FDA APPROVES KYPROLIS® (CARFILZOMIB) FOR COMBINATION USE IN THE TREATMENT OF PATIENTS WITH RELAPSED MULTIPLE MYELOMA - themmrf.org

FDA APPROVES KYPROLIS® (CARFILZOMIB) FOR COMBINATION USE IN THE TREATMENT OF PATIENTS WITH RELAPSED MULTIPLE MYELOMA

FDA APPROVES KYPROLIS® (CARFILZOMIB) FOR COMBINATION USE IN THE TREATMENT OF PATIENTS WITH RELAPSED MULTIPLE MYELOMA

THOUSAND OAKS, Calif. (July 24, 2015) – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Kyprolis® (carfilzomib) for Injection in combination with Revlimid® (lenalidomide) and dexamethasone (KRd) for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.

Amgen

Approval Expands Kyprolis Indication

Patients Treated With Kyprolis in Combination With Standard of Care Lived 50 Percent Longer Without Disease Worsening Compared to Standard of Care Alone in Pivotal Study

THOUSAND OAKS, Calif. (July 24, 2015) – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Kyprolis® (carfilzomib) for Injection in combination with Revlimid® (lenalidomide) and dexamethasone (KRd) for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.
“The expanded indication of Kyprolis provides patients with relapsed multiple myeloma a new therapeutic option, helping to address a real unmet need for this common blood cancer,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The approval of a second indication for Kyprolis in just three years demonstrates that it is becoming a critical component in the treatment of multiple myeloma, and underscores our commitment to advancing care for patients with this challenging disease.”
The FDA approved the expanded indication for Kyprolis based on data from the ASPIRE study. The study showed that patients treated in the KRd arm lived 50 percent longer (8.7 months) without their disease worsening compared to patients treated with Revlimid and low-dose dexamethasone (Rd) alone. The median progression-free survival (PFS) was 26.3 months (95 percent CI, 23.3 to 30.5 months) in the KRd arm compared to 17.6 months (95 percent CI, 15.0 to 20.6 months) in the Rd arm. The most common adverse events in the Kyprolis arm included pneumonia (1 percent), myocardial infarction (0.8 percent) and upper respiratory tract infection (0.8 percent).
“The ability of this Kyprolis treatment regimen to produce deep and durable responses is critical towards extending the time patients live without their disease progressing,” said ASPIRE principal investigator Keith Stewart, M.D., Ch.B.
Additional regulatory applications for Kyprolis are underway and have been submitted to health authorities worldwide.
Multiple myeloma is the second most common hematologic cancer.1 In the U.S., there are nearly 96,000 people living with, or in remission from, multiple myeloma.2 The estimated number of new cases of multiple myeloma in 2014 was more than 24,000 and the estimated number of deaths was 11,090.2
About ASPIRE
The international, randomized Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial evaluated Kyprolis in combination with lenalidomide and low- dose dexamethasone, versus lenalidomide and low-dose dexamethasone alone, in patients with relapsed multiple myeloma following treatment with one to three prior regimens. The primary endpoint of the trial was PFS, defined as the time from treatment initiation to disease progression or death. Secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DOR), disease control rate, health-related quality of life (HR-QoL) and safety. Patients were randomized to receive Kyprolis (20 mg/m2 on days 1 and 2 of cycle one only, escalating to 27 mg/m2 on days 8, 9, 15 and 16 of cycle one and continuing on days 1, 2, 8, 9, 15 and 16 of subsequent cycles), in addition to a standard dosing schedule of lenalidomide (25 mg per day for 21 days on, 7 days off) and low-dose dexamethasone (40 mg per week in four-week cycles), versus lenalidomide and low-dose dexamethasone alone. The study randomized 792 patients at sites in North America, Europe and Israel.
The OS results did not cross the pre-specified early stopping boundary for the interim analysis. At the time of the interim analysis, there were 143 deaths (36.1 percent) in the KRd group, compared to 162 deaths (40.9 percent) in the Rd group. The ORR was 87 percent with KRd and
67 percent with Rd. In the KRd and Rd groups, 14 percent versus 4 percent of patients achieved a stringent complete response, a measurement indicating depth of response. Median DOR was 28.6 months for patients receiving KRd (95 percent CI, 24.9 to 31.3 months) and 21.2 months for patients receiving Rd (95 percent CI, 16.7 to 25.8 months).
The rate of deaths due to adverse events (AEs) within 30 days of the last dose was balanced between the KRd arm and the Rd arm. The most common causes of death occurring in patients in the KRd arm compared to the Rd arm included cardiac disorders (3 percent versus 2 percent), infection (2 percent versus 3 percent), renal (0 percent versus less than 1 percent) and other AEs (2 percent versus 3 percent). Serious AEs were reported in 60 percent of the patients in the KRd arm and 54 percent of the patients in the Rd arm. The most common serious AEs reported in the KRd arm compared to the Rd arm were pneumonia (14 percent versus 11 percent), respiratory tract infection (4 percent versus 1.5 percent), pyrexia (4 percent versus 2 percent) and pulmonary embolism (3 percent versus 2 percent). Discontinuation due to any AE occurred in 26 percent of patients in the KRd arm versus 25 percent of patients in the Rd arm. Adverse events leading to discontinuation of Kyprolis occurred in 12 percent of patients
The ASPIRE data were presented at the 56th Annual Meeting of the American Society of Hematology and published in The New England Journal of Medicine in December 2014.
About Kyprolis® (carfilzomib) for Injection
Kyprolis® (carfilzomib) for Injection is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.
Kyprolis® is also indicated under FDA accelerated approval as a single agent for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx Pharmaceuticals is a subsidiary of Amgen and holds development and commercialization rights to Kyprolis globally, excluding Japan. Kyprolis is also approved for use in Argentina, Israel, Mexico and Thailand. For more information about Kyprolis, visit www.kyprolis.com.
Important Safety Information Regarding Kyprolis® (carfilzomib) for Injection WARNINGS AND PRECAUTIONS
Cardiac Toxicities:
New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of Kyprolis. In clinical studies with Kyprolis, these events typically occurred early in the course of Kyprolis therapy (< 5 cycles). Death due to cardiac arrest has occurred within a day of Kyprolis administration. Withhold Kyprolis for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart Kyprolis at 1 dose level reduction based on a benefit/risk assessment. While adequate hydration is required prior to each dose in Cycle 1, all patients should also be monitored for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate in patients with baseline cardiac failure or who are at risk for cardiac failure. In patients ≥ 75 years of age, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, and conduction abnormalities uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications.
Acute Renal Failure:
Cases of acute renal failure have occurred in patients receiving Kyprolis. Renal insufficiency adverse events (renal impairment, acute renal failure, renal failure) have occurred with an incidence of approximately 8% in a randomized controlled trial. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received Kyprolis monotherapy. This risk was greater in patients with a baseline reduced estimated creatinine clearance (calculated using Cockcroft and Gault equation). Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate.
Tumor Lysis Syndrome:
Cases of tumor lysis syndrome (TLS), including fatal outcomes, have been reported in patients who received Kyprolis. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS. Ensure that patients are well hydrated before
administration of Kyprolis in Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly including interruption of Kyprolis until TLS is resolved.
Pulmonary Toxicity:
Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred in less than 1% of patients receiving Kyprolis. Some events have been fatal. In the event of drug- induced pulmonary toxicity, discontinue Kyprolis.
Pulmonary Hypertension:
Pulmonary arterial hypertension (PAH) was reported in approximately 1% of patients treated with Kyprolis and was Grade 3 or greater in less than 1% of patients. Evaluate with cardiac imaging and/or other tests as indicated. Withhold Kyprolis for pulmonary 11 hypertension until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment.
Dyspnea:
Dyspnea was reported in 28% of patients treated with Kyprolis and was Grade 3 or greater in 4
% of patients. Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop Kyprolis for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart Kyprolis based on a benefit/risk assessment.
Hypertension:
Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with Kyprolis. Some of these events have been fatal. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold Kyprolis and evaluate. Consider whether to restart Kyprolis based on a benefit/risk assessment.
Venous Thrombosis:
Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed with Kyprolis. In the combination study, the incidence of venous thromboembolic events in the first 12 cycles was 13% in the Kyprolis combination arm versus 6% in the control arm. With Kyprolis monotherapy, the incidence of venous thromboembolic events was 2%. Thromboprophylaxis is recommended and should be based on an assessment of the patient’s underlying risks, treatment regimen, and clinical status.
Infusion Reactions:
Infusion reactions, including life-threatening reactions, have occurred in patients receiving Kyprolis. Symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration of Kyprolis. Administer dexamethasone prior to Kyprolis to reduce the incidence and severity 12 of infusion reactions. Inform patients of the risk and of symptoms and to contact a physician immediately if symptoms of an infusion reaction occur.
Thrombocytopenia:
Kyprolis causes thrombocytopenia with platelet nadirs observed between Day 8 and Day 15 of each 28-day cycle with recovery to baseline platelet count usually by the start of the next cycle. Thrombocytopenia was reported in approximately 40% of patients in clinical trials with Kyprolis.
Monitor platelet counts frequently during treatment with Kyprolis. Reduce or withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure:
Cases of hepatic failure, including fatal cases, have been reported (< 1%) during treatment with Kyprolis. Kyprolis can cause increased serum transaminases. Monitor liver enzymes regularly. Reduce or withhold dose as appropriate.
Thrombotic Thrombocytopenic Purpura /Hemolytic Uremic Syndrome:
Cases of thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) including fatal outcome have been reported in patients who received Kyprolis. Monitor for signs and symptoms of TTP/HUS. If the diagnosis is suspected, stop Kyprolis and evaluate. If the diagnosis of TTP/HUS is excluded, Kyprolis may be restarted. The safety of reinitiating Kyprolis therapy in patients previously experiencing TTP/HUS is not known.
Posterior Reversible Encephalopathy Syndrome (PRES):
Cases of PRES have been reported in patients receiving Kyprolis. Posterior reversible encephalopathy syndrome (PRES), formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS), is a neurological disorder which can present with seizure, headache, lethargy, confusion, blindness, altered consciousness, and other visual and neurological disturbances, along with hypertension, and the diagnosis is confirmed by neuro-radiological imaging (MRI). Discontinue Kyprolis if PRES is suspected and evaluate. The safety of reinitiating Kyprolis therapy in patients previously experiencing PRES is not known.
Embryo-fetal Toxicity:
Kyprolis can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. There are no adequate and well-controlled studies in pregnant women using Kyprolis. Kyprolis caused embryo-fetal toxicity in pregnant rabbits at doses that were lower than in patients receiving the recommended dose. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with Kyprolis. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
ADVERSE REACTIONS
The most common adverse events occurring in at least 20% of patients treated with Kyprolis in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, decreased platelets, dyspnea, diarrhea, decreased lymphocyte, headache, decreased hemoglobin, cough, edema peripheral.
The most common adverse events occurring in at least 20% of patients treated with Kyprolis in the combination therapy trial: decreased lymphocytes, decreased absolute neutrophil count, decreased phosphorus, anemia, neutropenia, decreased total white blood cell count, decreased platelets, diarrhea, fatigue, thrombocytopenia, pyrexia, muscle spasm, cough, upper respiratory tract infection, decreased hemoglobin, hypokalemia.
USE IN SPECIFIC POPULATIONS
Patients on dialysis: Administer Kyprolis after the dialysis procedure.
POST-MARKETING EXPERIENCE
The following adverse reactions were reported in the post-marketing experience: dehydration, thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), tumor lysis syndrome including fatal outcomes, and posterior reversible encephalopathy syndrome (PRES). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Full prescribing information is available at www.kyprolis.com.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen Inc., including Amgen Inc.’s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen’s business. Unless otherwise noted, Amgen is providing this information as of July 24, 2015, and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen and its partners to complete clinical
trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen’s products after they are on the market. Amgen’s business may be impacted by government investigations, litigation and product liability claims. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development.
In addition, sales of Amgen’s products (including products of Amgen’s wholly-owned subsidiaries) are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of Amgen’s products. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen’s products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen and its partners routinely obtain patents for their products and technology, the protection of Amgen’s products offered by patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen’s or its partners’ ability to obtain or maintain patent protection for Amgen’s products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen’s stock price may be affected by actual or perceived market opportunity, competitive position and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen’s business and results of operations. Amgen’s efforts to integrate the operations of companies it has acquired may not be successful. Amgen may experience difficulties, delays or unexpected costs and not achieve anticipated cost savings from its recently announced restructuring plan. Amgen’s business performance could affect or limit the ability of Amgen’s Board of Directors to declare a dividend or their ability to pay a dividend or repurchase Amgen common stock.
1. Dimopoulos, MA and Terpos E. Multiple Myeloma. Annals of Oncology 21 (Supplement 7): vii143–vii150, 2010.
2. Leukemia & Lymphoma Society. Facts 2014-2015. Available at: http://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/generalcancer/pdf/facts.pdf Accessed July 2015.
###
CONTACT: Amgen, Thousand Oaks Kristen Davis, 805-447-3008 (media) Trish Hawkins, 805-447-5631 (media) Arvind Sood, 805-447-1060 (investors)
 

