About

Mr. Elam is a native of Silicon Valley who has been managing and advising healthcare and technology companies in the US and Europe for more than 30 years.

Prior to founding Rezolute, Mr. Elam served in various senior leadership roles at different organizations including as Head of the Pulmonary Business Unit at Nektar Therapeutics (NASDAQ: NKTR). During his tenure at Nektar, he was instrumental in streamlining the organization and reshaping its pipeline. Prior to negotiating the sale of his division to Novartis, Mr. Elam spun two entities out of Nektar, including Pearl Therapeutics which was acquired in 2013 by AstraZeneca, for $1 billion.

Earlier in his career, Mr. Elam was CFO and co-founder of a web-based IT platform company serving the electronics and healthcare industries where, in addition to managing finance and business development, he established operations in the US as well as throughout Asia.

In the 1990s, Mr. Elam was a corporate partner at the law firm of Wilson Sonsini Goodrich & Rosati, where he advised domestic and ex-US healthcare and technology companies on various matters from debt and equity financings to licensing and cross-border transactions. His clients included emerging growth companies as well as mature corporations such as Genentech and Hewlett Packard. Notably, he represented Steve Jobs’ company, Next and negotiated the sale of Next to Apple in 1997.

Throughout his career, Mr. Elam has served on the board of directors of different healthcare companies and he currently serves on the board of Savara, Inc. (NASDAQ:SVRA) in Austin Texas, Peak Bio in Palo Alto California, and on the board of Rezolute.

Mr. Elam received his B.A. from Howard University and his J.D. from Harvard Law School.

Prior to joining Rezolute, Dr. Roberts directed clinical development at Fibrogen, Inc., where he helped successfully launch and execute the global Phase 3 program and pharmaceutical partnership for a novel oral therapy for anemia associated with kidney disease, concluding the largest Phase 3 program ever conducted in CKD anemia, and resulting in global NDA filings. During Dr. Roberts’ tenure, Fibrogen achieved the largest biotech IPO in the previous 10 years.

From 2007 until 2012 Dr. Roberts held clinical development positions of increasing responsibility at Metabolex, Inc., where he developed novel therapies for metabolic diseases such as diabetes, dyslipidemia, NASH, and gout. His program and clinical leadership from IND through clinical proof-of-concept helped secure a global licensing and co-development agreement with a major pharmaceutical partner for a novel diabetes therapy. He is an inventor or author on more than 20 patents and publications in the fields of Endocrinology and Metabolism. Dr. Roberts received his B.S. in biochemistry from the University of California, San Diego and his M.D. Magna Cum Laude from Georgetown University. He completed a residency in Internal Medicine and a fellowship in Endocrinology at Stanford University, where he also now serves as an Adjunct Associate Professor in the Division of Endocrinology.

Susan Stewart, JD has 30 years of experience in biopharmaceutical regulatory affairs and quality assurance, overseeing and developing innovative regulatory strategies and leading interactions with global health authorities. In addition to being an independent regulatory consultant for several years, she serves as chief regulatory officer for Frequency Therapeutics and Candel Therapeutics where she also oversees regulatory and quality functions, and previously was CRO at Kaleido Biosciences where she also senior vice president of regulatory and quality.  Prior to that, she served as senior vice president of regulatory affairs, quality and compliance at Tokai Pharmaceuticals and vice president, regulatory affairs at Transmolecular Therapeutics. She also spent 13 years at Genzyme Corporation (Sanofi) in regulatory and compliance roles, including serving as vice president, regulatory affairs, after beginning her career with Abbott Laboratories in regulatory and quality positions.  

Susan received her J.D. from Concord Law School at Purdue University Global, her LL.M from the Maurice A. Deane School of Law, Hofstra University, and her B.A. from the University of Massachusetts.  Sue is a Fellow of the Regulatory Affairs Professionals Society and holds both US and EU RAC certifications.

Dr. Hood, a long-standing member of the patient advocacy group Congenital Hyperinsulinism International, joins the Rezolute team as Director & Head of Scientific and Patient Affairs. She has served in various scientific and leadership capacities such as the President of the Board of Directors and Principal Investigator for the HI Global Registry. Dr. Hood’s breadth and depth of experience within the HI community will be of tremendous value in the execution of the RZ358 development program, and guide us in a direction that captures the needs of the patients and fosters collaborative relationships within the scientific community.

