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Agenda

 

Separate pathways for Nutrition, Pharma and Bio will be offered as breakout sessions that run concurrently throughout the conference's three days.

 

Download a PDF of the agenda  |  All Conference Details

8 a.m.

Check-in

✦ Lobby

8:30-10 a.m.

Opening Keynote: "The Adversarial and Collaborative Facets of Regulatory Affairs: Opportunities and Challenges"

✦ Great Plains B

This presentation will address challenges faced by a variety of stakeholders in balancing regulatory compliance and oversight with supporting agribusiness and ensuring safe, effective products are available and affordable.

Carlos Gonzalez, Ph.D.

Hill's Pet Nutrition

10-10:15 a.m.

Break

10:15-11:30 a.m.

Session One Breakouts

11:30 a.m.-12:30 p.m.

Lunch, sponsored by Accuon Labs Inc.

✦ Bistro

Accuon Labs Inc.

Sponsor

12:30-1:45

Session Two Breakouts

1:45-2 p.m.

Break

2:15-3:30 p.m.

Session Three Breakouts

3:15-3:45 p.m.

Break

3:30-4:15 p.m.

Speaker Panel and Day One Wrap-up

✦ Great Plains B

5:30-7 p.m.

Networking Dinners | RSVPs Required

✦ Off-site

Join us for dinners hosted across various KC restaurants by subject matter experts. Choose which group to dine with on the RSVP form, which is available on the registrant resources page.
Session 1

"Navigating and Understanding AAFCO"

✦ Great Plains B

Time 10:15-11:30 a.m.
Develop an understanding of AAFCO’s role in ingredient regulations, their history as an organization, the resources they provide, and how to engage with them as a professional.

Dan King

Minnesota Department of Agriculture | AAFCO

Session 2A

"Regulatory Jenga: Navigating Import and Export Regulations in Animal Nutrition with the USDA"

✦ Great Plains A

Time 12:30-1:45 p.m.
Gain a closer understanding of how USDA APHIS handles export and import of animal origin products, such as feeds, pet foods and ingredients. Learn about regulatory hurdles and some of the common mistakes that may cause delays and disruptions.

Lyn Huffaker, D.V.M., Ph.D.

LH Solutions, LLC

Session 2B

"Animal Supplements and Legal Risk Considerations"

✦ Great Plains B

Time 12:30-1:45 p.m.
To maximize economic success of any business venture, it is critical not to step on any potential landmines that may cause significant disruption to your business. In this session, get a clear look at how animal supplements are regulated and where the legal risks hide. Learn how to navigate product claims, stay compliant and avoid common pitfalls that can disrupt your business.

Bill Bookout

National Animal Supplement Council

Todd Harrison, J.D.

Venable, LLP

Session 3

"Import and Export of Nutrition Ingredients with the FDA"

✦ Great Plains A

Time 2:15-3:30p.m.
Join us for a practical look at FDA regulations for importing food and nutrition ingredients into the U.S. This course will outline the specific food regulations required at each stage in the import process from manufacturing in the foreign facility to distribution in the U.S. and whose responsibility it is for each activity.

Tim Lombardo

EAS Consulting Group

Session 1

"Introduction to the FDA"

✦ 221A

Time 10:15-11:30 a.m.
Understanding how CVM operates is critical to being an effective professional in animal health. This presentation will review the history of the FDA and the process of getting a drug to market through the agency’s processes.

Rob Hunter, Ph.D.

Animal Health Consultant

Session 2

Panel: "NexGen Products"

✦ 221A

Time 12:30-1:45 p.m.
New technologies are presenting new challenges for companies and the agency in getting products to market efficiently. Join these panelists as they share about their journeys in development and navigating the process to market, as well as how other organizations support the research and work.

Matt Zehnder

PastureBio

Terrell Suddarth

Hilltop Bio

Kevin Carrack, Ph.D.

US Pharmacopeia

Rob Hunter, Ph.D.

