New 2011 Webinar Series to Educate, Enhance and Empower Life Sciences Professionals

We have just launched our 2011 webinar series to educate, enhance and empower life sciences professionals. Webinar topics range from how to position for optimal capital raising, successfully commercializing products, picking the right growth targets, optimizing clinical trials, heightening R&D productivity, advancing in a shifting job market, creating a workforce strategy, and more.

Each of the webinars addresses how to respond to different critical issues in life sciences to become more efficient and effective. Attendees will range from clinical research professionals to broad leadership executives.

The first of the 13 webinars in the series, titled “Dynamics in the Life Science Industry: The Tsunami in Full Swing,” begins on March 10. This webinar will examine the state of the industry, the implications for changes as well as methodologies and leading practices to improvement.

“Many in life sciences understand the challenges that continue to plague our industry, as well as those that lie ahead,” said Advanced Clinical Executive Vice President Rosemarie Truman, a 19-year strategy veteran and chief presenter of the series. “From the economic crisis, globalization, new business models, the transition to personalized medicine and Health Care Reform, life sciences professionals have experienced massive disturbances, further strained by numerous quick fixes. This series will offer information and solutions to show life sciences professionals how to effectively respond to these challenges to achieve sustainability.”

Online registration is now open. Webinars are offered to participants at no cost, with the exception of one for which contact hours may be earned. Interested attendees can register online at advancedclinical.com/webinars.

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

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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

How do you advance discoveries? NOW--Win an iPad!

Now, winners receive an iPad and mention in our winners press release!

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 ask pharmaceutical, biotechnology, and medical device companies, “How do you advance discoveries?” What are the best practices you use to shorten clinical trials? How do you reduce risk and cost in drug development? Do you have a strong risk management approach, employee training, or metrics management? 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 June, and you will win an iPad! The winning list of ideas will be posted on June 20, 2010.



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

Advanced Clinical Facebook Page
http://twitter.com/AdvClinical
http://youtube.com/AdvancedClinical
http://AdvancedClinical.blogspot.com
http://AdvancedClinical.wordpress.com

See www.advancedclinical.com

Team Integration from Advanced Clinical

Many times there is limited or no effort taken to create a joint view of the goals that should be achieved during a clinical trial. As a result, the clinical team is not productive as a unit as they become "disengaged". Disengaged employees are 33% less productive on average according to several reports*.

This loss of productivity is unacceptable at Advanced Clinical. We want to give you your dream team.

This costs companies a lot of money, risk, and time. Several studies* have been performed on the linkage among team building, team cohesion, and team performance. An integrated team will achieve improvements in performance by developing the right "Team Culture" and adopting the behaviors needed to support and reinforce that culture. A strong Team Culture leads to reduction of waste, duplication, unnecessary processes and procedures. Most importantly, team culture leads to the willingness to succeed.

To keep clinicians and consultants in the loop with your project, Advanced Clinical has built a "Team Integration Method." Our method succeeds in creating a completely harmonized team, whether working on-site or off-site to ensure maximum employee engagement, productivity and overall performance.

Advanced Clinical believes our consultants should be "close" with not only their colleagues on a project, but the project managers and your colleagues as well. Bonding exercises and introductions take place before our clinical trials. Mutual respect and complete communication is ongoing to keep workplace karma good, and, ultimately, to ensure successful trials completion. Goal setting keeps their eyes on the prize, and personality awareness makes better working relationships.

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 be mentioned in our press release.

Enter today.

See www.advancedclinical.com


*Sources:

Bloom, G. A., Stevens, D. E., and Wickwire, T. L. (2003). Expert coaches’ perceptions of team building. Journal of Applied Sport Psychology. 15: 129-143.
Crron, A.V., Brawley, L.R., and Widmeyer, W. N. (1985). The Group Environment Questionnaire.
Carron, A.V., Bray, S.R., and Eys, M.A. (2002).Team cohesion and team success in sport. Journal of Sports Sciences, 20, 119-126.
Dirks, K.T. (2000). Trust in leadership and team performance: evidence from NCAA basketball. Journal of Applied Psychology, 85(6) 1004-1012.
Ebbeck, V. and Gibbons, S. L. (1998). The effect of a team building program on the self-conceptions of grade 6 and 7 physical education students. Journal of Sport and Exercise Psychology, 20; 300-310.
Everett, J. J., Smith, R. E., and Williams, K.D. (1992). Effects of team cohesion and identifiably on social loafing in relay swimming performance. International Journal of Sport Psychology. 23: 311-324.
Kozub, S.A. & Button, C.J. (2000). The influence of a competitive outcome on perceptions of cohesion in rugby and swimming teams. International Journal of Sport Psychology. 31: 82-95.
Landers, D. M. and Luschen, G. (1974). Team performance outcomes and the cohesiveness of competitive coacting groups. International Review of Sports Sociology. 5: 57-69.
Martin, R. and Davids, K. (1995). The effects of group development techniques on a professional athletic team. The Journal of Social Psychology, 135 (4) 533-535.
Meyer, B.B., Wenger, M.S. (1998). Athletes and adventure education: An Empirical Investigation. International Journal of Sport Psychology, 29, 243-266.
Murphy, J. M. (2001). The effect of a one-time team building exercise on team cohesion.
Sencecal, J., Loughead, T.M., and Bloom (2008). A season-long team-building intervention: examining the effect of team goal setting on cohesion. Journal of Sport & Exercise Psychology, 30, 186-199.