“Launching your Brand in Latin America Through Research & Clinical Studies” Presented by Abhita Batra

Zintro Webinar

Presented by Abhita Batra, Co-Founder and Managing Director – Advanced Biopharma Consulting, LLC.

Presenter’s Note:
“Conducting Clinical Trials in LATAM market is considered a challenge. In today’s world companies are interested in launching their products globally. Its time we understand how clinical trials can help you enter new markets and support better outcomes. We hereby discuss a particular case of clinical trials in Argentina, a pioneer in the region regarding participation in multinational clinical trials. We will review the current trial landscape, regulatory submission process and data quality and inspection outcomes. We will also approach another challenging question: How to find the right partner to ensure the swift execution of the trials and trigger the sales?”

About Abhita Batra:
Abhita is an accomplished management executive and entrepreneurial business leader with proven expertise in guiding strategic business direction in growth and early stage pharmaceutical, biotechnology and medical device companies. Abhita is the Co-Founder and Managing Director of Advanced Biopharma Consulting, LLC in 2009, a boutique advisory firm that offers business development, marketing and sales services for the pharmaceutical, biotechnology and medical device industries. Through ABC, she offers her client companies an established network of decision makers and strategic partners in Asia, LATAM, MENA, Americas and Europe. Abhita serves as Vice President Business Development and Marketing at Admac Group of Companies; where she manages a product portfolio encompassing 150 generics, including antibiotics and oncology drugs. She was successful in raising $10M capital, and setting up an oncology manufacturing facility in 2012, offering 26 generic oncology products.

Abhita is currently working on her Global MBA at UCLA Anderson and NUS, and has a Masters in Biotechnology with specialization in Pharmaceutical Sciences from the University of Pennsylvania.

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Transcript:

Enrique Levin: Hello and welcome. My name is Enrique Levin, Co-Founder and VP of Product at Zintro. Zintro’s a global online marketplace that helps connect companies with highly specialized consultants and other expertise providers for projects that range from one-hour phone consults to multimon on-site engagements and even full-time jobs.

Today’s webinar, “Launching Your Brand in Latin America through Research & Clinical Studies,” will be presented by Abhita Batra, Co-Founder and Managing Director of Advanced Biopharma Consulting, LLC. Abhita is an accomplished management executive and entrepreneurial business leader with proven expertise in guiding strategic business direction in growth and early-stage pharmaceutical biotechnology and medical device companies.
Abhita is the Co-Founder and Managing Director of Advanced Biopharma Consulting, LLC., founded in 2009, a boutique advisory firm that offers business development, marketing and sales services for the pharmaceutical, biotechnology and medical device industries.

Through ABC she offers her client companies an established network of decision-makers and strategic partners in Asia, Lethem, MENA, Americas and Europe. Abhita serves as Vice President of Business Development and Marketing at ANMAT Group of companies, where she manages a product portfolio encompassing 150 generics, including antibiotics and oncology drugs. She has also successfully raised $10 million in capital and has set up an oncology manufacturing facility in 2012, offering 26 generic oncology products.

She’s currently working on her global MBA at UCLA Anderson and NUS, and has a Masters in Biotechnology with specialization in pharmaceutical sciences from the University of Pennsylvania.

If you would like to ask Abhita any specific questions throughout the webinar, feel free to use the questions section of your GotoWebinar control panel. Just click on the little orange arrow on the top-right corner of your screen. You’ll see a question section. Feel free to use it at any time. Abhita will be responding to these questions at the end of the presentation, so stay tuned.

Without further ado, I would like to turn it over to Abhita Batra.

Abhita Batra: Thank you, Enrique. I would like to welcome you all. A very good morning, and a warm welcome from sunny California.

In today’s world, every company strives to meet projections through a new product or a new [inaudible 00:02:45] technology. Another way is by translating the language, culture and regional values and launching yourself in a new market.

I want to introduce you all to my boutique advisory forum, Advanced Biopharma Consulting, that specializes in new ideas and launching new technologies and products internationally. We offer management consulting and business [inaudible 00:03:12] expertise to early-stage companies and design their strategic market entry in various countries.

