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Clinical-Trials-2021

About Conference


Conference Name

Venue

Dates

Clinical Trials 2021

Montreal, Canada

September 17-18, 2021

9th International Conference on Clinical Trials, (Clinical Trials 2021) scheduled to be held during September 17-18, 2021 at Montreal, Canada. This Clinical Trials Conference includes a wide range of Keynote presentations, Oral talks, Poster presentations, Symposia, Workshops, Exhibitions and Career development programs.

ConferenceSeries LLC Ltd hosts 3000+ Global Events that includes over 1000+ International Conferences, 1000+ Symposiums and 1000+Workshops and preconference workshops on diverse Medical, Pharmaceutical, Clinical, Engineering, Science, Technology, Business and Management fields. Over 25 Million visitors flock to our websites to observe the attest developments in these fields.

Clinical Trials Conference is one of the well-established conference among Pharmaceutical Conferences organized by ConferenceSeries LLC Ltd

Why to Attend???

Clinical Trials 2021 Conference is a multidisciplinary program with broad participation with members from around the globe focused on learning about clinical research and its advances. This is your best opportunity to reach the largest assemblage of participants from Clinical Trials community that is from academia, clinical research entities, medical groups, related associations, societies and also from government agencies, pharmaceutical, biomedical and medical device industries.

Clinical Trials 2021 will discuss various disciplines involved in the pre-clinical research, conduct of clinical trials; it will educate health care researchers about design, operation, organizing, research computing, regulatory aspects and reporting of clinical trials. It promotes better understanding by the general public about the importance of clinical trials in prevention, diagnosis and treatment of disease. This conference conduct presentations, distribute information, meet with current and potential scientists, make a splash with new clinical research developments, and receive name recognition at this 2-days event. World renowned speakers and the most recent techniques, developments, the newest updates in Clinical Research are hallmarks of this conference.

Who Should Attend and Who You’ll Meet

Directors/Senior Directors/Executive Directors and Vice Presidents/Senior Vice Presidents/Executive Vice Presidents and Heads/Leaders/Partners of

  • CROs and CMOs
  • Clinical Research Sites
  • Pharma/Biotech and Medical Device industries
  • Hospitals, Associations

Medical Directors, Principal Investigators, Methodologists, and other clinical research professionals along with Academicians: University Faculties like Directors, Senior Professors/Assistant Professors/ Associate Professor, Research Scholars, scientists who are related to clinical and medical research.

Clinical/Pharmaceutical and biotech industry professionals with responsibilities in:

  • Clinical Research & Development 
  • Clinical Design/ Protocol Design/ Clinical Strategy
  • Global Clinical Operations/ Clinical Outsourcing 
  • Biostatistics/Data management
  • Patient Recruitment/Enrollment 
  • Clinical Trial Management/Clinical Trial Supplies
  • Regulatory Affairs

 

sessions and Tracks

Track 1: Drug Discovery and Development

The drug discovery process involves identifying a suitable target that is a molecule or a protein receptor that is specifically associated with a disease condition or pathology. Once a target is identified, the next step involves understanding how the target plays a role in the disease process. This is followed by testing of the target against different known and new compounds to identify either one or several ‘lead compounds’ which interact with the target and show the potential to either neutralize or slow the disease process.

Once researchers identify a promising compound for development, they conduct experiments to gather information on how it is absorbed, distributed, metabolized, and excreted, best dosage, Side effects, how it interacts with other drugs and treatments and its effectiveness as compared with similar drugs. The part of the development process in which the candidate drug is thoroughly investigated, optimized, and prepared for testing in humans is referred to as the ‘preclinical phase’. During the clinical phase of development, the efficacy and safety of a drug candidate is investigated in patients

Track 2: Preclinical Research

Preclinical research also named preclinical studies and nonclinical studies is a stage of research that begins before clinical trials, and during which important feasibility, iterative testing and drug safety data is collected. The main goals of preclinical studies are to determine the safe dose for First-in-man study and start to assess product's safety profile. Products may include new or iterated or like-kind medical devices, drugs, etc.

