Bloomington- Who Knew?

Bloomington, Indiana, has one of the most significant clusters of medical-device and life-science companies in the nation. Bloomington is home to industry giants such as Cook Medical, the world’s largest privately held medical device maker, which specializes in minimally invasive surgical devices that allow doctors to operate on patients who are too high-risk for major surgery.

Also in Bloomington is the startup Morris Innovative, which has designed an FDA-approved medical device that uses a futuristic new bio-tissue (created by Cook Biotech) to help patients heal faster.

Other examples of innovation abound: Indiana University pediatric surgeon Mark Rodefeld has invented a tiny pump that keeps a newborn’s blood oxygenated while surgeons repair the heart of a child born with a single ventricle. Aeon Imaging has developed a laser-scanning digital camera that uses near infrared light to see past cataracts and detect underlying eye diseases.

 I live only 20 minutes from Bloomington, and have lived here for most of my life, and I am ashamed to admit, I had no idea.

Is It Better to be On Your Own or in a Conglomerate?

I came across an interesting short blurb written by Maria Fontonazza entitled “How to Succeed in an Emerging Market” in which she lists what types of markets a medical device company needs in order to be successful.  She lists things we have talked about many times on our blog:

  •  A trained workforce.
  • Engineering skill that is supported by strong universities.
  • Access to risk capital.
  • A strong clinical and physician network.

What I found especially interesting was the fact that that she mentioned one of the challenges to gaining ground in some emerging markets is the cultural stigma around failing. She quotes Glen Giovannetti, Ernst & Young’s global life sciences center leader (Boston) who says, “It impedes entrepreneurship because it takes a bold person to leave an academic or corporate job at a successful company and take that risk to go out on their own.  From my own view, that is why you see new ideas and new businesses occur in conglomerate-type settings versus entrepreneurs out on their own.”

Hmmm… certainly something to consider.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

You Smeared What on Your Smartphone?

Hyun Gyu Park and Byoung Yeon Won at the Korea Advanced Institute for Science and Technology in Daejeon, South Korea believe that a biosample – sputum, saliva, blood, or even urine – could be applied to the screen of a smartphone for analysis. They point out that the screen is capable of detecting extraordinarily small differences in capacitance and it’s that capability which can be leveraged to diagnose everything from influenza to salmonella. The value of the analysis though, hinges on the ability to correlate differences in the capacitance of the sample with something clinically relevant.  While current touchscreens are still not able to identify individual pathogens, the touchscreen’s ability to differentiate between concentrations is a crucial first step.

I’m not sure if I like this idea or not.  Even though I still use the conventional cellular phone, I can see the benefits of using smartphones to communicate and access information quickly.  I just can’t picture myself smearing my bodily excretions on the screen of my phone.  It just seems a bit unsanitary.

 

New Tenant at Purdue Research Park Offers Drug Delivery System

A company that specializes in developing devices to deliver injected freeze-dried drugs, diagnostics and vaccines has become a tenant in the Purdue Research Park.

LyoGo, founded in 2009 by Rush Bartlett, Arthur Chlebowski, and Peter Greco, has developed patent-pending technology that stores a lyophilized, or freeze-dried, drug in one chamber and liquid diluents in the other. David Giddings, a medical industry veteran with more than 30 years of experience, is CEO. Charles Haywood, business development adviser, also is president and CEO of Mansfield-King, a contract manufacturer of personal-care products that was the fifth-fastest growing company in Indiana in 2010.

LyoGo was formed for the purpose of developing innovative drug-delivery systems. LyoGo is focused on engineering delivery systems which offer a superior user experience, are intuitive to use, improve safety and sterility, and substantially reduce or eliminate the need for refrigeration at room temperature, which improves drug storage and distribution. LyoGo develops systems for delivering drugs that are intentionally designed to easily fit into the established drug-filling processes of leading pharmaceutical companies.”

This is cool technology because freeze dried drugs don’t necessarily require refrigeration and can be kept for years at room temperature instead of a few hours. (Case in point- I have a jar of Folger’s Freeze Dried Coffee Crystals of which I only use a couple of tablespoonfuls once a year to make Christmas cookies.  I have had the same jar for years, and my cookies still taste great- ask my husband…) Drugs like this can be used for stockpiling vaccines and for diabetes and cancer drugs.  This is an excellent addition to West Lafayette’s life science industry.

