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

MEDIA 7 | January 9, 2020

Q&A with Sangram Vajre
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.


"Marketers who say they are going to transform their organization without support from Sales and buy-in from management fail to see success."

M7: Terminus is the leader of the account-based movement. What according to you are the common mistakes marketers make with ABM?
SV:
 Marketers who say they are going to transform their organization without support from Sales and buy-in from management fail to see success. The marketers who make a few sales people wildly successful, join campaigns to help them win deals, win their hearts and minds.

M7: Could you tell us a little bit about your podcast Flipmyfunnel? How did that idea come about?
SV:
 I was already talking to customers and amazing people in the industry and every time I would walk away with the thought that wish I recorded that conversation. Well, I just started doing that which turned into a podcast series that has now over 500 episodes and continue to rate in the top 50 business podcast.


"Terminus can quickly get a sales rep alerted when their target account is on the website which helps them prioritize which target accounts they need to spend more time with."

M7: What are some of the best indicators that a prospect is really engaged with your brand?
SV:
Visit to your website and the frequency of it. There are technologies like Terminus that can quickly get a sales rep alerted when their target account is on the website which helps them prioritize which target accounts they need to spend more time with. This could become one of the most important indicators of early success for companies in 2020.


M7: What marketing channels do you use and which ones do you see as the most promising given your target customers?
SV:
It’s always the combination that works since everyone is different but the goal is to surround them with your message on their channels so when they are ready, they think of you.


"Mature and forward thinking CMOs are starting to help their sales team win more and faster by focusing on pipeline velocity and expansion deals."

M7: What aspects of ABM do you think might change in the future?
SV:
I believe ABM is B2B. Most companies are still focused on top of the funnel. Mature and forward thinking CMOs are starting to help their sales team win more and faster by focusing on pipeline velocity and expansion deals.


M7: What is your favorite quote?
SV:
Selling is essentially transfer of feelings – Zig Ziglar.

ABOUT TERMINUS

Terminus is the leader of the account-based movement and the crucial link that connects B2B marketing and sales teams with their ideal customers. The Terminus solution arms marketing teams with an account-centric platform that delivers the intelligence and automation needed to scale ABM and revolutionize the way B2B marketing is done. Hundreds of organizations worldwide, including Salesforce, GE, Verizon, 3M and CA Technologies, turn to Terminus to more effectively target, engage and grow their best-fit accounts. Terminus offers savvy marketers the technology and proven expertise to radically improve ABM strategies and campaigns, increasing ROI and producing exceptional results. For more information, visit Terminus.

More C-Suite on deck

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 Jeanne Hopkins, CMO at Lola.com

MEDIA 7 | October 24, 2019

Jeanne Hopkins, CMO at Lola.com has profound expertise in data-driven, high-velocity customer acquisition and marketing organizations and inbound-based lead gen programs to support global demand for high-growth SaaS companies. Jeanne is also the co-author of "Go Mobile"?, the #1 best-selling mobile marketing book. She has been named to Sales Lead Management Association "Top 50"? 3 years in a row and "20 Women to Watch" in 2015/14/13 & 2011. MEDIA 7: What inspired you to get into marketing? JEANNE HOPKINS: After graduation, I took my first job in the accounting department at Baystate Medical Center. At my annual review, I was told that I was too “noisy” for an accounting department. I went on to work at Milton Bradley Company’s in-house advertising agency, MB Communications, as editor of their in-house newspaper, and later recruited to LEGO Systems to do marketing programs. I found myself at a self-funded start-up tech company in 2000, where I was running an inside sales team and building digital properties to generate leads. I moved into software, digital marketing, and lead generation at companies like MarketingSherpa, then HubSpot, SmartBear, Ipswitch (now Progress Software) – it’s all been a fantastic journey. M7: How is agile technology transforming corporate travel around the globe? JH: Small and mid-sized businesses have to be fast and efficient amidst growth, and booking, re-booking, and managing business travel can seriously impede efficiency and productivity. Finance teams are trying to manage, control, and get visibility into expenditures. Travelers are trying to do their jobs and don’t have time for expense reports. And travel arrangers (executive assistants and office admins) have plenty on their plates. Finally, there are tools that are addressing these direct needs at small and mid-sized businesses. Consumers have had the ease of booking travel through sites like Kayak and big businesses can afford the services and fees associated with high-end travel agencies. But the middle segment has been left out. Now, agile tools like Lola.com are making it really easy for corporate travelers to book, re-book, and take the task of expense reports off the table. And finance teams are able to set up travel policies in minutes, and easily manage, control, and get visibility into expenditures. The corporate travel market is huge, and agile technology is making it much easier for travelers and companies all-around.

