This category includes articles about social entrepreneurs, typically about businesses with a for-profit model with a social mission embedded into the fabric of the business.
This category includes articles about social entrepreneurs, typically about businesses with a for-profit model with a social mission embedded into the fabric of the business.
Entry into India, Innovairre’s 28th country, enables the company to leverage its proven fundraising solutions and support the urgent needs of the world’s second most populated nation.
PENNSAUKEN, NJ – March 24, 2015 – Innovairre Communications, a world leader in fundraising, formally announced a partnership with IQR Consulting, the 6-year-old data analytics/data services and marketing firm from Western India. The strategic partnership follows up on Innovairre’s commitment to growth by delivering new, advanced fundraising solutions.
Since forming Innovairre in December 2014, the company has introduced four new data/technology-driven products to the marketplace: Innovairre MC, a fully-integrated, cloud-based fundraising platform; Donor2, the marketplace’s first turnkey donor retention solution; Social Synchronization, a data-driven targeting solution that synchronizes offline marketing with social media activity; and e-Receipts, an omni-channel marketing automation solution that enhances donor engagement.
Beyond its commitment to data/technology-driven solutions, the partnership to enter the Indian market supports Innovairre’s commitment to international expansion. Don McKenzie, Innovairre President & CGO, stated, “The company has been methodical in our global expansion, starting with North America, expanding to Western Europe, and now we’re focused on emerging markets that have large, growing, philanthropically-minded middle-class populations and important social needs. Recently we entered Brazil, and that foray has been extremely successful. India, with its population of 1.3 billion and many important issues, was the next logical market for us.”
Rahul Nawab, CEO of IQR Consulting, indicated, “Innovairre’s fundraising expertise and comprehensive solution set is particularly well-matched with our evolving needs in India. We’re also confident IQR’s unmatched data and analytical strength in India will enable us to expand quickly, improving the lives of millions of Indians. We are overjoyed that Innovairre chose IQR Consulting as its strategic partner in India.”
Innovairre’s Indian entry is also part of Innovairre’s Asian expansion plans. The company has maintained a sophisticated manufacturing capability in China during the past 20 years, with three locations and one million sq. ft. of production, design, and service capabilities. Innovairre is also now exploring opportunities in other Asian markets.
About Innovairre Communications
Innovairre is the worldwide leader in fundraising, supporting agencies and nonprofit organizations. Innovairre services more than 500 charities, with 4000+ employees, working across five continents. Innovairre leverages a scientific marketing approach, including advanced data analytics and insights; progressive digital marketing; leading-edge technologies; a proven creative and testing methodology; and unsurpassed capabilities in direct mail development, digital printing, and premiums for the nonprofit sector. Innovairre also supports many leading commercial companies and has specialized expertise in the financial, insurance, healthcare, publishing, and retail categories. For more on Innovairre, visit Innovairre.com, or follow us on Twitter or LinkedIn @Innovairre.
About IQR Consulting
Established in 2009, IQR Consulting offers integrated, quality-driven solutions for its clients. The international company delivers real results through data analytics, product strategy, and reporting solutions to help clients obtain bottom-line results with a much-needed competitive edge. The analysts at IQR are experts in the use of segmentation as a means for highly targeted marketing. With accurate and actionable insights and analysis, IQR is helping credit unions, banks, and casinos leverage data assets to increase profitability and better compete against larger institutions. IQR’s rapidly-expanding client base includes Fortune 500 companies and is a testament to its success providing workable, strategic solutions to difficult problems. For more information, visit IQRdataanalytics.com, and follow us on Twitter @data_analysts.
Washington, D.C. – SCORE, – www.SCORE.org – announces the 2015 SCORE Awards taking place on September 17, 2015 in Washington, DC. The seventh annual awards gala recognizes exceptional American small business owners and non-profit organizations whose success has helped to impact our nation, and who have achieved this success in part through SCORE’s services. SCORE offers free small business advice through its nationwide network of 11,000+ volunteer mentors and through its comprehensive database of free webinars, templates, and tools at www.SCORE.org. Clients who have utilized these services and have been able to create new jobs, grow revenue, and realize their goals as small business owners will be among the award recipients.
