Q&A with Tom O'Regan, CEO at Madison Logic

MEDIA 7 | September 5, 2019

Q&A with Tom O'Regan
Tom O'Regan, CEO at Madison Logic is a global leader in account based marketing. In this role, O’Regan leads all company initiatives with an emphasis on positioning ActivateABMTM as the only truly global account based marketing platform built for B2B marketers.

Focused on driving Madison Logic momentum and enabling the Marketer to be the driving force for growth and change within the enterprise, O’Regan also sits on the Advisory Board of The Fiscal Times, both the Sales Executive Committee and B2B Operating Group at the IAB.

MEDIA 7: If I were to say to a bunch of people who know you, ‘Give me three adjectives that best describe you’, what would I hear?
TOM O'REGAN: 
Passionate, Optimistic, and Indefatigable

M7: Ovum has named Madison Logic a “Leader” in the Ovum Market Radar: Account-Based Marketing report. What factors have led Madison Logic to emerge as a leader in ABM?
TO'R:
Ovum recognized the strength of our ABM platform in achieving predictable growth among the fastest growing B2B organizations globally. Specifically, the ability to leverage intent data to target the right accounts, measure ABM effectiveness, shorten sales cycles, and accelerate growth. The Ovum report also highlights Madison Logic's data gateway that allows CRM and MAP platforms to connect seamlessly including Salesforce, Marketo, and Oracle Eloqua.


"AI will play a critical role in the dynamic account targeting, content personalization, and conversion metrics that will accelerate growth for B2B marketers."

M7: How will the bi-directional integration with Oracle Eloqua help Madison Logic to empower B2B marketers?
TO'R:
Communication between marketing and sales in addition to integrating with the leading CRM and MAP platforms are key factors for ABM success at large B2B organizations. With the Oracle Eloqua integration, Madison Logic seamlessly accesses target account lists to activate ABM Demand Generation and Advertising programs and transfers engagement data back into Eloqua for lead scoring. Joint clients can also take advantage of Journey Acceleration™, which personalizes messaging based on marketing funnel stage to increase the volume, velocity, and value of deals in the pipeline.


"Communication between marketing and sales in addition to integrating with the leading CRM and MAP platforms are key factors for ABM success at large B2B organizations."

M7: How do you see technology and artificial intelligence impacting the ABM landscape in the near future?
TO'R:
AI will play a critical role in the dynamic account targeting, content personalization, and conversion metrics that will accelerate growth for B2B marketers.



M7: Tom, your love for golf is well-known. Since when have you been playing golf and how do you manufacture time for it?
TO'R:
I’ve played golf since college and have met so many unbelievable people, explored so many amazing places around the world, and had incredible experiences enjoying the game of golf. With offices in NY, Boston, San Francisco, Seattle, London, Dublin, and Singapore, I have the opportunity to play with team members, partners, and clients once in a while. When I’m not working, I pick vacation spots partially on the quality of the links.

M7: What is your superpower?
TO'R:
I’d like to think I have a good eye for talent and finding people who have the skills, but more importantly I have the determination needed to grow and scale a business as a team.

ABOUT MADISON LOGIC

Madison Logic’s global account-based marketing (ABM) solution empowers B2B marketers to convert their best accounts faster. By integrating the ML Data Cloud with CRM and marketing automation platforms, intent data, and more than 20 other datasets, marketers execute a unified activation strategy across the funnel with ABM Advertising and ABM Demand Generation to align with sales, accelerate the buyer journey, and drive growth.

