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Pharmaceutical Technology (Iselin, NJ, www.pharmtech.com) and the Interphex 2006 Conference and Exhibition (Norwalk, CT, www.interphex.com) presented the aboriginal GenerationNext Awards for Emerging Leaders in Biologic Science and Technology on March 21, 2006. The winners, Sandy Cope, chief scientist, at AstraZeneca Pharmaceuticals (Wilmington, DE), Derek Y. P. Ung, a chief biopharmaceutical adeptness architecture architect at Johnson & Johnson (New Brunswick, NJ), and D. Christopher Watts, a agents Adolescent at the US Food and Drug Administration’s Center for Drug Evaluation and Analysis (Silver Spring, MD), were alleged for their aberrant adeptness to lead, to accompany able change, and to advance arete in their assignment on the technical, scientific, and authoritative aspects of biologic manufacturing. In acquiescence with one of the award’s criteria, anniversary adolescent able was adolescent than 35 years old.

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In addition, atonement mentions were awarded to Michael Fino, a assistant of bioprocessing advance at MiraCosta Academy (Oceanside, CA) and John Thomas Bradshaw, PhD, a chief development scientist at Artel (Westbrook, ME).

Four associates of Biologic Technology’s Editorial Advisory Board advised the award: David H. Bergstrom, PhD, chief vice-president and accepted administrator of Cardinal Health; Rory Budihandojo, computer validation administrator at Schering-Plough; Ruey-ching (Richard) Hwang, PhD, chief administrator of biologic sciences at Pfizer Global R&D; and R. Christian Moreton, PhD,vice-president of biologic sciences at Idenix Pharmaceuticals.

Sandy J. Cope

Senior Scientist Sandy J. Cope, PhD, has been allotment of the AstraZeneca conception aggregation back 2000, aboriginal at its Macclesfield, UK adeptness and again at its Wilmington, Delaware office. Back she aing the US team, she brought with her acumen about the attempt of solid dosage anatomy development and analysis accoutrement not about acclimated in their solid dosage anatomy development (e.g., dry granulation), which fabricated the accumulation added able and able in solid dosage anatomy development.

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Cope—who accustomed her B.A. and PhD from the University of Nottingham’s School of Pharmacy (Nottingham, UK)—also accomplished her colleagues in abounding new techniques for the accomplish of analytic food that were not accustomed to the administration because of its accent on solid dosage anatomy development. She additionally motivated the agents to assignment calmly and finer in commutual the studies bare to complete the activity on time. “The training programs were absolutely acceptable and acclimated abstracts from abounding sources that fabricated the training effective. Now, we can accomplish added than aloof solid dosage forms for aboriginal development and accept added the capability of our analytic accomplishment program,” said J. Richard Creekmore, administrator of action analytic technology and concrete sciences at AstraZeneca in his choice of Cope.

Cope additionally completed projects that bargain the facility’s operating costs while accretion its akin of acquiescence and artefact quality. Some projects served as a archetypal for added accessories throughout the aggregation and were completed at added AstraZeneca locations application the procedures and practices that she used. Cope advised these avant-garde projects by accolade abeyant solutions or genitalia of the band-aid to problems central the aggregation and alfresco the aggregation and putting them calm to accommodate different solutions to the Delaware facility.

Derek Y. P. Ung

Derek Y. P. Ung, a chief adeptness architecture architect at Johnson & Johnson was alleged a almsman of Biologic Technology’s GenerationNext accolade for his abstruse administration while alive at a Animal Genome Sciences accomplishment adeptness for CDI Activity Sciences.

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According to Ung, the adeptness was advised to abutment the assorted announcement technologies of animal genome sciences. “Most biotech accessories accept some adaptability in the after processing area; this adeptness is actual adjustable in the upstream as well. Whatever emerges as their advance candidate, this adeptness will be able to support. It’s additionally one of the ancient adopters of disposable technology in agreement of disposable bag beachcomber bioreactors and disposable in-process bag containers,” said Ung.

Ung formed for three years as the advance action architect on that project. He ahead formed as an industry adviser on the Fourth Year Architecture Activity at the University of Pennsylvania, Actinic Engineering, across he provided industry acumen and mentorship for biotech architecture projects. Ung additionally formed as a allotment and validation specialist for DowPharma (San Diego, CA), a abstruse corpuscle adeptness specialist at Lonza Biologics (Slough, UK), and modeled WDI and WFI bearing and accumulator systems at GlaxoSmithKline (King of Prussia, PA), across his recommendations adored the aggregation added than $500,000.

“It’s absolutely an account to be alleged by industry aeon for an accolade like this,” the 34-year-old Ung said. “The claiming now is to alive up to the expectations, but it’s absolutely nice to be accustomed aboriginal in life.”

Ung is currently alive at Johnson and Johnson Worldwide Engineering across he affairs on blockage for a while. “There’s added and added of a bio focus in the accomplished biologic world, and I plan to accommodate administration and advice in that area,” Ung said.

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In addition, Ung has spent time alive on apple-pie utilities baptize systems and is a affiliate and J&J adumbrative on ISPE’s Critical Utilities Association of Practice Steering Committee that’s in the action of autograph an ISPE baseline guide, of which he is a accidental writer.

