Inspirational Patient Perspective with NFL Legend Terry Bradshaw

Inspirational Patient Perspective with NFL Legend Terry Bradshaw
Terry Bradshaw, Co-Host and Analyst, FOX NFL SUNDAY

We are all human beings and we share the same values in life. We all want to be happy. As a survivor of depression, he likes to understand the drugs that are in his system. Terry did two things this morning : he woke up and loved that he was alive, and the second thing he does is smiles. Smile is a reflection of the inner spirit and character. In any business, you’re always in contact with strangers. We’ve got to sell things other folks, so you‘ve got to sell yourself first. Laughing and smiling is one way to do this.

Those people you are selling things do don’t care what’s going on. You’ve got to put a smile on up front. You need take charge and put on a good face. You need to let everyone know that everything is fine, and you can do that by simply smiling.

We’re in too big of a hurry, if we need to get something out of life we need to be patient. We need to surround ourselves with good people. Nothing happens that is good, and you’ll need to turn around and say thank you to someone else. Terry felt different growing up. He lived with a football in his hand, and continuously failed. Never made and organized football team, but he had a love for the pigskin. He dreamed of having a football, Santa brought him one and then learn how to throw it. He knew his calling early in line. He had a purpose in life to work hard.
What we’re doing in the Pharma industry is amazing, because we’re giving other people lives.

Terry is raising pigs and taking the meat and feeding the poor. He’s helping people who are hungry. He’s breeding one and raising 300 hogs a year, and all of the meat is being given to the poor. That’s one of the joys in his life. The commitment of the pharma industry to change people’s live is a joy. It will never be taken away. It takes a passion and commitment to do these things.

If you work hard and ever say never and believe in the people around you there's no magic to anything, life is fun as long as we put forth the effort, life is a kick. Business is fun. You have to keep things simple in life. One of the most wonderful thinks about life is the love of a parent. There isn’t anything better than the love of your mother. Don’t ever stay sad, or believe that you don’t deserve. If you make a different, it won’t be that bad next week. Take charge when you wake up in the morning, thank your higher power, smile and let everyone else know they’re important. Watch them change. Do something for someone, and let them know you care about them.

Welcome to The Second and Final Day of the Conference

We do hope you've been following along to our coverage from the conference. Yesterday we sat through many sessions and presentations. If you haven't had the opportunity to review our coverage, take the time to read through our highlights as well as video taken from the conference:

Leading Through Change: Innovation and the Future of the Biopharmaceutical Industry

MMAX: Development, Evolution, Growth and Maturation of a Large, Integrated Drug Development System

Virtual Pharma: Addressing Challenges and Opportunites in Biomedical R&D

Understanding the Concepts of Disruptive Innovation, Its Impact and what Pharma Can Do To Get Ahead of It

Wall Street’s 2009 Forecast and Analysis of Outsourcing Trends

Approaches to Address the Impact of Increasingly Complex Clinical Trials

Clinical Trials: What Does Global Mean to You?

Creating a Competitive Advantage through Sourcing


We also had an opportunity to conduct some excellent interviews with other conference participants:

18th Annual Parnterships with CROs sat down with Deirdre BeVard, Vice President, Clinical Operations and Data Management, ENDO PHARMACEUTICALS who participated in the conference as a speaker as well as a member of the conference's Advisory Board.


18th Annual Partnerships with CROs presents Steven Whittaker Director of Project Management and Operations, CV/Acute Care, ELI LILLY & COMPANY chairperson of conference track Strategic Sourcing: Alternative Development Models


We plan to continue our coverage throughout the day as we enter the second and final day of the conference. Be sure to subscribe to our feed to receive our regular posts.

Virtual Pharma: Addressing Challenges and Opportunities in Biomedical R&D

Peter B. Corr, PhD, Co-Founder and General Partner, CELTIC THERAPEUTICS MANAGEMENT COMPANY LLLP;Formerly Senior Vice President, Science and Technology, PFIZER

Dr. Corr believes that the current crisis was very predictable. The electronic industry has suffered the same fate. We live in a world that is constantly changing, and how will we adapt to that going forward? Some of the problems are that the pipeline deficiencies exist in Pharma. The critical short term capital is not accessible to the biotechs. There are 23 new compounds a year, and each compound is approximately $2-$3 billion dollars. The average drug will bring in $750 million dollars a year. Expiring patents will result in $2 billion in loss. What’s the problem? There are over 2300 compounds in clinical development around the world. Of the compounds, 67% are in small biotech companies. They have 2% of the R&D spending, 8% of the cash and 3% of the market.

There is little to no IPO market in the United States. Why did they begin the new venture? Therapeutics is getting the compound, preclinical development is making it a medicine, exploratory development focuses on making the drug work and discovering the dose. Venture capitalists are good at getting something within early Phase II data. Large pharma tech companies try to do it all, but they can’t. They’ll have to work with partners to obtain the products they need to grow. Alliances with small biotech companies, a capital market breakdown, and they need products which will be best sought out with partnerships.

