Cell & Gene Therapy | Innovation Summit

cgt-development

Manal Morsy Executive SVP and Head of Global Regulatory Affairs Athersys

Clarke Paramore VP HEOR BlueBirldBio

Shawn Liu President & CEO Avermax

Dr Aleš Štrancar Managing Director BIA Separations, a Sartorius Company

Tom Spitznagel SVP BioPharmaceutical Development Macrogencs

CELL & GENE INNOVATION - BIOPROCESSING, MANUFACTURING, SUPPLY CHAIN, AND COMMERCIALIZATION Delivering world class content and connecting business ideas with relationship opportunities to overcome key challenges and innovate breakthroughs in developing next generation biologics and advance therapies

When Great Minds Come Together...

Leverage Innovation to Convert Cutting-Edge Research to Advance Cell & Gene Therapies. Ensure technological, operational and commercial supremacy and retain success with proven next generation strategies and approaches at the Cell & Gene Therapy 2025, Innovation Summit held in Boston, USA. The CGT-development 2025, Innovation Summit is the leading Cell, Gene CART Therapy leaders Exchange, exclusively set to help pioneering professionals boost success and growth by providing the perfect modern era networking platform that is highly informative and delivers a dynamic cohesive environment to benchmark, learn, engage, debate, procure and interact at the highest level. Share ideas with dynamic leaders and gain valuable industry knowledge through cohesive closed networking. Converse with innovation that flourishes in Cell & Gene therapy communities and achieve seamless integrated success in Cell, Gene and Immunotherapy development life-cycle from discovery in the lab to clinical production and commercialization . Retain success with next generation strategies and approaches, streamlined to obtain seamless integrated success in your biological and novel product development life-cycle, from discovery in the lab to clinical production and commercialization - Innovation in biological production, process development, upstream and downstream.

A compiling program that reflects key strategic issues that senior executives have identified

Intelligence that flourishes within biological process communities.

" Biopharmaceuticals is becoming the core of the pharmaceutical industry, but not without significant transformation in the laboratory and in strategy, technology, and operations. "

" Biopharma products are moving from niche to mainstream, the industry is facing a paradigm shift in cost, quality, complexity, and scale. "

Program Chairman & Keynote Speaker Dr Aleš Štrancar, Managing Director BIA Separations,a Sartorius Company

The Cell & Gene Therapy Development, Innovation Summit brings you the latest in Development & Production Technologies and Commercialization Strategies. The Lastest Key Themes include: Innovations in CMC and Manufacturing Driving the Future of Cell & Gene Therapy: Avoid pitfalls and reduce bottlenecks, implementing new breakthrough Cell & Gene Therapy processing methodologies. Overcoming Regulatory CMC challenges associated with product development and approval. High Yielding AAV Platforms for Gene Therapy: Examining continued innovation in Gene therapies. CAR and T CELL Therapies - Pioneering point of care with innovative manufacturing and commercialization strategies: Revolutionizing cell and gene engineering - ground breaking autologous and allogeneic treatments for blood borne and solid tumors Will Allogeniec Replace Autologous Therapies? Current industry trends and innovation focuses. Understanding all strategic options in an unprecedented era of expedited regulatory pathways: Examining and defining the potential value for industry in accelerated development and conditional approval pathways from around the globe. Enabling more Precise, Efficient and Safer Genome Editing & Quantifying its Outcomes: Innovation in repurposing of CRISPR-Cas 9 and all its variants. NextGen tools for on and off target effects when using different enzymes & variants. Novel Gene Editing Applications in CART: Understand next generations technologies in adoptive T cell Immunotherapy Novel AAV Capsids for Gene Therapy: Discovery, Characterization and Manufacturing. Immunotherapy and targeted therapy spheres: Which combination therapy strategies will help realize the full potential? Honing combination therapy clinical strategies involving CAR T cell and TCR immunotherapy products Candidate. Embracing digital transformation and pioneering high-tech new strategies across the supply chain: Optimizing the supply chain end-to-end to meet the needs of patients and anticipate how to meet their needs tomorrow in a transformational way. Seeing digital and Industry 4.0 technologies as the next driver of innovation and patient-centricity. Achieving commercial scalability with ‘facilities of the future’ in patient-specific therapies: Develop a “fit-for-purpose” development pathway that is associated with “faster to market” options for clinical development. Novel CAR and T Cell Modalities - Innovation in Safety, Efficacy and Clinical Data Technologies and methods. Fundamental evolution to meet ATMP Quality and Process Challenges: Implementation of next generation digital bioprocessing 4.0 and integrating automation technology for Increased GMP compliance and consistency. Enabling acceleration of processing research and scale-up considerations. Advances in large scale manufacturing of personalized medicine: Cell Therapy Scale-Up and commercial manufacturing Strategies Regulatory pathway and novel pricing & Recalibration in development reimbursement models: Commercial opportunities and getting ahead the upcoming challenges and mechanisms for the US and further afield.

