Introduction to Savara’s Chief Medical Officer

Dear Shareholders,

After wrapping up our three-part series on autoimmune pulmonary alveolar proteinosis (aPAP) that provided perspectives on the disease from a physician, a patient, and an advocate, we thought we’d go in a different direction with this post and introduce you to the newest member of our executive team. The following is an interview with our recently appointed Chief Medical Officer (CMO), Dr. Badrul Chowdhury, an FDA veteran who joined Savara in November of last year. I felt it was apropos for you to hear from Badrul directly to learn about his background and what inspires him, and to discover why he was attracted to the CMO role at Savara.

We hope you enjoy getting to know Badrul!

Best regards,
Anne Erickson
VP, Investor Relations and Corporate Communications

An Interview with Dr. Badrul Chowdhury:

Please tell us about yourself and your background.

I am a medical doctor, U.S. Board Certified in Internal Medicine and in Allergy and Immunology and have a Ph.D. in Immunology. I trained in Internal Medicine at the Wayne State University School of Medicine in Michigan, and in Allergy and Immunology at the National Institutes of Health in Maryland. Early in my career, I was a faculty member at the University of Tennessee College of Medicine followed by nearly 20 years at the U.S. Food and Drug Administration (FDA). During my last 16 years at the FDA, I served as the Director of the Division of Pulmonary Allergy and Rheumatology Products, Center for Drug Evaluation and Research (CDER).

After nearly two decades at the FDA I decided it was time to leave my role in public service and, in April 2018, I went to Astra Zeneca (AZ). I was hired as a Senior Vice President and Head of Early Development in the Respiratory, Inflammation, and Autoimmunity group, followed by a role as the Chief Physician-Scientist in AZ’s Respiratory, Inflammation, and Autoimmunity group.

Happily, I’m here speaking with you because I recently left the ranks of big pharma to join the Savara family, a smaller, more nimble biotech company. My experience and expertise are in respiratory and autoimmune diseases which involve mastering the basic science of these diseases, clinical trials, and regulatory aspects of drug development. At a company the size of Savara, I hope to apply my skills and experience in a way that can positively impact both the strategic direction of the company as well as the day-to-day operations of the business.

Outside of work, I enjoy spending time on computer and IT related activities―applying and working with technology in all aspects of life. In the past, I had taken an interest in technology that was related to flying and aviation.

What attracted you to a role at the FDA? To a role in biotech?

My interest is in translational medicine―which, in a nutshell, is about applying basic scientific knowledge to all phases of drug development with the goal of making life saving and life enhancing medicines available to patients with an unmet medical need. Working for the FDA was an attractive option because it exposed me to the development of a wide breadth of drugs across many industries, and during a propriety time when the science and research on the development programs were not yet part of the public domain. Knowing what was not yet in the public domain gave me insight into what direction science in the industry was moving, and which development programs may become treatments a couple of years down the road. Also, with some limitations, this knowledge gave me the opportunity to help companies conducting science in related areas, often avoiding the pitfalls experienced by others before them.

The public health aspect of the FDA work was also of great interest to me. As an FDA physician-scientist I was able to interface with a heterogenous group of patients and work on programs that served a diverse set of diseases. This opened my eyes to a broad range of therapeutic areas and gave me experience supporting many different patient populations―populations that spanned diseases of epidemic proportions to ones that are considered orphan in nature (i.e., affected less than 200,000 patients in the U.S.). As a practicing physician, where my job was to interact with one patient at a time, I didn’t experience the power of public health in the way I did at the agency. As a physician, I certainly enjoyed working individually with patients, but I also derived great satisfaction in supporting the needs of patients, on a larger scale, in my public health role.

After having spent a good portion of my career at the FDA, I wanted to move on so that I could apply the knowledge and expertise I had gained in public health to a more focused role in the biotech industry. I wanted to be an integral part of a drug development team, take ownership of development programs and be involved in advancing an investigational therapy through development to commercialization.

Why did you want to join the Savara team? Why now?

Savara focuses on developing drugs for rare respiratory diseases and that is aligned with my expertise and interest. The allure of a small biotech, like Savara, is different than big pharma as it gives me the opportunity to be involved in many aspects of drug development and to have a broader impact across the organization.

Drug development in rare diseases is quite special as these patients have a real and urgent unmet need. A need that, quite often, is overlooked because there aren’t dozens of companies and endless research budgets focused on these rare afflictions. For me, it’s much more gratifying to develop drugs that aim to address this high unmet need and to help patients who often feel left out.

