Spotlite360 Introduces Pharmaceutical Industry Initiative for Supply Chain Tracking, Tracing, and Sustainability

Spotlite360 | July 07, 2021

SPOTLITE360 TECHNOLOGIES, INC. is happy to announce that it has started an initiative to provide tailored supply chain tracing and tracking solutions for pharmaceutical companies, for which it is now in contract discussions with pharmaceutical firms. This effort coincides with an impending regulatory shift in the USD 1.3 trillion pharmaceutical industry1 that will require companies to comply with the Drug Supply Chain Security Act (“DSCSA”), which requires the deployment of electronic tracing systems. The Company has recognized an opportunity to offer solutions to DSCSA compliance by combining RFID and IoT sensors with blockchain, machine learning, and enterprise tracking software licensed from TrackX Holdings Inc.

In addition to the cost of complying with new and upcoming laws such as the DSCSA, pharmaceutical sector participants confront the following persistent difficulties in their supply chains:

• Every year, about USD 200 billion in counterfeit medicines are sold worldwide.

• Pharmaceutical cargo theft costs more than USD 1 billion per year, with a median stolen value of USD 100,000 being more than the industry average.

• Inadequate storage and transportation practices (e.g., unrefrigerated trucks, shipment periods that exceed a drug’s shelf life) can cause pharmaceutical damage, which has been highlighted as a multibillion-dollar issue in 2018.

The Company’s existing SaaS solution, powered by Spotlite360 technologies tailored to clients in the pharmaceutical industry, will capture real-time and event-driven data that can identify inefficiencies and potential hazards for pharmaceutical firms, potentially mitigating issues such as those listed above. Furthermore, potential benefits to clients in the pharmaceutical industry include accountability of global suppliers, as well as validation of claims relating to environmental, social, and corporate governance (“ESG”) matters by providing proof of origin, reliably authenticating goods, and allowing visibility into the chain of custody.

Blockchain technology has already shown to be effective in various pharmaceutical supply chain functions, including DSCSA compliance. In 2020, a major technology company released a study of its blockchain pilot program in collaboration with pharmaceutical behemoth Merck & Co. and the United States Food and Drug Administration (“FDA”), which was judged initially viable as stated in its final report filed to the FDA5. Spotlite360’s newest effort for the pharmaceutical sector aims to set new industry standards by providing an improved value proposition through full visibility and tracking capabilities.

About Spotlite360 Technologies Inc.
Spotlite360 is a logistics technology solutions provider that unlocks value, opportunities, and efficiency for all supply chain participants. Spotlite360 aims to establish new standards of transparency, integrity, and sustainability in the pharmaceutical, healthcare, and agriculture industries by building on existing applications of IoT technology, distributed ledgers, and machine learning. As authorities worldwide continue to enforce additional tracing and accountability requirements for consumer protection, the need for dependable, cost-effective, and flexible monitoring technology is anticipated to grow. Spotlite360’s flagship SaaS solution has been designed to monitor the movement of a product in real-time by connecting with the systems of all major stakeholders in the supply chain, from raw materials to the hands of the end customer.


Accenture surveyed CMOs (or equivalent titles) and CIOs from many of the largest pharmaceutical companies ($5B+) in the world to understand the options, challenges and points of view of senior marketing and IT executives on the impact of digital strategies and capabilities on their business.


Accenture surveyed CMOs (or equivalent titles) and CIOs from many of the largest pharmaceutical companies ($5B+) in the world to understand the options, challenges and points of view of senior marketing and IT executives on the impact of digital strategies and capabilities on their business.

Related News


Merck Drives New Innovation & Adds Capacity to Advance Next Generation Antibody-drug Conjugate (ADC) Therapies

Merck | October 29, 2021

Merck, a leading science and technology company, today announced that its Life Science business sector has launched new technology and expanded capacity to advance ADC therapies. These initiatives underscore Merck's continued investment in novel modalities and support the company's efforts to double its ADC and high-potent active pharmaceutical ingredient (HPAPI) capacity in the near future. "ADCs have experienced remarkable growth, with commercially approved ADCs tripling in the past three yearsWe are a pioneer in this space, involved in 50 percent of the commercially approved ADCs on the market today. This latest innovation and additional capacity help bring novel treatments to cancer patients around the world and reinforce our commitment to shaping the future of these novel modalities. Andrew Bulpin, head of Process Solutions, Life Science, at Merck With the launch of its ChetoSensar™ technology, Merck is one of the front runners working to address the hydrophobicity of ADCs, in tandem with its CDMO services. Many ADC candidates have poor aqueous solubility and Merck estimates that more than 20 percent of ADC clinical terminations are caused by this issue. The company's new ChetoSensar™ technology improves ADC solubility, therefore giving hope to ADCs that were previously terminated. The payloads commonly used for ADCs are highly-complex molecules that take many steps to synthesize. Based on Merck's calculations, its new DOLCORE™ platform significantly reduces the development and manufacturing time required, increasing speed-to-market for a novel Dolostatin-based ADC payload by up to a year. In addition, the company will enhance the ADC capabilities of its clinical manufacturing facility in St. Louis, Missouri, USA, in December. This facility will provide larger footprint to enable large-scale production including chromatographic purification for early phase clinical supply. This follows last year's announcement of a €59 million expansion of Merck's facility near Madison, Wisconsin, USA, which will double its HPAPI kilo lab capacity and enable the company to expedite the manufacture of HPAPIs, ADC linker/payloads, and complex APIs. This innovation and additional capacity support the company's ambition to accelerate growth through investments in the "Big Three," including the Process Solutions business unit within the Life Science business sector as a key driver. With 15 years of experience developing and manufacturing ADCs, Merck offers unique CDMO services streamlined with a single, highly experienced provider. The company leverages its global network and deep expertise to tailor each molecule's unique journey, while creating the dynamic client partnerships drug manufacturers need to help reach their critical milestones. Merck integrates contract development and manufacturing with the industry's broadest product offering across multiple modalities. Customers can also seamlessly integrate BioReliance® services from the company's leading biosafety testing portfolio. Merck recently announced expansion projects in Darmstadt, Germany; Cork, Ireland; Buchs, Switzerland; Carlsbad, California, USA; Madison, Wisconsin, USA; Jaffrey, New Hampshire, USA; and Danvers, Massachusetts, USA. These expansions are part of an ambitious, multi-year program to increase the industrial capacity and capabilities of the Life Science business sector to support growing global demand for lifesaving medications and to make significant contributions to public health. About Merck Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck generated sales of € 17.5 billion in 66 countries. Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.

