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CENTER FOR PRECLINICAL STUDIES
Student Consulting Team
Diana Cugliari
Joshua Trach
Natalie Garda
Chikara Yoshida
Opportunity:
Commercialization of a University Facility
The McGowan Institute for Regenerative
Medicine is seeking to commercialize their
Center for Preclinical Studies, and has
requested a complete analysis for this
commercialization.
McGowan Institute for
Regenerative Medicine
Center for Preclinical Studies (CPCS)
Background
Jonathan Sacker
Core Recommendations
 Viability
 Shift Mindset
 Modify Processes
Commercialization Recommendations
 Generate $7.59 million per year in revenues
 Results in $300,000 per year in profit
 Startup funds need ~ $1.6 million over 3 years
 Achieve positive cash flow within 4th year
 Focus service on small, short-term, preclinical studies
 Target small to medium sized medical device companies
 Modify to an entrepreneurial, customer focused mindset
 Align processes to be customer service focused
 Invest in additional staff, equipment and marketing efforts
M-B-A Plan
 Market Orientation in a University Setting
 Business Model Alignment with Target
Markets
 Alignment of Systems and Processes to
Market Demands
Methods
 Conducted 36 interviews
Customers, Competitors, Other Universities, University of
Pittsburgh, McGowan Institute Staff Members
 Researched 6 data sources
IBIS World, Hoovers, Frost & Sullivan, Federal Drug Administration,
National Institute of Health, Clinicaltrials.gov
 Conducted an Analysis
 Developed a Strategic Plan
 Forecasted Projections
Market Orientation in a
University Setting
 Identify the Market
 Competitor Analysis
 Entrepreneurial Opportunities
U.S. Contract Research Organization
(CRO)
Industry Market
• $15-$17 Billion Revenue
• 6%-10% CAGR (-2020)
• $2 Billion Profit (~12.8%)
• $4 Billion Wages (~25%)
• 3,000 – 3,300 Companies
Target Market
$100M
Preclinical
Medical
Device CPCS
Specialties
$200M
Preclinical
Medical
Device
Key Corridors
31.8% West
20.1% Southeast
14.3% Mid-Atlantic
Key Players
• 3,000 – 3,300 Companies
• Concentration is Low
• Fragmented market
$16.9B Rev
• Research
– Interviewed 6 Preclinical medical device Contract
Research Organizations
• Average size and activity
– $12M in revenue
– 40 people on staff
– 350 pre-clinical studies annually
Competitor Analysis
• Pricing
– Hybrid of cost-plus and market based pricing
– Prices vary 20% to 30%
• Revenue goals
– Annual, monthly and daily
• Value chain activities
Competitor Analysis
Entrepreneurial Opportunities
• Viable opportunity to operate a
commercialized preclinical laboratory
– Process – adopt processes that align with
competitors and core capabilities
– Resource – utilize resources under university
umbrella
– Knowledge – focus on competitive advantage,
which is knowledge of niche areas
Core Recommendations
 Viability
 Shift Mindset
 Modify Processes
Business Model Alignment with
Target Markets
 Vision and Mission Statement
 Target Customer
 Value Proposition
 Value Chain
 Profit Mechanism
 Marketing Channels
Vision
To support regenerative medicine development, science,
researchers, and clinicians in the pursuit of bench to bedside
translation of technologies.
Mission
To be an expert research facility in Quality Management
Systems that advances regenerative medicine innovation by
combining our niche expert knowledge, collaborators, and
clinicians to further customers’ innovations.
Vision and Mission
Business Model
Value
proposition
Profit
Mechanism
Who?
Value Chain
What?
How?Why?Gassmann,
Frankenberger
and Csik, 2014
• Medical device companies
– Small to medium sized
• Early stage researchers
Target Customer: Who?
• FDA Good Laboratory Practice Compliant
• “One Stop Shop” for animal studies
• High Tech Facility
• Intellectual Powerhouse
• Extensive and Influential Network
Value Proposition: What?
