Keynote Addresses

View PDF

KeynotesIn literature and music, a keynote establishes the main underlying theme of a work of art. Think of the famous “da-da-da-DUM” in Beethoven’s 5th Symphony. Or in George Orwell’s Animal Farm: “All animals are equal, but some animals are more equal than others.” Similarly, a keynote address establishes the framework for program of events or convention agenda. Frequently the keynote speaker sets the underlying tone and summarizes the core message or most important revelation of an event. Some famous keynote speeches in the United States have been made at party conventions during Democratic and Republican presidential campaigns. Keynote speakers at these events have often gained nationwide fame and/or notoriety.

Over its first decade, the BPI Conference hosted a number of keynote speakers who gave their own memorable addresses. We list them here along with the companies they represented at the time.

In October 2004, Geoffrey F. Slaff (Amgen), Ken Taksen (Pfizer), James N. Thomas (Amgen), and Patrick Y. Yang (Genentech) spoke in Boston, MA. They focused on operational excellence and challenges faced by biopharmaceutical companies at the time.

In September 2005, Ronald C. Branning (Genentech), H. Michael Koplove (Wyeth BioPharma Operations Network), Duncan Low (Amgen), Karl Dane Wittrup, (Massachusetts Institute of Technology), and Michael W. Glacken (Millennium Pharmaceuticals) also spoke in Boston, MA. They discussed partnerships, facilities, process engineering, protein engineering, and current and future directions in bioprocessing.

In November 2006, Jon E. Clark (FDA CDER), Brett L. Schmidli (Schmidli & Associates), Anthony R. Mire-Sluis (Amgen), and Tim Moore (Genentech) spoke in San Francisco, CA. They covered FDA regulations and quality by design (QbD), operational excellence, and treating biomanufacturing as a strategic advantage.

In October 2007, Helen N. Winkle (FDA CDER), Tobias Massa (Bristol- Myers Squibb), Michael E. Kamarck (Wyeth), Markus Gemuend (Genentech), John Ward (Biogen Idec), and Barry C. Buckland (Merck Research Laboratories) spoke in Boston, MA. They talked about biomanufacturing strategy and capacity, regulatory modernization, industry expectations regarding quality assessment, and the future of both upstream and downstream processing.

In September 2008, Robert L. Garnick (Genentech), Rick Rutter (Pfizer), Jeanne Holm (NASA’s Jet Propulsion Laboratory), John K. Towns (Eli Lilly), Konstantin Konstantinov (Genzyme), and Rob Bryant (Computer Sciences Corporation) spoke in Anaheim, CA. They focused on biosimilars and product life-cycle changes, manufacturing support and strategies, knowledge management, and employee motivation.

In October 2009, Paul F. McKenzie (Centocor R&D), G.K. Raju (MIT Center for Biomedical Innovation), J.D. Kleinke (medical economist and author), Konstantin Konstantinov (Genzyme), Johannes R. Roebers (Elan Pharma International), and Ali M. Afnán (FDA CDER) spoke in Raleigh, NC. Their topics included the Affordable Care Act, operational excellence, future trends in facilities and operations, integrating new technologies in upstream and downstream processing, and quality.

In September 2010, Helen N. Winkle (FDA CDER), Thomas J. Vanden Boom (Hospira), W. Blair Okita (Genzyme), and S. Robert Adamson (Wyeth Biopharma) spoke in Providence, RI. They discussed regulatory modernization, biosimilars, sustainability, and process/product development.

In October 2011, Timothy S. Charlebois (Pfizer), Steven Kozlowski (FDA CDER), Esa Heinonen (Finnish Medicines Agency), Michael Betenbaugh (Johns Hopkins University), Jay S. Stout (Merck), Morris Rosenberg (Seattle Genetics), Tim Moore (Roche), and Jeffrey C. Baker (FDA CDER) spoke in Long Beach, CA. They talked about biosimilars, technological innovation, the international Chinese hamster ovary genome project, antibody–drug conjugates, plant capacity and process design, and integrating biomanufacturing networks.

In October 2012, John Stubenrauch (Merck), Thomas Stangler (Sandoz Biopharmaceuticals), Steven Kozlowski (FDA CDER), Jörg Thömmes (Biogen Idec), Matthew B. Walker (Pfizer), and Steven Meier (Genentech) spoke in Providence, RI. They focused on biologics access and affordability, regulation and QbD of biosimilars, driving value, partnering, and targeted drug development.

