Home > Companies > C-Suite On Deck > Q&A with Jay Gaines, CMO at Forrester

Q&A with Jay Gaines, CMO at Forrester

Q&A with Jay Gaines
Jay Gaines, CMO at Forrester has over 20 years of experience in organizational design and leadership, marketing strategy and planning, marketing budget and operations management, demand creation, sales and marketing alignment, and digital strategy in a variety of b-to-b industries.   

In this Q&A, Jay shares insightful thoughts about the audience-centric approach at SiriusDecisions and what marketing means to him.

MEDIA 7: How old were you when you had your first paying job?
JAY GAINES: I was 10 years old! I delivered newspapers in my neighborhood on my bike five days a week after school.

M7: You have been recognized as one of the top 10 CMOs in 2019 by The Silicon Review. What skills have enabled you to become a marketing industry leader?
JG: In my time at SiriusDecisions, I’ve had the good fortune to work closely with many amazing CMOs. That work provided me great insight into what makes for a highly effective and successful marketing leader. There are three primary skills that I think have helped me the most; first, to be a business leader and then a marketing leader. This means focusing on, being accountable for, and consistently reporting on marketing’s contribution to the same business goals that the CEO, CFO, board of directors and head of sales care about most. It also means always speaking the language of business, and avoiding marketing jargon when communicating with my colleagues outside of marketing. Second, is just being a good leader for my team by providing structure and clear goals, defending their focus, and promoting a culture of experimentation and rigor. Third, is constantly staying curious. Marketing is evolving so rapidly in terms of strategies, approaches, technologies, and measurement that part of any leader's job must be keeping up what’s new without chasing every new shiny object.

"Marketing is evolving so rapidly in terms of strategies, approaches, technologies and measurement that part of any leader's job must be keeping up what’s new without chasing every new shiny object."



M7: How impactful are the leadership summits from a marketing outreach perspective, and how significantly have they enabled SiriusDecisions to push towards the forefront as an industry leader?
JG: Our summits are a key driver of growth for us. We put a huge amount of effort into them and they have become a primary brand experience for our customers and other audiences. We attract thousands of B2B marketing, sales and product leaders to these events and use them to release our latest research, data and insights. Especially as SiriusDecisions has expanded into new geographies (Europe and Asia) and new verticals (healthcare, financial services, etc.) our events have enabled us to quickly establish presence, acquire audiences and build positive perception.

M7: You have been leading marketing initiatives for SiriusDecisions across various geographies including North America, EMEA and APAC. In your experience, how does the approach to marketing strategy vary based on different regions?
JG: At SiriusDecisions we take a very audience-centric approach in how we go to market through the use of audience frameworks and personas. We typically create personas centrally and then adapt them for geos and vertical industries. Most of the important differences we see are in persona preferences, in how they want to be contacted and engaged, how they consume information, and what their trusted sources of information are. So, while our campaign and program themes remain largely consistent globally the assets, tactics, and channels we utilize vary widely across geographies. For example, in Asia we’ve had great success and lean more heavily on mobile-specific strategies as well as a higher volume of smaller local events.


"Most of the important differences we see are in persona preferences, in how they want to be contacted and engaged, how they consume information, and what their trusted sources of information are."


M7: From a little cottage in Southport, Connecticut to a global leader in B2B marketing solutions, what has been the main force behind the overwhelming success of SiriusDecisions?
JG: By far the main driving force for SiriusDecisions has been our relationships with our clients and our commitment to their success. We have a deep culture of customer-centricity and helpfulness that permeates everything we do. For example, every piece of research we produce must pass the test of being supported by data and evidence, and also must include details about how to actually do whatever it is we’re recommending. Unlike many other firms similar to us, we also consider our work with clients to be collaborative. All of our research is based on our work with our clients and our ability to observe and measure what actually works and what doesn’t. This means we learn as much from them as they do from us and their success is our success.


"All of our research is based on our work with our clients and our ability to observe and measure what actually works and what doesn’t."