The investment strategy is to acquire ownership of potential products. They take the product through to Phase III, ready. And then distribute proceeds from sales to investors, they focus on developing their portfolio. Precompetitive alliances are essential in the success of these approaches. Information needs to be presented to the FDA about what the best way is to test a drug, and better test drugs. Everyone has a background level of information. A single format is then available to everyone. Companies will survive that effectively utilize the information. The goal was to bring all parties together. Precompetitive initiatives can save a lot of money for industry by working together. It doesn’t have to destroy the competitive nature.

Virtual Pharma is working together with a variety of CROs and other vendors in terms of bringing products to reality. The development organizations at Celtic is separate from management. Management does deals and gets the compounds. Development operations implement the overall strategy for particular product: Legal, Outsourcing, Finance, IT, HR and OA. The CRO and Development Partners work together with the Virtual Pharma company.

Advantages of virtual pharma model according to Celtic:

-Adapts more easily to strategic decisions

-Best in class

-Potential for faster development cycles

Updated:
Here is a short clip from this keynote presentation

Understanding the Concepts of Disruptive Innovation, Its Impact and What Pharma Can Do to Get Ahead of It

Clayton M. Christensen, Robert and Jane Cizik Professor of Business Administration, HARVARD BUSINESS SCHOOL

Puzzles related to innovation: Most companies were at some point regarded as successful, but ten years later, they were in the middle of the pack. Why is success so hard to sustain? Why is innovation so risky? Everybody has been trying to figure out why healthcare is becoming more expensive and becoming less successful?

Models from Dr. Christensen’s research:Performance of a service or product over time: in every market there is a trajectory of improvement that customers can use. Pace of technology is growing faster than the performance that computers can utilize or absorb. Breakthrough improvements have the same basic purpose, what they’re trying to do is trying to sustain trajectory of improvement. Companies that lead their industries find themselves on top of the industry when the battles are over, no matter how technology difficult it is. They went to make better products for better products for their best customers. Disruptive innovation can show itself in a more affordable, not as quality of product. Usually an entering company comes in and kills the leaders. Who will win the battle of selling better products?

Define your battles. The odds of success when you’re starting at the bottom of the trajectory are high. By using disruption, the entrant is more likely win. Another example of this car industry. In the 1960s, Japanese Cars entered the market. Entered with small products, and the American car industry sent little cars, but saw more profit from their larger cars, so there was no reason to focus on a place where their revenue wasn’t large. Currently, the bottom of the market is Kia. Toyota isn’t defending the small cars, because they’re investing in their larger cars. This concept lies behind why Walmart and Target killed the department store. Everyone is being toppled for expensive profit, but another one bringing in an affordable but profitable for the consumers.

Players in industries are going to prioritize innovations by what is more profitable. For airlines, it’s the length of the route, and smaller independent airlines are thriving on the small routes. Same thing in the Pharma industry. Blockbusters are much more profitable than small market drugs. Emerging markets aren’t improving more revenue at the pace desired. As Pharma companies have gotten bigger, blockbusters have become a higher priority, and they’re unable to support priority on smaller market drugs. Molecules appear at unprecedented rates, but since they’re not blockbusters, they don’t have the resources to push them across the goal line. A lot of capitol is being lost because drugs aren’t going to make the blockbuster money. Each disruption brings a larger group of people a simpler and more affordable version of a product. As hospitals compete against hospitals, they drive the costs up. Sustaining innovation increases costs, it’s disruptive innovations that bring affordability and accessibility to the marketplace.

To translate this to the Pharma industry, we must drive the use of technology to patient clinics. We can begin by doing the simplest things, then bring technology to them to do more sophisticated things. They give technology to doctors offices and homes so they can progressively do the most simple things, so they don’t have to do the things that historically became a doctor. We must enable lower cost venues of care to provide the simpler procedures to introduce affordability back into the market.

Updated:
Here is a short clip from this keynote presentation

Creating a Competitive Advantage through Sourcing

Speaker:Vasco Grilo, VP, Global Pharma R&D Sourcing, JOHNSON & JOHNSON

Very little reference that needs to be done internally in order to create these models in order to enhance the roles of suppliers. There are tremendous opportunities of developing strong relationships with suppliers. This is key for internal reliance with business partners. Once you have the support of the internal stake holders, you have to look at your supplier base. The tools to segment the supply base are important. J&J uses several – growth focused, risk management, Segment relationship value, which is how suppliers understand them. Are we really a customer of interest for the supplier and can they ever establish a real relationship with the supplier while also looking at the commodity market, certain commodities are strategic, some are critical. What does a strategic relationship look like? Key characteristics: assurance of supply (joint balance of power), quality (quality improvement council), service (supply chain optimization), cost/value (supply chain optimization) and innovation (first choice of new supplier in new product development). You can only do this with a certain number of suppliers.


It’s about compliance. Once you go through the relationships and capture the benefits from the suppliers. This is a key area of work for Johnson and Johnson. What are the opportunities? Identify Assumptions that must bear true, pressure test assumptions, and invest and implement.



