Ground Zero Pharmaceuticals, Inc.
January 7, 2013 Issue
The Most Powerful Name In Corporate News and Information
As a Regulatory Affairs and Product Development-Consulting Firm, Ground Zero Pharmaceuticals, Inc. is helping Small to Medium Sized Drug, Biologic and Medical Device Companies make early “go / no go” decisions for efficient use of Resources and Investor Dollars
About Ground Zero Pharmaceuticals, Inc.:
California in 1987 as an individual consultancy, Ground Zero Strategics,
Ltd. has grown into an integrated consulting firm, Ground Zero
Pharmaceuticals, Inc. (GZP) with a wholly owned Australian subsidiary,
Ground Zero Pharmaceuticals, Pty Ltd., and membership in BioSuccess Ventures
LLC. We have offices in Irvine, California; USA, Brisbane, QLD Australia;
and Melbourne, VIC Australia, with Associates throughout the US, Australia,
Canada, Germany, Malaysia, and Sweden.
Zero Pharmaceuticals, Inc.
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – January 7, 2013
CEOCFO: Mr. Siegel, what is Ground Zero Pharmaceuticals? What is your vision?
Mr. Siegel: We are a regulatory affairs and product development-consulting firm, helping companies worldwide, particularly small and medium sized firms, with their drug, biologic, medical device and combination product programs, in an integrated and focused manner. We are different from a typical CRO (Contract Research Organization) in that we do not have large groups of individuals waiting around for work to come in. We also do not sequester away groups of people in their particular areas of expertise, such that they do not talk to each other, but rather bring to bear chemistry, manufacturing, controls / product quality, preclinical/nonclinical, clinical, regulatory, and medical writing experts into teams. Each member has an average of twenty-two years of experience to provide a focused and targeted approach to product development in the medical product area. Our vision is simply to do it well the first time and never have to go backward, make sure that our clients understand the important regulatory underpinning of all that they do and all that they need to do to satisfy regulatory agencies, and frankly, save them resources, money and time in getting their medical products developed, reviewed and approved. Our vision is to be the best that we can be in that field.
CEOCFO: What is the typical way a drug development company would go about it? How would that contrast to your holistic approach?
Mr. Siegel: Traditionally, particularly in big pharma and big biotech, companies have had their own discovery organs. They discover a small molecule or biologic. They isolate or synthesize their compounds, test them in their own laboratories, rarely use any outside individuals, at least in the early stages to help them. They maintain information in a very proprietary manner. Then, eventually where necessary, they use outsource partners and other types of groups to move their programs forward, where their own resources either do not have the expertise or the time to handle the programs. The problem with keeping things very close to the vest is that they often do not get the benefit of cross-fertilization of ideas, expertise and experience from outside. They believe in their own programs to the point where unrealistic expectations and unrealistic assessment of data come into play. That allows them to be very quiet about what they are doing. If they are public, they have to report material progress, or lack thereof, on their development programs, but essentially they can keep most of the information quiet, and of course, anything that goes to the FDA or the EMA or other regulatory agencies is proprietary anyway with respect to release of the information by these agencies. Hope and commitment to an idea is the basis of the entrepreneurial spirit; however, reality is important as well. Where GZP intercedes, and prefer to be involved, is early in the process so that we can assess the developability of a compound along with the sponsor, who is the initial discoverer or developer of the product. We intercede early and ideally work with them more as partners and more as team members as opposed to simple external consultants. That is so that we can help them make “go / no go” decisions earlier in the process. This theoretically will prevent very costly end of phase 2 “no gos” and even worse phase 3 “no go’s”, whereby millions or tens or hundreds of millions of dollars have been spent on a program to no avail. The biomedical developmental life cycle is very expensive and time consuming, at best. We think that the average of eight, ten, twelve, thirteen years for development of a molecule is much too long. Part of our job, in our opinion, is to help do it “better, faster and cheaper” as long as the data will allow for forward movement. We are very, very objective about data. Data really are what the regulatory agencies listen to. Belief, hypotheses, even Nobel winning hypotheses, have not automatically led to successful drug or biologic programs; rather realistic assessment of the data, a realistic analysis of the develop-ability of a compound, the ability to formulate it, the ability to make it bioavailable, the generation of a reasonable safety margin, the calculation of a risk benefit ratio which makes sense in a commercializable product; these are the kinds of things that we help our sponsors to realistically assess. We believe in an early technical assessment (gap analysis) and continued assessment throughout the development cycle to realistically review data, assess the probabilities of success and help sponsors make a “go / no go” decision at all key interfaces with the regulatory agencies and behind the scenes for each medical product program. The difference is really that we are skeptical at the beginning of any program review. We are very open minded, but we do not automatically have a heavy investment in any program. We can objectively assess the data and help