“We are proud and excited to once again shine the spotlight on the small businesses and supporters that are changing the landscape of entrepreneurship in America,” said SCORE CEO Ken Yancey. “Every year our SCORE Award winners show us how bright the future of small business is in this country and how SCORE mentors are helping make that future even brighter.”
John Wandishin, Vice President of Marketing at Brother International, will serve as the Chair of the 2015 SCORE Awards. Brother (www.brother.com) is an industry leading provider of small and mid-sized business printing and imaging solutions developed to help increase productivity, improve workflow, and enhance organizational efficiency, all while helping to reduce costs.
“Brother is in the business of helping small business owners succeed,” Wandishin said. “It is a thrill to partner with SCORE in celebrating American small businesses that have found their success. I know in doing so we will inspire other entrepreneurs to launch new businesses or grow existing companies.”
The complete list of this year’s award categories is as follows:
This year’s nomination process includes the submission of a business “selfie” showcasing your outstanding business at work. Self-nomination is encouraged, there are no costs associated with nomination submissions and all nominations must be submitted by April 17, 2015. Voting will take place from March 20 through April 24, 2015. For further details about the SCORE Awards, past winners, award sponsors or to submit a nomination, visit www.score.org/score_awards
Since 1964, SCORE has helped more than 10 million aspiring entrepreneurs. Each year, SCORE provides small business mentoring and workshops to more than 375,000 new and growing small businesses. More than 11,000 business experts volunteer as mentors in over 320 chapters serving local communities with entrepreneur education.
For more information about starting or operating a small business, call 1-800/634-0245 for the SCORE chapter nearest you. Visit SCORE at www.score.org. Connect with SCORE at www.facebook.com/SCOREFans and www.twitter.com/SCOREMentors.
About The SCORE Foundation
The mission of The SCORE Foundation is to support and leverage the work of SCORE by soliciting, investing and managing resources for the benefit of SCORE. Learn more about The SCORE Foundation at www.scorefoundation.org
Saxon/Hart, New York City’s first cause marketing alliance, is proud to co-sponsor two days of beauty and renewal for fifteen special women, all of whom have battled breast cancer before the age of 40 and survived. As a part of the ongoing #BLANKCANCER awareness campaign, the ladies – patients at The Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai – will be treated to a day of beauty, pampering and makeovers.
Taking place on March 20th and 21st, the event is being co-sponsored and hosted at The Red Door Spa, located in Union Square, NYC. Services provided will include wig styling, haircuts, coloring and manicures.
Breast cancer is the most commonly diagnosed cancer in women in the United States. It is estimated that one in eight women will develop breast cancer in her lifetime. Among the fifteen women that will be participating, all have undergone breast cancer treatment, including surgery, chemotherapy and radiation.
Alexandra Russo, social worker at The Dubin Breast Center and group facilitator for the Young Women Connect Support Group, shares her excitement, stating, “These young women have endured many changes and losses through treatment and are eager to move towards regaining their sense of self, especially when it comes to body image. I know they are so appreciate of what’s sure to be a fun, restorative day of pampering.”
The #BlankCancer campaign aims to bring awareness to all cancers through a unique, interactive social media initiative, supported by makeover events like these. Participants can easily join the cause by printing a sign at www.saxonhart.com, filling in the blank – telling the world what they’d like to do to cancer – taking a selfie and sharing across Facebook, Twitter and Instagram.
“Each month, we honor and recognize different cancer fighters and survivors, in an effort to bring awareness to the cause. Our goal through the #BLANKCANCER campaign is to show that we are all in this fight together. We’re excited to honor these outstanding women, by helping them to see how beautiful they are both inside and out” says Heidi Burkhart, president of Saxon/Hart.
Projects in California, Connecticut, and Wisconsin to focus on racial disparities in child welfare and juvenile justice
WASHINGTON, DC — TODAY the National Council on Crime and Delinquency (NCCD), a grantee of the Social Innovation Fund’s Pay for Success program, announced projects in three states to assess feasibility and develop Pay for Success capacity. Three projects will receive technical assistance from NCCD for up to two years: YouthStat, a program of the City of New Haven, Connecticut; Alternatives to Detention and Placement, a program of the San Diego nonprofit the Children’s Initiative; and One Summer Plus, a program of Milwaukee’s nonprofit Community Advocates Public Policy Institute.
