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

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

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(at)advancedclinical(dot)com
1200 Lakeside Drive
Bannockburn, IL 60015
Ph: 202-438-2208

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

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

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

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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

Key Levers for R&D Effectiveness and Efficiency

Optimization needs to occur in two ways: “what is done” (effectiveness) and “how it is done” (efficiency). Key R&D areas that should be re-aligned to increase effectiveness include:

• From Opportunistic to Focused Innovation: Drive rigor into the selection of new products/solutions. Capitalize more effectively on new ideas that present great opportunities for the company


• From Full Integration to Partnership: Partner with other companies to manage risk and return on R&D capabilities; outsource capabilities that aren’t central to company strategy


• From Therapeutic Problem to Differentiated Customer Solutions: Shift from therapeutic R&D that addresses diseases to meeting patients’ needs through curing ailments and fully managing patient conditions. Payors and consumers are demanding solutions, as well as differentiation


• From a Functional to an Integrated Business Model: Map out an integrated R&D model focused on a specialized therapeutic, customer or scientific area to provide tighter coordination and more rapid decision-making; use comparative effectiveness to bring to market the right drug, biological entity and/or medical device
  

While “what companies do” creates 70-80% of problems for R&D, companies must not forget to also focus on the other 20%: addressing efficiency gaps to streamline its processes, people and technology. Efficiency gaps are broken out as follows: Technology and Resource Management, Project and Resource Management, Product Development Processes, R&D Investment Guidelines, and Asset, Knowledge and IP Management.

• Technology and Resource Management: There are few standard technologies to support R&D processes. Where technologies are used, they are used inconsistently, with overlapping duplicate efforts. There is no comprehensive application and information architecture that would allow Life Sciences companies to understand performance across ALL product development and clinical trial efforts. An integrated eClinical platform would provide fully integrated business and technology solutions to minimize duplication and harmonize data


• Project and Resource Management: Proper project management and associated resource allocation is critical to ensure the right resources are on the right projects at the right time. Project management needs to include a comprehensive, cross-functional approach including: risk management, decision management, issue management, change management, quality management, knowledge management as well as service/metrics management


• Product Development Processes: R&D also suffers from inconsistent development processes, poor collaboration, and weak customer insight. Developing, implementing and adhering to a standard set of product development processes (e.g. BLAs for vaccines), which include regular collaboration and market insight injection, will enable R&D to develop the drugs that consumers actually want and bring them to market quickly


• R&D Investment Guidelines: With tightening budgets, talent turnover, and increased competition, an R&D investment strategy is needed for sustained growth; companies need guidelines to mitigate risks and accelerate clinical trial time while reducing spending


• Asset, Knowledge and IP Management: Proactive collection of knowledge is critical to ensure continuous learning and constant improvement of current practices. In addition, codification of knowledge into repeatable processes and methods is also important to create intellectual property assets

Visit our Website for more on ILRDP Transformation! http://www.advancedclinical.com/

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