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By Sarah Wicks — On May 21, 2024, the EveryLife Foundation for Rare Diseases (ELF) will host a Scientific Workshop at the National Press Club in Washington, D.C. aimed at identifying and characterizing the challenges in developing therapies for ultra-rare diseases and conditions that affect exceedingly small populations.
To further expand patient input into product development, the FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products or “OTP” (formerly the Office of Tissues and Advanced Therapies, or “OTAT”) is holding a free public workshop titled, Clinical Trials: The Patient Experience.
These are exactly the types of things that were addressed at ELF Scientific Workshop in May 2024 which addressed challenges in developing therapies for ultra rare diseases (see our blog about this here , which includes a link to the recording).
The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.
Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.
Director, Cell Therapy Operations and Patient Services, Gamida Cell Austin Fisher, Executive Director, CART Patient Support and Distribution, Autolus Chris Boneham, Vice President Market Access U.S., Offer not valid on workshop only or academic/non-profit registrations. Drug Channels, or any of its employees.
Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC).
Academic centers should establish risk management programs to successfully commercialize cell and gene therapy products and to be a viable partner with contract research organizations (CROs) and manufacturers in developing these therapies. . Uharek is a hematologist and cell and gene therapy specialist at Berlin’s Charité Hospital.
Offer not valid on workshop only or academic/non-profit registrations. Download the full agenda and save your seat today! Offer applies to current rates only and may not be combined with other offers, category rates, promotions or applied to an existing registration. Drug Channels, or any of its employees.
The 2024 meeting will continue this tradition, featuring a program that integrates workshops, plenary sessions, and poster sessions. It also provides opportunities for networking, career development, and gaining insights into the latest trends and future directions in gene and cell therapy. Learn more on their website here.
The unique testing platform combines machine learning, automation and high-throughput screening directly on patient samples to predict responses to potential therapies and ultimately determine which therapies will be most effective for specific cancers. Learn more at notablelabs.com and follow us @notablelabs.
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Informa Connect’s PAP – Patient Assistance & Access Programs March 19-21, 2024 | Pre-Conference Workshops on March 18, 2024 Philadelphia Marriott Downtown in Philadelphia, PA Exclusive Offer – Be sure to use your exclusive promo code 24DC10 to save 10% off* of your registration.
Offer not valid on workshop only or academic/non-profit registrations. Drug Channels readers will save $300 off the standard registration rate when they use code MDU494.*. Offer applies to standard rates only and may not be combined with other offers, category rates, promotions or applied to an existing registration.
Progress has been made on raising awareness about the gender disparities and biases that exist within STEM fields through training programs and workshops to educate about unconscious biases and promoting diversity, but much work remains to be done.
By offering a range of services, such as vaccination clinics, wellness programs, and educational workshops, these facilities support the health and well-being of entire communities. This includes providing accessible therapy rooms, communication aids, and flexible service options.
Title Type Comments Close Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance Draft Guidance August 5 Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research (..)
A wide range of other meetings that will be occurring this month, with various webinars, committee meetings, and workshops spanning a variety of topics. Many of these are open to any interested listener. Upcoming E.U.
Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)
Choose between 3 Interactive Workshops on Day 2! Drug Channels readers are eligible for an exclusive savings of 10% off * the current rate by using promo code 21FRADC10 , be sure to reserve your seat today!
Informa Connect’s Access USA March 19-21, 2024 | Pre-Conference Workshops on March 18, 2024 Philadelphia Marriott Downtown in Philadelphia, PA Exclusive Offer – Be sure to use your exclusive promocode 24AUSA10 to save 10% off* of your registration.
Hands-on training course Webinar/ Seminar ( OPEN ) EMA 4/16/2024 4/16/2024 UKCA Sub-Group Committee Meeting ( CLOSED ) British In Vitro Diagnostics Association (BIVDA) 4/16/2024 4/17/2024 EMA multi-stakeholder workshop on psychedelics – Towards an E.U.
Etta Biotech will continue to launch electroporator products for cellular immunotherapy and drug delivery, to enrich its product lines and expand its scope of business, and to facilitate drug R&D and the large-scale application and promotion of cell therapy. About JS Bio.
