Dr. Brian Lumley is a highly qualified chemist with over 25 years of experience in analytical chemistry and separation science in the consumer healthcare sector. He has developed and validated over 100 analytical methods and has expertise in a wide range of techniques. Dr. Lumley is currently a team leader providing technical support to 19 sites within GSK and has extensive experience mentoring colleagues and students.
Formulation Science
Main steps of formulating a Drug Product
The role of Formulation Science in different
stages of Drug Development
Trends and challenges in formulation
development
Payload Core Product Line Accelerates ADC Clinical TimelinesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ddy1sT
Innovators currently must endure years of development and manufacturing to arrive at the most commonly used cGMP payloads. Explore our core product line for dolastatin and maytansinoid payloads which can get developers to the clinic faster while reducing risk.
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.
DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.
In this webinar, you will learn about:
• Advantages of dolastatin over other payloads in ADC therapies
• Proprietary DOLCore™ and MayCore™ products
• Flexibility to make new or established dolastatins
• Rapid synthesis technology accelerating the path to drug commercialization
• Seamless supply chain with reduced complexity and regulatory support
Presented by: David Goeddel, Ph.D., Director of API R&D
Formulation Science
Main steps of formulating a Drug Product
The role of Formulation Science in different
stages of Drug Development
Trends and challenges in formulation
development
Payload Core Product Line Accelerates ADC Clinical TimelinesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ddy1sT
Innovators currently must endure years of development and manufacturing to arrive at the most commonly used cGMP payloads. Explore our core product line for dolastatin and maytansinoid payloads which can get developers to the clinic faster while reducing risk.
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.
DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.
In this webinar, you will learn about:
• Advantages of dolastatin over other payloads in ADC therapies
• Proprietary DOLCore™ and MayCore™ products
• Flexibility to make new or established dolastatins
• Rapid synthesis technology accelerating the path to drug commercialization
• Seamless supply chain with reduced complexity and regulatory support
Presented by: David Goeddel, Ph.D., Director of API R&D
CHI’s Inaugural Biologics Formulation and Delivery Summit will provide a forum for focused discussions on current challenges and opportunities in delivery of biotherapeutics. This 2-part summit will discuss various formulation and device-based approaches for designing physiologically relevant, patient friendly, targeted biologics products.
Part 1: Formulation Strategies for Improved Delivery of Biologics (May 5-6)
Part 2: New Technologies for Biologics Delivery and Targeting (May 6-7)
CHI’s Inaugural Biologics Formulation and Delivery Summit will provide a forum for focused discussions on current challenges and opportunities in delivery of biotherapeutics. This 2-part summit will discuss various formulation and device-based approaches for designing physiologically relevant, patient friendly, targeted biologics products.
Part 1: Formulation Strategies for Improved Delivery of Biologics (May 5-6)
Part 2: New Technologies for Biologics Delivery and Targeting (May 6-7)
Focused Chemical/Microbiological technician highly effective at following USP methods and GMP practices with pharmaceutical and medical device experience.
Chemist accomplished in GC, HPLC, analytical and assay methods used on raw material and finished products to assure the quality and purity of products. Certified in Clinical Trials and Drug Development and worked side by side a chemical formulator R&D chemist for 3 years. Coordinated process validation procedures, stability program, chemical waste management system, calibration program, laboratory set up, ordering and SOP procedural writing.
Versed Microbiological surface and air quality testing, process validation, microbiological identification, trending, tracking, gram staining techniques and microbiological morphology. Certified in Pharmaceutical Microbiology.
1. Dr. Brian Lumley Ph.D. B.Sc.(Hons) MRSC
Tel: 01932 822269 (office) 07767 683600 (mobile)
Summary
Highly qualified chemist with 25 years experience working within the Consumer Healthcare sector. Leading a
team of technical support scientists, I have considerable experience in analytical chemistry and an expert in the
field of separation science. Working on respiratory tract, gastrointestinal and oral care products I have developed/
validated over 100 methods and also have experience in the in the formulation and manufacture of oral care and
respiratory products. My expertise in Analytical Chemistry has led to direct communication with external
regulatory bodies, such as the Chinese and European authorities in order to ensure products meet local
requirements. I also have a number of academic links including a visiting lectureship at Leicester University. As a
competent, self driven individual that works well within a team environment, including teams based in other
European countries, I am looking for a position in the Consumer Healthcare/Pharmaceutical sector where I can
bring immediate and strategic value to the business and develop my skill set further.
Achievements
• Developed, validated, transferred and troubleshot over 100 methods in the R&D and Manufacturing
environment.
• Investigated degradation mechanisms for chlorhexidine / phenylephrine and triprolidine determining
degradation products/pathways and concentration in GSK products, implementing ICH Q3B compliant
specifications.
• Prepared Regulatory Submission documents for antiseptic formulation for newborns in developing countries.
• Led several technical investigations for existing products, e.g. degradation of chlorhexidine, ethanol loss,
methyl paraben increase bringing each to a conclusion, allowing products to be released to the market.
• Extensive understanding of fluoride methodology leading to resolution of separate issues regarding analysis of
fluoride at contract analytical laboratories and manufacturing sites.
• Broad range of expertise including the analysis of the following compounds and their degradation products:
fluoride, preservatives chlorhexidine, phenylephrine, triprolidine, benzocaine, oxymetazoline, resorcinol,
flavours, paracetamol, caffeine, codeine, guaifenesin, benzocaine, diphenhydramine and ascorbic acid.
• Expertise in several dosage forms including toothpaste, mouthwash, powders, capsules, tablets and emulsions.
