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.
Essential Thrombocythemia
PharmaEssentia is now enrolling for a Phase 3 clinical research study in the U.S. for people with Essential Thrombocythemia (ET). For more information, please visit www.SurpassET.com or visit www.ClinicalTrials.gov (NCT04285086).
PharmaEssentia recognizes that some patients with serious or immediately life-threatening diseases may not be eligible for any clinical trials and may not have other options. PharmaEssentia has a protocol to consider expanded access to investigational products for patients residing in the United States who would benefit from our investigational therapies currently in development, under certain circumstances.
Requests for expanded access shall be evaluated in accordance with the PharmaEssentia Expanded Access and Compassionate Use Policy, the principles and criteria of which are summarized as follows:
Requests for access to investigational therapies must be made by a qualified and licensed physician by contacting PharmaEssentia. The physician requesting access must provide specific case information, including pertinent patient history, as well as the following:
No Personally Identifiable Information or Personal Health Information should be provided in any request. PharmaEssentia will make every effort to acknowledge individual requests that have been submitted in accordance with the above requirements.
PharmaEssentia is committed to a fair and unbiased evaluation of each request made for access to investigational therapies. All decisions are based solely on the clinical circumstances surrounding each request, in accordance with the principles detailed above. Whenever possible, patients will be referred to ongoing clinical trials as the primary route to access investigational medicines. While the above criteria are those that will be considered by PharmaEssentia in its evaluation of whether or not to offer expanded access, PharmaEssentia cannot make any guarantee that an investigational therapy will be made available.
Persons with questions about PharmaEssentia’s policy and procedures for expanded access or about expanded access to PharmaEssentia’s investigational drugs may send an email to medinfo@pharmaessentia-us.com.
To learn more about the FDA’s regulatory framework for expanded access, including expanded access for individual use please see: www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse
Meredith ManningMeredith Manning joined PharmaEssentia as General Manager for the U.S. in 2020, bringing with her more than 20 years of experience in global commercialization and brand building for biopharmaceuticals and medical devices. She was most recently Chief Commercial Officer at resTORbio™, and previously served as Vice President of Global Product Strategy in Hemophilia for Shire (formerly Baxalta) and Baxter. She previously held a series of marketing leadership roles at Vertex® and Pfizer.
Meredith received a B.S. at Colorado College and an MBA 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.
