NOW ENROLLING PHASE III sunRIZE TRIAL In the study of congenital hyperinsulinism

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Our Mission

Rezolute is a clinical stage biopharmaceutical company dedicated to developing transformative therapies for patients suffering from debilitating metabolic diseases.

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Leadership

nevan-charles

Nevan Charles Elam, JD

Chief Executive Officer & Founder

Mr. Elam is a native of Silicon Valley who has been managing and advising healthcare and technology companies 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 Aerogen in Galway Ireland and Pearl Therapeutics which was acquired 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.

Throughout his career, Mr. Elam has served on the board of directors of various healthcare companies in the US, Europe and Asia. He currently serves on the board of Savara, Inc. (NASDAQ:SVRA) in Austin Texas as well as on the board of Rezolute.

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

Brian-Roberts

Brian Roberts, MD

Chief Medical Officer

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

Susan Stewart, JD, LL.M

Chief Regulatory Officer

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.

daron-evans-final

Daron Evans, MS, MBA

Chief Financial Officer

Mr. Evans has over 15 years of experience leading public and private life science companies through financial operations, investor relations, and business development activities.

Prior to joining Rezolute, he served as Chief Executive Officer of AlloRock, Inc., a biotechnology company in the cardiometabolic disease space, as well as Chief Executive Officer of Specialty Renal Products, Inc., a medical device company in the dialysis space. Previously, Mr. Evans served as Chief Executive Officer of Nephros, Inc. (Nasdaq:NEPH), and Chief Financial Officer of Nile Therapeutics, Inc. (Nasdaq:NLTX). Since 2015, Mr. Evans has been Managing Director of PoC Capital, LLC, a fund focused on investing in public life science companies.

He holds a Bachelor of Science in Chemical Engineering from Rice University, a Master of Science in Biomedical Engineering from a joint program at the University of Texas at Arlington and Southwestern Medical School, and a Master of Business Administration from the Fuqua School of Business at Duke University.

davelyn-eaves-hood

Davelyn Eaves Hood, MD, MBA

Director & Head of Scientific and Patient Affairs

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

Erin O’Boyle

Senior Vice President & Head of Clinical Operations

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.

raj-agrawal

Raj Agrawal, MD

Vice President & Head of Ophthalmological Clinical Development

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.

michael-r-deperro

Michael R. Deperro

Senior Vice President & Head of Corporate Development

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.

michael-covarrubias

Michael Covarrubias

Senior Vice President & Head of Program & Portfolio Management

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.

gopal-saha

Gopal Saha, MBBS

Senior Vice President of Global Clinical Development

Dr. Gopal Saha has over 22 years of experience in drug development across a broad range of therapeutic areas such as endocrine, metabolic, nephrology, and oncology. Prior to joining Rezolute, Dr. Saha served as the Vice President of Clinical Development at Apollomics, Inc. and was responsible for proving clinical leadership for the global development of an oral treatment (cMET-inhibitor, TKI) for non-small cell lung cancers, glioblastoma, and other solid tumors due to a rare genetic mutation (cMET alteration). From 2013-2021, Dr. Saha played a key role at FibroGen, Inc. in the development and approval of Roxadustat (Evrenzo®, an oral HIF-PH inhibitor for treatment of renal anemia) in the EU, Japan, and China by providing clinical leadership in Phase 3 programs. Prior to FibroGen, Dr. Saha held a clinical development position at Metabolex, now Cymabay Therapeutics, from 2004 to 2013 where he developed treatments for diabetes, gout and other metabolic disorders. He holds several patents and authors more than 20 publications in the field of endocrine/metabolic, nephrology, hematology, and oncology. 

Dr. Saha earned his medical degree (MBBS) from Chittagong Medical College, Bangladesh in 1987 and he practiced medicine in South Africa before transitioning into drug development in the USA.

Jeff-Roeseler

Jeff Roeseler

Vice President of New Product Planning

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

Robyn Sweinhart

Vice President and Head of Quality

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.

chris-milks

Chris Milks

Vice President & Head of Finance

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.

Jeffrey Breit, PhD

Vice President, Drug Discovery and Pharmaceutical Sciences

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.

nevan-charles

Nevan Charles Elam, JD

Chief Executive Officer & Founder

Mr. Elam is a native of Silicon Valley who has been managing and advising healthcare and technology companies 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 Aerogen in Galway Ireland and Pearl Therapeutics which was acquired 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.

