Journal Archive

Commercial Insights

Cell & Gene Therapy Commercial Insight – April 2018

Mark Curtis & Richard Philipson

Providing a critical overview of the sector’s commercial developments – M&As, licensing agreements & collaborations, financial results, IPOs and clinical/regulatory updates, with commentary from our Expert Contributors.

CELL THERAPY:

April was a month of healthy financing activity for the T-cell industry. Just when we thought a series A couldn’t get any larger, Allogene hit the ground running with a $300 million financing to get deep into clinical development with a series of allogeneic CAR-T therapies. The company will be led by ex-Kite CEO Arie Belldegrun. Pfizer will retain a 25% equity interest in the company in exchange for the portfolio of assets it will contribute. The deal immediately positions Allogene as a market leader in allogeneic CAR-T therapy. Allogene’s primary competitor, Cellectis, successfully executed an IPO to haul in $165 million to continue clinical development of its universal T-cell therapies. Cellectis will use $100 million of its IPO proceeds to construct a gene editing facility to support its clinical programs. The advent of gene editing approaches to make allogeneic T-cell immunotherapy possible have propelled the technology and made the allogeneic versus autologous debate more relevant than ever.

GENE THERAPY:

This month sees Pfizer continuing to advance its rare disease and gene therapy pipeline, with the Phase 1 start of its AAV-based gene therapy for Duchenne muscular dystrophy, a program that comes from its acquisition of Bamboo Therapeutics in 2016. Pfizer leads the pack of big pharma companies advancing pipelines in rare diseases, following GSK’s recent exit from the field, and seems fully committed to getting novel therapies approved. In the opposite corner to the Pfizer leviathan, the small biotech company GenSight Biologics is making the best of results from its Phase 3 clinical trial in Leber’s hereditary optic neuropathy, which missed its primary endpoint of improvement in visual acuity; the company is pinning its hopes on differences in retinal ganglion cell macular volume in treated versus untreated eyes, but this is unlikely to be an endpoint acceptable to regulators, and it clearly hasn’t yet translated to a clinically meaningful effect on vision. It looks like more hard work ahead to get this treatment approved.

DOI: 10.18609/cgti.2018.040
Citation: Cell Gene Therapy Insights 2018; 4(4), 385-395.

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Interview

Fixing the weak links in the cell therapy manufacturing chain: processes, people and partnerships

Interview

Philip G Vanek

Phil Vanek GE

Phil is General Manager of GE Healthcare’s Cell and Gene Therapy business strategy, a business initiative funded in part by GE Healthymagination, a $6 billion strategy to revolutionize the world’s health by improving the quality, access and affordability of care. Prior to joining GE, Phil was Head of Business Development for Cell Therapy, and later Head of Innovation for Lonza’s Pharmaceutical division, helping to drive new technology initiatives focused on cell, protein and viral therapeutic manufacturing. Phil’s career has included a number of innovation, business and market development roles at Becton Dickinson, Invitrogen and Life Technologies, as well as two start-up biotechnology companies in the Washington, DC area. Additionally, Phil was an Instructor for Johns Hopkins University Advanced Academic Programs teaching Biotechnology Marketing for several years while working at BD and Lonza. Phil received his PhD in Biochemistry and Molecular Biology from Georgetown University Medical Center and subsequently held an IRTA fellowship at the National Cancer Institute in the Laboratory of Molecular Oncology and the Hollings Cancer Center in Charleston, South Carolina. Phil is an active board member of the Alliance for Regenerative Medicine and the ARM Foundation, as well as the Centre for Commercialization of Regenerative Medicine (CCRM) in Toronto. Phil has published a number of industry position pieces and serves on the Editorial Board of Cell and Gene Therapy Insights.

