Conference Day One
Wednesday | March 13, 2024
Event Live!
7:30 am Registration & Morning Coffee
8:15 am Chair’s Opening Remarks
Leading Approaches for Advancing Formulation Techniques in Nasal Delivery
8:30 am Fireside Chat: Addressing Challenges & Driving InnovationFireside Chat: Addressing Challenges & Driving Innovation
Synopsis
- Discussing the importance of nasal drug delivery as a less invasive alternative, reducing clinical risks
- Exploring the true challenges in formulation for nasal drug delivery, including passing the blood-brain-barrier, avoiding the first-by-pass and overcoming mucociliary clearance
- Highlighting recent industry innovations and approaches for enhancing efficacy and absorption for nasal drug delivery
9:00 am Harnessing the Potential of Nasal Drug Delivery with Nanoparticle Formulation
Synopsis
- Delving into the hurdles when formulating to bypass the blood-brain barrier via nasal drug delivery
- Analyzing differences in dose, bioavailability and target tissue based on particle size and molecule type on drug efficacy
- Highlighting the achievements of novel functionalized nanocarriers and reviewing possible future applications
9:30 am Exploring Potential Applications and Key Considerations in Intranasal Delivery
Synopsis
- Nasal delivery system reliability and development requirements
- Market Overview and potential growth areas
- User requirement challenges and explore future directions
10:00 am Morning Break & Speed Networking
11:00 am Enhancing Formulation & Stability Through Novel Techniques
Synopsis
- Exploring recent developments in nasal delivery of anti-infective and vaccines
- Investigating stable formulation developments with novel processing techniques: balancing stability, aerosolization efficiency and targeting
- Weighing up different systems i.e container dose systems for optimal compatibility early on
Innovative Strategies to Achieve & Evaluate Enhanced Targeting to the Brain
11:30 am The Fate of Nasally Administered Antibodies: Olfactory & Trigeminal Pathways to the Brain & Delivery to the Lymphnodes & Circulation
Synopsis
- Delving into strategies for crafting particles that are not only smaller but precisely tailored to enable API bypass of the blood-brain barrier when delivered to the upper nasal cavity
- Sharing best practices to assess and maintain the desired particle size for delivery to the brain
- Reducing additional challenges, including prolonging mucosal retention time, enhancing penetration through nasal epithelia, and limiting premature drug metabolism
12:00 pm Enhancing & Accurately Validating Delivery to the Brain for a Novel Nasal Anti-Epileptic Formulation
Synopsis
- Formulation approaches and device considerations for early stage development of a novel anti-epileptic
- Developing a robust analytical strategy to produce promising, translatable results from mouse models
- Employing blood biomarkers to precisely trace drug migration to the target areas of the brain
12:30 pm Networking Lunch
1:30 pm Why Intranasal Delivery for Effective Targeting to the Brain?
Synopsis
- Tailoring particle size to ensure efficient brain-targeted drug delivery, enhancing therapeutic efficacy
- Overcoming challenges related to drug expulsion, increasing retention in the brain by effectively managing P-glycoprotein efflux and nanocarrier transport
- Reducing impeding metabolic activity with enzyme inhibitors, enhancers and excipients to decrease frequency of administration
Assessing Nasal Physiology & Anatomy for Enhanced Bioavailability
2:00 pm Redefining Brain Disease Treatment with Olfactory Prodrugs
Synopsis
- Merging artificial intelligence methodologies with classical principles of structure-activity rational design to develop olfactory prodrugs
- Maximizing brain drug delivery efficiency by targeting specific nasal cell types for enhanced specificity and efficacy
- Minimizing systemic absorption and reducing the risk of side effects
2:30 pm Understanding Challenges & Best Practice in Nasal Delivery
Synopsis
- Provide a summary of the benefits and challenges of drug absorption in nasal administration
- Highlighting the role of permeation enhancers, and excipients in improving drug absorption in the nasal cavity and facilitating passage through the mucosal barrier and epithelia
- Assessing toxicity of your formulation to ensure safety appropriately assessed
3:00 pm Roundtable Discussion: Tailoring Formulation Strategy for Large & Small Molecule APIs
Synopsis
- Exploring factors such as nasal metabolism, hepatic metabolism and pH levels to avoid nasal mucosal toxicity, and smolality to enhance bioavailability
- Utilizing the protective aspect of the nasal cavity against external bio products while exploring sustained-release nano formulations
- Evaluating the impact of device choice in small vs. large molecules and incorporating viscosifying agents for improved drug retention and diffusion
3:00 pm Afternoon Break & Poster Session
Optimizing CMC Strategies for Seamless Transition to Commercialization
4:00 pm Streamlining Cost-Effective Scale-Up & CMC Development for Nasal Biologic Drugs
Synopsis
- Ascertaining industry best practices in developing CMC strategies for nasal drug delivery, ensuring a seamless transition from formulation to manufacturing
- Maintaining product stability and consistency during scale-up processes and planning for additional quality control timelines and costs
- Adjusting CMC strategy to keep nasal delivery device compatibility in mind, maximizing patient compliance, therapeutic effectiveness and maintaining low cost of delivery
4:30 pm Mastering Complex Regulatory Requirements for Combination Drugs with Thorough Test Plans
Synopsis
- Alternative in vitro approach to clinical endpoint studies for suspension based nasal products
- Identifying the essential regulatory requirements for developing a comprehensive test program for combination drugs
- Strategies for seamlessly formalizing test programs and moving beyond human factor testing to ensure box-to-disposal safety
- Addressing less traditional safety considerations, including the potential risks associated with blood-brain barrier pathogen piggybacking, in the testing of combination drugs
- Reviewing design history file requirements for nasal drug delivery components considering nasal spray as a combination drug
5:00 pm Successfully Developing and Launching Nasal Spray Products
Synopsis
- Provide a summary of considerations for effective formulation and process development leading into drug product development, including nasal spray device selection.
- Challenges and considerations for clinical manufacturing and process scale up.
- Commercial manufacturing and packaging for multiple nasal spray device types.
5:30 pm Fireside Chat: Delving into The Dry vs. Liquid vs. Spray Drying Debate
Synopsis
- Comparing water-based, hydroalcoholic, nonaqueous, suspensions, and emulsions in terms of stability and efficacy
- Investigating the suitability of dry powder, liquid, lyophilized, and spray formulations and their suitability for various APIs and delivery vehicles
- Contextualising formulation strategy with logistical factors including regulatory approval, ease of manufacturing and device availability