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Inpharmation — Case Studies

Case studies.

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Inpharmation runs global projects for the majority of top-50 pharmaceutical companies, across all major therapy areas., below you can browse a selection of projects showcasing examples of real-world strategic insights inpharmation delivers., to receive your full free copy of any case study:.

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Delivering gene therapy pricing strategy where payer interviews had failed: The power of Behavior-Based Pricing

Our client had a novel “one and done” gene therapy for an ultra-orphan disease. Despite previous payer research, the client lacked direction in which patient segments to target, what list to net pricing strategy to take, and what net price they could achieve. They needed an efficient and quantitative solution to inform their key development […]

Informing pricing prospects for a gene therapy in-licensing deal

To in-license, or not to in-license? Our client wanted to evaluate the price potential of a promising new product. The indication had a high unmet need and there was potential for the product to be used in future combination therapies. A lack of analogues and tight timelines added further complexity to the project. Inpharmation’s combination […]

Second indication, a second chance?

Analogue-based pricing had previously failed our client. They now had just eight weeks to make a launch or no-launch decision for a second indication. An evidence-based approach was needed to prevent repeating past mistakes.

Where do you start with pricing when the future landscape is unknown?

Limited clinical trial data, multiple lines of treatment and a changing pricing landscape presented challenges for the pricing assessment of an innovative oncology asset. However, Inpharmation’s evidence-based techniques were able to provide a flexible solution within the customer’s tight timelines.

How a flexible approach to pricing research allowed a rapid change of direction when unexpected trial results emerged

A pharma company wanted to launch its asset into a second indication. However, just as Inpharmation’s research was coming to an end, unexpected clinical trial results were revealed. This required a rapid change in strategy.

One chronic illness, many unlicensed treatments and one pipeline asset: Where do you start with pricing?

A leading pharma company needed to understand the price potential of their novel first-in class asset. Without any direct comparators, they were unsure what price they could achieve and how payers were going to behave. Inpharmation’s evidence-based approaches provided the perfect solution…

A clinical advance with a novel mechanism of action: What will its uptake look like?

With no obvious analogues and mixed messages from previous demand and qualitative research, our client was unsure what their novel asset’s uptake would look like. Inpharmation had the ideal approach to provide validated insights and evidence-based results…

How preconceived ideas of sample size nearly soured a great project

Pharma Specific Conjoint offered an ideal solution for our client. However, the significantly smaller sample size, compared to that of discrete-choice conjoint, lead to the project being met with reservations. A solution was needed to demonstrate the accuracy of our methodology.

How a lack of analogues could have undervalued a promising in-licensing opportunity

High unmet need offered a promising environment for a new asset; however, with no obvious analogues to quantify price potential, an approach ideal for an indication with no current treatments was needed…

A promising cardiovascular treatment in a highly prevalent disease

A highly prevalent disease with existing inexpensive therapies presented a challenging pricing environment for our client’s cardiovascular treatment. To deliver the optimal pricing strategy, Inpharmation used a combination of primary and secondary pricing techniques.

How analogue-based pricing confused a team of pricing experts

Traditional analogue-based pricing and qualitative payer interviews left our client confused when pricing an asset in a previously untreated disease with an uncertain patient population. Behavior-Based Pricing provided much needed clarity by drawing upon thousands of real-world payer decisions.

CASE STUDY: Working the problem — how to resolve sticking issues in tablet production

by I Holland

31 May 2018

In this case study, a prediction model is used in conjunction with an examination of a tablet profile to resolve sticking issues.

problem solving

I holland table.

Novartis, is a company providing innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products.

I Holland has origins that date as far back as 1910 when it was established as a general engineering and machining company by Messers Holland and Brewill. It is now a global manufacturer and supplier of tablet compression tooling.

The problem

The Italian division of Novartis approached I Holland and local agent Vis Viva with a sticking issue on an antiepileptic drug in the form of a coated tablet.

Novartis reported a strong sticking/picking problem causing the press to be stopped several times during manufacture for cleaning and maintenance of the punches, which resulted in production downtime.

Sticking and picking halted production

I Holland Image 1

These two problems can be caused by various factors related to the physicochemical properties of the formulation components, the surface characteristics of punch face, as well as factors related to the machinery and the environment, for example, compression force and speed, temperature and humidity.

Tablet sticking is one of the most common problems in tablet manufacture. This build-up of granule on the punch tip face causes tablet press downtime and reduced tablet output. It has a negative effect on tablet appearance and often results in the removal of tablet tooling from production for regular cleaning and maintenance, as experienced by Novartis.

Picking was another problem encountered by the company — this is when compressed granule that has adhered to the detail on the punch face, results in ‘picking out’ of parts from the tablet face.

Understanding problems that can occur during manufacture will ultimately result in higher yields, less waste and money saving implications. To achieve this ideal, it is important to understand the product being made and how it interacts with the tooling used during the production process.

Novartis had previously looked at the coating being used on the tooling to overcome the sticking/picking problem. Proactively seeking a solution, the company tried several different coatings including HC (Hard Chromium), CrN (Chromium Nitride) and TN (Titanium Nitride). With unsatisfactory results from these initial trials, Novartis Italy contacted I Holland for expert advice and analysis of the problem with the support of local agents Vis Viva.

Sample tools were examined, with the tablet design and tool material selection and coating studied. I Holland used its TSAR≈Predict (Tabletting Science Anti-Stick Research) model. With sticking and picking being such a universally significant problem in the pharmaceutical industry, I Holland invested in a two-year research programme to develop a predictive model that could be used to reduce downtime and ultimately costs. The model comprises data on a range of parameters including surface chemistry, temperature, humidity, size of the granule, and whether it is elastic or plastic for example, to provide fast guidance to the tablet producer. This reduces the need to carry out expensive in-the-field testing which is time consuming and requires the tablet manufacturer to take time out of tablet production to run trials with coated punches.

As well as using the predictive model, the tablet profile was examined. The type of profile required is influenced by several factors; the granule, embossing requirements, coating process, packaging and the company’s branding. If the design is to be heavily embossed with a lot of characters it is important to avoid tablet profiles with a deep cup, such as the ball or pill. Deep cup profiles can cause a softer core in the tablet which can in turn lead to sticking. It will also reduce the available space for the embossing itself; the use of a profile that is shallower, with a reduced cup depth, will allow for a larger embossing area.

The solution

The tablet design, including the embossing, was examined and new and improved designs were created which included anti-picking features. Together with results from the TSAR≈Predict model, which selected the use of I Holland’s PharmaCote CN+(Chromium Nitride Plus) surface engineered anti-stick coating, new upper and lower punches were provided and implemented in production.

The removal of the tablet tooling from production for regular cleaning and maintenance was required due to the problem of sticking

I Holland image 2

The selected anti-stick coating was used on the punches and applied to the tooling by using an electron beam process. This is one of the smoothest and most defect-free methods of applying a PVD coating as it does not create droplets during the atomisation process.The atomic particles are attracted to the tooling leaving an even surface which is far less susceptible to breakaway defects.

From the first trial of the new design and tooling using PharmaCote CN+, improvements were seen and all sticking/picking issues were instantly resolved resulting in a 25% increase in production. This was achieved over a five-day working week, with reduced hours, resulting in a full day’s production time saved.

Before the implementation of the new tablet design and tool coating, four batches of the tablet were produced during a 6-day working week. This included the extra time required for cleaning and maintenance due to the original sticking/picking problem. Once I Holland’s improvements were adopted, a further batch was produced in the same time-period with a total of five batches manufactured without the need to stop production.

As a result of this outcome, Novartis is now looking at further products to be analysed to improve production and reduce down-time.

The conclusion

I Holland’s understanding of years of tabletting science has proven that when coatings are developed correctly, and their beneficial characteristics are matched to those of the formulation, they can help to prevent sticky formulations adhering to the punch tip faces. I Holland has deployed many advanced techniques to help improve the performance of its coatings. As a result, it has a proven range of anti-stick solutions based on that research. TSAR≈Predict gives a predicted particle adhesion force against each of the PharmaCote anti-stick coatings in I Holland’s range.

To improve tablet production efficiency, it is imperative to implement an effective tooling specification. To find the correct design for the product being produced, consultation with an expert tablet designer should take place in the early stages of the process. The design should not only be unique and visually appealing, but also robust and producible in a rigorous tablet manufacturing environment. By making just a few simple changes to a design it can stop future problems.

