It is now imperative for life science companies to optimize Regulatory Affairs resources using next-generation technology if they are to ensure affordable patient access to treatments and achieve commercial viability, new independent research finds.

BOSTON, Nov. 12, 2024 /PRNewswire/ — ArisGlobal, an innovative technology company at the forefront of life sciences and creator of LifeSphere®, today confirmed that while unsustainable workload increases have created an irrefutable urgency around advanced AI adoption in Regulatory Affairs (RA), many life sciences companies are standing in the way of their own progress. These are the findings of new independent research.

The study, conducted by Censuswide in September, is striking both in its confirmation of how vital AI-powered process change has become, and in its revelations about persistent barriers that are compromising companies’ regulatory transformations. That is as soaring workloads overwhelm already-overstretched teams.

ArisGlobal commissioned the exclusive survey of senior US regulatory professionals in pharma/biopharma companies to examine the growing appetite for AI within an RA context.

Key findings

Process inefficiency is out of control: workloads have soared beyond the pace of company growth, a rate that will not slow any time soonDossier production, maintaining labeling compliance, managing data, document checking, and performing regulatory impact assessments, are major challengesAllocating more people is not an option: 96% say AI is needed to solve RA bottlenecksInterest is high across a range of specific automation use cases:Maintaining labelling compliance and deviations;Managing Health Authority interactions;Creating regulated content translations for different markets;Suggesting improvements to submissions/dossiers;Performing regulatory impact assessments;Authoring and summarizing submission documents; andGenerating entire regulatory submissions.

BUT: outdated mindsets are standing in the way of progress

The survey identified a series of perceived barriers still holding RA departments back from investing or expanding their investments in AI, even where these are now unjustified, e.g.

Unfavorable existing IT landscapes (45%);Risks still outweighing the benefits (44%); andData/content not being of a sufficient caliber to see value from AI (42%).

Budget, on the other hand, is far less of an issue.

Confirming that companies’ perceptions have not kept up with AI’s progress, respondents said they would be more proactive about adopting AI in RA if:

They found their competitors were using the technology (41%);Existing resource pressures continued (40%);The technology became more mature and proven (36%);Specific tools became available geared to the tasks regulatory teams find most challenging or expensive (35%); andRelevant IT systems were easier and more affordable to deploy (33%).

AI is the future

Senior regulatory professionals DO see AI in their futures, meanwhile:

Almost half (48%) of respondents believe AI will transform routine regulatory work and considerably streamline processesOver 2 in 5 (43%) believe AI will drive up accuracy and quality in the information they produce for regulators and patientsAlmost 2 in 5 (39%) see AI as critical to the regulatory function’s ability to keep pace with market demandsOver a third (35%) say AI will save a lot of time and money.

Commenting on the research findings, Ann-Marie Orange, ArisGlobal’s CIO and Global Head of R&D, said: “The pressure from regulators to drive up product quality and safety cannot be ignored, but nor can the drive to bring critical treatments and therapies to market more swiftly and cost-efficiently.

“It is why the industry must now double down on its adoption of AI, especially next-generation technologies such as Generative AI and machine learning. Up to now, life sciences companies have been standing in the way of their own progress, not appreciating what is already possible. But now the urgency to find step changes in process efficiency make it imperative to overcome those barriers and transform the way they work.”

Preeya Beczek, a respected regulatory consultant and founder and CEO of Beczek.COM, said: “AI is coming into its own in the life sciences regulatory space now, and companies ignore its potential at their peril. Think about it: R&D organizations must be both stringent in their regulatory compliance, and hyper-efficient in securing and maintaining marketing approval in order to get products to patients faster. That requires a gear shift which next-generation automation and AI can help deliver.”

The full survey report, The Imperative to Automate: Unsustainable Regulatory Workloads Leave No Choice About AI Adoption, will shortly be available to download from the ArisGlobal web site at https://www.arisglobal.com/. As well as a full analysis of the findings, the report includes practical recommendations on how life sciences regulatory functions can embrace AI capabilities today within their existing IT environments.

About the research

This report is based on an exclusive survey conducted for ArisGlobal by Censuswide between August 30 and September 06, 2024. The research was conducted among a sample of 100 US respondents in senior regulatory roles at pharma/biopharma companies.

About ArisGlobal

ArisGlobal, an innovative life sciences technology company and creator of LifeSphere®, is transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan, and China. For more updates, follow ArisGlobal on LinkedIn or visit www.arisglobal.com. 

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Four Recipients’ Work From Israel, Sweden, Canada and South Africa Earns The Sigourney Award-2024

SEATTLE, Nov. 12, 2024 /CNW/ — The Sigourney Award Trust annually recognizes outstanding work that advances psychoanalytic thought and principles throughout the world. Robin A. Deutsch, PhD and Analyst Co-Trustee of The Sigourney Award Trust, today announces three individuals and one organization whose work of the past decade earns The Sigourney Award-2024 and a substantial cash prize. Recipients include: Merav Roth, PhD (Tel Aviv, Israel); Björn Salomonsson, MD (Stockholm, Sweden); Dominique Scarfone, MD (Montreal, Canada); and The Ububele Educational and Psychotherapy Trust (Johannesburg, South Africa).