2 Days of Kids Summer Camp” appeared to be “2 Days of Spa and rejuvenation therapy for Mothers” I squished my eyes to take a second look and it said, “2 Days of Kids Summer Camp”. While the parents were all busy with work, the kids had a puppet-making workshop. The moment I received the mail, I enrolled my Kids. “2
However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect. While the ability to describe and specify aspects of the therapy is limited, the agency can specify the number and licensure of therapists who would participate in the MDMA treatment.
Lack of representation in clinical trials, e.g., a lack of racial and ethnic diversity, leads to suboptimal patient recruitment, skewed findings, limitations in the generalizability of study results to a broader population, inequitable health outcomes, and suboptimal development of innovative therapies for all.
You will meet individuals, advocacy leaders, industry, and research experts who have been there and done it, over two days of in-person only panel discussions, hands-on workshops, and expert office hours.” RDDS 2023 focuses on collaboration – the foundation of success in rare disease research.
Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)
Title Type Comments Close Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act Guidance June 5 Patient Preference Information—Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in (..)
This will include a number of conferences, webinars, and training sessions, as well as a long-awaited EMA workshop on psychedelics. Perhaps the most significant pharmaceutical news anticipated for April: the vote on the pharmaceutical legislation revision. regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:
Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)
. 🧪 From the Lab Other wet-lab papers worth checking out. (* = Recommended) *A temperature-sensitive genome-editing tool — which uses Cas9 — enhances adoptive T-cell therapy upon mild heating. Event The 2023 International Mammalian Synthetic Biology Workshop is on June 22-23 in San Jose. Nature Nanotechnology.
In a first, FDA tackles treatments for stimulant use disorder A new draft guidance from the FDA gives developers a roadmap to advance the development of novel therapies to address stimulant use disorders. Regulatory context FDA held a workshop in December 2019 to discuss development of substance use disorder therapies.
and the Doctor of Physical Therapy. Designed to reach diverse talent sooner in their undergraduate career, Tomorrow’s Innovators will provide them the support and education needed to reach their career goals within the biopharma industry. The three professional degrees include the J.D.,
Time to subsequent therapy was longer for I+V (HR 0.143, 95% CI 0.05-0.41). “We are encouraged by these results, which further support the efficacy of these two well-established therapies,” said Mohamed Zaki, M.D., IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S.
CDER is also on track to complete the 58 first-year requirements under the latest reauthorization of the Prescription Drug User Fee Act (PDUFA), which included updated programs or processes, web updates, guidance documents, public meetings or workshops, and more. Marks also offered thoughts on the “critical juncture” for gene therapies.
Since the last Codon Digest, I’ve published: Reasons to Be Grateful for Biotechnology (with Avadhoot Jadhav) AAV Foundations (Part I) An overview of AAV-based gene therapies, how they get made, and where they go wrong. Nevertheless, phage therapy did have a stint in the U.S. I’ll post an update soon. coli in mice.
Since the last Codon Digest, I’ve published: Reasons to Be Grateful for Biotechnology (with Avadhoot Jadhav) AAV Foundations (Part I) An overview of AAV-based gene therapies, how they get made, and where they go wrong. Nevertheless, phage therapy did have a stint in the U.S. I’ll post an update soon. coli in mice.
. 🧪 From the Lab Other wet-lab papers worth checking out. (* = Recommended) *A temperature-sensitive genome-editing tool — which uses Cas9 — enhances adoptive T-cell therapy upon mild heating. Event The 2023 International Mammalian Synthetic Biology Workshop is on June 22-23 in San Jose. Nature Nanotechnology.
For example, top FDA executives have previously heralded international convergence and harmonization as the solution to gene therapy development for diseases with small populations. Read full AgencyIQ analysis of the workshop here. ]. But if we had to guess, international regulatory harmonization will be a topic of interest for NASEM.
As the biotechnologist Alex Telford writes , “Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments.” Rex Burch and William Russell at Sheringham Town Hall for the Sheringham Workshop, 31 May, 1995.
At CTx, Rachel’s contributions to pioneering work drugging novel epigenetic targets led to a first-in-class asset in the clinic targeting ER+ breast cancer, including patients refractory to endocrine therapy. As a woman in STEM, what unique perspectives or strengths do you believe you bring to your work?
Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)
In September 2022, the FDA held a workshop focused on increasing the efficiency of biosimilar development programs. Read AgencyIQ’s full analysis of the workshop here. ] Read AgencyIQ’s full analysis of the workshop here. ] Read AgencyIQ’s full analysis of the BsUFA Commitment Letter here.]
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