consulting for life sciences 1 confidential october 14, 2014 strategic science and technology...
TRANSCRIPT
Consulting for Life Sciences
1Confidential
October 14, 2014
Strategic Science and Technology
Capabilities Discussion
www.novuslife.com
2
NovusLife: Who we are.
Confidentialwww.novuslife.com
Andrew J. YoungChief Executive OfficerAndrew 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, MDHead of Clinical ServicesDr. 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.
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NovusLife: Who we are.
Confidentialwww.novuslife.com
Philip T. Lavin PhD, FASA, FRAPSExecutive StrategistDr. 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 MantickPrincipal Consultant, Clinical EvidenceNeal 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.
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NovusLife: Who we are.
Confidentialwww.novuslife.com
Stephen Amato, PhD MBA RACHead of Regulatory ServicesDr. 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 AdamskyManager of Client FulfillmentHoward 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.
5Confidentialwww.novuslife.com
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 solutions-oriented 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”.
6Confidentialwww.novuslife.com
NovusLife: Where we offer solutions NovusLife helps companies throughout their entire drug development programs.
Pharmacovigilance / Commitments /Phase IV Clinical Trials / Registry
GxP CMC SystemsQA / QC Systems
Documentation Systems
Ongoing Validation
Process Optimization /
Product Stability
Regulatory Submission
and Approval
Commercial Manufacturing
QA / QC
Pre IND Phase
Phase I – II Clinical Trials
Phase III – IIIb Clinical Trials
Supporting Studies:
HEOR, etc.
Pharmacovigilance / Post- Marketing Commitments /Phase IV Clinical Trials / Registry
7Confidentialwww.novuslife.com
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.
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NovusLife: Where can we help?
Confidentialwww.novuslife.com
Phone:
781-790-8145
Facsimile:
781-996-3676
www.novuslife.com
Address:
NovusLife, LLC1344 Main StreetWaltham, MA 02451
Andrew Young’s Cell:617-852-9803
Email: