PREMIER CONSULTING BLOGS

• Using The 505(B)(2) Pathway To Streamline Approval Of Combination Products

  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.

• Aligning For 505(b)(2) Success: Oncology Combination Product First-In-Class Treatment Success

  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.

• Improving NDA Approval Odds For New Dosage Forms Of Approved Products

  Learn why providing a more convenient and/or faster-acting dosage form of a well-chosen drug provides significant benefits for patients.

• Prescription Digital Therapeutics: When Software Is The Active Ingredient

  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.

• Do You Have A Combination Product, And Is It Drug-Led Or Device-Led?

  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?”

• Development Of Oncology Therapies: Tips From The FDA To Drive Success

  From the clinical stage onwards, explore why oncology therapies’ development key performance indications (KPIs) are consistent with the average values of general therapeutics development.

• Patient-Centered Drug Development For Oncology Products

  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.

• Leveraging 505(b)(2): Real-World Evidence Rescues Program

  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.

• Nonclinical Development Basics: The Right Nonclinical Strategy And Study Designs

  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.

• 505(b)(2) CMC Basics: Aligning Chemistry, Manufacturing, And Controls With Clinical Trial Phases

  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.

• Leveraging Target Product Profiles To Optimize Portfolio Potential

  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.

• Navigating The 4 Critical Stages Of The Drug Development Process

  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” The Barriers: BTD For 505(b)(2)

  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.

• Fast Track Designations For Your 505(b)(2) Drug Development Program

  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.

• Key Considerations For An Effective Commercial Strategy

  Find out the questions sponsors can ask to ensure they have the best chance to develop an asset with commercial potential.

• Leverage FDA Feedback To Communicate Risk And Boost Confidence

  In this blog, discover the tips and tricks to figuring out how to translate the FDA’s feedback into a compelling investor pitch.

• Single-Arm Trials Using Real-World Evidence For Rare Disease Product Development

  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

   
• FDA INTERACT Meetings: Early Interactions For Cell And Gene Therapy Sponsors

  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.

• Back To Basics: 505(b)(2) FAQs Part 3: Regulatory Strategies

  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).

• Considerations For Each Stage Of Drug Development

  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. 

• How Preclinical And Nonclinical Studies Differ, And Where They Belong

  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.

• Combination Device Regulatory Strategy: Success With The FDA

  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.

• Advancing From Research To Development: What Can Go Wrong?

  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.

• Using The 505(b)(2) Pathway: Efficient Regulatory Approval For Combination Products

  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.

• Referencing A Listed Drug For The 505(b)(2) Pathway

  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.

• Back To Basics: 505(b)(2) FAQs Part 4: Regulatory Strategies – Pharmacokinetic Studies

  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)

• Back To Basics: 505(b)(2) FAQs Part 2: Clinical And Nonclinical Studies

  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).

• Back To Basics: 505(b)(2) FAQs Part 1

  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.

• Developmental And Reproductive Toxicology (DART) Studies: What Are They, And How Do They Fit Into Your Program?

  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.

• The FDA’s Technical Rejection Criteria For Study Data: Does Your eCTD Submission Comply?

  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.

• Pre-IND Meetings: How To Achieve Success For 505(b)(2)

  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.

• 505(b)(1) Versus 505(b)(2): They Are Not The Same

  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.

• ANDA Or 505(B)(2): Choosing The Right Abbreviated Approval Pathway For Your Drug

  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.

• New FDA Draft Guidance Provides Insights On Use Of Pros In Oncology Trials

  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.

• Beware of Underestimating The Value Of A Pre-NDA Meeting

  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.

• 5 Tips To Avoid An IND Clinical Hold: Regulatory Guidance And Insights

  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.

• Creating A Compliant eCTD: Avoiding Common Regulatory And Technical Pitfalls On The Path To Submission

  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.

• FDA Issues Guidance On Clinical Trials During COVID-19

  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.

• Streamline Early Clinical Development With An INTERACT Meeting

  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.