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Honey Reduces Antibiotic Resistance

I visited a local Honey Farm with my son’s preschool class earlier this year.  The owner was extolling the virtues of honey, talking about how honey had great antibacterial properties, was great for coughs, and, my personal favorite, how honey never spoiled. He actually said that honey found in the Pharos’s tombs from thousands of years ago could still be eaten today, so good were the antimicrobial properties.  At the time, I attributed this to someone who was a bit overly zealous about his product.  It turns out honey can reduce antibiotic resistance and clear chronically infected wounds, according to research presented at the Society for General Microbiology’s Spring Conference in Harrogate.

“Manuka honey could be an efficient way to clear chronically infected wounds and could even help reverse bacterial resistance to antibiotics, according to research presented at the Society for General Microbiology’s Spring Conference in Harrogate.

“Our findings with streptococci and pseudomonads suggest that manuka honey can hamper the attachment of bacteria to tissues which is an essential step in the initiation of acute infections. Inhibiting attachment also blocks the formation of biofilms, which can protect bacteria from antibiotics and allow them to cause persistent infections,” explained Professor Cooper. “Other work in our lab has shown that honey can make MRSA more sensitive to antibiotics such as oxacillin – effectively reversing antibiotic resistance. This indicates that existing antibiotics may be more effective against drug-resistant infections if used in combination with manuka honey.””

I’m sorry I doubted you, honey man… Perhaps tomorrow morning I will dust off the bottle of honey that has been biding its time in the back of my pantry for the last 10 years, pop it in the microwave to dissolve the crystals as per your instructions,  and use it on my breakfast toast.

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May 10, 2011 – Venture Philanthropy (IBEN)

IBEN – Venture Philanthropy & New Funding Approaches to Accelerate Innovation

Suzanne Clifford, President of Inspiring Transformations, will highlight innovative funding and patient engagement approaches for early stage innovations.  She will lead a dialogue about new trends in venture philanthropy and highlight successful partnerships between patient advocates and life science entrepreneurs.  Come ready to discuss innovative ways to collaborate, involving critical stakeholders and access funding.

Speaker: Suzanne Clifford, President of Inspiring Transformations

When: May 10th, 2011  5-7pm

Where: Riley Outpatient Center

This event is at Riley Hospital at the IU Medical Center. There is an attached parking garage just south of the building. After exiting the parking structure at ground level on the north side (past the elevators), entering the main hallway, there is a stairway down about 100 feet on the left hand side (a protective gate is at the top) to the auditorium. This stairway is past the information desk.

RSVP

Suzanne Clifford is President of Inspiring Transformations, a life science and healthcare innovation consulting practice.  Her specialties are creating innovative funding strategies, developing high impact market-driven business plans, mobilizing critical stakeholders and conducting due diligence.  Prior to consulting, two governors appointed her as the Director of the Indiana Division of Mental Health and Addiction where she ran six hospitals and coordinated prevention and treatment programs in 92 counties.  Suzanne was awarded the Sagamore of the Wabash which was the highest honor bestowed by an Indiana governor.  Prior to her government service, she worked for over ten years at Eli Lilly and Company in numerous management positions focused on diabetes care, women’s health, neuroscience, infectious diseases, oncology and cardiovascular disease.

 

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April 28, 2011 – ASQ Biomedical Midwest Discussion Group