M7: What is Marketing to you?
JG: To me marketing is the art and science of engaging target audiences through the delivery of value in order to achieve specific business outcomes. Value can be delivered in any number of ways including information, entertainment and purpose, and business outcomes can span everything from customer acquisition to retention to advocacy.

ABOUT SIRIUSDECISIONS

SiriusDecisions® is the leading global b-to-b research and advisory firm. We deliver actionable intelligence, strategic and operational frameworks, and personal guidance from experienced practitioners.

Sales, marketing and product executives rely on SiriusDecisions® to contextualize problems and bring to light opportunities to drive sustainable growth. Our holistic solutions are founded on proprietary research, a deep understanding of b-to-b complexities, and the tenet that organizational alignment brings better outcomes.

SiriusDecisions was acquired by Forrester (NASD: FORR) in January of 2019.

More C-Suite on deck

Q&A with Sangram Vajre, Co-founder & Chief Evangelist at Terminus

MEDIA 7 | January 9, 2020

Sangram Vajre, Co-Founder & Chief Evangelist at Terminus is also an author and host of the podcast FlipmyFunnel. He is one of the leading minds in B2B marketing. MEDIA 7: What are you passionate about? SANGRAM VAJRE: Three things: Lead professionally. Grow personally. Love family. M7: Terminus has been recognized as one of Georgia’s 40 fastest-growing companies by ACG Atlanta. What factors contribute to this pace? SV: One of our core values is #OneTeam – which means we think and act as one team and know that if we treat our team right, they will treat our customers amazing. There are no great companies, only great people that make those companies.

Read More

Q&A with Amy Barzdukas, Executive Vice President & Chief Marketing Officer at Poly

MEDIA 7 | November 21, 2019

Amy Barzdukas, EVP and Chief Marketing Officer at Poly is a marketing and communications leader with extensive experience in setting strategy, shifting perceptions, advising customers, digital marketing, revenue marketing, integrated marketing communications, and public relations in highly competitive product arenas. Amy is known for her ability to create and execute winning turnarounds on a global scale. MEDIA 7: What inspired you to get into marketing? AMY BARZDUKAS: I was always destined for marketing, even if I didn’t know it. As a child, I collected promotional brochures. I was fascinated by how the words and pictures were used to drive action. My first job was as an advertising copywriter, and I’ve never looked back. M7: How is Poly redefining the video conferencing experience for modern businesses? AB: We’re in an unprecedented time of change in our industry. Voice and video services are moving to the cloud, and companies are changing how they approach their communications needs. Poly is the largest provider of the devices – video conferencing, audio conferencing, headphones and desk phones – you use to connect to these services so you can collaborate with your colleagues. That uniquely positions us to shape the video conferencing experience, and we’re doing so in four ways. First, Poly has made both the Zoom Rooms and the Microsoft Teams video conferencing experience better than ever with our radically simple Poly Studio X video bars that deliver these experiences with no PC or Mac required. We’ve got decades of experience in understanding what makes meetings more human – for everyone in the room and those dialing in from other locations – and we’ve packed all of that into easy-to-install, easy-to-manage, and easy-to-use all-in-one powerhouses. Second, we are bringing the world of AV and video conferencing into the modern app economy. Our Studio X series and Poly G7500 video conferencing devices run a common platform that can be updated and enhanced through a series of regular software updates. This Poly platform, built on Android, can run applications like a smartphone does today. Third, Poly has introduced innovation that makes any video conference better. Our new Poly MeetingAI features use AI and machine learning to address the distractions that hit your senses in a meeting. We make it easier to hear what’s being said by blocking out the annoying noises that people make while talking, and we make it easier to see what’s going on in the room with the most advanced speaker tracking and framing, and our built-in production rules. Finally, we are pricing our solutions in a way that completely resets the calculations on what it costs to outfit a room. The Studio X30, for huddle room and smaller spaces, costs just about $2,100, including the Poly TC8 touch controller. All you add is the cloud service and a monitor, and you have a room up and running for under $2,500. That’s easily under the cost of other solutions and with better audio and video quality.

