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.

Indiana’s Life Sciences are Progressing and Growing

BioCrossroads recently did a report that tracked the progress of Indiana’s life sciences. The results indicate “a decade of substantial growth and measurable progress across a wide range of nationally significant indicators”.

For example, the report notes that by 2009, Indiana’s life sciences exports totaled $7.4 billion, ranking the third highest in the United States, behind only California and Texas.  The state has the third highest life sciences employment concentration* nationally, and has seen a 21% increase in life sciences employment, adding more than 8,800 new jobs to the industry since 2002. More than 50,000 workers at 825 companies comprise four life sciences sub-sectors: medical devices and equipment, drugs and pharmaceuticals, research, testing and medical laboratories, and agricultural feedstock and chemicals.  Indiana’s health information technology sector contributes an additional 2,500 workers and 72 companies.

According to BioCrossroads, this report underscores the state’s national rankings as a life sciences leader in the areas of exports, employment concentration, job growth and FDA filings.

As they say on the Indiana Beach commercial, “There’s more than corn in Indiana”.

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J & J to Get Out of Heart Stent Business

Some big news from Johnson & Johnson was announced this week.

Johnson & Johnson is getting out of the heart stent business.

The diversified healthcare company said Wednesday it no longer will develop its Nevo heart stent and will stop production of its Cypher stent as it pulls back on a segment of its cardiovascular business that has suppressed earnings in recent years.

Analysts believe J&J’s decision to leave the stent market ultimately will benefit the New Brunswick, N.J.-based company by allowing it to focus on higher-growth divisions such as Biosense Webster, which develops and markets electrophysiology navigation systems and ablation therapy devices. Annual Cypher sales had reached $2.6 billion, but the stent was on track to earn merely $400 million this year, according to Gabelli & Co. analyst Jeff Jonas. Its current sales amount to about 1 percent of company profit.

J&J executives said the company’s new focus will revolve around access, diagnostic and therapeutic products for cardiology procedures, products to diagnose, access and treat lower extremity disease, and the Incraft Stent-Graft System, an investigational device for treating abdominal aortic aneuryisms.

“With the removal of a large, ‘troubled’ player from the market, we’re inclined to think industry dynamics—like pricing—might improve on the margin as well,”  Leerink Swann LLC analyst Rick Wise wrote in a note to investors. “We also view the news positively for J&J, as the Cordis restructuring…should further drive positive operating leverage and better allow the company to focus on the business’ other, higher-growth divisions like Biosense Webster. All this should set the stage for J&J to drive better sales and operating in 2012 and beyond.”

It will certainly be interesting to see how this development affects Johnson & Johnson as well as its rivals.

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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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Life Sciences in the Midwest- New Developments

There have been several interesting developments in the life sciences industry in the Midwest this month.

Endocyte, a biopharmaceutical company developing targeted therapies for the treatment of cancer and inflammatory diseases, announced on February 4 the pricing of its initial public offering of its common stock.  Endocyte is based in West Lafayette and intends to utilize the proceeds from the IPO to fund its phase 3 clinical trial related to the use of EC145 and EC20 in platinum-resistant ovarian cancer and to move preclinical products forward in the development process.

For more information see Endocyte and Endocyte Announces IPO.

Danaher Corp. climbed to the highest price since 1980 after agreeing to pay $6.8 billion for diagnostic-equipment maker Beckman Coulter Inc. amid higher demand for medical tests from an aging U.S. population.   The Brea, California based Beckman manufactures products used to diagnose diseases and in the development of new drugs, including centrifuges, hematology analyzers and cell sorters. Beckman has a facility in Indianapolis that employs several hundred people.

See more on Beckman.

Marcadia Biotech Inc., a Carmel-based biopharmaceutical company founded by former Eli Lilly and Co. executives in 2006, has been acquired by Swiss life sciences giant Roche. Roche’s holdings include Roche Diagnostics in Indianapolis, which has about 3,500 local employees. Marcadia is a relatively small firm, but has raised millions in venture capital.

Read more about Marcadia.

I look forward to seeing the continual progression and development of businesses in our area.

October 15, 2010 – PDA All-Day Event

October 15, 2010 All-Day Event hosted by Lilly

Event Description

The October All-Day Event will begin with registration at 8:00 am and end at approximately 4:00 pm. It will include a catered lunch at noon. (AGENDA) The following topics will be discussed: Incoming Bombshell: FDA’s New Process Validation Guidance, Process Validation – Incorporating Quality Design and Risk Management: A Case Study, A Case Study of Process Development for a Lyophilized Vial (Manufacturing Process: Lab Trials, Up-Scaling, Clinical Manufacturing, and Process Validation), A Case Study on Registration and Stability Batches of a Biologic Drug Product, and Current Trends in Process Validation. Click here for details and list of presenters.

Registration will end on Friday, October 8, 2010.

REGISTER INDIVIDUAL

REGISTER MULTIPLE

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October 6, 2010 – Open House for Biologics

WHEN: October 6, 2010, 4:30p – 6:30p

WHERE: 1533 Northfield Drive, Ste 100, Brownsburg, IN 46112

Light hors d’oeuvres and drinks will be provided.

Biologics has chosen Brownsburg and Hendricks County as their new company headquarters to bring significant advancements in cleanroom and laboratory technology to the bio-pharmaceutical industry.