Read More

Q&A with Andrea Lechner-Becker, Chief Marketing Officer at LeadMD

MEDIA 7 | December 5, 2019

Andrea Lechner-Becker, Chief Marketing Officer at LeadMD is an experienced Marketing and Sales Executive with a demonstrated history of working in the marketing and advertising industry. Skilled in Business Process, Marketo, Sales, Customer Relationship Management (CRM), and IT Service Management, Andrea is also a strong business development professional and a storyteller. MEDIA 7: What inspired you to get into marketing? ANDREA LECHNER: Frankly, not having better options. I originally attended the University of Wisconsin-La Crosse thinking I’d major in Archaeology. I wanted to be Indiana Jones! But, after visiting the archaeology building – i.e. the cold, dark basement of the science building – where a girl sat to piece together pieces of an old Native American vase, I knew archaeology was not going to be the right path for me. And so, without being good at science and a major in art or art history was unlikely to pay my bills, I decided to go into “business”. I originally registered as a management major, but took my first marketing class and thought it was more interesting and switched my sophomore year. That was pretty much it. I’d never been involved in business classes or DECA in high school – I didn’t really know what to do or what jobs in marketing were even possible. I dumb lucked myself into it really. M7: As a storyteller, do you relate the brand to a story or story to the brand? AL: Both? Neither? I think there are stories in every brand, because there are people working on the brand and people engaging with the brand and people using what the brand creates. People, most often a single person, are at the heart of great stories. You can start with the “point” of the story you’re trying to tell. Say you have a software that help accountants better create reports for board meetings. It’s likely you’ll want to tell a success story about an accountant getting promoted to CFO in part because your software helped better communicate their work product to the board. You could have the idea for that and go looking for that story in your customers. OR, you could hear that story, and say, “That’s amazing!” and share it with customers, partners and internal people. Stories are all around us – the most important thing is to keep your ears and eyes open for finding them.

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 Jeanne Hopkins, CMO at Lola.com

MEDIA 7 | October 24, 2019

Jeanne Hopkins, CMO at Lola.com has profound expertise in data-driven, high-velocity customer acquisition and marketing organizations and inbound-based lead gen programs to support global demand for high-growth SaaS companies. Jeanne is also the co-author of "Go Mobile"?, the #1 best-selling mobile marketing book. She has been named to Sales Lead Management Association "Top 50"? 3 years in a row and "20 Women to Watch" in 2015/14/13 & 2011. MEDIA 7: What inspired you to get into marketing? JEANNE HOPKINS: After graduation, I took my first job in the accounting department at Baystate Medical Center. At my annual review, I was told that I was too “noisy” for an accounting department. I went on to work at Milton Bradley Company’s in-house advertising agency, MB Communications, as editor of their in-house newspaper, and later recruited to LEGO Systems to do marketing programs. I found myself at a self-funded start-up tech company in 2000, where I was running an inside sales team and building digital properties to generate leads. I moved into software, digital marketing, and lead generation at companies like MarketingSherpa, then HubSpot, SmartBear, Ipswitch (now Progress Software) – it’s all been a fantastic journey. M7: How is agile technology transforming corporate travel around the globe? JH: Small and mid-sized businesses have to be fast and efficient amidst growth, and booking, re-booking, and managing business travel can seriously impede efficiency and productivity. Finance teams are trying to manage, control, and get visibility into expenditures. Travelers are trying to do their jobs and don’t have time for expense reports. And travel arrangers (executive assistants and office admins) have plenty on their plates. Finally, there are tools that are addressing these direct needs at small and mid-sized businesses. Consumers have had the ease of booking travel through sites like Kayak and big businesses can afford the services and fees associated with high-end travel agencies. But the middle segment has been left out. Now, agile tools like Lola.com are making it really easy for corporate travelers to book, re-book, and take the task of expense reports off the table. And finance teams are able to set up travel policies in minutes, and easily manage, control, and get visibility into expenditures. The corporate travel market is huge, and agile technology is making it much easier for travelers and companies all-around.

