Michelle's Monday Minute: 22JUN06

Jumping right into today’s Monday Minute with loads to discuss -?

ICH Face-to-Face Meeting in Athens, Greece

Last week for the first time since 2019, the International Council for Harmonization of Requirements for Pharmaceuticals (ICH) Management Committee, Assembly and select Working Groups met in Athens face-to-face.? The best way to describe ICH is to imagine you were attending the United Nations for the biopharmaceutical industry. Over its 30 year history, ICH has grown and expanded its impact around the globe.? In Athens, it was especially inspiring to hear the daily updates from the Working Groups (M4Q(R2), E6(R3), Q5A(R2), Q9(R1), M10, Q13, and S1B(R1))* who made significant progress during the meeting.?

Items to highlight from the Athens meeting:

• The UK’s regulator MHRA was welcomed as a new ICH Member.
• Algeria’s regulator ANPP was welcomed as an ICH Observer.
• The new efficacy topic? Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials was approved as a New Topic.
• The final M10 guideline on Bioanalytical Method Validation was approved.
• The? draft M12 guideline on Drug-Interaction Studies was approved to be issued for public consultation.
• The press release is available here.

Of note, training on all the completed guidelines is available on the ICH website: starting at this All Guideline link; open the Quality, Safety, Efficacy or Multidisciplinary Guideline area of interest; then, click on the specific guideline and click again to expand the offerings under that guideline to view the trainings.

Writing global guidelines on critical topics is extremely challenging work and so crucial for global drug development. With all the challenges in the world today, it was inspiring to see our global community come together, listen to one another, make progress and decisions!

Do you wish to receive ICH email notifications?

If so, you can now sign-up for alerts via the ICH website. Here’s how: Go to ich.org, in the far upper right corner of the website, is the word “REGISTER”, click on “REGISTER” and fill out the requested email information to receive email notifications of press releases and other news.

IFPMA COVID Lessons Learned Publication

One ICH Member is the global trade association IFPMA (International Federation of Pharmaceutical Manufacturers and Associations). IFPMA recently published this report which is well worth the read: “Applying Lessons Learned from COVID: To create a healthier, safer and more equitable world.” COVID taught the global healthcare community priceless lessons which must be used to make the world a better place and prepare us for the future.

FDA’s Oncology Center of Excellence (OCE) Discusses a Variety of Topics

One year ago, StatNews’ Adam Feurstein interviewed Drs Richard Pazdur, Harpreet Singh, Paul Kluetz, and Marc Theoret from FDA’s OCE. In oncology drug development news, we hear about dose optimization, need for randomized trials, importance of survival data and enrolling patients who are representative of the overall population. Although this discussion was recorded one year ago, many of the topics remain important today. If you are new to drug development or in the midst of developing an oncology molecule, I encourage you to listen to this session and then think carefully about your development program. After reflecting, what may need to be modified in your clinical development program??

“Other Side”? from Wynonna Judd and Waxahatchee is my new fav song I’ve got on repeat. Hope you enjoy it too.?

Happy Monday all,

Michelle

*List of ICH Working Groups who met in Athens:

• M4Q(R2): Common Technical Document on Efficacy
• E6(R3): Good Clinical Practice
• Q5A(R2): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
• Q9(R1): Quality Risk Management
• M10: Bioanalytical Method Validation
• Q13: Continuous Manufacturing of Drug Substances and Drug Products
• ?S1B(R1): Rodent Carcinogenicity Studies for Human Pharmaceuticals