Entrada Therapeutics Appoints Biotech Industry Leader Mary Thistle to Its Board of Directors
BOSTON--(BUSINESS WIRE)--Entrada Therapeutics, Inc., a biotechnology company dedicated to transforming the treatment of devastating diseases using intracellular biologics, today announced the appointment of Mary Thistle to its Board of Directors. Ms. Thistle currently serves as Special Advisor at the Bill & Melinda Gates Medical Research Institute. She has more than 25 years of experience in finance, strategy and business development across a range of therapeutic areas, including a deep background in rare diseases. Ms. Thistle serves on the Board of Directors of Homology Medicines, Enterome SA and Ziopharm Oncology. "Mary is a recognized leader in the biotechnology industry and has a remarkable track record," stated Dipal Doshi, President and CEO of Entrada Therapeutics. "We look forward to having Mary’s counsel as we leverage our recent $116 million Series B financing to expand our pipeline and aim to bring new and needed treatment options to patients living with devastating diseases." Prior to joining the Bill & Melinda Gates Medical Research Institute, Ms. Thistle was Chief Operating Officer of Dimension Therapeutics. At Dimension, she oversaw the company’s Series B financing and initial public offering, expanded the pipeline through strategic business development transactions and led the sale of the company to Ultragenyx. Prior to joining Dimension, Ms. Thistle was Senior Vice President, Business Development at Cubist Pharmaceuticals, where she was responsible for multiple acquisitions and assisted in the sale to Merck. She has also held senior level positions at ViaCell in finance, operations and business development and then served as Senior Vice President, Business Development at PerkinElmer after ViaCell was acquired. Ms. Thistle began her career in finance as a Certified Public Accountant. "Entrada's Endosomal Escape Vehicle platform represents a significant advancement in the field of intracellular biologics," said Ms. Thistle. "The team’s research has the potential to address a wide range of diseases and therapeutic areas, and I’m excited to be able to contribute to Entrada’s mission.”
"We are delighted to welcome Mary to Entrada," commented Kush Parmar, Chairman of Entrada’s Board of Directors. "Her extensive industry experience will help ensure the Board effectively supports the Company’s long-term strategy." About Entrada Therapeutics
Entrada Therapeutics' mission is to transform the treatment of devastating diseases and improve patients' quality of life by developing intracellular biologics. Leveraging its proprietary Endosomal Escape Vehicle (EEV)™ platform, Entrada is creating a diverse and expanding pipeline of oligonucleotide, antibody, enzyme, protein and peptide programs to efficiently target and engage underlying drivers of diseases. The Company’s novel approach addresses current challenges associated with both large and small molecule therapeutics and represents a fundamental advancement in the field of intracellular biologics. For more information about Entrada’s pipeline and the broad therapeutic potential of the Company’s EEV™ platform, please visit www.entradatx.com . Contacts

Entrada Therapeutics Appoints Biotech Industry Leader Mary Thistle to Its Board of Directors

May 04, 2021 07:45 AM Eastern Daylight Time
BOSTON--( BUSINESS WIRE )--Entrada Therapeutics, Inc., a biotechnology company dedicated to transforming the treatment of devastating diseases using intracellular biologics, today announced the appointment of Mary Thistle to its Board of Directors. Ms. Thistle currently serves as Special Advisor at the Bill & Melinda Gates Medical Research Institute. She has more than 25 years of experience in finance, strategy and business development across a range of therapeutic areas, including a deep background in rare diseases. Ms. Thistle serves on the Board of Directors of Homology Medicines, Enterome SA and Ziopharm Oncology. "Mary is a recognized leader in the biotechnology industry and has a remarkable track record," stated Dipal Doshi, President and CEO of Entrada Therapeutics. "We look forward to having Mary’s counsel as we leverage our recent $116 million Series B financing to expand our pipeline and aim to bring new and needed treatment options to patients living with devastating diseases." Prior to joining the Bill & Melinda Gates Medical Research Institute, Ms. Thistle was Chief Operating Officer of Dimension Therapeutics. At Dimension, she oversaw the company’s Series B financing and initial public offering, expanded the pipeline through strategic business development transactions and led the sale of the company to Ultragenyx. Prior to joining Dimension, Ms. Thistle was Senior Vice President, Business Development at Cubist Pharmaceuticals, where she was responsible for multiple acquisitions and assisted in the sale to Merck. She has also held senior level positions at ViaCell in finance, operations and business development and then served as Senior Vice President, Business Development at PerkinElmer after ViaCell was acquired. Ms. Thistle began her career in finance as a Certified Public Accountant. "Entrada's Endosomal Escape Vehicle platform represents a significant advancement in the field of intracellular biologics," said Ms. Thistle. "The team’s research has the potential to address a wide range of diseases and therapeutic areas, and I’m excited to be able to contribute to Entrada’s mission.”
"We are delighted to welcome Mary to Entrada," commented Kush Parmar, Chairman of Entrada’s Board of Directors. "Her extensive industry experience will help ensure the Board effectively supports the Company’s long-term strategy." About Entrada Therapeutics
Entrada Therapeutics' mission is to transform the treatment of devastating diseases and improve patients' quality of life by developing intracellular biologics. Leveraging its proprietary Endosomal Escape Vehicle (EEV)™ platform, Entrada is creating a diverse and expanding pipeline of oligonucleotide, antibody, enzyme, protein and peptide programs to efficiently target and engage underlying drivers of diseases. The Company’s novel approach addresses current challenges associated with both large and small molecule therapeutics and represents a fundamental advancement in the field of intracellular biologics. For more information about Entrada’s pipeline and the broad therapeutic potential of the Company’s EEV™ platform, please visit www.entradatx.com .

