May 8, 2018 comslyndra

About Us

Company Progression

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Team

Co-Founder / Chief Executive Officer

Amy Schulman

Amy Schulman is a co-founder and Chief Executive Officer of Lyndra, Inc. and a Partner at Polaris Partners. Amy joined Polaris in 2014 and immediately assumed the role of Chief Executive Officer of Arsia Therapeutics, which was subsequently acquired by Eagle Pharmaceuticals in 2016. In 2015 she co-founded and joined Lyndra, Inc. as Chief Executive Officer. Prior to joining Polaris, Amy was Executive Vice President and General Counsel of Pfizer, Inc. where she was responsible for leading Pfizer’s Consumer Healthcare Business. Amy has received numerous awards including Scientific American’s 2015 Worldview 100 List, Fierce Biotech’s 2014 Top 15 Women in Biotech, and Fortune Magazine’s 2013 50 Most Powerful Women in Business. She is a Senior Lecturer at Harvard Business School and currently serves as Executive Chair of SQZ Biotech and Olivo Labs, LLC, and is on the Boards of Directors of Alnylam Pharmaceuticals, Blue Buffalo, Ironwood Pharmaceuticals, and the Whitehead Institute.

Co-Founder / Chief Scientific Officer

Andrew Bellinger

Andrew co-founded Lyndra and serves as its Chief Scientific Officer. He studied biophysics at Princeton and applied mathematics at NYU. He received a PhD from Columbia University studying mechanisms of calcium signaling in skeletal and cardiac muscle while developing novel therapies to treat muscular dystrophies. He has an MD from the College of Physicians and Surgeons at Columbia University and completed clinical training in internal medicine at the University of California, San Francisco and in cardiovascular disease at Brigham and Women’s Hospital and Massachusetts General Hospital. He is board certified in internal medicine and in cardiovascular medicine and continues to see patients at Brigham and Women’s Hospital. He led the development of the original Lyndra drug delivery technology while working at MIT with Dr. Robert Langer.

Chief Operating Officer

Jessica Ballinger

Jessica is a global drug and medical device executive with a proven ability to identify and respond to unmet patient needs and market opportunities. Prior to joining Lyndra, Jessica led organizations at Pfizer and Biogen focused on product design and commercialization, leveraging her strong technical background with expert organizational skills. Her passion for the patient drives innovative solutions and establishes or revitalizes value for patients and payers through new product launches. She has delivered new products in brands such as Genetropin®, Somatotropin®, Xalatan®, Avonex®, Plegridy®, Zynbryta®, Eloctate®, and Alprolix® and overseen product design in therapeutic areas such as neuroscience, cardiovascular and metabolism, immunology, allergy and respiratory, hematology, and rare diseases.

Chief Engineering Officer

Raymond Knox

Prior to joining Lyndra in 2016 Ray has worked in the Medical device industry for 28 years in the design, development and manufacturing of medical devices. Ray was VP of Manufacturing at 480 Biomedical, developing a novel bioresorbable drug eluting scaffold for the SFA. Ray has worked as the vice president of quality assurance and clinical quality at Boston Scientific, where he was responsible for the development of quality systems for the clinical organization, re-creation of post-market surveillance processes and development of analytical infrastructure for the successful product TAXUS®. Additionally, Ray has worked with Ximedica, Becton Dickinson, USCI, and Medtronic. His experience spans large-scale automated manufacturing, highly specialized research and development prototypes, innovative process development, characterization and process validation. Ray has successfully released 16, class 2 & 3, medical devices products in the US. Ray holds a bachelor’s degree in mechanical engineering from University College Dublin and a master’s degree in business administration from Assumption College.

Vice President, Pharmaceutical Sciences

David Altreuter

In joining Lyndra, David contributes professional experience and expertise in the formulation and early development of novel drug delivery systems. Since 2001, David has been engaged in formulation, process development, manufacturing and operations roles at Boston-area biotechnology companies. Most recently David comes from Quiet Therapeutics where he was VP of CMC and the founding US employee, developing a novel immune-oncology platform involving targeted delivery of plasmid-containing nanoparticles. Previously David was at Selecta Biosciences, directing formulation of polymeric immunomodulatory nanoparticles and leading multiple teams including Selecta’s first clinical program and its first corporate partnership. Earlier experience included manufacturing leadership at Alnylam Pharmaceuticals and formulation and process development at Acusphere. David has worked with many different classes active pharmaceutical agents and an extensive range of non-traditional formulation and production processes. David is a chemical engineer by training, with a BSE from Princeton University and a PhD from the University of California, Berkeley.

