NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.
A Diagnosis of Type 1 diabetes at the age of 6 and an early passion for science and research have propelled Randy Anderson, Ph.D., to become a force in the fight against the disease. Dr. Anderson has been making inroads into unraveling the mysteries of the disease since his senior-year zoology class at the University of North Carolina at Chapel Hill, when he convinced a biostatistics professor to serve as his advisor for an independent study he was conducting on quantitative blood glucose management in Type 1 diabetes. The study involved using mathematical and statistical modeling to attempt to predict blood glucose levels four hours into the future, based on current and historic glucose, diet, insulin, and exercise information. He learned that the problem was deceptively simple to state and monstrously difficult to solve. Dr. Anderson’s study spurred his interest in clinical trials and statistical analysis, leading him to switch from ethology to complete a Ph.D. in biostatistics. In 1984, Dr. Anderson began his biostatistics career at the Medical College of Virginia at Virginia Commonwealth University. As a graduate student, he provided statistical oversight for clinical studies in brain trauma and cardiovascular disease through various programs funded by the National Institutes of Health. After completing his Ph.D. in 1989, he joined the faculty of Bowman Gray School of Medicine (now Wake Forest University Medical School) as an assistant professor in public health sciences, where he continued to pursue his interest in diabetes by collaborating on the design of a NIH-funded insulin resistance atherosclerosis study in Type 2 diabetes. After managing two clinical trial programs in diabetic nephropathy for another global CRO, Dr. Anderson joined PPD in 1997 as director of biostatistics. He led the company’s statistical support services, including clinical trials design and analysis, statistical consulting, and FDA submission support for all Phase II to Phase IV clinical trials and expanded PPD’s expertise and breadth of experience in conducting diabetes clinical trials. Today as VP of global product development, Dr. Anderson works exclusively on strategic development planning for products to treat diabetes and its complications. Dr. Anderson’s scientific expertise has helped PPD broaden its diabetes business. The move from a statistical leadership role to a scientific leadership role has been career-defining for Dr. Anderson. Dr. Anderson says about 14 years ago, he had a project management assignment for a pivotal program in diabetic nephropathy. In that role, he realized the challenge of multidisciplinary endeavors requires that functional experts are prepared and ready in the right order, the right place, and the right time. He says the industry must learn to do more with less. In medical product development, there is a need to make greater use of automation to conduct and monitor clinical trials. For example, the industry has begun to regularly accrue study data electronically, but it needs to go further with automated data collection, process monitoring, and quality assurance, so that study status information is available in real time for decision support, as a standard, and problems are detected and addressed near their inception. F Unlocking the mysteries behind the mechanisms of diseases and finding the best path to bring innovative medicines to market are part of the DNA of these research experts. Dr. Randy Anderson, VP, Global Product Development (Diabetes) at PPD, developed his passion for science and research at an early age. Dr. Randy Anderson loves to dance to R&B. Name: Randy Anderson, Ph.D. Current position: VP, Global Product Development (Diabetes), PPD Education: Ph.D., Biostatistics, Medical College of Virginia, Virginia Commonwealth University, 1990; M.S., Experimental Psychology, Virginia Commonwealth University, 1981; B.A., Zoology, University of North Carolina, Chapel Hill, 1979 Date and place of birth: April 1957, Tarboro, N.C. First Job: Curb waiter for a small retail convenience store at age 10 First Industry-related Job: Senior statistician, Quintiles Dream Job: Writing novels and building small sailboats Professional Mentors: Professor H.E. Lehman, UNC-Chapel Hill Zoology; Professor Daijin Ko, his dissertation adviser; Professor Gary Koch of UNC-Chapel Hill Biostatistics Professional Associations: Juvenile Diabetes Research Foundation, American Diabetes Association, American Statistical