KeyResources
• Management
• Human capital
• Capital
investment
KeyActivities
• Good Laboratory
Practices
compliant
• Equipment
upgrades and
purchases
• Modify mindset
• Align processes
with industry
• Marketing
KeyPartners
• Clinicians
• Investigators
• FDA & NIH
• University
departments
• UPMC
• Foundations
Value Chain: How?
Profit Mechanism: Why?
• Small, short-term, large animal studies
• Pricing model
• Will be in positive cash flow by Year 4
Marketing Channels
Core Recommendations
 Viability
 Shift Mindset
 Modify Processes
Alignment of Systems and Processes to
Market Demands
 Process Flow
 Pricing Strategy
 Capacity
 Financial Projection
 Capital Investment
 Implementation Plan
Critical Areas
Timeliness
Pricing and
Pricing
Structure
Organizational
Structure
Standardization
Customer
Handling
Process Flow
Process Flow
CPCS Flow
Customer
Management
Study
Development
Conduct
Study
Produce
Findings
Render
Opinion
Recommend
Next Phase
Process Flow
Customer Management
Standardization:
• Forms and contracts
• Notifications
• Pricing
Organizational Structure:
• Empower executive
management
Study Development
Customer Management:
• Communication
Organizational Structure:
• Improve relationships
Recommended Modifications
Pricing
• Profit Margin must be considered
• Impact and perception of Indirect Cost
Pricing
Customer Focused Pricing
$80,800 Price quote for a small study
+ 61.5% Indirect cost
~$130,500 Total cost of study to customer
Bottleneck
Infrastructure
• 1 Operating Room
• 3 Intensive Care Units
Recommendation
Focus on small short-term studies
• High Volume
• Low Duration
Capacity Breakdown
• Conservative Maximum Revenue
3 Rooms x 26 weeks = 78 small studies/year
25% vacancy factor = 58 small studies/year
58 x $130,500 (price of small study)
= $7.596 M
• Aggressive Maximum Revenue
78 x $130,500 = $10.179 M
Core Recommendations
 Viability
 Shift Mindset
 Modify Processes
Financial Projections
Startup Funds
Investment towards:
• Increase staff to 16
people by year five.
• Purchase new high
tech equipment
• Start marketing and
promotion efforts
Credits
Current
University credit back to CPCS $238,000
Increase credit
Negotiate credit at 30% of indirect costs starting in yr. 2
• Capital Investment decreases to $1.285 million
• Achieves positive cash flow early in year 3
Implementation Plan
Year 0
Determine who you are and what you are going to be.
• Raise $865,000
• Standardize process to handle study requests
• Under costs (variable and fixed)
• Develop pricing model
• Standardize documents
• Standardized execution of documents
• Negotiate IC credit
• Start search process to hire managers
Implementation Plan
Year 1
Start the business
• Raise $548,000 to support year 2 activity
• Hire program and marketing managers
• Purchase and install most lucrative equipment
• Train staff according to developed processes
• Begin marketing efforts
• Start on-boarding new study requests
Implementation Plan
Year 2-5
In operation
• Raise $240,000 to support year 3 activity
• Continue to hire and train
• Continue to purchase and install equipment
• Continue marketing efforts
• Negotiate improved terms with vendor costs
Year 4
Review
• Stop and review results
• Plan for the next 5 years
Commercialization Recommendations
 Generate $7.59 million per year in revenues
 Results in $300,000 per year in profit
 Startup funds needed ~ $1.6 million over 3 years
 Achieve positive cash flow within 4th year
 Focus service on small, short-term, preclinical studies
 Target small to medium sized medical device companies
 Modify to an entrepreneurial, customer focused mindset
 Align processes to be customer service focused
 Invest in additional staff, equipment and marketing efforts
Core Recommendations
 Viability
 Shift Mindset
 Modify Processes
Jonathan Sacker
Thank you

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Final Presentation 41 McKinsey Cup

Editor's Notes

  1. Hello everyone, I am Diana Cugliari. My team and I had the opportunity to work with the McGowan Institute of Regenerative Medicine.
