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Commissioned
White Papers
Popular with our clients, white papers are a valuable way to
- present company strategy
- distinguish a technology or product
- present interesting and informative case
studies
- market to potential customers,
clinicians, partners and investors
Please give Dr. Hardin Young a call at
617-275-8845, ext. 3 to discuss your specific needs.
Complimentary PBC
White Papers
Our own complimentary white papers shed light on factors that we find
important to
the progress and success of applied bioscience. We hope you find
them interesting and informative. Also, don't forget our podcasts!
Please contact
us if you have any questions or any difficulty accessing the
document(s). Click the associated
link to download or use the white
paper request form to receive
the document by return e-mail.
Positioned
for Success: Building a
Biological Product Using a High-Value Preclinical Plan
Today’s
biotechnology executive charged with the development of a novel
biological product is faced with producing scientific validation,
innovation and ongoing forward progress on an aggressive timeline and a
limited budget. The natural response to this challenge is to
focus preclinical discovery and development on getting to the clinic as
quickly as possible. Yet this tactic often drives the development
process past one of the most influential factors for success, the
preclinical research plan. This white paper will explore several
ways a high-value preclinical research strategy can enable a company to
progress with greater overall speed and efficiency, reduce development
risk, and overcome road blocks in the development of novel biological
products.
Biological products are biologics
that contain a biological component such as cells or structures that
influence cell behavior. Biological products include cell and
tissue transplants, cellular therapeutics and products from tissue
engineering. By their nature, they encompass multiple biological
aspects and often, structural components as well, creating a unique
series of challenges.
Gathering the skills needed to
implement a high-value preclinical research and development plan is
well worth the effort and will provide both time and cost
savings. The old adage “pay now or pay later” applies. At
the end of the day, regulators will expect answers to key questions and
the clinical response will be an even tougher task master. Having
to fill in missing science or re-engineer even a portion of a product
strategy or process after you have begun clinical testing is not only
costly, but also difficult to do. Weaknesses in strategy tend to
escalate and second chances are rare. A high-value preclinical
plan ensures that the company puts its best foot forward.
Reducing Risk in Bioscience Development: Closing the Information to
Knowledge Gap
Top
biotechnology R&D executives maintain the vision of the company and
often represent the most knowledgeable and experienced members of the
team. In most biotechnology companies, the future success of the
company is often riding on their decisions. Their decisions must
be informed, astute and insightful. Productive insight is the
definition for breakthrough and a company looks to its scientific
leadership to provide that insight, set a productive pipeline strategy,
make its products, and keep it competitive.
But today’s senior R&D
executive is faced with the challenge of
turning a continuous stream of information into knowledge that can help
them set the right direction and fuel progress in their programs.
There is often a gap between the kind of insightful knowledge one needs
and the information gathered – the information to knowledge gap.
This is compounded by today’s world of technology, where the shear
amount of data that is generated and reported can prove overwhelming,
making the assimilation of information ever more critical. This
white paper discusses ways bioscience companies can improve the quality
and efficiency of translation of information into pertinent knowledge
to yield the insight needed for better strategy, decisions, and
direction.
Common
Factors
Impacting the Utility and Commericialization of any Cell Therapy
There is no denying that cell
therapy has the potential to be one of the most powerful therapeutic
options one can administer. Cell therapy can take several forms
and serve many purposes. A cell therapy may be used to alter normal
cell response, stimulate or reset a native signaling cascade, perform a
missing metabolic function, restore lost tissue, or change the normal
course of repair into true regeneration. Designing and
implementing a plan for commercialization can take many paths, each
with their own set of biological, technical and regulatory
considerations. However, there are some common factors that will
impact the clinical success and commercialization of any cell
therapy. This brief overview outlines a few of the basic factors
that will determine safety and efficacy.
Eight Ways
To Evaluate Emerging Clinical-Stage Biotechnology
Ready or not?
Clinical trials are generally
viewed as a sign that a company has
progressed to the next stage and investors usually perceive it as very
important validation of a technology and team. Entry into the
clinic can be a very positive, progressive step but it can also be a
costly step towards a
company’s end. Are there indicators that can discern the fundamental
readiness or quality of yet "unproven" technology? In many cases,
yes. Here
are a few analytical steps companies, potential partners, venture
investors and investment analysts can take to get a better read on
whether those plans for clinical testing will yield durable progress or
a potential pratfall.
How to Make the
Transition From Academic Research to Biotechnology:
Twelve Traits of an
Outstanding Industrial Biologist
Whether a scientist is a
postdoctoral fellow
contemplating his or her next move, a distinguished professor
considering
that big industry offer, or a new founder of a
biotech
start-up, a savvy appreciation of how science and research differs in
industry can make a person a more valuable player in their company and
their field. The right approach to industrial pursuit can ease the
transition and
help achieve a successful and personally rewarding career in
industry.
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