Guillaume Koszegi, President and Executive ConsultantHowever, re-engineering T cells in highly targeted and personalized treatment options comes with high treatment costs that considerably limit its large-scale adoption. Added to these challenges are the complex manufacturing, supply chain, and reimbursement issues.
“Given the high complexity and uncertainties involved in the commercialization of cell and gene assets, applying the blueprint of a standard pharmaceutical clinical development and launch plans does not translate well. Although certain knowledge and skillsets from other pharmaceutical successes are transferrable, a new skill set specific to the cell and gene therapy market is needed to create a profitable development and commercialization plan,” states Guillaume Köszegi, president and executive consultant, CAR T Global Consultant.
Assisting clients with the proper guidance and expertise to make cell and gene therapies economically and clinically feasible is CAR T Global Consultant Inc.’s goal.
As a privately-held global company with over two decades of industry experience, CAR T Global Consultant Inc. assists cell therapy firms in commercializing CAR T cell therapy assets. CAR T Global Consultant Inc. offers cell therapy specific expertise in four primary divisions including Executive planning, Commercialization, Medical Affairs and Clinical Operations. The company rapidly established itself as the go-to strategic partner in the USA, Canada and Europe. They are planning the expansion phase in the Asian market in 2023.
“We are well-versed with every nuance within the cell and gene therapy markets. We can fulfill the needs of small biotech companies that want to strengthen and secure their commercialization pathways and bigger pharmaceutical companies with current marketed assets that demand product differentiation, best-ofclass execution, and KOLs engagement. Depending on our clients’ specific demands, we build consultant teams tailored to their projects from our diverse network of talented industry leaders with specific cell therapy expertise,” states Köszegi.
The All-inclusive Cell and Gene Therapy Consultant Partner
CAR T Global Consultant Inc. set up shop to take cell and gene therapy assets of clients from ideation to commercialization and make it a reality for patients. It can help navigate the complex and multi-faceted process of a successful product launch by assisting them from the early stages of the cell therapy development path to pre-launch, identifying a suitable plan and the therapeutic product profile. CAR T Global Consultant Inc. specializes in supporting clients with market assessments, marketing plans, and pricing strategies related to commercialization. They support clients in leveraging the right strategies throughout the different lifecycle phases and guiding cell therapy companies with assets in development, assets less than three years from approval, and marketed assets.
To do so, CAR T Global Consultant Inc. specializes in four core service areas—commercialization services, executive global planning, medical affairs, and clinical operations services.
On the commercial services side, CAR T Global Consultant Inc. has four main offerings: strategic portfolio assessment, CAR T landscape analysis and competitive intelligence, commercialization readiness, and marketing strategy and brand differentiation.
As part of strategic portfolio assessments, CAR T Global Consultant Inc. conducts assessments to validate market size based on epidemiology figures and forecasts. These are founded on the prioritization of markets over selected years to create optimal prediction and profitability models based on current and future cost of goods (COGS) estimations. The company’s landscape analysis and competitive intelligence service helps benchmark with other cell and gene products in the market and refines global strategies to influence decisions such as manufacturing investments and other development, regulatory approvals, and reimbursement policies to guide a client's pathway.
Following the analyses, CAR T Global Consultant Inc. assists clients with commercialization readiness services, where it creates a suitable roadmap by identifying different cell and gene therapy treating centers in the prioritized markets, designing field readiness plans, building and validating commercial onboarding models, developing best-in-class ordering processes, and establishing the dossier of CAR T while aligning with regulatory requirements, health technology assessment (HTA) submissions, and reimbursement tactics.
CAR T Global Consultant Inc. also specializes in developing appropriate marketing strategies and brand differentiation for clients by defining their brand mission and engagement with experts via advisory boards, market research, surveys, and consultancy meeting.
Going further, CAR T Global Consultant Inc. offers medical affairs executive global planning services backed by its medical and scientific expertise. The company provides strategic support for regulatory submissions, including pre-IND, IND, BLA, orphan drug applications, and breakthrough therapy designations.
The field of cell and gene therapy is evolving quickly; to create a successful commercial pathway, we need to build from past experiences and predict future implications. That’s where we come in
In addition, CAR T Global Consultant Inc. has the expertise to offer top-notch consulting services around specific clinical operations, helping clients with their inhouse infrastructure and key processes to conduct clinical trials compliantly and efficiently.
“We have established relationships with many KOLs and we are knowledgeable CAR T matter-experts by continuously being up-to-date with the literature and attending the key conferences.
We share field insights and strive to constantly educate clients and their leadership teams via strategic discussions on ways to carry out their cell and gene therapy operations and shape their commercialization pathways,” says Köszegi.
Rearchitecting a New Horizon for Cell and Gene Therapies
CAR T Global Consultant Inc. is uniquely positioned with a strong network of talented industry leaders who share the same passion to assist clients with cell and gene therapy commercialization. In its endeavors to offer improved strategic, operational, and commercial support, CAR T Global Consultant Inc. has recently partnered with Titronbio. Dr MA Sersch MD, PhD, President and founder is a leading expert in the field of cell and gene therapy. Titronbio supports other innovative organizations in the area of cell and gene therapy bringing senior executive expertise to enhance strategy - including portfolio prioritization and development. Dr. Sersch has an impressive background of scientific, regulatory, and clinical development experience. The combined expertise of CAR T Global Consultant and Titronbio will help navigate the challenging early to late stage development phase of cell and gene therapies, guiding clients on their path to success.
Since the company was founded, CAR T Global Consultant Inc. has received many positive feedbacks from clients, where some applaud it for its diverse experience in CAR T, creating a holistic view of the market, while others choose it for its ability to offer strategic support and a strong mix of analysis and real-life learnings.
Its global perspective and customized approach have resulted in CAR T Global Consultant Inc. being wellpositioned to support companies in different regions and stages of development. It will continue to enhance its capabilities to fulfill the present and upcoming demands of clients for cell and gene therapy commercialization.
