This document provides information about the Cell & Gene Therapy conference taking place on October 10-11, 2018 in London. It includes details about the agenda, speakers, workshops, and registration information. The two-day conference will focus on topics related to manufacturing, regulation, and translational research of cell and gene therapies. There will be presentations from industry experts on developing stem cell and gene therapies, as well as workshops on practical development issues and competitive intelligence in the cell and gene therapy field.
What’s NEW in 2015’s program?
• More case studies on successful commercialization
• Insights on developing biosimilars under new CFDA guideline
• Emerging business models in regulated and developing markets
• New and timely topics on:
o Valuating biosimilars investments
o Successful technology transfer
o Key criteria in gaining approval
Also, NEW Expert Faculty includes:
Dr Shin Jae Chang, Vice President, Celltrion, Korea
Ira Jacobs, Global Oncology Lead, Biosimilars, Pfizer, US
Paul Thomas, Business Unit Head – Biosimilars, Biocon, India
Dr. Martina A. Sersch, Global Clinical Lead, Oncology Global Development, APAC Biotherapeutics Lead, Genentech, Inc. / F. Hoffmann-La Roche Ltd.
Raj Kannan, Vice President, Commercial Head, Biosimilars, Merck, Switzerland
Huiguo (Forrest) Hu, General Manager of International Business, Shanghai CP Guojian Pharmaceutical Co., Ltd, China
Ko Chung Lin, Chief Executive Officer, PharmaEssentia Corporation, Taiwan
Wen Yong, Vice Director, Drug Research Institutes, Biopharmaceutical Institute, Jiangsu AoSaiKang Pharmaceutical Co Ltd, China
http://www.biosimilarsasia.com
5th Annual Pre-Filled Syringes East CoastTeri Arri
Building on the success of previous sell-out shows, SMi Group is delighted to announce the return of the 5th annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 11th – 12th 2018 in Boston, Massachusetts, USA.
A rise in chronic diseases, improvements in technology and a growing demand for easy to use drug administration products has in recent years, created a booming Pre-Filled Syringes industry.
Some notable areas of increased attention have been the broader trends for combination products and biologics, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still several ongoing challenges that the key-thought leaders are battling to overcome such as chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.
Pre-Filled Syringes East Coast will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their PFS device.
Bioprocessing of Advanced Cellular Therapies CongressTony Couch
Last opportunity to get onto the programme.
Key sessions:
• Upstream process development for gene therapies
• Upstream process development for cell based therapies
• Downstream processing considerations
• Analytics - tackling measurement assurance for advanced cellular therapeutics
• Insights into Business Development and Reimbursement
• Regulatory perspectives
World ADC Frankfurt 2015 - sample brochureWorld ADC
The World ADC Frankfurt meeting has been established with the simple mission of speeding up the development of more potent and safe antibody drug conjugates.
Learn not only how to make an ADC, but how to make a great one. With insights on numerous novel payload technologies, robust strategies for preclinical evaluation and emerging clinical data, there is no better opportunity to accelerate your research.
What’s NEW in 2015’s program?
• More case studies on successful commercialization
• Insights on developing biosimilars under new CFDA guideline
• Emerging business models in regulated and developing markets
• New and timely topics on:
o Valuating biosimilars investments
o Successful technology transfer
o Key criteria in gaining approval
Also, NEW Expert Faculty includes:
Dr Shin Jae Chang, Vice President, Celltrion, Korea
Ira Jacobs, Global Oncology Lead, Biosimilars, Pfizer, US
Paul Thomas, Business Unit Head – Biosimilars, Biocon, India
Dr. Martina A. Sersch, Global Clinical Lead, Oncology Global Development, APAC Biotherapeutics Lead, Genentech, Inc. / F. Hoffmann-La Roche Ltd.
Raj Kannan, Vice President, Commercial Head, Biosimilars, Merck, Switzerland
Huiguo (Forrest) Hu, General Manager of International Business, Shanghai CP Guojian Pharmaceutical Co., Ltd, China
Ko Chung Lin, Chief Executive Officer, PharmaEssentia Corporation, Taiwan
Wen Yong, Vice Director, Drug Research Institutes, Biopharmaceutical Institute, Jiangsu AoSaiKang Pharmaceutical Co Ltd, China
http://www.biosimilarsasia.com
5th Annual Pre-Filled Syringes East CoastTeri Arri
Building on the success of previous sell-out shows, SMi Group is delighted to announce the return of the 5th annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 11th – 12th 2018 in Boston, Massachusetts, USA.
A rise in chronic diseases, improvements in technology and a growing demand for easy to use drug administration products has in recent years, created a booming Pre-Filled Syringes industry.
Some notable areas of increased attention have been the broader trends for combination products and biologics, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still several ongoing challenges that the key-thought leaders are battling to overcome such as chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.
