Press Releases

CSSi LifeSciences™ Executives Featured at Colorado BioScience Association BioBoot Camp 2017

Approximately 40 leading life science industry influencers participated in two-day Denver-based program, April 20-21, 2017

Glen Burnie, Md. (April 21, 2017) – Today, Friday, April 21, 2017, members of CSSi LifeSciences™’s executive team served as featured speakers for BioBoot Camp 2017, a signature program produced by the Colorado BioScience Association (CBSA). Jim Sergi, President of CSSi LifeSciences, and Heidi Nelson-Keherly, Ph.D., Executive Director of Preclinical Research at CSSi LifeSciences, provided real-world insights on successfully transitioning innovations into the marketplace to 30 life science start-ups from all across the state of Colorado.

“CSSi LifeSciences was honored to participate in CBSA’s BioBoot Camp,” said Sergi. “It was an incredible experience to be a part of such an effort in which some of Colorado and the industry’s leading life science experts gathered together to support CBSA and its mission as well as promote the growth of the industry within the state.”

Dr. Nelson-Keherly’s presentation “Preclinical Drug Discovery and Development” 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. Shortly after Dr. Nelson-Keherly spoke, Sergi gave a talk titled, “SmartStart™ your Clinical Drug Development,” where he 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 spoke about the strategic considerations needed to accelerate one’s clinical program, while mitigating risk and driving value.

BioBoot Camp continues to be one of the most important programs offered by the Colorado BioScience Association,” said April Giles, President & CEO of the Colorado BioScience Association. “Along with our partners at Dorsey and Whitney, we provide relevant business and clinical content to help bioscience start-ups address the necessary fundamentals to transform their technology into a viable company. Information provided by experts such as Dr. Nelson-Keherly and Jim Sergi is a critical part of this endeavor.”

For more than 10 years, BioBoot Camp has to provided individuals with the necessary tools and resources to meet their key development and commercialization goals. Attendee companies representing biotech, pharma, medical device, ag-bio, diagnostic and digital health sectors learn valuable information from experienced entrepreneurs about the trends, opportunities and challenges of transforming technologies into a viable and successful business venture, while trying to avoid legal, financial and regulated pitfalls that may be encountered along the way.

About CSSi LifeSciences:
CSSi LifeSciences ensures a successful and expeditious pathway to commercialization for our clients’ drugs and medical devices by providing insight-driven analysis that saves time, development costs and resources. CSSi LifeSciences enables faster, more informed decision making to increase commercial success, while reducing the risk of late-stage failures and post-authorization action. CSSi LifeSciences is headquartered in Baltimore, MD, with additional offices in San Francisco, CA, London, UK and Hyderabad, India. For more information, please visit: www.cssilifesciences.com, email: info@CSSiLifesciences.com or call: (888) 279-8388.

About Colorado BioScience Association:
Colorado BioScience Association champions life science. We serve 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, we provide opportunities for networking, education and professional development. We grow the bioscience workforce and lead business expansion policies to advance the industry in our 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 about us at http://www.cobioscience.com.

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Media Contact:
Courtney Megaughey
Public Relations and Marketing Coordinator
CSSi LifeSciences
(443) 308-5831
Cmegaughey@cssienroll.com

Tom Borak
Communications and Membership Manager
Colorado BioScience Association
(720) 382-5918
tborak@cobioscience.com

CSSi LifeSciences™ and the Prince William Science Accelerator Partner to Deliver Critical Support Services to Wet Lab Space Startups

Glen Burnie, Md. (April 6, 2017) – CSSi LifeSciences™, a trusted partner from discovery to commercialization for biologics and vaccines, is pleased to announce a strategic partnership with the Prince William Science Accelerator, the only public-private commercially available wet lab space in Northern Virginia. The partnership promotes the development of new businesses and the retention and expansion of existing businesses within the county’s growing and diverse life sciences community, through CSSi LifeSciences’ technical assistance, regulatory, clinical and commercial assessment for all Prince William Science Accelerator tenants.

The extensive preclinical, regulatory and clinical expertise of CSSi LifeSciences combined with the Prince William Science Accelerator’s innovative wet lab space will allow startup life sciences and biotechnology companies to have access to talent, multiple opportunities for collaboration and incredible prospect for expanded growth within the life sciences industry in the County. More specifically, the strategic partnership will deliver a productive environment and speed-to-market solutions to wet lab tenants through the use of unparalleled services and strategies and readily available space and equipment, as well as by providing access to industry networks, partnerships and internships.

