Announcements

Hi everyone,

Below please find the agenda for tomorrow’s AAPS Regulatory Sciences meeting (April 19^th, 12:05-12:55 p.m.).

1. Welcome – Amit
2. Introductions, new members (if any) – All
3. FDA draft guidance "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies” - Raja
1. response team to consider the recently posted draft guidance – Raja to sit on this team and represent the Regulatory Sciences Community
2. Boris Gorovits, of the AAPS Scientific Advisory Committee (SAC) to chair the response team
3. Plans for round-table discussions on this draft guidance – Amit and Shraddha

                                                               i.      Cross-community lunchtime webinar

4. New regulatory guidances – Allison Radwick
5. PharmSci360 – Updates on proposals submitted for symposia and/or hot topics (due April 7^th)
1. Patient Centric Specification – Stan, Kim, Shraddha, Amit
2. QbD Principles, Approaches and Compliance – Sandra Suarez-Sharp, Kim HuynhBa, Stan Altan, Vijay Tammara
3. Data Integrity and bioanalysis – Tahseen Mirza
4. Artificial Intelligence and Quality – Raja and Amit
5. Complex Excipients – Allison Radwick
6. Preclinical Statistics – Stan Altan
7. Pre-Clinical, Clinical Translational Tracks – Joan, Shraddha, Raja, Amit, Vijay
8. Career Development – Kim, Shraddha
6. Excipients Community May 23rd Open Scientific Discussion on the Analysis of Nitrosamines in Cellulose Ether - Allison Radwick
1. Excipients Community to moderate
2. Plans for co-promotion (Jen and Khushboo)
7. Webinar on TiO2 – Tahseen Mirza
1. With the IV/IVC Community
2. Tahseen to provide an announcement that can be shared with the RS Community
8. Other?

Thank you,

   Jen

AAPS is proud of our members honored in The Medicine Maker's 2024 Power List! 🏆 Congratulations to all individuals recognized this year for their impact in the world of pharmaceutical #drugdevelopment and manufacturing. Help us give them a round of applause. 👏 👏

Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Gene and Cell Therapy Products (GCTPs) Community on April 25, 2024, 12 pm – 1 pm EDT on the following topic:

Secondary malignancies post-CART cell therapy: Clinical and Regulatory Perspectives

·       Are you aware of the recent FDA requirement of class wide boxed warning on all commercial CAR-T therapies?

·       What do we know and not know about second malignancies?

·       What’s your experience in secondary malignancies and CART cell therapy?

Panelists:

Bruce Levine (Professor, Univ. PENN)

Nicole Verdun (Super Office Director, FDA, CBER)

Organized by:  

Vibha Jawa (BMS) Yan Ni (Passage Bio)

We start at 12:00 PM EDT sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts.

(Please remain on mute unless asking questions)

When: Thursday April 25, 12:00 – 1:00 PM EDT

Where: Please join from your computer, tablet or smartphone.
https://meet.goto.com/505947717

You can also dial in using your phone.
United States:    +1 (646) 749-3122

Access Code:    505-947-717

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 Thank you,

The AAPS GCTPs Communities Leadership Teams

Dear all,

   We are delighted to announce that Dr. Hong Wang, Senior Manager at U.S. Pharmacopeia (USP) will join us again on Apr 25th 12-1pm US EDT to give a talk on the Excipient Nomenclature Guidelines released to public in 2023. Please check out the abstract. We look forward to seeing you all in April again!

Presentation Title: Excipient Nomenclature Guidelines

Abstract:

This presentation will introduce the USP Excipient Nomenclature Guidelines released to the public in March 2023 and is the first USP nomenclature guidelines for excipients. Topics covered include the guideline’ outlines, excipient classifications, the definition of excipient component, and will further focus on two specific areas, nomenclatures for lipids and polymers which are multiple component-based excipients. With applications of more advanced analytical techniques for lipids and polymers, appropriate naming can be assigned in the USP/NF. Additionally, this discussion will delve into how the guidelines help align the names in USP/NF standards, FDA inactive ingredient database, and the FDA global substance registration system; address FDA’s Q1 sameness requirements for complex generics to indicate excipient types in meeting the needs of complex generics and innovative therapeutics; and to guide stakeholders to understand excipient composition and profiles.

Best regards,

Jiaying on behalf of AAPS Excipient Community LT

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AAPS NANO Community is pleased to announce our 3rd Seminar "Lipid Nanoparticle-Based Endogenous Targeted Delivery of Nucleic Acid Therapeutics" on May 9th, 2024 12:30 - 14:00 Eastern Time (US and Canada)

by Dr. Mansoor Amiji

Hello, Our monthly meeting is this Thursday, 12PM PT.  We hope you can join us!

