Speid and Associates is a Regulatory Affairs and Drug Development Consultancy Company. (Slides produced in 2010)

1. Speid & Associates, Inc.
Consultancy Services, Inc.
Lorna Speid, Ph.D., RAC
President
Speeding New Drugs to Market®
www.drugstomarket.com

2. Speid & Associates, Inc.
 Speid & Associates is a regulatory affairs
and drug development consultancy
- Dr. Speid is the principal consultant
- Associates with extensive experience in
regulatory affairs and drug development
are placed on projects as needed
- The associates are based in different
countries as well as in the United States –
most have some large pharma
experience

3. Speid & Associates, Inc.
 The company is a US-based California
corporation
 The clientele is US-based and international
 The company has collaborations and
partnerships with other reputable
companies to provide high quality services
in relevant areas of drug development to
Speid & Associates clients

4. Dr. Speid’s Credentials
 Registered UK Pharmacist
 B.Pharm.(Hons.) – King’s College, London University
 Ph.D. from University of Wales & Centre for Medicines
Research International (UK)
 Experience working for a number of international
pharmaceutical companies, including:
- Sanofi-Winthrop (UK)
- Ciba-Geigy/Novartis (HQ - Switzerland)
- GeneMedicine/Valentis, Inc. (US) - Dir. Reg Affairs
- NewBiotics (Officer of the Company), VP Regulatory Affairs &
Project Management [incl. clinical & QA])
- Avera (Officer of the Company), VP Regulatory Affairs

5. Dr. Speid’s Expertise
 Dr. Speid has very broad-based experience
- with international pharmaceutical industry
- as core team member of international project teams in large and small pharmaceutical
organizations
- setting up and managing project teams, including virtual teams
- with FDA and health authorities worldwide (CDER & CBER)
- with all major health authorities worldwide
- With INDs, MAAs, NDAs, CTDs
- Document management oversight experience
- Appeals procedures
- Has set up and monitored clinical trials in past, and therefore understands the clinical
process
- Good understanding of challenges faced by small and large companies – ability to
address these to optimize the potential for success in the small company setting
- A summary of case studies is available towards the end of this
presentation

6. Dr. Speid’s Bio
Lorna Speid, B.Pharm. M.R.Pharm.S., Ph.D., RAC is President of Speid &
Associates, Inc. a regulatory and drug development consultancy based in San
Diego, California. She works with small and large pharmaceutical companies,
assisting them at the various stages of the drug development process, including
European strategic regulatory affairs.
Dr. Speid began her career as a pharmacist in the UK, after which she completed
a Ph.D. at the Center for Medicines Research International, into the Safety
Assessment of Medicines, Pre and Post Marketing. She has worked for large as
well as small pharma companies, including Sanofi Winthrop in the UK (now Sanofi-
Aventis), Ciba Geigy and Novartis in Switzerland. Small companies that she has
worked for include Valentis, Inc., NewBiotics, and Avera, Inc., the last two
companies at Vice President of Regulatory Affairs level.
She has a Bachelor of Pharmacy degree from the University of London, and a
Ph.D. from the University of Wales, College Cardiff.Document management
oversight experience.
Dr. Speid is the author of Clinical Trials: What Patients and Healthy Volunteers
Need to Know – published by Oxford University Press.

7. Associates
 US and international located
 Wide range of skillsets [drugs, biologics,
diagnostics, devices, statistics, clinical,
marketing, EU/US/international]
 Experienced regulatory and drug development
professionals
- Most have large pharma experience
- Most have achieved Vice President level or Sr.
Director level
 Associates are assigned to projects as needed

8. Why Hire Us?
We believe that a
successful development
program requires more than
serendipity or luck
--- We have a proven track
record of past
achievements

9. Why Hire Us?
We work with our clients to
achieve successful global
registration, as
expeditiously as possible
--- help the client to put the
pieces of the development
jigsaw together
successfully.

