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

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 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

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

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SHL Medical partners with SteriPack Group to set up final assembly service

PR Newswire | January 25, 2024

SHL Medical, a world-leading solutions provider of advanced drug delivery systems and SteriPack Group, renowned global supplier of secondary packing and final assembly services to the pharmaceutical industry, enter a non-exclusive strategic partnership. Together, they aim to establish a pre-validated final assembly service at the SteriPack facility in Poland, enhancing the overall flexibility of supply chain strategies for their customers. In addition to SHL Medical's existing final assembly, labeling, and packaging¬ services in the United States, this collaboration extends high-quality CMO options to Europe. Markus Puusepp, SHL Medical's Chief Growth Officer, expressed enthusiasm about the partnership, stating "This partnership is a significant addition to the Molly platform value proposition. We share common values with SteriPack, from focus on the customer to a commitment to quality, making the decision to collaborate straightforward." Recognizing the importance of flexibility and time-to-market, especially in clinical production, the partnership with SteriPack will offer SHL Medical's customers highly flexible and personalized final assembly and packaging solutions. This is particularly beneficial for small batch handling in clinical supply and niche markets like rare diseases. Emphasizing the comprehensive capabilities of the Molly platform, SHL Medical aims to deliver right-sized solutions that ensure improved service, faster timelines, and a more streamlined supply chain for its diverse customer base. John Ward, SteriPack Group's VP Pharmaceutical Solutions commented "SteriPack Group looks forward to supporting SHL Medical and their customers in providing quality and flexible solutions to a fast- moving market. With an emphasis on creating service solutions designed around specific customer requirements, this partnership will make the process of working with the Molly platform an easy decision." About SHL Medical As a world-leading solutions provider of advanced drug delivery systems, SHL Medical is the partner of choice for many leading pharma and biotech companies. Driven by its company purpose – Enabling Patients' Independence – SHL Medical offers patient-centric solutions for the design, development, and manufacturing of autoinjectors, pen injectors, as well as innovative specialty delivery systems for large-volume and high-viscosity formulations. It also offers final assembly, labeling, and packaging solutions for its drug delivery systems. In response to the rising trend in home therapy, SHL Medical has increased its developmental work in the digital healthcare sector to help improve the drug delivery ecosystem. Located across Switzerland, Taiwan, Sweden, and the US, SHL Medical's global team of experts collaborate seamlessly as one team in utilizing its comprehensive in-house manufacturing capabilities. Its solutions offer customization and optimization for each project while proactively weaving sustainability-driven measures into its designs and processes to contribute to a cleaner earth. About SteriPack Group SteriPack Group is a globally renowned contract packing and manufacturing organisation serving the pharmaceutical and medical device sectors respectively. With a strong emphasis on innovation, quality and compliance, SteriPack's services to the pharmaceutical industry include device design and development, final assembly, labelling, secondary packing, serialisation and aggregation of injectable formats including vials, pre-filled syringes, and autoinjectors. SteriPack's tailored customer-focused solutions make it an ideally suited supplier for small to medium-sized batch volumes required for a growing market of targeted therapies as well as clinical trials. Its proven capabilities in cleanroom assembly and labelling as well as secondary packing services for drug delivery systems and medical devices, combined with significant investment into growing cold chain storage capacity, have helped to make it a trusted partner to top global pharmaceutical companies.

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Flagship Pioneering and Samsung Announce Collaboration to Advance Groundbreaking Technologies in Translational Science and Medicine

