Advanced Clinical Announces Bernice Welles as a Core Member of its Strategic Advisory Ecosystem

Advanced Clinical, a leading provider of clinical research services, announces Bernice Welles as a core member of its strategic advisory ecosystem.

Bannockburn, Ill. (Vocus) September 30, 2010

Advanced Clinical, a leading provider of clinical research services, announces Bernice Welles as a core member of its strategic advisory ecosystem.

As a strategic advisor, Bernice Welles has contributed to Advanced Clinical’s Industry Leading R&D Performance (ILRDP) framework that seeks to make the “business of R&D” more effective and efficient for Life Sciences companies. Bernice has been a key driver in the development and regulatory approval of drugs, biologics, devices as well as combination therapies across multiple therapeutic areas. “Moving a drug and/or biologic from development to approval is, possibly, the hardest earned process in the Life Sciences industry,” says Bernice Welles, Advanced Clinical Strategic Advisor.

Welles’ accomplishments span several leadership roles in companies at different stages of growth. At Genentech, Welles was appointed to several management positions to drive the drug and biologics development portfolio across multiple therapeutic areas. Two of Welles positions included: Senior Director of the Specialty Therapeutics Unit and Vice President of Product Development. One important program that Welles progressed was the Lucentis injection for wet age-related macular degeneration (AMD). AMD is a disease of the eye that is the leading cause of blindness in older Americans and causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities. By moving forward this program, several thousand patients were able to be treated.

Welles held a Venture Partner position at MPM Capital LLP, where she participated in discussions on medical devices and helped assess device instruments. At MPM, Welles also took the lead on several investments and helped portfolio companies such as CoTherix maneuver the regulatory process leading to an early approval for Ventavis®, a new therapy for pulmonary hypertension.

Welles currently holds executive positions as CEO of Alquest Therapeutics Inc. and Vice President, Clinical and Regulatory, of Enject Inc., both innovative biotechnology startup companies.

With years of experience heading teams across functional areas, Welles credits integration as being one of the keys to her success. Using her capability to integrate the knowledge she has gained during her career, Welles is able to pull together all of the elements of clinical and regulatory as well as leverage the science behind development programs to create a significant, positive impact on the Life Sciences industry.

“I am proud to be working with Advanced Clinical,” said Bernice Welles. “Being part of this expert strategic advisory team allows me to continue to work with a topflight team to create new levels of R&D Productivity for companies in Life Sciences and bring much needed treatments to the market for those who need them.”

About Advanced Clinical: Advanced Clinical provides consulting services, strategic sourcing (CRO), talent management, and technology solutions to the Life Sciences industry. With 15+ years of experience, Advanced Clinical is an established presence in the clinical research field, providing services specifically for Pharmaceutical, Biopharmaceutical, Biotechnology and Medical Device organizations. Advanced utilizes a value-based, “One Team” approach. To learn more, visit http://www.advancedclinical.com/.

Contact:
Rosemarie Truman
rtruman@advancedclinical.com
1200 Lakeside Drive
Bannockburn, IL 60015
Ph: 202-438-2208

Advanced Clinical is Making a Difference in Talent Management

We are pleased to provide vital talent for companies and meaningful career opportunities for clinical research professionals.

We offer talent management services through contract staffing, direct hire placement, executive search, and payrolling (“asset transfer”). These different talent acquisition paths allow Advanced Clinical to effectively and efficiently connect talent to career opportunities within the clinical research industry. Our ability to provide and manage talent directly impacts their clients’ R&D success. For candidates, we offer a “career platform,” giving them not only employment, but also the chance to:

• Make a difference
• Become a star
• Provide insight
• Be part of an exceptional, topflight team
• Pursue their dreams
• Grow personally and professionally

Some of our consultants’ experiences are described below:

Tim, whom we placed as a Clinical Project Manager, said, “[Advanced Clinical is] very much focused on building relationships, finding out where my interests lie, and where my needs are.”

Buddy, whom we placed into Clinical Data Management, said, “I’ve been very pleased to work with Advanced Clinical because I feel that they are very well connected and understand the industry. Advanced Clinical has helped me not just find the next gig, but they have helped build my career.”

See live examples of our refreshing approach to talent management and career placement: http://www.youtube.com/user/advancedclinicaljobs#p/u/7/WCM-KdbGmE4

Advanced Clinical believes that creating positive experiences for candidates is cornerstone to building a vibrant, loyal workforce. Successful talent management positively impacts clinical research companies through lower overhead, more productive teams, and stronger retention of critically needed talent.

