With Advanced Clinical's Executive Vice President, Rosemarie Truman, attending the 2010 Mid-Atlantic Biotech Conference, we would like to provide you with our ideas on achieving breakthrough in biotechnology through R&D Productivity. The following abstract will be presented at the Conference today, and we are giving you an sneak peek online in case you can't make it to the conference!
With recent announcements of significant budget cuts in the R&D workforce and spending, it is clear the R&D model has changed for biotech companies and an innovative turnaround in R&D is needed. Advanced Clinical's poster presentation will demonstrate a codified framework for biotechnology companies to achieve true R&D productivity.
Through a strong framework and approach, biotech companies can ensure their product has market adoption and is differentiated; they can ensure operational efficiency in the clinical trial and they can make sure the medical/scientific focus is correct.
The comprehensive framework will assess the "what," the "how" and the "why" of R&D productivity.
1. What is needed for effective R&D productivity? First, the right medical / scientific focus is required. This includes, but is not limited to:
Protocol
Target label claims
Doses and routes
Enrollment and drop-out rates
Heterogeneity of the population
Precision endpoints
2. How can R&D productivity be achieved? Clinical trial operational execution factors to assess include, but are not limited to:
Clinical operations, enrollment, investigators and sites
Regulatory management
Data management
Biostatistics
Drug supply
Labs
Medical writing
Medical safety and monitoring
3. Why should the drug reach the market? Will it have adoption? Market viability and comparative effectiveness are critical to a drug's success.
By providing a framework for biotech companies to ensure their product is successful, they gain a higher probability of success in getting much needed products to market.
Friday, October 29, 2010
Wednesday, October 27, 2010
Advanced Clinical to Present an R&D Productivity Poster at the 2010 Mid-Atlantic Biotech Conference
Join our Facebook page and watch for an update and pictures following the conference! www.facebook.com/advclinical
Advanced Clinical, a leading provider of clinical research services, announced today that Executive Vice President Rosemarie Truman will present a poster on R&D productivity at the 2010 Mid-Atlantic Biotech Conference on Friday, October 29, 2010. Ms. Truman will provide an overview of Advanced Clinical’s R&D framework and approach, which biotech companies can use to ensure their product has market adoption, is differentiated, has operational efficiency in a clinical trial, and has the correct medical/scientific focus.
“We look forward to presenting our R&D productivity framework for the biotechnology sector,” said Rosemarie Truman. “The framework we will discuss is proven to create step-change R&D improvement by improving probability of success as well as reducing cycle time and costs.”
About Advanced Clinical: Advanced Clinical provides consulting services, strategic sourcing (CRO), talent management, and technology solutions to the Life Sciences industry. With 15+ years of experience, Advanced Clinical is an established presence in the clinical research field, providing services specifically for Pharmaceutical, Biopharmaceutical, Biotechnology and Medical Device organizations. Advanced utilizes a value-based, “One Team” approach. To learn more, visit http://www.advancedclinical.com.
Contact:
Rosemarie Truman
rtruman(at)advancedclinical(dot)com
1200 Lakeside Drive
Bannockburn, IL 60015
Ph: 202-438-2208
Advanced Clinical, a leading provider of clinical research services, announced today that Executive Vice President Rosemarie Truman will present a poster on R&D productivity at the 2010 Mid-Atlantic Biotech Conference on Friday, October 29, 2010. Ms. Truman will provide an overview of Advanced Clinical’s R&D framework and approach, which biotech companies can use to ensure their product has market adoption, is differentiated, has operational efficiency in a clinical trial, and has the correct medical/scientific focus.
“We look forward to presenting our R&D productivity framework for the biotechnology sector,” said Rosemarie Truman. “The framework we will discuss is proven to create step-change R&D improvement by improving probability of success as well as reducing cycle time and costs.”
About Advanced Clinical: Advanced Clinical provides consulting services, strategic sourcing (CRO), talent management, and technology solutions to the Life Sciences industry. With 15+ years of experience, Advanced Clinical is an established presence in the clinical research field, providing services specifically for Pharmaceutical, Biopharmaceutical, Biotechnology and Medical Device organizations. Advanced utilizes a value-based, “One Team” approach. To learn more, visit http://www.advancedclinical.com.
Contact:
Rosemarie Truman
rtruman(at)advancedclinical(dot)com
1200 Lakeside Drive
Bannockburn, IL 60015
Ph: 202-438-2208
Friday, October 15, 2010
Working Her Dream Job: Insight from a Clinical Development Expert
Patricia Walicke MD, PhD, a core member of Advanced Clinical’s strategic advisory ecosystem, describes her experience in achieving her dream career: “I’ve followed a desire to try to make the world a better place and serve humanity through improving health and health care.”
