Executive Channel
What is The Executive Channel
In-depth analysis of strategic management best practices, and developments in policy and law that impact the industry. Featuring Academics, Consultants, as well as Policy & Legal Experts. Built for the Life Science Executive.
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Lee Buckler's Cell Therapy '08 Review and '09 Outlook (04:47)
Exciting things we've seen in 2008 are
- the involvement of pharma in cell therapy, investing like they haven't before, developing cell therapy products as drugs, and not just tools (including companies such as Pfizer, GSK, Roche, and Novartis)
- the number of late stage companies in the sector such as Osiris (see: Osteocel / NuVasis, and Prochymal + Chondrogen / Genzyme deals)
- the financing, partnerships and M&A activity with $400M private equity investment, $100M M&A, and $1.8bn non M&A deals.
Things to watch for in 2009 are
- some of the late stage companies (Osiris and Dendrion - i.e. Provange results in April)
- the struggling cell therapy companies and how they will find cash (M&A, Government, VC?)
- the role of the new Obama administration and the public pressure, interest, and enthusiasm for cell therapy -
Harvard Steps Into the Cell Therapy Funding Gap with a Mission for Academic Research to Get to Patients (06:24)
Brock Reeve explains the functioning of the Harvard Stem Cell Institute (HSCI). The HSCI is looking to make the bedside-to-bench and bench-to-bench loop in a way that unequaled anywhere, with the university, its 11 affiliated hospitals, drawing resources from the various schools (law, business, government, divinity). Brock tell us about about the HSCI partnership with GSK, as well as the other relationships they are seeking and building at the moment.
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Roche's Vertes on Big Pharma's Interest in Cell Therapy (03:59)
Alain Vertes of Roche presents the interest of big pharma in the cell therapy. He highlights the main points of his panel presentation:
1. Cell therapy is not a passing fad
2. Cell are not just transplants, they can also be drugs
3. Paradigm shifting applications for cell therapy
4. Protecting intellectual property
5. Potential for stunning efficacy and low risk of side effects -
US and EU Regulatory Synergies, and EMEA Committee for Advanced Therapies (03:34)
Christopher Bravery comments on the new committee for advanced therapies of the EMEA, and its impact on the development of cell therapy in Europe. Christopher also reflects on the similarity between US and European regulatory environments, and the importance of considering that in planning pivotal studies. He also gives us his definition of Cell Therapy and explains the business of ERA Consulting.
-
Molecular Diagnostics As The Next Major Conceptual Transition (06:05)
Jan Buck welcomes Dr. George Poste onto his show to discuss his uniquely rich view of the life science industry and highlights of his distinguished career. George tells us about his time at SmithKline Beecham, where he witnessed the dramatic transformations driven by molecular biology, genomics, and genetic engineering. Furthermore Jan and George look into molecular diagnostics and how they will allow us to transcend symptoms based empirical approaches and more rigorously characterize the underlying molecular pathologies.
-
Mapping the Human Genome, And The Innovator's Dilemma In The Pharma Industry (07:02)
On this latest edition of the Jan Buck Show, Dr. George Poste tells the story of one of the greatest broad-scale industry collaborations, the SNP Consortium (which became the HapMap Project). Aimed to study population genomics in relation with the analysis of susceptibility to disease and responsive to treatment, it harness the power of a large number of companies to create this body of data, furthering the research capabilities of all, while defraying risk and cost. Jan and George continue to discuss radical innovation, the innovator's dilemma, and how it has applied to pharma and it's blockbuster drugs.
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Taking Out A Small Number of Pharmaceutical Manufacturing Plants Could Dislocate Medicine Supply For Large Numbers of the Global Population (05:41)
Dr. George Poste tells the story of his involvement with the Antibioterrorism Task Force and the Office of the Secretary of Defense. When the DoD started looking at global infectious diseases - trying to measure the social, economic and military risk - they brought George in. Jan and George then discuss the post 9/11 era, and securing the medicine production and supply chain.