Association, Biometric Society, DIA Connected Via: Facebook Words to Live: Esse quam videri (To be, rather than to seem); You got to work at it — his maternal grandmother Dr. Randy Anderson loves to dance to R&B. Sheng Ding, Ph.D., has been passionate about chemistry since childhood, and today his work is revolutionizing the field of stem cell biology. Over the course of his career, Dr. Ding set out to make a difference with his research, always pushing to have his findings turned into new medicines. He learned from some of the best, doing his research in the laboratory of Nobel Prize winner Robert Grubbs, Ph.D., at the California Institute of Technology as an undergraduate. He also worked with Peter Schultz, Ph.D., at The Scripps Research Institute for his doctoral studies. In Dr. Schultz’s lab, Dr. Ding set out to determine if a chemical or chemicals might cause differentiated cells to turn back toward a more undifferentiated or stem-like state. In 2003, Dr. Ding and Dr. Schultz were the first to publish research showing a small molecule, reversine, could move a cell back to a less differentiated state, although not to full pluripotency. They were also the first to apply high throughput screening to find small molecules to control cell fate. At the time of the induced pluripotent stem cell (iPSC) breakthrough in 2006, Dr. Ding had already been looking for small molecules to reprogram cells and had recently co-founded with five other leaders in stem cell and developmental biology a start-up biotechnology company called Fate Therapeutics. Within the year, he was able to discover two small molecules to replace c-Myc and Sox2, two of the four iPSC reprogramming factors. Published in 2008, this study was the first to demonstrate that small molecules identified could compensate for critical reprogramming factors and improve efficiency. In 2009, his team was the first to report the creation of iPSCs without genetic manipulation using protein-induced reprogramming technologies, a discovery honored by The Scientist as the Top Technology of 2009. Additionally, his lab identified three small molecules for generating iPSCs in a manner that is 200 times more efficient than, and twice as fast as, conventional methods for reprogramming adult human cells. In collaboration with Fate Therapeutics, Dr. Ding is now pioneering the development of a pharmaceutical-grade iPSC to support commercial-scale drug discovery, toxicity screening, and cell therapy. Dr. Ding continues to regard Dr. Schultz as his professional mentor, describing him as the only person with whom he wanted to work with when applying for graduate school. F Dr. Sheng Ding A Differentiating Nature Name: Sheng Ding, Ph.D. Current position: Associate Professor in the Departments of Chemistry and Cell Biology at The Scripps Research Institute, and Scientific Founder of Fate Therapeutics Education: Ph.D., Chemistry, The Scripps Research Institute, 2003; B.S., Chemistry, California Institute of Technology, 1999 Date and place of birth: September 1975, Beijing First job: Assistant professor First industry-related job: Assistant Professor in the Chemistry Department at The Scripps Research Institute Professional mentor: Dr. Peter Schultz Professional associations: The Scripps Research Institute; American Chemical Society; American Society for Cell Biology; International Society for Stem Cell Research Curious. Easygoing. Dr. Sheng Ding worked in the laboratory of Nobel Prize winner Robert Grubbs, Ph.D., at the California Institute of Technology as an undergraduate. Dr. Sheng Ding, Associate Professor in the Departments of Chemistry and Cell Biology at The Scripps Research Institute and Scientific Founder of Fate Therapeutics, has set out to make a difference with his research, always pushing to answer the question of how his findings could be turned into new medicines. With an open mind and a willingness to seek and implement change, Peter Scholes, Ph.D., has been instrumental in uncovering unique methods to engender real improvements in the early drug-development process. Dr. Scholes is a firm believer that if you always do what you’ve always done, you’ll always get the same result. He believes that the desire for more cost- and time-effective drug development can only be met if molds are broken and balanced risks are taken. At Quotient Bioresearch, he has broken those molds and has successfully led the implementation of rapid formulation and clinical testing screening studies that have offered a meaningful way to accelerate early