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In this issue of Small Business News from The Stevie Awards:
How to Survive and Thrive in Uncertain Times
Finding the Silver Lining...
Podcast Interview: Nina Simosko of SAP
Small Business Blogs & Sites of Note
Calendar of Events for Small Business
HOW TO SURVIVE AND THRIVE IN UNCERTAIN TIMES

The Ken Blanchard Companies’ Executive Vice President of Sales, Howard Farfel, is a Finalist in the Worldwide VP of Sales of the Year category of  the 3rd annual Stevie Awards for Sales & Customer Services , to be announced February 9 in Las Vegas.   The following is taken from their newsletter Ignite!  You can view the current issue, past archives, and sign up for a free subscription here.

Howard FarfelIn times of uncertainty, people need information, direction, and a clear plan for action. If leaders do not address these issues, people will tend to imagine the worst. Self-preservation and an individual focus will end up replacing the collaboration and cooperation necessary for an organization to survive. The result is a loss of organization-wide focus that inevitably leads to declines in productivity and profitability—the very outcomes that companies are hoping to avoid.

It’s a pattern that Scott Blanchard, Executive Vice President of The Ken Blanchard Companies, has seen repeated many times. To survive and thrive during an uncertain economic environment, Blanchard recommends that leaders adopt three strategies: acknowledge reality, define a direction, and manage people’s energy.

Acknowledge Reality
During difficult times, employees need more information, not less.

Share the realities of the current economic situation with your employees. What does the situation look like from your point of view? Be honest. Now is not the time for sugar-coating. The stakes are too high. You want your people to know that they can trust you, and that begins by sharing information. Even if you do not have the complete answers that you would like to have, it is important to share what you do know. Nor is it the time to take a “wait and see” approach to communicating strategy or to provide information on an “as needed” basis.

Instead, maintain regular communication throughout your organization and insist that other leaders throughout the company—including department heads, mid-level managers, supervisors, and team leaders—do the same. Make sure that everyone makes an effort to increase the amount of communication that they are having with their direct reports.

Define a Direction
Employees want to know that senior leadership has evaluated the company’s position and has a plan for dealing with it. They also want to know how their role fits in and contributes to that overall plan.

The best companies right now are creating well-thought-out plans for people to come together and respond. Yet many companies remain at risk in this critical area because people lack clarity regarding exactly what they are supposed to be doing to achieve success on the job.

“In our experience, only about a third of people actually feel crystal clear about what their job responsibilities and their accountabilities are,” explains Blanchard. “Less than 25% of people understand exactly how their job contributes to the organization’s success. Less than 15% have real confidence that their senior executive group has a clear strategic plan that they understand and really agree with.”

What is the situation in your organization? Have you charted a course of action that is proactive and gives people a way to contribute, rather than sit back, worry, and wait?

Manage People’s Energy
Leadership is about managing energy, and right now it is incumbent upon every manager and every business to manage that energy as effectively as possible.

“If leaders don't manage people’s energy and their emotion and their fear, then what is going to happen is very predictable,” explains Blanchard. “Employees are going to spend more energy worrying about things that they cannot control, rather than focusing on doing things as best they can within their control.”

These are extraordinary times. Leaders need to think and act differently, and they need to take action now rather than sitting around and watching things unfold around them.

Focus on the positive. It helps to balance the viewpoint that everything is falling apart. What is the reality of business in your industry? Is business forecast to be flat? Down 10%? Even down 25%? Chances are the reality of the forecast is better than the rumors. Find the bright spots, present a balanced view. Let people know that good things are still happening.

Draw on past experience. Has your company faced a similar time in the past when business was extremely bad? Chances are, if you’ve been in business for any length of time, you have already faced difficult times successfully. Remind people of your company’s history of success.

Are you a newer company that has not experienced difficult times before? Look at this opportunity carefully. Could this be your time to show your commitment to your people? Is this an opportunity to show that everyone is in this together? Could you use this downturn to pull together and move forward while weaker companies contract and lose market share?

Looking Ahead
“It's hard to run a company when things are going well,” concludes Blanchard, “and it’s extremely hard to run a company when things are tough. Right now we are at a place where the pressure is up, the stress is up, and we need to pull together and really focus on working together to resolve these big issues.”

It would be nice to think that the current recession will be short and that conditions will improve quickly. The reality is that this recession will require a sustained effort on the part of companies to weather it out. It will be a challenge—but one to which strong companies, with good people practices, can rise. Acting strategically based on the realities faced, and managing people’s energy to remain focused and productive, will greatly increase your organization’s chances to survive and thrive in the year ahead.