PR Newswire | January 09, 2024

Flagship Pioneering, the bioplatform innovation company, and Samsung today announced a collaboration aimed at fostering cutting-edge biopharmaceutical innovation poised to transform the world of healthcare through groundbreaking advancements in translational science and medicine. Through this collaboration, Samsung will work alongside Flagship-founded companies, leveraging Samsung's leading technologies and capabilities to accelerate first and best-in-class therapies. The newly formed strategic partnership is an expansion of the ongoing cooperation between Samsung and Flagship. The collaboration between Samsung and Flagship leverages the expertise of both organizations in the areas of life science technology, artificial intelligence, and CDMO services, and extends across Flagship's ecosystem of companies. Key Highlights of the Collaboration: Revolutionary Technology: The collaboration will leverage state-of-the-art technology including artificial intelligence, translational medicine, access to high quality clinical samples and Samsung's clinical trials infrastructure, and investment by Samsung in Flagship-founded companies. Shared Vision: Flagship Pioneering and Samsung share a common vision of transforming conventional drug discovery and development approaches to help bring new targeted therapeutic solutions to patients. The collaboration is driven by a commitment to pushing the boundaries of what is possible in the bio-pharmaceutical industry. "This collaboration represents a significant milestone in the pursuit of innovation and scientific excellence," said Stephen Berenson, Managing Partner, Flagship Pioneering. "As partners, we will bring together Flagship Pioneering's unparalleled expertise in inventing and developing revolutionary bioplatform companies with Samsung's strategic capabilities to reshape and empower the bio-pharmaceutical landscape, ultimately resulting in bigger leaps for patient care." "This newly formed collaboration is an important evolution of the ongoing relationship between two companies," said Jaywoo Kim, executive vice president, Samsung C&T. "We look forward to seeing the accelerating effect of Samsung's various technical expertise and extensive commercial capabilities on the future innovations Flagship and its ecosystem of companies will bring to market." About Flagship Pioneering: Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $70 billion in aggregate value. To date, Flagship has deployed over $3.6 billion in capital toward the founding and growth of its pioneering companies alongside more than $27 billion of follow-on investments from other institutions. About Samsung C&T: Samsung C&T Corporation, a dynamic player in industries ranging from construction, trading, fashion and resorts, is actively expanding its portfolio with strategic investments in the biopharmaceutical industry. Since its investing in Samsung Biologics and Bioepis, Samsung Biologics' CDMO production capacity has grown to over 600 kilo liters and contribute greatly to the stabilization of the biopharmaceutical supply chain. In addition, Samsung Bioepis has improved the accessibility of many patients around the world by successfully launching seven biosimilar products. Samsung C&T will continue investment in innovative technologies and businesses that contribute to 'improving quality of life' in various areas of bio & healthcare.

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Performance Validation Joins ValGenesis Partner Program as Service Partner for the U.S. Market

PR Newswire | January 24, 2024

ValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), and Performance Validation, Inc. a 100% employee-owned company serving the life sciences industry since 1988, have partnered to deliver unique compliance-focused digital validation solutions for life sciences companies in the US. Performance Validation is an industry leader with over 30 years of experience in analyzing, identifying, and testing the most critical elements of the manufacturing process for FDA-regulated industries. The company provides environmental mapping, commissioning, qualification, computer system validation, and quality system consulting services. ValGenesis is the industry innovator of digitized validation. The company's platform, which includes its flagship VLMS offering, is used in over 100,000 GMP systems worldwide, helping life sciences companies advance their digital transformation strategy, enforce compliance, and enable standardization with 100% digital, risk-based validation software. In this partnership, Performance Validation will implement and manage next-generation digital validation tools developed by ValGenesis, including ValGenesis VLMS and VLMS Express, a simplified cloud-based digital validation solution for startups and midsized companies. ValGenesis and Performance Validation are providing an integrated governance approach to further strengthen risk and compliance across their customers' manufacturing processes. "We are excited to partner with Performance Validation. Their extensive experience and our industry benchmarked digital validation platform can help life sciences companies implement their digitization plans efficiently according to Industry 4.0 standards," says Bo Olsen, ValGenesis' SVP of Partners. "By establishing a clear strategy that addresses their risk and compliance implications upfront, we can assure them of true business transformation." "Performance Validation is thrilled to embark on this collaborative journey with ValGenesis, leveraging our extensive experience and knowledge of digital validation solutions. It's a powerful combination – our hands-on validation experience and their innovative digital tools. For our clients in the life sciences, this means more efficient, streamlined, and compliant solutions. We're not just adapting to Pharma 4.0; we're helping our clients lead the way in digital transformation," says Brad Henry, Vice President of Service Lines at Performance Validation. ABOUT PERFORMANCE VALIDATION Performance Validation (PV) is a global validation partner for pharmaceutical and medical device manufacturers. Headquartered in Indianapolis, IN, we specialize in turning compressed timelines into compliant ones using innovative, adaptive approaches that balance production realities with strict regulatory requirements. Our best-in-class, cGMP-compliant services cover diverse needs from fully managed CQV to on-demand temperature mapping, smoke studies, software assurance, and more. With a dedicated team consisting of more than 95% engineers, we work closely with regulators and equipment suppliers to keep validation ahead of production curves and keep quality moving forward. ABOUT VALGENESIS ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life sciences companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.