Moderator

Session 3

Panel: "CRO Selection and Oversight"

✦ 221A

Time 2:15-3:30p.m.
The value of using a CRO is best utilized when the sponsor and CRO develop clear communication and shared goals. Hear from two CROs on questions to ask and how to make the most of the relationship to develop a quality product and efficient process.

Kyle Kappeler

Attentive Science

Dominic Warrino, Ph.D.

KCASBio

Rob Hunter, Ph.D.

Moderator

Session 1

Introduction to the USDA

✦ 221B

Time 10:15-11:30 a.m.
This breakout provides an introduction to understanding the CVB, including history and how regulations became law. Discussion will focus on why Congress decided veterinary virus serums and toxins would be regulated by the USDA and also more about the structure of the agency and how it functions today.

Norm Brown, M.S.

Animal Health Consultant

Session 2

"Licensing New Products through CVB: Continuum of Studies Needed"

✦ 221B

Time 12:30-1:45 p.m.
Pitfalls in pushing ahead with submissions and studies without having the necessary information for the product is an ongoing challenge.T he course will provide an understanding of the process for licensing a veterinary vaccine with USDA/CVB.

Helen Smith, M.S.

Kemin

Session 3

"Qualification and Validation of Equipment for FDA, USDA and Medical Devices"

✦ 221B

Time 2:15-3:30p.m.
Validation requirements differ between USDA and FDA for vaccines, medical devices and drugs. Learn the differences and how to use a project specific validation plan with URS documents to provide a well laid out approach to managing project deliverables.

Terrie Jo Hamtak

Merck Animal Health (retired)

Sandy Dixon

Plastikon Healthcare

8:30-9 a.m.

Research and Networking Breakfast

✦ Great Plains B

Join us in Great Plains for a light networking breakfast and to hear about research from our grad students.

Sidharth Babu

Sensory and Consumer Sciences

Madison Bermisderfer

Animal Science

Logan Diller

Animal Science

Ashlee Gibbons

Animal Science

9-10:15 a.m.

"Standing in the Storm: Maintaining your Mojo in the Midst of Uncertainty"

✦ Great Plains B

You don’t need another productivity hack. You need a life that actually works; where energy, space and purpose coexist. This keynote delivers a fresh framework for leaders who are high performing and highly tired. Attendees will understand the relationship between energy, clarity and sustainable success; be introduced to a practical margin-building framework for themselves and their teams; and, walk away with tools to protect mojo and align daily work with deeper meaning.

Jim Bishop, M.S.

Conjunction Leadership

10:15-10:30 a.m.

Break

10:15-11:45 a.m.

Session One Breakouts

11:45 a.m.-12:45 p.m.

Lunch/Break

✦ Bistro

Come to the Bistro and enjoy some lunch with K-State Olathe Student Services and Faculty.
12:45-2:15 p.m.

Professional Skills Workshop:
"Translating Expertise: Professional Skills for Scientific Minds"

✦ Great Plains B

People with a scientific, technical or medical background can sometimes struggle in business-oriented conversations. Their methods of communication are highly effective in settings with scientific peers but often fail to work with business colleagues. This interactive workshop will provide learners with tangible communication processes and tools, including a stakeholder mapping process, the SBI feedback method, and the 5 Languages of Appreciation framework.

Brent Mayabb, D.V.M., M.S.

Royal Canin | Workshop Leader

2:15-2:45 p.m.

Break

2:45-4 p.m.

Session Two Breakouts

4-4:30

Day Two Wrap-up Session

4:30-6 p.m.

Social After Hours

✦ Off-site

Austin's Bar and Grill | North Olathe Location
11180 S. Lone Elm Drive
Olathe, KS 66061
Session 1

Panel: "Value of Interdisciplinary Approaches to Developing Nutrition Products"

✦ Great Plains B

Time 10:30-11:45 a.m.
Silos occur when teams or departments operate independently with limited interaction, leading to duplicated efforts, misalignment of goals, and wasted resources. Silos create significant obstacles, including poor communication, reduced efficiency, and barriers to innovation. An interdisciplinary approach facilitates innovation while ensuring regulatory compliance, consumer protection, and faster, more strategic market access.

