Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

Ask the Expert

Closing the Gap in Modern Process Control and Automation for QC/QA

Drug Digest December 2025

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

Emma Palmer Foster is a Director at Discovery Park Ventures.

The last decade has witnessed a boom in life science start-ups, and that pace is set to continue as the search goes on to find improved treatments for diseases including Alzheimer’s and cancer. Although the market is cooler at the moment (1),the science has been backed in recent years by record levels of funding, with investment into life sciences in the United Kingdom reaching a record £4.5 billion (approximately $5.73 billion USD) in 2021 (2).

Yet for early-stage companies, as well as those recently spun-out from universities, obtaining that first tranche of funding remains one of the biggest challenges that they have to face. Very often the issue is not the science, but the fact that these young businesses are unprepared for the realities of dealing with investors. Too often they lack clarity, fail to talk the language that investors need to hear, or provide insufficient evidence that they understand what it takes to make a commercial success out of a new scientific discovery.

Since its inception just over a year ago, Discovery Park Ventures’ (DPV) management has listened to over 50 pitches from early-stage life sciences companies, many of them recently spun-out from universities, all of whom have big hopes for their fledgling businesses. Of that number, Discovery has backed seven, with one more deal going through completion. This funding has generally gone to companies working in strategic areas of particular interest to DPV— such as neuroscience, advanced therapies, and artificial intelligence—and finding out the target areas of different funds is one of the most basic pieces of research that start-ups can undertake in order to give their applications more chance of success.

Significantly, in a climate where women are woefully excluded from venture capital finance, six of the companies that DPV has so far funded have female founders and/or CEOs. This includes Vitarka Therapeutics, which is creating combination medicine using RNAi therapies for patients with late-stage cancers and, most recently, BoobyBiome, founded by scientists Dr Lydia Mapstone, Dr Sioned Jones and Tara O’Driscoll, to develop a novel product for babies who do not have access to the beneficial microbiome in breast milk.

The first round of funding may not quite be a lottery win, but the sums involved— at DPV, that’s usually around £100,000 (approximately $127,000 USD)— are enough to help companies to achieve proof of concept. This allows them to concentrate for a while on gathering the data they need to take their ideas forward without becoming sidetracked by the demands of generating additional early funding. Typically, there may be just two people in the business at this stage, so relegating one to just chasing down finance can severely inhibit progress.

Meanwhile, the task of scrutinising so many applications and listening to pitches has provided DPV with an important level of insight into what these young companies need to do in order to be considered seriously by funders. Those that have made the grade are the ones that have demonstrated that they have thought about every aspect of their product and not become over-enthused by the joy of discovery. Of course, the science must be strong, the hypothesis exciting, and the product with the potential to scale, but that in of itself is not enough. Investors don’t just look at the science, they want to know that the people whom they are backing have the skills to deliver what they promise, and for prospective start-ups that means demonstrating that their business ethic is as strong as their laboratory know-how.

Successful start-ups are the ones who identify mentors and collaborate with peers to facilitate the network building necessary for one to flourish. These companies recognise that listening to sound advice and learning from other successful start-ups can help them to navigate obstacles and overcome hurdles. If they are serious about obtaining funding, then they will also learn to look at their pitch from the perspective of an investor, using effective language and explaining their proposal in a way that demonstrates their understanding of what problem their process or application can solve.

Let's be clear: it's the job of investors to probe for weaknesses, to identify where new technologies are adding unnecessary complexity, or where start-ups have failed to research their competitors. For instance, earlier this year Discovery Park Ventures was amongst the sponsors at BioSeed 2023. This annual rapid-response event provides early-stage life science companies with access to potential investors, offering them the opportunity to get their ideas heard by those who have the power to move them to the next stage.

For participants, the five minutes provided for setting out their store may not seem like sufficient time to explain the principles behind their ideas and convince their audience that they are worth funding. However, in reality, if they can’t sum up their proposal in less than half that time then they could struggle to find the backing that they are looking for.

