The second edition of the Dutch ATMP Summit will all be about ATMP innovations. Mark your calendar.
March 15th 2023, Amsterdam
The second edition of the Dutch ATMP Summit will focus on innovations in ATMPs. The program has been extended to a full day, and industry representatives will present their learnings on improving the production of cell therapy products in particular.
We are preparing presentations and discussions on emerging topics in the ATMP field, including: Standardization for Chain of Custody, Effective Microbial Control Strategies, and Alternative Approaches for Established Cell Therapy Products.
We look forward to seeing you at the 2nd Dutch ATMP Summit.
The second edition of the Dutch ATMP Summit will focus on innovations in ATMPs. The program has been extended to a full day, and industry representatives will present their learnings on improving the production of cell therapy products in particular.
We are preparing presentations and discussions on emerging topics in the ATMP field, including: Standardization for Chain of Custody, Effective Microbial Control Strategies, and Alternative Approaches for Established Cell Therapy Products.
We look forward to seeing you at the 2nd Dutch ATMP Summit.
Full day program
09:00 – 09:30 registration & walk-in
We will start the program with a cup of coffee and some snacks
09.30 – 09.45 welcome
Warm welcome from our CCO Edwin van den Bos
09.45 – 11.05 presentations
- Rob Hoeben (LUMC): Translational Research on Oncolytic Viruses: a Consortium Approach
- Stefan Braam (Ncardia): New developments in the use of iPSC-based cell platforms in drug discovery and cell therapy
11:05 – 11:20 break
Enjoy some coffee and refreshments and get ready for the next presentation
11.20 – 12.40 presentation
- Melissa van Pel (Necstgen): Next generation ATMPs
- Martijn Kelder (Cergentis): Genetic characterization of ATMPs: What and why the regulators want you to check
12:40 – 13:40 lunch
Enjoy a well prepared lunch and get ready for the next part of the Summit
13.40 – 15.00 presentations
- Cor Marsman (Progress): case study Performance of Aseptic Process Simulation studies in ATMP manufacturing
- Anja de Vries: Administration of out of specification ATMP products
15:00 – 15:15 break
Enjoy some coffee and refreshments and get ready for the final presentation
15.15 – 15.55 presentation
- Frank van Engelenburg (Progress): Microbial control strategy for ATMPs
15.55 – 16.10 round-up & closing of the Summit
16.10 – 17.30 Networking drinks
Speakers
Rob Hoeben
Dept of Cell and Chemical Biology, LUMC, Leiden
Rob Hoeben obtained his Master’s degree at Utrecht University with majors in Biology and Biochemistry in 1986. Then he moved to Leiden for his PhD research in the lab of Prof. Alex van der Eb to study the feasibility of gene therapy of hemophilia A. He obtained his PhD for his thesis ‘Towards gene therapy in haemophilia A: Vectors for the expression of blood‐clotting factor VIII in vivo’ at Leiden University in 1991. In his post-doctoral research he started working on adenovirus vectors for gene therapy and concentrated on their large scale production and their application in the field of cancer therapy. In 2000 he was appointed as full professor at Leiden University and the Leiden University Medical Center. Professor Hoeben has a long‐term interest in viruses and stem cells. His current research is focused on the development of oncolytic viruses and their application in cancer patients.
Stefan Braam
CEO at Ncardia and Cellistic
Stefan Braam is the founder and CEO of Ncardia and Cellistic. Stefan brings Ncardia/Cellistic over a decade of experience in stem cell technology, product development and general management. Earlier in his career, Stefan obtained a MSc and PhD (both cum laude) in stem cell biology under supervision of Prof. Dr Mummery and obtained international experience in labs in the UK and Australia. Stefan won the NGI venture challenge (2009), the Niaba biobusiness Masterclass (2010), published in leading scientific journals, is an inventor on multiple patent families, secured several grants and technology licensing agreements and was with increasing responsibilities instrumental in Ncardia/Cellistic pre-seed, seed, Series A and B and C financing rounds.
Melissa van Pel
Head of Cell Therapy at NecstGen
Dr. Melissa van Pel is Head of Cell Therapy at NecstGen where she is responsible for process development and clinical manufacture for novel Cell and Gene Therapy products.
She obtained her PhD degree at the University of Utrecht in 2003. After an academic career focusing on molecular, cellular and functional aspects of hematopoietic and stromal cell populations, Melissa’s work shifted towards mesenchymal stromal cell (MSC) biology and the clinical applications of MSCs. Using pre-clinical animal models, she investigated the role of MSCs in several disease models, including atherosclerosis, lung emphysema, hematopoietic stem cell engraftment and colitis. Building upon this experience in MSC research, her research lines continued into Cell Therapy product development, optimisation of manufacturing processes, validation and additional product characterisation of Cell Therapy products according to GMP- and international standards.
