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 Ed Breault, Chief Marketing Officer at Aprimo

MEDIA 7 | November 28, 2019

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

Read More

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

MEDIA 7 | November 28, 2019

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

Read More

Q&A with 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

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Pharmacy Market

Now Available – XDEMVY™ (lotilaner ophthalmic solution) 0.25%, the First and Only FDA Approved Treatment for Demodex Blepharitis

globenewswire | August 28, 2023

Tarsus Pharmaceuticals, Inc. whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, announced that XDEMVY™ (lotilaner ophthalmic solution) 0.25% is now available at pharmacies nationwide for prescription. The U.S. Food and Drug Administration (FDA) approved XDEMVY on July 24, 2023, for the treatment of Demodex blepharitis. “We are delighted that within weeks of FDA approval, XDEMVY is now available to millions of patients with Demodex blepharitis,” said Bobak Azamian, MD, PhD, Chief Executive Officer and Chairman of Tarsus. “The efforts of our team have created incredible interest in XDEMVY, the first and only approved solution for this highly prevalent disease. I’m so appreciative of our team and our partners who’ve worked diligently to bring this product to eye care providers and patients quickly and seamlessly following regulatory approval. We are proud to introduce XDEMVY to the eye care community and look forward to its potential to significantly change the way this disease is treated.” XDEMVY is the only FDA approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis. Demodex blepharitis is characterized by redness, inflammation, missing or misdirected eyelashes, itching along the eyelid base, and the presence of collarettes. XDEMVY is a prescription eye drop that is administered with one drop in each eye twice daily (approximately 12 hours apart) for 6 weeks. Tarsus is committed to ensuring that patients have affordable and broad access to XDEMVY and developed Tarsus Connect, a suite of assistance programs that provide financial support for eligible patients. More information about Tarsus Connect can be found on xdemvy.com or by calling: 1-866-846-3092. About Demodex Blepharitis Blepharitis is a common lid margin disease that is characterized by eyelid margin inflammation, redness and ocular irritation. Demodex blepharitis is caused by an infestation of Demodex mites, the most common ectoparasite found on humans and accounts for over two-thirds of all blepharitis cases. Demodex blepharitis may affect as many as 25 million Americans based on an extrapolation from the Titan study indicating 58% of patients presenting to U.S. eye care clinics have collarettes, a pathognomonic sign of Demodex mite infestation, and that at least 45 million people annually visit an eye care clinic. Demodex blepharitis can have a significant clinical burden and negative impact on patients’ daily lives. The Titan study also showed that current management tools, such as tea tree oil and lid wipes, are ineffective at targeting the root cause of Demodex blepharitis. About XDEMVY™ XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop for the treatment of Demodex blepharitis and is designed to target and eradicate the root cause of the disease – Demodex mite infestation. The active ingredient in XDEMVY is lotilaner, a well-characterized agent that eradicates Demodex mites by selectively inhibiting the GABA-Cl channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eyelash follicles where the mites reside. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found XDEMVY to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis. About Tarsus Pharmaceuticals, Inc. Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. Tarsus is studying three investigational medicines in clinical trials. In addition to XDEMVY (lotilaner ophthalmic solution) 0.25%, which is FDA approved in the United States for the treatment of Demodex blepharitis, Tarsus is also investigating TP-03 for the treatment of Meibomian Gland Disease, which is currently being studied in a Phase 2a clinical trial. In addition, Tarsus is developing TP-04 for the potential treatment of Rosacea and TP-05, an oral tablet for the prevention of Lyme disease. TP-04 and TP-05 are both currently being studied in Phase 2a clinical trials to evaluate safety, tolerability, and proof-of activity.

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Pharmacy Market

European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol® 0.1% for the Treatment of Dry Eye Disease

