Erik Hedrick, Ph.D.

Executive Vice President

Erik Hedrick is the Executive Vice President of Toxicology here at The Burdock Group, a safety and regulatory consulting firm located in Orlando, Florida, with over 30 years of established experience as the leader in regulatory and scientific consulting. We are a brick-and-mortar establishment that has on-site accountability, our own in-house toxicological library, and access to state-of-the-art scientific databases, to provide the most up to date and comprehensive compilation of information to ascertain what steps are needed to bring a client’s product to market. We are the experts at conducting gap analyses, navigating the specific nuances of the regulatory space, and providing outside the box solutions that are specifically tailored to the unique needs of your product.

Erik received his Ph.D. in Toxicology in 2016 from Texas A&M University and has seven years of post-doctoral experience from Texas A&M University and the Lerner Research Institute of the Cleveland Clinic.

With ten years of toxicology experience relating to molecular toxicology and, over fourteen years of experience in cell/molecular biology, biochemistry, and molecular oncology, Erik has acquired extensive experience utilizing in vitro and in vivo molecular, biochemical, and analytical techniques as well as animal husbandry in the field of molecular toxicology and oncology. He has published 21 peer reviewed publications in multiple highly respected journals (listed below). During this time, Erik has successfully obtained highly competitive sources of funding for research which include, a Merit Scholars Fellowship and Research Training Grant at Texas A&M University, the National Institute of Health (NIH) Ruth L. Kirschstein National Research Service Award (NRSA) and the Early Investigator Research Award during his postdoctoral tenure at Cleveland Clinic. Erik has presented his work at multiple scientific conferences to include the Society of Toxicology (SOT) annual meetings.

As the EVP of Toxicology here at Burdock Group, Erik's role is to ensure the safety and regulatory compliance of a client’s product before it comes out onto the market. His experience in toxicology has equipped him with the toolset to understand the unique safety requirements for an ingredient and what tests are needed to demonstrate safety. During Erik's tenure at The Burdock Group, he has become familiar with specific regulations within the United States and the European Union. This includes working with the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) within the United States as well as with the European Food Safety Authority (EFSA) within the European Union (EU).

Erik's work has included composition of:

Feasibility assessments for Generally Recognized as Safe (GRAS) dossiers
GRAS dossiers
Food Additive Petitions (FAP)
New Dietary Ingredient (NDI) Notifications (NDIN)
Gap analyses and regulatory assessments
Substantial equivalence and standard of identity assessments
Development and monitoring of safety/clinical studies
Publishing safety studies and other manuscripts
Safety assessment monographs
EPA pesticide and facility registration and consulting
Novel Food Applications for authorization of novel foods within the European Union (EU).

Working at Burdock Group, Erik has also become familiarized with:

Organisation for Economic Cooperation and Development (OECD) guidelines
Good manufacturing practices (GMP)
Good Laboratory Practices (GLP)

Erik has conducted multiple webinars at The Burdock Group, which include:

Ensuring the safety of cannabinoids and navigating the regulatory space for their use as food ingredients and dietary supplements
Cell-cultured meat and alternative protein products and ensuring their safety for humans and animals
Algae-based food ingredients and dietary supplements for use in the United States and the EU

Erik's unbridled level of ardor and professionalism for scientific research and understanding of the regulatory space as it relates to occupational health and safety and ensuring the safety/compliance of new products, provides the firm with a significant advantage in the regulatory marketplace. Erik's Ph.D. in toxicology, along with his decade of experience in toxicology and molecular biology and biochemistry, allow him to swifty navigate any project to completion. Erik specializes in toxicological safety assessments, development and monitoring of safety/clinical studies, and regulatory consulting. This involves determining what information and studies are needed to ensure a client’s product is safe and compliant with current regulations before it comes out to the market. His work includes composition of GRAS, GRAS notifications, FAP, CAP, NDIN, safety assessments, Novel Food Applications, study monitoring and clinical trial development with CROs, manuscript preparation, pesticide registrations, and other regulatory assessments/documentation. Erik also has experience with the FDA, EPA, EFSA, FTC, and other regulatory bodies. He is familiar with OECD, GLP, GMP, GCP, and ICH guidelines and their application to study development and monitoring.