-
The Biodesign Institute, A Radical Experiment To Extract The Low Intensity Signal That May Be Indicative Of Disease (08:14)
Dr. George Poste tells Jan Buck about his beginnings as veterinarian in the south of England, his escape from Europe to the United States in pursuit of greater scientific opportunity, and his recruiting at SmithKlein Beecham, taking genetic engineering technologies into the industry. George and Jan comment on the contribution the pharmaceutical industry has made towards human life. They continue to discuss his role in the creation of the Biodesign Institute of Arizona State University, where the life sciences are integrated with high level engineering, computing, and mathematical analysis. They measure hundreds or thousands of genes simultaneously, defining patterns of expression of multiple markers in the body, that may be indicative of disease.
-
A Look to the Future: Personalized Medicine, Consumer Driven Health, Synthetic Biology (07:47)
Jan Buck and Dr. George Poste take a look at the blockbuster based business model of the Pharma industry, and how it might evolve in the years to come. They identify two emerging trends. First, is personalized medicine. Diagnostics and therapy will be increasingly linked. Clinical trials will become smaller, more effective, and cheaper to run. Second is consumer driven health, in which we all take greater responsibility for our own health. Finally, George tells us of his latest governmental responsibility, heading a new task force on synthetic biology - genetically engineering microorganisms to develop a new industrial ecology that can create alternative energy, novel materials, and molecular species that would otherwise be impossible or prohibitively expensive to produce.
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Portrait of Wall Street's Pioneer Drug Analysts, Fred Frank (08:27)
The first biotech investment banker tells Jan how he got started in the business, as an analyst and a dealmaker, and continued to build the first formal life science focused research program at Lehman Brothers. Fred Frank, Vice-Chairman of Lehman Brothers (Barclays) discusses the tsunamis of change that are affecting the industry, and why Biotech and Pharma form natural partnerships. One is opportunity long and capital short, the other is opportunity short and capital. Fred illustrated this point by comparing the cash and innovation coming from the 100 largest pharma on one hand, and the 100 largest biotech on the other, demonstrating the need they have for one another.
-
Fred Frank on Blockbuster Drugs, and the 3 Eras of the Biotech Industry. (12:17)
Fred and Jan review the changing dynamics of the industry (pre-76, 1976 to 2000, and post-2000). They discuss the monumental changes faced by Pharma, the danger of stock buybacks, and the impact of blockbusters on the development of drugs and the valuation of companies. Fred and Jan also discuss some of the more successful business models today, including the Genentech / Roche agreement - although the recent capital acquisition does come under question.
-
Fred Frank on the Future of the Industry, and the Lehman / Barclays Deal. (05:10)
Jan Buck asks Fred Frank where the industry is heading, and if we should be expecting radical change in the near future. Fred Frank looks at the assumptions that fueled the growth of the industry from its earliest onset, and their relevance today. He then asks Fred about the Lehman / Barclays transaction. Is it a fit? Will there be a change in activities? What will determine the success of the acquisition?
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Visionaries: Bill Kridel on the Role of M&A Today. (06:33)
Bill Kridel discusses the strategic and rescue role of M&A today. Many companies leverage M&A for geographic and portfolio reasons - looking at some of the latest deals (Roche and Genentech, Daiichi and Ranbaxy). With the current market conditions M&A propositions from larger companies are becoming increasingly attractive.
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Visionaries: Bill Kridel on Biotech in 20 Years, Regenerative Medicine, Biomarkers, Personalized Medicine. (08:21)
Bill Kridel foresees three great tsunami that are bound to change the biotech industry and the quality of healthcare. These are regenerative medicine, biomarkers and molecular diagnostics, and personalized medicine. Bill also discusses pharma's solutions to increase innovation, and the increased international competitivity.
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Visionaries: Stelios on Financing, Productivity, and the Cost of Innovation. (09:39)
Stelios Papadopoulos, veteran of the Biotech Industry, looks at the financing environment today, and the "windowless paradigm" we've been operating in since 2003. He emphasizes the importance of changing investor sophistication and investment horizons. Stelios also addresses the cost of innovation and overall sector productivity. Finally Stelios looks back on his expectations for the market today, when he prepared them as an analyst 20 years ago.
