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October 10-12, 2010 – BioPartnering Europeâ„¢

September 27, 2010 By Leave a Comment

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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September 28, 2010 – Leveraging Project Management Skills as a Pharma US Regulatory Coordinator

September 20, 2010 By Leave a Comment

The September public meeting for the Life Sciences Project Management group (LSPM) will take place in Indianapolis on Tuesday, September 28 at Franklin University of Ohio. Franklin University of Ohio is located on the northeast side of Indy at 8415 Allison Pointe Blvd – zip code 46250.

“Leveraging Project Management Skills as a Pharma US Regulatory Coordinator”

Presenter: Jody Roth, Principal Advisor- US Regulatory, MS, PMP, RAC, Eli Lilly and Company
Synopsis: “Developing innovative new drugs for approval requires knowing and using Project Management skills and tools. This skill set is critical for a Regulatory Coordinator who must lead an internal project team to implement a regulatory strategy and interact, negotiate and influence the FDA in order to gain final approval. Please join us as Ms. Jody Roth discusses how a Regulatory Coordinator adopts and implements elements of the PMBOK during drug development.”

Jody Roth is a Principal Advisor in Regulatory, a PMP and has her Regulatory Affairs Certification (RAC). She has more than 7+ years experience in US Regulatory Affairs processes leading internal teams and interacting with FDA reviewers and project managers.

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December 3, 2009 – ASQ Biomedical Midwest discussion group

November 17, 2009 By Leave a Comment

How the FDA Uses Quality and Inspections

Meeting Date:  10/29/09
Meeting Location: University of Indianapolis
Schwitzer Student Center Building #7 Room #013   (located on the lower level)
See U of I web site for campus map & driving directions.  Parking is open after 5:00 pm.
Time: 5:30 pm till 6:00 pm Networking & Meal
6:00 pm till 8:00 pm Discussion session.

For questions or concerns contact John Freije directly via phone or email:
317-670-8138
john@freijequalityengineering.com

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What Does All The Lilly News Mean For Indiana & Life Sciences?

November 2, 2009 By Leave a Comment

Indianapolis based pharmaceutical company Eli Lilly has been in the news quite a bit recently. Maybe I just hear more about Lilly because I’m in Indiana. It’s clear to many in Indiana’s life science community that Lilly is one of a few foundational companies supporting Indiana’s life science presence. Here are some recent news postings regarding Lilly:

August 7, 2008: Lilly Sells R&D Facility to Covance – The commentary I heard about this deal was it would be very positive for both Lilly and Covance. This is supposed to help Lilly be more nimble regarding drug discovery.

July 22, 2009: Lilly Will House ImClone In New York Tech Park – The Lilly / ImClone news is evidence that New York is positioning itself to become a hub for biopharmaceutical research.

September 14, 2009: Lilly Unveils Blueprint for Speeding Innovative Medicines to Patients – Lilly unveiled a new operating model and announced a series of changes to speed medicines from its pipeline to patients. The interesting thing about this news that the local media picked up on was Lilly would be laying off 5,500 employees, many of which would be from Indy. The press release from Lilly doesn’t mention this explicitly.

October 14, 2009: Lilly Sells Tippecanoe Manufacturing Site To Evonik Industries – Instead of shutting the facility down, Lilly sold the site to Evonik, one of the world’s largest chemical companies. The employees of this facility will be offered employment with Evonik.

October 29, 2009: Lilly Opens Eco-Friendly Biotech Center in San Dieg0 – “We are moving full speed ahead toward building a biotechnology powerhouse,” said John Lechleiter, Ph.D., Lilly chairman and chief executive officer. “The science, technology and talent at our new center in San Diego will help bring novel biotech medicines to patients faster and more efficiently . . .” The biotechnology center is in close proximity to life science activity and research near the University of California and other prominent biomedical research institutes, which is consistent with Lilly’s FIPNet (fully integrated pharmaceutical network) strategy to leverage external resources and knowledge to advance its pipeline. The primary driver is biotech innovation.

October 30, 2009: Lilly CEO Calls for Repair of ‘Engine of Biopharma Innovation’ – Lechleiter offered a vision to San Diego officials for biopharmaceutical companies to “reinvent innovation” to make the most of today’s wealth of scientific knowledge to benefit patients and address unmet medical needs.