Read More

Q&A with Andrea Lechner-Becker, Chief Marketing Officer at LeadMD

MEDIA 7 | December 5, 2019

Andrea Lechner-Becker, Chief Marketing Officer at LeadMD is an experienced Marketing and Sales Executive with a demonstrated history of working in the marketing and advertising industry. Skilled in Business Process, Marketo, Sales, Customer Relationship Management (CRM), and IT Service Management, Andrea is also a strong business development professional and a storyteller. MEDIA 7: What inspired you to get into marketing? ANDREA LECHNER: Frankly, not having better options. I originally attended the University of Wisconsin-La Crosse thinking I’d major in Archaeology. I wanted to be Indiana Jones! But, after visiting the archaeology building – i.e. the cold, dark basement of the science building – where a girl sat to piece together pieces of an old Native American vase, I knew archaeology was not going to be the right path for me. And so, without being good at science and a major in art or art history was unlikely to pay my bills, I decided to go into “business”. I originally registered as a management major, but took my first marketing class and thought it was more interesting and switched my sophomore year. That was pretty much it. I’d never been involved in business classes or DECA in high school – I didn’t really know what to do or what jobs in marketing were even possible. I dumb lucked myself into it really. M7: As a storyteller, do you relate the brand to a story or story to the brand? AL: Both? Neither? I think there are stories in every brand, because there are people working on the brand and people engaging with the brand and people using what the brand creates. People, most often a single person, are at the heart of great stories. You can start with the “point” of the story you’re trying to tell. Say you have a software that help accountants better create reports for board meetings. It’s likely you’ll want to tell a success story about an accountant getting promoted to CFO in part because your software helped better communicate their work product to the board. You could have the idea for that and go looking for that story in your customers. OR, you could hear that story, and say, “That’s amazing!” and share it with customers, partners and internal people. Stories are all around us – the most important thing is to keep your ears and eyes open for finding them.

Read More

Related News

Medical, Diagnostics

Aspen Neuroscience to Partner with Rune Labs and Emerald Innovations to Incorporate both Active and Passive Digital Health Monitoring