those decisions be made early rather than later. That is where we differ from the typical approach to drug, biologic, combination product and medical device development. We do not have such an emotional and financial investment in the initial program; therefore, we can “see the forest for the trees and the trees for the forest.” That is how we look at each program that comes to us. Each program is considered independently and individually. We do not believe in saying “this molecule belongs to this class; therefore you will have a problem”. The FDA sometimes looks at products with attention to class, but they must look at each program individually. Therefore, we function in much the same manner as the FDA in its review of Sponsor programs. I am a former FDA toxicology reviewer and we have other team members who have been in regulatory agencies, but generally, they have industry experience in small to medium sized, as well as large companies with hands on product development experience. We are attempting to enable our clients to make an appropriate series of decisions along the way, so that they do not waste too much money, time, and resources in a failed enterprise.
CEOCFO: When you are speaking with a new client do they understand your approach fairly quickly? If they get it and they go along with it do you tend to get much “push back” when you say it is time to pull the plug and the developer says “I want to hang on”?
Mr. Siegel: Our clients “self select” us and we select them for mutual fit. We very rarely turn away a client. The three tenets for working with clients are: one, they do not do anything illegal, two, they do not to anything unethical, and three, they do not do anything which could compromise our reputation (or theirs) at the FDA while we are working with them. However, some companies really only want to listen to themselves; we can work with them, we have worked with them, but it is not a very positive experience. That is because they cannot see that “no” unfortunately, has a valid place in any type of product development enterprise, but particularly in the very risky arena of biomedical product development. In general, they get it. They understand it. The vast majority of our clients welcome and seem to relish our willingness and ability to be independent, to be objective and to suggest to them that “no” might be a good answer, if the data are not encouraging. In practice, it is more difficult than that. That is because so many of the small firms have placed their own resources at risk. They have to answer to investors. The investors do not like to hear “no” because they will pull the plug on the firm or the product investment. So often, firms are faced with dilemmas questions such as “will the company continue to exist if we do move ahead, what will our reputation be, what will the investors say next time we come to them?” Frankly, many of our clients just appear to need to say “yes” and to show “progress”. Unfortunately, many times what we consider, from a regulatory point of view, as very little progress often is positioned as “a great deal of progress” to investors. Part of the problem in this whole field is that the investors do not learn very readily. Often, they do not take a look at the history of the hundreds and hundreds of mistakes that have been made, because they also have hopes that their investment will be multiplied by a factor of, say, three to five, in two, three, or four years. That is often a very unrealistic projection of what might happen in this difficult, but rewarding field. Often, initial rounds of funding turn into secondary, tertiary, and quaternary rounds. The initial investors make their money, the secondary investors make their money, but the real problem comes when real money is put on the table in the form of tens of millions of dollars. That is where the heavier risk enters. It is a vicious cycle. If in fact a product does not appear to have a great amount of potential it will not be funded and the Sponsor will not even be able to test it. If in fact a great deal of hype surrounds a program there seems to be momentum carried by all parties involved; the management, the investors, boards of these companies, must assure that the program does not appear to be failing early. Therefore, to some extent it becomes a self-generating or self fulfilling prophecy that sometimes has very little basis in reality. I am an individual consultant through a number of consulting networks and have assessed over one hundred and sixty five programs; either the CMC or the nonclinical or the clinical or the regulatory or combinations of the above. These consults are based on publicly available information. However, that public information contains a great number of hints as to the data behind the summary statements and it is very easy, with a very high probability of success, (e.g. ninety to ninety five percent) to really provide advice as to whether the FDA is going to support a particular data set or a particular issue. This type of focused assessment is quite simple. Of course, my experience is thirty years long. However, we see companies making mistake after mistake, many times over many years. It seems as if the industry as a whole has not learned too many of the lessons, which are out there for anyone to see. There is a place for people who can be honest and honorable, encouraging but very realistic in providing appropriate services to the sponsors of these “very important for public health” programs. However, many medical product development programs really should not have gotten beyond a very early stage. Many of them continue way beyond an early stage where they should have been killed. It gives us no pleasure to suggest killing a program, but we think that for the good of the patients, for the veracity of the companies, the investors and the industry as a whole, it provides benefit no one to have such a high percentage of failures in phase 2 and phase 3.
