Cynthia Ludwig

Principal Scientist

SAgE Consulting

25 years as research chemist / director in pharmaceutical development, agriculture and analytical chemistry. Expertise in GMP, GLP & ISO

Call Rates

Duration Price
15 minutes $50.00
30 minutes $100.00
60 minutes $200.00

Tags

Analytical Chemistry Lab Proficiency Programs ISO certification Method Validation Lab Training

Biography

I am currently enjoying a diverse career as a consultant and Director, Technical Services at AOCS. At AOCS I am responsible for all Technical Services activities including methods development, Laboratory Proficiency Programs, Certified Reference Material and AOCS accreditations. Develop and build strategic plan for new products, investigating emerging markets, and potential new collaborations. Build global relations related to International Standards Organization (ISO) and regulatory bodies

I joined Monsanto in 1994 as an analytical chemist after about 5 years with Sigma Chemical company and US Paint Corporation. I have a deep knowledge of agriculture and creating external and internal learning experiences. As is summarized below my extremely broad experience base includes a wide range of emerging technologies. Most significant in recent years this includes analytical chemistry, pharmaceutical development, chipping technologies, dairy reproduction technologies and integrated farming systems. I have 20 published patents and >16 pending. In 2009 I was part of a team that won the Monsanto Pledge Award for seed chipping development platform deployment.  In 2007 and in 2008 I won Monsanto’s Technology Innovate Cooperate and Execute Award.

After working as a research analytical chemist on GLP compliant HPLC systems analyzing glyphosate and Roundup® samples for 9 months, I became the bio-analytical team leader and lab manager of the QC Commercial Release Lab performing HPLC, UV and other analyses on Posilac®. In 1996 I was assigned to develop new catalytic routes for glyphosate processes and a new analytical methods to support the research.

I joined the Celebrex® Medicinal Chemistry Team run by John Talley in 1997 – 2002. In that role I synthesized new molecules to identify new active ingredients and supported all COX-2 and Celebrex® related issues including Bextra® and Parecoxib regulatory submissions, patents, litigation, metabolite synthesis, and competitive intelligence. Two exciting assignments were as lead researcher and support for two patent infringement cases. I was responsible for the literature and experimental research needed to be done in order to prepare our expert witnesses for trial and to assist with the debrief and strategy sessions during the trials.

In 2002 I returned to Monsanto and served as the principal scientist of Gender Enriched Semen Development Team that delivered key process inventions enabling successful transition of R&D process of producing sexed straws to commercial development of Decisive®. I managed start up and site operations for pilot production site. I was a principal writer of several patent disclosures, experimental results and applications resulting in 5 issued patents and several pending applications.

From 2005 – 2008 I was assigned as a BioEnergy Scientist in the Automation and Engineering Group Monsanto. I was the voting representative to American Standard Testing Materials (ASTM) organization - biodiesel, ethanol, and sustainability committees. I participated in  collaborations with Gina Clapper at AOCS, Bob McCormick at NREL and other entities to support ASTM research needed to set biofuel standards. I worked with Steve Howell in conjunction with NBB, Kristy Moore of RFA, Randy Olson of IBB, and others to support the bioenergy industry and maintain strong relationships with those entities.

Importantly, I was also the process Optimization and Validation group lead that helped design several automation projects including the soybean, cotton, vegetable and corn chipping technologies. I followed the launch and advancement of those technologies by developing training for staff on presentation and messaging associated with Chipper / Sorter demonstrations and served as tour / road show coordinator for Chipper / Sorter. 

This led to my assignment in 2009 as Technology Communications Manager - Technology Tour Manager (Jan. 2009 – Jul. 2013). I managed all aspects of the St. Louis Technology Tour Program – message development, graphic design, visitor experience, technical content, staff training program & supervision. In January of 2013 the fruits of two years of project management resulted in the opening of the Ernest Jaworski Agricultural Science Gallery in the Chesterfield Research Center. I managed and led VIP tours for government officials, dignitaries, Top Producers and key industry partners and consulted with global Monsanto tour sites to ensure better consistency.  My team ran the Technology Outreach program that delivered learning and technology experiences to educational and customer venues.