businesswire | August 25, 2023

Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new drug treatment for dry eye disease in patients not responding to tear substitutes. The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized procedure for all 27 member states of the European Union (EU). Dry eye disease (DED) affects millions of people in Europe and is one of the most common ocular surface disorders. A leading cause of DED is inflammation of the ocular surface. The chronic inflammatory nature causes progressive corneal surface damage that can lead to direct or indirect visual impairment. In the EU only one drug therapy limited to a subset of DED patients with severe keratitis is currently approved. CyclASol is ciclosporin, solubilized in a novel, water-free excipient and was designed to address unmet needs, providing patients with a fast acting and well tolerable dry eye drug therapy. Dispensed in a unique 10 microliter small drop the solution does not contain water or anti-microbial preservatives, oils or surfactants. As a water-free product, there is no associated pH and no osmolarity. “Our in Heidelberg, Germany, invented water-free technology was designed to unfold the full potential of pharmaceuticals on the ocular surface,” said Christian Roesky, Ph.D., Chief Executive Officer of Novaliq. “The acceptance of the EU Marketing Authorization Application is a key milestone in our global efforts to address high unmet needs to better serve patients suffering from dry eye disease. We look forward to collaborating with the CHMP throughout the review process and hope to make CyclASol available for patients in Europe.” The clinical development program for the MAA is based on six clinical studies, which evaluated the safety and efficacy of CyclASol in a total of 1,575 patients with dry eye disease. Results from the two registrational studies, ESSENCE-1 and ESSENCE-2 consistently demonstrated that the product is effective for the treatment of DED. Continued improvement under therapy in both signs and symptoms of DED has been clinically demonstrated over a period of up to 56 weeks in an extension study of ESSENCE‑2. With its early onset of effect and its good tolerability profile CyclASol addresses unmet medical needs in DED. CyclASol was approved by the U.S. Food and Drug Administration (FDA) as VEVYE™ (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease on May 30, 2023. VEVYE is the first and only FDA approved cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment and is commercialized in Northern America by Harrow Health Inc, a leading U.S. eyecare pharmaceutical company. About Novaliq Novaliq is a private biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol® the worldwide first water-free ophthalmic technology. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases based on its proprietary water-free eyedrop technology. On May 18th, 2023, U.S. Food and Drug Administration (FDA) approved MIEBO™ (perfluorohexyloctane ophthalmic solution; formerly known as NOV03) followed by the approval of VEVYE™ (cyclosporine ophthalmic solution, development name CyclASol®) 0.1% on May 30th, 2023.

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PHARMACY MARKET

Biofourmis Accelerates and Simplifies Drug Development with Expanded Digital Clinical Trials Solution