Hosts:

  • Clark Byrum, Sr.
  • Cinda Kelly
  • Biologics
  • Hendricks County Economic Development Partnership

Please RSVP to kirby@successexpressmp.com

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October 10-12, 2010 – BioPartnering Europeâ„¢

BioPartnering Europeâ„¢ (BPE) Leading European life science partnering for 18 years.

The Indiana Health Industry Forum announced that it has signed a partnership agreement with TGV LLC, the organizer and producer of the international BioPartnering events. With this partnership, IHIF members will receive a 15% discount on the registration fee for the series of events.  To obtain the promo code for the IHIF member discount*, please contact IHIF at 317-278-9970 or e-mail info@ihif.org.  Additional information may be found on the IHIF website and calendar.

Conference Name: BioPartnering Europeâ„¢
Dates: 10-12 October 2010
Location: London, United Kingdom
Venue: QEII Conference Centre

BPE offers excellent partnering opportunities for the best and brightest in the life science industry. Three days of networking in 1 location to meet with decision-makers from leading biotechnology, pharmaceutical, and investment companies from around the world for face-to-face partnering meetings, presentations, expert panels, and exhibitions. Register for BPE and connect your company with The Global Life Science Networkâ„¢.

For more information and to register, visit: http://www.techvision.com/bpe/

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August 24, 2010 – Global Pharmaceutical & Biotechnology R&D

Global Pharmaceutical & Biotechnology R&D – Challenges, Opportunities & Pathways

Sponsor: BioPharmaPM
Web Site: http://www.mscholar.com/xgpo
Date:08/24/2010
Time: 1:00:00 PM
Location:Online EST
Details:
The pharmaceutical and biotech industries have entered an era of unprecedented change and Action for Results, Inc. (AfR) consultant Thomas J. Schulze, PhD, PMP, plans to guide industry professionals through it in a complimentary webinar. Schulze will address the issues that arise from threats to the industry’s current business model including profitability challenges, patent expirations, cost constrained healthcare systems and demanding regulatory requirements. Additionally, he will help attendees understand the objectives and outcomes necessary for successful drug discovery research, development and commercialization.

Contact:
Patrick J. Riley
pjriley@icmarcom.com
603-893-6510

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Eli Lilly Rolls Out Diagnostics Division

…”Diagnostics division to help drugmaker tailor treatments.”

Eli Lilly has created a new division to produce tests that will “winnow out the patients most likely to benefit from a Lilly drug.” This new concept of “personalized medicine” recognizes the reality that most drugs work in only about 1/3 of the patients who take them. These new tests will help Lilly identify the subgroups of patients who will benefit the most and at what dose. The diseases that this new Lilly division will be focusing on are Cancer and Alzheimer’s.

Will there be a trend for the life sciences industry that will push pharma companies to develop diagnostic tests alongside their experimental drugs? Terry Hisey, leader of the US life sciences practice, Deloitte Consulting, believes there will be.

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July 25 2010 – American Association for Clinical Chemistry Annual Meeting

AACC Annual Meeting

July 25, 2010
Anaheim, CA

http://www.aacc.org

Sponsored by: American Association for Clinical Chemistry

Contact: custserv@aacc.org / 202-857-0717

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May 24 & 25, 2010 – Clinical Trial Design For Medical Devices

Clinical Trial Design For Medical Devices

Who Should Attend

This two-day course is designed:

  • Device Manufacturers
  • Device Sponsors and Management
  • Clinical Laboratory Administrators, Directors, and Managers
  • HealthCare Professionals
  • CROs
  • Project Managers

Learning Objectives

The objective of this course is to provide an overview of the preparation, design and management aspects of clinical trials for medical devices.  Upon completion of this course, attendees will have an understanding of the unique challenges faced in clinical trials for medical devices, which will be useful in the future development of device technology.

This course will review challenges, roles and responsibilities of sponsors and investigators during the clinical development phase.  Participants will learn the essentials of coordinating, monitoring, and managing a clinical trial with an emphasis on good quality product outcome and meeting ICH E6 for Good Clinical Practice.

Register Now.

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A few simple truths about Bloomington life sciences

The original article was posted in The Herald Times, but below are a few points that we found important to touch upon. To read the full article, click here.

A few simple truths about life sciences in Bloomington:

  1. Individuals like Bill Cook shaped “life sciences” in Btown before anybody crafted the term.
  2. Bloomington was an early adopter, but is no longer alone and competition is growing.
  3. Manufacturing lines need more workers who are qualified.
  4. New laboratories need researchers today.
  5. The small life sciences companies need more capital ASAP.

The problem is that changes are not being made fast enough…

“It is not something that we can do overnight,” said Danise Alano, director of life sciences at City Hall. “But we are in this together to make this cluster as strong as it can be.”

Read More

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April 23-27, 2010 – ACRP Global Conference and Exhibition 2010

ACRP Global Conference and Exhibition 2010

The goal of the conference is to enhance the knowledge and skills of conference attendees in the conduct of clinical trials in order to evaluate the drug, biologic, and/or medical device’s safety and effectiveness in treating, preventing or diagnosing a specific disease or condition. In addition to providing clinical research education and training, this conference acknowledges the dedication and excellence of its membership.

Register here.

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ImmuneWorks Gets Major Partner

ImmuneWorks, the Indianapolis-based biotechnology firm that specializes in the development of treatments for various lung diseases, has reached a joint agreement with LungRx that will fund research and development efforts for the next three years.

Creo Quality would like to congratulate Wade Lange and ImmuneWorks for this recent partnership with LungRx. To read more about the partnership, click here.

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