10. Why Hire Us?
We can help you to
determine what your next
move should be with a NCE
or established drug,
biological, device or
diagnostic

11. Why Hire Us?
We can ‘jump start’ a stalled
program:
-Clinical holds
- Rejected marketing
applications (for any health
authority in the world)
-Dr. Speid has appeals
experience and a
proven track record of
success in this area

12. How We Work
 Strategic
 Tactical
 Hands-on
 We can work on location or remotely
- Our clients are as far away as in Australia, or as
local as San Diego
 Dr. Speid is available to act as a consultant
Vice President of Regulatory Affairs on an as
needed basis

13. Types of Customers
 Customer base
- Small companies
- Large pharma
- US based companies
- Companies in Canada, Europe, Australia and rest of
world
- Venture capital organizations
- Analysts
- Angel investor organizations
- Financial institutions, including Wall Street

14. Overview of Services
 Clinical trial applications – for individual
European countries, and other countries
 Investigational New Drug Applications
 Orphan Drug Applications
 New Drug Applications (electronic and paper
Common Technical Dossier formats)
 Marketing Authorization Applications
(electronic and paper Common Technical
Dossier formats)

15. Overview of Services cont.
 Abbreviated New Drug Application (ANDA)
 Premarket Approvals (PMA)
 510k applications
 505(b)(2) applications
 Fast Track applications
 Development of meeting strategy and briefing
package preparation
- End of Phase 1 / End of Phase 2 meetings
- Pre-NDA meeting

16. Overview of Services cont.
 Special Protocol Assessment strategy development
 Special Protocol Assessment preparation
 Pediatric strategy development
- US
- Europe
- International
 Marketed product support
 Postmarketed product support
 US Agent services for ex-US companies

17. Overview of Services cont.
 Regulatory authority meeting strategy
development
- Pre-IND
- Pre-IDE
- End of Phase 2 meeting
- Informal discussions with reviewers
- Pre-NDA meeting
- Meetings during NDA / Marketing Authorization
Application review

18. Overview of Services –
Types of Projects
 Drugs (small molecule)
 Biologics (large molecule)
 Gene Therapy
 Medical Devices
 In vitro Diagnostics
 Combination Products
 Generics
 Due Diligence
 Quality Assurance including audits [through partners]
 Strategic medical writing

19. Overview of Services –
Therapeutic Areas
 Experience with many therapeutic areas,
including:
- Anti-infective
- Oncology – gastric, colorectal, pancreatic, head and
neck, hematological
- Respiratory
- Women’s health
- Dermatology
- Anti-inflammatory and immunological diseases
- Central nervous system
- Bone

20. Overview of Services – Due
Diligence
 Conducted for companies, VCs and financial
institutions
- Review of company strategy
- Review of the compounds
 Extensive review of documents, including regulatory
correspondence
 Review of regulatory actions, e.g. warning letters
- Assessment of the company systems and management team
- Assessment of risk and probability of success
- Assessment of the regulatory hurdles, and time to market
- Preparation of report

21. Overview of Services -
Clinical
 Review of Summary Bases of Approvals
 Preparation of INDs, CTAs, IDEs
 Set up clinical trials
 Writing of Investigator’s Brochures
 Writing, editing or review of Protocols
 Submissions to IRBs and FDA
 Preparation of Informed Consent Documents
 Writing, editing and/or review of clinical study
reports

22. Overview of Services –
Devices and Diagnostics
 Strategic and hands-on
 US and European
- Relationship building with FDA
- Relationship building with Notified Bodies
 Rest of the world
 Health authority meeting requests and
preparations
- Briefing package preparations
 Clinical protocol design and preparation
 IRB/ethics committee liaison

23. Overview of Services -
INDs
 Assistance and advice in clinical hold situations
 Regulatory due diligence for licensing-in or
licensing-out situations
 Preparation of IND Annual Reports
 Advice regarding Quality Assurance issues
 Preparation of IND safety reports
 Preparation of INDs in the new eCTD format
 Preparation of INDs in the older 9 section
format

