Biologics Archives - Page 5 of 12 - Lachman Consultant Services, Inc.

Connect with Lachman Consultants at ISPE Singapore Affiliate Conference & Exhibition August 23 – 25, 2023

By Matt Taylor Aug 03, 2023 Biologics Data Integrity Manufacturing News Pharmaceutical industry

Join Lachman Consultant Services, Inc. online and in-person at Suntec Singapore for the 2023 ISPE Singapore Affiliate Conference & Exhibition, August 23rd – 25th. The exhibition showcases the latest technologies and services for pharmaceutical and biomanufacturing. The three-day conference is expected to include more than ninety international exhibitors and sponsors. Lachman Consultants is pleased to […]

Jul

Mother Nature Just Can’t Cut the Drug Industry a Break

By Bob Pollock Jul 21, 2023 ANDAs Biologics Biosimilars BLA Compliance FDA Generics NDA Regulatory Affairs

With the latest news that a tornado severely damaged a Pfizer sterile injectable plant in North Carolina, it is clear that Mother Nature is yet another interloper into the drug shortage problem in the United States. Ed Silverman, of the publication STAT, reports that “Among the damaged buildings was a Pfizer plant in Rocky Mount, […]

Jul

Removing Quality Roadblocks For Cell & Gene Therapies

By Matt Taylor Jul 11, 2023 Biologics Compliance FDA Manufacturing

REMOVING QUALITY ROADBLOCKS FOR CELL & GENE THERAPIES REGISTER HERE Keith Lamb, Executive Director, Lachman Consultant Services, Inc., will be joined by a panel of Cell & Gene Therapy (CGT) industry experts from leading organizations as they discuss the key considerations of successful CGT manufacturing and quality strategies. Roundtable topics will include: • Developing a […]

Jul

ISPE’s Biotech Conference Provides Important Insights

By John Darby Jul 10, 2023 Biologics Biosimilars BLA Compliance NDA Regulatory Affairs

The ISPE 2023 Biotechnology Conference was held from 26 to 27 June in Dublin, Ireland. Much of the focus of the conference was Cell and Gene Therapy and Advanced Therapy Medicinal Products (ATMPs), terms used in the US and EU for a range of emerging therapies and products in various stages of development. At the […]

Jun

Highlights from the Recent European Biomanufacturing Summit

By Mrinmoy Nag Jun 06, 2023 Biologics Biosimilars

The European Biomanufacturing Summit was held on May 31 and June 1, 2023, and was attended by industry leaders from multinational biotech and biologics companies, largely from Europe. The agenda on the first day of the conference included topics related to modernization and digitization of the pharmaceutical industry. The presenters talked about challenges in transforming […]

Mar

BLA One Time Report Deadline Coming Soon

By Bob Pollock Mar 21, 2023 Biologics BLA FDA Regulatory Affairs Reports

An email from the FDA explained that on March 17, 2023 the FDA added information to the Purple Book Database of Licensed Biological Products (here) to include information on new reporting requirements established by the Section 3201 of the Consolidated Appropriations Act of 2023. According to the Purple Book Q&A #8: “Section 506I(c) of the […]

Dec

FDA Proposes Rule to Change the IND Annual Report

By Bob Pollock Dec 08, 2022 Biologics Compliance FDA IND New Drugs Safety

Today’s pre-publication of the Federal Register contains a proposed rule (here) that will require the expansion of the current IND annual report. “Current § 312.33 requires sponsors that have an IND in effect to submit an annual report that must contain individual study information, which generally includes brief summaries of the status of each ongoing […]

Nov

CDER Advisory Committee Votes to Progress Quality Management Maturity

By Patrick Day Nov 09, 2022 Biologics Compliance FDA Generics New Drugs Quality

Is a mature pharmaceutical quality system really a competitive advantage? The industry held this as a belief, but progress in a tangible program was always elusive. On November 2nd, the CDER’s advisory committee, Pharmaceutical Science and Clinical Pharmacology Advisory Committee (PSCP‑AC), voted to establish a Quality Management Maturity (QMM) program to incentivize investments in mature […]

Nov

Face-to-Face Meetings – FDA Clarifies the Term

By Bob Pollock Nov 03, 2022 Biologics New Drugs

So, you have just been granted a face-to-face (FTF) meeting with the FDA. Woohoo! You’re going to Bethesda! Don’t be too quick to make those plane and hotel reservations. This morning, the FDA published a clarification from the FDA, CDER, Small Business and Industry Assistance (SBIA) program in its INDUSTRY NEWS section titled FDA Describes […]

Nov

Industry and Regulators Working to Prevent Drug Shortages

By Linda Evans O'Connor Nov 03, 2022 ANDAs Biologics Device FDA Industry NDA

I recently attended the ISPE Annual Meeting, held October 29 through November 2, 2022 in Orlando, Florida. The conference had varied content in areas such as Digital Transformation, Manufacturing Trends, Regulatory and Quality, Supply Chain Optimization, and Therapy Innovations. The conference was well attended by both industry and regulators. Although I found all of the […]

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Biologics

Connect with Lachman Consultants at ISPE Singapore Affiliate Conference & Exhibition August 23 – 25, 2023

Mother Nature Just Can’t Cut the Drug Industry a Break

Removing Quality Roadblocks For Cell & Gene Therapies

ISPE’s Biotech Conference Provides Important Insights

Highlights from the Recent European Biomanufacturing Summit

BLA One Time Report Deadline Coming Soon

FDA Proposes Rule to Change the IND Annual Report

CDER Advisory Committee Votes to Progress Quality Management Maturity

Face-to-Face Meetings – FDA Clarifies the Term

Industry and Regulators Working to Prevent Drug Shortages

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