
ABOUT PREMIER CONSULTING
Premier Consulting is a strategic product development and global regulatory consulting business unit of Premier Research, dedicated to supporting the specialized needs of emerging biotech, specialty pharma, and MedTech companies. We are informed by our Built for BiotechSM and Made for MedTechTM core capabilities to deliver end-to-end strategy, regulatory, nonclinical, CMC, quality, clinical, and commercial expertise. Our strategic insights help sponsor companies advance their programs through every development milestone, from the earliest stages through commercialization.
Please Contact Us to schedule a meeting or request more information.
PREMIER CONSULTING BLOGS
-
In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.
-
Discover why it is necessary to have the right regulatory and commercial plan in place early on based on sound science and medical, regulatory, and commercial assessments.
-
Learn why providing a more convenient and/or faster-acting dosage form of a well-chosen drug provides significant benefits for patients.
-
With smartphones now ubiquitous, read about how interest has increased in digital health solutions such as telemedicine platforms and apps used to track symptoms or medication usage.
-
The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
-
From the clinical stage onwards, explore why oncology therapies’ development key performance indications (KPIs) are consistent with the average values of general therapeutics development.
-
Since drug developers have been primarily concerned with satisfying regulatory requirements historically, discover how patient-centered drug development (PCDD) revolves around the patients and incorporates their voice in each phase of development.
-
Discover how a biotech company was assisted who could not afford the time and expense of conducting studies recommended by another of its consultants and agreed to by the FDA.
-
Successful nonclinical strategies leverage smart design to outline an optimized plan to de-risk critical early-stage milestones. Enhance your ability to assemble the right experts to determine the best strategy based on your product and the intended indication when considering which nonclinical studies are necessary for your program.
-
While the successful completion of clinical trials can certainly help to invite and maintain funding, learn why those trials are not meaningful without an appropriately designed, manufactured, and controlled drug product.
-
This guide discusses the critical role of target product profiles (TPPs) in product development and offer tips and best practices for integrating these tools into and across programs to optimize portfolio potential.
-
This document provides an overview of the critical planning activities and milestones in the drug development process and outlines important regulatory considerations at each stage.
-
Breakthrough therapy designation (BTD) is the most recent addition to the suite of expedited programs offered by the FDA. Explore how 505(b)(2) products can and have been approved with BTD.
-
One FDA tenet is to get safe, effective drugs to market as soon as possible. Understand the details of Fast Track designation (FTD) and how 505(b)(2) products can qualify for this program.
-
Find out the questions sponsors can ask to ensure they have the best chance to develop an asset with commercial potential.
-
In this blog, discover the tips and tricks to figuring out how to translate the FDA’s feedback into a compelling investor pitch.
-
In rare disease drug development, where a placebo control group may not be an option, a single-arm trial can be a successful approach. In this blog, gain insight into the regulatory considerations for single-arm trials
-
Discover how the INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) meeting offers sponsors of biologics (industry and investigators) an avenue for engagement with CBER in early development discussions.
-
As the 505(b)(2) expert, Premier Consulting is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Here is Part 3 in the series of frequently asked questions (FAQs).
-
This post provides an overview of the critical planning activities and milestones in the drug development process, along with important regulatory considerations at each stage.
-
In this blog post, learn when should each term be used, and the appropriate timelines for preclinical and nonclinical studies within a drug development program.
-
Breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents. Read how having an adaptive regulatory strategy is key.
-
With many steps between drug discovery and regulatory approval, there are several factors to consider at the earliest stages. Find advice for avoiding major pitfalls during the drug development process.
-
This blog post provides background on the regulatory submission and approval process for combination products and explores how developers may use a streamlined NDA process known as the 505(b)(2) pathway to reduce the size and/or scope of the nonclinical and/or clinical program for eligible combination products.
-
Section 505(b)(2) of the Food, Drug, and Cosmetic Act describes a 505(b)(2) new drug application (NDA) as an application where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.
-
As the 505(b)(2) expert, Premier Consulting is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Here is the final installment in the four part series of frequently asked questions (FAQs)
-
As the 505(b)(2) expert, Premier Consulting is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Here is Part 2 in the series of frequently asked questions (FAQs).
-
The topic of this post will be general 505(b)(2) questions, including what is and is not allowed for an approval via the 505(b)(2) regulatory pathway.
