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Article - Issue 63

Artificial Intelligence (AI) - From promise to practice

Article - Issue 63

Reimagining Pharmacovigilance

Article - Issue 63

Rethinking Inflammation

Article - Issue 63

Beyond Perfect Patients

Article - Issue 63

Reinvent Drug Development and Safety with AI

EDITORIAL SECTIONS

Why X-ray Inspection is a Viable Quality Assurance Solution for Pharma Products

Adopting the Power of AI to Drug Development Projects

A tremendous amount of documentation is created throughout the clinical trial lifecycle

Real-world Evidence

Hearing the diagnosis from the doctor that your child has spinal muscular atrophy SMA

Just in Time Manufacturing Creating more sustainable supply chains

Drug development has transformed immeasurably over the past decade Even before the Covid pandemic and the conflict in Ukraine

Challenges and Advantages of Using Artificial Intelligence in Pharma

Many advanced largescale AI initiatives still need to be proved successful in Pharma

Advisory Board

Victor M. Diaz Perez

Brian D Smith

Nigel Cryer FRSC

Quang Bui

Tamara Miller

Imedla Leslie Rillon

Andri Kusandri

Nicoleta Grecu

Alessio Piccoli

Pramod Kashid

Neil J Campbell

From Listening to Leading: Reimagining HEOR Through the Lens of Patient-Centred Evidence

Co-Founder & Director, MarksMan Healthcare
Dimple Dang CoFounder of MarksMan Healthcare is a strategic growth architect shaping the firms global footprint She forges highimpact collaborations leads business expansion and builds a talent ecosystem aligned with excellence Her leadership elevates credibility strengthens brand equity and positions MarksMan as a trusted strategic partner delivering value across global healthcare markets

Articles

Kinase Inhibitors as Antiviral Agents

The emergence of virus infections is a serious issue and the development of broadly acting antivirals has heightened concern for future viral epidemics The majority of these drugs operate directly on the proteins encoded by the individual viral genome However they have the following disadvantages i limited treatment coverage which does not address

Research Insights

Changing Paradigms In Bioequivalence Trials Submitted To The Ema For Evaluation – A Clinical And Regulatory Perspective

Abstract Background The selection of a robust bioequivalence BE study designs for registering a generic product remains still a hard task This task is still challenging despite the fact that generic products are much needed by health care providers in economical terms Thus BE study designs could be a means to

Case Studies

Effect Of Cold Spells And Theirmodifiers On Cardiovascular Disease Events: Evidence From A Double Prospective Study

Abstract Cardiovascular disease CVD is the most common cause of death globally remaining a considerable burden both in terms of health and costs As in many countries CVD mortality in the UK exhibits a marked seasonal variation more people die during the winter months DecemberMarch than in other periods of the year and the majority of deaths occur

Techno Trends

Merus Develops Novel Petosemtamab for the Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC)

Merus has introduced a pioneering treatment called petosemtamab tailored for patients grappling with recurrent or metastatic head and neck squamous cell carcinoma that has advanced despite prior treatment

White Papers

Cloud Computing in the Laboratory Informatics Solutions and Validation Approaches

In the modern business environment, a significant portion of work is conducted using computerized systems. Many solutions are used to complete tasks, including simple desktop programs like email and Microsoft Office to enterprise-wide, global systems like ERP (Enterprise Resource Planning), MES (Manufacturing Execution System), and LIMS

Perspectives on the Vaccine Industry

Josephine Cheng

As a Senior Consultant in Bioprocessing Strategy at Merck with over 14 years of
international biopharma experience, Josephine Cheng focuses on vaccine and mRNA market segments, where she translates strategies into market initiatives to enable the utilisation of best-in-class technologies and transforms industry insights into sustainable business strategies.
Josephine obtained Bachelor's and Master's degrees in Bio-resource's; Agriculture from the National Taiwan University.

Innovative Approaches for Safer and More Effective Healthcare

Dani

Dani is a content strategist passionate about crafting compelling narratives. With a knack for blending creativity and data-driven insights, she specialises in developing content that engages and converts.

Boosting NICU Safety

Norhan Attia

Norhan Attia, clinical pharmacist with five years' experience at Assiut University Hospital, Egypt, specialising in Neonatal Intensive Care. Expert in medication reviews, IV admixtures, and optimising pharmacotherapy outcomes. Currently a dedicated teaching assistant, focusing on pharmaceutical education and enhancing medication safety in NICU settings.

QSAR - Changing the Landscape of Antidiabetic Drug Discovery

Smriti Sharma

Smriti Sharma Bhatia is an associate professor of chemistry at Miranda House, University of Delhi, India. Her academic and research interests include Computational chemistry and drug design. Currently, her research group is focused on the design of oral drug formulations for Type 2 diabetes mellitus. She is a popular science communicator.

Six Sigma - Time, cost and product quality improvement

Ashwin Kuchekar

Ashwin Kuchekar is an Associate Professor and the Head of Career Services and Placement at the School of Pharmacy, Dr. Vishwanath Karad MIT-WPU in Pune. He completed his M. Pharm.in 2009 and Ph. D. in 2015. In 2012, he received the Senior Research Fellow (SRF) Award from the Council of Scientific Industrial and Research (CSIR). He is a trained specialist in Lean Six Sigma Black Belt (LSSBB). He has 7 years of industrial experience in reputed pharmaceutical companies such as Piramal, Lupin, and Abbott Healthcare. He has a unique blend of statistics and formulation development, Quality by Design with exposure to branded and generic product development. He has practical experience in the Design of Experiments and product formulation and process optimisation.

INDUSTRY UPDATES

press releasesRead more...

Roche announces grand opening of its Innovation Center Boston to drive advancements in Cardiovascular, Renal and Metabolic diseases

Roche SIX RO ROP OTCQX RHHBY announced today the grand opening of the Roche Genentech Innovation Center Boston expanding Roche and Genentechs US research presence in one

Ultragenyx Announces Approval of FAYUVI™ Gene Therapy, the First-Ever FDA-Approved Treatment for Sanfilippo Syndrome Type A (MPS IIIA)

Ultragenyx Pharmaceutical Inc NASDAQ RARE today announced that the US Food and Drug Administration FDA granted standard full approval of FAYUVI rebisufligene etisparvovechopf

Tenthpin Launches AI, IoMT-based Centre for Life Sciences Innovation Hub in Bengaluru

Switzerland based Tenthpin Management Consultants a global leader in management and technology consulting for Life Sciences companies has announced the launch of Innovation Hub in Bengaluru

Novo and Anthropic will collaborate to advance drug discovery with Claude

Novo Nordisk and Anthropic today announced a collaboration that will help Novo accelerate the development of new medicines and advance AIdriven software development

Leqembi® Pen subcutaneous formulation approved in Japan

BioArctic AB publs Nasdaq Stockholm BIOA B partner Eisai announced today that the subcutaneous autoinjector formulation of Leqembi known as Leqembi Pen in Japan has been approved as a new route of administration for the treatment of early Alzheimers disease

Twist Bioscience Joins Lilly TuneLab to Advance Antibody Drug Discovery

Twist Bioscience Corporation NASDAQ TWST a midcap growth and value biotech company today announced an agreement with Lilly TuneLab a collaborative AIML drug discovery platform created by Eli Lilly and Company