24. Overview of Services –
Clinical Trial Applications
 Expertise in new European Clinical Trial
process [European Clinical Trial Directive]
- Conversion of US IND to European Clinical Trial
Application
- Clinical trials for Russia and other Eastern
European countries via partners
- Clinical trial applications for China via partners

25. Overview of Services –
Toxicology
 Review of toxicology guidelines
 Development of toxicology strategy
- Acute toxicology study designs
- Sub-chronic toxicology study designs
- Chronic toxicology study designs
- Reproductive toxicology study designs
- Carcinogenicity study designs and strategy
 Liaison with major toxicology houses
 Preparation of toxicology protocols
 Review of toxicology reports
 Development of Pre-IND meeting strategy and
discussions with health authorities around the
toxicology issues

26. Overview of Services –
electronic CTDs
 Building of global eCTD strategy
 Organization of the internal and external
project teams
 Interpretation of the guidelines for the
compound in question
 Organization of discussions with Health
Authorities
 Publishing strategy derivation
 Expert writing

27. Global and International
Regulatory Affairs
 See separate presentation about this service
offering:
- Europe
Japan
- USA
- South Africa
- Australia
- Eastern Europe
- South America
- Africa and Middle East
- Asia including China and India

28. Partnerships
 Speid & Associates, Inc. has partnered with several
organizations in various parts of the world to bring
services to our clients. Please ask if you would like
additional information about the following:
- Life science services based in China – all aspects are available
- Document management services
- Clinical Research Organizations
- GLP toxicology services
- Analytical services
- Bankers, auction specialists, and fund raising specialists – preclinical -
Phase 2 data
- Specialized predictive individualized therapy services – for oncology and non
oncology drugs
- Notified Bodies

29. Case Studies
 Dr. Speid worked with a small virtual organization to develop the
regulatory strategy for a combination product . This involved being the
main point of contact for the Division Head at FDA. Dr. Speid was
instrumental in ensuring that the virtual team understood the
requirements for the product development concept. She wrote the Pre-
Investigational Drug Exemption meeting request and the Pre-
Investigational Drug Exemption briefing document.
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 Dr. Speid worked with a late stage company that was licensing in a drug
with a large amount of disorganized documentation. She created an
internal document that identified the document management needs of the
organization. Several vendors were brought into the company to present
their services. The best document management vendor was selected
after internal support was garnered for the document management
system.

30. Case Studies
 Dr. Speid created an NDA plan for a pharmaceutical company which had
licensed in a late stage haematological drug. Detailed operating plans
were put into place which included expert author meetings to assure the
creation of effectively written sections of the New Drug Application in
eCTD format.
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 Dr. Speid worked on a regulatory and development strategy for an ocular
implant combination product. This involved liaising with the combination
division and the drug division within the FDA to seek advice on the
appropriate registration pathway in the absence of guidelines. Clear
guidance was provided to the client to clarify the development and
registration pathway.

31. Case Studies
 Negotiated with health authorities as part of key regulatory meetings to
avoid the need to repeat or to conduct new toxicological studies. This
saved the company at least 6 months and approximately 500, 000 USD.
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 Acted as the US Agent for a German company. Filed safety reports to the
FDA for two studies that were ongoing in Germany.
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 Developed a regulatory strategy for a pediatric development which
involved US and European pediatric development for a monoclonal
antibody. This included consideration of the use of a parallel advice
procedure between the US and Europe.
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32. Case Studies
 Wrote a strategic briefing document for a large and mid-size
pharmaceutical company for a drug intended for an autoimmune disease.
This document was used as the basis for a meeting with the FDA. The
meeting was successful and opened the way for a potential approval.

33. Contact Information
 Dr. Lorna Speid
- Telephone 858 793 1295
- Cellphone 858 531 6640
- Email: lspeid@sndtm.com
www.drugstomarket.com