As head of the Cell Therapy manufacture team in the Leiden University Medical Center, she was responsible for the expansion of MSCs for application in national and international clinical trials, ranging from phase I to III, including overseeing MSC manufacture in production centers in Germany and Spain.
Melissa has published over 40+ peer-reviewed scientific publications and participated in multiple national and international research consortia.
Martijn Kelder, Ph.D.
Sales Director at Cergentis
Martijn Kelder is a molecular geneticist with an academic background in genomics and genome editing. At Cergentis he heads the commercial and customer facing team. Martijn is a subject matter expert on the (regulatory requirements for) genetic characterisation of genome editing outcomes in cell therapy products and pharmaceutical cell lines. Martijn holds both BSc and MSc in molecular biology from Utrecht University and a Ph.D. in molecular genetics from University of Edinburgh and has published in leading journals including Nature, PLoS Biology and Genome Medicine.
Cor Marsman
QA Manager, QP and RP
Managing consultant at Progress
Cor started his career in 1982 as a medical analyst at the Gemini Hospital in Den Helder. In 1992 he graduated from the VU in Amsterdam as Biologist, with a major in Neurosciences. Since 1992 he has had several operational and quality management functions in very diverse companies related to the healthcare industry, including blood products, medical devices, biotech products, vaccines and advanced therapy products. During his career he has had QA responsibility for several large qualification and validation projects for upstream, downstream and fill-finish activities and at several locations he has been project manager for Quality Systems overhaul. As Quality manager/director (a.i.) Cor has been responsible for maintaining and improving Quality Systems and the performance of the QA officers team. He has been registered as a Qualified Person for different companies and also as Responsible Person.
Anja de Vries
Consultant
ATMP Quality expert
Anja started her career as a research analyst at Shell in 1975. Since 1999 she has build up for more as 20 years an extensive experience in implementation and managing of QMS systems in very diverse pharmaceutical companies. She has conducted several audits of contract manufacturing organizations - and testing organizations against the applicable regulatory GMP standards and customer expectations.
With her knowledge of the complex regulatory elements she has guided some successful inspections of regulatory bodies. She was part of the start-up of an Advanced Therapy Medicinal Products company first as consultant. For nearly 3 years she was Director QA responsible for the Quality System and Compliance of that company.
Frank van Engelenburg
CMC leader
Managing consultant at Progress
Frank is an experienced CMC Leader and has successfully led numerous CMC projects ranging from early development projects to late stage development and for MAA/BLA. In his role as CMC Leader he has been responsible for meeting quality aspects of different biologics, CMC development strategy, CMC regulatory strategy, and for CMC planning and budget control.
Frank holds a PhD in virology and was trained as a molecular biologist. After completing his PhD he worked as a Senior Scientist as Sanquin for 11 years and subsequently joined Kinesis-Pharma (Currently Venn) as Senior Consultant CMC for 10 years.
Speakers
Rob Hoeben
Dept of Cell and Chemical Biology, LUMC, Leiden
Rob Hoeben obtained his Master’s degree at Utrecht University with majors in Biology and Biochemistry in 1986. Then he moved to Leiden for his PhD research in the lab of Prof. Alex van der Eb to study the feasibility of gene therapy of hemophilia A. He obtained his PhD for his thesis ‘Towards gene therapy in haemophilia A: Vectors for the expression of blood‐clotting factor VIII in vivo’ at Leiden University in 1991. In his post-doctoral research he started working on adenovirus vectors for gene therapy and concentrated on their large scale production and their application in the field of cancer therapy. In 2000 he was appointed as full professor at Leiden University and the Leiden University Medical Center. Professor Hoeben has a long‐term interest in viruses and stem cells. His current research is focused on the development of oncolytic viruses and their application in cancer patients.
Stefan Braam
CEO Ncardia and Cellistic
Stefan Braam is the founder and CEO of Ncardia and Cellistic. Stefan brings Ncardia/Cellistic over a decade of experience in stem cell technology, product development and general management. Earlier in his career, Stefan obtained a MSc and PhD (both cum laude) in stem cell biology under supervision of Prof. Dr Mummery and obtained international experience in labs in the UK and Australia. Stefan won the NGI venture challenge (2009), the Niaba biobusiness Masterclass (2010), published in leading scientific journals, is an inventor on multiple patent families, secured several grants and technology licensing agreements and was with increasing responsibilities instrumental in Ncardia/Cellistic pre-seed, seed, Series A and B and C financing rounds.