CEOCFO: What has changed most in the last few years with the FDA? What do you look at differently now than you might have five or ten years ago because of their regulations?
Mr. Siegel: In many different ways, the FDA has opened up. This may go against some contrarian opinions. In our broad and long-term experience we have seen the FDA become more flexible on the whole, much more oriented towards looking at individual programs and individual data. In addition, the Agency appears to be much more oriented towards facilitating drugs, biologics, devices and combination products intended for serious or life threatening disease. There is a huge lobby, and it is not just a lobby but it is a public health need, to have much more preventive medicine, and a much more aggressive intervention, even at a later stage, to keep down the costs of medical care to provide for a better life for those who have serious or life threatening illness, and to allow them to function, perhaps for a very long time. Therefore, we see the FDA being very facilitative for oncology programs, HIV AIDS, and also for serious diabetes and cardiovascular conditions. To us, the FDA has become in many ways more flexible. For example during reviews, even of INDs, which used to involve a 30-day black box, we now see interactive reviews quite frequently. You would see clinical holds that would be put in place between twenty-seven and twenty-nine days during the thirty-day review cycle. However, now we actually have a fairly significant percentage of FDA telephone calls during IND reviews for applications for novel products. We are the agents for the vast majority (about ninety-five percent) of our clients; all ex-US and most US clients. We have individual product reviewers calling and saying, “I would like a little bit more information on this, can you send it to me in the next two days.” Essentially, you can call it an interactive review and we are seeing this at all stages of development, during phase 1 or 2 clinical trials, after end of phase 2 meetings and even in between the formally allowed and encouraged meetings. That is a very big change over the last several years. I think, to a great extent that this has been brought about by the Prescription Drug User Fee Act (PDUFA) which is in its fifth incarnation, other legislation, including the recent FDASIA, all of which funded the hiring of many more reviewers and more Sponsor meetings granted with the opening up of the review process. That is another major change. Probably the third major change is a very, very strong emphasis on product safety. Even though the risk/benefit is looked at for each product and even though we think the FDA has proven to be somewhat more flexible, we also do see a very strong and heightened emphasis on safety. We look at early safety signals in the toxicology program, the safety pharmacology program and the early clinical trials, to prevent serious safety problems occurring in the later phases of development or worse, post-approval. There is a balance that the FDA must strike between facilitating movement of these products to the market, and at the same time, protecting patients from harm from products that may not have represent an appropriate risk /benefit balance. The increased safety emphasis is there and has been increasing over the last ten years.
CEOCFO: When a company engages you are they engaging for the full process and the full range of your services or do some people sort of come in for a piece at a time?