Track 3: Clinical Study Designs

Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research involving human beings. Clinical trials are typically conducted in four phases, each phase is considered as separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase. Types of study designs are Meta-Analysis, Systematic Review, Randomized Controlled Trial, Cohort Study, Comparative Study, Case-control Study, Cross-sectional study, Case Reports and Series, Animal Research Studies, Test-tube Lab Research

Track 4: Conducts of Clinical Trials

Clinical trials also known as clinical research studies that follow a pre-defined plan or protocol. Researchers design clinical trials (Clinical study designs) to answer specific research questions related to a medical product. Clinical trials, particularly those looking at new drugs, often start after successful animal studies. The most promising treatments then move into clinical trials.

There are four categories of clinical trials. The fourth occurs after the FDA has cleared a certain drug or therapy and continues to track the safety of the treatment. Phase 1, Phase 2, Phase 3 and Phase 4. A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. Test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. By taking part in clinical trials, participants can not only play a more active role in their own health care, but they can also access new treatments and help others by contributing to medical research.

Track 5: Pharmaceutical Formulations and NNDS

The drug delivery technology market is expected to reach USD 1,504.7 Billion by 2020 from USD 1,048.1 Billion in 2016, growing at a CAGR of 7.5% from 2015 to 2020. The global market for Novel Drug Delivery Systems (NDDS) is expected to hit USD 320 billion by the year 2021. With the rising number of patients suffering from different types of cancer, favorable reimbursement scenario in US, improved and  advanced healthcare infrastructure have driven North America to become the leading regional segment in the global NDDS in cancer therapy market. Among the NDDS technologies Embolization of Particles, Selective Internal Radiation Therapy (SIRT), Holmium-based Microspheres, Liquid Embolics and Nanoparticles are gaining importance from market point of view.

Track 6: Patient-Centric Clinical Trials

Generally accepted principles suggest that patient involvement should extend well beyond consideration as research subjects. Patients are key stakeholders in all aspects of trial design & execution. Patient-centric drug development also offers a huge opportunity to define meaningful outcomes from the patient perspective, as a way to ensure the needs and priorities of patient populations are reflected in research. Although efforts are made to control risks to clinical trial participants, some risk may be unavoidable because of the uncertainty inherent in clinical research involving new medical products. It's important, therefore, that people make their decision to participate in a clinical trial only after they have a full understanding of the entire process and the risks that may be involved.

Track 7: Clinical Research and Trials on AIDS / Cancer / Diabetes

HIV clinical trials are research studies done to look at new ways to prevent, detect, or treat HIV. Clinical trials are the safest and fastest way to determine if new medical approaches to HIV prevention or treatment are safe and effective in people. All the medicines used to prevent and treat HIV in the United States were first studied in clinical trials. Examples of HIV clinical trials are, studies of new medicines to treat HIV, studies of vaccines to prevent or treat HIV, studies of medicines to treat infections related to HIV

There are several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, and supportive and palliative care trials. Each type of trial is designed to answer different research questions and will help researchers learn things that will help people in the future.

Diabetes/Diabetes mellitus describes a group of metabolic diseases in which the person has high blood glucose, either because insulin production is inadequate, or because the body's cells do not respond properly to insulin, or both. Patients with high blood sugar will typically experience polyuria, and they will become increasingly thirsty (polydipsia) and hungry (polyphagia). Clinical trials are conducted for both the Type 1 and Type 2 diabetes.

Track 8: Clinical Trials on different Diseases and Disorders

Clinical Trials for different diseases and disorders are conducted for evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition and also finding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches. Some examples of the diseases/disorders for which clinical trials conducting are Cardiovascular, Digestive system, Respiratory system diseases and other parasitic, viral, bacterial and fungal diseases. And Clinical Trials on behaviors, mental, sleep and eating disorders.

Track 9: Clinical Data Management and Statistics

Clinical data management is the process of collection, cleaning, integration and management of subject data in compliance with regulatory standards. It is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials, this has been facilitated by the use of software applications that maintain an audit trail and provide easy identification and resolution of data discrepancies. CDM also supports the conduct, management and analysis of studies across the spectrum of clinical research. The ultimate goal of CDM is to assure that data support conclusions drawn from research. Achieving this goal protects public health and confidence in marketed therapeutics.