Melissa van Pel
Head of Cell Therapy at NecstGen
Dr. Melissa van Pel is Head of Cell Therapy at NecstGen where she is responsible for process development and clinical manufacture for novel Cell and Gene Therapy products.
She obtained her PhD degree at the University of Utrecht in 2003. After an academic career focusing on molecular, cellular and functional aspects of hematopoietic and stromal cell populations, Melissa’s work shifted towards mesenchymal stromal cell (MSC) biology and the clinical applications of MSCs. Using pre-clinical animal models, she investigated the role of MSCs in several disease models, including atherosclerosis, lung emphysema, hematopoietic stem cell engraftment and colitis. Building upon this experience in MSC research, her research lines continued into Cell Therapy product development, optimisation of manufacturing processes, validation and additional product characterisation of Cell Therapy products according to GMP- and international standards.
As head of the Cell Therapy manufacture team in the Leiden University Medical Center, she was responsible for the expansion of MSCs for application in national and international clinical trials, ranging from phase I to III, including overseeing MSC manufacture in production centers in Germany and Spain.
Melissa has published over 40+ peer-reviewed scientific publications and participated in multiple national and international research consortia.
Martijn Kelder, Ph.D.
Sales Director at Cergentis
Martijn Kelder is a molecular geneticist with an academic background in genomics and genome editing. At Cergentis he heads the commercial and customer facing team. Martijn is a subject matter expert on the (regulatory requirements for) genetic characterisation of genome editing outcomes in cell therapy products and pharmaceutical cell lines. Martijn holds both BSc and MSc in molecular biology from Utrecht University and a Ph.D. in molecular genetics from University of Edinburgh and has published in leading journals including Nature, PLoS Biology and Genome Medicine.
Cor Marsman
QA Manager, QP and RP
Managing consultant
Progress
Cor started his career in 1982 as a medical analyst at the Gemini Hospital in Den Helder. In 1992 he graduated from the VU in Amsterdam as Biologist, with a major in Neurosciences. Since 1992 he has had several operational and quality management functions in very diverse companies related to the healthcare industry, including blood products, medical devices, biotech products, vaccines and advanced therapy products. During his career he has had QA responsibility for several large qualification and validation projects for upstream, downstream and fill-finish activities and at several locations he has been project manager for Quality Systems overhaul. As Quality manager/director (a.i.) Cor has been responsible for maintaining and improving Quality Systems and the performance of the QA officers team. He has been registered as a Qualified Person for different companies and also as Responsible Person.
Anja de Vries
Consultant
ATMP Quality expert
Anja started her career as a research analyst at Shell in 1975. Since 1999 she has build up for more as 20 years an extensive experience in implementation and managing of QMS systems in very diverse pharmaceutical companies. She has conducted several audits of contract manufacturing organizations - and testing organizations against the applicable regulatory GMP standards and customer expectations.
With her knowledge of the complex regulatory elements she has guided some successful inspections of regulatory bodies. She was part of the start-up of an Advanced Therapy Medicinal Products company first as consultant. For nearly 3 years she was Director QA responsible for the Quality System and Compliance of that company.
Frank van Engelenburg
CMC leader
Managing consultant
Progress
Frank is an experienced CMC Leader and has successfully led numerous CMC projects ranging from early development projects to late stage development and for MAA/BLA. In his role as CMC Leader he has been responsible for meeting quality aspects of different biologics, CMC development strategy, CMC regulatory strategy, and for CMC planning and budget control.
Frank holds a PhD in virology and was trained as a molecular biologist. After completing his PhD he worked as a Senior Scientist as Sanquin for 11 years and subsequently joined Kinesis-Pharma (Currently Venn) as Senior Consultant CMC for 10 years.
Regular ticket
access to the Dutch AMTP Summit at March 15th 2023.
299,- excl VAT
Dutch ATMP Summit 2023
With this ticket you will get access the the Dutch ATMP Summit on Wednesday March 15th 2023 in Amsterdam. You can join all the talks of our speakers and meet your colleagues in the field during networking drinks. During the day there are refreshments.
Second ticket for half of the price.
Regular ticket
access to the Dutch AMTP Summit at March 15th 2023.
299,- excl VAT
Dutch ATMP Summit 2023
With this ticket you will get access the the Dutch ATMP Summit on Wednesday March 15th 2023 in Amsterdam. You can join all the talks of our speakers and meet your colleagues in the field during networking drinks. During the day there are refreshments.
Second ticket for half of the price!