How do you value innovation form a supplier? In terms of the ability of a particular supplier, a supplier might come forward with a new model for supply chain logistics. That might not necessarily be seen on an R&D budget. Where is it touching? Sometimes on the top line. Can you get this faster in the market? Segmentation: businesses cases or historical innovation: which stage of the process?

Updated:

Here is a short clip from this presentation

Approaches to Address the Impact of Increasingly Complex Clinical Trials

Pam Atwell, Director, Operational Strategy & Planning, Clinical Development Services, COVANCE INC .
William D. O’Riordan, MD, Medical Director, eSTUDYSITE

Ensure patients safety is the most important part of the trial. The current state of affairs in clinical trials is that an overwhelming 92% behind enrollment timelines. Trial delays have impact on the registrations of the products. What have we seen over the past few years? We’re looking for patients in nontraditional countries, we’re chasing patients where they haven’t been tapped into in the past. Even though they exist, we’re waiting for investigators to catch up to the demand to give us access to the patients. With out and investigator site, we can’t get patients enrolled in our clinical trials. In India, 2% of the global investigator pool in 2007. China didn’t approach 1% of the pool. Investigators are small percentage at the moment, top 20 growth rates are all in emerging markets: China, Estonia, Russia, Peru. We have not only more complex studies, but we also have more of them, with few investigators for find patients.

What does this mean for the emerging markets? Investigator sites aren’t in place and the protocols are very complex. Will we see the same churn rate as we see in the western countries? Research for a year and then dropping off?

FMEA – Processes Failure Mode & Effects Analysis (FMEA) Systemized group of activities to identify the mission failures and their impacts. It was developed by the US government. Covance has applied this to clinical trial management. The steps that have been identified for potential failures or places that failures could occur on a clinical trial. We can identify possible places to identify failure at a site. Pick up on the places for protocol deviation and violations that occur. You can then rank your failures. Risk score for all potential failures.

What are the barriers to success? Lack of fundamental understanding of the nature of risk management, Up-front planning requires initially more time and cost, ongoing review processes also require additional resources, appears to add complexity, and cultural change in how many clinical trials are currently conducted.

William – Proactive method of addressing as far as the concerns of the research sides. Average increase of CRF pages went from 55 in 1999 to 180 in 2006. Compensation per procedure has decrease 7.9%. Pharma must plan ahead better and better to proactively manage trials.

Covance has two committees:
Protocol review committee to examine proposed protocol, each member of panel has specific task to overlook. The committee reconvenes in one week and reports on the areas they were designed. They then decide whether or not to take the protocol. This must be done very early on.

Fast Start Committee is in charge of coordinating and implementing and protocol and addressing and solving complex issues contained in the new protocol.

Updated:

Here is a short clip from this track session

Clinical Trials: What Does Global Mean to You?

Speakers:Michael O’Brien, President & CEO, BEARDSWORTH

Art Gertel, VP, Strategic Regulatory Consulting, Medical Writing and QA, BEARDSWORTH

Navaneetha Rao, MS, ScD, Vice President, Clinical Research and Development, VICUS THERAPEUTICS

Renée E. Moore, President Global Operations, PROGENITOR INTERNATIONAL RESEARCH

What do we mean by globalization?

Definitions:

Regional – Localized to a distinct geography

International – multiple geographies

Global – The above plus employees in all major geographic areas in which clinical studies are being conducted.

Navaneeth Rao believed that many of the service providers are still mainly focused on execution aspect, because that’s how the CRO industry works. Many are not adapted to integrate the aspects he presents. The Service Provider looks at contextual localization. Renee Moore thought that geographical presence is a key primary concern where the study is projects. Being able to project an education strategy with the sponsor can provide this experience. Michael O’Brien thought that the drivers to globalization were lower cost basis, compress enrollment period, for marketing reasons. Very important for smaller CRO to represent where the price advantages are. It’s about value, not cost.

Partnership in a global environment. How do you best integrate the service of the sponsor? Can we maintain a partnerships moving on with the current clinical project? How do we maintain the integrity of the organism? What should sponsor considerations be? What does the staff retention look like? Loyalty, cost differential mythology, and locus of control. Renee Moore believed that the primary concern of the sponsor. Staff retention in an emerging market, the problem of increasing salary may arise. Staff retention is critical, and how do they maintain this over the period of the process. Is it appropriate to outsource outside your country? Outside your firm? Not every situation has the same solution, you must think outside the box.

Sponsor Trends – What are the trends? The advent of the outsourcing gate keeper, preferred provider, niche providers, effects of consolidation, effects of downsizing and local versus out of country. Clintrials.gov, the majority of clinical trials are ongoing in the US and Europe. The increasing competition and decreasing willingness of countries presents an overwhelming need to develop a global approach to clinical trials.

