Behind the Headlines Episode 27

Ask the Expert

Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Drug Digest September 2025

Artificial intelligence, machine learning, and novel instruments are helping drug developers.

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

J.P. Morgan Report Lists Biologics, Obesity, China

Top Trends Reshaping Pharma R&D

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Question mark background | Image Credit: © Leigh-Prather - © Leigh Prather - stock.adobe.com

Q: We are confused when it comes to audit and inspection terminology. The European regulations refer to self-inspection (1). FDA refers to audits and inspections (2), and the International Council for Harmonisation (ICH) refers to regulatory inspections and findings, audits, and other assessments (3). Can you provide some clarity?

A: As you noted, there is no harmonized terminology in the regulations. There is, however, a general understanding in industry that inspections generally mean inspections by regulatory or official bodies and audits mean assessments or investigations by firms or individuals from industry.

Is this merely a play of words or is there some fundamental difference between audits and inspections? They all serve the same purpose, namely for an independent person or persons to establish within a relatively short period of time whether particular requirements and commitments have been fulfilled, and importantly, whether documented proof of evidence is available.

From a regulatory authority perspective, an inspection assists in verifying whether a company adheres to the applicable laws, rules, and regulations, and to confirm that data and information supplied to the regulators are truthful and complete. This is, for example, the situation in case of clinical trial applications and marketing authorization applications (i.e., drug applications). As the situation at a company changes (e.g., new products) or the legislation changes, the authorities may need to conduct further inspections. As a company, you should have procedures in place that detail how you will host and support inspections by official bodies.

Clients (typically the licence holders) of contract manufacturing organizations (CMOs) may wish or have to perform audits of the CMO’s operations, either because they need to establish the CMO as a bona fide supplier or as part of an ongoing relationship assessment. Professional bodies may need to audit manufacturing facilities as part of a certification exercise (e.g., for ISO or EXCiPACT certification). Though there are many similarities with inspections by regulators, each audit type here warrants a focused, specific procedure, not least because it may involve different members of staff, a different routine, and likely a different set of documents to review.

And lastly, you need to perform your own audits. This involves audits of your suppliers, perhaps due diligence audits in case of an acquisition, and your internal audits (i.e., audits of your operations and your quality system). Each warrants its own procedure as you may have different persons involved in these different types of audits, and of course their intention differs. In the case of an internal audit (or self-inspection to use the European terminology), you will have full transparency and disclosure, whereas you will not have this with any other audit or inspection.

In summary, it really doesn’t matter how you call it, audit or inspection. Whichever terminology you prefer, you need to document this in your quality system. This can be done in a glossary, as and when used in
documentation, or in any other suitable place within your documentation. Just make sure it is clear to anyone within your company who is working under your quality system.

FDA. Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections. 

Siegfried Schmitt is vice president, Technical at Parexel.

When referring to this article, please cite it as Schmitt, S. Clearing Up Confusion in Inspection Terminology. 

Articles

Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.

Clearing Up Confusion in Inspection Terminology

Mike Hennessy Jr. is the Chairman and CEO of 

From a pure business perspective, while equal in many respects to computer chip manufacturing, the pharmaceutical industry pulls ahead because it does not experience the same high amplitude boom and bust periods. This is attractive to investors. We have noted, however, that many key products face looming patent expiration. Prices, especially for some new single dose treatments, can be eye-wateringly high and that for an increasing number of patients the traditional insurance cost-to-benefit model needs reinvention.

Despite these deeply entrenched problems, business prospects continue to shine, fueled in part by a new sense of discovery and remarkable invention. An era of personalized cancer vaccines could be at hand, and the general public is now aware of the efficacy of certain weight loss drugs which has evolved (in some cases) from former diabetes treatments to work effectively in both curbing weight but also in mitigating cardiovascular and related sequalae.

