Susan Haigney

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The European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) announced that the draft joint strategy for the European Union to 2028 (EMANS 2028) is now open for public consultation. The consultation period will be open until Nov. 30, 2024.

 has been reviewed and updated as regulatory and technical situations have changed rapidly (1). New regulations (e.g., legislation to address public health emergencies and reform of the EU medicines regulations) and technical advances, such as the use of artificial intelligence (AI), have spurred the changes to the original strategy.

“Since EMANS 2025, the availability and use of AI have become more commonplace, and the network aims to harness the full potential of AI across all the EMANS focus areas. The use of digital technology and AI has the potential to transform the network’s core work of evaluating human and veterinary medicines for authorization and monitoring their safety through the EU’s pharmacovigilance system. For veterinary medicines, the network will also push ahead with its vision to implement new digital solutions in its European Veterinary Big Data strategy,” the strategy document states (1).

The strategy to 2028 will focus on creating pathways to medicines in the EU. There is also a plan to find ways to leverage data, digitalization, and AI to improve processes.Innovation and competitiveness are priorities that will be nurtured through a regulatory science and research environment, according to EMA. Strengthening the supply chain and the sustainability of the EU network are also on the agenda. Each focus area will be evaluated by EMA and HMA to assess progress and adapt approaches, if necessary.

“The six focus areas have been carefully chosen to support the network’s core work of evaluating medicines as we take strides to promote the development of medicines and ensure that they reach those who need them,” said Maria Lamas, chair of the HMA Management Group, in a press release (2).

“The overarching theme of our updated strategy to 2028 is that of change—rapid, somewhat unpredictable, but nonetheless full of promise,” said Emer Cooke, EMA executive director, in the press release (2). “It will guide the network as it seizes opportunities and meets the challenges of the near future, including preparing for and responding to public health emergencies and threats such as antimicrobial resistance. Now is the time to share your views and help shape the direction of the network for the next few years.”

Stakeholders may provide input through an online questionnaire until Nov. 30, 2024. [https://ec.europa.eu/eusurvey/runner/EMANS2028publicconsultation] The strategy will be finalized after the consultation period and be implemented through multi-annual workplans. The final strategy is expected to be adopted by March 2025.

“While EMANS 2028 cannot preempt the legislative changes or predict the future, this strategy will prepare the network for the revisions to the pharmaceutical legislation and further changes to the technological and regulatory landscape,” Cooke says in the document’s introduction.

Seizing Opportunities in a Changing Medicines Landscape, The European Medicines Agency Network Strategy 2028 (draft)

EMA. Seizing Opportunities in a Changing Medicines Landscape. Press Release. Oct. 9, 2024. 

Articles

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.

EMA and HMA Publish Network Strategy for Public Consultation

CPHI Milan 2024: Heparin and Heparinoids in Pharmaceuticals

 sat down with Joan Bassa, Human Health Business Unit Director at Bioiberica, to talk about the history of heparin, its uses in pharmaceuticals, and what heparinoids have to offer the industry.

“Heparin has been [around] for more than 50 years, [and is] the product of [choice] against thrombosis, that, by the way, is still now one of the most frequent causes of death worldwide. There are other important new applications being researched. For example, there are clinical studies in different phases, some very advanced, on the use of heparin, for example, in malaria, as well as in some respiratory diseases like COPD [chronic obstructive pulmonary disease], or for instance, in facilitating the mechanism of childbirth in certain conditions that could affect the viability of the newborn. These probably are the most remarkable in the in the past few years.”

According to Bassa, heparinoids inhibit blood clots and anti-inflammatory properties, especially in patients who cannot use heparin. Heparinoids can be used in wound healing, ulcers, inflammatory diseases, or in vascular diseases. “Heparinoids can be administered orally in topical gels, for example, or ointments, or depending on the quality and the purity, they can also be injected,” says Bassa. “In the case of heparin, all the heparin, basically is injected. So, these are the main differences. But it's true that more and more, heparinoids are becoming an important product to be used in in these different applications.”

"At Bioiberica, we are committed to the highest manufacturing excellence standards," Bassa says. "Through our vertically integrated supply chain, we give peace of mind to our customers, ensuring the highest quality, safety, and full traceability of our products."

Click the above video to watch the full interview.

 is being held from Oct. 8–10, 2024 in Milan, Italy.