Contractual and financial consideration – Everyone structures their templates in different ways. Not all are changed. Michael O’Brien stated that there is a type of misalignment in a CRO with a sponsor. The sponsor is looking for the value of what they’re buying. It may be that the lack of clarity around the transfer of obligation to the CRO is partially the problem. CROs may take more risk in this relationship. Is the push to globalization enough of a step outside of the box to allow the relocation to the CRO. Renee Moore believed that the type of contract, service providers can and will enter into with a sponsor, driven by multiple factors. Smaller companies will have a little bit more of a challenge from a profit sharing model. Smaller may not be able to enter in to the contract without a neutral cash flow from the CROs. A built in risk when you’re working in global economies. An Example: 1.6 euros to 1.1 euros per 1 pound over six month period. Similar currencies are happening to all around the world. It is passed on to the current word. Putting in invoice that euro will be valued at what it is on the day of the contract.

Updated:

Here is an interview with Michael O'Brien and a small clip from this panel discussion:

MMAX: Development, Evolution, Growth and Maturation of a Large, Integrated Drug Development Solution

Harris Koffer, Pharm D, President and COO, RPS, INC.

James Dannemiller, Director, Site Research, WYETH RESEARCH

Harris Koffer and James Dannemiller started off discussing the understanding key trend and drivers for pharma. Over the last ten years, a peak of 50 drugs were approved in 1996, then dwindling to 22 drugs approved in 2006. The cost of developing drugs over this time as doubled. The market for Pharma products has continued to grow. The risks of drug development have continued to increase. Only one in five drugs for human testing actually reaches the market. Patent expirations on drugs has been putting pressure on the industry. Companies will loose significant revenue because of this between now and 2012. We’re also faced from external burden of a declining economy. Total health care expenditure was at slowest pace in 2007. Declining utilization of healthcare coupled with patients who can no longer to afford to medication will further decrease the productivity and profit of the Pharma industry. What is MMAX? Maximizing Monitoring, Availability and Excellence. Wyeth and RPS to make this program work. MMAX was established in 2005. The goal of this program was to reduce cost, improve quality, expedite clinical development process and improve site relationships. It operates under one global process. It includes one global structure reporting to Wyeth and one governance model. The strategic intent of MMAX was to implement structure that represented culture of Wyeth, structure to expand or contract with Wyeth’s portfolio, and to maintain Wyeth’s primary image.

Key objectives of MMAX:Quality – With activities, but also the quality from a site perspective, and to identify quality site that can perform the study based on the expectations.Speed – Ability for RPS to gear up for changes. Flexibility – ability to scale up or down as the needs of the organization mergeCost Effectiveness – Cost model that provides more streamline approach to cost.

Updated

Here is a brief clip from this keynote presentation

Leading Through Change: Innovation and the Future of the BioPharmaceutical Industry

Moderator: Christopher C. Gallen, MD, PhD, President & Chief Executive Officer, NEUROMED

Panelists:Jack H. Dean, PhD, ScD (Hon.), DABT, Fellow ATS, President, U.S. Science and Medical Affairs (R&D), SANOFI-AVENTIS (Ret.)

Elliott Levy, MD, Vice President, Clinical Development, BRISTOL-MYERS SQUIBB

Why are we involved in the Pharma industry? We’re in a society where humans live past the age of mid thirties, and this is the first time that that has ever happened in history. Our industries have created the conditions that make modern public health possible. Our industry is essential in giving humans an extra 60 years of living.

The macro challenges facing our economy have begun to present a problem. Massive amounts of money became available, and that’s funded the bubbles that fueled our growth. The practice of giving sub-prime loans grew. Then the bonds fell, and hundreds of billions of dollars were lost. Our real economy has been disrupted. Pharma’s point of view in all of this is that it will affect two main sectors: pharmaceutical and biotech. Pharma will mainly be facing internal industry. Small molecule products are where the funds come from, which the patents will be expiring. They won’t be replacing the revenue lost. The growth of the Pharma industry has been because of price increases. The research and productivity has to be increased to counter this diminishing aspect of revenue.

R&D productivity has been a problem. Success rates have been decreasing. Shifting tests overseas have helped the cost some. Vaccines have been focused on as a result. Blockbusters going off patent and Pharma isn’t producing enough products to meet their needs. We’ve seen sales go up, R&D expenditures have increased, and time lines have gotten shorter. Productivity has been halved.

Why is productivity declining in Pharma?Elliott Levy of Bristol –Myers Squibb sees two sets of assets that will be affected: external and internal. In external realm, the growing knowledge and interest in safety is a focus. We’ve developed ways to identify safety factors when testing drugs when they’re in development. We’re operating in an environment where the standards for safety has gone up. The competitive marketplace for drugs has become overcrowded. Hurdles for introduction to the market have gone up.
Jack H. Dean added his insights on the direction of safety issues. The industry has become too sensitive about preclinical safety. Many of the drugs that are marketed today wouldn’t be here. The other thing is that the easy things have been done. We’re battling very complicated diseases. We put too big of bet on molecular tools, we’ve forgotten the importance of the medical chemists. We’ve only explored about 10% of the chemical space. Clinical and preclinical safety presents hold backs.