The MWDG of the ASQ Biomedical Division Presents:
Bringing a new product to market and beyond: when and how statisticians can grease the chute by reducing uncertainty
Thursday, April 28, 2011, 5:30pm to 8:00pm
The program on “Bringing a new product to market and beyond: when and how statisticians can grease the chute by reducing uncertainty” will be presented by Carleton Southworth, AB, MS, RAC, Vice President, Biostatistics, with American Research Partners, a CRO he cofounded.
Carleton brings a wealth of experience in the device industry to share on this topic.  The following is a short biography:
Carleton Southworth was educated at Vassar College and the University of Tennessee. He began his career as a quality control manager at two high volume machine shops that manufactured medical device and automotive components. He worked next as a statistical quality engineer improving the manufacture of aerospace products at Sikorsky Aircraft. His work included refining the dynamic balance of rotating components and improving and validating machine tool performance.
In 1989 he assumed a position with Codman & Shurtleff, a J&J company specializing in medical devices for neurosurgeons. He worked for J& J for nearly 22 years. At Codman he worked as a statistical quality engineer, a biostatistician, a regulatory affairs professional, and in clinical quality assurance; he cut his teeth in clinical research by designing a study on a combination pediatric hydrocephalus drug-device aimed at preventing device infection. He also conducted this study.  In 1994 Codman & Shurtleff merged with J&J Orthopaedics to form Johnson & Johnson Professional, Inc.  Here, Carleton worked as a clinical research associate as well as serving as the company biostatistician and, intermittently, designing experiments aimed at improving manufacturing processes.  He designed a clinical study and analysis plan for a neurosurgical image guided surgical system. He spearheaded the execution of the clinical trial and gained market clearance ahead of schedule.
In 1998 J&J acquired DePuy Orthopaedics. Carleton worked for this company from 1999 until 2010 as a biostatistician in positions of increasing responsibility. He served as Manager of Biostatistics for over four years with world-wide responsibilities. He managed four biostatisticians serving DePuy Orthopaedics, DePuy International, Depuy Spine, Codman & Shurtleff, and DePuy Mitek (sports medicine).  He has contributed to dozens of clinical research studies on total joints, bone substitutes, trauma fixation devices, nerve stimulation devices, and many other medical devices in a broad cross-section of therapeutic areas. Several of these studies were for PMAs and included extensive contact with the FDA. In addition, he held responsibility for medical writing at DePuy Orthopaedics. Over the course of his career Carleton has solved a host of measurement and manufacturing problems including problems in machining, plating, injection molding, packaging and laboratory measurement of pharmaceutical compounds.
Currently Carleton is Vice President, Biostatistics with American Research Partners, a CRO he cofounded.  Carleton is a co-author and contributor to dozens of articles and presentations, and holds numerous patents in the U.S., Japan and Europe for neurosurgical and orthopaedic inventions. Additional information on his background may be found at www.americanresearchpartners.com
It will be held at the University of Indianapolis.  Schwitzer Student Center Building #7 Room #013
Indianapolis, IN 46227, with a buffet dinner at a cost of $12.50 for members and $15.00 for non-members.
Use the following link to register and for full details:
Please feel free to invite others to join us.  I look forward to seeing many of you at the program.

March 24, 2011 – Midwest Discussion Group

The MWDG of the ASQ Biomedical Division Presents:
Error Grid Analysis:  A History and Proposed Methodology
Thursday, March 24, 2011, 5:30pm to 8:00pm
The program on Error Grid Analysis will be presented by Dr. Ann Stankiewicz, Sr. QC Manager at Roche Diagnostics.
There is a significant advantage for companies to market an in vitro diagnostic product that is classified as CLIA-waived.  Their customers do not have to manage the complicated laboratory controls such as trending and proficiency testing that is otherwise required per the CLIA regulations.  In Guidance for Industry and FDA Staff:  Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of in vitro Diagnostic Devices (Issued January 30, 2008), the FDA recommends an approach to use to demonstrate that the device is simple and has an insignificant risk of an erroneous result.  One aspect of demonstrating that the device is accurate in clinical studies is the construction of an error grid.
In this presentation, a history of the error grids used to evaluate devices for glucose testing will be provided.  (There are relatively few other error grids available to use as examples.)  Then a proposed methodology for creating an error grid for Prothrombin time (INR) testing will be presented as an example of the steps that can be taken to create an error grid for any product.
It will be held at the University of Indianapolis.  Schwitzer Student Center Building #7 Room #013
Indianapolis, IN 46227, with a buffet dinner at a cost of $12.50 for members and $15.00 for non-members.
Use the following link to register and for full details:
Please feel free to invite others to join us.  I look forward to seeing many of you at the program.

April 12, 2011 – Intellectual Property for Startups (IBEN)

Indiana Biomedical Network presents “Intellectual Property for Startups Including Innovative Approaches” on April 12, 2011.

Life Science companies can strategically use patent protection to help raise funding, extend exclusivity in the marketplace, and guide future R&D.  An Intellectual Property (IP) strategy is one of the first critical components to commercializing technology through a startup or licensing. Join us for an open discussion on IP with members of Ice Miller’s Intellectual Property team. This is the perfect time to ask the experts about protecting your technology.

Speaker:Tom Walsh, Intellectual Property Group, Partner, Ice Miller LLP.

Tom Walsh is a member of Ice Miller’s Intellectual Property Group. He assists with the intellectual property issues facing new companies and established businesses. His experience includes patent prosecution in a variety of technology areas, licensing, intellectual property strategies, technology transactions, trademarks, and franchising.

When: April 12th, 2011  5-7pm

Where: Riley Outpatient Center
This event is at Riley Hospital at the IU Medical Center. There is an attached parking garage just south of the building. After exiting the parking structure at ground level on the north side (past the elevators), entering the main hallway, there is a stairway down about 100 feet on the left hand side (a protective gate is at the top) to the auditorium. This stairway is past the information desk.

