Clinical Trials
PharmaEssentia is committed to scientific excellence in its ongoing clinical research. We are deeply appreciative of the study sites, investigators, patients, caregivers, and clinicians who support our efforts through their participation.
ENROLLING: A Phase 3 open-label, multicenter, randomized, active-controlled study designed to compare the efficacy and safety and tolerability of ropeginterferon alfa-2b-njft compared with an available treatment as second-line therapy for adults with essential thrombocythemia (ET). For more information, please visit www.SurpassET.com or www.clinicaltrials.gov (NCT04285086).
ENROLLING: A Single-arm, multicenter study to assess the efficacy, safety, and tolerability of ropeginterferon alfa-2b-njft for adults with essential thrombocythemia (ET). More information on the study, including eligibility criteria, can be found by visiting www.ExceedET.com or www.clinicaltrials.gov (NCT05482971).
ENROLLING: A Phase IIIb, single-arm, multicenter study to assess the efficacy, safety, and tolerability of ropeginterferon alfa-2b-njft in adults with polycythemia vera (PV). Find more information by visiting www.EclipsePV.com or www.clinicaltrials.gov (NCT05481151).
PharmaEssentia USA Corporation
35 Corporate Drive, Suite 325,
Burlington, MA 01803, USA
Lih-Ling Lin, Ph.D.Lih-Ling Lin, PhD, joined PharmaEssentia in August 2022 to lead the company’s global research and development (R&D) activities to expand and diversify the pipeline and to enhance the company’s R&D engagement globally and in critical markets.
Prior to PharmaEssentia, Lih-Ling was a leader at Sanofi in Boston where she was the Head of Checkpoint immunology cluster in Immunology and Inflammation Research Area, following a long tenure at Pfizer in senior research and development roles. Her work in both companies led to the discovery of clinical candidates, including small molecules and antibodies for immune-mediated diseases.
Lih-Ling graduated from National Taiwan University with an undergraduate degree in Pharmacy and a master’s degree in biochemistry. She earned her doctorate in biochemistry at the University of Arizona. She has published more than 70 papers and patents on immunology-related topics.
Rachel LipsitzRachel Lipsitz joined PharmaEssentia USA in September 2022, bringing two decades of experience in developing and implementing strategic communications and advocacy relations programs for life sciences and biopharmaceutical companies.
She joined PEC USA from Bristol-Myers Squibb where she led all external science and R&D communications activities and was the communications lead for the company in California.
Rachel received a bachelor of science degree from The University of Texas at Austin where she majored in public relations with a focus in business foundations.
Raymond Urbanski, MD, PhDRay Urbanski joined PharmaEssentia in 2020 as SVP and Head of Clinical Development and Medical Affairs for the U.S. organization. An established clinical researcher, licensed clinician and pharmaceutical executive, Ray has more than 25 years of experience in research, clinical practice, and the pharmaceutical industry. Prior to PharmaEssentia, Dr. Urbanski served as Chief Medical Officer (CMO) and President of GT Biopharma, Inc. He was previously the CMO of MannKind Corporation, as well as at Mylan. Earlier, Dr. Urbanski spent almost a decade at Pfizer holding several positions, including CMO of the Established Products Business Unit and Senior Medical Director of the Oncology Clinical R&D group. Prior to industry, he spent three years in a private practice.
Ray received his MD and PhD in Pharmacology from the New Jersey Medical School, and completed his Residency and Fellowship training at Thomas Jefferson University Hospital in Philadelphia.
Sulin ShahSulin Shah joined PharmaEssentia in 2021 as U.S. General Counsel. Prior to joining PharmaEssentia, Mr. Shah served as U.S. General Counsel at Orphazyme where he supported extensive U.S. organizational and infrastructure development. Prior to Orphazyme, Sulin was Lead Counsel in U.S. Hematology for Takeda, following the acquisition of Shire. Earlier in his career, he served in private legal practice and management consulting roles in Chicago.
Shah earned his BS in business administration from the University of Illinois and his JD from Northwestern University.
Anjana PursnaniAnjana joined PharmaEssentia in 2022 as SVP and Head of People. Anjana is a business and organizational development leader with over 25 years of experience across pharmaceutical, consumer and financial industries. Most recently, Anjana ran a global Executive Coaching and Organizational Effectiveness firm, where she partnered with senior leaders and organizations to create sustainable growth and change. Prior to this, Anjana held a 20-year tenure as a high-performance marketing professional in the pharmaceutical and consumer packaged goods industries.
Anjana holds an MBA from Dartmouth and a BA in Economics from Rutgers University.
Jason MitchJason Mitch joined PharmaEssentia in March 2021, introducing more than 20 years of experience in biopharmaceutical companies focusing primarily on patient and market access. Prior to his tenure at PharmaEssentia, he supported access and reimbursement for Fergene, and previously developed his expertise through roles of increasing leadership during his tenure at Actelion.
