In this issue...

· From the Executive Director

· Upcoming Programs

· PR/Marketing Committee Activities

· Membership Corner

· Members In The News

Building Your Team ... The Important Hiring Decisions

Clinical Trials: Do It Right The First Time

Practical Knowledge -- How to Get Your News Out

From the Executive Director

I am so excited about this inaugural edition of BioNewslink, our electronic newsletter for members of BioStrategy Partners! As a member benefit, BioNewslink will appear three times a year. It is your forum to share news about yourself and your company, so please take advantage of it to let all of us in the "young company community" know what you’re up to!

Because we are a virtual organization of volunteers, it is very important to me that members develop productive relationships with others in our "young company community." BioSP offers several ways for you to get connected-- BioNewslink, networking at our programs, serving on one of our committees. See the column from Todd Abrams, Membership Chair, to learn more about the BioSP value proposition and how you can benefit from becoming involved.

BioSP is steadily building a reputation as a specialist in the needs of very young companies, particularly those with first- time or inexperienced CEOs. Our mission is to provide a continuum of services and infrastructure to young life sciences companies, enabling them to thrive in the Greater Philadelphia region. We are virtual, regional, and expert. A nonprofit 501(c)4 service organization founded in 2004, BioSP functions as a nursery, cultivating good business practices in young companies and helping them access the services they need to survive the critical early stages of development.

There aren’t many organizations focused on this stage of company development, so BioSP is both setting the standard of service and at the same time filling a gap in the region’s technology-based economic development armamentarium. Did you know that The Milken Institute in its 2005 report, The Greater Philadelphia Life Sciences Cluster: An Economic and Comparative Assessment identified new firm birth and growth support as an area where the region does not hold a competitive advantage and where improvement would yield great results? Surely it makes sense that helping companies upstream will pay dividends as more of them make it downstream. BioSP looks forward to continuing to do our part to make sure that Greater Philadelphia remains among the elite life sciences centers in the United States .

Thank you for supporting BioStrategy Partners. I look forward to seeing you at our next event.

Karen J. Hanson, Ph.D.
Executive Director

Upcoming Programs

The Program Committee is working on many upcoming programs.

SAVE THE DATES:

The next installment in our Practical Knowledge Series is "Building Your Team ... The Important Hiring Decisions -- Independent Consultants and Contractors or Direct Employees" on September 11, 2007 from 8AM to 10:30AM at Citizens Bank in Plymouth Meeting, PA. More details will follow.

On October 24, 2007 we will present Clinical Trials: Do It Right The First Time from 8AM to 11:30AM at the Commercialization Center in North Brunswick , NJ . More details will follow.

Topics being worked on to be scheduled at a later date include:
How to Get Your News Out, First Sightings (a follow-up to a very successful program last year) and an Investor Relations Panel.

We are always looking for program ideas and members for the Program Committee. If you have an idea or an interest in serving on the Committee, contact Emma Barsky (ebar sky@practicalsolutionsNJ.com) or Len Grunbam (l grunbaum@practicalsolutionsNJ.com). We would love to hear from you!

PR/Marketing Committee Activities

BioStrategy Partners has entered a very exciting time. With the KIZ soon to be under its umbrella and a goal to reach out, engage and assist emerging life science companies in the Pennsylvania , Delaware and New Jersey biotech communities, it is at a stage in its evolution that mandates new programming, new outreach and a new image.

The Marketing Committee has been working to help craft that image, and by early autumn, BioSP will be introducing a new logo-one we hope you will agree characterizes the dynamism and potential for growth of the organization.

We are also in the process of redesigning the BioSP website, and the product we will deliver will be user friendly, useful and, most important, add to the ability for BioSP members and portfolio companies to receive and exchange timely news not only about BioSP and the KIZ and their respective activities and events, but also about their own organizations and other activities in BioSP’s growing family. Keep a lookout!

And as the organization grows, the PR/Marketing Committee should, too. If you have an interest in lending a hand, just send me an e-mail at PaganoPR@aol.com, or give me a call at 212-213-2851.

Membership Corner

BioStrategy Partners holds a unique position in helping life science technology development in our region. I know of no other volunteer-based organization that has compiled such a diverse group of experts knowledgeable in all aspects of early-stage company development that then go out and give of themselves to help those companies succeed. Members come from pharmaceutical and biotechnology industry, marketing, academics (science and business), financial, legal, and consultants.