By adopting new science-based innovations, like those from I Holland, and investing in research and development, Novartis is pro-actively bringing important treatments to patients globally.

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Pharmaceutical →

• 09 Feb 2024

Slim Chance: Drugs Will Reshape the Weight Loss Industry, But Habit Change Might Be Elusive

Medications such as Ozempic, Wegovy, and Mounjaro have upended a $76 billion industry that has long touted lifestyle shifts as a means to weight loss. Regina Herzlinger says these drugs might bring fast change, especially for busy professionals, but many questions remain unanswered.

• 01 Aug 2023
• Cold Call Podcast

Can Business Transform Primary Health Care Across Africa?

mPharma, headquartered in Ghana, is trying to create the largest pan-African health care company. Their mission is to provide primary care and a reliable and fairly priced supply of drugs in the nine African countries where they operate. Co-founder and CEO Gregory Rockson needs to decide which component of strategy to prioritize in the next three years. His options include launching a telemedicine program, expanding his pharmacies across the continent, and creating a new payment program to cover the cost of common medications. Rockson cares deeply about health equity, but his venture capital-financed company also must be profitable. Which option should he focus on expanding? Harvard Business School Professor Regina Herzlinger and case protagonist Gregory Rockson discuss the important role business plays in improving health care in the case, “mPharma: Scaling Access to Affordable Primary Care in Africa.”

• 25 Jul 2023
• Research & Ideas

Could a Business Model Help Big Pharma Save Lives and Profit?

Gilead Sciences used a novel approach to help Egypt address a public health crisis while sustaining profits from a key product. V. Kasturi Rangan and participants at a recent seminar hosted by the Institute for the Study of Business in Global Society discussed what it would take to apply the model more widely.

• 06 Jun 2023

The Opioid Crisis, CEO Pay, and Shareholder Activism

In 2020, AmerisourceBergen Corporation, a Fortune 50 company in the drug distribution industry, agreed to settle thousands of lawsuits filed nationwide against the company for its opioid distribution practices, which critics alleged had contributed to the opioid crisis in the US. The $6.6 billion global settlement caused a net loss larger than the cumulative net income earned during the tenure of the company’s CEO, which began in 2011. In addition, AmerisourceBergen’s legal and financial troubles were accompanied by shareholder demands aimed at driving corporate governance changes in companies in the opioid supply chain. Determined to hold the company’s leadership accountable, the shareholders launched a campaign in early 2021 to reject the pay packages of executives. Should the board reduce the executives’ pay, as of means of improving accountability? Or does punishing the AmerisourceBergen executives for paying the settlement ignore the larger issue of a business’s responsibility to society? Harvard Business School professor Suraj Srinivasan discusses executive compensation and shareholder activism in the context of the US opioid crisis in his case, “The Opioid Settlement and Controversy Over CEO Pay at AmerisourceBergen.”

• 26 Apr 2023

How Martine Rothblatt Started a Company to Save Her Daughter

When serial entrepreneur Martine Rothblatt (founder of Sirius XM) received her seven-year-old daughter’s diagnosis of Pulmonary Arterial Hypertension (PAH), she created United Therapeutics and developed a drug to save her life. When her daughter later needed a lung transplant, Rothblatt decided to take what she saw as the logical next step: manufacturing organs for transplantation. Rothblatt’s entrepreneurial career exemplifies a larger debate around the role of the firm in creating solutions for society’s problems. If companies are uniquely good at innovating, what voice should society have in governing the new technologies that firms create? Harvard Business School professor Debora Spar debates these questions in the case “Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams.” As part of a new first-year MBA course at Harvard Business School, this case examines the central question: what is the social purpose of the firm?

• 28 Mar 2023

The FDA’s Speedy Drug Approvals Are Safe: A Win-Win for Patients and Pharma Innovation

Expediting so-called breakthrough therapies has saved millions of dollars in research time without compromising drug safety or efficacy, says research by Ariel Stern, Amitabh Chandra, and colleagues. Could policymakers harness the approach to bring life-saving treatments to the market faster?

• 12 Dec 2022

Buy-In from Black Patients Suffers When Drug Trials Don’t Include Them

Diversifying clinical trials could build trust in new treatments among Black people and their physicians. Research by Joshua Schwartzstein, Marcella Alsan, and colleagues probes the ripple effects of underrepresentation in testing, and offers a call to action for drugmakers.

• 06 Sep 2022

Curbing an Unlikely Culprit of Rising Drug Prices: Pharmaceutical Donations

Policymakers of every leaning have vowed to rein in prescription drug costs, with little success. But research by Leemore Dafny shows how closing a loophole on drugmaker donations could eliminate one driver of rising expenses.

• 22 Feb 2021
• Working Paper Summaries

Private and Social Returns to R&D: Drug Development and Demographics

Research and development (R&D) by pharmaceutical firms focuses disproportionately on medical conditions afflicting the elderly. The proportion of R&D spending targeting older age groups is increasing over time. Even though these investments in R&D prolong life expectancy and improve quality of life, they have little effect on measured productivity and output growth.

• 14 Dec 2020

What Does December's Drug-Approval Dash Mean for COVID-19 Vaccines?

Even in the best of times, pharmaceutical regulators tend to rush through drug applications in December. Now add in a ruthless pandemic. Research and insights from Lauren Cohen. Open for comment; 0 Comments.

• 28 Sep 2020

What Can Economics Say About Alzheimer's Disease?

This essay discusses the role of market frictions and "missing medicines" in drug innovation and highlights how frameworks and toolkits of economists can help our understanding of the determinants and effects of Alzheimer's disease on health.

• 01 Sep 2020

How to Launch a New Biosciences Product: Start Small or Dive in?

C16 Biosciences wants to replace palm oil, a major contributor to deforestation, with a lab-grown substitute. But CEO Shara Ticku faces a tough decision in bringing the product to market. Jeff Bussgang discusses his case study. Open for comment; 0 Comments.

• 10 Aug 2020

COVID's Surprising Toll on Careers of Women Scientists

Women scientists and those with young children are paying a steep career price in the pandemic, according to new research by Karim Lakhani, Kyle Myers, and colleagues. Open for comment; 0 Comments.

• 13 Jul 2020

Merck CEO Ken Frazier Discusses a COVID Cure, Racism, and Why Leaders Need to Walk the Talk

VIDEO: Ken Frazier, one of only four Black CEOs of Fortune 500 companies, speaks with Professor Tsedal Neeley about the search for a coronavirus vaccine, how racism at the workplace holds back America’s progress, and his own upbringing just one generation from slavery. Open for comment; 0 Comments.

• 09 Jun 2020

In a Pandemic, What’s the Best Strategy for the Global Vaccine Alliance?

How should the vaccine alliance Gavi respond to the worldwide need for a cure for the COVID-19 pandemic? Tarun Khanna discusses his case study. Open for comment; 0 Comments.

• 01 Jun 2020

Rebates in the Pharmaceutical Industry: Evidence from Medicines Sold in Retail Pharmacies in the U.S.

Retail pharmacy data illustrates it can be misleading to use list prices instead of net prices to understand pharmaceutical prices. Analysts and economists working in public policy should be extremely cautious in drawing policy conclusions based on list prices alone.

• 28 Feb 2019

Pursuing Precision Medicine at Intermountain Healthcare

What happens when Intermountain Healthcare invests resources in an innovative precision medicine unit to provide life-extending, genetically targeted therapies to late-stage cancer patients? Professors Richard Hamermesh and Kathy Giusti discuss the case and its connections to their work with the Kraft Precision Medicine Accelerator. Open for comment; 0 Comments.

• 12 Jun 2018

In a Landscape of 'Me Too' Drug Development, What Spurs Radical Innovation?

Pharmaceutical companies are criticized for not producing more breakthrough drugs. But new research by Joshua Krieger and colleagues shows that, given a financial windfall, drug giants turn on the innovation. Open for comment; 0 Comments.

• 21 Feb 2018

When a Competitor Abandons the Market, Should You Advance or Retreat?

Companies pay close attention when a competitor drops out of the market, according to new research by Joshua Lev Krieger. Too often, though, they come to the wrong conclusion. Open for comment; 0 Comments.

