Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 6th International Conference and Exhibition on Cell and Gene Therapy Madrid, Spain.

Day 1 :

Cell Therapy 2017 International Conference Keynote Speaker Falk Heinrichsohn photo
Biography:

Falk Heinrichsohn studied Business Administration in Merck, Germany. His main activities include, developing new business, establishing or changing company setups, improving existing business and structures. He has established a foundation called Fundação Século XXI – Sáude e Vida, to promote science and art and bringing them together in exhibitions under the umbrella theme of “Esperança de Vida” to sponsor young artists and patients with unmet medical need. He retired from corporate activity and from the foundation, and since then, he is a Freelance Consultant to various global leading alternative health and wellness companies and developed the first European affiliated Stem Cell Clinic in Malta in 2014 and in 2016, a clinic in Czech Republic, others are under development. Now, he is self-employed, at Aristoloft Lda, Portugal and formerly he worked as a Managing Director of various international subsidiaries of Merck KGaA & Merck Serono, Germany and also a Consultant to Precious Cells International, UK, a European cord blood bank. He is a member of International Consortium for Cell Therapy and Immunotherapy in Europe.

 

Abstract:

 

Background & Purpose: Cellular treatment and Complementary and Alternative Medicine (CAM) therapy are a potential alternative, disruptive medical treatment especially for an aging population, facing the limitation of evidence base medicine with long termed investigational character and a complex regulatory environment, while globally documented and accepted treatment.

 

Methods: For cellular treatment, there are two main pathways. First pathway is highly manipulated allogeneic and autologous cellular products, administered oral or via IV, intramuscular, etc., alone or in combination, which need to follow the existing regulatory 12-15 year lasting clinical trial path, or as a new technology, a new clinical trial and review concept as shown in Japan. The second pathway is to administer autologous stem cells in the frame of practice of medicine, the fastest way to personalize medicine with very limited, to no side effects, readily available today but questioned by some scientists and regulators in respect of safety and effectivity, and therefore considered as unproven medical treatment.

 

Results: Regulatory agencies are trying to find an approach which is beneficial and safe for patients. Unfortunately, by the time this reaches FDA and EMA regulated countries, this may take much time as it is a controversy and is discussed politically by various stakeholders.

 

Conclusions: Based on current scientific knowledge of risk-benefit of cellular treatment, countries outside the FDA/EMA regulated territory, advanced, approved, respective accepted autologous cellular treatments for patients, even via expansion of own stem cells. In the US, autologous stem cell treatment in the frame of practice of medicine is so far tolerated, but critically reviewed by the FDA with a trial to implement new regulatory limitations of stem cell treatment. The 21st century cure act is a step in the right direction in the US, but does not clarify most controversial issues in cell therapy, PoC treatment is highly debated in a historic FDA public hearing in September 2016. EMA Policy is similar to the US, while other countries are advancing further and faster with disruptive cell, stem cell & CAM technologies, resulting into growing international medical tourism and loss of new applied medical know-how in overregulated countries.

 

 

Background & Purpose: Cellular treatment and Complementary and Alternative Medicine (CAM) therapy are a potential alternative, disruptive medical treatment especially for an aging population, facing the limitation of evidence base medicine with long termed investigational character and a complex regulatory environment, while globally documented and accepted treatment.

 

Methods: For cellular treatment, there are two main pathways. First pathway is highly manipulated allogeneic and autologous cellular products, administered oral or via IV, intramuscular, etc., alone or in combination, which need to follow the existing regulatory 12-15 year lasting clinical trial path, or as a new technology, a new clinical trial and review concept as shown in Japan. The second pathway is to administer autologous stem cells in the frame of practice of medicine, the fastest way to personalize medicine with very limited, to no side effects, readily available today but questioned by some scientists and regulators in respect of safety and effectivity, and therefore considered as unproven medical treatment.

 

Results: Regulatory agencies are trying to find an approach which is beneficial and safe for patients. Unfortunately, by the time this reaches FDA and EMA regulated countries, this may take much time as it is a controversy and is discussed politically by various stakeholders.

