Live from Central Labs: Day 3

Central Labs Partnering event closed today which a motivational keynote from Lou Ferrigno. Pharmaceutical executives listened as Mr. Ferrigno explain how becoming fearless and taking strategic risk in this economy will lead to true success and breed innovation. In the afternoon, Wendy R. Sanhai, PhD, Senior Scientific Advisor, Office of the Commissioner, FDA; Samir Khleif, Head, Cancer Vaccine Section Investigator, NIH; William Wheeler, MD, FAAC, Global Medical Director, Centralized Cardiac Services, MDS PHARMA SERVICE; and Patrice Hugo, Vice-President of Scientific Affairs, MDS PHARMA SERVICES provided innovated strategies for working together to develop biomarkers for safety monitoring and surrogate endpoints.

IIR would like to thank all of those who attended and invite you to comment here on the event. We are looking for ideas on where to hold next year’s meeting and welcome your feedback here.

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Live from Central Labs: Day 2

Today, was the second day of IIR’s Annual Partnering with Central Labs event. Kenneth Kaitlin, PhD, Director and Professor of Medicine, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT, kicked off the meeting with a dynamic and engaging talk that discussed the current environment for pharmaceutical innovation, Tufts CSDD’s Annual Report on Trends in Drug Development, and new R&D strategies. The audience then heard J. Rick Turner, PhD, President and Chief Scientific Officer, TURNER MEDICAL COMMUNICATIONS, discuss Drug Safety Evaluation with a focus on benefit-risk assessments throughout development and therapy

which was followed by the grand opening of the Labs networking hall. The hall houses over close to 50 companies representing the nation’s leading central labs, imaging and ECG labs, in addition to numerous CROs and ancillary service providers.

This afternoon, participants broke into three tracks on Central lab Relationship Development, Standardization in Imaging Studies, and Improving & Standardizing ECG and Cardiac Safety Studies in which multiple panel sessions allowed for open discussions and debate. Participants were engaged, asking lots of questions to get the answers to their most pressing challenges in managing outsourcing lab partnerships.

The day closed with a reception hosted by the conference sponsor Esoterix. The Central Labs participants attended and visited with their outsourcing partners and looked for new services with some of the event new exhibitors including MNX Global LifeScience Logistics and diaDexus.

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Live from Central Labs: Day 1

IIR’s 7th Annual Central Labs Partnering with Central Labs, ECG, & Imaging Labs opened today at the Red Rock Resort and Spa in a Las Vegas, NV. In the wake of the news that will likely be the biggest deal of 2010, Pfizer’s acquisition of Wyeth, experts convened to discuss and share best practices partnering strategic Small Pharmaceutical Companies and uncover the latest strategies in biomarkers, personalized medicine, diagnostics and assay development.

Over 250 outsourcing executives from large and small biopharmaceutical companies including Amgen, Pfizer, Novartis and Celgene convened with the world’s largest central labs including Icon, Covance, and MDS Pharma Services.

Monday’s attendees heard about innovative ways to better manage outsourcing partnerships and improve and streamline clinical trials operations. In addition, they received a deeper understanding of the how new developments in biomarkers, personalized medicine, diagnostics and assay development will change the face of drug development in the immediate future.

The day closed with a wonderful reception hosted by Huntingdon Life Sciences. Dr. Douglas King, Director of Business Development for DCL Medical Laboratories said to one of the conference organizers “This is such a great event. You can look around the room and see deals being made!” Despite concerns about the economy and continued mergers the buzz was great as participants recognize that as large pharma continues to downsize their workforces outsourcing will continue to be a go to strategy for the long haul. Finally, after the close of the reception attendees left for the evening to meet one on one with their partners and take advantage of the beautiful casino at the Red Rock.

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An Optimistic Close to DDP 13 General Session - "the current economic environment is not even close to the depression"

In a dynamic and exciting presentation Todd Buchholz, former White House Director of Economic Policy and Author of New Ideas From Dead CEOs ended the general session at DDP with an optimistic and pragmatic view of the future of the global economy. He claimed 90% of Americans will keep their jobs in this economy. He emphasized that inflation is not what it was during the depression. He also hinted that things would begin to bounce back by September 2010 "the back to school buying season".

In response to a question regarding his optimistic view of when the economy will begin to recover Todd took us back to 2004 when the bubble really began to burst and compared the housing bubble, NASDAQ, and commodities. He said we're going back to a more normal time where we saw 2.2% growth versus 4.5% and that this retrenchment will put us back at a more reasonable and modest approach.