Read More


Aprecia Announces New Leadership Team

Aprecia Pharmaceuticals | October 21, 2021

Kyle Smith has been named President and Chief Operating Officer of Aprecia Pharmaceuticals, LLC, effective immediately. Mr. Smith is a 10-year veteran with Aprecia and has served as Vice President of Operations for the past 3 years. As President and Chief Operating Officer, Mr. Smith will be responsible for leading day-to-day business activities. Aprecia has further strengthened its leadership team by promoting Patrick Staudt to Vice President of Operations, effective immediately. A 14-year veteran of Aprecia, Mr. Staudt has led the East Windsor, NJ manufacturing operations for more than 10 years and has demonstrated the talent and experience to lead expected, expansive growth through multiple technology platforms. Mr. Smith and Mr. Staudt have been cornerstones of Aprecia's history of technology and manufacturing innovation. They have been key contributors in establishing the company as the leader in the development and manufacturing of pharmaceutical products through 3D-Printing. Their experiences with Aprecia have helped craft the company culture and 3DP pharmaceutical manufacturing innovation, and their contributions have created a momentum which continues to accelerate through important partnerships and novel products. "As Aprecia's technology platforms expand and industry partnerships advance, Aprecia requires additional talent and resources to meet these growing demands, We are fortunate to have these seasoned technology experts and corporate leaders to promote and guide the organizational growth well into the future." Chris Gilmore, Aprecia's Chief Executive Officer Mr. Kyle Smith holds a Master of Business Administration degree from Miami University, and a Bachelor of Science in Chemical Engineering from Georgia Institute of Technology. Mr. Patrick Staudt holds a Bachelor of Science degree in Biomedical/Medical Engineering from Drexel University. About Aprecia Founded in 2004, Aprecia received the first and only FDA approved three-dimensionally-printed (3DP) pharmaceutical product approval in 2015. Aprecia uses its ZipDose® Technology to create rapidly disintegrating oral dosage forms that are easy to take and easy to administer. Without compression during the 3DP manufacturing process, engineered and coated particles such as taste masking and modified release are possible on large dose products (over a 1000mg). Aprecia directly owns a patent estate for novel 3DP machines and pharmaceutical 3DP applications. It licenses its exclusive technology platform to pharmaceutical partners as a means to extend product lines, improve patient reach and experience, and address FDA requirements as a pediatric delivery form.

Read More


Moderna and Medison Pharma Collaborate to Commercialize Moderna's COVID-19 Vaccine in Central Eastern Europe and Israel

Moderna | June 08, 2021

Moderna, Inc., a biotechnology company that pioneered messenger RNA (mRNA) therapeutics and vaccines, and Medison Pharma, a leading commercial partner for highly innovative therapies in international markets, announced today a new agreement to commercialize the Moderna COVID-19 Vaccine in Central Eastern Europe and Israel. Poland, Czech Republic, Romania, Hungary, Bulgaria, Slovenia, Slovakia, Croatia, Estonia, Latvia, Lithuania, Serbia, Ukraine, Moldova, Albania, Bosnia, and Herzegovina, Kosovo, North Macedonia, Montenegro, and Israel are among the nations included by the pact. "We are excited to work with Moderna in 20 markets, covering over 175 million people across the whole Central Eastern Europe region and in Israel," stated Meir Jakobsohn, Medison Pharma's Founder and CEO. "With Moderna's ground-breaking mRNA vaccine and Medison's international commercialization platform for highly innovative treatments, our collaboration is a perfect fit." "We value this new collaboration with Medison Pharma to ensure the successful launch of our mRNA COVID-19 vaccine," stated Corinne Le Goff, Pharm.D., M.B.A., Chief Commercial Officer of Moderna. "By delivering our vaccines in collaboration with our partners, we stay consistent in our commitment to fighting the pandemic." About Medison Pharma Medison is a global pharmaceutical company that focuses on commercializing highly innovative therapies in international markets. Medison offers a full range of integrated services for companies looking to establish a presence in international markets, drawing on a 25-year track record and collaborations with major biotech companies. Medison also has a corporate venture arm with a dedicated research and evaluation team with significant scientific and commercial expertise. About Moderna Moderna has evolved from a science research-stage company advancing programs in the field of messenger RNA (mRNA) to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas such as mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant. Moderna maintains alliances with a diverse range of domestic & global government and commercial collaborators, allowing for the pursuit of both ground-breaking science and rapid manufacturing scale.

Read More