More C-Suite on deck

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 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 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 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

Related News

BUSINESS INSIGHTS

Teva Announces Unique Collaboration with HealthSnap to Expand the Reach of its Respiratory Digital Health Platform

Teva Pharmaceuticals | November 21, 2022

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced a new collaboration with HealthSnap, a leading full-service Virtual Care Management Platform for chronic disease management. The collaboration will enable more consumers to have access to Teva’s Digihaler® system, a digital health platform designed to enable patients to have more informed treatment discussions with their healthcare providers through personalized care. The collaboration will enable healthcare providers to better integrate patient data into their workflows, supporting proactive remote care across large populations. The platform can be used to monitor and manage large populations by a network of health systems. It can capture objective and actionable data for asthma patients, thereby creating the mechanism for personalized care. “Digital health platforms will succeed only by seamlessly integrating multiple data sources into workflows and systems like electronic medical records (EMR). We believe in building an ecosystem and are delighted to partner with HealthSnap as we seek to expand the reach of our platform, and continue to shape digital therapeutics and the integrated care landscape,” said Manny Montalvo, Senior Vice President, Head of Digital Health & Innovation at Teva. “We believe that the future of healthcare is in predictive and preventative care, which is a significant paradigm shift from the standard of care today. That is why we will focus our collaboration and our services on facilitating this change, to help providers deliver better care and help patients manage their condition.” “With a rich heritage of delivering innovative medicines, alongside technology development capabilities, Teva is uniquely positioned to help the healthcare ecosystem move toward greater integration of objective health data, and create meaningful population-scale solutions to help patients and providers. We envision broad utilization of our platform by consumers, healthcare providers and other technology organizations. In respiratory care, our long-term vision is ambitious and clear: harnessing the power of technology and therapeutics to predict asthma attacks.” Montalvo continued, “Over the past few years, through a talented and continuously evolving in-house team we have built a robust technology arm within Teva to continue exploring ways to improve patient outcomes. Through our vision for connected therapy, we strive to be at the nexus between patients, healthcare providers, technology, and the future of medicine, exploring new ways for digital health to serve as an economically sustainable solution for small and large healthcare provider organizations, offering timely, data-driven solutions to benefit patients. Our hope is that by working with HealthSnap and other capable companies in this space, we will fulfill our mission of improving the lives of patients, and do so by improving the health and effectiveness of our healthcare system – and we’re just getting started.” “By partnering with Teva, HealthSnap is expanding its reach to patients with respiratory diseases, allowing them to receive personalized care based on their data. HealthSnap is continuously seeking partnerships and we look forward to delivering quality at home programs with this new and exciting collaboration with Teva,” Samson Magid, Co-Founder and CEO of HealthSnap About Teva Teva Pharmaceutical Industries Ltd. has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com About Teva Digital Health Teva aims to be a global leader in personalized, predictive care, continuously investing in platforms and regulatory-compliant systems that will help change the nature of digital health as we know it. Teva’s proprietary software platform Digihaler® – developed and maintained in-house by a team of research specialists and programmers – is built into a series of FDA-approved inhalers, currently marketed in the U.S., and with plans to expand to Europe in 2023. About HealthSnap HealthSnap is an integrated Virtual Care Management Platform that helps healthcare organizations improve patient outcomes, reduce utilization, and diversify revenue streams. From chronic disease-agnostic Remote Patient Monitoringand Chronic Care Management to AI-guided care coordination, virtual care delivery, automated care management billing, population analytics - and so much more, HealthSnap is the simplest way to manage chronic conditions remotely.

Read More

PHARMACY MARKET

TC BioPharm Begins Dosing Phase 2B Clinical Study Evaluating its Lead Compound, OmnImmune®, in Patients with Acute Myeloid Leukemia