Pre-Filled Syringes East Coast will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their PFS device.
Bioprocessing of Advanced Cellular Therapies CongressTony Couch
Last opportunity to get onto the programme.
Key sessions:
• Upstream process development for gene therapies
• Upstream process development for cell based therapies
• Downstream processing considerations
• Analytics - tackling measurement assurance for advanced cellular therapeutics
• Insights into Business Development and Reimbursement
• Regulatory perspectives
World ADC Frankfurt 2015 - sample brochureWorld ADC
The World ADC Frankfurt meeting has been established with the simple mission of speeding up the development of more potent and safe antibody drug conjugates.
Learn not only how to make an ADC, but how to make a great one. With insights on numerous novel payload technologies, robust strategies for preclinical evaluation and emerging clinical data, there is no better opportunity to accelerate your research.
Highly Potent Active Pharmaceutical Ingredients 2017Fateja Begum
The Highly Potent Active Pharmaceutical Ingredients conference features key speakers of the industry presenting challenges, issues, innovation and new developments in various areas of HPAPI production, development and manufacturing.
SMi proudly presents due to the huge success of our Pharmaceutical Microbiology UK event the launch of SMi's Pharmaceutical Microbiology USA Conference in San Diego on 8th and 9th June 2017. Latest reports show that global rapid microbiology tests market to reach a net worth USD 19.5 Bn by 2022.* With the field growing at such a rapid rate SMi would like to take this opportunity to invite you to join us as we address the hot topics of the industry such as RMM, low endotoxin recovery, risk assessment and many more! With the forthcoming changes to annexe 1, take this opportunity to hear direct regulatory feedback and benchmark your strategies amongst industry peers. Our 2 day event will include presentations from both regulatory and industry experts sharing recent case studies and developing trends in the field of pharmaceutical microbiology
“A key source of growth in biologics over the next several years will be Biomanufacturing” Ge Li, Chairman and CEO, Wuxi” <outsourcing-pharma.com,>
“Other issues with single-use include standardization of systems, the dependability to vendors, and the supply chain and waste management but if we can overcome extractables and leachables, we will eventually be able to scale up to many thousands of liters.” Jason Li, Senior Director, Downstream Processing, Genor Biopharma <biopharma-reporter.com,>
Industry experts will discuss these and more at the 5th Annual Biomanufacturing Conference in Grand Hyatt Shanghai, China on 19 – 22 May 2015 during IBC’s Biopharma Development & Production (BDP) Week.
What's new this Year?
NEW LOCATION - Hong Kong.
PLASMA FRACTIONATION TECHNOLOGY WORKSHOP.
REGULATOR’S FORUM - meet Global and Asian regulatory experts for plasma and blood products.
GLOBAL EMERGING MARKETS Self Sufficiency Case Studies: China, India, Iran and more.
INSIGHTS to the first South East Asian plasma fractionation plant.
No other Bioplasma event can get you one-to-one access to senior decision-makers from both the international and regional Bioplasma industry.
Open Innovation Strategy in Sigma Life Sciences_NCET2 Webinar Oct 09Rebecca Poon
Use of open innovation to complement internal R&D function for bandwidth, increased efficiency and risk management with the goal of maintaining leadership in product and technology. Case studies in a life science company.
How True Open Innovation TM and its global network can expand the opportunity for drug development by increasing efficiency and decreasing costs
Luca Rastelli, PhD
Boston Strategics Corporation
October, 2013
SMi is proud to present the 2017 19th annual Superbugs & Superdrugs conference, taking place on 20th and 21st March in Central London.
Expanding horizons on the growing threat of anti-microbial resistance for almost two decades, the flagship show in the global Superbugs portfolio of events will once again play host to an international audience of scientific leaders, funding bodies and drug discovery specialists, providing a focal point to push industry collaboration through updates on clinical advancements and investment opportunities.
After the success of the previous edition - Bioprocessing of Advanced Cellular Therapies Congress 2016, MarketsandMarkets is pleased to announce the 2nd Annual Bioprocessing of Advanced Cellular Therapies Congress in London, UK.
Research Organizations and Pharma companies have been investing big time into the promise of cellular therapies and all signs point to the need to accelerate the process of moving from lab to patient using advanced manufacturing processes and solutions to commercialization.
With this objective, making the shift from manual processes to automation, bridging the gap between research lab and market place, and using novel and advanced technologies will be the key aspects for manufacturers to answer the challenge of scale-out.
The 2nd Annual Bioprocessing of Advanced Cellular Therapies Congress taking place on the 8th and 9th June, 2017 in London, UK focuses on this holistic approach by discussing the next generation bioprocessing, strategies, technologies and solutions to work together for this constantly evolving field.