• 09 Feb 2018

Developing Novel Drugs

This paper contributes to our understanding of how financing constraints affect the direction of innovation in drug development. The authors develop a new measure of drug novelty based on molecular characteristics, and explore the tradeoffs involved in decisions to develop more novel therapies. Open for comment; 0 Comments.

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Pharmaceutical and Biotech Manufacturing Case Studies

Save time, improve processes, and protect brand integrity.

Pharmaceuticals and biopharmaceuticals must meet the most stringent manufacturing and production standards to ensure patient safety. Exceptional quality control means verifying raw materials, cGMP compliance, and testing the integrity of packaged medicines. Read these case studies to learn more about our solutions for each step in the pharmaceutical manufacturing process to help improve practices and produce the highest quality products.

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• Two projects were initiated to evaluate the online process mass spectrometry
• One of the cell lines was a GS-CHO producing lgG4 monoclonal antibody (mAb)
• Precision of the Thermo Scientific Prima BT Bench Top Mass Spectrometer was 50x greater for both CO2 and O2, and drift between calibration was eliminated
• When monitoring 12 fermenters the price of the mass spectrometer was equivalent to the low performance sensors
• High precision and speed analysis
• RQ could be seen and corrective action taken
• Expensive media and labor hours were not wasted on failed fermentation batches
• The inclusion of methanol and ethanol analysis was realized at no extra cost
• Per FDA/GMP compliance requirements, customers must ID both bulk drug substance and final product
• Current technologies like peptide mapping are difficult and time consuming
• Many customers must send samples to centralized labs
• Point of use solutions to replace existing testing workflows
• Thermo Scientific TruScan RM Handheld Raman Analyzer with TruTools enables customers to remove the overall burden from QC labs
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Thermo Scientific TruScan RM Handheld Raman Analyzer with TruTools has been validated using production lots with results comparable to or superior to GC testing

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• Thermo Scientific TruScan RM/GP Handheld Raman Analyzer and microPHAZIR RX Analyzer provide point-of-use solutions to replace existing testing workflows
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Case studies

Applications of artificial intelligence in the pharmaceutical industry

Credit: Bert van Dijk/Getty images.

Alto Neuroscience uses AI to develop brain biomarkers

Founded in 2019, Alto Neuroscience is a clinical-stage biopharmaceutical start-up that uses its AI-enabled platform to measure brain biomarkers, including electroencephalogram (EEG) activity and behavioural patterns, wearable data, genetics, and other factors to drive targeted drug development in mental health.

Alto Neuroscience has several drugs in clinical development, including three in Phase II studies for major depressive disorder (MDD) and post-traumatic stress disorder (PTSD) (ALTO-100, ALTO-202, and ALTO-300) and four in Phase I for unspecified psychiatric disorders.

In October 2021, Alto Neuroscience announced that it had raised $40m in funding to advance its drug development process, including $8m in a seed funding round, and $32m in a Series A round led by Apeiron Investment Group.

In December 2021, Cerebral, a mental health start-up, and Alto Neuroscience announced a partnership to launch a decentralised clinical study in precision psychiatry to boost drug development and treatments for patients with mental disorders. The companies joined forces to conduct a Phase II clinical trial for Alto Neuroscience’s ALTO-300 depression drug candidate, and around 100 participants from Cerebral’s member network were enrolled from January 2022.

Participants undergo in-home evaluations measuring their brain activity, sleep, activity patterns, and genetics, as well as clinical outcomes such as depression and PTSD. Using Alto Neuroscience’s analytical approach to predicting patient outcomes, it will assess whether certain biomarkers are the best way to identify patients most likely to benefit from a given drug candidate. The Phase II study is expected to complete in June 2023.

In January 2023, Alto Neuroscience announced positive results for a Phase IIa trial of ALTO-100, a new drug for MDD. The trial recruited 228 patients with MDD or PTSD, of which 59 had an MDD biomarker profile that Alto identified as predicting drug efficacy. The trial's primary endpoint was a change in depression severity compared to baseline after six weeks. The biomarker-defined patients saw a greater reduction in the clinical assessment used for this compared to those without.

For clinical response, defined as a 50% reduction in symptoms of depression, a higher number of biomarker-defined patients (61%) achieved the desired result compared to patients without (33%). The trial is now in Phase IIb, focused solely on biomarker-defined patients to further demonstrate patient safety and efficacy.

The Phase IIb trial has been supported by a $35m Series B funding led by Lightswitch Capital and partners of Alkeon Capital secured in October 2022, and a further $25m equity investment added to the Series B fund by Alpha Wave Ventures in January 2023. Alto Neuroscience also entered into a $35m credit facility with K2 HealthVentures in 2023. The proceeds will be used to expand and continue the development of other mental-health-related therapeutics.

Clarify Health unveils GenAI copilot for predictive analytics

California-based enterprise analytics start-up Clarify Health Solutions (Clarify Health) has launched a closed beta of its GenAI copilot dubbed Clara. It is based on the startup’s Clarify Atlas platform that maps over 300 million patient journeys to deliver more than 18 billion AI-powered predictions and surface insights with speed and precision.     The copilot leverages Clarify’s healthcare claims dataset and employs advanced ML and NLP to deliver precise, relevant, and actionable data to healthcare professionals. It enables organisations to gain insights into influenceable behaviour changes that are pivotal in lowering healthcare costs and improving the quality of care. Users can access these insights instantly reducing the time for decision making.

Incentivised, higher-value care decisions can lead to better patient care and reduced costs. These strategies include pay-for-performance programs, bundled payments, shared savings models, value-based insurance design, patient education and decision support, and health information technology. Implementing these approaches requires collaboration among healthcare providers, payers, policymakers, and patients to align financial incentives with improved outcomes and cost-effectiveness.     Healthcare providers are always aiming to reduce costs, improve efficiency, and enhance patient outcomes. Clarify Health aims to empower organisations to identify opportunities to encourage and incentivise decisions that lead to higher-quality care and lower costs for patients by utilising Clara.

In April 2022, the start-up raised $150m in Series D funding led by SoftBank Vision Fund 2 along with other existing investors. It intended to utilise these funds to strengthen its clinical informatics capabilities and broaden its value-based payments technology. Clarify Health anticipates that Clara can transform the healthcare delivery landscape by offering organisations the opportunity to shape their development and tailor their capabilities to their unique needs.

REPROCEL streamlines big data analysis in drug development

Japan’s REPROCELL, in collaboration with IBM and STFC Hartree Centre, has launched Pharmacology-AI, a platform designed to simplify and accelerate the analysis of big data from drug development studies. The platform aims to help researchers identify inter-individual differences that significantly influence drug response or related clinical outcomes. It is designed to make the process of finding actionable insights from data quicker and easier, without the need for bioinformatics expertise.     Pharmacology-AI platform uses AI to analyse large datasets related to precision medicine. It simplifies analysis of large datasets, enabling researchers to quickly and easily reveal the genomic or clinical features driving drug response data, biomarker levels, or other clinical data outcomes.

The platform provides AI analysis outputs in an easily interpretable and interactive format via a secure web portal built in compliance with industry standards. It also allows for the combination of analysis with preclinical human tissue research to enhance translational data sets and increase the chances of clinical success.     Conventional analysis of large datasets in precision medicine can be time-consuming and complex, requiring high-level bioinformatics expertise. Pharmacology-AI addresses this challenge by employing AI. The platform can help improve the design of clinical trials, making them more successful and less costly.

It can also help identify patient populations most likely to benefit from new drugs much earlier in the drug development process. Furthermore, it can reveal why some patients respond to commonly prescribed drugs, while others gain little or no benefit. This could lead to more personalised treatment plans and improved patient outcomes. REPROCELL plans to expand the use of this technology across various organ systems and therapeutic areas.

GlobalData , the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Thematic Intelligence uses proprietary data, research, and analysis to provide a forward-looking perspective on the key themes that will shape the future of the world’s largest industries and the organisations within them.

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NOVO NORDISK

Novo Nordisk, the Danish insulin producer, created a blue ocean in the insulin industry by challenging the industry’s conventional wisdom about which buyer group to target. By looking across buyer groups, it gained new insights into how to unlock a leap in value for a previously overlooked set of buyers.