“We are excited about partnering with the Prince William Science Accelerator and extending our reach into the Virginia market,” said Jim Sergi, President, CSSi LifeSciences. “With Prince William County’s already well-established and growing life sciences ecosystem, we are committed to providing the Science Accelerator with the necessary services and resources needed to help add to its growing portfolio of wet lab tenants. Together, we are the ideal solution for bringing life sciences companies’ innovations to market faster and more cost-effectively.”

“The Prince William Science Accelerator has strong market appeal, as there is no other space like it in the region. Partnering with CSSi LifeSciences further enhances our unique offering and pro-business support that Prince William County is recognized for,” said Jeffrey A. Kaczmarek, Executive Director, Prince William County Department of Economic Development.

Over the years, CSSi LifeSciences has provided vital business and strategic support to “Big” biopharma, as well as incubators, and enabled the development of over 500 drugs, biologics and in-vitro diagnostics. CSSi LifeSciences has a defined process that lets its clients leverage its breadth of integrated services and growth strategies to develop strategic regulatory and clinical pathways to ensure commercial success and maximize shareholder value.

First established in 2014, the Prince William Science Accelerator was designed to provide an innovative environment for entrepreneurial research and product development. Ideally situated in Innovation Park near George Mason University, the 9,000 sq. ft. facility houses nine fully built-out wet laboratory spaces suited for each tenant’s specific needs. The Science Accelerator is amongst the largest and fastest-growing cluster of life and forensic sciences facilities in the region.

About CSSi LifeSciences:
CSSi LifeSciences ensures a successful and expeditious pathway to commercialization for our clients’ drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. CSSi LifeSciences enables faster, more informed decision making to increase commercial success, while reducing the risk of late-stage failures and post-authorization action. CSSi LifeSciences is headquartered in Baltimore, MD, with additional offices in San Francisco, CA, London, UK, and Hyderabad, India. For more information, visit www.cssilifesciences.com, email info@CSSiLifesciences.com or call (888) 279-8388.

About the Prince William Science Accelerator:
Located in the heart of Prince William County’s Science and Technology hub at Innovation Park, the Prince William Science Accelerator is a premier life sciences incubation facility, which features 9 fully built out, commercially available wet labs - the only public-private commercially available wet lab space in Northern Virginia. Competitive lease rates, flexible terms, location incentives, as well as a full complement of amenities are just some of the reasons why the Science Accelerator is an ideal option particularly for startups and growing life sciences companies. To learn more, please contact Chris Girdwood at (571) 839-0776 or email: cgirdwood@pwcgov.org or visit: www.PWCEconDev.org.

Media Contact:
Courtney Megaughey
Public Relations & Marketing Coordinator
CSSi
(443) 308-5831
Cmegaughey@cssienroll.com

CSSi LifeSciences™ Joins the Ranks of Top Industry Leaders at 12th Annual NIH CAP FeedFoward™ Sessions

Attending Companies Serve as Professional Mentors for Early-Stage Life Science Entrepreneurs

Glen Burnie, Md. (March 20, 2017) – CSSi LifeSciences™’s Jim Sergi and Heidi Nelson-Keherly, PhD recently served as professional mentors at the NIH CAP FeedForward™ Sessions in Irvine, CA (March 6-7, 2017) and Washington, D.C. (March 16-17, 2017). Managed by Larta Institute, this year’s events brought in 58 bioscience companies who received feedback from nearly 260 industry and domain experts, including representatives from GE, UMBC, Focus Bankers, and the FDA.

During the two-day workshops, Jim and Heidi provided the 2016-17 cohort of award-winning startup companies with the useful tools and resources as well as real world, pragmatic advice and solutions needed to meet their development and commercialization goals. These interactive discussions focused on servicing each company’s specific needs and covered pertinent industry topics such as identifying the best target market, designing the program studies for IND and NDA/BLA submissions, accessing capital, establishing product pricing, and preparing for possible commercial exits.

“During the FeedForward™ Sessions in Irvine, I had the honor and privilege of working alongside some of the industry’s most influential business leaders, executives and accredited investors in the industry,” said Jim Sergi, President, CSSi LifeSciences™. “We all gathered together for the common purpose of guiding and inspiring some of the brightest entrepreneurial minds to help them create a successful future for themselves. I was extremely grateful for the opportunity and appreciate Larta Institute for hosting and inviting CSSi LifeSciences™ to these wonderful events. We look forward to returning in the future!”

