March 4, 2013
11:00 am – 12:00 pm EST

Sponsored by

Symposium Course Description:

In the past decade significant advances have been made in developing stem cell therapies for the potential treatment of a range of diseases and conditions. Drug approval regulators have responded by issuing guidance documents for the development of such therapies. The approach, and testing required, to prove preclinical efficacy and safety of stem cell therapies will vary according to the unique characteristics of each therapy. Participants will gain an understanding of a typical preclinical development program that will provide regulatory comfort to allow progression of clinical trials.

Learning Objective Bullet Points: 

  • Up-to-date thinking on the regulatory preclinical testing strategy for stem cell therapeutics
  • Provide an example of a preclinical development program for a stem cell therapy

Who Will Benefit: 

  • Preclinical Development
  • Safety Assessment
  • Pharmacology
  • Translational Medicine

Program Agenda: 

  • 0-5 min: Introductions
  • 5-25 min: Approach to preclinical testing strategy of stem cell therapies
  • 25-45 min: Example of preclinical testing program
  • 45+ min: Conclusion and questions

Speaker Information: 


Michaela SharpeMichaela Sharpe, Ph.D.

Director Nonclinical Development,

OakMore Solutions Ltd

Michaela Sharpe is director of nonclinical development at Oakmore Solutions Ltd specializing in the fields of Regenerative Medicine, Vaccines and Innovative Therapies.  Before establishing OakMore Solutions she spent 12 years working in both the Biotechnology sector and large pharma. Most recently at Pfizer as head of the Stem Cell Safety Group designing and implementing the safety programmes for Pfizer’s lead stem cell based therapy products.

Michaela holds a degree in Microbiology and received her PhD in Molecular Genetics from the University of Cambridge.

Frank BonnerFrank Bonner


Stem Cells for Safer Medicine

Frank Bonner is an independent consultant in toxicology and non-clinical drug safety assessment and currently supports a wide variety of pharmaceutical, biotechnology and platform technology companies, providing scientific and regulatory advice for drug development. He gained a BSc. (Hons.) degree in Biochemistry (1976) and a PhD in Toxicology (1979) from the University of Surrey, UK.  He is also Chief Executive of Stem Cells for Safer Medicines, a Public-Private partnership which is focussed upon developing stem cell assays for predictive toxicology.

Frank has over 30 years of experience of toxicology and non-clinical drug development, gained in the pharmaceutical, biotechnology and contract research industries, is a regular invited speaker at scientific/technical meetings and a substantial publication list. He has a particular interest in mechanistic toxicology applied to problem solving and application of new technologies to improve predictive screening.

He is a Fellow of the British Toxicology Society, Past President of the Society and has participated on a number of national committees of the Association of the British Pharmaceutical Industry. He is a Non-Executive Director of Maccine Pte and also serves on the Scientific Advisory Boards for a number of companies engaged in a variety of life science technologies including systems biology, metabonomics, disease models and cell based assays. He is Visiting Professor of Toxicology in the Institute of Cellular Medicine, University of Newcastle where he is involved in postgraduate teaching in Medical and Molecular Biosciences.

Leigh BerrymanLeigh Berryman, B.Sc (Hons), M.S.B., C.Biol., Reg. Tox., RQAP-GLP


Maccine Pte Ltd

Leigh is a professional, accredited toxicologist with over 35 years of experience in the biopharmaceutical industry.  He has held scientific and management positions of increasing seniority in Europe (UK – 11 years and Holland – 6 years), in North America (Canada – 12 years and USA – 2 years) and has been located in Singapore for the last five years.

A particular career highlight was the foundation of LAB Research Inc. as a start-up organisation in Canada in 1998, which subsequently went public in 2006 with over 425 people in employment in four countries across Europe and North America. 

Towards the end of 2008, he joined Maccine Pte. Ltd in Singapore as Chief Executive Officer with a mandate to build on the past successes of Maccine and position the company to become one of the world’s paramount contract research facilities with a specialised focus in the increasingly critical area of translational research.
Extracurricular activity includes BioSingapore.  Leigh has been a Council Member since 2009 and fulfilled the role of Chairman from 2010-2012.  He is also a Scientific Consultant and/or Advisor to multiple other organisations.

Kishore Bhakoo, PhD

Director, Translational Imaging Industrial Laboratory; Head, Translational Molecular Imaging Group,

Singapore Bioimaging Consortium, Agency for Science, Technology and Research

Prof Bhakoo, BSc (Hons), PhD, graduated in Medical Biochemistry from the University of Kent at Canterbury in 1978. He received his PhD from Institute of Neurology, Queen Square, University of London in 1983, and completed his postdoctoral training at the Ludwig Institute for Cancer Research. In 1986, he was appointed a Wellcome Research Associate at Royal College of Surgeons and Institute for Child Health, London.

Prof Bhakoo was appointed as a Staff Scientist and University Research Lecturer at the MRC Magnetic Resonance Spectroscopy Unit, Department of Biochemistry, University of Oxford in 1996.

Prof Bhakoo returned to London as a MRC Group Head and Senior Lecturer at the MRC Clinical Sciences Centre, Hammersmith Hospital, Imperial College London (2002), to establish the Stem Cell Imaging Group. The group developed preclinical models directed towards improving our understanding of stem cell behaviour post transplantation, in different tissues including the brain, spinal cord and heart.

In 2009, Prof Bhakoo was appointed as the Head of the Translational Molecular Imaging Group, based within the Singapore Bioimaging Consortium (SBIC), where he is developing multi-modal imaging technologies to monitor stem cell-based therapies, inflammatory processes and oncology. In 2011, Prof Bhakoo was appointed Director of the newly established facility at A*STAR, the Translational Imaging Industrial Laboratory, which works directly with industry to develop new drugs through imaging technologies.

Prof Bhakoo also holds several external academic posts including, Adjunct Professor & Lead for Biological Chemistry, Metabolism and Nutrition at the Lee Kong Chian School of Medicine, a joint medical school between NTU and Imperial College London, and Adjunct Associate Professor in the Departments of Biochemistry and Orthopaedic Surgery, NUS.