Presentations
Translational Research on Oncolytic Viruses: a Consortium Approach
The use of oncolytic viruses forms an appealing approach for cancer treatment. On the one hand the viruses replicate in tumor cells, leading to their intra-tumoral amplification. On the other hand the viral infection will activate virus-directed immune responses, and may trigger immune responses directed against tumor cells and tumor antigens. To date, a wide variety of oncolytic viruses is being developed for use in cancer treatment. Relatively few pre-clinical and clinical studies evaluated different oncolytic viruses in comparative studies. I will summarize the steps and considerations essential in the development and characterization of oncolytic viruses. In addition, I will outline our multidisciplinary academic consortium that collaborates on the development of oncolytic viruses.
New developments in the use of iPSC-based cell platforms in drug discovery and cell therapy
Induced pluripotent stem cells (iPSCs) can be expanded indefinitely and can be differentiated into every cell type. As such, iPSC technology opened a new era of treating human diseases. Recent developments in iPSC technology will be presented. Ranging from human in vitro models in drug development (safety testing and discovery screening) to allogeneic cell therapy.
Next generation ATMPs
Cell and Gene Therapies offer amazing potential for curative therapies. Melissa will discuss the current and next generation of therapies in this rapidly evolving field.
Genetic characterization of ATMPs: What and why the regulators want you to check
Advanced therapy medicinal products (ATMPs) hold great promise in offering effective and targeted treatments for otherwise poorly treated diseases and injuries. While the field of cell and gene therapies only emerged over the past decade, at this time more than 1,200 active clinical trials are registered globally and several treatments are already commercially available. Genetic engineering of primary immune cells, including (viral) transgene integration or gene editing using tools including CRISPR/Cas9 and TALENs, is a critical step in generation of autologous or allogeneic cell therapies. Sadly, the past years have shown us that undesired editing outcomes including oncogenic translocations can severely affect product safety and efficacy. As such, regulatory agencies including the FDA and EMA are developing and continuously updating regulatory guidelines for manufacturers to comply with. This seminar will cover the current requirements for genetic characterization of ATMPs as stipulated by the FDA/EMA, and subsequently discuss which screening strategies are available to assess these characteristics. The final part of the presentation will cover which proprietary services Cergentis, a Dutch CRO providing genetic QC services, offers for genetic characterizations of pharmaceutical cell lines and ATMPs in support of regulatory (IND/BLA) filings.
Performance of Aseptic Process Simulation studies in ATMP manufacturing
ATMPs are generally produced using aseptic process steps to ensure a sterile medicinal product.
At regular intervals and at minimum 2x per year aseptic processes must be evaluated for the effectiveness of process controls safeguarding aseptic conditions and for its capability to yield sterile products (EU-GMP, annex-1; FDA Guide for Industry; Sterile drug products- produced by aseptic processing; USP <1116>). Such aseptic process evaluation is performed by means of simulating the process using a suitable culture medium instead of product.
Next to the verification of the process capability such Media Fill is often also used to (re-)qualify the personnel involved in performance of aseptic processes. These personnel members must be kept in a trained and qualified state in order to be allowed to perform aseptic processes.
Administration of out of specification ATMP products
In the exceptional circumstances the administration of a cell/tissue-based ATMP that does not comply with the specifications may be considered to avoid an immediate significant hazard to the patient. The supply of an OOS batch can only occur after evaluation of the risk of the product and considering the specific condition of the patient. This presentation will discuss the various aspects before an OOS ATMP product can be administered.
Microbial control strategy for ATMPs
Assurance of absence of microbial contamination is essential for the safety of ATMPs including cells based ATMPs. A microbial control strategy should be established that goes beyond testing of samples for microbial quality attributes sterility, bioburden, endotoxin and mycoplasma. The strategy should use risk assessment tools to get microbial contamination under control. Risk assessments covers microbial contamination risks of raw and starting materials, facilities and equipment, personnel, process and methods. This presentation will provide you with an outline for establishing a microbial control strategy for ATMPs.
This years edition of the Dutch ATMP Summit will take place at George Marina.
Spaklerweg 10A
1096 BA Amsterdam
About us
This summit is an initiative from Progress
We work together with our clients, in order to obtain their goals. We work as a team to reach to the top. Progress is an independent consultancy company with customers in the pharmaceutical and biotechnology industries and in the healthcare sector. We provide project management, engineering & C&Q, CMC and Quality services.
About us
This summit is an initiative from Progress
We work together with our clients, in order to obtain their goals. We work as a team to reach to the top. Progress is an independent consultancy company with customers in the pharmaceutical and biotechnology industries and in the healthcare sector. We operate internationally, project management, engineering & C&Q, CMC and Quality services.