Insulin is used by diabetics to regulate the level of sugar in their blood. Historically, the insulin industry, like most of the pharmaceutical industry, focused its attention on the key influencers: doctors. The importance of doctors in affecting the insulin purchasing decision of diabetics made doctors the target buyer group of the industry. Accordingly, the industry geared its attention and efforts to produce purer insulin in response to doctors’ quest for better medication.

The issue was that innovations in purification technology had improved dramatically by the early 1980s. Novo itself had already created insulin that was a chemically exact copy of human insulin. As long as the purity of insulin was the major parameter upon which companies competed, little progress could be made further in that direction and competitive convergence was rapidly occurring.

Novo Nordisk, however, saw that it could break away from the competition and create a blue ocean by shifting the industry’s longstanding focus on doctors to the users – patients themselves. In focusing on patients, Novo Nordisk found that insulin, which was supplied to diabetes patients in vials, presented significant challenges in administering. This led Novo Nordisk to the blue ocean opportunity of NovoPen, the first user-friendly insulin delivery solution that was designed to remove the hassle and embarrassment of administering insulin. Patients could take the pen with them and inject insulin with ease and convenience without the complexity and social embarrassment of syringes and needles.

To dominate the blue ocean it had unlocked, Novo Nordisk followed up by introducing NovoLet, a pre-filled disposable insulin injection pen with a dosing system that provided users with even greater convenience and ease of use. And it later brought out the Innovo, an integrated electronic memory and cartridge based delivery system.

Novo Nordisk’s blue ocean strategy shifted the industry landscape and transformed the company from an insulin producer to a diabetes care company. NovoPen and the later delivery systems swept over the insulin market. Sales of insulin in pre-filled devices or pens now account for the dominant share in Europe, Asia and Scandinavia, where patients are advised to take frequent injections of insulin every day. Today, almost thirty years since its initial blue ocean strategic move, Novo Nordisk remains the global leader in diabetes care, with some 70 percent of its total turnover coming from this offering, which originated largely in the company’s thinking in terms of users rather than influencers.

The Novo Nordisk case study illustrates how market boundaries can be reconstructed by looking across the chain of buyers, path three in   blue ocean strategy’s six paths framework .

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Case Studies in Pharmaceutical Project Management

A technical forum featuring Catalent Pharma Solutions, SAFC, and Neuland Laboratories.

Effective project management is an invaluable competency in a successful outsourcing relationship. Catalent Pharma Solutions, SAFC, and Neuland Laboratories, offer examples of successful project management, respectively in blow/fill/seal operations, viral-product manufacturing, and real-time project management in API manufacturing.

Project management underpins successful relationships between contract technology and service providers and their sponsor companies. As pharmaceutical companies increase their level of outsourcing, it becomes increasingly important for contract technology and service providers to provide not only the technical capabilities needed to execute a given project, but the management skills to deliver a project on time, to specifications, and with the necessary communication to prevent or mitigate project delays. To illustrate the importance of project management in outsourcing, several industry members provided case studies on how to coordinate, organize, and implement a successful project. Participating in this technical forum on project management are Norman Weichbrodt, strategic account manager at Catalent Pharma Solutions; Nick Johnson, marketing manager at SAFC; and Saharsh Rao Davuluri, president of contract research at Neuland Laboratories.

Gregor Schuster/Getty Images

Blow/fill/seal manufacturing

Norman Weichbrodt, strategic account manager at Catalent Pharma Solutions

Catalent Pharma Solutions is a provider of drug and biologic development services, delivery technologies, and supply solutions. Effective project management is the cornerstone of being a complete provider of services ranging from development of new products to technical transfer of existing products. Building the proper project team and employing the correct methodology for handling a complex project is the foundation on which success is achieved.

In July 2010, Catalent was approached by a major pharmaceutical customer to transfer an ophthalmic product approved for sale in Europe to Catalent's blow/fill/seal (BFS) manufacturing site in Woodstock, Illinois. The successful technical transfer of the manufacturing process for this product would potentially lead, following FDA approval of the product already made in the European facility, to approval of the drug for manufacture and sale in the United States.

Project scope. The actual scope of this project was much larger for the Woodstock facility than a simple technical transfer. The project required the following:

• A complete renovation of a formulation and filling suite, including a new separate air-handling system
• Designing, building, and qualifying an automated formulation skid
• Upgrading an existing BFS filling machine to match the capacity requirements for the product
• Designing, building, and qualifying new vial molding and filling systems to duplicate the existing European design
• Qualifying the room, formulation skid, BFS machine, and secondary packaging to produce stability and process-validation batches to support the customer's submission and approval timeline
• Developing and approving the required documentation for supply-chain, manufacturing, and quality assurance functions to meet the production timeline
• Analytical-method transfer for chemistry and microbial testing
• Complete process-validation protocols, test plans, and final reports to meet the submission timeline.

Cross-functional teams. To manage a project of this scope, the Catalent New Product Development (NPD) group and the site-management team agreed to form a group of cross-functional resources. The team members served as the primary representative of their functional area for the project and were assigned for the duration of the project. The project team consisted of a project manager from NPD, an engineering project manager, a development scientist, an operations specialist, a validation specialist, a quality-assurance product specialist, a technical writer, and various contract resources as required. A strategic account manager had overall responsibility for the project team. The establishment and use of an expanded core project team of cross-functional resources was a new approach for Catalent's Woodstock facility, but the scope and timeline for this project and the Catalent goal of meeting customer needs required an innovative solution.

The project was divided into six major activities: the room, the formulation skid, the BFS machine, method transfer, secondary packaging, and documentation. The NPD project manager was the owner of the overall project timeline. Each major activity was included in a Microsoft project schedule and maintained by the project manager. The engineering project manager handled all activities involving the renovation of the filling suite, making use of contractors from design through construction and qualification. He also participated in the design and construction of the formulation skid, primarily focusing on the software development. The development scientist and the operations specialist focused on the design of the formulation skid and the interface of the skid with the BFS machine to ensure the system had the proper design and controls to replicate the process already being used in Europe. The validation specialist developed the installatoin qualification, operational qualification), and product qualification protocols and had oversight of all factory acceptance testing (FAT) and site-acceptance (SAT) activities. The technical writer and the quality-assurance product specialist worked with the NPD project manager to manage the change-control process for the project and to complete all the required documentation, including material specifications, standard operating procedures, and manufacturing batch records. The NPD Project manager also provided oversight of the analytical method transfer, development of secondary packaging materials, and the documentation of project activities.

Technology transfer. The technology-transfer process was initiated by creating a comparability document that detailed every aspect of the manufacturing process. The process used in the European manufacture was listed step by step in the document with Catalent's suggestions and capabilities side by side. A final agreement for each step was included and served as the approved path forward. The specifications for in-process testing at each stage of the formulation as well as finished-product specifications were included in the document. The formulation process required bulk sterilization of a multicomponent polymer base with a relatively tight viscosity range. Two APIs were combined in a second part of the formulation and transferred to the polymer solution by sterile filtration. Of course, the entire formulation skid required steam sterilization of the product path through the BFS machine and maintenance of the sterile boundaries for the product during the entire filling process. Electronic documentation of all temperatures, times, and controls for each process step also were also required.

Communication. The NPD project manager and the strategic account manager facilitated weekly calls with the original equipment manufacturers of the formulation and BFS equipment as well as construction meetings during that phase of the project. Weekly calls were held with the customer representatives who were in liaison with the project team. A standard methodology was used to ensure that the meetings had a structured agenda and minutes issued for review in a timely fashion. A joint Project Steering Committee was formed, which was comprised of customer senior leadership members, Woodstock site leadership members, and Catalent business-development members.

Project Steering Committee meetings were held every three weeks during the course of the project. A formal presentation was made at each meeting to discuss progress toward major milestones in the project plan. Strategic decisions were discussed and developed through the Project Steering Committee meetings, and the decisions were ultimately made by the joint project team. This management design reduced the cycle time for critical decision-making between the customer and Catalent.

