Podcasts about project renewal

Amid the stresses of daily life and the uncertainty of the world around us, having a peaceful place to reflect and unwind can make all the difference. For participants in Project Renewal's horticultural therapy program, that sanctuary is the rooftop garden at one of the nonprofit's supportive housing sites, Bedford Green House. At heart of this healing space in the Bronx, is our guest Jonelle Green, Project Renewal's horticultural therapist. For more, visit projectrenewal.org.

Graymoor farm grows produce, sobriety Bounty is everywhere on the grounds of San Damiano Farm at Graymoor, the Philipstown home of the Franciscan Friars of the Atonement. Vegetables and flowers sprout from an array of raised garden beds, the progeny of a wet winter and spring, and the sweat of Derek Fox and other men. Fox is also blooming. He first entered St. Christopher's Inn, the friar's treatment program for men, in 2007, and achieved five years of sobriety before relapsing. He returned in August 2023 and, after graduating, moved on May 1 into San Damiano House, a transitional program just a short walk from St. Christopher's. "I wasn't even sure I wanted to do this," he said of returning to St. Christopher's. "But after a couple of weeks, the thirst came back of wanting to stay sober." St. Christopher's graduates sharing the same desire have planted, weeded and harvested at San Damiano since 2017, when the Franciscan Friars rescued an itinerant farming program for homeless men that a New York City nonprofit, Project Renewal, once operated on a plot at the Garrison Golf Course. Men who choose San Damiano over returning home or entering other transitional programs are required to work the farm for three hours each morning during a three-month waiting period before they can look for jobs in the community. Bob Conboy, a Garrison resident and the farm's longtime manager, imparts lessons in planting and growing the basil, carrots, eggplant, lettuce, sunflowers, tomatoes and other herbs, vegetables and flowers sold at the San Damiano farmers market on Fridays. Three restaurants - Riverview in Cold Spring, the Valley Restaurant in Garrison and the Farm to Table Bistro in Fishkill - also buy produce, said Conboy. Other lessons come from toiling outdoors on hot days and collaborating in the arduous work of farming, challenges that inculcate traits - a willingness to learn and take direction, patience and perseverance - needed to stay sober. An added reward, said the men, is seeing the seeds they plant and nurture flourish. "We spend a lot of time in the brutal heat, getting the beds ready, and it's just a pile of dirt," said Greg Miller. "Then, a few weeks later, you have these beautiful sunflowers." On a recent Wednesday, Miller and the other men listened as Conboy prepped them before they began planting bush beans, carrots and string beans in several of the farm's 245 raised beds. He told the men they needed to space the pelleted carrot seeds between 1 and 1 inches apart in the 10-inch-deep beds. San Damiano's farm has its roots in Renewal Farm, which launched at Camp LaGuardia, a homeless shelter that New York City opened in Chester. When Camp LaGuardia closed in 2007, the farm moved to The Garrison on Route 9. Two dozen men who stayed in dormitories at St. Christopher's planted and harvested produce, selling part of their yield from a roadside stand on Route 9. Graymoor began hosting the farm in 2011, repurposing badminton, basketball, handball and tennis courts built for a once-planned seminary. Facing financial difficulties, Project Renewal pulled out in 2017 but Graymoor decided to continue the program. Conboy, a former English teacher who retired nearly 20 years ago as chief financial officer for the Edgemont School District, began his journey to farm manager by volunteering with Renewal Farm when it moved to The Garrison. His farming lessons came from Brian Bergen, who grew organic produce at The Garrison's farm for the Valley Restaurant, as well as trial and error. His students have raised herbs such as oregano, thyme and sage, which Conboy highlighted as he walked rows of beds. Conboy pointed out Badger flame beets that look like sweet potatoes, eggplants, Swiss chard and Tuscan kale, all grown without pesticides and using compost from two piles stored at a former handball court. He pulled at some plants to uproot a handful of baby potatoes and passed beds with butternut squash, white onions. coleus and dahlias, all fl...

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Listen to a soundcast of the December 14, 2022, FDA approval of Xeloda (capecitabine) under Project Renewal, an initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.

The FDA's pilot program, project renewal, uses capecitabine for its first label makeover. What's new & what are the possible implications of the DPYD warning now in the prescribing information?