“NCCD strongly believes that Pay for Success creates a real possibility for sustained, positive change in the child welfare and juvenile justice systems,” said Kathy Park, acting president of NCCD. “We are proud to work with these three extremely dynamic programs to see if this innovative financing will work for them.”
In October, NCCD received $863,959 in investments from the Corporation for National and Community Service’s (CNCS) Social Innovation Fund (SIF). As part of the SIF’s Pay for Success Initiative, NCCD is helping strengthen the pipeline of state and local governments and service providers prepared to implement Pay for Success projects across the country.
“The SIF Pay for Success grantees held highly competitive, open competitions to select communities in need of services and here we’re seeing the results of those competitions,” said Lois Nembhard, acting director of the Social Innovation Fund. “We couldn’t be more enthusiastic for NCCD and their selection of programs, all charged with the important mission to measurably improve the lives of people most in need.”
The Social Innovation Fund and its non-federal partners have committed to investing more than $700 million in effective community solutions. NCCD’s project aims to assess feasibility and develop Pay for Success capacity in jurisdictions from the states with the highest rates of racial and ethnic disparities in these systems. NCCD released a request for proposals in December for programs in California, Connecticut, Illinois, Massachusetts, Minnesota, Nebraska, New Jersey, New York, Pennsylvania, Rhode Island, Washington, DC, and Wisconsin.
“We received competitive proposals from states across the country,” said Deirdre O’Connor, senior program specialist at NCCD. “Through careful review and discussion, we selected our final three programs. We look forward to working with each to bring them one step closer to successfully implementing the Pay for Success model.”
About New Haven’s YouthStat Program
This initiative brings together city departments, the Board of Education, state agencies and community groups to identify and evaluate at-risk adolescents, and then intervene and intercept as necessary with personalized action plans to engage the youth and provide positive options. Youth Stat utilizes a strengths-based approach and provides each participating youth with a support team, an individualized Success Action Plan, an adult mentor, academic support, after school or jobs skills programming, and access to mental health and basic need services.
About The Children’s Initiative
The Children’s Initiative provides leadership, technical assistance, advocacy and cross-system collaboration to improve the lives of children and families. The Children’s Initiative works to assist government, schools and community organizations in being more efficient, increasing investment in prevention and intervention programs, maximizing dollars for direct services in communities, reducing violence and crime, and increasing academic success for our children and youth. For more information about The Children’s Initiative, visit www.thechildrensinitiative.org.
About Community Advocates Public Policy Institute
The Public Policy Institute (PPI) was founded in 2008 as a division of Community Advocates, a nonprofit serving low-income people in Milwaukee since 1976. PPI pursues its mission to prevent and reduce poverty while fostering wellness through a combination of local and national-scope work. The approach includes public health prevention work, re-granting to community-based agencies, policy research/advocacy, and a Minority Male Achievement Initiative. PPI seeks to develop evidence-based policy and prevention programs to reduce poverty, narrow disparities, and promote social justice and public health.
About the National Council on Crime and Delinquency
NCCD promotes just and equitable social systems for individuals, families, and communities through research, public policy, and practice. NCCD offices are located in Washington, DC; Oakland, CA; and Madison, WI. For more information about NCCD, visit www.nccdglobal.org.
About the Social Innovation Fund
The Social Innovation Fund, a program of the Corporation for National and Community Service, combines public and private resources to grow the impact of innovative, community-based solutions that have compelling evidence of improving the lives of people in low-income communities throughout the United States. The SIF focuses on overcoming challenges in three areas of priority need: economic opportunity, healthy futures, and youth development. To learn more, visit www.nationalservice.gov/sif.
About the Corporation for National and Community Service
The Corporation for National and Community Service is a federal agency that engages more than five million Americans in service and champions community solutions through its AmeriCorps, Senior Corps, Social Innovation Fund, and Volunteer Generation Fund programs, and leads the President’s national call to service initiative, United We Serve. For more information, visit NationalService.gov.
