Author Archives: Cheryl Scott

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Niche Disease: Legionnaires’ Disease by Cheryl Scott Gram-negative, aerobic Legionella pneumophila bacteria were first identified as the cause of an outbreak of severe pneumonia at an American Legion Convention in a Philadelphia convention center in 1976. Since then (and probably long before), it has been responsible for occasional such outbreaks around the world. For example, an epidemic of the disease probably occurred in Minnesota in 1957. Such incidents are usually associated with poorly maintained artificial water systems (e.g., cooling towers…

October 15, 2015

Elucidation on India and China: Powerhouses of Asia 2015 Reports Assess Their Pharmaceutical Markets

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In the past year, CPhI Worldwide (a division of UBM EMEA) has released reports on both the Indian and Chinese pharmaceutical markets, findings of which were presented at CPhI India in Mumbai in early December 2014 and shortly after CPhI China in August 2015. India Looking Outward to Innovate The Indian report, CPhI India Pharmaceuticals 2015: Industry Explorations, was developed by CPhI in partnership with Global Business Reports (GBR) to provide a comprehensive analysis of the country’s pharmaceutical market. Overall, Indian companies…

October 15, 2015

Analysis and Characterization: The CMC Strategy Forum Series, Part 3 — Introduction

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The CMC Strategy Forums provide a venue for biopharmaceutical product discussion. They focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of the forum meetings are published in BioProcess International and on the CASSS website (www.casss.org). This process is meant to help ensure that biopharmaceutical products manufactured with…

September 23, 2015

Choosing Between Single-Use and Multiuse Technologies: A BPI Theater Roundtable at Interphex 2015

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On Tuesday, 21 April 2015, Eric S. Langer (managing partner at BioPlan Associates) chaired a midday roundtable titled, “Deciding on Single-Use vs. Stainless Steel Bioprocessing Strategy: What Do CMOs Know That Biopharmas Don’t?” Langer brought together these industry experts to discuss choosing between stainless steel and single-use technologies (SUTs) for different applications: William Hartzel (director of strategic execution at Catalent Pharma Solutions) Steven Perry (vice president of technical operations at Cook Pharmica) Joanna Pezzini (bioprocess engineer at MedImmune) Daniel Vellom…

August 24, 2015

New Approaches to Fill and Finish: A BPI Theater Roundtable at Interphex 2015

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On Wednesday, 22 April 2015, Susan Dexter (principal consultant at Latham BioPharm Group) chaired a midday roundtable titled, “Fill and Finish Manufacturing Strategies: Better or Just New?” She brought together three industry experts to provide mixed perspectives: Joseph Figlio (senior project officer for the manufacturing facilities and engineering division of the Biomedical Advanced Research and Development Authority, BARDA, in the US Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response) Victor Lee (vice president…

August 24, 2015

Managing Contract Relationships: A BPI Theater Roundtable at the 2015 BIO Convention

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On Wednesday 17 June 2015, Patricia Seymour (senior consultant at BioProcess Technology Consultants) chaired a midday roundtable titled, “Managing the Contract Relationship.” She brought together a panel of four experts with different perspectives (contract manufacturing, cell and protein therapies, and legal negotiations): Koen Hellendoorn (head of sales and customer account management at FujiFilm DioSynth Biotechnologies) Justin Skoble (senior director of technical operations for Aduro Biotech) Tom Douville (director of biopharmaceutical development at Kolltan Pharmaceuticals) Lily Vakili (senior counsel of Faber,…

August 24, 2015

Speeding Development and Lowering Costs While Enhancing Quality: A BPI Theater Roundtable at the 2015 BIO Convention

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On Tuesday, 16 June 2015, Thomas C. Ransohoff (vice president of BioProcess Technology Consultants) chaired a midday roundtable titled, “Stretching for the Trifecta: Innovative Strategies for Speeding Development, Lowering Costs, and Enhancing Quality.” He brought together a panel of four industry experts: Joanne Beck (senior vice president of process development at Shire Pharmaceuticals) Parrish Galliher (chief technology officer for upstream (Xcellerex) at GE Healthcare) Lynne Frick (director of continuous processing for the Americas at Pall Corporation) Mark Brower (senior research…

August 24, 2015

The Contractor Perspective: A BPI Theater Roundtable at the 2015 BIO Convention

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On Thursday, 18 June 2015, Gil Roth (founder and president of the Pharma & Biopharma Outsourcing Association, PBOA) chaired a midday roundtable titled, “CDMO Challenges and Opportunities.” He brought together a panel of four industry experts: Thomas Thorpe (chief executive officer of Afton Scientific) Michael Riley (vice president and general manager of Catalent Biologics) Victor Vinci (vice president and chief scientific officer for Cook Pharmica) Amit Arora (chief marketing officer at Jubilant HollisterStier) Points of View The Pharma and Biopharma…

August 24, 2015

Special Report: A World of Difference — Biosimilars and Biobetters Offer Unique Benefits — and Risks

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by John Otrompke, with Cheryl Scott and S. Anne Montgomery When the United States Food and Drug Administration (FDA) approved the country’s first ever biosimilar on 6 March 2015, it had been a long time coming. After all, the European Union had approved the first biosimilar in 2006, and a number of others have followed in Europe since then. Still, the approval of biosimilar filgrastim, a recombinant colony-stimulating factor used to offset the complications of chemotherapy, was a welcome step…

June 16, 2015

Spotlight: Niche-Disease — Barth Syndrome

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Barth syndrome is a serious X-linked genetic disorder that primarily affects boys. It is caused by a mutation in the tafazzin gene (Taz) that creates an inborn error of lipid metabolism. The condition is named after Dutch pediatric neurologist Peter Barth, who published his discovery of it in 1983. The syndrome often manifests at birth in a number of ways. Patients are born hypotonic, show signs of cardiomyopathy within the first few months of life, and despite adequate nutrition experience…

May 12, 2015