  2. I’d like to introduce my teammates: Natalie Garda Joshua Trach Chikara Yoshida
  3. Our client presented us with an opportunity to analyze. The McGowan Institute for Regenerative Medicine is seeking to commercialize a preclinical testing facility, and has asked us to complete an analysis for this commercialization.
  4. The University of Pittsburgh McGowan Institute for Regenerative Medicine is a research and development institute in areas of cellular therapies, tissue engineering, and medical devices. As these innovations are developed they are tested in the Institute’s Center for Preclinical Studies in large animal models. Due to the funding shrinkages within the University, and contracting government funding and other grant sources there is an eminent need for McGowan to find or develop alternate sources of revenue. Once such opportunity would be to commercialize this testing facility called the Center for Preclinical Studies (which is referred to as CPCS) to generate a revenue source. Thus McGowan through the CPCPS facility will enter the Contract Research Organization (CRO) market. This facility has capabilities/factors that are attractive to the commercial market. One of which, it operates under higher standards of the Good Laboratory Practices (GLP). By following these protocols results in their testing services beginning highly desirable in the commercial markets. But what does preclinical studies – testing mean? -----------------------------
  5. I would like to introduce you to Jonathan Sacker who has suffered from cystic-fibrosis (a genetic disorder that effects the lungs) since birth. This is Jonathan when he arrived at UPMC Transplant facility in February 2014 with a failing lung that was transplant 2 years prior in Oklahoma. Once he arrived in Pittsburgh he was immediately added to the transplant list, but people wait years for an organ time was not something Jonathan had. The prognosis was grim he was given a week to live, and if a lung was to become available he may be to sick to receive it. We share Jonathan’s story because of the cart on the left called the Hemolung RAS Respiratory Dialysis system that was developed at the McGowan Institute.. Jonathan is connected to the Hemolung, and simply put that cart contains a system that filters the blood of CO2, and pumps it back into Jonathan. But, before this device or any device that is used in the human body the prototypes need to be tested in a preclinical testing facilities. Meaning before it’s used on people… -----------------------------------
  6. It’s done here. Tested in CPCS which is a veterinary clinic that uses large animals (sheep, pig, K-9) to test these sorts of developments. It functions just like a human hospital with an operating and intensive care units, and it is these testing services that will be offered to the market.
  7. After all the research and analysis conducted over the past few months. These are the core recommendations to commercializing CPCS facility. > The endeavor to commercialize is a viable, from a market and facility perspective. > A shift in mindset is needed to move from academic knowledge business to an entrepreneurial customer service business. (which are opposite ends of the spectrum) > Processes will need modified to meet the demands of industry and customer service.
  8. Three points: Viable market - Mindset change Process modifications We determined that this facility can not only be self sustaining, but a significant money maker. Revenue $7.59 million per year Annual profit of $300,000 Capital investment needed $1.6 million Achieve positive cash flow within 4 years Focus Small, short-term preclinical GLP studies Target Small to Medium sized medical device companies Modify the mindset to entrepreneurial, customer focuses Build and align processes that are focused on the customer Invest in additional staff, equipment, and marketing efforts So how are these results achieved….
  9. By following the M-B-A Plan: M Marketing Orientation in a University Setting – this is shifting the mindset to being customer focused. Determine the needs and expectations of the customer For example customers are looking to speed, price, expertise. B Business Model Alignment with Target Markets Priority needs to be placed on strategic planning assessing the core capabilities, and identifying target customers according to the core capabilities. A Alignment of Systems and Processes to Market Demands Modify processes to meet the demands and expectation of the customer.