Here are some of my speculations about all the Lilly news:

  • Lilly is quickly moving more into the biotech sector. (Maybe most of big pharma is?) Lilly claims to be the 5th largest biotech in the world.
  • Lilly realizes Indiana is NOT a hub for biotech innovation.
  • Lilly will likely reduce its R&D presence significantly in Indianapolis. Indy will be primarily focused on manufacturing.

Life science leaders in Indiana need to figure out how to be successful in a world without a strong Indiana presence from Lilly.

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Pharma blogs – doomed if you do, doomed if you don’t (reblog)

October 28, 2009 By Leave a Comment

Here is an excerpt from ForeignExchange Translations blog post:

So while many companies remain skittish about the Internet, things are changing, albeit slowly, with more and more drug and device companies actively participating in social media, through blogs, Twitter accounts, online communities, and YouTube channels.

It’s been interesting to see that all this dialog has spawned a growing number of people who are monitoring social media by medical device and pharmaceutical companies. This cottage industry of observers and prognosticators announces which companies tweet the most or have the most followers, provides commentary on social media strategy, and offers advice to nervous social media managers.

Read the entire post

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Top Issues Facing Pharma (Recap from Indiana Life Sciences Forum)

October 21, 2009 By Leave a Comment

I’m a medical device guy. I know enough about pharmaceuticals to be dangerous. Actually, I know very little. My knowledge and understanding of the pharma industry increased exponentially today during the Indiana Life Sciences Forum. One of the panels was focused on Big Pharma:

Panel: Big Pharma – What are the Big Pharmas going to look like and what does that mean for the rest of us?

  • Sidney Taurel, Chairman Emeritus, Eli Lilly and Company (Confirmed)
  • William Ringo, SVP, Strategy and Business Development, Pfizer (Confirmed)
  • Jas Gidda, VP of Research and Development, Marcadia Biotech (Confirmed)
  • Matthew K. Hudes, National Managing Principal, Biotechnology, Life Sciences & Health Care, Deloitte LLP (Confirmed)
  • Moderated by:  G. Steven Burrill, CEO, Burrill & Company (Confirmed)
The closing comments from each panelist addressed the top issues big pharma needs to face in the next 10 years. Here are some of the responses:
Ringo
  • Change public perception of the pharmaceutical industry. Public perceives 60% of healthcare costs comes from pharma. In reality, it’s closer to 12%.
  • Improve productivity of research & development.
  • Figure out how to capitalize in emerging markets with established products.
Taurel
  • Improve the worldwide climate for innovation
  • Address market-based demands instead of cost-based demands
  • Establish regulatory standards / approaches for personalized medicine.
  • Adapt approach for patient outcomes.
  • Change internal thinking at big pharma companies from “ways to generate most revenue” to “what is best for the patient”.
Gidda
  • Focus on patient first.
  • Research & development.
  • Change public perception.
Hudes
  • Reform healthcare.
  • Increase mergers & acquisitions. Increase R&D.
  • Advancement of biosimilars and generics.
  • Increase spending and development in healthcare IT. $31B allocated by federal government that could be tapped by life science R&D.
Burrill
  • Change viewpoint from U.S. centric to more of a world view. Rest of world operates on single-payer system (governments).
  • Foster and finance innovation.
The panel was a group of heavy hitters in pharma. What I found most interesting about the discussion:
  1. A great deal of the discussion was about lowering costs. None mentioned value explicitly.
  2. Why hasn’t pharma ALWAYS had a patient first focus?
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September 23, 2009 – Indiana-Ohio AAPS Discussion Group (IODG)

August 25, 2009 By 2 Comments

Dr Raman (Ray) Baweja (FDA) and Dr Abdul Basit (University of London) will speak at the next meeting of the Indiana-Ohio AAPS Discussion Group (IODG). Networking starts at 5 PM, followed by dinner and the talk. The meeting will be at the Kingsgate Marriott in Cincinnati. Additional details will soon be available at http://aaps.org/inside/Discussion_Groups/IODG/index.asp.

AAPS is the American Association of Pharmaceutical Scientists.

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