Altasciences invites you to our new Exclusive Complimentary Symposium in the Babraham Research Campus, Cambridge, on September 7, from 1 p.m. to 5 p.m. Cambridge, United Kingdom.
Understanding the evolving drug development environment and choosing the right regulatory pathway is a priority. Over the past few years, significant changes have impacted funding, outsourcing, study design selections, trial management, overall drug development program timelines, and significant changes in the regulatory landscape.
Join our panel of experts as they will be touching upon many of these topics, including the new European Clinical Trials Regulation (CTR) and the UK MHRA CTA, one of the most important changes in the field of clinical trials in the last decade that could lead to challenges for Phase I clinical trials and its implementation by Member States in Europe.
1:00 p.m. to 1:10 p.m.: Introduction, Hazel Clay, Drug Development Advisor, Altasciences
1:10 p.m. to 1:45 p.m.: A Message from Chris Perkin, CEO, Altasciences
1:45 p.m. to 2:15 p.m.: The Experience of a Biotech as First in Class Human Recombinant Protein Platform Targeting Specific Key Disease Areas: Soluble Klotho Uncoupling Age-Related Disease From the Ageing Process, Pr. Syed Haq, CEO and CMO, Bio Immunitas
2:15 p.m. to 3:00 p.m.: Sinclair Nanopig™: The Next Generation Non-Rodent Model for (Bio)Pharmaceuticals Safety Assessment, Dr. Wendell P. Davis, VP Pathology, Altasciences
3:00 p.m. to 3:45 p.m.: Review of Current Regulatory Landscape and Strategic Considerations, Leslie Dowling, Senior Director Regulatory Affairs, tranScrip and Paul Sidney, VP Regulatory, Altasciences
3:45 p.m. to 4:15 p.m.: Recent Trends in the Biotech Funding Environment, Dr. Max Klement, Principal, Venture Investments, Novo Holdings
4:15 p.m. to 4:25 p.m.: Closing Remarks, Hazel Clay, Drug Development Advisor, Altasciences
4:25 p.m.: Networking & Cocktail, George Inn
This complimentary event is by invitation only and registration is essential.
Pr. Syed Haq, CEO and CMO, Bio Immunitas
Abstract: Soluble Klotho (sKL), a cleavage product derived from membrane-bound Klotho protein, is crucial in anti-ageing and age-related disorders. sKL possesses distinct functions compared to other forms of Klotho, and is generated through the proteolytic cleavage of full-length membrane-bound Klotho protein by secretases, resulting in its release into the circulation. This form of Klotho contains both a KL1 and KL2 domain. sKL is distinct from secreted KL, which is produced by alternative splicing of the Klotho gene and is distinct from the membrane-bound and soluble forms, only containing the KL1 domain. One of the key functions of sKL is its involvement in regulating phosphate and calcium metabolism. It acts as a co-receptor for fibroblast growth factor 23 (FGF23) through dimerisation of FGF23 via the KL2 domain, enhancing FGF23's activity in the kidney to promote phosphate excretion, and inhibit vitamin D synthesis. This mechanism helps maintain phosphate homeostasis. Furthermore, sKL has been implicated in anti-ageing processes, exhibiting anti-inflammatory effects by suppressing the nuclear factor-kappa B (NF-κB) signalling pathway, reducing the production of pro-inflammatory cytokines and regulating superoxide dismutase. This anti-inflammatory effect is significant in the context of many age-related disorders, including neurodegenerative diseases, cardiovascular diseases, and cancer, where inflammation is an integral part of their pathogenesis. At Bio Immunitas, we have achieved several milestones: (a) producing human recombinant sKL, that exhibits a gain-of-function through synergism uniquely with an endogenous recombinant derived human protein (Protein A), (b) large-scale GMP production of both recombinant human proteins in a low-cost and effective way, (c) exhibiting potent anti-inflammatory properties in multiple tested models, (d) clear anti-ageing function with senomorphism and anti-senescence by the test agent, and (e) have created a biologic that is both potent and non-toxic. The implication of our findings will not only aid our understanding of the importance of KL in a variety of diseases but heralds the possibility of potentially allowing us to uncouple age-related diseases from the ageing process in the future.
1. Kuro-o M. (2019). Klotho and aging. Biochimica et Biophysica Acta (BBA)—Molecular Basis of Disease, 1872(1), 5-9.
2. Hu MC, et al. (2010). Klotho deficiency causes vascular calcification in chronic kidney disease. J Am Soc Nephrol, 22(1), 124-136.
3. Semba RD, et al. (2012). SKL and mortality: the health, aging, and body composition study. Circulation, 125(15), 2219-2226.
2:15 p.m. to 3:00 p.m.