As we currently stand, the prototypical institutional investor, such as retirement fund or investment banks, will continue to back our industry with their (or other peoples’) dollars. But a key emerging trend, to replace an approximate loss of $200 billion by blockbusters to generics, will be pharmaceutical companies themselves reinvesting in their own future through mergers and acquisitions but also in increased R&D activities. Fresh from their 44th annual healthcare conference, Goldman Sachs forecasts that, “The pharmaceutical industry will need growth, and is sitting on a tremendous amount of cash. The firepower that we’ve calculated—i.e., cash plus modest leverage—amounts to $700 billion dollars globally. The baseline expectation is that there is going to be continued M&A, though there has been increased focus recently on regulatory uncertainty, particularly as it relates to larger deals” (1).

On the smaller scale, several companies were held recently up as exemplars for investor success, which includes the 324% one-month trailing total return (TTR) for Madrigal Pharmaceuticals (good Phase III results for treatments for non-alcoholic steatohepatitis), 312% TRR for Pliant Therapeutics (reporting positive Phase IIA results for oral medication to treat idiopathic pulmonary fibrosis), and 271 TTR for Reata Pharmaceuticals, which works on novel treatments for neurologic disorders and chronic kidney disease (2).

1. Haider, A. Pharmaceutical Companies Have $700 billion for Acquisitions and Investment. Intelligence Articles, Goldman Sachs. July 6, 2023.
2. Bolton, N. Top Pharmaceutical Stocks for Q2 2023, May 2023, Investopedia.

Mike Hennessy Jr. is the President and CEO of 

When referring to this article, please cite it as Hennessy, M. Billions of Reasons to be Buoyant. 

Pharma's ability to continually reinvent itself will be critical in growing future business operations.

Billions of Reasons to be Buoyant

Waters Corporation’s XBridge Premier GTx BEH size exclusion chromatography (SEC) columns

Waters Corporation’s XBridge Premier GTx BEH size exclusion chromatography (SEC) columns are designed to improve analysis while lowering the cost of gene therapies, specifically for adeno-associated viral (AAV) vectors. SEC is a technique used for aggregate and fragment analysis in the research, development, and manufacturing of biotherapeutic proteins, such as insulin and monoclonal antibodies.

The columns aim to reduce the cost of gene therapies by using three to 10x less sample, generating faster results and offering more drug substance information. Additionally, a new multi-attribute quantification method is intended to double analytical speed, quadruple sensitivity, and increases resolution of target analytes by up to 50%.

The Xbridge columns are designed to take robust physicochemical characterization and quantitative measurements. Aiming to double the speed of measuring the potency and safety of AAVs, the SEC columns are intended for process development, formulation studies, regulatory filing support, ongoing process monitoring, and quality control.

Waters Corporation’s XBridge Premier GTx BEH size exclusion chromatography (SEC) columns are designed to improve analysis while lowering the cost of gene therapies.

Size Exclusion Chromatography Columns

Charles Ross & Son Company's Sanitary Double Planetary Mixer Model DPM-4S and Sanitary Discharge System Model DS-4S

The ROSS line of Double Planetary Mixers, which come in various configurations and sizes ranging from half of a pint to 750 gallons, are designed for mixing thick, sticky, or putty-like materials. The pictured Sanitary Double Planetary Mixer Model DPM-4S and Sanitary Discharge System Model DS-4S were fully customized and engineered for efficient processing of medical-grade silicone formulations in a portable workstation.

The four-gallon Double Planetary Mixer features two patented HV stirrer blades. Rotating on their own axes, the blades orbit the mix vessel on a common axis using a slicing motion that pushes product forward and downward, an ideal process for ultra-high viscosity materials. Designed for vacuum operation, the mixer is equipped with an electromechanical lift to raise and lower the vacuum hood, as well as a 50-psig heating/cooling jacket on the mix can. Multiple sets of mix can and vacuum hood can be supplied for convenient cleaning with minimal downtime.

The accompanying Discharge System is designed to maximize product yield while also simplifying clean-up. It consists of a platen that is lowered hydraulically into a mix vessel. As the platen pushes down on the batch, product is forced out through a valve on the side or center bottom of the vessel with minimal product left behind. The change-can design enables semi-continuous operation, which can significantly increase production.