drug development. Chief among these breakthroughs is Quotient’s Translational Pharmaceutics platform that is helping to increase the speed and accuracy at which new pharmaceutical products progress through Phase I/IIa trials. He also has expertise in innovative applications of formulation design space strategies to enhance real-time flexibility within clinical studies for formulation modifications in response to emerging clinical data. This capability can reduce risks, decrease cycle times, and accelerate decision-making in early clinical development. Achieving these goals takes an entrepreneurial outlook and hard work. A driven individual, Dr. Scholes understands success comes as much from perspiration as from inspiration, firmly believing that you should never put off until tomorrow what you can do today. He understands also that achievement is not easily bought, and he draws on some very smart advice: if it was easy, anyone would do it. As important as hard work is, Dr. Scholes believes it’s also important to have fun, and he is surrounded by many talented people at Quotient, all of whom have a sense of humor. The daily jokes and laughs are important for a trusting and productive work environment, he says. He even found humor in responding to PharmaVOICE’s questionnaire, saying, with tongue firmly in cheek, that it has been the most challenging assignment of his career to date. Also vital to any personal or professional relationship are honesty and truth. An overriding integrity is apparent in how Dr. Scholes views the world. When it comes to problems facing our planet, he says we are sadly spoiled for choice. Among the problems that concern him are the environmental vandalism of global deforestation and the fact that in a world of often obscene wealth and waste, so many people don’t have food, shelter, or access to basic healthcare. It is with these issues in mind that he draws inspiration from people who have the courage and conviction to say what is right or wrong and have the willingness to do something about it, regardless of the status quo and the personal implications for themselves. Among those who stand out in history for doing this are Martin Luther King, Nelson Mandela, Mother Theresa, and pop star Sir Bob Geldof; however, he notes thousands of others do the same in ordinary life. F Dr. Peter Scholes has all of the Laurel & Hardy films on DVD, much to the despair, bemusement, and complete lack of appreciation of his family. Name: Peter Scholes, Ph.D. Current Position: VP, Pharmaceutical Sciences, Quotient Bioresearch Education: Ph.D., Department of Pharmaceutical Sciences, University of Nottingham. 1993; B.Pharm. (Hons) Pharmacy: 1st Class degree, Department of Pharmaceutical Sciences, University of Nottingham, 1989 Date and place of birth: Aug. 8, 1968, St. Helens, United Kingdom First Job: Boots chemist First Industry-Related Job: Development scientist, Beecham Pharmaceuticals Dream job: Philanthropy Connected via: LinkedIn Words to Live by: The glass is always half-full; it’s better to be an optimist rather than a pessimist — it won’t change the outcome but you’ll feel better about it An optimist by nature, Dr. Peter Scholes, VP, Pharmaceutical Sciences, Quotient Bioresearch, believes that with good science anything is possible as long as people are willing to do things differently. Driven. Integrity. Name: Craig Sorensen, Ph.D. Current Position: VP, Research and Development Network Design and Technology Integration, Vertex Pharmaceuticals Inc. Education: Ph.D., Washington University; B.S. University of Illinois Date and place of birth: May 1954, Chicago First industry-related job: OSI Pharmaceuticals Inc. Dream Job: Innkeeper Professional Mentors: Dr. Ed Voss, Carl Pierce, and John Stephenson Hobbies: Cooking, running, and gardening Connected Via: Facebook and LinkedIn Words to Live By: Adversity is a state of mind; you can work through anything Extroverted. Committed. Dr. Craig Sorensen, VP, Research and Development Network Design and Technology Integration, has helped to establish a new realm at Vertex Pharmaceuticals. Being extroverted and good with people is just what is needed in today’s changing and more interconnected biopharma industry. And Vertex Pharmaceuticals’ Craig Sorensen, Ph.D., has those qualities in abundance. As VP, research and development network design and technology integration, Dr. Sorensen has helped to establish a new realm at Vertex where scientific excellence stems not only from the hard work happening within its walls but