Joanne Broadhead PhD
`7, Willowcroft, Quorn, Leicestershire LE12 8HQ
`01509 556857 (home), 07979 744953 (mobile)
`Joanne@JoanneBroadheadConsulting.com
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`PROFILE
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`Experienced and highly motivated pharmaceutical consultant with over 15 years experience of
`pharmaceutical development. Able to work flexibly to deliver multiple projects to a variety of clients.
`Technical expert in parenteral product development and sterile product manufacture.
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`KEY SKILLS
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` Specialist technical expert in sterile product development and manufacture with a particular interest in
`freeze drying.
` Excellent written and oral communication skills: experienced author of numerous technical reports and
`regulatory documents
` Able to build relationships and rapidly develop effective networks across organisational and
`geographic boundaries, ensuring successful outcomes through collaborative working.
` Versatile and able to adapt to the differing ways of working encountered in SMEs, small and large
`pharma companies and academia.
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`EMPLOYMENT HISTORY
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`Consultant Director
`Joanne Broadhead Consulting Ltd
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`Provide consultancy services to the pharmaceutical industry and academia. Projects to date have
`included:
` Long term interim role for a vaccine company, providing technical expertise in product and process
`development, technology transfer and third party manufacturing.
` Provision of advice and support to several small companies wishing to develop and manufacture
`parenteral products.
` Provision of training in parenteral product development and manufacture
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`Part-time Lecturer
`School of Pharmacy,De Montfort University
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` Teach aspects of product development on undergraduate and postgraduate modules within the
`Pharmacy and Pharmaceutical Sciences disciplines.
` Lead pharmaceutical industry collaborative activities for the De Montfort University Quality by Design
`distance learning programme.
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`2011 to present
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`2011 to present
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`Team Manager, Liquids Manufacture (sterile and non-sterile)
`AstraZeneca R&D, Loughborough
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`2006 to 2011
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` Led the liquids manufacturing area contribution to three successful MHRA inspections and numerous
`internal audits.
` Led the transformation of the steriles manufacturing capability from small scale manual filling through
`to the successful validation of automated filling and freeze drying processes.
` Built a high performing team of technicians and scientists through external recruitment, coaching and
`performance development activities.
` Drove continuous improvement initiatives within the team including the implementation of visual
`planning techniques to improve communication and scheduling.
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`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1013
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`Exh. 1013, Page 1 of 3
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` Engaged with the supply chain organisation to influence supply strategy and ensure continuity of
`clinical supplies to studies (including the use of CROs where required).
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`2005 to 2006
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`2003 to 2004
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`Spring 2003
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`1999 to 2002
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`Senior Lecturer
`De Montfort University, Leicester
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`Team Manager
`AstraZeneca R&D, Macclesfield
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`Volunteer Project Manager
`Raleigh International, Malaysia
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` Led a staff team responsible for groups of 18-25 year old ‘venturers’ working on a project to construct
`footbridges in the Maliau Basin Conservation area of Sabah, Borneo.
` Collaborated with local project partners to ensure project deliverables were met.
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`Team Manager
`AstraZeneca R&D, Loughborough
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` Led a team of 8 scientists responsible for the development of solid and parenteral drug products.
` Participated in the review of potential in-license opportunities (including due diligence).
` Led research and technology efforts in the parenterals field, including initiating and co-ordinating
`internal and external research projects.
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`1996 to 1999
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`Senior Pharmaceutical Scientist
`Astra Charnwood, Loughborough
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`1994 to 1995
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` Led a multi-disciplinary team of scientists responsible for the development and manufacture of a
`freeze dried parenteral product from phase I to phase III of clinical development.
` Prepared resourced project plans, budgets and CMC sections of regulatory documents.
` Led the technology transfer of the manufacturing process to a Swedish production site.
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`Scientist
`Creative BioMolecules, Hopkinton, MA, USA
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` Developed parenteral formulations of the company’s lead product, osteogenic protein 1 (OP-1).
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`Pre-registration Pharmacist
`The Royal Free Hospital, London
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`1988 to 1989
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`EDUCATION AND QUALIFICATIONS
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`Ph.D. in Pharmaceutical Sciences
`University of Rhode Island/ SmithKline Beecham Pharmaceuticals, USA
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`Bachelor of Pharmacy degree
`First class honours, University of Bath
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`1989 to 1993
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`1985 to 1988
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`1989 to present
`2012 to present
`2013 to present
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`AFFILIATIONS
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`General Pharmaceutical Council (previously MRPharmS)
`Academy of Pharmaceutical Scientists (APS)
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`Leader of APS Parenterals Focus Group
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`Exh. 1013, Page 2 of 3
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`LIST OF PUBLICATIONS
` Quality by Design; Perspectives on the Current Status of Implementation, Joanne
`Broadhead, Walkiria Schlinwein and David Potter, GMP Review, 15(11), January 2013
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` A study of the molecular properties of water in hydrated mannitol, Derbyshire HM1, Feldman
`Y, Bland CR, Broadhead J, Smith G; J Pharm Sci. 2002 Apr;91(4):1080-8
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` Parenteral Dosage Forms, in Pharmaceutical Preformulation and Formulation (M. Gibson,
`ed). Pp. 331-354, 2001
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` Stable formulations comprising a nucleotide and a freeze drying additive, 2000 US Patent
`6130208, J. Broadhead
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` Dry-powder inhalers: evaluation of testing methodology and effect of inhaler
`design,Pharmaceutica Acta Helvetiae, Volume 70, Issue 2, July 1995, Pages 125-131, J
`Broadhead, S.K Edmond Rouan, C.T Rhodes
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` The Effect of Process and Formulation Variables on the Properties of Spray Dried Beta-
`Galactosidase, J. Pharm. Pharmacol 1994, 46 (6), 458-67, J.Broadhead, S.K. Rouan, I. Hau
`and C.T. Rhodes
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` The spray drying of pharmaceuticals, Drug Dev Ind Pharm 1992 Vol 18 (1169-206), C
`Rhodes,J Broadhead,C Rhodes
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`Exh. 1013, Page 3 of 3