CELL & GENE COMMERCIALIZATION FROM CONCEPT TO ROBUST PATIENT-CENTRIC DELIVERY

AAV Viral Vector Gene Manufacturing Single Use technology Gene Editing Next Generation Cell lines Continuous Manufacturing & Process Intensification

GMP Quality & Assurance Regulatory Affairs Scale-up & Tech Transfer Investment Re-reimbursement Outsourcing Strategies

Clinical CART Raw materials Tissue Engineering Cryopreservation Delivery

Immunotherapy Stem Cell RNAi CAR-T Allogeneic Autologous Regenerative Medicines Rare Disease

SPEAKERS

70

10

STREAMS

LEADERS

250

HOURS

18

ATTENDEE PROFILES

ATTENDEE PROFILES

Advanced-Therapies Innovation Summit delegates typically include CMO, CSO, Vice Presidents, Directors, and Heads of: Cell and Gene Manufacturing ATMP Development Cell and Gene Production Bioprocessing Product Research and Development Investigational Material Supply Chain Biomedical Engineering Blockchain Stem Cell Production Regenerative Medicine Immunotherapy AAV Viral Vector Manufacturing Sciences and Technologies Regulatory Affairs/Complaince Capacity Management Tissue Engineering Global Network Management Scale-up & Tech Transfer Quality Assurance/ Quality Control Analytics Procurement/Investment Collaborative/ Outsourcing Manufacturing Formulation Regulatory Affairs/Compliance Raw material qualification Drug delivery Technical Operations Procurement/Investment

65% VP level and above

80% Delegates and Speakers

Modern Era Networking Platform An executive format providing intimate interaction with industry peers, ideas and experiences. The Leader's Forum Unique model is developed and executed by utilizing technological advancements designed particularly to complement networking and communication, implemented exclusively for decision makers to enhance overall experience and provide specialist business information.

Business meetings - Consultative business meetings that focuses on cutting edge solutions to your current initiatives, priorities and future strategic objective.

Thought Provoking Content Globally distinguished speakers and Industry thought leaders providing highly rich Content. Share with fellow leaders and gain priceless industry knowledge, insight and inspiration over two highly informative productive days.

Discussion Groups Interactive round table style sessions on topics which are top of mind issues. Sessions encourage discussion, debate and learning in an unscripted and informal setting.

Innovate World Class speaker with the highest Credentials delivering unrivaled insight make up our compiling programs, if you would like to present to an interactive audience of pioneering industry leaders please contact

Collaborate Our summits are specially designed for company elites and span the entire Pharmaceutical and Life Science realm. For group bookings or an annual global members pass card please contact

Delegates Inquisitions.

Advance Market leaders with cutting edge capabilities present great innovation. If end users gain a distinct advantage by using your product or services please contact

The Marriot Waterfront Boston will host The Cell & Gene Therapy Development Innovation Summit 2025. The World class venue provides the perfect ambiance for leaders to congregate, bringing together the smartest people to share their experience, ideas, innovations and expertise. Access the right intelligence to design your future with robust strategies in confidence.

A major global hub, Boston has a unique cell & gene therapy DNA and culture; one that is collaborative in nature

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