Jason J. Rose, MD, MBA - Chief Executive Officer
Jesus Tejero, PhD - Chief Scientific Officer
Xueli Wang, MBA - Chief Financial Officer
Regulatory Consulting Team at PharmaDirections
Dr. Ed Branson - CMC Expert Biologics
Dr. Ed Branson is an experienced CMC operations executive who led the daily operations of seven GMP manufacturing organizations including cell culture, fermentation, vaccine and trans-dermal patch, transgenic plant, combination pulmonary drug/device and regenerative tissue manufacturing facilities. He managed pilot plants, directed production from preclinical through Phase III and brought five manufacturing facilities into GMP compliance.
Dr. Tilmann Brotz - Strategic Program Lead, Non-clinical Expert
Dr. Tilmann Brotz is a senior Development Sciences Consultant with over 15 years of experience in the biopharmaceutical industry leading toxicology, DMPK, in-vivo pharmacology, clinical pharmacology and diagnostic groups. He also has extensive experience with multiple clinical biomarker modalities (blood, histology, FDGPET and CT imaging). He is a CLSI FAST advisor and a member of the Scientific Review Board of the Alzheimer’s Drug Discovery Foundation.
Dr. Andrew Nicholls - Clinical Pharmacologist and Medical Monitor
Dr. Andrew Nicholls is a pharmaceutical physician with experience across a wide range of therapeutic areas and has a passion for scientiﬁcally–driven, eﬃcient drug development. He establishes productive working relationships in project teams with investigators and vendors. Eﬀective in medical writing and presentation of data, skilled in the use of data visualization methods and management of PK/PD analysis leading to persuasive and eﬃcient analyses of exploratory studies. Collaboration with Investigators and KOLs has resulted in eﬃcient, rigorous conduct of clinical studies and creativity in strategic planning. Strong clinical pharmacology background and familiarity with analytic tools ensures pharmacologically-driven protocol, program design and analysis. Designed and managed multiple ﬁrst-in-human studies, Phase I supportive studies, POC, dose response studies, and demonstration of eﬃcacy studies including large scale Phase II evaluations.
Mary Sherman, Ph.D - DMPK/Bioanalytical Expert
Dr. Mary Sherman is a skilled scientific advisor and program manager for late-stage Discovery through Phase III of drug development. She manages programs/studies from late-stage Discovery through Phase III, including bioanalytical, drug metabolism, PK/TK, immunogenicity and regulatory requirements. Additionally she provides support to both nonclinical and clinical studies. Dr. Sherman has a strong reputation for critical thinking, relationship building, social intelligence, and clear communications that establishes bridges between scientific and non-scientific stakeholder coupled with a proven analysis and strategic perspective combined with marketing, operations, and R&D integration.