Mr. Siegel: We have clients all over the therapeutic area spectrum, and have been in business as a corporation for thirteen years. We have clients that started about thirteen years ago with us. We have gone through multiple IND programs; long clinical programs; and marketing application review and approval. We have some clients that use us for a period of a year to two, perhaps in phase 2 or phase 3. It depends on the history of the program. It depends on whether the firm is outsourcing more, perhaps downsizing, or bringing in a new partner that requires consultant help. We used to do a lot of very early work, pre-phase 1, phase 1 into phase 2. That has morphed into a very broad spectrum of work at all stages of product development. We have a number of phase 3 programs now. We have taken a couple of clients from phase 2 through marketing application where we submitted the application on their behalf and it was approved by the FDA. We are a full spectrum firm, even though we are only thirty people strong. We provide services from very early development or late discovery, through approval. Few of our clients go all the way. That is because, usually, they are out-licensing their programs to large pharma or large biotech or their company is bought after the generation of successful Phase 1 or phase 2 data. Success for many of our clients actually involves the company being bought or having a program out-licensed to big pharma or big biotech where the latter will then finance the final stage of development through approval. We often lose those clients because the large companies have their own people, or are already working with large CRO’s. However, we have worked as partners with large CRO’s. I was at Quintiles once earlier in my career and we work well with such firms. In answer to your question, we do have a very broad spectrum of services. We do have some clients that come to us for a short period of time and then they leave. Usually, they find that they can use more of our services than they are initially looking for, once they get to know us. We have clients who say, “Can you help us with this biologics manufacturing issue?” Then they say, “Now we are doing some more preclinical or nonclinical testing – you have four toxicologists – can you help us?” I was an FDA toxicologist, for example. I have a very broad background in drug and biologic development. Companies who come to us for pre-IND meetings know that they can go all the way through IND, phase 1, phase 2 and phase 3 with us. They often expand their use of our services. We sometimes perform shorter-term tasks. Most of the clients who come to us work with us for significant periods of time, typically 3-6 years. Actually, clients I had at Quintiles in the 90s who went to other companies have brought us three different incarnations of client business as they have moved through their careers. We have a great deal of loyalty, because of the work that we do. We are available. We do not work “nine to five”. If there is a five AM telecom with a client in Australia, that works for us. If there is an eleven PM discussion with a Hong Kong client, that is also fine. It is not a problem for us to work globally. We actually have almost as many clients in Australia as we do in the US, at the moment.
CEOCFO: What is the most exciting part of the business for you, personally?
Mr. Siegel: The most exciting part of the business is seeing new technologies move from theory into practice. To think that our ultimate clients, who are the patients and health care providers who take care of them, could be benefitted by what we do and the work that we execute-that is very fulfilling. We have a great deal of excitement about what we do, a great sense of public health impact, plus we are always exposed to new and exciting medical product technology. We have small molecule and biologics work in about equal amounts. We get involved with cancer vaccines. We have several clients in this area. We are working on programs in gene and cellular therapies, and personalized medicine, and even though we are small, we are very sophisticated. Therefore, being exposed to these new therapies and approaches is important and exciting for us, intellectually and professionally, and enables us to be experienced and provide help to other firms working in very sophisticated areas. That is not saying that a relatively simple or repurposed product intended for chronic treatment of non-serious, life-threatening illness is not important. However, it really is exciting for us to be involved with these new technologies and also know that we are, perhaps, doing our part to help the patients and the healthcare providers.
CEOCFO: Why should investors and people in the business community pay attention to Ground Zero?
We provide what we feel
is a unique combination of expertise, experience, and approach in many
areas. We have direct impact on clients with, at any one time, aggregate
funding of as much as tens of millions of dollars and more. We understand
the business well and we can help clients make the maximally efficient use
of their investor dollars, resources, time, hopes and dreams. We feel that
this is important to all in the field, including the investors. I consult to
investors all the time. They are good people and they are bright people.
However, sometimes they believe the hype of the company management a bit too
much and need to look objectively at the entire package of information.
“We understand the business well and we can help clients make the maximally efficient use of their investor dollars, resources, time, hopes and dreams.”- Evan B. Siegel, M.Phil., Ph.D.
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