Corporate Leaders

Dr. Shefali Agarwal has nearly 20 years of biotechnology and pharmaceutical industry experience spanning drug development, clinical research, commercial strategy, and regulatory affairs. As a trained physician, she combines medical, business, and public health knowledge to lead and contribute to innovative projects across therapeutic areas including oncology, immunology, hematology, neurology, and cardiovascular diseases. Dr. Agarwal has expertise in all stages of drug development, from preclinical to post-marketing, with a deep understanding of medical and regulatory processes ranging from Investigational New Drug Applications to New Drug Applications.

Before joining Sironax, Dr. Agarwal was President, CEO, and Chair of the Board at Onxeo S.A. (now Valerio Therapeutics), a clinical-stage biotechnology company focused on developing drugs targeting DNA Damage Response (DDR). Prior to Onxeo, she was Chief Medical Officer at Epizyme, a clinical-stage company developing novel epigenetic therapies for cancer and other serious diseases. There, she led the global clinical development and regulatory strategy for tazemetostat. Before joining Epizyme, Dr. Agarwal was CMO at SQZ Biotech and held leadership roles at Curis and Tesaro. At Curis, she oversaw the Phase II study of its HDAC/PI3K dual inhibitor in diffuse large B-cell lymphoma (DLBCL) and the Phase I study of the oral checkpoint inhibitor in solid tumors. At Tesaro, she led the NDA and European Medicines Agency submission for ZEJULA in ovarian cancer. Dr. Agarwal also held positions of increasing responsibility at Covidien, AVEO, and Pfizer.

Dr. Agarwal has received numerous awards for her achievements and contributions in drug development. In addition to a medical degree from The Johns Hopkins University School of Medicine, she has an MIS in information systems from the University of Maryland and an MBBS from Bangalore University. Currently, she serves on the boards of Fate Therapeutics, Gritstone Bio, and ITBMed, and as a member of the Scientific Advisory Board Committee at Imvax.

Huiping Jiang, Ph.D., has more than 25 years of experience in drug development, including leadership roles at Valerio Therapeutics, Epizyme, Boehringer Ingelheim, and AstraZeneca, with expertise spanning global regulatory affairs, quality assurance, and discovery.

Dr. Jiang is a global regulatory expert with a proven track record of leading regulatory strategies for successful regulatory submissions, including New Drug Applications in the United States for TAZVERIK®, and global clinical trial applications including Investigational New Drugs in China. She also has extensive experience leading regulatory strategies for FDA advisory committee meetings and pre-approval inspections by regulatory authorities.

Dr. Jiang received a B.Sc. in biochemistry from Nanjing University and a Ph.D. in molecular and cell biology from University of Clarkson, conducting post-doctoral research in genetic engineering and signal transduction at California Institute of Technology.

During a career of more than 30 years, Dr. Nasir Khan has led the nonclinical safety advancement of more than 400 preclinical candidates and 300 investigational new drug/ clinical trial application submissions, as well as 63 New Drug Application/Biologics License Application approvals — including Celebrex®, Ibrance®, and Comirnaty® – across diverse therapeutic areas. His experience includes small molecules, biologics, antibody-drug conjugates, gene therapies, and vaccines. Prior to joining Sironax, he served as Chief Nonclinical Safety Officer at Pfizer, overseeing the nonclinical safety of the company’s global drug and vaccine portfolio.

Dr. Khan is a board-certified pathologist and toxicologist, served as a visiting professor with China Agricultural University in Beijing, and an international editor for the Journal of Toxicological Sciences. He is a Diplomate of the American College of Veterinary Pathologists and the American Board of Toxicology (DABT) and holds a Doctor of Veterinary Medicine (DVM) from University of Agriculture, Faisalabad (Pakistan), and a Ph.D. in veterinary pathology from the Ohio State University.

Yanping Xu, Ph.D., has more than 20 years of scientific and leadership experience with global biopharmaceutical companies, demonstrating a record of successfully leading multi-disciplinary project teams on small molecule drug discovery, from lead generation to candidate selections.

Before joining Sironax, Dr. Xu served as Head of Medicinal Chemistry at Janssen Shanghai, working with therapeutic area heads and other global stakeholders to define and operationalize innovative strategies for novel small molecule discovery and pipelines.

Before that, he spent 20 years at Eli Lilly and Company, first as a Senior Organic Chemist before eventually becoming Head of Discovery Chemistry Research and Technology and Research Advisor. He received the 2012 Lilly Research Award for his impactful contributions to novel target drug discovery and lead generation strategy.

