Bayer: Monsanto & Oncology
For Bayer, the acquisition of Monsanto is intended to build its Crop Science division; meanwhile two significant approvals and two new hires enhance progress in oncology.
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|Product||2016 Sales||2015 Sales|
All sales are in millions of dollars.
Exchange rate for all figures listed above:
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In millions of dollars, except EPS
Exchange rate for all figures listed above:
EUR 1.1072 = $1.00
In 2016, we again substantially raised both sales and earnings and thus posted a new record for our operating performance,” says Werner Baumann, chairman of Bayer AG.
According to Baumann, 2016 was “a very exciting and intensive year,” for the company as well as for himself, as he became chairman of the board of management in May 2016.
“Creating an integrated organizational structure and appointing the heads of the divisions to the Board of Management have proven to have been the right steps at the right time,” Baumann says. “We have a very good management team that works extremely well together.”
According to Baumann, a particular highlight of 2016 was the agreed acquisition of Monsanto, which is intended to further strengthen Bayer as a life science company and create substantial additional value in the long-term value through more innovation, stronger growth and greater efficiency. “The two businesses are highly complementary, both in terms of their geographical fit and their product portfolios,” Baumann states. “It is a good step for Bayer as a whole since the two companies’ combined expertise will improve our ability to help address one of the most urgent issues of our time: how to feed the some 10 billion people who are expected to be living on our planet by 2050.”
Baumann says with Monsanto, Bayer would be better able to provide farmers worldwide with a product offering that is tailored to their needs and offers them genuine added value: from the right choice of seeds through seed treatment to controlling weeds, pests and plant diseases.
“With regard to the increasing digitization of farming, Monsanto will give us valuable expertise,” Baumann states.
Despite the large investment being made to acquire Monsanto, Bayer will continue to pursue organic growth in Pharmaceuticals, Consumer Health, and Animal Health, Baumann says. “The necessary funding will also be available for investments at our sites as well as for smaller acquisitions and in-licensing,” he adds.
Financial & Product Performance
Sales of the Bayer Group in 2016 rose by 1.5 percent to €46.77 billion ($51.78 billion). Executives say the Life Science businesses contributed to this performance, growing to €34.94 billion ($38.68 billion).
In the first half of 2017, sales grew by 7.4% to €25.43 billion ($28.16 billion). The Life Science businesses recorded first-half 2017 sales of €18.39 billion ($20.37 billion).
Bayer reported 2016 income after income taxes of €4.83 billion ($5.34 billion) compared to the 2015 total of €4.1 billion ($4.54 billion). Earnings per share were reported at €5.44 ($6.02), 9.5 percent more than in 2015.
First-half 2017 net income was €3.75 billion ($4.15 billion), 23.7 percent more than in the same period last year. Diluted earnings per share were €3.79 ($4.20), 8.3 percent more than in first-half 2016.
Research and development expenses in 2016 rose by 9.2 percent to €4.67 billion ($5.17 billion), mainly due to higher R&D investment at Pharmaceuticals. Executives say the ratio of R&D expenses to sales was 10 percent compared with 9.3 percent in 2015.
First-half 2017 R&D expenses were ($2.57 billion), 4.1 percent more than in the same period of 2016.
Executives say in 2016, sales of the Pharmaceuticals division advanced 7.3 percent to €16.42 billion ($18.18 billion). The increase was attributed to key growth products. Sales of Pharmaceuticals improved 5.8 percent (Fx & portfolio adj.) to €8.57 billion ($9.49 billion) in first-half 2017.
The Pharmaceuticals segment focuses on prescription products, especially for cardiology and women’s healthcare, and on specialty therapeutics in the areas of oncology, hematology, and ophthalmology. The division also comprises the radiology business, which markets diagnostic imaging equipment together with the necessary contrast agents.
Bayer’s best-selling drug in 2016 was the blood thinner Xarelto, at €2.93 billion ($3.24 billion), 30 percent more than in 2015. Executives attributed the increase due to expanded volumes in Europe and Japan, and significant gains for license revenue in the United States, where Xarelto is marketed by a subsidiary of Johnson & Johnson (see profile on page 44). In first-half 2017, Xarelto sales were €1.59 billion ($1.75 billion), 20 percent more than in the same period of 2016.