To learn more, visit http://www.advancedclinical.com

Writing the Future of Clinical Research

The past several years have seen the rapid growth of the Medical Writing field, with the market more than doubling from an estimated $345 million in 2003 to $694 million in 2008, according to a Centerwatch Monthly report. Membership in the American Medical Writers Association, which sets the profession’s standards, increased 14% in the same time to nearly 5,700 members globally. Additionally, two dozen colleges and universities have recently established either certificate or degree programs in medical or scientific communication. Across the industry, Medical Writers are being highly prized for their ability to communicate scientific data effectively and efficiently, as well as taking on additional roles, such as transnational trial coordination and quality assurance, in the drug development process.

What do Medical Writers do?
Medical Writers both have a thorough background in scientific areas and are adept at communicating this information to various audiences. They perform numerous important functions, including the following:
• Communicate scientific and clinical data to a range of audiences in a wide variety of formats
• Combine scientific knowledge and their research skills to present information for targeted audiences
• Write clinical trial protocols, clinical study reports, and other documents for submission to the FDA
• Prepare journal articles, conference posters/presentations, internet content, and training/marketing materials

Is Medical Writing for me?
Before you consider entering the Medical Writing field, know that there are several key attributes that make the field a fit for individuals:
• Interest in scientific fields and writing
• Excellent written and oral communication skills
• High-level detail orientation
• Good interpersonal skills and “team player” attitude
• Ability to multi-task, learn “on-the-job”, and meet project deadlines

Additionally, Medical Writers are expected to have a level of technical knowledge and skills such as:
• Current scientific writing and editing techniques
• Software and systems, such as document management software, Microsoft Office suite, as well as reference, literature, and publishing software
• Company policies, procedures, and tools
• Industry guidelines
• Scientific area background with statistical knowledge preferred

Who do Medical Writers work for?
• Pharmaceutical companies
• Medical communication agencies
• Contract Research Organizations (CRO)
• Freelance Publishers
• Academic Medical Centers, Medical Associations, Publishers, Magazines, Websites

What are the benefits?
• High involvement with the latest scientific research and information
• Rewarding work that makes a difference
• Can have flexible work hours
• Current high market demand for Medical Writers
• A number of opportunities for career development
• High entry level compensation (~$50-60,000) and employee benefits
• Flexibility to switch jobs

What jobs are available?
Advanced Clinical has a number of exciting Medical Writing opportunities available across a wide range of experience, including:

Senior Medical Writing Program Manager (Oncology) – Northern Suburbs of Chicago, Illinois
One of our clients is seeking a Senior Medical Writing Program Manager (Oncology) also known as Global Medical Writing Lead, generally for early- to mid-stage development global project teams and may act as a back-up/supporting GMWRL for several projects.

The individual will provide:
• Project leadership with respect to program documents and writing activities commensurate with experience
• Review of work and manage/coordinate writing activities across an entire program, and may review and amend the work plans developed by a Document Working Group Facilitator (DWGF; lead medical writer in a working group) for a particular document
• Intellectual leadership and contributes document knowledge and expertise to the project team

Associate Director, Medical Writing – Princeton, New Jersey
A client in the Princeton NJ area is looking to add a permanent Associate Director of Medical Writing to their team.

The individual’s responsibilities include:
• Deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects
• Prepare clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format
• Coordinate and prepare Meeting Content Packages, and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents including clinical study reports, narratives, investigator brochures for Phase I to IV clinical trials, and drug safety related documents such as Periodic Safety Update Reports

Senior Medical Writers/Writing Team Leaders – Worldwide
A client is seeking experienced medical writers to serve as Team Leaders at their office locations around the world.

Team Leaders are strategic consultants, project leaders, and hands-on writers who:
• Serve as subject-matter experts for clients, guiding and advising them on strategies and best practices for achieving approval from health authorities
• Serve as subject-matter experts for team writers, providing leadership, advice, and continual mentoring
• Actively participate in development and writing of documents
• Ensure quality, adherence to budgets and timelines, and compliance with SOPs, policies, and other guidance as required by the company, regulatory bodies, and individual clients

See www.advancedclinical.com

Chart Your Path: Insight from an Accomplished Drug Development Expert

Gil Price – a physician who has worked with some of the largest pharmaceutical companies and has built two companies himself – has critical guidance for individuals charting their career path:

"The best advice I can give to anyone starting out in the life sciences industry, or any industry, is that you must be able to communicate effectively across multiple lines of management. You have to be able to speak to the CEO as well as the janitor. You need to be able to motivate individuals who have zero stake in your success, and get them to perform on your behalf. If you can’t do that, you will not be successful in any line of work."

While education, technical expertise and work style are all vital in a career path, the lack of ability to communicate with co-workers, management, patients, personnel, and/or the public, can leave your career growth unexpectedly stunted.

