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

2. 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

3. 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

4. -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

5. 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

6. 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

7. 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

8. 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

9. -Project scopes of all sizes are welcome.
Penny (Carpenter) Sattgast, MS
Penny founded PCS Biotech Services, LLC in March of 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 Penny brings 14 years of diverse clinical management and laboratory experience in the biologics industry to her business.
-Formed LLC in March 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.

10. Pierre, South Dakota

11. 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

12. 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

13. PCS Biotech Projects: Project Management for Clinical Efficacy Trials1
All-inclusive 2
Smaller Scope

14. 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.

15. 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

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

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

18.  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

19.  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 &

20. 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

21.  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

22. 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

24. Thank You!