We value our clients and understand their goals. Our network is not only limited to North and South America. We go beyond the Pacific and Atlantic to Southeast Asia, Europe and the Middle East. The regional language and cultural barriers for most of the companies are an advantage to our clients.

Since our inception, we’ve only worked with executives and decision-makers of the companies. We bring highly experienced professionals, MBAs from Ivy leagues, with decades of experience. We specialize in global market penetration strategies, long-term supply and distribution contracts, fundraising for R&D molecules and licensing, out-licensing, early licensing and tryouts.

We have worked with over 20 companies, and I’m currently representing a publicly-traded company in the U.S., of Frostenson and Ovarti [SP] in Europe and a Latin American CRO. In addition to that, we are representing [inaudible 00:04:20] Asian company for their collaborations in Europe. We can share our client portfolio at request.

Welcome to our first-ever webinar. We would like to introduce our webinar CDs by discussing and educating today’s companies in Pharma by [inaudible 00:04:41] medical device things about the unexplored territory of Latin America. We start with the most relevant topic that researchers strived to make a success in, clinical trials.

Let’s go global now and talk about clinical trials in Latin America, which is our strongest suite. A very relevant question is, “Is clinical research even necessary?” The answer is yes. It helps the researcher prove the clinical indication of a drug and medical device. We are able to prove the clinical relevance in humans and animals and established safety, toxicity and efficacy in various demographics. This eventually can [inaudible 00:05:27] to approve products that can finally be used in human population.

Let’s talk about the hidden content, Latin America, which has 21 countries, 569 million people. The healthcare in the region has improved, and many multinational companies are conducting the clinical trials for decades. There are highly experienced investigators with GCP training that [inaudible 00:05:53] that is very strong. Most importantly, the disease profiles and therapeutic standards resemble those of U.S. and Europe.

In addition to that, the advantage of inclusion of Latin America is an advantage for most of the companies enrolling patients for diseases with seasonal behavior. Patient enrollment can be done only around because of the opposite seasons in the northern hemisphere.

According to the recent publication in Nature, the research strength of Argentina is the highest in South America. Considering the collaboration and excellence of research in the region, clinical research costs are usually [inaudible 00:06:39]. Regulatory enforcement bodies and quality investigators, ethics committee, ensuring patient safety and respect for the rights, proactive GCP policy development and large research [inaudible 00:06:57] populations have been cited as contributing factors to the explosive growth of clinical trial management in the region.

If you want to do business in the Latin American market, the clinical trials and registration process needs to resonate with the regulatory needs of the market. ANMAT, ANVISA, ENVINO [SP], to name a few, are the regulatory bodies in Latin America.

This slide highlights how the regulatory framework has changed from the year 2005 to 2010 and 2011. The only thing considered earlier was if the document is GCP-compliant. The definition of GCP was quite broad and diverse at the time. In the recent years there has been a transition, and clinical trial process is very well laid out. As highlighted, there are defined submission requirements, consent forms, defined timelines and inspections of the clinical [inaudible 00:07:57].

Since 2011, the ethical committee clearly defined the composition, transparency and activities. Besides, the confidentiality of the process is maintained more than ever.

The table gives an overview of regulations and requirements regarding signatures on informed consent forms. A witness independent of the investigator and his team needs to be present during the informed consent process with the potential participant and study in some special social, economic, political situations when they are enrolling the patient. Such witness will sign and ICF, a statement [inaudible 00:08:47] that any cost related to the study uncovered and the subject will not cover any cost of procedures or material related to his participation in the study.

If the subjects are unable to give the consent, their legal representative can do so on their behalf. In Argentina, we also have specific content procedures for acute situations that require immediate medical intervention. The confidentiality section must comply with the requirements of the [inaudible 00:09:21] data protection, national law in Argentina and Chile. Enrique, can we have the first [inaudible 00:09:28] question?

