Our History


Our Leaders


Founders

“Humanity’s deepening understanding of biology is driving a revolution in bioengineering that parallels the industrial revolutions that followed the birth of modern physics and chemistry. Ossium is driving this progress forward by making the building blocks of life the raw materials of therapeutics. We’re building a future in which healthcare is about preserving health, not just treating symptoms.”

CEO, Co-Founder & President

Kevin Caldwell

CEO, Co-Founder & President

As CEO, Co-Founder & President of Ossium Health, Kevin Caldwell has built Ossium from a 2 person startup into a clinical stage bioengineering company.  Kevin set the company’s mission to improve human health through bioengineering and designed its platform-based model for cellular therapeutics development.  Kevin has led the company’s successful pursuit, negotiation, and execution of more than 50 business relationships, including multiple fundraisings and dozens of supply partnerships, clinical partnerships, and commercial contracts with biopharmaceutical companies.

Prior to founding Ossium, Kevin served as an Engagement Manager at McKinsey’s San Francisco office where he advised clients in the biotechnology and healthcare sectors. His projects ranged from due diligence of acquisition targets in the biotech startup ecosystem to restructuring distressed biopharma companies. Mr. Caldwell led more than 20 engagements with more than a dozen clients, leading teams that advised clients on revenue growth, go to market strategy, and organizational restructuring.

Before McKinsey, Kevin served as a Senior Investment Associate at Bridgewater Associates where he did quantitative research for the firm’s global macro investments. A graduate of both MIT and Harvard, Mr. Caldwell studied Physics and Economics at MIT before receiving his JD from Harvard Law School. Mr. Caldwell is a member of the Young President’s Organization (YPO), and a Fellow of the Leaders in Tech Program.

“Human beings are complex biological systems upon systems. Cell therapies offer a chance to utilize biology to do things we are just incapable of with current pharmaceutical approaches. Cells as medicine allow a therapy to interpret what is going wrong with the system and respond accordingly – not just with one molecule, but with dozens, in specific ratios leading a symphony of healing.”

Chief Science Officer, Co-Founder & EVP

Erik Woods

Chief Science Officer, Co-Founder & EVP

Dr. Woods has devoted his career to advancing cell selection, culture and cryopreservation to facilitate mainstream clinical use of cellular therapies.  Originally co-founding and leading General BioTechnology, LLC (GBT), a commercial cryobank, contract cell-manufacturing and R&D company, which he led for 15 years through successful acquisition by COOK Medical in 2012. During that time, he ran a continuously grant funded research program that created numerous successful technologies, including the first closed-system cryovial for cellular therapeutics, now marketed as CellSeal® by Sexton Biotechnologies, and the first mass produced human platelet lysate product, marketed as Stemulate®, both now used globally.

Following acquisition of GBT, Dr. Woods served as Senior VP of COOK Regentec and oversaw the scale up manufacturing of products in the US and Europe, and managed global projects involving multiple teams. Additionally, he served as an officer in Medistem, Inc., an early phase cell therapy company, where he developed isolation, manufacturing, and cryopreservation methods and prepared the CMC for their proprietary allogeneic Endometrial Regenerative Cell (ERC) technology IND and assisted in that company’s successful acquisition by Intrexon Corp.

Dr. Woods has a proven track record of developing new cell processing and banking technologies and translating them to the clinic. Over his career, he has been responsible for overseeing clinical laboratory operations as a board certified High Complexity Clinical Laboratory Director (HCLD), and in that capacity he ran the only FDA registered commercial sperm bank and the only umbilical cord blood bank in the state of Indiana, obtaining State Licensure, CLIA certification for testing, and American Association of Blood Banks (AABB) Accreditation.

Dr. Woods is a Fellow and Past President of the Society for Cryobiology and has published numerous peer reviewed manuscripts and book chapters and holds multiple patents in the field. Dr. Woods received his BA from Indiana University, his PhD from Purdue University, and he completed his postdoctoral research at the Indiana University School of Medicine.


