Kinapse: Life sciences & outsourcing

Founded in 2005, Kinapse provides consulting and outsourcing services to the lif
e sciences industries.
Our clients include many of the world’s leading pharmaceutical, biotechnology, med
ical device and specialty pharmaceutical companies, government organizations and
life sciences service providers.
Kinapse provides a broad range of services. Kinapse Consulting collaborates wit
h clients in defining measurable improvements and successfully implementing oper
ational changes. We have deep expertise and experience in life sciences operatin
g strategy, organisation and process design, resourcing strategy, capability dev
elopment and deployment and performance management.
Kinapse Outsourcing provides cost-effective writing and analytical services for
business critical information and documents for reporting and submissions.
Kinapse is headquartered in London, UK, and operates from 3 locations:
• Kinapse Europe (London, UK)
• Kinapse US (Philadelphia, PA)
• Kinapse India (Gurgaon, Delhi)
Additionally, we maintain a network of partners based in the Americas, Europe an
d Asia Pacific. This geographic spread enables us to provide services for our c
lients across the globe. You will find more information on our management team,
client list and our services delivery model in this section.
Kinapse provides consulting and outsourcing services to the global life sciences
industries.
Our clients include many of the world’s leading pharmaceutical, biotechnology, med
ical device and specialty pharmaceutical companies, government organizations and
life sciences service providers.
Kinapse specialises in addressing the challenges of life sciences. We understand
the complex issues faced throughout the life sciences value chain and offer inn
ovative insights, advice and service delivery to our clients.
We form strong, trust-based relationships with our clients’ personnel at all level
s. We deliver innovative solutions through our blended onshore-offshore delivery
model and hold ourselves accountable to committed results.
The Kinapse Advantage:
• Focus on the life sciences industries
• Deep industry experience and technical acumen
• Proven blended onshore-offshore delivery model
• Track-record of innovative solutions and results
Services
Kinapse provides consulting and outsourcing services to the global life sciences
industries. We work extensively with functional groups within pharmaceutical, b
iotech and devices companies, and also with their customers and suppliers. Examp
les of services and projects can be accessed using the functional area links on
the left sidebar.
Kinapse Consulting
Kinapse Consulting collaborates with clients in defining measurable improvements
and successfully implementing change in operations. We have deep expertise and
experience in life sciences operating strategy, organisation and process design,
resourcing strategy, capability development and deployment and performance mana
gement.
Examples of Kinapse consulting services:
• Portfolio strategy
• R&D globalisation strategies
• Organisation design including structures, roles and responsibilities
• Process redesign for enhanced quality, reduced cost
• Project, resource and capacity management
• Enhancement of outsourcing and offshoring effectiveness
• Capability redesign and deployment
• Performance management
• Market assessments
• Product launch strategy
• Lifecycle management strategy

Kinapse Outsourcing: “Kinapse Outsourcing provides cost-effective writing and anal