Highly Potent Active Pharmaceutical Ingredients 2017Fateja Begum
The Highly Potent Active Pharmaceutical Ingredients conference features key speakers of the industry presenting challenges, issues, innovation and new developments in various areas of HPAPI production, development and manufacturing.
SMi proudly presents due to the huge success of our Pharmaceutical Microbiology UK event the launch of SMi's Pharmaceutical Microbiology USA Conference in San Diego on 8th and 9th June 2017. Latest reports show that global rapid microbiology tests market to reach a net worth USD 19.5 Bn by 2022.* With the field growing at such a rapid rate SMi would like to take this opportunity to invite you to join us as we address the hot topics of the industry such as RMM, low endotoxin recovery, risk assessment and many more! With the forthcoming changes to annexe 1, take this opportunity to hear direct regulatory feedback and benchmark your strategies amongst industry peers. Our 2 day event will include presentations from both regulatory and industry experts sharing recent case studies and developing trends in the field of pharmaceutical microbiology
“A key source of growth in biologics over the next several years will be Biomanufacturing” Ge Li, Chairman and CEO, Wuxi” <outsourcing-pharma.com,>
“Other issues with single-use include standardization of systems, the dependability to vendors, and the supply chain and waste management but if we can overcome extractables and leachables, we will eventually be able to scale up to many thousands of liters.” Jason Li, Senior Director, Downstream Processing, Genor Biopharma <biopharma-reporter.com,>
Industry experts will discuss these and more at the 5th Annual Biomanufacturing Conference in Grand Hyatt Shanghai, China on 19 – 22 May 2015 during IBC’s Biopharma Development & Production (BDP) Week.
What's new this Year?
NEW LOCATION - Hong Kong.
PLASMA FRACTIONATION TECHNOLOGY WORKSHOP.
REGULATOR’S FORUM - meet Global and Asian regulatory experts for plasma and blood products.
GLOBAL EMERGING MARKETS Self Sufficiency Case Studies: China, India, Iran and more.
INSIGHTS to the first South East Asian plasma fractionation plant.
No other Bioplasma event can get you one-to-one access to senior decision-makers from both the international and regional Bioplasma industry.
Open Innovation Strategy in Sigma Life Sciences_NCET2 Webinar Oct 09Rebecca Poon
Use of open innovation to complement internal R&D function for bandwidth, increased efficiency and risk management with the goal of maintaining leadership in product and technology. Case studies in a life science company.
How True Open Innovation TM and its global network can expand the opportunity for drug development by increasing efficiency and decreasing costs
Luca Rastelli, PhD
Boston Strategics Corporation
October, 2013
SMi is proud to present the 2017 19th annual Superbugs & Superdrugs conference, taking place on 20th and 21st March in Central London.
Expanding horizons on the growing threat of anti-microbial resistance for almost two decades, the flagship show in the global Superbugs portfolio of events will once again play host to an international audience of scientific leaders, funding bodies and drug discovery specialists, providing a focal point to push industry collaboration through updates on clinical advancements and investment opportunities.
After the success of the previous edition - Bioprocessing of Advanced Cellular Therapies Congress 2016, MarketsandMarkets is pleased to announce the 2nd Annual Bioprocessing of Advanced Cellular Therapies Congress in London, UK.
Research Organizations and Pharma companies have been investing big time into the promise of cellular therapies and all signs point to the need to accelerate the process of moving from lab to patient using advanced manufacturing processes and solutions to commercialization.
With this objective, making the shift from manual processes to automation, bridging the gap between research lab and market place, and using novel and advanced technologies will be the key aspects for manufacturers to answer the challenge of scale-out.
The 2nd Annual Bioprocessing of Advanced Cellular Therapies Congress taking place on the 8th and 9th June, 2017 in London, UK focuses on this holistic approach by discussing the next generation bioprocessing, strategies, technologies and solutions to work together for this constantly evolving field.
SMi’s 4th annual Peptides conference will give you the perfect platform to network, collaborate and learn over 2 days, featuring various key presentations by senior level industry professionals. With topics such as peptide formulation and delivery, as well as new advances in alternative peptide analysis technologies, Cell Penetrating Peptides, enhancements in synthesis mechanisms, analytical monitoring techniques, and many more.
10 most trusted clinical laboratories in 2021Merry D'souza
To honor the diligent services of clinical laboratories, we came up with this edition of Insights Care - 10 Most Trusted Clinical Laboratories in 2021.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Tracks focus on R&D strategies, Biomarker development, Immuno-oncology, CDx development, AI and Big data analysis and approaches – Attending this Summit will provide you with the opportunity to mix and interact with experts working in all facets of Precision Medicine through the individual, panel and roundtable discussions on offer.
