The Importance Of Regulatory Science In A Societal And Industrial Perspective

The Importance Of Regulatory Science In A Societal And Industrial Perspective

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Description: Regulatory Science vs Regulatory Affairs: - Regulatory Science focuses on the scientific underpinnings and concerns. Regulatory science is an emerging area of interest within pharmaceutical medicine as the shaping and implementation of legislation and guidelines. Regulatory affairs and regulatory law refer to the administrative and legal aspects including implementation, compliance, or enforcement of existing legislations/laws.

 
Author: Marianne Kock  | Visits: 270 | Page Views: 405
Domain:  Medicine Category: Biotech/Pharma 
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Contents:
The importance of regulatory science in a societal
and industrial perspective
Annual Conference CORS
24 November 2016

Marianne Kock, Head of Global Regulatory Affairs &
Managing Director, Ferring Pharmaceuticals A/S

In my office…..at Ferring…

1

Copenhagen Center for Regulatory Science
(CORS)
Regulatory Science:
The science of developing new
• tools
• standards
• approaches
to evaluate the efficacy, safety, quality and performance
of medical products
in order to assess benefit/risk and facilitate a sound and
transparent regulatory decision making.
1985: A literature search would not find “regulatory science”
2014: A search for “regulatory science” resulted in 200,000 hits
2

Regulatory Science vs Regulatory Affairs

‣ Regulatory Science focuses on the scientific underpinnings
and concerns. Regulatory science is an emerging area of
interest within pharmaceutical medicine as the shaping and
implementation of legislation and guidelines
‣ Regulatory affairs and regulatory law refer to the
administrative and legal aspects including implementation,
compliance, or enforcement of existing legislations/laws

3

Regulatory Science: ideas for the future
‣ Regulatory Science must keep pace with biomedical research
to develop safe and effective medicines/treatments to serve
the needs of the patients and the society and which are
available at reasonable cost to patients
‣ New and innovative regulatory pathway is needed for drug
approvals, otherwise the pharmaceutical industry investment
will dry out
‣ New and more clinically meaningful endpoint with patient
involvement needs to be continuously developed
‣ Understanding the biology of diseases will help to better
define patient population resulting in increased responder rate;
improving benefit/risk
‣ Patients may have different perceptions of risk than regulators
‣ Improve the science of benefit/risk assessment by engaging
the patients
4

Industry perspective: example
Acceptable

Non-acceptable

Quality
Pharmacology
Non-clinical
Clinical Phase 1
Clinical Phase 2
Clinical Phase 3

Patients reported
Outcomes (PROs)

Risk Management Plan

5

Full risk / benefit
evaluation by Agency:
Might be approval

Experience or
Science?
Final label

Industry perspective: example
Quality
Pharmacology
Non-clinical
V
Clinical Phase 1
Clinical Phase 2
Clinical Phase 3
Risk Management Plan

Not enough!
Label

Price dossier
Reimbursement
6

NICE /
insurance
comp. etc.
Launch and a new product for patient

Regulatory
Science

Drug development in the future
‣ The process of drug development must be more efficient and
serve a medical need
‣ Must be beneficial for patients, doctors and society

‣ Biomarkers may become one of the key tools in improving the
drug development. International consensus on the qualification
of biomarkers must be agreed upon (Regulatory science)
‣ Similarly, companion diagnostics allow to better target
treatments for patients
7

Regulatory dossiers should be global
‣ R&D is global in nature
‣ Significant differences in the approval process for clinical trials
and products in different countries/regions
‣ In spite of harmonisation, there are significant regional/national
differences in regulatory requirements
‣ Significant differences between approved labels in the different
regions
‣ Identical regulatory dossier may lead to approval or rejection by
the FDA and the EU

8

Transparency of data and its use …

‣ Rolling evaluation of new products
‣ Transparency of data will help regulatory science (companies /
universities) by identifying assumptions, judgements, and related
processes during the regulatory evaluation process
‣ Those involved in development of regulations & legislations

9

Paradigme shifts have started and will impact
the evaluation of new medicinal products
From Programmatic to Cognitive/AI
(“Augmented Intelligence”)
IBM Watson Health

1
From Selective Data Analysis to Big
- Broad collaboration with pharmaceutical companies, Data Driven Solutions
hospitals and research institutions
2
- Analytical access to +200 data sources
From Product Centricity to Customer
- Centricity and 95% of accuracy in diagnosis, treatment
Oncology: Solutions
3
recommendations
- Analysis of 10 years’ research documentation: 6 new
From Product to Platforms
molecules in 10 weeks
4
Kaiser Permanente
Integrated patient records, including behavioural data
5
- Seamless management of customers, personalized
Physicians
management and treatments
Hospitals
Biotech / VC

From Closed to Open and Networked
Innovation

Patients
Insurance companies
Universities

10

From new products to accessing new technologies and the review of these.
In today’s Pharma, internal research is partly replaced by access to external
innovation from universities, biotechs
New
and different other companies
opportunities

Other
indications

New products
for patients
New way of capture data to give added
value: APPs, instruments etc.
11
Henry W. Chesbrough, “Why Companies Should Have Open Business Models”, MIT Sloan Management Review, Winter 2007, Volume 48, Np. 2, p.27.

Where can regulatory science act in a
societal and industrial perspective
 Be part of making regulations/ guidance's based on regulatory science on
how and what to be included in future applications/dossiers
 Find way to embrace global development and find ways to make R&D global
 Speed up evaluations of new medicinal products. Agencies direct access to
data as they are made ( rolling submissions)
 Be part of evaluate biomarkers which can be used
 Combination products: products with , pen, apps, instruments, databases..

 CORS Regulatory Science :
"The science of developing new tools, standards and approaches to evaluate the
efficacy, safety, quality and performance of medical products in order to assess
benefit-risk and facilitate a sound and transparent regulatory decision-making

12

Vision, future, collaboration

Thank you for Universities
your
attention.
Pharma
companies

Agencies

Customers/
patients

Looking forward to the collaboration..
13