-
Visionaries: Stelios on Biotech in 20 Years, Fundamental Science, Personalized Medicine, and Energy. (07:43)
Stelios shares his vision for Biotech in the next 20 years, comparing technical and fundamental problems, how they will be funded and solved. He also addresses the issue of energy, for which he thinks we will find biologically driven solutions. Stelios discusses the relevance of personalized medicine, and his choice of investment today.
-
KSR Demystified, Part 1 - Supreme Court Ruling on Patent Obviousness (08:27)
The Supreme Court’s ruling on intellectual property in the KSR vs. Teleflex case has kept many patent attorneys on the edge of their seat, as Matthew Siegal explains here, and in his Intellectual Property Strategist article (linked below). Matt and his colleague Ian DiBernardo go over the basis for the grant of a patent - the invention has to be new, useful, and non-obvious. They continue to explain how and why the KSR case is changing the non-obviousness requirement, making it more difficult to be fulfilled, and therefore harder for inventors to obtain patents.
-
KSR Demystified, Part 2 - Practical Business Implications (03:53)
In theory KSR makes it harder to patent, but the industry is very used to overcoming the non-obviousness clause of patentability, by showing the unexpected benefits. On the bright side of things, this may reduce the quantity of what some consider to be “unworthy patents.” Still Matthew’s advice to the industry remains the same: be prepared, and show improved results.
-
Former FDA Commissioner on Obama, Pace of Approval, Stem Cells (04:06)
What will happen to the FDA if Barack Obama gets elected? Dr. Lester Crawford, former Commissioner of the FDA, believes funding will increase, and with it so will the agency morale. This might increase productivity and help increase the pace of approval. The policies, however, are unlikely to change, as the FDA is a body with very few political appointees. When asked about stem cells, Dr. Crawford sees the US, not currently ahead of other nations, but ready to become the leader, as soon as it 'wakes up'. The FDA is also waving certain requirements for stem cell research to further support this effort.
-
BioDefense Funding, Cleveland Biolabs (02:47)
Alan Wolfman tells us about about Cleveland BioLabs, and how it is leveraging its BioDefense funding. He explains the size of, and requirements for the funding, the benefits and dangers of this strategy. Finally, Alan offers his best advice for obtaining government funding: be in very close contact with the agencies you are working with, and hoping to raise funds from.
-
Burnham CEO on New Florida Facility ()
Dr. John Reed, President & CEO of the Burnham Institute for Medical Research gives us a brief history of the institute and the discoveries that stemmed from its research. Dr. Reed discusses the ambitions and research focus set forward for the new Florida research facility, and how the the institute collaborates with industry. Stay tuned to watch the Burnham Delegation ring the NASDAQ's opening bell!
-
Forward Integration: from Biotech to Specialty Pharma ()
When should a development stage company take control of its products and build marketing and sales capabilities? Jeff Thomas, Lionel Leventhal, Steve Rauscher, Paul Cayer, and Michel de Rosen share their insight on, and experience with forward integration.
-
Jim Greenwood on Congress and Policy ()
BIO's CEO Jim Greenwood comments on the need for a supportive policy environment for Biotech in the context of the new Democratic Congress, BIO’s new advocacy team and what is expects from the next President of the United States in 2008.
-
Portfolio Management and Shareholder Value ()
Bringing together the perspectives of Big Pharma and Biotech: Are Pharma and Biotech competitors or allies? How should expectations be managed for successful partnerships? What is the view of the Street?
Lee Buckler's Cell Therapy '08 Review and '09 Outlook (04:47)
<strategic management>Exciting things we've seen in 2008 are
- the involvement of pharma in cell therapy, investing like they haven't before, developing cell therapy products as drugs, and not just tools (including companies such as Pfizer, GSK, Roche, and Novartis)
- the number of late stage companies in the sector such as Osiris (see: Osteocel / NuVasis, and Prochymal + Chondrogen / Genzyme deals)
- the financing, partnerships and M&A activity with $400M private equity investment, $100M M&A, and $1.8bn non M&A deals.