This list of members on this Web site does not so much represent a list of companies, although it is an impressive list, but rather a list of individuals within those companies willing to give of themselves to help our region reach its potential as a hotbed of biotechnology development. We have all the ingredients including big and mid sized pharmaceuticals, world class academic institutions, along with business and government who recognize this moment in time as our region’s opportunity to grow. BioSp has dedicated itself to ensuring that this opportunity is not missed.

BioSP is the managing partner in the BioLaunch 611 + Keystone Innovation Zone that is implementing the BioSP model for early stage company development. To learn more about the KIZ please go to www.biolaunch61 1.org . BioLaunch611+ KIZ has conducted diligence on 14 companies through June 2007 and has provided assistance to 13 companies.

More companies await our help and we need assistance of additional experts willing to participate in getting these companies off the ground. One of the distinctive features of BioSP is it provides an immediate opportunity to participate depending upon your skill set and desire. BioSP has committees including Marketing, Membership and Programs and we can promise an active and rewarding experience as part one of these committees. Further we can promise and deliver good fellowship and networking at events, and we can promise and deliver that members are supporting an important and good mission. I urge interested individuals to sign up for a BioSP or KIZ program and then talk with me or another member about how to join.

Members In The News

Impractical FDA Regulatory Compliance Practices Addressed by The Practical Solutions Group

New way to comply with the FDA regulations most emphasized in the Life Sciences Space

PRINCETON, N.J.--(BUSINESS WIRE)--Regulatory Compliance Simplified. Under this umbrella, The Practical Solutions Group, LLC (PSG), an FDA regulatory compliance consultancy, helps life sciences companies to implement common sense business operations for preclinical, clinical and manufacturing support that reduce business/operational risks (e.g., inefficiencies and costly delays) while maintaining regulatory compliance.

PSG provides interpretation of regulatory compliance requirements to pharmaceutical and biotechnology companies, and software companies that support them. Len Grunbaum, partner of The Practical Solutions Group, added "we have introduced some timely and welcome innovations to the regulatory compliance implementation landscape. Through our analysis of each company’s operational risk factors and practical recommendations, our clients realize business efficiencies while maximizing profitability and minimizing regulatory deficiencies." Those that engage The Practical Solutions Group earlier in the process have discovered that it is better business to proactively identify and address operational risks prior to them becoming regulatory issues which, in turn, could have profound implications on company’s profits.

"We advocate a practical way of meeting regulatory compliance requirements." Adds partner Emma Barsky, "We help companies to overcome the regulatory compliance burden while keeping operations simple, flexible and scalable." The partners operate under the premise that it is easier, less costly and less time-consuming to comply with FDA regulations by:

· Exercising common sense
· Assessing operational and business risks in adopting compliance practices,
· Applying hands-on understanding of the intent of FDA regulations
· Knowing how to minimize documentation without compromising quality

PSG has proven that this thinking allows companies to achieve and maintain regulatory compliance without having to:

· Add staff
· Engage in non-productive activities or
· Increase operating costs.

PSG’s approach results in financial benefits to life sciences companies, as these selected cases illustrate:

· A Contract Research Organization (CRO) can now save four-six weeks and tens of thousands of dollars each time their EDC system is configured to support a client clinical trial;

· A specialty sub-investigator has been able to triple in size without having to re-engineer its processes;

· By strategically reducing its documentation suite by 50%, a CRO is now in regulatory compliance;

· A software developer is now able to commercialize its product in the life science industry without having to re-vamp its corporate culture or structure.

Emma Barsky and Len Grunbaum are the partners of The Practical Solutions Group, LLC. Ms. Barsky leverages her proven expertise in the areas of GXP Quality Assurance and Project Management. Since the time the business was launched, Ms. Barsky has performed multiple overall quality and computer validation assessments, conducted multiple field investigations, helped start-up companies to build a quality infrastructure in order to successfully pass client audits and managed multiple projects that required the assistance of subcontractors.

Mr. Grunbaum is a recognized expert in the industry, particularly in the areas of data management computerized systems and processes that support them, Quality Assurance and Compliance with 21 CFR part 11. He has written extensively on these subjects, won best articles awards, and has delivered numerous tutorials and training sessions to clients and industry groups on the subject. He has also provided compliance enforcement training to the FDA and helped to build quality infrastructures for pharmaceutical and biotech companies, and organizations that support them.