the size of the
dedicate to managing multiple outsourcers, hence, the
real value in utilizing a “one
stop shop” provider. Previously
larger clients have often had access to a wide
range of their own internal resources so could more easily
select and manage services from multiple providers. However
presently the trend is toward strategic engagements, leveraging as many services as possible from one provider. The
breadth of services within Almac lends itself to this trend.
Boyer: Yes. The M&A activity suggests several companies
are building a broad range of services to offer within one
portfolio. Examples are CML/AAI Pharma, Confab and DPT,
Aenova and Haupt, etc.
Berger: The answer is both! Some companies are choosing
to focus on specialization to really help provide valuable solutions to pharma partners for better products and better supply
with expertise and technology. Others are putting together a
broad array of services to capitalize on the consolidation of
supplier bases by big pharma and consolidation in the pharma
industry as a whole. We feel that Catalent is unique in its scale
and ability to do both. We specialize in several major areas and
are able to provide unique drug development, delivery technology and supply solutions at large scale in many different fields.
These include complex oral dose form development, technology and supply, biologics development and clinical solutions,
clinical supply services worldwide and other specialized areas.
Catalent is also unique in the field in providing global regulatory
services to our clients to support their product development
and global commercialization needs. Clients are seeking a CMO
that identify and solve problems to help ensure that client projects stay on track and on budget. This allows us to partner on
large scale with nearly all top innovative biotechs and biopharmaceuticals, as well as generic companies.
Pharmaceutical Processing: Do you feel the pace of
pharmaceutical outsourcing will continue at its cur-
rent rate? Will it increase or decrease?
Downey: You only have to read the pharmaceutical head-
Pharmaceutical Processing: What specific qualities
do pharmaceutical companies look for in a contract
David Downey, VP Commercial Operations, ALMAC: Ease
of engagement is a key quality to any sponsor to contractor
relationship. We at Almac are here to make our client’s lives
as simple and straightforward as possible, with our level of
repeat business testimony to this approach. Technical knowledge and process experience, with expectations and responsibilities clearly communicated and planned, are vital for both
parties and will determine the success of any engagement.
Milton Boyer, President, OsoBio BioPharmaceutical
Manufacturing: The specific quality is “fit.” Fit has many definitions and permutations as each company and/or project is
unique. Quality is of paramount importance, but the CMO and
Drug Sponsor need to have complimentary quality systems.
Next would be capabilities, then speed or timing. Finally
price, far too often, is the ultimate deciding factor.
Elliott Berger, VP Global Marketing & Strategy,
We believe that there are two principal drivers
in the selection process. Firstly, whether the out-
sourcing partner can genuinely add value in terms
of experience, expertise, capabilities and technolo-
gies. In Catalent’s case, we have invested $1B over
the last five years and continue to invest $100MM
in capital ever year to broaden our capabilities, en-
hance global capacity, add new drug delivery tech-
nologies and differentiate our offer.
Secondly, pharma companies are looking for quality and reliability from their outsourcing partner.
Catalent has established a world-class manufacturing
and supply network with rigorous cGMP, EHS, security and
operational controls implemented throughout. We currently
supply 70 billion doses and 240,000 shipments annually to
over 80 countries and our inspection outcomes are three
times better better than the industry average. Our quality
systems and regulatory expertise ensure that we are accredited by over 30 global agencies.
Pharmaceutical Processing: Is there a trend towards
specialization or diversification amongst contract
manufacturers? Are sponsors looking for a “one
stop shop” for all their needs?
Downey: Historically this has often been determined by
■ By Mike Auerbach, Editor in Chief
Pharmaceutical Processing discusses current and future
outsourcing trends with a select group of companies
is a key