Amanda Anderson

Elanco | Panelist

Kelly Foos, J.D.

Post Consumer Brand | Panelist

Haley Larson, Ph.D.

K-State Olathe | Panelist

Kathy Gross, Ph.D., PAS, Dip. ACAN

K-State | Moderator

Session 2

"Regulatory Innovation in Action: The SRIS Pathway and the AAFCO–K-State Olathe Partnership for Ingredient Review"

✦ Great Plains A

Time 2:45-4 p.m.
Recent changes in the animal nutrition regulatory landscape have opened the door to modernizing how new ingredients are evaluated for use in animal feed and pet food. The newly established Scientific Review of Ingredient Submissions (SRIS) pathway—a partnership between AAFCO and Kansas State University—recruits, trains, and engages industry thought leaders to review ingredient definitions for inclusion in AAFCO’s Official Publication, the FDA-recognized listing of approved feed ingredients for livestock and pet food.

Haley Larson, Ph.D.

K-State Olathe

Session 1

"A Conversation on the Developing Technology of Monoclonal Antibodies"

✦ 221A

Time 10:30-11:45 a.m.
This facilitated conversation will provide an initial understanding of monoclonal antibodies use in animal health and a discussion of the most recent developments in the technology.

Jay Peterson

Elanco

Norm Brown, M.S.

Facilitator

Session 2

"Global Efforts: Changing Pharmacovigilance Landscape"

✦ 221A

Time 2:45-4 p.m.
A brief description of the history of Global Pharmacovigilance, an oversight of existing regulations and a summary of ongoing PV activities within Industry Associations.

Martin Tiemann, D.V.M.

Boehringer-Ingelheim Animal Health U.S.

Session 1

"USDA and FDA Compliance Through Facility Design"

✦ 221B

Time 10:30-11:45 a.m.
Understanding facility design features in response to regulatory compliance or process requirements is a challenge. Join us to learn more about facility needs, including general arrangement and utilities, that help ensure compliance.

Sandra Bachamp, M.S., P.E.

Novel Engineering and Consulting

Session 2

"Leveraging Bioassays for Quality Control & Regulatory Considerations in Animal Health Biologics"

✦ 221B

Time 10:30-11:45 a.m.
Enhance your understanding of how bioassays can be used to ensure product quality and regulatory compliance. This session also will equip participants with knowledge of cutting-edge tools for biologics development offering real-world case studies demonstrating best practices and common pitfalls in bioassay implementation.

Maria Dashek, D.V.M., Ph.D., DACPV

Promega

8:30-9:30 a.m.

Industry Resources Panel Breakfast

✦ Great Plains B

Sponsored by AHC, AHI, ADA, GADA, BioNexus, AAIV

Emily McVey

Panelist | Representing KC Animal Health Corridor (AHC)

Kathy Vannatta, MBA

Panelist | Representing Animal Health Institute as a member (AHI)

Stephanie Batliner

Panelist | Representing Generic Animal Drug Alliance (GADA)

Brent Mayabb, D.V.M., M.S.

Panelist | Representing Royal Canin and American Association of Industry Veterinarians (AAIV)

Paige Adams, D.V.M., Ph.D.

Moderator

9:30-9:45

Break

9:45-11 a.m.

Session One Breakouts

11-11:15 a.m.

Break

11:15 a.m.-12:30 p.m.

Session Two Breakouts

12:30-1:30 p.m.

Lunch/Break

1:30-3 p.m.

Case Study Working Groups

3-3:30 p.m.

Closing Remarks and Conference Wrap Up

✦ Great Plains

Session 1

"Understanding Ingredient Approval Pathways"

✦ Great Plains A

Time 9:45-11 a.m.
Gain the latest updates and insights in the animal ingredient review process. New pathways, changing definitions, and legislation proposals make navigating the latest information an ever-changing challenge.