Throughout his career, Mr. Elam has served on the board of directors of various healthcare companies in the US, Europe and Asia. He currently serves on the board of Savara, Inc. (NASDAQ:SVRA) in Austin Texas as well as on the board of Rezolute.

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

Brian-Roberts

Brian Roberts, MD

Chief Medical Officer

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

Susan Stewart, JD, LL.M

Chief Regulatory Officer

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.

daron-evans-final

Daron Evans, MS, MBA

Chief Financial Officer

Mr. Evans has over 15 years of experience leading public and private life science companies through financial operations, investor relations, and business development activities.

Prior to joining Rezolute, he served as Chief Executive Officer of AlloRock, Inc., a biotechnology company in the cardiometabolic disease space, as well as Chief Executive Officer of Specialty Renal Products, Inc., a medical device company in the dialysis space. Previously, Mr. Evans served as Chief Executive Officer of Nephros, Inc. (Nasdaq:NEPH), and Chief Financial Officer of Nile Therapeutics, Inc. (Nasdaq:NLTX). Since 2015, Mr. Evans has been Managing Director of PoC Capital, LLC, a fund focused on investing in public life science companies.

He holds a Bachelor of Science in Chemical Engineering from Rice University, a Master of Science in Biomedical Engineering from a joint program at the University of Texas at Arlington and Southwestern Medical School, and a Master of Business Administration from the Fuqua School of Business at Duke University.

davelyn-eaves-hood

Davelyn Eaves Hood, MD, MBA

Director & Head of Scientific and Patient Affairs

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

Erin O’Boyle

Senior Vice President & Head of Clinical Operations

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.

raj-agrawal

Raj Agrawal, MD

Vice President & Head of Ophthalmological Clinical Development

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.

michael-r-deperro

Michael R. Deperro

Senior Vice President & Head of Corporate Development

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.

michael-covarrubias

Michael Covarrubias

Senior Vice President & Head of Program & Portfolio Management

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.

gopal-saha

Gopal Saha, MBBS

Senior Vice President of Global Clinical Development

Dr. Gopal Saha has over 22 years of experience in drug development across a broad range of therapeutic areas such as endocrine, metabolic, nephrology, and oncology. Prior to joining Rezolute, Dr. Saha served as the Vice President of Clinical Development at Apollomics, Inc. and was responsible for proving clinical leadership for the global development of an oral treatment (cMET-inhibitor, TKI) for non-small cell lung cancers, glioblastoma, and other solid tumors due to a rare genetic mutation (cMET alteration). From 2013-2021, Dr. Saha played a key role at FibroGen, Inc. in the development and approval of Roxadustat (Evrenzo®, an oral HIF-PH inhibitor for treatment of renal anemia) in the EU, Japan, and China by providing clinical leadership in Phase 3 programs. Prior to FibroGen, Dr. Saha held a clinical development position at Metabolex, now Cymabay Therapeutics, from 2004 to 2013 where he developed treatments for diabetes, gout and other metabolic disorders. He holds several patents and authors more than 20 publications in the field of endocrine/metabolic, nephrology, hematology, and oncology. 

Dr. Saha earned his medical degree (MBBS) from Chittagong Medical College, Bangladesh in 1987 and he practiced medicine in South Africa before transitioning into drug development in the USA.

Jeff-Roeseler

Jeff Roeseler

Vice President of New Product Planning

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

Robyn Sweinhart

Vice President and Head of Quality

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.

chris-milks

Chris Milks

Vice President & Head of Finance

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.

Jeffrey Breit, PhD

Vice President, Drug Discovery and Pharmaceutical Sciences

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.

Board of Directors

nevan-charles

Nevan Charles Elam, JD

Chief Executive Officer & Founder

Mr. Elam is a native of Silicon Valley who has been managing and advising healthcare and technology companies 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 Aerogen in Galway Ireland and Pearl Therapeutics which was acquired 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.

Throughout his career, Mr. Elam has served on the board of directors of various healthcare companies in the US, Europe and Asia. He currently serves on the board of Savara, Inc. (NASDAQ:SVRA) in Austin Texas as well as on the board of Rezolute.