Donate
Patient NavigatorDonate

Myeloma Matters Podcast Series

Podcast Topic Date
Clinical Studies November 16, 2022 View Recording
Targeted Immunotherapy August 30, 2022 View Recording
Bone Health June 30, 2022 View Recording View Transcript

Expert Sessions

Program Chair(s) Date Location of Event
Hearn Jay Cho, MD, PhD
Joshua Richter, MD
December 20, 2022 Virtual Register Here Visit Exhibit Hall
Noa Biran, MD
Paul G. Richardson, MD
June 29, 2022 Virtual View Recording View Transcript & Slides Visit Exhibit Hall
Noa Biran, MD
C. Ola Landgren, MD, PhD
November, 10, 2021 Virtual View Recording View Transcript & Slides Visit Exhibit Hall
Irene Ghobrial, MD
Elisabet E. Manasanch, MD
August 18, 2021 Virtual View Recording View Transcript & Slides Visit Exhibit Hall

Patient Webinars

Webinar Topic Date      
Treatment Options for Patients Who Have Relapsed After Three or More Lines of Therapy, With an Update on Bispecific Antibodies  Friday, December 2, 2022, 1:00 PM-2:00 PM (ET) Register Now Visit Exhibit Hall
Multiple Myeloma Precursor Conditions Wednesday, August 17, 2022, 1:00 PM–2:00 PM (ET) View Recording View Slides Visit Exhibit Hall
Management of Patients Who Have Relapsed After One to Three Prior Lines of Therapy Wednesday, July 13, 2022, 2:00 PM–3:00 PM (ET) View Recording View Transcript
View Slides
Visit Exhibit Hall
Focus on Treatments, Monitoring, and Maintenance for Newly Diagnosed Multiple Myeloma Patients Thursday, June 9, 2022, 2:00-3:00PM View Recording View Transcript & Slides Visit Exhibit Hall
From Diagnosis to Prognosis: Understanding Multiple Myeloma (A Guide for Newly Diagnosed Patients) Tuesday, May 3, 2022, 2:00-3:00PM View Recording View Transcipt & Slides Visit Exhibit Hall
Treatment Options for Patients With Multiple Myeloma Who Have Relapsed After Three or More Lines of Therapy Tuesday, April 5, 2022, 1:00-2:00PM View Recording View Transcript & Slides Visit Exhibit Hall
Multiple Myeloma Highlights From the 2021 American Society of Hematology (ASH) Annual Meeting Tuesday, December 21, 2021 3:00 - 4:00 PM View Recording View Slides Visit Exhibit Hall
Precision Medicine: Updates for Multiple Myeloma Patients Tuesday, November 23, 2021 1:00 - 2:00 PM View Recording View Slides Visit Exhibit Hall
Maintenance Therapy for Multiple Myeloma Patients Tuesday, October 19, 2021 1:00 - 2:00PM ET View Recording View Slides Visit Exhibit Hall
Autologous Stem Cell Transplantation (ASCT) in Multiple Myeloma Wednesday, September 22, 2021
2:00 - 3:00PM ET
View Recording View Slides Visit Exhibit Hall 
Latest Updates on MRD Webinar Thursday, July 22, 2021
11:00AM - 12:00PM ET
View Recording View Slides Visit Exhibit Hall
ASCO Highlights Webinar Wednesday, June 23, 2021
4:00PM - 5:00PM ET
View Recording View Slides Visit Exhibit Hall

 

Managing Communication Preferences

Printed Materials: To opt out of receiving printed marketing materials at your postal address, such as advertisements, flyers or postcards, please write to us at the address below. Please be sure to include your name and mailing address exactly as they appear on the printed marketing materials you received.

Emails: To opt out of receiving marketing communications via email, please send an unsubscribe request to the email address below or click on the unsubscribe link at the bottom of the email that was sent to you and follow the directions on the resulting web page. Please note that you may continue to receive certain transactional or account-related electronic messages from us.

Text Messages: If you have consented to receive text messages, you may opt out of receiving them by using the method provided in the text message or by contacting us as set forth in the Contact Us section below.

Push Notifications: To opt out of receiving push notifications, please set your preferences within your device setting menu.

Updates to the Disclosures

Any changes to these Disclosures will be effective upon the earlier of thirty (30) calendar days following our dispatch of an email notice to you or thirty (30) calendar days following our posting of notice of the changes on the Website. These changes will be effective immediately for new users of our Website.

Please note that at all times you are responsible for updating your Personal Data to provide us with your most current email address. In the event that the last email address that you have provided us is not valid, or for any reason is not capable of delivering to you the notice described above, our dispatch of the email containing such notice will nonetheless constitute effective notice of the changes described in the notice.

If you do not wish to permit changes in our use of your Personal Data, you must so notify us prior to the effective date of the changes and discontinue using the Website. Continued use of our Website, following notice of such changes shall indicate your acknowledgement of such changes and agreement to be bound by the terms and conditions of such changes.

Links to Third Party Sites [and Social Media]

Some of our Website may enable users to submit their own content for contests, blogs, videos, and other functions. Please remember that any data you submit or post as user-generated content to the Website become public data. You should exercise caution when deciding to disclose your personal, financial or other data in such submissions or posts. We cannot prevent others from using such data in a manner that may violate these Disclosures, the law, or your personal privacy and safety. We are not responsible for the results of such postings.

Your Rights

  • Upon request, we will provide you with information about whether we hold any of your Personal Data along with any details required to be provided to you under applicable law.  In certain cases, you may also have a right to:
  • rectify any of your Personal Data that is inaccurate;
  • to restrict or limit the ways in which we use your Personal Data;
  • to object to the processing of your Personal Data;
  • to request the deletion of your Personal Data, and
  • to obtain a copy of your Personal Data in an easily accessible format.

To submit a request, please contact us as set forth in the Contact Us section below.  We will respond to your request within a reasonable time frame.

You also have the right to withdraw your consent to our processing of your Personal Data, when our processing is solely based on your consent. You can do this by discontinuing use of the Website, including by closing all of your online accounts with us and contacting us as set forth in the Contact Us section below to request that your Personal Data be deleted.  If you withdraw your consent to the use or sharing of your Personal Data for the purposes set out in these Disclosures, you may not have access to all (or any) of the Website, and we might not be able to provide you all (or any) of the Website. Please note that, in certain cases, we may continue to process your Personal Data after you have withdrawn consent and requested that we delete your Personal Data, if we have a legal basis to do so.  For example, we may retain certain information if we need to do so to comply with an independent legal obligation, or if it is necessary to do so to pursue our legitimate interest in keeping the Website safe and secure.

If you have any complaints regarding our privacy practices, you have the right to lodge a complaint with your national data protection authority (i.e., supervisory authority).

International Data Transfers

Adequacy Decision:  We may transfer your Personal Data to Switzerland and other countries which the European Commission has approved as providing adequate protection to personal data.  A list of these countries can be found here:

Standard Contractual Clauses:  The European Commission has adopted standard data protection clauses, which provide safeguards for personal data transferred outside of the EEA. We sometimes use Standard Contractual Clauses when transferring Personal Data from a country in the EEA to a country outside the EEA. You can request a copy of our Standard Contractual Clauses by contacting us as set forth in the Contact Us section below.

With your consent:  In respect of certain cross-border personal data transfers, such as in research studies that you provide consent to enter, we will obtain your consent to transfer your Personal Data outside the EEA after first informing you about the possible risks of such a transfer.

By contract:  We will transfer your Personal Data outside the EEA if the transfer is necessary to the performance of a contract between you and MMRF, or if the transfer is necessary to the performance of a contract between MMRF and a third party, and the contract was entered into in your interest.

In addition, we may transfer your Personal Data outside the EEA if the transfer is necessary to establish, exercise or defend legal claims or to protect your vital interests.  



Revised International Staging System (R-ISS) Criteria

Stage Criteria
I ß2-M less than or equal to 3.5mg/L and albumin greater than or equal to 3.5 g/dL
Absence of higher-risk DNA abnormalities
Normal lactate dehydrogenase (LDH)
II Not Stage I or III
III ß2-M greater than or equal to 5.5mg/L and either
Presence of higher-risk DNA abnormalities or
High LDH
ß2-M = beta2-microglobulin
Higher-risk DNA abnormalities include del(17p) and/or translocation (t4;14) and/or translocation (14;16)
LDH = lactate dehydrogenase

Measuring your prognosis

Test Indication Values Indicating a More Favorable Prognosis
Beta 2-microglobulin (β2-microglobulin or β2-M) Higher levels reflect more extensive disease and poor kidney function. <3.5 mg/mL
Albumin level Higher levels may indicate better prognosis. ≥3.5 g/dL
Lactate dehydrogenase (LDH) level Higher levels indicate more extensive disease. Age ≤60yrs.: 100-190 U/L
Age >60yrs.: 110-210 U/L
Freelite® serum free light chain assay Abnormal results may indicate poor prognosis (also indicates risk of progression of MGUS or asymptomatic myeloma to symptomatic myeloma). Free light chain ratio MGUS: 0.26-1.65
Asymptomatic myeloma: 0.125-8.0
Symptomatic myeloma: 0.03-32
Chromosome analysis (cytogenetic testing by either karyotyping or FISH) Presence of specific abnormalities may indicate poor prognosis. Absence of abnormalities
Gene expression profiling Presence of specific group of genes can predict low or high risk of early relapse. Personalize risk score

Patient Webinar

Webinar Topic Date
Learn Your Labs Tuesday, February 4, 2020 1:00PM ET View Recording View Slides
Supportive Care Wednesday, March 4, 2020 1:00PM ET View Recording View Slides
Smoldering Myeloma Thursday, April 23, 2020 1:00PM EDT View Recording

Accredited activities

View Activity

Topic Date Link
Putting the CAR(T) Before the Horse: Practicalities of T Cell-Activating Therapies in Multiple Myeloma Friday, December 9th, 2022 Learn More
What’s My (Next) Line? Treating Relapsed/Refractory Multiple Myeloma When Three Prior Treatment Lines Fail Expires: September 30, 2023 Learn More
Myeloma Masters: The Ultimate Myeloma Patient Care Quiz Show Expires: April 27, 2023 Learn More
Ace the Case: Worsening Fatigue and Diarrhea in a 64-Year-Old Woman With IgA Lambda Multiple Myeloma Expires: March 23, 2023 Learn More
Ace the Case: 71-Year-Old Woman With IgG Lambda Multiple Myeloma at Third Relapse Expires: March 9, 2023 Learn More
Ace the Case: 79-Year-Old Man With Lower Back Pain, Increasing Fatigue, and Right Rib Pain Expires: February 24, 2023 Learn More
A Glimpse Into the Future of Myeloma Patient Management Expires: January 24, 2023 Learn More

Patient toolkit

Program Chair(s) Date Location of Event Access Link
Program Chair Robert Z. Orlowski MD, PhD Elisabeth E. Manansanch, MD May 21, 2020 Virtual View Recording View Slides

Patient toolkit

Title Download Links
Managing Myeloma Resource Brochure English Spanish
Multiple Myeloma Disease Overview English Spanish
Multiple Myeloma Treatment Overview English Spanish
Multiple Myeloma Caregiver Guide English Spanish
Precision Medicine Brochure English Spanish
Immunotherapy English Spanish
Autologous Stem Cell Transplantation English
Myeloma Precursor Conditions English

Register to speak to a myeloma mentor



Let’s connect

Contact the MMRF with any questions or comments—whether you are a patient, caregiver, researcher or clinician, we are always glad to hear from you.



