8:30 am
Morning Coffee & Networking

Achieving Regulatory Harmonization to Ensure the Acceleration of Novel Animal Vaccines into the Global Market

9:30 am Panel Discussion: Achieving Harmonization Amongst all Stakeholders (Developers, Regulators, Manufacturers & End Users) to Expedite Approvals & Achieve Maximum Return of Investment for Effective Animal Vaccine Technologies

  • Tammie Wahaus Chief Executive Officer, ELIAS Animal Health
  • Steven Witte Director, Biologics Development Module, Agricultural Research Service, USDA
  • Sherry Layton Chief Executive Officer, Vetanco USA

Synopsis

  • Where are the current gaps and misalignments amongst stakeholders to ensure success is achieved from submission through to approval of next generation animal health vaccines?
  • How to balance the efficacy and safety concerns by regulatory agencies with consideration of the cost, practicality, and challenges faced in licensing the products?

10:30 am
Morning Break and Speed Networking

Improving the Economical Paradigm of Vaccine development for Animals with Cost & the Commercial Return in Mind

11:30 am Leveraging Successful Novel Technologies to Develop Therapeutically Valuable Vaccines for Multiple Diseases & Multiple Targets in Animals

Synopsis

  • How we can utilize platform technologies to decrease vaccine manufacturing times and accelerate licensing processes to advance the rate and return of interest in animal vaccine production
  • How to utilize platform technologies being used in human health and apply them to animal vaccines?
  • How to develop a platform for specific target animals which can be used against a variety of diseases to reduce manufacturing and production costs of animal vaccines?

12:00 pm Reducing Vaccine Development Times & Manufacturing Costs through De-Risking

  • Steven Witte Director, Biologics Development Module, Agricultural Research Service, USDA

Synopsis

  • De-risking is the process of reducing attrition rates in vaccine development through a robust Quality Design scheme
  • A significant amount of time and money is spent in late development on re-work, which also results in early production failures
  • By spending more time in early development and adopting a fast fail mindset, one can reduce overall cycle times and development costs

12:30 pm Streamlining Vaccine Manufacturing Costs: Exploring Innovative and Cost- Effective Production Approaches to Enhance both Safety and Efficacy

Synopsis

  • How to leverage novel manufacturing techniques to face the barrier of funding in animal health to keep vaccine dosage costs low, especially for farm animals?
  • How to harmonize with regulatory bodies to manufacture more vaccines simultaneously using modular technologies?
  • Reflecting on the use of non-fixed manufacturing facilities and how these can drive a more economical vaccine production

1:00 pm
Networking Lunch Break

Exploring the Benefits of Disease & Species Dependent Non-Injectable Vaccine Administration in Both Farm & Companion Animals

2:00 pm Novel Platform Technology to Aid Prevent Necrotic Enteritis in Poultry

Synopsis

  • Leveraging microbiome science and disease biology understanding, to develop animal vaccines with better efficacy & applicability
  • Novel platform technology for targeted mucosal immunity
  • Innovative vaccine to prevent and treat gut health disease

2:30 pm Inducing Mucosal Immunity Through the Use of Novel Platform Technologies

Synopsis

  • How do mucosal vaccines differ from traditional injectable vaccines?
  • How mucosal immunity is induced through novel technologies and the benefits of mucosal immunity in preventing diseases caused by bacterial, viral, and protozal pathogens
  • How to understand which diseases can be more effectively controlled with mucosal vaccination over systemic vaccination to overcome low-efficacy systemic vaccines for animal disease?

3:00 pm Employing Plant Delivered Oral Vaccines to Combat Traditional Vaccine Challenges

  • Tracy Raines Vice President Research and Development, Mazen Animal Health

Synopsis

  • Understanding mucosal vs. systemic stimulation and which diseases need mucosal immunity for protection
  • Navigating methods for producing and manufacturing plant delivered oral animal vaccines without compromising safety and efficacy
  • Oral vaccination as a gateway to reducing farmer labor, increasing worker safety and decreasing biosecurity dangers

3:30 pm
Chair’s Closing Remarks & End of Animal Health Vaccine Development Summit