Welcome to the M Lab™ Collaboration Centers – where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlab
Welcome to the M Lab™ Collaboration Centers – where customers can use non-GMP lab spaces to operate equipment, evaluate processes and receive real-time technical support without disrupting production.
Plan your visit: www.merckmillipore.com/mlab
Similar to SMi Group's Cell & Gene Therapy 2018 conference (20)
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Overview on Edible Vaccine: Pros & Cons with Mechanism
SMi Group's Cell & Gene Therapy 2018 conference
1. www.cellandgeneconference.com
register online or fax your registration to +44 (0) 870 9090 712
or call +44 (0) 870 9090 711
a: practicalities in the development of
stem cell therapies
Workshop leader:
paul stroemer, Director,
advanced Therapies consultancy
08.30 - 12.30
B: strategic competitive intelligence in the
cell and gene therapy space
Workshop leaders:
Timos papagatsias, CEO,
lucidQuest
13.30 - 17.00
plus TWo inTeracTiVe half-DaY pre-conference WorKshops | TuesDaY 9Th ocToBer 2018, copThorne Tara hoTel, lonDon, uK
sMi pharma
@sMipharm
#sMicgt
chairs for 2018:
• Pamela tranter, Head of Translational Research Group, ucl
• giuseppe ronzitti, Cell and Gene Therapy Specialist, genethon
KeY speaKers incluDe:
• Janet glassford, Senior Quality Assessor (biologicals), Mhra
• Kei Kishimoto, Chief Scientifi c Offi cer, selecta Biosciences
• shailesh gupta, Senior Scientist, astraZeneca
• Peggy sotiropoulou, R&D Manager, Research and Development,
celyad
• Julie Kerby, Head of Manufacturing Development, cell and gene
Therapy catapult
• lior raviv, Vice President, Development, pluristem
• diego aridgo, R&D Rare Disease Unit Head, chiesi
• Mehdi gasmi, Chief Science and Technology Offi cer, adverum
Biotech
• emanuela cuomo, Associate Director, Discovery Sciences, Cellular
Biology Team, astraZeneca
• Yen choo, Founder and Executive Chairman, plasticell
• ian McKay, Innovation Lead Advanced Therapies, innovate uK
2018 featured highlights:
• Discuss the challenges of accessing patients with commercial
ATMPs
• understand the advantages of a risk-based approach to cell and
gene therapy manufacturing
• hear the MHRA’s perspective of UK and EU regulatory affairs
regarding ATMPs
• explore the unique applications of the CRISPR/Cas9 system for drug
development at AstraZeneca
• gain insight into GMP Manufacture of plasmid DNA at the NHSBT
WORKSHOPS: 9TH
CONFERENCE: 10TH-11TH
OCT
2018COPTHORNE TARA HOTEL, LONDON, UK
SMi Presents the Launch of…
Cell & Gene
Therapy
from manufacturing to patient access: discover the world
of advanced therapy medicinal products
register BY 31st MaY and saVe £400
register BY 29th June and saVe £300
register BY 31st august and saVe £200
2. Manufacturing, regulation and translational research
Therapeutic applications of ATMPs
MAY 2018
Injectable Drug Delivery
16th - 17th May 2018,
London, UK
Pain Therapeutics
21st - 22nd May 2018,
London, UK
Highly Potent
Active Pharmaceutical
Ingredients
21st - 22nd May 2018,
London, UK
Pre-Filled Syringes
West Coast
4th - 5th June 2018,
San Diego, CA
Pharmaceutical
Microbiology West Coast
7th - 8th June 2018,
San Diego, CA
Drug Safety
11th - 12th June 2018,
London, UK
Pharmaceutical Freeze
Drying Technology
13th - 14th June 2018,
London, UK
BioBanking
13th - 14th June 2018,
London, UK
JULY 2018
ADMET
9th - 10th July 2018,
London, UK
Molecular Diagnostics
9th - 10th July 2018,
London, UK
SEPTEMBER 2018
Immuno-Oncology
26th – 27th September
2018, London, UK
Biosimilars And Biobetters
26th - 27th September
2018, London, UK
OCTOBER 2018
Cell & Gene Therapy
10th - 11th October 2018,
London, UK
Orphan Drugs
17th - 18th October 2018,
London, UK
NOVEMBER 2018
Superbugs & Superdrugs
USA
12th - 13th November
2018, New Jersey, USA
Biosimilars North America
14th - 15th November
2018, New Jersey, USA
Lyophilization USA
15th - 16th November
2018, New Jersey, USA
Ophthalmic Drugs
26th - 27th November
2018, London, UK
DECEMBER 2018
Cold Chain
10th - 11th December
2018, London, UK
JUNE 2018
SMi PHARMACEUTICAL EVENT PLANNER 2018
Cell & Gene Therapy
Day One | Wednesday 10th October 2018 www.cellandgeneconference.com
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks
Pamela Tranter, Head of Translational Research Group, UCL
OPENING ADDRESS
9.10 Mitigating the immunogenicity of AAV gene therapy vectors with
tolerogenic nanoparticles
• Cellular and humoral immunity against AAV can affect the
safety and efficacy of gene therapy and the ability to re-treat
patients later in life
• We have developed synthetic vaccine particles encapsulating
rapamycin (SVP-Rapamycin) that have been shown to mitigate
