PharmaTelevision - Janssen Research & Development LLC: Jay Siegel exlains why he sees a tremendous future for biological therapies

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Video title: Janssen Research & Development LLC: Jay Siegel exlains why he sees a tremendous future for biological therapies

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In this episode of PharmaTelevision NewsReview, filmed at #BIO 2012, Fintan Walton talks to Jay Siegel, Chief Biotechnology Officer and Head Global Regulatory Affairs at Janssen Research & Development LLC

Key challenges in biologics area

Fintan Walton:

Hello and welcome to PharmaTelevision News Review here at BIO in Boston, in 2012. On this show I have Jay Siegel, who is Chief Biotechnology Officer and Head of Global Regulatory Affairs at Janssen Pharmaceuticals, welcome.

Jay Siegel:

Thank you, pleased to be here.

Fintan Walton:

Good. Jay, you've got a full title, you've got responsibility for the whole area of biotechnology or biologics coming through Janssen Pharmaceuticals and it also stretches the other part of your job is regulatory affairs and of course the key issue for any pharmaceutical company, I suppose what's key issue is one how do you grow a biologics division and how do you deal with the regulatory issues of our time so you've got a full responsibility there no doubt?

Jay Siegel:

Yes, I really have two full time jobs.

Fintan Walton:

So lets focus first of all as in your role as Chief Biotechnology Officer, I suppose one of the things that people will always identify with Janssen of course Johnson & Johnson is that you are you know early pioneers in the area of biologics and that's developed over the years into a significant business, with a lot of experience behind you what do you see as the key challenges for an organization like yours specifically in area of biologics, may be there are none, but may be you can tell us something?

Jay Siegel:

No, well you know there is nothing but challenges in our business and we do indeed have a proud heritage. We are very one of our first biological products, one of the first antibodies OKT3 came out of Johnson & Johnson Ortho and work with their erythropoietins, so we acquired Centocor [PharmaDeals ID = 4357] 11 or 12-years ago, I was the President of Centocor R&D several years ago before we all came together as Janssen and we've had great success with Remicade, with Simponi, and with Stelara but great past success is not to the point of your questions, sufficient to rest amongst laurels, so for moving forward into the future, the technologies are evolving rapidly that's a great opportunity. It's a challenge in the sense that you can be and we have been a leader in monoclonal antibody technologies, now many companies can do that and the question is, how do you do that better? How do you move into other areas of biologics and biotechnology, new types of product classes, peptide therapies, alternative scaffold therapies, biologics that can do new and different, and better things that will differentiate our products from those of competitors.

Opportunities in biologics

Fintan Walton:

I suppose part of that question really is, we are obviously used to small molecules as a historical fact the emergence of biologics in the pharmaceutical industry has been important, but how much further can we go with that, is that still an infinite pool of therapeutic molecules going forward and will it continue to dominate?

Jay Siegel:

I believe there is a tremendous future for biological therapies, the largest group of products of success, I mean there is a number of cytokines and enzymes but monoclonal antibodies that technology is continuing to improve we can make them more specific, more potent, longer half lives, we can make them bispecific to hit more than one target at the same time, and we can make them faster, purer, and cheaper than ever before, not may be not cheaper than ever but we can have.

Fintan Walton:

Yes, but increasingly cheaper?

Jay Siegel:

Yes, and so I think there is a lot of legs for that technology alone, but there are many other opportunities that the technologies or biologics afford to us that we are just beginning to tackle in Janssen and in other places across our industry. How can you get biologics across the blood brain barrier into the brain? How can you get biologics into a cell so they can hit intracellular not just soluble and extracellular cell surface targets? How can you get them to cross the GI tract so you could take them as a pill or capsule as opposed to as an injection? These are all I think tractable problems, we have some good leads, some good ideas, some will fail I am sure, some will succeed, but I think they are gonna lead to lots of new generations of products and then the creation of whole new types of protein molecules, there is a lot of companies that we think we are in a leadership position in an area called alternative scaffolds. So antibodies if the basic antibody as a scaffold upon which you can build many different binding affinities, but there are other types of scaffolds, other types of proteins with different pharmacological properties from antibodies and different IP and that you could also build binding affinities on to with newer technologies and I see that as a huge area.