 

Conclusions: Based on current scientific knowledge of risk-benefit of cellular treatment, countries outside the FDA/EMA regulated territory, advanced, approved, respective accepted autologous cellular treatments for patients, even via expansion of own stem cells. In the US, autologous stem cell treatment in the frame of practice of medicine is so far tolerated, but critically reviewed by the FDA with a trial to implement new regulatory limitations of stem cell treatment. The 21st century cure act is a step in the right direction in the US, but does not clarify most controversial issues in cell therapy, PoC treatment is highly debated in a historic FDA public hearing in September 2016. EMA Policy is similar to the US, while other countries are advancing further and faster with disruptive cell, stem cell & CAM technologies, resulting into growing international medical tourism and loss of new applied medical know-how in overregulated countries.

 

 

Cell Therapy 2017 International Conference Keynote Speaker Ricardo Baptista photo
Biography:

Ricardo Baptista is a lead Scientist in the Process Development Team at Cell Therapy Catapult, London, UK. He is currently working on the development of scalable bioprocesses for manufacturing of human pluripotent stem cells, and on the industrialization of the production of stem cell derived products. He is also involved in projects aiming the automation and translation of bioprocesses for cell therapy manufacture. Previously in Cell Therapy Catapult, he held the role of Project Manager and Scientist in Product and Process Development team at CCRM-Centre for Commercialization of Regenerative Medicine, in Canada. His work on the production of NK-92 cells using stirred-tank reactor technology allowed for a reduction in the manufacturing costs over 50%, and facilitated initiation of Phase II trials with NK-92 cells in Princess Margaret Cancer Centre, in Toronto. He is a Biological Engineer and has obtained his PhD Degree in Biotechnology and Biochemical Engineering at Technical University of Lisbon, in 2005. His Post-Graduate work on the optimization of the production of human recombinant cytokines in mammalian cell bioreactors has supported projects in stem cell research at Dr. Joaquim Cabral and Dr. Peter Zandstra Stem Cell Bioengineering Labs. His second Post-doctoral work at Zandstra Lab in University of Toronto led to two relevant publications in stem cell bioprocessing. Recently, he has been invited as a Speaker in courses and workshops of cell therapy bioprocessing with lectures on Bioreactor Technologies and Process Intensification.

 

Abstract:

The commercialization of allogeneic stem cell derived medicines is committed to the development of processes. This process is done to generate consistent large amounts of pluripotent stem cells (PSCs) to be further differentiated to target somatic cell products. The pluripotent program of the cell and gene therapy catapult (CGT) focuses on the development of cost-effective bioprocesses for the industrial manufacturing of PSC-derived products in 2D and 3D culture systems. Here, we present a strategy for the development of closed, scalable, and controlled processes to generate high-density cultures of PSCs in aggregate-based stirred suspension culture, and highlight achievements in 2D-expansion process development. Cell banks of PSCs which are adapted to commercially available culture systems were established and characterized to industry standards. An iPSC line has been established from a pre-seed lot of the cell line. CGTRCiB10 was generated according to GMP principles. The ambr15® tool along with DOE methodology have been employed to support the establishment of a baseline process for the expansion of PSCs in stirred tank reactor (STR). This data suggests that the mixing parameters, energy dissipation and Kolmogorov size could support the scale-up of the vessel mixing properties and enable size-controlled cell aggregates in larger STR. We are currently exploring strategies for process intensification. Enzymatic dissociation of aggregates in the vessel was achieved, and rapid, closed medium exchange was possible using cell retention technologies. Defined media were evaluated for the expansion of CGTRCiB10  in adherent cultures. We used the quantum and the kSep® to develop an integrated, closed and semi-automated process for a cost-effective manufacture of iPSCs. Gene expression and metabolic patterns have been identified for PSCs cultured in adherent and dynamic suspension culture. This work shows the achievements of our program so far, and shows a bioengineer approach to develop scalable STR-processes for the controlled growth of PSCs in high-density aggregate-based suspension culture. This data suggests the potential use of cell retention technologies to support multiple unit operations such as feeding (perfusion culture) and cell harvest. Integration of the upstream processes of cell expansion and differentiation and downstream operations in the same vessel, would represent a step change in the development of cost-efficient processing platforms for the large-scale manufacturing of PSC-derived medicines.