Photos-for-ARCS-Newsletter-006

Penny Field presenting on biosimilars at the 2nd Pharmaceutical Regulatory Conference 24-28 March 2014, Beijing, China

Penny Field B.Sc., (Biol.), Hons., (Biotech.), MMedSc., (Drug Development)

Penny Field is the Principal Consultant of Bioregulatory Consulting; a service provider that specialises in the development and registration of biopharmaceuticals. Penny has consulted on the regulatory strategy and development of monoclonal antibodies, immunotherapeutics, recombinant proteins, gene therapies and biosimilars. Additionally Penny has experience in the registration of New Chemical Entities (NCE) and generics. She has prepared Investigational New Drug (IND), Clinical Trial Exemption (CTX) and Marketing Applications for recombinant proteins, vaccines, NCE, generics and blood products. Penny has written regulatory documents to successfully gain registration of products in EU, AU and NZ. Penny has a particular expertise in the chemistry, manufacturing and controls (CMC) of prescription medicines which was gained from working with vaccines and recombinant proteins at CSL and Amgen.

Penny Field has undergraduate qualifications in Biology with Honours in Biotechnology from Murdoch University and a Masters in Medical Science in Drug Development from the University of New South Wales (UNSW). Penny  lectured in the Postgraduate Program in Pharmaceutical Medicine and Drug Development (UNSW) for four years and is a Guest Lecturer in the RMIT Undergraduate Program in Pharmaceutical Sciences in the regulation of prescription medicines in Australia.

Testimonials:

“Penny has been instrumental in helping us achieve our first IND with a new drug technology platform. She was able to gently guide us through the regulatory maze with her expert knowledge on what information the FDA is looking for in the CMC section of an IND. She assisted us to make sense of volumes of manufacturing and analytical testing documentation and distil the key information out to present an excellent submission to the FDA. After submission, we only had one small request for some further clarification on the CMC section and our IND was open without delay. Penny proved to be a wonderful addition to our team complimenting the strengths that we had in house beautifully with her regulatory expertise and experience. She was very diligent and responsive and I could highly recommend her services. “

Dr Kimberley Lilischkis

Clinical and Regulatory Affairs Director,

Novogen

Hornsby, NSW, AUSTRALIA

“Penny is a global regulatory expert with extensive knowledge of biopharmaceutical manufacturing. Penny and I worked on a monoclonal antibody project where she could be counted on to advise on complex technical issues related to both manufacture and testing as well as the best regulatory strategy for success. I found Penny to be hard working, extremely well organized and very focused on project objectives and very dedicated to customer service. She proved to be a good team player and skilled at managing relationships despite the team being distributed across multiple time zones. Above all, she is a very pleasant person and a pleasure to work with.”

Liz Jenkins

Director

Jenkins & Jenkins Ltd,

Leys Barn, The Leys,

Tostock,

Suffolk, IP30 9PR,

United Kingdom

Penny Field has assisted our firm by providing expert scientific background information for general, and specific, use in our work and made a series of presentations at seminars hosted by this firm in Melbourne and Brisbane on the broad topic of identification of important issues arising in discovery to drug development.

The presentations included covering the topics of drug candidates, safety considerations, other important considerations, transition from discovery to development, preparation of a drug development plan, target product profile, regulatory strategy, orphan drugs, accessing unapproved medicines, personal importation, the special access scheme and clinical trials.

The assistance provided to us, and presentations made, by Penny demonstrated a deep understanding of the subject matter and provided practical advice for those attending as to how to implement the knowledge disclosed for their commercial benefit.

Penny’s presentations in Melbourne and Brisbane were very well received by all those attending.

I would certainly recommend Penny for any work within her field of expertise.”

Ian Pascarl

Partner

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