“The 2024 recipients’ work has uniquely and positively impacted populations, including the youngest among us, by expanding access and understanding of psychoanalysis as well as psychotherapy’s benefits to professionals and the general public,” says Dr. Deutsch. “The anonymous judges, who likewise conduct exemplary professional careers, evaluated work from 10 countries to select work that most closely aligned with Mary Sigourney’s original intent.”

Founded by Mary Sigourney in 1989, The Sigourney Award was established to recognize and promote exceptional work that advances psychoanalytic principles and their ability to better humankind.

Work Meriting The Sigourney Award-2024 (Alphabetical order)

Merav Roth, PhD (Tel Aviv, Israel)
Prof. Merav Roth’s exceptional interdisciplinary work included an unparalleled approach to psychoanalysis and literature, which gave readers a better understanding of the deep psychic processes involved in reading and earned her a reputation as a pioneering psychoanalytic thinker. Her notable work also expands to her impactful role as a writer and activist on trauma, ethics and culture in Israel and abroad.  Accomplishments in the past decade include her first book, A Psychoanalytic Perspective on Reading Literature – Reading the Reader (Routledge, 2020), where she described the unconscious processes involved in reading literature. As the former chair of the psychoanalytic psychotherapy program at Tel Aviv University, Roth established and still chairs “The Clinic For All” which provides pro-bono psychotherapy for deprived or disadvantaged populations. As a professor at the University of Haifa, Roth established a new philanthropic initiative, “Interweaving,” a culturally sensitive clinic for disadvantaged populations. Following the events of October 7 in Israel, Roth’s psychoanalytic work with trauma was swiftly employed to provide guidance and wide-reaching help, including establishing with two colleagues a philanthropic network of 450 psychoanalysts who provide long-term pro-bono support to survivors and their family members.

Björn Salomonsson, MD (Stockholm, Sweden)
Dr. Björn Salomonsson’s work has profoundly amplified psychoanalytic knowledge and infant caretaking techniques, and engaged non-psychoanalytic healthcare professionals participating in pre-, peri-, and post-natal care of mothers and infants. An Associate Professor at Swedish Psychoanalytic Institute, Salomonsson combined training in psychoanalysis and research to improve the early life of distressed babies by wholly refining Psychoanalytic Parent-Infant Psychotherapy (PIP) methodology. He also co-founded The A Primo Foundation, with successful courses for nurses, midwives and psychologists in Maternity Units and Child Health Centers. His work pioneered psychoanalytic techniques for working directly with child health nurses who had little to no prior psychoanalytic exposure. Nurses used the techniques to address perturbed infant-parent relationships and creatively and respectfully bring a psychoanalytic understanding of the infant’s and parents’ experience of troubled relationships. In his book Psychodynamic Interventions in Pregnancy and Infancy (2018), Salomonsson systematically describes how a therapist can practice treatment beyond the one-to-one model and deliver a multi-relationship-based psychoanalytic therapy model by actively engaging the infant during psychoanalytic therapy. Today, PIP is viewed as highly relevant for every analyst.

Dominique Scarfone, MD (Montreal, Canada)  
Prof. Dominique Scarfone’s influential work has advanced a veritable renaissance in the study and transmission of French psychoanalyst Jean Laplanche’s work and produced essential theoretical contributions in unconscious communication, temporality, and the translational model of the psyche. Providing a new approach to Freudian thinking, his endeavors bridge French, British and North American psychoanalytic culture. Scarfone’s work demonstrates how the marriage of tradition with radical thinking can expand the field of psychoanalysis. While maintaining a solid belief that Freud’s foundational method offers a common ground between these cultures, he has urged persistent questioning and reconsidering of Freud’s methods to liberate new thinking. Scarfone has illuminated a modern approach to how the psychosexual enters all these domains through work addressing clinical matters, questions of transference and repetition, one’s relationship to art and ethics, and the deep complexity of what it means to be human. Within the past ten years Scarfone has published three significant books including Laplanche (2014), The Unpast (2015), and The Reality of the Message: Psychoanalysis in the Wake of Jean Laplanche (2023).