prnewswire | August 28, 2023

Aspen Neuroscience today announced that it is partnering with Emerald Innovations, a pioneer in the creation of "invisible" off-body sensors for measuring health analytics, and Rune Labs, a software and data analytics company for precision neurology, to incorporate digital health (DHT) modalities in the company's Trial-Ready Screening Cohort Study. The Trial Ready Screening Cohort study was launched in 2022 to screen, enroll and begin manufacturing cells for potential patient candidates for the future Phase 1/2a clinical trial for ANPD001, a personalized (autologous) cell therapy to treat Parkinson's disease (PD) by replacing lost dopamine neurons. Aspen Neuroscience is advancing the collection of objective measures of motor function via passive in-home monitoring, working with Emerald Innovations' contactless biosensors, and active monitoring, working with Rune Labs' clinical development platform, StriveStudy. The use of DHT empowers trial investigators to include objective, long-term (pre-treatment) motor and sleep symptom capture, to provide data on each patient's rate of disease progression. "Parkinson's disease is very personal in nature, and we are working to develop a personal cell therapy for PD," said Damien McDevitt, PhD, Aspen president and CEO. "Everyone with Parkinson's has a unique experience, with varied symptoms. We look forward to working closely with the innovative and collaborative teams at Rune Labs and Emerald Innovations to capture a holistic and precise pattern of motor symptom activity over time for people in our screening study." "Parkinson's is a heterogeneous condition, adding to the challenge of assessing treatment benefit without a personalized view of each trial participant's symptom activity," said Brian Pepin, CEO of Rune Labs. "Through StriveStudy, our biopharma partners are able to collect large quantities of continuous multimodal data to characterize participant's disease activity across a range of clinical features. We are excited to collaborate with Aspen Neuroscience to help them characterize patient symptoms as they bring their personalized cell therapy into clinical testing." "We are delighted to collaborate with Aspen Neuroscience," said Dr. Dina Katabi, MIT professor and the co-founder and president of Emerald Innovations, Inc. "A significant hurdle in Parkinson's disease clinical trials is the reliable monitoring of disease progression and medication response without the need to enroll hundreds or even thousands of patients. Empirical evidence has demonstrated that readings from the Emerald sensor offer a dependable marker for tracking disease progression. The Emerald sensor gathers this data without body contact, relying solely on the analysis of radio signals in the environment as patients go about their normal lives." About DHT in the Trial Ready Cohort Screening Study Aspen will partner with Rune Labs to deeply characterize each patient's symptoms in the Trial Ready Cohort, including the collection of multimodal data, thereby enabling robust disease characterization over time. This will include objective measures of tremor and dyskinesia levels captured on FDA-cleared StrivePD on the Apple Watch, medication monitoring, as well as Apple HealthKit, including global activity (e.g., daily steps). Aspen and Emerald will collaborate to assess passive "invisible" in-home monitoring of participants enrolled in the Trial Ready Cohort. This will include gait speed measured across walking intervals, sleep onset, the amount of time between entering different sleep stages; sleep duration, sleep efficiency and WASO: the total time spent in the WAKE stage after sleep onset. About Parkinson's Disease Parkinson's disease is the world's second most common neurodegenerative disease, affecting more than 10 million people worldwide, including more than 1 million in the U.S., where an additional 90,000+ people are diagnosed every year. Patients can experience non-motor symptoms such as mental and behavioral changes, sleep problems, depression, memory difficulties and fatigue; and motor symptoms caused by the loss of dopamine neurons in the brain, including unintended or uncontrollable movements (dyskinesia), shaking (tremor), stiffness, and difficulty with balance and coordination, which worsen over time. By the time of diagnosis, it is common for people to have lost the majority of cells in the brain that make dopamine. To date, there is no disease-modifying therapy that can stop, replace or prevent the loss of dopamine neurons or slow the progression of PD. About Aspen Neuroscience Headquartered in San Diego, Aspen Neuroscience, Inc. is a clinical development-stage, private company focused on personalized (autologous) regenerative medicine. The company is developing patient-derived iPSCs to create personalized cell therapies that address diseases with high unmet medical needs, beginning with autologous neuron replacement for Parkinson's disease and extending across the brain and affected organs. A leading iPSC platform company, Aspen combines stem cell biology with the latest artificial intelligence and genomic approaches to investigate patient-specific, restorative treatments. The company has developed a best-in-class platform to create and optimize iPSC-derived cell therapies, which includes in-house bioinformatics, manufacturing and QC. About Emerald Innovations, Inc. Emerald Innovations is a health analytics company that specializes in digital health solutions for passive, contactless in-home monitoring. Emerald seamlessly captures continuous health data from patients as they go about their normal lives. The Emerald biosensors fall under a cutting-edge category known as "Invisibles." Installed in the homes of study participants, these sensors continuously analyze surrounding radio signals. Using artificial intelligence, they extract patients' physiological data while prioritizing their privacy. Emerald simplifies clinical trials for its clients by obtaining statistically significant biomarkers, making them readily available to clinicians and data analysts, and consistently providing updates on the progress of clinical trials. Emerald's clientele encompasses big pharma, Fortune 500 pharmaceutical firms, innovative biotech companies, and leading disease research foundations. About Rune Labs Rune Labs is a software and data analytics company for precision neurology, supporting care delivery and therapy development. StrivePD is the company's care delivery ecosystem for Parkinson's disease, enabling patients and clinicians to better manage Parkinson's by providing access to curated dashboards summarizing a range of patient data sources, and by connecting patients to clinical trials. For therapeutics development, biopharma and medical device companies leverage Rune's technology, network of engaged clinicians and patients, and large longitudinal real-world datasets to expedite development programs. The company has received financial backing from leading investors such as Eclipse Ventures, DigiTx, TruVenturo and Moment Ventures. For more information, please visit runelabs.io and strive.group.