  10. These are our methods used. Because McGowan/CPCS is entering such niche market we felt that these methods were the best way to find the valuable data needed for the analysis. Interviews: The interviews was a lengthy process, and we were surprised by the overwhelming. We put out many requests with the belief that only a small percentage would respond. It was the opposite, people were very willing to speak with us. Due to time constraint it became a challenge on who to choose to speak with. I believe even now we still have a few late responders willing to participate in an interview. Research Sources: We conducted some heavy research within these sources, not only to get the information but to determine if what is being reported was accurate. The market information coming up in the next few was vetted and averaged against all these data sources. Since honing in on the medical device segment of the market was such a niche market data was not available, so we sourced the National Institute of Health and Clinicaltrials.gov to determine a flow of research studies. The NIH providing research and development at start or early stages by the number of grants awarded. Clinical trials is the next phase after preclinical we sourced clinicaltrials.gov to telling us what came out of the preclinical phase. We minded that data many different ways, all of which would be an excellent prospecting tool for the marketing phase. -----------
  11. Thank you, Diana, First, I’ll explain US Contract Research Organization Industry Market: This industry includes companies that provide research services on a contract basis to the pharmaceutical and biotechnology industries. CRO provide biopharmaceutical development, preclinical research, clinical research and clinical trial management. Many CROs specifically provide clinical study and clinical trial support for drugs or medical device.
  12. In U.S CRO industry, Total revenue is $15 to 17 billion dollars. The US CRO industry is currently in the growth stage where average annual revenues are growing. CAGR (compound annual growth rate) over five years is going to be 6 to 10% Total profit is 2Billion dollars. So, profit margin is 12.8%, which is profitable. Total wages are 4B dollars. Very human capital intensive There are three thousand to thirty three hundred companies in the industry. I conducted the Market analysis. First, I’ll explain the CRO industry market in the US overall. And then, I’ll focus on medical device and biotechnology segmentations. Several sources have been researched to confirm the validity of the market data, such as IBISworld and other online articles. In U.S CRO industry, Total revenue is $15 to 17 billion dollars. The US CRO industry is currently in the growth stage where average annual revenues are growing. CAGR (compound annual growth rate) over five years is going to be 6 to 10% Total profit is 2Billion dollars. Total wages are 4B dollars It seems the market is cost intensive. There are three thousand to thirty three hundred companies in the industry.
  13. This pie chart shows Major Market Segmentation. As you can see, medical device companies accounts for 12% of total. We are here. And this segments is considered to grow due to aging population demands for medical devices. This shows products & Services, it turns out Preclinical trials account for 15% of CRO’s distribution. During past 5 years, demand for preclinical trials has increased, as it serves as the starting point for consecutive clinical trials. Considering these things, our assumption is Preclinical Trials for Medical device is 304M Market.
  14. More knowledge flow WITHIN corridors than between corridors As you can see, in terms of business location, the top three regions with the highest concentration of establishments are the West, which is 31.8%, Southeast is 20.1% and Mid-Atlantic is 14.3% As you can see, in terms of business location, the top three regions with the highest concentration of establishments are the West, which is 31.8%, Southeast is 20.1% and Mid-Atlantic is 14.3%
  15. Key players, in terms of competition, Again In the industry, there are 3000 to 3300 companies. However, As you can see, there are only 2 major players and their market share is around 7% or so, which means concentration is low. Despite the participation of several high-profile companies, the CRO industry is highly fragmented because there are many small, niche specialty operators. Note Ranking market share: Laboratory Corporation of America Holdings 7.6% Quintiles Transnational Holdings Inc. 7.0% Parexel International 4.4% Charles River Laboratories International, Inc. 3.7% As you can see, in terms of competition, there are only 2 major players and their market share is around 7% or so, which means concentration is low. Despite the participation of several high-profile companies, the CRO industry is highly fragmented because there are many small, niche specialty operators. To summarize, concentration is low but competition is high. Note Ranking market share: Laboratory Corporation of America Holdings 7.6% Quintiles Transnational Holdings Inc. 7.0% Parexel International 4.4% Charles River Laboratories International, Inc. 3.7%
  16. From our analysis, there is a viable and profitable opportunities. To realize this, there are 3 takeaways from TOWS analysis 1. Adopt processes that align with competitors and core capabilities. 2. Utilize resources under university umbrella 3. Focus on competitive advantage, which is knowledge of niche areas
  17. To summarize Market orientation analysis , we believe there is a viable and profitable market for CPCS. And there is a shift in mindset necessary from academic knowledge business to entrepreneurial customer service business. Next, Natalie is going discuss Business Model Alignment.