-
Development and Reproductive Toxicology studies, or DART studies, are required for most non-oncology programs between IND and NDA filings. This blog post discusses how their goal is to detect any effects of a drug within a complete reproductive cycle as relevant to humans: from initial conception to reproductive capacity in the next generation.
-
To help sponsors understand how the FDA uses the eCTD technical validation rules to verify conformance, the FDA developed the technical rejection criteria (TRC) for study data. Since its inception, the FDA monitored and analyzed conformance and revised the TRC but has not implemented them until now.
-
One of the greatest mistakes that the sponsor of a 505(b)(2) can make is to have an unsuccessful Pre-IND meeting. Read about the tools for making the Pre-IND meeting successful.
-
The 505(b)(2) pathway can yield significant benefits in drug development cost and time. But what are the differences in 505(b)(1) versus 505(b)(2)? They are not the same.
-
For developers seeking to obtain approval for previously approved drug products in the United States, the U.S. Food and Drug Administration (FDA) offers two abbreviated approval pathways — an abbreviated new drug application (ANDA) and a 505(b)(2) application. Read about these in the available blog.
-
Incorporating patient-reported outcomes (PROs) into clinical trials can help sponsors better understand patients’ symptoms and how a therapy will affect their quality of life. Read how that’s changed with the recent publication of a new draft guidance from the U.S Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), Core Patient-Reported Outcomes in Cancer Clinical Trials.
-
This blog covers the benefits and how to prepare for a pre-FDA meeting, what should be in your pre-NDA briefing package, potential topics for discussion as well as who should attend the pre-NDA meeting.
-
A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging biopharma companies.
-
Failure to comply with the regulatory and technical requirements when creating your eCTD could jeopardize the success of your submission and your product development plan as a whole, especially for early-stage biotechs. Here are strategies for avoiding some of the most common electronic publishing pitfalls on the path to submission.
-
In line with the challenges created by the COVID-19 pandemic, the FDA provided some recommendations with regard to the conduct, monitoring, and data aspects of ongoing and future clinical trials. Some of the key considerations for sponsors are below.
-
Read how the INTERACT meeting can be an invaluable engagement with the agency to inform the successful planning and execution of a novel product development program.
CONTACT INFORMATION
Premier Consulting
3800 Paramount Parkway Suite 400
Morrisville, NC 27560
UNITED STATES
FEATURED ARTICLES
-
Many 505(b)(2) development programs have been placed on clinical hold or disrupted because of incorrect or inadequate advice from professionals inexperienced in 505(b)(2) product development.
-
In this in-depth case study for an immuno-oncology program, learn how multidisciplinary development strategy assessment reduced a sponsor’s risk, controlled expenses, and optimized speed to market.
-
This guide explores the regulatory strategy considerations sponsors should bear in mind when working with global regulation agencies, with a focus on the development of drug and biologic products.
-
Discover how bringing a modified version of an existing drug to market through 505(b)(2) can offer a clear path to approval, a differentiated product, and at least some period of marketing exclusivity.
-
An international company developing an orphan drug product needed a partner experienced in FDA interactions to help it navigate the U.S. regulatory process from beginning formulation to NDA approval. Find out how this was done in the available case study.
-
Designing patient-centric programs can have a resoundingly positive impact on clinical research and the health and life of patients. Consider six ways to "reverse engineer" development strategy to accommodate the true rare disease patient journey.
-
Learn how the Research to Accelerate Cures and Equity (RACE) for Children Act aims to improve and expand treatment options for pediatric cancer patients.
-
Discover insight into the importance of nonclinical studies and review recommendations for assembling a nonclinical program team that optimizes the likelihood of moving candidates into clinical trials.
-
Discover how a biotech company that could not afford the time and expense to conduct studies recommended by its consultant and agreed on by the FDA was able to move its clinical trial forward.
-
This paper highlights the designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Explore the criteria, timeline and maintenance, and benefits of each designation.
-
A generic drug company always targets the introduction of its generic drugs when the reference product comes off patent. A generic cliff has it looking for alternative revenue sources.
-
Explore how the 505(b)(2) regulatory pathway can help drug developers gain approval for new drugs in a fraction of the time and cost required by traditional paths.