Dr. Hood received her undergraduate degree from Texas A&M University and MD from University of Texas-Houston Medical School. She later earned an MBA from Walden University. 

Erin O’Boyle joined Rezolute with nearly 20 years of operational and management experience across all phases of development covering several therapeutic areas, including oncology, anemia, idiopathic pulmonary fibrosis, and rare disease indications. Prior to joining Rezolute, Erin worked at Fibrogen where she led all clinical outsourcing and governance activities from 2013 to 2018. She successfully contracted and managed all vendors for each clinical department which supported their various programs. These programs ranged from the largest Phase 3 global anemia program ever conducted resulting in NDA filings to a small Phase 2 rare orphan pediatric study in Duchene Muscular Dystrophy.

Before transitioning to a clinical lead in both contracting and governance, Erin was the Head of Clinical Operations at Heron Therapeutics from 2005 to 2013. During her time at Heron Therapeutics, she successfully led a clinical program from Phase 1 up through NDA approval of SUSTOL® (granisetron), an extended-release injection, for subcutaneous use for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy. To date, this is the largest CINV program ever conducted.

Erin obtained a Bachelor’s degree in Biology from Stonehill College.

Dr. Agrawal is an Ophthalmologist and a Retina Specialist. Before he joined Rezolute, he was Senior Vice-President and Ophthalmology Lead at Coherus Biosciences where he led the development of two biosimilars in Ophthalmology. The program included planning global clinical trials as well as in discussions with multiple regulatory agencies. He was also involved in an in-licensing deal for one of the biosimilars from Europe for the North American market.

Before Coherus, Dr. Agrawal worked at Santen Inc. where he led the Retina program for the global company. During his tenure, he was involved in clinical development programs for in-house assets as well as for in-licensing of retina, glaucoma and cornea assets, as well as programs focused on artificial intelligence. He also worked closely with the business development group as well as venture capital arm of the company in due diligence for investment and other deals, including in acquisition of InnFocus Inc. for US$250m, as well as investment in Regenerative Patch Therapeutics for US$6m.

Dr. Agrawal was a full-time clinical ophthalmologist and retinal surgeon at the Keck School of Medicine, University of Southern California, as well as at the Doheny Eye Institute and the Los Angeles County Hospital. He was also the Co-Director of the Intraocular Device program at the Doheny Eye Institute. During his time at USC, he co-invented and co-developed ARGUS-II, the world’s first artificial bionic eye that allows patients blind due to certain ocular conditions, to regain vision, which is approved in many countries around the world. Dr. Agrawal hold multiple patents including for artificial vision and drug delivery devices.

Dr. Agrawal has published in many peer-reviewed journals, is a reviewer for multiple ophthalmology journals, and has been invited to speak at international meetings by his peers around the world. Dr. Agrawal is also the Founder, President and CEO of an international nonprofit, Retina Global, which provides clinical care to underserved patients and training to ophthalmologists around the world. Dr. Agrawal completed his medical schooling in India, followed by Ophthalmology residency and retina fellowship. He worked as a retina surgeon in India, Hong Kong and the Bahamas before joining USC in Los Angeles.

Prior to joining Rezolute in 2016, Mr. Deperro spent the past two decades in technical operations leadership roles within large pharma, biotech, generics and in a contract development and manufacturing capacity.

A former US Army Officer, Mike’s early career focused on the implementation of manufacturing and research infrastructure in the US and Ireland for companies including Schering Plough, Merck and Novartis. Transitioning from pharmaceutical engineering to operations management, he directed the startup of a generic parenterals business unit, focusing on plant establishment, product development and support of product launch for global markets. As Director of Manufacturing at Alkermes, Mike’s manufacturing operation supported global sales of Risperdal® Consta®, the launch of Vivitrol® and delivery of Phase 3 supplies for Bydureon®, all commercialized controlled release formulations utilizing injectable microsphere technologies. These commercial manufacturing operations encompassed polymerization, bulk sterile microsphere manufacture, and aseptic fill finish for US and ROW markets.

Most recently, as General Manager for GMP Operations at Bend Research, and Vice President of Operations for Agere Pharmaceuticals, Mr. Deperro led specialized teams charged with the delivery of early phase clinical supplies for complex, poorly soluble molecules in fast-paced multi-client environments. His passion for leadership, integration of complex technologies and a strong belief in positive patient outcomes provide a strong foundation for the development of sustainable operations at Rezolute.

