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

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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Big Pharma aims for reinvention

With some of his most profitable medicines going off patent, and the uncertainty of replacement drugs continuing to rise, US healthcare reform has been the least of Andrew Witty’s recent worries.

When the chief executive of GlaxoSmith­Kline presented his company’s most recent financial results last month, he gave a sense of how the UK’s biggest drugmaker – and the industry more generally – is responding to structural pressures: diversify to survive.

For his company, he says, this means a shift away from “white pills in western markets”, with the proportion of traditionally core patent-protected, chemically based drugs, which are sold mainly in North America and western Europe, falling to just more than a quarter of total sales.

For many years, large companies such as GSK have relied on a handful of typically high-priced, mass-market “blockbusters” that generate billions of dollars a year in sales. But as patents expire on drugs such as Lipitor, Pfizer’s anti-cholesterol medicine that is the biggest selling medication in history, big pharma is having to rethink its business model.

Most large pharmaceutical companies have adopted four principal strategies to diversify. First, expand the range of products in the research and development pipeline and the use of external as well as in-house scientists to discover them. Second, expand geographically, especially into emerging markets. Third, increase sales of products other than patented prescription medicines. Fourth, experiment with greater flexibility in pricing in different countries and with ways to ensure drugs provide value for money.

Read the rest of the article -- FinancialTimes.com

Visit us at www.advancedclinical.com

Propel clinical trials with Continuous Learning

Advanced Clinical, the trusted CRO among the world's top pharmaceutical, biotechnology, and medical device companies, is enhancing Continuous Learning as a part of their Industry Leading Trial Performance method.

Advanced Clinical is experienced enough with trials to know that trials sometimes deviate from the original plan to improve scheduling, avoid risk, and improve efficiency and optimize the entire project. Continuous learning keeps everyone working on a trial up-to-date with those improvements. Change is not always good for a trial, but continuous learning and improvements means the right changes are being made.*

Continuous learning leads to success,** which is what AC wants for its clients.

Does this sound like a good way to advance discoveries? We think it is. Enter our “how do you advance discoveries” contest and your company could win an iPad and get a mention in our press release.

See www.advancedclinical.com

Sources:

*Is Change Always Good In Business?, Brian Chernett, CEO of the Academy for Chief Executives .

**Success Made Simple, Erik Wesner.

Advanced Clinical launches “How Do You Advance Discoveries?” contest

Shorten clinical trials. Reduce risk. Reduce cost! We need YOUR ideas!

Eighty billion drugs are predicted to come off patent in the next three years. While some say this release of patents may save money for the healthcare system as a whole because generics will take the place of those coming off patent, there is no replacement for many drugs and there are patients that need these drugs. As a result, Pharmaceuticals and Biotech companies have two key imperatives:

• “Advance discoveries”, aka, reduce clinical trial timelines
  
• Reduce the escalating costs and risks associated with drug development

A recent article in the Wall Street Journal “Clinical Trial Death Watch” (March 16th 2010) echoes these imperatives. The message from the Wall Street Journal article is: there is a resounding need for efficiency and effectiveness to accelerate clinical trials. Even the government is trying to help with the acceleration of clinical trials. One recent study focused on collaboration. There are, however, still many complex issues that create barriers to realizing these imperatives. See, Forbes (March 26th, 2010 “Research and Markets: Investigating Clinical Trial Costs“).

Advanced Clinical wants to offer pharmaceutical, biotechnology and medical device companies a chance to be in our press release by answering the question: "How do you accelerate a clinical trial"?

Is it by ensuring strong team chemistry/integration; using robust communication methods, etc? Is it something else? Advanced Clinical would like your ideas to create Industry Leading Trial Performance in clinical research.

Let us know how you advance discoveries here. If you win, your ideas will be part of our press release in the beginning of August! The winning list of ideas will be posted on August 1st, 2010.

How do you advance discoveries?

For winning list announcement, you can follow Advanced Clinical on facebook or on one of our social networks:

http://www.facebook.com/pages/Advanced-Clinical/310724322038?ref=search&sid=1468411198.3440133258..1
http://twitter.com/AdvClinical
http://youtube.com/AdvancedClinical
http://AdvancedClinical.blogspot.com
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See www.advancedclinical.com