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Gene and Cell Therapies CMC & Vector Manufacturing Online Summit

  • 24th – 25th March 2021
  • Hopin flag Hopin
  • ONLINE

Addressing manufacturing controls for the cell and gene therapies, the subject matter experts from the industry will exchange practical experience and expectations on

  • critical elements of establishing a robust CMC strategy
  • CQAs (Critical Quality Attributes)
  • CPPs (Critical Process Parameters)
  • key factors in easing the complexity of vector production

for CGTP (cell and gene therapy products) in order to ensure the manufacturing process met technical, regulatory, and cost-efficiency standards for producing safe products. The brochure contains the additional info and the key insights.

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 About Gene and Cell Therapies Event

While the global gene and cell therapies markets expand, companies continue struggling with CMC, analytical, process development, and manufacturing challenges.

At the Gene and Cell Therapies CMC & Vector Manufacturing Online Summit on March 24th -25th, 2021, while addressing manufacturing controls for the cell and gene therapies, the subject matter experts from the industry will discuss

  • critical elements of establishing an efficient CMC (Chemistry Manufacturing Controls) strategy
  • CQAs (Critical Quality Attributes)
  • CPPs (Critical Process Parameters)
  • the key factors in easing the complexity of vector production

for CGTP (Cell and Gene Therapy Products)  in order to ensure

  • the manufacturing process met technical and regulatory requirements for producing safe products
  • commercially viable CGTP are delivered.

The leading practitioners and consultants will share their insights and perspectives towards achieving and scaling-up robust cost and quality efficient manufacturing and vector process development, exploring emerging technologies in the field.

Join virtually #VLGeneCell to explore industry standards and advancements on March 24th -25th, 2021.

Who should attend

Chief Executives, Vice Presidents, Directors, Heads, Leaders and Managers specializing in:

  • Adenovirus
  • Adeno-associated Virus (AAA)
  • Advanced Therapy Medicinal Product (ATMP)
  • Analytics
  • Analytical
  • Bioprocessing
  • Biotherapeutics
  • Chimeric antigen receptor T cells (CAR-T)
  • Cell Engineering
  • Cell Therapy
  • Cellular Immunotherapy
  • Cellular Therapy
  • Clinical Development
  • Chemistry, Manufacturing, and Control (CMC)
  • Comparability
  • Compliance
  • Gene Therapy
  • GMP (Good Manufacturing Practices)
  • Gene Therapy Medicinal Products (GTMPs)
  • Cell-Based Medicinal Products (CBMPs)
  • Immuno-Oncology
  • Immunology
  • Immunology Chemistry
  • Immunotherapy
  • Lentivirus (LV)
  • Manufacturing
  • Market Access
  • Medical Affairs
  • Non-Viral Vectors
  • Oncology
  • Product Characterisation
  • Process Development
  • Production Engineering
  • Quality Assurance
  • Quality Control
  • Research and Development (R&D)
  • Regenerative Medicine
  • Regulatory
  • Safety
  • Scale Up
  • Stem Cell
  • Supply Chain
  • Viral Vector

Key Practical Learning Points

  • Accelerating CMC & quality development of gene and cell therapies (GCT) products
  • Meeting consistent CGTP safety, efficiency criteria and GMP manufacturing standards
  • Optimising and scaling vector production processes and performance
  • Enabling new technologies and processes coupled with sophisticated CQAs

Albert Ribickas, US

BMT/QC Laboratories Manager, Cell Therapies Facility

Moffitt Cancer in Tampa Florida

Al Ribickas is the BMT/QC Laboratories Manager in the Cell Therapies Facility at the Moffitt Cancer in Tampa Florida. Al has provided leadership for cellular therapy facilities for over eighteen years. He attended the University of South Florida receiving a degree in Clinical Laboratory Sciences. He is board certified by the American Society of Clinical Pathology as a Medical Technologist, a Specialist in Blood Banking, and as a Hemapheresis Practioner. He has been at the Moffitt Cancer Center since it’s opening in 1987. He initially worked as a blood bank technologist in the transfusion service until 2001. During his time in the transfusion service, he was trained in extracorporeal photopheresis for the treatment of Sezary syndrome, and for the treatment of graft versus host disease. This inspired him to explore, and move to the apheresis collection and processing laboratories of the blood and marrow transplant program to enhance his skills, and contribute to the emerging area of cell therapies. Al has worked on the production of various cellular therapies clinical trial products, and the implementation of commercial FDA approved products.