Vice President, Regulatory & Quality

Jackie 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.

Vice President, Pharmacology & Toxicology

Susan Low

Susan has experience in pharmacology, toxicology and in vitro biology in the areas of molecular endocrinology, viral RNA stability, hemophilia and oncology. Susan led pharmacology, toxicology and biology efforts at BIND Therapeutics in the pursuit of developing and evaluating polymeric nanoparticles for oncology. Prior to her position at BIND, she developed Fc-fusion protein technology at Syntonix Pharmaceuticals with a particular focus on pharmacology and toxicology of FIX-Fc and FVIII-Fc fusion proteins for the treatment of hemophilia. Susan held post-doctoral positions at Brigham and Women’s Hospital, Harvard Medical School, and MIT after receiving her PhD in biology with a focus on molecular endocrinology from the University of Edinburgh.

Vice President, Finance

Carlos Famadas

Carlos Famadas oversees the finances for Lyndra, Inc. as VP of Finance. Prior to Lyndra, Carlos was the CFO and VP Operations for WHOOP, a wearable company, taking it from a Seed stage, pre-revenue company, to a Series C growth stage company. Carlos healthcare background includes driving the finance function for a Concord-based medical device company, Telcare, and Baltimore-based disease management company, XLHealth. Carlos’ experience includes managing teams, strategic planning, managing organizational growth and establishing systems and processes for growing startups. Carlos holds an A.B. in Economics from Harvard University and a MBA from Harvard Business School.

Scientific Fellow

Stephen Zale

Stephen Zale is Scientific Fellow at Lyndra. Previously, Stephen was Vice President of Development and founding scientist at BIND Therapeutics, and was Vice President of Injectable Products R&D at Alkermes where he led the group responsible for formulating Alkermes’ biodegradable polymer-based microsphere products, including Risperdal Consta, Vivitrol and Bydureon. Stephen received a Ph.D. in Biochemical Engineering and a B.S. in Chemistry, both from MIT.

Associate Director, Product Engineering

Tyler Grant

Tyler Grant earned his PhD from the University of Oxford in Biomedical Engineering, where he studied as a Rhodes Scholar. After his PhD, Tyler conducted a Postdoctoral Fellowship with Dr. Robert Langer at MIT, supported by the Max Planck Foundation. Tyler has developed a range of novel technologies including needle-free injection devices, orthopedic prostheses, tissue engineering scaffolds, and long-acting dosage forms.

Associate Director, Exploratory Technologies

Rosemary Kanasty

Rosemary joined the Lyndra team soon after the company was founded to lead efforts in formulation development. She earned her PhD in chemical engineering from MIT in the laboratories of Dr. Robert Langer and Dr. Daniel Anderson, where she studied novel polymers for gene therapy. She received her BS in chemical engineering from Michigan State University. After completing her undergraduate degree, she spent two years in West Africa as a Peace Corps Volunteer, teaching math and science to middle school students in underserved areas.

Board of Directors

Chair of the Board of Directors

Catherine B. Reynolds

Catherine B. Reynolds is a successful entrepreneur and philanthropist. She brings to the world of philanthropy the same energy and entrepreneurial spirit that ensured her success in the realm of commerce. After graduating from Vanderbilt University, she started her business career as a CPA, and then became the Special Assistant to the Board Chairman of a Fortune 500 company. As the leader of two businesses, Mrs. Reynolds went on to launch a new and affordable way for Americans to finance a college education. She developed a privately-funded supplement to government student loan programs and created the securitization market for student loans on Wall Street. Through her vision and perseverance, millions of Americans have been able to attend the college of their choice. In only one decade, this creative approach to private educational financing revolutionized student lending and spawned a multibillion-dollar industry. Mrs. Reynolds now devotes her time and abilities primarily to philanthropic pursuits. She was selected by BusinessWeek magazine as one of the 50 most philanthropic living Americans and is the first self-made woman ever to make their list. Mrs. Reynolds has received honorary degrees from Georgetown University, Morehouse College and Willamette University, as well as New York University’s Gallatin Gold Medal. She was selected recently as Washingtonian of the Year, honoring “local heroes whose good works and generous spirits make Washington a great place to live and work.”

