SD Biotech Summit -Animal Health Panel PENNY Carpenter Sattgast 04October2018

Agenda 1 2 3 4 5 Animal Health Biologics Experience Education and Career History 2 Animal Health Biologics Experience 3 PCS Biotech Services Overview 4 Examples of PCS Biotech Projects 5 Alternative Animal Health Vaccines

Education: Master of Science: Biology Microbiology and Infectious Disease Emphasis South Dakota State University, Brookings, SD Bachelor of Science: Biology for Information Systems Dakota State University, Madison, SD

-PCS Biotech Services, LLC -Novartis Animal Health Career History Corporate Biotech Sales Business Owner -PCS Biotech Services, LLC President & Founder -StarMark Cabinetry Designer Sales Sales skills Construction Knowledge Cabinetry Product Knowledge Design Skills Autocad Drafting Skills Accounting Skills -Grand Laboratories Scientist -Novartis Animal Health Senior Scientist & Project Manger -Elanco Animal Health Senior Scientist & Clinical Trial Study Director Government: Former President of the Harrisburg, SD School Board

Disease Model Experience Swine Challenge Model Bovine Challenge Model BRSV BVD Rotavirus Coronavirus K99 M. Bovis H.Somnus IBR PI3 M Haemolytica Influenza K88 987P F41 K99 Erysipelas H.Parasuis P.Multocida Actinobacillus 1,5, 7

Laboratory and Clinical Experience Clinical (Large and Small Animal) Virology Bacteriology Serology Cell Culture Assay Development Vaccine Formulation Upstream Bioreactors (Suspension Cell & Microcarriers) Animal Handling Vaccination Bleeding Challenge Administration Clinical Observation Scoring

Regulatory Experience USDA Path to Licensure for Biologics Outline of Production Manufacturing Reference Qualification Animal Welfare (IACUC) Regulatory for Global Marketing Studies GCP and GLP Project Management State Vet approvals, 103.3’s USDA-CVB Electronic Data Submissions Pharmacovigilance (Adverse Events) FDA-CVM CFIA

Quality and Project Management Experience Study Monitoring Laboratory and Clinical Process SOPs Data Management and Quality Control Clinical Study execution for internal and 3rd Party Protocol/Study Design Development Statisticians Data analysis and management Technical Report Writing

-Project scopes of all sizes are welcome. Penny (Carpenter) Sattgast, MS Penny founded PCS Biotech Services, LLC in March of 2017. Prior to that, Penny worked for Elanco Animal Health and served as a Clinical Trial Study Director and Scientist. While working full time for Novartis Animal Health, Penny attended South Dakota State University in Brookings, SD where she earned a Master’s degree in Microbiology in 2013. Penny brings 14 years of diverse clinical management and laboratory experience in the biologics industry to her business. -Formed LLC in March 2017 -Based in Pierre, SD -Bring 15 years of diverse clinical study management, disease model, and regulatory/compliance experience to PCS Biotech -Quality focus and on-time delivery of projects are the cornerstones of PCS Biotech Services. -Project scopes of all sizes are welcome.

Pierre, South Dakota

PCS Biotech Professional Services Clinical Trial Management (Non-GxP and GCP, and GLP) Protocol Writing Final Study Report Writing Project Management Study Design Regulatory Support Data Management Data summary & QC Case Report Form Design IACUC Support Study Monitoring Laboratory Support General Consulting GLP consulting Clinical Field Support Quality Control Pharmacovigilance Support Advocacy Lobbying Marketing Teaching Public Speaking

Large Animal Health Companies Small Start-Up Animal Health Companies Mid-Size Animal Health Companies Contract Research Organizations Small Human Health Companies Always looking to add to the list! Clients -South Dakota -Minnesota -Iowa -Nebraska -Florida -Missouri -Idaho

PCS Biotech Projects: Project Management for Clinical Efficacy Trials 1 All-inclusive 2 Smaller Scope

PCS Biotech Projects: Regulatory Guidance on Licensure Pathway Plant based, orally delivered product (feed additive Classification to determine if the product is under FDA or USDA jurisdiction Outline the process and studies for approval of an animal health biologic product through USDA guidelines under 9 CFR Outcome: From a Biologics perspective, it is not as important on HOW the product is made for classification, (i.e.; generated from animals or other methods), but more importantly on WHAT THE CLAIM IS that it protects against.