immunogenicity against a variety of biologic drugs by inducing
tolerogenic dendritic cells and antigen-specific regulatory T cells
• We will present pre-clinical data demonstrating the ability of
SVP-Rapamycin to inhibit the formation of anti-AAV antibodies
and share data from an ongoing clinical trial of SVP-Rapamycin
combined with a therapeutic enzyme
Kei Kishimoto, Chief Scientific Officer, Selecta Biosciences
9.50 Becoming cell therapy makers - Opportunities and challenges in
“in house” manufacturing of cell therapy products
• Reproducible manufacturing techniques - the basics of process
development
• The importance of closed and automated manufacturing
technologies
• Data management for improvement of process understanding
and control
• The importance of raw materials management
Lior Raviv, Vice President, Development, Pluristem
10.30 Morning Coffee
11.00 Spotlight: UK and EU regulatory affairs: MHRA’s perspective
• What support is available for companies from early in the
development process?
• Designing clinical trials in a way that comes up with the
evidence regulators need to accelerate ATMPs
• Ensuring safety while reducing cost of development: working
together with regulators to make the approval process more
efficient
• Impact of Brexit and further initiatives
Janet Glassford, Senior Quality Assessor (biologicals), MHRA
11.40 Opportunities and challenges of translating cell and gene
therapies in academia
• Review of the exciting and diverse pipeline of cell and gene
therapy projects within UCL with example case studies
• Opportunities for project funding: internal, public funds, industry
partners and University spin outs
• Understanding the de-risking and evidence required to support
the commercial route forward
Pamela Tranter, Head of Translational Research Group, UCL
12.20 Networking Lunch
1.20 Intravitreal rAAV gene therapy approaches for the treatment of
retinal disorders
• Indications that are currently pursued at Adverum
Biotechnologies
• Development of novel AAV capsid targeting the eye
• Advantages of gene therapy approaches to retinal disorders
Mehdi Gasmi, Chief Science and Technology Officer,
Adverum Biotech
2.00 Targeting solid and liquid malignancies with the same CAR
• What is an ideal target for CAR-T cell therapy?
• Challenges in targeting solid tumours using CAR T cells
• Autologous versus allogeneic CAR-T cells
Peggy Sotiropoulou, RD Manager, Research and Development,
Celyad
2.40 Afternoon Tea
3.10 Risk-based approaches to cell and gene therapy manufacturing
• Why manufacturing remains a significant challenge for cell and
gene therapies
• How Quality Target Product Profiles and process mapping
techniques can be used to generate a process risk assessment
and help you understand and accelerate your process
development
Julie Kerby, Head of Manufacturing Development,
Cell and Gene Therapy Catapult
3.50 Overcoming adeno-associated virus gene therapy limitations in
genetic neuromuscular diseases
• Rare, genetic neuromuscular diseases constitute a bigger
challenge given the absence of knowledge on the
physiopathological mechanisms and of therapeutic options
• Adeno-associated virus (AAV) vector-based gene therapy
became a principal actor in the development of therapies for
monogenic diseases
• Successful human trials of gene transfer in the liver for
hemophilia A and B, in the eye for congenital blindness and in
the nervous system for spinal muscular atrophy have unveiled
the therapeutic potential of this viral vector platform
• Development of technological tools to overcome the current
limitations of AAV gene therapy applied to neuromuscular
diseases
Giuseppe Ronzitti, Cell and Gene Therapy Specialist, Genethon
4.30 Chairman’s Closing Remarks and Close of Day One
Register online at www.cellandgeneconference.com
3. uPdates on cell theraPY deVeloPMent strategies
sponsorship anD eXhiBiTion opporTuniTies
sMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored
to complement your company’s marketing strategy. prime networking opportunities exist
to entertain, enhance and expand your client base within the context of an independent
discussion specific to your industry.
should you wish to join the increasing number of companies benefiting
from sponsoring our conferences please call: alia Malick, Director,
on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
MarKeting PartnershiP oPPortunities
sMi group is offering companies the opportunity to partner on our
dedicated events in order to help raise your company profile,add value,
create awareness of your products/services to our key audience within
the pharmaceutical industry.