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SHL Medical partners with SteriPack Group to set up final assembly service

PR Newswire | January 25, 2024

SHL Medical, a world-leading solutions provider of advanced drug delivery systems and SteriPack Group, renowned global supplier of secondary packing and final assembly services to the pharmaceutical industry, enter a non-exclusive strategic partnership. Together, they aim to establish a pre-validated final assembly service at the SteriPack facility in Poland, enhancing the overall flexibility of supply chain strategies for their customers. In addition to SHL Medical's existing final assembly, labeling, and packaging¬ services in the United States, this collaboration extends high-quality CMO options to Europe. Markus Puusepp, SHL Medical's Chief Growth Officer, expressed enthusiasm about the partnership, stating "This partnership is a significant addition to the Molly platform value proposition. We share common values with SteriPack, from focus on the customer to a commitment to quality, making the decision to collaborate straightforward." Recognizing the importance of flexibility and time-to-market, especially in clinical production, the partnership with SteriPack will offer SHL Medical's customers highly flexible and personalized final assembly and packaging solutions. This is particularly beneficial for small batch handling in clinical supply and niche markets like rare diseases. Emphasizing the comprehensive capabilities of the Molly platform, SHL Medical aims to deliver right-sized solutions that ensure improved service, faster timelines, and a more streamlined supply chain for its diverse customer base. John Ward, SteriPack Group's VP Pharmaceutical Solutions commented "SteriPack Group looks forward to supporting SHL Medical and their customers in providing quality and flexible solutions to a fast- moving market. With an emphasis on creating service solutions designed around specific customer requirements, this partnership will make the process of working with the Molly platform an easy decision." About SHL Medical As a world-leading solutions provider of advanced drug delivery systems, SHL Medical is the partner of choice for many leading pharma and biotech companies. Driven by its company purpose – Enabling Patients' Independence – SHL Medical offers patient-centric solutions for the design, development, and manufacturing of autoinjectors, pen injectors, as well as innovative specialty delivery systems for large-volume and high-viscosity formulations. It also offers final assembly, labeling, and packaging solutions for its drug delivery systems. In response to the rising trend in home therapy, SHL Medical has increased its developmental work in the digital healthcare sector to help improve the drug delivery ecosystem. Located across Switzerland, Taiwan, Sweden, and the US, SHL Medical's global team of experts collaborate seamlessly as one team in utilizing its comprehensive in-house manufacturing capabilities. Its solutions offer customization and optimization for each project while proactively weaving sustainability-driven measures into its designs and processes to contribute to a cleaner earth. About SteriPack Group SteriPack Group is a globally renowned contract packing and manufacturing organisation serving the pharmaceutical and medical device sectors respectively. With a strong emphasis on innovation, quality and compliance, SteriPack's services to the pharmaceutical industry include device design and development, final assembly, labelling, secondary packing, serialisation and aggregation of injectable formats including vials, pre-filled syringes, and autoinjectors. SteriPack's tailored customer-focused solutions make it an ideally suited supplier for small to medium-sized batch volumes required for a growing market of targeted therapies as well as clinical trials. Its proven capabilities in cleanroom assembly and labelling as well as secondary packing services for drug delivery systems and medical devices, combined with significant investment into growing cold chain storage capacity, have helped to make it a trusted partner to top global pharmaceutical companies.

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Flagship Pioneering and Samsung Announce Collaboration to Advance Groundbreaking Technologies in Translational Science and Medicine