  18. B - Priority must be placed on identifying key target markets consistent with CPCS capabilities and a business model that positions CPCS as a desirable solution for industry demands Vision and Mission Statement Value Proposition Identifying Target Markets Value Chain Marketing Channels
  19. Vision: To be an expert facility in Quality Management Systems of research that supports regenerative medicine development, science, researchers, and clinicians in the pursuit of bench to bedside commercialization of technologies. Mission: To be an expert research facility in Quality Management Systems that advances regenerative medicine innovation by combining our niche expert knowledge, collaborators, and clinicians to further customers’ innovations. The McGowan Institute’s Mission Statement is: To establish a national center of expertise in regenerative medicine focused on developing and delivering therapies that reestablish tissue and organ function impaired by disease, trauma or congenital abnormalities. To foster the generation of scientific knowledge in regenerative medicine and to share that knowledge with researchers, clinicians and the public through educational activities, training and publications. To educate and train scientists and engineers to pursue technologies related to regenerative medicine, and train a generation of clinicians in the implementation of regenerative therapies. To support the commercialization of technologies in regenerative medicine and thereby accelerate the translation of research discoveries to clinical implementation and patient benefit.
  20. Our customer is at the heart of the business model – we are addressing them always Please view our customer analysis appendix for the results of our interviews and research that lead us to determine this is your target customer
  21. What do we offer to the customer? Defines our products and services and describes how we cater to our target customer
  22. DIANA AND JOSH WILL DISCUSS THIS IN FURTHER DETAILS… What do we offer to the customer? Defines our products and services and describes how we cater to our target customer. Diversify by size of studies Length of time (small studies focus) Number animals (demands on ICU) Diversify by unique service offerings Live online broadcast of surgical procedures and ICU observations University expertise Refer business if out of scope If request is “greater” than the means of the facility
  23. Business Develop Time Spent: Based on our research, biotechnology companies make most of their buying decisions via people they know in the industry, tradeshows/conventions and scholarly journals. Tradeshows and direct selling will be the majority of efforts – these create leads. Less than 2% of these will convert to quotes/proposals. We do believe it is feasible to obtain the number of studies needed to achieve revenue – for example, we recommended the marketing manager attend 5 trade shows in year 1 to get the desired # of leads to convert
  24. There is a viable market for these service testing services. There is a shift in mindset necessary from academic knowledge business to entrepreneurial customer service business. Processes will need modified to meet the demands of customer service.
  25. So now that Natalie has shown how industry sponsors are coming through CPCS’ doors, this section will address how CPCS can align their systems and processes with similar successful university and industry CROs to meet market demands GO TO NEXT SLIDE
  26. After speaking with universities and industry CROs all around the country containing comparable programs to CPCS, we have identified critical areas where they have made improvements to their process flow and have reduced throughput time. These include: Timeliness Pricing and Pricing Structure Organizational Structure Standardization Customer Handling GO TO NEXT SLIDE
  27. Here we have an outline of CPCS’s current process flow when working with industry. Although all of these steps are important, our interviews showed that numerous comparable university facilities focused on modifying and improving the first two phases: Customer Management and Study Development Focusing on the first two phases is important because the later phases rely more heavily on the science and researcher rather than on the business aspect of the process. In cross referencing the critical areas with CPCS’ process flow, specifically the Customer Management and Study development phases, we’ve developed relevant and executable recommendations in order to better align with market demands. NEXT SLIDE