As for why I joined Savara when I did, the answer is simple and the decision was easy. I joined because of the pipeline of programs that target rare lung diseases, which is comprised of inhaled GM-CSF for the potential treatment of autoimmune pulmonary alveolar proteinosis (aPAP) and nontuberculous mycobacterial lung infection as well as inhaled vancomycin for the potential treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF. The inhaled GM-CSF in aPAP is our lead program and, I believe, this presents an exciting opportunity for patients and for me. I hope that with my experience and expertise I can help usher this program through the final phase of development and bring this important and promising drug to patients who currently have no pharmacological treatment options available to them.

Savara’s vision is to become THE orphan lung disease company. What does that mean to you?

Paradoxically, orphan diseases, as a whole, are rather common. Based on data from the NIH, there are about 7,000 orphan diseases, with a total of 25-30 million people living with an orphan disease in the U.S. At Savara, we are creating a niche within the orphan disease spectrum that that focuses on respiratory disease.

Savara is comprised of a dedicated group of people aligned by this shared vision and after only a few months at the company, it’s clear to me that my colleagues are genuinely interested in what they do, understand the needs of patients, and are dedicated to succeeding on behalf of patients with rare lung disease. Becoming THE orphan lung disease company is at the forefront of everything we do. It keeps us focused on the needs of patients whose unwavering bravery and courage inspire us every day.

Rare Disease Day® is at the end of the month. Do you have experience working on programs in rare disease? Why do you think funding/research in this area is so important?

While at the FDA, I had the opportunity to work on numerous rare disease programs, including respiratory diseases such as cystic fibrosis (CF) and interstitial lung diseases such as idiopathic pulmonary disease (and other subtypes of interstitial lung diseases). I also had the privilege of working on rare diseases while I was in the rheumatology and autoimmune disease area―some being very rare with prevalence rates lower than 1000 to 100 patients in the U.S. Developing drugs in orphan disease areas is difficult because the number of patients affected are small and sometimes these areas are not adequately funded for basic science research. Without funding and the basic scientific knowledge, identifying molecular targets for drug development is challenging. I applaud the efforts of Rare Disease Day® and hope it will bring more awareness for research and funding in this area.

(For more information on rare diseases, click here for the Rare Disease Day® website.)

You’ve been a member of many committees within high-profile organizations. What can you tell us about your time at the NIH, WHO, and the United Nations Environment Programme (UNEP)? How have these enriched your career in biotech? What important lessons did you learn?

Throughout the course of my career I have been involved in many committees nationally and internationally, as you noted. One that is of particular importance to me is UNEP, a leading global environmental authority responsible for a global climate treaty that I was part of. The goal of the treaty was to phase out the use of ozone-depleting substances, including from medical products. The challenge with phasing out ozone-depleting substances from medical products, such as propellants in metered dose inhalers, is that they are medically essential. Use of ozone-depleting substances in medically essential products could only be phased out when alternates were developed―alternatives that were acceptable medically, economically, and socially by all countries.

I was the U.S. medical lead for this global program and, proudly, I can say that the use of ozone depleting medical products has been entirely eliminated around the world. My experience working in this challenging area taught me many lessons. Most notably was how to build consensus and align a diverse set of entities, all with different interests and motivations, in order to achieve a mission and make it a win-win situation for all. That important lesson has applications in all aspects of my life.

What do you consider your greatest professional achievement?

I have been in drug development for a long time and have been a part of many programs and teams that make me proud. However, in keeping with the theme of rare disease, I would highlight my experience with sirolimus, a drug used to treat a rare disease called lymphangiomyomatosis (LAM).

LAM is a rare lung disease that affects young women in the prime of their life. With LAM there is abnormal growth of smooth muscles, particularly in the lung, leading to progressive loss of lung function. An NIH funded academic investigator-initiated study published in 2011 showed that sirolimus was effective in LAM. (Sirolimus is a drug that was approved in 1999 for the prevention of renal transplant rejection.) It turns out that sirolimus prevents the activity of a protein involved in the growth of smooth muscles in the disease. With positive data in hand, the challenge was to get a new indication for the existing product, so that patients with LAM would have access to, and reimbursement for, the drug.

At that time, under my initiative, the FDA brought together all the relevant parities―academia, the LAM patient advocacy group, the National Organization of Rare Disease and their legal partners, and Pfizer (the drug company that owned sirolimus)―to come together in an effort to get the LAM indication included in the sirolimus product labeling.

In 2015, sirolimus was approved for the treatment of LAM. It was, personally, incredibly gratifying to see positive views expressed about an FDA effort that I spearheaded and led. Views that, for me, sum up why I find drug development in rare diseases so satisfying and include statements such as this one from the LAM Foundation, “Good people everywhere go out of their way to help when they encounter an eminently worthy cause.”

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