PR Newswire | January 09, 2024

Flagship Pioneering, the bioplatform innovation company, and Samsung today announced a collaboration aimed at fostering cutting-edge biopharmaceutical innovation poised to transform the world of healthcare through groundbreaking advancements in translational science and medicine. Through this collaboration, Samsung will work alongside Flagship-founded companies, leveraging Samsung's leading technologies and capabilities to accelerate first and best-in-class therapies. The newly formed strategic partnership is an expansion of the ongoing cooperation between Samsung and Flagship. The collaboration between Samsung and Flagship leverages the expertise of both organizations in the areas of life science technology, artificial intelligence, and CDMO services, and extends across Flagship's ecosystem of companies. Key Highlights of the Collaboration: Revolutionary Technology: The collaboration will leverage state-of-the-art technology including artificial intelligence, translational medicine, access to high quality clinical samples and Samsung's clinical trials infrastructure, and investment by Samsung in Flagship-founded companies. Shared Vision: Flagship Pioneering and Samsung share a common vision of transforming conventional drug discovery and development approaches to help bring new targeted therapeutic solutions to patients. The collaboration is driven by a commitment to pushing the boundaries of what is possible in the bio-pharmaceutical industry. "This collaboration represents a significant milestone in the pursuit of innovation and scientific excellence," said Stephen Berenson, Managing Partner, Flagship Pioneering. "As partners, we will bring together Flagship Pioneering's unparalleled expertise in inventing and developing revolutionary bioplatform companies with Samsung's strategic capabilities to reshape and empower the bio-pharmaceutical landscape, ultimately resulting in bigger leaps for patient care." "This newly formed collaboration is an important evolution of the ongoing relationship between two companies," said Jaywoo Kim, executive vice president, Samsung C&T. "We look forward to seeing the accelerating effect of Samsung's various technical expertise and extensive commercial capabilities on the future innovations Flagship and its ecosystem of companies will bring to market." About Flagship Pioneering: Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $70 billion in aggregate value. To date, Flagship has deployed over $3.6 billion in capital toward the founding and growth of its pioneering companies alongside more than $27 billion of follow-on investments from other institutions. About Samsung C&T: Samsung C&T Corporation, a dynamic player in industries ranging from construction, trading, fashion and resorts, is actively expanding its portfolio with strategic investments in the biopharmaceutical industry. Since its investing in Samsung Biologics and Bioepis, Samsung Biologics' CDMO production capacity has grown to over 600 kilo liters and contribute greatly to the stabilization of the biopharmaceutical supply chain. In addition, Samsung Bioepis has improved the accessibility of many patients around the world by successfully launching seven biosimilar products. Samsung C&T will continue investment in innovative technologies and businesses that contribute to 'improving quality of life' in various areas of bio & healthcare.

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Performance Validation Joins ValGenesis Partner Program as Service Partner for the U.S. Market

PR Newswire | January 24, 2024

ValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), and Performance Validation, Inc. a 100% employee-owned company serving the life sciences industry since 1988, have partnered to deliver unique compliance-focused digital validation solutions for life sciences companies in the US. Performance Validation is an industry leader with over 30 years of experience in analyzing, identifying, and testing the most critical elements of the manufacturing process for FDA-regulated industries. The company provides environmental mapping, commissioning, qualification, computer system validation, and quality system consulting services. ValGenesis is the industry innovator of digitized validation. The company's platform, which includes its flagship VLMS offering, is used in over 100,000 GMP systems worldwide, helping life sciences companies advance their digital transformation strategy, enforce compliance, and enable standardization with 100% digital, risk-based validation software. In this partnership, Performance Validation will implement and manage next-generation digital validation tools developed by ValGenesis, including ValGenesis VLMS and VLMS Express, a simplified cloud-based digital validation solution for startups and midsized companies. ValGenesis and Performance Validation are providing an integrated governance approach to further strengthen risk and compliance across their customers' manufacturing processes. "We are excited to partner with Performance Validation. Their extensive experience and our industry benchmarked digital validation platform can help life sciences companies implement their digitization plans efficiently according to Industry 4.0 standards," says Bo Olsen, ValGenesis' SVP of Partners. "By establishing a clear strategy that addresses their risk and compliance implications upfront, we can assure them of true business transformation." "Performance Validation is thrilled to embark on this collaborative journey with ValGenesis, leveraging our extensive experience and knowledge of digital validation solutions. It's a powerful combination – our hands-on validation experience and their innovative digital tools. For our clients in the life sciences, this means more efficient, streamlined, and compliant solutions. We're not just adapting to Pharma 4.0; we're helping our clients lead the way in digital transformation," says Brad Henry, Vice President of Service Lines at Performance Validation. ABOUT PERFORMANCE VALIDATION Performance Validation (PV) is a global validation partner for pharmaceutical and medical device manufacturers. Headquartered in Indianapolis, IN, we specialize in turning compressed timelines into compliant ones using innovative, adaptive approaches that balance production realities with strict regulatory requirements. Our best-in-class, cGMP-compliant services cover diverse needs from fully managed CQV to on-demand temperature mapping, smoke studies, software assurance, and more. With a dedicated team consisting of more than 95% engineers, we work closely with regulators and equipment suppliers to keep validation ahead of production curves and keep quality moving forward. ABOUT VALGENESIS ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life sciences companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.

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