Agenda:

1. First time attendees/new member introductions

2. Standing:  Items of interest from other Communities to AAPS 

• ICH Guidance Updates: ICH M4Q,  ICHQ1 -  Kaly/Lori/All
• KENX Lab University  - Jun 4-6 (East Coast - Philadelphia): Lab management, Stability, Analytical Quality track  

3. Member Engagement: 

• Highlights & Reflections: Q1 Joint Quarterly Stability-Stats Meeting  
• Significant interaction/discussion in the community regarding Stability/LIMS systems, shelf-life projections, etc  - Kudos to the community!!

• Publications: Open access:
  • Lean Stability Case Studies—Leveraging Science- and Risk-Based Approaches to Enable Meaningful Phase Specific Pharmaceutical  
• 2 Articles: J. Phar. Innovation, Chris Latoz  & Lori shared by email 3/19, 3/20  to Stats/Stability list  
• Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes  - AAPS journal 2024  

4. Reminder: Topics for 2024 PharmSci 360 Submission  

• Proposal Submission deadline Apr 8; Rapid Fire  14June;  Call for proposals posted on Stability Community  

• One topic identified at Jan meeting – Manvi Hasija;  
• Others?

• Stability Community work with IQ Consortium to have a symposium at  AAPS – Lori/Kim/Manvi 

5. Increasing Member engagement: webinar and/or virtual discussion once per Quarter

Use one Stability monthly meeting slot for webinar and virtual discussion. 

a) Virtual Discussion (2Q):  at 9^th May Stability meeting 

• In-Use Stability Topic  identified - 5-6 discussion/focus points within topic (or benchmarking; Mini-case study)
• Summary 2 weeks (few focused topics)  prior – post and publicize to AAPS community; cross-post on communities

§  Zoom meeting; post in Stability Community & CMC Community, AAPS LinkedIn 

§  Dan, Sherilyn + Community member  - Moderators/Expert

2. Webinar in 3Q:  

• suggestions for topics/presenters – All
  • controlling the operations- temperature of the trucks or the monitors instead of qualify every single shipping route?
  • perform risk analysis: shipping trucks break down and justify the study they perform.   
  • Any recent poll about shipping best practices? 
• e.g. discussion of ICH Q14 ; or Mini-case study from Jan WCBP
• similar to KENX San Diego  -
• Stability aspects of ADCs – jointly with Sterile Product Community , 2-3 webinar series  
• Shipping - USP chapter and recent articles - which studies are necessary vs good to have- Nanda interest in webinar setup/Kim suggest speaker 

6. Sterile Products Community (if SPC members can join, Hitesh, Haresh, Yogita)

• Discussion on further collaboration : co-sponsor a presentation/ discussion with broader invitations
• Hiten/Haresh proposed a similar webinar for this year. Focus on "stability aspects of ADCs" it could be a series 2-3 webinars if needed. 
   

7. Joint Quarterly Stability-Stats Community 

- Reminder: Joint meeting with CMC Statistics Community: Lori/Kayla/Laura 

• 2Q:  Reference standard (RS) and use of long-term stability data to support requalification of RS  - Helen Strickland from Stats;  Stephanie Ferrari  for Stability   (Nanda is backup)
• 3Q: Comparability Part II   - Dan W. for Stability; Stats - Aili Cheng
• 1Q24: Use of means vs individual values to evaluate stability data  - Kayla Woodlief and Ben Ahlstrom – Completed - thanks!

  Microsoft Teams meeting

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Open position for a student volunteer:

We are seeking a student volunteer to engage with members of the online community platform. This position is open to any student member who is interested in volunteering for the Sterile Products Community (SPC) and has a general interest in sterile products.

Requirements:

·   Enrolled as a full-time student at an accredited university and preferably majoring in a pharmaceutical or biomedical sciences program

·     Preferably familiar with AAPS and engaged in the AAPS student chapter at the university.

Duties:

·     Act as a connecting link between students and SPC members

·     Stimulate interest among student members about the SPC.

·     Drive online discussions by posting new questions to build member engagement, particularly among student members

·     Help with programming and moderating for PharmSci 360, NBC

·     Help in organizing and promoting SPC events, programs, and webinars on social media and/or act as a moderator.

Opportunity:

·     A unique career development and advancement opportunity

·     Engage with mentors from the community executive committee.

Term: Minimum 1 year up to 3 years

Time Commitment: Time dedicated to engaging student members in the online community platform is flexible and may be conducted based on your availability. The student volunteer will be invited to monthly, one-hour community leadership teleconferences.

How to apply? – Email your CV and a short statement on how you would contribute to the SPC as a student volunteer to [email protected]

Hi everyone,

Below please find the agenda for our AAPS Regulatory Sciences meeting tomorrow (Friday, 15 March 2024).