prnewswire | September 21, 2023

Biofourmis, a leading global technology-enabled care delivery company, announced today the release of its expanded Digital Clinical Trials solution within the Biofourmis platform for biopharma and other life sciences companies. The solution offers robust digital tools and resources for trial sponsors and investigators aimed at accelerating drug development and improving access and diversity while also reducing costs. Biofourmis' Digital Clinical Trials solution includes a technology-enabled, scalable platform and services that support digital tools enablement, trial decentralization, safety monitoring, personalized care, easier participant recruitment and more equitable access to treatment options for patients everywhere. The solution helps sponsors and researchers accelerate clinical development with remote data collection and novel digital endpoints from Biofourmis' library of biomarkers across multiple therapeutic areas. The expanded solution offers a more holistic workflow, new data management automations and a seamless integration of essential clinical trial documentation, participant scheduling and data collection elements. Because the artificial intelligence (AI)-powered platform is highly configurable, study start-up timelines can be reduced from months to days. The connected platform seamlessly integrates with 40+ devices, enabling study teams the freedom to select the right device for the right disease area. Biopharma companies can also tap into Biofourmis' growing principal investigator (PI) network. The network includes experienced and esteemed PIs from leading academic medical centers as a valuable resource to manage digitally driven research and accelerate the pace of recruitment with access to patient databases. Health systems that already use the Biofourmis platform for technology-enabled care delivery at home can easily and quickly expand their clinical research initiatives by leveraging the connected platform to include the Digital Clinical Trials functionality. "We have consistently earned high satisfaction scores from both researchers and trial participants for our solutions. Now, we have identified additional ways to accelerate access to digital clinical trials, lower costs, and improve the experience for all stakeholders," said Biofourmis COO Jaydev Thakkar. "These new technology and service elements create a more holistic, turnkey solution that achieves those aims while offering greater synergies from drug development to commercialization and creating equitable access to treatment options and clinical research for patients everywhere." Market-leading enhancements to the Digital Clinical Trials solution include Robust eConsent and ePROs Capabilities: Robust screening and informed consent tools are integrated into workflows to accelerate recruitment, decrease enrollment time, and help ensure that participants fully understand risks and benefits associated with the trial. The documentation content is easily configurable and compliant with regulatory requirements. The enhanced ePROs (electronic patient-reported outcomes) collection capabilities drive adherence through automated reminders of participants' reporting requirements while offering them the ability to easily share outcomes beyond traditional clinical measures. Reporting flexibility offers investigators increased visibility into participant safety, health and experience. Dynamic Participant Scheduling: Upon enrollment, the Digital Clinical Trials solution helps research stay on course while encouraging participant adherence and engagement through a virtual visit and schedule of assessment module that streamlines all the "to-do" items for the participant and caregiver, intuitively listing all the required patient reporting and external assessment tasks. Reminders and notifications help participants stay adherent; but if a task is missed, the schedule can automatically adjust so the participant can remain enrolled, and the trial can move forward. InHome Services: As with all solutions within Biofourmis Connect and Care, In-Home Services such as nurse visits, phlebotomy, infusion, imaging, and other ancillary services delivered within the home are available via the connected platform to support decentralized clinical trials—which further reduces burden on investigators and participants. Unmatched Safety Monitoring: The solution leverages AI to monitor the efficacy and side effects of drugs. A specific example includes pre-screening for clinical events triggered by high potassium levels (hyperkalemia), which can reduce clinical trial costs by decreasing frequent manual checks by medical professionals while still protecting patient safety. In addition, cardiac safety monitoring capabilities such as auto-detection of QTc prolongation (an extended interval between the heart contracting and relaxing) can improve the safety of trials by detecting patients earlier who are at risk of developing critical heart arrhythmias due to drug side effects. "Leveraging digital tools and automating and accelerating trial processes for both researchers and participants can increase the likelihood that endpoints will be reached sooner, which lowers costs and simplifies tasks for everyone involved," Thakkar said. "More importantly, shorter trials with more meaningful results mean that groundbreaking new therapies can be discovered and developed faster to improve outcomes for patients worldwide." About Biofourmis Biofourmis brings the right care to every person, no matter where they are. The company's AI-driven solution collects and analyzes patient data in real time and identifies shifts that require proactive interventions. This vital innovation provides people everywhere with connected access to hospital-level services, virtual provider networks for remote care, in-home services, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis' connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care—ultimately making science smarter, healthcare simpler, and patients healthier.

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Pharmacy Market

Now Available – XDEMVY™ (lotilaner ophthalmic solution) 0.25%, the First and Only FDA Approved Treatment for Demodex Blepharitis

globenewswire | August 28, 2023

Tarsus Pharmaceuticals, Inc. whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, announced that XDEMVY™ (lotilaner ophthalmic solution) 0.25% is now available at pharmacies nationwide for prescription. The U.S. Food and Drug Administration (FDA) approved XDEMVY on July 24, 2023, for the treatment of Demodex blepharitis. “We are delighted that within weeks of FDA approval, XDEMVY is now available to millions of patients with Demodex blepharitis,” said Bobak Azamian, MD, PhD, Chief Executive Officer and Chairman of Tarsus. “The efforts of our team have created incredible interest in XDEMVY, the first and only approved solution for this highly prevalent disease. I’m so appreciative of our team and our partners who’ve worked diligently to bring this product to eye care providers and patients quickly and seamlessly following regulatory approval. We are proud to introduce XDEMVY to the eye care community and look forward to its potential to significantly change the way this disease is treated.” XDEMVY is the only FDA approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis. Demodex blepharitis is characterized by redness, inflammation, missing or misdirected eyelashes, itching along the eyelid base, and the presence of collarettes. XDEMVY is a prescription eye drop that is administered with one drop in each eye twice daily (approximately 12 hours apart) for 6 weeks. Tarsus is committed to ensuring that patients have affordable and broad access to XDEMVY and developed Tarsus Connect, a suite of assistance programs that provide financial support for eligible patients. More information about Tarsus Connect can be found on xdemvy.com or by calling: 1-866-846-3092. About Demodex Blepharitis Blepharitis is a common lid margin disease that is characterized by eyelid margin inflammation, redness and ocular irritation. Demodex blepharitis is caused by an infestation of Demodex mites, the most common ectoparasite found on humans and accounts for over two-thirds of all blepharitis cases. Demodex blepharitis may affect as many as 25 million Americans based on an extrapolation from the Titan study indicating 58% of patients presenting to U.S. eye care clinics have collarettes, a pathognomonic sign of Demodex mite infestation, and that at least 45 million people annually visit an eye care clinic. Demodex blepharitis can have a significant clinical burden and negative impact on patients’ daily lives. The Titan study also showed that current management tools, such as tea tree oil and lid wipes, are ineffective at targeting the root cause of Demodex blepharitis. About XDEMVY™ XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop for the treatment of Demodex blepharitis and is designed to target and eradicate the root cause of the disease – Demodex mite infestation. The active ingredient in XDEMVY is lotilaner, a well-characterized agent that eradicates Demodex mites by selectively inhibiting the GABA-Cl channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eyelash follicles where the mites reside. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found XDEMVY to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis. About Tarsus Pharmaceuticals, Inc. Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. Tarsus is studying three investigational medicines in clinical trials. In addition to XDEMVY (lotilaner ophthalmic solution) 0.25%, which is FDA approved in the United States for the treatment of Demodex blepharitis, Tarsus is also investigating TP-03 for the treatment of Meibomian Gland Disease, which is currently being studied in a Phase 2a clinical trial. In addition, Tarsus is developing TP-04 for the potential treatment of Rosacea and TP-05, an oral tablet for the prevention of Lyme disease. TP-04 and TP-05 are both currently being studied in Phase 2a clinical trials to evaluate safety, tolerability, and proof-of activity.

