Pharmatech Associates Showcases Strategic Program Development for Drug Sponsors and Innovators at CPHI Barcelona 2023

This week at CPHI Barcelona, Pharmatech Associates will showcase its expertise and capabilities that help global pharmaceutical and emerging biotech companies accelerate their innovation and speed delivery of breakthrough medicines and therapies to patients. Spanning a wide range of modalities and platforms, Pharmatech's expertise extends to cell and gene therapies, monoclonal antibodies (mABs), oral solids, steriles, biologics, digital technologies, and pharmaceutical continuous manufacturing (PCM). Pharmatech Associates experts will be on hand at CPHI Barcelona 2023, October 24-26, 2023, at the U.S. Pharmacopeia (USP) booth, Stand 4H17, zone Excipients.

"As pharma and biotechs work to transform molecules to medicines for biopharma therapies, they want to decrease regulatory risks and mitigate delays at every stage?from discovery, early development, and lab scale through to scalable manufacturing and U.S. market entry," said Sireesha Yadlapalli, chief executive officer, Pharmatech Associates. "This week, we will demonstrate how we help drug sponsors and pharmaceutical innovators meet international regulatory requirements and their own business objectives to supply quality medicines in major markets."

CPHI Barcelona Expert Live Sessions with Pharmatech Associates

On October 24 and 25, Pharmatech Associates experts will participate in several sessions:

• Implications of FDA's Quality Maturity Model (QMM) Initiative for API Manufacturers, Drug Sponsors and Drug Manufacturers, Sireesha Yadlapalli, CEO, Pharmatech Associates, Oct 24, 2023, 12:05 to 12:25 (CET), Room: 4.4, Conference Centre 4.

• Panel: Looking to the Future ? What's Next for the Generic Drugs Market? Moderator, Camille Dumont, manager, Customer Applications, Lonza; Panelists: Sireesha Yadlapalli, CEO, Pharmatech Associates; Juan Colberg, Global Green Chemistry Leader, Pfizer; Sven Stagemann, CEO, Leigniz JointLab; Markus Steiger, vice president, Medicines for Europe, Oct 24, 2023, 12:55 ? 13:40 (CET) Room: 4.4, Conference Centre 4.

• Continuous Improvement Through Continuous Manufacturing, Lawrence De Belder, Continuous Manufacturing Practice Lead, Pharmatech Associates, Oct 25, 2023, 15:05 ? 15:25 (CET) Room: 4.4, Conference Centre 4.

• Panel: Industry 4.0 ? Setting a New Standard for Manufacturing Quality, Moderator, John Giannone, VP Industry Programs Small Molecules & Growth Programs, U.S. Pharmacopeia (USP); Panelists: Lawrence De Belder, Continuous Manufacturing Practice Lead, Pharmatech Associates, Isamir Martinez, ACS Green Chemistry Institute; Danita Broyles, Harmony Biosciences; Sanjay Sharma, Global Head of Manufacturing, Dr. Reddy's, Oct 25, 2023, 15:55 ? 16:45 (CET) Room: 4.4, Conference Centre 4.

For more about Pharmatech Associates sessions and USP's activities at CPHI Barcelona, please visit here.

Accelerated Pathways to U.S. Markets

For drug sponsors and pharmaceutical organizations seeking to enter the U.S. market with quality medicines and reduced program risk, Pharmatech Associates is a trusted partner for product development, regulatory, and quality to assist clients as they navigate the regulatory landscape of FDA and international health authorities.

Advanced Manufacturing & PCM

Pharmatech Associates' collaborative efforts with USP and other healthcare stakeholders help lower barriers to the adoption of Advanced Manufacturing Technologies with pharmaceutical continuous manufacturing (PCM) as part of a solution to mitigate supply chain disruption and drug shortages and bring more quality products to market safely, sustainably, and cost-effectively.

Advanced Therapies & Biologics

Pharmatech, a wholly owned subsidiary of USP, continues to expand its capabilities that enable customers to consistently and efficiently produce cell and gene therapies and mABs therapies, that offer patients targeted treatments for a wide range of serious health conditions and diseases. In a recent client engagement for a pre-IND cell and gene therapy company requiring regulatory strategy to protect their proprietary starting material, Pharmatech Associates performed a development gap analysis that highlighted risks within their current program. The result was a clear roadmap that aligned with the client's business and IP strategy that they could use to chart their downstream FDA obligations, budget, and financing needs to fund their overall program.

About Pharmatech Associates ? a USP Company

Pharmatech Associates is a global consultancy for the life science industry and advises U.S. and global drug sponsors and manufacturers that supply quality medicines in many major markets. As a wholly owned subsidiary of U.S. Pharmacopeia (USP) with domain expertise ranging from small molecule to cell and gene therapy, biologics (specifically monoclonal antibodies), and advanced manufacturing technologies, Pharmatech Associates' services include product and process development, quality management, quality assurance, and product management. Pharmatech Associates assists clients in navigating the regulatory landscape of the FDA and international health authorities and provides guidance for U.S. market entry. Pharmatech Associates serves a range of clients from start-ups to large multi-national corporations from its headquarters in San Francisco, California.

Learn more at www.pharmatechassociates.com.