During his research career, Erik's interests included the development of new chemotherapeutic studies to target metabolic pathways in cancer. He has a strong background in biochemistry, molecular biology, and toxicology which significantly augments his ability to accomplish any endeavor set in front of him. Erik's graduate work consisted of working with orphan nuclear receptors [specifically nuclear receptor family 4 A1 (NR4A1)] and studying the role of Sp transcription factors as nononcogene-addiction genes. During his doctoral tenure, Erik elucidated previously unknown signaling pathways in triple negative breast cancer, developed and demonstrated the chemotherapeutic potential of methylene-substituted diindolyl methane analogs (c-DIMS) in a multitude of solid tumor malignancies, and mastered many scientific techniques, including cell culture, animal husbandry, CRISPR-Cas9 and lentiviral gene editing, siRNA transient transfection, RT-qPCR, molecular cloning techniques, western blotting, ELISA, Immunoprecipitation, immunofluorescence, Chromatin Immunoprecipitation (ChIP), confocal microscopy, protein purification techniques, DNA site-directed mutagenesis, chromatography (ion exchange ,Gel, Hydrophobic, Reverse Phase, IMAC, and Affinity label), flow cytometry.

Erik also worked as a postdoctoral research fellow at the Cleveland Clinic and continues investigating mechanisms of metabolic resistance in prostate cancer. Prostate cancer is a highly metabolically driven cancer that relies heavily on androgens and the androgen receptor (AR). However advanced prostate cancer involves metabolic pathways that preclude the AR and these pathways need to be elucidated and investigated. Erik has elucidated a role of mTORC1 in AR-negative CRPC and how mTORC1 senses androgens and other steroids as a survival mechanism in treatment of refractory prostate cancer. This research has allowed Erik to apply his current skills and develop new skills in treatment refractory prostate cancer, including HPLC and mass spectrometry. In pursuing this project, Erik has contributed to the field of prostate cancer by exploring novel treatment therapies and demonstrated the therapeutic potential of the mTORC1/PGRMC1 interface as an effective treatment target in AR-negative CRPC.

PUBLICATIONS:

https://pubmed.ncbi.nlm.nih.gov/?term=erik%20hedrick&sort=date

1. Hedrick ED, Agarwal E, Leiphrakpam PD, Haferbier KL, Brattain MG, Chowdhury S. Differential PKA activation and AKAP association determines cell fate in cancer cells. J Mol Signal. 2013 Oct 1;8(1):10. https://jmolecularsignaling.com/articles/10.1186/1750-2187-8-10

2. Safe S, Jin UH, Hedrick E, Reeder A, Lee SO. Minireview: role of orphan nuclear receptors in cancer and potential as drug targets. Mol Endocrinol. 2014 Feb;28(2):157-72.

https://academic.oup.com/mend/article/28/2/157/2556166?login=false

3. Lee SO, Li X, Hedrick E, Jin UH, Jalkens R, Backos D, Zijin L, Zhang Y, Wu Q, Safe S. Diindolylmethane Analogs Bind NR4A1 and Are NR4A1 Antagonists in Colon Cancer Cells. Mol Endocrinol. 2014 Oct;28(10):1729-39 https://academic.oup.com/mend/article/28/10/1729/2623280?login=false

4. Hedrick E, Lee SO, Kim G, Abdelrahim M, Jin UH, Safe S, Abudayyeh A. Nuclear receptor 4A1(NR4A1) as a Drug Target for Renal Cell Adenocarcinoma. PLOS One. 2015 Jun 2;10(6):e0128308.

