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The role of clinical pharmacology and experimental medicine

The high failure rate of investigational compounds during drug development, especially in late stages of the clinical development process, is widely seen as a key contributor to the outsize amount of time and resources necessary to develop new drugs. Advances in clinical pharmacology and experimental medicine have the potential to rebalance these trends by providing researchers with the tools to more efficiently and systematically identify promising targets and compounds, appropriate patient populations, and adequate doses for study much earlier in development. 

On July 28, the Center for Health Policy at Brookings, in collaboration with the International Consortium for Innovation & Quality in Pharmaceutical Development and the U.S. Food and Drug Administration (FDA), hosted a public meeting to tackle these issues. Through presentations and case studies, leading experts from industry, academia, and government agencies explored the evolving role of clinical pharmacology tools in pre-clinical and clinical development, existing gaps in the application of those tools, and how emerging science could be better leveraged to improve the efficiency of drug development programs and better optimize treatments. Discussion at this event will potentially be harnessed to inform downstream guidance documents, to establish best practices for the application of emerging clinical pharmacology tools, or to support academic publications. Speakers will convene privately to discuss such downstream deliverables and key takeaways from the conference.

Click here to access the full event agenda.

Video

• Introductory keynotes: Framing the issues
• Optimizing target and compound selection to enhance early stage decision-making
• The right dose for the right patient: Challenges and opportunities in dose optimization
• Precision medicine: Trial enrichment, biomarker science, and mechanistic reasoning to optimize patient selection
• Applications of clinical pharmacology to support demonstration of efficacy

Event Materials

• Event Slide Deck
• Clinical Pharmacology Public Conference
• Clinical Pharmacology Backgrounder
• Clinical Pharmacology Private Roundtable

Event Information

Over the past decade, drug shortages and product recalls in the U.S. have occurred at unprecedented rates, limiting patient access to critical medicines and undermining health care. A majority of these shortages and recalls have been due to manufacturing quality issues. In response to these problems, and as part of its ongoing efforts to ensure a continuous supply of high-quality pharmaceuticals in the U.S., the U.S. Food and Drug Administration (FDA) is pursuing a range of strategies designed to improve the flexibility, reliability, and quality of pharmaceutical manufacturing. Among these strategies is the promotion of new manufacturing technologies, including continuous manufacturing. Continuous manufacturing offers several important advantages over current approaches to manufacturing and has the potential to significantly mitigate the risks of quality failures. At present, however, these technologies and processes are not widely used by the pharmaceutical industry, and there remain a number of barriers to their broader adoption. In collaboration with a range of stakeholders, FDA is currently exploring ways in which it can help to address these barriers and facilitate the uptake of new manufacturing technologies.

Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held a workshop on October 19 entitled “Promoting Continuous Manufacturing in the Pharmaceutical Sector.” This workshop provided an opportunity for industry, academia, and government partners to identify the major barriers to the adoption of continuous manufacturing, discuss regulatory policies and strategies that could help to address those barriers, and explore approaches to improving public and private sector alignment and collaboration to promote the adoption of continuous manufacturing.

Event Materials

• Continuous Manufacturing Agenda
• CM Panelist Bio Sheet
• Participant list
• Continuous manufacturing discussion guide
• allslides_Continuousmanufacturingworkshop_101915
• meetingsummary_101915_continuousmanufacturing

The issue of Armenia enters the Turkish foreign policy agenda almost exclusively in the context of Western attempts at legislating genocide resolutions. The result is often a reactive nationalist defense.

In less than two years, by 2015, Turkey will find itself in a similar dilemma. Once again, it will be external dynamics that will drive the domestic and foreign policy debate, and quite predictably Turkey will react with anger and resentment to Western attempts at commemorating the centennial of the Armenian genocide. In order to avoid such an ordeal, Ankara needs to think about Armenian-Turkish relations now, before Western pressure builds up. The fact that Foreign Minister Ahmet Davutoğlu visited Yerevan last week is a step in the right direction and needs to be congratulated. Instead of panicking shortly before 2015, the Turkish government needs to pursue a multidimensional strategy, starting now. The first dimension of the strategy should be the opening of the border and the establishment of diplomatic relations between the two countries.