Read More

Q&A with Ed Breault, Chief Marketing Officer at Aprimo

MEDIA 7 | November 28, 2019

Ed Breault, Chief Marketing Officer at Aprimo is a marketer with over 18 years of industry experience. At Aprimo, Ed is responsible for the global brand and growth which includes all Paid/Owned/Earned media, Brand Experience, Product Marketing, Industry Marketing, Influencer Marketing, Strategic Communications, Content Marketing, Analyst Relations, Alliance Marketing, Public Relations, Events, Demand Generation and Account-Based Marketing. MEDIA 7: What’s your superpower? ED BREAULT: I would say it’s applying the full spectrum of art and science that is required in marketing today. Not just left or right brained, but whole-brained strategy. Being human yet data-driven and really understanding numbers and (the right) metrics to make connections to business drivers. Add storytelling to that, so I can effectively communicate to my team, the CEO and CFO as well as my Board of Directors on those metrics, and connecting all that we are doing in marketing to the mission of the business. Then quickly shifting gears to the art and creative aspects of marketing that are required to engage an audience and tell great commercial stories that take complex concepts and craft them in a way that is interesting for people to pay attention to. I have to be the ultimate point of truth for the brand. M7: At Aprimo, how have marketing leadership roles and responsibilities evolved over the past few years? EB: There are so many dimensions needed by marketing leaders today. There are several elements driving this evolution, it’s the new experience battlefront that is emerging and also marketers themselves driving changes. From a market perspective, there is a clear appetite for disruption and consumers are wanting more experiential elements to their buying experience and interactions with brands. Take a few direct to consumer disruptions like trialing products in-home, purchasing directly from a brand or even wanting to ensure that the producer’s trade practices are in line with the buyer’s or even a regulator’s for that matter. Then we want to try before we buy, and we emotionally care about the supply chain of products. Do we TRUST this brand to do business with them? Behind all of this is a story that needs to be told, and it is those marketers who know their audience well and make connections that will win the commercial game. Back to the marketer, there are so many diverse backgrounds that marketers bring now and I’m really intrigued by those who have unconventional backgrounds because they contribute something uniquely new to the field. I love hearing about the marketer’s journey.

Read More

Q&A with Sangram Vajre, Co-founder & Chief Evangelist at Terminus

MEDIA 7 | January 9, 2020

Sangram Vajre, Co-Founder & Chief Evangelist at Terminus is also an author and host of the podcast FlipmyFunnel. He is one of the leading minds in B2B marketing. MEDIA 7: What are you passionate about? SANGRAM VAJRE: Three things: Lead professionally. Grow personally. Love family. M7: Terminus has been recognized as one of Georgia’s 40 fastest-growing companies by ACG Atlanta. What factors contribute to this pace? SV: One of our core values is #OneTeam – which means we think and act as one team and know that if we treat our team right, they will treat our customers amazing. There are no great companies, only great people that make those companies.

Read More

Q&A with Amy Barzdukas, Executive Vice President & Chief Marketing Officer at Poly

