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


  • 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


  • 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


  • 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


  • 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

  • Robert Thorne Denali Fellow, Head of Postdoc Program, Denali Therapeutics


  • 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


  • 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?

  • Ryan Kole Chief Executive Officer, Beyond Barriers Therapeutics


  • 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

  • Parnian Lak Chief Executive Officer, OlferaTherapeutics


  • 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


  • 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

  • Michel Baudry Chief Scientific Officer, NeurAegis
  • Laleh Golshahi Engineering Foundation (Endowed) Associate Professor, Mechanical Engineering & Pharmaceutical Engineering, Virgina Commonwealth University


  • 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

  • Craig Behnke Executive Vice President - Production & Development, Lumen Bioscience


  • 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

  • Kapileswar Swain Director and R&D Site Head Nasal, Inhalation, Ophthalmic, Apotex


  • 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

  • Eric Kaneps Vice President, Sales & Marketing, Renaissance Lakewood


  • 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

  • Craig Behnke Executive Vice President - Production & Development, Lumen Bioscience
  • Zachary Warnken Director, Pharmaceutical Development, Via Therapeutics
  • Lillian Li CMC Product and Device Lead, Sanofi Pasteur


  • 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

6:00 pm Chair’s Closing Remarks

6:15 pm End of Conference Day One