interested in partnering? contact pav solanki, sMi Marketing on
+44 (0) 20 7827 6048 oremail: psolanki@smi-online.co.uk
cell gene therapy
www.cellandgeneconference.com day two | thursday 11th october 2018
8.30 registration coffee
9.00 chairman’s opening remarks
giuseppe ronzitti, Cell and Gene Therapy Specialist, genethon
oPening address
9.10 advances in cell therapy process development and optimisation
at plasticell
• Combinatorial screening of parameter space for process
development and optimisation in cell and gene therapy
• Expansion of hematopoietic stem cells from cord blood for
allogeneic transplantation
• Enhancement of viral transduction effi ciency for autologous
gene therapy to treat rare diseases
Yen choo, Founder and Executive Chairman, plasticell
9.50 generation of endogenous reporter iPs cell lines for optimizing
differentiation protocols, understanding disease biology driving
drug discovery projects
• CRISPR/Cas9 in engineering iPS cells to generate cellular
reagents for drug discovery
• Clone screening capabilities/methodologies
• Characterization, validation potential application of PGE
modifi ed iPS cell lines
shailesh gupta, Senior Scientist, astraZeneca
10.30 Morning coffee
11.00 supporting advanced therapies – the innovate uK perspective
• Support for advanced therapies – from Innovate UK and across
Government
• Innovate UK support for the commercialisation of advanced
therapies
• How the Advanced Therapy Treatment Centres will enable
adoption of advanced therapies in the NHS
ian McKay, Innovation Lead, Advanced Therapies, innovate uK
11.40 spotlight: harnessing crispr/cas9 for drug development
• Genome editing for target identifi cation
• Genome editing for cell model generation and target validation
• Genome editing to understand drug resistance
• Genome editing as a therapeutic
emanuela cuomo, Associate Director, Discovery Sciences, Cellular
Biology Team, astraZeneca
12.20 networking lunch
inTeracTiVe KeYnoTe aDDress
1.20 Towards operational excellence in cell and gene therapy
manufacturing and delivery
• First generation processes in cell and gene therapy industry
• ’Needle to Needle’ challenges
• Lean Six Sigma for advanced therapy medicinal products
fabio d’agostino, Partner, alira health
2.00 accessing patients with commercial advanced therapies
• Addressing market access and reimbursement of advanced
therapies (ATMPs)
• Logistics and restricted access programs constraints in bringing
ATMPs to patients in a commercial setting
• Rare disease patient access with ATMPs
Diego aridgo, RD Rare Disease Unit Head, chiesi
2.40 afternoon Tea
3.10 gMP Manufacture of Plasmid dna
• Good plasmid DNA manufacturing practice begins with an
appropriate vector design. The eukaryotic promoter, gene
sequence, and poly-A site primarily affect the therapeutic
effi cacy, remaining part of the vector is important for
manufacturing
• Choice of the plasmid’s origin of replication (ori) is critical for
the plasmid copy number and for the cultivation titer. ColE1-
derived, high copy-number pUC ori is widely established due to
high copy number. Introduction of random or defi ned mutations
into the pUC ori can further increase the plasmid yield
• Selecting appropriate host strain, maximizing titer by upstream
optimization, and achieving superior performance in small and
large-scale cGMP manufacturing
paul lloyd-evans, Head of Clinical Biotechnology Centre, nhs
Blood and Transplant
3.50 scalable production of adult progenitor cell populations for
skeletal regeneration – bridging the gap
• Comparison across bioreactor systems - visualization tools for
bioprocess effi ciency
• Evaluation of functionality of expanded cell populations in small
animal models – setting the target quality profi les
• Development of real-time decision-making tools for optimising
bioprocess management for high-risk autologous production
• Adding a third dimension - controlling complexity in tissue
engineered ATMPs
ioannis papantoniou, ATMP Bioprocessing Coordinator, Skeletal
Biology and Engineering Research Centre, Ku leuven
4.30 chairman’s closing remarks and close of Day Two
alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
MeDia parTners:
4. HALF DAY PRE-CONFERENCE WORKSHOP A
Tuesday 9th October 2018
Copthorne Tara Hotel, London, UK
8.30 - 12.30
Practicalities in the Development
of Stem Cell Therapies
Workshop Leader:
Paul Stroemer, Director,
Advanced Therapies Consultancy
Workshop Overview:
All cell therapies have unique challenges in their
development pathway. The route from initial innovation
to commencing clinical trials is rarely straight forward.
This workshop will focus on issues encountered in the
translational arc of cell therapies to help companies
minimize early setbacks. Topics for the day will cover the
span of product development from initial proof of concept
to clinical studies. Active participation in the workshop will
be highly encouraged.