MEDIA 7 | November 21, 2019

Amy Barzdukas, EVP and Chief Marketing Officer at Poly is a marketing and communications leader with extensive experience in setting strategy, shifting perceptions, advising customers, digital marketing, revenue marketing, integrated marketing communications, and public relations in highly competitive product arenas. Amy is known for her ability to create and execute winning turnarounds on a global scale. MEDIA 7: What inspired you to get into marketing? AMY BARZDUKAS: I was always destined for marketing, even if I didn’t know it. As a child, I collected promotional brochures. I was fascinated by how the words and pictures were used to drive action. My first job was as an advertising copywriter, and I’ve never looked back. M7: How is Poly redefining the video conferencing experience for modern businesses? AB: We’re in an unprecedented time of change in our industry. Voice and video services are moving to the cloud, and companies are changing how they approach their communications needs. Poly is the largest provider of the devices – video conferencing, audio conferencing, headphones and desk phones – you use to connect to these services so you can collaborate with your colleagues. That uniquely positions us to shape the video conferencing experience, and we’re doing so in four ways. First, Poly has made both the Zoom Rooms and the Microsoft Teams video conferencing experience better than ever with our radically simple Poly Studio X video bars that deliver these experiences with no PC or Mac required. We’ve got decades of experience in understanding what makes meetings more human – for everyone in the room and those dialing in from other locations – and we’ve packed all of that into easy-to-install, easy-to-manage, and easy-to-use all-in-one powerhouses. Second, we are bringing the world of AV and video conferencing into the modern app economy. Our Studio X series and Poly G7500 video conferencing devices run a common platform that can be updated and enhanced through a series of regular software updates. This Poly platform, built on Android, can run applications like a smartphone does today. Third, Poly has introduced innovation that makes any video conference better. Our new Poly MeetingAI features use AI and machine learning to address the distractions that hit your senses in a meeting. We make it easier to hear what’s being said by blocking out the annoying noises that people make while talking, and we make it easier to see what’s going on in the room with the most advanced speaker tracking and framing, and our built-in production rules. Finally, we are pricing our solutions in a way that completely resets the calculations on what it costs to outfit a room. The Studio X30, for huddle room and smaller spaces, costs just about $2,100, including the Poly TC8 touch controller. All you add is the cloud service and a monitor, and you have a room up and running for under $2,500. That’s easily under the cost of other solutions and with better audio and video quality.

Read More

Q&A with Ed Breault, Chief Marketing Officer at Aprimo

MEDIA 7 | November 28, 2019

Ed Breault, Chief Marketing Officer at Aprimo is a marketer with over 18 years of industry experience. At Aprimo, Ed is responsible for the global brand and growth which includes all Paid/Owned/Earned media, Brand Experience, Product Marketing, Industry Marketing, Influencer Marketing, Strategic Communications, Content Marketing, Analyst Relations, Alliance Marketing, Public Relations, Events, Demand Generation and Account-Based Marketing. MEDIA 7: What’s your superpower? ED BREAULT: I would say it’s applying the full spectrum of art and science that is required in marketing today. Not just left or right brained, but whole-brained strategy. Being human yet data-driven and really understanding numbers and (the right) metrics to make connections to business drivers. Add storytelling to that, so I can effectively communicate to my team, the CEO and CFO as well as my Board of Directors on those metrics, and connecting all that we are doing in marketing to the mission of the business. Then quickly shifting gears to the art and creative aspects of marketing that are required to engage an audience and tell great commercial stories that take complex concepts and craft them in a way that is interesting for people to pay attention to. I have to be the ultimate point of truth for the brand. M7: At Aprimo, how have marketing leadership roles and responsibilities evolved over the past few years? EB: There are so many dimensions needed by marketing leaders today. There are several elements driving this evolution, it’s the new experience battlefront that is emerging and also marketers themselves driving changes. From a market perspective, there is a clear appetite for disruption and consumers are wanting more experiential elements to their buying experience and interactions with brands. Take a few direct to consumer disruptions like trialing products in-home, purchasing directly from a brand or even wanting to ensure that the producer’s trade practices are in line with the buyer’s or even a regulator’s for that matter. Then we want to try before we buy, and we emotionally care about the supply chain of products. Do we TRUST this brand to do business with them? Behind all of this is a story that needs to be told, and it is those marketers who know their audience well and make connections that will win the commercial game. Back to the marketer, there are so many diverse backgrounds that marketers bring now and I’m really intrigued by those who have unconventional backgrounds because they contribute something uniquely new to the field. I love hearing about the marketer’s journey.

