Achieving Breakthrough Innovation in Biotechnology through R&D Productivity

October 29, 2010

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.

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Advanced Clinical to Present an R&D Productivity Poster at the 2010 Mid-Atlantic Biotech Conference

October 27, 2010

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


Working Her Dream Job: Insight from a Clinical Development Expert

October 22, 2010

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 http://www.advancedclinical.com


Advanced Clinical Announces Bernice Welles as a Core Member of its Strategic Advisory Ecosystem

September 30, 2010

 

Advanced Clinical, a leading provider of clinical research services, announces Bernice Welles as a core member of its strategic advisory ecosystem.

Bannockburn, Ill. (Vocus) September 30, 2010

Advanced Clinical, a leading provider of clinical research services, announces Bernice Welles as a core member of its strategic advisory ecosystem.

As a strategic advisor, Bernice Welles has contributed 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. Bernice has been a key driver in the development and regulatory approval of drugs, biologics, devices as well as combination therapies across multiple therapeutic areas. “Moving a drug and/or biologic from development to approval is, possibly, the hardest earned process in the Life Sciences industry,” says Bernice Welles, Advanced Clinical Strategic Advisor.

Welles’ accomplishments span several leadership roles in companies at different stages of growth. At Genentech, Welles was appointed to several management positions to drive the drug and biologics development portfolio across multiple therapeutic areas. Two of Welles positions included: Senior Director of the Specialty Therapeutics Unit and Vice President of Product Development. One important program that Welles progressed was the Lucentis injection for wet age-related macular degeneration (AMD). AMD is a disease of the eye that is the leading cause of blindness in older Americans and causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities. By moving forward this program, several thousand patients were able to be treated.

Welles held a Venture Partner position at MPM Capital LLP, where she participated in discussions on medical devices and helped assess device instruments. At MPM, Welles also took the lead on several investments and helped portfolio companies such as CoTherix maneuver the regulatory process leading to an early approval for Ventavis®, a new therapy for pulmonary hypertension.

Welles currently holds executive positions as CEO of Alquest Therapeutics Inc. and Vice President, Clinical and Regulatory, of Enject Inc., both innovative biotechnology startup companies.

With years of experience heading teams across functional areas, Welles credits integration as being one of the keys to her success. Using her capability to integrate the knowledge she has gained during her career, Welles is able to pull together all of the elements of clinical and regulatory as well as leverage the science behind development programs to create a significant, positive impact on the Life Sciences industry.

“I am proud to be working with Advanced Clinical,” said Bernice Welles. “Being part of this expert strategic advisory team allows me to continue to work with a topflight team to create new levels of R&D Productivity for companies in Life Sciences and bring much needed treatments to the market for those who need them.”

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@advancedclinical.com 
1200 Lakeside Drive 
Bannockburn, IL 60015 
Ph: 202-438-2208


Advanced Clinical Announces a New Approach to Project Management to Improve R&D Productivity

September 27, 2010

Advanced Clinical (AC), a leading provider of clinical research services, announces a new approach to project management to improve R&D productivity.

Bannockburn, IL (Vocus) September 17, 2010

Advanced Clinical (AC), a leading provider of clinical research services, announces a new approach to project management to improve R&D productivity.

Project management issues often plague clinical trials, and the planning process for trials is daunting. Numerous complexities need to be considered to construct a good clinical trial roadmap. Both medical/scientific and operational considerations demand careful management. Operational considerations include: country specific regulations; site monitoring intervals; drug shipments and handling; delivery methods, such as adaptive; and EDC technology. In addition, further planning and due diligence are critical to ensure comparative effectiveness. As a result, a new approach to project management is needed to improve R&D productivity.

AC starts with a strong foundation of processes, tools and templates for project management, including: risk management, knowledge management, continuous learning, resource management, benefits realization, financial management, service management, and many other elements, to delivery on key metrics.

AC has created a project management framework that identifies the right talent to make the project successful. The framework includes a comprehensive structure of components, such as therapeutic area; specific clinical trial method (e.g., Adaptive); clinical functions and country-specific requirements. Once the framework is applied, AC then identifies critical knowledge requirements and formulates a team of strategic advisor experts. This expert team provides critical insights to the project manager as well as the core team during the course of the trial.

The project management approach is based on AC’s Industry Leading R&D Performance (ILRDP) framework model, which contains, among other things, known risks for every part of a clinical trial and associated mitigation techniques as well as leading practices within and outside of the life sciences industry.

“Advanced Clinical drives rigor into project management to deliver strong results for clients,” said Leo Sheridan, CEO of Advanced Clinical. “It is a critical element of our ILRDP framework.”

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@advancedclinical.com 
1200 Lakeside Drive 
Bannockburn, IL 60015 
Ph: 202-438-2208


Advanced Clinical is Changing the Paradigm for Clinical Research Organizations Through Strategic Sourcing

September 9, 2010

Many Life Sciences companies need some or all functions of their studies outsourced in some manner. After eight months of studying sponsors’ needs, we are introducing a new outsourcing paradigm called “Strategic Sourcing.” This model will provide sponsors a solution specifically designed for their unique needs.

We have experience in all aspects of clinical research, including adaptive seamless trials across Phases I-IV. In addition, the Advanced Clinical team brings an expert ecosystem and industry affiliations (CDISC, DIA, ASA, SCDM, RAPS, IDSA, AMA, ACRP, ASM, CDER, CBER), therapeutic expertise in 17+ areas, and extensive methodology expertise.