Financier, philanthropist, and longtime president of the World Sephardi Federation Nessim Gaon was proud of the Sudanese birthright that made him part of a long lineage of Jews from Arab lands. However, with growing antisemitism in Sudan, he also believed Israel offered the only safe haven for Jews around the world and devoted his life to constantly improving the Zionist project.  Gaon's oldest grandchild, Dr. Alexandra Herzog, deputy director of Contemporary Jewish Life for American Jewish Committee, shares the story of her grandfather's flight from Sudan, his quest for equality in Israel, and his pursuit of peace between the Jewish state and Arab nations that led to the historic 1979 accord between Israel and Egypt. Along with Dr. Herzog, oral historian Daisy Abboudi describes great changes in Sudan that take place during the late 19th and early 20th centuries, which saw the country emerge from a period of Islamic extremism to a land of possibilities for Jewish pioneers. However, this brief window of openness closes once again as Gaon's cousins, Diana Krief and Flore Eleini, describe how following Israel's victory in the 1967 Six-Day War, Sudan once again became a terrifying place to be a Jew.  ___ Show notes: Sign up to receive podcast updates here. Learn more about the series here. Song credits:  Saza Niye Glemedin; Penceresi Yola Karsi: all by Turku, Nomads of the Silk Road Pond5:  “Desert Caravans”: Publisher: Pond5 Publishing Beta (BMI), Composer: Tiemur Zarobov (BMI), IPI#1098108837 “Hatikvah (National Anthem Of Israel, Electric Guitar)”; Composer: Composer: Eli Sibony; ID#122561081 “Frontiers”: Publisher: Pond5 Publishing Beta (BMI); Composer: Pete Checkley (BMI), IPI#380407375 “Adventures in the East”: Publisher: Pond5 Publishing Beta (BMI) Composer: Petar Milinkovic (BMI), IPI#00738313833. “A Middle East Lament”: Publisher: Pond5 Publishing Alpha (ASCAP); Composer: Dan Cullen (PRS), IPI#551977321 “Mystic Anatolia”: Publisher: Pond5 Publishing Alpha (ASCAP); Composer: Okan Akdeniz (MSG), IPI#37747892568 “Modern Middle Eastern Underscore”: Publisher: All Pro Audio LLC (611803484); Composer: Alan T Fagan (347654928) “Fields Of Elysium”; Publisher: Mysterylab Music; Composer: Mott Jordan; ID#79549862 ___ Episode Transcript: ALEXANDRA HERZOG: Oftentimes, I asked him, would you want to go visit Sudan? If you could, would you? And you know, he would tell me, ‘Well, I have this image in my head. And I want to keep it that way.' And I think that it was so loaded for him in terms of memories, in terms of, you know, vibrancy of life and I think he wanted to keep it as this frozen image. MANYA BRACHEAR PASHMAN: The world has overlooked an important episode in modern history: the 800,000 Jews who left or were driven from their homes in Arab nations and Iran in the mid-20th century. This series, brought to you by American Jewish Committee, explores that pivotal moment in Jewish history and the rich Jewish heritage of Iran and Arab nations as some begin to build relations with Israel. I'm your host, Manya Brachear Pashman. Join us as we explore family histories and personal stories of courage, perseverance, and resilience.  This is The Forgotten Exodus. Today's episode: Leaving Sudan MANYA: When Diana Krief and her 95-year-old mother Flore Eleini look back on their family's life in Sudan, they conjure dark memories. Flore remembers enjoying afternoon tea outside with her mother-in-law when soldiers armed with bayonets stormed the garden. FLORE ELEINI: Life was normal, life was good. And then, little by little. it deteriorated. We were the very, very last Jews to stay in the Sudan. And then, after the Six Day War, of course, they came, you know, in the street, they were shouting, kill, kill, kill, kill the Jews, kill, kill, kill the Jews. And one day, I thought it was our end. MANYA: Her daughter Diana remembers soldiers raiding their house and posters of decapitated Jews outside their home. DIANA KRIEF: It's actually by others that I came to know that I was Jewish, that I was a Jew, you know, born in a Jewish family. They used to come in front of the house with posters of Jews in the Mediterranean Sea with their heads cut off, and blood everywhere. That's the first time I had actually seen the land of Israel. I didn't know that we had a land before.  And it was “itbah” the whole time. And even when we would put the radio on, they would sing“itbah itbah al yahud.” That means “slaughter, slaughter the Jews”. And this always stayed in my memory. MANYA: In 1968, Flore and Diana were among the last Jews to flee Khartoum, the capital city of Sudan. They followed a path to Geneva blazed by Flore's cousin, Nessim Gaon, a financier and philanthropist born and raised in Sudan who had moved from Khartoum to Switzerland a decade earlier.  Gaon, who died in May 2022 at the age of 100, was a legend in modern Jewish history. As a longtime president of the World Sephardi Federation, he worked to raise the profile of Sephardic Jews around the world and level the playing field for them in Israel – where Arabic speaking Mizrahi and Sephardi Jews were often looked down upon.  On the contrary, Gaon believed they offered Israel a gift – a link between the Jewish state and their former homes in the Arab world. Gaon himself offered a shining example. He persuaded his dear friend, Israeli Prime Minister Menachem Begin to meet with Egyptian President Anwar el-Sadat, which led to the historic 1979 accord between Israel and Egypt – the first peace treaty between Israel and an Arab nation. ALEXANDRA: For him when Israel was built, it really was like a miracle. He really, truly believed in the possibilities that Israel could offer. He also realized that Sephardic Jews could play a role in creating a bridge between Israel and the Arab countries, and that they would be able to help in creating peace or at least creating dialogue between some of those countries. And that's really what he did in his conversations with Anwar el-Sadat and Menachem Begin.  MANYA: That's Gaon's oldest grandchild, Dr. Alexandra Herzog, who now serves as the deputy director of Contemporary Jewish Life for American Jewish Committee. As her last name indicates, her mother Marguerite, Gaon's daughter, married into the Herzog dynasty. Alexandra's paternal grandfather was former Israeli president Chaim Herzog, and her uncle Isaac Herzog, is the Israeli president today.  But in addition to that proud legacy, Alexandra is especially proud of the impact her maternal grandfather made in helping Sephardi and Mizrahi Jews – a slight majority of Israel's Jewish population, but a significant majority of its Jewish poor – thrive, succeed, and lead in the Jewish state. Gaon was the driving force behind Project Renewal, an initiative launched in the 1970s to rehabilitate some of Israel's most distressed neighborhoods and improve education and social services there. He developed a bar mitzvah program that provided the education, ceremony, and gifts for thousands of underprivileged boys. And tens of thousands of young Sephardi leaders from impoverished neighborhoods received university scholarships. ALEXANDRA: A lot of the people who came out of this program are actually mayors or members of the Knesset – important people in Israel who actually have, as a ripple effect, a strong impact on the lives of other people as well. MANYA: The history of Sudan's once tiny and tight-knit Jewish community is limited to the late 19th and early 20th centuries – a brief window when it was safe to be Jewish in that Northeast African country. But the Sudanese diaspora's connection to that country runs unusually deep.  Sudan, Egypt's neighbor to the south, was much more than a waystation during the age of migration. It was a land of possibilities. Even if their forefathers spent centuries elsewhere, their descendants today often identify with the fleeting generations spent in Sudan. DAISY ABBOUDI: If you speak to people who were there, and you say, where are you from, they will say, Sudan, in a very proud, but definitive way. MANYA: That's Daisy Abboudi, a London-based oral historian of Sudanese Jewish history, who began her career by interviewing her own grandparents. DAISY: Sudanese is very much part of their identity and their descendants kind of focus on Sudan. And I know, there's this kind of phenomena from around the Middle East – a kind of nostalgia of looking back. There's kind of an inherited nostalgia that exists as well. But it's particularly strong in Sudan for a country where people didn't have thousands of years of roots. And I'm kind of always wondering, why? Why has it got this pull? MANYA: The reason could be embedded in the history of Sudan and the pioneering spirit of the Jews who landed in this rustic pocket of Northeast Africa, where the Blue and White Nile Rivers converged, the constellations shone brightly in the night sky, and the scent of jasmine and gardenia floated in the air. In the early 19th century, Sudanese and Egyptian residents lived under Ottoman rule. Jews in Egypt – and the few there might have been in Sudan – faced harsh taxes. But that changed toward the end of the 19th century, as the Ottoman Empire fell, and British forces took over Egypt, before moving south. With them came Christian missionaries who intended to “civilize” the tribes there. An opposition and independence movement began to build, led by a self-proclaimed Mahdi, who claimed to be the foretold redeemer of the Islamic nation. The 1966 epic film, Khartoum, depicts the infamous 1884 Siege of Khartoum, in which the Mahdi, portrayed by Hollywood superstar Laurence Olivier, defeated the popular British General Charles Gordon, played by another Hollywood legend of Ten Commandments fame, Charlton Heston. DAISY: When this independence movement starts, it's led by a man who calls himself the Mahdi, which means the kind of chosen one, and he wins, basically. He conquers Sudan quite quickly and then promptly dies of malaria and his successor takes over. But this period of independence, once it was established, is called the Mahdia, after the Mahdi.  It was an Islamic state, basically in that it was quite extremist. All the non-Muslim people living in Sudan had to convert to Islam. This was a law that was targeted at the missionaries who were there, but of course these Jews that were living there got caught up in that policy. MANYA: When the British conquered the Mahdi in 1898, that conversion law was revoked, and some converts reverted back to Judaism. The British built a railway line to supply the army and connect Egypt to Khartoum, the capital of the dual British-Egyptian colony. And soon, Sudan became a destination for Jewish families who sought to build economic opportunities from the ground up. DAISY: It was a kind of a mercantile community, a lot of shops, import-exports, cloth, gum Arabic, hibiscus. A couple of families grew and then traded hibiscus, which was like the main ingredient in cough syrup at the time. Don't forget, at that time, Sudan was very new – Khartoum especially, in terms of on the map in terms of European consciousness, obviously not new in terms of how long it's actually been there. But it was kind of seen or perceived as this new frontier. It was a bit off the beaten track.  