High Priority Meetings Begin Soon in Washington DC, New York, Philadelphia and Pittsburgh
PHILADELPHIA – Keiretsu Forum Mid-Atlantic has recently announced its full meeting schedule for March 2015. These meetings are designed to invoke discussion on a wide range of different topics including the culture of entrepreneurs and more.
The Keiretsu Forum Mid-Atlantic New York chapter will hold its meeting on Tuesday, March 24 from 8:30AM to 12:30PM at 345 Park Avenue in New York City. The meeting will be held at the Loeb & Loeb location and will be open to members, guests, sponsors, partners and all presenting entrepreneurs.
The Keiretsu Forum Mid-Atlantic Philadelphia chapter will have its forum meeting on Wednesday, March 25 from 8:00AM to 12:00PM on the 12th floor of the Cira Center at 2929 Arch Street.
The Keiretsu Forum Mid-Atlantic Washington, DC chapter will have its meeting on Thursday, March 26 from 9:00AM to 1:00PM at 1050 Connecticut Avenue, NW.
The Keiretsu Forum Mid-Atlantic Pittsburgh chapter will have its meeting on Friday, March 27 from 8:30AM to 12:30PM on the 27th floor of 5th Avenue Place.
Keiretsu Forum Mid-Atlantic is actively looking for female investors, as they are beginning to take a more active role in angel investing. Only a decade ago, women made up less than 10 percent of angel investors. Now that number is closer to 20 percent, according to a recent Bloomberg article. Women are said to control 80 percent of all consumer spending and, as a result, are now moving into a much more powerful position with regards to investing as well. In 2014 alone, angel investors participated in over 67,000 deals for a total of $23 billion dollars.
Additionally, it’s important to note that there are only a few days left to take advantage of the Keiretsu Forum Mid-Atlantic “Founding Member” status. The status will disappear from all area chapters forever as of March 31, 2015. In exchange for a significant time commitment that includes leading one Due Diligence project each year while working on two others, every “Founding Member” will pay only half of the full member amount that they normally would. These “Founding Member” positions are already gone from the Philadelphia and Pittsburg chapters, though New York and Washington, DC still have positions available.
In addition to the aforementioned responsibilities, “Founding Members” will also need to bring qualified, accredited investor guests to the types of meetings that Keiretsu Forum Mid-Atlantic are having on a monthly basis across the United States – including the ones that are taking place in March.
To find out additional information about the Keiretsu Forum Mid-Atlantic March 2015 meeting schedule, or about the limited opportunity to obtain “Founding Member” status in a particular chapter, visit the organization’s official website at www.KeiretsuForum-MidAtlantic.com.
About Keiretsu Forum
Keiretsu Forum is a global angel investor network with more than 1400 accredited investor members throughout 34 chapters on three continents. Keiretsu Forum Mid-Atlantic (www.KeiretsuForum-MidAtlantic.com) consists of four chapters that function as a single entity – Philadelphia, DC, Pittsburgh and New York. Keiretsu is a Japanese term for a group of organizations with interlocking business relationships, and Keiretsu Forum is a group of accredited investors with interlocking investment interests. Each chapter or region meets monthly to present rigorously screened candidates for investments. Keiretsu Forum’s mission is “Great Association with Quality Deal Flow.”
The Mid-Atlantic Region presents approximately five deals a month, 60 a year, to its members and accredited investor guests. Slightly more than 10 percent get funded, which is higher than the industry average. Approximately 36 funding applications are submitted each month to the K4-MA DealRoom website, www.K4-DealRoom.com and vetted by industry specialists. Of the 36 funding applications submitted, about 10 are then vetted by members at monthly screening meetings. There, they participate in a highly structured presentation-and-feedback-learning session. Three to four of the screened companies are then invited to present at subsequent monthly Forum meetings. Entrepreneurs invited to move forward to the Forum meetings must participate in mandatory professional coaching sessions to optimize the delivery of their presentations and also agree to participate in the road show to all four cities in the region, with exposure to approximately 100 investors. Subsequently, all 1400+ members post information about their companies on the organization’s online global deal room for reference. For global information visit: www.KeiretsuForum.com.