The ROSS line of Double Planetary Mixers are fully customized and engineered for efficient processing of medical-grade silicone formulations in a portable workstation.

Mixing Systems for Ultra-High Viscosity Materials

The healthcare space is at its peak in technology and other digital transformations: machine learning, artificial intelligence (AI), and other aspects are showing promise for helping patients and improving efficiency in the labs. However, there have been significant data integrity lapses that have caused consequences in the pipeline, such as manufacturing plants closing, drug shortages, and US Food and Drug Administration (FDA) approvals not going through (1).

Shailesh Vengurlekar, senior vice president of Quality & Regulatory Affairs, LGM Pharma, echoes this challenge in today’s world of drug substance testing. “Some of the biggest challenges facing drug substance testing include supply chain deficiencies, and data integrity,” he says. “Post-pandemic supply chains are still recovering, and the pharmaceutical industry is no exception. Data integrity continues to be a major topic of concern as well and is one of the factors driving the industry’s embrace of digital transformation.”

Another major challenge is the lack of significance when large data sets are being interpreted over a sustained period. Quality-by-design (QBD) approaches are a way to ensure proper data interpretation in this type of scenario to help monitor and analyze the trends of biologics and other drugs (2).

Regulatory action was taken to try and improve this hurdle. FDA released a data integrity guidance in December 2018 due to the increased data integrity violations during current good manufacturing practice (CGMP) inspections in recent years. This included more regulatory actions, like warning letters, import alerts, and consent decrees to attempt to ensure the safety, efficacy, and quality of drugs (3).

Interpreting data and understanding the various components of biologic drug substance testing is an important skillset to know as a lab personnel. According to Khanh Ngo Courtney, senior director of Biologics at Element, the characterization and routine testing of biological therapeutics, with cell and gene therapies being a specific focus, require advanced analytical techniques and an understanding of the biology itself. Mahesh Bhalgat, chief operating officer of Syngene International, said on the fact that although many labs and lab personnel are technically sound, there is still a lack of understanding and decision-making on the use of analysis models for biological product characterization and for the mechanism of action (MoA) studies (2).

A way to solve this is by making sure the lab can provide as many assurances of product safety, strength, purity, quality, as possible, all of which depend on the data being discussed at the lab itself.Any data-driven decisions must be reproducible and based upon data that can support those outcomes (1).

Further, following the ALCOA method is another way that personnel can consider making sure they are on track with the right data:

Attributable: This is specific to staff members via audit trails and e-signatures and includes no password sharing and compliance to Part 11.

Legible: Make sure your data is usable and readable during internal audits.

Contemporaneous: Keep records of the tasks at hand during the performance of a task, not before or later.

Original: Store data in its original format, not manipulated, stored elsewhere, or shared with others.

Accurate: Use a system that minimizes errors, raw data and analytical results presented in a proper format (1).

This method also highlights the elements of making sure data are complete, consistent, enduring, and available, which can help ensure proper interpretation and lessening the hurdles that have come with data integrity.

Even with the challenge of data integrity at hand, there is hope for drug substance testing to continue adapting to the technological transformations that are growing at a fast pace. Additionally, as more process knowledge and analytical method data become available, optimization of process and analytical methods will continue to be required as part of continuous improvement concepts.

Vengurlekar feels that in the next 5–10 years, drug substance testing will see increased efforts to standardize testing protocols and ensure that the quality of results across laboratories improve, leading to more consistent and reliable testing outcomes. As for Courtney, many current methods all have their own difficulties, but finding the right analytical solution for the intended purpose is an unmet need for many quality-defining methods for advanced therapeutic molecules in this current day and age.

Chapman, J. Data Integrity 101: Why is it important? Redica Systems. 22 Oct 2020.

Mirasol, F. Biologics Testing Highlights Need for Analytical Skills. Pharm. Technol. 2022, 46 (1) 38–40.

UW-Madison School of Pharmacy. The Trouble with Biologics: Analyzing Large Molecules and Data Integrity. University of Wisconsin-Madison (accessed 11 August 2023).