The eye drug Eylea is the second best-selling drug for Bayer, due to the successful development of business in Europe, Canada, and Japan. Sales in 2016 totaled €1.63 billion ($1.8 billion), 32.3 percent more than in 2015. Sales in the first half of 2017 were €904 million ($1 billion), 14.4 percent more than in first-half 2016.
The blood-clotting medicines Kogenate/Kovaltry were the third best-selling drug products for Bayer in 2016. Sales increased slightly to €1.17 billion ($1.29 billion), mainly because of the successful introduction of Kovaltry in the United States, executives say. Sales in the first half of 2017 were €535 million ($592 million), 7.1 percent less than in the first half of 2016. Management attributed the decrease to significantly lower order volumes placed in the second quarter of 2017 by the company’s distribution partner.
2016 sales of the hormone-releasing intrauterine devices of the Mirena product family (which includes Mirena, Jaydess/Skyla, and Kyleena) grew 7.7 percent to €1.04 billion ($1.16 billion), making the products the company’s fourth best seller. Executives say the increase stemmed from the positive development in prices in the United States and from the introduction of Kyleena, a new low-dose product. Sales in the first half of 2017 were €591 million ($654.4 million), 16.8 percent more than in the first six months of 2016.
The kidney cancer drug Nexavar was Bayer’s fifth best-selling drug in 2016, recording sales of €870 million ($963 million), 2.5 percent less than in 2015. The decrease was attributed to higher competitive pressure in the United States. First-half 2017 sales were €436 million ($483 million), about the same as in first-half 2016.
The multiple sclerosis treatment Betaferon/Betaseron was the sixth best-selling drug in 2016, recording €734 million ($813 million), 10.9 percent less than in 2015. Executives say the decrease resulted mainly from weaker business performance in Europe and the United States. First-half 2017 sales were €356 million ($395.16 million), 7.8 percent less than in first-half 2016.
The oral contraceptives YAZ/ Yasmin/Yasminelle represented the company’s seventh best-selling prescription medicine franchise in 2016, at €678 million ($751 million), 4 percent less than in 2015. According to Bayer, higher demand in China and Russia stood against weaker business development in Europe, Brazil, and the United States. Sales in the first half of 2017 totaled €328 million ($363 million), 3 percent less than in the same period last year.
The hypertension and coronary heart disease drug Adalat was Bayer’s No. 8 best-selling pharmaceutical product in 2016, generating €624 million ($691 million), 1.4 percent less than in 2015. Sales in first-half 2017 were €345 million ($382 million), 7.5 percent more than in the first half of 2016.
Aspirin Cardio, marketed for the secondary prevention of heart attack, ranked No. 9 among pharma products in 2016 sales for Bayer. The product recorded sales of €538 million ($596 million), 2.7 percent more than in 2015. Sales in the first half of 2017 were €305 million ($338 million), 10.9 percent more than in the first half of 2016..
The diabetes drug Glucobay was the 10th best-selling pharma product for Bayer in 2016, recording sales of €515 million ($570 million), 1.5 percent less than in the previous year.
First-half 2017 sales were €297 million ($329 million), 11.2 percent more than in the same period of 2016.
Although not among the drugs with sales over $500 million, but some of Bayer’s hottest growth products in 2016 were the cancer drug Xofigo and the hypertension drug Adempas.
Sales of Xofigo were €331 million ($366 million), 28.8 percent more than in 2015. The drug’s sales growth was attributed to the positive development of business in the United States and Europe.
Sales of Adempas came in at €254 million ($281 million)compared with €181 million ($200 million) in 2015. Executives say the sales included the proportionate recognition of the one-time payment resulting from the sGC collaboration with Merck & Co. (see profile on page 51). Additionally, business developed especially positively in the United States, managers say.
In the first half of 2017 Xofigo sales were €205 million ($227 million), 31.4 percent more than in the first half of 2016. Adempas sales in first-half 2017 were €148 million ($164 million), an increase of 24.4 percent compared with the first half of 2016.
Bayer’s Consumer Health segment markets mainly nonprescription, OTC products in the dermatology, nutritional supplement, analgesic, gastrointestinal, cold, allergy, sinus and flu, foot care, and sun protection categories. The category recorded sales of €6.04 billion ($6.68 billion) in 2016, about the same as in 2015.