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0128308

5. Hedrick E, Crose L, Linardic CM, Safe S. Histone Deacetylase Inhibitors Inhibit Rhabdomyosarcoma by Reactive Oxygen Species-Dependent Targeting of Specificity Protein Transcription Factors. Mol Cancer Ther. 2015 Sep;14(9):2143-53. https://aacrjournals.org/mct/article/14/9/2143/122654/Histone-Deacetylase-Inhibitors-Inhibit 5. Hedrick E, Lee SO, Doddapaneni R, Singh M, Safe S. Nuclear Receptor 4A1 (NR4A1) as a Drug Target for Breast Cancer Chemotherapy. Endocr Relat Cancer 2015 Oct;22(5):831-40. https://erc.bioscientifica.com/view/journals/erc/22/5/831.xml

6. Gandhy SU, Imanirad P, Jin UH, NAIR V, Hedrick E, Cheng Y, Corton JC, Kim K, Safe S. Specificity protein (Sp) transcription factors and metformin regulate expression of the long non-coding RNA HULC. Oncotarget 2015 Sep 22;6(28):26359-72. https://www.oncotarget.com/article/4560/text/

7. Hedrick E, Lee SO, Doddapaneni R, Singh M, Safe S. NR4A1 Antagonists Inhibit β-1 Integrin-Dependent Breast Cancer Cell Migration. Mol Cell Biol. 2016 Apr 15;36(9):1383-94.

https://www.tandfonline.com/doi/full/10.1128/MCB.00912-15

8. Hedrick E, Cheng Y, Jin UH, Kim K, Safe S. Specificity Protein (Sp) Transcription Factors as Non-Oncogene Addiction Genes in Cancer Cells Oncotarget. 2016 Apr 19;7(16):22245-56.

https://www.oncotarget.com/article/7925/text/

9. Lacey A, Hedrick E, Li X, Patel K, Doddapaneni R, Singh M, Safe S. Nuclear receptor 4A1 (NR4A1) as a drug target for treating rhabdomyosarcoma (RMS). Oncotarget. 2016 May 24;7(21):31257-69.

https://www.oncotarget.com/article/9112/text/

10. Hedrick E, Li X, Safe S. Penfluridol Represses Integrin Expression in Breast Cancer through Induction of Reactive Oxygen Species and Downregulation of Sp Transcription Factors Mol Cancer Ther 2017 Jan;16(1):205-216. https://aacrjournals.org/mct/article/16/1/205/145994/Penfluridol-Represses-Integrin-Expression-in

11. Kasiappan R, Jutooru I, Karki K, Hedrick E, Safe S. Benzylisothiocyanate (BITC) Induces ROS-dependent Repression of STAT3 by Downregulation of Specificity Proteins in Pancreatic Cancer J Biol Chem 2016 Dec 30;291(53):27122-27133. https://www.jbc.org/article/S0021-9258(20)34385-4/fulltext

12. Hedrick E, Lee SO, Safe S. The Nuclear Receptor NR4A1 Regulates β1-Integrin Expression in Pancreatic and Colon Cancer Cells and Can Be Targeted by NR4A1 Antagonists” Mol Carcinog 2017 Sep;56(9):2066-2075. https://onlinelibrary.wiley.com/doi/10.1002/mc.22662

13. Karki K, Hedrick E, Kasiappan R, Jin UH, Safe S. Piperlongumine Induces Reactive Oxygen Species (ROS)- Dependent Downregulation of Specificity Protein Transcription Factors. Cancer Prev Res (Phila). 2017 Aug;10(8):467-477. doi: 10.1158/1940-6207.CAPR-17-0053. Epub 2017 Jul 3. https://aacrjournals.org/cancerpreventionresearch/article/10/8/467/46876/Piperlongumine-Induces-Reactive-OxygenSpecies-ROS

14. Hedrick E, Safe S. Transforming Growth Factor β/NR4A1 Inducible Breast Cancer Cell Migration and Epithelial to Mesenchymal Transition is p38α (MAPK14) Dependent. Mol Cell Biol. 2017 Mol Cell Biol. 2017 Aug 28;37(18). pii: e00306-17. https://www.tandfonline.com/doi/full/10.1128/MCB.00306-17

15. Cheng Y, Imanirad P, Jutooru I, Hedrick E, Jin UH, Rodrigues Hoffman A, Leal de Araujo J, Morpurgo B, Golovko A, Safe S. Role of metastasis-associated lung adenocarcinoma transcript-1 (MALAT-1) in pancreatic cancer. PLoS One. 2018 Feb 1;13(2):e0192264. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0192264