There wasn't the mod cons or luxuries even of the day. So, it was people who were willing to take a little bit of a risk and dive into the unknown who would actually go to Sudan. MANYA: According to historian Naham Ilan, though the community was deeply traditional, it was largely secular and introduced many of Sudan's modern conveniences.  Morris Goldenberg from Cairo was the first optician in Khartoum. Jimmy and Toni Cain, refugees from Germany, ran a music hall and cabaret. Jewish students attended private Christian schools. By 1906, the Jewish community of Egypt invited Rabbi Solomon Malka, a Moroccan rabbi who was ordained in British Mandate Palestine, to lead Sudan's Jewish community. He was supposed to stay for only a few years, but instead stayed and purchased his own manufacturing plants, producing sesame oil and macaroni. His son Eli would later write the foundational history of the community titled Jacob's Children in the Land of the Mahdi: Jews of the Sudan. DAISY: When Rabbi Malka came, he was the shochet, he was the mohel, he was the rabbi. He was everything, it was a one-man band. The community was already kind of focused in Khartoum in 1928 when the synagogue was built. The club was built in 1947. I think the peak in terms of numbers of the community was early to mid-1950s. And that was about 250 families. So even at its peak, it was a very small community. MANYA: Community is the key word. Everyone knew each other, looked out for each other, and when Israel was created in 1948, they raised money to help some of their fellow Jews seek opportunities in that new frontier. Those who left weren't fleeing Sudan – not yet. That shift didn't happen for at least another decade. When things did start to turn, Nessim Gaon would lead the exodus. He had seen what could happen when Jews ignored warning signs and stayed where they were unwelcome for too long. Gaon's family arrived in the early 20th Century when his father got a job working as a clerk for the British governor of Port Sudan. Gaon was born in Khartoum in 1922. ALEXANDRA: As for a lot of Sephardi families, they basically moved with opportunities and changes of power in different countries. So they went from Spain, to Italy, back to Spain. And then they went into the Arab lands. So I know that they went into Iraq, then they went into Turkey. And they spent quite some time actually in Turkey, until they finally went to Sudan and Egypt. MANYA: As a young man, Gaon left to attend the London School of Economics. Shortly after he returned, he encountered British officers recruiting soldiers to fight for Winston Churchill's campaign against the Nazis.  ALEXANDRA: He just went in, signed up, and the next day, he was sent to the front. His family was not so excited about that. And he was actually under age, he wasn't really supposed to be able to sign up at that time. But when they figured out his age, you know, in the army, it was already too late. He just felt that he needed to be useful and do something. And that's what he did.  MANYA: Though he knew about the uneasy life for Jews in Sudan preceding his family's arrival there, what Gaon witnessed during World War II while stationed in places like Iraq ensured he would never take for granted his safety as a Jew. ALEXANDRA: Even though he never spoke about all of the things that he saw in great detail, he did a lot after the war, to help survivors go to Israel. It was very important to him to try to help those who had survived to actually go into a place of safety. He knew what it meant to be a Jew in danger. MANYA: Gaon and his future wife of 68 years, Renee [Tamman], exchanged letters every day when he was away at war and kept every single one. And after his return, from that point on, they never spent more than three days apart. The couple soon began to build their family. But because of rudimentary medical care in Sudan, it was difficult. Three of their children died before their daughter Marguerite was born in 1956. They were buried in Khartoum's Jewish cemetery. Sudan became independent in 1956. But the ties to Egypt ran deep. Later that year, when French, British, and Israeli forces attacked Egypt over Gamel Abdel Nasser's nationalization of the Suez Canal, the anti-Jewish tensions trickled south. DAISY: The Suez Crisis, in the end of 1956, kind of spikes a bit of antisemitism. There is a talk in the newspapers about antisemitism, Zionist things, plots. There were a few things that made life slightly more difficult, but not in a very impactful way on daily life. MANYA: There were other signs too. When the winner of the Miss Khartoum beauty pageant was discovered to be Jewish, she lost her crown. When Jews had matza imported from London for Passover, it had to be packaged in plain boxes without a Magen David. Given what Gaon had witnessed in World War II, that was enough to leave. He, his wife, and only daughter at the time went to Geneva. ALEXANDRA: That was a blooming community, they were happy, they were together. And they were able to create and expand on their Jewish life. And I think that, at some point, when it became clear, when they saw the signs of that antisemitism coming their way again, they just felt like, “OK, we've seen this before, not just in Sudan, but also from the history of the Holocaust. And we need to take proactive measures, and make sure that we're safe. MANYA: When they left, Gaon and his wife told no one. They packed only enough bags for a vacation. They even left the doors unlocked and food in the refrigerator so no one dropping by their home would get suspicious. ALEXANDRA:  My grandmother always told us how some part of her broke a little when they just left the house. They really pretended that they were just going out and they would come back. They would tell us how hard it was when they turned and they looked at the house the last time and they knew that they had left most of their things. That they had a whole history there. That they had children there who were still going to be there and it was really difficult. And so, they took everything [with] them, left to Switzerland, and made a life there. MANYA: The decade that followed was particularly tumultuous in Sudan. The country had its first coup of many, and a military government took over. In 1960, all of the Jews who had left Sudan had their citizenship revoked. Another revolution in 1964 restored civilian rule.  DAISY: It's at that time, that a lot of the north-south tension kind of comes into things. And there was a lot of violence in that revolution, a lot of rioting. And the violence was tribal, north-south tribalism, a lot of violence against southern tribes, people from the South in Sudan.  But that scared the Jewish community that there would be violence and murders in the streets, and that signaled that this was no longer this stable country that they had been living in. And that's when more people start to leave. MANYA: By this point, acquiring an exit visa had become difficult for Jews, especially those who owned businesses and properties. Much like Gaon and his wife had left under cover of vacation, people began acquiring tourist visas with return tickets they never used. In the summer of 1967, the Six-Day War became a flashpoint in Khartoum. DAISY: There was a lot of rhetoric against Jews, in the newspapers, accusations of Zionism, Zionist spies, slurs, the lot. The Jewish young men who didn't know the right people to avoid it, were arrested for the duration of the war, and then released subsequently. And then after the Six Day War, the Arab League Summit, and the declaration of the three Nos. That actually happened in Khartoum, so you can imagine the atmosphere in Khartoum at that time was not pleasant. MANYA: The Three Nos. No peace with Israel, No recognition of Israel, No negotiations with Israel. These were the pillars of the Khartoum Resolution, the Arab world's proclamation denying self-determination for the Jewish people in their biblical homeland. The Arab League Summit convened in Khartoum on August 29, 1967 and the resolution was adopted days later. Flore recalls how Muslim friends and colleagues suddenly turned on them. Returning home from a trip, her husband Ibrahim's business partner brought back a framed picture and insisted that Ibrahim read its engraved inscription out loud: “The world will not have peace until the last Jew is put to death by stoning,” it said. Another friend asked Flore one day where she hid the device she used to communicate with Israel, implying she was a spy. During a visit to Geneva, Ibrahim was warned not to return because there was a price on his head. Flore said their delayed departure was a source of tension between her and her husband, who even for years afterward, couldn't believe his beloved Sudan had betrayed them. But the time had come for most Jews, including the extended family that Nessim Gaon had left behind, to abandon their homes and fortunes in Sudan and join him. FLORE: My husband had confidence in them. And we had a lot of problems between my husband and me because of this. Because I said ‘Ibrahim, this is not a country for us.' He says: ‘You don't know anything. They won't harm us. They won't do that.' He had confidence, he couldn't believe it. Until my husband became very old. He died at the age of 94. And he always, always, in his heart, he said that they cannot harm us. But he had illusions. He had illusions. MANYA: The Gaons also could not return. It was simply too dangerous. But in the 1970s, when Nessim Gaon learned vandals might have desecrated the Jewish cemetery in Khartoum, he resolved to retrieve their children and other family members who were buried there. From a distance, he coordinated an airlift for several prominent Sudanese families, including Rabbi Malka's descendants, to transfer the remains of their loved ones out of Sudan to be reburied in Jerusalem where he knew they would be safer. It was this sincere belief about the promise of Israel and the promise of peace in the region that led Gaon to encourage and attend a meeting between Menachem Begin and Anwar el-Sadat in 1977. ALEXANDRA: He saw opportunities there to create a peace with Egypt and he told Menachem Begin we can create peace with the Arab countries. And so Menachem Begin took him to meet with Anwar el-Sadat. They had a meeting and they hit it off right away, because they spoke the same language, they came from the same place.  MANYA: Over the next two years, Gaon worked discreetly in the background to ease both of their minds, find common ground, and reach a consensus. When the two leaders were ready to sign a treaty in 1979, Gaon gave them both the Swiss pens they used to make it official.  ALEXANDRA: They actually called him first thing after signing, and told him: ‘Nessim, it happened. We did it.' And, you know, it was something that he was very proud of, but that we were not really allowed to talk about in the outside.  