ABOUT CELLERGY PHARMACellergy Pharma is a privately-held biotechnology company that is developing novel CAR T cell products for treating severe atopic allergic diseases. The company is at the forefront of moving CAR T cells beyond the treatment of cancer, to the treatment of diseases caused by the immune system. Cellergy’s Lead product, CP-010, is in development for treating Uncontrolled Severe Allergic Asthma.https://cellergypharma.com

CAR T Cells provides consulting services in the areas of chimeric antigen receptor engineered T cells (CAR T cells), T-cell receptor engineered T cells (TCR T cells), and in immunotherapy, in general. Adapter CAR (switchable CAR) is an area of unique expertise.

I joined Miltenyi upon the acquisition of my third CAR T cell startup, Living Pharma. I worked with an amazingly talented and hard-working group to develop the Adapter CAR™ platform. Applications include hematological and solid organ cancers. Marketing chops: I convinced the company to trademark "Adapter CAR", and worked with the legal team to do it. I also coined the phrase “Personalized CAR T Cell Therapy” which was Living Pharma’s tagline and prominently displayed on our website.… Show more I joined Miltenyi upon the acquisition of my third CAR T cell startup, Living Pharma. I worked with an amazingly talented and hard-working group to develop the Adapter CAR™ platform. Applications include hematological and solid organ cancers. Marketing chops: I convinced the company to trademark "Adapter CAR", and worked with the legal team to do it. I also coined the phrase “Personalized CAR T Cell Therapy” which was Living Pharma’s tagline and prominently displayed on our website. Flatterting to see Miltenyi Biomedicine run with it, their right, as Miltenyi acquired Living Pharma.https://www.miltenyibiomedicine.com/research-pipeline Show less

Living Pharma was the first Adapter CAR (switchable CAR) T cell company in the world, and the third CAR T cell company that I have founded.An Adapter CAR, or switchable CAR, is a chimeric antigen receptor that recognizes a tag in a targeting molecule. Tagged fragment antibodies are common, but the technology can be used with any class of targeting molecule. An Adapter CAR has several advantages over the more common direct CAR platform:1.) It is a universal CAR.2.) It… Show more Living Pharma was the first Adapter CAR (switchable CAR) T cell company in the world, and the third CAR T cell company that I have founded.An Adapter CAR, or switchable CAR, is a chimeric antigen receptor that recognizes a tag in a targeting molecule. Tagged fragment antibodies are common, but the technology can be used with any class of targeting molecule. An Adapter CAR has several advantages over the more common direct CAR platform:1.) It is a universal CAR.2.) It enables multi-targeting by using a panel of adapters.3.) It enables patient specific matching of adapters to tumor targets.4.)It solves target-loss, tumor-antigen escape.5.) It has a built-in safety switch.I founded Living Pharma in January 2016, with one of the inventors of the technology, Dr. Eduardo Davila. We exclusively licensed the dominant and original Adapter CAR patent from the University of Maryland, Baltimore.Living Pharma was acquired one-and-one-half years after its founding by Miltenyi Biotec on June 29, 2017. I joined the acquiring company to continue to develop the technology, and to bring it to a first-in-human clinical study. Living Pharma is the third CAR T cell company that I have started. The first-in-the-world Adapter CAR company, it heralded the growing Adapter CAR segment of the CAR industry.To learn more, please view our website: https://livingpharma.com Show less

Juno Therapeutics is commercializing chimeric antigen receptor engineered T cells (CAR T cells) for the treatment of cancer. I joined Juno from my second CAR T cell startup, Restoration Oncology, and brought into the company what became the lead CAR T cell product, JCAR015.Juno Therapeutics was founded upon acquiring ZetaRx Biosciences, Inc, a Mike Jensen CAR T cell startup, and upon acquiring the products and technology of Restoration Oncology. The Fred Hutch CAR T's, including what… Show more Juno Therapeutics is commercializing chimeric antigen receptor engineered T cells (CAR T cells) for the treatment of cancer. I joined Juno from my second CAR T cell startup, Restoration Oncology, and brought into the company what became the lead CAR T cell product, JCAR015.Juno Therapeutics was founded upon acquiring ZetaRx Biosciences, Inc, a Mike Jensen CAR T cell startup, and upon acquiring the products and technology of Restoration Oncology. The Fred Hutch CAR T's, including what would become Breyanzi, completed the triumvirate. Yes, starting out, Juno had three distinct CD19 CAR T cell products, each made by a unique manufacturing process! Show less

Restoration Oncology, Inc. (ROI) is the second CAR T cell company that I have started. ROI was founded by two of the former ImmunoStem founders (See ImmunoStem below). We licensed three CAR T cell patents from Memorial Sloan Kettering Cancer Center including the in-the-news CD19 CAR patent, and a very interesting CAR T cells from stem cells patent, first proposed by ImmunoStem.ROI developed chimeric antigen receptor (CAR) engineered T cells for the treatment of cancer. Products… Show more Restoration Oncology, Inc. (ROI) is the second CAR T cell company that I have started. ROI was founded by two of the former ImmunoStem founders (See ImmunoStem below). We licensed three CAR T cell patents from Memorial Sloan Kettering Cancer Center including the in-the-news CD19 CAR patent, and a very interesting CAR T cells from stem cells patent, first proposed by ImmunoStem.ROI developed chimeric antigen receptor (CAR) engineered T cells for the treatment of cancer. Products included a CD19 CAR T for treating Acute Lymphoblastic Leukemia, and a PSMA CAR T for treating prostate cancer.ROI received three term sheet offers of investment of $30 million, $20 million and $10 million, from two tier-one venture capital companies and one privately held biotechnology company, respectively, ROI's lead product, ROI-19, became the Juno Therapeutic's lead product, JCAR015. The intellectual property, products and clinical program of ROI transitioned to Juno Therpeutics and contributed to the company's success. By acquiring ROI-19, Juno was able to leap into the flagship CAR T cell company tier, alongside Kite Pharma and Novartis. Show less

Solutions for the manufacture of cellular therapies. I was the US cell therapy SME for SANYO Biomedical which was acquired by PHCNA. SANYO had designed and built Dr. Shinya Yamanaka's GMP cell manufacturing suites in Osaka, Japan. I helped develop GMP manufacturing labs at several academic and industrial sites. The position allowed for an excellent reimmersion into cellular therapy, after a several years absence, and an interesting enough day job while I created my second CAR T cell startup,… Show more Solutions for the manufacture of cellular therapies. I was the US cell therapy SME for SANYO Biomedical which was acquired by PHCNA. SANYO had designed and built Dr. Shinya Yamanaka's GMP cell manufacturing suites in Osaka, Japan. I helped develop GMP manufacturing labs at several academic and industrial sites. The position allowed for an excellent reimmersion into cellular therapy, after a several years absence, and an interesting enough day job while I created my second CAR T cell startup, Restoration Oncology, Inc. Show less

Radiant Biosciences offered label-free technology consulting services. Clients include Silicon Kinetics, Inc., Plexera, LLC, and others. I set up evaluations of the Silicon Kinetics SKiPro System at several antibody discovery companies, and helped develop applications of their unique label-free technology. I also consulted at the re-born Plexera Bioscience, LLC, now called Plexera, LLC.

Co-founder of this spinout from public photonics company Lumera Corporation (LMRA) . Plexera Bioscience developed high-throughput, label-free drug discovery technology using high-density surface plasmon resonance (SPR) microarrays. I designed the business plan for the company, focusing the developing technology in the antibody discovery market. Applications in development included an Fc receptor array, and a protein kinase array, for which I was issued a patent.The platform was very… Show more Co-founder of this spinout from public photonics company Lumera Corporation (LMRA) . Plexera Bioscience developed high-throughput, label-free drug discovery technology using high-density surface plasmon resonance (SPR) microarrays. I designed the business plan for the company, focusing the developing technology in the antibody discovery market. Applications in development included an Fc receptor array, and a protein kinase array, for which I was issued a patent.The platform was very attractive to the antibody discovery market and we experienced SRO crowds when we presented early data at antibody discovery meetings. A collaboration I began with Dr. Dan Sexton at Dyax Corporation, was yielding nice data on an alpha stage PlexArray™ Analyzer system for analyzing phage display supernatants. A second collaboration at Los Alamos Labs yielded very nice antibody discovery data using prototype systems. http://www.plexera.com/pdf/PlexArrayHT_EN.pdfPlexera Bioscience was closed suddenly in 2008, after the sale of parent company Lumera Corporation to rival GigaOptix. I continued along with another co-founder in trying to raise private equity to fund the company, but LMRA BOD demands drove away the few potential investors that could be found during the peaking financial crisis. The assets were eventually purchased at a sizeable discount by an investor in China, and I eventually consulted for the reborn company, Plexera, LLC. http://www.plexera.com/. (BTW, I coined the name "Plexera".) https://www.photonics.com/a32940/Lumera_GigOptix_to_MergeTrue believer Wasatch Microfluidcs, Inc., then a one-man operation, whose recirculating pump was being evaluated in the PlexArray Analyzer flow cell at the time of Plexera Bioscience's closure, developed their own version of the PlexArray Analyzer, which they are marketing to the antibody discovery market, with a Plexera Bioscience former advisor as their CSO. Yes, it is a good idea. See: https://carterra-bio.com/ Show less

