CARL KEITH EDWARDS, III, PHD

(m)760-***-**** (h)951-***-**** ad2u84@r.postjobfree.com Temecula, CA 92592 linkedin.com/in/drcarlkedwardsiii Biopharmaceutical Leader Drug Discovery, Development, Preclinical, Clinical FDA Regulatory Global Leadership & Mgmt. Pioneers new Biopharmaceutical/Pharmaceutical innovations and technologies by scientific management/administrative leadership over global drug discovery, preclinical, and clinical development teams. Establishes inflammation, autoimmunity, autoinflammation, and oncology franchises by leading end-to-end drug discovery, development, IND, BLA/NDA commercialization. Product Launch & Commercialization

Preclinical, Translational Immunology

IND Filing, FDA negotiation, FIM, BLA

Biopharma Product/Program Mgmt.

Phase 1, 2, 3 Clinical Development

$MM+ Budget Optimization & Cost Control

Worldwide Regulatory Compliance

C-Suite Management and Mentoring

Innovative Product Design & Testing

Innovative Half-Life Extension Tech

Small Molecule and Protein-based Drugs

Scientific Writing and Communication

PROFESSIONAL EXPERIENCE

Sr. Principal Consultant, Board Member, DNX Biopharmaceuticals/Propelle Therapeutics, Inc., San Diego, CA, Philadelphia, PA USA 10/2023 – Present; Previously: Co-Founder, Chief Scientific Officer (CSO), Chief Development Officer (CDO) 7/2017 – 1/2022 Direct R&D operations, including early drug discovery, active molecule identification, preclinical development, IND submission, and phase I and II clinical trial designs. Onboard and fostered relationships with XL-protein, a PASylation company, by sourcing startups with novel half-life extension technologies. Have led the successful development of DNX-314, a PASylated IL-1 inhibitor, to alleviate inflammation in breast, lung, and skin cancer and systemic autoinflammatory diseases (SAIDs). Supervised 20+ on- and offshore employees (Shanghai JLABS, 2019 through 2022). Johnson and Johnson licensed DNX-314 for NSCLC (February 2022).

• Won J&J’s Lung Cancer QuickFire Innovation Award (2019) by formulating a grant, procuring a $1M+ investment, and a residency at the JLABS Shanghai facility. Oversaw R&D studies by supervising three personnel. Mediated license agreement for DNX-314.

• Secured $MM buy-in by writing and planning DOD research program grants as a PI; attracted venture capitalists and investors at conferences. Mitigated burn rate and negotiated cost-effective CRO contracts while optimizing a $15M budget.

• Spearheaded studies entailing preclinical testing, animal modeling, in vitro trials, and organoid research. Initiated research on rare and orphan diseases, such as acute and chronic inflammatory disorders, by enlisting academic clinicians.

• Facilitated drug discovery success by leading in vivo studies with high druggability and no adverse events. Established operational governance and submitted patents for drugs that mitigate breast, lung, and skin cancer.

• Instituted and governed the scientific advisory board by nurturing KOL partnerships; held quarterly meetings on business metrics. Cultivated collaborations with multiple investigators from UCSD and CU Anschutz.

• Presently furthering in-house development of a half-life extension technology for novel molecules by launching Propelle Therapeutics. Surveyed subject-matter expert companies and submitted a patent. Strong R&D focus with NCI (Bethesda, MD)

• Administered preclinical development by leveraging a ready-made mid-stage research compound; evaluated half-life and analytical and biochemical indications.

Executive Director & Global Head, Immune-Mediated Inflammatory Diseases (IMID), Crown Bioscience, San Diego, CA 01/22-10/23 Global Head of the IMID Franchise, responsible for strategic direction, budgeting, resource planning, and worldwide operational activities. Primary responsibilities: develop and deliver global strategy in Inflammation and Immunology, work with senior executives across all Crown Bioscience sites, partner with business development and marketing, manage global Inflammation and Immunology daily operations, provide external consulting services, and oversee Study Director execution of innovative rodent disease models to a worldwide clientele. As the recognized Crown Bioscience IMID Leader, I proposed and managed IMID R&D for new products to support business growth in five major areas of acute, chronic, and autoimmune disease areas: (1) Gastrointestinal, (2) Metabolic, (3) Bone, Skin and Joint, (4) Pulmonary, and (5) Transplantation (GvHD). Global IMID collaborated actively with clients to create IND-ready data for FDA and EMA Regulatory submissions. Responsible for San Diego, Taicang, Singapore, Leiden, and UK IMID divisions.

