December 2014 Spotlight

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Editorial Advisor Retires

BioProcess International — and the overall industry — will miss retiring editorial advisor Laurie Donahue-Hjelle, formerly associate vice president at Life Technologies, Inc., in Rockville, MD. She earned her BA in biochemistry at the University of CA–Berkeley and a PhD in molecular, cellular, and developmental biology at the University of CO–Boulder. For most of the 1990s, Laurie served on the faculty of Texas Tech University’s Health Sciences Center (department of cell biology and biochemistry), where her laboratory focused on the molecular mechanisms underlying stem-cell differentiation.

In 1997, Laurie left academia for the biotechnology industry, taking subsequent R&D management positions with Cascade Biologics and Sigma-Aldrich. Her teams developed media for primary and stem cell types and were the first to use transcriptomic approaches to develop such media. Laurie joined Life Technologies in 2006, ultimately holding several positions in its bioproduction division: Gibco product development leader, business leader for Gibco PD-Direct bioprocess services, and strategy leader for the bioproduction division. She led a team working with ProBioGen AG to develop and launch the Freedom CHO cell-line development platforms. She says those “democratized commercial biologic drug development by offering industry-standard quality and performance with minimal fees and no pull-through royalties. This enabled companies and academics to advance needed drug development with fewer financial barriers.”

Having retired from biotechnology outright, Laurie is moving to Taos, NM, to pursue an artistic career.

ISPE Awards Facilities of the Year

At its annual meeting in October, the International Society for Pharmaceutical Engineers (ISPE) announced its 2014 Facility of the Year Awards (FOYA), with Pfizer Ireland Pharmaceuticals as the overall winner. Celebrating its 10th year, FOYA showcases the industry’s accomplishments in facility design, construction, and operation while highlighting new technology applications and cutting-edge approaches.

“Winners represent a shared commitment and dedication of individuals and companies worldwide striving to enhance patient health and safety through innovation and advancements in pharmaceutical manufacturing technology,” said ISPE President and CEO John Bournas. Here are this year’s category winners:

  • Boehringer Ingelheim Pharma GmbH & Co . KG (equipment innovation) for its Aseptic Area 5 and Combi Line Project
  • F . Hoffmann-La Roche (sustainability) for its Analytical Laboratory “B250 – Q2K”
  • Grifols Therapeutics, Inc . (project execution) for its north fractionation facility
  • Patheon Pharma Services, formerly DSM Biologics (process innovation), for its “facility of the future”
  • Penn Pharmaceutical Services Ltd . (facility integration) for its Project PennDragon
  • Pfizer Ireland Pharmaceuticals (operational excellence) for its Network Strategy Implementation (NSI) capacity expansion
  • WuXi AppTec Biopharmaceutical Co . (honorable mention) for its CGMP bulk cell culture production facility.

Overall Winner: On an aggressive timeline, Pfizer Ireland added capacity by repurposing an existing manufacturing space for a new vaccine suite and a new small- to medium-scale multiproduct drug-substance bioprocessing suite at its Grange Castle plant in Clondalkin, Ireland. Lean management strategy and a 5S program ensured operational flow. A six-sigma toolkit was developed for all project personnel, and all production processes were value-stream mapped. This state-of-the-art project also included disposables and process analytical technology (PAT).

FOYA judging panel chair James Breen said, “We were impressed with the company’s ability to effectively manage the challenges of maintaining supply with the demolition of existing facilities, new construction, and start-up and integration activities.”

Find more information on all the 2014 award winners (and submit your project for 2015 consideration) online at www .FacilityoftheYear.org.

Biotech Boardrooms: A Man’s World?

It’s old news that women are the minority in science and engineering, but life sciences are where they are best represented. Even so, you don’t see a lot of women running biotechnology companies. UK bioexecutive recruitment firm Liftstream Ltd. published in October its gender diversity report: Diversifying the Outlook: The X&Y of Biotechnology Leadership. Providing a detailed analysis of female leaders in European and US biotech companies, the report is based on research involving 700 companies, 60 C-level interviews, and 530 survey respondents.