• Led Science in Education team initiative, delivering programs for local schools, Kings College, Leicester
University and the Science Fair, inspiring students to progress in science and advertising GSK to the
community.
• Visiting Lecturer at Leicester University, teaching undergraduate and post graduate students in
chromatography and electrophoresis including setting and marking an examination question.
Technique Proficiency
I am competent and can employ the following techniques without supervision:
HPLC HPLC-MS GC GC-MS CE IC
UV-Vis AA IR ICP-AES TGA Potentiometry
SEM EDAX ISE
Sample preparation/injection techniques including solid phase extraction, solid phase micro-extraction,
headspace sampling and thermal desorption.
I am also fully conversant with MS office, PowerPoint, Project and Access. Also in Design Expert and Statistica
software in addition to several chromatographic data systems including Empower, Atlas and Chromeleon
Career History
1990 to Present SmithKline Beecham/GlaxoSmithKline Consumer Healthcare R&D
2012 to current Team Leader, Global Technical Support
• Leading a team of scientists responsibilities included accepting work, setting objectives,
reviewing progress and agreeing timelines and budgets with customers.
• Providing technical support to 19 sites within the GMS network.
• Setting and reviewing personal development plans with direct reports and assigning
performance ratings and salary increases for the members of the technical support team.
• Providing suggestions for capital investment and producing justifications for purchases.
• Mentoring other members of the department and sponsoring the analytical team.
2. • Implementing training in the use of HPLC and GC within the department.
• Authoring over 20 reports detailing scientific investigations within the team.
• Lead user for Empower, organising training, upgrades and resolving issues for R&D.
• Ensuring HPLCs and HPLC-MS instruments are serviced and approving reports.
• Using analytical expertise to investigate product incidents.
• Representing R&D on Wider Assessment Panel for technical changes affecting multiple sites.
• Ensured the utilisation of Quality by Design methodologies for projects.
• Fully conversant with the documentation required for new products.
• Facilitating and authoring company documents including SOPs, Work Instructions and
Guidance Documents.
2001 to 2012 Senior Analytical Scientist / Senior Technical Support Scientist
Business Support Group / Global Technical Group
Working in a team environment supporting the development of new and existing products
responsibilities included:
• Development, validation and transfer of analytical methods, including active ingredients and
the qualification of unknown degradation products.
• Visiting sites and troubleshooting analytical methods in use in the manufacturing environment.
• Overseeing manufacturing campaigns at manufacturing sites.
• Designing and performing experiments to assess methodology and product issues.
• Statistically assessing and interpreting analytical data using software such as Statistica.
• Designing and implementing experimental designs to assess interactions in formulations and
robustness of methodologies.
• Conversant with Measurement Systems Analysis for the determination of the origin of the
variability in results for a product.
• Communicating results of analytical experiments via written reports and oral presentations.
• Managing analytical resource and ensuring appropriate loading for the department.
• Authoring and approving both internal and external reports and presentations.
• Maintaining and troubleshooting HPLC and CE systems for the department.
• Training R&D and Manufacturing staff in analytical procedures.
• Rationalisation of methods at both Maidenhead and Dungarvan sites leading to improved
manufacturing efficiency.
1994 to 2001 Analytical Scientist–New Product Development SmithKline Beecham/GlaxoSmithKline
CHRD
1992 to 1994 Assistant Scientist - Oral Health Analytical, SmithKline Beecham Consumer Health R&D
1990 to 1992 Laboratory technician- Personal Care Analytical, SmithKline Beecham Consumer Health
R&D
Academic Links
Leicester University : Visiting Lecturer in Separation Science
Kings College, London : Visiting Lecturer in Pharmaceutical Analysis
Queen Mary College, London : Academic links via Ph.D.
Education and Training
1998 to 2004 Ph.D. Queen Mary College, London University.
Thesis: “Optimisation of Packing Procedures for Capillary Electrochromatography and the
Synthesis and Characterisation of Novel Stationary Phases”
1992 to 1995 B.Sc. (Hons) Class I in Chemistry, Kingston University.
Graduateship of the Royal Society of Chemistry.
Awarded RSC Downland Section prize for best performance on the degree course.
1990 to 1992 HNC in Chemistry, Kingston polytechnic. Pass with 4 distinctions & 7 merits.
1988 to 1990 A Levels: Chemistry, History & Electronics; Rydens School, Walton-on-Thames, Surrey.
3. 1986 to 1988 GCSEs : 10 subjects; Rydens School, Walton-on-Thames, Surrey.
Publications
B. Lumley, T.M. Khong & D. Perrett, “An Improved Procedure for Packing Capillaries for Capillary
Electrochromatography”; Chromatographia, 2001, 54, 625-628
B. Lumley, T. M. Khong & D. Perrett, “The Characterisation of Chemically Bonded Stationary Phases by
Thermogravimetry”; Chromatographia, 2004, 60, 59
Posters
‘A Study of the Primary Breakdown Components of Chlorhexidine Gluconate by HPLC’, B.Lumley and T.M.
Khong, HPLC 1997.
‘Improved Procedure for Packing Capillaries for CEC’, B. Lumley, T. M. Khong and D. Perrett, 23rd
International Symposium on Chromatography 2000.
‘HPLC Analysis of 4-Aminophenol in Commercial Formulations Containing Paracetamol’, V. Thibon, B.
Conway, I. Way & B. Lumley, HPLC 2003.
‘Identification and Structure Determination of Phenylephrine Unkown Impurities Seen in Commercial Stability
Product’ Z. Marcinow, B. Lumley, C. Tedbury, B. Walsh, S, Hollas and M. E. Penas, GSK Poster Symposium.
Additional Information
Driving Licence : I hold a full, clean driving license