“Participating as a mentor was a very rewarding experience, as it allowed me to connect with aspiring entrepreneurs on both a professional and personal level,” said Heidi Nelson-Keherly, PhD, Executive Director, Preclinical Research, CSSi LifeSciences™. “This was not only a transformative experience for the mentees, but it also helped create a monumental opportunity for the mentors to discover and interact directly with emerging companies from all over the country. These events are valuable for addressing the business needs of both the mentor and mentee and establishing long-lasting strategic relationships. I thoroughly enjoyed the D.C.-based event and the opportunities it provided to CSSi LifeSciences™, the entrepreneurs and the industry as a whole!”

Larta Institute’s FeedForward™ Sessions have become a scouting ground for industry and early-stage investors to discover and meaningfully connect with companies in successive CAP cohorts. For the past 11 years, the program has remarkably obtained 39 acquisitions (most recent being Avalon Biomed, acquired by NuSmile and Advanced Circulatory Systems, acquired by Zoll), and $925M+ in funding generated by NIH CAP alumni companies.

“We truly appreciate CSSi LifeSciences™’s recent participation in our FeedForward™ Sessions, as the need for industry leaders to collaborate and foster the sharing of best practices with startup companies has never been greater,” said Judy Hsieh, Program Director, Larta Institute. “Jim and Heidi brought their exceptional preclinical and clinical research knowledge and therapeutic drug and device expertise to our mentee companies, who are in need of perfecting their business models in order to successfully transition their innovations into the marketplace. Getting the right people in the room for each company’s need has been a Larta trademark for the past twelve years.”

About CSSi LifeSciences™:
CSSi LifeSciences ensures a successful and expeditious pathway to commercialization for our clients’ drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. CSSi LifeSciences enables faster, more informed decision making to increase commercial success, while reducing the risk of late-stage failures and post-authorization action. CSSi LifeSciences™ is headquartered in Baltimore, MD, with additional offices in San Francisco, CA, London, UK, and Hyderabad, India. For more information, visit www.cssilifesciences.com, email info@CSSiLifesciences.com, or call (888) 279-8388.

About Larta Institute:
Larta Institute, founded in Los Angeles in 1993, is an internationally recognized and mission-driven innovation accelerator that provides a runway of success for world-changing ideas in agriculture, energy and healthcare. Larta Institute has helped more than 10,000 companies transform ideas into commercialized innovations that feed, fuel and heal the world. With a global network of entrepreneurs, mentors, investors, industry leaders, research institutions, government agencies and support organizations, Larta conducts commercialization assistance programs throughout the U.S. and in more than 20 countries. Follow us on Twitter@LartaInstitute.

About National Institutes of Health CAP:
The NIH Commercialization Acceleration Program (NIH CAP), Larta Institute’s longest running commercialization program, provides tailored one-on-one advisors and business assistance to NIH’s top tier grantees in Phase II of the SBIR/STTR program. Through Larta’s trademark network-centric practice, the entrepreneurs receive the guidance and tools they need to transition their technologies to the marketplace. Designed to service each company’s unique needs, the NIH CAP has a notable track record of 39 acquisitions (most recent being Avalon Biomed, acquired by NuSmile & Advanced Circulatory Systems, acquired by Zoll), and $925M+ in funding generated by NIH CAP alumni companies.

About FeedForward™ Sessions:
FeedForward™ Sessions are closed-door, invitation-only workshop sessions for participating NIH CAP companies to present their 18-month strategic plans to industry and domain experts drawn from senior stakeholders, investors and other representatives in the medical and healthcare community. Larta designs each session with specific company needs in mind, for feedback on everything to do with their business and marketing model and practical advice on building and operating their companies.

Media Contacts:
Courtney Megaughey
Public Relations & Marketing Coordinator
CSSi
(443) 308-5831
Cmegaughey@cssienroll.com
Mary Guiden
Colorado State University
(970) 491-6892
Mary.Guiden@colostate.edu

Biologics and Biosimilars FDA Naming Guidance

Glen Burnie, Md. (March 17, 2017) – In January, the FDA finalized guidance regarding how biosimilars and their biologic counterpart’s names should include a four-letter, FDA-designated suffix at the end of the nonproprietary name. The guidance was released with the goal of facilitating improved pharmacovigilance for biologics and biosimilars, stating that “nonproprietary names that include distinguishing suffixes can serve as a key element to identify specific products in spontaneous adverse event reporting and to reinforce accurate product identification in billing and claims records used for active pharmacovigilance.” This change will require companies to submit 10 suffixes to the FDA for consideration as part of the naming of biologics.