And in September 2013, James Thomas (Amgen), Abbie Celniker (Eleven Biotherapeutics), Peter Moesta (Bristol-Myers Squibb), Lars Pampel (Novartis Pharma), and Sandra Poole (Genzyme) spoke in Boston, MA. They offered strategies for producing high-quality biotherapeutics at low cost, a systems approach to biomanufacturing complexity, eliminating interfaces in platform development, and navigating a changing business landscape.

2014 Keynotes: This year’s Tuesday keynote speakers will be led by chairperson Guenter Jagschies (senior director of strategic customer relation in biotechnologies R&D at GE Healthcare Life Sciences). Tuesday’s keynote addresses will be given by John G. Cox (executive vice president of pharmaceutical operations and technology at Biogen Idec), Robert Mattaliano (group vice president and head of biologics at Sanofi-Genzyme’s R&D Center), and Geoffrey Ling (director of the biological technologies office at the Defense Advanced Research Products Agency, DARPA). They will be discussing success through innovation, patient and caregiver perspectives, and the need for biologics in battlefield medicine.

Keynote2Wednesday’s keynote addresses will be chaired by John Hallinan (chief business officer, MassBio). Ganesh V. Kaundinya (cofounder and chief scientific officer of Momenta Pharmaceuticals) and Ralph Lambalot (vice president of biologics development at AbbVie) will give keynote addresses that day. They will be discussing big-data analytics and the future of innovation in biomanufacturing.

John G. Cox (Biogen Idec)

John G. Cox (executive vice president of pharmaceutical operations and technology at Biogen Idec) will be joining us for the keynote session on Tuesday afternoon, 21 October 2014. His presentation is titled, “Delivering on a Global Biopharmaceutical Portfolio: Biogen Idec’s Strategy for Success Through Innovations in R&D, Protein Development, and Manufacturing.”

Abstract: Historically, the biotechnology industry has successfully advanced a common set of drug-substance platforms to deliver on the promise of recombinant proteins, fusion proteins, and monoclonal antibodies. The future requires renewed innovation in drug substance and drug product, with added focus on patient convenience. This presentation describes Biogen Idec’s innovative strategies to enable delivery of its novel pipeline.

Can you elaborate on the patient convenience aspect of your talk? Why is it an important part of your strategy? It’s interesting that so much of bioprocessing historically has been about drug substances. That’s where we felt that much value was created. But as we move forward and look at what’s going on in medicine, the patient convenience aspect — keeping the patient’s needs at the center — is broader than just the medicine itself. In part, it is about making sure that we’re providing medicine in a way that is convenient for patients to use.

Most of our drugs are used routinely, repeatedly, often for the life of a patient. So to provide something like an autoinjector, for example, is not an easy thing to do. It’s not trivial, but rather extremely important to patients who are struggling with certain types of diseases. That’s part of our strategy going forward. We added an autoinjector to a product that has been on the market for about 15 years, and it’s been greatly appreciated by patients. We are continuing to do that with new products.

Since 2013, Biogen Idec is the first and only US biotech company to be added to the Dow Jones Sustainability World Index. How do your company’s sustainability initiatives mesh with the drive to be innovative in R&D and manufacturing? It’s a nice marriage of innovation and benefit to the environment. As a company, we started looking at sustainability very closely a couple years ago. Some areas are a little more straightforward. For example, we’ve been adding buildings as the company has grown. We make sure that those buildings are LEED certified, “green” type of buildings.

And where we’ve gotten very innovative, I think, has been in some energy strategies and how we run our plant. In biotech manufacturing processes, you can use a tremendous amount of water. You use a number of chemicals that affect the waste stream as you clean your vessels. Through really good engineering — through good science and some innovation — you can have a big impact.

We have essentially doubled in terms of size and production and activity. At the same time, we have reduced our greenhouse gas emissions and our carbon footprint by roughly 10%. As a consequence, that’s something we’ve been getting recognized for. We’ve been recognized by Forbes and Newsweek as one of the top companies in sustainability.

How much do collaborations (such as with Sangamo Biosciences) play into the innovation strategy at Biogen Idec? What is the in-house focus on innovation and product development for biotherapeutics? I’m looking forward to talking even more about that in the presentation because the way we’ve approached it from a research perspective is that we’re looking at new therapeutic modalities. Sangamo has a gene-editing technology, really a mix of gene therapy and cell therapy, that we would like to apply to new disease areas.