The panel was also asked what they see the communications and human insights into the science? Elliot Levy stated that everyone is trying to find the right structure to expose maximum scientific talent. Drug discovery process and operational side of things, then pushes compounds that have limited potential in the market place. Do we need to become more global to exploit this? Need to tap intellect around the world. Negatively, it’s very difficult to manage global communications.

Where are our patients going to come from was another question posed to the panel. The experts believed that we have to go to places around the world where everyone else has the same problems, like diabetes. Basic R&D has been outsourced to the biotech industry. Now, we see that half of the products from internal efforts in pharma and half from biotech. Quarter of the money spent comes from biotech, making them the low cost producer. The credit crunch has closed down world IPO market. Levels of disinvestment have affected the venture capitalists, and many bioteches are running out of cash. IPO market will probably not open up in next year, and there will be a wipe out of the biotech industry before the credit crunch is over.
Universities could be the place to go in their absences. It’ll be needed to apply. To fill the gap may be impossible. Large scale Pharma between 2009-2010 will only be able to replace 39% of their Pharma revenue.

Dr. Levy stated that in the short term, larger Pharma companies will be able to inquire best talent from biotech. They’ll replenish the pipelines. In the long term, if bioteches fold, scientists will migrate to companies. But won’t happen, because no jobs for developers. So what will this do for productivity? Pharma R&D is over capacity. Could be there is no great impact.
What can CROs bring to productivity? Technology solutions are less important then talent and capability development. The industry can become much better. There are too many studies that take longer than originally planned. Companies need to decide what their core competences are. Could CROs fit into this picture?

Dr. Levy stated that in the next few years, a few macro trends not moving in same direction. Data needed, Pharma avoids fix cost investments. This favors CRO industry. Decreasing amount of spend from companies, lower money over all for CRO factors.

Dr. Dean stated that the companies will try to maintain flexibility in costs. They’ll be forced to rely on a flexible cost structure. They quality CROs who deliver good relationships and products will be favored. Cross functional integration into the cooperation will be sought after.
R&D will not increase. CRO penetration of the pharma industry will continue to accelerate as companies right size them selves because of focus on core competencies.

Updated:

Here is an interview with Christopher Gallen regarding this keynote panel:

And here is a short clip from this keynote panel:

Wall Street’s 2009 Forecast and Analysis of Outsourcing Trends

Moderator:John Kreger, Equity Research Analyst, WILLIAM BLAIR & COMPANY
Speakers:Derek Gustafson, Senior Vice President, Corporate Finance Division, MACQUARIE SECURITIES (USA) INC.
Randall Stanicky, CFA, Vice President, Global Investment Research, GOLDMAN SACHS
David H. Windley, CFA, CPA, Managing Director, Healthcare Equity Research, JEFFRIES & COMPANY

David: Forecast for industry growth, there is a dramatic growth in cancellations of gross bookings in the 2008. How much backlog have you added as a percentage of your revenue? Companies are adding business to backlog long before they convert it to revenue. Two outcomes: The revenue flows through after a break, or perhaps there is a hold, and the revenue leaks.

Randall Stanicky, Golamdan Sachs discussed what was going to happen with the CRO outlook for 2009 and beyond. What’s going to go on in this space? What will be the picture for actual growth?
What will happen in the upcoming years for Pharma:
- Pharma R&D spending is slowing – 0-5% annual growth which is likely the reality. If we look at the biotech side, they have less than 3 years of cash available. Many of these companies won’t be around for very long.
- Patent cliff is coming – increasing the need for more compounds. There is a need to continue to spend and find opportunities for new drugs- Post M&A restructuring will likely result in substantial R&D synergies
- CRO industry growth is increasingly and biotech funding decreasing, CROs are more dependent on greater outsourcing – strategic alliances will be key going forward
- Expect share shift towards larger CROs in the future, larger CROs are putting up larger booking numbers
- Outsourcing will continue to movie ex-US
- We see stable long term growth despite near-term headwinds
- “Street” view – tough 2009 but improvement in 2010. All 2009 growth was decelerated, but look to pickup in 2010. Consensus analysts 2009: -6% in w009, but 20% in 2010. But analysts her believe that things change quickly and meaningfully.
- CROs will be valued differently from the future John Kreger of William Blare and Company pointed out that stock prices and value prices, M&A is still pretty robust and will continue to be that way. Outsourcing stocks have performed nicely, but underperformed since September 2008.

Then the audience had a chance to ask their questions.Gross margins are holding in contrast at odds with specific contracts. Do you expect more of this to hold? The panel stated that looking at the fourth quarter of 2008, a lot of commentary about price discounting and offers of significant volume discounts. This will be detrimental effect on the margin. Key question is staffing levels. Companies retain too much capacity for the real amount of work that was there to be won. This time, can we get right amount of man power to get the job done?

