At Know The Edge Consulting, we specialize in providing top-tier consulting services in cell and gene therapy. With a focus on innovation and excellence, we help clients navigate the complexities of biotech investments.
Today, Cell and Gene Therapies (CGTs) represent the cutting edge of modern medicine, offering personalized treatments that are revolutionizing patient care despite their complex manufacturing processes. The journey to this point has paralleled other groundbreaking technologies, overcoming significant hurdles such as initial skepticism from investors and drug developers. In the early days, CGTs were on the “bleeding edge,” marked by uncertainty and challenges to success.
Understanding and navigating these edges—both cutting and bleeding—are crucial to succeeding in the CGT space. It requires foresight, innovation, and resilience to harness the full potential of CGTs and deliver transformative therapies that positively impact patients’ lives.
The starfish, renowned for its remarkable regenerative abilities (Starfish Regeneration), serves as an ideal symbol for our commitment to regenerative medicine. Given that cell and gene therapies (CGTs) embody this regenerative potential, the starfish aligns perfectly with our mission and values, making it a fitting choice for our logo. Additionally, the starfish’s five arms symbolize the five facets of modern medicine:
Founder and President
After spending several years as a team leader in drug discovery, Dr. Niss transitioned in 2009 to Pfizer’s regenerative medicine group, where he took on the role of leading the adult stem cell (ASC) efforts. His tenure at Pfizer was marked by significant achievements, notably spearheading a pivotal licensing deal with Athersys inc., a prominent company specializing in adult stem cells (ASC) at the time. As part of this collaboration, Dr. Niss chaired the joint research steering committee, facilitating productive synergies between Pfizer and Athersys. These collaborative efforts culminated in the successful initiation of a clinical trial utilizing Athersys’ proprietary cells.
Following the closure of Pfizer’s regenerative unit, Dr. Niss transitioned to EMD Millipore (now MilliporeSigma) to assume leadership of the R&D efforts focused on stem cells. Under his direction, Dr. Niss and his team achieved a significant milestone by pioneering the first successful manufacturing process utilizing microcarrier-driven mesenchymal stem cell (MSC) expansion in large bioreactors. This breakthrough not only demonstrated technical innovation but also translated into substantial commercial success, generating over $2 million in revenue.
In 2013, Dr. Niss embarked on a pivotal role at Novartis within the newly acquired cell therapy program based in Morris Plains. His primary responsibility was to lead the technical transfer efforts for ctlo19, which is now recognized as kymriah. Working closely with a diverse cross-functional team, Dr. Niss successfully managed the transfer process from the university of pennsylvania to Novartis’ Morris Plains manufacturing facility. Following this achievement, Dr. Niss transitioned to collaborating with the Chief Scientific Officer of novartis’ cell and gene therapy (CGT) unit. In this capacity, he played a crucial role in expanding the CGT pipeline, contributing his expertise to drive innovation and advance novel therapies within novartis’ portfolio.
Following his significant contributions in lentivirus-modified carts, Dr. Niss transitioned to Biogen as the CMC (chemistry, manufacturing, and controls) lead for a pioneering approach involving gene-edited hematopoietic stem cells (HSCS) targeted at treating sickle cell anemia and beta-thalassemia. In this pivotal role, Dr. Niss assumed responsibility for all aspects of CMC, from leading process development initiatives to meticulously selecting and overseeing contract development and manufacturing organizations (CDMOs). His expertise and leadership were instrumental in advancing Biogen’s innovative therapies towards clinical development, aiming to address critical unmet medical needs in genetic disorders affecting blood cells.
In 2017, Dr. Niss joined MustangBio during its start-up phase, where he played a pivotal role in its growth, ultimately serving as Chief Technology Officer. He spearheaded the establishment of a state-of-the-art manufacturing facility dedicated to cell therapies, ensuring it was fully equipped and staffed to meet stringent operational demands. Dr. Niss also led technical operations, overseeing seamless technology transfers and contributing to the successful filing of several investigational new drug applications (INDs). In collaboration with the executive team, Dr. Niss was able to secure over $50 million in new funding, significantly extending MustangBio’s financial runway.
In 2023, Dr. Niss assumed the role of Chief Technology Officer at eGenesis, a xenotransplant company, focusing on the establishment of clinical donor animal production. His responsibilities included the implementation of a robust quality organization and overseeing a strategic restructuring aimed at achieving clinical readiness. Thanks to these efforts, eGenesis achieved a significant milestone in 2024 by successfully donating the first porcine kidney for human transplant.
