Topic

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Articles

It is necessary to search beyond the term “data integrity” to stay abreast of developments in this field, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Evolving Regulatory Systems Stress Importance of Data Integrity

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Videos

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. 

Ask the Expert: Working with Regulators to Develop Orphan Drugs

, specializes in business development, new product planning, and early brand strategy. He helps companies lay the foundation for successful launches through data-backed strategies spanning indication assessment to portfolio strategy. With a strong background in pricing and market access, Nathan integrates both commercial and access insights into early asset development to maximize market opportunity.

 specializes in brand strategy, product launch, and advanced analytics. He helps companies navigate critical decisions across the asset lifecycle, from early strategy through launch execution, with a focus on maximizing patient access to treatment. Drawing on expertise in analytics, ML, and AI, Michael combines quantitative rigor with cross-functional insight to support more robust strategy and informed decision-making.

In part three of this four-part series regarding rare diseases, the authors examine how revenue concentration and accelerating patent cliffs undermine the traditional blockbuster model, whereas orphan drugs offer a structurally different strategy for stabilizing biopharma portfolios through more durable, predictable, and risk-adjusted long-term value creation.

Rare Disease Assets Hedge Against Portfolio Risk and Stabilize Long-Term Portfolio Value Potential 

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.

Women Making an Impact

In part two of this four-part series regarding rare diseases, the author examines how economic and structural forces are driving an access gap.

Rare Disease Treatments: Navigating the Economics of Global Innovation

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

Women in STEM: Cultivating Scientific Confidence

FDA has granted priority review to AstraZeneca's Datroway for the first-line treatment of metastatic TNBC treatment.

FDA Grants Priority Review to AZ's Datroway for Metastatic Triple Negative Breast Cancer

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 Role of Standards in Sustainability

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.

FDA Launches PreCheck Pilot Program to Bolster Domestic Drug Manufacturing

The European Commission has approved GSK’s adjuvanted recombinant respiratory syncytial virus vaccine, Arexvy, for use in adults aged 18 years and older. 

Quality Systems