Enrique Levin: Yes, definitely, Abhita. So guys, please take a second to respond to this question. So we have a question, “Have you conducted clinical trials in Latin America or Argentina before?” We’re going to give a couple of seconds for our attendees to respond. Okay. I think we can close. And let me share the results, just so you guys can have a look. Sixty percent of our attendees have not conducted clinical trials in Latin America and Argentina, and 40% have. Okay. Let me hide that. Back to you.

Abhita Batra: Okay. Here we will discuss the fee study of Argentina. Of all the 21 countries
in Latin America, which has 25 million inhabitants, where the literacy level is 96%, do you know
ANMAT, the national regulatory authority, is a pioneer regarding the regulations in Latin America, not only for clinical trials, but also for registration and reference products. It was certified in 2009 by a [inaudible 00:10:44], and the first regional regulatory authority of reference for medicines. It is a member of the Global Coalition for Regulatory Science Research.

Enrique, can we have the second poll question?

Enrique Levin: Definitely, Abhita. Our second question is, “If you have a new trial coming up, would you be comfortable bringing the trials to Latin America or Argentina? Let’s give it a couple of seconds for our audience to respond. Okay. I think we can close the poll, and let’s share it with our audience. So basically, 79% would.

Abhita Batra: Okay. Great. That’s positive. Okay. So why Argentina? Because of its long tradition of investigators of excellence, and it has consolidated [inaudible 00:11:48] regulatory framework in compliance with international guidelines.

The other factors are: there’s a large patient pool in public hospitals; there’s a close and reliable patient-doctor relationship, leading to good retention rates; cultural and social characteristics are similar to some European countries; the totality of its population is covered by health social services; there’s a close and reliable patient-doctor relationship that makes an accelerated patient recruitment, development; the pharmaceutical companies are a mix between international and national laboratories; many of the local laboratories have launched their own products and technologies; the state of regulatory affairs our country to develop clinical trials under international standards; Argentina has a lot of qualified research professionals who are trained and experienced.

Enrique, can we have the third poll question?

Enrique Levin: Absolutely, Abhita. Our third question is, “What are your two main concerns when deciding to bring clinical trials to Latin America or Argentina?” And we have the following options: subjection, protection and patient recruitment, GCP-compliance and data quality, investigator oversight of the trial, timelines of the regulatory submission process and clinical trial costs. Let’s give it a couple of seconds to get some answers. It seems like we have a very active audience today. I’m glad. I think we can close the poll now.

As you can see, it’s pretty evenly distributed with investigator oversight of the trial doesn’t seem to be a concern. We basically have on top, with 36%, timelines of regulatory submission process, and in second place, with 29%, we had GCP compliance and data quality.

Abhita Batra: Okay. So it seems like we’re going to address that pretty soon. Okay. Discussing the current landscape of clinical trials, the most prevalent disease profile in Argentina is oncology, followed by diabetes, cardiovascular, infectology and celiac disorders. In most of the clinical trial cases, most of the candidates are in Phase III studies, accounting for 64% of the leads.

The slideshows FDA inspections that have held in Argentina, between 2008 and 2013, a total of 84 inspections have taken place, and 30% of them were related to bio research, monitoring and drug-quality assurance.

On the pie chart on the right, you can see the inspection outcomes. OAI stands for “Official Action Indicated.” This is a negative outcome. It means that the critical findings oblige the regulatory agency to take action. For example, if at a clinical site the FDA finds that data was incorrectly captured, there are many major deviations and serious breaches to safety or compliance with GCP, they may resolve the data from the site.

NAI stands for “No Action Indicated.” This is a 10 of 10. It is equivalent to, “You’re doing an excellent job. Keep it up.”

VAI stands for “Voluntary Action Indicated.” This means there is room for improvement but not on clinical aspects. Therefore, suggestions are made by the regulatory agency, and an implementation plan is developed and instituted at the site-sponsor level.

As you can see, overall results look very good. 97.6% of inspections held by FDA in Argentina have favorable outcomes. Looking more closely now at the inspections related to bio-research monitoring and drug QA, the outcomes are even better. All the inspections have favorable outcomes. There were no OAI at all, and all the majority of inspections resulted in NAI. An interesting fact is that FDA usually inspects the clinical trial sites once the clinical trial is finalized, because they focus on the data that was submitted, and wants to ensure that it was collected in compliance with the GCP regulations and the protocol, and everything is accurate.

