Advanced Pharmaceuticals Workshop

This workshop is designed for people tasked with developing and maintaining an animal health company's product portfolio and involved with a company’s regulatory strategies. This includes individuals involved with regulatory affairs, veterinary product development, conducting due diligence for product or company acquisitions, those tasked with ensuring corporate compliance, and members of investment companies working to learn about the industry. Among others, this includes:

• Personnel new to the Industry
• Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) employees
• Entrepreneurs
• Regulatory agents
• U.S. agents of foreign corporations
• Process owners
• Record retention specialists
• Legal professionals
• Financial advisors and institutional investors
• Consultants, inspectors and cGxP experts

• Details regarding how and what studies, data and information goes into the main technical sections of New Animal Drug Application (NADA – pioneer products) and Abbreviated NADA (ANADA – generic products)
  
  
• Practical applications and real-world experience regarding interaction and submission of the major within an FDA/CVM NADA and/or ANADA
  
  
• Strategies and plans for navigating the FDA/CVM approval process

Rob Hunter, Ph.D.

Dr. Rob Hunter has 20 years of veterinary and human drug development experience with NASA, Pfizer, Elanco, Parnell, and Provetica. He has contributed to the approvals for Revolution®, Dectomax®, Aviax®, Doxidyl™, A180®, tylosin, Micotil®, Ovugel®, Kexxtone®, ractopamine, Experior™, Posilac® and Pulmotil®, with others currently in development or under regulatory review. Internationally recognized subject matter expert on pharmacokinetics, antimicrobial PK/PD, interspecies allometry, drug metabolism, bioequivalence and tissue residues/human food safety along with corresponding bioanalytical support. Dr. Hunter has served on and chaired several AHI committees and represented the U.S. veterinary pharmaceutical industry on the VICH bioequivalence expert committee. He has represented various companies at CVM/FDA, EMA/CVMP, APVMA, VDD (Canada), NVQRS/QIA (South Korea), Thailand FDA, NVAL (Japan), Ministry of Agriculture (Vietnam) and IVDC (China) regarding specific products, issues and/or policies. He is the current President of the American Academy of Veterinary Pharmacology and Therapeutics.

Stephanie Batliner

Stephanie Batliner has 26 years of animal health pharmaceutical experience with companies including Bimeda Inc., Bayer HealthCare Animal Health Division, Teva Animal Health and Phoenix Scientific Inc. Experienced with all aspects of FDA/CVM Regulatory Affairs, with a focus on chemistry, manufacturing and controls (CMC) and generic animal drugs. She has a deep knowledge of nearly every dosage form and aseptic processing considerations, including Type V Veterinary Master Files. Stephanie has held leadership positions in R&D Technical Development (including analytical methods development, formulation development and technical transfer), Quality Assurance, Quality Control, pre-market Regulatory Affairs and post-market life cycle maintenance Regulatory Affairs. Stephanie has served as Chairperson of Generic Animal Drug Alliance and is currently serving as a working subgroup chair. Stephanie has a Bachelor's of Science in Animal Science from the University of Missouri, Columbia.

Beth Kee, D.V.M.

Dr. Beth Kee graduated from the College of Veterinary Medicine at the University of Georgia. She fulfilled several roles at Elanco Animal Health, including as Associate Director of the Japan Hub in the Emerging Markets R&D Division; the Director of Global Regulatory Operations; Team Leader for Companion Animal Regulatory Innovation; then Director of Companion Animal Product Development, where she led the development and registration of animal health products for global use. Before leaving Elanco, Beth was tapped for a unique position in Alternative Innovation, in which she was responsible for creating opportunities outside Elanco's core business piloting new models of product development and testing novel regulatory and clinical development strategies. Beth was most recently the Senior Director of Clinical Development at Kindred Bio. Currently, Beth is the Senior Director of Clinical Development and Study Operations, leading the company’s efforts in ACI's core expertise: designing, conducting and reporting field studies in complex medical conditions. Beth lives in Indianapolis where she loves spending time outdoors, practicing yoga and traveling to new locations with her adventurous beagle pack.