Track 10: Pharmaceutical Sciences:

The Pharmaceutical sciences combine broad range of scientific disciplines that are critical to the discovery and development of new drugs and therapies. Pharmaceutical Sciences is a dynamic and interdisciplinary field that aims to integrate fundamental principles of physical and organic chemistry, engineering, biochemistry, and biology to understand how to optimize delivery of drugs to the body and translate this integrated understanding into new and improved therapies against human disease. At the many of institutes internationally recognized faculty contribute to the field through inquiry into the underlying mechanisms of drug interactions with the human body and development of advanced synthetic or biologically-derived materials that can modulate these interactions in pursuit of better and safer therapies and drug products.

The worldwide market for pharmaceutical science instruments and reagents came to $47.8 billion in 2012. This figure is relied upon to increment to $51.3 billion in 2013 and $77.6 billion in 2018, with an anticipated five-year compound yearly development rate (CAGR) of 8.6%.

Track 11: Pharmaceutics

Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or old drugs into a medication to be used safely and effectively by patients. It is also called the science of dosage form design. The largest pharma market globally is for musculoskeletal drugs.The segment accounted for 14% of the global total in 2021. Cardiovascular, oncology and ant-infective drugs are the second third and fourth largest markets.

Track 12: Pharmacy Practice

Pharmacy practice is the field of pharmacy which involves developing the professional roles of pharmacists. It includes Disease-state management, Clinical drug interventions, Pharmacy professional development and pharmaceutical care, pharmaceutical compounding and health psychology, patient care, drug abuse prevention, prevention of drug interactions or minimisation of adverse events and drug incompatibility and community pharmacy.

Track 13: Globalization of Clinical Trials

The globalization of clinical research is a relatively recent phenomenon, in which many of these studies are taking place on a global scale, with a significant increase of clinical trials in developing countries. Developed markets in the United States, Western Europe, Germany, and Japan still generate the lion’s share of clinical trial activity. Nearly 31% of the world's clinical trials are reportedly conducted outside of the United. According to the report China, Japan, India, and Korea are the most active settings for clinical trials among developing nations. It is predicted that Japan as the world’s second-largest pharmaceutical market by 2015.

According to the ClinicalTrials.gov the total number of studies registered in 2016 is 231,756. The percentage of studies registered from United States is 37%, Non-U.S is 47%. It is estimated to reach more than 280,000 study registries by 2021.

Track 14: Innovations in Clinical Trials

Clinical study design comprises the quantity of study volunteers, their segmentation based on varying factors, and their treatment throughout the clinical trial process. Study design is a key component of clinical trials, and the treatment of all patients directly impacts the statistical validity of data. Study group assignment has also been comprehensively improved in recent years. Researchers have found many benefits to randomized assignment versus observational assignment, based on characteristics like gender, age, race, etc. The randomized method has been found to yield more reliable results than observational study assignments.

In recent years, the use of Adaptive design methods in clinical research has become increasingly popular due to its flexibility and efficiency.  Adaptive designs offer the potential to reduce study duration and patient exposure whilst maximizing the probability of a successful outcome. Another innovation in clinical trials is the Bucket design. Bucket trials are designed to utilize one particular drug and test that drug against a number of different diseases. The advantage of this approach is that patients with different diseases can be 'pooled' together under one larger trial instead of lots of smaller trials, thereby saving time and resource in a similar approach, and there are more innovations in clinical trials.

Track 15: Future of Clinical Trials

The future of clinical trials illustrated as follows. Access and engage the patient online – Attract patients to the trial – Consent patients & convert to subjects – Remotely manage subjects & collect data. The sponsor plans to engage the patient through social media, such as Facebook, and regular e-mail updates in order to attract the patient to the trial, and once the patient agrees to learn more about the trial, the sponsor mails the patient a package containing mobile health devices, which collect medical diagnostic data and sends that data to the sponsor.  The patient turns on the tablet, which contains an electronic consent and a video of a physician explaining the clinical trial in detail. Humanization in digital media is believed to be an effective tool that is used to communicate with patients. During the clinical trial, the subject is able to access live physicians either virtually or through nearby medical community centers. Remote nurses visit the subject at their homes to collect samples.  In addition, the patient uses the mobile health device to automatically upload study data directly to the sponsor's EDC database.

