a·lac·ri·ty [uh-lak-ri-tee] cheerful readiness, promptness, or willingness
Europe: London BioScience Innovation Centre 2 Royal College Street London NW1 0NH
USA: Cambridge Innovation Center 1 Broadway, 14th Floor Kendall Square, Cambridge MA 02142

Product Development

Our team of over 300 life science consultants has expertise spanning:

  • Clinical & Regulatory
  • Drug Delivery & Formulations
  • Biostatistics
  • Supply Chain Management
  • Manufacturing & Quality
  • Toxicology
  • Preclinical & CMC

Clinical & Regulatory

Our clinical team comprise pharmaceutical physicians and clinical project managers. All have deep experience of planning and implementing clinical development programmes, both in biotech and multinational companies and for small molecules and biologics. They have made significant contributions to the development of multiple launched products and have held global responsibilities for marketed medicines.

The team’s experience spans most aspects of clinical development, including governance and compliance, GCP audits and inspections, training, medical affairs (pre- and post-launch), medical information, pharmacovigilance and SOP development and implementation. Highlights include:

  • Contributed to the approval of several products, including enalapril, lisinopril, simvastatin, loratadine, recombinant interferon alfa2b, molgramostim, adalimumab, lanreotide, bonviva, bupropion, epoprostenol sodium, remifentanil, atovaquone, zanamivir, ramipril, trandolapril, verapamil, ondansetron, lamotrigine, lamivudine, pergolide mesylate, fluoxetene and olanzapine
  • Directed clinical, medical and regulatory teams which took the second-generation smallpox vaccine, ACAM2000 from IND to BLA submission in less than four years (FDA approval in August 2007)
  • Submitted two BLAs, eight INDs and three CTXs for a range of vaccine candidates for smallpox, Japanese encephalitis, dengue fever, yellow fever, influenza, C. difficile, ETEC, typhoid and H. pylori
  • For Roche, acted as “Bone Expert” for the global Phase III program of Bonviva in postmenopausal women with osteoporosis (joint program with GSK). Also acted as Global Study Team Leader for the global Ph IV program for EPO (CREAT Study)

Drug delivery & Formulations

Our specialist in pharmaceutical formulations has played major roles in the development of 15 commercial products comprising oral, topical, transdermal and parenteral products containing novel chemical entities, fermentation products, semi synthetics and a biopharmaceutical (at least two of which became blockbuster products).

He has published widely on the subject, is an inventor on six patents and has lectured at USPTO. He has experience across both NCEs and biologics.

Biostatistics

Our consultant statistician has over 20 years experience in the application of statistics to industry. She provides statistical input into all areas of drug development, including assay systems, shelf life estimation, preclinical studies and Phase I/II/III clinical trials. She has represented clients at regulatory agency meetings in US, Europe and Japan and has provided support for regulatory submissions for new drugs.

She has also applied her skills to the healthcare sector, including a review of primary care emergency services, review of clinical audit processes and development of an adverse event reporting interpretation methodology.

Supply Chain Management

Our specialist supply chain consultant helps companies maintain regulatory compliance across multiple service providers and complex supply chains. He has set up and supported functional quality systems incorporating rigorous validation, record review, auditing, compliance and pharmacovigilance process. He has carried out numerous supply chain risk assessments across all stages of drug development and commercial supply, including:

  • Ensuring project management/regulatory/CMC/quality functions worked seamlessly to bring >10 new molecular entities to market, including Tarceva and frovatriptan
  • Helping a Japanese pharmaceutical company launch a product in US and EU. Designed and registered a robust, regulatory compliant supply-chain ensuring quality was maintained across numerous vendors. Prepared for the supply of product to three different licensing partners
  • Advising a Switzerland-based top 10 pharma company on sales, operations and capacity planning
  • Completing a feasibility assessment for launch of amoxicillin into the major EU markets, taking into account national levels of generic substitution, typical wholesaler margins and supply-chain characteristics

Manufacturing & Quality

Our manufacturing and quality team cover medical devices, diagnostics, biologics and small molecules. Before their consulting careers, the team held senior positions at blue chip companies. Key responsibilities and experience include:

  • As Head of Medical Notified Body, responsible for planning, delivery and periodic review of effectiveness of certification service lines including ISO9001, ISO13485, Medical Devices Directive, In Vitro Diagnostic Directive, FDA, CMDCAS (Canadian requirements), PAL (Japan) and TCP (Taiwan)
  • Completed over 300 medical device and in vitro diagnostics audits world wide. Prepared 510k submissions for in vitro diagnostics and active and non-active, sterile and non-sterile devices. Prepared technical files for CE marking for all types of medical devices & in vitro diagnostics
  • Qualified Person and Head of Quality for a leading biologics developer. Responsible for ensuring quality throughout the organisation, from Research through Development to Clinical Trials, encompassing GLP, GMP and GCP

Toxicology

Our lead toxicology consultant has acted for UK, US, Japanese and European companies on diverse toxicological aspects of conventional pharmaceuticals and recombinant DNA products and medical devices, as well as pesticides and industrial and consumer chemicals. Highlights of his career include:

  • For a major pharma, responsibility for toxicological aspects of the development of new human and veterinary medicines and pesticides. Scope included human vaccines and biotechnology products, product licensing negotiations and patent briefs
  • Played an active role in UK and German advisory committees concerned with chemicals and medicines, including Toxicity Advisory Committee, Carcinogenicity Advisory Committee, Radiation in the Environment Advisory Committee, Medical Aspects of Air Pollution Advisory Committee, Scientific Procedures on Animals, Advisory Committee on Industrial Chemicals, Medicines Commission (under Medicines Act), Veterinary Products Committee, Industrial Injuries Advisory Council, Gene Therapy Advisory Committee, Senatskommission zur Beurteilung der Gesundheitlichen Unbedenklichkeit von Lebensmitteln (DFG)
  • Temporary Adviser to WHO and the IPCS
  • Organised training courses for preclinical assessors in various national medicines evaluation agencies in Europe

Preclinical & CMC

Our preclinical and CMC consultants have deep expertise from many years of working in pharma and biotech companies. Key achievements and experience include:

  • For a leading biotech company, built a high-performing, multi-disciplinary CMC Development group (>150 members) with strong expertise in chemistry, pharmaceuticals, engineering and GXP compliance, with responsibilty for process chemistry, formulation development, analytical development, physical sciences, quality assurance and CMC project management.
  • Responsible for the development of novel manufacturing and formulation processes for complex molecules
  • Responsible for dozens of successful IND and CTA submissions for small molecules and biologics
  • Designated “Expert” in CMC filings, composing Expert Reports and Quality Overall Summaries for EU Filings
  • For a major pharma, played a leading role in developing standards, technologies and planning systems for Quality by Design programmes for dosage form design, technology transfer, product filings and continuous improvement