All times below are in central time (CT).

8:30 a.m. | Welcome and Introductions
Lauren Racki, Manager of Professional Development, K-State Olathe

8:45 a.m. | Introduction to CMC 
Stephanie Batliner, Director of R&D and Regulatory Affairs North America, Bimeda

• Guidance documents
• Pharmacopeia
• Supply Chain considerations throughout
• Drug Substance
  • Characterization
  • Manufacturer
  • Specifications
  • Analytical Methods
  • Drug master files, Type II VMF

10 a.m. | Break

10:15 a.m. | Drug Product
Stephanie Batliner, Director of R&D and Regulatory Affairs North America, Bimeda

• Composition and component ingredients
• Manufacturing methods
• Specifications
• Analytical methods
• Container/closure
• Inactivation Kinetics
• Stability studies
• Manufacturing Facilities
  
  • FDA Inspections
  • Type V VMF

Noon | Lunch

12:30 p.m. | Post Approval Maintenance
Stephanie Batliner, Director of R&D and Regulatory Affairs North America, Bimeda

1 p.m. | Target Animal Safety Study
Rob Hunter, Ph.D., Lead Advisor and Instructor, K-State Olathe

• Site Selection
• Final Study Report
• Monitoring

1:45 p.m. | Break
 

2 p.m. | Slaughter Authorization 
Rob Hunter, Ph.D., Lead Advisor and Instructor, K-State Olathe

• Data needed to get a Slaughter Authorization

2:45 p.m. | Navigating the Clinical Effectiveness Technical Section 
Beth Kee, D.V.M., Senior Director of Clinical Development and Study Operations, Animal Clinical Investigation (ACI)

• Introduction to TASS and Clinical
• What will be covered during the Clinical section
• Pilot studies for use in supporting pivotal work
• Key supporting regulatory documents
  
  

3:30 p.m. | Pivotal study stage 1: Planning (Part 1) 
Beth Kee, D.V.M., Senior Director of Clinical Development and Study Operations, Animal Clinical Investigation (ACI)

• Pre-Submission conference
• Protocol meetings
• Study design

4:15 p.m. | Wrap‐up and Concluding Remarks
Rob Hunter, Ph.D., Lead Advisor and Instructor, K-State Olathe

4:30 p.m. | Adjourn

All times below are in central time (CT).

8:30 a.m. | Welcome and Recap
Rob Hunter, Ph.D., Lead Advisor and Instructor, K-State Olathe

8:45 a.m. | Pivotal study stage 2 and 3: Study Initiation and In-life activities
Beth Kee, D.V.M., Senior Director of Clinical Development and Study Operations, Animal Clinical Investigation (ACI)

• Protocol training
• Implementation and Protocol
• Monitoring
• Data Management during this stage
• Pivotal study stage 4 and 5: End of live phase and Close Out
  • Animal Accountability
  • Test Article Accountability
  • Data Management at the end of this phase

10 a.m. | Break

10:45 a.m. | Pivotal study stage 6: Report Writing
Beth Kee, D.V.M., Senior Director of Clinical Development and Study Operations, Animal Clinical Investigation (ACI)

• Data compilation and review
• Data lock
• Analysis
• Report compilation
• Pivotal study stage 7: Submission

Noon | Lunch

12:30 p.m. | Human Food Safety
Rob Hunter, Ph.D., Lead Advisor and Instructor, K-State Olathe

• Bioanalytical Method
• Reminder of SA data
• Pivotal Toxicology data
• Pivotal Comparative Metabolism Data
• Pivotal Total (HOT) Residue Study
• Pivotal Marker (Cold) Residue Study
• Method Trial 

2:15p.m. | Break

2:30p.m. | Generic Approval/Bioequivalence
Rob Hunter, Ph.D., Lead Advisor and Instructor, K-State Olathe

• Bioanalytical Method
• Biowaiver
• Dissolution
• Solubility
• Blood level BE
  • PD or Clinical endpoint
• Residue Study

4:15 p.m. | Wrap‐up and Concluding Remarks

4:30 p.m. | Adjourn