1. Welcome – Amit
2. Introductions, new members (if any) – All
3. Excipients Community May 23rd OSD on the Analysis of Nitrosamines in Cellulose Ether - Allison Radwick
1. An IFF expert will lead the discussion
2. Impurities Community may partner
3. Does the Reg Sciences community want to partner?
4. Update on Patient-Centric Specification discussions – Stan, Kim, Shraddha, Amit

1. Session proposal for PharmSci360? Deadline April 8^th
2. Article?

5. PharmSci360 – Status of session proposals - All

1. Data Integrity – Tahseen Mirza
2. Complex Excipients – Allison Radwick
3. Other potential topics – identify list of topics and point-person for each
1. QbD principles, approaches, and compliance
2. Preclinical Statistics
3. QbD and Compliance – Vijay and Stan
4. Artificial intelligence and Quality
5. Pre-clinical, Clinical translational tracks
6. Kim and Shraddha represent career development (Career Transition in Industry: Why, When and How? (aaps.org)), so topic need not be a scientific one

6. New regulatory guidances – Allison Radwick
7. Webinars – potential topics and leaders
8. Other?

Thank you,

    Jen

Dear Community, 

Please feel free to join our upcoming Stability and Stats Community Joint Quarterly Meeting - Thurs Mar 14, 1:30-3PM CT.

The discussion will be on "Use of means vs individual values to evaluate stability data", led by Kayla and Kayla Woodlief & Ben Ahlstrom.

Thanks

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Dear Colleagues,

I hope this message finds you well. I am excited to announce the registration opening for our upcoming webinar: "Developing Your Personal Board of Directors for Career Advancement."

Date and Time: 11^th April 2024 at 12:30 pm ET

Registration Link: https://lnkd.in/e68bc_dr

This webinar aims to discuss strategies for building and sustaining an impactful board of directors that can contribute to our career progression. Your involvement and active participation as AAPS members are vital for the success of this event.

Please feel free to pass along the registration link to your contacts who might benefit from this webinar. Let's collaborate to increase awareness about the importance of having a personal board of directors for advancing our careers.

I appreciate your support and look forward to your participation in this enriching session.

Best regards,

Chuk

AAPS supports credible research and joins other science organizations in recognizing National #EthicsAwarenessMonth and the importance of ethically conducted and accessible #research in the pharmaceutical sciences. 

Dear all,

   We have invited Prof. Zhou from Purdue University to give us a talk on Influence of excipients on solid-state properties and physical stability of the spray-dried solid formulation for pharmaceutical proteins.

Also, this seminar will be joined by AAPS INHALATION & NASAL Community as well. Look forward to seeing you all there.

  !!! Please note that the meeting link has changed:

How to join: http://tinyurl.com/2a55nhsy (MS Teams Meeting ID: 234 576 468 255; Passcode: 9dxy8S)

If you have trouble in logging in, please email: [email protected] or [email protected]

Best regards,

Jiaying, Secretary of AAPS Excipient Community

Hi everyone - The minutes from the Reg Sciences meeting held on 16 February 2024 are now posted in the Library area of this site. The agenda for the February 16th meeting was as follows:

1. Welcome – Shraddha Thakkar
2. Introductions, new members – All
3. AAPS PPDM Community career development webinar, May/June 2024
1. Has a speaker (or two) from the RS Community been identified?
4. Follow-up from Stan’s presentation on patient-centric specifications:
1. What are the next steps?
1. Cross-community discussion? If so, which communities (CMC, bioanalytical, stats, others)? Who will coordinate?
2. Webinars? PharmSci360? For discussion with other communities.
5. 2024 PharmSci360 2024 session suggestions – All
1. Data integrity (with the CMC Community?) – Tahseen Mirza
2. Complex excipients (with the Excipients Community?) – Allison Radwick
6. New regulatory guidances (last 30 days) – Allison Radwick
7. Other?

Thank you!

Don't miss this! Scott Wallask interviewed our Executive Director Tina Morris about quality-by-design (#QbD) for Lab Manager. Read the #interview in "Elevating Lab Performance with Quality by Design".

Topic: “The Explanation For Why and Regulatory Implications When Bioavailability Calculations Exceed Unity,”

Feb 20, 2024, 11:00 AM – 12:30 PM (America/New York)/8.00-9.30 AM (US PT)

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Dear Colleagues,

I hope this message finds you well. I am excited to announce the registration opening for our upcoming webinar: "High-Content Modeling of Human Tissues and Diseases in vitro for Precision Drug Screening."

Date and Time: 5^th March 2024 at 12:30 pm ET

Registration Link: https://learning.aaps.org/topclass/topclass.do?expand-OfferingDetails-Offeringid=185775

This webinar will explore the latest trends in utilizing microphysiological systems for precision drug discovery, providing valuable insights into advancements in the field. As members of AAPS, your engagement and participation are crucial to making this event a success.

Please feel free to share the above registration link with your connections who may find this webinar insightful. Together, let's spread the word about the opportunities for precision medicine in drug development.

I appreciate your support and look forward to your participation in this enriching session.