CSSi LifeSciences™ has the experience and understanding of FDA regulations to ensure that biologics and biosimilars submissions contain the appropriate information and are properly filed with FDA.

FDA suggests that proposed suffixes should be:

  • unique
  • devoid of meaning
  • nonproprietary
  • nonproprietary
  • attached to the core name with a hyphen
  • four lowercase letters of which at least three are distinct
  • free of legal barriers that would restrict its usage

According to the FDA. the proposed suffix should not:

  • be false or misleading, such as by making misrepresentations with respect to safety or efficacy
  • include numerals and other symbols aside from the hyphen attaching the suffix to the core name
  • include abbreviations commonly used in clinical practice in a manner that may lead the suffix to be misinterpreted as another element on the prescription or order
  • look similar to or be capable of being mistaken for the name of a currently marketed product (e.g., should not increase the risk of confusion or medical errors with the product and/or other products in the clinical setting)
  • look similar to or otherwise connote the name of the license holder
  • be too similar to any other FDA-designated nonproprietary name suffix

The FDA will continue to consider the appropriate suffix format for interchangeable products and is expected to release a guidance later this year regarding interchangeability.

CSSi LifeSciences™ and BioMARC Announce Strategic Partnership to Provide a Single-Source Biopharmaceutical Manufacturing and Clinical Solution

Collaboration to Drive, Support, and Grow High-Containment Biologics Manufacturing

Glen Burnie, Md. (January 9, 2017) – CSSi LifeSciences™, a trusted partner from discovery to commercialization for biologics and vaccines, today announced a strategic partnership with Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC), a nonprofit Contract Manufacturing Service Unit owned and operated by Colorado State University. CSSi LifeSciences™ has extensive preclinical, regulatory and clinical expertise, while BioMARC produces biopharmaceutical products for non-clinical, clinical, and commercial use. Together, these two organizations offer unparalleled guidance for companies developing either biologics or vaccines.

“We are very pleased to establish this collaborative partnership with BioMARC,” said Jim Sergi, President, CSSi LifeSciences™. “We recognize the size and complexity of advanced development solutions for the manufacture and regulated release of viral vaccines and biologics, and are excited to provide a single-source solution to complement BioMARC’s internal resources. CSSi LifeSciences™ is committed to providing BioMARC with the integrated services and resources needed to grow its business and expand its offerings further into the market.”

“The pathway to commercialization for a new medical device can be ambiguous and complex due to ever-changing regulations and requirements. To help companies overcome this barrier, we developed our unique Medical Device CRO,” said Jim Sergi, President and Partner, CSSi LifeSciences™. “We take pride in being an industry leader, as well as creating a new breed of CRO, one that focuses specifically on the medical device industry. We believe taking this approach in today’s new world of healthcare is intelligent, critically honest, and backed by a history of verifiable results, including over two hundred and fifty successful 510(k) applications.”

Transforming a new biologic or vaccine entity into a treatment opportunity is a complex, expensive and time-sensitive process. As part of the collaboration, BioMARC and CSSi LifeSciences™ will work together to create an accelerated, cost-effective GMP and clinical development solution. The two companies complement one another, with proven expertise and experience in process development and cGMP manufacturing using validated processes, as well as preclinical, CMC and global regulatory development and clinical operations.

“Our combined capabilities will provide a fully-integrated, one-stop manufacturing solution for the accelerated preclinical, manufacturing and clinical testing of biological therapeutics, novel vaccines and diagnostic products intended for use in humans,” said Raymond Goodrich, PhD, Executive Director, Infectious Disease Research Center, which houses BioMARC on CSU's Foothills campus.

To date, BioMARC has brought a diagnostic parenteral product through clinical trial and commercial production (including PAI inspection), manufactured a virus vaccine for a phase I clinical study, established several master and working cell or virus banks, developed and qualified cell-based and analytical assays for product testing and release, and established a controlled process for manufacturing a vaccine product for preclinical studies in non-human primates bridging to a phase I study in humans.