Leah Wilkinson

AFIA

Session 2

"Licensing and Registration for US Pet Food Producers and Suppliers"

✦ Great Plains B

Time 11:15 a.m.-12:30 p.m.
How to navigate through licensing and registrations for pet foods in the US.

Cheryl Iverson

Merieux Lifesciences

Case Study
Working Group A

"Elements of a Label: Livestock and Companion Animals"

✦ Great Plains A

Time 1:30-3 p.m.

Garret Ashabranner, Ph.D.

K-State Olathe | SRIS

Kathy Gross, Ph.D., PAS, Dip. ACAN

K-State

Session 1

"Understanding ADUFA/AGDUFA Fees"

✦ 221A

Time 9:45-11 a.m.
During this presentation, plan to learn about the differences of ADUFA and AGDUFA fees, their history and how to understand what is needed.

Stephanie Batliner

Bimeda

Kathy Vannatta

Phibro

Session 2A

"CMC Overview"

✦ Great Plains A

Time 11:15 a.m.-12:30 p.m.
In this session, Drug Substance and Drug Product technical elements for CMC technical sections for veterinary drugs for registration with FDA-CVM will be explored and discussed. This includes considerations for analytical methods and formulation development, selection of packaging, scale up and post-approval changes.

Stephanie Batliner

Bimeda

Session 2B

"Clinical Efficacy vs Study Claims"

✦ 221A

Time 11:15 a.m.-12:30 p.m.
In pharmaceutical development, clinical efficacy and study claims are related but distinct concepts, and understanding the difference is important for interpreting results and marketing statements. Clinical efficacy is the proven, measured effect in well-controlled clinical trials. Study claims are the takeaways and marketing statements derived from that data which may or may not match the strength of the actual evidence.
From a regulatory perspective, clinical efficacy shows whether the drug produces the intended clinical benefit in the target patient population. It is the actual, measurable therapeutic effect of a drug in controlled clinical trials and is derived from predefined endpoints in trial protocols (most often those that show a clinical benefit or endpoint vs a biomarker). These are core to regulatory approval and label indications.

Melinda Poole, D.V.M.

Poole Veterinary Consulting

Case Study
Working Group B

"Labeling and the FDA"

✦ 221A

Time 1:30-3 p.m.
Apply what you’ve learned by practicing with a pharmaceutical label ready for market. Catch the mistakes and make suggestions to make sure you’ve met the regulatory requirements needed to pass inspection of the label.

Rob Hunter, Ph.D.

Animal Health Consultant

Jennifer Schofield, D.V.M., CPH

Elanco

Session 1

"Navigating the Regulatory Pathways of Novel Oral Biologics: Scaling a Scientific Discovery into Manufacturing at Scale and Setting up Quality Control"

✦ 221B

Time 9:45-11 a.m.
Explore how a novel oral biologic moves from the lab bench to regulated product status. This session covers the scientific pivots required during scale-up, building a manufacturing infrastructure and creating quality control systems when no precedent exists all in the context of pursuing a USDA conditional license.

Jolieke van Oosterwijk, Ph.D., M.S., MCB

US Biologic

Session 2

"Innovation to Organization: From Compliance in a Post-licensure Setting"

✦ 221B

Time 11:15 a.m.-12:30 p.m.
Examine what happens after a USDA conditional license is granted. This session explores compliance expectations across manufacturing, quality, sales and marketing and regulatory, with guidance on common pitfalls, strategies to mitigate risk and the frameworks needed to respond effectively.

John Brooke, Ph.D., MPH

US Biologic

Case Study
Working Group C

"Writing an Outline for Production (USDA)"

✦ 221B

Time 1:30-3 p.m.
Writing an outline for production is a long process that requires accuracy and know-how to follow through to completion. Take the process step-by-step to gain an understanding of how to prepare and complete a full outline of production for CVB licensure.

Norm Brown, M.S.

Animal Health Consultant

Terrie Jo Hamtak

Merck Animal Health (retired)