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First GenerationNext Awards at Interphex 2006
Pharmaceutical Technology (Iselin, NJ, www.pharmtech.com) and the Interphex 2006 Conference and Exhibition (Norwalk, CT, www.interphex.com) presented the first GenerationNext Awards for Emerging Leaders in Pharmaceutical Science and Technology on March 21, 2006. The winners, Sandy Cope, senior scientist, at AstraZeneca Pharmaceuticals (Wilmington, DE), Derek Y. P. Ung, a senior biopharmaceutical facility design engineer at Johnson & Johnson (New Brunswick, NJ), and D. Christopher Watts, a staff Fellow at the US Food and Drug Administration's Center for Drug Evaluation and Research (Silver Spring, MD), were selected for their exceptional ability to lead, to bring constructive change, and to maintain excellence in their work on the technical, scientific, and regulatory aspects of pharmaceutical manufacturing. In compliance with one of the award’s criteria, each young professional was younger than 35 years old.
In addition, honorable mentions were awarded to Michael Fino, a professor of bioprocessing lead at MiraCosta College (Oceanside, CA) and John Thomas Bradshaw, PhD, a senior development scientist at Artel (Westbrook, ME).
Four members of Pharmaceutical Technology's Editorial Advisory Board judged the award: David H. Bergstrom, PhD, senior vice-president and general manager of Cardinal Health; Rory Budihandojo, computer validation manager at Schering-Plough; Ruey-ching (Richard) Hwang, PhD, senior director of pharmaceutical sciences at Pfizer Global R&D; and R. Christian Moreton, PhD,vice-president of pharmaceutical sciences at Idenix Pharmaceuticals.
Sandy J. Cope
Senior Scientist Sandy J. Cope, PhD, has been part of the AstraZeneca formulation team since 2000, first at its Macclesfield, UK facility and then at its Wilmington, Delaware office. When she joined the US team, she brought with her insight about the principles of solid dosage form development and research tools not typically used in their solid dosage form development (e.g., dry granulation), which made the group more efficient and effective in solid dosage form development.
Cope-who received her B.A. and PhD from the University of Nottingham’s School of Pharmacy (Nottingham, UK)-also trained her colleagues in many new techniques for the manufacture of clinical supplies that were not familiar to the department because of its emphasis on solid dosage form development. She also motivated the staff to work efficiently and effectively in completing the studies needed to complete the project on time. “The training programs were quite good and used materials from many sources that made the training effective. Now, we can manufacture more than just solid dosage forms for early development and have increased the effectiveness of our clinical manufacturing program,” said J. Richard Creekmore, manager of process analytical technology and physical sciences at AstraZeneca in his nomination of Cope.
Cope also completed projects that reduced the facility’s operating costs while increasing its level of compliance and product quality. Some projects served as a model for other facilities throughout the company and were completed at other AstraZeneca locations using the procedures and practices that she used. Cope designed these innovative projects by finding potential solutions or parts of the solution to problems inside the company and outside the company and putting them together to provide unique solutions to the Delaware facility.
Said Creekmore, “If the pharmaceutical industry had more people like Dr. Cope, many of the challenges and shortcomings of the industry today would not exist or would be more easily solved.”
Derek Y. P. Ung
Derek Y. P. Ung, a senior facility design engineer at Johnson & Johnson was named a recipient of Pharmaceutical Technology’s GenerationNext award for his technical leadership while working at a Human Genome Sciences manufacturing facility for CDI Life Sciences.
According to Ung, the facility was designed to support the various expression technologies of human genome sciences. “Most biotech facilities have some flexibility in the downstream processing area; this facility is very flexible in the upstream as well. Whatever emerges as their lead candidate, this facility will be able to support. It’s also one of the earliest adopters of disposable technology in terms of disposable bag wave bioreactors and disposable in-process bag containers,” said Ung.
Ung worked for three years as the lead process engineer on that project. He previously worked as an industry consultant on the Fourth Year Design Project at the University of Pennsylvania, Chemical Engineering, where he provided industry insight and mentorship for biotech design projects. Ung also worked as a commissioning and validation specialist for DowPharma (San Diego, CA), a technical cell culture specialist at Lonza Biologics (Slough, UK), and modeled WDI and WFI generation and storage systems at GlaxoSmithKline (King of Prussia, PA), where his recommendations saved the company more than $500,000.
“It’s definitely an honor to be selected by industry peers for an award like this,” the 34-year-old Ung said. “The challenge now is to live up to the expectations, but it’s definitely nice to be recognized early in life.”
Ung is currently working at Johnson and Johnson Worldwide Engineering where he plans on staying for a while. “There’s more and more of a bio focus in the whole pharmaceutical world, and I plan to provide leadership and guidance in that area,” Ung said.