Executives attribute the lack of growth in this segment due to the low rate of transitioning prescription medicines to OTC; a weaker cold season; and reduced demand in the Emerging Markets.
Business with the antihistamine Claritin receded overall. According to executives, sales in Asia/Pacific were down against the strong prior year due to intensified competition and to price controls for prescription medicines in Japan. An increase in U.S. sales due to a product line extension with ClariSpray only partly offset this effect. Sales of the product in 2015 were €627 million ($694 million) compared with 2016 sales of €605 million ($670 million).
Sales of the analgesic Aspirin increased moderately. Executives say gains in the United States and Latin America more than offset declines in Europe that resulted from a weak cold season. Including Aspirin Cardio, sales climbed to €1 billion ($1.17 billion) compared with €997 million ($1.1 billion) in 2015.
Sales of the analgesic Aleve rose slightly to €416 million ($461 million), resulting from very favorable development in the United States, where the company benefited from the addition of Aleve Tens to the product portfolio.
Sales for the Bepanthen/Bepanthol wound healing and skin care products during 2016 advanced strongly, especially in Europe and particularly in France, Germany, and Russia. Sales grew 2 percent to €362 million ($401 million)
The skin and personal antifungal Canesten had 2016 sales of €269 million ($298 million) thanks to expanded volumes in all regions. Business developed especially well in Germany, due primarily to Canesten Gyn.
The Alka-Seltzer family of products to treat gastrointestinal complaints and cold symptoms registered slight growth to €253 million ($280 million) that was mainly attributable to a product line extension in the United States.
Sales of Dr. Scholl’s foot care products declined 7.1 percent to €235 million ($260 million) due to higher competitive pressure and a weak market environment in the United States.
One A Day vitamin product sales in 2016 grew 5.2 percent to €222 million ($246 million) largely as the result of product line extensions and the expansion of distribution channels.
Sales of the sunscreen product Coppertone were up slightly against its 2015 performance, to €219 million ($242 million). Higher demand in Asia/Pacific and Latin America more than offset U.S. declines.
Business with the prenatal vitamin Elevit saw particularly strong development, posting double-digit-percentage growth rates in Asia/Pacific and Europe/Middle East/Africa. Sales in 2016 grew 12.3 percent to €182 million ($202 million).
In the first half of 2017, Consumer Health recorded sales of €3.14 billion ($3.48 billion), 2.3 percent more than in the first half of 2016.
Bayer’s Crop Science segment is a world-leading agriculture enterprise with businesses in seeds, crop protection and nonagricultural pest control.
The Crop Protection/Seeds operating unit markets a broad portfolio of high-value seeds and innovative pest management solutions, while at the same time providing extensive customer service for sustainable agriculture. The Environmental Science operating unit provides products and services for professional nonagricultural applications, such as vector and pest control and forestry.
Overall, the global seed and crop protection market has been weak. Positive growth momentum in 2016 came from the North America and Eastern Europe regions. Market volumes decreased in Latin America, due especially to macroeconomic developments, unfavorable weather conditions and high inventories of crop protection products, particularly in Brazil.
Crop Science posted sales of €9.92 billion ($11 billion), a 2.1 percent decrease compared with 2015. In the first half of 2017, sales were €4.94 billion ($5.47 billion), 4.6 percent less than in the same period last year.
The most significant move for the Crop Science segment came on Sept. 14, 2016, when Bayer signed a definitive merger agreement with Monsanto for $128 per share. This represents a transaction value of around $66 billion.
At a special meeting on Dec. 13, 2016, Monsanto’s stockholders approved the company’s merger with a wholly owned subsidiary of Bayer AG. “The agreed acquisition reinforces our leadership position as a Life Science company and is a major strategic step forward for our Crop Science business,” executives say. Bayer expects closing of the transaction by the end of 2017.
Bayer’s Animal Health segment ranks among the leading international innovators in its field, developing and marketing products and solutions for the prevention and treatment of diseases in companion and farm animals.