Things to watch for in 2009 are
- some of the late stage companies (Osiris and Dendrion - i.e. Provange results in April)
- the struggling cell therapy companies and how they will find cash (M&A, Government, VC?)
- the role of the new Obama administration and the public pressure, interest, and enthusiasm for cell therapy
Harvard Steps Into the Cell Therapy Funding Gap with a Mission for Academic Research to Get to Patients (06:24)
<strategic management>Brock Reeve explains the functioning of the Harvard Stem Cell Institute (HSCI). The HSCI is looking to make the bedside-to-bench and bench-to-bench loop in a way that unequaled anywhere, with the university, its 11 affiliated hospitals, drawing resources from the various schools (law, business, government, divinity). Brock tell us about about the HSCI partnership with GSK, as well as the other relationships they are seeking and building at the moment.
Roche's Vertes on Big Pharma's Interest in Cell Therapy (03:59)
<strategic management>Alain Vertes of Roche presents the interest of big pharma in the cell therapy. He highlights the main points of his panel presentation:
1. Cell therapy is not a passing fad
2. Cell are not just transplants, they can also be drugs
3. Paradigm shifting applications for cell therapy
4. Protecting intellectual property
5. Potential for stunning efficacy and low risk of side effects
US and EU Regulatory Synergies, and EMEA Committee for Advanced Therapies (03:34)
<policy & law>Christopher Bravery comments on the new committee for advanced therapies of the EMEA, and its impact on the development of cell therapy in Europe. Christopher also reflects on the similarity between US and European regulatory environments, and the importance of considering that in planning pivotal studies. He also gives us his definition of Cell Therapy and explains the business of ERA Consulting.
US and EU Regulatory Synergies, and EMEA Committee for Advanced Therapies
Molecular Diagnostics As The Next Major Conceptual Transition (06:05)
<The Jan Buck Show>Jan Buck welcomes Dr. George Poste onto his show to discuss his uniquely rich view of the life science industry and highlights of his distinguished career. George tells us about his time at SmithKline Beecham, where he witnessed the dramatic transformations driven by molecular biology, genomics, and genetic engineering. Furthermore Jan and George look into molecular diagnostics and how they will allow us to transcend symptoms based empirical approaches and more rigorously characterize the underlying molecular pathologies.
Molecular Diagnostics As The Next Major Conceptual Transition
Mapping the Human Genome, And The Innovator's Dilemma In The Pharma Industry (07:02)
<The Jan Buck Show>On this latest edition of the Jan Buck Show, Dr. George Poste tells the story of one of the greatest broad-scale industry collaborations, the SNP Consortium (which became the HapMap Project). Aimed to study population genomics in relation with the analysis of susceptibility to disease and responsive to treatment, it harness the power of a large number of companies to create this body of data, furthering the research capabilities of all, while defraying risk and cost. Jan and George continue to discuss radical innovation, the innovator's dilemma, and how it has applied to pharma and it's blockbuster drugs.
Mapping the Human Genome, And The Innovator's Dilemma In The Pharma Industry
Taking Out A Small Number of Pharmaceutical Manufacturing Plants Could Dislocate Medicine Supply For Large Numbers of the Global Population (05:41)
<The Jan Buck Show>Dr. George Poste tells the story of his involvement with the Antibioterrorism Task Force and the Office of the Secretary of Defense. When the DoD started looking at global infectious diseases - trying to measure the social, economic and military risk - they brought George in. Jan and George then discuss the post 9/11 era, and securing the medicine production and supply chain.
The Biodesign Institute, A Radical Experiment To Extract The Low Intensity Signal That May Be Indicative Of Disease (08:14)
<The Jan Buck Show>Dr. George Poste tells Jan Buck about his beginnings as veterinarian in the south of England, his escape from Europe to the United States in pursuit of greater scientific opportunity, and his recruiting at SmithKlein Beecham, taking genetic engineering technologies into the industry. George and Jan comment on the contribution the pharmaceutical industry has made towards human life. They continue to discuss his role in the creation of the Biodesign Institute of Arizona State University, where the life sciences are integrated with high level engineering, computing, and mathematical analysis. They measure hundreds or thousands of genes simultaneously, defining patterns of expression of multiple markers in the body, that may be indicative of disease.