In addition, Ung has spent time working on clean utilities water systems and is a member and J&J representative on ISPE’s Critical Utilities Community of Practice Steering Committee that’s in the process of writing an ISPE baseline guide, of which he is a contributing writer.
“I did my masters in biomaterials/drug delivery, where I got exposed to the bio/pharma world, and it just seemed like a very challenging area to be in,” Ung said. “It’s something that is constantly challenging so it keeps me interested.”
D. Christopher Watts
D. Christopher Watts, received a GenerationNext Award, presented by Pharmaceutical Technology and Interphex Conference and Exhibition. Watts is a staff fellow in the Office of Pharmaceutical Science (OPS) at the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). He received the award for his outstanding work on the Process Analytical Technology (PAT) Team and for his exceptional ability to communicate, motivate, influence, and guide his peers. Watts directs his talents toward both the improvement of the pharmaceutical industry and the betterment of public health.
“It’s exciting to see that the work that we’ve done at the agency has really helped foster innovation within industry,” said Watts. He also said he felt honored by the ceremony, “especially when I met my fellow recipients. It was a humbling experience, to say the least.”
Watts was a member of the team that developed FDA’s “PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance,” guidance for the industry, which lays a regulatory foundation for encouraging industry to pursue innovative development, manufacturing, and quality assurance. He actively engages with industry leaders to explain, promote, and create a common understanding of the PAT initiative. Watt also has led the way in creating a workforce within FDA that has expertise in various fields of pharmaceutical science such as analytical chemistry, chemical engineering and information, and inspection and testing techniques. His work as a leader and trainer has brought valuable knowledge and greater efficiency to FDA.
A consistent theme of Watts’s career has been a spirit of teamwork. Both CDER and FDA separately awarded him for his intercenter collaboration. Watts, in turn, believes himself lucky to have been able to work closely not only with FDA’s reviewers at CDER, but also with investigators in the field. “I’m proud of what I’ve done to this point,” he says, “but I’d like to think that the [GenerationNext] reward is more a reflection of some of the amazing people I’ve worked with and what they’ve done, rather than what I’ve done.”
Watts takes the mission of promoting and protecting the public health seriously, and enjoys working with FDA to achieve that mission. He singled out the GMP initiative, question-based review, and the quality-by-design pilot program as initiatives he feels fortunate to have been able to participate in: “Hopefully, we can just continue to maintain that momentum that we’ve been able to build.”
Michael Fino received an honorable mention for his work at MiraCosta College in Oceanside, California. In 2004, the college hired Fino as the lead instructor of its bioprocess technology program and asked him to supervise its reorganization. Until that point, the program had focused primarily on the research-oriented aspects of biotechnology. Because of his eight years in the industry, Fino recognized that companies were seeking individuals with practical experience of biotechnology processes. He selected the necessary equipment and process tools and established a state-of-the-art biotechnology training facility to expose students to the full breadth of biopharmaceutical production. “It’s a very immersive experience for the students,” Fino remarks. Fino also developed a course called “Qualification and Validation in Biotechnology” that teaches biotechnology methods, cleaning, software, and process validation.
In addition to his activities at the college, Fino founded the first Southern California student chapter of the International Society for Pharmaceutical Engineering (Tampa, FL) and became its advisor. He has traveled to local high schools to raise awareness of biotechnology and to encourage students to pursue careers in science. Fino’s goal is “to change people’s expectations of what is possible at a community college.” Through all of his activities, Fino has demonstrated a commitment to spreading knowledge and an enthusiasm for biotechnology.
John Thomas Bradshaw
In recognition of his work as a senior development scientist at Artel, Pharmaceutical Technology gave John Thomas Bradshaw an honorable mention. Bradshaw was the lead scientist during the development of Artel’s “Multichannel Verification System” (MVS). The system uses a ratiometric absorbance methodology to calibrate, troubleshoot, and measure the performance of automated liquid handlers. “We ... presented the first viable commercial system for calibrating multichannel devices,” Bradshaw says.
After he started at Artel, Bradshaw learned the theory behind MVS, which the company’s founder had already elaborated. Bradshaw was intimately involved in early research for MVS and ultimately built prototypes and demonstrated them to people in the field. He “was involved clear up to the launch and beyond,” he explains. Because Artel is a small company, Bradshaw benefited from participating in “some parts [of the project] that traditionally a research and development scientist wouldn’t get to touch.”
Bradshaw has begun research 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 preparing the company to adapt to that environment. Bradshaw also is the coholder of patents for an apparatus and method for spectrophotometer calibration, and for a method of testing and validating nonaqueous pharmaceutical solutions.