As it is well known, shortly after the signature of the two protocols aiming at achieving these two goals in 2009, Ankara decided to index the ratifications of the protocols to the resolution of the Nagorno-Karabakh conflict. Linking the normalization of relations to a “frozen conflict” had the impact of freezing the protocols as well. It also showed that Turkey had no empathy for the Armenian political leadership, which took a lot of heat from the diaspora for dropping genocide recognition as a precondition for the normalization of relations with Ankara.

In retrospect, the Turkish decision to establish a precondition for normalization with Armenia was shortsighted because it practically gave Azerbaijan de facto veto power over Turkish-Armenian normalization. Instead, what Turkey should have done was to establish diplomatic and economic relations with Armenia with the hope that such a policy of engagement would in time create positive momentum and leverage in favor of a resolution in Nagorno-Karabakh. It remains unclear whether a breakthrough in this frozen conflict can be achieved in the absence of Turkey gaining more leverage in relations with Armenia. It looks like sequencing is the main problem here. The Turkish side is reportedly ready to open the border, establish diplomatic relations and even provide financial support to Armenia in return for an Armenian withdrawal from two of the seven occupied regions surrounding Nagorno-Karabakh. This proposal looks like the same one Prime Minister Recep Tayyip Erdoğan made a few years ago to his Armenian counterpart at the time, Robert Kocharyan. Kocharyan had refused the Turkish demand on the grounds that there should be no linkage between Nagorno-Karabakh and normalization with Turkey. It is hard to see why today the Armenian reaction to a very similar Turkish proposal would be any different.

Therefore, this most recent Turkish attempt at rapprochement with Armenia is also likely to fail in the absence of a unilateral Turkish gesture such as the opening of the border without preconditions. On the other hand, since Turkey is always in some kind of election season, it is almost impossible to see the Justice and Development Party (AKP) invest serious political capital in rapprochement by taking such a courageous step. Under such circumstances, it is not surprising that the Armenian media saw Davutoğlu's Yerevan visit as nothing more than a public relations campaign. If Turkey is really serious about normalizing relations with Armenia, it will have to take some risks in relations with Azerbaijan. The key will be to convince Baku that only the normalization of Turkish-Armenian relations will create positive momentum in solving the Nagorno-Karabakh dispute. Turkey needs to open the border first and expect its diplomatic and economic engagement policy with Armenia to pay off in the long run. The alternative is to continue with the current policy. The current Turkish policy has produced no change in Nagorno-Karabakh in the last 20 years. It is time to think more creatively.

I have been writing for years about the Armenian Genocide. The issue is of great emotional as much as ethical and historical significance to me. But for reasons I will explain for the first time, 1915 is also a very personal matter for me. No, not because I suddenly discovered I am of Armenian descent, but mainly because 1915 is the main reason my career took a turn toward academia rather than diplomacy.

I did not join the Foreign Service because I was detained almost 20 years ago, when I was a 25-year-old tour guide. The reason? I dared to answer a couple of questions about 1915 from a group of American tourists visiting the Museum of Anatolian Civilizations in Ankara. That day changed my life. I'm not naïve; I knew answering their question in public would be risky. And I would have probably refrained from doing so had they not asked me first whether there is freedom of speech in Turkey. Trying to make light of it, I quipped: "Yes, there is freedom of speech, but freedom after speech can get tricky." I did not know my joke would turn into self-fulfilling prophecy.

Shortly after explaining to my group why the term “genocide” is problematic for Turkish officialdom, I was arrested by guards in the museum, taken to a police station and interrogated for five hours. This unexpected encounter with Turkish law enforcement convinced me about a couple of things. First, I realized how difficult life in Turkey would be if I were of Armenian descent. "Are you Armenian?" was the first question I was asked in the police station. When I said "No," the police officer laughed and said I was not the first Turkish traitor they had interrogated. To this day, I wonder how life in Turkey would be if my name was Onik instead of Ömer.

Second, I was also convinced that I no longer wanted to become a diplomat. As a diplomat, I knew you turn into a defense attorney for your country. I also knew that in the larger scheme of things, what happened to me that day was not tragic or even very consequential. But the idea of defending a country that arrests a tour guide for speaking about what happened 100 years ago turned me off intellectually and emotionally. All of a sudden, Turkey's predicament had gained a disturbingly personal dimension in my eyes and thoughts. I remember having a conversation the night I was arrested with my father, a Turkish diplomat himself and in disbelief about my lack of situational awareness. "Do you think you think you live in Sweden?" he asked me with sarcasm and some anger. Anyway, the case was closed for me. I now had a police detention record. And this was enough to disqualify me from the Foreign Ministry exam.