As the Tour Program manager I was responsible for planning and executing all the regulator and legislative tours. These tours were customized for each visit to ensure that the areas of interest were specifically addressed in support for the government affairs agenda. This included meeting with the advance teams, secret service and staffers for approval on security and content. A few of the recent visits I led include: Senator Mitch McConnell, Senator Jerry Moran, Senator Debbie Stabenow, Missouri Freshman legislature. The tour program also worked very closely with our regulatory and government affairs groups to provide information to our visitors about the topics of interest to our industry.

As Integrated Farming Systems Learning Center Project Lead – (Jan 2013 – Nov 2013) I built and managed the cross functional team responsible for developing the Integrated Farming Systems Tour and Learning Center experience in Huxley IA.  The teams goals are to create the story and displays that will educate and inspire visitors to learn more and become FieldScripts users as well as design a versatile space for learning, conference and social events.

I am a highly skilled communicator, technical writer, creative thinker and project manager with the demonstrated ability to think strategically.

Experience

Director, Technical Services

American Oil Chemists' Society (AOCS)
March 2014 - present

Responsible for all Technical Services activities including methods development, Laboratory Proficiency Programs, Certified Reference Material and AOCS accreditations. Develop and build strategic plan for new products, investigating emerging markets, and potential new collaborations. Build global relations related to International Standards Organization (ISO) and regulatory bodies

Principal Scientist

SAgE Consulting
November 2013 - present

  • Patent Consulting - 

I am a named inventor on over 20 patents in 5 different scientific disiplines. Expertise in writing patent disclosure and experimental examples. Patent technical advisory services include patent application preparation, patentability searches, validity searches and freedom to operate searches

  • Expert Witness  -

Prepare reprots, rebuttals, depositions and testify as an expert witness supporting patent infringement and contract disputes in my areas of expertise

Analytical & Organic Chemist

Monsanto
July 1994 - February 2005

  • Sperm Physiologist and Process Development Chemist Senior Research Scientist Gender Enriched Semen Project (Apr. 2002 – Feb. 2005)

Principal scientist of team that delivered key process inventions enabling successful transition of R&D process to commercial development. Managed start up and site operations for pilot production site including hiring and training all staff. Completed the technology transfer to commercial including writing all the SOP’s, hiring the lab staff and developing the training program for all new personnel. Wrote patent disclosures, experimental results and applications resulting in 5 issued patents and several pending applications.

  • Organic Chemist – Celebrex Team - Medicinal Chemistry (Oct. 1997 – Apr. 2002)

Synthesized molecules to identify new active ingredients to be submitted as a New Drug Application to the FDA. Supported all COX-2 and Celebrex related issues including: Bextra and Parecoxib regulatory submission, patents, litigation, metabolite synthesis and competitive intelligence.

  • Catalysis Chemist - Glyphosate New Routes Scientist –Corporate Research (Mar. 1996 – Oct. 1997)

Built an analytical lab and developed analytical methods for the glyphosate research team.

  • Lab Manager - QC GMP Commercial Release Lab. — Protiva (Apr. 1995 – Mar. 1996)

Bio-analytical Sub-team leader. Reviewed/approved results. Performed HPLC, UV and other analyses. Wrote operating procedures and maintained training files. Member of the QC steering committee.

  • Analytical Chemist - Research Analyst —  Crop Protection (Jul.  1994-Apr. 1995)

Analyzed glyphosate research samples on 6 GLP compliant HPLC systems. Responsible for maintenance, calibration, validation and regular sample analysis.

Analytical Production Chemist

Sigma Chemical Co
September 1989 - April 1994

  • Production / Analytical Chemist

Worked in the assay lab running, FT-IR, NMR, ICP, UV-Vis, wet chemistry, refractometry, and various other tests. Synthesized and produced product lines including arachadonicethanolimide, omega-3 fatty acids, Coenzyme A series, AZT, NADH, NAD and multiple other products. Wrote Master Manufacturing Procedures for initiative to become GMP compliant in the production area. Developed new product assays. Integrated computer instrumentation for reporting data.

Education

Eastern Illinois University - Physical Organic Chemistry

Master's Degree
1987 - 1990

Thesis: “Coal Derivatization by Alkylation & Ether Cleavage Reactions”

Southern Illinois University - Organic Chemistry

Bachelor's Degree
1983 - 1987

Completed four years of undergraduate research in medicinal organic chemistry

Other

Patents

Inventor

See detailed list of 22 patents below

1.  Process for the staining of sperm. U.S. Patent (2008) # 7,335,507 B2

Cindy L. Ludwig, Muhammad Anzar, Jeffrey A. Graham, Jeanette Glaenzer

 

2.  Sperm suspensions for sorting into X or Y chromosome-bearing enriched populations Patent (2010) # 7,838,210 Ludwig; Cindy L., Crowley; Kathleen S., Graves; Charles N.

 

3.  Process for storing a sperm dispersion Patent (2011) # 7,892,725 Graham; Jeffrey A., Ludwig; Cindy L., Crowley; Kathleen S.

 

4. Use of a composition which regulates oxidation/reduction reactions intracellularly and/or extracellulary in a staining or sorting process Patent (2011) # 7,998,700 Cindy L. Ludwig, Jeff Graham, Kathy Crowley, Muhammad Anzar.

 

5.  Apparatus and methods for providing sex-sorted animal sperm. Patent HK (2010) # 1144713 Gary DURACK, Jeremy T HATCHER, Lon A WESTFALL, David R HELBING, Jeffrey D WALLACE, Gary P VANDRE, Bradley DIDION, Niraj V NAYAK, Muhammad ANZAR, Cindy L LUDWIG, Jeffrey A GRAHAM, Kathleen S CROWLEY.

 

6.  Sperm Cell Processing Method Patent (2013) # 8,617,904 Gary Durack, Muhammad Anzar, Cindy Ludwig, Jeffrey A. Graham, Kathleen S. Crowley, Bradley Didion,

 

7.  Methods for processing Sperm Cells Patent (2014) # 8,623,658 Jeffrey A. Graham, Cindy Ludwig, Muhammad Anzar, Kathleen S. Crowley, Bradley Didion, Gary Durack

 

8. Substituted benzopyran derivatives for the treatment of inflammation. U.S. Patent (2004) # 6,806,288

Carter, Jeffery S.; Obukowicz, Mark G.; Devadas, Balekudru; Talley, John J.; Brown, David L.; Graneto, Matthew J.; Bertenshaw, Stephen R.; Rogier, Donald J., Jr.; Nagarajan, Srinivasan R.; Hanau, Cathleen E.; Hartmann, Susan J.; Ludwig, Cindy L.; Metz, Suzanne. 

 

9. Fluoro-substituted benzenesulfonyl compounds for the treatment of inflammation U.S. Patent (2004) # 6,699,884 Brown, David L.; Graneto, Matthew J.; Ludwig, Cindy L.; Molyneaux, John M.; Talley, John J.;

 

10. Fluoro-substituted benzenesulfonyl compounds for the treatment of inflammation U.S. Patent (2004) # 6,673,818 Brown, David L.; Graneto, Matthew J.; Ludwig, Cindy L.; Molyneaux, John M.; Talley, John J.;

 

11. Regioselective synthesis of 3,4-di{(carboclyl or heterocyclyl)thiophenes U.S. Patent (2003) # 6,600,052

Brown, David L.; Ludwig, Cindy L.;

 

12. Substituted benzopyran analogs for the treatment of inflammation U.S. Patent (2002) # 6,492,390

Carter, Jeffery S.; Obukowicz, Mark G.; Devadas, Balekudru; Talley, John J.; Brown, David L.; Graneto, Matthew J.; Bertenshaw, Stephen R.; Rogier, Donald J., Jr.; Nagarajan, Srinivasan R.; Hanau, Cathleen E.; Hartmann, Susan J.; Ludwig, Cindy L.; Metz, Suzanne

 

13. Substituted benzopyran derivatives for the treatment of inflammation U.S. Patent (2001) # 6,271,253

Carter; Jeffery S; Obukowicz; Mark G; Devadas; Balekudru; Talley; John J; Brown; David L; Graneto; Matthew J; Bertenshaw; Stephen R; Rogier, Jr.; Donald J; Nagarajan; Srinivasan Raj; Hanau; Cathleen E; Hartmann; Susan J; Ludwig; Cindy L; Metz; Suzanne; Korte; Donald E

 

14. Process for the preparation of N-(phosphonomethyl)glycine by oxidizing an N-substituted N-(phosphonomethyl)glycine. U.S. Patent (2001) # 6,232,494 Morgenstern, David A.; Mckenzie, David E.; Orth, Robert; Oburn, David; Ludwig, Cindy; Wan, Kam To; Dzenitis, John M. 