Read More

Related News

Cell and Gene Therapy

Solvias to Perform Release Testing on World's First CRISPR-based Gene-Editing Therapy

Solvias | January 23, 2024

Solvias, a global provider of chemistry, manufacturing, and control (CMC) analytics, announced that it will perform analytical release testing services on the world's first CRISPR/Cas9 genome-edited cell therapy. The company has signed a long-term agreement with Vertex Pharmaceuticals for CASGEVY™ (exagamglogene autotemcel or exa-cel) which received U.S. Food & Drug Administration (FDA) approval for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso-occlusive crises. Solvias and Vertex Pharmaceuticals have worked together for several years to develop and validate test methods that are critical for the final release of patients' own edited cells, so that they can be delivered back to patients. The companies' collaboration included establishing the testing methods that will be scaled for commercializing CASGEVY. Solvias also has invested significantly in preparing one of its global facilities to support the commercial release work for this transformative therapy. Archie Cullen, Chief Executive Officer, Solvias, stated "Solvias is honored to be playing a critical role in delivering this breakthrough therapy to patients. Our decades of experience offering comprehensive GMP analytical services uniquely positions us to partner with companies in bringing their therapies to market. This collaboration highlights our deep scientific knowledge and creative solutions serving to advance even the most cutting-edge therapies." In addition to gaining FDA approval, CASGEVY recently received a positive opinion from the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use for conditional approval of the treatment of severe SCD and transfusion-dependent beta thalassemia (TDT). About Solvias Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the pharmaceutical, biotech, material science, and cosmetic industries. Its team of scientists and regulatory experts have years of experience in small molecules, biologics, and cell and gene therapies. The company offers comprehensive solutions from raw materials to drug products to final release testing, as well as API development and manufacturing for small molecules. Headquartered near Basel, Switzerland, Solvias operates five facilities to the highest standards and in accordance with ISO, GMP, GLP and FDA regulations.

Read More

Medical

Personalis and ClearNote Health Announce Partnership to Advance Epigenomic Technology

Personalis, Inc. | February 05, 2024

Personalis, Inc. a leader in advanced genomics for cancer, and ClearNote Health, Inc., a pioneer in epigenomic technologies, today unveiled an alliance through which Personalis will expand its pharmaceutical service offerings by distributing ClearNote’s cutting-edge epigenomic 5-hydroxymethylcytosine (5hmC) platform. “We have built a unique pharma channel based on our industry-leading tissue and MRD assays and ClearNote Health’s blood-based epigenomic approach is complementary to our offering as it helps our customers deepen their understanding of a patient’s response to immunotherapies,” said Chris Hall, CEO and President of Personalis. “Commercial partnerships such as this broaden our portfolio and are expected to appeal to a wide range of biopharma customers and accelerate our revenue growth.” Echoing this sentiment, Dave Mullarkey, CEO of ClearNote Health, remarked, “Partnering with Personalis presents an excellent opportunity to bring our 5hmC technology to the forefront of cancer research. This alliance is a testament to the synergy between our two companies, enabling us to expand our reach and significantly impact the biopharmaceutical industry. Together, we can accelerate the development of personalized therapies and make a real difference in the lives of patients.” ClearNote Health’s Epigenomics Platform represents a groundbreaking advance in cancer detection, offering real-time insights into disease-specific pathways. By tracking changes in 5hmC levels coupled with artificial intelligence-based analytical methods, the platform can detect cancer earlier, monitor disease progression, understand mechanisms of resistance, and identify promising drug targets and biomarkers. These insights are invaluable for optimizing drug development programs and delivering more effective treatments to patients. The Epigenomics Platform identifies changes in gene activation and gene regulation by labeling specific changes in the 5hmC landscape from plasma-derived cell-free DNA. This rich biological information, as part of clinical trials, enables the monitoring of cancer therapies in real time and contributes to an understanding of drug resistance mechanisms. The partnership marks a pivotal moment in cancer research, leveraging the strengths of both companies to offer unparalleled solutions in the biopharmaceutical industry. About ClearNote Heath, Inc. ClearNote Health is a cancer detection company focused on enabling people at risk for high-mortality cancers to live longer, healthier lives. Utilizing a standard blood draw, the company applies its proprietary epigenomic platform, combining biology and artificial intelligence, to identify DNA-based changes in biology as cancer develops. With lead programs in non-invasive early detection of pancreatic and ovarian cancers in patients at the highest risk for these diseases, ClearNote Health identifies cancers before they progress and when patients are most likely to benefit from treatment. ClearNote Health’s first commercially available test is the Avantect™ Pancreatic Cancer Test, which detects the presence of pancreatic cancer signals in patients at high risk of the disease, including those recently diagnosed with Type 2 diabetes. ClearNote Health is headquartered in San Diego, with additional presence in the San Francisco Bay area and internationally. The company’s CLIA- and CAP-accredited laboratory is located in San Diego, Calif. About Personalis, Inc. At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest time points, enable the selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California.