As a strategic advisor, Dr. Walicke brings years of leadership strategy experience across several areas of clinical research, including protocol design and clinical plan development across multiple phases. Additionally, she has experience in regulatory submissions and interactions as well as medical monitoring and safety. Her expertise combined with her current work as an independent consultant for clinical development programs contributes to Advanced Clinical’s Industry Leading R&D Performance (ILRDP) framework that seeks to make the “business of R&D” more effective and efficient for Life Sciences companies.
“The team at Advanced is very bright, dedicated and determined, and, by working together, we have the opportunity to share how to operate more efficiently and effectively in the industry,” said Patricia Walicke, Advanced Clinical Strategic Advisor.
Formerly a practicing neurologist, Dr. Walicke changed careers to drug development approximately 15 years ago. She has experience with biologics and small molecules, and has worked on indications in neurology, autoimmune rheumatologic disorders, dermatology, ophthalmology and oncology. She explains that creativity, balanced by practicality, is the key to drug development: “When evaluating a potential therapeutic, first it is important to think broadly of all the possible ways that it might be used in medicine. Then the range of indications needs to be narrowed down to what is feasible. Matching the mechanism of action of the compound to the pathophysiology of the disease is also an important determinant.”
Notably, Dr. Walicke led the Phase 3 team for approval of efalizumab (Raptiva) for psoriasis; helped design extension of rituximab to non-oncology indications, particularly multiple sclerosis; obtained the first clinical proof of concept for anti-NGF in analgesia; and has been awarded several drug patents. “Drug development was a way for me to help more people more efficiently. You can potentially help hundreds of thousands of people,” said Dr. Walicke.
In addition, Dr. Walicke took a leadership role in establishing clinical groups in two start-up companies and restructuring the clinical department for biopharmaceutical company Oxigene with relocation from the East Coast to the West Coast.
Of compiling clinical teams, Dr. Walicke says, “While it is important for the team to be knowledgeable, it is perhaps most important that the team members communicate effectively and stay focused on the overall goal.”
Dr. Walicke offers advice to others in the clinical field, based on attributes to which she credits her own success: “Represent the needs and interests of patients and clinicians within industry, follow the science, keep timelines and deliverables, and pay attention along the way.”
Find your dream job at www.advancedclinical.com
As a strategic advisor, Dr. Walicke brings years of leadership strategy experience across several areas of clinical research, including protocol design and clinical plan development across multiple phases. Additionally, she has experience in regulatory submissions and interactions as well as medical monitoring and safety. Her expertise combined with her current work as an independent consultant for clinical development programs contributes to Advanced Clinical’s Industry Leading R&D Performance (ILRDP) framework that seeks to make the “business of R&D” more effective and efficient for Life Sciences companies.
“The team at Advanced is very bright, dedicated and determined, and, by working together, we have the opportunity to share how to operate more efficiently and effectively in the industry,” said Patricia Walicke, Advanced Clinical Strategic Advisor.
Formerly a practicing neurologist, Dr. Walicke changed careers to drug development approximately 15 years ago. She has experience with biologics and small molecules, and has worked on indications in neurology, autoimmune rheumatologic disorders, dermatology, ophthalmology and oncology. She explains that creativity, balanced by practicality, is the key to drug development: “When evaluating a potential therapeutic, first it is important to think broadly of all the possible ways that it might be used in medicine. Then the range of indications needs to be narrowed down to what is feasible. Matching the mechanism of action of the compound to the pathophysiology of the disease is also an important determinant.”
Notably, Dr. Walicke led the Phase 3 team for approval of efalizumab (Raptiva) for psoriasis; helped design extension of rituximab to non-oncology indications, particularly multiple sclerosis; obtained the first clinical proof of concept for anti-NGF in analgesia; and has been awarded several drug patents. “Drug development was a way for me to help more people more efficiently. You can potentially help hundreds of thousands of people,” said Dr. Walicke.
In addition, Dr. Walicke took a leadership role in establishing clinical groups in two start-up companies and restructuring the clinical department for biopharmaceutical company Oxigene with relocation from the East Coast to the West Coast.
Of compiling clinical teams, Dr. Walicke says, “While it is important for the team to be knowledgeable, it is perhaps most important that the team members communicate effectively and stay focused on the overall goal.”
Dr. Walicke offers advice to others in the clinical field, based on attributes to which she credits her own success: “Represent the needs and interests of patients and clinicians within industry, follow the science, keep timelines and deliverables, and pay attention along the way.”
Find your dream job at www.advancedclinical.com
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