Volume 35, No.9
September 2023
Pages 23-28, 29

When referring to this article, please cite it as Murphy, J. 

Data Integrity’s Impact in Drug Substance Testing

Interpreting data and understanding the various components of biologic 
drug substance testing is an important skillset to know as a lab personnel.


Data Integrity's Impact in Drug Substance Testing

Feliza Mirasol is the science editor for 

On Aug. 28, 2023, US-based Cellares, an integrated development and manufacturing organization (IDMO), announced that Bristol Myers Squibb has joined its Technology Adoption Partnership (TAP) program, a program that offers cell therapy developers opportunity to adopt Cellares’ automated manufacturing technology platform, the Cell Shuttle. Under the agreement, Bristol Myers Squibb will submit a proof-of-concept transfer process for the manufacture of one of its chimeric antigen T cell (CAR-T) cell therapies using the Cell Shuttle.

According to a company press release, Bristol Myers Squibb will use the program to evaluate Cellares’ automated manufacturing process and produce comparability data to confirm that the Cell Shuttle is a viable, cost-efficient, and scalable manufacturing solution for cell therapies. Through its TAP program, Cellares is working with cell therapy developers to implement its manufacturing platform as a clinical and commercial-stage good manufacturing practice (GMP) manufacturing solution at its IDMO smart factories.

The company’s technology platform can support both autologous and allogeneic cell therapy processes as well as approximately 90% of cell therapy modalities. According to the company press release, manual processes can be automated and tech-transferred onto Cellares’ automated Cell Shuttle platform in six months’ time using the TAP program. Under TAP, participating cell therapy developers can tech-transfer their cell therapy processes onto a Cell Shuttle at any stage, such as during pre-clinical development, or in the clinic, or after regulatory approval. Automation, standardization, and software-defined manufacturing combine to make any follow-up tech transfer thereafter instantaneous to any other Cell Shuttle in any other IDMO smart factory in any global location, according to the press release.

“We’re pleased to welcome Bristol Myers Squibb to the TAP program, and we look forward to demonstrating the ease and efficacy of transferring one of [the company’s] cell therapy process[es] onto the Cell Shuttle in the months to come,” said Fabian Gerlinghaus, CEO, Cellares, in the press release. “By combining integrated automation with a high-throughput platform, the Cell Shuttle offers unrivaled scalability for the cell therapy industry, while improving quality and lowering COGS [cost of goods sold].”

The launch of the IDMO and smart factories

The partnership with Bristol Myers Squibb follows on the heels of Cellares’ initial launch as an IDMO, the first of its kind dedicated to clinical and industrial-scale cell therapy manufacturing, according to an Aug. 23, 2023 company press release. At the time of its launch, Cellares had raised $255 million in Series C funding, which was led by US-based investment firm Koch Disruptive Technologies and in which Bristol Myers Squibb participated, along with others.

With this funding, Cellares launched a commercial-scale IDMO smart factory in Bridgewater, NJ, the first of its kind, according to the company press release. The 118,000-ft2 smart factory is designed to integrate advanced robotics, purpose-built technology, and interconnected software and will be capable of producing 40,000 cell therapy batches per year. The Bridgewater site will be GMP-ready in the second half of 2024. Under the integrated technologies, IDMO smart factories can produce 10 times more cell therapy batches per year than traditional contract development and manufacturing facilities and with the same footprint and workforce, according to the release.

Cellares currently operates two smart factories in the United States and is planning a third. Its first smart factory, located in San Francisco, Calif., is currently being used for preclinical process development and for the tech transfer of manual processes onto the company’s Cell Shuttle platform for existing partners. The San Francisco facility will be GMP-ready in early 2024, according to the company press release. Cellares intends to deploy its smart factories around the world to serve global patient demand for cell therapies and will break ground on the first IDMO smart factory in Europe in 2024.