Read More

Medical

Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine

Capricor Therapeutics | January 24, 2024

Capricor Therapeutics a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, today announced that Capricor’s proprietary StealthX™ exosome-based multivalent vaccine (StealthX™ vaccine) for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen, an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines providing broader and more durable protection for COVID-19. As part of Project NextGen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor’s StealthX™ vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases (DMID) would oversee the study. “We are extremely pleased with the external support from the NIH, which highlights the clinical potential of our StealthX™ exosome platform technology and provides non-dilutive support for the advancement of our vaccine candidate,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “Our proprietary vaccine is multivalent, delivering both the highly mutagenic S protein (Spike) and the more stable N protein (Nucleocapsid) which potentially may offer broader and longer lasting immunity against SARS-CoV-2. We view the NIH SARS-CoV-2 project as the first clinical step towards development of a next generation vaccine platform that may be extended to other infectious diseases. Our platform is designed to combine the speed of response of an mRNA vaccine with the potential efficacy of a protein vaccine. Further, our StealthX™ vaccine is free of both adjuvant and lipid nanoparticles and in preclinical studies has generated a strong immune response at low doses. We believe our StealthX™ vaccine may offer a clinically meaningful alternative for highly mutating or novel infectious agents.” Dr. Marbán continued, “This is the opportunity we have been waiting for as it allows the exosome technology to be brought into the clinic as we continue to focus our resources on CAP-1002 for the treatment of Duchenne muscular dystrophy. Beyond SARS-CoV-2, we look forward to exploring the potential therapeutic utility of this platform, and more broadly, expanding our pipeline into therapeutics and future partnership opportunities.” About Capricor’s StealthX™ Vaccine The StealthX™ vaccine is a proprietary vaccine developed internally by Capricor utilizing exosomes that were engineered to express either spike or nucleocapsid proteins on the surface. Preclinical results from murine and rabbit models published in Microbiology Spectrum, showed the StealthX™ vaccine, resulted in robust antibody production, potent neutralizing antibodies, a strong T-cell response and a favorable safety profile. These effects were obtained with administration of only nanogram amounts of protein and without adjuvant or synthetic lipid nanoparticles (LNPs). Exosomes offer a new antigen delivery system that potentially could be utilized to rapidly generate multivalent protein-based vaccines. Exosomes, first identified as extracellular vesicles, are small vesicles enriched in specific subsets of proteins, RNAs and lipids and responsible for cell-to-cell communication. About Capricor Therapeutics Capricor Therapeutics, Inc. is a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy currently in Phase 3 clinical development for treating Duchenne muscular dystrophy (DMD). Further, Capricor has entered into a partnership for the exclusive commercialization and distribution of CAP-1002 for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Capricor is also developing its exosome technology as a potential next-generation therapeutic platform. Our proprietary StealthX™ exosome platform has potential for a broad range of new therapeutic applications in the field of vaccinology as well as targeted oligonucleotide, protein and small molecule therapeutics to treat or prevent a variety of diseases.

Read More

Cell and Gene Therapy

Solvias to Perform Release Testing on World's First CRISPR-based Gene-Editing Therapy