DOI: 10.18609/cgti.2018.031
Citation: Cell Gene Therapy Insights 2018; 4(4), 309-316.
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Review

Clinical Applications of Regulatory T cells in Adoptive Cell Therapies

Spotlight Article

Expert Insight

Gregory P Marshall II, Judit Cserny, Daniel J Perry, Wen-I Yeh, Howard R Seay, Ahmed G Elsayed, Amanda L Posgai and Todd M Brusko

SEPARATION AND EXPANSION TECHNOLOGIES

Interest in adoptive T-cell therapies has been ignited by the recent clinical success of genetically-modified T cells in the cancer immunotherapy space. In addition to immune targeting for malignancies, this approach is now being explored for the establishment of immune tolerance with regulatory T cells (Tregs). Herein, we will summarize the basic science and clinical results emanating from trials directed at inducing durable immune regulation through administration of Tregs. We will discuss some of the current challenges facing the field in terms of maximizing cell purity, stability and expansion capacity, while also achieving feasibility and GMP production. Indeed, recent advances in methodologies for Treg isolation, expansion, and optimal source materials represent important strides toward these considerations. Finally, we will review the emerging genetic and biomaterial-based approaches on the horizon for directing Treg specificity to augment tissue-targeting and regenerative medicine.

Submitted for peer review: Mar 15 2018 Published: May 30 2018
DOI: 10.18609/cgti.2018.042
Citation: Cell Gene Therapy Insights 2018; 4(1), 405-429.
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Expert Insight

The Importance of Collection, Processing & Biopreservation Best Practices in Determining CAR-T Starting Material Quality

Spotlight Article

Innovator Insight

Lou Juliano, George Eastwood, Todd Berard & Aby J Mathew

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

The approval of several CAR-T cell therapies highlights the ongoing transition of cell-based therapeutics from clinical trial to commercialization. This transition stage is difficult at the best of times, encompassing a shift from small- to large-scale drug production while maintaining product safety and efficacy. Cell therapy presents a unique challenge not extant to traditional medical treatments. Living cells embody an intrinsic variability of response and function that can impact their efficacy in a patient. It is important that pharmaceutical companies take pains to optimize their production workflow from the beginning, to ensure an effective and reliable product. The need for high-quality starting material is crucial to success, since the number of healthy cells in leukapheresis-derived starting material directly impacts the efficacy of the final product. In this article, we examine the processes that ensure optimal quality of the material that forms the basis of CAR-T therapies.

Submitted for peer review: Mar 22 2018 Published: May 14 2018
DOI: 10.18609/cgti.2018.032
Citation: Cell Gene Therapy Insights 2018; 4(4), 327-336.
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Overcoming Challenges for Engineered Autologous T Cell Therapies

Spotlight Article

Expert Insight

Marc Better, Vijay Chiruvolu & Marianna Sabatino

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

Axicabtagene ciloleucel is an engineered autologous anti-CD19 chimeric antigen receptor T cell therapy being developed for patients with refractory aggressive B-cell lymphoma. The product is manufactured in a central facility from cellular starting material containing a patient’s own T cells into which a chimeric antigen receptor transgene is directly introduced. This cellular starting material is highly variable from donor to donor and provides the single largest source of variability associated with the production process. Nonetheless, a robust manufacturing and distribution process was developed based on process understanding and appropriate process controls. Process characterization revealed process parameters that affect quality attributes, allowing appropriate control measures to be implemented. Process comparability criteria were also established as another mechanism to ensure process consistency as new manufacturing sites were introduced. A relationship between cellular characteristics of the incoming cellular starting material, cell growth and performance during manufacturing, and the ultimate product characteristics after administration to patients is also beginning to come into focus.

Submitted for peer review: Dec 19 2017 Published: May 14 2018
DOI: 10.18609/cgti.2018.014
Citation: Cell Gene Therapy Insights 2018; 4(4), 173-186.
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Utilization of Recombinant Albumins in the Expansion of Human T Lymphocytes

Spotlight Article

Innovator Insight

Atherly Pennybaker and Randall Alfano

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

As novel cellular therapeutics continue to demonstrate tremendous progress in the clinic, improvements in the understanding of cell culture media components and expansion media design must continue in parallel to achieve better manufacturing process definition and control. One such critical component, human serum albumin, has been demonstrated to promote growth and viability of mammalian cells when cultured ex vivo. Several serum free cell culture media products currently marketed incorporate albumin purified from human serum. Although these media formulations, known as xeno-free, have demonstrated satisfactory expansion capability of phenotypically correct cells, there are potential safety, supply, and reproducibility issues associated with using components isolated from serum. InVitria leverages an animal component free protein expression system to produce recombinant proteins, including human serum albumin, at large scale. The recombinant human serum albumin produced in a nonmammalian-based expression technology, known as Cellastim S®, exhibited exceptional ability to support expansion of T Lymphocytes sourced from peripheral blood of healthy donors in comparison to native sourced albumins from both human and bovine serum as well as other recombinant albumins produced in yeast. Further, Cellastim S® resembled serum-derived albumin albeit more consistent profile as determined by reverse phase HPLC and mass spectrometry. Taken together, Cellastim S® is an attractive recombinant alternative for serum-derived albumin in T Lymphocyte applications.