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MedTech

Vial Announces Strategic Partnership to Build CFR Part 11 Open Source e-Signature Platform with Documenso

PRNewswire | August 24, 2023

Vial, a global tech-driven CRO providing next-generation clinical trial management services, has announced a partnership with Documenso, an innovative open-source digital signing platform. The collaboration marks a significant step forward in revolutionizing document signing practices within the life science sector, providing a compelling alternative to traditional solutions like DocuSign. In an era where digital transformation is reshaping industries, Vial's partnership with Documenso is set to drive innovation in electronic document management, particularly in meeting the rigorous requirements of CFR Part 11 compliance. CFR Part 11 is a section of the Code of Federal Regulations (Title 21) established by the FDA. It lays out guidelines for electronic recordkeeping and signatures, ensuring data integrity and security in regulated sectors such as pharmaceuticals, biotechnology, and medical devices. "Vial's unwavering commitment to technological advancement has always been at the core of our mission to reimagine clinical trials. Our partnership with Documenso signifies an exciting leap towards innovation by addressing a critical need in the life science sector. Currently, very few providers offer solutions that align with the rigorous requirements of 21 CFR Part 11. We aim to collaborate with Documenso to develop one of the industry's first open-source document-signing products that meet the demands of 21 CFR Part 11. Together, we are poised to reshape how critical documents are managed and signed, driving us closer to a future where technology empowers every facet of scientific progress," said Simon Burns, CEO and Co-Founder of Vial. Vial's mission is to reimagine clinical trials to empower scientists to cure all human disease. Vial's driver for accomplishing this mission is applying a technology-forward approach. By deploying technology at every step, Vial is able to drive efficiencies in speed and cost savings for innovative biotech companies of all sizes. The Vial CRO distinguishes itself by leveraging its Vial Technology Platform, TrialOS, combining site start-up, visit data capture, and study analytics into one connected system. These best-in-class CRO services, combined with top vendor partnerships like Documenso, help accelerate the development of new therapies and devices for sponsors and patients. On the partnership, Timur, CEO, and Co-Founder of Documenso, commented, "Documenso is more than just a digital signing solution; it's a global commodity designed for longevity and scalability. We're excited to work alongside Vial in this endeavor, leveraging the power of Commercial Open Source (COSS) principles to provide a robust alternative to traditional solutions." About Vial Vial is a tech-first, next-generation CRO that promises faster and higher-quality execution of trials for less cost. The Vial Contract Research Organization (CRO) delivers on the promise of more efficient trials through its innovative technology platform that powers trials end-to-end from site startup to database lock. Vial's technology platform combines modern, intuitive eSource, EDC, and ePRO into one connected system, streamlining site processes and enabling considerable efficiencies. Vial operates across multiple Therapeutic Areas (Dermatology CRO, Ophthalmology CRO, Oncology CRO, Gastroenterology CRO, Neurology CRO, Cardiology CRO, Medical Device CRO, Rare Disease CRO, and Digital Therapeutics CRO). Vial is a San Francisco, California-based company with over 100+ employees. About Documenso Documenso is a groundbreaking open-source digital signing platform and alternative to traditional solutions like DocuSign. With a strong emphasis on customization and scalability, Documenso seamlessly integrates into business operations, offering extensive options for adaptation and an open API. Documenso was built for longevity and scale by embracing the capital efficiency and inclusiveness of the Commercial Open Source (COSS) movement. Documenso aims to create a global standard for digital signing that prioritizes inclusiveness and innovation.

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Industry Outlook

Cabaletta Bio and WuXi Advanced Therapies Announce Expansion of GMP Manufacturing Agreement to Include CABA-201

Globenewswire | August 23, 2023

Cabaletta Bio, Inc. a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that it has entered into certain work orders relating to Good Manufacturing Practice (GMP) manufacturing under its existing master services agreement with WuXi Advanced Therapies (WuXi ATU), a global Contract Testing, Development and Manufacturing Organization (CTDMO). As part of the agreement, WuXi ATU will serve as a cell processing manufacturing partner for the planned global clinical development of CABA-201 in multiple indications, including potential late-stage clinical trials and commercial readiness activities for CABA-201. “We have had a successful collaboration with WuXi ATU over the past two years for the GMP compliant production of novel cell therapies. Based on this initial collaboration, we chose to expand our partnership to include WuXi ATU as a manufacturer for our CABA-201 clinical programs,” said Gwendolyn Binder, Ph.D., President of Science and Technology of Cabaletta. “WuXi ATU’s dedicated production capacity for CABA-201 supports our planned global expansion and commercial preparedness efforts and will enable us to dose patients in multiple clinical trials with separate parallel cohorts, while maintaining a capital-efficient manufacturing strategy.” Under the terms of the agreement, WuXi ATU will provide GMP manufacturing of CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, to support any of Cabaletta’s planned clinical trials, including the previously announced separate Phase 1/2 clinical trials of CABA-201 for the treatment of patients with systemic lupus erythematosus and idiopathic inflammatory myopathies, or myositis. In addition, WuXi ATU will continue to serve as the Company’s cell processing manufacturing partner for the MusCAARTes™ Phase 1 clinical trial of MuSK-CAART. “We are delighted to expand our partnership with Cabaletta to advance the development of CABA-201 for patients with autoimmune diseases,” said David Y. H. Chang, Ph.D., President and Chief Technology Officer of WuXi ATU. “We look forward to applying our expertise in cell and gene therapy manufacturing to better support our customers to bring potentially life-saving treatments faster to patients in need.” About Cabaletta Bio Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in systemic lupus erythematosus and myositis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. About WuXi Advanced Therapies (WuXi ATU) As the advanced therapies business unit of WuXi AppTec, WuXi Advanced Therapies is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support customer programs around the world.