Figure 1 (Catalent): A blow/fill/seal suite at Catalent’s Woodstock, Illinois, facility. (FIGURES 1-3 (CATALENT) ARE COURTESY OF THE AUTHOR)

An example of such decision making was approval of a change to the SAT/FAT strategy originally planned for the formulation skid. The formulation skid is a fully automated two-tank system with over 100 control and process valves that are actuated in approximately 20 sequences. When the software development lagged behind the construction of the hardware, the opportunity arose to do a mechanical FAT, ship the formulation skid to the Woodstock site, complete the installation and mechanical troubleshooting of the skid and wait for the software to complete the qualification as a SAT. This decision saved as much as six weeks in the project schedule and enabled Catalent to meet the customer's timeline for stability and process-validation manufacturing. It also resulted in a formulation system that is part of a robust technical transfer process from the customer through the NPD group to Catalent's commercial manufacturing team.

Execution. To date, all of the engineering, stability, and process-validation batches have met the in-process and final-product test specifications. With nine batches produced, there have been no out-of-specification results for bulk or final product. In addition, no human error deviations have occurred in the formulation and filling of these batches.

Figures 1–3 (Catalent) show the facility upgrade and project equipment after installation.

Figure 2 (Catalent): A blow/fill/seal cavity fill machine at Catalent’s Woodstock, Illinois, facility.

In summary, Catalent did not employ new or groundbreaking methodology for this project. However, supplying the proper structure and resources for a project team is the crucial first step in meeting a customer's timeline and supplying the customer with quality product, reliably supplied.

Figure 3 (Catalent): A fully automated formulation skid at Catalent’s Woodstock, Illinois, facility.

Viral product manufacturing

Nick Johnson, marketing manager at SAFC

This case study in project management involved the partnership between SAFC and Oncolytics Biotech, a biotechnology company headquartered in Calgary, Canada, which has developed a novel cancer treatment, Reolysin, based on a modified wild-type reovirus expressed in suspension-adapted human embryonic kidney cells (HEK 293). In 2007, Oncolytics partnered with SAFC's Carlsbad, California, site as part of the commercialization process for Reolysin. After officially announcing SAFC as the contract manufacturer for the project in early 2011, Oncolytics announced in November 2011 that validation studies were underway. Now in Phase III clinical trials, SAFC and Oncolytics have worked as partners to manage this project from the initial phases of identifying how to make the technology work through to making the consistent batches required for licensure. The current goal is to obtain a successful regulatory approval for Reolysin.

Project challenges. The production of the modified reovirus presented a significant manufacturing challenge. Not only was it going to be the first time for this type of product to be made on such a large scale, it also involved transferring technology from a contract development organization (CDO) in Canada to the SAFC site in Carlsbad. At the beginning of the project, there were four partners in different locations, including Oncolytics, its CDO, SAFC, and SAFC Biosciences in St Louis, which developed the novel media used in the production process.

SAFC Carlsbad already was filling the bulk product for clinical trials out of a product that was being made at another CMO in the United Kingdom. As the product progressed into later-stage clinical trials, the production was ramped up and transferred to Carlsbad, at first on a 40-L scale, and up to the present 100-L batches. The technology transfer was a whole new ballgame in terms of scale and complexity and required a new project team to be formed. On the SAFC side, this included a director of operations plus senior managers in manufacturing, quality assurance, quality control, and project management. Business-development support was also brought in when new scopes of work and new contracts needed to be worked out and finalized.

Despite the disparate locations, the communication between the teams in the different sites worked well with routine weekly conference calls and many coordinating activities carried out electronically. Some face-to-face meetings were essential, including the manufacturing representative and project manager visiting the CDO to address process scale-up. A week also was spent with all partners, including the CDO, watching the process and filming it so that it could later be used for operator training in Carlsbad.

The whole process took quite some time with many technical challenges, leading to a stop–start of operations from late 2008 through to 2009. By the end of 2009, however, sufficient clinical material had been made to continue with the trials, so there was less urgency from that perspective. Once the 100-L scale was reached, one or two batches were made per year until the program was ready to initiate process validation batches. Now that the product has advanced to conformance batches, three to six batches will be made per year.

Tracking progress. From a production standpoint, Gantt charts (i.e. charts used to show the project's schedule) are used for all SAFC projects. They are mapped out further than just a single department and include everything that might affect the timeline from the vendor through to the customer. The anticipated timings were all shared with the customer as well as the troubleshooting of possible technology-transfer issues that the technical team mapped. The team was tasked to look through historical data from the previous partnership to identify where there were areas for improvement and to help resolve issues quickly with input from both the SAFC team and the CDO. Specifically, SAFC Biosciences also helped by developing a custom growth media that increased the viral productivity and eased the purification process.

When SAFC inherited the contract, it already contained the required specifications that were used as an ultimate metric for success. The new goal became making and purifying the product to the required level for a commercial launch. After a number of changes to the process on the CDO's side and a few creative manufacturing approaches from SAFC, these specifications were exceeded and brought the project to the current point. Oncolytics is now in a position where accessing materials for its clinical needs is no longer a constraint, and the project has advanced into process validation in anticipation of commercial launch.

Issue resolution. One issue the team faced was the presence of an impurity that prevented the product from meeting specifications. The teams were brought together, and all the possibilities that might have led to the impurity were considered. From there, action items were distributed to the teams for them to pursue, including the review of historical data. This approach was successful as by the time of the next team meeting, the problem had been pinpointed. By adapting the process for the next batch slightly, a solution was found allowing the product to met specifications and the issue was resolved.

A key factor in the overall project's success was the customer relationship. In addition to the customer having a very good project manager, the relationship was developed based on trust and a common goal. Another key factor was ensuring that we had the resources needed to move the project forward. When the program moved into the process-validation phase, a second project manager was added to increase bandwidth. The way all parties worked together allowed the manufacturing to enter into conformance batches within a relatively short period of time with only a limited number of clinical batches having been completed.

Real-time project management

Saharsh Rao Davuluri, president of contract research at Neuland Laboratories

On-time execution of API project development is a challenge for manufacturers. Neuland Laboratories has designed its GuarD project-management system around the principles of critical chain project management (CCPM), a concept developed by Eliyahu Goldratt, a prominent management consultant, who introduced the theory of constraints business model. Unlike other project-management systems, CCPM emphasizes flexible start dates and shared project resources. CCPM also uses buffers as a shared project resource rather than an individual task resource, thus enabling the overall project to be completed on time without requiring the individual tasks to be completed on time.

Process and organization. Neuland is an API and contract manufacturer based in Hyderabad, India. Almost 80% of the company's products are sold into the US and European markets, and these product must meet strict regulatory standards. In a typical year, Neuland scientists complete 30–40 projects ranging from complete API development, production of starting materials, and development of alternate processes for new molecular or chemical entities, as well as a variety of contract-manufacturing assignments for pharmaceutical ingredients and peptides. Depending on their complexity, projects may require process chemistry, analytical chemistry, technology transfer, production, developmental quality assurance, supply-chain management, regulatory affairs support, and project-management services.

Figure 1: (Neuland). A screenshot illustrating how a project’s progress can be tracked and how a user can participate directly through the GuarD web portal. (FIGURE 1 (NEULAND) IS COURTESY OF THE AUTHOR)

Organizational framework and real-time monitoring. Under GuarD's CCPM approach, each project is broken down into its basic tasks by a cross-functional team. The project has a designated team leader, usually an experienced scientist from the process-chemistry department, and a project manager responsible for managing timelines and communications. The team leader is the technical head of the project and responsible for overall execution.

Once the project has been divided into the basic tasks and sub-tasks, the details are transferred to a Microsoft project software template. This ensures that all the dependencies, resource requirements, and tentative start and end dates are recorded. The project is not considered "live" until the cross-functional team signs off on the detailed project plan. The finalized project document is uploaded to a web portal, and managers update respective tasks and sub-tasks as the project progresses. Managers can make qualitative updates detailing how tasks are proceeding, or quantitative updates to help respective task managers track how long a task will take to complete. Teams are encouraged to make at least one status update per day.

The ability to make both qualitative and quantitative updates in the GuarD project-management system is highly useful. Personnel in downstream operations, and more importantly the client, get an accurate picture of progress upstream and can plan accordingly. Neuland's customers also can track a project's progress and participate directly through the GuarD web portal.

Benefits. A key advantage of the GuarD system is that its detail and interactive nature make it easier to promptly identify and manage delays at any step, thereby facilitating on-time completion. For example, when the process-chemistry department requires more time to complete their tasks, the project manager is immediately aware of the situation and can work with all task managers to identify opportunities downstream to recover that time. Although it is important for the project manager to investigate the reasons for the delay, the immediate focus is on finding ways to deliver a quality project on time. Solutions might include running additional shifts or vessels or staggering batches. In most cases, customers are invited to join these discussions and contribute to the solution based on their experience and priorities.