Submitted for peer review: Mar 8 2018 Published: May 14 2018
DOI: 10.18609/cgti.2018.024
Citation: Cell Gene Therapy Insights 2018; 4(4), 231-239.
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Challenges in Developing GMP-Compliant Manufacturing Facilities for CAR-T Cells

Spotlight Article

Interview

Lothar Germeroth

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

Lothar Germeroth is Senior Vice President Juno Therapeutics, Inc. and Managing Director Juno Therapeutics GmbH. Dr Germeroth has over 25 years of management experience in the field of biotechnology. Most recently, Dr Germeroth served as the CEO at IBA GmbH and the COO at Stage Cell Therapeutics GmbH, and served eight years as CEO in three different German Biotech companies (Jerini BioTools GmbH, Chemotopix GmbH, Cytos Proteome Therapeutics GmbH) and as Chief Business Officer at Cytos Biotechnology AG in Switzerland. Dr Germeroth studied chemistry in Frankfurt/Main and obtained his PhD in Biochemistry in the department of Nobel Prize Laureate Professor Hartmut Michel at the Max-Planck Institute of Biophysics in Frankfurt.

DOI: 10.18609/cgti.2018.044
Citation: Cell Gene Therapy Insights 2018; 4(4), 431-436.
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Advances in Targeting CAR-T Therapy for Immune-Mediated Diseases

Spotlight Article

Expert Insight

Jinmin Lee, Aimee S Payne

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

In recent years, genetically engineered cell therapies based on chimeric antigen receptor (CAR) technology have transformed the cancer treatment landscape. The groundbreaking success of CD19-specific CAR-T cell therapies in inducing lasting remissions of previously refractory B cell neoplasms has stimulated increasing interest in evaluating the potential of CAR technology to extend beyond cancer to induce safe and durable remissions of immunologic diseases. This review will highlight recent preclinical advances in targeting cytotoxic and regulatory CAR-T therapy to autoimmune and alloimmune disease indications, including pemphigus vulgaris, Factor VIII inhibitors, and HLA-mediated transplant rejection.

Submitted for peer review: Mar 27 2018 Published: May 14 2018
DOI: 10.18609/cgti.2018.026
Citation: Cell Gene Therapy Insights 2018; 4(4), 255-265.
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Unlocking the Potential of CAR-T Therapies for Solid Tumors

Spotlight Article

Interview

Tamara J Laskowski

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

Tamara Laskowski

Dr. Tamara J. Laskowski received her doctorate degree in Human Molecular Genetics and Immunology from University of Texas Health Science Center where her work focused on genome editing of patient-derived stem cells to correct genetic mutations causative of Wiskott-Aldrich Syndrome, a immunodeficiency disorder that results in severe impairments to the immune system. Through her work, she demonstrated the ability to repair the underlying defects and restore normal immune function. Subsequently, Tamara joined Dr. Laurence J.N. Cooper’s laboratory at MD Anderson Cancer Center as a fellow. Her work focuses on engineering stem cells with the goal of generating off-the-shelf NK and T-cell immunotherapies for targeting solid tumor malignancies. Dr. Laskowski also shares an interest in technology innovation, and has developed novel multi-plex assays for testing therapies against solid tumors. In 2017, this work led to an invitation to participate in the National Science Foundation (NSF) Innovation Corps, an exclusive program through which she was trained on strategies for expanding the economic and societal benefits of innovative ideas which have commercialization potential. She was the sole recipient of an award for outstanding performance upon completion of the program. In addition to her research work, Dr. Laskowski also serves as a scientific communications coach and peer editor at MD Anderson, helping to promote effective communication between scientists and the public.