When involved in clinical trials, a number of critical people are involved on the path to drug development. Not only might there be communication issues, but another major challenge is drug supply, specifically if the drug is hard to manufacture. This means you will need the manufacturing group to collaborate with you on the way to getting the drug produced.

Background and Training Shapes Your Career’s Success

Communication is key, and so is training. Price received training in Big Pharma early in his career. When he was starting out, GlaxoSmithKline (GSK) presented him with an enticing offer to come on board. At GSK, the executive who hired Gil was also a magnificent mentor. Price was placed into a variety of positions that covered all aspects of drug development, manufacturing, basic sciences and regulatory, a type of training that may be difficult to find in a smaller biotech company, often only existing in large pharmaceutical companies. He calls this time of his career "an 11-½ year internship."

After leaving GSK, Price went to work at Quintiles as executive vice president, with an assurance from the CEO to work more with public markets. He worked with clinical trials for four years and, during this time, Quintiles expanded and acquired several companies in Europe. A former colleague from GSK then called him about an opportunity at MedImmune.

Due to his experience at GSK, Price was given the tremendous opportunity to work on multiple product launches and new invitations for old products. He worked on medical affairs in an umbrella department that was largely responsible for all post-marketing activities involved in commercial drug development, post-marketing pharmacovigilance, post-marketing clinical studies, drug information and publication responsibilities.

After MedImmune is when Price carved out his entrepreneurial career. First, he started his own biotechnology company. He pulled a team together and raised money, then 26 months later, sold the company to a private group on the west coast. Next, he started Drug Safety Solutions, for which he is currently owner, providing services to biotechnology and pharmaceutical companies for all aspects of pharmacovigilance.

Insight and Advice to Further Your Career Path

Price has advice for future entrepreneurs: "If you ever want to be entrepreneurial, being part of a small biotechnology company is an important experience to have."

Although barriers are in every career, they are expected, and will vary with each position. A major barrier in this industry, says Price, may be that the world can throw you a curveball: "All of a sudden, you are basing decisions on the idea that a drug is going to work. Sometimes a drug just doesn't work, even if you perform everything appropriately. Of course you try to discover this as early as possible so you can 'kill' a failing drug quickly. By that time, however, you’ve spent millions of dollars, only to see it go up in flames."

What does Price recommend to someone trying to figure out what next steps to take to chart his/her path?

"It is important to reach out to colleagues who have been successful. Communicate with others who fall under your umbrella of interest so that you can understand what a proper path looks like."

There are many individuals, he says, who have limited interaction with the broader community in conferences, such as Association of Clinical Research Professionals (ACRP) meetings. Many focus on meetings in their particular therapeutic area, such as a cardiology conference. However, staying so narrowly focused eliminates the individual from networking with other drug development physicians and professionals.

While you can never over-expand your network, working in the life sciences industry has significant benefits over many other career paths:

"What this path allows you to do is to potentially impact the health of millions. Your career path has the aspect of being intellectually stimulating and cutting edge where you can affect the lives and well being of thousands of patients."

Let Advanced Clinical keep you on track: advance your path to a rewarding career.

See www.advancedclinical.com

Design Your Dream Job Contest: What Should You Expect to Get from your Dream Job?

Common complaints of clinical job positions from GlassDoor.com are: “Lack of personal development opportunities," "lack of career progression within the company," "a lot of talk and no action," "under pay from market rate," and "no incentive to do better.” In addition, several former clinical employees working with CROs and clinical contract staffing companies have stated on Jobvent.com that they are "fed up with back-stabbing and incompetence,” an “unhealthy environment,” and high turnover.

“What Should You Expect?”

The best companies will provide the opportunity to grow your career, challenge yourself and allow you to provide insight and a point of view. The company as well as the job itself should offer a positive and challenging environment to help cultivate your skill set. Here is the top list of things that you should expect when you get a job.

Make a difference.
You should have the chance to make a difference in clinical research, helping bring drugs to market.

Have your ideas heard.
The company should allow you to showcase your expertise to further the Life Sciences field, creating new efficiencies and effectiveness in companies based on experience.

Become a Star.
While working at a company, they should have resources to get your name out there. You should have plenty of opportunities to effectively market yourself and your abilities to the Life Sciences industry

Be CHALLENGED.
Learn new skills and encounter new opportunities with their breadth and depth of available work experiences.

Be Part of a Community.
Beyond just exchanging information with each other, the company should have an elite team and consultant community that collaborates. Look for an extensive alumni program, superior benefits and a comprehensive loyalty program.

Pursue your Dreams.
Make sure you are truly happy at your workplace and can maintain an optimal work and life balance. Accommodating your personal preferences and career goals goes hand in hand.

Grow!
Understand your desired career path and ensure that you have job opportunities that help you build your skills in your desired direction. There should be sufficient intellectual capital that will help you get best practices experience every day.