One product we’re looking at, for example, is for sickle-cell anemia. It presents a whole new set of bioprocessing and supply chain challenges. We are actually looking forward to that because of the transformational impact it can have for patients. It’s different from the usual processes we have, for example, with monoclonal antibodies.

What role is information technology (“big data”) playing in R&D innovation at Biogen Idec? Big data is something that our company and most companies are exploring and pursuing. We are all experiencing a convergence of information technology, engineering, and life sciences. It has the potential to change medicine fairly dramatically.

As a company focused on multiple sclerosis, for example, we are using genomics to try understanding that disease much better: some of its causes, how it affects patients, and what the patient population looks like. The goal is to provide drugs that are much more personalized. Biogen Idec has a number of multiple sclerosis drugs. To help patients and physicians identify which drug will work best for which patient is one of the ultimate goals for that type of work.

Having access to data — whether it’s genomics data or information from the medical field and patient populations — pulling that all together and understanding it is what big data is all about. As a company, we’re working to see how we can use such data ultimately to help patients.

How are you using other technology to improve manufacturing, and what are some of the tools that are most helpful? What I’ll talk about more in my presentation is our approach to bioprocessing in our facilities. We have some very large-scale and some smaller-scale facilities that are fairly traditional for biotech processing. We have also introduced into those facilities some disposables concepts that are becoming fairly popular. We see sort of a hybrid approach to using stainless steel and disposables — particularly in those smaller facilities — for accelerating clinical production timelines.

The other tool we’re using significantly is analytics. We’ve added some fairly sophisticated statistical process control and analytical tools to our production processes. Such technologies — a mix of true process unit operational strategies with analytical and statistical tools — are improving the robustness and throughput of our production.

Are any other process innovation trends (e.g., continuous processing) helping you to improve protein development manufacturing sustainability? What types of technological innovations are needed in these areas? I do think significant innovation is needed. In this industry, we have had a historical set of unit operations that are fairly standard across companies, particularly in downstream processing. Some companies have used continuous perfusion technologies. But most (like Biogen Idec) are using batch-type cell culture. At a minimum, having more continuous or completely continuous downstream processing could have a big impact on overall throughput of our plants.

Many of us in biotechnology have invested hundreds of millions — even billions — of dollars in our existing infrastructure. The pipelines going forward include products for Alzheimer’s disease, for example, with huge needs, huge patient populations that would require massive volumes of product. So there is a very strong need for a paradigm shift in bioprocessing. That’s going to be much of the point of my presentation.

Geoffrey Ling (DARPA)

Geoffrey Ling (director of the biological technologies office at the Defence Advanced Research Products Agency) will be joining us for the keynote session on Tuesday afternoon, 21 October 2014. His presentation is titled, “Biologically Derived Medicines on Demand for Battlefield Medicine.”

Abstract: The current medical supply paradigm is nonresponsive to far-forward emergency settings, emergent in-theater threats, and biopreparedness stockpiling. Often it takes weeks or months to manufacture and airlift organic pharmaceuticals and protein therapeutics to the battlefield frontlines where they are needed most. A new manufacturing paradigm must be created to enable fast responses to specific threats without requiring specific threat preparedness. That might eliminate the need to medically guess an enemy’s intent, thus enhancing disaster responsiveness. DARPA’s Biologically Derived Medicines on Demand (Bio-MOD) effort aims to develop novel, flexible methodologies for genetic engineering and modifying microbial strains, mammalian cell lines, and cell-free systems to synthesize multiple protein-based therapeutics in single doses (over short timeframes) that meet purity, efficacy, and potency standards. Success in this effort will relieve the logistics burden and enable cost-effective production of small-quantity medications, which could be particularly useful in the manufacture of orphan drugs.

Can you briefly describe the DARPA Bio-MOD Program and the reasoning behind the effort? The program is actually part of a larger effort that we like to call “battlefield medicine.” Conceptually, this program is meant to develop a capability for military providers to make medications (therapeutics) at the time they’re needed, in the quantities needed, and the specific types that are needed.