Dennis Pierro, PhD, director of BioMARC, also welcomed the new collaboration. “The partnership with CSSi LifeSciences™ significantly strengthens our core capabilities and service offerings in the area of product lifecycle management,” he said. “CSSi LifeSciences’™ broad experience and expertise in regulated products means that we can now better help vaccine and biologic developers efficiently move products into the marketplace to the benefit of patients.”

Over the years, CSSi LifeSciences™ has provided vital business and strategic support to “Big” biopharma, as well as incubators, and enabled the development of over 500 drugs, biologics and in-vitro diagnostics. CSSi LifeSciences™ has a defined process that lets its clients leverage its breadth of integrated services and growth strategies to develop strategic regulatory and clinical pathways to ensure commercial success and maximize shareholder value.

A formal announcement about the newly developed partnership will be made at today’s CSSi LifeSciences™ Partnering Forum 2017, taking place during J.P. Morgan 35th Annual Healthcare Conference week. For more information on CSSi LifeSciences™ and its diversified services, visit www.cssilifesciences.com/CRO, email info@CSSiLifesciences.com, or call (415) 317-4903.

About CSSi LifeSciences™:
CSSi LifeSciences™ ensures a successful and expeditious pathway to commercialization for our clients’ drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. CSSi LifeSciences™ enables faster, more informed decision making to increase commercial success, while reducing the risk of late-stage failures and post-authorization action. CSSi LifeSciences™ is headquartered in Baltimore, MD, with additional offices in San Francisco, CA, London, UK, and Hyderabad, India. For more information, visit www.cssilifesciences.com, email info@CSSiLifesciences.com, or call (888) 279-8388.

About Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC):
BioMARC is a nonprofit Contract Manufacturing Service Unit owned and operated by Colorado State University. In addition to manufacturing and testing services, BioMARC offers product and process development services, which includes the creation of development programs focused on implementation of Current Good Manufacturing Practice regulations and scalability issues. Visit www.biomarc.colostate.edu for more information.

About Colorado State University (CSU):
Founded in 1870 as the Colorado Agricultural College, CSU is now among the nation's leading research universities. Located in Fort Collins, CSU currently enrolls more than 33,000 students, and has more than 1,800 faculty members working in eight colleges.
CSU is recognized as a premier research institution and routinely ranks as one of the top American universities without a medical school in research expenditures. In Fiscal Year 2016, CSU research expenditures totaled $332 million; this was the ninth consecutive year research expenditures at the university have topped $300 million. More information is available at www.colostate.edu.

Media Contacts:
Courtney Megaughey
Public Relations & Marketing Coordinator
CSSi
(443) 308-5831
Cmegaughey@cssienroll.com
Mary Guiden
Colorado State University
(970) 491-6892
Mary.Guiden@colostate.edu

CSSi LifeSciences™ Launches Fully Integrated Medical Device CRO

Accelerating Research Breakthroughs and Product Developments to Commercialization

Glen Burnie, Md. (November 2, 2016) – CSSi LifeSciences™, a trusted partner from discovery to commercialization for drugs and medical devices, is excited to announce the establishment and launch of its fully integrated Medical Device CRO. CSSi LifeSciences™ Medical Device CRO aims to positively impact the timeline of regulatory clearance and increase profitability for medical device companies, in order to successfully launch their innovative research discoveries and product concepts into the market.

CSSi LifeSciences™ supports small and large companies in avoiding the “large CRO shuffle” by providing highly specialized regulatory and clinical expertise in medical devices, while also offering unparalleled and cost-efficient services from start to finish. The company’s goal is to accelerate product development by providing insight-driven guidance that saves time and cost.

“The pathway to commercialization for a new medical device can be ambiguous and complex due to ever-changing regulations and requirements. To help companies overcome this barrier, we developed our unique Medical Device CRO,” said Jim Sergi, President and Partner, CSSi LifeSciences™. “We take pride in being an industry leader, as well as creating a new breed of CRO, one that focuses specifically on the medical device industry. We believe taking this approach in today’s new world of healthcare is intelligent, critically honest, and backed by a history of verifiable results, including over two hundred and fifty successful 510(k) applications.”

In an effort to meet the growing demands of the medical device market, CSSi LifeSciences™’s team of medical device experts serve as a liaison for device manufacturers from inception to commercialization, leveraging deep subject matter expertise and regulatory experiences to effectively move new products to market with speed, accuracy, and the quality necessary to ensure safety, compliance, and health authority approval.