16. Safe S, Abbruzzese JL, Abdelrahim M, Hedrick E. Specificity Protein Transcription Factors and Cancer: Opportunities for Drug Development. Cancer Prev Res (Phila). 2018 Mar 15. pii: canprevres.0407.2017. https://aacrjournals.org/cancerpreventionresearch/article/11/7/371/47160/Specificity-Protein-Transcription-Factors-and

17. Hedrick E, Mohankumar K, Safe S. TGFβ-induced Lung Cancer Cell Migration is NR4A1-dependent. Mol Cancer Res. 2018 Aug 2. pii: molcanres.0366.2018. doi: 10.1158/1541-7786.MCR-18-0366. https://aacrjournals.org/mcr/article/16/12/1991/89817/TGF-Induced-Lung-Cancer-Cell-Migration-Is-NR4A1

18. Lacey A, Hedrick E, Cheng Y, Mohankumar K, Warren M, Safe S. Interleukin-24 (IL-24) Is Suppressed By PAX3- FOXO1 and Is A Novel Therapy For Rhabdomyosarcoma. Mol Cancer Ther. 2018 Sep 6. doi: 10.1158/1535- 7163.MCT-18-0118. https://aacrjournals.org/mct/article/17/12/2756/273075/Interleukin-24-IL24-Is-Suppressed-by-PAX3-FOXO1

19. Hedrick E, Li X, Cheng Y, Lacey A, Mohankumar K, Zarei M, Safe S. Potent inhibition of breast cancer by bisindole-derived nuclear receptor 4A1 (NR4A1) antagonists. Breast Cancer Res Treat. 2019 May 22. doi: 10.1007/s10549-019-05279-9. https://link.springer.com/article/10.1007/s10549-019-05279-9

20. Hedrick E, Mohankumar K, Lacey A, Safe S. Inhibition of NR4A1 Promotes Ros Accumulation and IL24- Dependent Growth Arrest in Rhabdomyosarcoma. Mol Cancer Res. 2019 Aug 28. doi: 10.1158/1541-7786.MCR-19- 0408. https://aacrjournals.org/mcr/article/17/11/2221/89942/Inhibition-of-NR4A1-Promotes-ROS-Accumulation-and

21. Safe S, Shrestha R, Mohankumar K, Howard M, Hedrick E, Abdelrahim M. Transcription factors specificity protein and nuclear receptor 4A1 in pancreatic cancer.World J Gastroenterol. 2021 Oct 14. doi: 10.3748/wjg.v27.i38.6387. https://www.wjgnet.com/1007-9327/full/v27/i38/6387.htm

22. Hedrick E. From Lab Bench to Consumer: The Regulatory and Safety Challenges of Cultivated Meat. Food Safety Magazine. https://www.food-safety.com/articles/8660-from-lab-bench-to-consumer-the-regulatory-and-safety-challenges-ofcultivated-meat.

PRESENTATIONS / CONFERENCES:

• Erik Hedrick, Agarwal E, Leiphrakpam PD, Haferbier KL, Brattain MG, Chowdhury S. “Differential PKA activation and AKAP association determines cell fate in cancer cells.” (UNMC Omaha NE)

• Erik Hedrick, Un-Ho Jin, Stephen Safe and Syng-Ook Lee “NR4A1 Antagonists inhibit Cancer Cell Growth, Survival and Invasion” (CVM Graduate/Postdoctoral Research Symposium College Station TX January 2014)

• Erik Hedrick, Un-Ho Jin, Stephen Safe and Syng-Ook Lee “NR4A1 Antagonists Inhibit Cancer Cell Growth, Survival and Invasion” SOT conference March 2014 (Phoenix AZ)

• Erik Hedrick, Lisa Crose, Corinne Linardic, Stephen Safe “Histone Deacetylase Inhibitors Inhibit Rhabdomyosarcoma by Reactive Oxygen Species-Dependent Targeting of Specificity Protein Transcription Factors”(CVM Graduate/Postdoctoral Research Symposium, College Station TX January 2015)

• Erik Hedrick, Syng-Ook Lee2, Jagun M. Somagoni3, Mandip Sachdeva Singh3 and Stephen Safe “Nuclear Receptor 4A1 (NR4A1) as a Drug Target for Breast Cancer Chemotherapy” (SOT Conference, San Diego CA March 2015)