By filling out this form you are agreeing to receiving MMRF communications. You may unsubscribe at any time via your email.

Revised International Staging System for multiple myeloma

Stage Criteria
I ß2-M<3.5mg/L and albumin ≥3.5 g/dL and Absence of high-risk DNA abnormalitiesaand Normal lactate dehydrogenase (LDH)
I Not Stage I or III
III ß2-M≥5.5mg/L and
Presence of high-risk DNA abnormalitiesaor
High LDH
ß2-M = beta2-microglobulin
aHigh-risk DNA abnormalities include del(17p) and/or translocation t(4;14) and/or translocation t(14;16)

Measuring your prognosis

Test Indication Values Indicating a More Favorable Prognosis
Beta 2-microglobulin
(β2-microglobulin or β2-M)
Higher levels reflect more extensive disease and poor kidney function <3 mg/mL
Albumin level Higher levels may indicate better prognosis ≥3.5 g/dL
Lactate dehydrogenase (LDH) level Higher levels indicate more extensive disease Age ≤60yrs.: 100-190 U/L
Age >60yrs.: 110-210 U/L
Albumin level Higher levels may indicate better prognosis ≥3.5 g/dL
FreeliteTM serum free light chain assay Abnormal results may indicate poor prognosis (also indicates risk of progression of MGUS or asymptomatic myeloma or symptomatic myeloma Free light chain ratio MGUS: 0.26-1.65
Asymptomatic myeloma:0.125-8.0
Symptomatic myeloma:0.03-32

Patient Summits

Program Chair(s) Date Location of Event
Andrzej J. Jakubowiak, MD, PhDv
Benjamin Derman, MD
Monique A. Hartley-Brown, MD, MMSc
Jing Christine Ye, MD, MSc
September 10, 2022 Chicago, IL (Online & In Person) Register Here
Ravi Vij, M.D., MBA August 20, 2022 St. Louis, MO (Online & In Person) Register Here Visit Exhibit Hall
C. Ola Landgren, M.D., Ph.D.
Joshua Richter, M.D.
June 18, 2022 Miami, FL (Online & In Person) View Recording View Slides Visit Exhibit Hall
Sagar Lonial, MD
Ajay K. Nooka, MD, MPH
April 23, 2022 Atlanta, GA
(Online & In Person)
View Recording View Slides Visit Exhibit Hall
Laura Finn, MD, MS March 19, 2022 Virtual View Recording View Slides Visit Exhibit Hall
Jeffrey Allan Zonder, MD February 19, 2022 Virtual View Recording View Slides Visit Exhibit Hall
Ravi Vij, MD, MBA January 29, 2022 Virtual View Recording View Slides Visit Exhibit Hall
Harsh V. Parmar, MD
David H. Vesole, MD, PhD, FACP
December 4, 2021 Virtual View Recording View Slides Visit Exhibit Hall
Larry D. Anderson, Jr, MD, PhD
Ankit J. Kansagra, MD
November 20, 2021 Virtual View Recording View Slides Visit Exhibit Hall

 

Meet Lauren Charamut

  • Title: Associate Director, Events and Partnership
  • Biked: Bryce to Zion with the Road to Victories 2018 Team
  • Favorite Mid-Ride Snack: Stroopwafel
  • Favorite Part of Cycling: The uphill climb

 

Meet Lauren Charamut

  • Title: Associate Director, Events and Partnership
  • Hiked: Mt. Democrat, Mt. Fuji, Havasu Falls (Grand Canyon), Patagonia, Mt. Washington (countless times)
  • Favorite Trail Snack: Stroopwafel
  • Best Training Advice: “Keep your boots in the sun”



 

Meet Brianne:

  • Senior Associate, Events and Partnerships
  • Favorite 5K Fundraising Tip: Make your ask in several different ways (in person, on Facebook, by email, etc.!)
  • Cheer Squad: My boyfriend, parents, two brothers and best friends.

Contact Me

 

Meet Ashley:

  • Manager, Events and Partnerships
  • 1 year with the MMRF Walk/Run Team
  • Favorite 5K Fundraising Tip: Set a goal and break it down for your supporters (Example: If 20 people donate $25 I’ll reach my goal of $500 towards a cure!).
  • Cheer Squad:  My parents, sister and local community.

Contact Me

 

Meet Ed:

  • Race Manager, MMRF Team for Cures 5K Walk/Run Program
  • 3 years with the MMRF Walk/Run Team
  • Favorite 5K Fundraising Tip: Take advantage of the power of social media.
  • Cheer Squad: My family. (Father: Ed, Mother: Susan, Sister: Kiera) And my super supportive girlfriend, Elyse.

Contact Me

 

Meet Jane:

  • Director, Events & Partnerships
  • 13 years with the MMRF Endurance Team, and 3 years with the MMRF Walk/Run Team
  • Favorite 5K Fundraising Tip: Cast a wide net. You never know who will surprise you.
  • Cheer Squad: My husband Michael and 3 grown kids.

Contact Me



 

Meet Lauren Bruce

  • Associate Manager, Events and Partnerships
  • Newest member of the MMRF Team for Cures staff
  • 8-time Marathon Finisher (4x Chicago, Rock N Roll Raleigh, Marine Corps Marathon duo team, and DIY duo team in 2020), 30+ Half Marathon finishes
  • Favorite Race Day Tip: Wear more sunscreen and body glide than you think you need!
  • Marathon Mantra: Yes, you can!
  • Cheer Squad: Her 2 cats and running partner, Ethan

 

Meet Jane

  • Director, Events & Partnerships
  • 13 years with the MMRF Endurance Team
  • 8-time Marathon Finisher (Chicago, Boston 2X, Disney, National, Philly 2X, Mystic)
  • Favorite Race Day Tip: You will not sleep well the night before your marathon, so don’t sweat it! Hoard sleep leading up to race weekend
  • Marathon Mantra: You did your homework. You’ve got this!
  • Cheer Squad: Husband and 3 grown kids

Contact Me

Leadership and Corporate Connections

For further inquiries on leadership and our strategic plan please fill out the below information. Once submitted, a member of our team will contact you as soon as possible.

Company Website:
Total Employees:
Annual Revenue:
Is your organization a 501(c)(3)?:
Is there a written strategic plan?:
Have you read the Playbook?:


Facebook Live Events

Faculty Date Event Topic
Ola Landgren, MD
Dennis Verducci, MSN, RN, NP-BC, OCN
September 7, 2022 MM Precursor Conditions View Recording
Andrew Yee, MD
Stephanie Sanford, NP
July 28, 2022 MM Following Relapse After 1-3 Prior Lines of Therapy View Recording
Ravi Vij, MD
Angela Vickroy, NP
July 20, 2022 FAQs From the American Society of Clinical Oncology Annual Meeting View Recording
Sergio Giralt, MD
Emily Patterson, NP
June 29, 2022 Treatments, Monitoring, and Maintenance for Newly Diagnosed Patients View Recording View Transcript
Ken Shain, MD, PhD
Christine Simonelli, BSN, RN, OCN
May 24, 2022 MM Diagnosis and Prognosis View Recording View Transcript
Sandy Wong, MD
Donna D. Catamero, ANP-BC, OCN, CCRC
April 14, 2022 MM Following Relapse After 3 or More Lines of Therapy View Recording View Transcript
Craig E. Cole, MD,
Amy Pierre, RN, MSN, ANP-BC
October 25, 2021 MM Precursor Conditions in the Black Community View Recording






High Impact Topics Videos

High impact topic videos, or HITs, are videos that use engaging animations and narration to present information on topics of importance to myeloma patients and their caregivers. Presented in a patient-friendly manner and viewable on iPads, tablets, and smartphones, these HITs bring to life and explain concepts that can sometimes be difficult for patients and caregivers to understand.

The MMRF wishes to thank the following reviewers and contributors to these HITs: Craig Emmitt Cole, MD; Faith E. Davies, MBBCh, MRCP, MD, FRCPath; Marc Davis; Irene Ghobrial, MD; Colin Todd Kennedy; Amrita Y. Krishnan, MD; Ola Landgren, MD, PhD; Louise Miller Lavin, BSN, MSN, LPCC; Joshua Richter, MD; Nina Shah, MD.

Title Description
MRD (Minimal residual disease) Learn what MRD is, how it is measured, and what it might mean if your doctor tells you that you are MRD positive or MRD negative.
Immunotherapy Understand how your immune system interacts with your myeloma, and how new immunotherapies are helping patients’ immune systems recognize and destroy myeloma cells.
Genomics Hear how doctors can use genomic information from your myeloma cells to provide therapy that is tailored to your myeloma subtype.
Learn Your Labs This video provides information on laboratory tests that myeloma patients may undergo. Learn about why and how the tests are done and what the results mean.
Autologous Stem Cell Transplantation (ACST) Learn the risks and benefits of ACST, a key part of a personalized treatment plan for many myeloma patients.
Clinical Trials Discover how clinical trials work.
Multiple Myeloma Precursor Conditions Find out the difference between monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) and what factors may put individuals with these conditions at higher risk for progressing to multiple myeloma.
MMRF's The Right Track(TM) Program This HIT shows patients who have been diagnosed with multiple myeloma how to get on the right treatment path to their best outcome as quickly as possible.

Grace Allison

RN, BSN, OCN, RN-BC – Patient Navigation Center

Grace has been a registered nurse for more than 30 years. She spent the last 28 years working at one of the largest myeloma programs in the U.S., the University of Arkansas for Medical Sciences (UAMS). She was fortunate to have spent her career at UAMS under the tutelage of one of the most well known myeloma physicians, Dr. Bart Barlogie. She received her nursing education in Ireland, and completed a bachelor’s of nursing degree at the University of Arkansas. She is a member of the Oncology Nursing Society and a nationally Oncology Certified Nurse. She is also a board certified medical-surgical registered nurse (RN-BC).