DOI: 10.18609/cgti.2018.038
Citation: Cell Gene Therapy Insights 2018; 4(4), 369-375.
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Utlization of CAR-T Therapy for Ovarian Cancer

Spotlight Article

Interview

Janos L Tanyi

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

Dr Janos L Tanyi graduated summa cum laude from the University of Debrecen, Hungary with a degree in medicine. He completed residency training in obstetrics and gynecology at the Baylor College of Medicine in Houston, and a gynecologic oncology fellowship at the University of Pennsylvania (UPenn). Dr Tanyi also obtained PhD degree in 2008 at the Semmelweis University, Budapest. His research identified lysophosphatidic acid as an important therapeutic target for ovarian cancer. Dr Tanyi was then recruited as an assistant professor to the Department of Obstetrics and Gynecology at UPenn. His clinical and translational research focuses primarily on tumor immunology and immunotherapy. This includes identifying mechanisms by which tumors escape immune attack and developing personalized immunotherapies like dendritic cell vaccines and CAR-T technology for ovarian cancers. Dr Tanyi has participated as a principal investigator in multiple clinical trials and laboratory investigations. He has authored over 80 scientific publications, six book chapters and given a large number of invited lectures worldwide and nationwide.

DOI: 10.18609/cgti.2018.029
Citation: Cell Gene Therapy Insights 2018; 4(4), 287-294.
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Advances in Using CAR-T cell Therapy to Treat HIV

Spotlight Article

Interview

Scott G Kitchen

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

Dr. Scott G Kitchen’s research interests are focused on investigating the effects of viral infection, as well as other cellular abnormalities, on human hematopoiesis and on exploring ways to correct defects that exist in immunity to viral and cellular antigens. Dr. Kitchen’s laboratory is interested in understanding the mechanisms that limit the immune systems’ ability to clear infection or cancer and in developing ways that augment these responses. They are also interested in developing gene therapy-based approaches to engineer human hematopoietic stem cells to reconstitute and/or enhance immune responses following their development into mature cells that specifically target HIV infection as well as other viral and cellular antigens. In addition, his laboratory is interested in the development of mouse/human chimeric models that allow the characterization of human hematopoiesis and engineered immunity in a surrogate in vivo host.

DOI: 10.18609/cgti.2018.034
Citation: Cell Gene Therapy Insights 2018; 4(4), 357-362.
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Addressing the Challenges of Commercial-Scale Manufacture of Viral Vectors for CAR-T Therapies

Spotlight Article

Interview

Calley Hirsch & Xavier de Mollerat du Jeu

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

Calley hirschXavier du Mollerat

Calley Hirsch is a Development Scientist II at CCRM in Toronto, where she specializes in upstream lentiviral production and gene delivery technologies for immunotherapy applications. Prior to working at CCRM, Dr. Hirsch was a postdoctoral fellow at the Lunenfeld-Tanenbaum Research Institute in Toronto and MD Anderson Cancer Center in Houston working on pluripotent stem cells and somatic cell reprogramming. Dr. Hirsch received her PhD from the University of Saskatchewan.
Xavier de Mollerat du Jeu is the Director of R&D for Cell Biology and Transfection at Thermo Fisher Scientific. Dr. de Mollerat du Jeu works on creating and improving nucleic acid delivery for research and therapeutic applications. He identified new DNA delivery approaches for hard to transfect cell lines and primary and stem cells, and he is the inventor of Lipofectamine 3000. Dr. de Mollerat du Jeu’s team is also focusing on new delivery solutions for CRISPR delivery, new scalable lentiviral production systems, mechanical delivery approaches for primary T cells, and in vivo delivery of RNAi and mRNA for research and therapeutic application. He studied molecular biology and plant physiology at the University of Montpellier II in France, and received his PhD in human genetics from Clemson University. Dr. de Mollerat du Jeu’s thesis work involved identifying the genes responsible for Split Hand/Split Foot Malformation 3. His post-doctoral fellowship research was in the laboratory of Dr. Michael G. Rosenfeld at UCSD, where he studied the roles of microRNAs in pituitary gland development.