He truly believed in the possibilities, in the outcome. That's what he focused on. He wanted to better the lives of people both in Israel and in Egypt, and he cared about, you know, the Sephardi Jews that were part of that narrative as well. MANYA: Sudan was one of only two Arab nations who supported the accord. Egypt was suspended from the Arab League for ten years and el-Sadat was assassinated in 1981.  Still, Gaon never stopped trying to pave the way for more peace negotiations. In fact, much later Israel tapped him to meet privately with Palestinian leader Yasser Arafat. Unfortunately, the outcome was not the same. ALEXANDRA: We did not really want him to go and meet with Arafat because we were worried. I mean, Arafat had a long history of terrorism and we were a little bit scared. Arafat actually told him that at some point, there was a murder order on his head. They were considering killing my grandfather. And they decided not to, because he realized that he was an Arab like him. When my grandfather told us about this, we all went like, [gasp], what are you saying? But he was very calm about it. And he said: ‘You know, I, I stood there and Arafat told [me], I knew that you were doing a lot of good things. And you know, you were not doing anything bad towards the Arab populations. And you are very respectful. This is your background as well. And so we decided not to go ahead with it.' But I think my grandfather found it very difficult to talk to Arafat. And Arafat was not ready to make peace. MANYA: By this time Gaon had become a grandfather, Alexandra's Nono – the one who taught her how to whistle and play backgammon. The one who blessed her before long trips. The one who taught her his first language, Arabic. The one who passed down his love for the beauty of Sephardic Jewry and his concern about it being overshadowed and undervalued around the world and in Israel. ALEXANDRA: He was so idealistic about Israel, and really believed in it and thought it was such an important project. He also was very critical of it in terms of its treatment of Sephardic Jews. He was very sensitive to it, and he really worked hard to change that.  He was a little bit darker skinned. And he came from Sudan, he was born there. So he saw himself really, as a Sephardic Jew who had the opportunity here to educate this new country and to help this new country understand how Sephardic Jews could actually help and be positive agents within the country. MANYA: He also believed that the Jewish world must acknowledge and respect its own rich diversity for the benefit of everyone – Jewish, non-Jewish, Israeli or Diaspora. As president of the World Sephardi Federation, he traveled the world to encourage others to step up and show that Jewish history is not just an Eastern European, Ashkenazi narrative. ALEXANDRA: The more you're open to people who come from a different background, the more you also know how to interact with non-Jews and with countries that are maybe antagonistic to you. I think that it was a way for him to sort of bridge conflict to say: if you make an effort within the Jewish people, then you learn how to talk to everybody. MANYA: Daisy Abboudi said telling the stories of Sephardic and Mizrahi Jews is complicated. Are they migrants? Are they refugees? What do they want to be called, and why? And then there's the ambivalence some Israelis have had about welcoming all Jews, some of whom still feel affection for nations that wish Israel did not exist. In their eyes, it's a fine line between affection and loyalty. DAISY: It's not an easily packaged short story. It feeds into so many different kinds of strands and politics and it's such a messy period of history anyway, with colonialism and the end of colonialism and nationalism, and, and, and, and. I think it is too big and too much for people to kind of get their heads around. And so people just don't. MANYA: But Gaon believed that leveling the playing field and making sure everyone has equal opportunities to education and leadership is where it starts. As part of Project Renewal, he often walked the streets of the most distressed neighborhoods in Israel to hear firsthand what residents there needed and advocated for them. In addition to the scholarships, bar mitzvah programs, and Project Renewal initiative, Gaon also held court at the King David Hotel whenever he traveled to Jerusalem. Sephardi residents would line up around the block to meet the man who invested and believed in them. ALEXANDRA: Years later, when he was quite influential, he got a letter from the Sudanese government to tell him that they would love it if he took back the nationality. At the time, he decided not to.  He wanted to keep the memories and the life that he had in Sudan and all of the legacy of Sudan without specifically being connected to a government or a political situation that he disagreed with and that was difficult and unpleasant to Jews. I know that oftentimes, I asked him, would you want to go visit Sudan? If you could, would you? And you know, he would tell me, ‘Well, I have this image in my head. And I want to keep it that way.' And I think that it was so loaded for him in terms of memories, in terms of, you know, vibrancy of life and what he experienced, and I think he wanted to leave it that way, and not be sort of surprised or sad, or, shocked by the changes possibly. I think he wanted to keep it as this frozen image. I hope that one day I can go both to Sudan and to Egypt and see those places myself and get a sense of putting the pieces of the puzzle together and getting a sense of what life might have been. MANYA:  It's unclear when it will be safe for Jews to travel to Sudan again. Between November 1984 and January 1985, Sudanese, Israeli and U.S. officials worked with Gaon and Alexandra's father, Joel Herzog, to facilitate an airlift of thousands of Ethiopian Jews from refugee camps in Sudan to Israel. Operation Moses, as it was called, ended abruptly in January 1985 as soon as Sudan's Arab allies caught wind of the joint effort, stranding many Ethiopian Jews there. Some were eventually rescued, but not all.  ALEXANDRA: He not only helped fund the mission, which was very secretive, but he also took care of all of the details of the infrastructure from making sure that they could take a bus, to the plane, to a ship. He really took care of all of the details. And it was important to him because he wanted to make sure that fellow Jews would be in a place of safety. MANYA: Tribal conflict and civil wars also have continued. Feeling neglected by Khartoum, the largely agrarian South Sudan gained independence in 2011 after two civil wars. Warring factions within the South agreed to a coalition government in 2020.  Meanwhile, since 2003, millions of Darfuri men, women and children from three different ethnic groups have been targeted in what is considered the first genocide of the 21st Century – atrocities that continue today.  In 2019, Sudanese dictator Omar al-Bashir was pushed out of office by a series of peaceful protests. The following year, Sudan's fledgling civilian government announced its intentions to join the Abraham Accords as part of a larger effort to engage with the international community and secure international assistance. This included an agreement by the United States to remove Sudan from its state sponsor of terrorism list. But yet another military coup in 2021 derailed any efforts toward diplomacy and that plan was put on hold until a civilian government is restored.  Gaon died before seeing it become a reality.  ALEXANDRA: He really saw Sudan as his home. That was the place that he knew, that he grew up in. And I mean, again, he had gone to London before to study, he still came back to Sudan. You know, he went to war, he came back to Sudan and came with a lot of different layers of understanding of what it meant to be a Jew, in a lot of different countries, a lot of different places.  MANYA: Alexandra said he carried those layers and lessons with him throughout his life, as well as immense pride that he came from a long lineage of people living in Arab lands. For Nessim Gaon, the Jewish tradition was and always should be a big, diverse, inclusive tent. ALEXANDRA: One of the memories that really sticks with me is how during the Kohanim prayers at the synagogue, my grandfather would take his tallit, his prayer shawl, and put it on top of all of his children and grandchildren. And my grandmother would do the exact same thing with us in the women's section.  And of course, from time to time I would peek and look at this beautiful tent that was extended above all of my family members. And what was really special to me, was how we knew at that moment that we were being blessed by both my grandparents and that if someone was around and looked completely alone, they were welcomed under our tent.  And this really represents for me, what my grandparents were, they were warm. They were inclusive, loving and generous. And really they extended the tent, our family tent, to all the Jewish people. MANYA: Sudanese Jews are just one of the many Jewish communities who in the last century left Arab countries to forge new lives for themselves and future generations. Join us next week as we share another untold story of The Forgotten Exodus. Many thanks to Alexandra, Flore, and Diana for sharing their families' stories. Does your family have roots in North Africa or the Middle East? One of the goals of this series is to make sure we gather these stories before they are lost. Too many times during my reporting, I encountered children and grandchildren who didn't have the answers to my questions because they never asked. That's why one of the goals of this project is to encourage you to find more of these stories.  Call The Forgotten Exodus hotline. Tell us where your family is from and something you'd like for our listeners to know such as how you've tried to keep the traditions and memories alive. Call 212.891-1336 and leave a message of 2 minutes or less. Be sure to leave your name and where you live now. You can also send an email to theforgottenexodus@ajc.org and we'll be in touch. Tune in every Friday for AJC's weekly podcast about global affairs through a Jewish lens, People of the Pod, brought to you by the same team behind The Forgotten Exodus.  Atara Lakritz is our producer, CucHuong Do is our production manager. T.K. Broderick is our sound engineer. Special thanks to Jon Schweitzer, Sean Savage, Ian Kaplan, and so many of our colleagues, too many to name, for making this series possible. And extra special thanks to David Harris, who has been a constant champion for making sure these stories do not remain untold. You can follow The Forgotten Exodus on Apple Podcasts, Spotify, or wherever you listen to podcasts, and you can sign up to receive updates at AJC.org/forgottenexodussignup. The views and opinions of our guests don't necessarily reflect the positions of AJC.  You can reach us at theforgottenexodus@ajc.org. If you've enjoyed the episode, please be sure to spread the word, and hop onto Apple Podcasts to rate us and write a review to help more listeners find us.  