Solvias | January 23, 2024

Solvias, a global provider of chemistry, manufacturing, and control (CMC) analytics, announced that it will perform analytical release testing services on the world's first CRISPR/Cas9 genome-edited cell therapy. The company has signed a long-term agreement with Vertex Pharmaceuticals for CASGEVY™ (exagamglogene autotemcel or exa-cel) which received U.S. Food & Drug Administration (FDA) approval for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso-occlusive crises. Solvias and Vertex Pharmaceuticals have worked together for several years to develop and validate test methods that are critical for the final release of patients' own edited cells, so that they can be delivered back to patients. The companies' collaboration included establishing the testing methods that will be scaled for commercializing CASGEVY. Solvias also has invested significantly in preparing one of its global facilities to support the commercial release work for this transformative therapy. Archie Cullen, Chief Executive Officer, Solvias, stated "Solvias is honored to be playing a critical role in delivering this breakthrough therapy to patients. Our decades of experience offering comprehensive GMP analytical services uniquely positions us to partner with companies in bringing their therapies to market. This collaboration highlights our deep scientific knowledge and creative solutions serving to advance even the most cutting-edge therapies." In addition to gaining FDA approval, CASGEVY recently received a positive opinion from the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use for conditional approval of the treatment of severe SCD and transfusion-dependent beta thalassemia (TDT). About Solvias Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the pharmaceutical, biotech, material science, and cosmetic industries. Its team of scientists and regulatory experts have years of experience in small molecules, biologics, and cell and gene therapies. The company offers comprehensive solutions from raw materials to drug products to final release testing, as well as API development and manufacturing for small molecules. Headquartered near Basel, Switzerland, Solvias operates five facilities to the highest standards and in accordance with ISO, GMP, GLP and FDA regulations.

Read More

Medical

Personalis and ClearNote Health Announce Partnership to Advance Epigenomic Technology

Personalis, Inc. | February 05, 2024

Personalis, Inc. a leader in advanced genomics for cancer, and ClearNote Health, Inc., a pioneer in epigenomic technologies, today unveiled an alliance through which Personalis will expand its pharmaceutical service offerings by distributing ClearNote’s cutting-edge epigenomic 5-hydroxymethylcytosine (5hmC) platform. “We have built a unique pharma channel based on our industry-leading tissue and MRD assays and ClearNote Health’s blood-based epigenomic approach is complementary to our offering as it helps our customers deepen their understanding of a patient’s response to immunotherapies,” said Chris Hall, CEO and President of Personalis. “Commercial partnerships such as this broaden our portfolio and are expected to appeal to a wide range of biopharma customers and accelerate our revenue growth.” Echoing this sentiment, Dave Mullarkey, CEO of ClearNote Health, remarked, “Partnering with Personalis presents an excellent opportunity to bring our 5hmC technology to the forefront of cancer research. This alliance is a testament to the synergy between our two companies, enabling us to expand our reach and significantly impact the biopharmaceutical industry. Together, we can accelerate the development of personalized therapies and make a real difference in the lives of patients.” ClearNote Health’s Epigenomics Platform represents a groundbreaking advance in cancer detection, offering real-time insights into disease-specific pathways. By tracking changes in 5hmC levels coupled with artificial intelligence-based analytical methods, the platform can detect cancer earlier, monitor disease progression, understand mechanisms of resistance, and identify promising drug targets and biomarkers. These insights are invaluable for optimizing drug development programs and delivering more effective treatments to patients. The Epigenomics Platform identifies changes in gene activation and gene regulation by labeling specific changes in the 5hmC landscape from plasma-derived cell-free DNA. This rich biological information, as part of clinical trials, enables the monitoring of cancer therapies in real time and contributes to an understanding of drug resistance mechanisms. The partnership marks a pivotal moment in cancer research, leveraging the strengths of both companies to offer unparalleled solutions in the biopharmaceutical industry. About ClearNote Heath, Inc. ClearNote Health is a cancer detection company focused on enabling people at risk for high-mortality cancers to live longer, healthier lives. Utilizing a standard blood draw, the company applies its proprietary epigenomic platform, combining biology and artificial intelligence, to identify DNA-based changes in biology as cancer develops. With lead programs in non-invasive early detection of pancreatic and ovarian cancers in patients at the highest risk for these diseases, ClearNote Health identifies cancers before they progress and when patients are most likely to benefit from treatment. ClearNote Health’s first commercially available test is the Avantect™ Pancreatic Cancer Test, which detects the presence of pancreatic cancer signals in patients at high risk of the disease, including those recently diagnosed with Type 2 diabetes. ClearNote Health is headquartered in San Diego, with additional presence in the San Francisco Bay area and internationally. The company’s CLIA- and CAP-accredited laboratory is located in San Diego, Calif. About Personalis, Inc. At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest time points, enable the selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California.