Best regards,

Chukwunonso Nwabufo, MSc, MBA, PhD(c)

Chair, AAPS Pharmacokinetic, Pharmacodynamic, and Drug Metabolism Community

Ready to advance your science? AAPS is the only organization dedicated to programming specifically for pharmaceutical scientists like you. Discover ways to broaden your knowledge and network from AAPS President Gopi Shankar, Ph.D., M.B.A., FAAPS.

What's better than advice from your mentors? AAPS community leaders share their advice regularly. In October, the Past Chair of the #womeninscience community, Priya Muralidharan, MS, Ph.D., spoke during a #PharmSci360 #careerdevelopment session. Discover the insights from Bioanalysis Zone.

#WIPS

Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Biomarkers and Precision Medicine (BPM) Community on the following topic:

 
Featured 2023 PharmSci 360 Biomarker Posters:  A Collection for Community Discussion

This OSD will showcase the following posters that caught our Biomarker Community's interest.

·         Use of Human Plasma as a Surrogate Matrix for Quantitation of Modified Protein Therapy across Multiple Tumor Tissues

·         Comprehensive LC-MS/MS Analysis of VSV-GP Lipidome

Presenters:

• Mackenzie Mellenbruch (ICON)
• Yuecheng Xi (Boehringer-Ingelheim)

 
 Organizers:  Carmen Fernández-Metzler (PharmaCadence), Karen Quadrini (Prothena Biosciences) and Chunyan Tinder (Tasso, Inc.)

 
We start at 12:00 EST sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts.

(Please remain on mute unless asking questions)

 
When: Tuesday, Jan 30, 2024, 12 pm – 1 pm EST

Where: Please join from your computer, tablet or smartphone.
https://global.gotomeeting.com/join/305789893

You can also dial in using your phone.
United States: +1 (872) 240-3412
Access Code: 305-789-893

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Meeting ID: 305 789 893
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Hi everyone,

Happy New Year!

Below please find the agenda for tomorrow’s AAPS Regulatory Sciences Community meeting (Friday, January 19^th, from 12:05-12:55 p.m.):

1. Welcome – Shraddha Thakkar
2. Introductions, new members – All
3. Patient centric specifications – Stan Altan
4. AAPS PPDM Community career development webinar, May/June 2024
1. Has a speaker (or two) from the RS Community been identified?
5. 2024 PharmSci360 2024 session suggestions – All
1. Data integrity (with the CMC Community?) – Tahseen Mirza
2. Complex excipients (with the Excipients Community?) – Allison Radwick
6. New regulatory guidances (last 30 days) – Allison Radwick

7. February meeting date
1. Meeting scheduled for February 16^th but Jen is not available – can someone else take minutes for that meeting?
8. Hot Topics - All

Thank you,

    Jen

AAPS released our annual #salarysurvey, the only salary survey focused on #pharmaceutical scientists, in October. Ben Comer chatted with AAPS President President Gopi Shankar, Ph.D., M.B.A., FAAPS about the 2023 survey results for Life Science Leader.

Dear all, please note that the time of the discussion has been changed to Jan 25th 12-1pm.

Look forward to seeing many old and new faces next week!

Best regards,

Jiaying (Secretary of AAPS Excipient Community)

---

Dear all,

   Happy New Year and Welcome back! The AAPS Excipient Community LT would like to start our 2024 Open Scientific Discussion series on Jan 19^th  12-1pm US EDT with focus on “ HPβCD usage in Biologics Product” and open to any other topics you’d like to bring up. Look forward to seeing you again in 2024!

  Best regards,

  AAPS Excipient Community LT.

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Join AAPS and the FDA Center for Drug Evaluation and Research (FDA CDER) for the FDA/CDER – AAPS public #workshop, “Therapeutic Drug Monitoring of Biologics - Current Practice, Challenges and Opportunities," on February 26.

#CareerSuccess "It's worth my time to talk to someone and give advice," explained AAPS leader Cindy Oksanen, Ph.D. to Drug Discovery & Development. Thanks for your #mentorship at AAPS, Cindy! Discover more about her #CareerDevelopment and legacy.

Contact Vinaya Kapoor or Sherilyn Campie if you need the Teams link

🧪 Attendees at the 2023 #PharmSci360 in Orlando discovered cutting edge science across the pharmaceutical continuum. Each educational session is now available on-demand. 

Get your #research in front of potential clients or recruiters at #NBC2024 in May. Poster #abstracts for the 2024 National Biotechnology Conference in San Francisco are now being accepted for review.

Submit today!

REMINDER - 

Don't miss the webinar on Photostability of Biologics.