Neuland's project-management system helps its clients in several ways. It provides a platform of almost 100% transparency, providing more insight than weekly calls or project reports. A smart phone app will soon allow customers to access their projects real-time. It also enables higher on-time completion rates. Although the GuarD approach cannot promise 100% on-time completion, it has enabled Neuland to make considerable progress towards this goal.

Customer trends: biopharmaceutical companies

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Pharmaceutical industry: challenges in the new century case study analysis & solution, harvard business case studies solutions - assignment help.

Pharmaceutical Industry: Challenges in the New Century is a Harvard Business (HBR) Case Study on Strategy & Execution , Fern Fort University provides HBR case study assignment help for just $11. Our case solution is based on Case Study Method expertise & our global insights.

Strategy & Execution Case Study | Authors :: Stephen P. Bradley, James Weber

Case study description.

Provides a broad overview of the numerous internal and external forces that were driving change in the global pharmaceutical industry in 2003. These forces--including downward price pressures, political and social pressures, increased development costs, new technologies, new and different competitors, consolidation, and threats to its basic business models--were changing the way drugs were discovered, developed, manufactured, tested, regulated, marketed, sold, and purchased. A rewritten version of an earlier case.

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Step 5 - Porter 5 Forces / Strategic Analysis of Industry Analysis Pharmaceutical Industry: Challenges in the New Century

In our live classes we often come across business managers who pinpoint one problem in the case and build a case study analysis and solution around that singular point. Business environments are often complex and require holistic solutions. You should try to understand not only the organization but also the industry which the business operates in. Porter Five Forces is a strategic analysis tool that will help you in understanding the relative powers of the key players in the business case study and what sort of pragmatic and actionable case study solution is viable in the light of given facts.

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5 Pharmaceutical Cybersecurity Case Studies [2024]

In today’s digital age, cybersecurity has become a cornerstone of operational integrity across all industries, with the pharmaceutical sector facing some of the most critical challenges. As pharmaceutical companies harness advanced technologies for drug development and manufacturing, they inevitably encounter increased cybersecurity risks. These risks range from intellectual property theft to potentially compromising patient data, posing substantial threats to public health and corporate stability. This article delves into five comprehensive case studies from leading pharmaceutical companies. Each study showcases how these entities have successfully navigated the complex landscape of cyber threats through innovative strategies, ensuring the security of their digital and physical assets and safeguarding their crucial role in global healthcare.

Related: AI in Pharmaceutical Industry: Success Stories

1. Strengthening Cyber Defenses in the Pharmaceutical Industry by BioPharmSecure

Company profile.

BioPharmSecure, headquartered in San Francisco, California, has been a pharmaceutical development and manufacturing leader since its founding in 1988. The company specializes in biotechnology products, including vaccines and therapeutic drugs, and employs over 8,000 staff worldwide. Known for its innovation and rigorous quality standards, BioPharmSecure is committed to delivering safe and effective healthcare solutions. Their operations are crucial for public health, and they maintain strict compliance with global pharmaceutical regulations and standards. BioPharmSecure’s dedication to excellence and innovation has advanced therapeutic science and ensured it remains at the forefront of the pharmaceutical industry.

BioPharmSecure faced increasing concerns over cybersecurity threats specific to the pharmaceutical sector, such as intellectual property theft, data breaches involving sensitive patient information, and disruptions in the manufacturing supply chain. These threats were exacerbated by the adoption of digital technologies in drug development and production processes, which, while enhancing efficiency and precision, also introduced new vulnerabilities. The potential for cyberattacks to compromise drug formulation secrets and patient data posed severe risks to patient safety, regulatory compliance, and the company’s reputation. Addressing these vulnerabilities became imperative to protect their critical research and development data and ensure the integrity of their manufacturing processes.

To address these cybersecurity challenges, BioPharmSecure launched a comprehensive cybersecurity overhaul. The initiative began with establishing a state-of-the-art Cybersecurity Operations Center (COC) to oversee the security of their digital and physical operations. They deployed advanced cybersecurity technologies, including machine learning algorithms for predictive threat analysis and automated systems for real-time threat detection and mitigation. The company also implemented enhanced encryption protocols for data storage and transmission and introduced biometric security measures to control access to sensitive areas in their facilities. Additionally, BioPharmSecure committed to ongoing cybersecurity education for its workforce, concentrating on anti-phishing tactics and secure management of data. To maintain a proactive stance against potential cyber threats, the company regularly conducted cybersecurity audits and stress tests to strengthen its systems.

The new cybersecurity strategies employed by BioPharmSecure led to significant improvements in their defense against cyber threats. The company achieved a notable reduction in attempted cyber intrusions, with no successful breaches reported since the implementation of the upgraded systems. Enhanced security measures have also improved compliance with international health and safety standards, bolstering BioPharmSecure’s reputation as a secure and reliable entity in the pharmaceutical industry. These advancements have protected critical health information and proprietary data and reinforced stakeholder trust in BioPharmSecure’s commitment to safeguarding public health. The strengthened cybersecurity framework has enabled the company to continue innovating and delivering high-quality healthcare products with enhanced confidence and security, positioning BioPharmSecure as a leader in pharmaceutical cybersecurity.

2. Enhancing Cybersecurity Measures at GlobalMed Pharma

GlobalMed Pharma, based in Basel, Switzerland, has been an influential player in the global pharmaceutical industry since 2001. The company is acclaimed for its broad selection of healthcare products, spanning both generic and specialized pharmaceuticals. GlobalMed employs over 12,000 individuals across multiple continents, focusing on research, development, and distribution of innovative medical solutions. They uphold the highest healthcare delivery and patient safety standards, maintaining compliance with stringent European and international pharmaceutical regulations.

GlobalMed Pharma identified a growing threat from cybercriminals targeting the pharmaceutical industry, aiming to steal critical drug formulations and disrupt manufacturing operations. The risks were compounded by GlobalMed’s extensive use of interconnected systems for research data management, production control, and supply chain logistics, making the entire operational chain vulnerable to cyberattacks. Such attacks could lead to substantial financial losses, compromise patient safety, and damage the company’s standing in the pharmaceutical market. The urgency to protect their digital and physical infrastructure from these sophisticated cyber threats became a top priority for the company’s executive leadership.

Faced with these threats, GlobalMed Pharma launched an extensive program to strengthen their cybersecurity defenses. The cornerstone of this initiative was the creation of a dedicated Pharmaceutical Cybersecurity Task Force composed of IT security experts and pharmaceutical scientists. This team was tasked with integrating advanced cybersecurity frameworks into existing systems, including deploying next-generation firewalls and intrusion detection systems. GlobalMed also adopted blockchain technology to secure its drug supply chain against tampering and counterfeit risks. To solidify its defense against cyber threats, the company launched extensive cybersecurity awareness and training programs for all employees, emphasizing the importance of security practices in everyday operations. Additionally, GlobalMed partnered with international cybersecurity firms to conduct periodic external audits and simulate cyberattack scenarios to evaluate the effectiveness of their defenses.

The cybersecurity enhancements implemented by GlobalMed Pharma proved highly effective. The company reported a significant reduction in cyber incidents, with a strong security posture preventing major breaches. The improvements in cybersecurity protocols have also facilitated compliance with international regulatory standards for pharmaceutical manufacturing and data protection. By fortifying its cyber defenses, GlobalMed protected its proprietary information and production capabilities and reinforced its reputation as a trustworthy and secure leader in the pharmaceutical industry. These measures have ensured that GlobalMed Pharma can continue to deliver high-quality medical products while safeguarding the confidentiality and integrity of sensitive data across its global operations.

3. Securing Digital Assets at NextGen PharmaTech

Based in Boston, Massachusetts, NextGen PharmaTech has consistently led in pharmaceutical advancements since its founding in 1998. The firm focuses on creating advanced pharmaceuticals and crafting solutions tailored to individual health needs. Employing over 7,000 individuals globally, NextGen PharmaTech is committed to pushing the boundaries of medical science and enhancing health outcomes with its innovative research and eco-friendly initiatives. The firm takes great pride in its forward-thinking approach to healthcare, seamlessly incorporating cutting-edge technologies into its daily operations.

