Altasciences invites you to our new Exclusive Complimentary Symposium in the Babraham Research Campus, Cambridge, on June 6, from 1 p.m. to 6 p.m. Cambridge, United Kingdom.
This complimentary event is by invitation only and registration is mandatory by filling out the form on your right.
Grasping the dynamic landscape of drug development and selecting the appropriate regulatory route is crucial. In recent years, notable shifts have influenced financing, outsourcing, study design choices, trial oversight, project timelines, and regulatory frameworks.
Join our expert panel as they discuss the challenges and strategies of using juvenile nonhuman primates in early discovery studies for advanced therapies, conducting clinical trials in Canada – a strategic regulatory pathway, unveiling the future: harnessing AI in drug discovery, and the journey of an obesity compound that has been 20 years in the making. Fasten your seatbelts for an insightful journey through these pressing topics shaping the pharmaceutical industry today.
1:00 p.m.: Introduction, Hazel Clay, Drug Development Advisor, Altasciences
4:15 p.m.: Networking and Cocktails
This complimentary event is by invitation only and registration is essential.
Dr. James Minnion, PhD, Vice President, Research and Development, Metsera
Without a doubt, the only certainty in the constantly changing therapeutic space of obesity is that the need for effective drugs will continue to grow. Over the past two decades, there have been changes in society’s opinion of obesity and changes in the attitudes of health service providers and insurers to its treatment. What an acceptable target product profile is, and what the best class of drugs to meet these needs is, has also rapidly evolved. What hasn’t changed are the challenges faced in developing safe and effective treatments. These challenges are unique - particularly in preclinical studies, where exaggerated pharmacology, e.g., weight loss, limits achievable drug exposure. This journey of a compound, 20 years in the making in academia, through to early-stage clinical trials in a biotech, will touch upon the scientific, technical, and commercial challenges of developing obesity drugs.
Robert Wilson, Drug Development and Clinical Pharmacology Director, Healx
Healx stands at the forefront of innovation in drug discovery, leveraging cutting-edge AI technology to address the urgent needs of individuals suffering from rare diseases. With a mission to transform the landscape of treatment options for these underserved communities, Healx employs a multifaceted approach aimed at expediting the development of novel therapeutics. By simultaneously identifying lead molecules and druggable mechanisms, as exemplified by a case history of their work in treating Neurofibromatosis Type 1 (NF1), Healx significantly diminishes both the time and risk associated with traditional drug discovery processes. Central to their success is a robust and comprehensive technology platform meticulously crafted to guide promising molecules through the complex journey to clinical development. This approach has garnered validation through Healx's successful pipeline and strategic partnerships, reaffirming the efficacy and reliability of their methodology. By seamlessly integrating diverse methodologies and tapping into a vast knowledge base, Healx demonstrates unparalleled versatility in addressing a wide spectrum of rare diseases. In doing so, Healx heralds a new era in drug discovery, poised to deliver unprecedented impact and hope to those in need.
Dr. Laura McIntosh, PhD, Executive Director, Program Management and Regulatory Affairs, Altasciences
Early-phase trials play a pivotal role in drug development, with sponsors continuously seeking accelerated, cost-effective, and efficient approaches to maximize the value of their molecule. Sponsors face an array of decisions, such as timelines, trial design and duration, dosing regimens, patient populations, and location. Certain countries offer strategic advantages that safely accelerate Phase I program initiation, streamline processes, and help reduce overall costs. In fact, distinct and tangible benefits exist to conducting early-phase studies in Canada that merit exploration and consideration in drug development planning. Join our panel of experts as they delve into the numerous advantages of conducting clinical trials in Canada, including convenient access to trial sites, availability of high-quality research subjects, potential cost savings, and an expedited and streamlined regulatory process, leading to a meaningful reduction in timelines.
James Minnion is Vice President of Research & Development at Metsera, where he leads programs in the injectable portfolio and directs the Metsera Innovation Centre, the company's research labs in London.
Previously, Minnion was a co-founder of Zihipp, where he served as Chief Scientific Officer responsible for the day-to-day management of all R&D, manufacturing, analytical, and preclinical activities, as well as regulatory strategy and the preparation of regulatory documents. Minnion completed an undergraduate degree in molecular and cellular biology at the University of Glasgow, with an industrial placement year at GSK before returning to his doctoral studies at Imperial College. He completed his PhD at Imperial College under the supervision of Professor Sir Stephen Bloom. After completing his studies, he remained in the Bloom research group, helping to develop a portfolio of satiety hormone analogues for the treatment of obesity and choosing promising candidates for clinical assessment. Jointly at Imperial College and Zihipp, Minnion led the development of six programs which entered Phase 1 trials.
rbert Makori, BVM, MSc, PhD, DABTDr. Norbert Makori joined Altasciences in 2021 as Vice President of Toxicology. He has over 20 years of industry experience as a toxicologist (general and reproductive toxicology), including roles as a study director role, and in management. Prior to joining Altasciences, Norbert led the General Toxicology department at Charles River’s site in Ashland, Ohio, for five years. Prior to that, he held the position of Leader of Toxicology and Immunotoxicology at WIL Research Labs. Norbert also led the reproductive toxicology team at SNBL (now known as Altasciences’ preclinical site in Seattle), before it became part of the Altasciences family. Norbert is a Diplomate of the American Board of Toxicology (DABT) and has a PhD in Comparative Pathology.
Robert Wilson is a seasoned professional with over three decades of extensive experience in the pharmaceutical industry. Currently serving as the Drug Development & Clinical Pharmacology Director at Healx, he is pivotal in overseeing preclinical development activities, including DMPK, toxicology, translational pharmacology, and clinical trial enabling activities. At Healx, Robert leads the transition of potential therapeutic drugs identified for rare diseases, utilizing cutting-edge AI technology through various biological systems to exploratory clinical trials. Robert's distinguished career includes over two decades of service at GSK (GlaxoSmithKline), where he specialized in clinical pharmacology modelling and simulation. During his tenure, he acquired a deep understanding of drug development across the entire lifecycle, from discovery to development and from program work to full clinical development. His expertise spans diverse therapeutic areas, including respiratory and inflammatory diseases, with proficiency in both biopharmaceuticals (mAb and dAb) and small molecules. Robert has a strong academic background, studying at the University of Liverpool. His technical prowess encompasses regulatory affairs, translational pharmacology, kinetics, modelling and simulation, DMPK, FTIH, PK/PD, in vivo studies, and biopharmaceuticals. Robert has provided scientific guidance, technical writing, and interpretation assistance in regulatory documentation, including MAA/IND submissions, scientific advice, PIP (Pediatric Investigation Plan), and orphan drug processes across multiple regions, including the EU, US, and Japan. With his wealth of experience and expertise, Robert Wilson continues to make significant contributions to advancing drug development and clinical pharmacology, driving innovation and bringing hope to patients with rare diseases.
Laura McIntosh joined Altasciences in 2022 and leads the program management team. She graduated from the University of Manitoba with a PhD in Cell Biology, before undertaking post-doctoral studies in early diagnostic tools for skin cancer. Laura’s robust scientific knowledge is combined with extensive experience in leadership and product development, having previously tenured as a venture partner, and led R&D in multiple biotech startups to develop innovative biological products and services. Laura is driven by a passion for understanding clients' long-term strategies, and finding inspiration in customizing programs with a comprehensive solution. Her commitment to understanding the bigger picture and anticipating all stages of the sponsor’s drug development strategy is foundational to efficiently leading each program.
The event will be held at the Babraham Research Campus, in Cambridge, United Kingdom
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Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programmes, to offer an integrated/synchronised approach to CRO and CDMO services.