Videos

Pharmaceutical Technology Europe sat down with Joan Bassa, Human Health Business Unit Director at Bioiberica, to talk about the history of heparin, its uses in pharmaceuticals, and what heparinoids have to offer the industry. 

AAPS PharmSci 360 2024: Predictive Models for Poorly Soluble Drugs

As a preview of what’s to come at this year’s AAPS PharmSci 360, being held Oct. 20–23, 2024 in Salt Lake City, Utah, 

® sat down with Niloufar Salehi, advisor at Eli Lilly & Company, to discuss the problems associated with the formulation of poorly soluble drugs. Salehi also provided a look at how predictive models and other tools can be used to predict and improve solubility in both small-molecule and biologic drugs.

“There are several predictive tools that are used in order to determine poor solubility at [the] early stage of development,” says Salehi in the interview. “One of those is, for example, in silicon modeling that involves using computer simulations to provide insight on how [a] drug will behave in different media, and that can help scientists to identify the potential solubility issues before going any further. Also, another approach is high-throughput screening, which allows [a] researcher to quickly test the solubility of a large number of compounds, and that's enabled the scientists to identify whether there is any modification required for the further development.”

Salehi will be moderating the Symposium: Accelerated Development of Poorly Soluble Drugs Using Predictive Tool at AAPS PharmSci 360 on Tuesday, Oct. 22, 2024. Presentations include the following:

Biorelevant Media and Relevance in Current Time
Speaker: Sandra Klein, University of Greifswald

 Predictive Tools in Early Drug Product Development
Speaker: Fady Ibrahim, Sanofi

Role of Multi-Compartment Systems for Low-Solubility Weak Base Drug
Speaker: Yasuhiro Tsume, University of Michigan

 Predictive Dissolution Data with Pre-Clinical and Clinical Studies
Speaker: Stephen D. Stamatis, Eli Lilly & Company.

Pharmaceutical Technology sat down with Niloufar Salehi, advisor at Eli Lilly & Company, to talk about the session she is moderating at AAPS PharmSci 360 2024, Symposium: An Accelerated Development of Poorly Soluble Drugs Using Predictive Tool.

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In a joint statement on Oct. 8, 2024, Colorcon, a specialty excipients company, and LOTTE Fine Chemical, a specialty chemical company, announced they were partnering to develop and manufacture drug and dietary supplement products using LOTTE’s AnyCoat Hypromellose products. Through the partnership, Colorcon will have exclusive representation of LOTTE’s AnyCoat-C Hypromellose polymers, used in solution/suspension, controlled-release, and immediate-release formulations; and AnyCoat-P Hypromellose Phthalate polymers, used for enteric coating to deliver a drug safely into the intestines.

“Colorcon is proud to announce our partnership with LOTTE Fine Chemical as we continue to support the formulation development needs of our customers around the world,” stated Kurt Fegely, vice-president of Excipient Technologies for Colorcon, in the press release (1). “LOTTE has been a leader in the specialty chemical industry for more than six decades and they have continued to innovate and evolve during that time. This partnership combines an impressive product portfolio for immediate, delayed, and controlled release with a global network of technical innovation and service that will accelerate formulation development, helping our customers compete in an increasingly competitive market.”

“This agreement is significant in that it represents a long-term collaboration in the pharmaceutical cellulose ether market between recognized market leaders. Through this relationship with Colorcon, an organization with proven expertise and leadership in the pharmaceutical industry, we will be able to deliver the most optimized value to our global customers,” Kim Yong-seok, chief executive officer for LOTTE Fine Chemical, added in the release.

“We are excited to bring together LOTTE Fine Chemical’s expertise in cellulose ether chemistry—and their commitment to high quality manufacturing—with Colorcon’s 60+ years of dedication to service excellence, supply reliability, and technical applications support,” said Simon Tasker, chief executive officer for Colorcon (1). “Our combined offering positions us to bring enhanced value to our customers and is a clear demonstration of our commitment to the global pharmaceutical and nutraceutical industries.”

 recently spoke with Ali Rajabi-Siahboomi, vice-president and chief innovation officer at Colorcon, about the evolution of coating design and how it has impacted investment, as well as innovations in packaging for oral solid dosage products (2). Coating design for solid dosage products has evolved from sugar coating to film coating to solvent-based and then to aqueous coating over the years, according to Rajabi-Siahboomi.