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Pharmacy Market

European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol® 0.1% for the Treatment of Dry Eye Disease

businesswire | August 25, 2023

Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new drug treatment for dry eye disease in patients not responding to tear substitutes. The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized procedure for all 27 member states of the European Union (EU). Dry eye disease (DED) affects millions of people in Europe and is one of the most common ocular surface disorders. A leading cause of DED is inflammation of the ocular surface. The chronic inflammatory nature causes progressive corneal surface damage that can lead to direct or indirect visual impairment. In the EU only one drug therapy limited to a subset of DED patients with severe keratitis is currently approved. CyclASol is ciclosporin, solubilized in a novel, water-free excipient and was designed to address unmet needs, providing patients with a fast acting and well tolerable dry eye drug therapy. Dispensed in a unique 10 microliter small drop the solution does not contain water or anti-microbial preservatives, oils or surfactants. As a water-free product, there is no associated pH and no osmolarity. “Our in Heidelberg, Germany, invented water-free technology was designed to unfold the full potential of pharmaceuticals on the ocular surface,” said Christian Roesky, Ph.D., Chief Executive Officer of Novaliq. “The acceptance of the EU Marketing Authorization Application is a key milestone in our global efforts to address high unmet needs to better serve patients suffering from dry eye disease. We look forward to collaborating with the CHMP throughout the review process and hope to make CyclASol available for patients in Europe.” The clinical development program for the MAA is based on six clinical studies, which evaluated the safety and efficacy of CyclASol in a total of 1,575 patients with dry eye disease. Results from the two registrational studies, ESSENCE-1 and ESSENCE-2 consistently demonstrated that the product is effective for the treatment of DED. Continued improvement under therapy in both signs and symptoms of DED has been clinically demonstrated over a period of up to 56 weeks in an extension study of ESSENCE‑2. With its early onset of effect and its good tolerability profile CyclASol addresses unmet medical needs in DED. CyclASol was approved by the U.S. Food and Drug Administration (FDA) as VEVYE™ (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease on May 30, 2023. VEVYE is the first and only FDA approved cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment and is commercialized in Northern America by Harrow Health Inc, a leading U.S. eyecare pharmaceutical company. About Novaliq Novaliq is a private biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol® the worldwide first water-free ophthalmic technology. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases based on its proprietary water-free eyedrop technology. On May 18th, 2023, U.S. Food and Drug Administration (FDA) approved MIEBO™ (perfluorohexyloctane ophthalmic solution; formerly known as NOV03) followed by the approval of VEVYE™ (cyclosporine ophthalmic solution, development name CyclASol®) 0.1% on May 30th, 2023.