In 2016, the Animal Health market continued to develop positively with reported growth of 2.2 percent to €1.52 billion ($1.67 billion). The dynamic performance in the first half of the year was driven especially by the market for companion animal parasiticides in the United States and Europe. Executives say the company registered currency-adjusted sales growth in Europe/Middle East/Africa and Latin America.
In the first half of 2017, Animal Health sales amounted to €890 million ($985 million), 6.7 percent more compared with the same period last year.
Bayer’s Covestro unit is one of the world’s leading suppliers of high-tech polymer materials and develops innovative product solutions for a wide variety of everyday uses. In 2016, Covestro’s main customer industries (automotive, construction, electrical and electronics, and furniture) continued to develop positively, though sales were about even with the previous year at €11.83 billion ($13.09 billion).
Executives say in 2016 selling prices receded overall, due primarily to lower raw material prices. Volumes were above the level of the prior year overall.
In first-half 2017, sales reached €7.04 billion ($7.8 billion), 20.9 percent more than in first-half 2016. Executives attributed the increase to significantly higher selling prices, especially at Polyurethanes, and all business units reported higher volumes.
On June 7, 2017, Bayer reduced its directly held interest in Covestro from 53.3 percent to 44.9 percent, by placing 17.25 million shares at a price of €62.25 ($68.92) per share. Bayer AG’s interest in Covestro was reduced by a further 4 percentage points through the contribution of Covestro shares to the Bayer Pension Trust e. V. In addition, Bayer has issued €1 billion in bonds maturing in 2020 that can be redeemed in cash, Covestro shares or a combination of the two. Covestro continues to be fully consolidated in Bayer’s financial statements, as, even with these transactions having been completed, Bayer will still hold the de facto majority at a Covestro stockholders’ meeting.
Covestro remains fully consolidated on account of its continued majority interest of around 64 percent at present. This business posted currency- and portfolio-adjusted sales on a level with the prior year.
“We are very pleased with the way Covestro has developed since its stock market listing in October 2015,” Baumann says. “It confirms that separating the two enterprises was the right move for both of them. Thanks to its very good business performance, Covestro has successfully established a good position on the capital market in its first year of independence; Bayer has excellent growth perspectives resulting from its focus on the Life Sciences.
“It remains our intention to divest our entire interest in Covestro in the medium term.”
R&D, Pipeline Progress
According to Baumann, Bayer will continue to increase what it spends on R&D “because innovation is our core competence. In the Life Science areas in particular, there is great demand for new products and solutions.
“For example, better treatments are needed for conditions such as cancer and cardiovascular disease. Likewise, solutions are required to achieve the necessary increase in agricultural productivity and feed the growing world population. In addition, investments in self-care are designed to keep our aging population healthy and contribute to the sustainability of public health care systems around the world.”
In the Pharmaceuticals segment, executives estimate the combined peak annual sales potential of six promising product candidates in the mid-to late-stage pipeline to be at least €6 billion. The combined peak sales potential of Bayer’s crop protection and seed technology pipelines should total more than €5 billion from products that have been or will be brought to market between 2015 and 2020.
Bayer’s Pharmaceutical pipeline is particularly focused on oncology. Products in development include antibody-drug conjugates, which recognize certain proteins on the surface of cancer cells and can be used to transport radioactive thorium-227 to cancer cells. By using different antibodies, conjugates can be developed for various tumor types.
Another research area is blocking oncogenic signaling pathways in specific tumor types. One approach aims to block the signaling pathways which prevent cancer cell death and often result in mutations, while another approach seeks to exploit the differences in the metabolic activity of tumor cells. A third approach is investigating cancer stem cells that may result in the development of resistance mechanisms and the failure of chemotherapy and radiation therapy. And a further approach is focused on the epigenetic changes which play a role in malignant cancers.
Bayer is also doing research in immuno-oncology. Bayer researchers are working mainly in collaboration with scientists from the DKFZ on approaches leading to a reactivation of the immune system to eliminate the tumor cells without affecting healthy nontumoral cells. The immune system’s memory function may result in long-term therapeutic success.
So far in 2017, Bayer has delivered some promising pipeline developments in oncology.
April 2017 brought the approval by the U.S. Food and Drug Administration of Stivarga (regorafenib) tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar (sorafenib). Stivarga is the first treatment to demonstrate significant improvement in overall survival in second-line HCC patients.