TC BioPharm | November 23, 2022

TC Biopharm a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer today announced the dosing of its first three patients within its Phase 2b clinical trial of OmnImmune®, an allogeneic unmodified cell therapy focused on treating Acute Myeloid Leukemia. The initial 5 patients in the trial are deemed a "safety cohort", spaced two weeks apart with safety review by an oversight board to confirm no drug related toxicity issues, subsequent to 5 patients being dosed the study will advance to open enrollment. This safety cohort is in line with TCBP's step-wise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient. "The launch of our Phase 2B trial is a key milestone in the development of our lead therapeutic, OmnImmune®, for patients with AML and for TC BioPharm's emerging pipeline of 'off-the-shelf' gamma-delta T cell therapies. This study design includes a 5 patient safety cohort prior to open enrollment, we expect to complete the safety cohort before the end of 2022. The next step in the study is a 19 patient interim review, which will allow TCBP to review dosing and increase dosing to a higher level should our team deem it necessary for efficacy, or we can elect to maintain our current dosing level of 7x10^7 or 700 million cells per dose. We look forward to moving ahead with our Phase 2b trial with a target for open enrollment in January 2023, as well as our efforts to expand our clinical efforts in the US in the first half of 2023." Bryan Kobel, CEO of TC BioPharm TC BioPharm's Phase 2B trial, dubbed ACHIEVE, will enroll adults diagnosed with AML who have either relapsed or are refractory to prior treatments as well as a cohort for patients with myelodysplastic syndromes conditions that can occur when the blood-forming cells in the bone marrow become abnormal. The trial is expected to enroll approximately 37 patients. About TC BioPharm PLC TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue. TC BioPharm uses an allogeneic approach in both unmodified and CAR modified gamma-delta T cells to effectively identify, target and eradicate both liquid and solid tumors in cancer. TC BioPharm is the leader in developing gamma-delta T cell therapies, and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line - Phase 2b/3 pivotal trial for OmnImmune® in treatment of acute myeloid leukemia using the Company's proprietary allogenic CryoTC technology to provide frozen product to clinics worldwide. TC BioPharm also maintains a robust pipeline for future indications in solid tumors as well as a significant IP/patent portfolio in the use of CARs with gamma-delta T cells and owns our manufacturing facility to maintain cost and product quality controls.

Read More

BUSINESS INSIGHTS

BioMarin Announces Advancements in FDA Review of ROCTAVIAN™ (Valoctocogene Roxaparvovec) for Adults with Severe Hemophilia A

BioMarin Pharmaceutical Inc. | November 24, 2022

BioMarin Pharmaceutical Inc. announced advancements in the U.S. Food and Drug Administration review of the Biologics License Application of ROCTAVIAN™ for adults with severe hemophilia A. The Company was recently notified by the FDA that after further consideration, at this time, the Agency no longer plans to hold an advisory committee meeting to discuss the BLA for ROCTAVIAN that is currently under review. Previously, the FDA communicated to the Company that it did intend to hold an advisory committee meeting but did not specify a date. The Company also remains on track to host the scheduled FDA Pre-Licensure Inspection (PLI) of BioMarin's gene therapy manufacturing facility located in Novato, CA. "The review of a BLA is a dynamic process, and we appreciate FDA's ongoing engagement as we work toward delivering a potentially transformative treatment choice to those patients with severe hemophilia A. We look forward to further dialogue with the Agency as it reviews our application." Hank Fuchs, M.D., President of Worldwide Research and Development at BioMarin About valoctocogene roxaparvovec The FDA granted Regenerative Medicine Advanced Therapy designation to valoctocogene roxaparvovec in March 2021. RMAT is an expedited program intended to facilitate development and review of regenerative medicine therapies, such as valoctocogene roxaparvovec, that are expected to address an unmet medical need in patients with serious conditions. The RMAT designation is complementary to Breakthrough Therapy Designation, which the Company received for valoctocogene roxaparvovec in 2017. In addition to the RMAT Designation and Breakthrough Therapy Designation, BioMarin's valoctocogene roxaparvovec also received orphan drug designation from the EMA and FDA for the treatment of severe hemophilia A. Orphan drug designation is reserved for medicines treating rare, life-threatening, or chronically debilitating diseases. The European Commission (EC) granted conditional marketing authorization to valoctocogene roxaparvovec gene therapy under the brand name ROCTAVIAN™ on August 24, 2022. Robust Clinical Program BioMarin has multiple clinical studies underway in its comprehensive gene therapy program for the treatment of severe hemophilia A. In addition to the global Phase 3 study GENEr8-1 and the ongoing Phase 1/2 dose escalation study, the Company is also conducting a Phase 3, single arm, open-label study to evaluate the efficacy and safety of valoctocogene roxaparvovec at a dose of 6e13 vg/kg with prophylactic corticosteroids in people with severe hemophilia A. Also ongoing is a Phase 1/2 Study with the 6e13 vg/kg dose of valoctocogene roxaparvovec in people with severe hemophilia A with pre-existing AAV5 antibodies (Study 270-203) and a Phase 1/2 Study with the 6e13 vg/kg dose of valoctocogene roxaparvovec in people with severe hemophilia A with active or prior Factor VIII inhibitors. About Hemophilia A People living with hemophilia A lack sufficient functioning Factor VIII protein to help their blood clot and are at risk for painful and/or potentially life-threatening bleeds from even modest injuries. Additionally, people with the most severe form of hemophilia A often experience painful, spontaneous bleeds into their muscles or joints. Individuals with the most severe form of hemophilia A make up approximately 50 percent of the hemophilia A population. People with hemophilia A with moderate or mild disease show a much-reduced propensity to bleed. Individuals with severe hemophilia A are treated with a prophylactic regimen of intravenous Factor VIII infusions administered 2-3 times per week or a bispecific monoclonal antibody that mimics the activity of Factor VIII administered 1-4 times per month. Despite these regimens, many people continue to experience breakthrough bleeds, resulting in progressive and debilitating joint damage, which can have a major impact on their quality of life. Hemophilia A, also called Factor VIII deficiency or classic hemophilia, is an X-linked genetic disorder caused by missing or defective Factor VIII, a clotting protein. Although it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous mutation, a new mutation that was not inherited. Approximately 1 in 10,000 people have hemophilia A. About BioMarin BioMarin is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening genetic diseases and medical conditions. The Company selects product candidates for diseases and conditions that represent a significant unmet medical need, have well-understood biology and provide an opportunity to be first-to-market or offer a significant benefit over existing products. The Company's portfolio consists of eight commercial products and multiple clinical and preclinical product candidates for the treatment of various diseases.

