PREMIER CONSULTING BLOGS

• 5 Steps To Planning And Executing IND-Enabling Nonclinical Studies

  In this checklist, authors outline five steps for planning and executing scientifically rigorous, compliant IND-enabling nonclinical studies to help move development programs forward.

• Product Expertise And Market Knowledge Secures Fast-Track Review

  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.

• Developing Digital Medicines And Therapeutics: 5 Steps For Success

  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.

• The Dynamic Landscape Of Digital Medicines And Therapeutics

  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.

• In Silico In Action: A Case Study In Relapsing Remitting Multiple Sclerosis

  Discover how in silico recreation can be a valuable tool for predicting the efficacy of new treatments.

• IVDR Survival Guide: Navigating Product Classification & Compliance Expectations

  Address common questions concerning the IVDR product classification system and how to comply with the new clinical evidence and performance expectations.

• A Guide To In Silico Modeling And Simulation

  Discover how in silico trials meet ethical codes and can be used to evaluate drug candidates.

• Using 505(B)(2) 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.

• 505(b)(2) Success In Oncology Combination Product Treatment

  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.

• Is Your Combination Product 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 that couldn't afford the time and expense of conducting studies recommended by another consultant got assistance for FDA approval.

• Relying On Nonclinical Development Basics For Your Program

  Enhance the ability to assemble the right experts to implement the best strategy when determining which nonclinical studies are necessary for a program.

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

  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.

• Leveraging Target Product Profiles To Optimize Portfolio Potential

  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.

• Navigating The 4 Critical Stages Of Drug Development

  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.

• “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.