Read More

Medical, Diagnostics

Aspen Neuroscience to Partner with Rune Labs and Emerald Innovations to Incorporate both Active and Passive Digital Health Monitoring

prnewswire | August 28, 2023

Aspen Neuroscience today announced that it is partnering with Emerald Innovations, a pioneer in the creation of "invisible" off-body sensors for measuring health analytics, and Rune Labs, a software and data analytics company for precision neurology, to incorporate digital health (DHT) modalities in the company's Trial-Ready Screening Cohort Study. The Trial Ready Screening Cohort study was launched in 2022 to screen, enroll and begin manufacturing cells for potential patient candidates for the future Phase 1/2a clinical trial for ANPD001, a personalized (autologous) cell therapy to treat Parkinson's disease (PD) by replacing lost dopamine neurons. Aspen Neuroscience is advancing the collection of objective measures of motor function via passive in-home monitoring, working with Emerald Innovations' contactless biosensors, and active monitoring, working with Rune Labs' clinical development platform, StriveStudy. The use of DHT empowers trial investigators to include objective, long-term (pre-treatment) motor and sleep symptom capture, to provide data on each patient's rate of disease progression. "Parkinson's disease is very personal in nature, and we are working to develop a personal cell therapy for PD," said Damien McDevitt, PhD, Aspen president and CEO. "Everyone with Parkinson's has a unique experience, with varied symptoms. We look forward to working closely with the innovative and collaborative teams at Rune Labs and Emerald Innovations to capture a holistic and precise pattern of motor symptom activity over time for people in our screening study." "Parkinson's is a heterogeneous condition, adding to the challenge of assessing treatment benefit without a personalized view of each trial participant's symptom activity," said Brian Pepin, CEO of Rune Labs. "Through StriveStudy, our biopharma partners are able to collect large quantities of continuous multimodal data to characterize participant's disease activity across a range of clinical features. We are excited to collaborate with Aspen Neuroscience to help them characterize patient symptoms as they bring their personalized cell therapy into clinical testing." "We are delighted to collaborate with Aspen Neuroscience," said Dr. Dina Katabi, MIT professor and the co-founder and president of Emerald Innovations, Inc. "A significant hurdle in Parkinson's disease clinical trials is the reliable monitoring of disease progression and medication response without the need to enroll hundreds or even thousands of patients. Empirical evidence has demonstrated that readings from the Emerald sensor offer a dependable marker for tracking disease progression. The Emerald sensor gathers this data without body contact, relying solely on the analysis of radio signals in the environment as patients go about their normal lives." About DHT in the Trial Ready Cohort Screening Study Aspen will partner with Rune Labs to deeply characterize each patient's symptoms in the Trial Ready Cohort, including the collection of multimodal data, thereby enabling robust disease characterization over time. This will include objective measures of tremor and dyskinesia levels captured on FDA-cleared StrivePD on the Apple Watch, medication monitoring, as well as Apple HealthKit, including global activity (e.g., daily steps). Aspen and Emerald will collaborate to assess passive "invisible" in-home monitoring of participants enrolled in the Trial Ready Cohort. This will include gait speed measured across