through partnerships and relationships, founded by his team in academia, non-profit foundations, and industry. His achievements and the scientist he has become today have been influenced by three important mentors early in his career: Dr. Ed Voss from the University of Illinois; his thesis advisor from Washington University, Carl Pierce; and John Stephenson from OSI Pharmaceuticals. Dr. Sorensen understands the challenges the industry faces, particularly with regard to identifying good targets, and it makes sense, therefore, that he remains so committed to the pursuit of science and excellence through working with partners and seeking insight from many sources. Dr. Sorensen leads his team to partner externally to create two-way relationships that will decrease costs to all participants, de-risk the opportunities, and leverage experts globally to face the challenges. He has worked to establish a unique mindset not commonly found in industry: when faced with a challenge, look outside your own walls, and make the connections that may not immediately be obvious. This comes naturally to Dr. Sorensen, who enjoys being with people and collecting their ideas. Knowledge is important to Dr. Sorensen, and the best advice he ever received is that people are interested only in what you know, not what you think; if they want to know what you think, they will ask. Dr. Sorensen is equally outgoing and committed, and he is passionate about finishing whatever he starts. It should come as no surprise then that Dr. Sorensen has energy to spare, and he channels this into activities, including running, cooking, and gardening. He has completed 10 marathons, has run across the state of Illinois twice, and has on his bucket list hiking Machu Picchu and traveling down the Amazon. But his interests also run to expanding his knowledge, and high on his reading list are the works of Dante and the writings of American novelist, poet, dramatist, and essayist Reynolds Price. In fact, when he has the time he would like to re-read Dante’s Divine Comedy and learn another language. A committed, hardworking, and thoughtful scientist, Dr. Sorensen draws inspiration from those who continue to achieve and push boundaries, despite obstacles. In particular, he is inspired by British theoretical physicist Stephen Hawking, who is surrounded by adversity but never lets that stop him. That dedication resonates with Dr. Sorensen who lives by the motto: adversity is a state of mind; you can work through anything. F A Partner in Excellence Dr. Craig Sorensen has run 10 marathons. At work, at home, and in his philanthropic pursuits, Randy Anderson, Ph.D., deals with and is searching for a cure for diabetes. Having lived with the condition for 47 years, it is understandable that it would become his focus in his career. As VP, global product development (diabetes) at PPD, his assignment is to lead the company’s global product development efforts in diabetes. PPD is currently supporting development of multiple products in both Type 1 and Type 2 diabetes. To be able to help define the development strategy for these products is an awesome privilege and responsibility, he says. After Dr. Anderson’s eldest son was diagnosed with diabetes in 1999, he became closely involved with the Juvenile Diabetes Research Foundation (JDRF), an organization founded by parents of children with Type 1 diabetes. He has served as a board member of the Eastern North Carolina chapter and continues to serve as a board member, volunteer, and major donor, supporting JDRF fundraising events throughout eastern North Carolina. In addition, he served JDRF International as a member of the foundation’s Clinical Trials Section of the Medical Sciences Review Committee from 2003 to 2006, providing statistical science review of numerous clinical trial proposals submitted to JDRFI for funding. He continues to serve as an ad hoc member of the foundation’s new Medical Affairs Committee, which develops JDRF’s strategies and policies for medical safety in clinical trials. He also has been involved in the organization’s two annual fundraisers since their inception: Walk to Cure Diabetes and Hope Gala. Dr. Anderson’s interest in the JDRF work is centered on strategies for demonstrating immune tolerance induction and beta cell regeneration, two of JDRF’s major cure objectives. He has worked closely with JDRF scientists, PPD colleagues, and JDRF-funded investigators to optimize translational trial designs that help shorten research delays that can occur between preclinical