In the RESORCE trial, Stivarga was shown to provide a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo; the median OS was 10.6 [(n=379) (CI 9.1, 12.1)] vs 7.8 [(n=194) (CI 6.3, 8.8)] months, respectively (HR 0.63, 95 percent CI 0.50-0.79; p<0.0001).2 This translates to a 37 percent reduction in the risk of death. The number of deaths in each arm included 233 of 379 (62 percent) with Stivarga and 140 of 194 (72 percent) with placebo. The FDA approval expands Bayer’s leadership in liver cancer with a treatment plan in HCC involving use of Stivarga directly after progression on Nexavar.
Stivarga is an oral inhibitor of multiple kinases involved in normal cellular functioning and in pathological processes such as oncogenesis, tumor angiogenesis, metastasis, and tumor immunity.
“Bayer is proud to have played a significant role in the treatment of hepatocellular carcinoma,” says Robert LaCaze, executive VP and head of the Oncology Strategic Business Unit at Bayer. “We first embarked on our scientific research in this area 20 years ago and we have remained steadfast in our mission to deliver new treatment options to these patients. We could not have done it alone: we would like to thank the patients, caregivers and investigators for their participation and engagement in the study.”
In September, Aliqopa (copanlisib) received approval from FDA for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.
Aliqopa is a novel intravenous PI3K inhibitor with inhibitory activity predominantly against the PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells.
The FDA granted approval under the accelerated approval pathway based on data from the open-label, single-arm Phase II CHRONOS-1 [NCT01660451] trial investigating Aliqopa in 104 adult patients with follicular B-cell non-Hodgkin’s lymphoma who had relapsed disease following at least two prior systemic therapies.
Bayer continues to advance several products in its pipeline. In August 2017, Bayer announced that the first U.S. patient was enrolled in ASTEROID (Assess Safety and Efficacy of Vilaprisan in Subjects with UTERine FibrOIDs) – a Phase III clinical trial program assessing the safety and efficacy of vilaprisan, an oral and selective progesterone receptor modulator (SPRM), in women with symptomatic uterine fibroids.
“Bayer has a rich legacy in women’s health research, and we are dedicated to investigating vilaprisan as a potential medical treatment option for women with symptomatic uterine fibroids,” says Dario Mirski, M.D., Bayer’s senior VP and head of medical affairs for the Americas. “The initiation of this trial reinforces our ongoing commitment to finding innovative solutions for women suffering from gynecological conditions.”
In June 2017, Bayer announced that it had enrolled the first patient in a global Phase IV study assessing the clinical effects of riociguat in patients with pulmonary arterial hypertension (PAH), who were being treated with a phosphodiesterase-5 inhibitor (PDE-5 inhibitor), either as monotherapy or in combination with an endothelin receptor antagonist (ERA), and who did not reach their therapeutic goal. The study, which is a part of a collaboration between Bayer and Merck, is seeking to enroll patients at 26 sites in the United States with a total of 100 study sites worldwide.
“Bayer is committed to improving the lives of patients living with pulmonary arterial hypertension through ongoing research that addresses important clinical questions on how to manage the disease,” says Aleksandra Vlajnic, M.D., VP of medical affairs at Bayer. “This study will help improve our understanding of therapeutic choices and how they may impact these patients.”
REPLACE (Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy) is an international, multicenter, randomized, controlled, open-label, Phase IV 24-week study to assess the clinical effects of transitioning from a PDE-5 inhibitor to riociguat. The study will enroll 218 patients with PAH who are not at treatment goal and on stable treatment for at least 6 weeks with PDE-5 inhibitor therapy (sildenafil or tadalafil) with or without endothelin receptor antagonist (ERA) combination.
In an unusual approval of an app with a medical device, Bayer received FDA’s nod in May for a supplemental biologics license application for myBETAapp and the Betaconnect Navigator.
With this software in relapsing-remitting multiple sclerosis, people using the electronic Betaconnect autoinjector to administer Betaseron (interferon beta-1b) can use Bluetooth technology to connect their current autoinjector to the new myBETAapp on their mobile device or computer. Patients have the opportunity to share their injection data with their
BETA Nurse and healthcare team. Viewing this data through the Betaconnect Navigator may be a useful tool for the health care team to gain insights into patients’ injection history and provide support to those taking Betaseron.