  28. So focusing on the Customer Management and Study Development phases We recommend CPCS focus on… First: Standardizing Documents -> The successful university preclinical initiatives model themselves after industry CROs by standardizing PNIPG Protocol Request Forms (which currently take 4-6 weeks in CPCS’ process flow) NDA form and contracts IACUC notifications (what I mean by that is how CPCS is sending study request forms to IACUC) Pricing model for Small, Medium, and large studies As well as GLP vs Non-Glp (Which I’ll talk more about in a few slides) Addressing organizational structure in Lead Conversion, Our research has shown that empowering executive management to sign off on documents and agreements is vital in limiting the number of offices study information passes through, thus shortening the overall process flow Moving into study development, it is vital to have everyone understand the full flow – before and after their part -> Other universities call this their “total buy in” from the top-down which builds accountability and efficiency within the process flow. There also needs to be an increased involvement by the PI (principal investigator) -> Through our interviews with former and current Pis, they’ve expressed that a lot of times they are kept in the dark and don’t know what’s happening when contracts are at for ex: The Office of Research, etc.) efficient relationships with the IACUC Piggybacking off these modifications in communication, It is also important to to build (Institutional Animal Care and Use committee) where the program manager works closely with the IACUC director so they know what types of studies they’ll be receiving As well as improving relationships with the Office of Research working closer with officers when negotiating contracts and agreements NEXT SLIDE
  29. There are a few pricing changes and mindset shifts that come with the territory of working more with industry. 1) Profit Margin must be considered. Current pricing structure utilized is reimbursement of costs. Now this is consistent with grant reimbursement pricing. However, when entering the industry market, you need to come up with a different pricing model to include profit margin (Current profit margins in the CRO industry are around 12%) 2) Impact and perception of Indirect Cost When evaluating the price of a study, the customer is looking at the absolute bottom line including the IC So we recommend that each line item already have the university IC (Indirect Cost) built in NEXT SLIDE
  30. So this is a graphic showing how Indirect Cost impacts the total bottom line price (For 2015 fiscal year University IC is 61.5%) NEXT SLIDE
  31. We recognize there is opportunity to make modifications to the facility and expand capacity, however for the scope of this project we have assessed the asset as it stands today Therefore, based on current infrastructure (1 Operating room and 3 ICUs), we recommend high volume, low duration (small short term studies). In a few slides I’ll break down our capacity revenue projections but first I’ll talk about pricing NEXT SLIDE
  32. As I mentioned a few minutes ago, we recommend that CPCS focus on small GLP low duration studies, so here we have a capacity breakdown showing Conservative Maximum Revenue Projections as well as Aggressive Maximum Projections It’s important to note that our definition of a small study is 14 days from beginning to end. Also we added a 25% vacancy factor for the conservative max so that results in 58 studies With that in mind you can expect revenues of a little over 7 and a half million dollars Same process for Aggressive Max Revenue resulting in a little over 10 million If McKinsey asks what to do about current studies on campus Talk about faculty who referred out studies (outsourced) That we have an In house lead source for CPCS to further explore specifically how they can phase in some of that currently outsourced potential rev
  33. So based on our systems and process alignment research, we’ve confirmed that it is indeed viable for an university center to align their systems and processes with market demands And we’ve identified what specific modifications within CPCS’ process flow are necessary to do so. It is important to note that these changes will not happen overnight and can only occur when there is a mindset shift and a total buy-in I’ll now hand it off to Diana who will further break down what it will take from a financial perspective to align with market demands NEXT SLIDE AND FIN FOR MY PART There is a viable market for these service testing services. There is a shift in mindset necessary from academic knowledge business to entrepreneurial customer service business. Processes will need modified to meet the demands of customer service.