walking intervals, sleep onset, the amount of time between entering different sleep stages; sleep duration, sleep efficiency and WASO: the total time spent in the WAKE stage after sleep onset. About Parkinson's Disease Parkinson's disease is the world's second most common neurodegenerative disease, affecting more than 10 million people worldwide, including more than 1 million in the U.S., where an additional 90,000+ people are diagnosed every year. Patients can experience non-motor symptoms such as mental and behavioral changes, sleep problems, depression, memory difficulties and fatigue; and motor symptoms caused by the loss of dopamine neurons in the brain, including unintended or uncontrollable movements (dyskinesia), shaking (tremor), stiffness, and difficulty with balance and coordination, which worsen over time. By the time of diagnosis, it is common for people to have lost the majority of cells in the brain that make dopamine. To date, there is no disease-modifying therapy that can stop, replace or prevent the loss of dopamine neurons or slow the progression of PD. About Aspen Neuroscience Headquartered in San Diego, Aspen Neuroscience, Inc. is a clinical development-stage, private company focused on personalized (autologous) regenerative medicine. The company is developing patient-derived iPSCs to create personalized cell therapies that address diseases with high unmet medical needs, beginning with autologous neuron replacement for Parkinson's disease and extending across the brain and affected organs. A leading iPSC platform company, Aspen combines stem cell biology with the latest artificial intelligence and genomic approaches to investigate patient-specific, restorative treatments. The company has developed a best-in-class platform to create and optimize iPSC-derived cell therapies, which includes in-house bioinformatics, manufacturing and QC. About Emerald Innovations, Inc. Emerald Innovations is a health analytics company that specializes in digital health solutions for passive, contactless in-home monitoring. Emerald seamlessly captures continuous health data from patients as they go about their normal lives. The Emerald biosensors fall under a cutting-edge category known as "Invisibles." Installed in the homes of study participants, these sensors continuously analyze surrounding radio signals. Using artificial intelligence, they extract patients' physiological data while prioritizing their privacy. Emerald simplifies clinical trials for its clients by obtaining statistically significant biomarkers, making them readily available to clinicians and data analysts, and consistently providing updates on the progress of clinical trials. Emerald's clientele encompasses big pharma, Fortune 500 pharmaceutical firms, innovative biotech companies, and leading disease research foundations. About Rune Labs Rune Labs is a software and data analytics company for precision neurology, supporting care delivery and therapy development. StrivePD is the company's care delivery ecosystem for Parkinson's disease, enabling patients and clinicians to better manage Parkinson's by providing access to curated dashboards summarizing a range of patient data sources, and by connecting patients to clinical trials. For therapeutics development, biopharma and medical device companies leverage Rune's technology, network of engaged clinicians and patients, and large longitudinal real-world datasets to expedite development programs. The company has received financial backing from leading investors such as Eclipse Ventures, DigiTx, TruVenturo and Moment Ventures. For more information, please visit runelabs.io and strive.group.