Tomorrow - Thursday - 9:30am PST

Speaker:  Sreedhara Alavattam, Genentech

#AAPS2023 AAPS is pleased to announce Anurag Rathore, Ph.D., will become Editor-in-Chief of The AAPS Journal in 2024, following the retirement of Ho-Leung Fung, Ph.D., FAAPS, who has led the peer-reviewed publication for 18 years. #AAPSJ #peerreview

#WorldQualityMonth New AAPS resources addressing pharmaceutical quality will be available throughout the month of November as AAPS participates in World Quality Month, an annual celebration led by the ASQ - World Headquarters and ASQExcellence.

Dear PPDM Community Members,

I trust this message finds you well. In our continuous pursuit of knowledge and collaboration, we are thrilled to announce the establishment of a Scientific Contribution Subcommittee aimed at writing and publishing focused white papers on a select aspect of PPDM.

Why Join?

By joining the Scientific Contribution Subcommittee, you will not only be at the forefront of shaping the narrative within our field but also play a crucial role in driving meaningful discussions and insights. One of the exciting aspects of this initiative is the potential for your contributions to be published. The white paper resulting from our collective efforts will provide a platform for showcasing your expertise and insights to a broader audience, both within our community and beyond. This aligns with our overarching themes of Innovate, Excel, and Inspire

Key Responsibilities:

• Collaborate with fellow subcommittee members to identify and define the specific aspect of PPDM to be addressed in the white paper.
• Conduct thorough research and analysis on the chosen topic.
• Contribute to the writing and review process, ensuring the white paper reflects the highest standards of quality and relevance.
• Participate in regular meetings to discuss progress, share insights, and coordinate efforts with other subcommittee members.

Time Commitment:

Active participation in the Scientific Contribution Subcommittee is estimated to require approximately 5 hours per week writing the paper and 1-hour biweekly progress meeting (or as the subcommittee deems adequate to achieve desired success in real time) .

Express Your Interest:

If you are passionate about making a meaningful contribution to the development and advancement of PPDM knowledge and wish to be a part of this exciting initiative, please respond to this email no later than 5 pm ET on November 17th, 2023.

Your dedication and expertise are invaluable to the success of this endeavor, and we look forward to collaboratively driving innovation, excelling in knowledge, and inspiring through publication within our vibrant PPDM community.

Thank you for your ongoing support.

Best regards,

Chuk

AAPS supports scientists at every stage of their career journey. We release the only annual salary survey of and for #pharmaceutical scientists. This tool assists both employees and employers for #salarynegotiations.

Members can access this resource.

INTERPHEX Global and AAPS established an independent, all-volunteer Scientific Programming Advisory Committee to review and select programming for the all-new INTERPHEX Conference. “At AAPS our goal is always to bring the latest research and insights to the forefront where they can impact how we do business, and thus, how we help patients,” AAPS President Gopi Shankar, PhD, MBA, FAAPS, said. 

Agenda:

1. First time attendees/new member introductions
2. Standing:  Items of interest from other AAPS Communities
3. 2024 Stability Community Leadership:  Start after PharmSci 360.  Many Thanks to Lori and the 2023 Leadership team! 
4. Member Engagement: Highlights 2023 PharmSci 360 (community meeting etc) 
5. Recap of 2023 accomplishments   
6. Goals for 2024 -  Team,  All members
7. Next Qtr meeting with CMC Statistics Community : Dec
• Facilitators:  new volunteers? 
8. Sterile Products Community

Webinar Photostability of Biologics, presented by Sreedhara Alavattam, Genentech: Thursday, Dec 7, 12:30pm EST / 9:30am PST

Stability Community can help socialize/advertise

• Discussion on further collaboration (if SPC members can join, Hitesh, Haresh, Yogita): photostability or other topics or agree to co-sponsor some presentation/discussion with broader invitations)
8. Nanda's survey  request

Join us!  (Contact Lori McCaig if you need invite)

Dear PPDM Members,

I hope this message finds you all in good health and high spirits. It is my pleasure to welcome you back from the AAPS Pharmsci360 meeting, where I trust you gained valuable insights and knowledge to enhance your work in the pharmaceutical and biotechnology fields.

As we return from this enriching experience, I'd like to take this opportunity to remind you of our monthly PPDM community calls, which occur every first Friday of the month from 12 to 1 pm ET. These calls are a cornerstone of our community, and they provide a platform for us to share ideas, discuss developments, and foster collaboration.

I kindly request that you confirm your availability for our upcoming monthly meetings. Please let us know if this time still works for you no later than 5 pm ET on the 2^nd of November 2023. If we do not hear back, we will assume that the schedule still works well for everyone.

I would also like to extend a warm welcome to our new PPDM members. We are excited to have you join our community of professionals dedicated to innovation, excellence, and inspiration. I encourage all our members, new and existing, to participate in our discussions and engage with us on the AAPS community website. If you have not formally joined our community, please kindly join us via this link: Pharmacokinetics, Pharmacodynamics, & Drug Metabolism Community - AAPS Main Site . Sharing your experiences and expertise will contribute to the growth and vibrancy of our community.