Adrian Rosenkranz

Chief Operating Officer
Salesforce Essentials

Adrian Rosenkranz, a Multiple Myeloma caregiver, is the COO of Salesforce Essentials; in that role he’s responsible for steering the company’s operations, vision, and customer experience. With over a decade of experience in enterprise software, Adrian is widely respected for being a boots-on-the-ground leader with a track record of driving growth. Prior to his current position, Adrian held roles at Salesforce in Sales Strategy & Ops, Sales, and Corporate Marketing, giving him valuable experience in multiple revenue functions.  

Adrian serves on the board of the Stanford Athletics Buck/Cardinal Club, which supports all varsity sports at Stanford University. He has also served as an advisor for Harvard Business School's Kraft Precision Medicine program, using his experience with direct-to-consumer teams to help nonprofits accelerate precision medicine efforts via direct-to-patient engagement. 

Adrian earned his BS from Stanford University, where he also served as the kicker for the Stanford football team under Coach Jim Harbaugh. He currently lives in San Francisco, where he loves to exercise and explore the outdoors. 

 

Candice Del Rio

Candice Del Rio

MS, BSN, BA, RN – Manager, Patient Navigation Center

Candice Del Rio is the Manager of the Patient Navigation Center at the MMRF. She is responsible for overseeing the daily operations of the PNC and guiding myeloma patients through their disease journey. She most recently worked at the Massachusetts General Hospital for over 11 years as a Staff Nurse in the inpatient Hematology/Oncology unit and as a Clinical Research Nurse in the Bone Marrow Transplant Department. Prior to her career in nursing, she worked in marketing and advertising in the real estate industry for 4 years. She earned a BA degree in Communications with a concentration in Sociology from Boston College and completed her nursing education with BSN and MS degrees from Northeastern University.

 

Brittany Hartmann

RN, BSN – Patient Navigation Center

Brittany Hartmann, RN, joins the MMRF as a Nurse in the Patient Navigation Center. Brittany worked as a Myeloma Clinical Coordinator in a high-volume call center at the Ruttenberg Treatment Center at Mount Sinai Hospital in New York City for the past 5 years. Here, she supports myeloma patients in a variety of ways from triaging calls, to educating patients on their myeloma, labs and test results, and coordinating with research and management to implement integral changed and streamline processes for access to new treatments. Prior to Mount Sinai, she worked as an Oncology nurse at Saint Barnabas Medical Center in New Jersey. Brittany earned her Bachelor of Science in Nursing at the University of Delaware, where she had the opportunity to be a student nurse for a private physician for over a year.

Mindy Flinn, MBA – Vice President of Development

Mindy Flinn joined the MMRF in May 2020 as the Vice President of Development where she works with a talented team raising philanthropic support for the organization. She brings over 23 years of development experience to this position. Ms. Flinn spent over a decade in development at Mayo Clinic in Rochester, MN and in Jacksonville, FL, where she oversaw the stewardship of top-level benefactors and served as a major gift officer. She also worked for the LIVESTRONG Foundation in Austin, TX as a major gift officer and was Director of Philanthropic Resources at MD Anderson Cancer Center in Houston, TX. Prior to joining the MMRF, she was Senior Director of Development at Yale School of Medicine. Ms. Flinn received her Bachelor of Science in Biology from Bethel University and a Master of Business Administration from Cardinal Stritch University. Her additional accomplishments include successfully climbing Mt. Kilimanjaro in 2012 as a member of Survivor Summit and skydiving. 

Rob Miani - Chief Financial Officer

Rob Miani joined the MMRF team as Chief Financial Officer in 2016. Most recently he was the Vice President of Finance and Corporate Controller of Aptuit, LLC, a global contract research organization providing integrated early discovery to mid-phase drug development services in the pharmaceutical industry. Rob has over 20 years of leadership experience in the private and public sectors, holding managerial positions in the renewable energy, private equity, Internet and technology industries, including Davenport Newberry, Oak Investment Partners and INT Media Group. He began his career with Arthur Anderson LLP in the Assurance and Business Advisory Services Division. Rob is a CPA and received his BS degree in Accounting from Fairfield University.

Mike Mortimer

Managing Partner and Founder
GHO Capital

Chairman of the Board
MMRF

Mike is an experienced healthcare industry senior executive who brings a 30+ years track record in operational and management positions.

In his former role as an Executive Vice President in the core leadership team at Quintiles (now IQVIA), Mike was instrumental to driving the international growth of a now leading global Clinical Research Organisation. Prior to Quintiles, Mike was a Senior Vice President at Charles Schwab, responsible for the global retail and internet organizations.

Mike currently sits on the boards of Envision, X-Chem, Ardena, BioAgilytix, Validant and Alcaliber and has overseen successful exits from Quotient Sciences and Caprion Biosciences.

Originally from the US and holding a bachelor’s degree in Behavioural Sciences from the Ohio State University, Mike has worked and lived across the USA, UK and Asia.

Paul Giusti

President
Riverwoods Holdings, LLC

Paul Giusti is the former President and Chief Executive Officer of the Multiple Myeloma Research Foundation (MMRF). Prior to the MMRF, Mr. Giusti worked as a Chief Executive Officer, leader, executive and entrepreneur for over 30 years; he has founded, managed and led a variety of businesses. Early in his career, Mr. Giusti worked as an executive for GE where he held a number of management positions with a wide range of responsibilities.

Mr. Giusti has worked closely with the MMRF since its founding in 1998. In addition to chairing the successful $100 million capital campaign, he has served as a consultant for a number of foundation projects, led several MMRF outreach efforts and spoken on behalf of the MMRF.

Mr. Giusti holds a Bachelor of Science degree from the Colorado School of Mines and an MBA from Harvard University.

Kathy Giusti

Founder and Chief Mission Officer
MMRF and MMRC

Faculty Co-Chair, HBS Kraft Precision Medicine Accelerator
Harvard Business School

Kathy Giusti, a multiple myeloma patient, is the Founder of the Multiple Myeloma Research Foundation (MMRF) and the Multiple Myeloma Research Consortium (MMRC). She is also the Chief Mission Officer of the MMRF. Kathy is the Henry & Allison McCance Family Senior Fellow at Harvard Business School, where she serves as Faculty Co-Chair of the HBS Kraft Precision Medicine Accelerator. Kathy has more than two decades of experience in the pharmaceutical industry, previously holding senior positions at G.D. Searle and Merck.

Since founding the MMRF in 1998, Kathy has become a widely respected leader in establishing innovative, collaborative research models in the areas of tissue banking, genomics, and clinical trials. These models are dramatically accelerating the pace at which lifesaving treatments are brought to patients and are building an end-to-end solution in precision medicine. Today, she is recognized as a pioneer of precision medicine, a champion of data sharing, and a strong advocate for patient engagement.

In 2016, Kathy was named Faculty Co-Chair of the Harvard Business School (HBS) Kraft Precision Medicine Accelerator, a $20 million program endowed by Robert Kraft and the Kraft Family Foundation. Under her leadership, the HBS Kraft Precision Medicine Accelerator convenes best-in-class leaders from science, business, and technology to identify and solve challenges slowing the advancement of precision medicine. The HBS Kraft PM Accelerator disseminates best practices and models to overcome these challenges, and ultimately enables faster adoption of high-impact innovations.

Kathy has earned numerous prestigious awards and recognitions, including being named 1 of 3 Top Business Leaders Disrupting Medicine by Fortune Magazine and #19 on Fortune’s World’s 50 Greatest Leaders list. She was also named one of the world’s 100 Most Influential People by TIME magazine. Kathy received the Open Science Champion of Change award by the White House. In addition, she has been honored with the American Association for Cancer Research Centennial Medal for Distinguished Public Service and the Healthcare Businesswomen’s Association’s Woman of the Year Award.

Kathy serves on the advisory boards of Verily and Verily’s Project Baseline and is a member of the Harvard Business School (HBS) Health Advisory Board. She a Member of the FasterCures Non-Profit Council. Kathy previously served on President Obama’s 2015 Precision Medicine Initiative Working Group, the President’s Council of Advisors on Science and Technology (PCAST), National Cancer Advisory Board (NCAB), and the National Cancer Policy Board (NCBP).

Kathy has been featured on the Today Show, NBC Nightly News, CBS Evening News, Fox News, CNN, and Bloomberg. Her efforts have also been profiled by Fortune, The Wall Street Journal, Harvard Business Review, The New York Times, Forbes, The New Yorker, WIRED, and Fast Company.

Kathy received her MBA in general management from Harvard Business School and holds an honorary Doctorate from the University of Vermont.

Learn more about Kathy.

Sarah Coulter

RN, OCN

Sarah has been a registered nurse for the past five years, specializing in Hematology Oncology and Bone Marrow Transplant. She has spent over ten years in the Oncology field and started her career at Yale New Haven Hospital. Over the last three years, Sarah worked as a traveling nurse in California, South Carolina, Florida, Texas and Maryland. She earned her nursing degree from St. Vincent’s School of Nursing. She is chemotherapy certified and is currently in school to obtain her master’s degree in nursing education.

 

Erin Mensching

RN, BSN, BA, OCN – Patient Navigation Center

Manager

Erin is the Manager of the Patient Navigation Center. She is passionate about helping to guide myeloma patients and to further research for the myeloma community. She has been a registered oncology nurse for ten years. She served on the Patient Council Committee at the Norwalk Hospital and is a member of the Oncology Nursing Society. Erin is a graduate of Fairfield University’s School of Nursing and earned her bachelor’s degree in psychology from the University of North Caroline at Chapel Hill. Prior to becoming an oncology nurse, Erin was a healthcare representative for Pfizer and Sanofi-Aventis.

 

Christopher Williams - Vice President of Business Development

 Christopher Williams was named Vice President of Business Development at the MMRF in 2017, responsible for business development, partnership and joint venture efforts for the foundation. He is a business development leader with a strong scientific background, specializing in the pharmaceutical and diagnostics space. Most recently he served as the VP of Business Development at WaveSense where he was in charge of their US commercialization strategy and product expansion, as well as being responsible for overseeing their strategic partner relationships.

Previously Chris was VP of Business Development at SkylineDx, providing commercialization strategy for their oncology portfolio. With PerkinElmer, as the Market Segment Leader in Oncology, he had responsibility for their cancer diagnostic products including strategy, launch activities, external presentations and marketing execution.

While at Millennium Pharmaceuticals, Chris held roles in the Protein Science, Technology Development and Proteomics groups. He also had scientific roles at Schering-Plough and the Sandoz Research Institute.

Chris holds graduate and post-graduate degrees in Microbiology/Molecular Biology and Protein Biochemistry from Clemson University. 

Steve Varley - Vice President, Development

Steve Varley joined the MMRF team in 2018 and is responsible for the fundraising efforts of the organization. Most recently he served as Associate Dean for Advancement at Yale University, leading the fundraising efforts for Yale School of Nursing. Previously he worked as the Vice President for Advancement at Gardner-Webb University where he organized and successfully executed the University’s most recent capital campaign. Steve received a BS degree from Chowan University and holds an MBA from Gardner-Webb University.

Laura Gilman - Vice President of Events

Laura Gilman is the Vice President of Events at the MMRF where she manages the entire events portfolio. Prior to joining the MMRF in 2010 Ms. Gilman was the Vice President of Citigroup’s Investment Research Conferences where she directed the design and execution of the bank’s high profile research conferences and events. Before joining Citigroup, Ms. Gilman was the Director of Meetings, Client Relations and Incentives at Victoria’s Secret Beauty. She began her career at Morgan Stanley managing the bank’s IPO Roadshows. Ms. Gilman has over 20 years of experience designing and executing events and initiatives that generate revenue. She received her B.A. in English Literature from the Catholic University of America and lives in Westport, CT with her husband and son.