Member of the Board

Zafrira Avnur

In October 2016 Ms. Avnur Joined Quark Venture Inc. as Chief Scientific officer at Quark Venture Inc., a venture investment fund focused on life sciences investments. Ms. Avnur was the Global Head of Academic Innovation, Roche Partnering from 2009 until October 2016. In this role she was responsible for creating relationships with the world’s leading academic institutions and world class innovators, gaining Roche early access to innovation.  For her last two years at Roche, Ms. Avnur was also named Global Head of Neglected Diseases Roche Partnering. Ms. Avnur created the ROADS (Roche Alliance with Distinguished Scientists) program, a model for collaboration between Industry and Academic institutions. Preceding her academic innovation leadership role, Ms. Avnur moved to Roche Partnering group (Basel, Switzerland, 2006) and assumed responsibility for scientific evaluations of partnering opportunities and started the “Finder” group for Biomarkers for all therapeutic areas. Prior to her partnering roles, Ms. Avnur worked in diagnostics and pharmaceuticals research and development for nearly 20 years. Her focus areas included diagnostics, the finding of biomarkers in various therapy areas, preclinical pharmacology (osteoporosis), overseeing the advancement of compounds from the bench into the clinic, and the design and execution of early clinical studies that characterize the pharmacodynamics and clinical effects of a number of compounds. Ms. Avnur was named Distinguished Scientist, the highest scientific appointment at Roche.

Member of the Board

Edmund Harrigan

Edmund P. Harrigan, M.D. joined the pharmaceutical industry in 1990, following seven years in the private practice of neurology. He served as Senior Vice President of Worldwide Safety and Regulatory for Pfizer Inc. from 2012 to 2015, where he led a 3,500-person organization in 80 countries that was responsible for managing regulatory interactions with global health agencies, as well as collecting, interpreting and reporting clinical safety data for more than 600 marketed products. Dr. Harrigan’s prior experience includes executive leadership roles at Sepracor, Neurogen and Karuna Pharmaceuticals as well as at Pfizer where he served as SVP, Head of Worldwide Business Development, SVP, Head of Worldwide Regulatory Affairs and Quality Assurance, and Vice President, Head of Neuroscience and Ophthalmology. Earlier in his career at Pfizer, Dr. Harrigan served as Vice President of Clinical Development, Therapeutic Area Head, CNS and Pain. He currently serves on the Board of Directors of Acadia Pharmaceuticals and Karuna Pharmaceuticals. Dr. Harrigan earned his B.A. degree in Chemistry from St. Anselm College and holds an M.D. from the University of Massachusetts.

Co-Founder / Member of the Board

Robert Langer

Dr. Langer is the David H. Koch Institute Professor at Massachusetts Institute of Technology and a Co-Founder of Lyndra. Dr. Langer has written over 1,300 articles and has nearly 1,100 patents worldwide. Dr. Langer’s patents have been licensed or sublicensed to over 300 pharmaceutical, chemical, biotechnology and medical device companies leading to over 100 products in use or in clinical trials. He is the most cited engineer in history and has received over 220 major professional awards including the Queen Elizabeth Prize for Engineering in 2015, Priestly Medal in 2012, National Medal of Science in 2008, Charles Stark Draper Prize in 2002 (considered the equivalent of the Nobel Prize for engineers), and the Lemelson-MIT prize in 1998 for being “one of history’s most prolific inventors in medicine.”

Co-Founder / Chief Executive Officer

Amy Schulman

Amy Schulman is a co-founder and Chief Executive Officer of Lyndra, Inc. and a Partner at Polaris Partners. Amy joined Polaris in 2014 and immediately assumed the role of Chief Executive Officer of Arsia Therapeutics, which was subsequently acquired by Eagle Pharmaceuticals in 2016. In 2015 she co-founded and joined Lyndra, Inc. as Chief Executive Officer. Prior to joining Polaris, Amy was Executive Vice President and General Counsel of Pfizer, Inc. where she was responsible for leading Pfizer’s Consumer Healthcare Business. Amy has received numerous awards including Scientific American’s 2015 Worldview 100 List, Fierce Biotech’s 2014 Top 15 Women in Biotech, and Fortune Magazine’s 2013 50 Most Powerful Women in Business. She is a Senior Lecturer at Harvard Business School and currently serves as Executive Chair of SQZ Biotech and Olivo Labs, LLC, and is on the Boards of Directors of Alnylam Pharmaceuticals, Blue Buffalo, Ironwood Pharmaceuticals, and the Whitehead Institute.