Jason received an MFT from Hahnemann University and a BS from The Ohio State University.
Roddy McilwainRoddy joined PharmaEssentia in 2021 as Head of Sales and Marketing. Prior to PharmaEssentia, he served as Vice President of Oncology-Hematology Sales at Jazz Pharmaceuticals. During his tenure, he successfully led launches for four products in the leukemia, transplant and lung cancer markets. He cultivated his earlier career in sales and marketing roles at Otsuka America Pharmaceuticals, Genentech and Ortho Biotech (now Johnson & Johnson).
Roddy received his BS in marketing from the University of South Carolina and an Executive MBA from Webster University.
Samuel LinSam serves as the Vice President of Business Operations and Strategy for PharmaEssentia USA. He brings more than 15 years of professional experience in the areas of business development, project management and consulting in IT and healthcare, patent law, and engineering. Prior to his tenure at PharmaEssentia, Sam was a patent agent for a private law firm in Washington DC, and previously a patent examiner with the U.S. Patient and Trade Office (USPTO).
Sam earned his BS from the University of Maryland, an MBA from Duke University and an MPH in Health Management from Harvard University.
Meredith ManningMeredith Manning joined PharmaEssentia USA Corporation in 2020 and currently serves as President of the Americas. She has more than 25 years of experience in global commercialization and brand building for biopharmaceuticals and medical devices. Meredith has played an instrumental role in defining and leading PharmaEssentia’s strategic growth and ambition across the Americas, including building a robust leadership team, bringing the organization’s first asset to market and growing the company into a recognized global biopharmaceutical innovator.
Prior to joining PharmaEssentia, Meredith was Chief Commercial Officer at resTORbio™, and previously served as Vice President of Global Product Strategy in Hemophilia for Shire (formerly Baxalta) and Baxter. She has also held a series of marketing leadership roles at Vertex® and Pfizer.
Meredith received a BS at Colorado College and an IMBA from the University of Chicago Booth School of Business.
Jack Hwang, Ph.D.Jack Hwang joined PharmaEssentia in 2006 and has served as General Manager in Taiwan since 2015. With training in organic chemistry, he has held a series of leadership roles at prior companies, including as Senior Director at Optimer Pharmaceuticals, Senior Group Leader at Array BioPharma®, and earlier as a research scientist at Amgen® and Ligand® Pharmaceuticals.
Jack completed his Ph.D. in organic chemistry and post-doctoral fellowship in natural product synthesis at the University of Pennsylvania.
Albert Qin, M.D. Ph.D.Albert Qin, who joined PharmaEssentia in 2017, brings more than 20 years of experience in the biotech and pharmaceutical industry with an emphasis on clinical development. Recent leadership roles include Chief Medical Officer at China Health Group, Chief Scientific Officer and Corporate Officer at SymBio Pharmaceuticals, and Medical Director at ImmunoGen™. Earlier in his career, he held clinical development and R&D roles at Pfizer, Bayer and Biogen®. At Biogen, he did innovative research and made discoveries related to cytokines, immunology, and gene therapy.
Albert completed his medical degree in the Department of Medicine at Shandong Medical University in China and his Ph.D. in biochemistry and molecular pharmacology at Harvard Medical School. He completed a visiting research fellowship at Brigham and Women’s Hospital.
Ching-Leou Teng, Ph.D.Ching-Leou Teng offers extensive pharmaceutical science and development expertise to the PharmaEssentia team. After joining the company as head of operations in 2003, she became Chairperson in 2009. Prior to PharmaEssentia, Ching-Leou held multiple leadership roles in drug delivery research and pharmaceutical development at Ionis™ (formerly ISIS) Pharmaceuticals, and previously served as a reviewer in the Pharmacokinetics Evaluation Branch of the Division of Biopharmaceutics at the Food and Drug Administration (FDA). Early in her career, Ching-Leou was a registered pharmacist at hospitals in Taiwan.
Ching-Leou completed her B.S. in pharmacy at Taipei Medical College, followed by an M.S. in pharmaceutical science at North Dakota State University. She completed her Ph.D. and post-doctoral fellowship at the University of Michigan.
Ko-Chung Lin, Ph.D.Ko-Chung Lin has led PharmaEssentia since 2002, driven by rich and diverse career experiences at leading U.S. pharmaceutical companies. He is recognized for medicinal chemistry advances in pegylation, including the invention of pegylated-interferon, that have led to the development and successful entry of multiple leading therapeutics. Prior to PharmaEssentia, Ko-Chung was head of the Adentri® and pegylated-Avonex® programs at Biogen®. Earlier in his career, he contributed to inventions in HIV in his research roles at Monsanto.
Ko-Chung received B.S. and M.S. degrees in chemistry from National Taiwan Normal University, his Ph.D. from the University of Missouri, and completed a post-doctoral fellowship at the University of Michigan.