Collaboration Puts AvalonBay Among Leading Red Cross Partners
ARLINGTON, VA — AvalonBay Communities, Inc., a NYSE listed real estate investment trust (REIT), has announced a partnership with the American Red Cross to support their core mission of preventing and alleviating human suffering in the face of emergencies. AvalonBay has committed $1 million over a four year period to fund the Red Cross partnership.
Timothy J. Naughton, Chairman and CEO of AvalonBay, commented: “We are honored to partner with the American Red Cross. Our commitment to investing in building strong communities includes making those communities better prepared for natural and human disasters. The Red Cross has supported AvalonBay and the residents of our apartment communities in times of need in many ways throughout the years, and we look forward to deepening our relationship with them and supporting their mission.”
The partnership will actively engage AvalonBay’s associates as well as residents of its apartment communities across the country in a variety of Red Cross activities including blood drives, CPR training, individual disaster response training, community response education, pet preparedness and local volunteer opportunities.
“We are truly excited about AvalonBay’s commitment to their communities through the American Red Cross,” said Linda Mathes, CEO of the American Red Cross in the National Capital Region. “This collaboration provides life-saving information and resources directly to the Company’s residents and employees – enhancing their safety and readiness. Our relationship strengthens local communities and creates a powerful network of preparedness.”
The national partnership with the Red Cross is one component of AvalonBay’s philanthropic efforts and commitment to corporate responsibility. The company has a history of giving back by sharing its resources, talent and time to make meaningful, lasting change in the neighborhoods where it does business and promote the well-being of those who live there. In addition to its focus on community preparedness, AvalonBay supports charitable organizations, in its local markets, focused on affordable housing and supporting the disadvantaged.
About AvalonBay Communities, Inc.
As of December 31, 2014, the Company owned or held a direct or indirect ownership interest in 277 apartment communities containing 82,487 apartment homes in eleven states and the District of Columbia of which 26 communities were under construction and eight communities were under reconstruction. The Company is an equity REIT in the business of developing, redeveloping, acquiring and managing apartment communities in high barrier-to-entry markets of the United States. More information may be found on the Company’s website at http://www.avalonbay.com.
Teams Made Up of Association CEO, Member and Young Leader Spend One Day with Other Teams to Craft Plan for Change
Washington, D.C. – Association leaders from across the region will participate in a day-long capacity-building workshop on March 20 designed to spark big changes within individual organizations and across the association landscape.
Co-hosted by Tom Raffa and Seth Kahan, “Grand Challenges: Harnessing Your Association’s Unique Business & Social Value to Drive Membership and Benefit Society” brings together three members from each participating association to plan a Grand Challenge. Each invited association will bring their current CEO, one association member and an up-and-coming young leader.
“A Grand Challenge is a skeleton key that opens three doors: growth; mission impact; and sustainable, profitable revenue,” says Seth Kahan, author of 2013’s Getting Innovation Right. “A Grand Challenge is especially valuable to scalable associations because it grows their stakeholder base exponentially. A Grand Challenge is a bold, audacious, socially beneficial goal aligned with the organization’s mission that captures the public’s imagination.”
“There will be three people from every organization which will allow us to do a deep dive into the realities of systemic change, and to work with tomorrows’ leaders, as well as today’s,” said Kahan.
“We want to help associations transcend the ‘membership mindset’ and catalyze a movement aimed at leveraging the power of associations to solve the world’s greatest challenges,” said Tom Raffa, CEO of Raffa, a B-Corp certified, national top 100 accounting, consulting and technology firm. “My experience shows that early adopters will lead the transformation that is happening in this sphere and redefine what the association community can accomplish together.”
CEOs who are in the midst of conducting their own Grand Challenges will be sharing what they are learning: the good, the bad, and the ugly, so attendees can build on their know-how as they shape your own challenges.
The keynote speaker will be Lisa Earle McLeod, Sales Leadership expert for Forbes.com, and author of four bestselling books, including Selling with Nobel Purpose. McLeod is a sought-after expert, having appeared on NBC Nightly News, The Today Show, and Good Morning America. Her next book is entitled Leading with Nobel Purpose.