Track 16: CRO/ Sponsorship Clinical Trials

CRO (Contract Research Organization) is an organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices. CROs range from large, international full-service organizations to small, niche specialty groups. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance. CROs also support foundations, research institutions, and universities, in addition to government organizations.

Sponsorship: In the conduct of clinical trials, a sponsor is an individual (institution, company or organization) that takes the responsibility to initiate, manage or finance the clinical trial, but does not actually conduct the investigation. A sponsor-investigator, on the other hand, takes on the responsibility as a clinical study sponsor and also conducts or oversees the clinical trial. Thus, a sponsor-investigator must comply with the applicable regulatory requirements that pertain to both the sponsor and the investigator

Track 17: Clinical Trials Site Management and Business Development

The conduct of clinical trials is one of the most expensive aspects of the development of new medicinal products. It is important, therefore, that the studies should produce high-quality data in the shortest possible time. More companies are trying to use single, larger, complicated trials in an attempt to gain the greatest amount of information about a product and thus reduce the lead time to market. A key element in ensuring this goal is the close cooperation between those responsible for the provision of the clinical trial supplies. The provision of clinical trial supplies is usually organized by a special group, often within the product development department, and it is prudent to discuss a proposed trial with this group at an early stage so that any potential difficulties can be identified and resolved. The major steps in clinical trial supplies are 1)Placing an order for clinical trial supplies, 2) Manufacturing of clinical trial supplies, 3) Blinding of clinical trial supplies, 4) Obtaining comparators, 5) Packaging, 6) Labelling, 7) Documentation, 8) Expiry dating, 9) Dispatch of supplies, 10) Disposal of clinical trial supplies.

The value of some study drugs can reach tens of millions of dollars, making it essential to avoid overproduction, oversupply, and inventory expiration.  With the high costs and strict handling requirements for many biopharmaceutical products entering clinical development, the logistics of clinical trial supplies are more critical than ever.

Track 18: Outsourcing in Clinical Trials

Outsourcing of clinical trials presents the US Food and Drug Administration (FDA) and companies with new issues around quality and responsibilities. By properly transferring responsibilities to contract research organizations (CRO) sponsors can eliminate some potential problems. As sponsor has to indicate what specific responsibilities they are transferring to the CRO in writing. Anything that’s not specifically described in writing is deemed to be retained by the sponsor

Globalization, outsourcing and increasing complexity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies.

Track 19: Bioethics and Quality Regulation

Bioethics is the study of the typically controversial ethical issues emerging from new situations and possibilities brought about by advances in medicine. It is also moral discernment as it relates to medical policy, practice, and research. Bioethicists are concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, clinical research, and philosophy etc. One of the first areas addressed by modern bioethicists was that of human experimentation. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was initially established in 1974 to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects.

Clinical research ethics are the set of relevant ethics considered in the conduct of a clinical trial in the field of clinical research. It borrows from the broader fields of research ethics and medical ethics. Quality of clinical trials depends on data integrity and subject protection. Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. The GCP standard applies to all aspects of the clinical trial process.

Track 20: Clinical and Medical Case Reports

A case report is a means of communicating something new that has been learnt from clinical practice. It could be about an unusual or previously unknown condition, a rare presentation or complication of a known disease, or even a new approach to managing a common condition. A case report provides the detailed report of symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient and play major role in the field of medical research and evidenced based medicine. Moreover, case reports can serve as an early warning signal for the adverse effects of new medications, or the presentations of new and emerging diseases.

