Transcript Strategic Science and Technologies Presentation

Consulting for Life Sciences
Capabilities Discussion
Strategic Science
and Technology
October 14, 2014
www.novuslife.com
Confidential
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NovusLife: Who we are.
Andrew J. Young
Chief Executive Officer
Andrew has 20 years of experience in the technology and
biotechnology service industries. He is an experienced entrepreneur
and leader that has spent his career assisting both startups as well as
Fortune 500 companies solve complex project and resourcing issues
to help bring medicines to market. He founded NovusLife with values
and principals to help patients in need.
James E Shipley, MD
Head of Clinical Services
Dr. Shipley brings 20+ years of drug development experience to
NovusLife. Dr. Shipley has been a key contributor for more than 30
drug development programs, resulting in 5 FDA drug approvals. Dr.
Shipley’s career includes extensive experience in clinical operations,
pharmacovigilance, regulatory activities and quality assurance, as
well as pharmacology and toxicology.
www.novuslife.com
Confidential
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NovusLife: Who we are.
Philip T. Lavin PhD, FASA, FRAPS
Executive Strategist
Dr. Lavin is a well-known clinical development professional with a
long history supporting clinical trials. He has been involved in 50 FDA
approvals to date including 38 PMAs (inclusive of PSA and CA-125).
He has presented multiple studies to regulatory agencies in defense
of design and approval. He has won multiple awards from
professional societies. He co-founded Boston Biostatistics in 1983
now known as Aptiv Solutions.
Neal Mantick
Principal Consultant, Clinical Evidence
Neal contributes nearly 30 years of experience in pharmaceutical
product development. For the past 20 years, he focused on the
design and management of a wide variety of global, clinical research
and commercialization programs, such as observational research
studies and patient registries, which helped to expand physician and
patient access to new, innovative drug products.
www.novuslife.com
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NovusLife: Who we are.
Stephen Amato, PhD MBA RAC
Head of Regulatory Services
Dr. Stephen F. Amato has 25 years of experience in the
pharmaceutical, biotechnology and medical device industries. In
addition to his role as Head of Regulatory Services at NovusLife, he is
a Senior Faculty member in Regulatory Affairs at Northeastern
University. Dr. Amato’s has extensive experience in BLA, IND,
505(b)(2), 510(k), and PMA FDA regulatory submissions. He is also
experienced with EU regulatory affairs including CE-marking, and
submissions to the European Medicines Association (EMA).
Howard Adamsky
Manager of Client Fulfillment
Howard Adamsky has been deeply involved in
resourcing for over twenty years. As a leader, writer and
public speaker, Howard, works with organizations to
support their efforts in building great project teams.
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NovusLife: How we work.
• We seek to be an extension of your existing team; we are not a
CRO.
• We have a deep pool of thought leaders and experienced staff who
are proactive, dedicated, and team oriented.
• We will work within your existing organizational structure,
procedures, and timelines OR we can recommend a solutionsoriented program plan.
• We will demonstrate flexibility and responsiveness in our scope of
work and offer solutions only if requested.
• We operate under the principle that this is "your show and your
rules”.
www.novuslife.com
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NovusLife: Where we offer solutions
NovusLife helps companies throughout their entire drug development programs.
Documentation
Systems
Ongoing
Validation
Pre IND
Phase
Commercial
Manufacturing
QA / QC
Process
Optimization /
Product Stability
GxP CMC Systems
QA / QC Systems
Phase I – II
Clinical Trials
Regulatory
Submission
and Approval
Phase III – IIIb
Clinical Trials
Pharmacovigilance
Pharmacovigilance /
/ Post- Marketing
Commitments /
Commitments /
Phase IV Clinical
Phase IV Clinical
Trials / Registry
Trials / Registry
Supporting
Studies:
HEOR, etc.
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Why NovusLife?
NovusLife can help you design and implement the strategies and programs required to support the
development and launch of your drug product(s).
Benefits to clients:
• We are part of your team.
 You keep full control over your projects, meet your timeline and budget milestones, and
achieve your corporate goals.
• We help you create an efficient roadmap toward the approval, launch, and optimal
uptake of your new product.
 Engage the appropriate stakeholders early and often to identify and gather the most
important clinical evidence.
 Set the guardrails within which your research vendors (e.g. CROs, EDC, etc.) operate.
 Anticipate emerging issues and possible detours along the clinical development path and
apply the right solutions.
• We can lead clinical development projects from inception through completion – or
support specific steps in-between based on your requirements.
 Ensure continuity of goals and action plans among your vendors and stakeholders along the
research path.
 Avoid the pitfalls of missed opportunities.
www.novuslife.com
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NovusLife: Where can we help?
www.novuslife.com
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Address:
Phone:
Email:
NovusLife, LLC
1344 Main Street
Waltham, MA 02451
781-790-8145
[email protected]
[email protected]
[email protected]
Andrew Young’s Cell:
617-852-9803
781-996-3676
Facsimile:
www.novuslife.com