Now, taking a look at ANMAT here, ANMAT is the authority of Argentina. It’s the Ministry of Health. We can see that from 1997 to 2011, there were, in total, 7-1-0, 710 inspections that took place regarding the clinical trials only. Out of these, 96% had positive outcomes, and only 4% have indicated official action that was required. A difference between FDA and ANMAT inspections of that and [inaudible 00:17:51] inspections while the trial is ongoing. This is so, because the focus of the agency is to verify the compliance to regulations and GCP, but mostly to proactively watch out for the rights and safety of the subjects here.

The trial submission process in Argentina is simple and clearly defined in our regulations. Minimum documents needed are insurance policy, protocol, informed consent form and investigative brochure. All of these documents must be translated in Spanish, except for the investigative brochure. The ICF must be customized to local regulations, local language, and must be approved by DNPDP, National Directorate of Protection of Personal Data, which focuses mostly on the aspect of confidentiality and data protection.

Once the documents are ready, they are submitted to IEC, International Ethics Committee. IEC, Institutional Ethics Committee, in Argentina is equivalent to IRB in the U.S., which usually requests some additional documents clearly stated in their SOPs. For example, template of the investigator agreement. Most of the IEC certified in the country meet at least once a month, or usually every two weeks.

With the first sites, IEC approval, some additional documents stated in our regulations, the electronic submission can be made to ANMAT, which is the Ministry of Health. If everything goes well and no objections are made, approval is expected within three to four months. Additional sites can be entered after the approval is ready, and are approved fast-track between two to four weeks later. Depending on the geographical location of the sites, some additional regulatory submissions need to be put into place, but this can be done in parallel with the Ministry of Health submission, in order to avoid the meetings.

Regarding oncology, which is one of the country’s major areas of clinical research, you can see some local data on slides. This is the epidemiological landscape of cancer in Argentina. The incidence is medium to high, compared to low. The most significant challenge we face are breast cancer prostate cancer, colorectal cancer and lung cancer. These are also the main diseases for which multinational companies bring their clinical trials to Argentina. There is a wealth of experience in clinical trials in these areas, and also, many [inaudible 00:21:03] leaders in oncology who also play a very active role, not only in research, but also within international medical associations and academic projects.

Regarding infectious diseases, and more specifically HIV, you can see in the slide some recent news about a local trial GARDEL [inaudible 00:21:31], published in the Lancet in 2014, April, exploring the dual therapy versus triple therapy in patients, in adult patients, with HIV infection. They investigated whether dual therapy with Lamivudine, Lopinovir plus Lamivudine was non-inferior to the standard triple therapy. And the study concluded that dual therapy regimen warrants for the clinical research and consideration as a potential therapeutic option for antiretroviral-naive patients, since in both the groups the wider load response was, to put it simply, the same.

And of course, this had a huge impact on treatment costs, patient compliance, [inaudible 00:22:27], generation of viral resistance, among others.

Did you know that Dr. Cahn, the lead investigator of the trials, is one of the pioneers of research in Argentina and a very well world-renowned key opinion leader? Cahn is the Head of the Unit of Infectious Diseases Hospital, Juan A. Fernandez, and Professor at the University of Buenos Aires. He was part of international working groups and conferences of HIV AIDS since 1989. He was the president of the international AIDS Society from 2006 to 2008. He is a former member of the Governing Council of the International AIDS Society and former board member of the International Society of Infectious Diseases.

On several occasions, he was an advisor to Pan American Health Organization, PAHO, and World Health Organization, WHO, and joined the United Nations Program on HIV AIDS.

Some more interesting questions. Did you know that this study with [inaudible 00:23:48] patients was performed in 19 centers, mostly located in Argentina, Peru, Spain and Mexico? Did you know that the study was funded by AbbVie?