“The creation of the first IDMO marks the beginning of a new era, in which cell therapies will finally be able to reach those in need,” said Gerlinghaus in the press release. “We’ve developed integrated technologies for the entire drug development and manufacturing life cycle. Now we’re leveraging these technologies to offer global manufacturing services for the living drugs of the 21st century. Our partners are some of the best academics, biotechs, and large pharma companies in the world. We’re enabling them to meet total patient demand, improve consistency and quality, lower manufacturing costs, and accelerate expansion to new markets.”

Bristol Myers Squibb has joined Cellares’ Technology Adoption Partnership program just as Cellares launches operations as an integrated development and manufacturing organization.

Bristol Myers Squibb Joins Cellares Program Focused on Automated Cell Therapy Manufacturing as Cellares is Launched as First IDMO

The Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs whose prices will be directly negotiated with drug companies on Aug. 29, 2023. According to an agency press release, these negotiations will occur during 2023 and 2024, with any negotiated prices coming effective at the start of 2026.

The most commonly treated conditions in the list include diabetes, heart disease, blood clots, arthritis, and psoriasis. According to a 

 released by the agency, the full list of drugs is:

Eliquis (apixaban), intended for prevention and treatment of blood clots.

Jardiance (empagliflozin), intended for treatment of diabetes and heart disease.

Xarelto (rivaroxaban),  intended for prevention and treatment of blood clots, as well as reduction of risk for patients with coronary or peripheral artery disease.

Januvia (sitagliptin), intended for treatment of diabetes.

Farxiga (dapagliflozin), intended for treatment of diabetes, heart disease, and chronic kidney disease.

Entresto (sacubitril/valsartan), intended for treatment of heart failure.

Enbrel (etanercept), intended for treatment of rheumatoid arthritis, psoriasis, and psoriatic arthritis.

Imbruvica (ibrutinib), intended for treatment of blood cancers.

Stelara (ustekinumab), intended for treatment of psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis

Fiasp and Novolog (insulin aspart), as well as various derivatives, intended for treatment of diabetes.


Of that list, apixaban affected the greatest number of Medicare patients from June 2022 to May 2023, with approximately 3.7 million patients; it also had the highest bill, approximately $16.4 billion, of the selected medicines. Ibrutinib had the smallest patient population in that timeframe, at approximately 20,000, while insulin aspart and its derivatives had the lowest price tag of approximately $2.5 billion. In total, the selected drugs comprised approximately 8.2 million patients at a price tag of $50.5 billion, according to the fact sheet.

According to the press release, CMS encourages the public to submit input on the medicines selected for negotiation. CMS also plans to host a series of patient-focused listening sessions this fall as part to provide an opportunity for patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties to share input relevant to drugs selected for the first cycle of negotiations.

The Centers for Medicare & Medicaid Services (CMS) has announced the first 10 drugs covered under Medicare Part D selected for negotiation. 

White House Sets Medicare Price Negotiation Targets

Bristol Myers Squibb announced FDA approval of Reblozyl (luspatercept-aamt) as a first-line treatment for anemia without previous erythropoiesis stimulating agent use (ESA-naïve) on Aug. 28, 2023. The drug is indicated for adult patients with low-to-intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.

According to a company press release, FDA approval was based on interim results from the Phase III COMMANDS trial. In the trial, 58.6% of patients treated with luspatercept-aamt achieved the primary endpoints of concurrent RBC transfusion independence of at least 12 weeks and mean hemoglobin increase of at least 1.5 grams per deciliter within the first 24 weeks. This was deemed to be superior efficacy to epoetin alfa, an ESA which had a 31.2% efficacy rate, regardless of ring sideroblast status.

“Today's expanded approval of [luspatercept-aamt] marks an important milestone in our commitment to MDS patients with anemia by providing a durable and more effective treatment option, with more convenient and less frequent administration,” said Wendy Short-Bartie, senior vice-president and general manager, U.S. Hematology and Cell Therapy, Bristol Myers Squibb, in the release. “We remain dedicated to addressing hard-to-treat diseases with significant burden to patients and look forward to bringing this important option earlier in the treatment process.”