Leadership Team

Wa'el Al Rawashdeh

Director of Development

Wa'el Al Rawashdeh

Director of Development

Dr. Al Rawashdeh has an interdisciplinary career focusing on the clinical translation of cell therapies and development of molecular imaging platforms. Prior to joining Ossium, he held a number of critical roles at Miltenyi Biotec, a global market-leader in cell processing, that enabled the creation of a successful CAR T cell therapy program. Dr. Al Rawashdeh developed industry-leading non-clinical development (NCD) and molecular imaging platforms and led the in vivo NCD packages of the CAR T cell therapy program, which in 4 years resulted in 4 CIT approvals in Germany, 1 IND pivotal trial FDA application, and 1 successful approval of an ‘orphan drug’ by the EMA. Dr. Al Rawashdeh developed a novel animal model that permitted the approval of the first CAR T cell clinical trial in Europe targeting melanoma.

On the research front, Dr. Al Rawashdeh spearheaded the initiation of an industry-academia consortium that successfully secured a major grant of $1.6 million from the EU European Funding for Regional Development initiative to develop novel CAR T cell therapies against solid tumors and cell tracking strategies, and led the project up to the time of his departure in 2021, when he joined Ossium. .

As a postdoc at RWTH Aachen University, Germany’s top engineering university, Dr. Al Rawashdeh co-developed novel optical imaging technology that convinced MiLabs, a global leader in molecular imaging, to adopt the technology and build and commercialize a hybrid tomography system that generated over $10 million in sales to date. Furthermore, on the basis of his original research and project design where he recruited industry partners from Germany, Italy and the UK, he secured a $1 million grant from the European Union’s European Commission in the highly competitive multi-country BioPhotonics call.

Dr. Al Rawashdeh completed his BS from California State University, Fresno, and his MSc and Ph.D. from RWTH Aachen University.

Oliver Cácananta

Senior Director of Regulatory Affairs

Mr. Cacananta is a 25-year veteran of the biopharmaceutical industry, having worked broadly with biologics, combination medical devices, and small molecule drugs. He has extensive involvement in collaboration or leadership of approved marketing and investigational regulatory filings (BLAs, MAAs, PMA, CE Mark, 510(k), NDA, INDs/IDEs as well as CMC and other pre- and post-approval commitment submissions) and in organizing and participating in various agency interactions (e.g., PDUFA meetings and advisory panel). His global experience spans multiple therapeutic areas, including vaccines for influenza and biodefense medical countermeasures, diabetes and other metabolic disorders, endovascular disease, blood pathogen reduction technologies, and cell therapy for ophthalmology and medical aesthetics, and diverse geographies, working with partners and agencies across North America, Europe, Asia-Pacific (primarily China, Japan, and Australia), South America, and Middle East-North Africa.

Mr. Cacananta’s career and contributions to research and science are rooted in the intersections of the biotech and pharmaceutical industry and the quality and regulatory pathways by which treatment and technological innovations reach patients. As a regulatory professional, his impact comes from shepherding research products through the product lifecycle, from clinical trials to market approval, all the while ensuring that products are safe and efficacious and are within the regulatory parameters set forth by governing agencies.

Mr. Cacananta has worked at a variety of large and small biotechnology companies, including Lineage Cell Therapeutics, Cerus Corporation, Medtronic, Amgen, Emergent BioSolutions, BioMarin Pharmaceuticals, and Chiron Corporation. He received his BS in Biological Sciences from California State University, East Bay, and MBA in Global Management from the University of Phoenix.

Jay Gardner

Director of People & Talent

Ms. Gardner is a hands-on People leader with deep experience supporting high-growth startups across SaaS, cleantech, and fintech. Her focus is building scalable People and Talent infrastructure that emphasizes connection and engagement across multiple locations, teams, and levels.