“Grand Challenges” is invitation-only and already includes leaders from the American Geophysical Union (AGU); American Association of University Women (AAUW); Endocrine Society; Industrial Hygiene Association (AIHA); and American Nurses Association (ANA).
Grand Challenges: Harnessing Your Association’s Unique Business & Social Value to Drive Membership and Benefit Society
March 20, 9:30 am – 6:30 pm
American Geophysical Union in Washington, DC
$300 for each association team
Contact Seth Kahan at Seth@VisionaryLeadership.com if your association is interested in attending.
About Tom Raffa
Tom Raffa helps nonprofit organizations and businesses build capacity and sustain excellence in all areas of their operation. He is the President and CEO of Raffa, PC, a B-Corp certified, national top 100 accounting, consulting and technology firm and founder of Companies for Causes, a collective of socially conscious CEOs whose mission is to solve the problems of their community using targeted philanthropy and hands-on engagement from member CEOs. Raffa is the recipient of the 2014 Pearl Foundation Award for Innovation in Philanthropy.
About Seth Kahan
Seth Kahan has worked with over 100 CEOs and agency heads in both the private and public sectors. He has led change initiatives working with the Peace Corps, World Bank, Shell, and Prudential, and is identified as a Thought Leader and an Exemplar in Change Leadership. Kahan is the bestselling author of Getting Change Right: How Leaders Transform Organizations from the Inside Out.
SDSU Kyoto Prize Symposium honors Robert Langer, Sc.D., whose work has impacted an estimated two billion lives.
SAN DIEGO (Monday, March 16, 2015) — A teacher, engineer, inventor, entrepreneur and pioneer — just some of the words that describe Robert Langer, Sc.D., the founder of the field of tissue engineering used in medicine for the regeneration of tissues and organs, and the creator of the revolutionary drug delivery system (DDS) technologies.
It is estimated his work has impacted at least two billion lives.
Langer is the Kyoto Prize Laureate in advanced technology for this year’s Kyoto Prize Symposium at San Diego State University on Wednesday, March 18. He will be honored and will lecture on “Biomaterials and Biotechnology: From the discovery of the first angiogenesis inhibitors to the development of controlled drug delivery systems and the foundation of tissue engineering.”
“I am thrilled personally for myself, and I also am thrilled that my field, bioengineering, is being recognized,” Langer said.
Sponsored by the Inamori Foundation, the Kyoto Prize Symposium features lectures by esteemed scholars in three fields, including basic sciences, advanced technology and the arts and philosophy. One of SDSU’s signature events, the annual symposium honors these laureates who have had outstanding lifetime achievement.
“I think if you really believe in yourself, if you are persistent and work hard, there is very little that is truly impossible.”
Langer, who said he was inspired to create and invent because of his desire to do good and use science and engineering to accomplish that, founded tissue engineering which is indispensable for the implementation of regenerative medicine. His technique applies biodegradable polymer technologies to construct “scaffolds” for cell growth, contributing to the regeneration of tissues and organs. His development of DDS technologies allows for the controlled release of proteins, nucleic acids and other macromolecular drugs.
Though his contributions to his field are monumental, Langer said he is most proud of the young minds he has trained in his lab — 800 is the latest count. Many have gone on to successful careers and more than 270 are now professors.
“If I had any advice, any words of wisdom for young people it would be to dream big dreams about how you can do things to help people and to improve the world,” Langer said. “And there may be many times when you try to do something, when you try to develop a new product, or create a new engineering principle or whatever your dream is, that people tell you that it’s impossible, that it will never work. But I think that is very rarely true. I think if you really believe in yourself, if you are persistent and work hard, there is very little that is truly impossible.”
The most cited engineer in history
At 43, Langer was the youngest person in history to be elected to all three American science academies: the National Academy of Sciences, the National Academy of Engineering and the Institute of Medicine. He is the most cited engineer in history; his research has been cited more than 170,000 times and his laboratory at MIT is the largest biomedical engineering lab in the world. He has written more than 1,300 articles and has more than 1,000 patents worldwide.
Langer has received more than 200 major awards and is one of four living individuals to have received both the United States National Medal of Science and the United States National Medal of Technology and Innovation.