Co-Founder / Member of the Board

Giovanni Traverso

Dr. Traverso is an Assistant Professor of Medicine and Associate Physician in the Division of Gastroenterology, Brigham and Women’s Hospital (BWH), Harvard Medical School. Dr. Traverso grew up in Peru, Canada and the United Kingdom. He received his BA from Trinity College, University of Cambridge, UK, and his PhD from the lab of Professor Bert Vogelstein at Johns Hopkins University. He subsequently completed medical school at the University of Cambridge, internal medicine residency at the Brigham and Women’s Hospital and his gastroenterology fellowship training at Massachusetts General Hospital, both at the Harvard Medical School. Dr. Traverso’s previous work focused on the development of novel molecular tests for the early detection of colon cancer. For his post-doctoral research he transitioned to the fields of chemical and biomedical engineering in the laboratory of Professor Robert Langer at the Massachusetts Institute of Technology (MIT) where he developed a series of novel technologies for drug delivery as well as physiological sensing via the gastrointestinal tract. Dr. Traverso’s was named one of the most promising innovators under 35 by the MIT Tech Review’s TR 35. He continues to collaborate closely with Professor Langer and is a Research Affiliate at MIT. His current research program is focused on developing the next generation of drug delivery systems to enable efficient delivery of therapeutics through the gastrointestinal tract.

Company advisors

Dr Wilding is an internationally recognized expert in the design, development and clinical evaluation of drug delivery systems. In 2005 he received the Controlled Release Society career achievement award in oral drug delivery and in 2013 became an eminent fellow of the UK Academy of Pharmaceutical Scientists. In 2015, he received an honorary doctorate from Monash University in recognition of his outstanding contribution as a scientific innovator and leader in drug development. He has supervised several PhD students and has published over 250 research papers, abstracts and patents. He is a special Professor in the School of Pharmacy at the University of Nottingham and in 1997 was appointed as an expert scientist for the FDA in the area of food effects on drug bioavailability. In a long career commercializing science, Dr Wilding was also the cofounder of R5 Pharmaceuticals, Zysis, Modern BioSciences and BioCity Nottingham. He currently consults for large number of pharmaceutical and biotech companies on a range of strategic and technical drug development issues.

Colin Gardner was born and educated in Scotland, receiving a BSc and PhD in chemistry from the University of Glasgow.  After post-doctoral studies at Harvard Medical School (Biophysics) and MIT (Chemical Engineering), he returned to Europe and spent 6 years in drug discovery at the Merrell International Research Center in Strasbourg. 

 

Thereafter he joined Merck and Co. in the US, spending the first 4 years as a leader in a drug delivery group.  He was then appointed to lead the interface between drug discovery and early pharmaceutical development, where he changed the paradigm of early intervention which has become standard in the industry.  He progressed in the department to become VP and Global Head of formulation design and development for all Merck products – he was involved in the development of 16 NCEs whose combined maximum annual sales averaged $20Bn and three vaccines.   

 

In 2001, Colin took early retirement from Merck to become the CSO of a start-up formulation company (TransForm Pharmaceuticals) in the Boston area.   Four years later TransForm was acquired by Johnson & Johnson and led to major changes in the way in which J&J integrated discovery and early development. Colin stayed on as the President and Site Leader of TransForm.

 

Colin retired from TransForm/J&J in June 2009 and is now an industry consultant.   He has consulted with over 30 small and medium-sized pharmaceutical and device companies in the Boston area.  Two of these companies have conducted successful IPO’s and two others have been acquired by larger organizations.

Dr. Thomas Laughren currently serves as the director of Laughren Psychopharm Consulting, LLC, a company that seeks to assure the development of safe and effective psychiatric drugs by working with pharmaceutical companies in the planning and execution of their psychiatric drug development programs so as to meet the high standards of FDA and other regulatory agencies. He is retired as Division Director for the Division of Psychiatry Products, Center for Drug Evaluation and Research, at FDA (Silver Spring, MD). Prior to coming to FDA in September 1983, Dr. Laughren was affiliated with the VA Medical Center in Providence, RI, and was on the faculty of the Brown University Program in Medicine, also in Providence.

 

Dr. Laughren received his medical degree from the University of Wisconsin–Madison, and he also completed residency training in psychiatry at the University of Wisconsin. Dr. Laughren is board certified in general psychiatry.

 

As Division Director for the Division of Psychiatry Products, Dr. Laughren oversaw the review of all psychiatric drug development activities conducted under INDs and the review of all NDAs and supplements for new psychiatric drug claims. He has authored or coauthored many papers and book chapters on regulatory and methodological issues pertaining to the development of psychiatric drugs and is a frequent speaker at professional meetings on these same topics. Dr. Laughren has received numerous awards for his regulatory accomplishments.