Furthermore, we encourage each of you to invite your colleagues to formally join the PPDM community. The more diverse perspectives we have, the stronger and more dynamic our community becomes. Let's work together to make a difference in our industry.

Looking ahead, we are currently in the process of compiling webinars for 2024. If you have ideas or plans for organizing webinars within our community, please reach out to Jongbong as soon as possible. Your contributions and involvement in this endeavor will be greatly appreciated.

Lastly, to allow everyone time to settle in after the Pharmsci360 meeting, our next PPDM community call will be scheduled for next Friday. A calendar invite will follow up before the end of this week.

Thank you for being an essential part of the PPDM community. Together, we can continue to innovate, excel, and inspire in our ever-evolving field.

Best regards,

Chuk

Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Gene and Cell Therapy Product (GCTP), Biomarkers and Precision Medicine (BPM) and BioAnalytical (BA) Communities on Nov 2, 2023, 12 pm – 1 pm EDT on the following topic:

Development of Companion Diagnostics for AAV Gene Therapy

•       Introduction to companion diagnostics (CDx) for AAV gene therapy

•       Effect of pre-existing AAV immunity on gene therapy

•       Biomarkers for patient enrollment into gene therapy trials and FDA guidance

•       Pre-existing anti-AAV antibody assay formats

•       Overview of CDx development process

•       Regulatory strategies and landscape on gene therapy CDx development

•       Regulatory strategies for Analytical and Clinical Validation

•       FDA and EU regulatory landscape for Gene Therapy CDx

•       Implementation of CDx for gene therapy

•       The need for partnership

•       Dx Partner engagement 

•       Challenges of CDx development for gene therapy

Discussion Leaders:

Yanmei Lu (Sangamo Therapeutics), George Bashirians (CompanionDx Consulting), Maham Ansari (Precision For Medicine) and Natasha Thorne (FDA CDRH)

Organized by:  

Yanmei Lu (Sangamo Therapeutics), Yan Ni (Passage Bio), Karen Quadrini (Passage Bio), and Sanjeev Bhardwaj (Moderna)

We start at 12:00 EDT sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts.

(Please remain on mute unless asking questions) 

When: Thursday, Nov 2, 2023, 12 pm – 1 pm EDT

Where: Please join from your computer, tablet or smartphone.
https://meet.goto.com/505947717

You can also dial in using your phone.
United States: +1 (646) 749-3122
Access Code: 505-947-717

Join from a video-conferencing room or system.
Dial in or type: 67.217.95.2 or inroomlink.goto.com
Meeting ID: 505-947-717
Or dial directly: [email protected] or 67.217.95.2##505947717

New to GoToMeeting? Get the app now and be ready when your first meeting starts:
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Please feel free to share with colleagues who may be interested in this topic.

Monday, October 23, 2023

Spotlight Stage B, Exhibit Hall West A4 – B3
Orange County Convention Center, Orlando, FL

If you are attending PharmSci 360 this week in Orlando FL, come by and say hello!
Lori McCaig (Chair) and Kim Huynh-Ba (Learning Engagement Manager and Founding Member) will be there to answer any of your questions.  

AAPS Stability Community Membership Meeting

Monday October 23 5 PM - 6 PM ET
308 AB West

Please join us for the Gene and Cell Therapy Products (GCTP) Community Membership Meeting at 2023 PharmSci 360 annual meeting in Orlando, FL

When: Monday, the October 23rd, 2023 from 4:00 to 5:00 PM EST

Where: Spotlight Stage A Exhibit Hall West A4-B3  Orange County Convention Center, Orlando, FL 

Who: Vittal Shivva (Genentech) will debrief community mission, goals, achievements and accomplishments

Looking forward to meet you all in-person.

Best wishes,

Vittal Shivva

Dear all

We will be hosting the annual meeting of the Inhalation & Nasal Community (INC) during 2023 PharmSci360.

Monday, Oct 23

5-6 pm ET

206 AB West, Orange County Convention Center

Orlando, FL

Please join us to get updates about community activity in 2022-23, welcome the new leadership board, and plans for the next year.

If you plan to attend this year's PharmSci 360, please join AAPS Protein Purification, Storage, Transportation, and Drug-Device Combination Community Membership Meeting. The detailed meeting information is listed below. Please feel free to let me know if you have any questions. 

Monday, Oct 23
5:00 PM – 6:00 PM ET

AAPS Protein Purification, Storage, Transportation, and Drug-Device Combination Community Membership Meeting

208 AB West, Orange County Convention Center

Community Leader: Yuan Cheng, Ph.D., Senior Principal Scientist, Regeneron Pharmaceuticals

Agenda:

• Standing:  Items of interest from other AAPS Communities
• Member Engagement:  AAPS PharmSci 360 less than two weeks away!
• Slate for 2024 Community Leadership - handover next meeting
• Benchmarking results on stability organization (Kayla Woodlief)
• Preview for Dec Qtr meeting with CMC Stats
• Continued discussion with Sterile Products Community

Join us!  (Contact Lori McCaig if you need invite)

Please consider attending the upcoming American Association of Pharmaceutical Scientists (AAPS) | @aapscomms LBDDS community webinar on "Standards in Nanotechnology for Medical Products" by Dr. Anil Patri (Director, Nanotechnology Core Facility & Chair, Nanotechnology Task Force at US Food and Drug Administration).