Dr. Xu received a B.Sc. in chemistry from Fudan University and a Ph.D. in organic synthesis from Wayne State University, completing a post-doctoral fellowship at the University of Notre Dame.

Before joining Sironax, Jian Cui, Ph.D., was President of Waterstone Pharmaceuticals (Wuhan) from 2018 to 2021 and Head of Waterstone Research Institute from 2012 to 2016. In addition, he was a Senior Director and the Head of Global CMC Solutions (GCS) China at BioDuro LLC, Beijing, from 2016 to 2018. Previously, Dr. Cui worked as a Principal Scientist at Schering-Plough Research Institute and Merck Research Lab in New Jersey for more than seven years.

Dr. Cui has received the President’s Award for Development and the Pharmaceutical Sciences Excellence Awards from Schering-Plough. He also was a distinguished expert of the Hubei Province’s “Hundred Talents Program.”

Dr. Cui received a B.S. in chemistry from Peking University and a Ph.D. in medicinal chemistry from the University of Illinois at Chicago College of Pharmacy. He was a Postdoctoral Fellow at the University of Delaware and Indiana University.

Weiliang Fan, Ph.D., joined Sironax in 2019, establishing the company’s pharmacology department and leading discovery biology, preclinical pharmacology, and translational medicine. Dr. Fan has more than 15 years of scientific research experience in biology, with expertise in autophagy, programmed cell death, vesicular transport, and neuroimmunology.

Before joining Sironax, Dr. Fan conducted seven years of basic biological research, focusing on the field of cell death, at the National Institute of Biological Sciences (NIBS) in Beijing. He received a B.Sc. in biotechnology from Zhejiang University and a Ph.D. in genetics from Zhejiang University, with doctoral training at the University of California, Berkeley.

David Hernandez has more than 25 years of clinical development and clinical operations experience, having led Phase 1–4 programs in the United States, China, Japan, and Europe.

Prior to joining Sironax, Mr. Hernandez served as Vice President, Head of Clinical Operations at Poplar Therapeutics, establishing clinical operations governance, quality strategy, and CRO oversight in support of the company’s transition from Phase 1 to Phase 2 development. Earlier, he spent five years as Vice President, Head of Clinical Development Operations at HanAll Biopharma, where he built the U.S. Clinical Development Operations infrastructure, served on the U.S. executive and global R&D leadership teams, and helped expand the organization from a single U.S. program to a multi-program portfolio.

Mr. Hernandez also has significant experience working across Asia and global development organizations. At Merck Biopharma, he served as Head of Clinical Operations for Japan and, earlier as Head of Clinical Operations for the Asian R&D Hubs in Japan and China. He helped strengthen the integration of those countries into global development programs and supported regulatory and inspection-readiness activities involving the PMDA (Pharmaceutical and Medical Devices Agency) and NMPA/CFDA (National Medical Products Administration).

Mr. Hernandez has a strong foundation in CNS and neuroscience, with experience spanning Parkinson’s disease, Alzheimer’s disease, schizophrenia, bipolar disorder, and autism. He has a B.A. in neuroscience and behavior from Columbia University.

Dr. Ellie Hu has more than 20 years of pharmaceutical and biotechnology leadership experience. A board-certified neurologist, she has expertise spanning clinical development, medical affairs, regulatory strategy, and global program leadership across Phase I–III clinical trials, IND and NDA submissions, and lifecycle management. She has led drug development in neurological indications and obesity for IND submissions, design of SAD/MAD Phase Ib/Phase IIa studies, Phase II POC dose selections, adaptive protocol designs, safety monitoring and data analyses, program strategies, and regulatory dossiers.

Dr. Hu’s scientific and clinical expertise is particularly strong in neurology and neurodegenerative diseases, including ALS, Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, neuropathies, and movement disorders. Her background includes direct responsibility for clinical strategy, protocol development, medical monitoring, safety oversight, data review, statistical analysis planning, regulatory submissions, and cross-functional leadership across global development programs. She has worked with regulatory authorities in the United States, Europe, and the United Kingdom and has supported programs that received FDA Fast Track and Regenerative Medicine Advanced Therapy designations.

Dr. Hu holds an M.D. from Beijing University of Chinese Medicine and Pharmacology and a Ph.D. in neuroscience, immunology, and microbiology/virology from Kent State University.