Read More

BUSINESS INSIGHTS

Teva Announces Unique Collaboration with HealthSnap to Expand the Reach of its Respiratory Digital Health Platform

Teva Pharmaceuticals | November 21, 2022

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced a new collaboration with HealthSnap, a leading full-service Virtual Care Management Platform for chronic disease management. The collaboration will enable more consumers to have access to Teva’s Digihaler® system, a digital health platform designed to enable patients to have more informed treatment discussions with their healthcare providers through personalized care. The collaboration will enable healthcare providers to better integrate patient data into their workflows, supporting proactive remote care across large populations. The platform can be used to monitor and manage large populations by a network of health systems. It can capture objective and actionable data for asthma patients, thereby creating the mechanism for personalized care. “Digital health platforms will succeed only by seamlessly integrating multiple data sources into workflows and systems like electronic medical records (EMR). We believe in building an ecosystem and are delighted to partner with HealthSnap as we seek to expand the reach of our platform, and continue to shape digital therapeutics and the integrated care landscape,” said Manny Montalvo, Senior Vice President, Head of Digital Health & Innovation at Teva. “We believe that the future of healthcare is in predictive and preventative care, which is a significant paradigm shift from the standard of care today. That is why we will focus our collaboration and our services on facilitating this change, to help providers deliver better care and help patients manage their condition.” “With a rich heritage of delivering innovative medicines, alongside technology development capabilities, Teva is uniquely positioned to help the healthcare ecosystem move toward greater integration of objective health data, and create meaningful population-scale solutions to help patients and providers. We envision broad utilization of our platform by consumers, healthcare providers and other technology organizations. In respiratory care, our long-term vision is ambitious and clear: harnessing the power of technology and therapeutics to predict asthma attacks.” Montalvo continued, “Over the past few years, through a talented and continuously evolving in-house team we have built a robust technology arm within Teva to continue exploring ways to improve patient outcomes. Through our vision for connected therapy, we strive to be at the nexus between patients, healthcare providers, technology, and the future of medicine, exploring new ways for digital health to serve as an economically sustainable solution for small and large healthcare provider organizations, offering timely, data-driven solutions to benefit patients. Our hope is that by working with HealthSnap and other capable companies in this space, we will fulfill our mission of improving the lives of patients, and do so by improving the health and effectiveness of our healthcare system – and we’re just getting started.” “By partnering with Teva, HealthSnap is expanding its reach to patients with respiratory diseases, allowing them to receive personalized care based on their data. HealthSnap is continuously seeking partnerships and we look forward to delivering quality at home programs with this new and exciting collaboration with Teva,” Samson Magid, Co-Founder and CEO of HealthSnap About Teva Teva Pharmaceutical Industries Ltd. has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com About Teva Digital Health Teva aims to be a global leader in personalized, predictive care, continuously investing in platforms and regulatory-compliant systems that will help change the nature of digital health as we know it. Teva’s proprietary software platform Digihaler® – developed and maintained in-house by a team of research specialists and programmers – is built into a series of FDA-approved inhalers, currently marketed in the U.S., and with plans to expand to Europe in 2023. About HealthSnap HealthSnap is an integrated Virtual Care Management Platform that helps healthcare organizations improve patient outcomes, reduce utilization, and diversify revenue streams. From chronic disease-agnostic Remote Patient Monitoringand Chronic Care Management to AI-guided care coordination, virtual care delivery, automated care management billing, population analytics - and so much more, HealthSnap is the simplest way to manage chronic conditions remotely.