Why are large Pharma companies are cutting back on R&D when the opposite needs to happen? Steve –Companies need to find ways to be more productive. They can focus on cutting R&D on short term basis, at the same time, they’re looking internally to be more productive to find more ways to be the same.

Preclinical companies are doing worse. Do you see any vertical integration, Pharma buying them rather than let them go out of business?It will come down to the strategic type of deals and if they evolve. Industries may strategically partner, which would be linking to early development to later development. So far, this hasn’t happened. If we see all Phases overlap, then there’s a very strong argument for companies to go vertical. Other industries viewing disruptive change, companies will come in and do it better, the displacement of existing large companies is inevitable. Short term versus long-term. Pharma deferring studies that are important to long-term growth but at the same time Pharma needs new drugs to come out of the pipeline in order to gain more profit.

What are some of the current struggles with Pharma currently? Lack of compounds, Patent cliff, growth forecast leads a significant challenge to meet the top line. How much money does pharma have to spend? Secondly, macro level, find out what the biggest drivers are. IMS, updated growth forecast, 2 ½% and it’s negative in the US, there is a precedence in the US industry. This panelist believes that they haven’t found the magic bullet to keep R&D spending from going up. The FDA’s demand on safety aren’t going to let up, we’ve got to offset to make the million dollars a compound number go down. The Pharma industry needs to let R&D grow to let compounds come through the pipeline to end up as a revenue.

What level of consolidate in the generic industry?If you are a US based generic manufacture, the global generic industry, they’re getting much more aggressive, in every aspect of their pursuit. If there is going to be a next wave to save the train wreck in 2012, the follow will be on biologics. The momentum is on a regulatory requirement on clinical trials for generic drugs.

Biotechs are running out of cash. Who will rescue them?This industry needs novel drugs. Good technology will get funded. Next wave of consolidation, pharma will acquire biotech. We’ve seen mega mergers over the past few months. Panelists assumes that strategic money will flow from
Pharma into Biotech companies.

Live from the 18th Annual Partnerships with CROs

We're coming to you live from this year's Partnerships with CROs, kicking off our live coverage of conference activities. We'll be posting updates daily here on our blog so be sure and subscribe to our feed to get our regular updates. But you can also follow along on our twitter stream where we'll be sharing thoughts and perspectives through each day. For those of you in attendance, share you're own thoughts and tweets by using #CROS where other clinical and pharma professionals will be sharing their impressions.

The first day involved in-depth workshops that covered topics such as Implementing Standardized CRO Performance Metrics, Strategies for Small Pharma and Biotech, and Conducting Clinical Trials in Non-Traditional Markets. We had the opportunity to sit through the afternoon workshops and will be sharing details with you here.

We also had an opportunity to meet with Lesly Atlas, Conference Director for this year's Partnerships with CROs as she welcomed attendees to the conference.

This conference promises to bring industry leaders and professional to network, discuss and share insights, ideas and perspectives. We look forward to bringing you posts daily of the great presentations and activities. Be sure to check back often to follow all of the coverage.

Driving Global Growth: Strategic Considerations for Conducting Global Trials in Nontraditional Markets

Moderator: Mark Roseman, Vice President, Account Manager, PPD, INC

Workshop Faculity: Simon Britton, Vice President, Account Management, PPD, Inc

Mitchell Katz, Vice President, Business and Clinical Operations, Eisai Global Clinical Development

Jorge G. Guerra, Senior VP, Global Clinical Operations, Biogen Idec

Jose Eduardo Neves, Medical Director, Astrazeneca

Earlier today at this panel, members of the CROs industry discussed the best ways to conduct clinical trials in nontraditional countries.

What are the issues facing in the pharma and biotech industry today? The panelists stated that cost was an issue in addition to understanding the regulatory climate outside the US. Keeping on top of the ever-changing environment also presents a challenge. It’s also important to recognize that going into new markets and keeping the costs down while ensuring the quality. It is also difficult to address the concerns of the people about the safety of the trials.

When looking to expand to other areas, the majority of the panel members agreed that Europe and North America have similar standards. For Japan, they’re looking to expand past Japan, to Korea, China and even India. Large pharma have offices in Japan, and they’re trying to force Japan to be part of the global studies.

The panelists were asked whether companies expanding or relying on CROs? The panelists responded: Astrazenica uses CROs are in terms of individual programs. Mitchell Katz states that Eisai Global Clinical Development has affiliates in offices across the globe. Experience in the country will come from the service provider. PPD states that it’s understanding what’s in the country. Some companies are trying to grow in global needs, others are trying to grow in terms of registration studies. Many of the CROs were already running studies, so Astrazenica saw the opportunity to be in that country. PPD, Inc says pharma growing commercial groups and taking research out. Mitchell Katz of Eisai Global states that it’s not where to go, based on the practice of medicine. Their protocols depend collaboratively on CROs who already have experience with that particular country.

