DCAT - Drug, Chemical & Associated Technologies Association

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BOARD OF DIRECTORS

PROGRAM MANAGEMENT COUNCIL

Education Committee Survey
Please respond by: April 4, 2008

Thank you for your interest in this survey. The DCAT Education Committee is interested in better meeting your business development needs. We are conducting this survey to augment our understanding of your educational priorities. Respondents will be entered into a drawing to win a $25 Visa gift card.

Respondents:

Section I will provide us with general demographic information so we can understand who is responding to our survey and segment the answers accordingly. Section II will address your interest in potential program topics.

Section I

Required information:

Name:

required

Company:

required

Have you ever attended a DCAT Education program? Yes No

1) Which market segment do you represent?

Ethical Pharmaceuticals Manufacturer

Generics Pharmaceuticals Manufacturer

Nutraceuticals Manufacturer

Raw Material & API Manufacturer

Excipient Manufacturer

Chemical & Ingredient Distributor

Other Distributor

Equipment Manufacturer

Packaging Materials/Packager/Contract Packaging

Other:

2) What is your job function?

Sales/Marketing

Purchasing/Sourcing

Technical (i.e R & D, Manufacturing, Analytical)

Management

Other:

3) I work for a company with sales of:

Less than $15 million

$15-$50 million

$50-$100 million

$100-$500 million

$500 million-$2 billion

$2 billion +

Section II

How likely are you to attend a course on the following subjects?

1) Outsourcing of Potent Pharmaceutical Chemicals and Products
Recently the pharmaceutical industry has seen an increasing trend of outsourcing R&D and manufacturing operations, where the products are more potent. This course will offer business, legal, and environmental health and safety perspectives including lessons learned from drug innovators and CMOs. The session will include case studies from drug innovators and answer questions on what contracts should contain, due diligence, and how to identify a CMO to safely manufacture a potent compound. Hear from CMOs on development scale issues; policies and procedures; certification; and containment requirements.

Very likely

Somewhat likely

Not of interest

2) Key Success Factors in Managing Alliance Partners
This course will focus on managing business relationships with alliance partners. Topics to be covered include approaches to managing relationships; essential tools and skills (decision making, conflict resolution, negotiations); legal and business constraints (contracts, competition, IP); real life examples. This course would benefit industry professionals who want to improve relationship management skills.

Very likely

Somewhat likely

Not of interest

3) Successful Supplier – Customer Outsourcing Relationships
This course will provide an overview of the keys to successful supplier relationships. Topics will include: Choosing the right partner; Preparation of proposals; Preparation of Technology Transfer packages; Effective communication methods; Overcoming cultural, language, time zone difference; Evaluating and providing feedback after project completion.

Very likely

Somewhat likely

Not of interest

4) Pharma and Skincare - a striking resemblance!
This course will provide an overview of the skincare industry, including categories of skin care products and their use, the regulatory environment which differentiates cosmaceutical products from OTC cosmetic drug products and dermatological and what constitutes a cosmetic active ingredient vs an OTC cosmetic/drug active ingredient and the functional categories of inactive ingredients used in typical formulations. Similar to pharmaceuticals, we see that active ingredients used in OTC cosmetic/drugs and dermatological are subject to FDA regulations with regards to cGMP manufacturing and claim substantiation, whereas active ingredients which are used to support only cosmetic claims are not. Examples are anti-oxidants, anti-aging, UV-filters, tanners, etc. Life cycles of products in this market segment are typically much shorter than for pharma and with requirements and filing for these products nearing the scrutiny of pharma, participants will learn about the dynamics in this high paced industry.

Very likely

Somewhat likely

Not of interest

5) The Impact of State Regulations on the Pharmaceutical & Chemical Industries
This course will provide an overview of state enacted or proposed regulations affecting the chemical and pharmaceutical industries and how companies can best handle multi-state regulatory issues. Topics to be covered include State Right To Know laws, Florida Drug and Cosmetics Act, California proposed “Green Chemistry” Policy, California Pedigree Law and the EU proposed GMP regulations for excipient manufacturing. The course will look at compliance issues with current, as well as proposed, regulations and how to keep abreast and manage the evolving regulatory environment.

Very likely

Somewhat likely

Not of interest

6) Emerging Technologies in Process Development
This course will provide an overview of new technologies that are of growing interest in the chemical and pharmaceutical industries. Possible discussion topics will include: PAT Tools; Biocatalysis; Green Manufacturing; Continuous processing; Microreactors; SMB and other large-scale chromatography methods. Ideal for those involved in the areas of procurement, sales & marketing, and business development who need to stay abreast of the principles and technologies used by industry for large-scale manufacturing.

Very likely

Somewhat likely

Not of interest

7) Incubator sites
This course will explore the types and locations of incubator sites; outline how to establish a company in an incubator site; review assistance programs from government agencies; analyze alternate ways of financing the operations; provide case study analysis of companies that have set up incubator sites.

Very likely

Somewhat likely

Not of interest

8) API Sourcing of Specialty Pharma
Specialty pharmaceutical companies, defined as companies with development of targeted therapeutic areas, offer select opportunities for contract manufacturing organizations. This discussion would analyze specialty pharmas’ supply chain and manufacturing strategies. Discussion could include costs and benefits of global API sourcing, strategies for managing customs, implementing a global pricing scheme, and optimizing costs.

Very likely

Somewhat likely

Not of interest

9) Strategic Sourcing Summit & Showcase: This two-day course offers presentations with focuses on topics related to supply management and procurement. Please describe in the space below the topics you would like to see covered:

10) Nutrition & Health Forum:
This two-day course offers presentations that focus on topics related to supply management and procurement specifically for the dietary supplement industry. Please rank the topics below that you would be most interested in attending. (5 being most interested and 1 being least interested)

a) New Products - Nutritional Ingredients

b) Research Update on Nutritional Ingredients (such as clinical protocol, largest current study, expert opinion, etc)

c) Health Claims

d) GMP or Regulatory Topics

e) Other topics

11) Please rank the potential program topics below that you would be most interested in attending: (5 being most interested and 1 being least interested)

a) Industry M&A activity with a focus on Asia-Pacific region

b) New developments in synthesis. Production of intermediates & APIs for the Pharmaceutical Industry

c) Working with cultural differences

d) Industry job trends, US and global

e) Industry trends & general market info

f) Packaging, new regulations and techniques in the drug industry

g) Intellectual property environment in the US, Europe, China and India

h) Annual generic update, e.g. Waxman-Hatch, exclusivity period, orphan drug program, cross-border issues, patent litigation & special issues, etc.

i) America’s healthcare system and its impact on the pharmaceutical industry

j) New FDA guidelines for inspections of chemical facilities

12) Please advise us on any additional topics or speakers that would be of interest to you. Please be as specific as possible.

Thank you for participating! Your input will be reviewed by the Education Committee and used to formulate future programs. Please click the button below to submit your survey and to be entered into the drawing for a $25 Visa gift card.