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K-State Olathe
22201 W. Innovation Dr.
Olathe, KS 66061-1304

913-541-1220
913-541-1488 fax
olatheinfo@k-state.edu

Regulatory Affairs in Animal Health Seminar Series

K-State Olathe is hosting seminars designed to provide hot topic information in regulatory affairs and connect industry with regulatory agencies. Upcoming seminars are below.

CRO-Sponsor Relationships: Best Practices to Improve Efficiency and Regulatory Process Outcomes 

1-5 p.m. | March 5

Seminar Overview

Strong sponsors partnerships with contract research organizations (CROs) can deliver substantial benefits for animal health product development both in efficiency and deliverable quality resulting in faster product approvals. However, strategic partnerships require significant investment of effort to develop and maintain. By jointly confronting the barriers to success, and coming to agreement on the needed changes and time commitment required, sponsors and CROs can increase their probability of success.

This seminar will explore the benefits, barriers and best practices for success for truly productive partnerships.
 

Register Now

   


Agenda

1 p.m. | Welcome

Paul Casady, executive in residence, professor of practice, K-State Olathe
 

1:05 p.m. | Laying the Foundation for Effective Sponsor/CRO Relationships

Kelly Lechtenberg, president, MVS, CSRC, VRC

Session will discuss the history of relationship development, current market conditions and trends for the future.

 

1:30 p.m. | Sponsor Perspectives on Effective Relationships with CROs

Doug Shane, assistant researcher for clinical efficacy, Food Animal, Bayer LLC

Karen Bond, senior clinical trials manager, Dechra

Melissa Andrasik, non-clinical studies manager, Product Development, Dechra

Speakers will discuss the benefits of partnerships, the dangers of accepting unrealistic expectations, and key factors for success in establishing partnerships.

 

2:15 p.m. | Break

 

2:30 p.m. | CROs Perspectives on Effective Relationship with Sponsors

Dr. Chris Chase, president, Research Technology Innovation (RTI), South Dakota State University

Speaker will discuss the benefits CROs can provide, ways to set achievable expectations, and key factors for success in establishing partnerships. 

 

3:15 p.m. | Academic Perspectives on Sponsor/CRO Partnerships

TBA

Description to come.

 

3:45 p.m. | Observations from the Receiving End: What Data Package Quality Reveals About Partnerships 

Donna Gatewood, president, EDGE Veterinary Vaccines Consulting Group or other internal USDA speaker

Speakers will share their perspectives on what aspects of a partnership work well from the perspective of data package review and product approvals.

4:30 p.m. | Panel Discussion

Moderated panel discussion with all speakers. 

 

4:55 p.m. | Closing Remarks

Paul Casady, executive in residence, professor of practice, K-State Olathe

Speakers

Melissa AndrasikMelissa Andrasik, R.V.T., B.S.

Non-clinical Studies Manager
Dechra Development LLC

Biography

 

Melissa Andrasik has worked for many years in the field of veterinary medicine in multiple disciplines. Her experiences have taken her from clinical emergency and specialty medicine, to full-time academia, to lecturing at national veterinary conferences, to writing a clinical pathology book.

For the last eight years, she has worked for Dechra as a clinical trials manager and as a non-clinical studies manager. Both positions have afforded her the opportunity to work with external partners and build relationships that benefit Dechra as well as the clinics and test facilities with which she interacts. 


 

Karen BondKaren Bond

Senior Clinical Trials Manager
Product Development 
Dechra Development LLC

Biography


Karen Bond has been employed in the animal health industry for more than 30 years in various roles relating to data quality, ranging from monitor to trial manager. 

She actively serves on the SQA Animal Health Specialty Section EDC Subcommittee and AHI Submission Standards Working Group in the hopes of defining data quality standards for the future.

 

Christopher ChaseChristopher Chase, D.V.M., Ph.D.

Chief Scientific Officer / President
RTI LLC

Biography


Christopher Chase leads business development and strategic planning at RTI (Research Technology Innovation), an animal health contract research organization. He works extensively with clients to identify the current challenges and needs of the animal health industry.

He is currently a professor in the Department of veterinary science at South Dakota State University.

Chase co-founded RTI LLC in 1994, serving as president since 1998.

His expertise in animal disease research allows him to integrate veterinary research with the practical aspects of clinical medicine to provide direction in protocol development.


  

Donna GatewoodDonna Gatewood, D.V.M., M.S.

President
EDGE Veterinary Vaccines Consulting Group

Biography

 

Upon completion of her graduate work, Donna Gatewood held leadership positions in the veterinary vaccine industry in Research and Development and in Regulatory Affairs.

She left industry to join the USDA’s Center for Veterinary Biologics, where she worked in the Policy Evaluation and Licensing Unit, first as a senior staff reviewer and then as section leader for virology. As a section leader, she was part of the CVB’s Expanded Management Team and participated the development of center policy.

She received her M.S. in microbiology from Kansas State University in 1992 and her doctor of veterinary medicine from Tuskegee University in 1986.


 

Kelly LechtenbergKelly Lechtenberg, D.V.M., Ph.D.

President/Owner
Midwest Veterinary Services, Central States Research Center, Veterinary and Biomedical Research Center and Timber Creek Vet Hospital

Biography


Kelly Lechtenberg is the founder/owner of Midwest Vet Services (1987); Central States Research Center (Vet Diagnostic Lab – 1996); Veterinary and Biomedical Research Center, Manhattan, KS (2013);Timber Creek Vet Hospital (with his daughter), Manhattan, KS (2015); Zue Diligence (2018), and Lechtenberg Farms which operate in Nebraska and Kansas, and include a commercial cattle feedlot and grazing unit, swine production unit and corn/soybean farm.

Douglas ShaneDouglas Shane, D.V.M., Ph.D.

Assistant Research Clinical Efficacy
Bayer Animal Health

Biography

 

Douglas Shane joined Bayer Animal Health as an assistant researcher on the North American clinical development team in 2017.

Currently, he is the site chair for the Bayer STEM Education Initiative Making Science Make Sense. He is responsible for farm animal field efficacy projects in Clinical Development as well as post-launch/marketing studies.

Shane was a concurrent D.V.M./Ph.D. student at the Kansas State University College of Veterinary Medicine, completing his D.V.M. in 2015 and a Ph.D. in production medicine and epidemiology in 2016.