Read More

PHARMACY MARKET

TC BioPharm Begins Dosing Phase 2B Clinical Study Evaluating its Lead Compound, OmnImmune®, in Patients with Acute Myeloid Leukemia

TC BioPharm | November 23, 2022

TC Biopharm a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer today announced the dosing of its first three patients within its Phase 2b clinical trial of OmnImmune®, an allogeneic unmodified cell therapy focused on treating Acute Myeloid Leukemia. The initial 5 patients in the trial are deemed a "safety cohort", spaced two weeks apart with safety review by an oversight board to confirm no drug related toxicity issues, subsequent to 5 patients being dosed the study will advance to open enrollment. This safety cohort is in line with TCBP's step-wise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient. "The launch of our Phase 2B trial is a key milestone in the development of our lead therapeutic, OmnImmune®, for patients with AML and for TC BioPharm's emerging pipeline of 'off-the-shelf' gamma-delta T cell therapies. This study design includes a 5 patient safety cohort prior to open enrollment, we expect to complete the safety cohort before the end of 2022. The next step in the study is a 19 patient interim review, which will allow TCBP to review dosing and increase dosing to a higher level should our team deem it necessary for efficacy, or we can elect to maintain our current dosing level of 7x10^7 or 700 million cells per dose. We look forward to moving ahead with our Phase 2b trial with a target for open enrollment in January 2023, as well as our efforts to expand our clinical efforts in the US in the first half of 2023." Bryan Kobel, CEO of TC BioPharm TC BioPharm's Phase 2B trial, dubbed ACHIEVE, will enroll adults diagnosed with AML who have either relapsed or are refractory to prior treatments as well as a cohort for patients with myelodysplastic syndromes conditions that can occur when the blood-forming cells in the bone marrow become abnormal. The trial is expected to enroll approximately 37 patients. About TC BioPharm PLC TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue. TC BioPharm uses an allogeneic approach in both unmodified and CAR modified gamma-delta T cells to effectively identify, target and eradicate both liquid and solid tumors in cancer. TC BioPharm is the leader in developing gamma-delta T cell therapies, and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line - Phase 2b/3 pivotal trial for OmnImmune® in treatment of acute myeloid leukemia using the Company's proprietary allogenic CryoTC technology to provide frozen product to clinics worldwide. TC BioPharm also maintains a robust pipeline for future indications in solid tumors as well as a significant IP/patent portfolio in the use of CARs with gamma-delta T cells and owns our manufacturing facility to maintain cost and product quality controls.