Mr. Deperro received his B.S. in Mechanical Engineering from the University of Notre Dame.

Mr. Covarrubias joins Rezolute with over 30 years of biopharmaceutical development, manufacturing and CMC project management experience. His work ranges from early stage through commercial product development, approval/launch and lifecycle management. He has worked at leading pharmaceutical companies on products that span a range of pediatric, rare disease, autoimmune and oncology indications. He brings specific experience with late-stage product development, product and process characterization, validation and global marketing authorization submissions and health authority engagement.

Mike received his B.A. in Biochemistry from Whittier College and his M.S. in Biochemistry and Molecular Biology from Indiana University, Bloomington.

Mr. Roeseler joins Rezolute with over 20 years of commercial leadership experience in the pharmaceutical and biotechnology industry including building commercial teams in support of rare disease launches, product and lifecycle management, brand strategy and payer marketing. 

Prior to joining Rezolute, Jeff was the founder of Biocentric, LLC, where he provided strategic advice to clinical stage rare disease companies as they advanced their portfolios towards commercialization. Earlier in his career Jeff was the head of global marketing at Insmed where he led the development and global commercialization of a novel first-in-class therapy for a rare, life- threatening respiratory disease. From 2001- 2013 Jeff held various management roles of increasing responsibility across the commercial organization of Shire. During his tenure, he supported the launch of multiple blockbuster medicines and the integration of the Advanced Bio Healing acquisition. 

Jeff received his B. A. and M.B.A from Regis University in Denver, CO.

Robyn Sweinhart joins Rezolute with over 30 years of diverse global pharmaceutical and management experiences. She has worked at leading pharmaceutical companies over a multitude of dosage forms, at all stages of the product lifecycle, supporting several therapeutic areas from treating mental illness, addiction, diabetes, sepsis, and women’s health, as well as experience in vaccine development.

Robyn brings specific experience in establishing quality management systems and defending compliance in diverse situations including dozens of pre-approval inspections, general inspections and consent decree remediation that has demonstrated an established track record of success in working with global regulatory authorities.

Robyn obtained a Bachelor’s degree in Biology from the University of North Carolina.

Mr. Milks joins Rezolute with over 18 years of biotech industry experience in finance and operations. Prior to joining Rezolute, Chris led the Clinical Finance group at FibroGen where he also oversaw the Clinical Outsourcing group. Earlier in his career, Chris held positions of increasing responsibility at Gilead Sciences, mostly on the Financial, Planning and Analysis team. In that role, he supported all functions, from a finance perspective, including G&A, Sales and Marketing and Research and Development. Additionally, he managed operations for the Access and Emerging Markets team working with partners internationally to increase access to its medicines in low and middle-income countries. Chris started his career at PriceWaterhouseCoopers while working toward his CPA.

Chris received his B.S. in Accounting from Santa Clara University and his M.B.A. from Haas School of Business at the University of California, Berkeley.

Dr. Breit has worked in early-stage and clinical drug development for over 15 years.  Prior to joining Rezolute, Dr. Breit directed numerous small and large molecule preclinical development programs for the oral, inhalation and parenteral delivery of anti-cancer compounds, drugs for the treatment of inflammatory disorders as well as vaccines.  At Bend Research/Lonza Dr. Breit worked with preclinical R&D and clinical stage CMC teams at large and small pharmaceutical and biotechnology companies, advancing compounds from early preclinical development into clinical evaluation.  Challenging drug development problem statements such as early-stage compound characterization and the creation of new technologies were hallmarks of his time at Bend Research. Activities included the creation of novel drug delivery platforms (nanotechnology, polymer conjugates), spray dried engineered particles as well as the development of machine learning tools to optimize antibody manufacturing. 

Subsequent to working at Bend Research/Lonza, Dr. Breit worked as a consultant with various biotechnology companies in preclinical and clinical development, including Rezolute.  Since joining Rezolute in 2018, Dr. Breit has focused on enabling late-stage development activities for RZ358 and RZ402; he has also led efforts focused on early-stage drug creation and development.    

Dr. Breit has received industry recognition through invited lectures, publications and patents.  He received his Bachelor of Science degree from UC Santa Barbara and his Ph.D. from the College of Medicine at the University of South Alabama, his NIH funded postdoctoral fellowship was conducted while at Roche Palo Alto.  While at Roche his research focused on understanding genomic polymorphisms’ roles in complex disease states such as cancer, diabetes and obesity.