Track 21: Pharmacovigilance and Drug Safety

The pharmacovigilance is related to collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products, and it is needed in different stages of product life cycle, and the safety surveillance and risk management. Information received from patients and healthcare providers via pharmacovigilance agreements, plays a critical role in providing the data necessary for Pharmacovigilance to take place, in order to market or to test a pharmaceutical product, adverse event data must be submitted to the local drug regulatory authority. Finally pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients by safety surveillance and risk management

 

 

 

 

 

Market Analysis

The Growing Pharmaceuticals Market: Expert Forecasts and Analysis

The global pharmaceuticals market was worth $934.8 billion in 2017 and will reach $1170 billion in 2021, growing at 5.8%, according to a recent pharma market research report by The Business Research Company.

This is an accelerated pace compared to 5.2% for the years before 2017, but is slower than the other two large healthcare segments, medical equipment and healthcare services. Healthcare as a whole is growing at over 7% year on year.

The factors that affect the pharmaceutical market size include disease prevalence, drug affordability, consumer attitudes, government policies and some supply-side factors:

  • Disease prevalence is related to population size, age, genetic inheritance and behaviour (infectious disease incidence is lower where sanitation practices are better; sedentary lifestyles also encourage chronic disease).
  • Affordability is related to income but also to drug prices.
  • Consumer attitudes include willingness to use alternative therapies or distrust of taking drugs.
  • Government (and insurance company) policies affect reimbursement and who the payer is. Other government policies determine regulation, which can be a significant barrier to the launch of new treatments.
  • A major supply-side factor is availability of an appropriate treatment, which may be a matter of quantity, as in an epidemic, or of drug discovery and development.

PESTEL Analysis for the Pharmaceuticals Market

Current and ongoing changes in political, economic, social, technological, legal and environmental factors are influencing growth in the healthcare market, where drugs play an important part. The following factors are all boosting healthcare market growth:

  • Reduced taxes and lowered drug prices in the USA
  • GDP growth of over 6% in China and India
  • Widespread population aging and sedentary lifestyles leading to increased chronic disease prevalence
  • Industrialized data services in R&D enabling the use of clinical trial data in trial simulations
  • Lowered regulatory barriers for new drugs in the USA
  • High urban pollution levels increasing the incidence of conditions like asthma

As a result, healthcare expenditure per capita is set to rise from its 2017 level of $1137 to $1427 by 2021.

Pharmaceutical Market Restraints and Drivers

Part of the explanation for the relatively slow current growth of the pharma market is that the launch of major new products has slowed and that companies are restricting their R&D investment. For example, despite the huge potential for any effective and safe new drug for treating Alzheimer’s disease, Pfizer has ended its Alzheimer’s research program while AstraZeneca and GSK have cut back. High failure rates, the $2 billion average cost of developing a new drug, and falling returns on investment — down from 10.1% a year in 2010 to 3.2% in 2017 for the big pharma companies, according to Deloitte’s — are restraining the launch of high-priced new breakthrough drugs such as those that boosted the market in earlier years.

Most pharmaceutical industry growth now is coming instead from the increased size of the global aging population, which boosts demand for long-term treatments for chronic diseases, and better access to healthcare in emerging economies.

The Changing Geography of Pharma Markets

Growth over past decades means that North America and Western Europe still account for 56% of the global market, but Asia Pacific has overtaken Western Europe as the second largest region. Growth in Asia Pacific is fueled by increased affordability of drugs resulting from the launch of low-priced generics. Other factors that are positive for growth in Asia Pacific are the rise of GDP per capita in the region, government programs to support healthcare, and rapid urbanization, which brings both doctors and pharmacies within easy reach of increasing proportions of growing populations. Pharma sales in Asia Pacific will grow at 8.4% a year to 2021.

The story is a similar one at the level of country. The USA, by itself worth 25% of the global total, is restraining global growth by rising at below 5% a year, while the much smaller pharma markets of India and China are both achieving double that pace.

Key Segments in the Pharmaceutical Market

The largest pharma market globally is for musculoskeletal drugs. These are treatments for diseases such as rheumatoid- and osteo- arthritis, osteoporosis, carpal tunnel syndrome, tendonitis, rotator cuff tear, muscular dystrophy, myasthenia gravis, lupus erythematosus and others. Major drugs in this segment include Piroxicam Glaxo, Dolonex, Felden, and Piroxicam Pfizer. The segment accounted for 14% of the global total in 2017. Cardiovascular, oncology and ant-infective drugs are the second third and fourth largest markets.