When conducting Mitchell: It’s not about cost savings, it’s about the right countries and people to focus your studies on. Planning on the front end, do global trials (regulatory issues), but not practical in competitive to be able to do all trials in US.Jorge: Ideal to attract all patients in US. But all in US, you could gain a lot of time if you could guarantee acceleration.

Two-thirds of trials are still being conducted in regional market. Will this change soon? Astrazeneca provided the example in terms of the current state of China. If China wants to become world power, it must reform some institutions. Same to clinical, we’ll still see growth, but in nontraditional markets, they have to adapt to the system as well. Mitchell- will be balanced. Traditional drug development was all domestic at one point. Most small and medium sized companies didn’t have structure. But now we’ll see that the industry has allowed us to go global. This is a very approved approach for drugs being approved. Can’t afford to do that, and will be more balanced in terms of globalization.

Regulatory challenges are real because of the constantly changing climates. For regulatory approval process, there needs to be planning. But is this reality? No. Patient population is opportunity in China, it’ll be a realistic place to plan a study. We depend on CROs to guide us through these countries. Critical to stay on changes, some countries are getting better and some are getting worse, and CROs can guide small companies in these matters.

Governance and Supplier Relationship Management

SRM Case Study of Bristol-Myers Squibb Frances Grote, BMS Supplier relationship management

BMS instituted supplier relationship management in 2005 to work with their suppliers. They grew into a partnerships approach when working with their CROs. The companies needed added value, so they looked at supplier relationship management.

Key to success for supplier relationship management:
-Someone needs to be the driver. A group that is not the direct user of the services, and the ideas need to have a person to implement them, but isn’t’ there to get the job done. It’s a full time commitment, but after it’s in place, doesn’t need full time oversight.
-Senior leadership within business unit. They people who will use it need to buy in. They’re the stake holders and they’ll build your culture.

If someone sits in the suppliers side, that doesn’t mean that they’re another person. If it’s our project, they’re on your team. If you’re improving process, you’ll need to make improvement available to suppliers. If suppliers supply info to other customers, you’re receiving it as well. You all sell what you’ve created to the public, so share and benefit when you can.

If you do SRM well, you could become as important as you are to your suppliers. They’ll want to go back to you, if you have strong SRM, they’ll continue coming back to you. The governance success factors are that you do need committees, as they are key for relationship health but key to keeping internal people. Very strong issue escalation pathways. They need to know who to take it to, someone to hear it, and that’ll help them solve that problem.

Performance management:
- KPIs need to be tied to deliverables
- Deliverables based contracting seems to be key
- KPIs need to be tied to deliverables- Scorecards and KPIs are in place

At BMS, management changes that stayed because of MSAs (before SRM) not service level agreements but expectations about quality, governance. Neither side is up on all, but they’re there. SRM was in the philosophy, and it was more sophisticated. Governance proved to be very powerful. KPIs with metrics and score cards prove the data.

FierceBiotech is the Official Digital Media and Live Coverage Partner at Partnerships with CROs 2009

NEW YORK, NY and ORLANDO, FL (April 27, 2009) - FierceBiotech, the biotech industry's daily news monitor, has joined the Institute for International Research as the official digital media and live coverage partner of the 18th Annual Partnerships with CROs event. From April 28-30, FierceBiotech editors will provide coverage of the event including live reports on its homepage, e-newsletter, and Twitter. The Partnerships with CROs team will also highlight FierceBiotech's coverage through their official communication to attendees and the event website.


"FierceBiotech readers consistently rank Partnerships with CROs as one of their top event priorities of the year," says Arsalan Arif, Publisher of FierceBiotech. "Because FierceBiotech is the first place biotech leaders turn for news, providing live coverage through our unparalleled digital platforms fits our core mission to serve our readers with timely, relevant information."
FierceBiotech's coverage will be live at FierceBiotech.com on Tuesday, April 28. Live coverage will also be available through Twitter by following @FierceBiotech or tracking the official Partnerships with CROs discussion tag #CROs via Twitter search.


About Partnership with CROs
Partnerships with CROs, created and developed by IIR, has set the standard in outsourcing and clinical development conferences. The event provides the information to engage clinical development and outsourcing partners to foster relationships that bring critical therapies to patients safely and efficiently. The event is designed for VPs, Directors and Senior Managers of: Clinical R&D, Clinical Operations, Global Outsourcing, Strategic Sourcing, Contracts Administration, Procurement/Purchasing, R&D Finance, Regulatory Affairs, Clinical Affairs, and more. To learn more about this event, please visit: http://www.cropartners.com/.