A Look to the Future: Personalized Medicine, Consumer Driven Health, Synthetic Biology (07:47)
<The Jan Buck Show>Jan Buck and Dr. George Poste take a look at the blockbuster based business model of the Pharma industry, and how it might evolve in the years to come. They identify two emerging trends. First, is personalized medicine. Diagnostics and therapy will be increasingly linked. Clinical trials will become smaller, more effective, and cheaper to run. Second is consumer driven health, in which we all take greater responsibility for our own health. Finally, George tells us of his latest governmental responsibility, heading a new task force on synthetic biology - genetically engineering microorganisms to develop a new industrial ecology that can create alternative energy, novel materials, and molecular species that would otherwise be impossible or prohibitively expensive to produce.
A Look to the Future: Personalized Medicine, Consumer Driven Health, Synthetic Biology
Portrait of Wall Street's Pioneer Drug Analysts, Fred Frank (08:27)
<The Jan Buck Show>The first biotech investment banker tells Jan how he got started in the business, as an analyst and a dealmaker, and continued to build the first formal life science focused research program at Lehman Brothers. Fred Frank, Vice-Chairman of Lehman Brothers (Barclays) discusses the tsunamis of change that are affecting the industry, and why Biotech and Pharma form natural partnerships. One is opportunity long and capital short, the other is opportunity short and capital. Fred illustrated this point by comparing the cash and innovation coming from the 100 largest pharma on one hand, and the 100 largest biotech on the other, demonstrating the need they have for one another.
Fred Frank on Blockbuster Drugs, and the 3 Eras of the Biotech Industry. (12:17)
<The Jan Buck Show>Fred and Jan review the changing dynamics of the industry (pre-76, 1976 to 2000, and post-2000). They discuss the monumental changes faced by Pharma, the danger of stock buybacks, and the impact of blockbusters on the development of drugs and the valuation of companies. Fred and Jan also discuss some of the more successful business models today, including the Genentech / Roche agreement - although the recent capital acquisition does come under question.
Fred Frank on Blockbuster Drugs, and the 3 Eras of the Biotech Industry.
Fred Frank on the Future of the Industry, and the Lehman / Barclays Deal. (05:10)
<The Jan Buck Show>Jan Buck asks Fred Frank where the industry is heading, and if we should be expecting radical change in the near future. Fred Frank looks at the assumptions that fueled the growth of the industry from its earliest onset, and their relevance today. He then asks Fred about the Lehman / Barclays transaction. Is it a fit? Will there be a change in activities? What will determine the success of the acquisition?
Fred Frank on the Future of the Industry, and the Lehman / Barclays Deal.
Visionaries: Bill Kridel on the Role of M&A Today. (06:33)
<strategic management>Bill Kridel discusses the strategic and rescue role of M&A today. Many companies leverage M&A for geographic and portfolio reasons - looking at some of the latest deals (Roche and Genentech, Daiichi and Ranbaxy). With the current market conditions M&A propositions from larger companies are becoming increasingly attractive.
Visionaries: Bill Kridel on Biotech in 20 Years, Regenerative Medicine, Biomarkers, Personalized Medicine. (08:21)
<strategic management>Bill Kridel foresees three great tsunami that are bound to change the biotech industry and the quality of healthcare. These are regenerative medicine, biomarkers and molecular diagnostics, and personalized medicine. Bill also discusses pharma's solutions to increase innovation, and the increased international competitivity.
Visionaries: Stelios on Financing, Productivity, and the Cost of Innovation. (09:39)
<strategic management>Stelios Papadopoulos, veteran of the Biotech Industry, looks at the financing environment today, and the "windowless paradigm" we've been operating in since 2003. He emphasizes the importance of changing investor sophistication and investment horizons. Stelios also addresses the cost of innovation and overall sector productivity. Finally Stelios looks back on his expectations for the market today, when he prepared them as an analyst 20 years ago.
