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Bridging the Gap: from Discovery to Commercialization Bridging the Gap: from Discovery to Commercialization Bioscience Discovery Visualizing Evaluation the Gap Grant Program page 6 page 24 Colorado by Directory the Numbers: of Bioscience 2011 update Companies and page 11 Resources page 42 Fitzsimons Life Science District a great place to raise an idea Located in Aurora, Colorado, it’s one of the largest bioscience developments in the country, a place where there’s plenty of room to grow an idea from discovery to market viability. Whether you start in the bioscience incubator or move into a state-of-the art lab facility, everything you need is close at hand. A cluster of talent and resources is available to you, including direct access to the more than 80 core laboratories at the University of Colorado Anschutz Medical Campus – all just steps away. Features throughout the district, such as parks and conference facilities, are designed to inspire collaboration. And a nearby mix of shops, restaurants and homes let your people thrive right along with your ideas. For leasing and land purchase opportunities at the Colorado Science + Technology Park, within the Fitzsimons Life Science District, call 720-941-7100. Join the conversation at FitzScience.com FIT 110352 Brand Ad_M.indd 1 3/23/11 1:32 PM Improve the health of your business. Collaborations between bioscience 227 acres of state-of-the-art patient successful Colorado companies such companies and faculty researchers at care, research and education, the as Myogen/ Gilead Sciences Colorado, the University of Colorado Anschutz Anschutz Medical Campus provides GlobeImmune, ARCA, and ApopLogic Medical Campus are flourishing. unique opportunities for business Pharmaceuticals. And with Denver Which means the opportunities for development. The University’s International Airport being only 15 improvement—in the health of Technology Transfer o ce, ranked minutes away, access to both coasts Coloradoans and in the health of among the top 20 universities for takes only a few hours. your business—are excellent. creating start-up companies, creates With 2,000 of the nation’s best and a pipeline to success— with almost brightest researchers, 22 new core $3 billion generated for the economy Contact us today—and let us research labs, onsite a liate hospitals, and between 2002-2010. Just ask new business solutions for you. Contact: [email protected] STATE-OF-THE-ART LABS RESEARCHERS AWARDS START-UPS 11-CUD-010 BioMed _ImproveBiz_Ad.indd 1 4/15/11 7:11 AM Looking for a place to locate a bioscience company? Put us under the microscope. Metro Denver is home to some of America’s top university laboratories and research centers including the country’s largest medical-related development – the $5.2 billion Fitzsimons Life Science District and the adjacent Anschutz Medical Campus. We are the bioscience center of the Rocky Mountain West, offering companies access to knowledge workers, venture capital, and incubators. Not to mention an enviable lifestyle that helps retain our highly-skilled workforce. Examine us closely at www.metrodenver.org/bioscience. You’ll find that Metro Denver is well positioned for the future of bioscience. MDE11008 BioSciAd8.25x10.88.indd 1 4/11/11 3:11 PM TABLE OF CONTENTS Welcome to the Colorado BioScience Association’s seventh edition of Bioscience Colorado, the state’s only in depth guide 22 and directory to the bioscience industry. Webb-Waring Biomedical This publication is an integral part of the Research Program: Association’s mission to support the regional Boettcher Investigators bioscience community through advocacy, resources and advancement of opportunities for collaboration. 24 With a printed circulation of 6,000 and Bioscience Discovery over 10,000 on-line impressions, this publica- Evaluation Grant tion is one of our industry’s greatest voices Bridging the Gap Program locally, nationally and internationally. This from discovery to year’s issue of Bioscience Colorado takes a commercialization closer look at the process from discovery to commercialization. As we explore each step 33 of a company’s lifecycle it is clear that Colo- 6 Colorado’s Clinical rado has the drive and dedication to succeed! Visualizing the Gap Trial Landscape Holli Baumunk 8 36 Discovery to Mile High Development: Manufacturing President and CEO The Story of Colorado BioScience Association Technology Transfer 39 Produced by: Changing the Lives of 11 Patients for the Better: Colorado by the The True Measure of Colorado BioScience Association Numbers: Success for Colorado’s 216 16th Street, Suite 850 2011 update Bioscience Industry Denver, CO 80202 www.CoBioScience.com (303) 592-4073 16 42 Weaving a Web of Directory of Bioscience Published by: Support Companies and Colorado BioScience Association and and