Date: October 3, 2023, 12:30pm EST

https://www.pathlms.com/aaps/webinars/37780   This is the registration link and please note that it is free.

"When done right, peer review is a highly constructive process that moves science forward," said @theaapsjournal Editor-in-Chief Ho-Leung Fung, Ph.D. AAPS joins STEM organizations in recognizing this week as Peer Review Week.

Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Personalized Medicine (PM) and Biomarkers and Precision Medicine (BPM) Communities on 17 October 2023, 12 pm – 1 pm EDT on the following topic:

Precision Medicine in Oncology

·         How does AI/ML enable the development of on-demand, neoantigen-based cancer therapies?  Challenges with the advent of AI and personalized cancer medicine.

·         How does the path for approval vary between personalized cancer vaccines and traditional therapies?

·         Challenges in Translational Research – the translatability crisis

·         Suggestions to improve Translational Research

Discussion Leaders:

Guilhem Richard (EpiVax Therapeutics) and Attila Sayhan (Brown University)

Organized by:  

Vibha Jawa (BMS), Karen Quadrini (Passage Bio) and Carmen Fernández-Metzler (PharmaCadence)

We start at 12:00 EDT sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts.

(Please remain on mute unless asking questions) 

When: Tuesday, October 17, 2023, 12 pm – 1 pm EDT

Where: Please join from your computer, tablet or smartphone.
https://global.gotomeeting.com/join/305789893

You can also dial in using your phone.
United States: +1 (872) 240-3412
Access Code: 305-789-893

Join from a video-conferencing room or system.
Dial in or type: 67.217.95.2 or inroomlink.goto.com
Meeting ID: 305 789 893
Or dial directly: [email protected] or 67.217.95.2##305789893

New to GoToMeeting? Get the app now and be ready when your first meeting starts:
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Please feel free to share with colleagues who may be interested in this topic.

Thank you,

The Leadership Teams of the AAPS BPM and PM Communities

AAPS Global Health Community Membership Meeting

• Date/Time: Monday, Oct 23, 4 – 5:00 PM
• Place: Spotlight Stage B, Exhibit Hall West A4-B3, Convention Center

We are looking for your active participation in our community. Please attend and share your ideas.

Looking forward to seeing you all.

- Sudip

Reminder:  The Joint Quarterly Meeting of the Stability and CMC Statistics Communities is this coming Thursday Sept 7, 2023 at 11:30am Pacific Time. 

This quarter's topic:  Comparability!

If you need the invite, please contact Lori McCaig or Chris Latoz.

Early Bird Pricing through August 29th.

While you are there, don't miss the AAPS Stability Community Membership Meeting
Monday, Oct 23, 5:00 PM – 6:00 PM ET
308 AB, West
Community Leaders to host: Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik Consulting & Training and Lori McCaig, PhD – Seagen Inc.

Dear all,

My name is Bart Hens, current chair of the OBAM community at AAPS, and former postdoc researcher at the University of Michigan under the supervision of Prof. Gordon Amidon.

In collaboration with the Oral Biopharmaceutics Community (OBAM) of AAPS, we are interested in gathering more information about the current role of animal testing at the level of academic institutions and research organisations (CRO, pharma industry). We have made two different surveys; one for people in academia and the other one for people in pharma industry/ CROs. Please select below the right one for you depending on your current role/ position.

If you would have 5 min available of your time to complete the following survey, that would be much appreciated!!

• Link academia: https://forms.office.com/r/ykzfD3MGj7
• Link industry: https://forms.office.com/r/q99kgczPCf

Thanks in advance!

Best!

Bart Hens

Bart HENS

Drug Product Design Biomodeler / Biopharmaceutics Scientist

Pfizer Sandwich – Pharm Sciences Small Molecules

Drug Product Design

AGENDA

1. Standing Agenda Item:  Updates on items/activities of interest from other AAPS Communities
2. Member Engagement:  AAPS PharmSci 360 Oct 22-26.  Sessions by Community members, community meeting Oct 23 5-6pm
3. Next Qtr Discussion with CMC/Stats - Sept 7
4. Benchmarking topics:  Acceptance criteria in regulatory protocols in 7.1/8.1 and 7.3/8.3
5. Photostability continued

AAPS is seeking members to participate in the Mentoring Program. This program facilitates supportive, professional relationships between scientists based on their career experiences, networks, and goals. 