Our move to strategic sourcing provides the following:

  • Accelerated Trials: Advanced Clinical’s codified methodology, “Industry Leading R&D Performance” (ILRDP), allows us to accelerate clinical trials and create success at the lowest Total Cost of Ownership. ILRDP is patent pending and is the foundation for our services and solutions.
  • “One Team” Client Partnering Model: We align with each client’s vision and works to ensure transparency, two-way open dialogue, and one point of accountability. The “One Team” approach creates a program management structure that combines Advanced Clinical and client leadership for successful implementation and management.
  • Value: We use a value-based approach to deliver solutions at the lowest Total Cost of Ownership. Codified delivery tools ensure consistency and allow us to incorporate best practices from each trials experience. This learning approach creates measurable net profit impact for clients.
  • Lowest Total Cost of Ownership: We employ a hybrid approach to staffing teams. Clinical trials require continuity over time, and we provide a dedicated and thoroughly trained team. We supplement the team with contingent talent to increase flexibility.
  • eClinical Platform: Our technology platform supports all elements of managing a clinical trial: a Clinical Data Management System, Interactive Voice Response System (IVRS), Interactive Web Response System (IWRS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), and Business Intelligence/Reporting.

“Our clients expect their CRO to have proven experience, they expect lowest Total Cost of Ownership, and they expect the company to provide value,” said Leo Sheridan, CEO of Advanced Clinical.

Rosemarie Truman, Executive Vice President of Solutions, adds, “Advanced Clinical’s differentiators are what clients should expect from any CRO, and we provide these in all of our solutions.”

To learn more, visit http://www.advancedclinical.com


Writing the Future of Clinical Research

September 2, 2010

The past several years have seen the rapid growth of the Medical Writing field, with the market more than doubling from an estimated $345 million in 2003 to $694 million in 2008, according to a Centerwatch Monthly report. Membership in the American Medical Writers Association, which sets the profession’s standards, increased 14% in the same time to nearly 5,700 members globally. Additionally, two dozen colleges and universities have recently established either certificate or degree programs in medical or scientific communication. Across the industry, Medical Writers are being highly prized for their ability to communicate scientific data effectively and efficiently, as well as taking on additional roles, such as transnational trial coordination and quality assurance, in the drug development process.

What do Medical Writers do?

Medical Writers both have a thorough background in scientific areas and are adept at communicating this information to various audiences. They perform numerous important functions, including the following:

  • Communicate scientific and clinical data to a range of audiences in a wide variety of formats
  • Combine scientific knowledge and their research skills to present information for targeted audiences
  • Write clinical trial protocols, clinical study reports, and other documents for submission to the FDA
  • Prepare journal articles, conference posters/presentations, internet content, and training/marketing materials

Is Medical Writing for me?

Before you consider entering the Medical Writing field, know that there are several key attributes that make the field a fit for individuals:

  • Interest in scientific fields and writing
  • Excellent written and oral communication skills
  • High-level detail orientation
  • Good interpersonal skills and “team player” attitude
  • Ability to multi-task, learn “on-the-job”, and meet project deadlines

Additionally, Medical Writers are expected to have a level of technical knowledge and skills such as:

  • Current scientific writing and editing techniques
  • Software and systems, such as document management software, Microsoft Office suite, as well as reference, literature, and publishing software
  • Company policies, procedures, and tools
  • Industry guidelines
  • Scientific area background with statistical knowledge preferred

Who do Medical Writers work for?

  • Pharmaceutical companies
  • Medical communication agencies
  • Contract Research Organizations (CRO)
  • Freelance Publishers
  • Academic Medical Centers, Medical Associations, Publishers, Magazines, Websites

What are the benefits?

  • High involvement with the latest scientific research and information
  • Rewarding work that makes a difference
  • Can have flexible work hours
  • Current high market demand for Medical Writers
  • A number of opportunities for career development
  • High entry level compensation (~$50-60,000) and employee benefits
  • Flexibility to switch jobs

What jobs are available?
Advanced Clinical has a number of exciting Medical Writing opportunities available across a wide range of experience, including:

Senior Medical Writing Program Manager (Oncology) – Northern Suburbs of Chicago, Illinois

One of our clients is seeking a Senior Medical Writing Program Manager (Oncology) also known as Global Medical Writing Lead, generally for early- to mid-stage development global project teams and may act as a back-up/supporting GMWRL for several projects.

The individual will provide:

  • Project leadership with respect to program documents and writing activities commensurate with experience
  • Review of work and manage/coordinate writing activities across an entire program, and may review and amend the work plans developed by a Document Working Group Facilitator (DWGF; lead medical writer in a working group) for a particular document
  • Intellectual leadership and contributes document knowledge and expertise to the project team

Associate Director, Medical Writing – Princeton, New Jersey

A client in the Princeton NJ area is looking to add a permanent Associate Director of Medical Writing to their team.

The individual’s responsibilities include:

  • Deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects
  • Prepare clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format
  • Coordinate and prepare Meeting Content Packages, and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents including clinical study reports, narratives, investigator brochures for Phase I to IV clinical trials, and drug safety related documents such as Periodic Safety Update Reports

Senior Medical Writers/Writing Team Leaders – Worldwide

A client is seeking experienced medical writers to serve as Team Leaders at their office locations around the world.

Team Leaders are strategic consultants, project leaders, and hands-on writers who:

  • Serve as subject-matter experts for clients, guiding and advising them on strategies and best practices for achieving approval from health authorities
  • Serve as subject-matter experts for team writers, providing leadership, advice, and continual mentoring
  • Actively participate in development and writing of documents
  • Ensure quality, adherence to budgets and timelines, and compliance with SOPs, policies, and other guidance as required by the company, regulatory bodies, and individual clients