• Responsible for IMID’s global focus to offer advanced solutions for treating acute and chronic inflammatory human diseases.

• Coordinated Global R&D efforts for IMID’s product portfolios using in vitro, ex vivo, and in vivo IND submissions in the U.S. (San Diego), Shanghai, PRC, Singapore, U.K., Leiden, The Netherlands, and Lausanne, Switzerland.

• Responsible for coordinating Study Director activities, which include target validation, preclinical proof of concept (POC), mechanism of action (MOA), Standard of Care (SOC) validation, clinical trial design, regulatory agency consultation, and biomarker discovery for clients. In addition, we routinely implemented scientific technologies to design and construct humanized IMID rodent models (HuGEMM) for Gut, Lung, Skin, Bone, Joint, and Metabolic (Liver) Inflammation and Autoimmune Diseases. Head & Vice President of Preclinical Research & Development, Amicrobe, Inc. 05/14 – 06/17 Orchestrated and designed the end-to-end preclinical development program, including phase I and II clinical trials and IND submissions. Superintended development of A-blocks-based hydrogel solutions utilizing antimicrobial properties in leucine and lysine compounds. Drove strategic stakeholder communications with KOLs, CROs, and the FDA.

• Generated $10M in investments by assessing and prospecting various grant funding programs. Prepared extensive grants for governmental agencies, such as NIH, DOD, CDC, SBIR, DARPA, and BARDA. Acted as PI on 3 DOD phase II proposals.

• Forwarded approval of an etanercept drug and supported the GLP Toxicology program. Regulated animal modeling, including in vivo, in vitro, half-life, and pharmacokinetic studies. Implemented clinical trial protocols in collaboration with clinicians.

• Discerned disease indications in animal models by interfacing with FDA CBER and CDER scientists. Devised regulatory paperwork, such as pre-IND briefing documents. Presented IND submissions to the FDA as the spokesperson.

• Built and supervised a virtual team by contracting 5-6 CROs personnel. Conducted market research, performed cost negotiations, and coordinated staff workflows.

Vice President, Principal Consultant, Hinova Pharmaceuticals, Inc. (Sabbatical from CU Anschutz) Chengdu, China 01/12 – 06/17 Achieved stringent budget and timeline requirements while furthering prostate cancer, multiple sclerosis, rheumatoid arthritis, and schizophrenia programs. Promoted small molecule R&D as a consultant by advising on IND application regulations in the US. Oversaw animal studies and formulated IND submissions and regulatory documentation to the Chinese FDA. Professor of Medicine & Division Head of Immunology (Sabbatical from CU Anschutz), Sichuan University, China 09/12 – 09/14 Directed multiple research studies, implemented a drug discovery program, and consulted several biopharmaceutical startups across China. In addition, taught a graduate-level immunology course (two semesters) with laboratory and administered projects, theses, and dissertations for 5 Ph.D. and 4 MS students. Led all inflammation and immunology drug discovery, regulatory, process development (CMC), and clinical efforts for the National Key Laboratory of Biotherapy and Cancer Research. Professor of Medicine, University of Colorado Denver Anschutz Medical Campus 01/05 – Present Built and inaugurated the Department of Dermatology’s Cutaneous Inflammation Research Laboratory from the ground up. Launched Bard Center for Entrepreneurship as a founding faculty member.

• Raised ~$3.5M in funding from NIH, National Psoriasis Foundation, and National Alopecia Areata Foundation.

• Enabled the department to grow strong industry collaborations as a faculty board member. Publicized in-house research and secured licensing opportunities by networking with different biopharmaceutical companies. Defined confidentiality protocols.