Dr. Wendell P. Davis, VP Pathology, Altasciences
Abstract: Minipigs have been used for decades to support pharmaceuticals and medical device development. The recent IQ DruSafe minipig survey (2022) revealed that minipigs are used increasingly in the (bio)pharmaceutical industry and nonclinical contract research organisations (CROs) to support IND-enabling toxicology studies, primarily in the development of protein molecules and oral small molecule products.
However, challenges to the broader use of traditional minipigs persist due to various concerns, including increased test article requirements for in vivo studies, availability of historical control data, development of swine-specific assays (e.g., cross-reactivity), and uncertainties regarding CRO experience and capabilities.
The development of the next-generation Sinclair Nanopig™ may assist in mitigating/minimising these key challenges by addressing the supply constraints of other non-rodent species, and allowing for routine consideration of the minipig as a non-rodent species for nonclinical (bio)pharmaceuticals development.
The highlighted information and data include breeding history (genetic and nutrition selection), basic physiological characteristics (sexual maturity and body weight equivalence to Beagles enable lower test article requirements), comparison of the background toxicological reference data (to Göttingen minipigs™ and Beagles), and evolving genomic/proteomic characterization—with focus on the metabolism and immune system vs. human. We believe the next-generation Sinclair Nanopig™ is a cost-effective non-rodent species alternative because this model:
Ideally, our scientific background data and characterisation efforts will propel more pharmaceutical industries to include Sinclair Nanopig™ in the species selectivity for early screenings (metabolism and pharmacological targets assays), and pivotal regulatory toxicology studies.
3:00 p.m. to 3:45 p.m.
Leslie Dowling, Senior Director Regulatory Affairs, tranScrip and Paul Sidney, VP Regulatory, Altasciences
Abstract: It’s a common assumption that pharma/biopharma companies are focused on regulatory submissions to the US FDA. In fact, US-based contract research organisations often provide what they refer to as their “standard IND-enabling program” when starting discussions with new clients. In reality, for a variety of reasons, the drug development strategy of many companies is to conduct first-in-human (FIH) healthy volunteer clinical safety studies outside of the USA. Foreign clinical trial data is accepted under US food and drug regulations to support new drug applications (NDA) (e.g., 505 (b)(2)), and abbreviated new drug application (ANDA) submissions. While the generation and conduct of suitable nonclinical toxicology studies to ensure the safety of phase I healthy clinical subjects is detailed in international harmonised guidance ICH M3 R2, the presentation of this data as a well-argued case, conforming to local regulatory expectations and standards, are key to a successful foreign regulatory authority submission.
This presentation will provide an example overview of a foreign health authority’s differing requirements for gaining approval to conduct a FIH clinical trial, by comparing Health Canada’s CTA process, EMA’s clinical trial regulation requirements and submission (via their clinical trial information system), and the UK’s MHRA/Research Ethics Committee’s combined review CTA submission (via their integrated research application system), to the US FDA’s investigational new drug (IND) submission process.
The presentation will compare the advantages and challenges of the submission documentation requirements, and the submission and approval processes and timelines across Canada, US, EU and UK, for first-in-human clinical trial conduct.
3:45 p.m. to 4:15 p.m.
Dr. Max Klement, Principal, Venture Investments, Novo Holdings
As the dust settles in 2023, a more discriminate financing environment is emerging. There continues to be plenty of private money, with $35B of venture capital raised in 2022, and a number of European VCs raising their largest funds to date. Total financing levels also remain robust, with over $4B invested into private biotech companies in Q1 2023. However, investors aren’t investing capital as before, the current climate requires biotechs to think more carefully about their financing strategy and path to value creation. At Novo Holdings, we believe this is a great time for investing in cutting-edge science and seasoned management teams to advance innovative new therapies for patients. During the discussion we will focus on the current financing environment and the impact it has had on biotechs, and leverage our experience at Novo Holdings to share strategies how biotech companies can be successful in this environment.