He received his bachelor’s degree from Cornell University in 1970 and his Sc.D. from the Massachusetts Institute of Technology in 1974, both in chemical engineering. He has received more than 24 honorary doctorates from universities including Harvard, Yale, Northwestern and Boston.
Each year, as part of the events, SDSU graduate students who have an SDSU faculty adviser are invited to compete for an Inamori Fellowship. Applicants must have at least two semesters remaining in their program and are reviewed on work completed and planned; academic background; scholarly accomplishments; training environment including time used to focus on research; and a faculty mentor recommendation. Each Inamori Fellow receives a $5,000 scholarship.
This year’s Inamori Fellows are:
Kyoto Symposium event details
The symposium will be held from 10 to 11:30 a.m. on Wednesday, March 18, in Montezuma Hall at the Conrad Prebys Aztec Student Union.
The event is free and open to the public, but registration is requested. Register online.
About San Diego State University
San Diego State University is a major public research institution offering bachelor’s degrees in 89 areas, master’s degrees in 78 areas and doctorates in 21 areas. The university provides transformative experiences, both inside and outside of the classroom, for its 34,000 students. Students participate in research, international experiences, sustainability and entrepreneurship initiatives, and a broad range of student life and leadership opportunities. The university’s rich campus life features opportunities for students to participate in, and engage with, the creative and performing arts, a Division I athletics program and the vibrant cultural life of the San Diego region. For more information, visit www.sdsu.edu.
Study Timeline Remains Unchanged, IRB Approval Process Begun
Minor Changes to Patient Eligibility, Endpoint Assessment and Crossover of Patients
KNOXVILLE, Tenn.– (BUSINESS WIRE) — Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT) (http://www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company (“Provectus” or the “Company”), announced today that the amended protocol for its phase 3 study of PV-10 as a treatment for melanoma is now available at: http://clinicaltrials.gov/ct2/show/study/NCT02288897. The Company does not require additional review from the U.S. Food and Drug Administration(the “FDA”) to start the phase 3 study, and has begun the process of gaining approval from the Institutional Review Board (IRB) of each individual site for the amended protocol.
Minor changes to the protocol affect patient eligibility, endpoint assessment and late crossover of patients. Specifically, the protocol has changed upon the advice of the FDA in the following ways:
The Company amended its phase 3 protocol following a Type C meeting with the FDA to review certain operational aspects of the protocol. The meeting was held by teleconference on January 29, 2015. Topics formally reviewed included subject eligibility requirements, primary and secondary study end points, and study lesion definitions and conventions for defining disease progression. The outcome of the review does not affect the fundamental design of the study nor the patient population.
The amended protocol states that the study is “an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy with dacarbazine (DTIC) or temozolomide (TMZ) to assess treatment of locally advanced cutaneous melanoma in patients who are BRAF V600 wild-type and have failed at least one immune checkpoint inhibitor or are not otherwise candidates for an immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator’s choice of dacarbazine or temozolomide as determined by Investigator preference and/or local availability of the agent. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.”
As a result of the FDA review, the protocol has been amended from enrolling BRAF V600E wild-type patients to V600 wild-type patients, thereby excluding a small fraction of melanoma patients with the BRAF V600K mutation. The protocol was also amended to require failure of a single immune checkpoint inhibitor (vs. previous eligibility requiring failure of ipilimumab or another immune checkpoint inhibitor). Eligible subjects will be required to have 1-5 target lesions having a maximum diameter of at least 10 mm per lesion (vs. 2-5 target lesions each having a maximum diameter of 5 mm); this change brings the definition of target lesions into full conformity with RECIST 1.1.
The Primary Outcome Measure is progression-free survival (PFS) to be assessed every 12 weeks up to 18 months.
The Secondary Outcome Measures include complete response rate (CRR) and its duration (to be assessed every 12 weeks up to 18 months); Overall survival (OS) to be assessed every 12 weeks up to 18 months; and number of participants with adverse events assessed every 4 weeks until 28 days after last treatment. Safety and tolerability will be assessed by monitoring the frequency, duration, severity and attribution of adverse events and evaluating changes in laboratory values and vital signs. The previous secondary endpoint of “change in total symptom score from baseline using the patient reported Skindex-16 instrument (to be assessed 12 weeks after Day 1)” has been re-assigned exploratory endpoint status; this may change once the Company completes an ongoing assessment of the suitability of the Skindex-16 instrument for this patient population.