“Collectively, our medical device team has over 100 years of development and commercialization experience, coupled with global regulatory knowledge that goes beyond published guidance documents and initiatives,” said Sergi. “Our team possesses the necessary skills and resources to make our clients’ medical device efforts an end-user success.”

CSSi LifeSciences™ supports all phases of medical device development, from design engineering and testing to clinical studies and reimbursement. The company offers a broad suite of comprehensive and scalable services, including regulatory filings to US and foreign Notified Bodies; clinical study planning, monitoring, and reporting; FDA and EMA Agent for Foreign Registration; medical device testing and Design History Files; Quality Management Systems (21 CFR 820 and ISO 13485); health authority interactions; and, regulatory and scientific communication.

To learn more about CSSi LifeSciences™ Medical Device CRO, please visit www.cssilifesciences.com/CRO, email info@CSSiLifesciences.com, or call (415) 317-4903.

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. The company’s headquarters is located in Baltimore, MD, with additional offices in San Francisco, CA; London, UK; and Hyderabad, IND. For more information, visit www.cssilifesciences.com, email info@CSSiLifesciences.com, or call (415) 317-4903.

Media Contacts:
Courtney Gaddi
Public Relations & Marketing Coordinator
CSSi
(443) 308-5831
Cgaddi@cssienroll.com

CSSi LifeSciences™ Launches Fully Integrated Medical Device CRO

Accelerating Research Breakthroughs and Product Developments to Commercialization

Glen Burnie, Md. (October 13, 2016) – CSSi LifeSciences™, a trusted partner from discovery to commercialization for drugs and medical devices, is excited to announce the establishment and launch of its fully integrated Medical Device CRO. CSSi LifeSciences™ Medical Device CRO aims to positively impact the timeline of regulatory clearance and increase profitability for medical device companies, in order to successfully launch their innovative research discoveries and product concepts into the market.

CSSi LifeSciences™ supports small and large companies in avoiding the “large CRO shuffle” by providing highly specialized regulatory and clinical expertise in medical devices, while also offering unparalleled and cost-efficient services from start to finish. The company’s goal is to accelerate product development by providing insight-driven guidance that saves time and cost.

The pathway to commercialization for a new medical device can be ambiguous and complex due to ever-changing regulations and requirements. To help companies overcome this barrier, we developed our unique Medical Device CRO,” said Jim Sergi, President and Partner, CSSi LifeSciences™. “We take pride in being an industry leader, as well as creating a new breed of CRO, one that focuses specifically on the medical device industry. We believe taking this approach in today’s new world of healthcare is intelligent, critically honest, and backed by a history of verifiable results, including over two hundred and fifty successful 510(k) applications.

In an effort to meet the growing demands of the medical device market, CSSi LifeSciences™’s team of medical device experts serve as a liaison for device manufacturers from inception to commercialization, leveraging deep subject matter expertise and regulatory experiences to effectively move new products to market with speed, accuracy, and the quality necessary to ensure safety, compliance, and health authority approval.

Collectively, our medical device team has over 100 years of development and commercialization experience, coupled with global regulatory knowledge that goes beyond published guidance documents and initiatives,” said Sergi. “Our team possesses the necessary skills and resources to make our client’s medical device efforts an end-user success.

CSSi LifeSciences™ supports all phases of medical device development, from design engineering and testing to clinical studies and reimbursement. The company offers a broad suite of comprehensive and scalable services, including regulatory filings to US and foreign Notified Bodies; clinical study planning, monitoring, and reporting; FDA and EMA Agent for Foreign Registration; medical device testing and Design History Files; Quality Management Systems (21 CFR 820 and ISO 13485); health authority interactions; and, regulatory and scientific communication.

To learn more about CSSi LifeSciences™ Medical Device CRO, please visit www.cssilifesciences.com/CRO, email info@CSSiLifesciences.com, or call (866) 277-4888.

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. The company’s headquarters is located in Baltimore, MD, with additional offices in San Francisco, CA; London, UK; and Hyderabad, IND. For more information, visit www.cssilifesciences.com, email info@CSSiLifesciences.com, or call (866) 277-4888.