The Ububele Educational and Psychotherapy Trust (Johannesburg, Republic of South Africa)
The Ububele Educational and Psychotherapy Trust’s outstanding work addresses the country’s traumatic past and current uncertainties, major challenges to personal relationships, mental-health challenges related to poverty, unemployment, poor infrastructure, and other crises by ingeniously magnifying the accessibility and efficacy of psychoanalytic treatment in South Africa. Ububele’s approach is rooted in the lived experiences of Johannesburg and Alexandra’s community of over 500,000 people overburdened by harsh poverty, serious crime, corruption and the lesser recognized but lasting impact of apartheid. An essential awareness and acknowledgement of transference and the influence of the unconscious informs unique initiatives centered on promoting healthy parent-child attachment through the development of low-cost, replicable models of psychoanalytically informed interventions. Two examples include the Ububele Umdlezane Parent-Infant Programs focused on the first thousand days of life and the Therapy and Assessment Clinic which conducts psychoeducational assessments and psychotherapy services. Ububele’s capacity building methods offer initial and continuing training emphasizing the transference relationship and the necessity of working beyond the surface. The training provides youth and caregivers the psychoanalytically informed psycho-emotional support needed to succeed in breaking inter-generational cycles of emotional poverty and mental health despair. 

“The Sigourney Award’s canons are unwavering and the Trust works tirelessly to ensure that Mary Sigourney’s intent is honored with a wholly independent assessment of exceptional work with each year’s Awards. We are fortunate to attract applications and nominations from around the world representing ground-breaking work that has advanced psychoanalytic thought and principles,” says Michael J. Harrington, JD, Attorney Co-Trustee of The Sigourney Award Trust.

Visit The Sigourney Award to review all recipients’ announcements. Applications for The Sigourney Award-2025 open March 1, 2025 for qualifying work completed between 2015-2024. Follow social platforms on Facebook, Instagram and LinkedIn @SigourneyAward, and X @sigourney_the.

About The Sigourney Award
The Sigourney Award Trust, a wholly independent nonprofit organization established by Mary Sigourney in 1989, annually bestows The Sigourney Award as international recognition and reward for outstanding work that has advanced psychoanalytic principles. Ms. Sigourney was a psychotherapist, publisher, and community activist who had a passionate interest in psychoanalysis and understood its ability to benefit and extend human conversation across various disciplines. Since 1990, The Sigourney Award has rewarded and promoted outstanding work. To date, 149 Award recipients from 22 countries represent her global vision. Judges of The Sigourney Award remain anonymous to ensure an unbiased and thorough evaluation practice. Work honored by The Sigourney Award has significantly contributed to human affairs on topics ranging from clinical psychoanalysis, neuroscience, feminism, and political oppression.

Media Contact: Kelly Wisecarver, kelly@wisecarverpr.com

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NEW YORK, Nov. 12, 2024 /PRNewswire/ — ArcSpan Technologies, a leader in audience monetization for global publishers, proudly announces that Mollie Spilman, a widely respected leader in advertising technology, has joined the company’s Advisory Board. As ArcSpan’s Audience Monetization System (AMS) continues to set new standards in AI-powered contextual and behavioral solutions, Spilman’s deep industry experience will further accelerate ArcSpan’s expansion and impact across North America, EMEA, and APAC markets.

Spilman brings a distinguished career in audience data enrichment, activation, and performance measurement. Her previous roles include Chief Revenue Officer at Oracle Advertising, Chief Operating Officer at Criteo, and Chief Marketing Officer at Yahoo!, showcasing her expertise in driving revenue and innovation within advertising technology. Her strategic insights and hands-on experience will be invaluable in guiding ArcSpan’s mission to empower publishers with next-generation data solutions that maximize audience signals and revenue potential.

“We are thrilled to welcome Mollie to ArcSpan’s Advisory Board,” said Art Muldoon, Co-founder and CEO of ArcSpan. “As a visionary industry leader with a wealth of experience in digital business transformation, Mollie’s expertise will be instrumental in elevating customer success. Her insights will support our efforts to boost targeted advertising sales and ROI for publishers globally.”

“I am honored and excited to join the Advisory Board and work alongside a talented and experienced group of executives to continue ArcSpan’s momentum,” said Mollie Spilman. “In a short amount of time, ArcSpan’s focus on processing and converting first-party data signals to generate advertising value through a turnkey platform has surpassed many existing solutions in helping publishers grow audience monetization. There’s so much more on the horizon that will keep ArcSpan at the forefront of our rapidly evolving industry.”

With Spilman’s appointment, ArcSpan strengthens its commitment to transforming the publisher ecosystem through AI-powered solutions that elevate audience value, enabling publishers worldwide to capture more revenue in a complex, evolving media landscape.

About ArcSpan Technologies

ArcSpan Technologies is a premier audience monetization company enabling publishers globally to maximize the revenue potential of their first-party data. Powered by advanced AI, ArcSpan’s Audience Monetization System (AMS) builds stronger data signals and incorporates comprehensive programmatic analytics that drive superior sales results. This next-generation data management platform (DMP) offers a comprehensive, user-friendly, and cost-effective solution for publishers, designed to efficiently process, manage, model, and activate data to optimize audience monetization and return on investment.

Founded by digital industry veterans from Accordant Media, Dentsu, NewsCorp, Adobe, and Beeswax, ArcSpan is committed to championing consumer data privacy and promoting industry transparency. The company is headquartered in New York City, with an office in London, and can be found online at www.arcspan.com.

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