Dr. Lawrence S. Olanoff is Special Advisor to the President for Corporate Relations at the Medical University of South Carolina (MUSC). After a long career in the pharmaceutical industry, he retired from his last position as President and Chief Operating Officer (2006-2010) at Forest Laboratories, Inc., and served as a Director of Forest Laboratories, Inc. until 2014. He is currently a Board member at Ironwood Pharmaceuticals Inc. He also serves as a member of the non-profit Boards of the Institute for Applied Neurosciences at the Medical University of SC, the Clinical Biotechnology and Research Institute at Roper St. Francis Hospitals, and the WestEdge Development Project and on advisory boards for the Harrington Discovery Institute and BioMotiv, as well as several pharmaceutical companies.

 

Dr. Olanoff was President and Chief Executive Officer of Celsion Corporation from 2005 to 2006. From 1995 until 2005, Dr. Olanoff was responsible for the leadership of research and development activities for Forest Laboratories, Inc. From 1993 to 1995, Dr. Olanoff was Senior Vice President-Clinical Research and Development at Sandoz Pharmaceutical Corporation. From 1984 to 1993, Dr. Olanoff was employed by The Upjohn Company, where his last position was Corporate Vice President-Clinical Development and Medical Affairs.

 

Dr. Olanoff holds MD and PhD (Biomedical Engineering) degrees from Case Western Reserve University and was a medical resident and clinical pharmacology fellow at MUSC. He is the author or co-author of numerous scientific publications in the fields of clinical pharmacology, drug delivery and pharmacokinetics. During his industry career, he was involved in the approval of some 30 new drugs, new indications or novel formulations in the US.

René Russo, PharmD, BCPS is the President and Chief Executive Officer at Arsanis, Inc, a biotechnology company focused on the development of human monoclonal antibodies for the prevention and treatment of serious infectious diseases. Dr. Russo engaged a diverse group of investors into two private financing rounds and through global research foundation grants to fund the company in advance of a successful initial public offering. This effort raised more than $150M in just under 18 months. Prior to Arsanis, Dr. Russo spent 11 years building key medical functions at Cubist Pharmaceuticals culminating in a $9.6B acquisition of the company by Merck. At Cubist, she contributed to the successful launch and commercialization of daptomycin (reaching over $1B in sales annually worldwide) and held various positions including Vice President, Global Medical Affairs where she led Global Medical Sciences, Clinical Microbiology, Health Economics/Outcomes Research and Field Medical Teams for a portfolio of anti-infective products. Dr. Russo played a key role in Cubist’s successful integration of two public companies, Optimer and Trius, in 2013. Dr. Russo serves as a director for Life Science Cares, where she chairs the Nominating and Governance Committee for this rapidly growing nonprofit organization leveraging the collective impact of the Boston life sciences industry to address the cycle of poverty in the Boston area.

Charles, board certified in general psychiatry, is founder and president of Beasley Pharmaceutical and Biotechnology Consulting, LLC. He worked in clinical development and drug safety for Eli Lilly for over 27 years, retiring as a Distinguished Lilly Scholar in 2015.  His work included late-stage development with fluoxetine, olanzapine, atomoxetine, duloxetine, and tadalafil.

 

Charles has published over 95 peer-reviewed articles.  He is an inventor on eight olanzapine patents.  Memberships include AOA and the ASCP. He is a Distinguished Life Fellow of the APA. He is a fellow of the ACPsych, the ACNP, and the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the UK.

Dr. Peter Belafsky, M.D., Ph.D., M.P.H has dedicated his career to the care of individuals with devastating swallowing disorders and is currently working on exciting and new advances in the treatment of dysphagia. After obtaining a combined medical degree and masters in public health from Tulane University in New Orleans, Dr. Belafsky completed a surgical internship and subsequent Ph.D. in Epidemiology from the Tulane University Department of General Surgery and Graduate school. He was a clinical assistant professor in the Department of Epidemiology and Biostatistics and taught Epidemiology 601 and 603 in the evenings while completing his residency in Otolaryngology at Tulane. He finished a fellowship in Laryngology/Bronchoesophagology at the Wake Forest University Department of Otolaryngology in Winston-Salem, North Carolina.

 

After the completion of his fellowship, Dr. Belafsky moved cross-country to accept a position as a clinical Laryngologist and Director of the Scripps Center for Voice and Swallowing in La Jolla, California.  He left Scripps in 2004 to accept a position as Associate Professor and Medical Director of the Center for Voice and Swallowing at the University of California, Davis. In late 2011, he was promoted to Professor from Associate Professor at UCD. Dr. Belafsky’s has dedicated his professional life to the care of individuals with profound swallowing difficulty. Dr Belafsky has authored or co-authored over 110 peer-reviewed articles, 10 book chapters, and a textbook on Esophagoscopy. He has lectured extensively both nationally and internationally. He has developed novel biomechanical swallowing devices and holds several patents.