WATERTOWN, Mass.--(BUSINESS WIRE)--Today Lyndra Inc., an emerging biopharmaceutical company developing oral dosage forms designed to release drug for up to a week or longer, announced it has strengthened its clinical and regulatory development focus with the addition of Kelly Lindert, M.D., Senior Vice President Clinical Development & Strategy and Jacqueline Schumacher, Vice President Regulatory.
Lyndra’s technology is the first ultra-long-acting, sustained release oral dosage form. Lyndra’s system has the potential to enable linear drug release of small molecules and peptides for seven days or more from each orally administered capsule. “As Lyndra prepares to transition into a clinical stage development company, we are focused on improving patient health outcomes through improved adherence and sustained, steady state pharmacokinetic profiles. Our unique method of sustained local gastrointestinal delivery is a game changer for patients and caregivers," remarked Lyndra Chief Scientific Officer and Co-Founder, Andrew Bellinger. “Kelly and Jackie are joining Lyndra’s leadership team at an important time for the company as we move into our first clinical trials. With substantial expertise in clinical and regulatory development, we expect both will help us execute on our ambitious clinical development goals for 2017.”
"I am elated to join this team at such an exciting time," said Dr. Lindert. “I’m impressed how Lyndra as a new startup has moved quickly through preclinical to preparing to initiate first-in-human clinical studies in just a little over two years. I am honored to lead our Clinical Development efforts, and I look forward to accelerating our ability to execute as a clinical stage company.”
“I am thrilled to be a part of this team as it enters a new chapter in Lyndra’s history,” said Ms. Schumacher. “I believe there is enormous potential to partner with worldwide regulatory agencies to deliver meaningful, differentiated products to patients, and I look forward to what we can accomplish together.”
Lyndra: A Dose Goes a Long Way
Lyndra aims to fundamentally change the way patients take medicines through the development of oral, ultra-long-acting, sustained release oral therapies that drastically improve healthcare outcomes. The Lyndra platform was developed at the Massachusetts Institute of Technology, in the laboratory of Dr. Robert Langer in collaboration with the Bill and Melinda Gates Foundation. Lyndra formulations transform medications taken daily or more frequently into a weekly or monthly dose, promising to improve patient adherence as well as to optimize the pharmacokinetic profile of the dosage form.
About Kelly Lindert, MD
Kelly Lindert joins the Lyndra team from Tokai Pharmaceuticals, where she held the role of Executive Vice President of Development. Prior to this, she worked at Novartis Vaccines and Diagnostics, where she worked for nearly eight years in roles of increasing responsibility, most recently as the Global Head of Development for the company’s influenza vaccines program. At Novartis, she was responsible for executing rapid and efficient clinical development programs and for the regulatory filings and approvals of several products. Before her time at Novartis, Dr. Lindert was engaged in the phase 1 through 4 clinical development of products in the fields of urology, nephrology, endocrinology and infectious disease at Altus Pharmaceuticals, Acambis (since acquired by Sanofi), Anesiva (formerly Corgentech Inc.) and ALZA Corporation (since acquired by Johnson & Johnson). She holds a Bachelor’s degree from Vassar College and an M.D. from the University of Chicago, each with honors, and she trained in Urology at the Stanford University Hospitals.
About Jacqueline Schumacher
Prior to joining Lyndra, Jackie spent most of her 30+ year career in Pharmaceutical Sciences within Pfizer, starting as an analytical chemist followed by a long tenure within the CMC Regulatory organization. She has led teams to develop successful global CMC registration strategies for new small molecules, product enhancements, inhalation and injectable products. Jackie also held several business-facing/commercial roles, including regulatory leadership within the nascent Established Products Sterile Injectables organization and later as Portfolio Optimization and Strategy Leader; facilitating a matrixed team of colleagues tasked with radically optimizing the value of the 600+ molecule portfolio. In addition to her Pfizer-based experiences, she has chaired an industry trade association, IPAC-RS, focused on strategic pharmaceutical and regulatory development objectives for orally inhaled and nasal drug products. Jackie earned her B.A. degrees in Chemistry and Classical Studies from Hamilton College.