Read More

BUSINESS INSIGHTS

BioMarin Announces Advancements in FDA Review of ROCTAVIAN™ (Valoctocogene Roxaparvovec) for Adults with Severe Hemophilia A

BioMarin Pharmaceutical Inc. | November 24, 2022

BioMarin Pharmaceutical Inc. announced advancements in the U.S. Food and Drug Administration review of the Biologics License Application of ROCTAVIAN™ for adults with severe hemophilia A. The Company was recently notified by the FDA that after further consideration, at this time, the Agency no longer plans to hold an advisory committee meeting to discuss the BLA for ROCTAVIAN that is currently under review. Previously, the FDA communicated to the Company that it did intend to hold an advisory committee meeting but did not specify a date. The Company also remains on track to host the scheduled FDA Pre-Licensure Inspection (PLI) of BioMarin's gene therapy manufacturing facility located in Novato, CA. "The review of a BLA is a dynamic process, and we appreciate FDA's ongoing engagement as we work toward delivering a potentially transformative treatment choice to those patients with severe hemophilia A. We look forward to further dialogue with the Agency as it reviews our application." Hank Fuchs, M.D., President of Worldwide Research and Development at BioMarin About valoctocogene roxaparvovec The FDA granted Regenerative Medicine Advanced Therapy designation to valoctocogene roxaparvovec in March 2021. RMAT is an expedited program intended to facilitate development and review of regenerative medicine therapies, such as valoctocogene roxaparvovec, that are expected to address an unmet medical need in patients with serious conditions. The RMAT designation is complementary to Breakthrough Therapy Designation, which the Company received for valoctocogene roxaparvovec in 2017. In addition to the RMAT Designation and Breakthrough Therapy Designation, BioMarin's valoctocogene roxaparvovec also received orphan drug designation from the EMA and FDA for the treatment of severe hemophilia A. Orphan drug designation is reserved for medicines treating rare, life-threatening, or chronically debilitating diseases. The European Commission (EC) granted conditional marketing authorization to valoctocogene roxaparvovec gene therapy under the brand name ROCTAVIAN™ on August 24, 2022. Robust Clinical Program BioMarin has multiple clinical studies underway in its comprehensive gene therapy program for the treatment of severe hemophilia A. In addition to the global Phase 3 study GENEr8-1 and the ongoing Phase 1/2 dose escalation study, the Company is also conducting a Phase 3, single arm, open-label study to evaluate the efficacy and safety of valoctocogene roxaparvovec at a dose of 6e13 vg/kg with prophylactic corticosteroids in people with severe hemophilia A. Also ongoing is a Phase 1/2 Study with the 6e13 vg/kg dose of valoctocogene roxaparvovec in people with severe hemophilia A with pre-existing AAV5 antibodies (Study 270-203) and a Phase 1/2 Study with the 6e13 vg/kg dose of valoctocogene roxaparvovec in people with severe hemophilia A with active or prior Factor VIII inhibitors. About Hemophilia A People living with hemophilia A lack sufficient functioning Factor VIII protein to help their blood clot and are at risk for painful and/or potentially life-threatening bleeds from even modest injuries. Additionally, people with the most severe form of hemophilia A often experience painful, spontaneous bleeds into their muscles or joints. Individuals with the most severe form of hemophilia A make up approximately 50 percent of the hemophilia A population. People with hemophilia A with moderate or mild disease show a much-reduced propensity to bleed. Individuals with severe hemophilia A are treated with a prophylactic regimen of intravenous Factor VIII infusions administered 2-3 times per week or a bispecific monoclonal antibody that mimics the activity of Factor VIII administered 1-4 times per month. Despite these regimens, many people continue to experience breakthrough bleeds, resulting in progressive and debilitating joint damage, which can have a major impact on their quality of life. Hemophilia A, also called Factor VIII deficiency or classic hemophilia, is an X-linked genetic disorder caused by missing or defective Factor VIII, a clotting protein. Although it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous mutation, a new mutation that was not inherited. Approximately 1 in 10,000 people have hemophilia A. About BioMarin BioMarin is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening genetic diseases and medical conditions. The Company selects product candidates for diseases and conditions that represent a significant unmet medical need, have well-understood biology and provide an opportunity to be first-to-market or offer a significant benefit over existing products. The Company's portfolio consists of eight commercial products and multiple clinical and preclinical product candidates for the treatment of various diseases.

Read More