Karen Dietz, JD, MBA - Chief Administrative Officer and General Counsel

 

Karen Dietz, JD, MBA, is the Chief Administrative Officer and General Counsel. Karen is responsible for overseeing the Legal and Human Resource Departments, corporate governance, compliance, contributes to strategic planning, oversees planning and execution of the organization’s operating plans, and collaborates with other disease foundations to share insights from MMRF success.

Additionally, Karen has concentrated efforts on optimizing the governance structure of the MMRF’s subsidiary companies: Myeloma Investment Fund (MIF) and the Multiple Myeloma Research Consortium (MMRC). Karen has worked with the consortium sites and pharma companies to launch nearly 100 multi-center clinical trials including the first-ever myeloma platform trial, MyDRUG.

Prior to joining the MMRF in 2007, Karen worked as In-House Counsel at Océ Imagistics North America a subsidiary of Canon Printers, was the Legal Counsel for the United States Junior Chamber of Commerce, and worked at the Law Firm of Attorney Raymond Lubus, Corporate Payroll Services, Orion Mobility, and Praxair.

Karen earned her Doctorate of Jurisprudence and her Masters of Business Administration from Western New England University. Karen earned her Bachelor of Science in Justice and Law Administration from Western Connecticut State University.

 

 

 

 

 

 

Anne Quinn Young, MPH - Chief Marketing and Development Officer

Anne Quinn Young, MPH, is the Chief Marketing and Development Officer at the MMRF and is responsible for overseeing the strategy and execution of the organization’s marketing, communications, patient engagement, and fundraising efforts in support of the organization’s mission to accelerate precision medicine and a cure for every patient.  

Anne has been named to the PharmaVoice 100, and represents the MMRF on a number of working groups and committees including the Direct-to-Patient (DTP) solutions team at the Harvard Business School (HBS) Kraft Precision Medicine Accelerator and the Cancer Support Community Frankly Speaking About Cancer: Multiple Myeloma National Advisory Board. She has co-authored a number of peer-reviewed abstracts and publications on the MMRF Precision Medicine Model and identifying knowledge gaps and opportunities to improve patient empowerment and engagement in optimizing their own outcomes.

Prior to joining the MMRF in 2002, she was a consultant in the Healthcare Practice of Datamonitor, a global market research and business intelligence company. She previously worked in healthcare public relations at Burson-Marsteller and the Chandler Chicco Agency, following a postgraduate internship at the Department of Justice, Antitrust Division. Anne has a Masters of Public Health from the Mailman School of Public Health of Columbia University and graduated cum laude from Dartmouth College with a Bachelor of Arts in Government.

 

 

Lori Tauber Marcus

Founder
Courtyard Connections

Vice Chairman of the Board
MMRF

Lori Marcus is an independent board director and keynote speaker. She is currently serving in the role of Vice Chairman of the MMRF board. Lori is also the Chairman of the board of DNA Diagnostics Center, a growing leader in private DNA testing services, where she guides overall strategy and governance for corporate growth. Additionally, she is an independent Board Director for SHARE, a 40-year-old survivor-led organization based in New York City that provides support, information, and resources to women affected by breast and ovarian cancers. Lori also currently serves on the CMO advisory board for VentureBeat and is a board advisor to Carrington Farms.

Most recently, Ms. Marcus served as Interim Global Chief Marketing Officer for Peloton Interactive, Inc., a private equity and venture capital backed home fitness innovator. At Peloton, Lori drove business growth with strategy, brand marketing, communications, PR, social/digital media, consumer insights, data analytics, creative services, and community engagement. Prior, Lori was Chief Global Brand and Product Officer at Keurig Green Mountain. With more than 30 years of broad-based marketing and general management experience, Lori was responsible for global brand and product management for the Keurig system of innovative brewers and beverages. During her tenure at Keurig Green Mountain, she also led the company’s global marketing efforts and all aspects of e-commerce, digital/social media, marketing insights, and graphic design. Lori was also Chief Marketing Officer of The Children’s Place Retail Stores and SVP Marketing at PepsiCo.

Lori is a graduate of the Wharton School, University of Pennsylvania.

Steven Labkoff, MD, FACP, FACMI - Chief Data Officer 

Dr. Steven Labkoff is the Chief Data Officer at the Multiple Myeloma Research Foundation. Dr. Labkoff is a global medical leader with a track record of developing cutting edge strategies towards new healthcare delivery models. He has demonstrated success in the convergence of medicine, life sciences and policy across disparate organizations including government, non-government organizations (NGOs), health plans and academic institutions. He joined the MMRF after a 25-year career in healthcare informatics for the Life Science Industry where he worked on a wide array of issues ranging from the secondary uses of healthcare data for Life Sciences, health information technology policy, Big Data and analytics and medical affairs. He was most recently Executive Director, Medical Strategy at Purdue Pharma. In that role he led Purdue’s Big Data initiative as well as medical strategy for both pipeline and inline products. Prior to Purdue he was Vice President of Life Sciences at Intelligent Medical Objects focused on leveraging medical vocabularies, ontologies, and terminologies for Life Science customers.

From 2011-2014 he was Executive Director, R&D Informatics and Head of Strategic Programs in AstraZeneca’s Research & Development Information Department where he led groups on Real World Evidence and Payer Evidence, Personalized Medicine and Biomarkers and Clinical Trials Design and Interpretation, dedicated to leveraging healthcare data for the development of ethical pharmaceuticals.

Previously, Dr. Labkoff was an instructor of Medicine and Medical Informatics at Brigham and Women’s Hospital, Harvard Medical School. He completed a post-doctoral fellowship at Harvard Medical School and Massachusetts Institute of Technology in Medical Informatics where he focused on the uses of point-of-care computing and mHealth. He did his cardiology training at the University for Medicine and Dentistry of New Jersey, his medical training at the University of Pittsburgh and at the Albert Einstein Medical Center in Philadelphia. He is a Fellow of the American College of Physicians and the American College of Medical Informatics, and an executive board member of the American Medical Informatics Association.

 

Hearn Jay Cho, MD, PhD - Chief Medical Officer 

Hearn Jay Cho, MD, PhD joined the MMRF as Chief Medical Officer (CMO). Dr. Cho is responsible for developing the MMRF’s clinical research strategy and accelerating drug development programs as well as for leading the Multiple Myeloma Research Consortium (MMRC), a group of 25 leading research centers dedicated to researching and advancing treatment options for multiple myeloma patients.

Hearn Jay Cho is an Associate Professor of Medicine at the Icahn School of Medicine at Mt. Sinai and an Attending Physician with the Multiple Myeloma Service at the Mt. Sinai Tisch Cancer Institute. Dr. Cho’s laboratory is investigating novel therapies for multiple myeloma in two areas.

First, they are investigating immunologic therapies with a focus on using cutting edge genomic and immunologic assays to map the interaction between myeloma and the immune system in the tumor microenvironment. These projects illuminate the mechanisms of action of novel immune therapies in both laboratory models and clinical trials and will inform the design of rational combinations. This program has a special focus on immunologic therapy in the setting of autologous stem cell transplantation for myeloma.

Second, Dr. Cho’s group discovered that two of the type I Melanoma Antigen GEnes (MAGE), MAGE-A3 and MAGE-C1, are commonly expressed in multiple myeloma and are correlated with progression of disease and proliferation. They demonstrated that type I MAGE plays a critical role in conferring resistance to chemotherapy and inhibition of apoptosis in myeloma cells through regulation of Bcl-2 family proteins and the tumor suppressor p53. Dr. Cho’s group is conducting biochemical and structural studies to identify novel pharmacologic strategies for inhibition of type I MAGE activity in myeloma.

 

 

Randi S.Randi S

51, from Fort Lauderdale, FL
Initially Diagnosed: 2016
Current Diagnosis: Relapsed, Refractory
Treatment Received: SCT, Cytoxan, Revlimid, Velcade

Upon Randi’s diagnosis, she conducted an abundance of research and tried to keep an optimistic mindset. She decided to pursue the treatment plan that had a more holistic approach, and if it came to a point in which she needed a transplant, she wanted to pick the environment that felt the most nurturing. Randi knew that there were many steps and lifestyle changes that she had to make towards her healing. Her diagnosis affected her in medicinal, environmental, holistic, mental, personal and spiritual ways. She continues to maintain her super healthy lifestyle and practices good dietary habits. It was difficult for Randi to believe that she had cancer, as she had to learn to recreate herself and was grateful to be alive. Randi is very active in the multiple myeloma community and participates in races all over the country. She told her doctors that she was willing to do her homework to propose to them ways in which she could slowly return to participating (to a certain degree) in some of her active hobbies and most importantly, she has learned to listen to her body.

Evelyn H.

62, from the Houston, TX area
Initially Diagnosed: 2014
Current Diagnosis: recently completed 2nd Autologous Stem Cell Transplant
Treatments Received: bortezomib, dexamethasone, lenalidomide , carfilzomib , daratumumab, and pomalidomide

Evelyn has been living with MM for almost nine years.  What she has learned from this was to expect the unexpected.  She had her first relapse in January of 2021, which was unexpected.  After completing treatment she was back into a complete response.  What she has found helpful to persevere along the journey was a strong support team – in healthcare, spiritual aspects, family and circle of friends.  She believes it’s imperative to have the entire team working in tandem.  Developing short term and long term treatment plans with her healthcare team, and allowing room for adjustment as needed has been a part of process.  Evelyn looks forward to helping others navigate their unexpected.

Tricia C.Tricia C

59, from Rocky Hill, CT
Initially Diagnosed: 2014
Current Diagnosis: In Remission
Treatment Received: SCT, RVD, IVIG, Clinical Trial Participant

In 2005, Tricia was dealing with extreme fatigue. Her primary care physician ordered routine bloodwork and found that she was severely anemic. She was then sent to a local hematologist who did a bone marrow biopsy. At this time she was diagnosed with smoldering myeloma after receiving a second opinion. It wasn’t until 2014 that she was diagnosed with active Multiple Myeloma. Tricia participates in MMRF events in hopes of furthering multiple myeloma research. She enjoys sharing her personal experience with other myeloma patients and is looking forward to helping others understand this disease better and find resources for them that will help with their personal myeloma journey.

Lisa B.

37, Trumbull, CT
Initially Diagnosed: MGUS 28, MM 30
Current Diagnosis: Multiple Myeloma-stable
Treatment Received: Revlimid, Velcade, Dex, Autologous SCT, Pomalyst, Carfilzomib @ MSK in NY

Lisa was diagnosed with MGUS at age 28  -  discovered during a routine physical exam showing high protein levels in her bloodwork, but she was otherwise asymptomatic. After 18 months,  MGUS developed into MM, requiring immediate treatment at age 30. Dealing with cancer at such a young age was shocking, challenging and unrelatable/lonely, but with a strong support system, cancer mentors, great doctors/treatment, The MMRF, a positive outlook, education, faith and perseverance she reached complete remission after transplant and lived a very 'new normal' life, still able to balance career, life, and her condition.  Lisa relapsed after about 5 years, but her condition is currently stable. Lisa wants to help other cancer patients by mentoring, sharing experiences,  and offering resources, but most importantly helping them realize they are not alone.

Ethan H.Ethan H

28, from Worcester, MA
Initially Diagnosed: 2013
Current Diagnosis: In Remission, Multiple myeloma with solitary plasmacytoma
Treatment Received: Radiation, Bone replacement, SCT, VRD, Ninlaroe

I was diagnosed with multiple myeloma seven years ago at the age of 22. It started with pain in my hip that was quickly diagnosed as cancer. I understand the disruption to “normalcy” that a multiple myeloma diagnosis may have caused for you. I’ve made it my mission to make a difference for others dealing with this disease. This time period can be filled with uncertainty, but the thing that has always helped, whether it was the day of the diagnosis or currently, is the importance of having people in your life that are there for you.

