [cited 2024 Oct 28].

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Agency IQ

JULY 22, 2024

Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs). AgencyIQ provides a status update for regulated industry.

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The Connected Lab

JUNE 2, 2021

The impact of these technologies on drug development, production and logistics is so disruptive that many consider the sector to be entering a fourth industrial revolution, known as Pharma 4.0. Here, we look at how Pharma 4.0 Join our Laboratory 4.0 Digitalization and Internet of Laboratory Things Strategies to Enrich Industry 4.0

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Perficient: Drug Development

FEBRUARY 27, 2024

Imagine this: You are a marketer at a medical device organization. It’s every marketer’s dream. Let’s look at a few ways medical device marketers can supercharge the digital product catalogs. Your products are cutting-edge, innovative, and best-in-class. Many of us remember the days of paper catalogs and brochures.

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The Pharma Data

DECEMBER 15, 2020

Company plans to meet with regulatory authorities as it evaluates next development steps. Company to host Key Opinion Leader (KOL) webinar to discuss these results today, December 16, at 8:00 am EST; registration link below. Interested parties can register for the webinar here. Kenilworth, N.J. ,

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Conversations in Drug Development Trends

FEBRUARY 28, 2023

Four decades later, Rob realized he had coincidentally dedicated his life — a life saved because of that charity — to driving life-saving treatments to market in the very same way, as the Executive Director of Uplifting Athletes. We are joining these researchers and patient communities on a decades-long journey to get a drug to market.

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Agency IQ

NOVEMBER 3, 2023

The agency further proposed a five “stage” phaseout of its current enforcement discretion, which would walk in the medical device regulatory requirements – from adverse events reporting to pre-market review – over four years. Under the proposed rule, these tests would be able to continue operating under the current status quo.

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Perficient: Drug Development

JULY 18, 2023

The uncertain economy has also caused organizations to cut back on travel budgets – making webinars more attractive. It’s no wonder that many events have had lower post-pandemic attendance rates as people become increasingly wary about where and how they invest their time.

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Agency IQ

AUGUST 23, 2024

At a high level, the establishment of OPEQ brought together previously disparate offices involved in pre-market review (the Office of Device Evaluation and its divisions) and post-market work related to compliance and surveillance (the Office of Compliance) and Office of Surveillance and Biometrics).

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Agency IQ

AUGUST 2, 2024

Happy 40 th Birthday, generic drugs: September 24 will mark the 40 th anniversary of the 1984 signing of the Hatch-Waxman Act, which created a formal pathway for the approval of generic drugs. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election.

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Perficient: Drug Development

FEBRUARY 11, 2024

At this time many of you may have heard about the official Sitecore Mentor Program , run by Nicole Montero from the Sitecore Technical Marketing Team. Mentor Program celebrates its second year with a significant growth of positive outcomes and success stories from both mentors and mentees.

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Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

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Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

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Agency IQ

APRIL 12, 2024

In drug development, biochemical assays might be used to determine a product’s binding affinity to a target receptor of interest, along with the strength, stability and duration of the target-ligand complex after the product binds to the receptor. What does progressive implementation of a potency assurance strategy mean? If so, how?

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Agency IQ

OCTOBER 27, 2023

the drug and device) of the combination product.

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Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. the drug and device) of the combination product.

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Agency IQ

MARCH 1, 2024

Start Date End Date Event Event Type Center 02/26/2024 02/26/2024 FDA/CDER and American Association of Pharmaceutical Scientists (AAPS) Hybrid Public Workshop Public CDER 02/27/2024 02/27/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer, Black History Month Program: “Real Talk: Our Stories as Black Oncologists at the FDA” Webcast (..)

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Agency IQ

FEBRUARY 2, 2024

Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)

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Agency IQ

DECEMBER 1, 2023

Prohaska, Kavita C. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. The final rule takes into account the recommendations of the Blood Products Advisory Committee, serving as a device classification panel, regarding the classification of these devices.

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Agency IQ

AUGUST 2, 2024

While ASTP/ONC’s work is likely to be higher-level than FDA’s, the strategic plan on AI could, depending on its development, roll down to FDA policy. The HHS announcement also comes with a note that the Department will be hosting a webinar about federal workforce opportunities in this area.

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Alta Sciences

OCTOBER 28, 2024

TOP NONCLINICAL SCIENTIFIC RESOURCES Webinar : Innovative Surgical Solutions in Safety Assessment Studies Explore how innovative surgical solutions are enhancing nonclinical safety assessments. Issue 41 of The Altascientist focuses on bioanalytical testing for immunomodulatory drugs. Catch up on what you might have missed below!

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Perficient: Drug Development

JANUARY 8, 2025

Its difficult, in the consulting services industry, to explain the requirement for existence of a core thought leadership group to augment the sales and marketing teams that are tasked with collection of logos. They published juicy whitepapers and hosted cant-miss webinars about sustainable investing and ESG trends. The result?

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Conversations in Drug Development Trends

MARCH 11, 2025

To address these concerns in CAR T therapy trials , Worldwides Dr. Simran Padam, Dr. Amy Raymond, and Nathan Chadwick discussed with Dr. Chris Jenkins of Sabai Global and Dr. Tahseen Mozaffar of UC Irvine in an on-demand webinar, Expanding CAR T Beyond Oncology: Medical, Operational & Practical Considerations.

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