“But the development of this robust and optimized formulation that we've had, and the umbrella of open dry system, has made it much easier to have the right film coating, but at the same time, apply it much more efficiently and take that on board with the increasing population,” he says. “Therefore, there is an increasing demand on making sure that the tablets coming into the market are coated.”

PharmTech.com/view/cphi-milan-2024-evolution-of-coating-design to watch the interview with Ali Rajabi-Siahboomi

Colorcon is showcasing its products at Booth 6D58 at CPHI Milan, which is being held from Oct. 8–10, 2024 in Milan, Italy.

Colorcon. Colorcon and LOTTE Fine Chemical Announce Global Partnership to Support the Development and Manufacture of Pharmaceutical and Dietary Supplement Formulations Using the AnyCoat Hypromellose Product Family. Press Release. Oct. 8, 2024.

Thomas, F. CPHI Milan 2024: Evolution of Coating Design. 

Through the global partnership, Colorcon will exclusively represent LOTTE’s AnyCoat Hypromellose products.

Colorcon and LOTTE Fine Chemical Announce Partnership

CPHI Milan 2024: The Role of Excipients in Pharmaceuticals

 sat down with Vinod Tuliani, Head of Pharmaceutical Sciences at Roquette, to talk about new developments in the use of excipients in dosage forms and methods of delivery. Tuliani discusses how the industry is working on new delivery forms for biologics and how this impacts excipient producers.

Regarding methods of delivery, Tuliani points to oral delivery as a focus for Roquette. “The biggest area really for us is in oral delivery, simply because there's a measure of convenience with oral delivery. People would rather take a tablet or a capsule rather than, you know, have to take an injection, which is, I think, common across the world. So clearly, we are very active in the area of oral delivery.”

New delivery methods for biologics are important for both patients and manufacturers, says Tuliani. “I think it's a huge plus for customers and patients, if they're able to obtain some of these medications through a route that's not injectable; certainly, people who have to take repeated injections would much prefer an oral delivery mechanism. We have been working on oral delivery systems for proteins and peptides, and we have been making good progress in that area, using conventional formulations, but delivered in a new way,” says Tuliani. “There's a lot of excitement in the field of delivery of proteins and peptides through alternate means.”

 is being held from October 8–10, 2024 in Milan, Italy.

Pharmaceutical Technology® Europe sat down with Vinod Tuliani, Head of Pharmaceutical Sciences at Roquette, to talk about new developments in the use of excipients in dosage forms and methods of delivery. 

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CPHI announced the winners of the 2024 Pharma Awards on Oct. 8, 2024 at CPHI Milan in Milan, Italy (1). And the winners are:

Future Leader Award: Megan Smyth, Almac Sciences

Woman of the Year Award: Julia Tsetis, OFET Pharmaceutical Group

CEO of the Year: Guy Clark, CNX Therapeutics

API Development and Innovation: Lonza, AI-Enabled Route Scouting Service

Drug Delivery and Device Innovation: Adare Pharma Solutions

Finished Formulation: Unistraw, UniLayer Straw Delivery System

Manufacturing Excellence: RheaVita, RheaLyo GMP-Flex continuous freeze-dryer

Packaging and Machinery: Smurfit WestRock, CereScreen Digital Display Label

Regulatory and Compliance: ProPharma Group, Prodigy

Start-Up Initiative: Acu-Flo Ltd, Nebu-Flow nebulizer platform

Sustainability Award: Evonik Industries AG, PhytoSquene

Heart of Pharma Award: West Pharmaceutical Services

Accelerating Innovation Award: AustinPx, KinetiSol Technology.

The new Future Leader category was awarded to Megan Smyth of Almac Sciences for rising through five levels in her seven years at the company and for being awarded a UK Research and Innovation (UKRI) Future Leaders Fellowship. “Megan has built an innovative flow chemistry platform at Almac and there is a clear strategic alignment between her career intentions and the future requirement for leadership within the company,” CPHI stated in the press release.

The other new category, Woman of the Year, went to Julia Tsetis, CEO of OFET Pharmaceutical Group, for her commitment to innovation, sustainability, and social responsibility. “In her role as CEO of the OFET Pharmaceutical Group she is regarded as a true visionary and trailblazer in the pharmaceutical industry and has left an indelible mark on the global healthcare landscape,” the press release stated.

Guy Clark, CEO of CNX Therapeutics, was awarded CEO of the Year for significantly growing the company and transitioning it to a standalone entity with £50 million in revenues with more than 20 products sold worldwide.