About Scott Blanchard
Scott Blanchard is Executive Vice President of Client Solutions and co-founder of Blanchard’s Coaching Services, which has coached more than 10,000 clients worldwide. Since joining Blanchard, Scott has played a number of different roles, including trainer and organizational consultant. As a Senior Consulting Partner, Scott has led major training interventions at numerous Fortune 500 companies.

Scott is the author of several books, including Leverage Your Best, Ditch the Rest, coauthored with Madeleine Homan, and Leading at a Higher Level. He is the coauthor of the Blanchard Coaching Essentials training program. Scott was educated at Cornell University and received his master’s degree in organizational development from American University in Washington, D.C.

About The Ken Blanchard Companies:
With nearly three decades of helping leaders and organizations, more than 18 million books in print, programs offered in more than 12 languages, and clients across five continents, The Ken Blanchard Companies is recognized as one of the world’s leading training and development experts. Its groundbreaking thinking and memorable learner experiences create lasting behavioral change that has measurable impact on the organizations with which it works—companies that wish to develop leadership capacity, improve workplace cultures, drive organizational change and strategic alignment, and become high-performing organizations. Using a collaborative diagnostic process The Ken Blanchard Companies help identify each organization’s unique needs and business issues, and then help to develop an appropriate leadership strategy to drive results and profits. As the innovator of Situational Leadership II, the most widely used leadership development system in the world, The Ken Blanchard Companies’ behavioral models add a situational context to the training experience so individuals learn to be more productive in real-world scenarios and make the shift from learning to doing more quickly and effectively. Learning takes place through both instructor-led and virtual experiences offered by a worldwide network of consulting partners, trainers, and coaches. To learn more, visit www.kenblanchard.com.

FINDING THE SILVER LINING IN INTERNATIONAL REGULATORY SOLUTIONS

Good news! There is a silver lining for some to the current financial crisis. The Stevie Award-winning Octagon Research Solutions, Inc., in Wayne, Pennsylvania, is bucking the current trend and adding staff to augment its growing business providing regulatory, clinical, process, and IT solutions to the pharmaceutical and healthcare industries.

Monique GarrettOctagon Research Solutions, Inc., will be celebrating its tenth anniversary this year. Founded by entrepreneurs James Walker and Kirk Gallion in October 1999, Octagon started out as a very small business indeed, in a tiny office above a donut shop. The company name, which could so easily have been donut ring-related, in fact aptly reflects the eight imperatives on which the company is run.

Fortunately for its founders, Octagon has been a company of rapid growth. Its corporate headquarters in Pennsylvania were recently expanded, and in 2005 it answered the call from the industry for a global presence by launching an international office in the U.K. 

We asked Monique Garrett, Octagon’s Vice President of Marketing, to explain what was happening in the pharmaceutical industry and how it was affecting her company.

The Next Big Thing: Global Standards
“In the fairly recent past, submitting a drug for approval in the U.S. required preparing hundreds of volumes of documents, which had then to be literally trucked over to the FDA before an approval process could commence,” explained Garrett. “In order to be compliant for submission in other countries, significant modifications were required, and pharmaceutical companies would hire armies of temporary staff to prepare, check, and collate all the necessary research material and documents.”

According to Garrett, the pharmaceutical industry is at last starting to come together on global standards and practices for seeking approval of new drugs.  This is one of the main goals of the International Conference on Harmonisation for Registration of Pharmaceuticals for Human Use (ICH), a unique project that brings together the regulatory authorities and pharmaceutical experts of Europe, Japan, and the United States to discuss scientific and technical aspects of product registration. The objective is to increase efficiencies in drug development processes in different countries using global standards and practices.  The effort is proving successful, and many countries have now accepted a common format.

With global standardization, U.S. submissions can now be made in Japan and the European Union with minimum changes, representing greater efficiencies for all concerned.
 
Adding to the speedier processing is the fact that the FDA in the U.S. now accepts submissions in electronic format, either on CD or through the FDA’s electronic gateway.  This is a huge improvement—not only by eliminating the shipping of truckloads of documents (not to mention saving the trees it took to prepare them), but also in expediting the approval process itself.

On their end, the FDA is implementing more efficient practices to shorten review times while maintaining public safety standards.

Innovative Solutions
Adds Garrett:  “Nowadays the companies in the life sciences industries that Octagon serves are seeking to do more with less, and we are able to offer them a great solution.”  Another change that Garrett is seeing these days is that the pharmaceutical industry is seeking to improve processes across the board, not just by department. 

“Companies want to deliver the same quality and results in a shorter time using fewer people,” says Garrett. “Blockbuster drugs could be earning a company millions of dollars a day, so any time saved in the approval process has real value.”

The aim is to improve R&D while finding the shortest route to get submissions for new drugs into the final format. While this used to be a process that passed through many people and departments, companies are now looking at the big picture to find a more holistic approach. Such an approach is a sea change for the industry, and one that Octagon is well placed to support.