Visionaries: Stelios on Financing, Productivity, and the Cost of Innovation.
Visionaries: Stelios on Biotech in 20 Years, Fundamental Science, Personalized Medicine, and Energy. (07:43)
<strategic management>Stelios shares his vision for Biotech in the next 20 years, comparing technical and fundamental problems, how they will be funded and solved. He also addresses the issue of energy, for which he thinks we will find biologically driven solutions. Stelios discusses the relevance of personalized medicine, and his choice of investment today.
Visionaries: Stelios on Biotech in 20 Years, Fundamental Science, Personalized Medicine, and Energy.
KSR Demystified, Part 1 - Supreme Court Ruling on Patent Obviousness (08:27)
<policy & law>The Supreme Court’s ruling on intellectual property in the KSR vs. Teleflex case has kept many patent attorneys on the edge of their seat, as Matthew Siegal explains here, and in his Intellectual Property Strategist article (linked below). Matt and his colleague Ian DiBernardo go over the basis for the grant of a patent - the invention has to be new, useful, and non-obvious. They continue to explain how and why the KSR case is changing the non-obviousness requirement, making it more difficult to be fulfilled, and therefore harder for inventors to obtain patents.
KSR Demystified, Part 1 - Supreme Court Ruling on Patent Obviousness
KSR Demystified, Part 2 - Practical Business Implications (03:53)
<policy & law>In theory KSR makes it harder to patent, but the industry is very used to overcoming the non-obviousness clause of patentability, by showing the unexpected benefits. On the bright side of things, this may reduce the quantity of what some consider to be “unworthy patents.” Still Matthew’s advice to the industry remains the same: be prepared, and show improved results.
Former FDA Commissioner on Obama, Pace of Approval, Stem Cells (04:06)
<policy & law>What will happen to the FDA if Barack Obama gets elected? Dr. Lester Crawford, former Commissioner of the FDA, believes funding will increase, and with it so will the agency morale. This might increase productivity and help increase the pace of approval. The policies, however, are unlikely to change, as the FDA is a body with very few political appointees. When asked about stem cells, Dr. Crawford sees the US, not currently ahead of other nations, but ready to become the leader, as soon as it 'wakes up'. The FDA is also waving certain requirements for stem cell research to further support this effort.
Former FDA Commissioner on Obama, Pace of Approval, Stem Cells
BioDefense Funding, Cleveland Biolabs (02:47)
<strategic management>Alan Wolfman tells us about about Cleveland BioLabs, and how it is leveraging its BioDefense funding. He explains the size of, and requirements for the funding, the benefits and dangers of this strategy. Finally, Alan offers his best advice for obtaining government funding: be in very close contact with the agencies you are working with, and hoping to raise funds from.
Burnham CEO on New Florida Facility ()
<strategic management>Dr. John Reed, President & CEO of the Burnham Institute for Medical Research gives us a brief history of the institute and the discoveries that stemmed from its research. Dr. Reed discusses the ambitions and research focus set forward for the new Florida research facility, and how the the institute collaborates with industry. Stay tuned to watch the Burnham Delegation ring the NASDAQ's opening bell!
Forward Integration: from Biotech to Specialty Pharma ()
<strategic management>When should a development stage company take control of its products and build marketing and sales capabilities? Jeff Thomas, Lionel Leventhal, Steve Rauscher, Paul Cayer, and Michel de Rosen share their insight on, and experience with forward integration.
Jim Greenwood on Congress and Policy ()
<policy & law>BIO's CEO Jim Greenwood comments on the need for a supportive policy environment for Biotech in the context of the new Democratic Congress, BIO’s new advocacy team and what is expects from the next President of the United States in 2008.
Portfolio Management and Shareholder Value ()
<strategic management>Bringing together the perspectives of Big Pharma and Biotech: Are Pharma and Biotech competitors or allies? How should expectations be managed for successful partnerships? What is the view of the Street?