About FierceBiotech
FierceBiotech, a FierceMarkets publication, is the biotech industry's daily monitor and first place to turn when news happens. Published daily on multiple platforms--e-mail, web, mobile edition, RSS, and Twitter - FierceBiotech is the most actively read daily publication in the life sciences. For more and to sign up today, please visit: FierceBiotech.com


About FierceMarkets
FierceMarkets, a leader in B2B e-media, provides information and marketing services in the Telecommunications, Life Sciences, Healthcare, IT, and Finance industries through its portfolio of e-mail newsletters, Web sites, webinars, and live events. Every business day, FierceMarkets' wide array of publications reaches more than 800,000 executives in over 100 countries. For more, please visit: Fiercemarkets.com


About IIR
IIR is the world's leading knowledge and skills transfer company with a global network of 47 companies and 112 operating units. Every year, IIR works with 650,000+ business executives providing them with knowledge and skills through training, conferences, seminars, e-Learning, blended solutions, exhibitions, consulting and mentoring. To learn more about IIR, please visit http://www.iirusa.com/.

Speaker Profile: Peter B. Corr

Dr. Peter B. Corr is Co-Founder and General Partner of Celtic Therapeutics Management LLLP. Dr. Corr retired from Pfizer Inc in December 2006 where he was Senior Vice President for Science and Technology. In 2002 and 2003, he also headed worldwide pharmaceutical research and development for Pfizer.



Previously, Dr. Corr served as Executive Vice President, Pfizer Global Research & Development; and President, Worldwide Development. He also served as Senior Vice President, Discovery Research, at Monsanto/Searle and then, President of Pharmaceutical Research and Development at Warner Lambert/Parke Davis.



Dr. Corr, who received his doctorate from Georgetown University School of Medicine, spent 18 years as a researcher in molecular biology and pharmacology at Washington University in St. Louis. When he left Washington University, Dr. Corr was Professor, Department of Medicine (Cardiology) and Professor, Department of Pharmacology and Molecular Biology. His research has been published in more than 160 scientific manuscripts.

Speaker Profile: Harris Koffer, Pharm.D

Dr. Harris Koffer is President and Chief Operating Officer for Research Pharmaceutical Services (RPS), a clinical research organization providing services to the Pharmaceutical and biotechnology industries in support of clinical drug development.

Prior to joining RPS, Dr. Koffer served as Vice President, Clinical Trials and Pharmaceutical Business Development, for Quest Diagnostics; Vice President and General Manager of Covance Clinical Services and President of Covance Periapproval Services. In these roles, he was responsible for global central laboratory services as well as full service clinical research and development capabilities for Phases 1 through 4 of drug development.

In addition to over 28 years of experience in clinical drug development, he has served as Adjunct Assistant Professor of Pharmacy in Medicine at the University of Pennsylvania School of Medicine and Clinical Associate Professor of Pharmacy at the Philadelphia College of Pharmacy and Science.

Dr. Koffer has published and presented numerous papers in the fields of cardiovascular clinical pharmacology and pharmacoeconomics.

He earned both a BS in Pharmacy and a Doctor of Pharmacy degree from the Philadelphia College of Pharmacy and Science and completed a Fellowship in Clinical Pharmacology at Thomas Jefferson University Hospital in Philadelphia.

Harris Koffer will be presenting MMAX: Development, Evolution, Growth and Maturation of a Large, Integrated Drug Development Solution along with Jim Dannemiller, M.S., Wednesday, April 29 at 9:15.

Speaker Profile: Christopher C. Gallen, MD, PhD

After receiving his M.D. and Ph.D. (Biochemistry) degrees and completing a medical internship at the Emory University School of Medicine, Dr. Gallen went on to complete Psychiatry residency training at Stanford and Neurology residency training at the University of California, San Diego. He then joined the Neuropharmacology Department of The Scripps Research where he developed an international reputation in brain functional imaging, published the first definitive demonstration of human cerebral plasticity, and was as a scientific support to the successful IPO and secondary offerings of Biomagnetic Technology Inc (BTi). Dr. Gallen next took on responsibilities rising to Senior Director of Medical and Scientific at Quintiles directing several successful registration programs. Dr. Gallen then started the Premier Research Worldwide CRO, led its IPO, grew it into a successful trans-Atlantic CRO and conducted trials in a wide variety of therapeutic areas and approaches. Dr. Gallen subsequently moved to work in big pharma with responsibilities as Vice President of Medical Development at Pharmacia including three major roles, Head of Global CNS Medical Development, Head of Clinical Operations managing the “internal CRO” for conduct of all clinical trials in all Therapeutic Areas in the Western Hemisphere and eventually, after helping lead a successful re-engineering, as Kalamazoo R&D Site Head CNS and ID, Dr. Gallen subsequently became Vice President and Chief of Operations for Clinical Research and Development at Wyeth in charge of a range of global clinical development functions. In this role Dr. Gallen partnered with Accenture to help create the Alliance for Clinical Data Excellence (ACE) outsourcing of Wyeth Clinical Data Management to Accenture and to drove the successful re-engineering of Wyeth to the top quintile of clinical research performance. Dr. Gallen subsequently became President and CEO of Neuromed, a Philadelphia and Vancouver-based biopharma company developing products to manage and treat complications of pain, epilepsy and hypertension.



Christopher Gallen will be hosting the panel discussion "Leading Through Change: Innovation and Future of the BioPharmaceutical Industry," Wednesday, April 29, 2009 at 8:30 AM.