Another great example now on preclinical aspect of research in Argentina, this is Dr. Gabriel Rabinovich and his team. He is the editor of a dozen scientific journals and visiting professor at Howard, Maryland and Paris, also a world-renowned investigator in the fields of immunology, cancer and, most specifically, the role of Galectin. Shortly after starting his thesis, he identified, purified and characterized a protein called Galectin, Gal-1, which proved to be a smart master key of cancer and autoimmune diseases, in the first case, by preventing the action of T lymphocytes that could destroy tumors, and the second, by stopping the immune system attack against the body.

He’s an investigator who’s recently on the cover of Cell. He discovered the mechanism by which tumors escape and anti-VEGF therapies and how this could be overcome.

Well, we come to a very important question here, “How do you choose the right partner for the management of clinical trials?” Recruitment in clinical trials is always a challenge. First tip, think about bring your trials to Latin America. Explore the feasibility of your project in the region with a local vendor who’s experienced through several phases of clinical trials and is aware of the challenges, healthcare system, investigator network, local practices, and the regulatory and [inaudible 00:25:56] processes.

Although there are well-established sites and investigators in [inaudible 00:26:02] areas mentioned before, there is a space and willingness to go outside of these areas. Ophthalmology, gynecology, dermatology are the areas capturing more interest in the region.

Set a time for a face-to-face meeting, and be sure to address all your fears and concerns right on when you meet the vendor. Being able to discuss openly about any issues or concerns will help you develop a trust with your CRO, which is [inaudible 00:26:41] for a successful outcome.

It is important to be informed that key opinion leaders in the region are present there, and you need to be in touch with them.

Explore the potential partnership with either the CRO or [inaudible 00:26:58]. There are several grand opportunities for research and development that can be made available through these partnerships.
Proactively establish and maintain regular communication between the regulatory authorities and sponsors at the investigation sites.

When [inaudible 00:27:22] success in clinical trials, choosing the right partner is essential. We have partnered with R&D, operated under the leadership of Mr. Pablo, who has been helping companies who are entering Latin America, through launch of successful clinical trials, for two decades.

How do they ensure the success in clinical trials? We’ll discuss about that in the next few slides. I would like to invite Laura. Laura, please take over from here and help our audience understand that.

Laura: Hi, Abhita, thank you. I will briefly introduce you to Research & Development CRO. Research & Development is the only national CRO in the market with more than 20 years of continuity. This is a lot to say within the current landscape, where several multinational companies, both pharmaceutical companies and multinational CROs have already established their offices in Latin America.

A fact to bear in mind and place this in context is that our first MOA regulation about clinical trials was published in 1997, and as Abhita mentioned before, Argentina was a pioneer in the region.

Research & Development CRO has been in the market since the very beginning. Our leadership is conducted by Dr. Pablo Liuboschitz, who is our CEO since 2008. He is a Bachelor in Science and Master in Business Administration and has broad experience in clinical trials and their multiple roles.

Dr. Santiago Liuboschitz is a medical doctor. He is now VP at Research & Development CRO and was also a cofounder with Pablo. A great part of his career took place within the pharmaceutical industry as Medical Director, Head of Clinical Research, and lastly as regional medical director at SmithKline Beecham.

Next slide please. Why is Research & Development your best partner? Research & Development CRO has unique capabilities to offer. We have full-scope clinical research services ranging from phases I to IV, and also including products and devices registration. We have broad therapeutic experience, which we shared it with you [inaudible 00:29:54] forward, and no turnover of staff, which accounts for our seniority level research professionals, a huge network of experienced investigators and sites, local regulatory know-how and strategic planning, lower costs, as Abhita has already highlighted before in her presentation.

Our broad knowledge about the medical environment, key opinion leaders and our relationship with sites and investigators having been through more than 20 years of conducting seriously and professionally clinical trials in the region.

Our expertise and regulations, local customs and culture, procedures and know how, allow us to deliver quality data in compliance with TCP, in a cost-effective, flexible manner. Besides, you can avoid the red tape working with large CROs, but still [inaudible 00:30:51] through R&D and our CRO consortium partners. I will introduce our consortium members in a while.