Fintan Walton:

I mean in terms of creativity and innovation it's absolutely limitless in a sense isn't it, it's infinite?

Jay Siegel:

I think so, and I think some of the prior limitations that the length of time it took to discover and develop the costs of manufacturing are also actually not by no means disappearing as challenges or problems, but there is also advances made in many of those areas as well.

Fintan Walton:

Well they need to be made as well of course.

Jay Siegel:

Yes.

Jay Siegel's views: Regulatory issues and impact on pharma industry

Fintan Walton:

So that brings us on to the other job, the other day job which is the Head of Global Regulatory Affairs and you're an ex FDA guy, now working in the pharmaceutical industry, people often talk about the issues of trying to get approval not just here in the US with FDA but worldwide and there is an increasing issues relating to patient safety, all of these things are obviously natural concerns that everybody would have, but as a man who is actually responsible and actually active in that area, how do you see our industry going in terms of that, because it appears that these there are high and high restrictions which means it's more costly to get a product to the market and that has an impact on price and everybody wants cheaper drugs and so forth, so as the man involved in this essentially important part of the industry, what's the future like?

Jay Siegel:

You know and that I think perhaps the most important question facing our business and I work at that both in my sense as our Head of Regulatory Affairs, but also I am on the executive committee of BIO and through BIO and through other avenues I am also very actively engaged in public policy, because I think there are scientific regulatory and policy aspects to the question you are asking. There is no question that the demand for data is becoming greater and greater and not just by regulators, patients are more informed, they are having internet, physicians they recognize that they need to understand, they want to understand the benefits as well as the risks of our product increasingly, they are co-paying for the product and have more involvement in their own care all good things there and of course they are payers particularly in Europe increasingly in the US that are also demanding data often different types of data from what regulators are demanding so they simply get a, not that it simple but only get a regulatory approval by no means guarantees market success one has to have the data to supply a (indiscernable) to getting those data are increasingly expensive. Balanced against that first of all the science is advancing in ways that there are just extraordinary opportunities, so this for me is a core problem not just for our industry but for our society, because the opportunity to cure disease, to prolong and improve the quality of human life is really there, we can imagine it, we can see it happening, it is and yet these issues getting this information, the safety of drugs is very important how do we put all that together and make it happen. Well there are new tools for generating data, there are new ways to do clinical trials more efficiently, there is new internet based trials, data new better ways to explore databases, one can get information from sources other than clinical trials increasingly with the use of electronic medical records, health insurance databases there is the opportunity to learn about drugs and their effects through more and more sources, there is more potential lot of potential to educate the public to be more actively involved in engaging in clinical trials and becoming true participants in medical research. And I think that ultimately we need to engage our society and educate our society and engage it in a debate, because at some point, there always at some point has to be a balance, yes it would be there are always gonna be more information, there is always more study if you could do more things you can measure more people you could study, more certainty you could have and getting the right point of what where getting that certainty is in the public benefit where is having too negative an impact on the ability to get new therapies to people, that's a critical role of a regulator today, and a critical role of society today.

Fintan Walton:

But in the end it's about collaboration between the different stakeholders and patient health and that those stakeholders are obviously government, it's obviously patient groups, it's the patient themselves and obviously then the pharmaceutical industry itself, so do we have sufficient collaboration to make that happen as somebody who is operating there?

Jay Siegel:

I think it's variable, okay now one of the things that, where just this weekend Congress is work on the new PDUFA, Prescription Drug User Fee Act V, I was quite involved from the early conceptual stages and through the negotiating stages with that and there is a lot of work and that has is a creation of work from regulators as well as pharmaceutical industry but with public interest group and patient group input as well is intended to create a more collaborative environment, while keeping the regulator independent ensuring that the regulator makes clear to the sponsor what needs to be done to achieve success and how to get that done. Hopefully we expect the differences between the house and senate versions are small to be reconciled soon in final passage, but this broader collaborative environment you are speaking about is both critically important, but also critically hard to engineer, because among other things there is more and more country regulatory authorities that are more and more able to and eager to influence what are the requirements for drug approval, so we started with the FDA over the last couple of decades, Europe has gotten more coordinated more advanced and very important Japan very important their drug in influencing drug development, but now there is important markets with more and more competent regulatory authorities around the world that we have to work with.