• Introduced human immunology studies within the lab and a research program comprising patents and publications by guiding six personnel. Edited and reviewed scientific papers for six different high-impact journals. Graduate School Faculty appointment.

• Elected as a full research member at the American Association of Immunologists, American College of Rheumatology, and Society for Investigative Dermatology.

• Actively maintained Visiting Faculty appointments in the Department of Medicine, Division of Infectious Diseases Chief Scientific Officer, Western States Biopharmaceuticals 06/08 – 09/13 Previously: Vice President, Cofounder, & General Manager. Established a new organization to forward novel molecule development for chronic inflammatory diseases. Filed five patents and won

~2.5M in funding from US and Chinese angel investors. Licensed technology to an offshore company. Carl Keith Edwards, III, Ph.D. 01/2024 Page 02 951-***-**** ad2u84@r.postjobfree.com linkedin.com/in/drcarlkedwardsiii

• Partnered with CU School of Medicine lab members to discover highly novel drug targets: T cell-inducing surface molecules

(TCISMs). Facilitated expansion of a 25-member global R&D team. Composition of matter patent issued (EP 2 393 514 B1 2017) Director of Autoimmune Diseases Research & Development, Inflammation Research, Amgen 11/94 – 01/06 Previously, I was a clinical research project leader (CRPT), principal research fellow, and executive consultant. Spearheaded the organization-wide global soluble TNFα receptor program (PEGsunercept) as well as the Kineret (recombinant methionine Interleukin-1 Receptor Antagonist [rmetIL-1ra], Anakinra) FDA approval (Lead BLA Team Immunopharmacologist). Managed external Amgen Grants and Material Transfer Agreements (MTA’s) for inflammation compound portfolio; implemented research and clinical advisory boards. Superintended $25-75M budgets and managed a 40-150-member team at multiple global sites.

• Boosted staff performance by performing oversight, conducting bi-monthly meetings, and setting and reviewing KPIs.

• Advanced PEGsunercept™ (PEGylated sTNFRI) from early drug discovery to Phase 2C trials.

• Oversaw early drug discovery effort identifying Prolia® (Denosumab, anti-RANK Ligand) in Inflammation Research. Senior Immunologist & TNFα Inhibitors Project Team Lead, Marion Merrell Dow, Inc. (Aventis-Sanofi) 08/91 – 11/94 Launched a research project on anti-inflammatory molecules and identified an orally active small-molecule drug for various chronic inflammatory diseases. Advanced the IND submission and phase I safety study of first-in-human (FIH) clinical development. EDUCATION & PROFESSIONAL DEVELOPMENT

Post-Doctoral Fellowship, Indiana University School of Medicine Doctor of Philosophy in Immunology & Veterinary Pathobiology, University of Illinois Urbana-Champaign Master of Arts in Immunology, University of Colorado Boulder Bachelor of Science in Microbiology, Colorado State University Training & Certifications: Leadership & Strategy in Pharmaceuticals & Biotech Program, Harvard Business School; Developing the Strategic Leader, Center for Creative Leadership; Executive Advanced Seminar in Communication Skills, The Buckley School of Public Speaking; Introductory & Management Courses, Dale Carnegie Training; Seven Habits of Highly Effective People, Franklin Covey. PATENTS & PUBLICATIONS

Patents: 55 US and international patents either issued or filed as of 12.01.2021. First Authorship Publications (selected from 125+ peer-reviewed publications):

• Edwards 3rd, C. K., Green, J. S., Volk, H-D., Schiff, M., Kotzin, B. L., Mitsuya, H., Kawaguchi, T., Sakata, K-M., Cheronis, J., Trollinger, D., Bankaitis-Davis, D., Dinarello, C. A., Norris, D. A., Bevilacqua, M. P., Fujita, M., Burmester, G-R. (2012). Combined anti-tumor necrosis factor-α therapy and DMARD therapy in rheumatoid arthritis patients reduce inflammatory gene expression in whole blood compared to DMARD therapy alone. Frontiers in Immunology, 3:366. PMID: 23264777.