Harnessing the wealth of exciting science emerging from universities across the UK must be a national priority. Backing is available for the right companies, but only those who have done the work to make themselves into a fundable proposition will earn it.

1. UK BioIndustry Association. Venture Deals Continue to Flow for UK Biotech Under Dark Clouds. Press Release, April 23, 2023.

2. UK BioIndustry Association. Investment in UK Biotech Jumps 60% to £4.5bn in 2021. Press Release, Jan. 26, 2022.

Articles

Start-ups are plagued with common issues that dramatically decrease their odds of achieving investor funding.

Perfecting the Pitch: Learning to Attract Investor Funding

The European Medicines Agency (EMA) has created a concept paper that addresses the need to establish a guideline on the quality aspects of messenger RNA (mRNA) vaccines, emphasizing the number of clinical trial applications and marketing authorization applications for mRNA-containing products significantly increasing over the past few years and still growing.

Further, EMA looks to focus on mRNA vaccines because their classification depends on the target and/or whether they are obtained chemically or biologically. New technology for these types of vaccines is not fully accounted for in the existing guidance, which is why a newer guidance is necessary for EMA to highlight specific aspects regarding the manufacturing process, characterization, specifications, and analytical control for mRNA vaccines for the prevention of infectious disease.

According to the company press release, the scope of the guideline will be limited to mRNA vaccines against infectious diseases. Further, mRNA-based therapeutics will be out of scope of the document, and it is not intended to address specific requirements for mRNA vaccines to be used in clinical trials.

EMA looks to focus on mRNA vaccines because their classification depends on the target and/or whether they are obtained chemically or biologically. 

EMA Aims to Develop Guideline for mRNA Vaccines

Biosynth announced on July 11, 2023 that it has acquired celares, a leader in the development and manufacture of conjugate vaccines and bioconjugate drugs, activated PEGs, and polymer-based drug delivery excipients, according to a company press release. The acquisition will continue to strengthen the area of conjugate vaccines and bioconjugate drugs and will expand Biosynth’s capabilities from good manufacturing practice facilities located in Berlin, Germany.

“celares is an established leader in bioconjugation, and we are extremely excited to be acquiring such a great team of specialists. celares is a perfect complement to our wider business, enabling us to provide bioconjugation services and the production of PEGylation reagents and polymers for drug delivery,” said Urs Spitz, PhD, CEO and president of Biosynth, in a press release. “Together, we can support customers from development to commercialization. celares is a perfect fit for Biosynth—where chemistry meets biology.”

“We are thrilled to have joined the Biosynth group,” added Ralf Kraehmer, PhD, managing director of celares, in a press release. “As established leaders in bioconjugation, celares combines decades of chemical and biotechnological experience within the company and offers customers the possibility to access forward-looking technologies. Optimal polymer-based conjugations and formulations and manufacturing processes of drug compounds is part of our development. We see great similarities in Biosynth with their customer led strategy and passion for the life science industry.”

The acquisition will continue to strengthen the area of conjugate vaccines and bioconjugate drugs and will expand Biosynth’s capabilities from good manufacturing practice facilities located in Berlin, Germany.

Biosynth Acquires Celares for Growing Conjugate Vaccine Market

Hear about a recent collaboration between Associates of Cape Cod, Inc., and Waters Corporation established 

Learn how liquid handling automation in the laboratory can increase efficiency and reduce OOOs.

Understand how the Andrew+ Pipetting Robot can help labs transition from laborious manual procedures to error-free, robotic workflows.

Videos

Associates of Cape Cod, Inc. & Waters Corporation Automation Collaboration

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

The INTERPHEX Exhibitor Awards recognized several parenteral packaging and handling advancements at INTERPHEX 2023, which took place between April 24–26, 2023 at the Javits Center in New York, NY (1). The Best in Show award went to IMA Life North America for its INJECTA aseptic fill/finish system, which has evolved to integrate its gloveless module. Robotic technologies help achieve gloveless processing and eliminate human intervention at crucial stages of the process, such as the aseptic assembly of sterile components loaded using rapid transfer ports. The system does not lose the sterility guaranteed by the autoclave, does not come into contact with the operator, and is assembled entirely in aseptic conditions following isolator decontamination. The extensive use of robotics drastically reduces the number of manual operations, eliminating the need for productivity-sapping integrity checks and simplifying compliance with Annex 1, which views gloves and manual operations as major sources of contamination (2).