Guidance Resources Colorado Office of Economic Development and International Trade 18 When the Going Gets Tough, the Tough Get Creative Financing BIOSCIENCE COLORADO 2010/2011 5 Visualizing the Gap Discovery Valley of Death Preclinical Development FDA Clinical Trials FDA Approval (CO Sherpas) Review Average 6.5 years 30 days Average Average Average Average Approval 1.5 years 2 years 3.5 years 1.2 years Tech Transfer Business Development Assets Synthesize Chemical Compound IND Phase I Phase II Phase III FDA evaluates submission Office disclosures • CID4 510k • FBBp Determine Formulation, Develop PMA 20-80 100-300 1000-3000 Finalize manufacturing and Apply for Patent • Larimer Bioscience Cluster Delivery Technology healthy patient patient marketing issues • CBSA volunteers volunteers volunteers • Rocky Mountain Innosphere Conduct Preclinical FDA monitors Laboratory/Animal Studies Conduct Evaluate, Confirm post-submission development Research & University Assets Pharmacology FDA safety efficacy, efficacy, • CIMB Pharmacokinetics evaluates studies Pharmaco- pharmaco- • C2D2 economics, economics, • Advanced Diagnostics Labs - Nat’l Jewish Device Prototyping Biotech Conduct quality of quality of • Biochem Genetics Lab Dept Pediatrics, UC Denver Device Quality Systems Pharma formulation, life life • Ctr for Genetics & Therapeutics Lab, Nat’l Jewish Device Manufacturing Device dosage, • CO Genetics Lab Dept Pathology, UC Denver Diagnostic tolerance Assess side Monitor • DNA Diagnostic Lab UC Denver studies effects adverse • Genomics Proteomics Core Rocky Mtn Reg reactions Center of Excellence from long • High Throughput Sequencing Core Consortium term use for Comparative Genomics • Morphology and Phenotyping Core • Gates Regenerative Medicine • Mycobacteria Research Labs CSU • Network of Translational Technologies, CO Clinical Trials & Translational Svc Inst. IND/PMA NDA NDA • The Carl and Hazel Felt Lab for Pulmonary Filed Filed Approval Research National Jewish Financing Qualifying Therapeutic Discovery Projects, Boetcher Webb-Warning Biomedical Grants & Government Grants Bioscience Discovery Evaluation Grant Program Venture Capital M&A and IPO Biotech 10,000 Compounds 1,000 Compounds 5 Compounds enter trials 1 Compound approved Discovery Biotech/Pharma Average Discovery to Commercialization Cost $800 million to $1 billion 10+ years Time/ Cost to Market Device/Diagnostic Average Discovery to Commercialization Cost $5 million to $100 million 5+ years Colorado’s Royal Gorge Bridge, the world’s highest suspension bridge 6 2010/2011 BIOSCIENCE COLORADO Visualizing the Gap Discovery Valley of Death Preclinical Development FDA Clinical Trials FDA Approval (CO Sherpas) Review Average 6.5 years 30 days Average Average Average Average Approval 1.5 years 2 years 3.5 years 1.2 years Tech Transfer Business Development Assets Synthesize Chemical Compound IND Phase I Phase II Phase III FDA evaluates submission Office disclosures • CID4 510k • FBBp Determine Formulation, Develop PMA 20-80 100-300 1000-3000 Finalize manufacturing and Apply for Patent • Larimer Bioscience Cluster Delivery Technology healthy patient patient marketing issues • CBSA volunteers volunteers volunteers • Rocky Mountain Innosphere Conduct Preclinical FDA monitors Laboratory/Animal Studies Conduct Evaluate, Confirm post-submission development Research & University Assets Pharmacology FDA safety efficacy, efficacy, • CIMB Pharmacokinetics evaluates studies Pharmaco- pharmaco- • C2D2 economics, economics, • Advanced Diagnostics Labs - Nat’l Jewish Device Prototyping Biotech Conduct quality of quality of • Biochem Genetics Lab Dept Pediatrics, UC Denver Device Quality Systems Pharma formulation, life life • Ctr for Genetics & Therapeutics Lab, Nat’l Jewish Device Manufacturing Device dosage, • CO Genetics Lab Dept Pathology, UC Denver Diagnostic tolerance Assess side Monitor • DNA Diagnostic Lab UC Denver studies effects adverse • Genomics Proteomics Core Rocky Mtn Reg reactions Center of Excellence from long • High Throughput Sequencing Core Consortium term use for Comparative Genomics • Morphology and Phenotyping Core • Gates Regenerative Medicine • Mycobacteria Research Labs CSU • Network of Translational Technologies, CO Clinical Trials & Translational Svc Inst. IND/PMA NDA NDA • The Carl and Hazel Felt Lab for Pulmonary Filed Filed Approval Research National Jewish Financing Qualifying Therapeutic Discovery Projects, Boetcher Webb-Warning Biomedical Grants & Government Grants Bioscience Discovery Evaluation Grant Program Venture Capital M&A and IPO Biotech 10,000 Compounds 1,000 Compounds 5 Compounds enter trials 1 Compound approved Discovery Biotech/Pharma Average Discovery to Commercialization Cost $800 million to $1 billion 10+ years Time/ Cost to Market Device/Diagnostic Average
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