• Edwards 3rd, C. K., Pedler, M., Yang, D. F., Fitzpatrick, J. E., Fujita, M., Jonscher, K., Norris, D. A. (2012). Recent observations on the heterogeneity of human effector memory T cells and novel cytokines implicated in cutaneous inflammation and psoriasis. Psoriasis Forum, Fall Quarter, 126-42.

• Edwards 3rd, C. K., Bendele, A. M., Reznikov, L. I., Fantuzzi, G., Chlipala, E. S., Li, L., Moldawer, L. L., Mountz, J. D., Li, Y-Y. Y., Dinarello, C. A. (2006). Soluble human p55 and p75 tumor necrosis factor receptors reverse spontaneous arthritis in transgenic mice expressing transmembrane tumor necrosis factor-alpha. Arthritis & Rheumatology, 54:2872-85. PMID: 16947419.

• Edwards 3rd, C. K., Martin, S. W., Seely, J., Kinstler, O., Buckel, S., Bendele, A. M., Feige, U., Kohno, T. (2003). Design of PEGylated soluble tumor necrosis factor receptor type I (PEG sTNF-RI) for chronic inflammatory diseases. Advanced Drug Delivery Reviews: Site-Specific PEGylation of Polypeptides, 55:1315-36. PMID: 14499710.

• Edwards 3rd, C. K. (1999). PEGylated recombinant human soluble tumor necrosis factor receptor type I (r-Hu-sTNF-RI): novel high- affinity TNF receptor designed for chronic inflammatory diseases. Annals of the Rheumatic Diseases, 58 Suppl 1:I73-81. PMID: 10577978.

Carl Keith Edwards, III, Ph.D. 11/2023 Page 03 951-***-**** ad2u84@r.postjobfree.com linkedin.com/in/drcarlkedwardsiii

• Edwards 3rd, C. K., Ghiasuddin, S. M., Schepper, J. M., Yunger, L. M., Kelley, K. W. (1988). A newly defined property of somatotropin: priming of macrophages for production of superoxide anion. Science, 239:769-71. PMID: 2829357. Peer-Reviewed Publications (selected from 125+ peer-reviewed publications):

• Powers, N. E., Swartz welter, B., Marchetti, C., de Graaf, D. M., Lerchner, A., Schlapschy, M., Datar, R., Binder, U., Edwards 3rd, C. K., Skerra, A., Dinarello, C. A. (2020). PASylation of IL-1 receptor antagonist (IL-1Ra) retains IL-1 blockade and extends its duration in mouse urate crystal-induced peritonitis. Journal of Biological Chemistry, 295:868-82. PMID: 31819009.

• Bevilacqua, M. P., Huang, D. J., Wall, B. D., Lane, S. J., Edwards 3rd, C. K., Hanson, J. A., Benitez, D., Solomkin, J. S., Deming, T. J.

(2017). Amino acid block copolymers with broad antimicrobial activity and barrier properties. Macromolecular Bioscience, 17. PMID: 28248002.

• Wang, S., Gao., X., Shen, G., Wang, W., Li, J., Zhao, J., Wei, Y-Q., Edwards 3rd, C. K. (2016). Interleukin-10 deficiency impairs regulatory T cell-derived neuropilin-1 functions and promotes Th1 and Th17 immunity. Scientific Reports, 6:24249. PMID: 27075020.

• Xiong, L., Edwards 3rd, C. K., Zhou, L. (2014). The biological function and clinical utilization of CD147 in human diseases: a review of the current scientific literature. International Journal of Molecular Sciences, 15:17411-41. PMID: 25268615.

• Mountz, J. D., Zhou, T., Long, R. E., Bluethmann, H., Koopman, W. J., Edwards 3rd, C. K. (1994). T cell influence on superantigen- induced arthritis in MRL-lpr/lpr mice. Arthritis & Rheumatology, 37:113-24. PMID: 7907476. Carl Keith Edwards, III, Ph.D. 11/2023 Page 04 951-***-**** ad2u84@r.postjobfree.com linkedin.com/in/drcarlkedwardsiii

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