April 2020: From the Editor

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As I write, the world is in a state of medical and economic uncertainty related to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the coronavirus disease (Covid-19) that it causes. Our company group, Informa Connect, has been forced to reschedule some major conferences — including BPI West and BPI Europe — but it’s not alone. Many life-science meetings have been canceled or postponed, and some Biogen employees probably wish their management meeting late in February had been as well. That company has become infamous for an outbreak, and many organizations are asking employees who can do so to work from home. Others have suspended international business travel and conference attendance. The Pharmaceutical Research and Manufacturers of America (PhRMA) temporarily closed its offices after a visitor tested positive.

The biopharmaceutical industry usually thinks of pandemic preparedness and infectious-disease outbreaks as potential business opportunities. In fact, I’ll be delving more into the subject of SARS-CoV-2 vaccine development in an eBook for release in May. By that time, either we’ll have managed to “flatten the curve,” or we’ll have a full-blown global catastrophe on our thoroughly washed hands. But events in early March have shown us that these incidents create business challenges as well — those more widespread than the opportunities ever could be.

Will mortality rates approach those of the Spanish influenza a century ago? So far, the current situation has served mostly as a test of preparedness. Governments, companies, and other organizations all are learning how ready they are (or not) and how well their plans work (if they have any). What looks sensible on paper may not reflect the reality of how human beings function in a crisis: Who knew a respiratory-disease outbreak would cause a toilet-paper shortage?

This issue’s unofficial subtheme highlights the topic of viral contamination, particularly with bovine serum products. A virus that is endemic in the worldwide population of cattle cannot be tolerated in cell cultures. How does the serum industry address that? And what can users do to manage the risk? Of course, it’s not the only potential contaminant of concern. One of our supplier-side articles takes a wider view in testing fetal bovine serum for several adventitious agents.

So viruses seem to be a hot-button topic these days. Last year it was Zika, the year before it was Ebola — and lesser zoonotic influenzas and SARS coronavirus outbreaks have come and gone. None have closed borders and interrupted supply chains like the current incident has. As of 3 March, the World Health Organization estimated the Covid-19 death rate at around 3%, but it’s much higher for older and health-compromised patients and much lower for younger, healthier people. As individuals are reminded to practice social distancing, companies too must be nimble in reacting to the situation as it changes every day. Those that take the right actions and precautions without over- or underestimating the need for them will come out of it all in the best shape to move on into the future.

Training and staffing are keys to success, and you’ll find discussions of both in the front and back of this issue. If current events have taught us anything, it’s that people are the heart of it all.

 

 

 

Welcome Editorial Advisor Hiten Gutka
The editors of BPI are pleased to introduce Hiten Gutka, PhD, as the newest advisor on our editorial board. Hiten is a senior scientist in biologics drug-product development at Bristol-Myers Squibb (BMS). He might be familiar to readers as author of “Rational Selection of Sugars for Biotherapeutic Stabilization: A Practitioner’s Perspective” and as a coauthor of other BPI pieces on biophysical stability prediction and biosimilar product characterization. Hiten also coedited Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development (Springer), a 2018 anthology that explores the complexity of biosimilars regulation in key geographies.

Before joining BMS, Hiten was associate director of formulation development at Outlook Therapeutics (formerly Oncobiologics), where he developed a proprietary bevacizumab product for intravitreal injection. He focused on formulation and stabilization of novel insulin analogs at Thermalin Diabetes, and he worked at Biocon, USV, and Reliance Biopharmaceuticals in India on analytical and pharmaceutical development of biosimilar insulins, cytokines, and hormones.

Hiten earned his doctorate in pharmacognosy (pharmaceutical biotechnology track) from the University of Illinois at Chicago, College of Pharmacy. His research involved structural and functional characterization of fructose 1,6-bisphosphatase from Mycobacterium tuberculosis and Francisella tularensis. During the program, Hiten did a co-op in MedImmune’s formulation development group. He earned his bachelor’s degree in pharmaceutical sciences from the University of Mumbai, India, and his master’s in pharmaceutical sciences from the University Institute of Chemical Technology, also in Mumbai.

Hiten is a current member of the American Association of Pharmaceutical Sciences (AAPS) and serves on the editorial board of the Taylor & Francis journal mAbs (part of the Informa family of publications).

We are pleased to access Hiten’s expertise and eagerly await his contributions as a reviewer. Please join us in welcoming him to the BPI family.

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