Media Contacts:
Courtney Gaddi
Public Relations & Marketing Coordinator
CSSi
(443) 308-5831
Cgaddi@cssienroll.com

CSSi LifeSciences™ and Innosphere Announce Pioneering Partnership to Deliver Innovative Medical and Drug Advancement Solutions

Partnership to Support Life Science Startups from Discovery to Commercialization in Colorado

Glen Burnie, Md. (August 11, 2016) – CSSi LifeSciences™, a trusted partner from discovery to commercialization for drugs and medical devices, today announced a corporate strategic partnership with Innosphere, a Colorado nonprofit incubator. The partnership will drive innovation and support entrepreneurship in Colorado by delivering unique medical device and drug development solutions to emerging life science companies in Colorado. This alliance is a deliberative result of Innosphere growing its innovations program and seeking to dramatically enhance services for client companies.

We are excited to form a new partnership with Innosphere and expand our footprint into the Colorado market,” said Jim Sergi, President, CSSi LifeSciences™. “This next-level integration will allow Innosphere’s client companies to utilize our comprehensive suite of services in order to develop their therapeutic drugs and devices with cost-efficient predictability, that drive value, extend market share, and maximize ROI. Together, we hope to help companies bridge the ‘Valley of Death’ and accelerate research breakthroughs, while accessing our global network of strategic partners.

The new collaboration will ensure a successful and expeditious pathway to commercialization for Colorado-based bioscience companies through cutting-edge, insight-driven analysis, strategies, and solutions that save time, development costs, and resources. CSSi LifeSciences™ will provide Innosphere with a full suite of services and deep subject matter expertise to help support the incubator’s client company portfolio. CSSi LifeSciences™ will also participate in regulatory, clinical, and commercial assessment as well as the onboarding process of Innosphere’s new prospective client companies. Additionally, CSSi LifeSciences™ will provide commercial development support, education and training programs to Innosphere’s client companies.

A critical ingredient for companies in the bioscience industry is clear guidance on regulatory, reimbursement, and engineering protocols,” said Mike Freeman, Innosphere CEO. “Innosphere’s partnership with CSSi LifeSciences™ provides that support system, and is an important element of Innosphere’s plan for growing the innovations program.

Over the years, CSSi LifeSciences™ has provided vital business and strategic support to “Big” biopharma, as well as incubators, and enabled the development of over 500 drugs, biologics, and in-vitro diagnostics. CSSi LifeSciences™ has a defined process that lets its clients leverage its breadth of integrated services and growth strategies to develop strategic and regulatory plans to ensure commercial success and maximize shareholder value. The company’s headquarters is located in Baltimore, MD, with additional offices in San Francisco, CA; London UK; and Hyderabad, IND.

Innosphere is Colorado’s leading technology incubator. In 2015, Innosphere supported 42 client companies, and 18 companies graduated from the program. Additionally, its client companies raised

$87.9M total capital and created 296 full and part-time jobs. Innosphere supports entrepreneurs building potential, high-growth companies in life sciences, health innovations, software and hardware, and energy and advanced materials.

CSSi LifeSciences™ and Innosphere will announce their newly developed partnership to attendees of Innosphere’s ‘Innovation After Hours’ networking forum, scheduled for this evening, August 11th. For more information on CSSi LifeSciences™ and its diversified services, visit www.cssilifesciences.com. More information on Innosphere and its incubator services can be found at www.innosphere.org.

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 info@CSSiLifesciences.com.

About Innosphere:
Innosphere is a technology incubator that accelerates the success of high-impact science and technology startups. Innosphere has two physical locations in Fort Collins and Denver, Colorado to support entrepreneurs building potential, high-growth companies in health innovations, life sciences, software & hardware, and energy & advanced materials. Innosphere’s incubation program focuses on ensuring companies are investor ready, connecting them with experienced advisors, and making introductions to corporate partners. Once accepted into the program, companies receive customized development plans and ongoing support to ensure they’re getting the know-how to raise the right kind of capital, and all the resources to scale. www.innosphere.org.

Media Contacts:
Courtney Gaddi
Public Relations & Marketing Coordinator
CSSi
(443) 308-5831
Cgaddi@cssienroll.com


Emily Wilson
Communications Director
Innosphere
(970) 295-4481
Emily@innosphere.org

CSSi LifeSciences™ Participates in Colorado BioScience Association’s Long-Awaited BioBoot Camp 2016

Denver-based Program Focuses on Successful Development & Commercialization of Life Science Innovations

Glen Burnie, MD. (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 info@CSSiLifesciences.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 info@CSSiLifesciences.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.