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Where Does the Future Lie for Systemic Delivery of Drugs by Inhalation?

One of the highlights this morning at DDP 2009 was the panel moderated by Martin E. Judge, PhD, Sourcing Director of Diabetes Research Unit at Novo Nordisk A/S which featuring Alfred E. Mann, Chairman and Chief Executive Officer of Mannkind Corporation, Igor Gonda the President & Chief Executive Officer of Aradigm Corporation and John Patton the Chief Research Fellow of Nektar titled "Where Does the Future Lie for Systemic Delivery of Drugs by Inhalation? ".

The panelists discussed the value and benefit of inhalable insulin. John Patton discussed where he felt Exubera. had stumbled while Al Mann discussed the uniqueness of Mannkind's inhalable insulin currently in trials. In addition, they discussed how pricing is affecting reimbursement and risk and offered thoughts on how companies need to communicate and measure the benefit ratio.

Dr. Judge asked the panelists if inhalable insulin can and will demonstrate improved efficacy and safety. They all agreed that this was the big challenge. While that was one of the causes of the Exubera failure, Al Mann contends his product will meet this challenge.

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Riding out the "Consolidation Wave" at DDP

Almost every conversation I've had at DDP at some point turns to contraction in the industry and how smaller drug delivery and biotech companies will weather the current economic downturn. Then today WSJ reports that Pfizer is talking to Wyeth about a purchase. A number of experts here have indicated that while the current credit crisis will make deals harder this will not stop the flurry of activity we are likely to see over the next few months as companies whose funding has dried up present numerous opportunities for big pharma. It seems this is a great time to be at the deal making event of the year.

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Open Business Models - How to Thrive in the New Innovation Landscape

Innovation and the economy are two recurring themes at DDP 2009. During his keynote Dr. Henry Chesbrough, Executive Director of the Center for Open Innovation at Haas School of Business at U C Berkeley discussed how Ryan Air, Apple and Proctor & Gamble have successfully embraced open innovation by thinking long term and reevaluating internal patent and licensing policies.

He told a captive audience of over 400 Drug Delivery executives what they need to do to embrace open innovation to help their organization react to the changing R&D pipeline paradigm facing the industry.

Here is one of his slides that outlines open innovation in life sciences.


ok now back to the show....more to come.

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Drug Delivery Partnerships Live from the Red Rock

It is with great pleasure that we launch IIR's Future of BioPharma blog live from the 13th Annual Drug Delivery Partnerships event at the Red Rock Resort and Spa in Las Vegas, NV.

The Executive Director, Tricia Carle opened DDP this morning and introduced the conference co-chair Dr. Peter Kramer, Executive Director of External Science & Technology, Strategic Transactions Group at Bristol Myers Squibb who remarked that we are at the cross roads of change and innovation in the Biopharmaceutical drug delivery industry. He then introduced Debra Bingham a partner at Valeo Partners who kicked us off with a Letterman style Top 10 list of the 2008 Events that will Impact in Drug Delivery in 2009.

10. Branded DD products go generic
9. Nektar sells inhalation business to Novartis for $115 million in October 2008
8. The dismantling of Alza - Acquired for $12 billion in 2001
7. Pfizer pulls Exubera from the market in 10/07 and Novo stops development
6. Pfizer reports lung cancer in study and Nektar discontinues Exubera partnering
5. 2008 Roche acquires Mirus for RNAi delivery for $125 million
4. Jan 27, 2006 inhaled insulin approved
3. Large restructuring of big pharma 2006- Present creating an entrepreneurial spirit
2. Mandate for healthcare policy change in U.S.
1. The current financial crisis

So what will the impact of these events be?

1. Regulatory pressures and changes (regulatory, pricing, generics, doctor relationship controls)
2. Increased financial pressure on CEOs and boards of emerging companies
3. Increased M& A activity
4. Pay and regulatory pressure to prove the benefit of rug delivery - What is the value proposition of our technology not just in extending patents but in increasing value for the end user and convincing third party payers that your product is worth reimbursing
5. Continued opportunity to enable delivery of difficult therapeutics

Stay tuned for more Drug Delivery updates live from the Red Rock! And be sure and sign up for our DDP LinkedIn group to continue networking with industry peers.

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