
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
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In this checklist, authors outline five steps for planning and executing scientifically rigorous, compliant IND-enabling nonclinical studies to help move development programs forward.
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Unearth how an international company was able to realize the full potential of its product by combining product expertise with target market knowledge to create a winning strategy.
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Download this checklist to access five key steps for ensuring regulatory requirements and commercial goals are built into a cohesive go-to-market strategy that addresses barriers and drives adoption.
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Driven by advances in technology and increased acceptance of telehealth, uncover how digital medicines and DTx are poised to become an integral part of the healthcare model.
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Discover how in silico recreation can be a valuable tool for predicting the efficacy of new treatments.
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Address common questions concerning the IVDR product classification system and how to comply with the new clinical evidence and performance expectations.
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Discover how in silico trials meet ethical codes and can be used to evaluate drug candidates.
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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.
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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.
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Learn why providing a more convenient and/or faster-acting dosage form of a well-chosen drug provides significant benefits for patients.
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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.
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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?”
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From the clinical stage onwards, explore why oncology therapies’ development key performance indications (KPIs) are consistent with the average values of general therapeutics development.
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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.
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Discover how a biotech company that couldn't afford the time and expense of conducting studies recommended by another consultant got assistance for FDA approval.
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Enhance the ability to assemble the right experts to implement the best strategy when determining which nonclinical studies are necessary for a program.
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While the successful completion of clinical trials can invite and maintain funding, those trials are not meaningful without an appropriately designed, manufactured, and controlled drug product.
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This guide discusses the critical role of target product profiles (TPPs) in product development and offers tips and best practices for integrating these tools into and across programs to optimize portfolio potential.
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Get an overview of the critical planning activities and milestones in the drug development process and learn which important regulatory considerations should be taken at each stage.
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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.
CONTACT INFORMATION
Premier Consulting
3800 Paramount Parkway Suite 400
Morrisville, NC 27560
UNITED STATES
FEATURED ARTICLES
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Whether you are a researcher, scientist, or industry professional, access these insightful guides and checklists that provide valuable advice and best practices for planning and executing nonclinical studies.
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Gain insight into opportunities that leverage regulatory pathways and factors that will ultimately determine the commercial success or failure of digital products currently in development.
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Many 505(b)(2) development programs have been put on hold or disrupted due to incorrect or inadequate advice. Gain insight on how to rectify past mistakes and avoid future ones in three program examples.
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Discover the advantages of the 505(b)(2) pathway, look at common misconceptions, and offer practical advice on its application in the real world.
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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.
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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.
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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.
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This article answers seven questions commonly received about developing a timely and well-structured IND submission.
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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.
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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.
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Learn how the Research to Accelerate Cures and Equity (RACE) for Children Act aims to improve and expand treatment options for pediatric cancer patients.
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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.
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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.
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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.
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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.
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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.