DOI: 10.18609/cgti.2018.039
Citation: Cell Gene Therapy Insights 2018; 4(4), 377-384.
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Driving CAR-T Manufacture Optimization through Technology Innovation

Spotlight Article

Interview

Philip H Coelho

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

Philip H Coelho, Founder and Chief Technology Officer (CTO) of ThermoGenesis Corp., the device Division of Cesca Therapeutics is an engineer/inventor, educated at the University of California, Davis, where he specialized in thermodynamics and machine design. He has been awarded more than 40 US patents related to cell selection, cell cryopreservation, cell washing, automated cryogenic freezing and storage of cells and harvesting clotting proteins from blood. As Founder, Chairman and CEO of ThermoGenesis Corp., Mr. Coelho developed the Thermoline ultra rapid blood plasma freezers and thawers, the CryoSeal automated system for preparing fibrin sealant from a surgical patient’s blood, the BioArchive robotic system for controlled-rate freezing and cryogenically archiving units of hematopoietic stem and progenitor cells derived from placental/cord blood and the AutoXpress System, which automates harvesting of HSPCs from cord blood into a 25 ml dual-compartment freezing bag. The BioArchive® and AutoXpress Systems have established the highest quality GMP standards in cord blood processing and banking worldwide. Over the last 9 years, Mr. Coelho, and an excellent team of engineers and cell biologists, began developing next-generation, GMP compliant, programmable systems that improve the speed and efficiency of the isolation, capture and purification of stem, progenitor and immune cells residing within peripheral or placental/cord blood, bone marrow aspirate and leukapheresis. These research projects evolved into the CAR-TXpress™ platform, an automated method of manufacturing therapeutic doses of CAR-T cells in a functionally closed cell processing system.

DOI: 10.18609/cgti.2018.036
Citation: Cell Gene Therapy Insights 2018; 4(4), 317-325.
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Strategies to Control CAR-T Cell Therapy: Perspective on Next-Generation CARs

Spotlight Article

Expert Insight

Eduardo Laborda & Travis S Young

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

Chimeric antigen receptor T (CAR-T) cells have produced remarkable results in clinical trials, resulting in the recent FDA approval of the first two products, Kymriah and Yescarta, for the treatment of B-cell malignancies. However, clinical experiences of severe adverse events, relapses related to antigen loss and the dearth of successes in solid tumors have defined the challenges to advancing the field. Recently, an explosive growth in synthetic biology strategies to program control into CAR-T cells has created an armamentarium of methods to overcome these challenges. Here we provide an overview of the types of control systems in these next generation CAR-T platforms and provide a perspective on how they address the delicate balance of efficacy and safety with engineered T cells.

Submitted for peer review: Mar 19 2018 Published: May 14 2018
DOI: 10.18609/cgti.2018.028
Citation: Cell Gene Therapy Insights 2018; 4(4), 275-285.
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Innovative Technologies for CAR-T Manufacturing: the Key to Commercialization

Spotlight Article

Interview

Stanley Kowalski & Daniella Kranjac

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

Stanley Kowalski is Co-founder and CEO of FloDesign Sonics, Inc. In this role, he is responsible for the direction and strategy of the company. He is dedicated to commercializing FDS’s acoustic platform into multiple markets. His current market focus is life sciences where FDS’s patented 3D force field provides delicate handling, selection and sorting of cells for both scaling up and out. He boldly believes that their innovative cell handling engine can enable the 4th pillar of medicine while significantly driving down the costs of cell and gene therapy. This ultimately brings the manufacturing closer to the patient. Stanley possesses an insatiable entrepreneurial drive. He is Chairman of the board at FloDesign and founding CEO of FloDesign Wind Turbine, FloDesign Water Turbine and FloDesign Sonics. Throughout Mr. Kowalski’s career, he has helped to engineer and deliver many products to market, with a core focus on science-based, enabling technologies.

Daniella Kranjac is a Co-Founder and General Partner at Dynamk Capital, a venture capital fund investing in startup and growth companies in life sciences tools, technologies and services. Dynamk’s mission is to help companies reach their full potential providing access to capital, strategy, business development and flawless commercial execution. Daniella began her career as a Co-Founder of Wave Biotech LLC where she drove the growth of a disruptive technology, leading the $30 million group to a successful exit and acquisition by GE Healthcare in 2007. At GE, Daniella held several business development & commercial leadership roles, establishing a several hundred million dollar enterprise solutions business.Daniella’s unique perspective on the global healthcare market is owed to varied experiences in pharma, biologics and biosimilars, vaccines and cell therapies as these markets have evolved in the United States, Europe, Latin America, China and the Middle East.