Casey Joe W.Casey Joe W

36, from Acworth, GA
Initially Diagnosed: 2008
Current Diagnosis: In Remission
Treatment Received: Bone replacement, SCT, Velcade, Revlimid, Ninlaro

I was diagnosed with Multiple Myeloma when I was 26 years old. I was a bit lost at first because I was very young when I received this diagnosis, but I soon realized that everyone experiences it differently. Since my diagnosis, I’ve had to cut back on a lot of physical things I used to do, like exercising. I’ve learned how to manage my energy and put it towards things that matter most to me. I am very motivated to share my experiences with others battling this disease and hope to empower other patients during their journey.

Annamarie K.Anna Marie K

50, from Norwalk, CT
Initially Diagnosed: Husband JP in 2014
Current Diagnosis: Relapsed, Refractory

My husband, JP, was diagnosed with multiple myeloma six years ago at the age of 48. We do whatever we can to support the MMRF and to keep a positive mindset about our situation. It has been a journey from day one, but I feel we are confident going forward. I’m thrilled to be at this point in our lives to be able to help others. I’m so appreciative of the help we’ve received, and I’m grateful for this opportunity because we understand how this journey with multiple myeloma can be overwhelming.

Carmen P.Carmen P

52, from Little Silver, NJ
Initially Diagnosed: 2002
Current Diagnosis: Relapsed, Refractory
Treatment Received: Tandem SCT, Allogenic SCT, RVD, Clinical Trial Participant

Carmen’s experience leading up to her diagnosis was unique in that she did not present any symptoms and was diagnosed via pre-pregnancy bloodwork. It revealed that she had low platelets and was anemic. At the time, Carmen was diagnosed with smoldering multiple myeloma, as she did not meet the criteria to be diagnosed with active multiple. Carmen’s multiple myeloma status continued to be smoldering for a total of 8 years until December 2010. Carmen strives to stay positive and maintain a healthy and active lifestyle. She has persevered and embraces the changes that her diagnosis has caused in her life.

Andrew G.Andrew G

67, from Harrisburg, PA
Initially Diagnosed: 2013
Current Diagnosis: In Remission
Treatment Received: SCT, RVD, Revlimid for maintenance

Andrew’s biggest challenge after receiving his diagnosis was educating himself on this disease. His healthcare team embraced his determination to educate himself, which gave him additional confidence in his doctors. Andrew has kept a  positive outlook and is self-motivating. One motivating factor he had was retirement; although, he only wanted to semi-retire. He remains an active grandfather to his two young grandsons and helps his daughter by babysitting them. He feels that his multiple myeloma journey has made him a better person in that he is more compassionate and understanding.

Jessie D.Jessie D

54, from Vermillion, SD
Initially Diagnosed: 2016
Current Diagnosis: Smoldering
Treatment Received: None at this time

Jessie is determined to not let her diagnosis define her and dominate her life; therefore, she has taken control of the situation by continuing her research and education on her diagnosis and learning the importance of practicing self-awareness and self-advocacy for her own health. She has become dedicated in her efforts to incorporate being health-conscious in her lifestyle. Prior to her diagnosis, Jessie’s sense of self was connected to her career. Now, she's revisiting this and learning how to reinvent herself and the lifestyle she plans to lead.

Jeffery G.Jeffrey G

59, from Chicago, IL
Initially Diagnosed: 2010
Current Diagnosis: Relapsed, Refractory
Treatment Received: Tandem SCT, Ninlaro, Revlimid, Velcade, Pomalyst, Darzalex

Jeffery stresses the importance of staying motivated and positive. He manages his lifestyle and nutrition to do what he can to have a full and active life. He is determined to continue his active hobbies. Before and after his diagnosis, he has continued to participate in his hobbies as a marathon runner, hunter, fisherman, and hiker. He climbed Mt. Kilimanjaro earlier this year and is taking a summer vacation with his wife to Montana to backpack and hike. Doing the things he loves helps him feel empowered against his disease. He also has found strength in becoming an active member of the multiple myeloma community. Jeffery has been extensively involved in the "mother ship" of MMRF. Jeffery is passionate about raising awareness of MMRF and helping others navigate their way and to find their path.

Daniel Auclair, PhD – Chief Scientific Officer 

Dr. Daniel Auclair is the Chief Scientific Officer for the MMRF and has been with the organization for over a decade. He is responsible for oversight of the development and execution of the organization’s scientific plan. In addition, he is responsible for all the MMRF preclinical and translational activities. Dr, Auclair is also deeply involved in the Multiple Myeloma Research Consortium (MMRC), a network of 25 multiple myeloma centers of excellence across the U.S. through which 82 multiple myeloma clinic trials have been run to date.

Dr. Auclair was selected by PharmaVoice in 2017 as one of the 100 Most Inspiring People in the life-sciences industry. After completing his graduate studies in Montreal and postdoctoral fellowship at Dana-Farber Cancer Institute/Harvard Cancer Center where he conducted seminal multiple myeloma genomic work, Dr. Auclair then spent a decade in early cancer drug discovery in biotech/pharma, mostly at Bayer where he worked, among others, on overseeing the Bayer-Millennium cancer genomics drug collaboration as well as on Nexavar and Stivarga. He also worked at the Broad Institute of MIT and Harvard where as a senior manager in the Cancer Program he was involved in a wide range of academic and industry collaborations centered around cancer genomics and precision medicine initiatives. 

Michael Andreini – President and Chief Executive Officer

 

Michael Andreini is the President and Chief Executive Officer of the Multiple Myeloma Research Foundation (MMRF) and the Multiple Myeloma Research Consortium (MMRC). Michael brings nearly 15 years of strategic consulting and operational experience in the life sciences industry. Prior to joining the MMRF, Michael was an Associate Principal at IQVIA in the consulting services organization where he developed strategies for biopharma, medical device, and non-profit organizations to drive innovation and operational excellence across a diverse set of business challenges including R&D and launch strategy, commercial due diligence and portfolio optimization, and organizational effectiveness. Before joining IQVIA, Michael worked at Fuld & Company, a boutique consulting firm specializing in competitive intelligence and strategy, and prior to that, at Siemens Healthcare Diagnostics in the Global Technical Operations group where he resolved technical issues for immunoassay reagents and systems. Michael earned a B.A. in chemistry with a minor concentration in economics from Colgate University.

 

Paul Giusti – President, Riverwoods Holdings, LLC

Paul Giusti is the former President and Chief Executive Officer of the Multiple Myeloma Research Foundation (MMRF). Prior to the MMRF, Mr. Giusti worked as a Chief Executive Officer, leader, executive and entrepreneur for over 30 years; he has founded, managed and led a variety of businesses. Early in his career, Mr. Giusti worked as an executive for GE where he held a number of management positions with a wide range of responsibilities.

Mr. Giusti has worked closely with the MMRF since its founding in 1998. In addition to chairing the successful $100 million capital campaign, he has served as a consultant for a number of foundation projects, led several MMRF outreach efforts and spoken on behalf of the MMRF.

Mr. Giusti holds a Bachelor of Science degree from the Colorado School of Mines and an MBA from Harvard University.

Kathy Giusti – Founder and Chief Mission Officer 

Faculty Co-Chair, HBS Kraft Precision Medicine Accelerator
Harvard Business School

Kathy Giusti, a multiple myeloma patient, is the Founder of the Multiple Myeloma Research Foundation (MMRF) and the Multiple Myeloma Research Consortium (MMRC). She is also the Chief Mission Officer of the MMRF. Kathy is the Henry & Allison McCance Family Senior Fellow at Harvard Business School, where she serves as Faculty Co-Chair of the HBS Kraft Precision Medicine Accelerator. Kathy has more than two decades of experience in the pharmaceutical industry, previously holding senior positions at G.D. Searle and Merck.

Since founding the MMRF in 1998, Kathy has become a widely respected leader in establishing innovative, collaborative research models in the areas of tissue banking, genomics, and clinical trials. These models are dramatically accelerating the pace at which lifesaving treatments are brought to patients and are building an end-to-end solution in precision medicine. Today, she is recognized as a pioneer of precision medicine, a champion of data sharing, and a strong advocate for patient engagement.

In 2016, Kathy was named Faculty Co-Chair of the Harvard Business School (HBS) Kraft Precision Medicine Accelerator, a $20 million program endowed by Robert Kraft and the Kraft Family Foundation. Under her leadership, the HBS Kraft Precision Medicine Accelerator convenes best-in-class leaders from science, business, and technology to identify and solve challenges slowing the advancement of precision medicine. The HBS Kraft PM Accelerator disseminates best practices and models to overcome these challenges, and ultimately enables faster adoption of high-impact innovations.

Kathy has earned numerous prestigious awards and recognitions, including being named 1 of 3 Top Business Leaders Disrupting Medicine by Fortune Magazine and #19 on Fortune’s World’s 50 Greatest Leaders list. She was also named one of the world’s 100 Most Influential People by TIME magazine. Kathy received the Open Science Champion of Change award by the White House. In addition, she has been honored with the American Association for Cancer Research Centennial Medal for Distinguished Public Service and the Healthcare Businesswomen’s Association’s Woman of the Year Award.

Kathy serves on the advisory boards of Verily and Verily’s Project Baseline and is a member of the Harvard Business School (HBS) Health Advisory Board. She a Member of the FasterCures Non-Profit Council. Kathy previously served on President Obama’s 2015 Precision Medicine Initiative Working Group, the President’s Council of Advisors on Science and Technology (PCAST), National Cancer Advisory Board (NCAB), and the National Cancer Policy Board (NCBP).

Kathy has been featured on the Today Show, NBC Nightly News, CBS Evening News, Fox News, CNN, and Bloomberg. Her efforts have also been profiled by Fortune, The Wall Street Journal, Harvard Business Review, The New York Times, Forbes, The New Yorker, WIRED, and Fast Company.

Kathy received her MBA in general management from Harvard Business School and holds an honorary Doctorate from the University of Vermont.

 

Laugh for Life:
New York

POSTPONED

Ziegfield Ballroom

Event information

Donec ullamcorper nulla non metus auctor fringilla. Duis mollis, est non commodo luctus, nisi erat porttitor ligula, eget lacinia odio sem nec elit. Donec sed odio dui. Donec ullamcorper nulla non metus auctor fringilla. Etiam porta sem malesuada magna mollis euismod. Maecenas sed diam eget risus varius blandit sit amet non magna. Sed posuere consectetur est at lobortis.

Etiam porta sem malesuada magna mollis euismod. Sed posuere consectetur est at lobortis. Vivamus sagittis lacus vel augue laoreet rutrum faucibus dolor auctor. Duis mollis, est non commodo luctus, nisi erat porttitor ligula, eget lacinia odio sem nec elit. Morbi leo risus, porta ac consectetur ac, vestibulum at eros.

Nicole Sandilands

RN, BSN, OCN

Nicole has been a registered nurse for five years, specializing in oncology and palliative care. She began her career as an inpatient oncology nurse at Yale providing bedside care to patients and then transitioned to Norwalk Hospital where she worked as a chemotherapy infusion nurse. She received her nursing degree from Fairfield University and is currently pursuing her doctorate in nursing practice (DNP). Her research focus is on “Chemo Brain” which is studying the cognitive changes experienced from receiving chemotherapy.