The API Development and Innovation category went to Lonza for its AI-Enabled Route Scouting Service, which uses artificial intelligence (AI)-enabled predictive tools “that combine theoretical retrosynthesis with supply chain intelligence to identify commercially viable routes. This crystallizes the company’s advanced, data-driven approach to retrosynthetic analysis for designing optimal synthesis routes for small molecule APIs.”

Adare Pharma Solutions won the Drug Delivery and Device Innovation category for its tremors and other uncontrolled body treatments. “Based on an innovative sprinkle formulation, it is a game-changer for patients who struggle to take capsules due to hand tremors or difficulty in swallowing as it can be easily mixed into soft foods or liquids,” CPHI stated.

The Finished Formulation award was given to Unistraw’s UniLayer Straw Delivery System 2mg Loperamide HCl straw, which delivers medication via a plant-sourced and fully compostable polymer straw. This sustainable solution enhances compliance and reduces misuse.

The RheaLyo GMP-Flex continuous freeze-dryer +1 2 from RheaVita was given the award in the Manufacturing Excellence category. It is the first continuous freeze-drying system for aseptic good manufacturing practice production.

CereScreen Digital Display Label from Smurfit WestRock received the Packaging and Machinery award for its seamless integration of digital screens into clinical trial investigational medicinal product packaging. “The screen allows for multiple pages and contains all required label content, including QR codes and other information. In addition, the labels can be customized to suit the specific needs of the trial, including support for multiple languages,” CPHI stated.

The Regulatory and Compliance category was given to Prodigy from ProPharma Group. The suite of AI and advanced automation applications solve productivity challenges that can cause delays and incur costs. “It effectively removes delays, de-risks program delivery, shortens time-to-insight and enhances the overall medicinal value of its clients’ assets,” the press release stated.

Acu-Flow Ltd’s Nebu-Flow nebulizer platform received the Start-Up Initiative Award for overcoming technical limitations by “generating a soft aerosol, with high inhalable fraction (>90%), which can aerosolize biological formulation, such as RNA.”

The Supply Chain Excellence category was awarded to QYOBO GmbH for “a platform that provides crucial insights into global supply chains to help companies identify, manage, and anticipate supply risks. With data from over 250 sources, QYOBO offers a comprehensive view of supply chains for over two million drugs in over 40 countries, enabling quick, informed actions to mitigate risks and prevent drug shortages.”

Evonik Industries AG received the Sustainability Award for their PhytoSquene plant-based squalene for parenteral applications. “This is the first plant-derived, GMP-quality squalene. Pharmaceutical-grade squalene is currently sourced from shark liver oil, which depletes shark populations and negatively impacts marine biodiversity, whereas PhytoSquene is made from amaranth oil from the herbaceous plant 

, which can be grown as a renewable feedstock in many regions of the world.”

The Heart of Pharma award went to West Pharmaceutical Services for its collaboration with the Fox Chase Cancer Center, a National Cancer Institute (NCI)-designated Comprehensive Cancer Center, in the delivery of cancer screenings to residents of Pennsylvania via a mobile screening unit. 

AustinPx received the Accelerating Innovation Award for its KinetiSol Technology, which is a fusion-based, solvent-free process designed to address poor drug solubility. “As new molecules emerge with complex properties, traditional formulation methods struggle to meet the demand for effective drug absorption. KinetiSol disrupts the status quo by rapidly converting crystalline drugs into amorphous solid dispersions, significantly enhancing bioavailability.”

“CPHI continues to drive the future of pharma by creating a platform where innovation thrives, and the brightest minds can exchange ideas and form impactful partnerships that elevate the entire pharmaceutical industry,” said Tara Dougal, Brand and Content Director at Informa Markets, in the press release. “I am thrilled to congratulate the winners of 2024 CPHI Pharma Awards, with special recognition to those honored in our new categories, the Future Leader Award and Start-up Initiative Award. These trailblazers are not just advancing drug discovery and delivery but inspiring the next wave of innovation and leadership in pharma. A heartfelt thank you to everyone who participated and to our esteemed jury, whose insights have helped spotlight the very best our industry has to offer.”

1. CPHI. CPHI Excellence in Pharma Award Winners 2024. Press Release. Oct. 8, 2024.
2. CPHI. Awards—CPHI Milan. 

cphi.com/en/europe/cphi-celebration/awards.html

The winners of this year’s awards showcase achievements in pharma excellence.