Finally, based on advice from FDA, late crossover of patients at the end of the study has been eliminated and “clinically significant progression” has been eliminated from the definition of progression. The latter change brings the definition of progression into tighter conformance with RECIST 1.1 criteria, while the former change removes the possibility that crossover of patients at the end of the study who have not already progressed on the comparator arm could detrimentally impact secondary endpoints.
About Provectus Biopharmaceuticals, Inc.
Provectus Biopharmaceuticals, Inc., specializes in developing oncology and dermatology therapies. PV-10, its novel investigational drug for cancer, is designed for injection into solid tumors (intralesional administration), thereby reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and cancers of the liver. The Company has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications. PH-10, its topical investigational drug for dermatology, is undergoing clinical testing for psoriasis and atopic dermatitis. Provectus has completed phase 2 trials of PV-10 as a therapy for metastatic melanoma, and of PH-10 as a topical treatment for atopic dermatitis and psoriasis. Information about these and the Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company’s website at www.pvct.com or contact Porter, LeVay & Rose, Inc.
FORWARD-LOOKING STATEMENTS: This release contains “forward-looking statements” as defined under U.S. federal securities laws. These statements reflect management’s current knowledge, assumptions, beliefs, estimates, and expectations and express management’s current views of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” and other similar terms. Forward-looking statements are subject to a number of risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements. Readers should not place undue reliance on forward-looking statements. Such statements are made as of the date hereof, and we undertake no obligation to update such statements after this date.
Risks and uncertainties that could cause our actual results to materially differ from those described in forward-looking statements include those discussed in our filings with the Securities and Exchange Commission (including those described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2014) and the following:
A public-private partnership aims to end hunger and malnutrition in Africa
MINNEAPOLIS, Minn. (March 16th, 2015) — This month marks a watershed moment in nutrition and food security in Ethiopia: For the first time ever, local producers will begin fortifying wheat flour with the vitamins and minerals children need to develop and adults need to thrive. This achievement was made possible by a public-private partnership that stretches from mills, universities and government agencies in Ethiopia to the world’s largest multinational food companies, facilitated by a U.S.-based nonprofit.
Partners in Food Solutions (PFS) which, in partnership with TechnoServe and the U.S. Agency for International Development, connects employees at General Mills, Cargill, DSM and Bühler with high-potential food processors in five African countries, has worked with ASTCO, one of Ethiopia’s largest flour mills, to develop the technology and processes needed to fortify flour effectively and safely. Volunteer experts shared business and technical expertise with their Ethiopian counterparts through email, Skype, a proprietary web platform and occasional visits.
Other PFS volunteer experts have worked with more than 600 African food companies to improve food safety, packaging, processes, marketing and more to help them strengthen their businesses. In the end, this provides a sustainable route to affordable, nutritious, safe food for the local market and increases or sustains markets for the crops of smallholder farmers.
“The path to true food security in Africa isn’t simply more food aid,” said Jeff Dykstra, co-founder and CEO of Partners in Food Solutions. “The only sustainable way to end hunger is to strengthen the food supply chain. That’s why we’re focused on working with small and growing food processors.”
Chronic food insecurity and malnutrition are grave problems in Ethiopia, where two out of every five children suffer from stunting, which means a lack of critical nutrients has made them small for their age. Although the country’s economy is based largely on agriculture, millions of people require humanitarian assistance to survive. The availability of nutritious fortified wheat, a dietary staple in Ethiopia, is one step toward expanding access to nutritious food and reducing hunger.
In addition to ASTCO, about 150 wheat processors are receiving training or individualized assistance. The USAID helped fund the project, which PFS took on in partnership with the Africa-based organization TechnoServe and the African Alliance for Food Processing.
ASTCO and Partners in Food Solutions will celebrate the launch of its fortified flour at a ceremony in Addis Ababa on March 17, 2015.