• Erik Hedrick, Syng-Ook Lee, Gyungeun Kim, Un-Ho Jin, Stephen Safe, and Ala Abudayyeh “Nuclear receptor 4A1(NR4A1) as a Drug Target for Renal Cell Adenocarcinoma” (SOT Conference, San Diego CA March 2015)

• Erik Hedrick, Yating Cheng, Un-Ho Jin, Kyounghyun Kim, Stephen Safe “Specificity Protein (Sp) Transcription Factors as Non-oncogene Addiction Genes in Cancer Cells” (CVM Graduate/Postdoctoral Research Symposium, College Station TX, January 2016)

• Erik Hedrick, Yating Cheng, Un-Ho Jin, Kyounghyun Kim, Stephen Safe “Specificity Protein (Sp) Transcription Factors as Non-oncogene Addiction Genes in Cancer Cells” (SOT conference, New Orleans LA March 2016)

• Erik Hedrick, Lisa Crose, Corinne Linardic, Stephen Safe “Histone Deacetylase Inhibitors Inhibit Rhabdomyosarcoma by Reactive Oxygen Species-Dependent Targeting of Specificity Protein Transcription Factors” ( FASEB conference; KLF/Sp transcription factors in Disease and Regenerative Medicine, Snowmass CO, August 2016)

• Erik Hedrick, Stephen Safe “TGFβ/NR4A1 Inducible Breast Cancer Cell Migration and Epithelial to Mesenchymal Transition is p38α (MAPK14) Dependent” (Imaging Sciences Spotlight Series, College Station TX October 2016)

• Erik Hedrick, Stephen Safe “TGF /NR4A1 Inducible Breast Cancer Cell Migration and Epithelial to Mesenchymal Transition is p38α (MAPK14) Dependent” (Toxicology Forum, College Station TX December 2016)

• Erik Hedrick, Stephen Safe “TGF /NR4A1 Inducible Breast Cancer Cell Migration and Epithelial to Mesenchymal Transition is p38α (MAPK14) Dependent” (Imaging Sciences Spotlight Series, CVM Graduate/Postdoctoral Research Symposium, College Station TX January 2017)

• TGFβ/NR4A1 Inducible Breast Cancer Cell Migration and Epithelial to Mesenchymal Transition is p38α (MAPK14) Dependent (SOT conference, Baltimore MD March 2017)

• Erik Hedrick, “DIINDOLYLMETHANE ANALOGS AS NOVEL NR4A1 ANTAGONISTS AND AS A NOVEL CLASS OF ANTICANCER AGENTS AND SP TRANSCRIPTION FACTORS AS NONONCOGENE ADDICTION GENES THAT ARE TARGETS OF ROS INDUCING AGENTS” (Cleveland Clinic Lerner Research Institute seminar, May 2017)

• Erik Hedrick “mTORC1 activation by androgens as a metabolic phenotype of advanced androgen receptor (AR)- independent prostate cancer” (Cleveland Clinic Lerner Research Institute seminar, July 24th, 2018)

• Erik Hedrick “Androgen-Dependent mTORC1 Activation in Advanced Androgen Receptor (AR)-Independent Prostate Cancer” (Cleveland Clinic Lerner Research Institute seminar, February 26th, 2020)

• Erik Hedrick “THE 50 SHADES OF CANNABIS: the gray pathway to regulatory compliance for non-THC/CBD cannabinoids” (Burdock Group Webinar, July 27th, 2022)

• Erik Hedrick “ASK THE EXPERT, Alternative Protein Sources- EU & US Regulatory Perspectives” (Burdock Group Webinar, Nov 16th, 2022)

• FDLI’s Food and Dietary Supplement Safety and Regulation Conference. March 23-24th, 2023

• IFT FIRST Annual Event and Expo. Burdock Group Booth. July 16th -19th, 2023

• Erik Hedrick "Regulatory and Safety Considerations for Algal-based Food Ingredients and Dietary Supplements" (Algae Production, Products and Equipment Webinar, September 20th, 2023)

• Eurofins BioPharma Product Testing. Information requirements for biocidal product authorization. October 25th, 2023

• RIFM’s 2nd Annual Science Symposium. November 29th, 2023