MassDevice
FDA warns Globus subsidiary HBT over ViaCell production facility issues
December 6, 2018
The FDA this week released a warning letter it sent to a Globus Medical  (NYSE: GMED ) subsidiary Human Biologics of Texas, which produces the company’s ViaCell allograft product, over issues it found during an inspection of the facility in April. The federal watchdog noted multiple infractions during the initial inspection, and also provided a response to corrective actions the company said it was taking in response to the earlier noted issues. In its in inspection, FDA investigators noted failures to document and investigate deviations in its production of the ViaCell product as well as trends of deviations away from the agency’s core current good tissue practice requirements. “For example, since the start of ViaCell processing in October 2016 through August 2017, you have had monthly sterility failure rates of [redacted] during seven of those months, with one month having a sterility failure rate of [redacted]. Your firm failed to conduct an investigation of all these sterility failures to determine the cause. You also failed to investigate additional sterility failures that occurred from October 2017 through February 2018. By neglecting to identify the cause of the sterility failures, you also failed to take appropriate corrective action(s) to prevent recurrence of the failures,” the FDA wrote in its letter. The agency also noted a failure to “validate and approve a process according to established procedures where the results of processing cannot be fully verified by subsequent inspections and tests,” according go the FDA notice. The example provided again related to the facility’s ViaCell manufacturing process. The federal watchdog said that it has received two responses from the company so far this year, but outlined some “comments and concerns” in relation to their corrective actions. The FDA said that it received a response in May outlining corrective actions, but voiced concerns that the actions mostly focus on sterility testing which it said were not reliable, and did not address validation issues with the ViaCell manufacturing process. The agency also noted that while the company reported a decrease in sterility failure rate, it did not discuss plans to “determine the cause of the sterility failures” or why the rate of failures was so high. The federal watchdog also posted a response to a letter received in September with concerns over the company’s corrective steps. In its response, Globus’ HBT subsidiary said that it launched additional validation activities covering ViaCell production in May, but the FDA stated that its concerns about the firm’s validation of the ViaCell production process remain. The agency noted a number of issues it has with the company’s corrective process, including another noted reliance on sterility testing and concerns over possible contamination during processing. “A disinfection or sterilization process must be validated based on the capability of that process to reduce or eliminate an expected level and mix of microorganisms on the particular product that will be put through the process. Thus, you should carefully consider the capability of your microbiological testing, disinfection, and sterilization processes when you evaluate pre-processing cultures to determine whether or not the HCT/Ps should be processed,” the FDA wrote in its notice. The FDA also knocked the company on not excluding or discarding samples from donors positive for Clostridium, Streptococcus pyogenes or “any other microorganism that you have determined to be difficult to eliminate, unless you have a terminal sterilization process validated to a sterility assurance level of 10-6.”
In its last point, the agency referenced a lack of positive results from all environmental and personnel monitoring sample testing, saying that having producing no positives is “highly unusual, especially when your sterility failure rates were so high.”
“We strongly suggest you review your environmental monitoring program to ensure that it is capable of detecting microorganisms in your environment and on your personnel,” the federal watchdog wrote. The FDA gave the company 15 working days to respond to the issues. Last month, Globus Medical posted third quarter earnings that handily topped expectations from analysts on Wall Street.

FDA warns Globus subsidiary HBT over ViaCell production facility issues

Pall (NYSE: PLL) manufactures and markets filtration, purification, and separation products and integrated systems solutions worldwide. The company's life sciences segment provides technologies that facilitate the process of drug discovery, development, regulatory validation, and production used in the research laboratories, pharmaceutical and biotechnology industries, food and beverage industry, blood centers, and hospitals at the point of patient care. It was founded in 1946 and is based in Port Washington, New York.

Pall

Karen A. Foster , Vice President , ViaCord , said , `` We are excited by our collaboration with Pall Corporation in developing this innovative bag that allows us to continue offering families the highest quality product .

Wells Fargo Success Story

Professional Services

Platform Overview

ViaCell

Compete with ViaCell?

Compete with ViaCell?

Discover the right solution for your team