More PCS Biotech Regulatory Projects -Project Vetting for startup company: Veterinary diagnostic kit Expansion of product License to Canada -FDA Import Permit regulations and Processes for India manufactured IVP to be conducted in the united States

PCS Biotech “On-Site” CRO Projects -Clinical Field support -Challenge and Necropsy Day -Clinical Study Master File Audits -Laboratory support -Study monitoring

PCS Biotech Quality-Based Projects: Quality Systems Implementation Gap analysis between sites and/or functions Quality Project Management for (21CFR) GLP Clinical Study Preparedness

 Bringing Alternative Vaccines to Market: Production and Prescription Platform Product Biologics The USDA-Center for Veterinary Biologics (CVB) allows biologics manufacturers to use advanced technologies to license products -Manufactured with a standardized production platform (PP). CVB recognizes the need and desire to get new or updated products to the market faster Source: Program 2: Panel Discussion-The Regulatory View from USDA - Diagnostics, Guidance on Platforms and Prescriptions, and Bringing Alternative Vaccines to Market-Senior Staff Veterinarian USDA APHIS VS STAS Dr. Amy Gill Presentation from “Animal Health in the Heartland” Symposium, July 2018-Platform and Prescription Platform Biologics

 Production Platform Product Biologics Veterinary Services Memorandum 800.213 & 800.214 utilizes a single “backbone” vector or expression system (VES) Has a standard process for inserting a gene(s) of interest (GOI) into the backbone Generates different recombinant Seeds or Sequences(constructs). -Used to produce product following a standardized method for manufacture. -The final product is non- replicating and nonviable. Source: USDA Veterinary Services Memorandum NO. 800.213 & 800.214

Production Platform Product Biologics Continued In general, a Platform is defined by: Initial Product Vector or Expression System (VES) Gene (antigen) of Interest (GOI) Manufacturing Process Efficacy/Safety After initial product, reduced minimum requirements to license subsequent GOI variants Source: Program 2: Panel Discussion-The Regulatory View from USDA - Diagnostics, Guidance on Platforms and Prescriptions, and Bringing Alternative Vaccines to Market-Senior Staff Veterinarian USDA APHIS VS STAS Dr. Amy Gill Presentation from “Animal Health in the Heartland” Symposium, July 2018-Platform and Prescription Platform Biologics

 Prescription Platform Product Biologics Veterinary Services Memorandum 800.214 Custom veterinary biological product prepared for an individual animal or animals under a prescription written by a licensed veterinarian. Tested for safety and purity, but no efficacy claims Based on initial product fully licensed as described for a Platform Product Source: Program 2: Panel Discussion-The Regulatory View from USDA - Diagnostics, Guidance on Platforms and Prescriptions, and Bringing Alternative Vaccines to Market-Senior Staff Veterinarian USDA APHIS VS STAS Dr. Amy Gill Presentation from “Animal Health in the Heartland” Symposium, July 2018-Platform and Prescription Platform Biologics

Prescription Platform Product Biologics Continued The platform is considered “established” No changes can occur except the inserted GOI, but not limited to just GOI variants… Different GOI can be swapped for the original GOI Limited to species, age, dose, route and maximum antigenic content established in licensed initial product Source: Program 2: Panel Discussion-The Regulatory View from USDA - Diagnostics, Guidance on Platforms and Prescriptions, and Bringing Alternative Vaccines to Market-Senior Staff Veterinarian USDA APHIS VS STAS Dr. Amy Gill Presentation from “Animal Health in the Heartland” Symposium, July 2018-Platform and Prescription Platform Biologics

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