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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Advancing Discoveries: Adaptive Designs in Clinical Trials

What is Adaptive?

In the past several decades there has been a recognized trend of increased spending within pharmaceutical, biopharmaceutical, medical device as well as biotechnology research without a proportional increase in success rate of clinical trials - there used to be 8 IDAs for 1 commercial success; now 16 INDs for 1 commercial success. Some of these could be due to diminishing improvement margins for new drugs, unchanging failure rates, escalating costs, and other clinical limitations. By advancing discoveries, Advanced Clinical seeks to determine the most efficient and effective way to conduct clinical trials without decreasing the safety or efficacy of the trial. Adaptive designs have recently become the frontrunner in advancing clinical trials. Adaptive designs are clinical study designs that utilize accumulating clinical data to modify the study as it progresses, without undermining the validity and integrity of the trial. Not all clinical trials are suited for adaptive design. Stay tuned for our next blog post on Adaptive Risk Management, and FDA accepted adaptive designs/regulatory perspectives!

Why do it?

Adaptive clinical designs save resources and increases efficiency of the clinical trial. Greater flexibility within the adaptive design framework can translate into better treatment of patients within trials (stopping ineffective/dangerous doses early), more efficient drug development, and better use of available resources (need for less patients). Adaptive designs are not only advantageous to drug development, but they are ethically beneficial to the patients. Trials can be cut earlier if they are ineffective, thus efficiently and effectively ensuring patients are well served with the appropriate dosages. This is most important not only because the clinical trial can save resources by cutting off ineffective arms, but the trial can also stop harmful treatments early on in order to prevent patient harm and preserve the overall safety of the clinical trial. Adaptive designs for clinical trials provide efficient tools to demonstrate the safety and effectiveness of new medical products in faster timeframes with more certainty, at lower costs, and with better information.

Types of Adaptive Design Options (click picture to view!)

With adaptive study design, there are many design options that affect different aspects of a trial. above are some of the more widely known adaptive options.

What are the Pros and Cons of Adaptive Design? (click picture to view!)

Adaptive designs, though having a lot of advantages, can have some disadvantages as well. Stay tuned for our next blog posting about the risks and regulatory perspectives surrounding adaptive designs.

Also, don't forget to add our facebook page! www.facebook.com/advclinical

See www.advancedclinical.com

Risk Management from Advanced Clinical

Risk is a huge problem in clinical trials, and Advanced Clinical is swift and professional about identifying, assessing, prioritizing, mitigating and tracking risks to proactively avoid those risks – before they become issues that cause the trial to delay the trial. Some risks, unmitigated, can cause 2 years of delay! At a direct and indirect slippage cost of $6MM - $15MM/day, that adds up!

Advanced Clinical:

o Assesses risks
o Prioritizes risks
o Reduces uncertainty
o Mitigates risks
o Manages/monitors risks
o Optimizes procedures to reverse risks

Advanced Clinical recognizes the four types of risk: operational, strategic, financial, and market, so no area is overlooked. Advanced Clinical also assesses the scale of the impact, and the likelihood of occurrence of the risk over the trial period.

We want success and advancement for your discovery's trial as much as you do, and managing and mitigating risks is one of our keys to success.

Does this sound like a great 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