Key Benefits of Attending:
• Acquire insight into the development process for cell
therapies
• Learn to identify potential issues and solutions to
maintain program timelines
• Participate in a meeting simulating interaction with a
competent authority
Agenda
8.30 Registration and coffee
9.00 Opening remarks and introductions
9.10 Overview of cell therapies
• Current products
• Prospective indications
• Regulatory outlook
9.40 Bridging the “Valley of Death”
• Developing the Target Product Profile
• Design of testing strategy
• Translation to the clinic
10.30 Morning Coffee
11.00 Manufacturing issues
• Technology transfer
• Product characterization
• Assay development
• Delivery challenges
11.30 Interactive Session: Preparation for a Competent
Authority meeting
• Candidate ATMP scenario
• Preparation of questions
• Simulated meeting
12.20 Closing remarks
12.30 End of workshop
About the Workshop Leader:
Paul is the Director of Advanced Therapies Consultancy.
He has a wealth of experience in the Pre-clinical, Safety,
Regulatory and Clinical study aspects of stem cell therapies.
Paul worked with ReNeuron in the development of its lead
cell line. He earned a PhD in Neuroscience at the University
of Texas Medical Branch at Galveston with
About the Organisation:
Advanced Therapies Consultancy was started in early 2018
to help emerging (and mature) biotechnology companies in
developing novel products. Mistakes are commonly made
early in developing advanced therapies. The Advanced
Therapies Consultancy helps clients focus on clinical use of
their product. This approach identifies potential issues that
can be rectified in the development pathway saving time
and money.
5. HALF DAY PRE-CONFERENCE WORKSHOP B
Tuesday 9th October 2018
Copthorne Tara Hotel, London, UK
13.30 - 17.00
Strategic Competitive Intelligence in
the Cell and Gene Therapy space
Workshop Leader:
Timos Papagatsias, CEO,
LuciQuest
Workshop Overview:
This workshop will focus on how stakeholders can combine
the latest advancements in Strategic Competitive
Intelligence in order to uncover opportunities and threats
for their companies and brands in the Cell and Gene
Therapy space. Workshop participants will also be provided
with a short step-by-step guide on how to use competitive
intelligence to generate actionable insights which will help
them gain a competitive advantage over others.
Benefits and Attending:
• Learn about Strategic Competitive Intelligence and how
to generate actionable insights
• Understand how to most effectively conduct CI in the Cell
and Gene Therapy space and remain competitive
Agenda
13.30 Registration and coffee
14.00 Introduction to Strategic Competitive Intelligence
• What CI is, what it is not and how to do it
• What you can and what you cannot do with CI
• Evolution of CI and its tools
• Importance of CI in the Cell and Gene Therapy
space
14.30 Afternoon Tea
15.00 How to gain or maintain a competitive advantage
in the Cell and Gene Therapy space, whether you
are a newcomer or established player
• What can you learn from your competitors and
the marketplace using CI in the Cell and Gene
Therapy field?
• Using CI to improve strategic and tactical
decisions on vector platform choice, trial design,
regulatory approach, payor interactions etc.
• Minimizing uncertainty in a rapidly moving space
• Combining database use and targeted primary
competitive intelligence
• Leveraging social media and social networks
to monitor competitor activity and identify
emerging threats and opportunities
15.30 “Future-proofing” your efforts by identifying
early warning signals and opportunities for your
company in the Cell and Gene Therapy space
• Short step-by-step guide / case study
16.00 QA
17.00 Closing remarks
About the Workshop Leader:
Timos has over 10 years’ experience working as a strategy
and intelligence consultant across the Pharma / Biotech and
the Life Sciences Investment industries. He has advised 18
out of 20 top Pharma and Biotechnology companies and
has also worked with a large number of medium and small
size firms on multiple topics (market entry and market access
optimization, patient centricity, digital healthcare and social
media, clinical product development and trial design, brand
positioning, portfolio analysis etc.) across therapy areas
and geographies. He is currently the CEO of LucidQuest,
a boutique strategic intelligence consultancy that focuses
both on traditional therapy areas (oncology, haematology,
immunology, CV/Met, CNS etc.) as well as on developing
insights into patient centricity, digital healthcare/IoE and
personalized medicine (gene and cell therapies).
About the Organisation:
LucidQuest provides strategic intelligence and evidence-
based investment insights for the Life Sciences and other
industries. We partner with leading Pharma, Biotech and
Healthcare companies and consultancy firms, providing
support across multiple therapy areas (respiratory, CV
Met, onco / haem, CNS, vaccines, gene and cell therapy
etc.) and also in the rapidly evolving Digital Healthcare /
IoE space. We further provide investment insights to hedge
funds, PE, VC, angel investors etc., leveraging our in-house
and our network’s scientific and commercial expertise.