and clinical development. In addition to his work with JDRF, Dr. Anderson organizes, through his church, a team of volunteers to work on Habitat for Humanity homes one Saturday every two months. He laments the national difficulty in getting to a sustainable energy economy, and the environmental consequences thereof. He counts among those who most inspire him former President and Nobel Peace Prize winner Jimmy Carter and others who work selflessly for peace, mostly for little to no recognition or economic benefit. One of the most inspiring things about Dr. Anderson is his ability to work with everyone and to turn a difficult situation into a winning one. While at Wake Forest University Medical School, he was assigned to work with a neuroradiologist on an NIH contract. Little did he know that colleagues had all worked with this person in the past and quickly passed thereafter on the privilege, because this ornery principal investigator (PI) from Texas had a reputation of being a bit tough, and his grant application priority score was 293, vastly below funding level. In their first meeting, the PI plopped down in a chair in Dr. Anderson’s office and said, “They say to get grant funding, I have to work with a statistician, so what are you going to do for me?” Dr. Anderson managed to avoid a defensive response and worked to develop the relationship by speaking the PI’s language. While difficult, Dr. Anderson was excited about the work and was eager to learn the science needs and provide some help. The pair revised and resubmitted the grant application, and it came back with a priority score of 1, the highest possible rating. He insists the score was not so much a result of his contribution, but because of the magic of scientific collaboration. Consequently, the PI’s funding tripled over the next two years. F Family: Wife, Melonia Phillips Anderson; Sons, Eric Victor, 14, and Carter William, 12 Hobbies: Sailing and kayaking Reading List: Making Peace with Conflict; Sailing for Dummies by J.J. and Peter Isler; Handyman magazine; James A. Michener; Diabetes Care; Diabetes; Nature; and New England Journal of Medicine Giving Back: Juvenile Diabetes Research Foundation, Habitat for Humanity Bucket List: Hold a grandchild; help cure Type 1 and Type 2 diabetes Inspiration: Jimmy Carter, advocates for peace Top iPod downloads: R&B and country, including Al Green, Alan Jackson, Alicia Keys, Alison Krauss Screensaver: At the helm of his Windrider 17 sailboat Most Unusual Place Visited: On his family farm is a small creek with row upon row of ancient sea shells upon its banks, yet the nearest ocean is more than 50 miles away Life Lessons: The truth will set you free — his father, quoting from the Gospel of John Under The Cloak of Invisibility: Visit the U.S. Congress to hear what members think when the cameras are off Getting Personal with Dr. Randy Anderson Dr. Randy Anderson • Soldier for Diabetes With a physician mother and a high-energy physicist father, it was almost inevitable that Sheng Ding, Ph.D., would select a life in the sciences. But that very nearly all came undone when he set his sights on working in the laboratory of Peter Schultz, Ph.D., at The Scripps Research Institute. That’s because Dr. Schultz was the only person Dr. Ding wanted to work with when he was applying for grad school. His narrow focus very nearly cost him his place at the institute. Fortunately for Dr. Ding, and for the field of stem cell biology, Dr. Schultz came to the rescue, and more than 10 years later Dr. Ding remains with Scripps. Perhaps what makes Dr. Ding such a good scientist is he is not afraid to defy conventional wisdom to explore a new idea. Dr. Ding is a highly awarded scientist, having received, among other accolades, the 2008 New Faculty Award from the California Institute for Regenerative Medicine, and the 2008 Prostate Cancer Foundation Challenge Award. He was also named as one of the top five scientists in 2009 by The Scientist. F Dr. Sheng Ding • Science in his Cells Getting Personal with Dr. Sheng Ding Family: Wife, son, mother, father, brother Hobbies: Traveling, photography, climbing Driven by passion, commitment, and dedication to his work, Craig Sorensen, Ph.D., has helped to propel Vertex Pharmaceuticals to tremendous growth since joining the company nine years ago. Dr. Sorensen currently serves as VP of research and development network design and technology integration. For many scientists, excitement is stirred by one big breakthrough or discovery, but for Dr. Sorensen