“The majority of patients with MDS experience chronic anemia and require RBC transfusions,” said Tracey Iraca, executive director, MDS Foundation, in the release. “The approval of [luspatercept-aamt] in the first-line treatment of anemia for patients with lower-risk MDS represents a crucial step in making transfusion independence possible for more patients.”

Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) is approved as a first-line treatment for anemia in adults with lower-risk myelodysplastic syndromes.

FDA Approves Bristol Myers Squibb Anemia Treatment

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On Aug. 30, 2023, Pfizer and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, given as a single dose to those 5 years of age and older. The recommendation comes regardless of COVID-19 vaccination history. Additionally, CHMP recommended the updated vaccine for those 6 months to 4 years old; it would be given as part of or all of the main three-dose vaccination series (depending on prior dosage amount), or as a single dose for individuals with a complete COVID-19 primary vaccination course (or SARS-CoV-2 infection).

The vaccine is based on BioNTech’s messenger RNA (mRA) technology and was developed by both companies. The CHMP’s recommendation relied on previous clinical, non-clinical, and real-world evidence showing the safety and efficacy of COVID-19 vaccines from Pfizer and Biotech. The application also contained pre-clinical data demonstrating the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine has a significantly stronger response against multiple XBB sublineages as compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. There was also pre-clinical data showing that the updated vaccine induces serum antibodies that neutralize the recently World Health Organization-designated variant of interest EG.5.1 (Eris).

Once the European Commission finishes its review of the CHMP’s recommendation the improved vaccine with be ready to ship in the EU immediately. The companies have been manufacturing the vaccine to secure supply ahead of the fall and winter season, when COVID-19 vaccination is predicted to increase. Pfizer and BioNTech have also submitted an application with FDA and are expecting a decision soon. The companies have given data to other regulatory authorities worldwide.

“This season’s vaccine is ready to ship as soon as the final regulatory decision is made, so that people across Europe can better help protect themselves against COVID-19 illness as the risk rises,” said Albert Bourla, Chairman and chief executive officer at Pfizer in a Pfizer press release. “It's been nearly a year since many citizens in the European Union were vaccinated against COVID-19 and the updated formulation provides the opportunity for them to receive a vaccine more closely matched to current sublineages."

The updated vaccine will be ready to ship following a positive European Commission review. 

Pfizer and BioNTech Get Positive Opinion in Europe for Omicron XBB.1.5-adapted COVID-19 Vaccine

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

In this excerpt from a recent episode of the 

, Chris Spivey, editorial director, hosts a panel on advances in mRNA. In this clip, Chris, Kate Broderick, and Tom Madden discuss how extensive research is being conducted around various gene editing techniques and what that means for the future of mRNA. Other topics include epigenetic approaches to modulate gene expression, the expression of monoclonal antibodies, and protein replacement treatments.

For the complete discussion, check out the full podcast episode 

, chief innovation officer at Maravai LifeSciences has extensive experience and expertise in leading and liaising with multi-disciplinary groups from discovery and R&D to engineering and clinical teams. She brings strong and broad scientific expertise to TriLink Biotechnologies, which covers multiple areas, including gene delivery, medical devices, gene therapies for the treatment of various infectious diseases, cancer immunotherapies and vaccine development. Additionally, she has extensive experience with non-viral delivery systems for a wide range of vaccine targets and cancer immunotherapies.

, president & CEO of Acuitas Therapeutics, is a world-renowned expert in the area of nanotechnology. Dr. Madden co-founded Acuitas Therapeutics in February 2009 and has guided the company into its position as a global leader through the development and application of lipid nanoparticle (LNP) technology. Acuitas Therapeutics partners with leading pharmaceutical and biotechnology companies and prestigious academic institutions around the world, providing its proprietary LNP delivery technology to enable new drugs based on nucleic acid therapeutics.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

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Extensive research on various gene editing techniques could inform the future of mRNA therapies.

Featured Content

Behind the Headlines Episode 27

Ask the Expert

Drug Digest September 2025

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

Top Trends Reshaping Pharma R&D