Drugs for treating metabolic disorders such as diabetes and diseases of the thyroid and pituitary glands will be the fastest-growing segment of the global pharma market to 2021. This segment will grow at 9% a year going forward, following recent growth of 11.6%, but it will remain in fifth place for market size.

Anti-diabetic drugs are the largest subsegment of the global pharmaceutical industry, worth over $85 billion in 2017; second are the anti-virals and third come anti-hypertensives. Drugs for some of the less prevalent cancers — thyroid, skin and ovarian cancer — are the fastest-growing subsegments. This is in part because the US Federal Drug Administration has allowed a less rigorous regulatory procedure and lower endpoint benchmark for cancer drugs, so increasing the rate of innovation.

Competitive Landscape & Top Pharmaceutical Companies

Pharmaceutical drugs are subject to a large number of laws and regulations that deal with patenting, testing, safety, efficacy and marketing and affect the size and growth rates of the market. Together with the high R&D costs involved in creating new drug solutions, these can act as barriers to entry for small companies. However, pharmaceutical companies produce both generic and branded drugs. Generics, which are copies of patent-expired drugs, are opportunities for smaller entrants. They are taking an increasing share of the market, particularly in developing economies, where governments are encouraging their production in order to make lower-price treatments more widely available.

In the overall market, top pharmaceutical companies include:

  • Novartis
  • Sanofi
  • Pfizer
  • Hoffman-La Roche
  • Gilead

Together the top ten pharmaceutical companies account for 30% of global sales, making the market moderately fragmented. Within individual segments, however, the share of these pharmaceutical companies varies: Hoffman-La Roche is by some way the leading pharmaceutical company in the large oncology drugs market, but Sanofi leads in the cardiovascular and metabolic disorders segments.

In markets where biologics have penetrated, the leading players are not in the top ten pharma manufacturers: Biogen, for instance, leads in the central nervous system segment, while Bristol-Myers Squibb and Eli Lilley have significant shares in oncology.

Deal activity in the healthcare industry has surged in recent years. Most mergers and acquisitions are aimed at boosting product portfolios and expanding the market reach of products and services. For example, in August 2014 Merck acquired a clinical-stage pharmaceutical company, Idenix Pharmaceuticals Inc., for nearly $4 billion. Through this acquisition Merck strengthened its product portfolio by adding Idenix’s potential hepatitis drugs.

Data Segmentations: Pharmaceutical drugs global market, global pharmaceutical drugs market by therapeutic area segments and subsegments; pharmaceutical drugs market by region and country and by therapeutic area segments; branded versus generic drugs markets by country; competitor drug sales and market shares by therapeutic area; global healthcare market historic and forecast size and growth; healthcare market regional and country size and growth; healthcare market competitive landscape.

A look ahead into 2019 Global Market Analysis : 

One of the key items to look for in 2019 is how the pharmaceutical industry will fare with new product approvals. In 2018, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved a record-high 59 new molecular entities (NMEs), surpassing the previous record of 53 NME approvals in 1996 and the 46 NMEs approved in 2017. The 59 NME approvals in 2018 was nearly double the 10-year (2009–2017) average of 33 NME approvals by FDA’s CDER. The record-number of NME approvals continues an upward trajectory for NME approvals (with the exception of 2016 when 22 NMEs were approved) over the last several years. FDA’s CDER approved 41 NMEs in 2014, 45 NMEs in 2015, 46 NMEs in 2017, and the 59 NMEs thus far in 2018.

In addition, continuing a recent trend, orphan drugs accounted for a large percentage of NME approvals. More than half (58%), or 34, of the NME approvals in 2018 were for orphan drugs, defined as drugs that treat 200,000 or fewer people in the US. In 2017, 39%, or 18 of the 46 NMEs approved by the FDA’s CDER were orphan drugs, which continued a recent trend of approximately 40% of NME approvals being orphan drugs. In 2016, 9 of the 22 NMEs approved by the FDA were orphan drugs. Of these 22 NME approvals, two were diagnostic agents, so 9, or 45%, of the new drugs approved in 2016 were orphan drugs. In 2015, 47%, or 21 of the 45 NMEs approved by the FDA’s CDER were orphan drugs, and in 2014, 41%, or 17 of the 41 NMEs approved were orphan drugs.

