Copy
Featured in this Issue
History of the Telegraft 
Recording the History of ISCT and Cell and Gene Therapy for 26 Years
FACT Evaluation of Clinical Outcomes for HPC Transplantation:
(Clinical outcome, Patient outcome, Survival, Transplantation, CIBMTR)
ISCT Member Spotlight
Featuring Pranathi Maddi
Master Programme Scholarships
Cultivating Experts in Europe 
Reports from the Frontlines
COVID-19 Research Updates & Dr. Satyam Arora Donates Plasma 

Member News & Resources
News & Press Releases
ISCT Community Calendar
ISCT Career Center
ISCT Webinars Program
ISCT Volunteer Center
Telegraft Hub
L
PC Forum (Login Needed) 
Regular Updates Reflecting on the Roots of ISCT CARs in the Crowded Streets: The Road Ahead for Cellular Therapy in India 
Cytotherapy
® Corner
Hot Topics in the July and August Issues
ISCT Early Stage Professionals Series
Impacts & Experiences from ESP Mentorship
ISCT Lab Practices Committee Snapshot

Staff Recruitment, Training, Retention, Clean Room Space Utilization, Resource Management
FACT Report
Upcoming Opportunities, New Standards, Resources, and Inspections during COVID-19
PACT Update
Incorporating Gene Editing Source Materials into the Cell and Gene Therapy Manufacturing Workflow

Global Regulatory Surveillance
North America Watchdog
®
(Updates from Health Canada and the US FDA)
Australia and New Zealand Watchdog®
(Funding of Kymriah, Medical devices & software, TGA support for sponsors and manufacturers during COVID-19)
Europe Watchdog®
(Updates from CAT, EC, EMA, EU, and WHO)
 
From the President's Desk
by Bruce Levine, PhD

ISCT President Bruce Levine reflects in this month's column on the hard work that has gone into paving the path that ISCT treads today. Along this road, he writes a heartfelt tribute to Dr. Nancy Collins, whose hard work, vision, and character has led ISCT by example since its inception.
 
History of the Telegraft
Recording the History of ISCT and Cell and Gene Therapy for 26 Years
by Nancy H. Collins, PhD

Outgoing Senior Editor of The Telegraft, Dr. Nancy H. Collins, reviews the 26 year history of the publication from its founding, and its evolution in content, organization, and production as an electronic vehicle of communication of important professional and scientific activities.
One of my last duties as Senior Editor of The Telegraft is to thank Meagan Pasternak, our ISCT Head Office liaison, for her commitment during my tenure, and that of my predecessor. Two years ago, she patiently taught me what I needed to know, as the present publication is vastly different from the one we produced 26 years ago.

The changes in content and production in The Telegraft seen in the past two years became reality thanks to Meagan’s organizational ability, patience, and diplomacy. Trying to capture the important news from an organization which is led and staffed by dynamic individuals, during a time of exponential growth and important world-wide need, is like trying to catch a moving train – and Meagan did it with grace and dogged commitment.

She now moves onto other responsibilities for the society, and her duties have been taken on by Ken Ip, whose IT expertise will be invaluable in reaching our next goals of creating a more sophisticated and user-friendly Telegraft and expanding to other electronic platforms. I made a point of thanking Meagan at the end of each conference call, because she made it all happen. Without her, we would have seen a lesser product.

Thank you Meagan!
From the Editors
CARs in the Crowded Streets: The Road Ahead for Cellular Therapy in India 
By Rounak Dubey, MD, DNB

In this month’s editorial, Rounak Dubey, Telegraft Junior Associate Editor, writes about the development of cellular therapy in India, surveying the state of clinical trials and commercial enterprise in biotechnology in the region . 

UPDATES AND REPORTS (Back to Top) 

As an international society, ISCT is in a unique position to communicate the response to the COVID-19 pandemic by scientific, medical, and commercial professionals in the cell and gene therapy community. The incredible advancements in basic and applied research, clinical treatment, scientific innovation, and biotechnology since our Society’s founding in 1992, gives us hope that the cell and gene therapy community will contribute substantially to the resolution of the present crisis.

To help hasten that day, Telegraft will continue to spotlight special features and publications from members, and maintain a point of connection on social media. 


Recent updates:

Reports from the Front Lines #ISCTTogether is a conduit of information on both social media and our Telegraft site to share experiences from regions of the world facing different stages of the ongoing pandemic. #ISCTTogether is also a means to reach out to colleagues around the world to support them professionally and personally through sharing experiences, stories, reflections, obstacles, solutions, moments of inspiration, and more.

We highly encourage your participation and welcome submissions of all forms!
Please consider using either platform to share with your colleagues internationally during this unprecedented time. Send your contribution to isct@isctglobal.org or visit the Telegraft Hub.

We will continue these activities in the Telegraft and Reports from the Front Lines #ISCTTogether until such time as we feel they are no longer needed. We hope that is soon.

 
After recovering from COVID-19one of our own editors, Dr. Satyam Arora, answered the urgent call to donate blood plasma for research. 

This was a first for a recovered healthcare worker at Dr. Arora's hospital in Noida, India.
Read the July 25th article in the Times of India
Featured Member:
Pranathi Madde, MBBS
 
Our member spotlight in this issue focuses on Pranathi Madde, a technical specialist at the Mayo Clinic in Minnesota. Learn about Pranathi's insights into training needs in the Cell and Gene Therapy field, and about the moments and environments that inspired her lifelong passion for science. 
 