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Dr. Hazel Clay, BS, PhDDrug Development Advisor, AltasciencesHazel Clay joined the Altasciences team in 2022 with over 30 years’ experience supporting the development of innovator pharmaceutical assets. Prior to joining Altasciences, she held a variety of different positions at Labcorp, from Toxicology Study Director to Head of Study Direction, where responsibilities included Independent Toxicology Reviewer for their UK clinic and Ethics Committee. She was a founder member of Program Management service to accelerate sponsors through to first-in-human studies. Latterly, she was Executive Director, Science and Strategy, for Early Phase Development Solutions, leading a global team of drug development specialists. During this time, she was the industry lead for the nonclinical module at Leeds University Masters Course in Biopharmaceutical development. Hazel is passionate about providing bespoke solutions for biotech companies and supporting their goals through nonclinical development and transitioning to first-in-human studies through to clinical proof of concept. She has extensive experience in navigating the challenges of drug development. |
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Pr. Syed Haq, MBBS, BS, PhD, DIC, MRCP(UK) CEO and CMO, Bio Immunitas A multi-award-winning scientist and clinician, Professor Syed Haq is the CMO and Founder of Bio Immunitas Ltd, anEIS-qualified pharmaceutical company focused on developing therapeutics for targeting systemic inflammatory disorders. |
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Dr. Wendell P. Davis, DVM, DACVPVP Pathology, AltasciencesDr. Wendell Davis joined Altasciences in 2022. He is a nonclinical development professional with extensive experience in toxicologic pathology and a proven track record of building and leading high functioning pathology groups in both the biotechnology and CRO sectors. He is a proven leader with a passion for building pathology capabilities and mentoring pathologists, research, and laboratory scientists. As a study pathologist and peer reviewer, he has experience evaluating small molecules, biologics, oligonucleotide, and an array of RNA therapeutics modalities across a range of preclinical species and routes of administration, in support of both early candidate selection and regulatory filings. Dr. Davis has co-authored over 25 publications, abstracts, and poster presentations. Prior to joining Altasciences, he held management roles in pathology and preclinical safety at Alnylam Pharmaceuticals, Charles River Laboratories, and Biogen Idec. Dr. Davis also maintains an active role in the industry as a member of the Society of Toxicologic Pathology and as a diplomat member of the American College of Veterinary Pathologists. |
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Leslie DowlingSenior Director Regulatory Affairs, tranScripLeslie joined Real Regulatory in 2017, which was acquired by tranScrip in 2022 to become tranScrip’s Regulatory Affairs department. She has worked in regulatory affairs since 1997, mainly in human medicines, but also with medical devices and veterinary medicines. She is experienced in managing multiple regulatory projects simultaneously, working in matrix organisations, both within small/medium pharma and as consultant/CRO with small/medium/large pharma clients. Leslie has CTA experience in Phase I to III studies, including first-in-human and paediatric studies, mostly in the UK and the EU, as well as in Eastern Europe, Australia, Canada, Israel, and India. Her MAA experience includes new MA applications as well as post-registration maintenance and variations, mostly in the UK and EU but also in the Americas, Middle East, Africa, and Asia Pacific. Her therapeutic area experience includes oncology, orphan conditions, neurology, and anti-infectives. Leslie has experience with advanced therapy medicinal products (primarily gene therapies), orphan medicinal products, scientific advice/protocol assistance, paediatric investigation plans, and PRIME application. Current holder of a Regulatory Affairs Certification [RAC(EU)], with triennial recertification maintained, and a Fellow of The Organisation for Professionals in Regulatory Affairs (FTOPRA), Leslie served as the Editor-in-Chief of the TOPRA journal Regulatory Rapporteur for 12 years, and was the Chair of the Regulatory Affairs Professionals Society (RAPS) RAC(EU) Examination Committee for six years. She has a Bachelor of Science in Biochemistry and a Master of Science in Instrumental Analytical Chemistry. |
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Paul SidneyVP Regulatory, AltasciencesPaul joined Altasciences as Senior Director, Compliance and Regulatory Affairs in 2020, with over 35 years’ experience in regulatory affairs and compliance. He has held senior management roles developing and directing multi-site GLP and GCP regulatory programs. He started his career with Sandoz Pharmaceuticals in the medical affairs department in a team preparing and submitting new drug submissions to Health Canada. He subsequently joined BioResearch Laboratories (now Charles River Laboratories) initially managing a team of auditors assuring compliance for regulated nonclinical toxicology studies and clinical research in a Phase I clinical research unit. His regulatory and compliance responsibilities grew within Charles River Laboratories to provide multi-site global oversight both in GLP/GCP regulated research and also as a quality systems and regulatory lead supporting the corporate mergers and acquisitions team. The latter role required that quality system and compliance programs be developed and implemented in European and North American sites. Paul has maintained an active role in many regulatory, quality and compliance societies (RAPS, SQA, RQA, ASQ, and CCSQA). He was the founding president of the CCSQA and has presented on regulatory and compliance topics at society conferences and academic institutions in Europe, North America, Japan and China. Paul holds a Bachelor of Science from McGill University. |
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Dr. Max KlementPrincipal, Venture Investments, Novo HoldingsDr. Max Klement is a Principal in the Venture Investment team of Novo Holdings based in London. Max’s career spans both Biotech and Venture Capital for over 10 years, where he has supported Biotech companies in financing strategy and drug development. |
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.