The key question for the pharmaceutical industry in 2019 is whether the innovation train will continue to roll.

Despite the optimism for product innovation based on NME approvals in 2018, other issues may have a dampening effect, notably financing into the biopharmaceutical industry. “Biopharma has had a rocky few months, and many expect life to get tougher as we head into 2019,” said Amy Brown, author of a recent report by Vantage, the editorial arm of Evaluate Ltd, in highlighting key predictions for the pharmaceutical industry in 2019. “The sector will need to deliver on its innovation promises next year if it wants to rise above wider economic and financial concerns.”

In the US, a total of $4.0 billion was invested into biotechnology-related industries in the third quarter of 2018 (the latest available data as of press time), which represented a 1% decrease from the second quarter of 2018 while deals remained constant quarter on quarter with 120 deals each in the third and second quarters of 2018, according to the Healthcare MoneyTree report by PwC and CB Insights. The biotechnology subsector raised $2.160 billion in the third quarter of 2018, a 7% increase from the second quarter of 2018. Out of the 59 deals, closed in the third quarter, six were mega-round deals, which contributed $1.176 billion of the dollars invested in the third quarter. The drug-development subsector raised $884 million in the third quarter of 2018, a 31% decrease from the second-quarter of 2018. Out of the 31 deals closed, none were mega-round deals. For the other subsectors in biotechnology-related industries, the medial device & equipment industry raised $750 million in 45 deals in the third quarter of 2018, a decrease of 4% from the second quarter of 2018, in terms of dollars invested, according to the PwC/CB Insights’ Healthcare MoneyTree report. The drug-discovery subsector raised $517 million in 16 deals in the third quarter of 2018, and the disease-diagnosis subsector raised $325 million in five deals.

The Vantage report also made several other noteworthy predictions relating to product developments for 2019. AbbVie’s Humira (adalimumab), an anti-inflammatory drug for treating arthritis, plaque psoriasis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis, will continue to be the world’s biggest-selling drug in 2019, with sales of just under $21 billion. For new product launches in 2019, Alexion Pharmaceuticals’ Ultomiris (ravulizumab) for treating adult patients with paroxysmal nocturnal hemoglobinuria, a rare and life-threatening blood disease, which was approved by the FDA in December 2018, has potentially the largest upside for a new drug approval with a net present value of $10.9 billion. The Vantage report also predicts that AstraZeneca will net the most new sales in 2019, increasing by $2.3 billion over the previous year’s total.

Macroeconomic changes will also be an important consideration for 2019. A recent analysis by PwC for its 2019 global outlook noted a slowdown in global economic growth following a mini-boom between the end of 2016 and early 2018. In the US, the PwC report projects that the boost from fiscal stimulus is likely to fade, higher interest rates may dampen consumer spending and a strong dollar could continue to drag on net exports for growth to moderate from an estimated 2.8% in 2018 to around 2.3% in 2019. On the plus side, the US will record its longest-ever business cycle expansion in July 2019, when the period of growth that began in mid-2009 surpasses the length of the expansion that ran from 1991 until 2001, but this could come to an end in 2020 or 2021, according to the PwC analysis.

In the Eurozone, the PwC report projects that uncertainty relating to global trade tensions and Brexit will take a toll while the European Central Bank is likely to offer less support to growth as its quantitative easing policy ends. Growth in China is also expected to slow relative to 2018 due to potential impact of US tariffs and the need for the government to control debt. The report also noted that other emerging market currencies could come under periodic pressure from a strong US dollar, but this effect is likely to lessen later in 2019 due to the US economy slowing.

The PwC report also says that trade wars will continue in 2019, which will impact overall economic performance but also create uncertainty for policy makers in terms of considering the impact of potential tariffs on growth and inflation and for businesses, which will seek to mitigate the impact on their supply chains and customers. The main focus of tensions is likely to remain US-China trade although the report points out other scenarios are possible.

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Conference Date September 17-18, 2021

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