These seven points were developed and are currently utilized by Advanced Clinical’s “AC Experience” framework for its consultants. We expect our consultants to work at the highest level possible, and we provide them with the opportunity and environment to do so.

So… “What's Your Dream Job?"

World-class Clinical Strategic Sourcing Organization (hybrid CRO and Clinical Contracting solutions), Advanced Clinical, wants you to “design your dream job,” and give us suggestions on how to provide the perfect work environment for clinical consultants. We will not only take requests to heart, but match you with a job as best as we can.

The best entry will win a $200 gift card to any store of his or her choosing, and two runners-up will each win an iPod shuffle.

You can enter by submitting a description of your dream job, a video, or any other creative form.

Design your dream job here.

Enter to win …August 17th is the new date we will choose a winner!

See www.advancedclinical.com

Advancing Discoveries: Regulatory and Risk Decisions in Adaptive Designs

Although adaptive designs produce numerous benefits for clinical trials, there are also a number of risks associated with it. Below, Advanced Clinical outlines some of the key risks when conducting adaptive designs as well as ways people mitigate them. Also are some FDA-accepted designs, including the more well known Bayesian approach.

What are the big, key risks?

One major concern is the effect of adaptive designs on statistical measures. Though addressed broadly, the issue of preservation of type I error rate remains a key issue in adaptive design. Also, changes in sample size, hypotheses, and other statistical measures affect the validity of the outcome data in clinical trials. Logistic concerns include methods on how to collect data. With interim decision making, data must be collected rapidly, and with short follow-up times in order for that data to remain relevant to the current state of the study. The main procedural issue to be followed closely relates to data review, careful decision making, and implementation of decisions during adaptive trials while maintaining trial integrity.

click picture for full view!

How do you mitigate those risks?

To mitigate risks that come with adaptive design, careful planning pre-clinical trial must take place. The right statistical measures must be in place and through simulation, the right statistical changes must be determined in case interim data suggests changes on statistical procedures. During clinical trials, it is recommended to have a Data Monitoring Committee (DMC) to review interim results and determine whether relative changes can be made. Also during trials, the use of clinical technologies such as EDC, IVRS and IWRS as well as light EDC are highly recommended in order to deal with the logistic concern of quick, responsive data analysis.

Some commonly accepted designs approved by the FDA (click picture for full view!)

Bayesian Adaptive Dose Allocation Approach (click picture for full view!)

See www.advancedclinical.com

Advancing Discoveries: Adaptive Designs in Clinical Trials

What is Adaptive?

In the past several decades there has been a recognized trend of increased spending within pharmaceutical, biopharmaceutical, medical device as well as biotechnology research without a proportional increase in success rate of clinical trials - there used to be 8 IDAs for 1 commercial success; now 16 INDs for 1 commercial success. Some of these could be due to diminishing improvement margins for new drugs, unchanging failure rates, escalating costs, and other clinical limitations. By advancing discoveries, Advanced Clinical seeks to determine the most efficient and effective way to conduct clinical trials without decreasing the safety or efficacy of the trial. Adaptive designs have recently become the frontrunner in advancing clinical trials. Adaptive designs are clinical study designs that utilize accumulating clinical data to modify the study as it progresses, without undermining the validity and integrity of the trial. Not all clinical trials are suited for adaptive design. Stay tuned for our next blog post on Adaptive Risk Management, and FDA accepted adaptive designs/regulatory perspectives!

Why do it?

Adaptive clinical designs save resources and increases efficiency of the clinical trial. Greater flexibility within the adaptive design framework can translate into better treatment of patients within trials (stopping ineffective/dangerous doses early), more efficient drug development, and better use of available resources (need for less patients). Adaptive designs are not only advantageous to drug development, but they are ethically beneficial to the patients. Trials can be cut earlier if they are ineffective, thus efficiently and effectively ensuring patients are well served with the appropriate dosages. This is most important not only because the clinical trial can save resources by cutting off ineffective arms, but the trial can also stop harmful treatments early on in order to prevent patient harm and preserve the overall safety of the clinical trial. Adaptive designs for clinical trials provide efficient tools to demonstrate the safety and effectiveness of new medical products in faster timeframes with more certainty, at lower costs, and with better information.

Types of Adaptive Design Options (click picture to view!)

With adaptive study design, there are many design options that affect different aspects of a trial. above are some of the more widely known adaptive options.

What are the Pros and Cons of Adaptive Design? (click picture to view!)

Adaptive designs, though having a lot of advantages, can have some disadvantages as well. Stay tuned for our next blog posting about the risks and regulatory perspectives surrounding adaptive designs.

Also, don't forget to add our facebook page! www.facebook.com/advclinical

See www.advancedclinical.com