The award for Best New Product/Service went to the BoMa Dosing System from DEC Group, which recently established a Filling Solution Technologies Division. Judges selected the patented BoMa precision filling technology for its ability to precisely dose highly sensitive pharmaceutical products without the stress and shear associated with pumps and other conventional filling methods. The system harnesses the physics principles of Boyle’s Law, or pressure and volume of a gas have an inverse relationship with constant temperature, and uses a vacuum to smoothly and precisely handle tiny amounts of product and a wide range of fluid densities and viscosities (3).

A robotic innovation, the bionically-inspired, energy-free ADHESO gripping technology from Schunk, captured the Editor’s Choice award. ADHESO end effectors grip without mechanical force, external energy supply, or residue generation enabling gentle product handling and compatibility with cleanroom requirements. Modeled on Van Der Waals adhesive forces used by animals, such as geckos, for locomotion, the grippers use gentle pressure to pick and one of four release options for placing: rotary movement, tilting movement, sliding movement, or pressing. Alternatively, it is also possible to equip the gripper with an active wiper, which prevents mechanical stress on the workpiece at the placing position. Four standardized ADHESO gripper pad sizes with matching ISO flange adapter serve a wide range of applications (4).

The Ready Pack system from West Pharmaceutical Services earned the Best Technologies award. The ready-to-use sterile packaging system provides all the components needed to fill/finish sterile products, including sterilized NovaPure stoppers, Flip-OffCCS (clean, certified, sterilized) seals, and Corning Valor ready-to-use vials utilizing Stevanato Group's EZ-fill tray or nest and tray formats. Available from stock in small order quantities, Ready Pack kits are particularly well-suited for R&D purposes or small filling operations and designed to support a smooth transition from early-stage pilot manufacture to larger commercial-scale operations and accelerate speed to market (5, 6).

West Pharmaceutical Services, which is celebrating its 100th anniversary, also took home honors for two poster sessions, a Third Place for Evolving Component Technologies to Meet the Needs of Large Volume Injections and a Fifth Place for Functional Assessment of Adeno-Associated Virus Stored in Daikyo Crystal Zenith Vials at Ultra-cold Temperatures(1). 

INTERPHEX 2024 will return to the Javits Center on April 16–18, 2024 (1).

1 RX (Reed Exhibitions). Pharmaceutical Manufacturing and Biotech Industries Showcase Latest Innovations throughout INTERPHEX 2023. Press Release. May 4, 2023.

2 IMA Life. IMA Life Wins Top Prize at INTERPHEX New York 2023. 

3 Dec Group. DEC Group Wins INTERPHEX Award for BoMa Filling Solution. 

5 West Pharmaceutical Services. West's Ready Pack™ Containment Solution with Corning® Valor® RTU Vials Utilizing Stevanato Group's EZ-fill® Technology Recognized for Best Technologies Award at INTERPHEX. Press Release. May 2, 2023.

6 West Pharmaceutical Services. West Ready Pack, Product Sheet. January 2023.

Parenteral packaging and handling advancements receive awards.

INTERPHEX 2023 Honors Packaging Innovations

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA recently granted full, or traditional, approval to Eisai Pharmaceutical’s Alzheimer’s treatment Leqembi, converting an earlier conditional approval status with further data from a multi-regional study of nearly 1800 patients. Results indicated that the drug slows the rate of cognitive and functional decline in early Alzheimer’s patients, compared to placebo, but also raised certain safety concerns. The 

for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition.