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PHARMACY MARKET

Biofourmis Accelerates and Simplifies Drug Development with Expanded Digital Clinical Trials Solution

prnewswire | September 21, 2023

Biofourmis, a leading global technology-enabled care delivery company, announced today the release of its expanded Digital Clinical Trials solution within the Biofourmis platform for biopharma and other life sciences companies. The solution offers robust digital tools and resources for trial sponsors and investigators aimed at accelerating drug development and improving access and diversity while also reducing costs. Biofourmis' Digital Clinical Trials solution includes a technology-enabled, scalable platform and services that support digital tools enablement, trial decentralization, safety monitoring, personalized care, easier participant recruitment and more equitable access to treatment options for patients everywhere. The solution helps sponsors and researchers accelerate clinical development with remote data collection and novel digital endpoints from Biofourmis' library of biomarkers across multiple therapeutic areas. The expanded solution offers a more holistic workflow, new data management automations and a seamless integration of essential clinical trial documentation, participant scheduling and data collection elements. Because the artificial intelligence (AI)-powered platform is highly configurable, study start-up timelines can be reduced from months to days. The connected platform seamlessly integrates with 40+ devices, enabling study teams the freedom to select the right device for the right disease area. Biopharma companies can also tap into Biofourmis' growing principal investigator (PI) network. The network includes experienced and esteemed PIs from leading academic medical centers as a valuable resource to manage digitally driven research and accelerate the pace of recruitment with access to patient databases. Health systems that already use the Biofourmis platform for technology-enabled care delivery at home can easily and quickly expand their clinical research initiatives by leveraging the connected platform to include the Digital Clinical Trials functionality. "We have consistently earned high satisfaction scores from both researchers and trial participants for our solutions. Now, we have identified additional ways to accelerate access to digital clinical trials, lower costs, and improve the experience for all stakeholders," said Biofourmis COO Jaydev Thakkar. "These new technology and service elements create a more holistic, turnkey solution that achieves those aims while offering greater synergies from drug development to commercialization and creating equitable access to treatment options and clinical research for patients everywhere." Market-leading enhancements to the Digital Clinical Trials solution include Robust eConsent and ePROs Capabilities: Robust screening and informed consent tools are integrated into workflows to accelerate recruitment, decrease enrollment time, and help ensure that participants fully understand risks and benefits associated with the trial. The documentation content is easily configurable and compliant with regulatory requirements. The enhanced ePROs (electronic patient-reported outcomes) collection capabilities drive adherence through automated reminders of participants' reporting requirements while offering them the ability to easily share outcomes beyond traditional clinical measures. Reporting flexibility offers investigators increased visibility into participant safety, health and experience. Dynamic Participant Scheduling: Upon enrollment, the Digital Clinical Trials solution helps research stay on course while encouraging participant adherence and engagement through a virtual visit and schedule of assessment module that streamlines all the "to-do" items for the participant and caregiver, intuitively listing all the required patient reporting and external assessment tasks. Reminders and notifications help participants stay adherent; but if a task is missed, the schedule can automatically adjust so the participant can remain enrolled, and the trial can move forward. InHome Services: As with all solutions within Biofourmis Connect and Care, In-Home Services such as nurse visits, phlebotomy, infusion, imaging, and other ancillary services delivered within the home are available via the connected platform to support decentralized clinical trials—which further reduces burden on investigators and participants. Unmatched Safety Monitoring: The solution leverages AI to monitor the efficacy and side effects of drugs. A specific example includes pre-screening for clinical events triggered by high potassium levels (hyperkalemia), which can reduce clinical trial costs by decreasing frequent manual checks by medical professionals while still protecting patient safety. In addition, cardiac safety monitoring capabilities such as auto-detection of QTc prolongation (an extended interval between the heart contracting and relaxing) can improve the safety of trials by detecting patients earlier who are at risk of developing critical heart arrhythmias due to drug side effects. "Leveraging digital tools and automating and accelerating trial processes for both researchers and participants can increase the likelihood that endpoints will be reached sooner, which lowers costs and simplifies tasks for everyone involved," Thakkar said. "More importantly, shorter trials with more meaningful results mean that groundbreaking new therapies can be discovered and developed faster to improve outcomes for patients worldwide." About Biofourmis Biofourmis brings the right care to every person, no matter where they are. The company's AI-driven solution collects and analyzes patient data in real time and identifies shifts that require proactive interventions. This vital innovation provides people everywhere with connected access to hospital-level services, virtual provider networks for remote care, in-home services, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis' connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care—ultimately making science smarter, healthcare simpler, and patients healthier.

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