 

15. Preparation of benzopyrancarboxylates and quinolinecarboxylates as cyclooxygenase-2 inhibitors U.S. Patent (2000) # 6,077,850 Carter, Jeffery S.; Obukowicz, Mark G.; Devadas, Balekudru; Talley, John J.; Brown, David L.; Graneto, Matthew J.; Bertenshaw, Stephen R.; Rogier, Donald J., Jr.; Nagarajan, Srinivasan R.; Hanau, Cathleen E.; Hartmann, Susan J.; Ludwig, Cindy L.; Metz, Suzanne

 

16. Substituted benzopyran derivatives for the treatment of inflammation U.S. Patent (2000) # 6,034,256 Carter, Jeffery S.; Obukowicz, Mark G.; Devadas, Balekudru; Talley, John J.; Brown, David L.; Graneto, Matthew J.; Bertenshaw, Stephen R.; Rogier, Donald J., Jr.; Nagarajan, Srinivasan R.; Hanau, Cathleen E.; Hartmann, Susan J.; Ludwig, Cindy L.; Metz, Suzanne

 

17.  Substituted benzopyran derivatives for the treatment of inflammation U.S. Patent (2006) # 7,109,211 Carter, Jeffery S.; Obukowicz, Mark G.; Devadas, Balekudru; Talley, John J.; Brown, David L.; Graneto, Matthew J.; Bertenshaw, Stephen R.; Rogier, Donald J., Jr.; Nagarajan, Srinivasan R.; Hanau, Cathleen E.; Hartmann, Susan J.; Ludwig, Cindy L.; Metz, Suzanne

 

18. Substituted benzopyran derivatives for the treatment of inflammation U.S. Patent (2006) # 7,138,411 Carter, Jeffery S.; Obukowicz, Mark G.; Devadas, Balekudru; Talley, John J.; Brown, David L.; Graneto, Matthew J.; Bertenshaw, Stephen R.; Rogier, Donald J., Jr.; Nagarajan, Srinivasan R.; Hanau, Cathleen E.; Hartmann, Susan J.; Ludwig, Cindy L.; Metz, Suzanne; Donald E. Korte

 

19.  Benzopyran compounds useful for treating inflammatory conditions U.S. Patent (2007) # 7,259,266 Carter, Jeffery S.; Obukowicz, Mark G.; Devadas, Balekudru; Talley, John J.; Brown, David L.; Graneto, Matthew J.; Bertenshaw, Stephen R.; Rogier, Donald J., Jr.; Nagarajan, Srinivasan R.; Hanau, Cathleen E.; Hartmann, Susan J.; Ludwig, Cindy L.; Metz, Suzanne

 

20.  Automated systems and assemblies for use in evaluating agricultural products and methods therefore US Patent (2010) # 7,830,504 Deppermann; Kevin L., Modiano; Steven H., Ludwig; Cynthia L., White; Brad D., Calabotta; Beth J.

 

21.  Automated Systems and assemblies for use in evaluating agricultural products and methods therefor Patent (2010) # 7,830,504 Kevin Deppermann, Steve Modiano, Cindy L. Ludwig, Brad White, Beth Calabotta.

 

22.  Preparation and use of plant embryo explants for transformation Patent (2013) # 8,362,317 Beth Calabotta, Kevin Deppermann, Erik Dersch, Jerry Heise, Angela Koestel, Cindy Ludwig, Brian Martinell, Edward Williams.

 

6/18/2016 5:00:16 PM,
Cynthia Ludwig replied:

My clients vary widely - associations in need of project management, companies who need and expert witness in defense of critical litigation support, startegic plan development, technical writing, SOP review and editing are some of my recent endeavors.