Read More

Medical

Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine

Capricor Therapeutics | January 24, 2024

Capricor Therapeutics a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, today announced that Capricor’s proprietary StealthX™ exosome-based multivalent vaccine (StealthX™ vaccine) for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen, an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines providing broader and more durable protection for COVID-19. As part of Project NextGen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor’s StealthX™ vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases (DMID) would oversee the study. “We are extremely pleased with the external support from the NIH, which highlights the clinical potential of our StealthX™ exosome platform technology and provides non-dilutive support for the advancement of our vaccine candidate,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “Our proprietary vaccine is multivalent, delivering both the highly mutagenic S protein (Spike) and the more stable N protein (Nucleocapsid) which potentially may offer broader and longer lasting immunity against SARS-CoV-2. We view the NIH SARS-CoV-2 project as the first clinical step towards development of a next generation vaccine platform that may be extended to other infectious diseases. Our platform is designed to combine the speed of response of an mRNA vaccine with the potential efficacy of a protein vaccine. Further, our StealthX™ vaccine is free of both adjuvant and lipid nanoparticles and in preclinical studies has generated a strong immune response at low doses. We believe our StealthX™ vaccine may offer a clinically meaningful alternative for highly mutating or novel infectious agents.” Dr. Marbán continued, “This is the opportunity we have been waiting for as it allows the exosome technology to be brought into the clinic as we continue to focus our resources on CAP-1002 for the treatment of Duchenne muscular dystrophy. Beyond SARS-CoV-2, we look forward to exploring the potential therapeutic utility of this platform, and more broadly, expanding our pipeline into therapeutics and future partnership opportunities.” About Capricor’s StealthX™ Vaccine The StealthX™ vaccine is a proprietary vaccine developed internally by Capricor utilizing exosomes that were engineered to express either spike or nucleocapsid proteins on the surface. Preclinical results from murine and rabbit models published in Microbiology Spectrum, showed the StealthX™ vaccine, resulted in robust antibody production, potent neutralizing antibodies, a strong T-cell response and a favorable safety profile. These effects were obtained with administration of only nanogram amounts of protein and without adjuvant or synthetic lipid nanoparticles (LNPs). Exosomes offer a new antigen delivery system that potentially could be utilized to rapidly generate multivalent protein-based vaccines. Exosomes, first identified as extracellular vesicles, are small vesicles enriched in specific subsets of proteins, RNAs and lipids and responsible for cell-to-cell communication. About Capricor Therapeutics Capricor Therapeutics, Inc. is a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy currently in Phase 3 clinical development for treating Duchenne muscular dystrophy (DMD). Further, Capricor has entered into a partnership for the exclusive commercialization and distribution of CAP-1002 for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Capricor is also developing its exosome technology as a potential next-generation therapeutic platform. Our proprietary StealthX™ exosome platform has potential for a broad range of new therapeutic applications in the field of vaccinology as well as targeted oligonucleotide, protein and small molecule therapeutics to treat or prevent a variety of diseases.

Read More

Spotlight

SiriusDecisions

SiriusDecisions

SiriusDecisions® is the leading global b-to-b research and advisory firm. We deliver actionable intelligence, strategic and operational frameworks, and personal guidance from experienced practitioners. Sales, marketing and product executives rely on SiriusDecisions® to contextualize problems and bri...

Events

Resources

resource image

The SiriusDecisions B-to-B Marketing Automation Study Infographic

infographic

resource image

The SiriusDecisions B-to-B Marketing Automation Study Infographic

infographic

resource image

SiriusDecisions B-to-B Fundamentals with Elisabeth Medaris

Video

resource image

The SiriusDecisions B-to-B Buying Decision Process Framework

Whitepaper

Events