NextGen PharmaTech faced significant cybersecurity challenges, primarily due to the sensitive nature of its research data and the high value of its intellectual property. Cyberattacks aimed at stealing proprietary research or disrupting clinical trials posed severe risks, including potential delays in drug development, loss of competitive advantage, and breaches of patient confidentiality. The adoption of cloud computing and mobile technologies, while increasing operational flexibility, also introduced additional security vulnerabilities that must be addressed to prevent data leaks and ensure regulatory compliance.

NextGen PharmaTech developed a comprehensive digital security strategy to tackle these complex cybersecurity challenges. This strategy included deploying a centralized security management system to monitor and control access to sensitive data across all platforms. The company enhanced its network security by implementing sophisticated encryption methods and real-time threat detection systems powered by artificial intelligence. NextGen adopted a multi-factor authentication system to further secure its cloud-based data and set up a series of secure, private cloud environments designed to minimize external access risks. The company also established a regular security training schedule for its employees, focusing on the best practices for maintaining data integrity and recognizing potential phishing attempts.

The strategic cybersecurity measures adopted by NextGen PharmaTech led to a dramatic improvement in the security of their digital and physical assets. The company experienced a decreased frequency and severity of cyber threats, with no significant data breaches occurring since implementing the new security protocols. Enhanced security measures allowed NextGen to maintain its lead in pharmaceutical innovation while upholding strict compliance with global data protection laws. The robust cybersecurity framework not only safeguarded NextGen’s valuable research data but also strengthened the trust of its stakeholders and patients, ensuring the company’s continued growth and success in the competitive pharmaceutical industry.

Related: Impact of AI in Pharmaceutical Industry

4. Advancing Cybersecurity Protocols at HealthSynth Pharma

HealthSynth Pharma, established in 1990 and headquartered in London, UK, is a pioneering entity in the pharmaceutical industry, focusing on developing and manufacturing synthetic and bio-engineered drugs. With a workforce exceeding 10,000 employees across its global operations, HealthSynth is recognized for its commitment to healthcare innovation and patient safety. The company excels in producing next-generation therapeutics and is committed to maintaining stringent quality and safety standards to meet European and international healthcare regulations.

As HealthSynth Pharma expanded its digital operations, including automated production lines and data-driven drug development, it became increasingly susceptible to cyber threats. Specific concerns included the risk of industrial espionage, where proprietary drug formulas could be targeted, and ransomware attacks that could cripple manufacturing capabilities. Integrating IoT devices into their manufacturing processes introduced additional vulnerabilities, potentially allowing hackers to manipulate drug formulations or production schedules, posing severe risks to product safety and company integrity.

HealthSynth Pharma undertook a rigorous enhancement of its cybersecurity infrastructure to counter these emerging cyber risks. The company established an in-house Cybersecurity Innovation Unit focused on developing custom solutions tailored to the unique needs of pharmaceutical manufacturing. This unit deployed advanced network segmentation to isolate critical production systems from general IT networks, significantly reducing the risk of cross-contamination during a breach. HealthSynth also adopted a zero-trust security model, requiring continuous verification of all entities interacting with its systems, internally or externally. Furthermore, the firm deployed AI-driven systems to oversee and scrutinize network traffic, identifying anomalous behaviors indicative of potential cybersecurity incidents. HealthSynth initiated a company-wide cybersecurity training program to bolster these technological measures to educate employees on the latest security practices and the importance of data confidentiality.

The comprehensive cybersecurity upgrades at HealthSynth Pharma have markedly fortified the company’s defenses against cyber threats. Since implementing these measures, HealthSynth has reported a significant decline in security incidents, with no successful breaches impacting their critical systems. These enhanced security protocols have protected valuable intellectual property and ensured the uninterrupted operation of their manufacturing facilities. As a result, HealthSynth has reinforced its reputation as a secure and reliable leader in the pharmaceutical industry, trusted by healthcare providers and patients worldwide. The firm’s assertive cybersecurity tactics have established new benchmarks in the sector, fostering an environment focused on relentless advancement and alertness to cyber risks.

5. Cybersecurity Transformation at GenBioTech

GenBioTech, based in San Diego, California, has been a trailblazer in genetic and biotechnological research since 2002. The organization focuses on custom-tailored healthcare, using genetic insights to individualize patient treatment plans. GenBioTech employs over 9,000 professionals globally who work tirelessly to push the boundaries of medical science and enhance therapeutic efficacy. Its dedication to innovative technologies and a focus on patient care has earned it a prestigious position in the biotech industry.

GenBioTech faced escalating cybersecurity challenges as its reliance on data-intensive technologies grew. The collection, analysis, and storage of vast amounts of sensitive genetic information made the company a prime target for cyberattacks aiming to steal or manipulate critical data. These potential breaches threatened patient privacy and jeopardized the integrity of GenBioTech’s research outcomes. The need to secure their extensive databases against sophisticated cyber threats became a top priority to preserve the trust of their patients and uphold their leading position in the industry.

GenBioTech responded to these looming threats by initiating an all-encompassing cybersecurity strategy. The organization overhauled its digital infrastructure, integrating top-tier data encryption and fortified cloud storage to secure patient information. They incorporated a sophisticated intrusion detection system that leverages machine learning to detect and address security threats instantly. GenBioTech equipped all devices with the latest antivirus software and regular security updates to ensure robust endpoint security. The company also established a mandatory cybersecurity certification program for all employees, emphasizing the importance of data security in maintaining patient confidentiality and trust. GenBioTech formed strategic partnerships with leading cybersecurity firms to further enhance its cybersecurity posture to conduct regular audits and red team exercises.

The strategic cybersecurity measures implemented by GenBioTech have effectively shielded the company from various cyber threats. Since these enhancements, GenBioTech has not encountered any significant data breaches, demonstrating the effectiveness of its upgraded security systems. The company’s robust approach to cybersecurity has protected sensitive genetic data and strengthened its stakeholders’ confidence. By prioritizing cybersecurity, GenBioTech continues to lead in personalized medicine, ensuring that patient data is secure and that the integrity of their innovative research is maintained. This commitment to cybersecurity excellence has further solidified GenBioTech’s reputation as a forward-thinking and secure leader in the biotechnological industry.

Related: Healthcare Cybersecurity Case Studies

The case studies presented in this article illustrate the paramount importance of robust cybersecurity measures in the pharmaceutical industry. By proactively addressing potential cyber threats, the featured companies have protected their sensitive data and proprietary technologies and reinforced the trust placed in them by patients and healthcare providers worldwide. These examples serve as a beacon for other players in the pharmaceutical field, emphasizing that investing in advanced cybersecurity measures is not just a regulatory necessity but a strategic imperative that can dictate a company’s long-term success and reliability. A continuous dedication to cybersecurity advancements is crucial to preserve the pharmaceutical industry’s role in enhancing global health integrity and effectiveness.

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Drug Patents, Exclusivity & Lessons from Humira: A Biosimilars Boom

Understand drug patents, FDA exclusivity and the future of intellectual property. See how Humira's exclusivity loss illustrates key pharma industry challenges.

When a pharmaceutical company develops a new drug, it’s covered under patent protection, which means only the pharmaceutical company that holds the patent is allowed to manufacture, market and profit from the drug.

Typically, pharmaceutical companies own or have co-production and/or license rights related to many patents covering pharmaceutical and other products, their uses, formulations, and product manufacturing processes.

This article will explore why drug patents are important, examine a case study of how loss of exclusivity can impact a company, and preview some regulatory changes that may impact intellectual property rights in the near future.

Drug Patents & Exclusivity: What Are the Differences & How Do They Work?

According to the FDA , patents are a property right granted by the United States Patent and Trademark Office anytime during the development of a drug and can encompass a wide range of claims. Typically, the term of a new patent is 20 years from the date on which the application was filed in the US, after which point, generic versions of the drug that have been approved by the FDA can be marketed by other firms.

Two decades seems like a long time, but a developer’s 20 years of patent protection often includes many years during which a drug cannot be marketed because it has not yet been approved by the FDA. For instance, development and clinical trials might take so much time that drug developers are left with insufficient years of market exclusivity to recoup their costs.