Dr. Christiane Niederlaender, UK

Vice President Technical

Parexel International

Christiane has spent 9 years at the UK medicines regulator MHRA, most recently as the Unit Manager of the Biologicals Unit. In that capacity, she chaired and oversaw all formal scientific advice meetings and had in-depth involvement in Brexit preparedness. At the same time, Christiane was a Senior Assessor and the UK delegate at the EMA committee for advanced therapies (CAT). She was a UK CAT Rapporteur responsible for managing the portfolio of all UK ATMP products (cell and gene therapies). She was also the Rapporteur for the EMA CAT Gene Therapy Guideline and quality lead for the gene therapy section of the new draft guideline for investigational ATMPs. She was a drafting group member in all other quality-related ATMP drafting groups, including GMP for ATMPs.  Prior to joining MHRA, Christiane worked with the UK regulator for the European Tissues and Cells Directive as a quality manager and inspector.

Christiane has experience in CMC and regulatory strategy for all types of biological products, with a particular focus on gene and cell therapies, novel biotherapeutics, biosimilars, and vectored vaccines. While at MHRA, she was the principal quality/CMC assessor for 10 centralized MAAs, including two full dossier applications for ATMPs as sole UK quality assessor (including CAR-T, see publications). She has in-depth knowledge of all European procedure types, both centralized and MR/DCP, and can give advice on ATMP classification, ODD, and the PRIME program.

As an ex-member of the EMA CAT committee, Christiane is familiar with the thinking of all European regulators in the ATMP space and is used to dialogue and negotiation with many regulatory agencies, as well as presenting her thinking during committee discussions. 

Christiane undertook her undergraduate studies in biochemistry, neurobiology, and molecular biology at Heidelberg University in Germany before obtaining her Ph.D. in molecular developmental neurobiology at Kings College London in the UK. Christiane has published her academic research in many high impact journals, including Nature.

Barbara Sanders, NL

VP Vector Development

VectorY

Passionate about re-engineering viruses to serve instead of to strike, Dr. Barbara Sanders has dedicated the last decade of her career to the Viral Vector Development arena within Janssen Vaccines (Johnson and Johnson) and at uniQure. During these years, she led multiple Discovery Teams within Vector Development to successfully design & develop several viral vectored candidates which are currently in the clinic.

Dr. Monica Commerford, US

Head of Viral Vector Services Regulatory Affairs

Thermo Fisher Scientific

Monica M. Commerford, Ph.D., is the Head of Regulatory Affairs at Thermo Fisher Scientific Patheon Viral Vector Services. She is an expert in the microbial control, product quality microbiology, and sterility assurance of Investigational New Drug Applications and Biological License Applications and performed pre-license inspections of biological product manufacturing facilities. She previously worked as a Microbiologist and Consumer Safety Officer in Branch IV in the Division of Microbiology Assessment, Office of Process and Facilities, Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the Food and Drug Administration. In addition, she has participated in writing policies and a draft guidance document for the Office of Pharmaceutical Quality. Dr. Commerford earned her B.S. in Biochemistry and Molecular Biology from Michigan State University and her Ph.D. in Microbiology and Molecular Genetics from Harvard University. In addition to her regulatory experience, she was also a Sallie Rosen Kaplan post-doctoral research fellow in the Laboratory of Molecular Biology at the National Institutes of Health.

Eileen Coleman, US

Head Of Quality at Viral Vector Services

Thermo Fisher Scientific

Dr. Rahul Kaushik, DE

Ex-Head of AAV facility

DZNE

Dr. Rahul Kaushik is an experienced biochemist, molecular biologist, and cell biologist with 12+ years of preclinical research experience in neuroscience. He has a long-standing interest and experience in using viral vectors and their use in gene manipulation, editing, and potential therapies. As molecular biology unit and project leader at German Center for Neurodegenerative Diseases (DZNE), he designed several novel and innovative AAV and LV vectors and established a small-scale AAV production. Later he was working as a senior scientist at ViGeneron, with an aim to develop innovative gene therapy solutions for retinal disorders.

Dr. Rajiv Gangurde, US

Chief Technology Officer

SparingVision

Dr. Rajiv Gangurde joined SparingVision as Chief Technology Officer in October 2020. In this role, he oversees technical operation activities, including process and analytical development, manufacturing, and quality assurance. 