ImmunoStem made what was, in 2015, a startling proposal - allogeneic T cells including CAR T cells made from stem cells. Lead product ISI-001 was a polyclonal anti-EBV T cell product made from healthy donors. CD19 and CD20 CAR T cells were in the pipeline. ImmunoStem's RegenImmune platform manufactured CAR T cells from stem cells using the OP9-DL1 system (hence the name ImmunoStem). Quite a bit ahead of its time, the company was unable to raise significant funding.… Show more ImmunoStem made what was, in 2015, a startling proposal - allogeneic T cells including CAR T cells made from stem cells. Lead product ISI-001 was a polyclonal anti-EBV T cell product made from healthy donors. CD19 and CD20 CAR T cells were in the pipeline. ImmunoStem's RegenImmune platform manufactured CAR T cells from stem cells using the OP9-DL1 system (hence the name ImmunoStem). Quite a bit ahead of its time, the company was unable to raise significant funding. RegenImmune was patented by an institution that had reviewed ImmunoStem's business plan, and patented without attribution to ImmunoStem, and licensed to a struggling biotech company. You might say it was Fate. Show less

Xcyte Therapies developed T cell immunotherapies for oncology indications. Xcyte’s Xcellerated T Cells™ lead product did not perform well in clinical studies, and the company ceased operations. Compared to today’s technology, Xcyte’s was equivalent to expanding all of the hay in a haystack to look for the needle, but the company did develop a key tool for the manufacture of CAR T cells, the CD3/CD28 Xcyte™ Dynabeads®, currently used in the manufacture of the FDA approved Novartis Kymriah® CD19… Show more Xcyte Therapies developed T cell immunotherapies for oncology indications. Xcyte’s Xcellerated T Cells™ lead product did not perform well in clinical studies, and the company ceased operations. Compared to today’s technology, Xcyte’s was equivalent to expanding all of the hay in a haystack to look for the needle, but the company did develop a key tool for the manufacture of CAR T cells, the CD3/CD28 Xcyte™ Dynabeads®, currently used in the manufacture of the FDA approved Novartis Kymriah® CD19 CAR T cell product as well as in other CAR T cell products. Veterans of Xcyte would later go on to found Juno Therapeutics. Show less

Aastrom (Ann Arbor Stromal Cell) Biosciences’ original mission was to develop bone marrow expansion technology, the rationale being that a single bone marrow aspirate could be expanded to yield a complete cellular product suitable for transplantation. Unfortunately, the company was never able to expand hematopoietic stem cells, and the field began moving towards using mobilized peripheral blood as a source for HSC’s. Aastrom had a near-meltdown experience as a result, and I was hired to… Show more Aastrom (Ann Arbor Stromal Cell) Biosciences’ original mission was to develop bone marrow expansion technology, the rationale being that a single bone marrow aspirate could be expanded to yield a complete cellular product suitable for transplantation. Unfortunately, the company was never able to expand hematopoietic stem cells, and the field began moving towards using mobilized peripheral blood as a source for HSC’s. Aastrom had a near-meltdown experience as a result, and I was hired to investigate new cellular therapy opportunities for the company’s capabilities. During 2002-2004, we pursued a cellular immunotherapy program that included investigational Phase I dendritic cell vaccine and T-cell immunotherapy clinical studies with leading academic partners. However, the cancer vaccine field began to fall out of favor with investors, and the company’s semi-automated bioreactor was not suitable for growing suspension cells like T cells. The CEO of the company decided to reposition Aastrom as a regenerative stem cell company, as putative mesenchymal stem cells could be expanded in the bioreactor, but not HSC’s. His rationale was that as the expanded marrow product had been infused into bone marrow transplant patients, using the same product to pack non-union bone fractures would face a low regulatory hurdle, and so Aastrom became a regenerative stem cell therapy company, with bone regeneration as its lead clinical focus.As my interests were in cancer immunotherapy, I left Aastrom for T-cell immunotherapy pioneer Xcyte Therapies. I brought along with me a great interest in the Juan Carlos Zuniga-Pflucker technology of directing stem cells into T cells, having been informed of the technology by a University of Toronto Sunnybrook Research Institute licensing representative, while at Aastrom. This was to become the namesake technology of my first T cell immunotherapy startup, ImmunoStem. (https://pubmed.ncbi.nlm.nih.gov/12479821/) Show less

Miltenyi Biotec markets the CliniMACS Cell Selection System used in stem cell therapy applications. I was the business unit manager for clinical products, North America. The leading clinical application of the CliniMACS was selection of HSC's from haploidentical donors for allogenic HSC transplantation. Emerging applications included cellular immunotherapy.

Bioinstrumentation product management. A leading program was clinical microbiology flow cytometry including rapid antimicrobial susceptibility testing and rapid UTI screening.

I developed antibody drug conjugates (ADC's), antibody toxin conjugates and radioimmunoconjugates. I managed an immune tolerance research project.

I was engaged in studying the T-cell receptor repertoire, prior to the elucidation of the structure of the T cell receptor. I was fortunate to have worked in the visionary Linda Sherman/Norman Kleinman lab during a remarkable time in the field of immunology.