This is where exclusivity comes in. In order to incentivize the development of new drugs, the FDA grants drug developers market exclusivity after a new drug is approved, during which time, no other firm is permitted to sell the drug, whether or not it is protected by a patent.

The length of time that FDA grants new drug exclusivity depends on the type of exclusivity. Types of exclusivity include:

Loss of patent exclusivity for a product is often followed by a significant reduction in sales as competitors gain regulatory approval for generic and other competing products and enter the market. Similar competition can be triggered by the loss of exclusivity for a biological product.

Read More: Inflation Reduction Act and the Impact on Biosimilars

Why Drug Patents Are Important

Unsurprisingly, pharmaceutical companies have strong opinions about intellectual property. According to Merck , intellectual property is an “enabler of access to innovative, quality-assured medicines and vaccines.”

The company explains: “Strong intellectual property systems are the cornerstone of innovation, catalyzing the investment needed to embark on the long, costly, and high-risk process of developing new and improved medicines and vaccines. Intellectual property systems not only reward innovation, but also allow scientists to build on each other’s discoveries and provide a framework for collaboration.”

Novartis adds, “Intellectual property (IP) rights are essential to our business as an innovative medicines company since they protect our innovation and investments in research and development, manufacturing and marketing of our products.”

Sanofi says, “We rely on our patents and other proprietary rights to provide exclusive rights to market certain of our products. If such patents and other rights were limited, invalidated or circumvented, our financial results could be adversely affected.”

Furthermore, lack of effective intellectual property protection for products is one of the primary considerations for pharmaceutical companies in limiting their operations in some countries. If a company can’t protect its patent somewhere, why would they take the risk of marketing their drug there?

Case Study: AbbVie’s Humira

In 2023, AbbVie experienced the loss of exclusivity (LOE) for Humira, a monoclonal antibody therapeutic that works by targeting TNF-alpha. Humira was granted FDA approval in 2002 for rheumatoid arthritis, but the biologic had since earned additional indications for Crohn’s disease and ulcerative colitis.

Although LOE is common in the pharmaceutical industry, what happened with Humira is significant because the therapeutic had a net revenue of $18.6 billion in the U.S. in 2022, which represented approximately 32% of AbbVie’s revenue.

Nine biosimilars entered the market in 2023 in direct competition with Humira, more than any other biologic on the market today. These included Amgen’s Amjevita, Celltrion’s Yuflyma, Boehringer Ingelheim’s Cyltezo, and Alvotech and Teva’s Simlandi .

As a result of this competition, global Humira sales decreased 32% in 2023. This decline had an impact on AbbVie’s financial performance in 2023 . For the full year, the company’s worldwide net revenues decreased by 6% on a reported and constant currency basis.

Furthermore, according to a biosimilar report released by Samsung Bioepis in July, Humira’s market share dropped 13% to March 2024.

This example illustrates the impact loss of exclusivity can have on a major pharmaceutical company—and why drug patents and exclusivity are so crucial. Had the company lost exclusivity earlier, it may never have recouped its research and development costs for the drug.

The Future of Generics and Biosimilars

Several regulatory proposals have come down the pipeline that have the potential to impact intellectual property rights in the pharmaceutical industry moving forward. In general, governmental authorities are increasingly looking to facilitate generic and biosimilar competition for existing products through new regulatory proposals intended to achieve, or result in, changes to the scope of patent or data exclusivity rights and through the use of accelerated regulatory pathways for generic and biosimilar drug approvals.

Suggested Reading: 5 Biosimilar Manufacturing Strategies for competing in a post-patent expiry era.

On April 26, 2023, the European Commission (EC) adopted a proposal for a new Directive and a new Regulation, which represents the largest pharmaceutical reform in over 20 years.

The main objectives of the revision are to:

• Make sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines
• Enhance the security of supply and ensure medicines are available to patients, regardless of where they live in the EU
• Continue to offer an attractive and innovation-friendly environment for research, development, and production of medicines in Europe
• Make medicines more environmentally sustainable
• Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach.

Sanofi called this proposal “concerning” because of its potential reduction of market exclusivity for orphan medicines; greater transparency of R&D costs; faster availability of generics and biosimilars; and more stringent obligations for the supply of medicines.

“If passed in its current form, the legislation could have a detrimental impact on access, innovation and competitiveness in Europe,” Sanofi said in its annual report.

The United States seems to be following a similar trend. In July, the Senate unanimously passed a bill aimed at limiting the number of patents drugmakers can introduce and making it easier for biosimilar competitors to enter the market.

The legislation specifically targets a practice that involves filing several non-innovative patents around a single drug in order to create an impenetrable "thicket" around the product, thereby extending its market exclusivity and ultimately delaying generic competition.

Hailed by some as a “potential victory for drug pricing reform,” the pharma patent reform bill could help promote generic and biosimilar competition for prescription drugs and lower their costs. However, sections of the bill drew objections from drug manufacturers.

Megan Van Etten, Deputy Vice President of Public Affairs at PhRMA, a trade group representing companies in the pharmaceutical industry in the United States, told FirstWord Pharma that the group has “concerns with Congress prohibiting innovators from enforcing lawfully granted patents."

Furthermore, in December 2023, the Biden administration proposed a framework to guide government agencies on how to use march-in authorities if a drug's price is considered too high. This proposal is aimed at high-priced drugs that rely on taxpayer-funded inventions.

According to NPR , activists have pushed the government for years to use “march-in rights” when a taxpayer-funded invention isn't publicly available on reasonable terms. They claim the law allows the government to march in and license certain patents of high-priced drugs to other companies to sell them at lower prices. The pharmaceutical industry disagrees.

PhRMA’s Van Etten had this to say in response: “If finalized, this misinterpretation of the Bayh-Dole Act would have a devastating effect on public-private research collaborations and chill American innovation across industries such as tech, energy, defense and more. While repercussions would be felt by all who rely on collaboration with government-funded organizations to innovate, the potential impact on medical innovation, particularly for our most vulnerable patients and families waiting for new treatments and cures, is extremely concerning.”

As curbing drug prices remains a priority for many lawmakers, more proposals are sure to come. Especially as the presidential election approaches, the future remains uncertain.

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Teva Pharmaceutical Industry Harvard Case Solution & Analysis

Home >> Harvard Case Study Analysis Solutions >> Teva Pharmaceutical Industry

Teva Pharmaceutical Industry Case Study Solution

How teva pharmaceutical industries limited can tackle the bargaining power of suppliers.

• By maintaining efficient supply chain techniques.
• Developing-devoted and honest suppliers whose business solely depends on the firm.

2.3 Bargaining power of buyers

Buyers always want the best products in the limited and at the least price. This became the barrier for the Teva Ltd for the long run. The smaller yet most powerful the base of customer for Teva is, the higher would be the bargaining power of its customers.

How Teva Pharmaceutical Industries Limited can tackle the Bargaining power of Buyers

• By developing the efficient and large base of customers.
• By innovating a new product which decreases the surrender of existing clients of Teva Pharmaceutical Industries Limited to its rivals.

2.4 Threat of substitutes

As the drug industry is growing rapidly; the threat of substitutes are higher for Teva industries Ltd.

How Teva Pharmaceutical Industries Limited can tackle the Threat of substitutes

• By developing the products based on the customer’s needs.
• By growing the switching cost of the product.

2.5 Competitive rivalry

Teva Ltd has been operating in a very competitive drug industry’s environment, such as: Merch, Novartis, Pfizer etc. These drug industries compete with Teva in a very ruthless manner.

How Teva Pharmaceutical Industries Limited can tackle the competitive rivalry?

• Expanding its business.
• Providing good quality products at reasonable prices.
• Innovating new products.

These are the important factors for the Teva Ltd to look up to and understand the surrounding environment in order to gain the maximum profits and to hold a safest place in the drug’s market.

1.Value Chain strategy

Teva Israel’s chain has the larger value system that mainly includes the upstream (suppliers) or downstream (Distribution channels) or both. Manager at Teva industry are promoted to see each activity by Teva pharmaceuticals’ industry value chain.

• In Teva, there are two plants in Israel that are currently capable of eight billion tablets and one in Canada with the same scale. The backbone of Teva’s supply chain was managed through several centers of excellence located globally to take advantage of differences in local labor skills and costs, tax provisions, and intellectual property regulations.

There are five possible procedures of value chain strategy of any pharmaceutical company likewise Teva, these are

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