ytical services for business critical information and documents for reporting an
d submissions.
Examples of Kinapse outsourcing services:
• Medical and scientific writing for submissions, academic and commercial publicat
ions
• Regulatory documentation, such as full Common Technical Document (CTD) submissio
ns, Chemistry Manufacturing and Controls (CMC) documents
• Clinical trial disclosure processes
• Clinical and scientific data analysis including data entry, checking and statist
ical analysis
• Marketing and sales analytics
• Productivity analyses, such as capacity modelling, performance tracking and repo
rting
Insights
A selection of Kinapse insights and presentations is available here. If you wou
ld like more information on any of these or any other insights please contact us
.
Discovery Innovation – Productive Partnering for Shared Success
Phase II clinical development has traditionally been considered the ‘sweet spot’ for
big pharma partnering deals. However our recent analysis reveals that discovery
and early-stage clinical alliances are of increasing importance to big pharma’s l
ong-term business strategy. This paper highlights the shifting industry trends r
esponsible for the growth in earlier-stage partnering and describes how key stak
eholders in the discovery space are evolving. We discuss the implications of thi
s changing landscape for big pharma, and outline the new competences required to
maximize value, mitigate risks and ultimately deliver new treatments to market.
Real World Development: Increasing Value for Patients
The traditional drug development paradigm must change. We propose a fundamentall
y new approach which will create a win-win partnership between industry, academi
a, health authorities, health technology assessment (HTA)/health economic progra
m (HEP) bodies and patients. We call this new approach “Real World Development” the
underlying principle of which is to constantly assess the product in as close to
post-marketing use as possible. Key components of this approach are the use of
adaptive trial design and capitalisation of existing real world data sources. It
enhances the evaluation of benefit/risk, enable earlier patient access to innov
ative medicines, and improve value for money.
Improving Clinical Site Productivity
There are a number of factors in the industry that make clinical trials more cos
tly, more time-consuming and requiring more patients than in previous years. Mor
e than ever, sponsor companies are being pushed to deliver clinical trials quick
er and more cost effectively. The purpose of this paper is to look at ways in wh
ich clinical trials can be run more effectively and thus improve productivity. T
he paper introduces the Kinapse Clinical Site Productivity Framework as a mechan
ism to evaluate seven key areas in the patient recruitment process. By assessing
each key area, issues can be identified, prioritised and solutions designed and
improvements made.
Practical Approaches to Early Stage Life Sciences Technology Valuations
Early stage partnering has become a key component of life sciences business stra
tegy, however valuation of early stage assets is a continuous area of valuation
practice. This article provides a framework for building realistic and widely ac
cepted early stage valuations that facilitate productive transactions and form t
he basis for successful long-term partnerships.
Internet usage of Indian General Practitioners
General Practitioners (GPs) form a vital part of the medical fraternity in India
and are a major part of the pharmaceutical companies’ prescriber base. A rapid de
velopment has taken place in the use of Internet by the medical fraternity in I
ndia over a past few years and pharmaceutical companies have been making a lot o
f efforts to use Internet as a channel to connect to GPs both for marketing thei
r products as well as knowledge sharing. A survey was conducted involving more
than 100 GPs across 3 Indian cities to evaluate opinions and perceptions of the
Indian GPs on their professional use of Internet. This paper tries to analyse th
eir opinions and provide recommendations on how the industry can further use Int
ernet to improve their reach to GPs.
Discovery Metrics – Creating the Right Balance
Metrics can be powerful tools for driving performance, but the measurement of ef
fort and output in Discovery organizations is often felt to be in fundamental co
nflict with the need for the creative, unconstrained culture required to drive i
nnovation. In addition, many would argue that Discovery metrics largely fail to
yield benefits. This paper explores the reasons behind that, and looks at an app
roach to defining metrics that are ‘fit for purpose’.
Earned Value Management, an approach for effectively managing pipeline value
Life sciences R&D organizations have made advancements in managing the performan
ce of their development projects and portfolios, yet prioritization, resource an
d budget allocation, and the tracking of value creation remain hard to achieve.
This article argues that life sciences R&D organizations should adopt EVM, descr
ibes the benefits of applying EVM at the project level, and explores the potenti
al for additional benefits at the portfolio level.
Big Pharma R&D – thinking big, acting small
The pharmaceutical industry is experiencing an extended phase of consolidation i
n an attempt to realise economies of scale and mitigate risks. Kinapse analysis
suggests that Big Pharma might now be too big and shows how to break it into sma
ller operating entities to help increase R&D productivity.
Emerging R&D Opportunities: Making the Most of Latin America
Latin America is becoming an increasingly popular destination for the off-shorin
g of clinical trials. Advantages include cost savings, availability of clinical
trial patients, and high quality urban healthcare facilities. However many cha
llenges remain. This paper explores the landscape for clinical development in L
atin America.
Creating Value from the Portfolio: The Case for an Asset Value Mindset
Creating value from product portfolios remains a challenge. Future success will
be dependent on the adoption of an asset value creation mindset and the willingn
ess to adopt new business models. This article looks at new ways of thinking ab
out pharmaceutical assets.
Regulators Keep the Pipeline Flowing
Regulatory Affairs organizations have sometimes been viewed by colleagues as org
anizations with a negative perspective. However the best Regulatory Affairs org
anizations take a proactive, market-led approach, helping colleagues get to appr
ovals. It is the contention of this paper that, in the current industry environ
ment, pharmaceutical Regulatory Affairs groups should be designed to keep pipeli
nes safely open.
Opportunities for Global Pharmaceutical Companies in China
China’s pharmaceutical market is the ninth largest in the world and was estimated
to be worth US$19.2 billion in 2005. Many global pharmaceutical companies have e
stablished a presence in China but is this investment delivering results? This p
aper defines the Chinese opportunity and outlines 3 critical success factors fo
r global pharmaceutical companies hoping to optimize their investment
Improving R&D Operational Effectiveness through Offshoring
Presentation to Financial Times Global Pharmaceuticals and Biotechnology Confere
nce
India – Global pharmaceutical powerhouse-or contract research workshop?
With increasing scrutiny on budgets globalisation may offer a way of reducing co
sts in drug discovery. This paper analyses the opportunities for pharmaceutical
 development in India across the value chain.
Framework to assess feasibility of offshore BPO
Global Business Process Outsourcing (BPO) is projected to grow significantly. In
this paper, we focus on the feasibility of Offshore BPO which is a rapidly grow
ing segment of the overall BPO market.

Pharmaceutical Research Institutes in India

This paper provides the profiles of some of the leading medical and drug researc
h institutes in India. Thirteen such institutes, including hospitals, educationa
l institutes and research centres, have been profiled in this document.
Managing product benefit-risk in a challenging environment
Times have rarely been more challenging in the world of drug safety. The pharmac
eutical industry and its Regulators are under pressure to improve the benefit-ri
sk profiles of therapeutics, as further high profile safety issues become appare
nt. This paper argues that holistic risk management interventions need to be ini
tiated and tracked using improved evidence from healthcare data systems.
News
Kinapse to present at the 2009 Project & Portfolio Management in the Pharmaceuti
cal Industry Conference in Vienna, Austria
Friday, September 18th, 2009
Kinapse to present at the 2009 Project & Portfolio Management in the Pharmaceuti
cal Industry Conference in Vienna, Austria
London, UK (September 4th, 2009)
Kinapse are pleased to announce their role as collaborative partner and sponsor
of the 5th Annual Project & Portfolio Management in the Pharmaceutical Industry
Conference in Vienna, Austria on the 17th and 18th September.
New Website and Logo launch
Sunday, August 23rd, 2009
Kinapse is pleased to announce the launch of its new logo and Website. Kinapse
has grown considerably since its conception and to reflect the larger client bas
e and our diversifying capabilities, we have developed a new logo and branding.
Patient compliance is a major issue
Sunday, August 23rd, 2009The pharmaceutical industry loses $177 billion annually
as a result of poor patient compliance and adherence to medication. With avera
ge non-compliance rates hovering around 50% the industry urgently needs to find
ways of helping patients be morecompliant.