BioPharm Editorial Advisory Board
BioPharm International Editorial Advisory Board
BioPharm International® Editorial Advisory Board comprises distinguished specialists involved in the biologic manufacture of therapeutic drugs, diagnostics, and vaccines. Members serve as a sounding board for the editors and advise them on biotechnology trends, identify potential authors, and review manuscripts submitted for publication.
Ramin B. Arani
Director, Biostatistics
Sandoz Biopharmaceuticals
Rory Budihandojo
GMP Consultant
Uwe Gottschalk
Vice-President,
Chief Technology Officer,
Pharma/Biotech, Lonza AG
Fiona M. Greer
Senior Consultant
BioPharmaSpec (UK)
Emily Heffernan
US Director New Process Technology
Arcadis U.S., Inc.
Denny Kraichely
Global Program Leader,Vaccine Development Management
Pfizer
Eric S. Langer
Managing Partner
BioPlan Associates, Inc.
Hank Liu
Associate Vice President, CMC & Quality
Ocugen
Herb Lutz
Biomanufacturing Consultant
Herbert Lutz Consulting
Hanns-Christian Mahler
Chief Enablement Officer, CEO
ten23 health
Click here for a spotlight on Hanns-Christian Mahler
Jerold Martin
Independent Consultant
Monika Paule
CEO
Caszyme
Anurag Rathore
Biotech CMC Consultant
Faculty Member, Indian
Institute of Technology
Susan J. Schniepp
Distinguished Fellow
Regulatory Compliance
Associates, Inc.
Tim Schofield
Consultant
CMC Sciences, LLC
Parviz A. Shamlou
Senior Vice President,
Science & Technology
Abzena
Humberto Vega
Sr. Director Ext. Mfg. DP &
Critical Materials
Bristol Myers Squibb
Steven Walfish
Senior Principal Scientist
USP
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial Success
June 4th 2025Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