Since the Turkish Foreign Service had now lost a brilliant (!) future diplomat, I turned my gaze to academia and decided to continue my seditious activities in the United States by writing a dissertation on Turkey's identity problem. My focus was on the interplay between Kemalism, the official ideology of the republic and the Kurdish question and political Islam. Ever since I started working in academia and think-tanks, I made an involuntary reputation for myself as a public intellectual with pro-Kurdish, pro-Islamic, pro-Armenian tendencies. I guess that's a small price to pay for trying to be a liberal in today's Turkey. The alternative would have been a life in Turkish diplomacy talking about the "so-called Armenian Genocide,” the separatist-terrorist organization called the Kurdistan Workers' Party (PKK) and various "coup" attempts against the sacred Turkish state during the Gezi protests and the corruption investigations.

At the end of day, my arrest 20 years ago was a blessing in disguise. I'm happy my Armenian journey took me where I am.

This article was originally published in Today's Zaman.

Event Information

This year marks the centenary of the atrocities perpetrated against the Armenian people of the Ottoman Empire during World War I by the governing Committee of Union and Progress. Most scholars and many governments consider these horrific events––in which more than one million people were systematically massacred or marched to their deaths––to constitute the first modern European genocide. Turkish society has begun to open up and confront the issue over the last decade. Turkish authorities, however, continue to reject the use of the term genocide, contest the number of deaths, and highlight the fact that many other minority groups, Muslims, and Turks were killed in the same period as the war-ravaged empire unraveled. For descendants of the survivors, Turkey’s official refusal to reckon fully with this painful chapter of its past is a source of deep distress and concern and undermines societal efforts toward understanding and reconciliation. Armenians have also raised the question of reparations, further adding to the problem.

On May 13, the Center on the United States and Europe at Brookings (CUSE), together with the Massachusetts Institute of Technology (MIT) Center for International Studies, the Hrant Dink Memorial Human Rights and Justice Lectureship at MIT, and the Carnegie Endowment for International Peace held a conference with several leading scholars of the Armenian genocide and other international experts. Speakers considered the historical record and circumstances of the genocide amid the disorder of World War I; how Turkey, Armenia, and other key actors have dealt with the legacy of 1915; and how this legacy continues to reverberate in the region today, with protracted conflicts in the Caucasus and where religious and ethnic minority groups have been deliberately targeted for expulsion and death amid the upheavals in Iraq, Syria, and other states that emerged from the rubble of the Ottoman Empire.

Join the conversation on Twitter using #Armenia1915

Video

• 1915 and the unmaking of peoples: Deportations, massacres, and genocide
• The making of an “almost intractable conflict” and attempts at its resolution
• 2015 and its horrors : A century after 1915

Audio

• Armenians and the legacies of World War I

Transcript

• Transcript (.pdf)

Event Materials

• 20150513_armenia_transcript

In August, the White House announced the cancellation of the Moscow summit between Presidents Barack Obama and Vladimir Putin, while still saying that U.S. relations with Russia remain a priority. By all accounts, the Snowden case appears to have further complicated already strained U.S.-Russia relations. With President Obama headed to St. Petersburg, Russia for the G20 summit on September 6 and 7, the likelihood of an Obama-Putin bilateral meeting remains unanswered and unlikely.

With an eye toward a possible bilateral meeting in St. Petersburg, Brookings experts Steven Pifer, Clifford Gaddy and Angela Stent address these developments and future prospects for the U.S.-Russia cooperation on issues like Syria and arms control.

Steven Pifer:

“I think people now see the reset as a failure. I actually think the reset succeeded, because the goal was not to get us to Nirvana with Russia, but to lift us out of the hole that we found ourselves in in 2008.”

Clifford Gaddy:

“Steve has said that the relations are not as bad, are at their worst since, you know, the fall of communism. I would probably say they probably are as bad.”

Angela Stent:

“It's not clear what the U.S.-Russian agenda is going forward. The things we would like to accomplish — more arms control, an agreement on missile defense, even, you know, more U.S. investment in Russia — the Russians don't seem to be interesting in responding. We do need to work together — and we will, still, on post-2014 Afghanistan, on Iran — but it's really unclear what an agenda would be going forward.”

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• Download the transcript