6. Cell GeNE THERAPY
Conference: 10th -11th October 2018, Copthorne Tara Hotel, London, UK
Workshops: 9th October 2018, Copthorne Tara Hotel, London, UK
4 WAYS TO REGISTER
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
Online at www.cellandgeneconference.com
POST your booking form to: Events Team, SMi Group Ltd,
1 Westminster Bridge Road, London, SE1 7XW
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk
Unique Reference Number
Our Reference P-264
Payment must be made to SMi Group Ltd, and received before the event, by one of
the following methods quoting reference P-264 and the delegate’s name. Bookings
made within 7 days of the event require payment on booking, methods of payment:
□ UK BACS Sort Code 300009, Account 00936418
□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU
Swift (BIC): LOYDGB21013, Account 00936418
IBAN GB48 LOYD 3000 0900 9364 18
□ Cheque We can only accept Sterling cheques drawn on a UK bank.
□ Credit Card □ Visa □ MasterCard □ American Express
SMi Group will apply surcharges to commercial cards
Please tick here □ if the card provided is not a commercial card
Card No: □□□□ □□□□ □□□□ □□□□
Valid From □□/□□ Expiry Date □□/□□
CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card
Cardholder’s Name:
Signature: Date:
I agree to be bound by SMi’s Terms and Conditions of Booking.
Card Billing Address (If different from above):
Documentation
I cannot attend but would like to Purchase access to the following Document Portal/
Paper Copy documentation. Price Total
□ Access to the conference documentation
on the Document Portal £499.00 + VAT £598.80
□ The Conference Presentations – paper copy £499.00 - £499.00
(or only £300 if ordered with the Document Portal)
PAYMENT
vat
VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged
on Document portal and literature distribution for all UK customers and for those EU
Customers not supplying a registration number for their own country here
CONFERENCE Prices GROUP DISCOUNTS AVAILABLE
I would like to attend: (Please tick as appropriate) Fee TOTAL
□ Conference 2 Workshops £2697.00 + VAT £3236.40
□ Conference 1 Workshop □ A □ B £2098.00 + VAT £2517.60
□ Conference only £1499.00 + VAT £1798.80
□ 2 Workshops only £1198.00 + VAT £1437.60
□ 1 Workshop only □ A □ B £599.00 + VAT £718.80
PROMOTIONAL LITERATURE DISTRIBUTION
□ Distribution of your company’s promotional
literature to all conference attendees £999.00 + VAT £1198.80
The conference fee includes refreshments, lunch, conference papers, and access to
the Document Portal. Presentations that are available for download will be subject
to distribution rights by speakers. Please note that some presentations may not be
available for download. Access information for the document portal will be sent to
the e-mail address provided during registration. Details are sent within 24 hours post
conference.
□ Book by by 31st May to receive £400 off the conference price
□ Book by 29th June to receive £300 off the conference price
□ Book by 31st August to receive £200 off the conference price
EARLY BIRD
DISCOUNT
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
Title: Forename:
Surname:
Job Title:
Department/Division:
Company/Organisation:
Email:
If you would like to continue to receive email updates about our
events, please tick □
Company VAT Number:
Address:
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Mobile:
Switchboard:
Signature: Date:
I agree to be bound by SMi’s Terms and Conditions of Booking.
ACCOUNTS DEPT
Title: Forename:
Surname:
Email:
Address (if different from above):
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Payment: If payment is not made at the time of booking, then an invoice will be issued and must
be paid immediately and prior to the start of the event. If payment has not been received then
credit card details will be requested and payment taken before entry to the event. Bookings within
7 days of event require payment on booking. Access to the Document Portal will not be given until
payment has been received.
Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates may
not ‘share’ a place at an event. Please make separate bookings for each delegate.
Cancellation: If you wish to cancel your attendance at an event and you are unable to send
a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge,
providing that cancellation is made in writing and received at least 28 days prior to the start of the
event. Regretfully cancellation after this time cannot be accepted. We will however provide the
conferences documentation via the Document Portal to any delegate who has paid but is unable
to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to
provide documentation in these circumstances. We cannot accept cancellations of orders placed
for Documentation or the Document Portal as these are reproduced specifically to order. If we
have to cancel the event for any reason, then we will make a full refund immediately, but disclaim
any further liability.
Alterations: It may become necessary for us to make alterations to the content, speakers, timing,
venue or date of the event compared to the advertised programme.
Privacy policy / Opt Out: For full details on our privacy policy please go to
http://smi-online.co.uk/privacy-legals/privacy-policy. If you no longer wish to receive email
updates you can opt out by going to the following webpage http://www.smi-online.co.uk/opt-out
Terms and Conditions of Booking
Delegate Details
venue Copthorne Tara Hotel, London, UK
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: events@smi-online.co.uk or fax +44 (0) 870 9090 712