Media Contacts:
Courtney Gaddi
Public Relations & Marketing Coordinator
CSSi
(443) 308-5831
Cgaddi@cssienroll.com


Tom Borak
Title Communications Manager
Colorado BioScience Association
(720) 382-5918
tborak@cobioscience.com

CSSi LifeSciences™ President Jim Sergi Serves as Professional Mentor at 11th Annual NIH CAP FeedFoward™ Session in Washington, D.C.

Industry Expert Advises Medical and Healthcare Entrepreneurs on Best and Worst Practices for Product Development & Commercialization

Glen Burnie, MD. (March 15, 2016)– Jim Sergi, President of CSSi LifeSciences™, recently participated as a professional mentor at the National Institutes of Health (NIH) Commercialization Accelerator Program (CAP) FeedForward™ Session, organized by Larta Institute. 70 companies enrolled in the NIH CAP and 40 mentors, including representatives from GE, Siemens and John Hopkins University, participated in the highly anticipated two-day workshop in Washington, D.C.

As a mentor, Jim provided various medically and healthcare-driven entrepreneurs and startup companies with personalized feedback on the companies’ commercialization challenges, goals and program deliverables as presented in their 18-month “Commercialization Roadmap” and overall commercialization strategy. He also facilitated interactive discussions among participants and attending companies focusing on the pertinent topics of developing a successful business model, building a compelling value proposition and implementing an effective exit strategy.

“I am very grateful to have been given the opportunity to serve as a mentor at Larta Institute’s NIH CAP FeedForward™ Sessions this past week in D.C.,” said Jim Sergi, President of CSSi LifeSciences™. “It was a pleasure to be able to provide entrepreneurial firms with useful tools and resources necessary to meet their key development and commercialization goals. It is my hope that the participants I interacted directly with walked away with real world, pragmatic advice and solutions in which they can implement immediately to dramatically increase their business model and successfully transition their innovations into the marketplace.”

Jim is a recognized thought leader in the clinical research world 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.

“We were so pleased Jim Sergi was available to bring his clinical research and commercialization expertise to our FeedForward™ sessions in Washington, D.C.,” said Judy Hsieh, Program Director, Larta Institute. “Getting the right people in the room for each company’s need is a Larta trademark.”

Larta Institute’s FeedForward™ Sessions are face-to-face, private workshops held as a part of the NIH CAP for medical and healthcare entrepreneurs to receive individualized and group input in a constructive manner, as well as in a candid and informal setting. These two-hour-long, roundtable sessions allow participating companies the opportunity to test run their business strategy on experienced and qualified industry leaders and experts. This is not only a transformative experience for entrepreneurs, but it also creates a monumental opportunity for industry leaders and experts to discover and interact directly with emerging companies from across the country. The next FeedForward™ Session event will be held on Monday, March 21 in Irvine, California.

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 info@CSSiLifesciences.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.

About Larta Institute:
Larta Institute, founded in Los Angeles in 1993, is an internationally-recognized technology accelerator that has helped more than 10,000 companies transform ideas into commercialized, socially-beneficial innovations in science and technology, particularly in agriculture and the life sciences. With a global network of entrepreneurs, mentors, investors, industry leaders, research institutions, government agencies and support organizations, Larta conducts commercialization accelerator programs throughout the U.S. and in more than 20 countries. For additional information about Larta Institute, visit the organization’s website at www.larta.org.

About the National Institutes of Health CAP:
The NIH Commercialization Acceleration Program (CAP), Larta Institute’s longest running commercialization program, provides tailored one-on-one advisors and business assistance to NIH’s top tier grantees in Phase II of the SBIR/STTR program. Through Larta’s trademark network-centric practice, our entrepreneurs receive the guidance and tools they need to transition their technologies to the marketplace. Designed to service each company’s unique needs, our NIH CAP has a notable track record of 26 acquisitions and over 680 deals signed.

About FeedForward™ Sessions:
FeedForward™ Sessions are closed-door, invitation-only workshop sessions for participating NIH CAP companies to pitch their 18-month strategic plans to industry and domain experts drawn from senior stakeholders, investors and other representatives in the medical and healthcare community. Larta designs each session with specific company needs in mind, for feedback on everything to do with their business and marketing model and practical advice on building and operating their companies.

Media Contacts:
Courtney Gaddi
Public Relations & Marketing Coordinator
CSSi
(443) 308-5831
Cgaddi@cssienroll.com


Corey Carleton
Communications Director
Larta Institute
(213) 538-1441
ccarleton@larta.org