 

William_McKiernan_BW

William S. McKiernan

President
WSM Capital, LLC

Bill McKiernan is president of WSM Capital, LLC, a private equity firm he founded to invest in payment and other technology companies. Prior to founding WSM Capital, Bill founded CyberSource Corporation in 1994. CyberSource provides payment processing and other related services to online businesses. He was Chairman and CEO for 16 years. In July 2010, Visa, Inc. acquired CyberSource in a transaction valued at $2 billion. Mr. McKiernan served as Executive Advisor to Visa, Inc. for two years following the acquisition before founding WSM Capital in 2012.  

Mr. McKiernan holds a BS from Boston College and an MBA from the Harvard Business School. Prior to founding CyberSource he held positions at Price Waterhouse, IBM, and McAfee Associates.

In addition to the MMRF, he serves on the boards of trustees of Boston College, Bellarmine College Prep, and American Ireland Fund and is a member of Harvard Business School Global Advisors.

Greg Rubenstein - Vice President of Marketing and Communications

Greg Rubenstein is the VP of Marketing & Communications at the MMRF, where he leads all brand marketing strategy and execution in support of the organization.

Prior to joining the MMRF, Greg spent the majority of his career working for Advertising firms like Grey NY, Saatchi & Saatchi, FCB Health, and Deutsch -- servicing clients across a wide variety of sectors, including Healthcare, Technology, Financial Services, and Consumer Packaged Goods. He has brought to market countless products and campaigns over nearly 20 years, including high-profile healthcare launches in Vaccines and Women’s Health. In 2013 he joined a technology startup called Vettery, where he helped to launch the brand and all of its communications while serving as the company’s Chief Client Officer & lead brand strategist.

Greg is a graduate of Cornell University, with a B.S. in Psychology & Human Development. He resides in Irvington, NY with his wife and two sons.

Kristen Donadio

RN, BSN

Kristen has been a registered nurse for a little over 20 years. She spent the last 18 of those years working at the John Theurer Cancer Center (JTCC) in various nursing positions in both the Myeloma and Bone Marrow transplant clinics. Her last 2 years at JTCC were spent as the Administrative Supervisor of the Myeloma Division. She graduated from Stockton University with a degree in Public Health Administration, followed by an Accelerated Bachelor’s of Science in Nursing degree from Fairleigh Dickinson University. She is a member of the Oncology Nursing Society and she holds a certification in chemotherapy/biotherapy/immunotherapy administration. She is currently working towards her master’s degree in Healthcare Administration.

Sarah Coulter

RN, OCN

Sarah has been a registered nurse for the past five years, specializing in Hematology Oncology and Bone Marrow Transplant. She has spent over ten years in the Oncology field and started her career at Yale New Haven Hospital. Over the last three years, Sarah worked as a traveling nurse in California, South Carolina, Florida, Texas and Maryland. She earned her nursing degree from St. Vincent’s School of Nursing. She is chemotherapy certified and is currently in school to obtain her master’s degree in nursing education.

 

Meryl Zausner

Former Chief Financial Officer
Novartis Corporation

Meryl Zausner has over 35 years of management experience across the pharmaceutical and consumer products industries. Meryl was instrumental in creating the blueprint for the successful Novartis Oncology Business Unit and engineering the launch of the first Novartis shared services organization.  A recognized developer of diverse talent, The Healthcare Businesswomen Association honored Meryl with its prestigious Woman of the Year Award.

For much of her corporate career, Meryl worked at Novartis AG, the Swiss pharmaceuticals company, in roles of increasing responsibility across diversified businesses. From April 2012 through 2014, Meryl was Chief Financial and Administrative Officer of Novartis Pharmaceuticals Corporation in the US, and a member of the Pharmaceutical Executive Committee and Global Finance Leadership Team. While in this role, Meryl also resumed responsibility as Chief Financial Officer and Executive Vice President of Novartis Corporation in the US.

Acknowledging her strong leadership and broad achievements, Novartis selected Meryl to train and serve as a certified Executive Coach to senior executives, a position she held from May 2015 until her retirement at the end of June 2017.  She has a BS in Economics and Accounting from the University at Albany and her CPA.

Meryl is a Board member and Chair of the Audit Committee of the Multiple Myeloma Research Foundation, and Board member of Deirdre’s House, an advocacy center for children who are victims of abuse or neglect.  Former board positions include HBA Advisory Board, PhRMA Audit and Finance Subcommittee member, and the T.J. Martell

Foundation. PharmaVoice magazine recognized Meryl among its Most Inspiring, and she received Gilda Club’s Red Door Honoree. Meryl resides with her husband in Naples, Florida and Long Branch, New Jersey.

Steven Shak, MD

Co-Founder, Chief Scientific Officer
Genomic Health

Dedicated to optimizing cancer treatment outcomes and bringing the patient voice into product development, Steve Shak, M.D. has served as the Co-Founder and Chief Scientific Officer of Genomic Health since 2012, and was the Chief Medical Officer from 2000 – 2013. Under Steve’s leadership Genomic Health used innovative molecular diagnostic methods and rigorous clinical studies to develop the Oncotype DX® breast cancer and colon cancer assays and has maintained an 80% product development success rate. Steve has been a leader in personalized medicine for more than two decades.

Prior to co-founding Genomic Health in 2000, Steve served for 14 years in various roles in Discovery Research and Medical Affairs at Genentech, Inc., a biotechnology company dedicated to using human genetic information to discover, develop, manufacture and commercialize medicines to treat patients with serious or life-threatening medical conditions. Steve led the clinical team that gained approval for Herceptin®, a targeted biologic treatment for breast cancer. He also initiated the cancer clinical trials of the anti-angiogenesis agent, Avastin®.

In addition, Steve discovered Pulmozyme®, a mucus-dissolving enzyme that is approved worldwide for the treatment of the genetic disease cystic fibrosis.

Prior to joining Genentech, Steve was an Assistant Professor of Medicine and Pharmacology at New York University School of Medicine.

Steve holds a Bachelor of Arts degree in Chemistry from Amherst College and an M.D. from New York University School of Medicine, and completed his post-doctoral training at University of California, San Francisco.

Rodger Riney

Former CEO and Founder
Scottrade

Rodger Riney grew up in Kirkwood, Missouri, and graduated from the University of Missouri with a Civil Engineering degree and an MBA.

In 1969, he joined Edward D. Jones & Co. in Saint Louis and later became a partner. In 1980, he left to enter the relatively new discount brokerage industry by starting Scottrade. Over the years, Scottrade evolved into an online brokerage and bank supporting its 3 million clients through 500 branch offices nationwide.

In the fall of 2015, Rodger was diagnosed with multiple myeloma and in late 2017, Scottrade was sold to TD Ameritrade.

In 2019, Mr. Riney started Lightchain Capital LLC, with a focus on various capabilities investing in early-stage biotech technologies with an emphasis on therapeutics for blood cancer and multiple myeloma.

Michael Reinert

Partner
Fox Rothschild LLP

Michael Reinert is a leading music industry attorney who most recently served as Executive Vice President of Business & Legal Affairs for the Universal Motown Republic Group, a division of UMG Recordings, Inc. In that position, he had the pleasure of working with great talent such as Stevie Wonder, Elton John, Taylor Swift, Amy Winehouse, Lil Wayne, Nelly, Jack Johnson and many other platinum selling acts.

Prior to joining Universal ten years ago, Michael was the Vice President of Business & Legal Affairs for PolyGram Records, handling those duties for the legendary Verve Records label and Mercury Nashville Records where he worked with the likes of Herbie Hancock and Shania Twain. Michael started his career in private practice representing many artists, producers and writers before joining the corporate ranks.

Michael was an Adjunct Professor of Law at his alma mater, The Benjamin Cardozo School of Law of Yeshiva University, for ten years teaching Contract Drafting and Negotiation in the Music Industry. He has been a contributing editor to the Practicing Law Institute volumes on the same subject and continues to lecture at various schools and seminars around the country.

He currently serves as the Chairman of the Entertainment Law Initiative of the Grammy Foundation, a division of the National Academy of Recording Arts and Sciences, which focuses on legal education programs for aspiring entertainment attorneys.

Michael attended the Horace Mann School for Boys in Riverdale and Tulane University in New Orleans, a place he considers his second home. He lives in Manhattan with his wife of 30 years, Karen. They have a daughter and two beautiful grandchildren.

Marie E. Pinizzotto, M.D., MBA

President and CEO
Carol A. Ammon Foundation

Marie E. Pinizzotto, M.D., MBA, is currently the President and CEO of the Carol A. Ammon Foundation, a foundation focused on health care and education. Prior to running the foundation, she was president of Drug Safety Solutions, L.L.C., a Pharmacovigilance and Risk Management consulting company whose main focus was narcotics and other high-risk drugs.  Prior to starting her own company she worked at Endo Pharmaceuticals Inc. where she was Senior Director of the Global Safety and Pharmacovigilance department.  In this role she was responsible for pharmacovigilance of all Endo products, marketed and investigational. Marie was also responsible for the safety components in the following disciplines; Clinical Research, Medical Affairs and Clinical Education and Development. In addition, she led the Risk Management Team and was responsible for the creation and implementation of Endo’s risk management programs. Additionally, she was Senior Director of Report Evaluation and Safety Surveillance for the Women’s Health Division and Consumer Products at Wyeth. 

Dr. Pinizzotto received her B.S in Chemistry, magna cum laude, from the University of Pittsburgh, Pittsburgh Pennsylvania and her medical degree from Jefferson Medical College (now Sidney Kimmel Medical College)in Philadelphia. She completed her residency at The Medical Center of Delaware, where she practiced obstetrics and gynecology for nine years. She still maintains privileges at the hospital.  Most recently, Dr. Pinizzotto earned her MBA at the University of Delaware.

Currently, Dr. Pinizzotto is the named Chair of Obstetrics and Gynecology at Christiana Care Hospital, Newark, Delaware, and is also a trustee of the hospital.  She is a member of the finance committee and has participated on the Quality and Safety Committee at Christiana Care Health Systems.

In addition, she is a board member at Eisenhower Medical Center, Rancho Mirage, California, and also sits on the quality improvement committee. Marie is named Chair, The Marie E. Pinizzotto, MD Chair of Academic Affairs, at Eisenhower Medical Center.

Dr. Pinizzotto is a director of The Carol A. Ammon Foundation, The Multiple Myeloma Research Foundation and the Palm Springs International Film Festival. She also participates on the following advisory boards:  Scientific Steering Committee on Personalized Medicine for the Multiple Myeloma Research Foundation; The Presidents Leadership Council  of the University of Delaware, the Presidents Leadership Council at Jefferson Medical College and she is one of the founding members of the MGH Leadership Council for Psychiatry at Massachusetts General.

David R. Parkinson, MD

Chairman of the Clinical Advisory Board
Zyngenia. Inc.

From 2007 until 2012, Dr. Parkinson served as President and CEO of Nodality, a South San Francisco-based venture-financed biotechnology company developing technologies to enable personalized medicine and more efficient drug development in cancer and autoimmune diseases.

Before joining Nodality, Dr. Parkinson was Senior Vice President, Oncology R&D, at Biogen Idec, overseeing oncology discovery research efforts and the development of the oncology pipeline. Previously he had served tenures as Vice President and Head of the Oncology Therapeutic Area at Amgen and Vice President and Head of Global Clinical Oncology Development at Novartis. During his tenures at Amgen and Novartis, Dr. Parkinson was responsible for clinical development activities leading to a series of successful global drug registrations for important cancer therapeutics, including Gleevec®, Femara®, Zometa®, Kepivance®, and Vectibix®.