Janssen Pharmaceuticals's role in biosimilars

Fintan Walton:

Okay, so lets just look another area which covers goes back to your other role with as Chief Biotechnology Officer, but also it does have an element of regulatory affairs to it and that is the area of biosimilars which obviously is an emerging area, just going back to your own company Janssen Pharmaceuticals, is this a play for you?

Jay Siegel:

We've explored several times over the last few years the potential for bringing biosimilars into markets in the US and Western Europe and have decided that is not an area that we are interested in where our fundamental our overarching philosophy of our strategy is to be medical innovators we believe that, that's a very important means we believe we are well positioned to do that.

Fintan Walton:

Okay. Well Jay Siegel, thank you very much indeed for coming on the show.

Jay Siegel:

Well thank you, certainly have enjoyed talking with you.

Fintan Walton

Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).

Jay Siegel

Chief Biotechnology Officer and Head of Pharmaceutical Global Regulatory Affairs

At the time of recording this PTV interview Jay Siegel serves as Chief Biotechnology Officer and Head Global Regulatory Affairs at Janssen Research & Development LLC. As Chief Biotechnology Officer, he leads an organization responsible for expanding and applying the Company's extensive capabilities in the discovery and development of protein and cell-based products. Partnering across all therapeutic areas in pharma and medical devices, the center of excellence provides expert input and services in Biologics Clinical Pharmacology, Biologics Toxicology, Biologics Discovery and Cell Therapy, and in conjunction with PDMS, protein and cell product development. As Head of GRA, Jay leads an organization of more than 600 employees in Europe, North America, Latin America, Asia/Pacific (including Japan), the Middle East and Africa, including staff from local operating companies. GRA focuses on the following objectives: facilitate the relationship between J&J Pharma and global health authorities; influence and interpret global regulatory requirements and enable J&J Pharma to meet those requirements; drive the development of regulatory strategy for products from all therapeutic areas; deliver high quality, on-time submissions to regulatory authorities; and ensure that patients receive maximal benefits from our products both at an individual-product application and a broader policy level. Jay is actively engaged in policy development at the national and international levels in the regulatory, biotechnology, and clinical development arenas. He currently serves on the Board of Directors of the Biotechnology Industry Organization, the Executive Committee of the Clinical Trials Transformation Initiative, an Institute of Medicine Expert Panel. Since joining Johnson & Johnson in 2003 as President of Centocor Research & Development, Inc.,Jay has had a variety of responsibilities including, immediately prior to assuming his current roles as 2009, serving as Group President of Research & Development with oversight of research and development in Biotechnology, Immunology and Oncology. Prior to joining Johnson & Johnson, Jay spent 20 years at the FDA Center for Biologics Evaluation & Research in positions of increasing responsibility regulating the biotechnology industry. Jay received a B.S. in Biology from California Institute of Technology and an M.D. from Stanford University. He trained in Internal Medicine at the University of California, San Francisco, and in Infectious Diseases and Immunology at Stanford University. Jay has authored numerous publications in the areas of clinical trial design, biotechnology, and immunology. He is recipient of numerous honors including the U.S. Public Health Service's highest honor, the Distinguished Service Medal and, twice, the HHS Secretary's Award for Distinguished Service. He has been elected to fellowship in the American College of Physicians, the Infectious Disease Society of America, and the Society for Clinical Trials.

PharmaVentures

PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialisation.

Janssen Research & Development LLC

Janssen Research & Development LLC formerly known as Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), provides research and development support for the pharmaceutical business units of parent company Johnson & Johnson. The company divides its main research processes into three franchises: central nervous system and internal medicine; biotech, immunology, and oncology (in concert with fellow J&J subsidiary Janssen Biotech); and virology (with another J&J unit, Tibotec). The subsidiary which represents the largest segment of J&J's pharmaceutical R&D also does research in collaboration with other pharmaceutical organizations and biotech researchers.