ISCT is proud to offer full tuition scholarships for 3 ISCT EU Members to enroll in the 2021/2022 Master in Manufacturing of Advanced Therapy Medicinal Products (ATMPs) at the University of Granada/ Andalusian Network for the design and translation of Advanced Therapies

SCHOLARSHIP APPLICATIONS OPEN UNTIL SEPT. 25
“This Master course has fit perfectly into my professional career. It has helped to evolve my knowledge in the field and fully met my expectations. I would highlight the excellent quality of the didactic material and the chance to conduct practical modules in real GMP facilities. The international character of the course has allowed us to share technical and regulatory experiences with participants from other European countries.”
 
Jaime Tabera Fernández
Quality Assurance Manager Transplat
Clinic Hospital Barcelona
Spain
FACT Evaluation of Clinical Outcomes
For Hematopoietic Progenitor Cell Transplantation: From Internal Assessment to External Benchmarking
By Kara Wacker, MBA, RAC
 
Because of the complexities associated with analyzing outcomes in blood and marrow transplantation (BMT), FACT-JACIE Standards emphasize both structural characteristics for transplant programs and processes of care. Despite the recognition at the outset that patient survival outcomes are difficult to accurately and fairly assess, FACT determined that one-year survival would be an appropriate metric for programs to benchmark. When a program does not meet expected one-year survival, it must submit a corrective action plan (CAP) that meets FACT or JACIE guidelines.
 
ISCT 2019-2020 Mentoring Program
An Early Stage Professionals Initiative
By Guy Klamer, PhD

Read a spotlight on feedback from mentees of the 2019 program, aimed at helping potential mentors and mentees that are considering applying to future rounds.

To be involved in the next round of the program, look out for application forms sent by ISCT Head Office. Each group is assigned an ISCT ESP facilitator to support initial group establishment and communication. The program runs for approximately 8 months (November – June), so keep an eye out in coming months!
 
ISCT Lab Practices Committee (LPC) Snapshot:
Design of an Aseptic Process Validation
by Gloria Carmona Sánchez, MSc, MPharm

The testing of whether the manufacturing procedures are adequate to prevent contamination during production is the objective of the aseptic process validation, also known as “media fill”

The design procedure must follow as closely as possible the routine manufacturing process, and is fundamental to guarantee the success of zero growth. It is also important that personnel training and selection of the adequate growth media need to pass growth promotion testing before using and after incubation. Last, but not least, everything must be documented in order to generate evidence of every performed step.

This Telegraft LPC Snapshot article will cover aspects to consider in order to design and perform a successful media fill.
 
Here Comes TED!

The Telegraft editorial board believes that we can all benefit from hearing how our colleagues explain our fascinating field to those outside it.

The first of our series was the highly instructive TEDMED talk given by Dr. Carl June on CAR-T therapy development that was published in the
April Telegraft. Dr June is one of the subjects of the Cytotherapy series Talking with Giants which was also presented in that issue of Telegraft. In June, we highlighted a TEDx talk at the London Business School, by Dr. Crystal Ruff, explaining for the public what stem cells are, how they can be used, and the potential they have for the future. 

If you have given a TED talk on any of its platforms about regenerative medicine or any of the areas of concern of ISCT, or listened or watched one that you think would be of interest to the audience of the Telegraft, please contact the editors. We would like to compile a library for the benefit of ISCT members.
Did you miss our recent webinar?
ON DEMAND ACCESS FREE-OF-CHARGE FOR ISCT MEMBERS
VISIT OUR WEBINAR ARCHIVE (MEMBER LOGIN REQUIRED)
Curating clinical innovation into viable, approved products
 
The recent progress of regenerative medicine is remarkable on a global scale, and collaboration between industry, academia, and regulation will soon become more important for practical applications in clinical development.

There are several differences in approval process in Japan from that in other countries. In Japan, the 1st CAR-T treatment (tisagenlecleucel) was approved in 2019 based on two multinational clinical trials. In the first presentation of this webinar, Dr. Hirose will share with us his experience for practical applications from the viewpoint of a foreign-affiliated pharmaceutical company.
Registrations are still active
Access by clicking the banner above!
Telegraft Editorial Board

SENIOR EDITOR
Nancy H. Collins, PhD
ASSOCIATE EDITOR
Russell Cruz, MD
JUNIOR ASSOCIATE EDITORS
Satyam Arora, MD
Rounak Dubey, MBBS, MD


CONTRIBUTING EDITORS 
Shyam Bhakta, MD, MBA
Ashley Krull, BSc, PhD
Anne Lamontagne, MSc
Janet Macpherson, PhD 
Lynn O'Donnell, PhD 
Michele Sugrue, MT 
Wouter Van't Hof, PhD
Joaquim Vives, PhD
Email
Website
Twitter
LinkedIn
ISCT
Suite 325 - 744 West Hastings Street Vancouver, BC V6C 1A5
+1 (604) 874-4366 | isct@isctglobal.org 

Want to change how you receive these emails?
You can update your preferences or unsubscribe from this list.