  34. Conservative Sales Projections were forecasted over five years. Using a price quote of $130,500 for short-term small study Allowing the plan to gradually phase in. Sales revenue includes university indirect costs. First year allows for the marketing efforts to ramp up, staff to be trained to handle industry requests, and general growing pains when a system is changed. Second year assumes that marketing efforts from prior year will have great impact on sales. Third year allows for improvement of the management of study requests, allows for more people to be hired and trained. Fourth year reflects well on the way to maximum capacity. Fifth year reaches maximum capacity. Sales included university indirect costs, and is reflected as cost of services on this pro-forma. Number of studies needed to reach the projected sales. By year 5 you are on-boarding 3 studies every (bi-weekly)
  35. Based on forecasted sales and estimated expenses the results are shown here. There are losses in year 1-3 that require the startup funds of about $1.647 million Startup funds will be used towards: Year 1: In addition to regular fixed costs Doubling payroll – by hiring a management team Purchasing of new high tech equipment starting with video and imaging Start marketing and promotion efforts
  36. Opportunity to reduce capital investment: Currently McGowan is receiving a credit back from the University’s Division of Laboratory Research. The maximum credit back currently is $238,000. All conservative calculations of capital needed and profit are based on the current credit. Based on our research similar successful university preclinical testing center models they were able to negotiate a higher credit of back to the center ranging between 30-35% of the indirect cost collected. We recommend negotiating this type of credit structure with the university. By negotiating a 30% credit to start by year 2 it reduces Capital Investment needed to $1.285 million, and achieves positive cash flow by year three
  37. Determine who you are and what you are going to be.
  38. Start the business
  39. In operation – making tweaks along the way. Year 4 stop and review make plan for next 5 years.
  40. Conclusion We have identified an alternative source of revenue by commercializing CPCS services. If you commercialize the center CPCS you can achieve a positive cash flow of about $300,000 to $1MM conservatively within 4 years. However you will need to invest about $1.6 MM in equipment, people, and processes. To achieve this, you will need to: 1) Focus on niche market that aligns with your capabilities and capacity at your facility. - small to medium sized medical device companies and early stage researches - your sweet spot is small studies due to the size of your facility 2) To be competitive w/ CROs you need to align your processes to be more customer service focused - Invest in more staff, equipment, and marketing processes.
  41. There is a viable market for these service testing services. There is a shift in mindset necessary from academic knowledge business to entrepreneurial customer service business. Processes will need modified to meet the demands of customer service. ---- Oh and one last thing…….
  42. I would to introduce you to Jonathan Sacker who has had cystic-fibrosis (a genetic disorder that effects the lungs) since birth. This is Jonathan when he arrived at UPMC Transplant facility in February 2014 with a failing lung transplant he received 2 years prior in Oklahoma. Once he arrived in Pittsburgh he was immediately put on the transplant list, but people wait years for an organ, and this being Jonathan’s second to take a long time. The prognosis was grim he was given a week to live, and if a lung did not become available, and the kicker, as if one is needed, if a lung was to become available he may be to sick to receive it. We share Jonathan’s story because of the cart on the left called the Hemolung RAS Respiratory Dialysis system that was developed at the McGowan Institute. Simply put that cart filters the blood of CO2, and pumps it back into Jonathan. But, before this device can be used on Jonathan the prototypes need to be tested in a preclinical, meaning before it’s used on people. This is done here…. ----------------------------------- Slide 46 To go back to Jonathan, and his story. Jonathan was on the Hemolung for three weeks. The device helped his body heal strong to receive his second lung transplant 3 weeks later. ------------------------ In what was literally the 12 hour and a team of people to make it happen February 2014 Jonathan arrived at the UPMC Transplant facility his lung transplant of 2 years was failing. He was referred to UPMC and Dr. Christian Bermudez and Dr. Maria Crespo as a last resort. He was given 3-5 days to live. Literally in the 12th hour there was miracle. Hemolung was approved by FDA for use under emergency compassionate approval. This cleaned the CO2 in Jonathan’s system and kept him alive while waiting for 2nd lung. That lung came in March 2014. 8 months later Jonathan was back to living a normal life. The Hemolung was the bridge that kept him alive, and as Jonathan puts it “healed” him enough for surgery. This is why you seek to keep facilities like CPCS open. http://mirm.pitt.edu/wp-content/uploads/2015/08/UPMC-Patient-First-in-US-Implanted-with-Medical-Device.pdf
  43. This is Jonathan in August 2014, just 5 months later when he was released from the hospital. That’s Pete DeComo with him the CEO to ALung Technologies the company that Hemolung.
  44. This is Jonathan 9 months after his release. It’s reasons like this that McGowan and CPCS exist, and need to commercialize in order to further these types of developments.