RSVP

 

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Process Validation Slides from MWDG

I was copied on an email from Ann Stankiewicz, President of ASQ Biomedical Midwest Discussion Group.

By popular request, we are providing a copy of Erol Cetinok’s presentation on Process Validation from the February 24 meeting of the ASQ Midwest Biomedical Discussion Group.

Best regards,

Ann

I’m including the slides with this post:

PROCESS VALIDATION, FDA Guidance, 2.25.11

 


March 8, 2011 – IBEN: Building Your Professional Network

Dr. Schreiber will be discussing the value of building a network to help move you research, business, and career forward. Commercializing a technology requires knowing and finding excellent people and companies. Dr. Schreiber has expanded his network through being on the boards of the Indiana Health Industry Forum, the IUPUI School of Engineering, the Indiana chapter of the International Council on Systems Engineering, Rose Hulman, EDF Ventures, and several life science startups.

Join us and learn more on how you can grow and leverage your network to effectively get things done.

Speaker: Joerg Schreiber, Ph.D., President, White Arrow Consulting

When: Mar 8th, 2011  5-7pm

Where: Riley Outpatient Center
This event is at Riley Hospital at the IU Medical Center. There is an attached parking garage just south of the building. After exiting the parking structure at ground level on the north side (past the elevators), entering the main hallway, there is a stairway down about 100 feet on the left hand side (a protective gate is at the top) to the auditorium. This stairway is past the information desk.

RSVP: http://www.ihif.org/conference/register/35

Dr. Schreiber joined Roche Diagnostics (previously Boehringer Mannheim Germany) in 1986 and moved to the US in 1994.  He held several functions in R&D (analytics, process development) and Operations (quality system, purchasing), before he assumed responsibility for the business unit R&D in the US organization in 1996.  Being responsible for a multi-project pipeline where project teams are in different locations as well as come from different cultures, it was imperative, not only to continuously improve the development philosophy and tools, but also to work consistently with the information and knowledge created across all projects in the pipeline. In 2001 Dr.Schreiber accepted the position of VP R&D and Business Development for a newly created business, MyDoc.com, wherein Roche Diagnostics built an internet-based medical practice. In his latest endeavor for Roche Diagnostics Dr. Schreiber commercialized technology, which Roche Diagnostics was not using actively, to create more value and to benefit the Central Indiana Region.

Being conscious of the fact that knowledge and people contribute vastly to the success of R&D and business in general, Dr. Schreiber is a strong promoter of Knowledge Management in all endeavors and has experimented repeatedly to find optimal ways to create a knowledge creating and sharing culture and to support the necessary underlying tool structure. While at Roche, he co-chaired the Roche Diagnostics Knowledge Board promoting Knowledge Management company wide.

After his retirement from Roche, Dr. Schreiber works as Business Development consultant in the Life Sciences and has joined the Boards of The Cientive Group Inc. and AION Diagnostics, which he chairs. He has founded and uses as his business platform White Arrow Consulting LLC (www.whitearrowconsulting.com). From 2005 to 2007 he worked with Quadraspec Inc. as Chief Operating Officer. From 2007 to 2010, he worked with Physical Logic AG as VP R&D, CEO, and Director of its Diabetes Business Unit. Currently, he serves as CEO of Access Health Wealth.

Dr. Schreiber holds a Ph.D. in physics from Giessen University, Germany, specialized in biophysics and was a post doc at the National Institute for Environmental Health Sciences in Research Triangle Park, NC, USA.

He was a board member of the Center for Enterprise Leadership at the Boston University and the Connectivity Industry Consortium, is Chairman of the Indiana Health Industry Forum and holds several other board positions in professional, civic, and art organizations, where he continues to work in an interdisciplinary context.

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February 8, 2011 – IBEN Inventions At The Bedside

Speaker: Keith L. March, M.D., Ph.D.
IU School of Medicine
Professor of Medicine; Cryptic Masons Medical Research Foundation Prof

When: Feb 8th, 2011  5-7pm

Where: Riley Outpatient Center
This event is at Riley Hospital at the IU Medical Center. There is an attached parking garage just south of the building. After exiting the parking structure at ground level on the north side (past the elevators), entering the main hallway, there is a stairway down about 100 feet on the left hand side (a protective gate is at the top) to the auditorium. This stairway is past the information desk.