Before joining Ossium, Ms. Gardner established the People team as employee #18 at Turntide Technologies, a cleantech electric motor startup with backing from Jeff Bezos, Bill Gates, and Robert Downey Jr. During her tenure, she cemented the People team as the connective tissue for a before-its-time hybrid model of 6 offices and 40% remote staff, and drove 555% headcount growth across the company. At Turntide she rolled out multiple people-focused initiatives including introducing OKRs, creating a recruiting playbook, founding a DEBI (Diversity, Equity, Belonging, & Inclusion) team, and building out the onboarding program Turntide 101. Ms. Gardner also spent 4 years in HR Consulting, working with startups across the nation to implement HR systems and best practices. Her team supported between 30-40 clients at any given time to onboard companies’ first hires, create a foundational HR base, and set the company up for future success with a focus on proactive consultative HR.

Prior to finding her calling in the People space, Ms. Gardner worked in guest operations at San Francisco’s two science museums: The California Academy of Sciences (where she presented public engagement shows underwater as a scuba diver) and the Exploratorium. Ms. Gardner received her BA in Feminist Studies from Stanford University, where she won a national championship as a member of the women’s water polo team and was named to the All-American team all four years. She also spent six months playing professional water polo overseas in Greece.

Brian Johnstone

VP of Research

For the past 20 years, Dr. Johnstone has been actively involved in translating adult stem cell therapies into treatments for a host of diseases affecting the major organs of the body. In 2004, he co-authored one of the first studies demonstrating the potential for treating cardiovascular diseases with novel adult stem cells isolated from fat.

Since then, Dr. Johnstone has continued to develop and test new medical uses for adult stem cells as part of his own research as well as in collaboration with international academic centers and pharma / biotech firms.

Outside of the research setting, Dr. Johnstone co-founded NeuroFx, an early-stage biotech firm developing a novel therapy for neurological disorders. Dr. Johnstone led the R&D program at NeuroFx for two years, where he was directly responsible for preclinical and chemistry, manufacturing, and controls development activities. He continues to act as an advisor for NeuroFx. Additionally, Dr. Johnstone has formed two other biotech companies, Chemigen, which is developing a small molecule drug for treating Lou Gehrig’s disease, and EmphyMab Biotech (now Allinaire), which is developing biologics to treat serious lung diseases.

Before becoming an entrepreneur, Dr. Johnstone was an early employee at Sangamo Biosciences for 6 years, where he managed the preclinical development program for their lead gene therapy candidate for cardiovascular diseases, which is currently in Phase II clinical testing. Dr. Johnstone received his Ph.D. from the University of Maryland, College Park, and completed a postdoctoral fellowship at the University of California, Los Angeles.

Margie Mathewson

VP of Business Operations

Dr. Mathewson’s career has focused primarily on helping start-ups and small businesses build out robust operations, from internal structures and systems to external partnerships. Prior to joining Ossium, Dr. Mathewson was the 7th team member at Point, a FinTech start-up offering non-traditional options for home equity funding, where she led Business Operations. While there, she drove development of an underwriting process for nontraditional, complicated customers that allowed funding of Point’s initial set of homeowners, including the first to successfully exit the investment. She also communicated complex mathematical concepts to homeowners to educate them on the Point investment model and how their equity sale would work.

Dr. Mathewson also worked as a consultant for McKinsey & Company, where, among other projects, she helped develop a rapid growth strategy for a successful health system, overhauled a sales and supply chain planning process to improve communication and ensure every customer got what they ordered on time, and restructured the international sales team for a major global telecom. Dr. Mathewson completed her PhD at the University of California, San Diego, where she was an NSF Fellow and founded a successful mentorship program for first generation college students in engineering.