Right now, when you go to war you try to determine a priori what medicines you might need. I’ll give you an example. Say that you and I have to go into Afghanistan with a number of soldiers. We’ll take along so many doses of ibuprofen, Cypro, Benadryl, Heparin, insulin, and so on, because we want to take care of the local population. Now we have this big container full of stuff. Of course, if it’s insulin and Heparin, then we may have to refrigerate it as well. So we head over to Afghanistan where we find that the infections we’re seeing actually require an antifungal agent, not an antibiotic. Now we have this whole pile of Cypro that we don’t really need; what we really need is some amphotericin B. But we guessed wrong. Then we come across a village with a lot of diabetic issues, and we use up all of our insulin. Now the amount of insulin we brought along was woefully insufficient for our mission.

We want to take all that away: one, having to stockpile and carry stuff around that you may not need; and two, having to depend on the cold chain. Refrigeration requires a lot of technology and a lot of power and so on. We want to come up with a system that is very basic in nature, so that (for lack of a better term) you can “dial-a-drug” just like you can “dial-a-meal.” You need insulin, you push a button and this machine makes insulin for you. You need Heparin, you push a button and it makes Heparin for you. You need a small organic molecule (such as ibuprofen), you have another machine and push a button, that makes ibuprofen for you or Benadryl, and so on.

There are two types of battlefield medicine. A small organic-molecule synthesizer could make your typical organic-synthesis–based drugs (ibuprofen, Benadryl, that sort of thing), and another machine could make your biologically produced, protein-based therapeutics (insulin, Heparin, and so on). You could push a button and get it made.

That’s conceptually how we want to do it. You push a button, you get the drug you need, use what you need and don’t make too much, and you don’t have waste. That’s the whole idea behind battlefield medicine and Bio-MOD.

How big would that physical system be? This is an R&D project, so, right now I have not put a constraint in terms of size, weight, and power requirements for a prototypic physical system. However, when all is said and done and the prototyping has been completed, after the proof-of-scientific principle has been met and we have a fieldable unit . . . in my mind, the ideal fieldable unit would be the size of an attaché case. It would be something that a medic can take into a small village in Afghanistan. Will it ever achieve that? I don’t know, but that’s what I’m hoping that it will be.

How much of the system depends on modeling and IT systems? From a supportive standpoint, in terms of the basic science that has to be done, it depends somewhat on those. They are all existent things. This is not creating new science as much as efficiently adapting existing science and knowledge. We’re not creating brand new biologically derived therapeutics. Our goal is to produce already approved therapeutics, for which all of the science has already been done.

This is a manufacturing question, not a discovery study. It is how to optimize manufacturing. Because of that, we can leverage common laboratory tools that are already in use rather than custom tools. When you have to customize them — that is, to adapt them — most bioreactors, separators, and other equipment have already been built on different scales. The question is how to optimize them.

Optimizing to an attaché case for bioreactors sounds like something our audience would definitely be interested in. Right. It is a difficult problem. And I bet you your audience — wonderful scientists and technologists — would say, “That’s a hard problem.” And you might ask, “But is it an intractable problem?” And I bet you they would say: “No, it’s not intractable. It’s difficult, but it’s not intractable.” That’s kind of where we are.

What is the biggest challenge the Bio-MOD Program needs to overcome to be successful? Well, right now it’s finding what that optimal system would look like. Should it be a cell-free system, a mammalian cell-based system, a nonmammalian cell-based system? Which is best? We don’t know yet. We have efforts ongoing with all those concepts to see which one is the best. Could it be a hybrid of them? We’ll find that out, as well.

What is the fundamental producer of Bio-MOD products? That is the very first (and very important) Bio-MOD question to fully answer. Once you have that, then you can optimize how to maintain viability of the platform, how to maintain feeding the platform, and so on. Those things then become fairly straightforward. They’ll follow behind it. I’m not saying they are easy, but they become straightforward. The biggest, most difficult hurdle is determining the best primary platform. And that’s what we’re doing right now.

Why are you attending the BPI Conference? The conference assembles the finest minds in the world that do this. Whenever you do these things, you don’t want to do them in a vacuum. This is a big, hard, challenge. What I want to know is what the scientific community thinks about what we’re doing and our progress therein. It’s also a place where our investigators will be. They can present this concept and get some critiques and suggestions from that community as well.

This is not a secret program. It is really trying to advance medical care. To do that, you constantly want to be sure that the community can help contribute some criticism, be that negative criticism or even positive criticism. We are hoping to come up with suggestions on how to make it better. That’s why you go to venues like this. Where else can you find in one place this amazing quality of intellectual resources than at the BPI Conference?

 

 

Leave a Reply