Eisai and partner Biogen had gained FDA accelerated approval for the drug in January 2023 based on evidence from a Phase II study. However, reimbursement was limited by the earlier decision of the Centers of Medicare and Medicaid Services (CMS) to pay for Alzheimer’s drugs only for those patients enrolled in clinical trials to further test the safety and efficacy of the therapy. This approach utilized CMS’ Coverage with Evidence Development (CED) policy, which limits access to certain innovative medical products while clinical trials continue and is most commonly used for new medical devices. It was very unusual and controversial for CMS to curb coverage for a drug granted accelerated approval by FDA and reflects concerns about potentially huge outlays for Medicare on a therapy that may have limited efficacy and potential adverse effects.

Now with the sponsor presenting trial data supporting full FDA approval, 

 it will provide appropriate, broader coverage for Leqembi. But reimbursement still will be contingent on physicians enrolling patients in registries so that CMS may track the effectiveness of the treatment and emergence of side effects going forward with broader patient use.

Eisai set the stage for FDA full approval by 

conducting a large Phase III placebo-controlled, double-blind, randomized study in North America, Europe, and Asia

. Study 301 Clarity AD enrolled 1795 patients with early Alzheimer’s disease, as seen in measures of mild cognitive impairment or mild dementia stage disease. Half of the participants received treatment and half placebo, with further stratification based on severity of disease, use of other medications, geographical region, and evidence of relevant genetic markers.

FDA approval on July 6, 2023 was based on 

indicating that the drug may slow progression of Alzheimer’s symptoms, as measured on global cognitive and functional scales. An FDA advisory committee had voted on June 9, 2023 that study results verified clinical benefit of Leqembi for its indicated use. However, the treatment will carry a boxed warning alerting patients and prescribers to the potential risks for individuals experiencing amyloid-related imaging abnormalities (ARIA) that may be associated with headaches, dizziness, as well as more serious brain edema. FDA recommends testing for a certain genetic marker that may be related to this condition.

Utilization and prescribing of the drug are uncertain, as many questions remain to be addressed concerning long-term effectiveness and prevalence and severity of side effects. And while Medicare and insurers will pay for much of the proposed $26,000 a year drug cost, patients will be responsible for considerable cost-sharing for the therapy, as well as a range of clinical visits and tests. At the same time, the relatively small positive effect on patient health may deter prescribing until additional data emerges. Utilization also may rise in the future with the development of new formulations that don’t require such frequent infusion, and more advanced diagnostics may better identify patients most likely to benefit and less likely to suffer serious side effects from the drug.

Jill Wechsler is Washington reporter for 

FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition

Large Clinical Trial Supports Alzheimer Drug Full Approval

Thermo Fisher Scientific announced on July 6, 2023 the entering of an agreement to acquire CorEvitas, LLC for $912.5 million in cash, according to a company press release.

The acquisition of CorEvitas will include their 12 registries, including nine autoimmune and inflammatory syndicated registries, and approximately 300 employees. Further, the company is expected to hit a revenue of $110 million in 2023.

“The addition of CorEvitas will further advance our capabilities to better serve our pharma and biotech customers and strengthen our value proposition. CorEvitas is an excellent strategic fit for Thermo Fisher and highly complementary to PPD, our leading clinical research business,” said Marc N. Casper, chairman, president, and chief executive officer of Thermo Fisher, in a press release. “There is strong market demand for real-world evidence which improves decision making and reduces the time and cost associated with drug development. As the trusted partner, we continue to further differentiate our capabilities to help our customers accelerate innovation and drive productivity. We look forward to welcoming CorEvitas to Thermo Fisher.”

According to the press release, the transaction is expected to be completed by the end of 2023 where CorEvitas will become a part of Thermo Fisher’s Laboratory Products and Biopharma Services segment.

“This is an exciting next step for CorEvitas. Thermo Fisher shares our science-led and mission-driven culture and commitment to driving innovation and improving patient outcomes. I am confident that becoming part of a global leader with deep life science expertise, commercial reach, international presence, and proven operational excellence will provide significant opportunities for both our customers and our colleagues,” said Raymond H. Hill, chairman and chief executive officer of CorEvitas, in a press release. “I look forward to working with the entire Thermo Fisher team as we enter this next phase of growth.”