Sagar Munjal

Senior Vice President of Clinical Development

Dr. Sagar Munjal has more than eighteen years of experience in drug development and product strategy.  His expertise spans clinical development (phase I-IV), clinical operations, medical affairs, R&D, and global product launches. Dr. Munjal has worked in eight therapeutic areas, has brought four products to the market. He has worked extensively with regulatory and government agencies, including the FDA, EMA, MHRA, ANVISA, DCGI. Dr. Munjal has drug development experience in small molecules, drug-device combination products and biologics.

Dr. Munjal has managed global teams in US, Europe and India. He has worked with small and big CRO’s, investors and scientific advisors. Dr. Munjal successfully negotiated a complex failed phase 3 study with FDA to manage product approval.

Before joining Ossium, Dr. Munjal worked at Dr. Reddy’s Laboratories Inc-USA, and was chief medical officer at Promius Pharma LLC, a wholly owned subsidiary of Dr. Reddy’s. Before Dr. Reddy’s, he worked at Johnson & Johnson, Altria and in clinic as an investigator. Dr. Munjal has published more than 30 manuscripts related to clinical studies, presented more than 60 abstracts in various scientific meetings and was recipient of 2017 Harold G. award for key scientific contribution in migraine area by American Headache Society. Dr. Munjal received his MD at Karnataka University Dharwad, India and his MS in clinical research and biostatistics from Virginia Common Wealth University.

Chip Walker-Wilson

VP of Legal

Chip Walker-Wilson is the Vice President of Legal, and he is responsible for overseeing Ossium Health’s legal and corporate governance functions.

Prior to joining Ossium Health, Mr. Walker-Wilson served as legal counsel at Cytokinetics, a clinical-stage biopharmaceutical company with development programs in the areas of cardiovascular and neurological diseases.  At Cytokinetics, Mr. Walker-Wilson primarily supported the Research & Development Department, including the Clinical Operations, Non-Clinical Development, Research, Biometrics and Informatics groups.  Prior to Cytokinetics, Mr. Walker-Wilson served as legal counsel at Dynavax Technologies Corporation, a biotechnology company with development programs in vaccines, cancer immunotherapies and autoimmune and inflammatory diseases.  At Dynavax, Mr. Walker-Wilson provided support across the company, including the Research & Development, Technical Operations, Corporate Governance, Business Development, Information Technology, Regulatory, Quality, Human Resources and Medical Affairs groups.  Prior to Dynavax, Mr. Walker-Wilson served as legal counsel at Abbott Laboratories.  Mr. Walker-Wilson supported Abbott Diabetes Care, which is a medical device manufacturer that develops and sells blood glucose monitoring products.  At Abbott, Mr. Walker-Wilson primarily worked with the Sales, Marketing, Strategic Partnership and Alliances, Business Development and Customer Service groups.  Prior to Abbott, Mr. Walker-Wilson worked at the law firms of Orrick, Herrington & Sutcliffe and Sheppard, Mullin, Richter & Hampton, where his practice focused primarily on corporate and securities law and finance law.

Mr. Walker-Wilson received his B.A. in Legal Studies (with a minor in Rhetoric) from the University of California, Berkeley and his J.D. from the University of California, Berkeley School of Law.



Board of Directors

Kevin Caldwell

CEO & Co-Founder, Ossium Health

Edgar G. Engleman

Partner & Chief Scientific Advisor, Vivo Capital

Jesse Horwitz

Co-Founder, Hubble Contacts

Ron Paulus

Executive in Residence, General Catalyst

Bill Trenchard

Managing Partner, First Round Capital

Erik Woods

Chief Science Officer & Co-Founder, Ossium Health


Platform


The Next Generation of Stem Cell Therapies

Ossium has created a new paradigm for cell therapy development by bringing the deceased donor transplant ecosystem into the fight against diseases of the blood and immune systems.



Partners


Let's Work Together

We work closely with healthcare providers, life science companies, and organ procurement organizations to develop and deploy cell therapies.

Healthcare Providers

Life Science Companies

Organ Procurement Organizations


Join Our Team

At Ossium, we’re always looking for talented, mission-driven people.