ComplianceOnline

Course Description:

Participants will be introduced to major clinical steps and considerations in the new drug development process. Starting with the selection of medically promising molecules, through the execution of major I-IV phases of clinical trials, and ending in clinical profiling for marketing.

The course will address:

  • Standard procedures;
  • New strategies implemented in clinical trials;
  • Selection of clinical investigators, consultants and opinion leaders;
  • Interactions with regulatory agencies in various countries;
  • Impact of regulations on the programs; as well as other common challenges.

Participants will learn about similarities and differences in clinical strategies for standard vs unique molecules, for domestic vs global programs, and for large pharma projects vs small biotech companies.



Learning Objectives:

  • To understand the role of medical input in the selection of potentially therapeutic molecules and their subsequent clinical profiling.
  • To understand and be able to design the most appropriate strategy for a clinical program, including all clinical developmental phases, from IND to NDA/PLA.
  • To understand basic trial methodologies, study execution, monitoring and evaluation processes.
  • To understand the selection of the investigators and consultants in various countries; the criteria for study placement and their cost, as well as the concept of “go no go” clinical decision for the molecule.
  • To become familiar with common challenges and key issues effecting trial designs and their execution in different countries and difficult investigators.
  • To understand how to work with multifunctional and often multicultural teams.
  • To discuss the clinical part of FDA and ICH guidelines and their impact on clinical programs.

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar



Who will Benefit:

  • Junior or new staff of clinical pharmacology and clinical research departments.
  • Pre-clinical, business, legal and marketing professionals who wish to become familiar with the clinical drug development process and the interpretation of clinical data.
  • Investment or licensing community members who are interested in clinical programs, particularly in the process of planning, costs, timing and issues of clinical evolutions and/or profiling of new molecule.
  • Clinical research associates, project managers, research scientists, medical writers, clinical statisticians, junior regulatory personnel, licensing and acquisition staff.
  • Any college graduates who are contemplating careers in clinical research involving the bio-pharma industry.




Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (8:30 AM – 5:00 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time

Morning Session A, 9:00 AM - 12:30 PM

Clinical considerations during preparation and conduct of first clinical trials in humans. Major goals are safety, early activity, and dose finding.

  • Challenges while deciding how and when to start a clinical program.
  • Patients or volunteers?
  • Define primary, disease dependent goals: safety only, or early efficacy, or “proof of concept”, or just PK.
  • Predictability of animal safety and activity to man. Problems with species specificity.
  • Clinically desirable formulations and their challenges.
  • Who decides which molecule goes to clinical Phase I testing. Differences between big pharma and small biotech/startups.
  • Financing issues.
  • Trial site selection and decisions regarding number and type of sites.
  • The targeted profile of a potential drug. Anticipated diseases /symptoms. Is market big or small for specialized diseases /orphan indications.
  • Potential clinical drug/drug interactions.
  • Impact of international/global vs. domestic strategy.
  • Considerations for acquisition and early licensing.
  • Q & A, open discussion forum.

Afternoon Session B, 1:00 PM - 4:30 PM

Phases I and/or I/II and II A or B. Early activity and efficacy. Early safety profile.

  • Are we searching primarily for early activity or already efficacy.
  • Investigator vs company sponsored IND.
  • Preliminary safety considerations. Evaluation and decision regarding acceptability of early side effects.
  • How to accrue/encourage participation of volunteers and/or patients.
  • Clear activity targets or “broad net”.
  • Exploration of one or more clinical indications, cost vs benefit.
  • Typical trial designs vs new approaches.
  • How do we define and explore potentially “effective vs active” doses.
  • Importance of pharmacokinetics in deciding the best dose ranges and regimens.
  • Collaborations with regulatory agencies.
  • Study monitoring.
  • Formulation changes and their impact on clinical trials.
  • Major “go no go” decisions.
  • “End of Phase II” meeting with the FDA and other agencies.
  • Strong suggestion of efficacy in Phase II. The next steps…
  • Q&A, open discussion forum.

Morning Session C, 8:30 AM - 12:30 PM

Providing definitive evidence of efficacy and safety.

  • Selecting most promising medical indications from the results of Phase II.
  • Marketing input into the targeted profile of a potential drug.
  • Agreements with regulatory agencies regarding definitive clinical trials: designs, dose selection, primary endpoints, statistical considerations.
  • Dependence of clinical trial design on disease under study, compassionate follow up programs.
  • How many independent trials are needed.
  • Challenges in the execution of a very large clinical program in a timely and efficient manner. Number and selection of multiple centers. Choice of domestic vs international sites,
  • Basis of investigator selection and importance of multi-center investigator meetings to secure consistency in the program and the pool-ability of results.
  • Impact of differences in local/national medical practices, diagnoses, and protocol compliance.
  • Safety evaluation in the conduct and interpretation of clinical trial conduct and results.
  • Importance of proper monitoring and monitor selection, CRO, and MRO.
  • Implementation of GCP (FDA versus ICH), detecting and dealing with investigator fraud or lack of adherence to the protocol.
  • Challenge of getting proper rate-of-patients-accruals. Methods to increase efficient enrollment and cost.
  • Strategies on dealing with two good, international pivotal trials where one ends up with strongly positive results whilst the other strongly negative.
  • Crucial interactions. Individual, small, or big multi-center meetings with investigators, monitoring consultants, regulatory agencies and opinion leaders.
  • Risk versus benefit consideration.
  • Q&A, open discussion forum.

Afternoon Session D, 1:00 PM to 5:00 PM

Final regulatory submissions. Secondary indications. Marketing support. Special issues.

  • NDA/PLA/Foreign regulatory submissions. Strategies regarding type, timing, electronic vs. old “paper standard”.
  • Advisory Committee clinical presentations.
  • Post approval safety programs.
  • Post approval clinical commitments.
  • Secondary/extended clinical indications. Academia and/or industry.
  • Approved clinical claims vs physician’s decisions on choice of treatment and use of the drug.
  • Safety problems showing up in Phase IV trials or post marketing phases. Late or rare toxicities.
  • Medical aspect of drug pricing issues.
  • Why the cost of clinical R&D —with the extending scope, duration and number of all trials— is rising. Its impact on clinical programs.
  • Q&A, open discussion forum.




Meet Your Instructor

Zofia Dziewanowska MD, PhD
Pharmaceutical Executive /Clinical Research & Regulatory

For over 30 years, Zofia E Dziewanowska MD, PhD, has been in charge of new drug development, including all Phases(I to IV, domestic and international) for big pharma like Merck and Hoffman la Roche, and smaller biotech start-ups like Genta and Ligand. Early in her career, she personally designed and conducted multiple clinical trials. Subsequently, she became the senior Clinical R&D Executive responsible for medical strategies, execution and management of programs which spanned multiple therapeutic areas. Dr. Dziewanowska submitted many successful NDAs. She has also participated in the selection of molecules for clinical development, including their profiling and post approval programs. She presented to regulatory agencies in US and Europe. Her academic affiliations included medical schools and institutes in the US and Europe. She organized numerous professional meetings and educational programs. Presently, she is a senior consultant to the biopharmaceutical industry as a founder and medical director of New Drug Associates.





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