Let’s take a look, now, at quality in Argentina. I’ll show you something about the performance of Research & Development in other sponsor audits. These are the results of our performance. The last audit was in 2013, and they were [inaudible 00:31:21] for both at Research & Development’s facilities and research sites. As you can see, at the CRO, we had only eight major findings among 63 findings, which is 12%, at investigator sites, which is the graph you can see on your right. You can see that site performance was good, and from a total of 205 findings, across 14 audits, most of them were minor findings.

Next, please. The areas of expertise of the CRO match with the areas of research being conducted in the country. Oncology is our major strength. We have worked in several very innovative approaches, most recently with active and mono-therapies, are also known as “cancer vaccines.”

Ophthalmology is an area in which we are strong and also keep growing. We are currently working in large, multinational trials [inaudible 00:32:22]. We are looking forward to expand to new therapeutic areas and also willing to bring more early-phase trials and trials with medical devices to Argentina. These are not very common, but Argentina has full capabilities to perform these with excellence.

You can see also on the graph that we have experience of pulmonary disease, in metabolic diseases, and also we are very strong in cardiovascular diseases.

Next, please. On this slide you can see some of our clients. Among them you can find big pharmaceutical companies, smaller biotech companies, and also international pharmaceutical companies who have their own innovative pipelines. And as you can see, we can adapt to multiple company sizes, cultures and styles. Our focus is to provide customized, personalized services and not a one-size-fits-all solution.

Next, please. These are our consortium members. If you wish to take your study to the global level but keep it customized, personalized and in a [inaudible 00:33:45] approach, we can offer the services warranty and the consortium. It is constituted by several renowned CROs. They all have experienced staff and in-depth local expertise.

We have ClinDatrix covering the United States and Canada, ClinActis service for Asia-Pacific clients, DOKUMEDS, supporting trials in Central-Eastern Europe, DOT International, covering Japan, QnQ for African sites, Venn Life Sciences in European clinical sites, and Research & Development, covering Central and South America from our headquarters here in Argentina.

Thank you for your attention, and if you have any questions, please go ahead.

Enrique Levin: Thank you very much, Abhita. We’re going to move to the Question section. If you guys have any questions, feel free to use the Question section of your GotoWebinar platform. We have one question from Alex, “What’s the one thing we can do right away to move towards consulting in Costa Rica, for example?”

Abhita Batra: Alex, please get in touch with me. I would ensure that you are accustomed with the regulatory needs. We need to put together, and this time firstly, are you looking at generic molecules, or you looking at R&D molecules? Even in R&D, are you looking at orphan molecules, or are you looking at a few other categories, which can fast-track the process? So please get in touch with me, and I’ll explain to you the whole process. If the molecules are good enough, the process can be shortened, and the product could be registered in a few months. Otherwise, if it’s a generic product, it may take a while, up to year. So please get in touch with me, and I’ll ensure that you’re in touch with the right distributors, and if need, we can put you in touch with the right CRO and a partner for the long-term clinical trials.

Enrique Levin: Thank you very much, Abhita. I think we don’t have any other pending questions. I would like to tell everyone to feel free to contact Abhita directly. You can see the contact information on screen right now, or by going to her central profile. Abhita, I’m behalf of Zentro and our over 170,000 members, thank you so much for sharing your insights.

Guys, this closes today’s presentation. I wish you all a very nice day.

Abhita Batra: Thank you, Enrique, for allowing us to impart the knowledge and expertise that we have to a big audience. I would like to request you, if you can put [inaudible 00:36:35] the whole question of number-four before everyone leaves.

Enrique Levin: Absolutely. So we’re going to put the last question at this time. Veronique asks if will be sharing the presentation. The answer would be yes. In the following week you will receive an email with the link to the recording of the presentation. I will also be available in our blog, blog.zintro.com/webinars. So feel free to reach out to us if you need any help with that.

Okay. So I think we can close the poll question. Okay? And basically, “What else would you like to learn about Latin America, Argentina in future webinar series?” and 36% responded about research, incorporated groups in North America, and another 36% of respondents, “finding opportunities for research and development.” And 27% responded, “regulations for clinical trials.”

So thank you very much, everyone. This closes today’s presentation. Have a great day.

Abhita Batra: Thank you.