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

nerissa-kreher

Dr. Kreher is a pediatric endocrinologist with more than 15 years of biotech industry experience in both Clinical Development and Medical Affairs. She has spent her career focused on drug development for patients with rare diseases in multiple therapeutic areas. Dr. Kreher is currently the Chief Medical Officer of Entrada Therapeutics where she is responsible for Clinical Development, Medical Affairs, Regulatory, and Patient Advocacy. Her prior roles include Chief Medical Officer at Tiburio Therapeutics and Avrobio. Earlier in her career, she held roles of increasing responsibility at companies including Zafgen, Enobia (acquired by Alexion) and Genzyme. Dr. Kreher completed her pediatric endocrinology fellowship and pediatric residency at Riley Hospital for Children in Indianapolis. She received her M.D. from East Carolina University School of Medicine and her B.S. in Biology from The University of North Carolina at Chapel Hill.

vlad-hogenhuis

Dr. Hogenhuis joined Rezolute as a board member in March 2021. He is currently the Chief Executive Officer of Chimera Bioengineering, where he also serves on the Board of Directors. He previously served as Chief Operating Officer of Ultragenyx with responsibilities for global commercial operations, business development, and manufacturing of medicines for patients with rare diseases. Before that, Dr. Hogenhuis served as Senior Vice President and Global Franchise Head, Specialty Pharmaceuticals of GlaxoSmithKline. Earlier in his career, he served in leadership positions at Merck in the US, China, and Europe, where he was responsible for managing the P&L of specialty and cardiovascular care medicines. He also served as a National Institutes of Health Fellow in Medical Decision Making at New England Medical Center in Boston, and as a Naval Lieutenant Surgeon in the Royal Dutch Navy. Dr. Hogenhuis currently serves on the board of GATT Technologies B.V., a private company in the Netherlands developing novel surgical hemostats and sealants. He previously served as a member of the Board of Directors of Vision 2020, a global initiative for the elimination of avoidable blindness, a joint program of the World Health Organization and the International Agency for the Prevention of Blindness. Dr. Hogenhuis received his M.D. Cum Laude from the University of Leiden in the Netherlands, and a M.B.A. from the Wharton School of Business at The University of Pennsylvania, Philadelphia.

gil-labrucherie

Mr. Labrucherie brings more than 20 years of senior leadership experience in finance, legal, and corporate development to the Board. Prior to serving as CFO of Nektar, he was Senior Vice President, General Counsel and Secretary of Nektar from 2007 to 2016. Earlier in his career, Mr. Labrucherie was an executive at different organizations where he was responsible for global corporate alliances and mergers and acquisitions. Mr. Labrucherie began his career as an associate in the corporate practice of the law firm of Wilson Sonsini Goodrich & Rosati. Mr. Labrucherie received his J.D. from UC Berkeley School of Law, where he was a member of the California Law Review and Order of the Coif, and received his B.A. from the University of California, Davis. Mr. Labrucherie is a member of the State Bar of California and is a Certified Management Accountant.

young-jin-kim

Mr. Kim is Chairman & CEO of Handok Inc., one of the leading pharmaceutical companies in the Republic of Korea. Mr. Kim also serves on the Board of Directors of Genexine Inc. 

Mr. Kim joined Handok Inc. in 1984 and spent two years between 1984 and 1986 working at Hoechst AG in Frankfurt, Germany. Between 1991 and 2005, he served as CEO of Roussel Korea, Hoechst Marion Roussel Korea, and Aventis Pharma Korea, and was also appointed as the Country Manager of Hoechst AG and Aventis in Korea between 1996 and 2005. In 1996, he was appointed as CEO of Handok. Mr. Kim has been serving as President of Handok Jeseok Foundation since 2014. He also has been serving as President of KDG (Korean-German Society) since 2010. Mr. Kim received an M.B.A. at the Kelley School of Business at Indiana University in 1984 and received the award of Distinguished Alumni Fellows from Indiana University. Mr. Kim completed the Advanced Management Program at the Harvard Business School in 1996.

philippe-fauchet

Mr. Fauchet has spent more than 35 years in the pharmaceutical industry, including most recently as the chairman of GlaxoSmithKline Japan where he joined as President & Representative Director in 2010. Previously, he served as Senior Vice President, Corporate Business Development, Head of Sanofi-Aventis Group and as a member of the Management Committee. Philippe is currently a director and senior advisor to several biotech companies, as well as a venture partner in an investment firm.