Liftstream reports that women are underrepresented among biotechnology boards and executive staffs. Female board directors in US and EU small-to-midsized enterprises (SMEs) account for only 9.7% and 11.2% of those positions respectively, and only 4% of company chairpersons are women. Analysis of larger companies indicated more female board members (19.2%) but fewer executive women (13.9%). Unstructured hiring processes and overreliance on personal networks (among predominantly male influencers) were identified as underlying causes limiting opportunities for women in biotechnology leadership. The report also examines how this sector’s reliance on venture-capital (VC) financing influences appointments, noting a lack of gender diversity in the VC world. Diversity case studies come from Merck Serono, Cubist Pharmaceuticals, Johnson & Johnson, and Biogen Idec.

Liftstream recommends that CEOs and chairs lead the charge on gender diversity. Recruiters should provide greater advocacy to companies and women on leadership. And investors should ensure that executive appointments are optimized for diversity. Liftstream’s (male) CEO Karl Simpson commented, “Gender inequality at the top of companies remains a significant problem. Our reported data and examination of influencing factors present evidence designed to help accelerate opportunities for women to secure vital leadership roles in biotechnology. Improving gender diversity will strengthen leadership teams and improve business. We want to provide evidence for leaders to act on, and this report expands the sector’s knowledge about gender diversity in biotech leadership.”

Liftstream will work with its global executive network to develop initiatives for broadening awareness and representation of female leaders in biotechnology and highlight established organizations that lead in this area. Download the full free report at www.liftstream.com/ diversity-report.html.

Partnerships Are Essential Against Ebola

In the battle against the Ebola virus, incentives from governments and healthcare policymakers are vital for advancing the current treatment pipeline, says a GlobalData analyst. They can mitigate risk and up-front costs for the companies involved. Daian Cheng covers infectious diseases for GlobalData. Despite a clear need for novel therapeutic approaches to combat the virus, he says it has not represented an attractive investment so far due to its low incidence of outbreaks in countries that cannot afford expensive medicines.

“Those two factors drastically reduce the ability of drug developers to recoup their R&D costs,” says Cheng. “So far, clinical-stage experimental treatments have all been advanced (at least in part) with the financial support of public entities. Contribution of public resources to R&D has increased as fears of the virus have spread.”

Cheng notes that GlaxoSmithKline’s therapeutic vaccine is the most advanced Ebola pipeline candidate so far. It was originally developed jointly by the US National Institute of Allergy and Infectious Diseases (NIAID) and Okairos, a company GSK acquired in 2013. This vaccine contains a chimpanzee-derived adenoviral vector that carries a single Ebola gene to target the Zaire strain responsible for the current outbreak. A phase 1 study in healthy UK volunteers started in September, and initial manufacturing costs are supported by a recently formed international consortium. It is financed by a joint US$4.5 million grant from the Wellcome Trust, the Medical Research Council, and the UK Department for International Development. Experts expect data on safety and dosing in healthy volunteers by the end of this year.

Cheng points to other companies with promising treatments partially supported by public funding: Johnson & Johnson, Mapp Biopharmaceutical, and NewLink Genetics. “Ultimately, more partnerships between public entities and pharmaceutical companies are needed to bring to market novel therapies that combat neglected diseases, particularly those that (like Ebola) affect resource-deprived regions of the world.”

Why “Get Rid of” a Good Thing? 

When GlaxoSmithKline announced this fall that it would spin out its human immunodeficiency virus (HIV) work into a new publicly financed subsidiary, some industry experts were surprised. It’s a promising business, after all. With 20 years of industry experience behind him, UK Warwick Business School professor John Lyon offers this analysis of what may seem like a big pharma company turning away from an important therapeutic area:

“GSK has disappointed over the past few quarters,” says Lyon, “with falling sales of some product lines in major territories (particularly the United States), which has been reflected in its share price.” For a company with so many candidates in development, he said, “good news and hidden-asset value are often camouflaged by bad news.” He says that companies can unlock value by “hiving off assets associated with good-news stories,” such as segments in which chronic treatments would translate to increasing and sustained sales. “A further advantage of such an arrangement is the ease with which analysts and the general public can assess the business and business model, through which they can evaluate cash flows with more certainty.”

Drug companies often form joint ventures, Lyon points out. And an initial public offering (IPO) such as this can help bring in partners through private placing of the stock. He pointed to Pfizer as a possibility here. “As well as bringing valuable research capabilities together through the underlying major stockholders, the IPO allows for rights issues to provide further resources for growth funding in this marketplace.”

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