“Since introducing the first FDA approved treatment option for relapsing-remitting multiple sclerosis patients more than two decades ago, we’ve listened closely to the community to understand their needs and how we can support them,” says Mark Rametta, D.O., FACOI, FACP, Bayer’s medical director for Neurology. “The myBETAapp and Betaconnect Navigator add to the services that we’ve developed based on patient feedback, including 24/7 access to nurse support and the first and only electronic autoinjector for patients taking Betaseron.”
The Importance Of Partnerships
Bayer continues to work with partner companies and universities to bring about pipeline successes. “Last year, for example, we concluded a cooperation agreement with Danish company FaunaPhotonics,” Baumann says. “Together we are seeking to develop novel sensor solutions which will improve farmers’ ability to monitor the development of pest populations and thus control pests more effectively.”
Another example is the joint venture, BlueRock Therapeutics, that was established with Versant Ventures in December 2016 with combined funding of $225 million. The venture will develop stem cell therapies for curing a range of diseases.
“BlueRock Therapeutics is the second large investment made by the Bayer Lifescience Center, which has the mission to rapidly uncover, encourage and unlock fundamental scientific breakthroughs in medicine and agriculture,” Baumann says.
Employee Expansion In Oncology
Bayer has put even more emphasis on its oncology drug development with significant appointments in that area. In May 2017, Bayer announced the appointment of Bhavesh Ashar as senior VP and head of Oncology for the company’s Pharmaceuticals Division in the United States.
Ashar reports to Carsten Brunn, head of Bayer Pharmaceuticals for the Americas region. Brunn himself was appointed in January 2017.
“Bhavesh is a well-respected, results-driven leader with extensive industry knowledge and a proven track record of launching products and driving growth in oncology,” Brunn says. “We are delighted to have Bhavesh join Bayer’s U.S. Pharmaceuticals organization. I’m confident that he will help to advance our growing leadership in oncology and our ongoing commitment to meeting the needs of people living with cancer.”
Previously, Ashar served as VP and general manager of U.S. Oncology at Sanofi and was responsible for managing a diverse portfolio comprising solid tumor, hematology, and transplant products. Ashar was with Sanofi for more than 14 years and held positions of increasing responsibility in sales and marketing, with a strong focus on specialty markets. Prior to joining Sanofi, Ashar served as an engagement manager with McKinsey & Company.
In June 2017, Bayer announced the appointments of Rebecca Jolley as senior VP and commercial head, Oncology and Dr. Scott Z. Fields, senior VP and pharmaceutical development head, Oncology. Both are members of the Oncology Leadership Team and report to Robert LaCaze, executive VP and head of the Oncology Strategic Business Unit.
“It is important that we stay focused on the science coupled with speed and agility to help bring important new medications and indications to patients as quickly and prudently as possible” LaCaze says. “Scott’s global product development expertise combined with Rebecca’s experience in successfully bringing products to market strengthens our ability to get medicines to patients.”
Previously, Jolley served as senior VP, Americas Commercial, Oncology Business Group at Eisai, where she was responsible for leading the Oncology commercial strategy and implementation across all approved products and pipeline assets. Before joining Eisai, she worked at Novartis for more than two decades in a variety of roles of increasing responsibility, including sales, market access, marketing, brand leadership, and general management. She started her career with Novartis in the United Kingdom, then transferred to the United States to join Novartis Oncology, where she led launches in breast cancer, pancreatic cancer, rare diseases, and cancer supportive care, and gained leadership experience in a variety of disciplines across a number of regions. She holds a degree in geography and biological sciences from Lancaster University, England.
Scott Fields, M.D., joined from Vertex Pharmaceuticals, where he was VP and head of Clinical Oncology and responsible for the global development of all oncology assets. Prior to joining Vertex, he held a number of leadership roles within the pharmaceutical industry at SmithKline Beecham, Amgen, Eisai, and Arno and gained experience as a practicing oncologist in academic settings. He earned his medical degree from SUNY Downstate and did his Internal Medicine and Hematology/Oncology training at Columbia University Medical Center.