Dr. Susan Niu has extensive pharmaceutical industry experience in both clinical development and medical affairs. Her expertise across early- to late-stage development includes oncology/immuno-oncology, rheumatology and immunology, transplantation, rare diseases, cell and gene therapy, pediatrics, neurology, dermatology, respiratory, and ophthalmology.

Before joining Sironax, Dr. Niu served as Head of Non-Oncology Clinical Projects at CSPC Pharmaceutical Group Limited, leading five medical departments with more than 20 clinical research physicians and more than 20 project managers accountable for approximately 40 clinical projects. She successfully guided medical programs across autoimmune diseases, respiratory diseases, CNS disorders, and rare diseases from first in human to pivotal studies and from IND to NDA.

Earlier, Dr. Niu spent more than 10 years at Astellas Pharma China, most recently three and half years as Medical Head of Development, and led multiple functions (physicians, clinical pharmacology, medical writing, biomarker/CDx). She made significant contributions to 10 BLA/NDA approvals/early access in China, including global simultaneous submissions/approvals and accelerated approvals. Prior to that, she conducted immunology research as a postdoctoral fellow and assistant research fellow at the China Academy of Traditional Chinese Medicine and Hong Kong Baptist University, leading three national research projects and publishing more than 20 SCI (Science Citation Index) papers.

Dr. Niu Susan holds an MD and Ph.D. in medical immunology from Beijing University of Chinese Medicine and completed five years as a postdoctoral fellow/assistant research fellow in immunology.

Olya Wright has more than 16 years of experience in regulatory affairs, including leadership roles at Valerio Therapeutics, Epizyme/Ipsen, GTx, TherapeuticsMD, and Endo Pharmaceuticals, with expertise spanning global regulatory affairs and quality assurance.

Ms. Wright has significant expertise in developing global regulatory strategies, medical writing, and managing regulatory and clinical operations for early- and late-stage small and large molecules. She is experienced with novel drugs and biologics across multiple therapeutic areas and has successfully implemented accelerated regulatory pathway strategies. She has extensive experience with FDA and EMA meetings, successful advisory committees, and pre-approval inspections, as well as with global regulatory strategies, including North America, EU, and APAC regions.

Ms. Wright has a B.Sc. in biology from Middle Tennessee State University and an M.S. in regulatory science from Northeastern University.

Catherine Freiman has more than 20 years of biotechnology and pharmaceutical experience, with significant expertise in medical affairs, field medical leadership, clinical development support, and neuroscience. Prior to joining Sironax, she served as Executive Director, Medical Affairs at Intra-Cellular Therapies and Johnson & Johnson, where she led a national MSL organization and helped integrate the Intra-Cellular Therapies’ Medical Affairs organization into J&J.

Previously, Ms. Freiman held senior medical affairs leadership positions at Cerevel Therapeutics/AbbVie and Biogen. At Cerevel, she built the company’s first field medical organization and developed its medical affairs infrastructure, strategy, training, and operating processes across several neuroscience programs. Additionally, she served as Field Lead for the multiple sclerosis MSL team at Genentech and held senior MSL roles at Novartis in MS, Alzheimer’s disease, Parkinson’s disease, and other therapeutic areas.

Ms. Freiman holds a B.S. in biology from the University of Michigan and a Ph.D. in neuroscience from the University of Wisconsin–Madison, completing postdoctoral fellowships in neurobiology at Yale University and neurology at the University of Michigan. She is a member of the American Academy of Neurology.

Philippe Edouard is a seasoned legal executive in the life science industry, with an emphasis on companies having global reach. He has a strong background in general legal and intellectual property matters and significant experience in strategy development, transaction support, litigation management, and IP portfolio management.

Previously, Mr. Edouard was Vice President, Head of Legal at Inozyme Pharma, a publicly traded, clinical stage biotech acquired by BioMarin in 2025, where he oversaw legal support for corporate, licensing, and financing activities. Prior to Inozyme, he was Vice President, Intellectual Property & Contracts at Visterra, a subsidiary of Otsuka Pharmaceuticals, where he implemented IP strategy, supported life science transactions, and provided general legal support toward the development of flagship program, sibeprenlimab. Prior to Visterra, Mr. Edouard was a senior attorney at Shire Pharmaceuticals through its acquisition by Takeda. There, he led high stakes IP litigation for Shire’s Adderall XR® and managed IP portfolios for Takeda’s blockbuster, Entyvio®.