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MedTech

Vial Announces Strategic Partnership to Build CFR Part 11 Open Source e-Signature Platform with Documenso

PRNewswire | August 24, 2023

Vial, a global tech-driven CRO providing next-generation clinical trial management services, has announced a partnership with Documenso, an innovative open-source digital signing platform. The collaboration marks a significant step forward in revolutionizing document signing practices within the life science sector, providing a compelling alternative to traditional solutions like DocuSign. In an era where digital transformation is reshaping industries, Vial's partnership with Documenso is set to drive innovation in electronic document management, particularly in meeting the rigorous requirements of CFR Part 11 compliance. CFR Part 11 is a section of the Code of Federal Regulations (Title 21) established by the FDA. It lays out guidelines for electronic recordkeeping and signatures, ensuring data integrity and security in regulated sectors such as pharmaceuticals, biotechnology, and medical devices. "Vial's unwavering commitment to technological advancement has always been at the core of our mission to reimagine clinical trials. Our partnership with Documenso signifies an exciting leap towards innovation by addressing a critical need in the life science sector. Currently, very few providers offer solutions that align with the rigorous requirements of 21 CFR Part 11. We aim to collaborate with Documenso to develop one of the industry's first open-source document-signing products that meet the demands of 21 CFR Part 11. Together, we are poised to reshape how critical documents are managed and signed, driving us closer to a future where technology empowers every facet of scientific progress," said Simon Burns, CEO and Co-Founder of Vial. Vial's mission is to reimagine clinical trials to empower scientists to cure all human disease. Vial's driver for accomplishing this mission is applying a technology-forward approach. By deploying technology at every step, Vial is able to drive efficiencies in speed and cost savings for innovative biotech companies of all sizes. The Vial CRO distinguishes itself by leveraging its Vial Technology Platform, TrialOS, combining site start-up, visit data capture, and study analytics into one connected system. These best-in-class CRO services, combined with top vendor partnerships like Documenso, help accelerate the development of new therapies and devices for sponsors and patients. On the partnership, Timur, CEO, and Co-Founder of Documenso, commented, "Documenso is more than just a digital signing solution; it's a global commodity designed for longevity and scalability. We're excited to work alongside Vial in this endeavor, leveraging the power of Commercial Open Source (COSS) principles to provide a robust alternative to traditional solutions." About Vial Vial is a tech-first, next-generation CRO that promises faster and higher-quality execution of trials for less cost. The Vial Contract Research Organization (CRO) delivers on the promise of more efficient trials through its innovative technology platform that powers trials end-to-end from site startup to database lock. Vial's technology platform combines modern, intuitive eSource, EDC, and ePRO into one connected system, streamlining site processes and enabling considerable efficiencies. Vial operates across multiple Therapeutic Areas (Dermatology CRO, Ophthalmology CRO, Oncology CRO, Gastroenterology CRO, Neurology CRO, Cardiology CRO, Medical Device CRO, Rare Disease CRO, and Digital Therapeutics CRO). Vial is a San Francisco, California-based company with over 100+ employees. About Documenso Documenso is a groundbreaking open-source digital signing platform and alternative to traditional solutions like DocuSign. With a strong emphasis on customization and scalability, Documenso seamlessly integrates into business operations, offering extensive options for adaptation and an open API. Documenso was built for longevity and scale by embracing the capital efficiency and inclusiveness of the Commercial Open Source (COSS) movement. Documenso aims to create a global standard for digital signing that prioritizes inclusiveness and innovation.

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Industry Outlook

Cabaletta Bio and WuXi Advanced Therapies Announce Expansion of GMP Manufacturing Agreement to Include CABA-201

Globenewswire | August 23, 2023

Cabaletta Bio, Inc. a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that it has entered into certain work orders relating to Good Manufacturing Practice (GMP) manufacturing under its existing master services agreement with WuXi Advanced Therapies (WuXi ATU), a global Contract Testing, Development and Manufacturing Organization (CTDMO). As part of the agreement, WuXi ATU will serve as a cell processing manufacturing partner for the planned global clinical development of CABA-201 in multiple indications, including potential late-stage clinical trials and commercial readiness activities for CABA-201. “We have had a successful collaboration with WuXi ATU over the past two years for the GMP compliant production of novel cell therapies. Based on this initial collaboration, we chose to expand our partnership to include WuXi ATU as a manufacturer for our CABA-201 clinical programs,” said Gwendolyn Binder, Ph.D., President of Science and Technology of Cabaletta. “WuXi ATU’s dedicated production capacity for CABA-201 supports our planned global expansion and commercial preparedness efforts and will enable us to dose patients in multiple clinical trials with separate parallel cohorts, while maintaining a capital-efficient manufacturing strategy.” Under the terms of the agreement, WuXi ATU will provide GMP manufacturing of CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, to support any of Cabaletta’s planned clinical trials, including the previously announced separate Phase 1/2 clinical trials of CABA-201 for the treatment of patients with systemic lupus erythematosus and idiopathic inflammatory myopathies, or myositis. In addition, WuXi ATU will continue to serve as the Company’s cell processing manufacturing partner for the MusCAARTes™ Phase 1 clinical trial of MuSK-CAART. “We are delighted to expand our partnership with Cabaletta to advance the development of CABA-201 for patients with autoimmune diseases,” said David Y. H. Chang, Ph.D., President and Chief Technology Officer of WuXi ATU. “We look forward to applying our expertise in cell and gene therapy manufacturing to better support our customers to bring potentially life-saving treatments faster to patients in need.” About Cabaletta Bio Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in systemic lupus erythematosus and myositis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. About WuXi Advanced Therapies (WuXi ATU) As the advanced therapies business unit of WuXi AppTec, WuXi Advanced Therapies is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support customer programs around the world.

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