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1 month ago | 
cellandgene.com | Peter H. Calcott |James Jardine
FOCUS ON REGULATORY & COMPLIANCEThe U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025. Insights From The FDA's New FAQThe FDA's new FAQ offers crucial insights into best practices, from regulatory meetings to quality control and preclinical studies. Dive in for expert guidance.
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Jan 10, 2025 | 
outsourcedpharma.com | Peter H. Calcott |Louis Garguilo |Soudeh F. Tehrani |Lisa Lemelin
We’re ready to help usher your next drug into market! 2025’s first Outsourced Pharma Capacity Update provides a unique, virtual experience and the details necessary to find a CDMO for your specific timeline, volume, and production needs. Join us the last week of January as we draw the curtains on the industry’s best and give you complimentary VIP access to the resources available to support your success.
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Jan 7, 2025 | 
drugdiscoveryonline.com | Peter H. Calcott |Matthew Schiesher
FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025. Innovative AI-Driven Solutions To Address The Growing Complexity Of APIsComputer-aided synthesis planning (CASP) can mitigate the impact of rising complexity. We discuss the award-winning AI and vast data that propel a leading predictive retrosynthesis technology.
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Jan 7, 2025 | 
laboratorynetwork.com | Tim Sandle |Peter H. Calcott
By Tim Sandle, Ph.D.Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025. By Peter H. Calcott, Ph.D., FRSC, Calcott Consulting LLCFDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.
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Dec 11, 2024 | 
pharmaceuticalonline.com | Peter H. Calcott
By Peter H. Calcott, Ph.D., FRSC, president and CEO, Calcott Consulting LLC
FDA (CDER) issued a draft guidance in November 2024, Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics (ONT), to support clinical development and marketing of these products.1 As is customary, industry has 60 days to assess it and reply with feedback for consideration.
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Dec 11, 2024 | 
outsourcedpharma.com | Peter H. Calcott |Louis Garguilo
By Peter H. Calcott, Ph.D., FRSC, president and CEO, Calcott Consulting LLC
FDA (CDER) issued a draft guidance in November 2024, Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics (ONT), to support clinical development and marketing of these products.1 As is customary, industry has 60 days to assess it and reply with feedback for consideration.
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Nov 20, 2024 | 
advancingrna.com | AR Welch |Advancing RNA |Peter H. Calcott |Michael Nguyen
Webinar: Early Preclinical Development of mRNA/LNP projects - Setting Up Your Project for a Successful Transition to cGMP ManufacturingJoin us on December 2nd to explore mRNA construct development at Lonza, focusing on cGMP manufacturing, analytical advancements, and testing methods. Gain insights into the transition from research to manufacturing and the technologies shaping mRNA development for future projects. Click here to learn more.
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Oct 18, 2024 | 
clinicalleader.com | Peter H. Calcott
By Peter H. Calcott, Ph.D., FRSC, president and CEO, Calcott Consulting LLC
In September 2024, FDA issued the latest version of Bioresearch Monitoring Technical Conformance Guide: Technical Specifications Document: version 3.1.1 The original version was issued in late 2017, with substantial changes in 2020 and 2022. This version is probably going to be in place for a significant length of time.
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Oct 16, 2024 | 
outsourcedpharma.com | Louis Garguilo |Peter H. Calcott |Rebecca Coutts |James Jardine
Webinar: Reducing Risks by Outsourcing Your OSD Manufacturing and PackagingJoin Ropack on October 23rd as we explore how outsourcing can facilitate access to advanced equipment, streamline production scaling, and minimize risks related to supply chain disruptions and regulatory challenges. Whether considering outsourcing or currently engaging in outsourcing, we will provide valuable insights to help you make informed decisions that align with your operational and strategic goals.
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Sep 26, 2024 | 
advancingrna.com | Peter H. Calcott
Guest Column
| September 26, 2024
By Peter H. Calcott, Ph.D., president and CEO, Calcott Consulting LLC
The EMA issued a draft guidance to industry for comment on July 17, 2024, titled Guideline on the Development and Manufacture of Oligonucleotides.1 The consultation will finish Jan. 31, 2025.