He received his M.D. from the University of Toronto Faculty of Medicine in 1977, with Internal Medicine and Hematology/Oncology training at McGill University and at New England Medical Center. Dr. Parkinson has authored more than 100 peer-reviewed scientific papers, and is a past Chairman of the Food & Drug Administration (FDA) Biologics Advisory Committee as well as a recipient of the FDA’s Cody Medal.

Laugh for Life:
New York

POSTPONED

Ziegfield Ballroom

Event information

Donec ullamcorper nulla non metus auctor fringilla. Duis mollis, est non commodo luctus, nisi erat porttitor ligula, eget lacinia odio sem nec elit. Donec sed odio dui. Donec ullamcorper nulla non metus auctor fringilla. Etiam porta sem malesuada magna mollis euismod. Maecenas sed diam eget risus varius blandit sit amet non magna. Sed posuere consectetur est at lobortis.

Etiam porta sem malesuada magna mollis euismod. Sed posuere consectetur est at lobortis. Vivamus sagittis lacus vel augue laoreet rutrum faucibus dolor auctor. Duis mollis, est non commodo luctus, nisi erat porttitor ligula, eget lacinia odio sem nec elit. Morbi leo risus, porta ac consectetur ac, vestibulum at eros.

Gerald McDougall

Partner
PricewaterhouseCoopers LLP

Mr. McDougall is Partner at PricewaterhouseCoopers Health Sciences Practice, where he provides services to academic medical centers, bioscience companies, pharmaceutical companies, research universities, colleges, health systems, and other research organizations. His practice provides a broad range of research business and compliance services, including strategic and business planning, financial analysis, research compliance, clinical research operations improvement, and information systems implementation services.

In addition, his practice provides support services to the entire research continuum, from grant-funded basic science research, to translational research and clinical trials, including a dedicated group focusing on Clinical Research Consulting services.

Susan Marvin

Chair of the Board – The Marvin Companies

Susan Marvin, Chair of the Board of The Marvin Companies, was part of the third-generation management team in what is today a fourth-generation family owned and operated company.

Active in both profit and nonprofit boards, Susan serves on The Marvin Companies Board of Directors, M. A. Mortenson Company Board of Directors, the Multiple Myeloma Research Foundation (MMRF) Board of Directors, the National Association of Manufacturers Board of Directors, the University of Minnesota Foundation Board of Trustees and she is Chair of the Minnesota Chamber Foundation Board. She is a member of the Young Presidents’ Organization (YPO) Gold.

Prior to her current role, Susan was President of Marvin Windows and Doors where she oversaw the fenestration business.

Susan is a 1979 graduate of the University of Minnesota where she earned an undergraduate degree in Journalism.  A native of Warroad, Minnesota, Susan now lives in both Warroad and Minneapolis with her husband, Keith Schwartzwald.

Hugh Martin

Vice President of Strategy, Smart Communities
Verizon

Hugh Martin joined Verizon through the acquisition of Sensity Systems by Verizon in October 2016. Hugh created the vision for Sensity Systems and the Light Sensory Network and is responsible for steering the company’s strategic course. His 35-year track record as an entrepreneurial leader of cutting-edge technology companies, new ventures, and high-growth businesses includes serving at the helm of numerous highly successful organizations. In 2011, he was named CEO for Fortune magazine’s ‘Executive Dream Team: The startup edition,’ acknowledged for his ‘management chops’ and for successfully taking public two companies, in two different industries. Most recently, the World Economic Forum recognized Hugh and Sensity as a Technology Pioneer.

Prior to Sensity, Hugh was chairman and CEO of Pacific Biosciences, a leading company in third-generation DNA sequencing. He founded Pacific Biosciences in 2004 with a team from Cornell University and piloted the company through its IPO in 2010 and commercialization in 2011. Before that, he was chairman, president, and CEO of ONI Systems, a high-speed optical telecommunications systems company he founded in 1998 and took public in 2000. Named the Fastest Growing Company in Silicon Valley in 2001, ONI was sold to Ciena in 2002; Hugh then served as a consultant to Ciena.

During his career, Hugh also was president and director of 3DO, an interactive gaming company; served as a CEO-in-residence at the venture capital firm of Kleiner Perkins Caufield & Byers; and ran desktop engineering for Apple Computer. Earlier, he founded Ridge Computers, designer of the world’s first commercial reduced instruction set computing (RISC) minicomputer.

He earned a BS in electrical engineering from Rutgers, the State University of New Jersey-New Brunswick.

David L. Lucchino

Co-Founder, President and Chief Executive Officer
Frequency Therapeutics

David has played an integral role in launching, building and operating several successful companies in the life sciences. In 2014, he, along with Robert S. Langer at the Massachusetts Institute of Technology and other co-founders, started Frequency Therapeutics with the goal of developing regenerative medicines based on discoveries related to activating progenitor cells.

Before Frequency, David was President and Chief Executive Officer of Entrega Bio, a PureTech Health-founded biotechnology company focused on oral drug delivery technology. Prior to that, David co-founded, also with Dr. Langer, Semprus BioSciences. At Semprus, David oversaw the development of the company’s lead medical product, which focused on surface modifications designed to reduce infection and clotting, and which received FDA and European CE marketing clearance. Semprus was acquired in 2012 by Teleflex, Inc. Prior to Semprus, David worked at the investment firm Polaris Partners.

David currently serves as the Chairman of the Board of Directors of MassBio. He is a member of the College of Fellows of the American Institute for Medical and Biological Engineering and was appointed by Governor Charlie Baker to the Commonwealth’s Science, Technology, Engineering and Math Advisory Council. He also serves as a trustee of Mt. Auburn Hospital, a Harvard Medical School facility, a trustee of the Multiple Myeloma Research Foundation, and a member of the Board of Advisors of Life Science Cares.

David earned a B.A. from Denison University, an M.S. from the Newhouse School of Journalism at Syracuse University and an M.B.A. from the MIT Sloan School of Management as an Alfred P. Sloan Fellow.

Dana LaForge

Partner
Brera Capital Partners, LLC

Dana LaForge is a Partner at Brera Capital Partners, a private equity fund, and the Founder and Managing Partner of Colonnade Financial Group, a private equity services firm.

Prior to Brera and Colonnade, Dana was head of Financial Institutions Investment Banking and Chief of Staff of Banking and Capital Markets at Deutsche Bank and its predecessor companies. Earlier in his career, he was a bond trader and founded the Mortgage Finance Group.

Dana has served on numerous portfolio company boards and is the Chairman of GAB Robins NA. He was one of the earliest Directors of the Multiple Myeloma Research Foundation joining the Board in 1999 and helping guide the Foundation from start up through today serving as the organization’s only Chairman since being elected in 2003.

Dana earned a BS from Washington and Lee University and an MBA from Harvard Business School. He lives in New York City with his wife, Kathleen McCabe and their two daughters.

Rodney Gilmore

Corporate and Business Law
Doty Barlow Britt & Theiman LLP

Rodney Gilmore is an attorney in the California Bay Area and a longtime college football broadcaster.

Gilmore joined ESPN in August of 1996 as a college football analyst. He currently works on ESPN/ABC Saturday telecast and contributes to studio shows including College Football Live, Outside the Lines and SportsCenter. He previously served as an ESPN studio analyst and a contributor to ESPN.com and ESPN The Magazine (out of print as of 2019).

Prior to joining ESPN, Gilmore worked as an analyst with Prime Sports Network in California (1993-95), covering Pac-10 football, along with SportsChannel Bay Area from 1991-93 and the Pacific Sports Network in 1990. He was nominated for an Emmy Award in 1994 for live sports coverage of Pac-10 football.

A 1982 Stanford University graduate with a degree in English, Gilmore was a defensive back under coaches Bill Walsh, Rod Dowhower, Paul Wiggin and George Seifert, and also played baseball for Stanford.

Following graduation from Stanford, he earned his law degree from the University of California at Berkeley (Boalt Hall) in 1986, and was admitted to the California State Bar the same year.  He began his law career in Los Angeles with the firm of Manatt Phelps & Phillips, LLP before returning to the Bay Area in 1988. He became a partner in the San Francisco business law firm Greene Radovsky Maloney & Share LLP in 1993. In 1997, he joined the Palo Alto, CA business law firm of Doty, Barlow, Britt & Thieman LLP. Rodney specializes in transactional law with an emphasis on business formation and planning, mergers and acquisitions, and commercial transactions. He also has extensive experience in commercial real estate matters, including sales and acquisitions, financings and leases.

Gilmore is a longtime volunteer for Stanford. He is a member and former officer of two entities sponsored by the Stanford Alumni Association. He previously served as chairman of the Stanford Athletic Board and as a member of the Board of Directors of the Stanford Alumni Association. He is also an active member of several Bar Associations and several local community organizations.

An Oakland, CA native, Gilmore is a member of the Oakland Babe Ruth Baseball Hall of Fame. He lives in the Bay Area with his wife, Marie, the former Mayor of Alameda, CA, and has two adult children (Anthony and Nicole).

Thomas Conheeney

Retired President
SAC Capital

Tom was appointed President of SAC Capital in July 2008. He joined SAC in October 1999 as Chief Operating Officer.

Prior to joining SAC, Tom was President of Investment Management Services, Inc (“IMS”) from 1996 to 1999. He joined Moore Capital /IMS in 1993 and served as its Director of Trading Operations and then Vice President until IMS split off from Moore in 1995. Tom joined Moore Capital /IMS from Goldman Sachs Trust Company, where he was a Vice President with responsibilities for daily operations, technology, and client services. From 1986 to 1993, Tom was in the operations and equity divisions of Goldman, Sachs & Co., becoming Vice President in 1991.

He retired from SAC December 2014.

Karen E. Andrews

Karen E. Andrews

Senior Vice President and General Counsel
March of Dimes

Karen E. Andrews is currently SVP and General Counsel for the March of Dimes. Previously Karen was the General Counsel and Corporate Secretary of BBDO Worldwide, Inc. where she was responsible for the management of the legal activities of over 150 individual operating units throughout the world.

Prior to joining BBDO Worldwide, Ms. Andrews was Associate General Counsel and Director of Television Business Affairs at Time Inc. Ms. Andrews began her career in law as a Litigation Associate at the New York law firm of Weil, Gotshal & Manges where she specialized in Entertainment Litigation.

Ms. Andrews graduated cum laude from the University of Vermont with a Bachelor of Science degree in biology and earned her law degree, cum laude, from Temple School of Law.

Ms. Andrews is a member of the American Bar Association and the New York State Bar Association.

In 1998, Ms. Andrews co-founded the Multiple Myeloma Research Foundation with Kathy Giusti.

Kenneth Anderson, MD

Director
Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute

Dr. Anderson graduated from Johns Hopkins Medical School. He trained in internal medicine at Johns Hopkins Hospital and completed hematology, medical oncology, and tumor immunology training at the Dana-Farber Cancer Institute.

Dr. Anderson is the Kraft Family Professor of Medicine at Harvard Medical School and serves as Chief of the Division of Hematologic Neoplasia, Director of the Jerome Lipper Multiple Myeloma Center, and Vice Chair of the Joint Program in Transfusion Medicine at the Dana-Farber Cancer Institute.

He received the Waldenstrom’s Award in 2003 for his translational research directed to the development of novel therapeutics targeting the myeloma cell in its microenvironment and is a Doris Duke Distinguished Clinical Research Scientist.

In addition to serving on the Board of Directors of the MMRF, Dr. Anderson serves as Chairman of the MMRF’s Scientific Advisory Committee, Chairman of the Multiple Myeloma Research Consortium, and Chairman of the National Comprehensive Cancer Network’s Multiple Myeloma Clinical Practice Guidelines Committee.