Cover Story
Partnerships
Win-Win Strategy
Among the options available to the pharma companies, partnerships and strategic alliances seem to have the potential to open the doors for synergic collaborations to create win-win situations in the long-run.
Bridging the innovation gap
What needs to be done to improve or change the R&D productivity of the pharmaceutical industry? Is biotech consolidation the answer, and if not, what is?
Neil J Campbell
CEO,
Mosaigen, Inc. and Partner,
Endeavour Capital Asia Ltd.,
USA
Is there a win-win partnering strategy?
Due to emerging factors such as escalating financial risks, lack of new blockbuster drugs and evolving global capabilities, the time is right for US biotechnology firms and Indian pharmaceutical companies to join forces in the pre-commercial phases of drug research and development.
Vipin K Garg
President and CEO,
Tranzyme Pharma,
USA
Critical issues for partnership and investment
Multinational pharmaceutical companies are rushing to China with an aim to access the low-cost scientific talent and also claim a stake in Asia's largest pharmaceutical market. But the Chinese business climate is far from what one normally encounters in the West.
Mark J Benedyk
Head,
La Jolla Incubator,
The Pfizer Incubator, LLC,
USA
The growth factors
Developing a product pipeline is being considered seriously and will be an essential factor for the growth of the Indian pharma market.
R B Smarta
Founder and
Managing Director,
Interlink Marketing
Consultancy Pvt Ltd. and
Member, Drugs and
Pharma National Committee,
Confederation of
Indian Industry (CII),
India
What lies ahead?
Biosimilars will eventually bring down the cost of biological medicines and in doing so will expand the market.
Cecil Nick
Principal Consultant,
PAREXEL Consulting,
UK
Tailored and efficient therapeutics
The ongoing merger of nanoscience with mitochondrial medicine gives rise to novel strategies for diagnosis and therapy of mitochondrial disorders.
Volkmar Weissig
Associate Professor of
Pharmacology,
Department of
Pharmaceutical Sciences,
College of
Pharmacy Glendale,
Midwestern University,
USA
Gerard G M D'Souza
Formulation
Development Scientist,
Northeastern University,
Bouve College of
Health Sciences,
USA.
Sarathi V Boddapati
Formulation
Development Scientist,
Novavax Inc,
USA
Technology convergence in development of targeted therapeutics
The use of multi-functional nanosystems affords convergence of technologies for simultaneous or sequential target-specific delivery of multiple drugs or by combining drugs with different energy modalities.
Mansoor M Amji
Professor and Associate
Department Chairman,
Department of
Pharmaceutical Sciences,
School of Pharmacy
and
Co-Director of
Nanomedicine
Education and
Research Consortium
Padmaja Magadala
Department of
Pharmaceutical Sciences,
School of Pharmacy
Bouve College of
Health Sciences,
Northeastern University,
USA
A decentralised multi-polar model
Where the pharmaceutical industry is being unable to successfully translate core models of drug discovery from theory to practice, the two-pronged approach of Evolva Biotech in building a diversified and risk balanced compound pipeline stands as a case in overcoming the hurdles faced by the industry in the R&D paradigm.
Panchapagesa
Muthuswamy Murali
Managing Director
Opportunities and challenges
A roadmap for Asian vaccine research and development programmes can lead to a strong regional vaccine industry, self-sufficient healthcare policy and the possibility of economic growth through the manufacturing of valuable biological products.
Pele Choi-Sing
Chong
Investigator and Director,
Vaccine Research and
Development Center,
National Health
Research Institutes,
Taiwan
Evaluation of vaccines
Although vaccine evaluation differs in various aspects from that for therapeutic drugs, many procedures specific for therapeutic drugs have been applied to vaccine evaluation.
Yoshinobu Horiuchi
Head,
Laboratory of Pertussis and
Endotoxin Control,
Department of Bacterial
Pathogenesis and
Infection Control,
National Institute of
Infectious Diseases,
Japan
Using tumour-associated peptides
Effective next-generation cancer vaccines have to include relevant and well characterised antigens known to be presented by real tumour tissue.