Apply Today

🎉 AAPS is pleased to announce that The AAPS Journal's impact factor increased this past year. The AAPS Journal is a forum for cutting-edge #research backed by a robust peer review process. Our members have free, unlimited, electronic access to The AAPS Journal. #AAPSJ

🔊Tune in: The Editor-In-Chief for AAPS Open provides insights on the future trends for biologic #drugdevelopment and #manufacturing on a recent PharmTech Group Drug Solutions Podcast episode. 

Reminder – our monthly AAPS Stability Community Meeting is this Thursday 
Abbreviated agenda is below

Agenda:

1. Announcement:  next Qtr meeting with CMC Statistics Community is Sept 7, discussion topic = Stability Comparability facilitated by Sherilyn Campie (Stability) and Vaneeta Grover (Statistics)
   
   
2. Standing Agenda items:
   1. review of community postings (nothing pressing)
   2. updates on items/activities of interest from other AAPS communities
   3. opportunity for benchmarking (defer to end of meeting if time, otherwise submit via Community Site or email)
      
      
3. Main Topic:  Discussion on Photostability for Biologics, led by Haresh More and guests from Sterile Products Community
   
   1. Following the discussion, we can consider ideas for future collaboration:

📢 Join us for an insightful AAPS webinar on "Basic Concepts of Model-Informed Drug Development"! 🌐

🗓️ Date: 15th August 2023
⏰ Time: 12:30 pm EDT

💡 Gain a deep understanding of the fundamental principles behind Model-Informed Drug Development (MIDD) in this engaging session. 📚

👥 Who should attend? Researchers, clinicians, and pharmaceutical professionals eager to enhance their knowledge of MIDD and its impact on drug development.

🔎 Explore key topics:

✅ Role of pharmacokinetic-pharmacodynamic (PK-PD) modeling

✅ Application of quantitative methodologies in clinical trial design

✅ Integration of modeling and simulation in regulatory decision-making

🎙️ Featuring renowned experts in the field who will share their invaluable insights and experiences. Don't miss this opportunity to expand your expertise!

🚀 Register now to secure your spot!

https://lnkd.in/eRf7zATN

🌐 Stay ahead in the ever-evolving world of drug development. Join us for this transformative webinar and unlock the power of Model-Informed Drug Development.

Here you go for full 2023 AAPS PharmSci 360 program 

Agenda

• Overview of Accelerated Stability Study Modelling Strategies – Stan Altan and Bill Porter
• Uses of Accelerated Stability Data in the Large Molecule Modality – Dan Willingmyre
• Discussion Topics
• Topic 1:
• What challenges have you encountered, scientific or regulatory, in the use of accelerated stability testing to support product shelf-life assignment?
• What are the regulatory hurdles in using accelerated stability studies to support a filing?
• What experiences have you had supporting expiry at the long-term condition by modelling accelerated data? 
• Topic 2:
• What are the common designs you use for accelerated stability testing?
• Is it related to stage of product development (early, mid, late)?
• Do you have a set of “standard” designs?
• Topic 3
• What other scientific questions can you address with accelerated stability testing?
• Topic 4
• What challenges have you had with leveraging accelerated stability testing to support stability profile comparability assessments after process or formulation changes?
• Topic 5
• How do you leverage accelerated stability data to support temperature excursions, supply chain handling and patient convenience allowances?

Please note the new day and time for our monthly meetings.  There was a conflict for the previous time slot. 

The meetings will be held at 1:00 PM EDT every first Tuesday of the month.  The next meeting will be on 6 June 2023.  

AAPS BPABC Monthly Meeting

Please join my meeting from your computer, tablet or smartphone.

https://meet.goto.com/542142965

You can also dial in using your phone.

Access Code:

542-142-965

United States:

+1 (646) 749-3122

Join from a video-conferencing room or system.

Meeting ID:

542-142-965

Dial in or type:

67.217.95.2 or inroomlink.goto.com

Or dial directly:

[email protected] or 67.217.95.2##542142965

Get the app now and be ready when your first meeting starts:

https://meet.goto.com/install

Agenda

• First time attendees/new member introductions (5min)
• Opportunity for collaboration with Sterile Product Community (Vinaya)
• Approached by Haresh More, member engagement manager, interested specifically in photostability in biologics products but could be more in future
• Possibilities – joint meeting/informal discussion, joint survey/white paper, speakers
• Recap of KENX Laboratory University (Lori, all who attended/presented)
• AAPS PharmSci 360 Oct 22-26 Orlando FL – registration open, Rapid Fire submissions due June 15 (Lori/Kim)
• Volunteering (Lori)  a) positions for next year; b) anyone can lead a project of interest
• Follow-up:  Stability community's interests/ideas on regulatory sciences topics in order to updating AAPS RS101 training content, tailoring to AAPS community needs
  Contact chair if you need invite for meeting