This episode is also available as a blog post: https://thecitylife.org/2022/07/14/project-renewal-open-117-supportive-affordable-homes-with-aquaponics-farming-in-the-bronx/ --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/citylifeorg/message Support this podcast: https://anchor.fm/citylifeorg/support

For Pride Month, we speak with Eric Rosenbaum, President and CEO of Project Renewal, about Marsha's House—the city's only shelter dedicated to serving LGBTQ young adults, ages 18 to 30. Project Renewal is a New York City-based nonprofit, working since the 1960's to end the cycle of homelessness by empowering individuals and families to renew their lives with health, homes and jobs. For more, visit www.projectrenewal.org

In this episode, we will be learning about Occupational Therapy in community-based settings and more. You will hear from the professional experiences of Patricia Motus, OTR/L, RYT a Filipina-American occupational therapist, a native New Yorker and a registered yoga teacher with 20 years of direct care experience working in community-based mental health programs in New York City focused on serving those impacted by trauma, domestic violence, homelessness, lack of access and resources, and individuals diagnosed with HIV/AIDS, and co-existing health conditions. Patricia's clinical experience includes work with clients with mental health concerns in a variety of settings, models and programs such as hospitals, vocational rehabilitation settings, homeless and domestic violence shelters and programs, sheltered workshops, the school-based settings, adult and geriatric home care services, group homes, and other supported residential settings. Her experience and passion also extends to academia where she is currently an Adjunct Instructor at Stanbridge University's OTA program and teaches weekly healing yoga classes at Wholistic Transitions, her Holistic OT Private Practice. Show Key Points:· Patricia gives us a glimpse of her background and interests· Patricia describes The Uncommon OT work that she has done over the years, the settings and populations she served· Patricia acknowledges and names OT pioneers in each setting· Patricia describes how each position led to the other· Patricia describes OT treatment activities and types of groups· Patricia discusses what she's taken away from each position· Patricia discusses the thriving OT internship program RESOURCE LIST:transitionsot@gmail.comLinkedIn: https://www.linkedin.com/in/patricia-motus-otr-l-ryt-a26a999/Website: www.transitionsot.comFacebook: Transitions OTTwitter: transitionsOTIG: @transitionsotUnited Cerebral Palsy https://www.adaptcommunitynetwork.org/Mount Sinai Medical Center https://www.mountsinai.org/care/occupational-health/services-programs/patient-services/careers-vocational-servicesNew York Presbyterian Hospitalhttps://www.nyp.org/psychiatryBarrier Free Living https://www.bflnyc.org/Village Care https://www.villagecare.org/Project Renewal https://www.projectrenewal.org/how-we-innovate-occupational-therapyStanbridge University https://www.stanbridge.edu/Wholistic Transitions www.wholistic-transitions.com Therapeutic Play Foundation https://www.therapeuticplayfoundation.org/mommy-matters.htmlAs always, I welcome any feedback from all of you or if you are interested in being a guest on future episodes, please do not hesitate to contact Patricia Motus at transitionsot@gmail.com or DM via Instagram @transitionsotWe hope you will LISTEN, FOLLOW & SHARE The Uncommon OT Series Podcast with all your friends and colleagues! You can find us on Spotify, Stitcher, Apple & Google Podcasts. Happy Listening Everyone!Become a Patron to support The Uncommon OT Series Podcast project Via Patreon.

*This episode is suggested for older audiences only.*I talk with my friend M. Stratton about trauma recovery, therapy, acting, art and literally everything in between. In this episode we are encouraging our listeners to consider donating to Project Renewal in NYC. Their mission is "to end the cycle of homelessness by empowering individuals and families to renew their lives with health, homes, and jobs" They also provide them with mental health resources (therapy, rehab, NA, etc). "80% of chronically homeless adults struggle with mental illness, substance use disorder, or both, and fragmented treatment exacerbates their harsh reality: a revolving door of emergency rooms, jails, shelters, and the streets." You can read more about them and learn how to donate by clicking this link! https://donatenow.networkforgood.org/ProjectRenewal

Project Renewal provides supportive services to nearly 15,000 New Yorkers each year, in part, through their workforce programs. Barbara Hughes and Allison Messina discuss Project Renewal's social purpose catering company City Beet Kitchens, and the Next Step internship program, providing training for careers in homeless services. For more, visit projectrenewal.org and citybeetkitchens.org.

Project Renewal provides supportive services to nearly 15,000 New Yorkers each year, in part, through their workforce programs. Barbara Hughes and Allison Messina discuss Project Renewal’s social purpose catering company City Beet Kitchens, and the Next Step internship program, providing training for careers in homeless services. For more, visit projectrenewal.org and citybeetkitchens.org.

Reefer Reporters Thursday April 15th with Kim and CindyThis weeks stories include:Organigram reporting losses, Strict new rules in Canada for medical; patient growers, Some Doctors still unsure about medicinal cannabis efficacy, "Project Renewal" confiscates 7mil worth of cannabis, 121,000 in cannabis seized from Tobray home, Charlottes Web extends it's global brand, Denver poised to approve delivery and lounges, former cop sentenced in warehouse robbery, Mississippi court hears case contesting cannabis, How go, black pepper and tea can alter your cannabis experience

On the Sole DXB’s 10-year anniversary, Rohma Theunissen asks Sole Partner, Raj Malhotra to share 5 things that he learned from his journey with Sole DXB that he wishes he knew when he was starting out. #BiteSizedConversationsHosted by: Rohma TheunissenAbout Raj Malhotra Rajat moved to Dubai after having lived in Los Angeles, Kuwait, Italy, India, and New York. Having graduated from NYU in 2002, Rajat took a year-long sabbatical working on teaching at Project Renewal in NYC. In 2004, he moved to Dubai to establish a telecom and security business that grew to cover 11 countries from Vietnam to Algeria, of which he served as CEO MEA for 8 years. Rajat had also partnered with Sunny Rahbar, co-founder of the Third Line Gallery, on a collaborative project that had seen them host multiple curated exhibitions with NYC gallery, On Stellar Rays. In 2013, Rajat came on board as the fourth partner at Sole. More recently, Rajat built a private recording studio in Dubai, using it as a space for artists to collaborate. About Sole Founded in 2010, Sole is a leading platform for connecting communities through creativity and culture. The grassroots organization has built a rapidly growing community through its annual Sole DXB cultural festival, which saw over 36,000 people from more than 60 countries attend the eight annual edition in December 2019. Sole operated a boutique creative agency and published an annual print magazine. The creative agency has worked with numeous global brands including Gucci, Burberry, Saint Laurent, Farfetch and Jordan Brand. Our latest initiative is sole.digital, a feature-focused, mixed media site dedicated to bringing you the best in culture, first. We work with our roster of global contributors to present the people and ideas that will shape the future of fashion, music, sports, and visual arts, and to engage our audience in conversations on social issues like race, sustainability, and our environment. For more information on Sole, visit: https://www.sole.digital/

“There is a great space for us to be present digitally. To complement the things we are doing, not replace them. And that part I don’t think will ever go away, because if we get it right, why would we not want to continue doing that?”At the end of 2020, Rohma Theunissen caught up with Raj Malhotra, one of the four partners at Sole to talk about the evolution of events and brand experiences as a result of the pandemic, everything the Sole team has been working on, the digital space, where the Sole brand stands today on its 10-year anniversary and what we can expect from the brand moving forward. Note: As the UAE undergoes a second wave of the virus, this episode was recorded virtually to uphold social distancing practices. Hosted by: Rohma TheunissenAbout Raj MalhotraRajat moved to Dubai after having lived in Los Angeles, Kuwait, Italy, India, and New York. Having graduated from NYU in 2002, Rajat took a year-long sabbatical working on teaching at Project Renewal in NYC. In 2004, he moved to Dubai to establish a telecom and security business that grew to cover 11 countries from Vietnam to Algeria, of which he served as CEO MEA for 8 years. Rajat had also partnered with Sunny Rahbar, co-founder of the Third Line Gallery, on a collaborative project that had seen them host multiple curated exhibitions with NYC gallery, On Stellar Rays. In 2013, Rajat came on board as the fourth partner at Sole. More recently, Rajat built a private recording studio in Dubai, using it as a space for artists to collaborate.About SoleFounded in 2010, Sole is a leading platform for connecting communities through creativity and culture. The grassroots organization has built a rapidly growing community through its annual Sole DXB cultural festival, which saw over 36,000 people from more than 60 countries attend the eighth annual edition in December 2019. Sole operated a boutique creative agency and published an annual print magazine. The creative agency has worked with numerous global brands including Gucci, Burberry, Saint Laurent, Farfetch and Jordan Brand.Our latest initiative is sole.digital, a feature-focused, mixed media site dedicated to bringing you the best in culture, first. We work with our roster of global contributors to present the people and ideas that will shape the future of fashion, music, sports, and visual arts, and to engage our audience in conversations on social issues like race, sustainability, and our environment. For more information on Sole, visit: https://www.sole.digital/

On Sunday, March 29, 2020, WBAI 99.5 FM City Watch Host David Brand spoke with former Queens District Attorney candidate and progressive leader Tiffany Caban, Queens Patch reporter Maya Kaufman, and Barbara Hughes, Executive Director of Project Renewal's City Beet Kitchens.