DOI: 10.18609/cgti.2018.037
Citation: Cell Gene Therapy Insights 2018; 4(4), 337-344.
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Ethical Considerations in the Translation of CAR-T Cell Therapies

Spotlight Article

Expert Insight

Kathleen J Imbach, Arjun Patel & Aaron D Levine

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

Despite the enormous promise of chimeric antigen receptor T (CAR-T) cell therapies, the translation and commercialization of these therapies raise a number of pressing ethical questions. These concerns include managing the toxicities associated with these powerful therapies both for research participants in clinical trials and patients receiving approved therapies. The safety concerns are a key issue for the field today but will become even more pressing as CAR-T cell therapies move from their current status as last-resort approaches closer to the therapeutic front-lines. They also include ensuring equitable access to these innovative therapies – along both financial and geographic lines – and managing expectations and patient demands for access to high potential but not yet proven interventions. The article aims to articulate these and other key ethical challenges for the field and suggest some strategies to help navigate these challenges and facilitate the successful translation and commercialization of CAR-T cell therapies.

Submitted for peer review: Apr 3 2018 Published: May 14 2018
DOI: 10.18609/cgti.2018.030
Citation: Cell Gene Therapy Insights 2018; 4(4), 295-307.
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Commercial Business Models for Immunotherapies

Spotlight Article

Interview

Helen Tayton-Martin

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

Helen Tayton-Martin has over 25 years of experience working within the pharma, biotech and consulting environment in disciplines across preclinical and clinical development, outsourcing, strategic planning, due diligence and business development. She co-founded Adaptimmune from the former company, Avidex Limited, where she had been responsible for commercial development of the soluble TCR program in cancer and HIV from 2005 to 2008. Dr Tayton-Martin transitioned to become Adaptimmune’s Chief Business Officer in March 2017, having served as its Chief Operating Officer since 2008, a role in which she oversaw the transition of all operations in the company from 5 to 300 staff, through transatlantic growth, multiple clinical, academic and commercial collaborations and private and public financing through to its NASDAQ IPO. Today, she is responsible for optimizing the strategic and commercial opportunity for Adaptimmune’s assets, leading on business development and commercial activities. Her role encompasses all aspects of pipeline and technology assessment, strategic portfolio analysis, integrated program management and commercial planning and partnerships, including the company’s strategic partnership with GSK. Dr Tayton-Martin also serves as a non-executive director of Trillium Therapeutics Inc. She holds a Ph.D. in molecular immunology from the University of Bristol, U.K. and an M.B.A. from London Business School.

DOI: 10.18609/cgti.2018.035
Citation: Cell Gene Therapy Insights 2018; 4(4), 345-355.
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Pricing Models & Strategies to Make CAR-T Therapy Affordable

Spotlight Article

Interview

Dan Ollendorf

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

Dr Dan Ollendorf has been the Chief Scientific Officer for the Institute of Clinical and Economic Review (ICER) since 2007. In this role, he is responsible for the conduct of systematic reviews of the comparative effectiveness of high impact health care technologies, integration of decision analysis and budgetary impact modeling into reviews of clinical evidence, engagement and collaboration with multiple stakeholders, and coordination as well as scientific oversight of the broader health technology assessment process. His 30 years of health care experience include work in the hospital, informatics, insurance, managed care, and consulting sectors. Dan holds a PhD in clinical epidemiology from the University of Amsterdam, a Masters in Public Health from Boston University, and a Bachelor of Arts from the University of Rochester. He has authored over 60 peer-reviewed articles in major journals, and was on the Editorial Board of the Journal of Managed Care Pharmacy from 2009-2012. Dan currently serves on the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) HTA Council Working Group, and the Policy Forum of Health Technology Assessment International (HTAi).

DOI: 10.18609/cgti.2018.033
Citation: Cell Gene Therapy Insights 2018; 4(4), 363-368.
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