The transaction is expected to be completed by the end of 2023 where CorEvitas will become a part of Thermo Fisher’s Laboratory Products and Biopharma Services segment.

Thermo Fisher Scientific Agrees to Acquire CorEvitas

Caribou Biosciences announced on July 6, 2023 that Pfizer made a $25 million equity investment in the company, according to a company press release. The purchase by Pfizer closed on June 30, 2023.

“We believe Pfizer’s investment in Caribou highlights the potential of our clinical programs, and we are excited to establish this partnership with one of the world’s premier biopharmaceutical companies,” said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer, in a press release. “We are actively advancing our allogeneic CAR-T cell therapy pipeline and look forward to providing updates from all of our programs over the next six months, including six-month dose escalation data from our ANTLER Phase I clinical trial for CB-010, dose escalation updates on our CaMMouflage Phase I clinical trial for CB-011, and submission of an investigational new drug application for CB-012.”

Caribou will take the investment proceeds to advance CB-011, which is an immune cloaked allogeneic CAR-T cell therapy currently being evaluated in the CaMMouflage Phase I clinical trial in patients with relapsed or refractory multiple myeloma. In addition, Caribou will maintain full ownership and control of its pipeline of allogeneic CAR-T and CAR-NK cell therapies.

Caribou will maintain full ownership and control of its pipeline of allogeneic CAR-T and CAR-NK cell therapies.

Caribou Biosciences Receives $25 Million Equity Investment from Pfizer

Feliza Mirasol is the science editor for 

On July 03, 2023, UK-based synthetic biology company Camena Bioscience announced that it has closed a $10 million Series A financing round, which was led by Mercia, a UK-based venture capital firm. With the new funding, Camena intends to scale operations and continue developing gSynth, its enzyme-based DNA synthesis platform.

According to a company press release, demand for DNA synthesis technology has been growing as synthetic genes are being widely used in research to better understand the mechanisms of disease and in the drug discovery process to combat disease. Cost, time, and accuracy of traditional DNA synthesis methods (developed in the 1980s) remains prohibitive, however, particularly when creating long or complex sequences of genes. The technology developed by Camena overcomes these limitations with the use of a novel enzymatic technology that can accurately produce synthetic DNA, according to the press release.

“We are delighted to have closed this latest round of funding with Mercia, which provides further validation of Camena’s approach. The ability to read, write, and manipulate DNA is the foundation of the synthetic biology value chain, yet developments in DNA synthesis have not kept pace with DNA sequencing and editing capabilities,” said Steve Harvey, CEO, Camena, in the release. “Camena’s gSynth platform is revolutionizing the DNA synthesis market by unlocking access to genes and accelerating discovery pipelines.”

“The invention of next-generation DNA sequencing technologies transformed our ability to ‘read’ DNA. Our goal is to enable our customers to ‘write’ DNA with the same confidence and ease,” Harvey added.

“The market for synthetic genes is growing rapidly, but much of the demand is for complex genes which are extremely difficult to produce accurately. Camena’s technology is a game changer that could unlock a much bigger global market. We’re excited to support Camena on its next stage of growth,” said Lee Lindley, investment manager, Mercia, in the release.

Camena Bioscience has completed $10 million in Series A financing on the back of growing demand for DNA synthesis.

Camena Bioscience Raises $10 Million to Pursue DNA Synthesis Technology

Kelly Doering, senior director at Aspen Technology, sat down with Grant Playter, associate editor, to unpack various strategies for holistic data integration into pharma operations. 

Topics of discussion include how manufacturing parameters impact the value of different data sets, balancing data democratization with very large data volumes, the role of data in promoting global access to medicine, and more.

Kelly Doering, senior director at Aspen Technology, unpacks various strategies for holistic data integration into pharma operations.

Featured Content

Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Behind the Headlines Episode 28

Ask the Expert

Drug Digest December 2025

A “Plan, Prevent, Prove” Approach