Imagine a world in which every person without a home or right out of prison could have a second chance through food. That is was Project Renewal is trying to do together with City Beet Kitchens in New York. Mariana and Diego went to the heart of one of their kitchens in midtown Manhattan to learn how food can turn around people's lives.The holiday season is all about food and community. There’s no better time to show your support for food radio by becoming a member! Lend your voice and help HRN continue to spreading the message of equitable, sustainable, and delicious food – together, we can change minds and build a better food system. Go to heritageradionetwork.org/donate today to become a crucial part of the HRN community.Buenlimón is powered by Simplecast.

14% of the nation’s homeless live on the streets of New York City, and this month, temperatures have begun to drop into the 20s. Project Renewal is one of dozens of New York City organizations that coordinate to help fight homelessness. McCaffrey Blauner met with Project Renewal board member Lee Stringer, whose life experience gives him a unique insight into the experience of many of the city’s homeless.

Subscribe to the podcast through iTunes and Google Play. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Dr. Clifford A. Hudis (CH): Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast, series where we explore policy and practice issues that can impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer.  My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series. For today's podcast, I am delighted to have as my guest, Dr. Richard Pazdur, the Director of the Food and Drug Administration's Oncology Center of Excellence. The OCE was established to expedite the review of novel cancer therapies and products by bringing together expertise from across the FDA. And we'll touch on this a little bit during our conversation. Dr. Pazdur, welcome and thank you for joining me today. Dr. Richard Pazdur (RP): It's a pleasure Dr. Hudis. CH: Thanks. So I want to kick off our discussion by diving right into a hot button issue, expanded access. Can you provide our listeners with some background on this, and explain what the FDA's expanded access program is, and why an oncologist might want to pursue expanded access for an individual patient? RP: Of course. The FDA's expanded access program provides a way that patients with serious or life-threatening diseases or conditions such as cancer can try investigational medical products for treatment when no satisfactory therapies are available, and when there is no opportunity for the patient to enroll in a clinical trial. The process-- to make a request, the patient's physicians will approach the pharmaceutical company to ask for its agreement that the company will provide the medical product. The company has the right to approve or disapprove the physician's request. Then the physician needs to send the request to the FDA. This process can be complex to navigate, particularly for oncologists or physicians who don't have experience working with the clinical trials or these types of requests. FDA allows the vast majority of these requests to proceed. And the FDA has been working to improve the expanded access programs for a number of years, including the development of a more streamlined application process, a more streamlined form. But for many key health care professionals, especially those not familiar with the expanded access program, this process may appear confusing or somewhat burdensome. CH: And so is this a segue to Project Facilitate, which you announced at our annual meeting a few weeks ago? Can you talk a little bit about that and, its practical implications? RP: Yes. The Project Facilitate call center is a pilot program only for oncology that will serve a single point of contact. We have FDA oncology staff there, oncology nurses, oncology pharmacists who will assist the physician and their health care team throughout the process to submit and expanded access request for an individual cancer patient. This is a concierge service to support the patient's medical team throughout the process. It ranges from the initiation of the FDA form 3926. The process will also provide information about IRBs, particularly central IRBs, and really will also follow up on the status of a given patient to determine if that patient has received any benefit from the therapy and if there were any adverse events that need to be reported to the FDA. CH: So imagine that Project Facilitate works as hoped for. What's the thumbnail before and after experience? That is, how will things appear to be different to the physicians and to the patients? RP: It should make the process easier for physicians to get information that they need to submit an expanded access request. As I said before, it's often somewhat complicated, especially for physicians don't have experience with either the drug or with the process. And it's obviously easier to talk to somebody over the phone to ask specific questions rather than just being directed to a website. We're also working in conjunction with Reagan-Udall Foundation for the FDA, which started the expanded access navigator website to educate patients and health care professionals about the expanded access process. This navigator approach offers information provided by companies about their expanded access policy, and now includes the expanded access programs listed in ClinicalTrials.gov. Patients and physicians can look for treatment options. They could discuss clinical trials, and company information could be provided at the navigator at Navigator.Reagan-Udall.org. So this is really to give patients and their physicians information about what is out there. Once the patient obviously has this information and their doctor, then the doctor can utilize the Project Facilitate, which allows easier access to actually submitting these forms and going through the actual process. I'd like to emphasize that companies are now required by the 21st Century Cures Act to publicly list their expanded access policy. And the Reagan-Udall Navigator website helps them comply with that requirement. Again, so once the physician and the patient have identified the investigational therapy they want to try, the physician or other members of the health care team then can contact Project Facillitate for assistance in locating IRB resources and help with the FDA form 3926. CH: So I think you mentioned this when you launched this or announced it at the annual meeting just now, that physicians do already-- or at least before project facilitate often would successfully go straight to pharmaceutical companies and ask for treatments. And I guess in some cases they'd be denied, and in some cases they would be approved. And that would be through the company's expanded access programs. Obviously, that means that regulators wouldn't necessarily know the full extent of expanded access use. So assuming that Project Facilitate will allow the FDA to collect much more data on expanded use, how will the data be useful? And obviously, I'm hinting at the fact that some fear that it will be actually a negative. RP: Well, prior to launching Project Facilitate, the expanded access requests for cancer patients arrived at multiple places within the FDA and were forwarded separately to FDA oncology or hematology   divisions. Sometimes these requests could be delayed, being sent from one place to another in the agency. So this gives a focus point for physicians to contact. In addition, we're seeing that most of the expanded access requests were coming from patients and physicians at larger academic centers. The patients who don't live near these cancer centers and may not be able to get on clinical trials can also hopefully have access to investigational agents by having a more facile and easier process to use here. We're also seeing that many companies have turned down requests from patients, and we have no idea what really the number of requests a company may get if they're turning down these requests. Because generally, they don't come to the FDA. So really, by having the initial contact at the FDA we'll be able to determine number one, the number of patients that are requesting a single patient access. We'll also be able to determine and discuss with the companies their reasons for denying these requests. And there could be multiple reasons. And we also have a process in place that can follow up with what are the benefits that an individual patient may have from this therapy or, as I stated before, were there any adverse events. We have also heard this kind of urban myth-- and I label that in quotations, "urban myth," that companies fear that perhaps adverse events may be held against them when their drug is coming for drug approval. We have not done that. We take into context where the adverse event reporting is coming from. And there really are no instances that I am aware of in oncology where a report of an adverse event has delayed or curtailed an approval of a drug. CH: So really, this is a bright ray of sunshine on a dark corner of drug access. And if it works right, you'll just have much more understanding of the overall use of expanded access. Right? RP: Yeah. I think that gives some clarity to the process here. Here again, we don't know the numbers at this time of actually the number of patients. We only know the numbers of patients that receive a affirmative position from the drug company regarding that the process can continue. But we don't know the numbers of patients that may be requesting single patient access and are denied by an individual drug company. And also, the reasons. And, as I stated before, there can be very legitimate reasons, including inadequate supply of the drug, lack of support staff to follow up on these drug requests, potential interference with clinical trials that the patient may be eligible for. CH: You just used a phrase about patients requesting. And I thought as you described this process you were referring to physicians requesting on behalf of patients. And so I do want to ask, are there resources that are aimed directly at patients or is it really solely aimed at the oncologists in this case? RP: Well, here again, this is a two-prong process. Project Facilitate, the FDA portion of this, is for physicians to call up for assistance in filling out the form and also navigating the process once the decision is made. The other prong of this is, as I stated before, by Reagan-Udall foundation, which patients can call to look at what our options available to them that are potentially listed on ClinicalTrials.gov. And that is also for patients and physicians. However, the portion of the program that is Project Facilitate is for the requesting physician. CH: All right. Well, that's clear. So once we talk about patient's involvement, and even many physicians I think for that matter, we quickly can drift towards the very heated discussion that took place in public over the last year in the area or that we call Right to Try. And I wonder if you could talk for a minute and help us, for the listeners, make this distinction between expanded access and Right to Try. RP: Of course. These programs, Right to Try and single patient INDs are really mutually exclusive programs. The main difference between these programs are first, that under Right to Try the drugs have to complete a Phase I trial. For single patient INDs, it could be done anywhere, even within the context that the drug is being conducted in a Phase I trial. However, the major difference is that the FDA and the IRB does not review Right to Try applications, whereas under a single patient IND, the FDA obviously has to give permission for the patient to proceed as well as an IRB has to review these requests. CH: So to be very clear, Project Facilitate is supporting the single patient INDs, and Right to Try is a separate matter entirely. They are distinctly different programs. Project Facilitate does not apply to Right to Try. That is an independent, separate program. CH: Great. So, you know, one of the problems for a busy clinician is figuring out how to do all this under pressure with a sick patient, and the other pressures of clinic and administration and research. If our listeners want to learn about this more casually, where can they go not under duress, just to start reading up and learning about how to access the program? RP: They could go-- physicians can go and learn more about the program at our website, www.FDA.gov/oce. The Project Facilitate phone number is 240-402-0004. That's 240-402-0004. And the email address is ONCProjectFacilitate@FDA.HHS.gov. CH: That's great. So hopefully, some of our listeners will take advantage of that and learn about this when they're not under pressure so that they're familiar with it if they have to turn to it some months later. Now you mentioned that the host is the Oncology Center of Excellence. And I mentioned in my introduction that we would want to talk a little bit about that. CH: You've been at the helm of the OCE since it was established a little over two years ago, I think. Now that you've been in the role a while, I wonder if you could talk a little bit about your view of what the OCE should be accomplishing, and maybe how that aim has evolved over these two years. RP: Yes. The OCE basically was an offshoot of the Moonshot Program several years ago, and was aimed to be the first center that coordinates activity among the therapeutic center. Obviously, at the FDA there is a center for drugs, a center for biologics, and a center for radiologic health and devices. And they all can review oncology products. The OCE has a designation to really coordinate the activities, particularly in the clinical review of the products that involve the treatment of cancer. So, this is a unique center within the FDA, and is somewhat of an experiment at the FDA to see how we can really coordinate the activities of drugs that affect