Harpreet Singh
Managing Director and
Chief Scientific Officer
Toni Weinschenk
Head of Discovery immatics
biotechnologies GmbH,
Germany
A new guideline on trial data provides opportunities for Japanese biopharmaceutical companies and global contract research organisations to work together to speed up drug development in Japan.
Mark A Goldberg
President,
Clinical Research
Services and
Perceptive
Informatics Inc.,
PAREXEL International
Corporation, USA
Enhancing the quality of clinical trials
Adaptive / flexible trial design has begun to catch-up with the clinical trial services providers due to its umpteen benefits that go a long way in delivering better drugs in a much shorter time. This article looks at different types of adaptive designs available, their characteristics, infrastructure, and the associated legal aspects.
Mark Chang
Scientific Fellow,
Biostatics and
Medical Writing,
Millennium
Pharmaceuticals Inc,
USA
Identifying tissue-specific drug effects
The maturation of metabolomics technologies is expected to have profound effect on pharmaceutical R&D. Over the past few years, technologies have matured to the stage where comprehensive and quantitative investigation of global metabolome has been made possible.
Matej Orešic
Research Professor,
Systems Biology and
Bioinformatics,
VTT Technical Research
Centre of Finland,
Finland
Improving internal communication
The adoption of simple and easy-to-use Web 2.0-inspired technologies and approaches inside the enterprise provides companies with opportunities to improve their collaboration, communication and knowledge sharing.
Simon Revell
Manager of Enterprise 2.0
Technology Development,
Information and
Knowledge Management,
Pfizer Inc, UK
Outsourcing pharma or biotech research IT can be very difficult to implement but with a well-planned strategy the benefits can easily outweigh the risks.
Chip Allee
CEO,
CeuticalSoft Inc.,
USA
Embracing process analytical technology
The idea behind Process Analytical Technology has been a proven technology in oil refineries, petrochemical, food 7a
beverage and semiconductor industries. Pharmaceutical and Biotech companies can ensure improved quality, reduced scrap and enhanced productivity by learning from the experiences of these industries.
Pala Bushanam
Janardhan
Business Consultant,
Manufacturing and
Plant Automation Services,
Life Sciences and
Healthcare Practice,
HCL Technologies Ltd.,
India
A holistic approach
Despite the advantages PAT offers to the pharmaceutical industry, many companies remain hesitant about its implementation due to high investment costs.
Ingrid Maes
Consultant,
Innovative Technologies,
Competence
Centre Phamaceutics,
Siemens AG,
Belgium
Driving process excellence and product safety
Biopharmaceutical manufacturing processes like cell culture, harvesting and downstream purification are rapidly gaining importance as process robustness and assurance of product safety in these processes are being considered seriously. This article looks into the lean concepts and ready-to-use technologies that are gaining prominence in the manufacturing of biopharmaceuticals.
Eric Grund
Director,
FastTrak
Biopharma Services,
GE Healthcare,
India
Superficial imitation or a paradigm shift?
True innovation is not achieved by superficial imitation or the isolated or random use of lean tools & techniques and systems ("know how"), but instead requires the "know why"-i.e., an understanding of underlying principles.
Randy Cook
Director of Education
Brian Atwater
Associate Professor,
Business Administration
Jacob Raymer
Assistant
Director of Education
The Shingo Prize - for
Operational Excellence,
Jon M Huntsman
School of Business,
Utah State University,
USA
An unexpected benefit of PAT / QbD
The spectroscopic signature of a product, developed for PAT, may also be used in the field to determine whether a product is real or counterfeit.
Emil W Ciurczak
Chief Technical Officer,
Cadrai Technology Group,
USA
What makes them effective?
Only a cross-functional and integrated approach can be successful in defeating counterfeiting and fraud, as well as the diversion of pharmaceutical products.
Thomas Völcker
Marketing & Sales Director,
Schreiner ProSecure,
Germany