Rajiv has over 14 years of industry experience in biopharmaceutical development, harnessed in the biotechnology hub of Massachusetts, USA. Most recently, Rajiv served as Senior Director and Head of Chemistry, Manufacturing, and Controls (CMC) at Voyager Therapeutics, a gene therapy company based in Cambridge, MA. In this role, he was responsible for CMC strategy and management of the company’s entire gene therapy portfolio. Prior to Voyager, Rajiv was Director of Bioprocess Development and Manufacturing at Genocea Biosciences, where he led upstream and downstream process development and biochemistry groups for early- and late-stage recombinant-protein-based therapeutic vaccines. Prior to Genocea, Rajiv served as Head of Protein Sciences at LakePharma (previously called Blue Sky Bioservices), leading therapeutic protein production efforts for pre-clinical studies.

Rajiv obtained his Ph.D. in Life Sciences from Mumbai University in India and did postdoctoral research at the Department of Biochemistry at the New Jersey Medical School and at the Department of Molecular and Cellular Biology at Harvard University.

John Taylor, US

Process Development Scientist

MilliporeSigma

John Taylor is a field-based Process Development Scientist at MilliporeSigma based in Philadelphia, Pennsylvania, USA. John is focused on robust process design, optimization, and scale-up of MilliporeSigma bioprocessing technologies used in biotherapeutics purification. John's current role has allowed him to support cell and gene therapy companies as they navigate through the challenges associated with process development and implementation. Prior to joining MilliporeSigma, he was an Assistant Scientist at Janssen R&D, where he focused on the process development of quick-to-market monoclonal antibodies. John received his M.S. in Biochemical Engineering from Villanova University in 2020 and his B.S. in Biological Engineering from NC State University in 2015. 

Dr. Nicole Faust, DE

CEO

CEVEC Pharmaceuticals

Nicole Faust is the CEO of CEVEC Pharmaceuticals. Until 2019 she was also Chief Scientific Officer of the company, responsible for directing CEVEC´s technology focus towards gene therapy and establishing the company´s viral vector production platforms. Before joining CEVEC, she held scientific management positions with Lonza Cologne and Artemis Pharmaceuticals. Nicole holds a Ph.D. in cell and molecular biology from the University of Freiburg and an MBA from Educatis University, Switzerland. She is a member of the American Society for Gene and Cell Therapy and currently Chair of the Gene Therapy Advisory Committee of the Alliance for Regenerative Medicine (ARM).

Dr. Hemant Dhamne, IN

Head, Vector and CAR-T Cell Process

Immuneel Therapeutics Pvt Ltd

Hemant Dhamne obtained his Ph. D from the ACTREC, Mumbai (2014) in Applied Virology. His Ph.D. thesis was on the Lentiviral Vector Mediate Long Term Expression of Therapeutic Proteins. He completed his doctoral work in the labs of Dr. Robin Mukhopadhyaya and Dr. Rajiv Kalraiya. His doctoral studies mainly focused on developing the novel LV platform using the inhouse HIV-1 derived vector system and its application for cell engineering and tumor targeting in pre-clinical models. From 2014 to 2015, he was a postdoctoral fellow in the laboratory of Dr. Amit Dutt in the same institute, working on functional genomics aspects spanning novel miRNA discovery and novel mutations in cancer-causing genes and associated pathways. Thereafter, he joined Gene Therapy Division at Intas Pharmaceuticals, Ahmedabad. He worked on early-stage product development of AAV mediated gene therapy for diseases such as hemophilia, neuronal and eye disorders. He successfully developed the pilot-scale manufacturing platforms using suspension cell lines in upstream and chromatography in downstream processes. He also contributed to assay development. He served as Research Scientist from 2015 to 2017 and as Senior Research Scientist from 2017 to 2019. He also developed early-stage designs and assays for CAR-T research. 

From 2018 to 2019, he completed a Diploma in International Business Management from Ahmedabad Management Association in affiliation with California State University. 

In 2019, he joined Immuneel Therapeutics as Head of Vector & CAR-T Manufacturing. His work encompasses the process development and GMP grade manufacturing of autologous CAR-T cells for clinical trials. The disease areas mainly include leukemias and lymphomas. 

He has 7 peer-reviewed publications in the field of gene therapy and functional genomics.

Dr. Zhu Pirot, US

Vice President, Translational Sciences

Kriya Therapeutics

Dr. Zhu Zhen Pirot is the vice president of translational science at Kriya Therapeutics. She currently leads AAV gene therapy vector development, characterization, and analytical science in the company. Dr. Pirot previously worked in Sangamo Therapeutics as the head of the analytical department responsible for analytical method development to characterize AAV gene therapy vectors and product release in supporting gene editing, gene & cell therapy programs. She has extended experience and knowledge in AAV gene therapy development from 2000 at Avigen Inc. Her industry experience also includes cancer drug discovery & development at Chiron /Novartis and bioanalytical assay & biomarker development at Geron Corp. She was trained as Medical Doctor in China and gained Ph.D. in cell & molecular biology from the University of Turin in Italy.

