Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.

Research into Cold Cancers Heating Up

Activation and expansion are essential for success in both autologous and allogeneic therapies.

Development of Gamma-Delta T-Cell Therapies

Continuous manufacturing and a quality-by-design development approach are a natural fit.

QbD for Small-Molecule Continuous Process Development

Topic

, 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.

Articles

In part four of this four-part series on rare diseases, the authors examine how orphan drug economics are reshaping biopharma deal-making behavior, accelerating earlier-stage transactions, and shifting the geography of innovation sourcing, with future rare disease innovation increasingly emerging outside traditional US and European development centers.

Rare Disease Therapies: How Orphan Drugs Are Reshaping Global Biopharma Sourcing

Elisabeth Gardiner, PhD, is chief scientific officer at Tevard Biosciences, joining the leadership team in 2025 to spearhead the company’s pioneering tRNA-based gene therapies for rare diseases with high unmet need. With more than 25 years in the biopharmaceutical industry, she has directed and managed drug discovery and development efforts yielding 11 IND filings, four Phase I/II trial candidates, and one Phase III candidate. Prior to Tevard, Elisabeth held senior R&D leadership roles at Tactile Therapeutics, Alterome Therapeutics, Aravive, and Kinnate Biopharma, where she directed multidisciplinary teams and advanced programs from discovery to clinical-stage development across neurology, oncology, and rare disease. Elisabeth gained experience in tRNA biology while working at aTyr Pharma and at Scripps Research Institute in the lab of Paul Schimmel. Elisabeth’s commitment to the ethical development of effective and accessible medicines is her key focus in life. In addition to her professional work, Dr. Gardiner acts as a patient advocate in the rare disease and oncology space. Elisabeth earned her Ph.D. from the University of Wisconsin-Madison and holds a B.S. and an M.S. from Texas A&M University.

Videos

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

The Importance of Drug Development for Rare Diseases

Lars Hahn is senior vice-president, Global Sales Organization, at Vetter.

Trust-based CDMO partnerships are becoming essential to accelerate injectable drug development, manage risk, and ensure resilient biopharma supply.

Navigating Biopharma Complexity: Why Long-Term Partnerships Matter 

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

Outsourcing Formulation Activities May Advance Drug Development

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

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

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

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 

Suzanne Jansen is an experienced pharmaceutical professional with a strong background in quality control and clinical research. Currently serving as manager of the QC Laboratory and qualified person (QP) at ICON in the Netherlands, she oversees pharmaceutical analysis and release testing of investigational medicinal products (IMPs), as well as ensures compliance with good manufacturing practice standards. With more than a decade of experience, including 9 years as a pharmacist and QP at ICON’s on-site manufacturing facility, Suzanne has deep expertise in IMP development, manufacturing, and regulatory compliance. She holds a master’s degree in Pharmacy from the University of Groningen.

Suzanne Jansen, MSc, PharmD, ICON, says early-phase clinical success depends on flexible, simple formulations that support wide dose ranges, matching placebos, and robust stability.

Flexible Formulation Strategies Boost Early-Phase Clinical Success

Cheryl Barton is director of PharmaVision, 

New disease-modifying agents are being evaluated in the clinic that could change the course of treatment for Alzheimer’s disease patients.

European Biotechs Impacting Treatment of Alzheimer’s Disease

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.

Women Leading Biotech: Precision Medicine

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.