RSVP: http://www.ihif.org/conference/register/35

Keith L. March, MD, PhD

§  Professor, Departments of Medicine, Cellular and Integrative Physiology, and Biomedical Engineering, Indiana University School of Medicine and the Krannert Institute of Cardiology

§  Director, Indiana Center for Vascular Biology & Medicine (ICVBM)

§  Director, IUPUI Vascular and Cardiac Center of Adult Stem Cell Therapy (VC-CAST)

§  Director, VA Center for Regenerative Medicine
Keith March has dedicated his career to bringing new medical approaches to patients.  His publications include more than 100 manuscripts. He was the editor of the first book dedicated to cardiovascular gene transfer.  Dr. March’s research has resulted in more than 40 worldwide (19 U.S.) patents, with others pending. He invented the Closer, a widely-utilized patented suture-mediated closure device, used to close the puncture wound in an artery following heart catheterization. This device allows a patient to “walk off the table” after a catheterization without requiring prolonged bedrest.  Abbott Vascular, an affiliate of Abbott Laboratories, acquired the company that developed this technology in 1999 and the Closer approach is used annually worldwide in 500,000 patients.  He has served as a scientific advisor to numerous pharmaceutical, biotechnology and medical device companies.

His laboratory focuses on vascular biology, with a particular emphasis on the function and translational study of CD34+ stem cells found in the adipose tissue, which his laboratory identified as peri-vascular cells with critical roles in vasculogenesis, angiogenesis, and adipose tissue regulation. Dr. March is recognized as a leading expert in the field of adult stem cell research, particularly that involving adipose-derived stromal stem cells.  In 2008, he became chair of the NIH/NHLBI DSMB that oversees cell therapy trials in the areas of heart, lung, and blood diseases.

In addition to his research roles, Dr. March has served as the president (2007) of the International Federation of Adipose Therapeutics and Science (IFATS); and serves as the Chief Medical Advisor for the Cell Therapy Foundation.  In both affiliations, he has worked to advance collaboration as well as awareness about the significance of adult stem cells.

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January 27, 2011 – Midwest Discussion Group

MDWG Presents a Discussion of The Quality Loop.

January 27, 2011 from 5:30- 7:30 PM at University of Indianapolis, Switzer Hall

Buffet dinner meeting.

Howard T. Cooper, CQM, CBA, and CQA, will lead a discussion of Juran’s Quality Loop as it applies to our profession.

Juran, the well-known quality guru developed the concept of the “Quality Loop” or “Quality Spiral”. Juran describes this as a “Conceptual model of interacting activities that influence the quality of the product or service in the various stages ranging from the identification of needs to the assessment of whether these needs have been satisfied”.

Juran’s concept begins with identification of a need, and once this need is defined, multi functional groups work together to seek practical ways and means to fulfill the need. This results in a new or improved product (drug or device). However before these products become realities (commercialized), there must be assessments  to determine the product’s ability to meet user needs.

Howard has prepared a series of discussion questions that are sure to result in a lively discussion of our role in the Quality loop.

Please use this link http://www.acteva.com/booking.cfm?bevaid=214802 to register and for complete details of the event.

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Top Graduate Schools for Biomedical Engineering (MD&DI)

Here is a list of the Top Graduate Schools for Biomedical Engineering / Bioengineering:

1. Johns Hopkins University – Baltimore, MD
2. Georgia Institute of Technology – Atlanta, GA
3. University of California-San Diego – La Jolla, CA
4. Duke University – Durham, NC
5. Massachusetts Institute of Technology – Cambridge, MA
5. University of Washington – Seattle, WA
7. Rice University – Houston, TX
7. University of Pennsylvania – Philadelphia, PA
9. Boston University – Boston, MA
10. Stanford University – Stanford, CA
10. Washington University – St. Louis, MO

The list came from the U.S. News & World Report.

Some of my observations:

  • Washington University in St. Louis is the lone Midwest school.
  • Appears to be similarity between strong biomedical graduate programs and biotech / life science hubs: Boston, RTP, Southern California.
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January 12, 2010 – Fundraising Strategies and Trends: Angels & VCs (IBEN)

Indiana Biomedical Entrepreneur Network (IBEN)

Fundraising Strategies and Trends: Angels & VCs

Where: Riley Outpatient Center (Directions)
When: 1/12/2010 at 5pm

Come learn about the current investment environment and how to effectively position your company to be an attractive investment opportunity.

Cost is free, but registration is required.

Click to Register

Speaker(s):
Oscar Moralez, Co-founder & Managing Partner, StepStone Business Partners
Michael Shepard , Partner, Heron Captial

Moderator(s):
Jeremy Schieler, IUETC

IBEN is sponsored by Ice Miller, IUETC, and IHIF

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