cancer patients. And here again, the oncology center is primarily designated for the clinical review. And we don't really get into the manufacturing of drugs. That's handled in the individual centers, whether it be a biologic and CBER, the Center for Biological Evaluation and Research or CDER, the Center for Drug Evaluation and Research. With that given said, in addition to the actual bread and butter of reviewing applications, we have many research projects that we're doing. We have a big project looking at real world data. We have a project looking at updating labels called Project Renewal. We have, as I stated before, this project that we launched at this year's ASCO, Project Facilitate. We also have a project aimed at really improving our relationships with international drug regulators. We have monthly meetings, teleconferences with five different regulatory agencies throughout the world to go over applications and discuss different regulatory policies. We have a host of a symposium that we conduct both here at the FDA, inviting external stakeholders including physicians, leading academics, patients to come to the FDA really to discuss important topics to our drug reviewers and the entire discipline of regulatory and oncology, so to speak, how we make decisions in medicine. We have a whole, also, program that we're developing aimed at educating physicians and other health care professionals for educating other health care professionals on how we evaluate drugs, what our thought processes are here at the FDA. So, in addition to the regulatory work, there is a whole body of scientific work that we're also doing, including independent research on different databases, looking at patient populations more likely to respond to different drugs, ways of evaluating and describing toxicities, ways of really looking at patient experiences while they're getting drugs, and different ways of reporting patient reported outcomes. We'd like to thank ASCO, obviously, for their assistance during and helping us with many of these projects throughout the year, especially the educational projects involving fellows, involving different topics that we've found of interest that needed to really have a public disclosure in the community, really, to get input from leading academics, as well as treating physicians. CH: Wow. You are busy. And there's a lot we could unpack there. But I do want to pick up on a couple of things. First of all, you described this as an experiment, so I'm curious. And not to put you on the spot, but if you have an experiment, I presume that just some metric that you would use to call it a success or failure. And I wonder where you think you are right now in that regard. It sounds like you've gotten a tremendous amount done. But are you satisfied, for example? Have you covered the ground you wanted to or do you think that you could be doing more? RP: Well, people who know me realize that I'm never satisfied. So, I think we're in the middle of this experiment. I think it's going quite well. And I think that this is really going to be aimed at-- and the evaluation of the success or failure of this is going to be really how the individuals that work here at the FDA really evaluate drugs and how we facilitate the evaluation of drugs. And also the really important of retention of staff here at the FDA is a major issue, also. And I think many of the projects that we have ongoing really develop our reviewers in really having a real world approach to how oncology drugs are used. So it's very difficult to say what success and failure will ultimately be. But I think we're on, really, the correct path, and pretty much a straight path of looking at a successful venture here. CH: You know, one of the things you said reminded me of another urban myth. And I don't know if you realize this. But when you describe the careful coordination with, I think you said five regulatory agencies around the world, it raises the myth, I believe, but you can address this with some facts, that many people in the United States believe that others around the world have faster access to a broader range of effective therapies. I wonder if you want to expand on that or comment on that at all before we move on. RP: Well, that is an urban myth, and probably was generated 20, 30, 40 years ago when that may have been the fact. Obviously, that antedated my coming to the FDA. But I can say the vast majority of drugs are approved first in the United States. And those include very important drugs such as the PD1 drugs, the targeted drugs, et cetera. They are approved first in the United States. We have taken a very active approach to really rapid approvals of our drugs without sacrificing quality, by having a smarter approach to how we review these drugs, with putting multiple reviewers on particular applications, by cutting down on unnecessary paperwork that many of our reviewers had to do, and really focusing on really the core material that we have at hand, and really emphasizing does this drug really demonstrate safety and efficacy. At the end of the day, I charge all of our reviewers with the following statement. Would the American public be better with this drug than without it? And that's the ultimate decision that we have to make at the time of approval. CH: Well, that's another perfect segue to a hot topic, which you and I have discussed actually offline before this. But I'm going to come back to it. The expedited approval of anticancer therapies was recently the subject of a paper in The Journal of the American Medical Association. And if I remember correctly, they looked at 93 cancer drugs that had been approved through accelerated approval process. But what they claimed is that only 19 of the 93 clearly extended the lives of the patients taking them. That's a value judgment, obviously, about why drugs are approved and introduced to the market. But I wonder if you would want to talk a little bit about your view of some of the complexities and challenges that are inherent in accelerated drug approval, and what your view is of this particular study of the approval outcomes. RP: I think many times people don't understand that it isn't just about overall survival. Obviously, that's the gold standard. But we've had very careful discussions throughout the years that there are many ways to evaluate benefit to the patient. And that includes reduction of the size of the tumor, delay in the progression of the disease, the establishment of complete response rates in hematological diseases. So we have to have some flexibility, both in terms of how we approve drugs and what clinical trials we're going to ask for after drugs have been approved on the accelerated approval pathway. Although overall survival is a very important end point, it's an important efficacy endpoint as well as a safety endpoint, it does have limitations. As we move more toward a targeted therapy and subsegment common diseases into molecular subtypes, many times we find that we have very limited populations. And simply, we don't have the size of a population that we approve the drug on to really do a large, randomized trial. So we have to weigh that issue with what type of trial we're going to ask for, both with the initial approval of the drug as well as with, perhaps, the subsequent studies that we ask for after an accelerated approval. In addition to that, many times we find that we have situations where the disease itself may have a very long natural history, such as CLL or other diseases that may have very long natural histories, where one cannot really do a long-term survival study because it would extend many, many, many years. And many times-- and I think we have to be realistic about this, that there may not be equipoise here to allow a randomized trial to be done looking at overall survival as a primary end point. For example, if we already have information that a drug may have a response rate of 50% or 60% and the comparator drug may have a response rate of 10%, patients will not want to go on a study that looks at overall survival as the primary end point. And many times, we have to take a look at time to progression or progression free survival and those end points, and actually allow for a switch in therapies or crossover at the time of disease progression, which renders the evaluation of overall survival somewhat difficult, and may confound that evaluation. So, there are many reasons why overall survival, although a gold standard, may not be applicable to all situations. And I think that's going to be increasingly so as we get into a more targeted therapy approach and have better definitions of who is going to respond. So here again, it's long natural history of diseases either by its natural history or by the therapies that have been approved that prolong disease. It could be due to the limited populations, which preclude a randomized trial. And it could be due to the lack of equipoise, which really bands that patients have access during the course of disease. I think a much more important question, and one that we are constantly looking at, is not so much what does an individual drug do to the natural history of the disease and prolonging survival in patients that have metastatic disease, but what is the impact over the years of multiple drugs being approved on the basis of progression-free survival or response rates when they are used either in combination or sequentially. And we could see that, for example, in multiple myeloma, where the course of that disease has been significantly changed, and patients' lives have been prolonged. And the vast majority of the drugs that have been approved have been on non-survival endpoints. And this is true not only for multiple myeloma, but also probably for renal cell cancer. CH: Yeah. That's interesting. It's a challenging analysis, of course. But that would be a very interesting, essentially public health roll up of all of these incremental decisions. Right? RP: Correct. CH: Yeah. So, as I said before, the OCE has been in operation just over two years. During that time, more than 80 therapies and products have been approved, I think. Right? And there've been more than a dozen guidance documents approved, 60 workshops and symposia for oncologists and for patients. And there were several of those workshops that we at ASCO were privileged to co-sponsor along with you. This is the favorite child question. But what's your proudest achievement so far? RP: A difficult question, but an easy question, too. It's about the people that work here and the patients that we serve. And I think my brightest moments are when we see the development of our people coming in and taking leadership positions both within the agency in a regulatory context of their job, but also in the academic fields and participating in conferences, publishing papers, and really finding enjoyment in the job that they have outside of the day-to-day regulatory activity. One of the things that I have always emphasized since I came here 20 years ago from an academic medicine position at M.D. Anderson is really to give the agency a much more academic perspective. And I've always stated that I think we do much more academic work here at the FDA than many academic centers. And I'm not talking about the generation simply of papers or research grants. I'm talking about actually critical thinking of what goes on at an application, since we have a multi-disciplinary team of statisticians, clinicians, clinical pharmacologists, toxicologists, manufacturing people that all work together. So it's really about-- my greatest accomplishment is really about the young people that have come in that I've mentored, and really have assumed roles, and really will be my lasting legacy here. But I also want to emphasize that one of the things that I have repeatedly highlighted to this staff is really to consider the patient in really any regulatory decision. Here again, it's not about a P value. It's not about a primary end point. Granted, those things are important, but we really have to bring together the whole body of information about a drug in making a regulatory decision and making that a patient-focused thing. And as I stated before, at the end of the day will the American patient-- will the American public be better off with this drug than without it? CH: Well, Rick, I got to say that's an inspiring description. It makes me wish I were younger, and maybe I could come and be mentored. But alas, it may be too late for me. But we really are proud to work with you, and to work with so many of your staff in many productive collaborations. I want to thank you again for joining me today for this ASCO in Action podcast. We always appreciate your expertise and your perspectives. And we look forward to continuing to work with you to ensure that patients with cancer have access to safe and effective treatments. RP: And thank you, Cliff. It's been a pleasure. And here again, I really think ASCO for providing a lot of resources to us in conducting symposium, and really in fostering better cancer care for patients. I think that's the ultimate goal of both organizations. CH: It sure is. And I want to remind our listeners that you can follow the FDA Oncology Center of Excellence on Twitter. Their handle is @FDAOncology. That's one word. You can follow me @CliffordHudis, and you can follow ASCO @ASCO. For more information on the latest cancer policy news and updates, visit ASCOAction.ASCO.org. And Rick, I'm going to ask you once more to remind the listeners of the way they can access Project Facilitate. RP: They can learn about Project Facilitate from our website at www.FDA.gov/OCE. And our project facilitate phone number is 240-402-0004. And the email address is ONCProjectFacili tate@FDA.HHS.gov. ONCProjectFacilitate is spelled O N C P R O J E C T F A C I L I T A T E @FDA.HHS.gov. CH: That's great. So until next time, I want to thank everyone for listening to this ASCO in Action podcast.  

