Susan Haigney

In this episode of Ask the Expert, Susan J. Schniepp and Siegfried Schmitt discuss how companies should approach preventing product recalls.

Quality control for pharmaceuticals is evolving with the assistance of digital tools, sustainability practices, and a push to move manufacturing onshore.

Tony Lakavage, executive vice president and head of Global External Affairs, US Pharmacopeia (USP), discusses how IRA negotiations, Most Favored Nation pricing, US manufacturing push, and new FDA biosimilar guidance are reshaping the industry.

Tony Lakavage, executive vice president and head of Global External Affairs, US Pharmacopeia (USP), discusses drug supply chain vulnerabilities tied to China dependence, urging resilience through mapping, nearshoring, and manufacturing reform.

Industry experts explain how incorporating sustainability into the early development phase creates greener pharmaceutical manufacturing.

This week, the industry experienced accelerated digital transformation, regulatory evolution, and a strategic shift toward complex, patient-centric modalities.

The two companies have entered into a licensing agreement to commercialize biosimilars in Latin America.

The 2mg/kg every-4-weeks dosing regimen for pegunigalsidase alfa in adults with Fabry disease who are stable with an enzyme replacement therapy has been approved in Europe.

Developments across the sector highlight a period of rapid acceleration and structural modernization.

The companies have extended a commercial supply partnership for the manufacture of Sohonos (palovarotene), which is a treatment for the ultra-rare disease, fibrodysplasia ossificans progressiva.

Elisabeth Gardiner, PhD, CSO of Tevard Biosciences, explains some of the challenges associated with the development of treatments for rare diseases.

Industry experts discuss the benefits of utilizing contract development and contract research organizations in drug discovery and development.

PharmTech spoke with Andrew Mitchell, associate vice president of Business Development at BioVectra, about which 2025 trends will continue to impact the pharma industry and how CDMOs can offer solutions.

In this episode of Ask the Expert, Susan J. Schniepp, Nelson Labs, and Siegfried Schmitt, Parexel, discuss the benefits of orphan drug development and how a mid-sized company can work with regulators through the pathway to approval.

Dr. Jennifer Levin Carter, CEO and founder of Medzown, shares her experience as a CEO in the biotech industry and gives insights on how women can succeed in the pharmaceutical industry.

Márcio Temtem, Hovione, discusses how to tackle pharma complexity via regional growth in the US, Ireland, and Portugal, using digital tools to accelerate development.

PharmTech spoke with women working in the pharmaceutical industry about the innovations they are seeing in bio/pharma and the role women play in the development of critical treatments for patients.

Márcio Temtem, Hovione, discusses how his company integrates modular hardware and modeling software to accelerate pharmaceutical R&D and optimize manufacturing processes.

PharmTech spoke with Klaudia Lechowska, Business Development Specialist at Mabion Biologics CDMO, about how women working in STEM fields bring unique perspectives to the important work of rare disease treatment.

Marcio Temtem, vice president, Strategic Business Management, Hovione, addresses molecule complexity, speed, and regionalization via integrated manufacturing.

Oncologist Dr. Maria de Miguel, MD, PhD, MBA, Director, Clinical Research for START Rioja, spoke with PharmTech about the importance of STEM education in early phase drug development.

PharmTech spoke with Elisabeth Gardiner, chief scientific officer at Tevard Biosciences, about how hands-on, early exposure to STEM fields can demystify complex concepts.

PharmTech spoke with Dr. Stacy Lindborg, president and CEO of IMUNON, about her experience at IMUNON, which is developing a novel DNA-based approach to treat ovarian cancer.

The companies’ “Change the Target. Change What’s Possible” targets the potential of Factor XIa inhibition in the development of treatments for thromboembolic disease.

Anthony Lakavage, executive vice president and head of Global External Affairs at USP, talks about how sustainability efforts are more than just protecting the environment and how pharmaceopeias are participating in the endeavor.

The PreCheck Pilot Program is designed to strengthen the US pharmaceutical supply chain by increasing regulatory predictability and streamlining the assessment of new domestic manufacturing sites.

PharmTech spoke with Katy MacLellan, Technical Team leader, Symbiosis Pharmaceutical Services Ltd., about the women in the pharmaceutical industry that inspire her.

In a 2026 industry outlook interview, Raj Puri explains balancing speed with the financial and regulatory risks of accelerated drug launches via alignment.

In a 2026 industry outlook interview, Raj Puri discusses how the tariffs hinder US pharma investment but drive demand for geographically segregated supply chains.

Repertoire’s T cell receptor-epitope discovery platform will be used to develop tolerizing therapy development candidates with Eli Lilly and Company.