CSSi LifeSciences(TM) Participates in Colorado BioScience Association's Long-Awaited BioBoot Camp 2016

Glen Burnie, MD – On Friday, April 29, 2016, CSSi LifeSciences™ team members participated as featured speakers for the highly-anticipated BioBoot Camp 2016, a signature program produced by the Colorado BioScience Association. The two-day event brought together a group of more than 45 entrepreneurs, inventors and university professionals from across Colorado and the region to the offices of Dorsey & Whitney in Denver, Colorado from April 28-29, 2016.

Heidi Nelson-Keherly, Ph.D., Executive Director of Preclinical Research at CSSi LifeSciences™, presented on “Preclinical Drug Discovery and Development” during the second day of the event. Dr. Nelson-Keherly outlined the major steps required for commercializing a drug, including details from the discovery phase as well as the manufacturing and safety studies needed for the Investigational New Drug (IND) filing. She also covered the steps needed to prepare and submit the IND application to the Food and Drug Administration prior to first-in-man studies. Dr. Nelson-Keherly has nearly 20 years of experience in working with small and mid-size biotechs to develop their drug programs through to IND submission. Throughout her professional career, Dr. Nelson-Keherly has managed over 300 drug development programs and was responsible for several multi-therapeutic clinical research sites that participated in over 80 Phase II-IV clinical trials.

Immediately following Dr. Nelson-Keherly’s morning presentation, CSSi LifeSciences™ President Jim Sergi spoke to a full audience of eager-to-learn individuals about the topic of “SmartStart™ your Clinical Drug Development”. During his presentation, Jim discussed the major clinical and regulatory processes required for commercializing a drug or biologic for a New Drug Application or Biologic License Application filing. He also talked about the strategic considerations needed to accelerate one’s clinical program, while mitigating risk and driving value. Jim is a well-known thought leader in the clinical research industry and has played a major role in the commercial success and launch of over 400 drugs and biologics. In addition, he has established an effective and efficient model for helping companies and clients create a strategic pathway from discovery to commercialization that has resulted in a reduction of development time, costs and resources.

“Dr. Nelson-Keherly and I were honored to have been invited to participate in this year’s BioBoot Camp,” said Jim Sergi, President of CSSi LifeSciences™. “We were very grateful for the opportunity and enjoyed providing like-minded individuals with real world, pragmatic advice and solutions to help perfect their business model and successfully transition their innovations into the marketplace. The program was a great success!”

The Colorado BioScience Association’s BioBoot Camp is a two-day program that provides eager individuals with the necessary tools and resources needed to meet their key development and commercialization goals. Attendees representing biotech, pharma, medical device, diagnostic and digital health sectors had the chance to hear, firsthand, how experienced entrepreneurs from the life science industry address the trends, opportunities and challenges of transforming technologies into a viable and success business venture.

“BioBoot Camp has become a signature program for the Colorado BioScience Association since its inception nearly ten years ago,” said April Giles, President & CEO, Colorado BioScience Association. “Along with our partners at Dorsey and Whitney, we strive to provide relevant business and clinical content to our companies that are just beginning their journey into company development. Information delivered by speakers such as Dr. Nelson-Keherly and Jim Sergi provide our companies with useful tools and insight from industry experts in all facets of life science company development.”

CSSi LifeSciences™ strives to provide innovative, fully integrated solutions and improved efficiencies that extends throughout the entire product lifecycle of a new drug or device, with the added benefit of improving quality health outcomes for patients. To learn more about CSSi LifeSciences™, please visit www.cssilifesciences.com or email us at lifesciences@cssienroll.com.

About CSSi LifeSciences™:

CSSi LifeSciences™ provides fully integrated, specialized regulatory and clinical services to support the entire product lifecycle, from discovery to commercialization, for pharmaceutical and medical device companies. With global expertise, CSSi LifeSciences™ has been a key partner in the development of more than 500 drugs, biologics, medical devices and in-vitro diagnostics. For more information, visit www.cssilifesciences.com or email us at lifesciences@cssienroll.com.

About Colorado BioScience Association:

The Colorado BioScience Association serves as the hub of Colorado’s thriving bioscience sector by connecting innovators to funding, infrastructure, research and talent. From promising young companies to established corporations and institutions, it provides opportunities for networking, education and professional development. The Association grows the bioscience workforce and leads business expansion policies to advance the industry in the state. CBSA represents more than 350 member organizations, including biotechnology, pharmaceutical, medical device, diagnostic, ag bio and mobile digital health companies, research and academic institutions and service providers. Learn more at http://www.cobioscience.com.

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