it is more the whole experience, or what he describes as a kaleidoscope of ever-changing moments. His interests extend far beyond Vertex to incorporate many areas of science and health. He remains committed to the industry through his active membership in several organizations, including the American Chemical Society (ACS) since 1993; Sigma Xi, The Scientific Research Society, since 1988; the American Association of Immunologists since 1984; and the American Society of Investigative Pathology since 1983. Dr. Sorensen was also a member of the New York Academy of Sciences from 1986 until 1994. He is also active in his local community, frequently volunteering at events at the Newton Free Library in Newton, Mass., and supporting local theater. Additionally, he formerly volunteered at the AIDS Action Committee Buddy Program, providing support to people living with AIDS, and he participates in many fundraising programs for the disease. F Dr. Craig Sorensen • Scientific Kaleidoscope Top iPod downloads: Giacomo Puccini, Lena Horne, New Order, and Lady Gaga Most unusual place visited: The Kali Temple in Kolkata, West Bengal, India Bucket list: To hike Machu Picchu in Peru; to travel down the Amazon; to re-read the Divine Comedy by Dante Alighieri; and to learn another language Getting Personal with Dr. craig Sorensen For Peter Scholes, Ph.D., gaining broad knowledge of each aspect of the drug development process has been paramount. It is this desire that led him to smaller companies, where he has been able to fully explore his interests and gain knowledge across CMC, clinical, and preclinical areas to aid personal growth and career progression. In the pursuit of knowledge, Dr. Scholes has undertaken courses in Six Sigma, experimental design, project management, e-submissions, validation of pharmaceutical processes, technology transfer, pharmaceutical preformulation, chemistry/pharmacy requirements for regulatory submissions, vaginal drug delivery, pharmaceutical project management and risk management, and tableting technology. Despite this quest for knowledge, Dr. Scholes does not set himself specific goals. Rather, his objective is always to succeed in the next task, whether that be short-term operational or longer-term strategic. He works alongside colleagues and clients, not apart from them. Those who have worked with him say he contributes in the capacity of a valued partner and collaborator on client projects and demonstrates a high level of ownership of the technical success of projects. Among his career highlights to date are his Ph.D. graduation; his first conference podium presentation, which was with the Controlled Release Society (CRS) in 1992; and working on defining and implementing the use of formulation design space strategies in early-clinical development to empower flexible protocols and study designs at Quotient. Dr. Scholes is an industry leader with more than 15 years of experience in the pharmaceutical sector. In 2007, he became VP of pharmaceutical sciences at Quotient Bioresearch. He previously worked in several management roles at 3M Pharmaceuticals and 3M Drug Delivery Systems, concluding in the leadership of a growing team of 35 employees focused on technology innovation and early product development. During his career, Dr. Scholes has played key roles in two successful product approvals and launches, taking an active role in Chemistry and Manufacturing Controls (CMC) activities. Dr. Scholes has made significant contributions to many areas of the pharmaceutical industry, including giving lectures at the University of Aston and supervising Ph.D. students at the University Strathclyde in Glasgow. He also contributes to industry discussions through his membership of the Academy of Pharmaceutical Sciences (APS) Biopharmaceutics Focus Group committee. In addition to membership of APS, he is also a member of the Royal Pharmaceutical Society of Great Britain and the American Association of Pharmaceutical Scientists (AAPS). F Dr. Peter Scholes • The Broader Picture Family: Married; a 14-year-old daughter Hobbies: Traveling, playing/watching soccer, reading (crime, thrillers, travel writing), walking Reading List: Ghost Train to the Eastern Star by Paul Theroux Top iPod download: Crowded House Screensaver: A picture of the Grand Tetons in Wyoming from a recent family vacation Most unusual place visited: Climbed Mt. Sinai in the dark to watch the sunrise Under Cloak of Invisibility: Sit in the corner of a G8 summit meeting Getting Personal with Dr. Peter Scholes