“I did my masters in biomaterials/drug delivery, across I got apparent to the bio/pharma world, and it aloof seemed like a actual arduous across to be in,” Ung said. “It’s article that is consistently arduous so it keeps me interested.”

D. Christopher Watts

D. Christopher Watts, accustomed a GenerationNext Award, presented by Biologic Technology and Interphex Conference and Exhibition. Watts is a agents adolescent in the Appointment of Biologic Science (OPS) at the US Food and Drug Administration’s Center for Drug Evaluation and Analysis (CDER). He accustomed the accolade for his outstanding assignment on the Action Analytic Technology (PAT) Aggregation and for his aberrant adeptness to communicate, motivate, influence, and adviser his peers. Watts directs his talents against both the advance of the biologic industry and the advancement of accessible health.

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“It’s agitative to see that the assignment that we’ve done at the bureau has absolutely helped advance accession aural industry,” said Watts. He additionally said he acquainted accustomed by the ceremony, “especially back I met my adolescent recipients. It was a base experience, to say the least.”

Watts was a affiliate of the aggregation that developed FDA’s “PAT—A Framework for Avant-garde Biologic Development, Manufacturing, and Affection Assurance,” advice for the industry, which lays a authoritative foundation for auspicious industry to accompany avant-garde development, manufacturing, and affection assurance. He actively engages with industry leaders to explain, promote, and actualize a accepted compassionate of the PAT initiative. Watt additionally has led the way in creating a workforce aural FDA that has ability in assorted fields of biologic science such as analytic chemistry, actinic engineering and information, and analysis and testing techniques. His assignment as a baton and trainer has brought admired ability and greater ability to FDA.

A constant affair of Watts’s career has been a spirit of teamwork. Both CDER and FDA alone awarded him for his intercenter collaboration. Watts, in turn, believes himself advantageous to accept been able to assignment carefully not alone with FDA’s reviewers at CDER, but additionally with board in the field. “I’m appreciative of what I’ve done to this point,” he says, “but I’d like to anticipate that the [GenerationNext] accolade is added a absorption of some of the amazing bodies I’ve formed with and what they’ve done, rather than what I’ve done.”

Watts takes the mission of announcement and attention the accessible bloom seriously, and enjoys alive with FDA to accomplish that mission. He singled out the GMP initiative, question-based review, and the quality-by-design pilot affairs as initiatives he feels advantageous to accept been able to participate in: “Hopefully, we can aloof abide to advance that drive that we’ve been able to build.”

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Michael Fino

Michael Fino accustomed an atonement acknowledgment for his assignment at MiraCosta Academy in Oceanside, California. In 2004, the academy assassin Fino as the advance adviser of its bioprocess technology affairs and asked him to administer its reorganization. Until that point, the affairs had focused primarily on the research-oriented aspects of biotechnology. Because of his eight years in the industry, Fino accustomed that companies were gluttonous individuals with applied acquaintance of biotechnology processes. He alleged the all-important accessories and action accoutrement and accustomed a advanced biotechnology training adeptness to betrayal acceptance to the abounding across of biopharmaceutical production. “It’s a actual immersive acquaintance for the students,” Fino remarks. Fino additionally developed a advance alleged “Qualification and Validation in Biotechnology” that teaches biotechnology methods, cleaning, software, and action validation.

In accession to his activities at the college, Fino founded the aboriginal Southern California apprentice affiliate of the International Society for Biologic Engineering (Tampa, FL) and became its advisor. He has catholic to bounded aerial schools to accession acquaintance of biotechnology and to animate acceptance to accompany careers in science. Fino’s ambition is “to change people’s expectations of what is accessible at a association college.” Through all of his activities, Fino has approved a charge to overextension ability and an activity for biotechnology.

John Thomas Bradshaw

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In acceptance of his assignment as a chief development scientist at Artel, Biologic Technology gave John Thomas Bradshaw an atonement mention. Bradshaw was the advance scientist during the development of Artel’s “Multichannel Verification System” (MVS). The arrangement uses a ratiometric absorbance alignment to calibrate, troubleshoot, and admeasurement the achievement of automatic aqueous handlers. “We … presented the aboriginal applicable bartering arrangement for calibrating multichannel devices,” Bradshaw says.

After he started at Artel, Bradshaw abstruse the approach abaft MVS, which the company’s architect had already elaborated. Bradshaw was carefully complex in aboriginal analysis for MVS and ultimately congenital prototypes and approved them to bodies in the field. He “was complex bright up to the barrage and beyond,” he explains. Because Artel is a baby company, Bradshaw benefited from accommodating in “some genitalia [of the project] that commonly a analysis and development scientist wouldn’t get to touch.”

Bradshaw has amorphous analysis in fluorescence to extend MVS’s capabilities to picoliter volumes and higher-density applications. He believes that 1536-well applications will eventually become the standard, and is advancing the aggregation to acclimate to that environment. Bradshaw additionally is the coholder of patents for an accoutrement and adjustment for spectrophotometer calibration, and for a adjustment of testing and acceptance nonaqueous biologic solutions.

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