Scientific Advisors – RZ358

jerrold-olefsky

Dr. Olefsky is Distinguished Professor of Medicine at the University of California, San Diego (UCSD) Division of Endocrinology and Metabolism and the Associate Dean of Scientific Affairs for the UCSD School of Medicine.  He is also a member of the Institute of Medicine and the American Academy of Arts and Sciences. One of his seminal contributions to the field of Medicine has been the identification of the role of insulin resistance as a primary cause of Type II (non-insulin dependent, adult-onset) diabetes, polycystic ovarian syndrome, and other human diseases. His work has also helped develop insulin-sensitizing drugs that are now standard therapies for Type II diabetes. More recently, his lab has developed studies establishing the role of macrophage-mediated tissue inflammation as a key cause of obesity-related insulin resistance. He has conducted numerous studies to help define the basic genetic and cellular mechanisms underlying decreased insulin action in human pathophysiologic states.

adrian-vella

Dr. Vella is a Professor of Medicine in the Endocrinology Division at the Mayo Clinic College of Medicine. He is a leading expert in hypoglycemic disorders and was involved as an investigator in the early clinical trials of RZ358. Dr. Vella has published over 160 peer-reviewed articles related to endocrinology, metabolic disorders, and diabetes and currently serves as a member of the Clinical and Translational Science Awards Postdoctoral Programs Committee at the Mayo Clinic Graduate School of Biomedical Sciences and at the Mayo Clinic College of Medicine and Science. He was a Mayo Foundation Scholar and Visiting Research Fellow in the Diabetes & Inflammation Laboratory at the Cambridge Institute of Medical Research in Cambridge, UK. Dr. Vella completed his Endocrinology fellowship at the Clinician-Investigator Training Program at the Mayo School of Graduate Medical Education and his Internal Medicine residency at the Mayo Clinic in Rochester. He received his M.D. from the University of Malta.

Scientific Advisors – RZ402

robert-b-bhisitkul

Dr. Bhisitkul is a Professor of Clinical Ophthalmology and retinal specialist at the University of California, San Francisco School of Medicine’s Department of Ophthalmology. In his 20 years of experience as a retinal surgeon and clinical scientist, Dr. Bhisitkul has been an investigator in 15 randomized clinical trials of novel therapies for retinal diseases, including anti-VEGF therapies for DME, and served as Clinical Trial Director for the SEVEN-UP Study, the first longitudinal trial to determine long-term vision outcomes for macular degeneration patients undergoing multi-year anti-VEGF therapy. His laboratory research focuses on basic mechanisms of retinal diseases in animal models and cell culture, as well as new technologies for retinal surgery and treatments. Dr. Bhisitkul has served as a consultant and clinical advisor for numerous pharmaceutical companies including those with market-leading products for macular edema. Dr. Bhisitkul has served as Associate Editor and Web Editor of the British Journal of Ophthalmology and is an ad hoc reviewer for several journals including Ophthalmology, American Journal of Ophthalmology and IOVS.He earned his M.D. from Stanford University and Ph.D. in Neuroscience from Yale University. and completed his residency and fellowship training at the Massachusetts Eye and Ear Infirmary and Harvard Medical School.

quan-dong-nguyen

Dr. Nguyen is a Professor of Ophthalmology at the Byers Eye Institute, Stanford University School of Medicine. He is known for his innovative work in early proof-of-concept, first-in-human clinical trials to evaluate potential pharmacotherapeutic agents for retinal vascular and uveitic diseases. Dr. Nguyen serves as principal investigator on multiple clinical trials sponsored by the National Eye Institute and other organizations for macular edema (from diabetes and uveitis), neovascular age-related macular degeneration (AMD), and ocular inflammatory and uveitic diseases. He and his team were among the first clinician-scientists in the world to evaluate aflibercept for neovascular AMD and ranibizumab for DME. The initial results of these studies served as the foundation for subsequent trials leading to the approval of EYLEA and Lucentis by the U.S. Food and Drug Administration and other regulatory authorities. Dr. Nguyen has published over 300 peer reviewed articles and is on the Editorial Board of several journals, including the Journal of Ophthalmic Infection and Inflammation and Ophthalmic Surgery, Laser, and Imaging Retina.