Mr. Edouard began his legal career as an associate at IP boutique Finnegan Henderson and general practice firm Brown Rudnick. Prior to going into law, he worked as a scientist at Genetics Institute, Millennium Pharmaceuticals, and Biogen. Mr. Edouard received a B.A./M.A. in molecular biology and biochemistry from Boston University, JD from Boston University School of Law, and MBA from NYU Stern.

Robin Sutherland has more than 20 years in executive leadership in management of various corporate functions at start-ups, women’s health, healthcare and rehabilitation, advocacy groups, multinational finance and global biotech organizations. Her experiences range from managing up to 25 sites and teams throughout North America, Europe, and Asia, to creating and leading healthcare product lines, strategic planning, project management, relationship management, human resources, clinical operations, IT, and patient services. She has supported IPO work within biotechnology and has worked for privately held, venture capital and private equity-backed and publicly traded organizations.

Prior to joining Sironax, Ms. Sutherland served as Vice President, Global Head of Human Resources at Valerio Therapeutics and Valour Bio, where she led HR, facilities, and internal communications and supported the finance and IT functions. Earlier she joined Renovia at its inception in 2017 through 2022. Earlier work in biotech included leadership roles in HR and Clinical Operations at Flex Pharma and Ironwood Pharmaceuticals, and leading U.S. operations for Quanticate, a UK-based CRO.

Prior to focusing on the biotech sector, Ms. Sutherland served as COO for Epoch; led operations for Fidelity Investment’s Veritude; created regional operations for healthcare and award-winning general recruitment firms; and led product lines and rehabilitation centers for a publicly traded rehabilitation organization. In addition, Ms. Sutherland has served as Board Chair and trustee for Bridgewell, a large human services nonprofit, since 2014.

Ms. Sutherland has a B.S. in occupational therapy from Tufts University and a Master’s Certificate in Human Resources from Cornell University’s School of Industrial & Labor Relations.

Dr. Anand Rajarethinam is a seasoned clinical research leader with over 28 years of experience spanning contract research organizations and biopharmaceutical sponsor companies, with expertise managing complex clinical research programs across all phases of development. His therapeutic experience includes oncology and immuno-oncology, central nervous system disorders, cardiovascular disease, diabetes, hypertension, obesity, and insomnia. He has guided multidisciplinary teams in delivering high-quality data and regulatory submissions, and is proficient in data management, analytics, and programming platforms, leveraging technology to enhance clinical data quality, efficiency, and insight generation.

Prior to joining Sironax, Dr. Rajarethinam served as Vice President of Clinical Data Sciences at Valerio Therapeutics and as Executive Director of Clinical Data Sciences at Epizyme (now Ipsen). He established and led CDS functions, managed global vendor partnerships, and oversaw programming and biometrics deliverables supporting key new drug applications, biologics license applications, and development safety update reports.

Dr. Rajarethinam has an M.D. from T.D. Medical College, Alleppey, India, and a two-year Professional Diploma in Network-Centered Computing from the National Institute of Information Technology.

Erik Kopp is an accomplished communications professional with extensive expertise and experience within the life sciences industry, including branded and generic pharmaceuticals, medical devices, and clinical research services. His work has spanned internal, external, and investor/financial communications in domestic and international markets.

Prior to joining Sironax, Mr. Kopp led corporate communications at BioXcel Therapeutics, including strategic communications for the FDA approval of the company’s first drug, IGALMI® (dexmedetomidine) for the treatment of agitation associated with schizophrenia or bipolar I or II disorders in adults.

Before BioXcel, he served as Senior Internal Communications Director at CVS Health.
Earlier, he worked as Senior Director of Corporate Communications at Parexel, a leading global biopharmaceutical services organization. Mr. Kopp has also held leadership positions at Boston Scientific, Novartis, and Barr Pharmaceuticals.

Mr. Kopp has a B.A. in communication from Goshen College and an M.A. in journalism and public affairs from American University.

Ms. Liwen Hou, CPA, joined Sironax in 2018. She has nearly 15 years of considerable financial experience in the biopharmaceutical and pharmaceutical industry. As Vice President of Accounting and Controller, she leads financial activities including accounting, financial reporting, treasury management, tax planning, financing activities, and procurement. As a founding employee of Sironax, she made critical contributions in the buildout and operations of the company in its early days.

Prior to joining Sironax, she worked at BeiGene Ltd. (now BeOne Medicines) from 2011 to 2018, supporting its growth into a public company. Ms. Hou has a Certificate of CPA, having received a master’s degree in business administration from Tsinghua University.