Project Renewal helps people stay in the work force and helps industries -- such as the food service industry - find great employees through it's supportive assistance and job training programs. Directors Barbara Hughes and Allison Messina, discuss how two key programs in the project renewal program are facing funding gaps. For more, visit projectrenewal.org

Project Renewal helps people stay in the work force and helps industries -- such as the food service industry - find great employees through it's supportive assistance and job training programs. Directors Barbara Hughes and Allison Messina, discuss how two key programs in the project renewal program are facing funding gaps. For more, visit projectrenewal.org

Project Renewal helps people stay in the work force and helps industries -- such as the food service industry - find great employees through it's supportive assistance and job training programs. Directors Barbara Hughes and Allison Messina, discuss how two key programs in the project renewal program are facing funding gaps. For more, visit projectrenewal.org

Pamela Bell founded prinkshop using a model she calls “creative capitalism” which proves a business can be both profitable and philanthropic. With the launch of prinkshop’s wear what you care about apparel and accessories, Pamela hoped to turn bystanders into activists and bring together art and commerce. Today, she is proud to tout prinkshop partnerships with global advocacy organizations like Girl Up, the NIRH, the Special Olympics, and Lady Parts Justice and to collaborate with brands like J Crew and West Elm. Prior to prinkshop Pamela was a founding partner of the global, iconic brands Kate Spade and Jack Spade. Pamela’s passion for philanthropy and the arts runs deep. She currently sits on the board of Project Renewal in NYC, a 50 million dollar homeless agency where she co-founded the Bowery Arts Project. The Project's volunteers teach art classes to homeless addicts. Pamela also sits on the Board of The American Theatre Wing, is a Tony voter, and is a new member of the 3Generations board, a non-profit dedicated to helping survivors tell their stories to the world using film. Recently, Pamela became a member of the 2018 Council of Fashion Designers of America and is a fellow at the Eugene Lang Entrepreneur Center at The Columbia Business School as well as a Fellow at The Disruptor Foundation.  Above all Pamela is a mother, wife and step-mother. Listen in to Lou Diamond's visit with Pamela at prinkshop's headquarters.   *** Connect to Lou Diamond: www.loudiamond.net Subscribe to Thrive LOUD: www.thriveloud.com/podcast    

Breast cancer survivor, Christine Egan, shares her tips for newly diagnosed women. Diagnosed at age 42, Egan chose an integrative approach to treatment. She underscores doing your homework to decide the best care for your type of breast cancer and bringing someone to act as a second set of ears to meet with doctors. Mary Solomon, ScanVan Director for non-profit Project Renewal, discusses how the programhelps underserved women in New York City and underscores the importance of early detection. This show is broadcast live on Wednesday's at 12PM ET on W4WN Radio – The Women 4 Women Network (www.w4wn.com) part of Talk 4 Radio (http://www.talk4radio.com/) on the Talk 4 Media Network (http://www.talk4media.com/).