Octagon has a strong commitment to providing innovative technology solutions and expert consultative services to pharmaceutical and biotechnology companies. Octagon leads the electronic transformation of clinical R&D through its many activities including:

  1. Developing new--and enhancing existing--technology solutions that assist companies in improving their clinical R&D processes. This includes Octagon’s process management solution, ViewPoint™, and its regulatory submission document authoring templates tool, StartingPoint™.
  2. Launching new consultative services that assist companies in compliance with industry standards.  This includes Octagon’s Submission Stewardship Program™, which supports the production and maintenance of regulatory submissions; its Structured Product Labeling (SPL) Stewardship Program, which includes training, implementation consulting, and conversion services; and its Clinical Data Strategies, which include consulting and training on emerging CDISC data standards and conversion services.
  3. Acquiring an electronic data capture company to become the only organization in the industry with full data collection to submission capabilities.
  4. Hosting various educational seminars and webinars to help companies address emerging regulations and standards involving clinical R&D submissions.

Future Benefits Beyond Pharmaceuticals
“The challenges being faced by the pharmaceutical industry in nailing down their processes while remaining agile and competitive are very similar to those being faced by other industries worldwide,” concludes Garrett.  “Industry analysts have recommended that Octagon look to offer their solutions outside the pharmaceutical R&D arena, and this is something we are actively looking to implement in the future.”

About Monique Garrett
Ms. Garrett is currently responsible for all marketing activities at Octagon, bringing over thirteen years of industry experience to her role. Prior to joining Octagon, Ms. Garrett was employed for four years by an electronic publishing software vendor. In her previous role as Director of Regulatory Strategies, she was responsible for tracking industry trends and helping to identify, develop, and communicate electronic publishing solutions for the Life Sciences industry. Her prior responsibilities included managing the U.S. sales support group and directing multiple client software implementations.

Ms. Garrett also spent six years in the pharmaceutical industry working in the areas of regulatory operations, document management, and electronic publishing, developing best practices, processes, and training to support those systems. This included four years managing the regulatory submissions, electronic publishing, and official regulatory files at AstraMerck and two years managing regulatory filings for Sterling Winthrop (Sanofi).

Ms. Garrett earned her B.S. in Human Resources with honors from the University of Delaware and a Masters in Management from Pennsylvania State University.

About James Walker
 James C. Walker, CEO, Chairman, and founder of Octagon Research Solutions, Inc., has been working in the pharmaceutical industry for fifteen years. Prior to founding Octagon, he worked as the Senior Manager of Worldwide Regulatory Affairs for the Schering-Plough Corporation.   Mr. Walker has extensive experience in all phases of clinical research and both FDA and European regulations. He is skilled at process improvement and providing insight across multiple disciplines within drug development.  Mr. Walker holds a B.S. in Biological Sciences from Villanova University, a Masters in Environmental Sciences from Rutgers University, and an M.B.A. from Duke University.

About Octagon Research
Octagon Research Solutions is the leader in the electronic transformation of clinical R&D. It offers a suite of regulatory, clinical, process, and IT solutions to the life sciences industry. Their integrated suite of offerings is built upon deep domain knowledge, cross-functional eSub expertise, a holistic process approach, and integrated solutions.

PODCAST INTERVIEW: NINA SIMOSKO OF SAP

Nina SimoskoThe 2008 Stevie Awards for Women in Business were presented in New York on November 14. Among the honorees was Nina Simosko, Global Chief Operating Officer with the SAP Education division of SAP AG. Nina won the Stevie Award for Best Executive – Service Businesses – More Than 2,500 Employees.

We spoke with Nina about how she got her start in business, how she's grown her division for 17 straight quarters, and why she created her NinaSimosko.com blog.

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SMALL BUSINESS BLOGS & SITES OF NOTE

Blogs, or web logs, are all the rage these days. Each month in this space we'll point you to several blogs that we think might be of interest to you.

Wake Up World TV : Online show that does to morning TV what the Daily Show has done to the evening news.
Banished Words List : Lake Superior State University's 34th annual List of Words Banished from the Queen's English for Misuse, Overuse and General Uselessness.
Hulu.com : The Associated Press named this popular site for online movies and TV programs their Web Site of the Year 2008.
Business Pundit : Business info from Drea Knufken, an author and blogger with a background in business management.

CALENDAR OF EVENTS FOR SMALL BUSINESS
Calendar of Upcoming Events for Small Business Owners and Managers
February : Entries open for 6th annual International Business Awards
March 31 : Entry deadline for 7th annual American Business Awards
April 30: Last date late entries will be accepted for 7th annual American Business Awards