Profile

Dr. Mark Arnold, Ph.D., FAAPS

Owner and Principal,
Bioanalytical Solution Integration

Contact Details

Bioanalytical Solution Integration

My Content

1 to 10 of 10 total

FDA workshop announcement: ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology

Posted By Mark Arnold 06-03-2026 09:42
Found In Egroup: Translational and Clinical Science Community \ view thread
FDA, Health and Environmental Sciences Institute and Safety Pharmacology Society announced a Hybrid Workshop: ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology Date: July 28, 2026 Time: 9:00 a.m. - 4:00 p.m. ET Location: Attend In Person or Online Virtual: Teams In Person: FDA ...

FDA draft guidance on "Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing"

Posted By Mark Arnold 06-02-2026 14:29
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
The FDA released today (2Jun26) this draft guidance: "Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing" This 23-page draft guidance covers how to use prior knowledge to support chemistry, manufacturing, and controls (CMC); nonclinical; and clinical ...

New FDA draft guidance: Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products

Posted By Mark Arnold 06-01-2026 17:42
Found In Egroup: Translational and Clinical Science Community \ view thread
On Friday, May 27th, 2026, the FDA issued a new draft guidance: "Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products". It is a very short guidance at just 4 pages, but aligns well with the past year's publications, announcements, and guidance on reducing ...

FDA publishes 2 final guidances related to BE studies

Posted By Mark Arnold 05-28-2026 12:33
Found In Egroup: Translational and Clinical Science Community \ view thread
FDA published two final guidances for industry: "Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA" and "Statistical Approaches to Establishing Bioequivalence". From the announcement: "The guidance for industry entitled "Bioequivalence Studies with Pharmacokinetic ...

FDA restrospective analysis of NHP monoclonal data supports streamlining nonclinical testing

Posted By Mark Arnold 05-11-2026 08:46
Found In Egroup: Translational and Clinical Science Community \ view thread
FDA's Nakissa Sadrieh and Yanning Hao just published an analysis of NHP data from monoclonal antibody testing that supports streamlining animal testing. For those interested in NAMs, the abstract draws you into to reading more with its brief summary of findings: "Among the mAbs evaluated, long-term ...

New FDA CMC guidance for Cell and Gene Therapy products

Posted By Mark Arnold 05-05-2026 21:26
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
FDA releases new final guidance "Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application". This guidance is brief at only 8 pages and is focussed at giving sponsors and manufacturers greater flexibility for CGT products ...

FDA publishes on NAMs in JAMA

Posted By Mark Arnold 04-20-2026 16:10
Found In Egroup: Translational and Clinical Science Community \ view thread
More insights from the FDA on implementing new approach methodologies were just published in JAMA. https://jamanetwork.com/journals/jama/fullarticle/2848148?resultClick=1 #fda #NAM ------------------------------ Mark Arnold Ph.D., FAAPS Westampton, NJ [email protected] Bioanalytical Solution ...

FDA releases draft guidance on Establishing Impurity Specifications for Antibiotics

Posted By Mark Arnold 04-17-2026 09:30
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
AAPS normally doesn't have a lot of discussion on antibiotics, but for those who work in this space, the Agency just released a new draft guidance "Establishing Impurity Specifications for Antibiotics". From the announcement: "The draft guidance provides recommendations regarding the establishment ...

ICH releases presentation on M15 MIDD

Posted By Mark Arnold 04-09-2026 08:00
Found In Egroup: Translational and Clinical Science Community \ view thread
ICH just released a presentation on "M15: General Principles for Model-Informed Drug Development" It provides an overview of M15 and notes several times that additional training materials will be developed. You can access the 23 slides here: https://database.ich.org/sites/default/files/ICH_Step_4_ ...

EMA journal article "3Rs at the European Medicines Agency: Past and future activities"

Posted By Mark Arnold 03-27-2026 15:41
Found In Egroup: Translational and Clinical Science Community \ view thread
EMA has analyzed its data over the last 15 years in implementing the 3Rs and now in the context of NAM what has occured with new regulations and international harmonization efforts. The articles Abstract: "Driven by scientific advancements, the replacement, reduction and refinement of animal use (i.e. ...