Dr. Cristina Baricordi, IT

Senior Scientist

AVROBIO

Cristina Baricordi is a biomedical scientist focused on gene therapy and hematopoietic stem cell biology. Her work at San Raffaele TIGET (Milan, Italy) and Dana Farber Cancer Institute (Boston, MA) has focused on the use of retro- and lentiviral vector tagging as a tool to track the activity and dynamics of genetically-engineered cells in clinical and pre-clinical settings. She received her Ph.D. in Pharmacology and Toxicology from the University of Bologna in 2018. In 2019, she was a founding scientist of the Gene Therapy and Biology Team at AVROBIO. Cristina’s current research includes developing a novel platform for the in-depth characterization of the CD34+ drug product.

Dr. Man-Shiow Jiang, US

Senior Director, Viral Vector of Process Technology Development

WuXi Advanced Therapies

Man-Shiow Jiang is the Senior Director, Viral Vector of Process Technology Development at WuXi Advanced Therapies located in Philadelphia, PA and responsible for developing World-Class AAV and Lentiviral Platforms. She has nearly 20 years of experience in the life sciences industry. She studied at the Johns Hopkins University School of Medicine where she earned a Ph. D. in Biochemistry, Cellular and Molecular Biology (BCMB).

Dr. Klaus Richter, DE

Expert Scientist & Group Leader AUC

Coriolis Pharma

Dr. Klaus Richter is the leader of the AUC group at Coriolis Pharma, which is dedicated to the biophysical characterization of drug products and drug substances ranging from small molecules and peptides to viral particles and liposomes. He is a biochemist by training and received a Ph.D. from the Technical University of Munich in the field of protein characterization and worked for several years in the area of structure-function and structure-activity relationships of pharmaceutically relevant proteins before joining Coriolis Pharma. Klaus obtained his Habilitation in 2012 and is the (co-) author of more than 70 publications in the field of protein characterization with diverse biophysical methods, in many cases applying analytical ultracentrifugation (AUC) as a tool to investigate protein structure, protein interaction, and stability.

Nelis Denys, BE

Product Manager

Unchained Labs

Nelis Denys is the Product Manager for Lunatic and Stunner at Unchained Labs. Nelis earned his MS in Biochemical Engineering Technology from Ghent University, where he investigated polymer influence on polyelectrolyte matrices.

Prior to Product Management, he learned the ins and outs of the Lunatic & Stunner line as the Product support engineer.

Albert Ribickas, US

BMT/QC Laboratories Manager, Cell Therapies Facility

Moffitt Cancer in Tampa Florida

Dr. Christiane Niederlaender, UK

Vice President Technical

Parexel International

Barbara Sanders, NL

VP Vector Development

VectorY

Dr. Monica Commerford, US

Head of Viral Vector Services Regulatory Affairs

Thermo Fisher Scientific

Eileen Coleman, US

Head Of Quality at Viral Vector Services

Thermo Fisher Scientific

Dr. Rahul Kaushik, DE

Ex-Head of AAV facility

DZNE

Dr. Rajiv Gangurde, US

Chief Technology Officer

SparingVision

John Taylor, US

Process Development Scientist

MilliporeSigma

Dr. Nicole Faust, DE

CEO

CEVEC Pharmaceuticals

Dr. Hemant Dhamne, IN

Head, Vector and CAR-T Cell Process

Immuneel Therapeutics Pvt Ltd

Dr. Zhu Pirot, US

Vice President, Translational Sciences

Kriya Therapeutics

Dr. Cristina Baricordi, IT

Senior Scientist

AVROBIO

Dr. Man-Shiow Jiang, US

Senior Director, Viral Vector of Process Technology Development

WuXi Advanced Therapies

Dr. Klaus Richter, DE

Expert Scientist & Group Leader AUC

Coriolis Pharma

Nelis Denys, BE

Product Manager

Unchained Labs

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What our
participants
are saying

Well done for a successful interesting conference! Very insightful speakers and well thought presentations / messages.

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Attendee

It was great to hear from the various members of the panel. You are doing a great keep audience engage with Vonlanthen conferences during trying times because of Covid19. I foresee the market after the pandemic as a combined effort of online and offline events.

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Attendee

It was truly a wonderful experience. Congratulations for the organization in such COVID 19 context. Hope to make a real meeting ASAP.

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